Public Health, Workforce, Quality, and Related Provisions in PPACA: Summary and Timeline

Public Health, Workforce, Quality, and Related Provisions in PPACA: Summary and Timeline
Public Health, Workforce, Quality, and
Related Provisions in ACA: Summary and
Timeline
C. Stephen Redhead, Coordinator
Specialist in Health Policy
Elayne J. Heisler, Coordinator
Analyst in Health Services
May 17, 2013
Congressional Research Service
7-5700
www.crs.gov
R41278
CRS Report for Congress
Prepared for Members and Committees of Congress
Public Health, Workforce, Quality, and Related Provisions in ACA
Summary
In March 2010, President Obama signed into law a comprehensive health reform bill, the Patient
Protection and Affordable Care Act (ACA; P.L. 111-148), and a package of amendments to ACA,
the Health Care and Education Reconciliation Act of 2010 (HCERA; P.L. 111-152). Health
reform was one of President Obama’s top domestic policy priorities during his first term, driven
by concerns about the growing ranks of the uninsured and the unsustainable growth in spending
on health care and health insurance. Improving access to care and controlling rising costs were
seen to require changes to both the financing and delivery of health care. This report—one of a
series of CRS products on ACA, as amended—focuses on the law’s workforce, public health,
health care quality, and related provisions. It includes summaries of these provisions, explores
some of their implications for health policy, and contains an associated timeline.
This report is primarily for reference purposes. The material in it is intended to provide context
to help the reader better understand the intent of ACA’s individual provisions at the time of
enactment. The report does not track or discuss ongoing ACA-related regulatory and other
implementation activities.
ACA includes numerous provisions intended to increase the primary care and public health
workforce, promote preventive services, and strengthen quality measurement, among other
things. It amends and expands many of the existing health workforce programs authorized under
Title VII (health professions) and Title VIII (nursing) of the Public Health Service Act (PHSA);
creates a Public Health Services Track to train health care professionals emphasizing team-based
service, public health, epidemiology, and emergency preparedness and response; and makes a
number of changes to the Medicare graduate medical education (GME) payments to teaching
hospitals, in part to encourage the training of more primary care physicians. The new law also
establishes a national commission to study projected health workforce needs.
In addition, ACA creates an interagency council to promote healthy policies and prepare a
national prevention and health promotion strategy. It establishes a Prevention and Public Health
Fund to boost funding for prevention and public health; increases access to clinical preventive
services under Medicare and Medicaid; promotes healthier communities; and funds research on
optimizing the delivery of public health services. Funding also is provided for maternal and child
health services, including abstinence education and a new home visitation program. ACA also
establishes a national strategy for quality improvement; creates an interagency working group to
advance quality efforts at the national level; develops a comprehensive repertoire of quality
measures; and formalizes processes for quality measure selection, endorsement, data collection,
and public reporting of quality information. It creates and funds a new private, nonprofit
comparative effectiveness research institute.
Other key provisions in ACA include new requirements for the collection and reporting of health
data by race, ethnicity, and primary language to detect and monitor trends in health disparities;
and electronic format and data standards to improve the efficiency of administrative and financial
transactions between health care providers and health plans; programs to prevent elder abuse,
neglect, and exploitation; a new regulatory pathway for licensing biological drugs shown to be
biosimilar or interchangeable with a licensed biologic; new nutrition labeling requirements for
chain restaurant menus and vending machines.
Congressional Research Service
Public Health, Workforce, Quality, and Related Provisions in ACA
Contents
Introduction...................................................................................................................................... 1
Report Overview .............................................................................................................................. 2
Health Centers and Clinics .............................................................................................................. 5
Overview and Impact of ACA ................................................................................................... 5
Sec. 5601. Health Center Appropriations ............................................................................ 6
Sec. 10503. Community Health Center Fund...................................................................... 7
Sec. 4101. School-Based Health Centers ............................................................................ 7
Sec. 5208. Nurse-Managed Health Clinics ......................................................................... 7
Sec. 5606. State Grants to Providers ................................................................................... 8
Sec. 10504. Access to Affordable Care Demonstration ...................................................... 8
Health Workforce ............................................................................................................................. 8
Overview and Impact of ACA ................................................................................................... 8
National Health Service Corps ................................................................................................ 10
Sec. 5207. NHSC Appropriations ..................................................................................... 11
Sec. 10503. Community Health Center Fund.................................................................... 12
Sec. 10501(n). Part-Time Service, Loan Repayment, Teaching........................................ 12
Sec. 5602. Designating Medically Underserved Populations and HPSAs ........................ 12
Sec. 10908. Loan Repayment Tax Exclusion .................................................................... 12
Physician Workforce................................................................................................................ 13
Sec. 5201. Federally Supported Student Loan Funds........................................................ 13
Sec. 5301. Primary Care Training and Enhancement ........................................................ 14
Sec. 5203. Pediatric Specialist Loan Repayment Program ............................................... 14
Sec. 5508(a) and (c). Teaching Health Centers ................................................................. 14
Sec. 10501(l). Rural Physician Training Grants ................................................................ 15
Sec. 10502. Hospital Construction Grants ........................................................................ 16
Dental Workforce..................................................................................................................... 16
Sec. 5303. Training in General, Pediatric, and Public Health Dentistry ........................... 16
Sec. 5304. Alternative Dental Health Care Provider Demonstration ................................ 17
Nursing Workforce .................................................................................................................. 17
Sec. 5202. Nursing Student Loan Program ....................................................................... 18
Sec. 5308. Advanced Nursing Education Grants .............................................................. 18
Sec. 5309. Nurse Education, Practice, and Retention Grants............................................ 18
Sec. 5310. Student Loan Repayment and Scholarship Program ....................................... 19
Sec. 5311. Nurse Faculty Loan Program ........................................................................... 19
Sec. 5312. Authorization of Appropriations ...................................................................... 19
Sec. 5509. Medicare Graduate Nurse Education Demonstration Program ....................... 19
Sec. 5316. Family Nurse Practitioner Demonstration ....................................................... 20
Geriatric and Long-Term Care Workforce............................................................................... 20
Sec. 5302. Training Opportunities for Direct Care Workers ............................................. 20
Sec. 5305(a) and (b). Geriatric Education and Training.................................................... 21
Sec. 5305(c). Geriatric Education and Training ................................................................ 21
Sec. 5507. Health Workforce Demonstrations; Family-to-Family Centers ....................... 21
Sec. 8002(c). Personal Care Attendants ............................................................................ 22
Public Health Workforce ......................................................................................................... 22
Health Workforce Loan Repayment Program ................................................................... 22
Sec. 5206. Public Health Workforce Grants for State and Local Programs ...................... 22
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Public Health, Workforce, Quality, and Related Provisions in ACA
Sec. 5313. Grants for Community Health Worker Programs ............................................ 23
Sec. 5314. Public Health Fellowships ............................................................................... 23
Sec. 5315. United States Public Health Sciences Track .................................................... 23
Sec. 10501(m)(1). Preventive Medicine and Public Health Training Grants .................... 23
Sec. 10501(m)(2). Reauthorization of Public Health Workforce Programs ...................... 24
U.S. Public Health Service (USPHS) Commissioned Corps ................................................... 24
Sec. 5209. Elimination of Cap on USPHS Regular Corps ................................................ 24
Sec. 5210. USPHS Ready Reserve Corps ......................................................................... 24
Workforce Diversity Training .................................................................................................. 25
Sec. 5307. Cultural Competency, Prevention, and Public Health and Individuals
with Disabilities Training ............................................................................................... 25
Sec. 5401. Centers of Excellence ...................................................................................... 26
Sec. 5402. Health Care Professionals Training for Diversity............................................ 26
Sec. 10501(d). Increasing Diversity in Physician Assistant Education ............................. 26
Sec. 5403. Interdisciplinary, Community-Based Linkages ............................................... 26
Sec. 5404. Workforce Diversity Grants ............................................................................. 26
Allied Health Workforce.......................................................................................................... 27
Sec. 5205. Allied Health Workforce Recruitment and Retention Programs...................... 27
Mental and Behavioral Health Workforce ............................................................................... 27
Sec. 5306. Mental and Behavioral Health Education and Training Grants ....................... 27
Health Workforce Evaluation and Assessment ........................................................................ 28
Sec. 5101. National Health Care Workforce Commission ................................................ 29
Sec. 5102. State Health Care Workforce Development Grants ......................................... 29
Sec. 5103. Health Care Workforce Program Assessment .................................................. 29
Sec. 5104. Task Force on Alaska Health Care................................................................... 30
Sec. 5701. Reports............................................................................................................. 30
Medicare GME Payments........................................................................................................ 30
Sec. 5503. Distribution of Additional Residency Positions .............................................. 31
Sec. 5504. Counting Resident Time in Other Settings ...................................................... 32
Sec. 5505. Rules for Counting Resident Time for Non-Patient Care Activities................ 32
Sec. 5506. Preservation of Resident Cap Positions from Closed Hospitals ...................... 32
Prevention and Wellness ................................................................................................................ 33
Overview and Impact of ACA ................................................................................................. 33
Coverage of Clinical Preventive Services ......................................................................... 33
Wellness Programs Provided by Employers and Insurers ................................................. 35
Community-Based Prevention Programs .......................................................................... 36
Prevention in Private Health Insurance ................................................................................... 37
Sec. 1001. Regarding Coverage of Preventive Services ................................................... 37
Sec. 1302. Essential Health Benefits Requirements.......................................................... 37
Prevention Under Medicare ..................................................................................................... 38
Sec. 4103. Medicare Annual Visit and Personalized Prevention Plan............................... 38
Sec. 4104. Removal of Cost-Sharing for Medicare Preventive Services .......................... 38
Sec. 4105. Evidence-Based Coverage of Medicare Preventive Services .......................... 39
Sec. 10501(i)(2). Preventive Services Furnished at FQHCs ............................................. 39
Prevention Under Medicaid ..................................................................................................... 39
Sec. 4106. Medicaid Preventive Services for Adults ........................................................ 39
Sec. 4107. Medicaid Tobacco Cessation Services for Pregnant Women........................... 40
Sec. 4108. Incentives for Chronic Disease Prevention Under Medicaid........................... 40
Wellness Programs .................................................................................................................. 41
Sec. 1001. Reporting Requirements for Group Health Plans/Gun Ownership ................. 41
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Sec. 1201. Regarding Prohibiting Discrimination Based on Health Status....................... 41
Sec. 4303. CDC Grants for Employer-Based Wellness Programs .................................... 42
Sec. 4402. Effectiveness of Federal Health and Wellness Initiatives ................................ 42
Sec. 10408. Workplace Wellness Program Grants ............................................................ 42
Community-Based Prevention Programs ................................................................................ 43
Secs. 3509 and 3511. Offices on Women’s Health ............................................................ 43
Sec. 4001. National Prevention, Health Promotion and Public Health Council ............... 43
Sec. 4002. Prevention and Public Health Fund ................................................................. 43
Sec. 4003. Clinical and Community Preventive Services Task Forces ............................. 44
Sec. 4004. Education and Outreach Campaign Regarding Preventive Benefits ............... 44
Sec. 4102. Oral Health Activities ...................................................................................... 45
Sec. 4201. Community Transformation Grants ................................................................. 45
Sec. 4202. Community Wellness Pilot; Medicare Wellness Evaluation............................ 46
Sec. 4203. Wellness for Individuals with Disabilities ....................................................... 46
Sec. 4204. Immunizations ................................................................................................. 46
Sec. 4206. Demonstration Project Concerning Individualized Wellness Plan .................. 47
Sec. 4301. Research on Optimizing the Delivery of Public Health Services .................... 47
Sec. 4304. Epidemiology and Laboratory Capacity Grants .............................................. 47
Sec. 4306. CHIPRA Childhood Obesity Demonstration Project ...................................... 48
Sec. 10334. Offices of Minority Health ............................................................................ 48
Sec. 10407. Better Diabetes Care ...................................................................................... 48
Sec. 10411. Congenital Heart Disease Programs .............................................................. 49
Sec. 10412. Public Access Defibrillation Programs .......................................................... 49
Sec. 10413. Young Women’s Breast Health Awareness .................................................... 49
Sec. 10501(g). National Diabetes Prevention Program ..................................................... 50
Maternal and Child Health............................................................................................................. 50
Overview and Impact of ACA ................................................................................................. 50
Maternal and Early Childhood Home Visitation ..................................................................... 51
Sec. 2951. Maternal, Infant, and Early Childhood Home Visiting Programs ................... 51
Support for Pregnant and Parenting Teens and Women .......................................................... 51
Secs. 10211-10214. Pregnancy Assistance Fund .............................................................. 51
Postpartum Depression ............................................................................................................ 52
Sec. 2952. Support, Education, and Research for Postpartum Depression ....................... 52
Break Time for Nursing Mothers to Express Breast Milk ....................................................... 53
Sec. 4207. Reasonable Break Time for Nursing Mothers ................................................. 53
Teen Pregnancy Prevention and Adoption Support ....................................................................... 53
Overview and Impact of PPACA ............................................................................................. 53
Personal Responsibility Education and Abstinence Education ............................................... 54
Sec. 2953. Personal Responsibility Education .................................................................. 54
Sec. 2954. Restoration of Funding for Abstinence Education........................................... 55
Adoption Support .................................................................................................................... 55
Sec. 10909. Expansion of Adoption Credit and Adoption Assistance Programs .............. 55
Quality ........................................................................................................................................... 55
Overview and Impact of ACA ................................................................................................. 55
National Strategy to Improve Health Care Quality and Quality Measurement ....................... 58
Sec. 3011. National Strategy ............................................................................................. 58
Sec. 3012. Interagency Working Group on Health Care Quality ...................................... 58
Sec. 3013. Quality Measure Development ........................................................................ 59
Sec. 3014. Quality Measurement ...................................................................................... 59
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Public Health, Workforce, Quality, and Related Provisions in ACA
Sec. 3015. Data Collection; Public Reporting................................................................... 60
Quality Improvement and Patient Safety................................................................................. 61
Sec. 3501. Health Care Delivery System Research; Quality Improvement ...................... 61
Sec. 3508. Quality and Patient Safety Training in Clinical Education .............................. 61
Sec. 10303(b). Hospital-Acquired Conditions .................................................................. 62
Sec. 10303(c). Clinical Practice Guidelines ...................................................................... 62
Care Coordination ................................................................................................................... 63
Sec. 3502. Community Health Teams to Support Medical Homes ................................... 63
Sec. 3503. Medication Management Services in Treatment of Chronic Disease .............. 63
Sec. 3506. Program to Facilitate Shared Decisionmaking ................................................ 63
Sec. 3510. Patient Navigator Program .............................................................................. 64
Sec. 5405. Primary Care Extension Program .................................................................... 64
Sec. 5604. Co-locating Care in Community-Based Mental Health Settings ..................... 65
Sec. 10333. Community-Based Collaborative Care Networks ......................................... 65
Sec. 10410. Centers of Excellence for Depression ........................................................... 65
Nursing Homes and Other Long-Term Care Facilities and Providers ........................................... 66
Overview and Impact of ACA ................................................................................................. 66
Sec. 6101. Disclosure of Owners and Other Parties.......................................................... 67
Sec. 6102. Compliance and Ethics Requirements for Nursing Facilities .......................... 68
Sec. 6103. Nursing Home Compare Medicare Website .................................................... 68
Sec. 6104. Reporting of Expenditures ............................................................................... 68
Sec. 6105. Standardized Complaint Form ......................................................................... 69
Sec. 6106. Ensuring Staffing Accountability .................................................................... 69
Sec. 6107. GAO Study and Report on Five-Star Quality Rating System.......................... 69
Sec. 6111. Civil Money Penalties ...................................................................................... 69
Sec. 6112. National Independent Monitor Demonstration Program ................................. 70
Sec. 6113. Notification of Facility Closure ....................................................................... 70
Sec. 6114. Culture Change and Information Technology Demonstrations ....................... 71
Sec. 6121. Dementia and Abuse Prevention Training ....................................................... 71
Sec. 6201. Background Checks on Employees of Long-Term Care Facilities.................. 71
Comparative Effectiveness Research ............................................................................................. 72
Overview and Impact of ACA ................................................................................................. 72
Secs. 6301 and 10602. Patient-Centered Outcomes Research .......................................... 73
Sec. 6302. Federal Coordinating Council for Comparative Effectiveness Research ........ 74
Health Data Collection................................................................................................................... 75
Overview and Impact of ACA ................................................................................................. 75
Sec. 4302. Health Disparities Data Collection and Analysis............................................. 76
Sec. 5605. Key National Indicators ................................................................................... 77
Sec. 10407(c). Vital Statistics............................................................................................ 78
Health Information Technology ..................................................................................................... 78
Overview and Impact of ACA ................................................................................................. 78
Sec. 1104. Administrative Simplification: Operating Rules.............................................. 80
Sec. 10109. Administrative Simplification: Additional Standards; ICD-10 ...................... 81
Sec. 1561. Standards for Enrollment in Federal and State Programs ................................ 81
Emergency Care ............................................................................................................................. 82
Overview and Impact of ACA ................................................................................................. 82
Sec. 3504. Regionalized Systems for Emergency Care .................................................... 83
Sec. 3505. Trauma Care Centers ....................................................................................... 83
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Sec. 5603. Emergency Medical Services for Children ...................................................... 84
Pain Care Management .................................................................................................................. 85
Overview and Impact of ACA ................................................................................................. 85
Sec. 4305. Advancing Research and Treatment for Pain Care Management .................... 85
Elder Justice ................................................................................................................................... 86
Overview and Impact of ACA ................................................................................................. 86
Sec. 6703. Elder Justice..................................................................................................... 87
Biomedical Research and Medical Products.................................................................................. 91
Overview and Impact of ACA ................................................................................................. 91
Biomedical Research ............................................................................................................... 92
Sec. 9023. Qualifying Therapeutic Discovery Project Credit ........................................... 92
Sec. 10409. Cures Acceleration Network.......................................................................... 93
FDA Requirements for Medical Products ............................................................................... 94
Sec. 3507. Presentation of Prescription Drug Benefit and Risk Information .................... 94
Sec. 10609. Labeling Changes .......................................................................................... 94
Revenue Provisions Related to FDA-Regulated Products....................................................... 94
Sec. 9008. Annual Fee for Brand Name Pharmaceuticals ................................................. 94
HCERA Sec. 1405 (repeals ACA Secs. 9009, 10904). Medical Device Tax .................... 95
Sec. 10907 (nullifies Sec. 9017). Excise Tax on Indoor Tanning Services ....................... 95
Biosimilars ..................................................................................................................................... 96
Overview and Impact of ACA ................................................................................................. 96
Sec. 7001. Short Title ........................................................................................................ 97
Sec. 7002. Approval Pathway for Biosimilar Biological Products ................................... 97
Sec. 7003. Savings ............................................................................................................ 98
Nutrition Labeling ......................................................................................................................... 98
Overview and Impact of ACA ................................................................................................. 98
Sec. 4205. Nutrition Labeling of Restaurant Menus and Food Sold in Vending
Machines ........................................................................................................................ 99
340B Drug Pricing ......................................................................................................................... 99
Overview and Impact of ACA ................................................................................................. 99
Sec. 7101. Expanded Participation in 340B Program ..................................................... 100
Sec. 7102. Improvements to 340B Program Integrity ..................................................... 101
Sec. 7103. GAO Study on Improving the 340B Program ............................................... 101
Medical Malpractice and Liability Reform.................................................................................. 101
Overview and Impact of ACA ............................................................................................... 101
Secs. 6801 and 10607. Medical Malpractice and Liability Reform ................................ 102
Sec. 10608. Liability Protection for Free Clinics ............................................................ 103
Tables
Table 1. ACA Titles and Relevant CRS Reports .............................................................................. 3
Table A-1. ACA Provisions Amended or Struck by ACA Title X and/or HCERA ...................... 104
Table B-1. Timeline of Public Health, Workforce, Quality, and Related ACA Provisions .......... 106
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Appendixes
Appendix A. ACA Provisions Amended or Struck by ACA Title X and/or HCERA .................. 104
Appendix B. Timeline of Public Health, Workforce, Quality, and Related ACA Provisions ...... 105
Appendix C. Acronyms Used in the Report................................................................................. 126
Contacts
Author Contact Information......................................................................................................... 128
Acknowledgments ....................................................................................................................... 128
Key Policy Staff ........................................................................................................................... 129
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Public Health, Workforce, Quality, and Related Provisions in ACA
Introduction
On March 23, 2010, President Obama signed into law a comprehensive health reform law, the
Patient Protection and Affordable Care Act (ACA).1 The following week, on March 30, 2010, the
President signed the Health Care and Education Reconciliation Act of 2010 (HCERA), which
amended numerous health care and revenue provisions in ACA.2
Among its many provisions, ACA restructures the private health insurance market, sets minimum
standards for health coverage, and, beginning in 2014, will require most U.S. residents to obtain
health insurance coverage or pay a penalty. The law provides for the establishment by 2014 of
state-based health insurance exchanges for the purchase of private health insurance. Qualifying
individuals and families will be able to receive federal subsidies to reduce the cost of purchasing
coverage through the exchanges.
In addition to expanding private health insurance coverage, ACA requires state Medicaid
programs to expand coverage to all eligible nonelderly, non-pregnant individuals under age 65
with incomes up to 133% of the federal poverty level (FPL). Under ACA, the federal government
will initially cover 100% of the expansion costs, phasing down to 90% of the costs by 2020.
Medicaid law allows the Secretary of Health and Human Services (HHS) to withhold existing
federal Medicaid matching funds if states refuse to comply with the expansion. However, in
National Federation of Independent Business v. Sebelius, the U.S. Supreme Court found that the
Medicaid expansion violated the Constitution by threatening states with the loss of their existing
federal Medicaid matching funds.3 The Court precluded the HHS Secretary from penalizing states
that choose not to participate in the Medicaid expansion (see text box).
ACA also amends the Medicare program in an effort to reduce the rate of its projected growth;
imposes an excise tax on insurance plans found to have high premiums; and makes many other
changes to the tax code, Medicare, Medicaid, and the State Children’s Health Insurance Program
(CHIP). In addition to changes to private insurance and these federal health programs, ACA
includes numerous provisions intended to increase the primary care and public health workforce,
promote preventive services, and strengthen quality measurement, among other things.
ACA is projected to have a significant impact on federal direct spending and revenues. The law
includes direct spending to subsidize the purchase of health insurance coverage through the
exchanges, as well as increased outlays for the expansion of state Medicaid programs. ACA also
includes numerous mandatory appropriations that provide billions of dollars to fund temporary
programs to increase access and funding for targeted groups, provide funding to states to plan and
1
P.L. 111-148, 124 Stat. 119. During the year-long legislative debate on health care reform, the House and the Senate
passed separate health reform bills. On November 7, 2009, the House voted 220-215 to approve the Affordable Health
Care for America Act (H.R. 3962). The Senate passed its own health reform legislation, the Patient Protection and
Affordable Care Act (H.R. 3590, as amended), on December 24, 2009, by a vote of 60-39. On March 21, 2010, the
House voted 219-212 to approve the Senate-passed bill, clearing it for the President’s signature.
2
P.L. 111-152, 124 Stat. 1029. Note that several other bills that were subsequently enacted during the 111th and 112th
Congresses made more targeted changes to specific ACA provisions. All references to ACA in this report refer to the
law as amended by HCERA, unless otherwise specified.
3
NFIB v. Sebelius, No. 11-393, slip op. (June 28, 2012), available at http://www.supremecourt.gov/opinions/11pdf/11393c3a2.pdf.
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Public Health, Workforce, Quality, and Related Provisions in ACA
establish exchanges, and support many other research and demonstration programs and
activities.4 The costs of expanding public and private health insurance coverage and other
spending are offset by revenues from new taxes and fees, and by savings from payment and
health care delivery system reforms designed to slow the growth in spending on Medicare and
other federal health care programs.
U.S. Supreme Court Decision on ACA (June 28, 2012)
In National Federation of Independent Business v. Sebelius (NFIB), the Court ruled on the constitutionality of both the
individual mandate, which requires most U.S. residents (beginning in 2014) to carry health insurance or pay a penalty,
and the Medicaid expansion. The Court upheld the individual mandate as a constitutional exercise of Congress’s
authority to levy taxes. The penalty is to be paid by taxpayers when they file their tax returns and enforced by the
Internal Revenue Service.
In a separate opinion, the Court found that compelling states to participate in the ACA Medicaid expansion—which
the Court determined to be essentially a new program—or risk losing their existing federal Medicaid matching funds
was coercive and unconstitutional under the Spending Clause and the Tenth Amendment. The Court’s remedy for
this constitutional violation was to prohibit HHS from penalizing states that choose not to participate in the
expansion by withholding any federal matching funds for their existing Medicaid programs. However, if a state accepts
the new ACA expansion funds (initially a 100% federal match), it must abide by all the expansion coverage rules.
Under NFIB, all other provisions of ACA remain fully intact and operative. For more information, see CRS Report
R42698, NFIB v. Sebelius: Constitutionality of the Individual Mandate, by Erika K. Lunder and Jennifer Staman, and CRS
Report R42367, Medicaid and Federal Grant Conditions After NFIB v. Sebelius: Constitutional Issues and Analysis, by Kenneth
R. Thomas.
Implementing ACA also is likely to affect discretionary spending, which is provided in and
controlled by annual appropriations acts. The law established numerous new discretionary grant
programs and provided for each an authorization of appropriations. It also reauthorized funding
for many existing discretionary grant
This report is primarily for reference purposes. The
programs. While the authorizations of
material in it is intended to provide context to help the
appropriations for most of these existing
reader better understand the intent of ACA’s individual
programs expired prior to ACA’s
provisions at the time of enactment. The report does not
enactment, typically they continued to
track or discuss ongoing ACA-related regulatory and
other implementation activities. Each section of the
receive an annual appropriation. Funding
report includes a text box listing more recent CRS
for all these discretionary programs, both
products on ACA implementation as well as other
new and existing, is subject to action by
important publications and reports.5
6
congressional appropriators.
Report Overview
This report—one in a series of CRS products summarizing ACA that were issued after the law’s
enactment—describes the law’s workforce, public health, quality, and related provisions. ACA is
composed of 10 titles (see Table 1). The provisions summarized in this report are for the most
4
For a summary of all ACA’s mandatory appropriations, including details of the obligation of these funds, see CRS
Report R41301, Appropriations and Fund Transfers in the Patient Protection and Affordable Care Act (ACA), by C.
Stephen Redhead.
5
CRS products on ACA and its implementation are available at http://www.crs.gov.
6
For a summary of all ACA’s discretionary spending provisions, including details of annual appropriations since the
law’s enactment, see CRS Report R41390, Discretionary Spending in the Patient Protection and Affordable Care Act
(ACA), coordinated by C. Stephen Redhead.
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Public Health, Workforce, Quality, and Related Provisions in ACA
part found in Title II (Medicaid, maternal and child health); Title III (Medicare, quality of care);
Title IV (prevention and wellness); Title V (health workforce); Title VI (comparative
effectiveness research, elder justice); Title VII (drugs and biologics); and Title IX (revenues).
Title X, which was added as a manager’s amendment to the underlying bill, amended (and in
some cases repealed) numerous existing provisions in Titles I through IX and added several new
provisions. As already noted, ACA was further amended by the companion reconciliation
legislation, HCERA. Table A-1 in Appendix A at the end of the report, shows which of the ACA
sections discussed in this report were amended by Title X and/or HCERA.7
Table 1. ACA Titles and Relevant CRS Reports
ACA Title
Title 1–Quality, Affordable
Health Care for All
Americans
Topic
Private Insurance
Relevant CRS Reports
CRS Report R42069, Private Health Insurance Market
Reforms in the Patient Protection and Affordable Care Act
(ACA), by Annie L. Mach and Bernadette Fernandez.
CRS Report R42663, Health Insurance Exchanges Under the
Patient Protection and Affordable Care Act (ACA), by
Bernadette Fernandez and Annie L. Mach; CRS Report
R41166, Grandfathered Health Plans Under the Patient
Protection and Affordable Care Act (ACA), by Bernadette
Fernandez.
Title II–Role of Public
Programs
Medicaid and CHIP;
Maternal and Child
Health
CRS Report R41210, Medicaid and the State Children’s
Health Insurance Program (CHIP) Provisions in ACA: Summary
and Timeline, by Evelyne P. Baumrucker et al. and this
report.
Title III–Improving the
Quality and Efficiency of
Health Care
Medicare; Quality
Discussed in this report and CRS Report R41196,
Medicare Provisions in the Patient Protection and Affordable
Care Act (PPACA): Summary and Timeline, coordinated by
Patricia A. Davis.
Title IV–Prevention of
Chronic Disease and
Improving Public Health
Prevention and
Wellness
Discussed in this report and CRS Report R40978,
Medicare Coverage of Clinical Preventive Services, by Sarah A.
Lister and Kirsten J. Colello.
Title V–Health Care
Workforce
Health Workforce
Discussed in this report.
Title VI–Transparency and
Program Integrity
Program integrity
provisions including
physician ownership of
hospitals; nursing
homes; Medicare and
Medicaid fraud-related
provisions; elder
justice; and
comparative
effectiveness research.
Medicare-related provisions discussed in CRS Report
R41196, Medicare Provisions in the Patient Protection and
Affordable Care Act (PPACA): Summary and Timeline,
coordinated by Patricia A. Davis; Medicaid-related
provisions discussed in CRS Report R41210, Medicaid and
the State Children’s Health Insurance Program (CHIP)
Provisions in ACA: Summary and Timeline, by Evelyne P.
Baumrucker et al.; nursing home changes; elder justice
and comparative effectiveness research are discussed in
this report.
Title VII–Improving Access
to Innovative Medical
Therapies
Prescription drugs and
Biologics
Discussed in this report.
7
The full text of ACA, as amended by HCERA and other legislation enacted during the 111th and 112th Congresses (see
footnote 2), is available at http://www.house.gov/legcoun/Comps/PPAACA_BEL.pdf.
Congressional Research Service
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Public Health, Workforce, Quality, and Related Provisions in ACA
ACA Title
Topic
Relevant CRS Reports
Title VIII–CLASS Acta
Creation of the
Community Living
Assistance Services and
Supports Program
CRS Report R40842, Community Living Assistance Services
and Supports (CLASS): Overview and Summary of Provisions,
by Kirsten J. Colello and Janemarie Mulvey.
Title IX–Revenue Provisions
Amendments to the tax
code and changes in
taxes for health care
providers and health
insurance providers.
CRS Report R41128, Health-Related Revenue Provisions in
the Patient Protection and Affordable Care Act (ACA), by
Janemarie Mulvey.
Title X–Strengthening
Quality, Affordable Health
Care for All Americans
Amendments to Titles
I-IX; Indian Health Care
Improvement
Amendments are discussed in the reports covering each
title. CRS Report R41630, The Indian Health Care
Improvement Act Reauthorization and Extension as Enacted by
the ACA: Detailed Summary and Timeline, by Elayne J.
Heisler and CRS Report R41152, Indian Health Care:
Impact of the Affordable Care Act (ACA), by Elayne J. Heisler.
Source: CRS Analysis of the ACA.
a.
This title was repealed by the American Tax Payer Relief Act of 2010 (P.L. 112-240); see CRS Report
R42944, Medicare, Medicaid, and Other Health Provisions in the American Taxpayer Relief Act of 2012,
coordinated by Jim Hahn.
The summaries of the ACA provisions are grouped and discussed under the following section
headings: (1) Health Centers and Clinics; (2) Health Workforce; (3) Prevention and Wellness; (4)
Maternal and Child Health; (5) Teen Pregnancy Prevention and Adoption Support; (6) Quality;
(7) Nursing Homes and Other Long-Term Care Facilities and Providers; (8) Comparative
Effectiveness Research; (9) Health Data Collection; (10) Health Information Technology; (11)
Emergency Care; (12) Pain Care Management; (13) Elder Justice; (14) Biomedical Research and
Medical Products; (15) Biosimilars; (16) Nutrition Labeling; (17) 340B Drug Pricing; and (18)
Medical Malpractice and Liability Reform. Each section of the report begins with a brief
overview of the ACA provisions to be summarized and includes some discussion of relevant
policies in place at the time of ACA’s enactment as well as the intent, and, where available,
projected impact, of the law.
ACA specifies numerous dates for new or expiring legal authorities, for the initiation or
completion of key administrative and regulatory activities, and for the establishment or
termination of commissions and other statutory bodies. Table A-1in Appendix A provides a
detailed timeline of all such dates. Unless otherwise stated, all references in this report to “the
Secretary” refer to the Secretary of Health and Human Services (HHS). A list of all the acronyms
used in the report is provided in Appendix B.
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Health Centers and Clinics
Overview and Impact of ACA
PHSA Sec. 330 authorizes the health centers program, administered by the Health Resources and
Services Administration (HRSA), which provides grants to community health centers, migrant
health centers, health centers for the homeless,
and health centers for residents of public
Health Centers
housing. Health centers are a key component of
CRS Report R42433, Federal Health Centers, by Elayne
the nation’s health care safety net and are
J. Heisler.
required to furnish comprehensive and
U.S. Government Accountability Office, Health Center
affordable primary care to the community
Program: Improved Oversight Needed to Ensure Grantee
residents they serve. Health centers also often
Compliance with Requirements, 12-546, May 2012,
provide case management, health education, and
http://www.gao.gov/products/GAO-12-546.
other supportive services to meet the needs of
U.S. Government Accountability Office, Health Center
their patients. Health centers must be located in
Program: Improved Oversight Needed to Ensure Grantee
(or serve) medically underserved communities or Compliance with Requirements, 12-546, May 2012,
http://www.gao.gov/products/GAO-12-546.
populations. Approximately half of all health
centers serve rural populations. In order to
U.S. Government Accountability Office, Hospital
ensure that services are accessible to the entire
Emergency Departments: Health Center Strategies that
May Help Reduce Their Use, GAO-11-414R, April 11,
community, health centers must treat all patients
2011, http://www.gao.gov/products/GAO-11-414R.
without regard to their ability to pay. Centers
U.S. Government Accountability Office, School-Based
offer sliding-scale fee arrangements based on
Health Centers: Available Information on Federal Funding,
patients’ financial circumstances. Prior to the
11-18R, October 8, 2010,
ACA, there were more than 1,100 health centers
http://www.gao.gov/products/GAO-11-18R.
operating over 7,500 service delivery sites in
U.S. Government Accountability Office, Medicare
every U.S. state and territory. According to
Payments to Federally Qualified Health Centers, GAO-10HRSA, in FY2008 these facilities served more
576R, July 30, 2010,
than 17 million unique patients and responded to
http://www.gao.gov/products/GAO-10-576R.
over 67 million patient visits.8 A substantial body
of evidence shows that health centers increase
access to primary health care services. This helps improve the health of the community by
lowering infant mortality, reducing racial and ethnic disparities in health and increasing access to
health care, and lowering spending by averting more expensive emergency room visits.9
At the time of enactment some thought that health centers could provide access to care to those
who would become newly insured under the ACA. ACA provides a total of $11 billion in
supplemental funding for community health centers over the five-year period FY2011 through
FY2015.10 The law creates a multi-billion Community Health Center Fund, from which the
Secretary is required to transfer $9.5 billion for center operations and patient services. A separate
8
For more information on the health center program, including current data on the number of delivery sites, see
http://bphc.hrsa.gov.
9
Research on outcomes associated with health centers is discussed in CRS Report R42433, Federal Health Centers, by
Elayne J. Heisler.
10
From FY2011 through FY2013, the Community Health Center Fund has not been used to supplement health center
appropriations; rather, annual appropriations for health centers have been reduced and partially supplanted by CHCF
funds. See discussion in CRS Report R42433, Federal Health Centers, by Elayne J. Heisler.
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Public Health, Workforce, Quality, and Related Provisions in ACA
appropriation provides the remaining $1.5 billion, which is for health center construction and
renovation. These ACA funds add to the $2 billion in FY2009 supplementary funds that were
provided for the health centers program in the American Recovery and Reinvestment Act
(ARRA; P.L. 111-5). The ARRA funds included $1.5 billion for health center construction and
renovation, and $500 million for center operations and patient services.11 In addition to the
supplemental appropriations, ACA increases the amounts authorized to be appropriated for health
centers under the regular annual appropriations process and permanently authorizes the health
centers program. The program had been authorized through the end of FY2012.
ACA also appropriates funds for a grant program to establish school-based health centers
(SBHCs) and authorizes grants for the operation of such centers. SBHCs are not explicitly
authorized in the PHSA, but have been established pursuant to the general authority to establish
community health centers.12 Another ACA provision establishes a grant program to fund the
operation of nurse-managed health clinics to provide primary health care to vulnerable and
underserved populations. Funding for this program is subject to future action in annual
appropriations bills.
Two additional ACA provisions are summarized at the end of this section. Neither specifically
mentions health centers or clinics, though both address access to care among the medically
underserved. The first authorizes state grants to health care providers who treat the medically
underserved, and the second creates a state demonstration program to provide the uninsured with
access to health care.
Sec. 5601. Health Center Appropriations
This section amends PHSA Sec. 330 by authorizing to be appropriated for the health center
program the following amounts: $2,988,821,592 for FY2010; $3,862,107,440 for FY2011;
$4,990,553,440 for FY2012; $6,448,713,307 for FY2013; $7,332,924,155 for FY2014; and
$8,332,924,155 for FY2015. For FY2016 and subsequent fiscal years, the amount authorized to
be appropriated for that year is to be based on a specified formula that takes into account the
preceding year’s appropriation, the per patient costs, and increases in the number of patients
served by the health centers program.
Nothing in this section prevents a community health center (CHC) from contracting with
specified entities for the delivery of primary health care services that are available at such entities
to individuals who would otherwise be eligible for free or reduced-cost care if that individual
were able to obtain that care at the CHC. Such services may be limited in scope to the primary
health care services available at the facility. In order to receive funds under such a contract, the
clinic/hospital may not discriminate on the basis of an individual’s ability to pay and must
establish a sliding fee scale for low-income patients.
11
For more information on ARRA funding for health centers, see CRS Report R40181, Selected Health Funding in the
American Recovery and Reinvestment Act of 2009, coordinated by C. Stephen Redhead.
12
See discussion in U.S. Government Accountability Office, School-Based Health Centers: Available Information on
Federal Funding, 11-18R, October 8, 2010, http://www.gao.gov/assets/100/97141.pdf.
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Public Health, Workforce, Quality, and Related Provisions in ACA
Sec. 10503. Community Health Center Fund
This section, as amended by HCERA Sec. 2303, establishes a Community Health Center Fund
and appropriates a total of $11 billion over the five-year period FY2011 through FY2015 to the
fund. The following amounts are to be transferred from the fund to increase funding, over the
FY2008 level, for health center operations and patient services: $1 billion for FY2011; $1.2
billion for FY2012; $1.5 billion for FY2013; $2.2 billion for FY2014; and $3.6 billion for
FY2015. Funds are to remain available until expended. The section also appropriates $1.5 billion
for health center construction and renovation for the period FY2011 through FY2015, to remain
available until expended.
Sec. 4101. School-Based Health Centers
Subsection 4101(a) requires the Secretary to create a grant program for the establishment of
SBHCs. To receive a grant, an SBHC or a sponsoring facility of an SBHC must agree to use grant
funds for certain specified purposes including facility construction, expansion, and equipment.
SBHCs are prohibited from using funds for personnel or to provide health services. The Secretary
is required to give preference to SBHCs that serve a large population of children eligible for the
Medicaid and CHIP programs. The section appropriates, out of Treasury funds not otherwise
appropriated, $50 million for each of FY2010 through FY2013, to remain available until
expended.
Subsection 4101(b), as amended by ACA Sec. 10402(a), creates a new PHSA Sec. 399Z-1,
School-Based Health Centers, requiring the Secretary to award grants for the operating costs of
SBHCs. To receive a grant, an SBHC must meet certain specified criteria, unless granted a waiver
for a specified time period, match 20% of the grant amount from non-federal sources unless
granted a waiver by the Secretary, agree to use grant funds for certain specified purposes
(including equipment, training, and personnel salaries), and agree to use grant funds to
supplement and not supplant funds received from other sources. SBHCs are required to provide
only age-appropriate services and are prohibited from providing abortion services and from
providing services to minors without parental or guardian consent. Entities that are in violation of
state reporting and parental notification laws, and entities receiving funding under PHSA Sec. 330
that would overlap with the SBHC grant period are prohibited from receiving funds under this
section. The Secretary is authorized to give preference to applicants who demonstrate ability to
serve communities with specified barriers to access. In addition, the Secretary is authorized to
consider whether an applicant received a grant under this section to establish an SBHC. The
section authorizes to be appropriated SSAN for each of FY2010 through FY2014.
Sec. 5208. Nurse-Managed Health Clinics
This section creates a new PHSA Sec. 330A-1, Nurse-Managed Health Clinics, requiring the
Secretary to establish a grant program to fund the operation of Nurse-Managed Health Clinics
(NMHCs) that provide comprehensive primary health care and wellness services to vulnerable or
underserved populations. To be eligible to receive a grant, an NMHC must submit an application
to the Secretary containing assurances that (1) nurses are a major provider of services at the
NMHC, (2) the NMHC will provide care to all patients regardless of income or insurance status,
and (3) the NMHC will establish a community advisory committee where the majority of
members are individuals served by the NMHC. When determining grant amounts, the Secretary is
required to take into account the financial need of the NMHC, including other funding sources
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Public Health, Workforce, Quality, and Related Provisions in ACA
available to the NMHC, and other factors determined appropriate by the Secretary. The section
authorizes to be appropriated $50 million for FY2010, and SSAN for each of FY2011 through
FY2014.
Sec. 5606. State Grants to Providers
This section, as added by ACA Sec. 10501(k), authorizes states to award grants to health care
providers who treat a high percentage of the medically underserved or other special populations.
Funds allocated to the Medicare, Medicaid, and Tricare programs may not be used to award
grants or administer the grant program.
Sec. 10504. Access to Affordable Care Demonstration
This section requires the Secretary, within six months of enactment, to establish a three-year
demonstration project in up to 10 states to provide access to comprehensive health care services
to the uninsured at reduced fees. Each state may receive up to $2 million. There are authorized to
be appropriated SSAN to carry out the demonstration.
Health Workforce
Overview and Impact of ACA
Health workforce policy is an important component of health care reform. Transforming the
nation’s health care delivery system—from one focused on fragmented specialty care for acute
illness to one that places more emphasis on primary care, disease prevention, and the coordination
and management of care for chronic illness across settings—will require significant changes in
health workforce education and training. Health policy experts are concerned about the current
size, specialty mix, and geographic distribution of the healthcare workforce. Certain geographic
areas, such as inner cities and rural areas, experience significant healthcare provider shortages.
HRSA, which administers most of the federal health workforce programs, estimated that, prior to
ACA, an additional 7,000 physicians would be needed in federally designated health professional
shortage areas (HPSAs).13 Existing health care provider shortages are projected to increase based
on growing patient demand for services. HRSA estimates that by 2020 there will shortages in a
number of physician specialties and nearly 67,000 too few primary care physicians. Additionally,
a federal advisory group on the nursing workforce estimates that as of 2000 there was a 6%
shortage of nurses and that this shortage is expected to grow to 20% in 2020.14 Enactment of ACA
is likely to further exacerbate health workforce shortages as the newly insured seek health care
services.15
13
U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health
Professions, Physician Supply and Demand: Projections to 2020, October 2006. Note that areas designated as health
professions shortage areas are eligible for a number of federally supported health workforce programs. Physician
shortages and general supply issues are discussed in CRS Report R42029, Physician Supply and the Affordable Care
Act, by Elayne J. Heisler.
14
National Advisory Council on Nursing Education and Practice (NACNEP), Fifth Report to the Secretary of Health
and Human Services and Congress, Meeting Held April 2005, December 2007, ftp://ftp.hrsa.gov/bhpr/nursing/fifth.pdf.
15
Michael J. Dill and Edward S. Salsberg, The Complexities of Physician Supply and Demand: Projections Through
(continued...)
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Public Health, Workforce, Quality, and Related Provisions in ACA
The federal government has a long-standing role in the education and training of the health
workforce. PHSA Title VII supports health professions workforce development—including the
education and training of physicians, dentists, physician assistants, and public health workers—
through grants, scholarships, and loan repayment. Title VII includes a number of programs to
support physician training in primary care, including training in rural or otherwise underserved
areas, and student loan repayment
programs to encourage medical
Health Workforce
students to enter primary care. Some
researchers have found that Title VII
CRS Report R42029, Physician Supply and the Affordable Care Act, by
Elayne J. Heisler.
programs increase the number of
primary providers and the primary
CRS Report R42880, Physician Practices: Background, Organization, and
care competency of the physician
Market Consolidation, by Suzanne M. Kirchhoff.
workforce as a whole.16 Title VII also Council on Graduate Medical Education, Twentieth Report,
includes programs to encourage
Advancing Primary Care, Rockville, MD, December 2010
racial and ethnic diversity in the
Institute of Medicine, The Future of Nursing: Leading Change, Advancing
health care workforce. In the early
Health, Washington, DC, October 5, 2010.
1970s, annual funding for Title VII
Institute of Medicine, The Mental Health and Substance abuse
programs reached over $2.5 billion
Workforce for Older Adults: In Whose Hands? Washington, DC., July
(in 2009 dollars); in recent years, it
10, 2012.
has been about $200 million.
Health Resources and Services Administration, Strategies for
Enumerating the U.S. Government Public Health Workforce, Rockville,
MD, February 2012.
ACA reauthorizes and expands
numerous existing PHSA health
Health Resources and Services Administration, The Registered Nurse
workforce programs. The law also
Population: Findings from the 2008 National Sample Survey of Registered
creates several new PHSA workforce
Nurses, Rockville, MD, September 2010.
programs to increase training
Health Resources and Services Administration, Negotiated
experiences in primary care, in rural
Rulemaking Committee on the Designation of Medically Underserved
areas, and in community-based
Populations and Health Professional Shortage Areas: Final Report to the
Secretary, Rockville, MD, October 31, 2011.
settings. Research has found that
location and experience during
National Governors Association, The Role of Nurse Practitioners in
residency training is an important
Meeting Increasing Demand for Primary Care, Washington, DC,
December 20, 2012.
factor in determining future
practice.17 ACA includes programs
that provide training opportunities and fellowships to increase the supply of other types of
providers with identified shortages such as pediatric subspecialists, public health workers, and
geriatricians. Finally, ACA modifies Medicare graduate medical education (GME) payment
policy. Medicare subsidizes medical residency training through GME payments to teaching
hospitals. ACA’s changes to GME payments, along with a new health center grant program and a
number of other provisions, are intended to promote primary care training in nonhospital settings.
(...continued)
2025, Association of American Medical Colleges, Washington, DC, November 2008.
16
Robert L. Phillips, Jr. et al., Specialty and Geographic Distribution of the Physician Workforce: What Influences
Medical Student & Resident Choices? Robert Graham Center, Washington, DC, March 2, 2009.
17
U.S. Government Accountability Office, Graduate Medical Education: Trends in Training and Student Debt, 09438R, May 4, 2009; Howard K. Rabinowitz, James J. Diamond, Fred W. Markham, et al., “Critical Factors for
Designing Programs to Increase the Supply and Retention of Rural Primary Care Physicians,” Journal of the American
Medical Association, vol. 286, no. 9 (September 5, 2001), pp. 1041-1048; and Carl G. Morris, Brian Johnson, and Sara
Kim, et al., “Training Family Physicians in Community Health Centers: A Health Workforce Solution,” Health
Services Research, vol. 40, no. 4 (April 2008), pp. 271-276.
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Public Health, Workforce, Quality, and Related Provisions in ACA
The summaries of the ACA health workforce provisions that follow are grouped as follows: (1)
National Health Service Corps; (2) physician workforce; (3) dental workforce; (4) nursing
workforce; (5) geriatric and long-term care workforce; (6) public health workforce; (7) U.S.
Public Health Service Commissioned Corps; (8) workforce diversity training; (9) allied health
workforce; (10) mental and behavioral health workforce; (11) health workforce evaluation and
assessment; and (12) Medicare GME payments. Each of these sections begins with some
additional background and discussion of the impact of ACA’s provisions.
National Health Service Corps
PHSA Title III authorizes the National Health Service Corp (NHSC) program, which provides
scholarships and student loan repayments for medical students, nurse practitioners, physician
assistants, and others who agree to a period of service as a primary care provider in full-time
clinical practice in a federally designated HPSA—a geographic area, population group, medical
facility, or other public facility that the Secretary has designated as having an inadequate supply
of qualified health care providers (such as physicians, dentists, mental health providers or other
health care providers). NHSC clinicians may fulfill their service commitments in health centers,
rural health clinics, public or nonprofit medical facilities, or within other community-based
systems of care. The NHSC serves as a major source of providers for health centers. HRSA
estimates that more than half of NHSC clinicians fulfill their service commitment in a health
center.18 However, there is far more demand for NHSC clinicians than supply. There are also
many more clinicians interested in scholarships or loan repayment opportunities than can be met
under the program’s budget.19
ACA provides a total of $1.5 billion in supplemental funding for the NHSC over the five-year
period FY2011 through FY2015.20 This funding adds to the $300 million in FY2009
supplementary funds that were provided for the NHSC in the American Recovery and
Reinvestment Act of 2009 (P.L. 111-5, ARRA).21 In addition, ACA increases the amounts
authorized to be appropriated for the NHSC under the regular annual appropriations process and
permanently authorizes the NHSC program. The program had been authorized through the end of
FY2012.
ACA modifies the NHSC program by permitting NHSC clinicians to fulfill their service
commitments through part-time work. It is believed that this strategy may encourage more
younger providers, particularly newly graduated physicians interested in work-life balance, to
participate in the program.22 In addition, female physicians, on average, work fewer hours than do
18
Department of Health and Human Services, Health Resources and Services Administration, Justification of
Estimations for Appropriations Committees, FY2013, Rockville, MD.
19
Ibid.
20
The ACA funding provided for the NHSC was intended to be supplemental funding. However, from FY2011 through
FY2013, annual appropriations for the NHSC program have been eliminated and supplanted by the ACA funding. See
discussion in CRS Report R42029, Physician Supply and the Affordable Care Act, by Elayne J. Heisler.
21
For more information on ARRA funding for the NHSC, see CRS Report R40181, Selected Health Funding in the
American Recovery and Reinvestment Act of 2009, coordinated by C. Stephen Redhead.
22
U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health
Professions, Physician Supply and Demand: Projections to 2020, October 2006; and U.S. Government Accountability
Office, Graduate Medical Education: Trends in Training and Student Debt, 09-438R, May 4, 2009.
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Public Health, Workforce, Quality, and Related Provisions in ACA
their male counterparts.23 Thus, part-time service opportunities may also encourage female
physicians to participate in the NHSC.
ACA also includes provisions to encourage medical residency training in community-based sites,
called teaching health centers (discussed below under “Physician Workforce”). These sites
include health centers and rural health clinics, two settings that frequently use NHSC providers.
As a corollary to this provision, ACA amends the NHSC program to permit its providers to count
time spent teaching toward fulfillment of their NHSC service commitment.
Finally, ACA requires the Secretary to redefine how HPSAs are designated. The HPSA
designation—which is currently based on a service area’s physician-to-population ratio—
determines where NHSC clinicians are placed. Over time, the HPSA designation has been used
for other purposes such as to establish preference for federal grants programs administered by
HHS. GAO has raised concerns that the methodology used to designate HPSAs does not
effectively identify shortage areas and is not updated often enough.24 HHS has been working
since 1998 to develop alternative methodology to designate HPSAs.25 ACA sets a timeline for
developing and finalizing a new HPSA designation methodology. ACA also amends the Internal
Revenue Code (IRC) to clarify that amounts received from state-operated loan repayment
programs that aim to bring health professionals to shortage areas are not taxable income. Prior to
the ACA, amounts received from the NHSC were excluded from taxable income, but amounts
received under state programs were not, which reduced the value of the state loan repayment
program awards and made participation less attractive to health professionals.
Sec. 5207. NHSC Appropriations
This section amends PHSA Sec. 338H(a), authorizing the following amounts for NHSC
scholarships and loan repayments: $320,461,632 for FY2010; $414,095,394 for FY2011;
$535,087,442 for FY2012; $691,431,432 for FY2013; $893,456,433 for FY2014; and
$1,154,510,336 for FY2015. For FY2016 and subsequent fiscal years, the amount authorized to
be appropriated is based on the amount appropriated for the preceding fiscal year, adjusted by the
product of the change in the costs of health professions education and the change in the number
of individuals residing in HPSAs.
23
U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health
Professions, Physician Supply and Demand: Projections to 2020, October 2006.
24
U.S. Government Accountability Office: (1) Health Care Shortage Areas: Designation Not A Useful Tool for
Directing Resources to the Underserved, GAO/HEHS-95-200, Washington, DC, September 8, 1995; (2) Health
Workforce: Ensuring Adequate Supply and Distribution Remains Challenging, GAO-01-1042T, Washington, DC,
August 1, 2001; and (3) Health Professional Shortage Areas, GAO-07-84 Washington, DC, October 2006.
25
In 1998, the Secretary published a proposal to revise the HPSA methodology (Department of Health and Human
Services, “Designation of Medically Underserved Populations and Health Professional Shortage Areas; Proposed
Rule,” 63 Federal Register 46583-46555, September 1, 1998). The proposal was subsequently withdrawn. In February
2008, HHS proposed a new rule (Department of Health and Human Services, “Designation of Medically Underserved
Populations and Health Professional Shortage Areas; Proposed Rule,” 73 Federal Register 11232-11281, February 29,
2008). In July 2008, the Secretary announced that HHS would issue a new notice of public rulemaking for further
review and public comment prior to issuing a final rule.
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Sec. 10503. Community Health Center Fund
This section, as amended by HCERA Sec. 2303, establishes a Community Health Center Fund
and appropriates a total of $11 billion over the five-year period FY2011 through FY2015 to the
fund. In addition to the transfers for community health centers (described above), the following
amounts are to be transferred from the fund to increase funding, over the FY2008 level, for the
NHSC: $290 million for FY2011; $295 million for FY2012; $300 million for FY2013; $305
million for FY2014; and $310 million for FY2015. Funds are to remain available until expended.
Sec. 10501(n). Part-Time Service, Loan Repayment, Teaching
This section amends PHSA Sec. 331(i), allowing the Secretary to waive the requirement that
NHSC service be provided in full-time clinical practice so that the service obligation may be
fulfilled on a half-time basis (i.e., a minimum of 20 hours per week in clinical practice).
Individuals fulfilling their service obligation in this manner are required to agree to double the
period of obligated service that would otherwise be required, or, if receiving loan repayment,
accept a minimum of two years of obligated service and 50% of the amount that would otherwise
be provided. The section also amends PHSA Sec. 337 by deleting language that prohibits the
reappointment of members to the NHSC National Advisory Council. It amends PHSA Sec. 338B,
increasing the maximum annual NHSC loan repayment amount from $35,000 to $50,000,
adjusted annually for inflation beginning in FY2012. Finally, the section further amends PHSA
Sec. 338C(a) by striking the requirement added by ACA Sec. 5508(b) and instead permitting the
Secretary to treat teaching as clinical practice for up to 20% of the period of obligated NHSC
service.26 However, for NHSC clinicians participating in the teaching health centers GME
program under new PHSA Sec. 340H (established by Sec. 5508(c) of ACA), up to 50% of time
spent teaching may be counted towards the NHSC service obligation.
Sec. 5602. Designating Medically Underserved Populations and HPSAs
This section requires the Secretary, through a negotiated rulemaking process, to establish a
comprehensive methodology and criteria for designating medically underserved populations and
HPSAs. The Secretary is required to consider the availability, timeliness, and appropriateness of
the data necessary to make the designation and the impact of the methodology and criteria on
various populations, institutions, and stakeholders. In doing so, the Secretary must (1) appoint a
rulemaking committee and receive timely reports from the committee; (2) publish an interim final
rule, subject to public comment and subsequent revision, by July 1, 2010; and (3) publish a final
rule by July 1, 2011.
Sec. 10908. Loan Repayment Tax Exclusion
This section amends IRC Sec. 108(f) to exclude from an individual’s gross income for tax
purposes any amount received under any state loan repayment or loan forgiveness programs that
are intended to increase the availability of health care services in HPSAs or other underserved
26
ACA Sec. 5508(b) would have allowed up to 50% of the time spent teaching by an NHSC member to be counted
towards his or her service obligation.
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Public Health, Workforce, Quality, and Related Provisions in ACA
areas as determined by a state. The tax exclusion applies to amounts received by individuals in
taxable years beginning after December 31, 2008.27
Physician Workforce
ACA reauthorizes and expands the Title VII primary care education and training programs and
adds new programs to encourage pediatric subspecialists. Research has shown that there are
shortages of pediatric subspecialists and suggests that pediatricians may not subspecialize for
financial reasons. The salary difference between a general pediatrician and the pediatric
subspecialist is small; in contrast, the salary difference between a primary care physician caring
for adults and a specialist can be significant.28 As noted earlier, ACA establishes a new grant
program to promote community-based residency training. Despite evidence that such programs
may be an effective way of increasing the primary care workforce caring for the underserved,
some have suggested that these community-based settings may not have the staffing or other
resources to provide training.29 This grant program, which provides funding for faculty and other
resources, may facilitate the health centers establishing residency programs. ACA also includes a
new program to provide training to medical students interested in rural practice. A number of
medical schools have implemented specialized rural training during medical school and evidence
suggests that such programs can encourage medical students to practice in rural areas.30
Sec. 5201. Federally Supported Student Loan Funds
This section amends PHSA Sec. 723(a) requiring medical students who receive loan funds to
practice in primary care for 10 years or until the loan is repaid, whichever comes first. For a
medical student who fails to comply with such requirements, the loan accrues interest at a rate of
2% per year higher than the initial rate. In addition, the Secretary is prohibited from requiring
parental financial information when determining a loan applicant’s financial need. Instead, the
school loan officer has discretion in determining whether to seek this information. The section
also adds a sense of Congress that funds repaid under the loan program should not be transferred
to the Treasury or used for any purpose other than to carry out this provision.
27
The America’s Job Creation Act of 2004 (P.L. 108-357) amended the IRC to exclude from an individual’s gross
income for tax purposes any amount received from NHSC loan repayment programs, beginning after December 31,
2003.
28
Kevin O'Leary, Gerald Katz, and Fred Hollander, “The Shortage of Pediatric Subspecialists,” Children’s Hospitals
Today, Winter 2003; and Scott A. Shipman, Jon D. Lurie, and David C. Goodman, “The General Pediatrician:
Predicting Future Workforce Supply and Requirements,” Pediatrics, vol. 113, no. 3 (March 2004), pp. 435-442. See,
also, American Medical Group Association, 2008 Medical Group Compensation and Financial Survey: 2008 Report
Based on 2007 Data, ed. RSM McGladrey, Inc. Consulting (Alexandria, VA: American Medical Group Association,
2008).
29
Fitzhugh Mullan, Candice Chen, and Elizabeth Wiley, The Case for Teaching Health Centers, Medical Education
Futures Study, Policy Brief, Washington, DC, July 14, 2009, http://www.medicaleducationfutures.org.
30
Howard K. Rabinowitz, James J. Diamond, Fred W. Markham, et al., “Critical Factors for Designing Programs to
Increase the Supply and Retention of Rural Primary Care Physicians,” Journal of the American Medical Association,
vol. 286, no. 9 (September 5, 2001), pp. 1041-1048.
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Sec. 5301. Primary Care Training and Enhancement
This section strikes the existing provisions in PHSA Sec. 747 and replaces them with new
language authorizing the Secretary to award five-year grants or contracts to accredited public or
nonprofit hospitals, schools of medicine or osteopathic medicine, academically affiliated
physician assistant training programs, or other public or private nonprofit entities for the purpose
of supporting primary care training programs. Funds are to be used to plan, develop, or operate
accredited training programs in family medicine, general internal medicine, or general pediatrics
and to provide financial assistance in the form of traineeships and fellowships, among other
things. The Secretary is also authorized to award five-year grants or contracts to schools of
medicine or osteopathic medicine for the purpose of capacity building in primary care. Funds are
to be used to establish, improve, or integrate academic units or programs in the various primary
care fields. Priority is to be given to entities proposing innovative approaches to clinical teaching
in primary care and who have a record of training primary care practitioners, among other things.
The section authorizes to be appropriated $125 million for FY2010, and SSAN for each of
FY2011 through FY2014, and requires that 15% of the amount appropriated in each fiscal year be
allocated to physician assistant training programs that prepare students for practice in primary
care. For purposes of carrying out programs that integrate academic administrative units in the
various fields of primary care, the section authorizes to be appropriated $750,000 for each of
FY2010 through FY2014.
Sec. 5203. Pediatric Specialist Loan Repayment Program
This section amends PHSA Title VII, Part E by adding a new subpart 3, Recruitment and
Retention Programs, and, within that new subpart, creates a new PHSA Sec. 775, Investment in
Tomorrow’s Pediatric Health Care Workforce. The new section requires the Secretary to establish
and implement a pediatric specialty loan repayment program under which eligible individuals
agree to work full-time for not less than two years in a pediatric medical specialty, in pediatric
surgery, or in child and adolescent mental and behavioral health care (which could include
substance abuse prevention and treatment). Eligible individuals, including practicing or intraining pediatric medical specialists, pediatric surgical specialists, and child and adolescent
mental and behavioral professionals, would have to work for a provider serving in a HPSA or
medically underserved area, or among a medically underserved population that has a shortage of
the specified pediatric specialty and a sufficient pediatric population, as determined by the
Secretary, to support the specified pediatric specialty. In addition, individuals must be U.S.
citizens or permanent legal residents and, for those currently enrolled in a graduate program, the
program must be accredited and students must have an acceptable level of academic standing.
The program will pay up to $35,000 for each year of service, for a maximum of three years. There
are authorized to be appropriated (1) $30 million for each of FY2010 through FY2014 for loan
repayments for pediatric medical specialists and pediatric surgical specialists; and (2) $20 million
for each of FY2010 through FY2013 for loan repayments for child and adolescent mental and
behavioral health professionals.
Sec. 5508(a) and (c). Teaching Health Centers
Subsection 5508(a) adds at the end of PHSA Title VII, Part C a new PHSA Sec. 749A, Teaching
Health Centers Development Grants, authorizing the Secretary to award grants to teaching health
centers (THC) to establish newly accredited or expanded primary care residency training
programs. The section defines a THC as a community-based, ambulatory patient care center that
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operates a primary care residency program, including the following entities: FQHCs, community
mental health centers, Rural Health Clinics (RHCs), Indian health centers,31 and entities receiving
funds under PHSA Title X (family planning program). It requires that grants be awarded for not
more than three years with a maximum award of $500,000. Grant funds must be used for
activities associated with establishing or expanding a primary care residency training program
including curriculum development; faculty and trainee recruitment, training, and retention;
accreditation; and other specified purposes. The Secretary is required to give preference to
applications that document an existing affiliation agreement with an Area Health Education
Center (AHEC) that sponsors projects to increase and improve health personnel services in
medically underserved communities. In addition, there are authorized to be appropriated $25
million for FY2010, $50 million for FY2011 and for FY2012, and SSAN for each fiscal year
thereafter. No more than $5 million annually may be used for technical assistance program grants.
Subsection 5508(c) amends PHSA Title III, Part D by adding a new Subpart XI, Support of
Graduate Medical Education in Qualified Teaching Health Centers, and, within this subpart,
creates a new PHSA Sec. 340H, Program of Payments to Teaching Health Centers that Operate
Graduate Medical Education Programs. The new section requires the Secretary to make
payments for direct and indirect costs to qualified THCs for the expansion of existing or the
establishment of new approved graduate medical residency training programs. It specifies how
the direct and indirect graduate medical education payments to THCs and the annual updates for
payments are calculated. It also requires the Secretary to limit the funding of full-time equivalent
residents to ensure that these payments do not exceed the annual appropriation under this section.
The section specifies that THC graduate medical education payments are in addition to any
indirect or direct payments made to teaching hospitals and do not count against the limit on the
number of full-time equivalent residents paid for by Medicare or by Children’s Hospital Graduate
Medical Education Programs. The section also requires the Secretary to determine any changes to
the resident reporting requirements to determine whether hospitals have received overpayments.
It specifies annual reporting requirements and authorizes the Secretary to audit THCs. The section
requires the Secretary to reduce the amount of payments made to a THC by 25% if a THC fails to
report certain information, and specifies a THC’s opportunity to remediate the failure to report.
The section also requires the Secretary to promulgate regulations to carry out this section, and
appropriates SSAN, not to exceed $230 million, for the period of FY2011 through FY2015.
Sec. 10501(l). Rural Physician Training Grants
This section adds a new PHSA Sec. 749B, Rural Physician Training Grants, requiring the
Secretary, acting through HRSA, to award grants to medical schools to recruit and provide
focused training and experiences to students likely to practice medicine in underserved rural
communities. Priority is to be given to medical schools with a demonstrated record of training
students to practice in such communities, that have established rural community institutional
partnerships, or who submit a long-term plan for tracking program graduates. Entities receiving
grants would be required to use funds to establish, improve or expand a rural-focused training
program that meets certain specified requirements. The section requires the Secretary to define,
by regulation, the term “underserved rural community” for the purpose of this section within 60
days of enactment. Grantees would have to use the funds to supplement and not supplant federal
31
Indian health centers refer to health centers that are operated by the Indian Health Service, an Indian Tribe, a Tribal
Organization, or an Urban Indian Organization as these terms are defined in Sec. 4 of the Indian Health Care
Improvement Act (25 U.S.C. § 1604).
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and non-federal funds received from other sources, and maintain expenditures of non-federal
amounts at levels not less than those expended in the fiscal year prior to the entity’s receipt of the
grant. The section authorizes to be appropriated $4 million for each of FY2010 through FY2013.
Sec. 10502. Hospital Construction Grants
This section authorizes to be appropriated and appropriates $100 million for FY2010, to remain
available through FY2011, for debt service on, or construction or renovation of, a hospital
affiliated with a state’s sole public medical and dental school. The section specifies that the
Secretary may only make appropriated amounts available upon receipt of an application from a
state governor that meets certain specified requirements.
Dental Workforce
ACA also addresses training in dentistry. Researchers have expressed concerns about the
availability of dental services, especially for disadvantaged populations.32 GAO found that
children enrolled in Medicaid lack access to dental care because dentists do not accept Medicaid,
or because there are few providers in a geographic area.33 In a 2005 report examining dental
training, HRSA recommended that federal programs that support the dental workforce,
particularly those that provide support for dental faculty and address student indebtedness, be
expanded. Increasing specialization may exacerbate concerns about the adequacy of the general
dental workforce. Dental school debt has increased by 55% from 1996 to 2006, controlling for
inflation.34 Due in part to increased amounts of student debt, more dental school graduates are
choosing dental specialties because they can often earn more than general dentists.35
ACA implements a number of changes to encourage training in primary care dentistry. Some of
these changes are in response to the 2005 HRSA report as they support efforts to expand dental
faculty, and provide loan repayment for dental students and faculty.36 In addition, these programs
seek to expand the dental workforce available for the underserved through programs that support
alternative dental care providers.
Sec. 5303. Training in General, Pediatric, and Public Health Dentistry
This section redesignates PHSA Sec. 748, as amended by ACA Sec. 5103, as PHSA Sec. 749 and
inserts a new PHSA Sec. 748, authorizing the Secretary to make grants or enter into contracts
with specified entities to support training, provide financial assistance, and fund projects for
dental students, dental residents, dental hygienists, practicing dentists, or dental faculty in the
32
U.S. Department of Health and Human Services, Health Resources and Services Administration, Financing Dental
Education: Public Policy Interests, Issues and Strategic Considerations, Rockville, MD, 2005; and Cynthia Shirk, Oral
Health Checkup: Progress in Tough Fiscal Times? National Healthy Policy Forum, Washington, DC, March 29, 2010.
33
U.S. Government Accountability Office, Medicaid: State and Federal Action Have Been Taken to Improve
Children’s Access to Dental Services, But More Can Be Done, 10-112T, October 7, 2009.
34
U.S. Government Accountability Office, Graduate Medical Education: Trends in Training and Student Debt, 09438R, May 4, 2009.
35
Ibid.
36
U.S. Department of Health and Human Services, Health Resources and Services Administration, Financing Dental
Education: Public Policy Interests, Issues and Strategic Considerations, Rockville, MD, 2005.
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fields of general dentistry, pediatric dentistry, or public health dentistry. The section also
establishes a faculty loan repayment program under which individuals agree to serve full-time as
faculty members in one of the specified dental fields, and the program agrees to pay specified
percentages of the principal and interest on their outstanding student loans based on the number
of years served as a full-time faculty member. Entities eligible for the programs under this section
include dental and dental hygiene schools and approved residency or advanced educational
programs in the specified fields. Eligible entities also may partner with schools of public health so
that dental residents or dental hygiene students may receive master’s-level training in public
health. When making training awards, the Secretary is required to give priority to certain
qualified applicants. When making awards for both the training and faculty loan repayment
programs, the Secretary is required to give preference to applicants based on their record of
providing care in underserved areas or to populations experiencing health disparities, entities that
have established a formal relationships with certain specified types of providers, or to entities that
in the two fiscal years prior to receiving the award had an increased rate of placing their graduates
in settings that serve health disparity populations. The section authorizes an appropriation of $30
million for FY2010, and SSAN for each of FY2011 through FY2015 and permits entities to carry
over funds across fiscal years.
Sec. 5304. Alternative Dental Health Care Provider Demonstration
This section adds a new PHSA Sec. 340G-1 that authorizes the Secretary to establish a
demonstration program to train or employ alternative dental health care providers in order to
increase access to dental health care services in rural and other underserved communities.
Alternative dental health care providers include community dental health coordinators, advance
practice dental hygienists, independent dental hygienists, primary care physicians, dental
therapists, dental health aides, and any other health professionals the Secretary determines
appropriate. Entities eligible for this grant program include qualified institutions of higher
education; public-private partnerships; FQHCs; health facilities operated by the Indian Health
Service (IHS), an Indian Tribe, a Tribal Organization or an Urban Indian Organization, as
specified; state or county public health clinics; public hospitals or health systems; or other entities
as specified. The Secretary is authorized to award 15 grants of not less than $4 million over a
five-year period. The section also specifies the funding disbursement formula for grants and
requires that demonstration projects begin within two years after enactment and conclude not
later than seven years after enactment. Additionally, this section requires the Secretary to contract
with the Institute of Medicine (IOM) to conduct a study of the demonstration program regarding
access to dental health care. Nothing in the section prohibits an IHS-approved dental health aide
training program from being eligible for a grant under this section. There are authorized to be
appropriated SSAN to carry out this section.
Nursing Workforce
The National Advisory Council on Nurse Education and Practice (NACNEP) reports that there
will be 10,000 too few nurses in 2020 to meet the nation’s health care needs.37 Furthermore, this
group expressed concerns that the existing and future nursing workforce may not be adequate, or
sufficiently skilled, because the health care work environment has become increasingly
37
NACNEP, HRSA, Bureau of Health Professionals, Division of Nursing, First Report to the Secretary and to the
Congress, Rockville, MD, November 2001.
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complex.38 Nursing workforce development programs authorized under PHSA Title VIII fund
grants and scholarships for graduate and undergraduate nursing education in specified areas of
nursing including cultural competency, workforce diversity, nurse faculty members, advanced
education nurses, and geriatric nursing. ACA expands these programs and addresses a number of
the concerns raised by NACNEP and other experts. In particular, ACA seeks to increase the skill
level of the nursing workforce by authorizing programs to train advanced practice nurses and
family nurse practitioners.
Sec. 5202. Nursing Student Loan Program
This section amends PHSA Sec. 836 by increasing the annual maximum amount of loan funds a
recipient can receive during FY2010 and FY2011 from $2,500 to $3,300; increasing the final
two-year amounts from $4,000 to $5,200 per year; and increasing the total loan amount from
$13,000 to $17,000. The section provides, for loans made after FY2011, for a cost-of-attendance
increase for the yearly and aggregate amounts. It also amends applicable dates to require that
financial need be a criterion for receiving a loan after 2000. Additionally, it provides for partial
loan cancellation for loan recipients working as full-time nurses in public or nonprofit settings
who received loan funds before September 29, 1995.
Sec. 5308. Advanced Nursing Education Grants
This section amends PHSA Sec. 811 to establish separate authorizations for the support of nurse
practitioner and nurse midwifery programs. It also inserts new language establishing expanded
grant eligibility criteria for nurse midwifery programs. The section deletes the prohibition on
obligating more than 10% of the traineeships for individuals in doctoral programs.
Sec. 5309. Nurse Education, Practice, and Retention Grants
This section amends PHSA Sec. 831 by renaming the grant program, Nurse Education, Practice,
and Quality Grants, and deleting from the program’s listed priority areas support for internship
and residency programs to encourage mentoring and the development of specialties within
nursing. The section restates certain specified grant priority activities, and redefines nursing
schools to have the same meaning as the term in Sec. 801(2). The section authorizes to be
appropriated SSAN for each of FY2010 through FY2014. (See also ACA Sec. 5312, below.)
Also, the section adds a new PHSA Sec. 831A, Nurse Retention Grants, authorizing the Secretary
to provide funding to eligible entities for nurse retention and promotion (“career ladder”)
programs, and for the enhancement of patient care that is directly related to nursing activities. The
Secretary is required to give preference to entities that have not received a grant under this
subsection, to entities that have not received a grant under the earlier nursing “career ladder”
grant program, and to entities that address other high-priority areas as determined by the
Secretary. The section authorizes to be appropriated SSAN to carry out grant programs in this
section for each of FY2010 through FY2012. (See also ACA Sec. 5312, below.)
38
NACNEP, HRSA, Bureau of Health Professionals, Division of Nursing, Meeting the Challenges of the New
Millennium: Challenges Facing the Nurse Workforce in a Changing Health Care Environment, Sixth Report to the
Secretary of Health and Human Services and the Congress, Rockville, MD, January 2008.
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Sec. 5310. Student Loan Repayment and Scholarship Program
This section amends PHSA Sec. 846 by expanding eligibility for the nursing student loan
repayment and scholarship program to individuals who agree to serve as nurse faculty at an
accredited school of nursing for two years or more. The section also contains several technical
and conforming amendments for PHSA Title VIII, including redesignating Sec. 841 (Funding) as
Sec. 871, and Sec. 855 (Geriatric Education and Training, discussed below) as Sec. 865.
Sec. 5311. Nurse Faculty Loan Program
This section amends PHSA Sec. 846A by renaming the nurse faculty loan program School of
Nursing Student Loan Fund. It adds the requirement that loan fund agreements must be made
with accredited schools of nursing. Priority is given to support for doctoral nursing students. The
section also increases the annual loan limit from $30,000 to $35,500 for FY2010 and FY2011 and
provides for cost-of-attendance adjustments in subsequent years. ACA authorizes to be
appropriated SSAN for each of FY2010 through FY2014.
Additionally, the section creates a new PHSA Sec. 847 authorizing the Secretary, acting through
HRSA, to enter into an agreement with eligible individuals for the repayment of qualified
education loans for the purpose of increasing the number of qualified nursing faculty. Award
recipients are required to serve as a faculty member at an accredited school of nursing for at least
four of the six years after (1) the individual receives a qualifying degree; or (2) the date the
individual entered the agreement. Priority is given to support for doctoral nursing students. The
section also sets the annual loan limit at $10,000 for individuals with a master’s or equivalent
degree in nursing ($20,000 for those with a doctorate or equivalent degree in nursing), and an
aggregate loan limit of $40,000 for individuals with a master’s or equivalent degree in nursing
($80,000 for those with a doctorate or equivalent degree in nursing) for FY2010 and FY2011.
Thereafter, the annual and aggregate loan limits would be adjusted to provide for a cost-ofattendance increase. The section authorizes to be appropriated SSAN for each of FY2010 through
FY2014.
Sec. 5312. Authorization of Appropriations
This section amends PHSA Sec. 871 (as redesignated by Sec. 5310 of ACA) by authorizing to be
appropriated $338 million in FY2010 for Title VIII Parts B, C, and D (i.e., Secs. 811, 821, and
831, and new Sec. 831A), and SSAN for each of FY2011 through FY2016.
Sec. 5509. Medicare Graduate Nurse Education Demonstration Program
This section requires the Secretary to establish a graduate nurse education demonstration program
in Medicare. Under the demonstration program, up to five eligible hospitals will receive Medicare
reimbursement for clinical training costs attributed to providing advanced practice nurses with
qualified training. An advanced practice nurse includes a clinical nurse specialist, a nurse
practitioner, a certified registered nurse anesthetist, and a certified nurse midwife as defined by
Medicare statute. Advance practice nurses will receive training in the clinical skills necessary to
provide primary care, preventive care, transitional care, chronic care management, and other
nursing services appropriate for the Medicare-eligible population. At least half of all clinical
training will occur in non-hospital community-based care settings. However, the Secretary is
authorized to waive this requirement for eligible hospitals located in rural or medically
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underserved areas. For any year, Medicare’s payment amount may not exceed the amount of
training costs attributed to an increase in the number of advance practice nurses enrolled in a
qualified program during the year compared to the average number who graduated from that
program in each year from January 1, 2006, to December 31, 2010 (as determined by the
Secretary). To carry out this section, there are appropriated, out of any funds in the Treasury not
otherwise appropriated, $50 million for each of FY2012 through FY2015, with amounts
remaining available until expended.
Sec. 5316. Family Nurse Practitioner Demonstration
This section, as added by ACA Sec. 10501(e), requires the Secretary to establish a demonstration
program to provide recently qualified nurse practitioners with 12 months of training for careers as
primary care providers in FQHCs and NMHCs (see Sec. 5208 of ACA). Eligible FQHCs and
NMHCs will receive three-year grants to create a training model that may be replicated
nationwide. Grant amounts may not exceed $600,000 per year. To be eligible for acceptance into
a training program, a nurse practitioner has to demonstrate a commitment to a career as a primary
care provider in an FQHC or NMHC. Preference will be given to bilingual candidates. The
Secretary is authorized to award grants to one or more FQHCs or NMHCs with expertise in
establishing nurse practitioner residency training programs to provide technical assistance to
other grantees. There are authorized to be appropriated SSAN for each of FY2011 through
FY2014 to carry out the demonstration program.
Geriatric and Long-Term Care Workforce
The IOM, among others, has raised concerns about whether the geriatric workforce is sufficiently
skilled to provide care to an aging population.39 The IOM also has raised concerns about the
training of direct care workers, noting that these workers are the primary source of care for older
adults, but have little training in geriatric medicine. PHSA Titles VII and VIII include programs to
augment the geriatric workforce by training physicians, dentists, mental health professionals, and
nurses in geriatric care. ACA creates new, and amends existing, programs for geriatric training.
These new programs draw from the IOM recommendations in that they establish programs to
increase training for the direct care workforce, provide training in geriatrics for the health care
workforce, and provide incentives for other types of providers to enter the field of geriatrics.
Sec. 5302. Training Opportunities for Direct Care Workers
This section adds a new PHSA Sec. 747A that requires the Secretary to establish a grant program
to provide new training opportunities for direct care workers employed in specified long-term
care settings. Entities eligible for grants include accredited institutions of higher education that
have established a partnership with a long-term care setting as specified. Eligible entities are
required to use grant funds to provide tuition and fee assistance for eligible individuals, defined as
individuals who are enrolled and making satisfactory progress in courses provided by an eligible
entity. Individuals receiving assistance under this section are required to work in the field of
geriatrics, disability services, long-term services and supports, or chronic care management for a
39
Institute of Medicine, Retooling for an Aging America: Building the Health Care Workforce (Washington, DC: The
National Academies Press, 2008).
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minimum of two years. There are authorized to be appropriated $10 million for the period
FY2011 through FY2013.
Sec. 5305(a) and (b). Geriatric Education and Training
Subsection 5305(a) amends PHSA Sec. 753 by adding two new subsections. The first subsection
requires the Secretary to award grants or contracts for geriatric workforce development
fellowship and training programs to qualified entities that operate a Geriatric Education Center
(GEC). The awards must be used to (1) offer short-term intensive courses on geriatrics, chronic
care management, and long-term care; and (2) offer family caregiver and direct care provider
training, or develop and incorporate into all training courses best practices material on mental
disorders among the elderly, medication safety issues for the elderly, and managing dementia.
Each award is $150,000 with no more than 24 GECs authorized to receive an award. There are
authorized to be appropriated $10.8 million for the period FY2011 through FY2014.
The second subsection creates incentive grants or contracts for certain qualified health
professionals entering the field of geriatrics, long-term care, and chronic care management.
Health professionals receiving this award are required to teach or practice in one of the above
fields for a minimum of five years. There are authorized to be appropriated $10 million for this
program for the period FY2011 through FY2013.
Subsection 5305(b) further amends PHSA Sec. 753 by expanding eligibility for geriatric
academic career awards to qualified faculty at any accredited health professions school, as
determined by the Secretary. Entities receiving an award must meet specified targets and use
award funds to supplement and not supplant funds otherwise available to the GEC.
Sec. 5305(c). Geriatric Education and Training
This subsection amends PHSA Sec. 855 to include new language establishing traineeships for
individuals preparing for advanced degrees in geriatric nursing or other nursing areas that
specialize in elder care. It authorizes to be appropriated SSAN for each of FY2010 through
FY2014. [Note: ACA Sec. 5310 redesignated PHSA Sec. 855 as Sec. 865.]
Sec. 5507. Health Workforce Demonstrations; Family-to-Family Centers
Subsection 5507(a) amends Title XX of the Social Security Act (SSA) by adding a new Sec.
2008, Demonstration Projects to Address Health Professions Workforce Needs, establishing two
separate demonstration projects. The first project requires the Secretary, in consultation with the
Secretary of Labor, to award grants that provide individuals receiving assistance under the State
Temporary Assistance for Needy Families (TANF) program and other low-income individuals
with the opportunity to obtain education and training for occupations in the health care field that
pay well and are expected to either experience labor shortages or be in high demand. Funds may
be used to provide individuals with financial aid, child care, case management, and other
supportive services, and are not be considered income for the purposes of determining eligibility
for benefits under any means-tested program. The second project requires the Secretary to award
grants to states to conduct demonstrations for the purpose of developing core training
competencies and certification programs for personal or home care aides. The section
appropriates $85 million to carry out both demonstration projects for each of FY2010 through
FY2014. The Secretary is required to use $5 million of the amount appropriated for each of
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FY2010 through FY2012 to carry out the second demonstration project. After FY2012, no
appropriated funds may be used to carry out this project.
Subsection 5507(b) amends SSA Sec. 501(c), which appropriated $5 million for FY2009 for the
Secretary (through grants, contracts, or otherwise) to provide funding for special projects of
regional and national significance for the development and support of family-to-family health
information centers. ACA appropriates $5 million for each of FY2009 through FY2012 to provide
for the development and support of these centers.
Sec. 8002(c). Personal Care Attendants
This section establishes a Personal Care Attendants Workforce Advisory Panel, no later than 90
days after enactment, for the purpose of examining and advising the Secretary and Congress on
workforce issues related to such workers.
Public Health Workforce
The PHSA authorizes the Secretary to conduct programs for public health workforce development
by providing grants or contracts to schools, state and local health agencies, and others to operate
public health training, re-training, and placement programs.40 Programs include grants for Public
Health Training Centers; tuition, fees, and stipends for traineeships in public health and in health
administration; and residency programs in preventive medicine and dental public health. ACA
reauthorizes these programs and creates some new ones, including a U.S. Public Health Sciences
Track for graduate training in public health disciplines.
Health Workforce Loan Repayment Program
This section creates a new PHSA Sec. 776 requiring the Secretary, depending on appropriations,
to establish a loan repayment program for public health or health professionals who agree to work
in a federal, state, local, or tribal public health agency or a related training fellowship after
graduation. Among other contractual obligations, recipients are required to serve for at least three
years, or as determined by the Secretary. Annual repayment is capped at $35,000 per individual,
or one-third of total debt, whichever is less. The section authorizes the appropriation of $195
million for FY2010, and SSAN for each of FY2011 through FY2015.
Sec. 5206. Public Health Workforce Grants for State and Local Programs
This section amends PHSA Sec. 765 to add public health workforce loan repayment programs to
the list of allowable activities for public health workforce development grants. It also creates a
new PHSA Sec. 777 authorizing the Secretary to make grants to eligible educational entities to
award scholarships for the training of mid-career professionals in public health and allied health.
There are no stated scholarship amounts or service obligations. The section authorizes the
appropriation of $60 million for FY2010, and SSAN for each of FY2011 through FY2015.
40
PHSA Title VII, Part E, Subpart 2, comprising Secs. 765-770.
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Sec. 5313. Grants for Community Health Worker Programs
This section, as amended by ACA Sec. 10501(c), creates a new PHSA Sec. 399V, requiring the
CDC Director to award grants to eligible entities to promote healthy behaviors and outcomes for
populations in medically underserved communities through the use of community health workers
(CHWs). The Secretary is required, among other things, to establish guidelines for the training
and supervision of CHWs. The section authorizes to be appropriated SSAN for each of FY2010
through FY2014.
Sec. 5314. Public Health Fellowships
This section adds a new PHSA Sec. 778, authorizing the Secretary to expand existing CDC
public health training fellowships in epidemiology, laboratory science, and informatics; the
Epidemic Intelligence Service (EIS); and other training programs that meet similar objectives.
Participants may be placed in state and local health agencies, and states can receive federal
assistance for loan repayment programs for such participants. The section authorizes, for each of
FY2010 through FY2013, the appropriation of $24.5 million for EIS fellowships, and $5 million
each for epidemiology, laboratory, and informatics fellowships.
Sec. 5315. United States Public Health Sciences Track
This section adds a new PHSA Title II, Part D, “United States Public Health Sciences Track,”
consisting of four new PHSA sections. New PHSA Sec. 271 establishes a science track at
academic sites selected by the Secretary, to award degrees that emphasize team-based service,
public health, epidemiology, and emergency preparedness and response. The track is to be
organized so as to graduate, annually, specified minimum numbers of students of medicine,
dentistry, nursing (including advanced nursing), public health, behavioral and mental health,
physician assistance, and pharmacy. New PHSA Sec. 272 delegates administration of the science
track to the U.S. Surgeon General (SG), according to specified requirements.
New PHSA Sec. 273 establishes requirements for selection of students for the science track, and
their service obligations, under the administration of the SG. The SG may provide students with
funding for tuition and a stipend for up to four years, subject to specified contractual obligations,
among them a requirement to serve in the United States Public Health Service (USPHS)
Commissioned Corps for a specified time period. Among other things, the SG is required to
develop criteria for the appointment of promising science track faculty, students, and graduates to
elite federal disaster preparedness teams to train and respond to public health emergencies. New
PHSA Sec. 274 requires the Secretary, beginning in FY2010, to transfer from the Public Health
and Social Services Emergency Fund SSAN to carry out this new Part.41
Sec. 10501(m)(1). Preventive Medicine and Public Health Training Grants
This subsection replaces the previous PHSA Sec. 768 with new language, requiring the Secretary
to award grants or contracts for preventive medicine residency training. Eligible entities are
41
The Public Health and Social Services Emergency Fund (PHSSEF) is an HHS account administered by the Secretary,
which Congress has historically used to provide one-time funding for non-routine activities. Congress appropriates
amounts to the PHSSEF for specified purposes. ACA does not authorize or appropriate funds to the PHSSEF.
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accredited schools of medicine, osteopathic medicine, or public health; accredited public or
private hospitals; state, local, or tribal health departments; or consortia of the above.
Sec. 10501(m)(2). Reauthorization of Public Health Workforce Programs
This subsection reauthorizes public health workforce programs in PHSA Secs. 765-769 (as
amended by ACA) by amending PHSA Sec. 770(a), authorizing to be appropriated $43 million
for FY2011, and SSAN for each of FY2012 through FY2015.
U.S. Public Health Service (USPHS) Commissioned Corps
The USPHS Commissioned Corps is a branch of the U.S. uniformed services, but is not one of
the armed services.42 The Corps is based in HHS under the authority of the U.S. Surgeon General
(SG). USPHS commissioned officers are physicians, nurses, pharmacists, engineers, and other
public health professionals who serve in federal agencies, or as detailees to state or international
agencies, to support a variety of public health activities. Corps officers serve in regular or reserve
status. Due to a statutory cap on the number of Regular Corps officers, many officers were placed
when on active-duty status in the Reserve Corps instead. ACA eliminates the cap and places
active-duty reserve officers into regular status. Also, ACA establishes a Ready Reserve Corps of
officers who are subject to intermittent involuntary deployment to bolster the available workforce
for both routine and emergency public health missions, such as serious natural disasters and
infectious disease outbreaks. It is expected that Ready Reserve Corps officers will be drawn
mainly from professionals who work in the private sector, not in the federal workforce, between
deployments.
Sec. 5209. Elimination of Cap on USPHS Regular Corps
Sec. 202 of P.L. 102-394, FY1993 appropriations for Labor/HHS/Education, capped the number
of commissioned officers in the USPHS Regular Corps (versus the Reserve Corps) at 2,800 and
prohibited the use of appropriations from that act, or any subsequent appropriations act, to fund
additional positions.43 This section amends Sec. 202 of P.L. 102-394 to eliminate the cap.
Sec. 5210. USPHS Ready Reserve Corps
This section replaces PHSA Sec. 203 with new language designating active-duty officers in the
USPHS Reserve Corps as members of the Regular Corps, effective upon enactment. The section
also establishes a Ready Reserve Corps of officers who are subject to involuntary call to active
duty (including for training) by the SG, in order to bolster public health workforce capacity. The
section authorizes the appropriation, for each of FY2010 through FY2014, of $5 million for
recruitment and training, and $12.5 million for the Ready Reserve Corps.
42
10 U.S.C. § 101. The USPHS Commissioned Corps is authorized in PHSA Secs. 201-224 (42 U.S.C. §§ 202-233).
For more information see HHS, USPHS Commissioned Corps, http://www.usphs.gov/default.aspx.
43
The ceiling was raised to 4,000 in Sec. 222 of P.L. 111-8, the Omnibus Appropriations Act, 2009.
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Workforce Diversity Training
The IOM has raised concerns about the racial and ethnic diversity of the health care workforce.44
A more diverse healthcare workforce—including a more diverse group of providers in training—
is important because (1) minority groups disproportionately live in areas with provider
shortages,45 (2) patients who receive care from members of their own racial and ethnic
background tend to have better outcomes,46 and (3) members of racial and ethnic minority groups
are more likely to enter primary care and practice in shortage areas.47 In addition, research has
found that all students benefit from a more diverse student body. Specifically, non-minority
students who attend more diverse medical schools feel more prepared to provide care to a diverse
racial and ethnic population.48 PHSA Title VII authorizes programs to increase the diversity of the
health care workforce and to create interdisciplinary community-based training. ACA
reauthorizes and amends a number of these programs and creates a new program to increase the
diversity of the nursing workforce. ACA also expands the role of the AHEC program—centers
that sponsor projects to increase and improve health personnel services in medically underserved
communities—by requiring coordination with ACA-established teaching health centers and
primary care extension programs.
Sec. 5307. Cultural Competency, Prevention, and Public Health and
Individuals with Disabilities Training
This section amends PHSA Sec. 741, requiring the Secretary to support the development and
evaluation of research, demonstration projects, and model curricula for use in health professions
schools and continuing education programs for providing training in cultural competency,
prevention, public health proficiency, reducing health disparities, and aptitude for working with
individuals with disabilities. The Secretary is required to collaborate with specified entities and
other organizations as deemed appropriate, and to coordinate with curricula and research and
demonstration projects developed under PHSA Sec. 807 (see next paragraph). The Secretary also
is required to evaluate the adoption and implementation of the curricula, to facilitate their
inclusion into quality measurement systems as appropriate, and to make them available through
the Internet. There are authorized to be appropriated SSAN for each of FY2010 through FY2015.
In addition, the section amends PHSA Sec. 807—a grant program for cultural and linguistic
competence training for nurses—to create a program for the nursing workforce that is parallel to
the one authorized under Sec. 741 (as amended) and to require coordination with that program. To
carry out Sec. 807, there are authorized to be appropriated SSAN for each of FY2010 through
FY2015.
44
Institute of Medicine, In the Nation’s Compelling Interest: Ensuring Diversity in the Health Care Workforce
(Washington, DC: National Academy Press, 2004).
45
CRS Report RL32546, Title VII Health Professions Education and Training: Issues in Reauthorization, by Bernice
Reyes-Akinbileje.
46
Institute of Medicine, In the Nation’s Compelling Interest: Ensuring Diversity in the Health Care Workforce
(Washington, DC: National Academy Press, 2004).
47
U.S. Government Accountability Office, Graduate Medical Education: Trends in Training and Student Debt, 09438R, May 4, 2009.
48
Institute of Medicine, In the Nation’s Compelling Interest: Ensuring Diversity in the Health Care Workforce
(Washington, DC: National Academy Press, 2004).
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Sec. 5401. Centers of Excellence
This section amends PHSA Sec. 736 by modifying the Centers of Excellence (COE) funding
formula to add an additional set of specifications for allocating funds among the various types of
COEs when the appropriation is $40 million or more. It authorizes to be appropriated for the COE
program $50 million for each of FY2010 through FY2015, and SSAN for each subsequent fiscal
year.
Sec. 5402. Health Care Professionals Training for Diversity
This section amends PHSA Sec. 738(a) by increasing the annual limit on the loan repayment
amount to $30,000. In addition, the section amends PHSA Sec. 740 by authorizing the following
appropriations: (1) for Sec. 737 scholarships, $51 million for FY2010, and SSAN for each of
FY2011 through FY2014; (2) for Sec. 738 loan repayments and fellowships, $5 million for each
of FY2010 through FY2014; and (3) for Sec. 739 educational assistance, $60 million for FY2010,
and SSAN for each of FY2011 through FY2014.
Sec. 10501(d). Increasing Diversity in Physician Assistant Education
This section amends PHSA Sec. 738(a) by adding schools offering physician assistant education
programs to the list of specified health professions schools.
Sec. 5403. Interdisciplinary, Community-Based Linkages
This section amends PHSA Sec. 751, Area Health Education Centers, replacing the existing
provisions with new language. The new section expands the current AHEC program and requires
the Secretary to award (1) infrastructure development grants to medical and nursing schools to
plan, develop, and operate AHEC programs; and (2) point-of-service maintenance and
enhancement grants to maintain and improve the effectiveness of existing AHEC programs. As
with the current AHEC program, the new section requires a non-federal match, sets the minimum
award at $250,000, and places certain time limits on the award period. It authorizes to be
appropriated $125 million for each of FY2010 through FY2014. It is the sense of Congress that
every state have an AHEC program.
In addition, the section replaces the existing section with a new PHSA Sec. 752, Continuing
Educational Support for Health Professionals Serving in Underserved Communities, requiring the
Secretary to award grants to health professions schools, academic health centers, and state or
local governments, among others, to fund innovative activities to enhance education through
distance learning, continuing education, collaborative conferences, and telehealth, with a focus on
primary care. It authorizes to be appropriated $5 million for each of FY2010 through FY2014,
and SSAN for each subsequent fiscal year.
Sec. 5404. Workforce Diversity Grants
This section amends PHSA Sec. 821 by expanding the allowable uses of diversity grants to
include stipends for diploma or associate degree nurses to enter a bridge or degree completion
program, student scholarships or stipends for accelerated nursing degree programs, and advanced
education preparation. In lieu of the existing consultation requirements, it requires the Secretary
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to take into account the recommendations of the NACNEP and consult with nursing associations
including the National Coalition of Ethnic Minority Nurse Associations and other appropriate
organizations.
Allied Health Workforce
ACA amends eligibility for an existing education loan forgiveness program to include allied
health professionals. Allied health providers, such as audiologists, nutritionists, dieticians, and
occupational, physical or rehabilitation therapists, share in the responsibility for delivering health
care services.
Sec. 5205. Allied Health Workforce Recruitment and Retention Programs
This section amends Sec. 428K of the Higher Education Act of 1965 to include, among those
eligible for a loan forgiveness program, an individual who is employed full-time as an allied
health professional in a federal, state, local and tribal public health agency. Additional qualified
employment locations include acute care and ambulatory care facilities, and settings located in
HPSAs, medically underserved areas or among medically underserved populations, as recognized
by the Secretary.
The section defines the term “allied health professional,” as described in PHSA Sec. 799B(5), as
an individual who has graduated and received an allied health professions degree or certificate
from an institution of higher education and is employed with a federal, state, local, or tribal public
health agency, or other qualified employment location.
Mental and Behavioral Health Workforce
ACA creates a new PHSA Title VII grant program for training mental and behavioral health
providers. According to the President Bush’s New Freedom Commission on Mental Health, there
is a shortage of behavioral health care providers, and this shortage is notably severe in rural
areas.49 Due to the lack of specialty behavioral health providers in rural areas, primary care
providers who practice in nonmetropolitan areas play a large role in behavioral health care.
Sec. 5306. Mental and Behavioral Health Education and Training Grants
This section amends PHSA Title VII, Part D by deleting Sec. 757 (authorizing appropriations
for Part D through FY2002), redesignating Sec. 756 (as amended by ACA Sec. 5103) as Sec. 757,
and adding a new PHSA Sec. 756, Mental and Behavioral Health Education and Training
Grants. The new section authorizes the Secretary to award grants to (1) eligible institutions of
higher education to support the recruitment and education of students in social work programs,
interdisciplinary psychology training programs, and internships or other field placement programs
related to child and adolescent mental health; and (2) state-licensed mental health organizations to
train paraprofessional child and adolescent mental health workers.
49
The President’s New Freedom Commission on Mental Health, Achieving the Promise: Transforming Mental Health
Care in America, July 2003, http://www.mentalhealthcommission.gov/reports/reports.htm.
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The section requires at least four of the grant recipients to be historically black colleges or
universities, or other minority-serving institutions. For grants for education and training in social
work, priority must be given to applicants that are accredited by the Council on Social Work
Education, have a graduation rate of at least 80% for social work students, and are able to recruit
from and place social workers into areas with a high-need and high-demand population. For
grants in graduate psychology, priority must be given to institutions that focus on the needs of
specified vulnerable groups. For grants to train professional and paraprofessional child and
adolescent mental health workers, priority must be given to applicants that, among other things,
(1) have demonstrated the ability to collect data on the number of child and adolescent mental
health workers trained and the populations they serve upon completion of the training; (2) are
familiar with evidence-based methods; (3) have programs designed to increase the number of
child and adolescent mental health workers serving high-priority populations; and (4) provide
services through a community mental health program described in PHSA Sec. 1913(b)(1).
For FY2010 through FY2013, the section authorizes to be appropriated $8 million for training in
social work, $12 million for training in graduate psychology, $10 million for training in
professional child and adolescent mental health, and $5 million for training in paraprofessional
child and adolescent mental health.
Health Workforce Evaluation and Assessment
ACA establishes a National Health Care Workforce Commission to undertake comprehensive
workforce planning. At the time of the ACA’s enactment experts believed that existing groups—
such as the Advisory Council on Graduate Medical Education, the Advisory Committee on
Training in Primary Care Medicine and Dentistry, the Advisory Committee on Interdisciplinary,
Community-based Linkages, and the NACNEP—were not coordinated and that comprehensive
workforce planning was needed to better synchronize federal workforce investments.50 Some
have argued that the lack of a comprehensive workforce policy has contributed to concerns about
the size, geographic, and specialty distribution of the current health professions workforce.51 In
addition, GAO has noted that data challenges hamper efforts to evaluate programs funded under
PHSA Title VII, and such data may be necessary inputs for comprehensive workforce planning.52
ACA establishes a grant program to enable states to undertake state-level health workforce
planning and includes provisions intended to increase the data collected and analyzed under ACA
Title V (Health Workforce) programs. It also creates a National Center for Health Care Workforce
Analysis (NCHWA) to centralize data collection and analysis,53 and establishes a federal task
force on Alaska health care delivery.
50
David C. Goodman, “Improving Accountability for the Public Investment in Health Profession Education: It’s Time
to Try Health Workforce Planning,” Journal of the American Medical Association, vol. 300, no. 10 (September 10,
2008), pp. 1205-1207.
51
Ibid. See, also, Association of Academic Health Centers, Out of Order Out of Time: The State of the Nation’s Health
Workforce, Washington, DC, 2008, http://www.aahcdc.org.
52
U.S. Government Accountability Office, Health Professions Education Programs: Action Still Needed to Measure
Impact, 06-55, February 28, 2006.
53
Prior to the ACA, HRSA had an entity that conducted similar activities, called the National Center for Health
Workforce Analysis.
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Sec. 5101. National Health Care Workforce Commission
This section, as amended by Sec. 10501(a) of ACA, establishes a National Health Care Workforce
Commission (Commission) to serve as a national resource focused on evaluating and meeting the
need for health care workers. Composed of 15 members appointed by the U.S. Comptroller
General, the Commission is required to recognize partnerships that develop and offer effective
health care career pathways; disseminate information on promising practices; and communicate
important policies and practices regarding recruitment, retention, and training of the health care
workforce. The Commission is required to review health care workforce supply and demand and
make recommendations on national priorities and policies as well as review and make
recommendations on one or more additional specified high priority topics and, beginning in 2011,
submit annual reports on both activities to Congress and the Administration. The Commission is
required to (1) review implementation progress reports and report on the state health care
workforce development grants program (established by Sec. 5102 of ACA); (2) study effective
mechanisms for financing education and training for careers in health care; (3) make
recommendations about improving health care workers’ safety, health, and protections in the
workplace; and (4) assess reports from the NCHWA (established under PHSA Sec. 761(b), as
amended by Sec. 5103 of ACA). There are authorized to be appropriated SSAN to carry out this
section.
Sec. 5102. State Health Care Workforce Development Grants
This section establishes a competitive health care workforce development grants program for the
purpose of enabling state partnerships to plan and implement activities leading to coherent and
comprehensive health care workforce development strategies at the state and local levels. HRSA
is responsible for (1) administering the program, in consultation with the Commission
(established by Sec. 5101 of ACA); (2) providing technical assistance to grantees; and (3)
reporting performance information to the Commission. For planning grants, the section authorizes
to be appropriated $8 million for FY2010, and SSAN for each subsequent fiscal year. For
implementation grants, it authorizes to be appropriated $150 million for FY2010, and SSAN for
each subsequent fiscal year.
Sec. 5103. Health Care Workforce Program Assessment
This section amends PHSA Sec. 761 by requiring the Secretary to (1) establish a National Center
for Health Care Workforce Analysis (NCHWA); (2) establish State and Regional Centers for
Health Workforce Analysis; and (3) increase grant amounts for longitudinal evaluations of
specified individuals who have received education, training, or financial assistance from
programs under PHSA Title VII. The section authorizes the following appropriations for each of
FY2010 through FY2014: (1) $7.5 million for the NCHWA; (2) $4.5 million for State and
Regional Centers; and (3) SSAN for grants for longitudinal evaluations. No later than 180 days
after enactment, all responsibilities of HRSA’s existing National Center for Health Workforce
Analysis must be transferred to the new NCHWA.
The section amends PHSA Sec. 791 by adding new language requiring the Secretary to give
preference in awarding grants or contracts under Secs. 747 and 750 to any qualified applicant that
utilizes a longitudinal evaluation and reports data from such system to a national workforce
database. It also amends Secs. 748, 756, and 762 to include additional duties regarding
performance measures and guidelines for longitudinal evaluations for the Advisory Committee on
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Training in Primary Care Medicine and Dentistry; the Advisory Committee on Interdisciplinary,
Community-based Linkages; and the Advisory Council on Graduate Medical Education.
Sec. 5104. Task Force on Alaska Health Care
This section, as added by ACA Sec. 10501(b), establishes the Interagency Access to Health Care
in Alaska Task Force to develop a strategy to improve delivery of care to beneficiaries of federal
health care systems in Alaska. Composed of nine federal officials appointed by specified
Secretaries, the task force is required, within 180 days of enactment, to submit a report to
Congress with recommendations, policies, and initiatives. The task force will be terminated upon
submission of the report.54
Sec. 5701. Reports
This section requires the Secretary to submit to Congress an annual report on the activities carried
out under the amendments made by Title V (Health Care Workforce) of ACA, and the
effectiveness of such activities. In addition, the Secretary may require, as a condition of receiving
funds under these amendments, that recipients of such awards report on the activities carried out
with the awards, and the effectiveness of such activities.
Medicare GME Payments55
Medicare subsidizes the costs of medical residency training by making two types of payments to
teaching hospitals. First, direct graduate medical education (DGME) payments help cover the
costs of the residency training program, including resident salaries and benefits, supervisory
physician salaries, and administrative overhead expenses. DGME payments are calculated based
on the product of three factors: a hospital-specific per resident amount, a weighted count of fulltime equivalent (FTE) residents supported by the hospital, and the hospital’s Medicare patient
share. Second, indirect medical education (IME) payments, which vary with the intensity of a
hospital’s residency program, are intended to compensate hospitals for the higher costs of patient
care in teaching hospitals. Those costs may be the result of such factors as having sicker patients
and the fact that inexperienced residents may order more tests. The IME adjustment is a
percentage add-on to a hospital’s Medicare payments for inpatient care and is based, in part, on
the hospital’s resident-to-bed ratio. Medicare includes the time that residents spend in both patient
care and non-patient care activities, including didactic activities, when calculating DGME
payments. When calculating IME payments, however, only the time spent in patient care
activities is included. In 2008, Medicare DGME and IME payments totaling an estimated $9
billion were paid to more than 1,100 teaching hospitals to educate and train about 90,000
residents, equivalent to approximately $100,000 per resident. While health policy analysts view
54
For report, see Interagency Access to Health Care in Alaska Task Force, Report to Congress, Washington, DC,
September 17, 2010, http://www.healthcare.gov/news/reports/alaskataskforce.html.
55
For a review of medical education in the United States and an analysis of the GME program and its potential role in
health care delivery reform, see the Medicare Payment Advisory Commission’s June 2009 Report to Congress:
Improving Incentives in the Medicare Program, Chapter 1, at http://www.medpac.gov/chapters/Jun09_Ch01.pdf; and
Medicare Payment Advisory Commission, Graduate Medical Education Financing: Focusing on Educational Priorities,
Report to the Congress: Aligning Incentives in Medicare, Washington, DC, June 2010,
http://www.medpac.gov/documents/Jun10_EntireReport.pdf.
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Medicare GME payments as a potentially important instrument for influencing health workforce
policy, to date they have largely not been used to shape the physician workforce.
With certain exceptions, Medicare caps the number of residents used to calculate GME payments
for individual teaching hospitals at the level reported at the end of 1996.56 The cap was
implemented because of concerns that there would be an oversupply of physicians. Now with
experts concerned that physician supply may be insufficient to meet demand, a number of
physician and hospital groups have called for additional Medicare-supported residency slots.57
ACA increases the number of residents that Medicare supports through provisions that would
redistribute unused residency slots and preserve residency positions from closed hospitals, but
does not remove the limit on Medicare-supported residency slots. Although Medicare does not set
targets for the type or mix of resident physicians that a hospital trains, under ACA the
redistributed slots must largely be used for training in primary care or general surgery.
Medicare allows teaching hospitals to receive DGME and IME payments for the time residents
rotate in nonhospital settings provided (1) they are performing patient care, and (2) the hospital
pays all or substantially all (i.e., 90%) of the costs of the training at the nonhospital site, costs
which include the resident stipends and fringe benefits and those associated with supervising
physicians.58 Time spent in non-patient care activities in the nonhospital setting is not counted
when calculating either type of payment. A hospital that jointly operates a residency program with
another hospital cannot include the time spent by residents working at a nonhospital site if it
incurs all or substantially all of the costs for only a portion of the residents in that program at the
non-hospital site. Additional regulatory requirements discourage rotations in nonhospital settings.
Moreover, hospitals have a financial incentive to retain the often lower-cost clinical labor that
residents provide. While experts see value in having residents gain experience in nonhospital
settings such as community health centers and nursing facilities, residency programs today are
largely based in inpatient, acute-care teaching hospitals. Some have argued that this may make
residents less likely and less prepared to be a community-based provider.59 Research has found
that residents who train in health centers are more likely to provide care to the underserved,
including by working at a health center.60
Sec. 5503. Distribution of Additional Residency Positions
This section establishes criteria to be used to reduce the otherwise applicable resident limit for a
hospital that has unused residency positions, as defined, and directs the Secretary to redistribute
65% of those unused positions and assign them to other qualifying hospitals. Hospitals that meet
56
The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 permitted a one-time
redistribution of up to 75% of a certain teaching hospital’s unused resident positions to hospitals seeking to increase
their medical residency programs, according to specific priorities.
57
See, for example, an editorial arguing to lift the cap by the president of the Association of American Medical
Colleges (AAMC), published in the Wall Street Journal on January 4, 2010, at http://online.wsj.com/article/
SB10001424052748703483604574630321885059520.html; or the AAMC’s policy brief, Physician Shortages to
Worsen Without Increases in Residency Training, Washington, DC, accessed January 31, 2013,
https://www.aamc.org/download/153160/data/physician_shortages_to_worsen_without_increases_in_residency_tr.pdf.
58
Medicare GME payments are summarized in MedPAC’s June 2009 Report to Congress: Improving Incentives in the
Medicare Program, Chapter 1, at http://www.medpac.gov/chapters/Jun09_Ch01.pdf.
59
Ibid.
60
Carl G. Morris, Brian Johnson, and Sara Kim, et al., “Training Family Physicians in Community Health Centers: A
Health Workforce Solution,” Health Services Research, vol. 40, no. 4 (April 2008), pp. 271-276.
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certain specified criteria are exempt from the redistribution of any of their unfilled positions. No
more than 75 FTE additional residents can be made available to a qualifying hospital.
A hospital that qualifies for an increase in residency positions is required to maintain its base
level of primary care residents and ensure that not less than 75% of the additional positions are in
primary care or general surgery residency. When determining the increase in a hospital’s resident
limit, the Secretary is required to take into account such factors as the likely speed with which the
hospital would fill the positions, and whether the hospital has an accredited rural training track.
Residency positions are allocated, according to a specified formula, among the following
qualifying facilities: (1) hospitals located in states with low resident-to-population ratios; (2)
hospitals located in states with a high percentage of the population living in a HPSA; and (3) rural
hospitals. DGME and IME payments for the redistributed residency positions will be made on the
same basis as the payments for existing residency positions.
Sec. 5504. Counting Resident Time in Other Settings
This section requires that all time spent by a resident in patient care activities be counted towards
the DGME payment, regardless of the setting, provided the hospital incurs the costs of the
stipends and the fringe benefits of the resident during the time spent in that setting. If more than
one hospital incurs those costs, then each hospital counts a proportional share of the time that the
resident spends training in that setting. Further, all the time spent by a resident in patient care
activities in a nonhospital setting counts towards the IME payment, provided the hospital
continues to incur those same costs. Again, if more than one hospital incurs the costs, then each
hospital counts a proportional share of the time that the resident spends training in that setting.
Sec. 5505. Rules for Counting Resident Time for Non-Patient Care Activities
This section, as amended by Sec. 10501(j) of ACA, requires that resident time spent in certain
non-patient care activities—including attending conferences and seminars, but not research unless
it is associated with the treatment or diagnosis of a patient—in a nonhospital setting that is
primarily engaged in furnishing patient care be counted towards the DGME payment. In addition,
Medicare must count all the vacation, sick leave, and other approved leave spent by the resident
as long as the leave time does not extend the training program’s duration.
Similarly, when calculating IME payments, resident time spent in hospital settings (as defined) on
certain non-patient care activities—including attending conferences and seminars, but not
research unless it is associated with the treatment or diagnosis of a patient—counts towards the
IME payment.
Sec. 5506. Preservation of Resident Cap Positions from Closed Hospitals
This section directs the Secretary, by rulemaking, to establish a process to redistribute medical
residency slots from a hospital with an approved residency program that closes on or after a date
that is two years before enactment to increase the otherwise applicable residency limit for other
hospitals. Such residency slots would be redistributed based on a specified priority order, with
first priority given to hospitals located in the same or contiguous core-based statistical area as the
hospital that closed.
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Prevention and Wellness
Overview and Impact of ACA
ACA substantially expands federal disease prevention and health promotion efforts through
several approaches. Subsequent subsections of this section discuss how the law: (1) expands
coverage of clinical preventive services under Medicare, Medicaid, and private health insurance;
(2) encourages the development and expansion of wellness programs by employers and insurers;
(3) calls for a national strategy for disease prevention and health promotion; and (4) expands
federal research, grantmaking, and other public health activities aimed at the prevention of
disease risk factors such as obesity and tobacco use, providing a permanent annual appropriation
to support this expansion. These provisions are found primarily in ACA Title IV, “Prevention of
Chronic Disease and Improving Public Health,” and in Title X, Subtitle D.
Coverage of Clinical Preventive Services
ACA expands requirements for coverage of clinical preventive services under Medicare,
Medicaid, and private insurance. Although the approach is different for each of these, two key
elements are incorporated in all three: (1) linking coverage requirements to recommendations of
the U.S. Preventive Services Task Force (USPSTF)61 and, in some cases, additional advisory
bodies; and (2) eliminating most or all cost-sharing for use of clinical preventive services.62
Medicare Part B covered a number of clinical preventive services prior to ACA, including a onetime initial preventive physical examination (IPPE), certain cancer screenings and immunizations,
and other services. Cost-sharing was waived for some, but not all, preventive services. ACA now
requires that Part B also cover an annual wellness visit and health assessment, and waive any
cost-sharing for almost all previously covered preventive services. In addition, ACA allows the
Secretary to modify coverage of preventive services to comport with USPSTF recommendations,
including by withholding payment for services that the USPSTF recommends against using.
Finally, ACA provides that FQHCs may be reimbursed for providing Medicare-covered
preventive services. The Congressional Budget Office (CBO) and the Centers for Medicare and
Medicaid Services (CMS) Actuary projected that, in aggregate, these expansions of covered
benefits will incur a net cost for the Medicare program (although the provision that authorizes the
withholding of payments for ineffective services was projected to be cost-saving).63 These
provisions are summarized below in the section “Prevention Under Medicare.”64
61
The USPSTF is an independent panel of private-sector experts in primary care and prevention that assesses scientific
evidence of the effectiveness of a broad range of clinical preventive services. It is reauthorized by ACA Sec. 4003. See
U.S. Preventive Services Task Force, http://www.uspreventiveservicestaskforce.org/.
62
Beneficiary cost-sharing has been shown to decrease utilization of certain preventive services in some contexts.
Elimination of cost-sharing is sometimes recommended to improve utilization.
63
CBO, “H.R. 3590, Patient Protection and Affordable Care Act,” cost estimate for the bill as passed by the Senate on
December 24, 2009, March 11, 2010, p. 10 of 16, http://www.cbo.gov/doc.cfm?index=11307&zzz=40511; and Richard
S. Foster, Chief Actuary, Centers for Medicare and Medicaid Services, “Estimated Financial Effects of the ‘Patient
Protection and Affordable Care Act,’ as Amended,” Letter, April 22, 2010, Table 3, p. 5 of 8.
64
For general information on Medicare, see CRS Report R40425, Medicare Primer, coordinated by Patricia A. Davis
and Scott R. Talaga.
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State Medicaid programs must cover
a suite of preventive services under
Prevention and Wellness
the Early and Periodic Screening,
CRS Report R40661, Wellness Programs: Selected Legal Issues, by Jody
Diagnostic, and Treatment Services
Feder et al..
program (EPSDT) for beneficiaries
65
CRS Report R41166, Grandfathered Health Plans Under the Patient
under 21 years of age. Neither
Protection and Affordable Care Act (ACA), by Bernadette Fernandez.
preexisting law nor ACA explicitly
require state plans to cover
GAO, Preventive Health Activities: Available Information on Federal
Spending, Cost Savings, and International Comparisons Has Limitations,
preventive services for adults,
GAO-13-49, December 6, 2012, http://www.gao.gov/products/GAOalthough coverage may be required
13-49.
if a service meets another applicable
GAO, Prevention and Public Health Fund Activities Funded in Fiscal Years
requirement, such as a physician’s
2010 and 2011, GAO-12-788, September 13, 2012,
service. However, ACA requires
http://www.gao.gov/products/GAO-12-788.
state Medicaid plans to cover
GAO, Medicare: Use of Preventive Services Could Be Better Aligned with
tobacco cessation counseling and
Clinical Recommendations, GAO-12-81, January 18, 2012,
drug therapy for pregnant women.
http://www.gao.gov/products/GAO-12-81.
In addition, ACA provides for
GAO, Medicare: Many Factors, Including Administrative Challenges, Affect
enhanced federal Medicaid
Access to Part D Vaccinations, GAO-12-61, December 15, 2011,
matching funds for states that opt to
http://www.gao.gov/products/GAO-12-61.
cover without cost-sharing a
HHS, Office of the Surgeon General, National Prevention Strategy,
complete package of preventive
2011, and National Prevention Council Action Plan, 2012,
services for eligible adults
http://www.surgeongeneral.gov/initiatives/prevention/index.html.
recommended by the USPSTF, as
well as recommended
immunizations. The CBO and the CMS Actuary projected a net cost to the Medicaid program for
the state option to cover adult preventive services, and net savings for the provision that provides
coverage of tobacco cessation services for pregnant women.66 These and additional provisions are
summarized below in the section “Prevention Under Medicaid.”
Prior to ACA, federal law did not require private insurers to cover preventive services. Under
ACA, group health plans and health insurance issuers in the group and individual markets must
now cover specified evidence-based clinical preventive services, including immunizations,
without any cost-sharing. Preexisting health plans are “grandfathered” and are exempt from this
requirement. In addition, beginning in 2014, qualified health plans that participate in insurance
exchanges must cover a package of preventive services that are defined by the Secretary. These
provisions are summarized below in the section “Prevention in Private Health Insurance.”67
An ACA provision clarifies requirements for coverage of breast cancer screening services under
Medicaid and private insurance. The provision says that “for the purposes of this Act, and for the
purposes of any other provisions of law, the current recommendations of the [USPSTF] regarding
breast cancer screening, mammography, and prevention shall be considered the most current other
than those issued in or around November 2009.”68 (Emphasis added.) In November 2009, the
65
For general information on Medicaid, see CRS Report RL33202, Medicaid: A Primer, by Elicia J. Herz.
See supra note 63. In the CMS Actuary’s letter, Medicaid preventive service provisions are presented in Table 4 on
p. 2 of 4.
67
For more information, see CRS Report R42069, Private Health Insurance Market Reforms in the Patient Protection
and Affordable Care Act (ACA), by Annie L. Mach and Bernadette Fernandez.
68
ACA § 1001, creating a new PHSA § 2713. This provision is PHSA §2713(a)(5); 42 U.S.C. § 300gg–13(a)(5).
66
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USPSTF updated its recommendation regarding the use of mammography for breast cancer
screening. Previously, the panel recommended that routine screening for women begin at age 40;
it now recommends that routine screening begin at age 50 and continue through age 74.69 The
ACA provision negates the November 2009 recommendations and directly affects the expansions
of benefits covered under Medicaid and private insurance. Although the Secretary has more
discretion with respect to the application of this provision under Medicare, Secretary Sebelius
signaled when the revised USPSTF recommendations were announced that she did not intend to
change federal coverage policies in response, and Medicare policy continues to provide coverage
for annual screening mammography for women beginning at age 40.70
Wellness Programs Provided by Employers and Insurers
Employers and insurers, faced with rising health care costs, have adopted various strategies to
reduce these costs including incentivizing healthy behaviors through wellness programs. Such
programs offered by employers may be subject to a number of federal laws, including the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), which amended the Employee
Retirement Income Security Act (ERISA), the PHSA, and the IRC to improve portability and
continuity of health coverage. Prior to ACA, HIPAA created certain nondiscrimination
requirements, which prohibit a group health plan or a group health insurance issuer from basing
coverage eligibility rules on health-related factors including health status (physical or mental),
claims experience, receipt of health care, medical history, genetic information, evidence of
insurability, or disability.71 In addition, a group health plan or health insurance issuer may not
require that an individual pay a higher premium or contribution than another “similarly situated”
participant, based on these health-related factors. However, HIPAA clarifies that this requirement
“do[es] not prevent a group health plan and a health insurance issuer from establishing premium
discounts or rebates or modifying otherwise applicable copayments or deductibles in return for
adherence to programs of health promotion and disease prevention [i.e., wellness programs].”72
The HIPAA wellness program regulations issued prior to ACA divide wellness programs into two
categories.73 First, if a wellness program provides a reward74 based solely on participation in a
wellness program (or if the wellness program does not provide a reward), the program complies
with the HIPAA nondiscrimination requirements without having to satisfy any additional
69
USPSTF, “Screening for Breast Cancer,” released November 2009, updated December 2009,
http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm. For women between age 40 and 49, the USPSTF
recommends patient/provider consultation regarding the risks and benefits of breast cancer screening in women of that
age. The USPSTF does not recommend against screening of women that age, but that screening be considered pursuant
to consultation, rather than provided routinely.
70
HHS, “Secretary Sebelius Statement on New Breast Cancer Recommendations,” press release, November 18, 2009,
http://www.hhs.gov/news; and CMS, “Medicare Quick Reference Information: Preventive Services,” May 2012,
http://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/downloads/MPS_QuickReferenceChart_1.pdf.
71
29 U.S.C. § 1182(a); 42 U.S.C. § 300gg-1(a); 26 U.S.C. § 9802(a). It should be noted that the Internal Revenue Code
does not apply to health insurance issuers.
72
29 U.S.C. § 1182(b)(2)(B); 42 U.S.C. § 300gg-1(b)(2)(B); 26 U.S.C. § 9802(b)(2)(B).
73
“Nondiscrimination and Wellness Programs in Health Coverage in the Group Market,” 71 Fed. Reg. 75014
(December 13, 2006).
74
The regulations provide that a reward can take the form of a discount or rebate of a premium or contribution, a
waiver of all or part of a cost-sharing mechanism (e.g., deductibles, copayments, or coinsurance), the absence of a
surcharge, or the value of a benefit that would otherwise not be provided under the plan (e.g., a prize). 29 C.F.R. §
2590.702(f)(2)(i); 45 C.F.R. § 146.121(f)(2)(i); 26 C.F.R. § 54.9802-1(f)(2)(i).
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standards, as long as the program is made available to all similarly situated individuals. Second, if
the conditions for obtaining a reward under a wellness program are based on an individual
meeting a certain standard relating to a health factor, then the program must meet additional
requirements. Under one of these additional requirements, a reward offered by this type of
wellness program must not exceed 20% of the cost of employee coverage under the plan.75
ACA essentially codifies the HIPAA wellness program regulations, but for applicable rewards, it
raises the cap on the allowed value of the reward to 30% of the cost of employee coverage, and
gives discretion to the Secretaries of HHS, Labor, and the Treasury to increase the reward value
up to 50%. ACA also establishes reporting requirements for certain plans and insurers that
implement wellness and health promotion activities; establishes grant programs to assist
employers in establishing and evaluating workplace wellness programs; requires the Secretary to
evaluate wellness initiatives for the federal workforce; and bars wellness programs from
collecting information about the lawful possession of firearms. These ACA provisions are
summarized below in the section “Wellness Programs.”
Community-Based Prevention Programs
ACA establishes a framework for federal community-based (i.e., public health) prevention
activities, including a coordinating council, a national strategy, and a national education and
outreach campaign. In addition, ACA supports a new approach to federal grantmaking, based on
preventing risky behaviors such as physical inactivity and tobacco use.
A key element of this approach is the Prevention and Public Health Fund (PPHF). ACA provided
a total appropriation of $5 billion to this new fund for the period from FY2010 through FY2014,
and a permanent annual appropriation of $2 billion for each year thereafter, with the stated
purpose “to provide for expanded and sustained national investment in prevention and public
health programs to improve health and help restrain the rate of growth in private and public sector
health care costs.”76
The PPHF and several new grantmaking authorities in ACA (such as the Community
Transformation Grants) mark a shift in focus in federal prevention activities, away from diseasespecific or “categorical” programs (e.g., those for heart disease, cancer, etc.) and toward
preventable or modifiable risk-factors for disease, such as poor nutrition, sedentary behavior, and
tobacco use. Regular appropriations to CDC have generally been provided for disease-specific
activities.77 However, the agency asserts that this approach is limiting, and has asked Congress for
authority to give state grantees greater flexibility in their use of appropriated funds, saying “The
existing resources dedicated to preventing and reducing chronic diseases, conditions and risk
factors do not reflect with (sic) the burden of chronic diseases and the risk factors that cause
them. Limited resources could be more effectively and efficiently managed if CDC and states
75
In addition to employees, if dependents (such as spouses or spouses and dependent children) participate in the
wellness program, the reward must not exceed 20% of the cost of the coverage in which an employee and any
dependents are enrolled. The cost of coverage is determined based on the total amount of contributions made by both
the employer and the employee for the benefit package under which the employee and any dependents receive
coverage. 29 C.F.R. § 2590.702(f)(2)(i); 45 C.F.R. § 146.121(f)(2)(i); 26 C.F.R. § 54.9802-1(f)(2)(i).
76
ACA Sec. 4002; 42 U.S.C. § 300u-11.
77
CRS Report R41737, Public Health Service (PHS) Agencies: Overview and Funding, FY2010-FY2012, coordinated
by C. Stephen Redhead and Pamela W. Smith.
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were provided with flexibility to use resources to enhance collaborations among key chronic
disease and risk factor prevention programs.”78 In order to assure the effective application of
funding to risk-based rather than disease-based programs, ACA requires reviews, evaluations, and
reports for specific prevention programs, as well as a comprehensive review by GAO, at least
every five years, of every federal disease prevention and health promotion initiative, program,
and agency. In addition, many of the community-based prevention activities authorized in ACA
must comport with recommendations of the Task Force on Community Preventive Services
(TFCPS). The TFCPS, administered by CDC, conducts evidence reviews to determine the
effectiveness of community (i.e., population-based) interventions, using a process similar to that
of the USPSTF, discussed earlier.79 ACA codifies authority for the TFCPS.
Applicable ACA provisions are summarized below in the section “Community-Based Prevention
Programs.”
Prevention in Private Health Insurance
Sec. 1001. Regarding Coverage of Preventive Services
Among other things, this section creates a new PHSA Sec. 2713 requiring a group health plan or
a health insurance issuer in the group or individual health insurance market, for plan years
beginning six months after the date of enactment of ACA, to cover the following preventive
services, without cost-sharing requirements: (1) items or services recommended (i.e., with a grade
of A or B) by the USPSTF; (2) immunizations recommended by the ACIP; (3) for infants,
children and adolescents, preventive care and screenings provided for in comprehensive
guidelines supported by HRSA; and (4) for women, such additional preventive care and
screenings not described by the USPSTF as provided in comprehensive guidelines supported by
HRSA. A plan or issuer may either cover or decline to cover additional services not recommended
by the USPSTF. For the purposes of this section, the current USPSTF recommendations
regarding breast cancer screening, mammography, and prevention are considered the most current
other than those issued in or around November 2009.80 The Secretary is permitted to develop
guidelines to allow a group health plan and a health insurance issuer offering group or individual
health insurance coverage to utilize value-based insurance design.81
Sec. 1302. Essential Health Benefits Requirements
This section defines the elements of an “essential health benefits package,” those benefits that
must be provided by plans offered by qualified health plans that participate in insurance
78
For example, see the program activities table for Chronic Disease Prevention, Health Promotion, and Genomics in
CDC, FY2011 Justification of Estimates for Congressional Committees, pp. 117-118, http://www.cdc.gov/fmo/topic/
Budget%20Information/index.html.
79
Task Force on Community Preventive Services, http://www.thecommunityguide.org/index.html.
80
See discussion in the earlier section, “Coverage of Clinical Preventive Services.”
81
Value-based insurance design refers to coverage that encourages the use of services that have clinical benefits
exceeding the costs, while discouraging the use of services when the expected clinical benefits do not justify the costs.
See, for example, statement of Peter R. Orszag, “Health Care and the Budget: Issues and Challenges for Reform,”
before the Committee on the Budget, United States Senate, June 21, 2007.
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exchanges.82 Plans must cover, among other required benefits, preventive and wellness services,
which are not defined in the law. Plans may not apply the deductible to any preventive services
specified in PHSA Sec. 2713, as established in Sec. 1001 of ACA (above). The Secretary is
required to determine the specific elements of such coverage, which must be provided for plan
years beginning on or after January 1, 2014.
Prevention Under Medicare
In addition to the provisions summarized below, see the following sections later in this report,
which also address certain aspects of Medicare coverage and prevention: “Sec. 4202. Community
Wellness Pilot; Medicare Wellness Evaluation”; and “Sec. 4204. Immunizations.”
Sec. 4103. Medicare Annual Visit and Personalized Prevention Plan
This section, as amended by ACA Sec. 10402(b), amends SSA Sec. 1861 to require that Medicare
Part B cover, beginning in 2011, personalized prevention plan services, including a
comprehensive health risk assessment. The personalized plan could include several specified
elements, among them: review and update of medical and family history; a 5- to 10-year
screening schedule and referral for services recommended by the USPSTF and ACIP; a list of
identified risk factors and conditions and a strategy to address them; lists of all medications
currently prescribed and all providers regularly involved in the patient’s care; review or referral
for testing and treatment of chronic conditions; and cognitive impairment assessment.
All beneficiaries enrolled in Part B are eligible for personalized prevention plan services once
every year, without any cost-sharing. During the first year of enrollment, beneficiaries may
receive only the initial preventive physical examination (IPPE). Beneficiaries may receive
personalized prevention plan services each year thereafter provided that they have not received
either an IPPE or personalized prevention plan services within the preceding 12 months. The
Secretary is required to develop appropriate guidance, and to conduct outreach and related
activities, with respect to personalized prevention plan services and health risk assessments.
Sec. 4104. Removal of Cost-Sharing for Medicare Preventive Services
This section, as amended by ACA Sec. 10406, amends SSA Sec. 1861 to define preventive
services covered by Medicare as a specified list of currently covered services, including
colorectal cancer screening services even if diagnostic or treatment services are furnished in
connection with the screening. The list also includes the IPPE, as well as the personalized
prevention plan services that are covered pursuant to ACA Sec. 4103. Coverage remains subject
to all criteria that previously applied to each covered preventive service.
In addition, this section amends SSA Sec. 1833 to waive beneficiary coinsurance requirements
for most preventive services, requiring Medicare to cover 100% of the costs. Services for which
no coinsurance is required are the IPPE, personalized prevention plan services, any additional
82
Note that under PHSA Sec. 2707, coverage provided by health insurance issuers in the individual or small group
market must include coverage of the essential health benefits package as described in section 1302(b) of ACA. See also
CRS Report R42663, Health Insurance Exchanges Under the Patient Protection and Affordable Care Act (ACA), by
Bernadette Fernandez and Annie L. Mach.
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preventive service covered under the Secretary’s administrative authority, and any currently
covered preventive service (including medical nutrition therapy, and excluding
electrocardiograms) if it is recommended (i.e., with a grade of A or B) by the USPSTF. The
section generally waives the deductible for the same types of preventive services noted above for
which coinsurance is waived. It does not, however, waive the deductible for any additional
preventive service covered under the Secretary’s administrative authority.
Amendments made by this section became effective on January 1, 2011.
Sec. 4105. Evidence-Based Coverage of Medicare Preventive Services
This section authorizes the Secretary to modify the coverage of any currently covered preventive
service (including services included in the IPPE, but not the IPPE itself), to the extent that the
modification is consistent with USPSTF recommendations. The section also allows the Secretary
to withhold payment for any covered preventive service graded D (i.e., not recommended) by the
USPSTF. The enhanced authorities do not apply to services furnished for the purposes of
diagnosis or treatment (rather than as preventive services furnished to asymptomatic patients).
The provision states that these authorities were effective January 1, 2010. For practical purposes,
these provisions were effective upon enactment.
Sec. 10501(i)(2). Preventive Services Furnished at FQHCs
This section amends SSA Sec. 1861(aa)(3)(A) to provide that FQHCs may receive
reimbursement for Medicare covered preventive services, as defined in ACA Sec. 4104, furnished
on or after January 1, 2011.
Prevention Under Medicaid83
Sec. 4106. Medicaid Preventive Services for Adults
This section amends SSA Sec. 1905(a)(13) to, among other things, expand the current Medicaid
state option to provide other diagnostic, screening, preventive, and rehabilitation services to
include (1) any clinical preventive services recommended (i.e., with a grade of A or B) by the
USPSTF; and (2) immunizations recommended for adults by the ACIP, and the cost of their
administration. Effective in 2013, states that elect to cover these additional services and prohibit
cost-sharing for them receive an increased federal medical assistance percentage (FMAP), which
varies depending on whether the beneficiary is “newly eligible.”84 The law makes the regular
FMAP (which generally ranges between 50% and 76% in any given fiscal year, depending on the
state) explicitly available for adult preventive services and immunizations.
83
For more information about these and other Medicaid provisions in ACA, see CRS Report R41210, Medicaid and the
State Children’s Health Insurance Program (CHIP) Provisions in ACA: Summary and Timeline, by Evelyne P.
Baumrucker et al.
84
The definition of “newly eligible” is discussed in CRS Report RL32950, Medicaid’s Federal Medical Assistance
Percentage (FMAP), FY2013, by Alison Mitchell and Evelyne P. Baumrucker.
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For newly eligible individuals who receive adult preventive services (including immunizations)
for which cost-sharing is prohibited, states receive a one percentage point increase in their FMAP,
in addition to the increased FMAP applicable to services provided to newly eligible mandatory
individuals.85 For most formerly eligible individuals who receive adult preventive services
(including immunizations) for which cost-sharing is prohibited, states receive the regular FMAP
plus an additional one percentage point.86
Sec. 4107. Medicaid Tobacco Cessation Services for Pregnant Women
This section requires states, effective October 1, 2010, to provide Medicaid coverage to pregnant
women for counseling and drug therapy for tobacco cessation. Such services include diagnostic,
therapeutic, and counseling services, prescription and non-prescription tobacco cessation products
approved by the FDA, and other services that the Secretary recognizes to be effective. These
services exclude coverage for drugs or biologics that are not otherwise covered under Medicaid.
Cost-sharing for these services is prohibited, as is true for other pregnancy-related services under
Medicaid. Beginning January 1, 2013, states receive a one percentage point increase in their
regular FMAP for these smoking cessation services for pregnant women if they elect to cover the
new optional adult preventive care benefit (described above, ACA Sec. 4106).87
States may continue to exclude coverage of smoking cessation services for Medicaid beneficiaries
other than pregnant women. However, beginning on January 1, 2014, ACA requires state
Medicaid programs that offer prescription drug coverage to cover smoking cessation drugs
(including FDA-approved over-the-counter products) for most beneficiaries.88
Sec. 4108. Incentives for Chronic Disease Prevention Under Medicaid
This section requires the Secretary to award grants to states to provide incentives for Medicaid
beneficiaries to participate in healthy lifestyle programs. Such programs must be comprehensive
and targeted to the needs of Medicaid beneficiaries; must address criteria developed by the
Secretary according to evidence-based guidelines from the USPSTF, TFCPS, and the National
Registry of Evidence-based Programs and Practices;89 and must have demonstrated effectiveness
for managing cholesterol and/or blood pressure, losing weight, quitting smoking, and/or
preventing or managing diabetes. This section appropriates $100 million for the program for the
five-year period beginning on January 1, 2011. The Secretary may waive specified administrative
requirements, and must ensure that participating states make the program widely available.
Incentives received by a beneficiary cannot be taken into account for the purpose of determining
eligibility for, or the amount of, benefits under any federally funded program.
85
Ibid.
The CBO and the CMS Actuary projected a net cost to the Medicaid program for the state option to cover adult
preventive services. See supra note 63.
87
The CBO and CMS Actuary projected a net savings for the provision that provides coverage of tobacco cessation
services for pregnant women. See supra note 63.
88
ACA Sec. 2502.
89
The National Registry of Evidence-based Programs and Practices is a database of interventions for the prevention
and treatment of mental and substance use disorders, administered by SAMHSA. See http://www.nrepp.samhsa.gov/.
86
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Wellness Programs
Sec. 1001. Reporting Requirements for Group Health Plans/Gun Ownership
Among its provisions, this section creates a new PHSA Sec. 2717. This new section requires the
Secretary to develop reporting requirements for group health plans and health insurance issuers
with respect to plan or coverage benefits and health care provider reimbursement structures that,
among other things, implement “wellness and health promotion activities.” Health plans and
insurance issuers are required annually to submit to the Secretary and to enrollees a report on
whether the benefits under the plan or coverage satisfy these and other elements. The new section
also requires the Secretary to promulgate regulations providing criteria for determining whether a
reimbursement structure meets these elements. Under this new section, wellness and health
promotion activities may include personalized wellness and prevention services “that are
coordinated, maintained or delivered by a health care provider, a wellness and prevention plan
manager, or a health, wellness or prevention services organization that conducts health risk
assessments or offers ongoing face-to-face, telephonic or web-based intervention efforts for each
of the program’s participants.” These activities could include wellness and prevention efforts such
as smoking cessation, weight management, and healthy lifestyle support.
Also, the new PHSA Sec. 2717, as established by Sec. 1001 and amended by Sec. 10101(e) of
ACA, contains provisions relating to gun rights. Among them, a wellness or health promotion
activity (as referenced above) cannot require disclosure or collection of any information relating
to the presence or storage of a lawfully possessed firearm or ammunition in the residence or on
the property of an individual; or to the lawful use, possession, or storage of a firearm or
ammunition by an individual.90
Sec. 1201. Regarding Prohibiting Discrimination Based on Health Status
New PHSA Sec. 2705, created by ACA Sec. 1201, amends HIPAA’s nondiscrimination
requirements. Among other things, this new section largely codifies an amended version of the
HIPAA wellness program regulations. Wellness programs that do not require an individual to
satisfy a standard related to a health factor as a condition for obtaining a reward (or that do not
offer a reward) do not violate HIPAA, so long as participation in the programs is made available
to all similarly situated individuals. Wellness programs that impose conditions for obtaining a
reward, based on an individual meeting a certain standard relating to a health factor, must meet
additional requirements. Among them, the reward must be capped at 30% of the cost of the
employee-only coverage under the plan (instead of 20% under regulations issued prior to ACA),
but the Secretaries of HHS, Labor, and the Treasury may increase the reward up to 50%. The
HHS Secretary, in consultation with the Secretaries of the Treasury and Labor, must establish a
10-state pilot program in which participating states are required to apply the wellness program
provisions to health insurers in the individual market.
Also, although ACA Sec. 1201 only modifies the PHSA, ACA Sec. 1562, as amended by Sec.
10107, also makes these provisions applicable to group health plans and health insurance issuers
regulated under ERISA and the IRC.
90
ACA neither requires nor prohibits physicians asking their patients about gun ownership. See CRS Legal Sidebar,
Physicians’ Freedom to Ask Patients About Gun Ownership, posted Dec. 18, 2012, by Kathleen Swendiman.
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Sec. 4303. CDC Grants for Employer-Based Wellness Programs
This section, as amended by Sec. 10404, adds a new Part U in PHSA Title III, “Employer-Based
Wellness Program,” including several new sections. A new PHSA Sec. 399MM requires the CDC
Director to provide employers with technical assistance and other resources to evaluate workplace
wellness programs. The Director also is required to build evaluation capacity among workplace
staff and to provide resources, technical assistance, and consultation. A new PHSA Sec. 399MM1 requires the Director to conduct a national survey of employer-based health policies and
programs, and to report to Congress with findings and recommendations. In addition, a new
PHSA Sec. 399MM-2 requires the Secretary to evaluate all programs funded through the CDC
before conducting such an evaluation of privately funded programs, unless an entity with a
privately funded wellness program requests such an evaluation. Finally, a new PHSA Sec.
399MM-3 prohibits the use of any recommendations, data, or assessments carried out under this
Part to mandate requirements for workplace wellness programs.
Sec. 4402. Effectiveness of Federal Health and Wellness Initiatives
This section requires the Secretary, in order to determine whether existing federal health and
wellness initiatives are effective in achieving their stated goals, to conduct an evaluation and
report to Congress regarding changes in the health status of the American public, and specifically
the federal workforce. The evaluation must include absenteeism, productivity, workplace injury,
and medical costs incurred by employees; and health conditions, including workplace fitness,
healthy food and beverages, and incentives in the Federal Employees Health Benefits Program.
Sec. 10408. Workplace Wellness Program Grants
This section requires the Secretary to award grants to eligible employers to provide employees
with access to comprehensive workplace wellness programs. Eligible employers employ fewer
than 100 employees who work 25 or more hours per week, and do not provide a wellness
program as of the date of enactment. The Secretary must develop program criteria consistent with
evidence-based research and best practices, considering the Guide to Clinical Preventive
Services,91 the Guide to Community Preventive Services,92 and the National Registry for
Effective Programs.93 Programs must be made available to all employees and must include
specified components, including education, efforts to encourage participation, initiatives to
change unhealthy behaviors, and supportive work environments. There are authorized to be
appropriated $200 million in total, to be available until expended, for FY2011 through FY2015.
91
This guide is published by the U.S. Preventive Services Task Force (USPSTF).
This guide is published by the Task Force on Community Preventive Services (TFCPS).
93
The National Registry of Evidence-based Programs and Practices is a database of interventions for the prevention
and treatment of mental and substance use disorders, administered by SAMHSA. See http://www.nrepp.samhsa.gov/.
92
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Community-Based Prevention Programs
Secs. 3509 and 3511. Offices on Women’s Health
ACA creates a new PHSA Sec. 229, establishing in the Office of the Secretary an Office on
Women’s Health, for the establishment of goals and objectives, expert consultation, and other
specified duties. Among them, the Secretary is required to establish a National Women’s Health
Information Center and an HHS Coordinating Committee on Women’s Health. The Secretary may
provide funding and make interagency agreements as necessary to carry out these duties, and
must conduct evaluations of such activities and provide periodic reports to Congress. There are
authorized to be appropriated SSAN for FY2010 through FY2014. The section transfers to this
new office all functions of the existing Office on Women’s Health of the Public Health Service.
In addition, the section establishes new offices of women’s health, with specified duties, in CDC
(new PHSA Sec. 310A), AHRQ (redesignated PHSA Sec. 925), HRSA (new SSA Sec. 713), and
FDA (new FFDCA Sec. 1011). For each, there are authorized to be appropriated SSAN for
FY2010 through FY2014. The section also amends current authority for offices of women’s
health in the NIH and SAMHSA, to establish that the director of each office would report to the
senior official of the respective agency. Sec. 3511 of ACA authorizes the appropriation of SSAN
for the NIH and SAMHSA offices.
This section does not alter existing regulatory authority; terminate, reorganize, or transfer
authority away from women’s health offices in existence as of enactment, unless approved by
Congress; or change existing administrative activities at HHS regarding women’s health.
Sec. 4001. National Prevention, Health Promotion and Public Health Council
This section, as amended by Sec. 10401, requires the President to establish a National Prevention,
Health Promotion and Public Health Council, composed of secretaries, chairmen, and directors of
federal departments, boards and agencies (as specified), and to appoint the U.S. Surgeon General
as chairperson. The Council is required to provide federal coordination and leadership with
respect to prevention, wellness, and health promotion practices; to develop a national prevention,
health promotion, and public health strategy; and to report annually to the President and Congress
on activities under the strategy and progress toward identified goals, among other specified
activities. The President also must establish an Advisory Group on Prevention, Health Promotion,
and Integrative and Public Health, composed of 25 nonfederal members, to advise the Council
and report to the Surgeon General on lifestyle-based chronic disease prevention and management,
integrative health care practices, and health promotion.
Sec. 4002. Prevention and Public Health Fund
The stated purpose of this section is to establish a Prevention and Public Health Fund “to provide
for expanded and sustained national investment in prevention and public health programs to
improve health and help restrain the rate of growth in private and public sector health care costs.”
The section authorizes the appropriation of, and appropriates to the fund from the Treasury, the
following amounts: $500 million for FY2010; $750 million for FY2011; $1.00 billion for
FY2012; $1.25 billion for FY2013; $1.50 billion for FY2014; and $2.00 billion for each fiscal
year thereafter. The Secretary is required to transfer amounts from the fund to HHS accounts to
increase funding, over the FY2008 level, for programs authorized by the PHSA for prevention,
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wellness, and public health activities, including prevention research and health screenings. The
House and Senate Committees on Appropriations have the authority to transfer monies in the fund
to eligible activities under this section.
Sec. 4003. Clinical and Community Preventive Services Task Forces
Subsection 4003(a) reauthorizes and extends the authority for the U.S. Preventive Services Task
Force (USPSTF). It strikes and replaces PHSA Sec. 915(a), the previous authority for the
USPSTF, with language requiring the AHRQ Director to convene and administer a Preventive
Services Task Force, composed of individuals with appropriate expertise. This task force is
required to review scientific evidence related to the effectiveness, appropriateness, and costeffectiveness of clinical preventive services in order to develop recommendations for the health
care community, and to update previous clinical preventive recommendations, for publication in
the Guide to Clinical Preventive Services. The task force has specified duties, including
development of topic areas for review, review and revision of existing recommendations at least
once every five years, and improved integration with federal government health objectives and
related targets for health improvement, among others. All members of the task force convened
under this subsection, and any recommendations made by such members, are to be independent
and, to the extent practicable, not subject to political pressure. There are authorized to be
appropriated SSAN for each fiscal year to carry out task force activities.
Subsection 4003(b) provides explicit authority for the existing Task Force on Community
Preventive Services (TFCPS). It creates a new PHSA Sec. 399U requiring the CDC Director to
convene and administer a Community Preventive Services Task Force (“Community Task
Force”), composed of individuals with appropriate expertise, to review the scientific evidence
related to the effectiveness, appropriateness, and cost-effectiveness of community preventive
interventions for the purpose of developing recommendations for publication in the Guide to
Community Preventive Services. The Community Task Force has specified duties similar to those
of the Preventive Services Task Force above, except applied to policies, programs, processes, or
activities designed to affect or otherwise affecting health at the population level. There are
authorized to be appropriated SSAN for each fiscal year to carry out these activities.
Each task force must coordinate its activities with the other and with the ACIP. In addition,
neither task force is subject to requirements of the Federal Advisory Committee Act (FACA).94
Sec. 4004. Education and Outreach Campaign Regarding Preventive Benefits
This section requires the Secretary to carry out seven communications activities regarding health
promotion and disease prevention, generally oriented toward common and serious chronic health
problems, including poor nutrition, tobacco use, and obesity. First, the Secretary, in consultation
with the IOM, must plan and implement a national public-private partnership for a prevention and
health promotion outreach and education campaign. Second, through the CDC Director, the
Secretary must develop and implement a science-based media campaign, according to several
specified conditions. Third, in consultation with private-sector experts, the Secretary must
develop a website containing information for health providers and consumers regarding specified
94
For information about the Federal Advisory Committee Act, see CRS Report R40520, Federal Advisory Committees:
An Overview, by Wendy Ginsberg.
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chronic diseases and conditions. Fourth, through the CDC Director, the Secretary must develop a
program to disseminate information about health promotion to health care providers who
participate in federal health care programs. Fifth, through the CDC Director, the Secretary must
develop a Web-based tool that individuals can use to develop personalized prevention plans.
Sixth, the Secretary must establish an Internet portal for accessing risk-assessment tools
developed and maintained by private and academic entities. Finally, the Secretary must provide
guidance and relevant information to states and health care providers regarding preventive and
obesity-related services that are available to Medicaid enrollees, including obesity screening and
counseling for children and adults. In addition, each state must design a public awareness
campaign to educate Medicaid enrollees regarding the availability and coverage of such services.
The section states that funding for these activities takes priority over funding provided through
CDC grants for similar purposes, and that no more than $500 million could be spent on the
activities required under this section. There are authorized to be appropriated SSAN for each
fiscal year to carry out these activities.
Sec. 4102. Oral Health Activities
This section creates a new PHSA Title III, Part T, and “Oral Healthcare Prevention Activities.”
It includes a new Sec. 399LL that requires the Secretary, through the CDC, to establish a fiveyear national public education campaign on oral health, including prevention of oral diseases such
as dental carries, periodontal disease, and oral cancer. In addition, a new PHSA Sec. 399LL-1
requires the Secretary, through the CDC, to award grants to demonstrate the effectiveness of
research-based dental caries disease management activities. A new PHSA Sec. 399LL-2
authorizes the appropriation of SSAN to carry out this new PHSA Part. Additionally, the section
amends PHSA Sec. 317M to mandate a school-based dental sealant program that was previously
discretionary, and to require the Secretary to award program grants to each of the 50 states and
territories, and to Indians, Indian tribes, tribal organizations, and urban Indian organizations.
The section also adds a new PHSA subsection 317M(d) (redesignating existing subsections),
requiring the Secretary, through the CDC, to enter into cooperative agreements with states,
territories, and tribal entities to establish oral health leadership and programs to improve oral
health. There are authorized to be appropriated SSAN for FY2010 through FY2014 for this
activity. Finally, the section requires the Secretary to update, improve, and implement oral health
components in several specified national health surveys and surveillance systems, including the
National Oral Health Surveillance System (NOHSS), administered by CDC. For NOHSS, there
are authorized to be appropriated SSAN for each of FY2010 through FY2014 to increase
participation from the current 16 states to all 50 states, the territories, and the District of
Columbia. Also, the Secretary is required to ensure that NOHSS measures early childhood caries.
Sec. 4201. Community Transformation Grants
This section, as amended by ACA Sec. 10403, requires the Secretary, through the CDC Director,
to award competitive grants for the implementation, evaluation, and dissemination of evidencebased community preventive health activities, in order to reduce chronic disease rates, address
health disparities, and develop a stronger evidence base of effective prevention programming.
Eligible entities are state or local government agency, a national network of community-based
organizations, a state or local non-profit organization, or an Indian tribe. Grantees are required to
develop community transformation plans that include the policy, environmental, programmatic,
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and infrastructure changes needed to promote healthy living and reduce health disparities; and to
conduct health promotion activities and evaluations and disseminate findings. The CDC Director
is required to provide appropriate training and technical assistance. There are authorized to be
appropriated SSAN for FY2010 through FY2014 to carry out this program.
Sec. 4202. Community Wellness Pilot; Medicare Wellness Evaluation
Subsection 4202(a) requires the Secretary, through the CDC, to award grants to state or local
health departments or Indian tribes for pilot programs to provide community prevention
interventions, screenings, and clinical referrals for individuals between 55 and 64 years of age.
Grantees are to use funds to deliver interventions to improve nutrition, increase physical activity,
reduce tobacco use and substance abuse, improve mental health, and promote healthy lifestyles
among the target population; to identify risk factors for cardiovascular disease, stroke, and
diabetes; and to ensure that individuals with these risk factors receive follow-up services to
reduce such risk. Grantees must refer insured individuals with risk factors to participating
providers, and must work with community partners to assist uninsured individuals in finding
public coverage options or other sources of care. The Secretary must conduct annual program
evaluations by examining changes in the prevalence of uncontrolled chronic disease risk factors
among new Medicare enrollees (or individuals nearing enrollment) who reside in states or
localities receiving grants under this section as compared with national and historical data. There
are authorized to be appropriated SSAN for FY2010 through FY2014 to carry out this subsection.
Subsection 4202(b) requires the Secretary to conduct an evaluation of community-based
prevention and wellness programs, and, based on findings, develop a plan to promote healthy
lifestyles and chronic disease self-management among Medicare beneficiaries. To fund the
evaluation, the Secretary is required to transfer to CMS $50 million in total from the Medicare
Part A and Part B trust funds, in whatever proportion the Secretary determines.
Sec. 4203. Wellness for Individuals with Disabilities
This section adds a new Sec. 510 of the Rehabilitation Act requiring the Architectural and
Transportation Barriers Compliance Board, in consultation with FDA, to issue regulatory
standards for minimal technical criteria for medical diagnostic equipment (as specified) used in
medical settings.95 The standards must ensure that individuals with disabilities can use, enter, and
exit such equipment independently, to the maximum extent possible. The board is required
periodically to review the standards and amend them as necessary.
Sec. 4204. Immunizations
This section amends PHSA Sec. 317 to provide explicit authority to the Secretary to negotiate
and enter into contracts with manufacturers for the purchase of vaccines for adults, and for states
to purchase such vaccines at the prices negotiated by the Secretary. The section also amends
PHSA subsection 317(j) to permanently reauthorize the program of immunization grants to states.
95
Section 502 of the Rehabilitation Act established the Architectural and Transportation Barriers Compliance Board to
develop design standards for, and to assure compliance by, facilities designed, built, altered, or leased with federal
funds, in order to improve access for people with disabilities.
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In addition, the section adds a new PHSA subsection 317(m), which requires the Secretary,
through the CDC, to conduct a demonstration program of grants to states to improve
immunization coverage of children, adolescents, and adults. States must use grant funds to
implement recommendations of the TFCPS, or other evidence-based interventions, and must
report to the Secretary regarding progress in improving immunization rates in high-risk
populations. The Secretary must report to Congress within four years regarding the effectiveness
of the program and recommendations regarding whether it should be extended or expanded.
There are authorized to be appropriated SSAN for FY2010 through FY2014 to carry out this
subsection.
Finally, the section requires a GAO study of the impact of vaccine coverage under Medicare Part
D on access to those vaccines by beneficiaries who are 65 years of age or older. It appropriates $1
million for FY2010 for this study. (The GAO study is listed in the text box at the beginning of
this section of the report.)
Nothing in the section or any other provision of ACA is to be construed to decrease children’s
access to immunizations.
Sec. 4206. Demonstration Project Concerning Individualized Wellness Plan
This section creates a new PHSA subsection 330(s), requiring the Secretary to establish a pilot
program in not more than 10 community health centers (CHCs) to test the impact of providing atrisk individuals who use the centers with individualized wellness plans, designed to reduce risk
factors for preventable conditions as identified by a comprehensive assessment. A wellness plan
could include one or more of the following: (1) nutritional counseling; (2) a physical activity
plan; (3) alcohol and smoking cessation counseling and services; (4) stress management; (5)
dietary supplements that have health claims approved by the Secretary; and (6) compliance
assistance provided by a CHC employee. Risk factors must include weight, tobacco and alcohol
use, exercise rates, nutritional status, and blood pressure. Wellness plans must make comparisons
between the individuals involved and a control group of individuals with respect to these risk
factors. There are authorized to be appropriated SSAN to carry out these activities.
Sec. 4301. Research on Optimizing the Delivery of Public Health Services
This section requires the Secretary, through the CDC, to fund research on public health services
and systems, to include (1) examining evidence-based prevention practices, including comparing
community-based public health interventions in terms of effectiveness and cost; (2) analyzing the
translation of interventions from academic to real-world settings; and (3) identifying effective
strategies for organizing, financing, or delivering public health services in community settings,
including comparing state and local health department structures and systems in terms of
effectiveness and cost. Such research must be coordinated with the TFCPS.
Sec. 4304. Epidemiology and Laboratory Capacity Grants
This section amends PHSA Title XXVIII, “National All-Hazards Preparedness for Public Health
Emergencies,” adding a new Subtitle C, “Strengthening Public Health Surveillance Systems,”
consisting of a new PHSA Sec. 2821, “Epidemiology-Laboratory Capacity Grants.” The purpose
is to establish a grant program, subject to the availability of appropriations, to strengthen national
epidemiology, laboratory, and information management capacity for the response to infectious
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diseases and other conditions of public health importance. Eligible entities are state, local, or
tribal health departments, tribal jurisdictions, or academic centers that meet CDC-specified
criteria. There are authorized to be appropriated $190 million for each of FY2011 through
FY2013, of which at least $95 million per fiscal year must be used to award grants for
epidemiology and disease control capacity, at least $60 million per fiscal year for grants for
information management capacity, and at least $32 million per fiscal year for laboratory capacity.
Sec. 4306. CHIPRA Childhood Obesity Demonstration Project
The Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA; P.L. 111-3)
contains several quality of care provisions, including one requiring the Secretary to conduct a
demonstration project to develop a model for reducing childhood obesity. CHIPRA authorized the
appropriation of $25 million for the period FY2009 through FY2013 for this demonstration. This
ACA section amends SSA Sec. 1139A(e), replacing the authorization of appropriations with a
total appropriation of $25 million for the period of FY2010 through FY2014.
Sec. 10334. Offices of Minority Health
This section amends PHSA Sec. 1707, elevating the existing Office of Minority Health (“the
Office”) in the Office of Public Health and Science at HHS by placing it within the Office of the
Secretary. The Office is to be headed by a Deputy Assistant Director for Minority Health (DAD)
who reports directly to the Secretary. The Secretary, through the DAD, is required to award grants
and contracts, and to enter into agreements with certain types of entities to assure improved health
status of racial and ethnic minorities, and to develop measures to evaluate the effectiveness of
activities aimed at reducing health disparities and supporting the local community, as specified.
The Secretary must report to Congress biennially regarding the program. A similar requirement is
placed on HHS agency heads regarding their respective Offices of Minority Health, which must
be established as described below. The section authorizes the appropriation of SSAN for each of
FY2011 through FY2016 for the Office.
The section also adds a new PHSA Sec. 1707A, requiring the heads of CDC, HRSA, SAMHSA,
AHRQ, FDA, and CMS to establish offices of minority health within the respective agencies.
Each office’s director is appointed by and reports directly to the agency head. The Secretary is
required to designate as specified, for carrying out the activities of the section, an appropriate
amount of funds appropriated for each agency for a fiscal year.
Finally, the section amends PHSA Title IV, redesignating the NIH National Center on Minority
Health and Health Disparities as an Institute. It expands the Institute Director’s authority to make
research endowments to include those made to certain centers of excellence for research
education and training. It also changes eligibility requirements for centers to receive certain
endowments, making the calculation based upon the national median of endowment funds. The
section requires the Institute Director, as the primary federal official responsible for coordinating
all NIH research and activities on minority health and health disparities, to plan, coordinate,
review and evaluate research and other activities conducted or supported by NIH.
Sec. 10407. Better Diabetes Care
This section requires the Secretary, in collaboration with CDC, to prepare and publish a biennial
national diabetes report card, and, to the extent possible, a report card for each state. In addition,
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the Secretary is required, through the CDC, to promote the education and training of physicians
on the importance of birth and death certificate data, encourage state adoption of the latest
standard revisions of birth and death certificates, and work with states to re-engineer their vital
statistics systems. The Secretary is also required, in collaboration with IOM, to study and report
on the impact of diabetes on medical practice, and the appropriateness of medical education
regarding diabetes. Finally, the Secretary is allowed to promote improvements to the collection of
diabetes mortality data. There are authorized to be appropriated SSAN to carry out this section.
Sec. 10411. Congenital Heart Disease Programs
This section amends Part P of Title III of the PHSA adding a new PHSA Sec. 399V-2. This new
section authorizes the Secretary, through the CDC, to enhance and expand infrastructure to track
the epidemiology of congenital heart disease; to organize such information into a nationally
representative surveillance system; or to award a grant to one eligible entity to undertake these
activities. This surveillance system must be made available to the public and must comply with
the HIPAA Privacy Rule.96
This section also amends Subpart 2 of Part C of Title IV of the PHSA by adding at the end a new
PHSA Sec. 425. This new section authorizes the Director of the NIH National Heart, Lung, and
Blood Institute (the Director) to expand, intensify and coordinate research with respect to
congenital heart disease. The Director must consider the application of this research to minority
and medically underserved populations. There are authorized to be appropriated SSAN for each
of FY2011 through FY2015 for both the surveillance system and the expanded research program.
Sec. 10412. Public Access Defibrillation Programs
This section amends and reauthorizes PHSA Sec. 312, which requires the Secretary to award
grants for public access defibrillation programs. Specifically, ACA requires that information
clearinghouses established to increase access to defibrillation in schools be administered by an
organization with expertise in pediatric education, pediatric medicine, and electrophysiology and
sudden death. Also, the section authorizes the appropriation of $25 million for each of FY2003
through FY2014.
Sec. 10413. Young Women’s Breast Health Awareness
This section adds a new Part V to PHSA Title III, “Programs Relating to Breast Health and
Cancer,” consisting of a new PHSA Sec. 399NN. This new section requires the Secretary, through
the CDC, to conduct a national evidence-based education campaign, with several specified
elements, to increase breast cancer awareness among young women between the ages of 15 and
44. Among other things, the Secretary is required, within 60 days of enactment, to establish an
advisory committee to assist in conducting the campaign. The section also requires the Secretary,
through the CDC, to conduct prevention research on breast cancer in younger women. In
addition, the NIH is required to develop and validate new screening tests and methods for
prevention and early detection of breast cancer in young women. The section authorizes the
appropriation of $9 million for each of FY2010 through FY2014 for these activities.
96
45 CFR Part 160 and Part 164, Subparts A and E. For more information, see HHS, Office of Civil Rights, “Health
Information Privacy,” http://www.hhs.gov/ocr/privacy/index.html.
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Sec. 10501(g). National Diabetes Prevention Program
This section creates a new PHSA Sec. 399V-3 requiring the Secretary, through the CDC, to
establish a national diabetes prevention program, targeted at high-risk adults, with specified
program components. Entities eligible for program grants are state or local health departments,
tribal organizations, national networks of community-based non-profits focused on health and
well-being, academic institutions, or other entities, as the Secretary determines. There are
authorized to be appropriated SSAN for each of FY2010 through 2014.
Maternal and Child Health
Overview and Impact of ACA
Infant mortality, low birth weight, and complications of pregnancy and childbirth
disproportionately affect low-income and minority populations. Access to health care coverage
and related psychological, educational, and material support has been shown to positively
influence these outcomes.
The federal government funds health care coverage and services to increase access to maternity
care for low-income women, improve the quality of the care pregnant women receive, and
improve pregnancy outcomes. Several federal programs support access to health care for lowincome pregnant women and their families.
Maternal and Child Health
Specifically, Medicaid coverage is the
largest single source of federal support for
CRS Report R42428, The Maternal and Child Health Services
Block Grant: Background and Funding, by Amalia K. Corbymaternal and child health care. Other major
Edwards.
sources of maternal and child health funding
CRS Report RS20301, Teenage Pregnancy Prevention:
are the Maternal and Child Health Services
Statistics and Programs, by Carmen Solomon-Fears.
Block Grant Program and Healthy Start,
both of which support state-level initiatives.
CRS Report RS20873, Reducing Teen Pregnancy: Adolescent
Family Life and Abstinence Education Programs, by Carmen
In addition to health care services, these
Solomon-Fears.
programs provide links to other support
systems, including housing, nutrition, and
education assistance.
As noted elsewhere in this report, the ACA expands eligibility and coverage requirements for
Medicaid and increases funding for community health centers, which are both important
providers of maternal and child health care. The ACA also promotes other policies that may
improve access to prenatal care for low-income women and that are associated with improved
outcomes for mothers and infants, such as home visiting and school-based support for pregnant
and parenting teens and women. Additionally, the ACA funds programs that encourage
breastfeeding for those who are able, and promotes screening and treatment of post-partum
depression.
The ACA appropriates $1.5 billion over five years (FY2010-FY2014) to support evidence-based
early childhood home visiting programs. Home visitation is used to deliver support and services
to families or individuals in their homes. Early childhood home visitation programs typically seek
to improve maternal and child health; early childhood social, emotional, and cognitive
development; and family/parent functioning. Depending on the particular model of early home
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visitation being used, the visitors may be specially trained nurses, other professionals, or
paraprofessionals. Participation of families is voluntary. Early childhood home visitation
programs are in operation in all 50 states and the District of Columbia. In addition to private and
state and local public funds provided for early childhood home visitation, a number of federal
programs have been used to support early childhood home visiting programs. Sources include,
among others, Medicaid, the Temporary Assistance for Needy Families (TANF) block grant,
Community-Based Grants to Prevent Child Abuse and Neglect, the Maternal and Child Health
(MCH) Services Block Grant, Healthy Start, and Early Head Start. Prior to the enactment of the
ACA there was no dedicated federal support for early childhood home visitation and the Obama
Administration, as part of its “Zero to Five Initiative,” (discussed in its FY2010 budget request),
sought mandatory federal funding for this purpose.97
The ACA also appropriates $250 million over 10 years ($25 million for each of FY2010 through
FY2019) to establish a new competitive grant program to enable states to provide services for
pregnant and parenting teens and women. With regard to postpartum depression, the ACA
authorizes funding for support, education, and research, and requires HHS to conduct a study on
the benefits of screening for that condition. The ACA requires employers to provide certain
nursing mothers of infants both time and a place to express breast milk while at work.
Maternal and Early Childhood Home Visitation
Sec. 2951. Maternal, Infant, and Early Childhood Home Visiting Programs
This section amends Title V to add a new SSA Sec. 511, Maternal, Infant, and Early Childhood
Home Visiting Programs. This section requires states to conduct a unique statewide needs
assessment as a condition of receiving their FY2011 MCH Services Block Grant funds. This
section also appropriates $1.5 billion over five years (FY2010-FY2014) to support evidencebased early childhood home visiting programs.
This section appropriates a total of $1.5 billion for FY2010 through FY2014 for the home
visitation grant program: $100 million for FY2010; $250 million for FY2011; $350 million for
FY2012; $400 million for FY2013; and $400 million for FY2014. Of the amount appropriated for
this program, 3% must be reserved for research and evaluation, and 3% for making grants to
tribal entities for home visitation services to Indian families. The new early childhood home
visitation grant program is collaboratively administered by two HHS agencies: the ACF and the
MCH Bureau of HRSA.
Support for Pregnant and Parenting Teens and Women
Secs. 10211-10214. Pregnancy Assistance Fund
These sections create and fund a new competitive grant program administered by the HHS
Secretary to help pregnant and parenting teens and women. Sec. 10211 defines terms associated
with the new pregnancy assistance fund. Sec. 10212 creates a new Pregnancy Assistance Fund
97
For more information, see CRS Report R40705, Home Visitation for Families with Young Children, by Emilie
Stoltzfus and Karen E. Lynch.
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that requires the HHS Secretary (in collaboration and coordination with the Secretary of
Education) to establish a competitive grant program to states to help pregnant and parenting teens
and women. Sec. 10213 allows states to make pregnancy assistance grant funds available to (1)
institutions of higher education, (2) high schools and community service centers, (3) a state’s
attorney general, and/or (4) to increase public awareness and education.
Sec. 10214 authorizes and appropriates $25 million annually for each of the 10 fiscal years
FY2010 through FY2019 for the new pregnancy assistance fund.
Postpartum Depression
Sec. 2952. Support, Education, and Research for Postpartum Depression
This section of the ACA encourages the Secretary to expand and intensify specified types of
research—including epidemiology, improved screening and diagnosis, clinical research, and
public education—to expand understanding of the causes and treatments for postpartum
depression and related conditions. Further, this section creates a new SSA Sec. 512 that requires
the HHS Secretary to study the benefits of screening for postpartum conditions (including
postpartum depression and postpartum psychosis) and, within two years of enactment (i.e., no
later than March 23, 2012), to submit a report to Congress on the results.
In addition, under the new SSA Sec. 512, Services to Individuals with a Postpartum Condition
and their Families, the HHS Secretary is authorized to award grants to eligible entities to
establish, operate and coordinate effective and cost-efficient systems for the delivery of essential
services to individuals with, or at risk of, postpartum depression (including postpartum psychosis)
and their families. The law authorizes funding of $3 million for these grants for FY2010, and
such sums as may be necessary for each of FY2011 and FY2012. The section stipulates that the
HHS Secretary may, to the extent practicable and appropriate, integrate this program with other
grant programs administered by HHS, including grants related to health centers for medically
underserved populations (authorized under Sec. 330 of the PHSA). Eligible grantees include
public or nonprofit private entities, state or local government public-private partnerships,
recipients of Healthy Start grants, public or nonprofit private hospitals, community-based
organizations, hospices, ambulatory care facilities, community health centers, migrant health
centers, public housing, primary care centers, and homeless health centers.
Finally, ACA Sec. 2952 states that it is the sense of Congress that the Director of the National
Institute of Mental Health (NIMH) may conduct a nationally representative longitudinal study
(during the period FY2010-FY2019) on the relative mental health consequences for women of
resolving a pregnancy, intended and unintended, in various ways (e.g., carrying the pregnancy to
term and parenting the child, carrying the baby to term and placing the child for adoption,
miscarriage, and abortion). Subject to the completion of such a study, beginning within five years
after enactment (i.e., March 23, 2015), and periodically thereafter for the duration of the study,
the NIMH Director may submit to Congress reports on the study’s findings.
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Break Time for Nursing Mothers to Express Breast Milk
Sec. 4207. Reasonable Break Time for Nursing Mothers
This section amends Sec. 7 of the Fair Labor Standards Act (FLSA),98 to require employers to
provide a reasonable break time for an employee to express breast milk for her nursing child (for
one year after the child’s birth). The break time must be made available each time such an
employee needs to express milk. Further the employer must provide a space for the employee to
express milk that is not a bathroom, is shielded from view, and is free from intrusion from
coworkers and the public. The section stipulates that an employer is not required to compensate
an employee for this break time. Further, because it amends the part of FLSA related to maximum
work hours, this section’s requirement does not apply to employees who are exempt from federal
overtime pay provisions of that law (e.g., executive, administrative, and professional employees).
In addition, the ACA explicitly states that employers of fewer than 50 employees are not subject
to these requirements if they would impose an undue hardship by causing the employer
significant difficulty or expense when considered in relation to the size, financial resources,
nature, or structure of the employer’s business. Finally, these provisions do not preempt any state
law that provides greater protections to employees.
Teen Pregnancy Prevention and Adoption Support
Overview and Impact of PPACA
Prior to enactment of the ACA, several laws addressed the subject of teen pregnancy prevention.
PHSA Title XX (Adolescent Family Life (AFL) Demonstration Projects) authorizes a number of
voluntary teen pregnancy prevention, counseling, and related programs. PHSA Title X
(Population Research and Voluntary Family Planning Programs) authorizes grants for
comprehensive voluntary family planning services, education, and research, including such
activities for adolescents. PHSA Sections 318 and 318A authorize grants for technical assistance
and voluntary services (including screening, treatment, counseling, and education) to address
sexually transmitted diseases in women (these provisions do not explicitly address adolescents).
P.L. 111-117, the Consolidated Appropriations for FY2010, included a new discretionary Teen
Pregnancy Prevention (TPP) program, identical to one proposed in the President’s FY2010
budget, that provides grants and contracts, on a competitive basis, to public and private entities to
fund “medically accurate and age appropriate” programs that reduce teen pregnancy. The TPP
program is administered by the new Office of Adolescent Health within HHS. P.L. 111-117 also
provided a separate appropriation (within the Public Health Service Act program evaluation
funding) to carry out evaluations of teenage pregnancy prevention approaches.99 There are also
98
The Fair Labor Standards Act is the primary federal statute dealing with maximum hours and minimum wages for
employees.
99
For more information on the discretionary Teen Pregnancy Prevention (TPP) program, see CRS Report R40618,
Teen Pregnancy Prevention: Background and Proposals in the 111th Congress, by Carmen Solomon-Fears.
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several other federally funded programs that provide pregnancy prevention information and/or
services to teens.100
SSA Sec. 510 authorizes a separate state formula grant program to support abstinence-only
education programs. Funds are awarded to states based on the proportion of low-income children
in each state compared to the national total, and may only be used for teaching abstinence. To
receive funding, a state must match every $4 in federal funds with $3 in state funds. Sec. 510
provided $50 million for each of the six fiscal years (FY1998-FY2003). Prior to the ACA, the
program had not been reauthorized, although appropriations were extended through 2009.101
The ACA restores funding for the abstinence-only approach to teen pregnancy prevention.
Congress had let the funding for the SSA Sec. 510 abstinence education program expire on June
30, 2009. The ACA resumes that funding, appropriating $250 million for the program at $50
million per year for five years. Concurrently, the ACA also establishes a new state formula grant
program and appropriates $375 million at $75 million per year for five years (FY2010-FY2014)
to enable states to operate a new Personal Responsibility Education program, which is a
comprehensive approach to teen pregnancy prevention that educates adolescents on both
abstinence and contraception to prevent pregnancy and sexually transmitted diseases, and also
provides youth with information on several adulthood preparation subjects (i.e., healthy
relationships, adolescent development, financial literacy, parent-child communication,
educational and career success, and healthy life skills). The ACA also amends the adoption tax
credit.
Personal Responsibility Education and Abstinence Education
Sec. 2953. Personal Responsibility Education
This section adds a new SSA Sec. 513, Personal Responsibility Education, to be administered by
the ACF. This section establishes a new state formula grant program and appropriates $75 million
annually for each of the five fiscal years FY2010 through FY2014 to enable states to operate a
new Personal Responsibility Education program. Under the funding allocation formula, each state
receives an amount based on the size of its youth population (persons ages 10 through 19) as a
percentage of the national youth population. However, each state receives a minimum allotment
of at least $250,000 for each of the five fiscal years FY2010 through FY2014.
The section also specifies that each state’s Personal Responsibility Education program must
include at least three of the six stipulated adulthood preparation subjects, which are (1) healthy
relationships, including marriage and family interactions; (2) adolescent development, including
the development of healthy attitudes and values about adolescent growth and development, body
image, racial and ethnic diversity, and other related subjects; (3) financial literacy; (4) parentchild communication; (5) educational and career success, including developing skills for
employment preparation, job seeking, independent living, financial self-sufficiency, and
100
These programs include Medicaid Family Planning, the Maternal and Child Health block grant, the Temporary
Assistance for Needy Families (TANF) program, the Title XX Social Services block grant, and a couple of teen
pregnancy prevention programs administered by the Centers for Disease Control and Prevention.
101
For more information, see CRS Report RS20873, Reducing Teen Pregnancy: Adolescent Family Life and
Abstinence Education Programs, by Carmen Solomon-Fears.
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workplace productivity; and (6) healthy life skills, including goal-setting, decision making,
negotiation, communication and interpersonal skills, and stress management.
The Secretary is required to annually reserve $10 million (out of the $75 million annual
appropriation) for grants to entities to implement innovative youth pregnancy prevention
strategies and target services to high-risk, vulnerable, and culturally under-represented youth
populations. An entity that is awarded a grant is required to participate in a rigorous federal
evaluation of the activities funded by the grant. The Secretary is required to reserve 5% of
remaining funds for allotments to Indian tribes and tribal organizations and 10% of remaining
funds for technical assistance and evaluation expenditures by the Secretary.
Sec. 2954. Restoration of Funding for Abstinence Education
This section amends SSA Sec. 510 by appropriating $50 million for each of FY2010 through
FY2014 for the abstinence-only education block grant program to states.
Adoption Support
Sec. 10909. Expansion of Adoption Credit and Adoption Assistance Programs
This section amends IRC Sec. 23b, which had, prior to the enactment of the ACA, provided both
an adoption tax credit and income tax exclusion for taxpayers with qualified expenses related to a
domestic or international adoption of a child.102 The ACA increased the qualified expense
limitation for the adoption tax credit and the income exclusion for qualified employer-provided
adoption assistance programs to $13,170 for tax year 2010 (a $1,000 increase over prior law) and
it indexes this new amount to inflation for tax year 2011. In addition, for tax years 2010 and 2011,
the ACA made the adoption tax credit refundable. Finally, the elimination of the exclusion for
employer-provided adoption assistance and the changes in the adoption tax credit scheduled to go
into effect with tax year 2011 were delayed by one year. Under the ACA, those changes took
effect in tax year 2012 (i.e., the tax year beginning after December 31, 2011). The Joint
Committee on Taxation estimated tax expenditures resulting from ACA amendments to these
adoption-related tax benefits will total $1.2 billion.103
Quality
Overview and Impact of ACA
Prior to the ACA, numerous stakeholders, including policymakers, had engaged in a wide range
of efforts to improve health care quality. These efforts generally focused on developing,
improving and refining metrics for measuring the quality of care delivered in a number of
settings; publicly reporting comparative information on quality performance; and aligning
payment policies with performance on metrics as a mechanism to incentivize and encourage
102
103
For more information see CRS Report RL33633, Tax Benefits for Families: Adoption, by Christine Scott.
See JCX-17-10, p. 3, at http://www.jct.gov/publications.html?func=startdown&id=3672.
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provider accountability (e.g., value-based purchasing). In addition, a number of approaches that
seek to improve the delivery of health care services, and thus both quality and efficiency, had
gained attention, including efforts focused on improved coordination of care; the development of
new patient-centered care models, for example, medical homes; and the enhancement of patient
safety. However, these efforts had not generally been guided by a single federal strategy, entity, or
set of priorities or goals, nor had they benefitted from a coordinated infrastructure specifically
devoted to improving health care quality.
ACA employs a multi-faceted approach to improving the quality of health care, which relies for
the most part on a collection of incremental steps that together aim to make progress toward
addressing the key issues outlined
above. ACA specifically leverages
Quality
three broad mechanisms to improve the CRS Report R42347, Health Care Quality: Enhancing Provider
Accountability Through Payment Incentives and Public Reporting, by
quality of health care:
1. Codifying a series of
provisions which together
comprise a national-level
approach to the improvement
of health care quality, quality
measurement, and the use of
quality data;
2. Supporting quality
improvement and patient safety
activities through research
support, grants to implement
research findings, and
educational efforts; and
3. Incentivizing the development
or implementation of, or
facilitating, a number of health
service delivery reforms (such
as care coordination through
medical homes or other
approaches) including those
that target quality improvement
reforms across the spectrum of
payers, including private health
insurers, Medicare, and
Medicaid.
Amanda K. Sarata.
CRS Report R40749, Measuring Health Care Quality:
Measure Development, Endorsement, and Implementation, by
Amanda K. Sarata.
Agency for Healthcare Research and Quality. "National
Healthcare Quality Report," 2010.
http://www.ahrq.gov/qual/nhqr10/Key.htm.
National Quality Forum, "Measure Development and
Endorsement Agenda." January 2011, Washington, DC,
http://www.qualityforum.org/MeasureDevelopmentandEndorseme
ntAgenda.aspx.
National Quality Forum, “Measurement Application Partnership:
MAP Pre-Rulemaking Report: 2013 Recommendations on
Measures Under Consideration by HHS,” Final Report, February
2013.
http://www.qualityforum.org/Publications/2013/02/MAP_PreRulemaking_Report_-_February_2013.aspx.
RAND Health, "Technical Report: An Evaluation of the Use of
Performance Measures in Health Care." Washington, DC, 2011,
http://www.rand.org/content/dam/rand/pubs/technical_reports/20
11/RAND_TR1148.pdf.
The Joint Commission, “Improving America's Hospitals: The Joint
Commission' Annual Report on Quality and Safety," Santa Monica,
CA, 2011,
http://www.jointcommission.org/assets/1/6/tjc_annual_report_20
11_9_13_11_.pdf.
United States Government Accountability Office. "Health Care
Quality Measurement: HHS Should Address Contractor
Performance and Plan for Needed Measures." January 2012,
http://www.gao.gov/assets/590/587658.pdf.
Regarding the first of these
mechanisms, the ACA seeks to create a coordinated strategy for quality measurement. Prior to
ACA’s enactment, health care quality improvement efforts were largely uncoordinated, although
in some cases efforts were led by AHRQ and CMS. These efforts—spanning quality improvement
activities at the delivery level, measure development, measure endorsement, measure selection
and implementation, public reporting of quality data, and inter-agency coordination of health care
quality activities—were often linked, but were not systematically coordinated. In addition,
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progress in these areas was not necessarily being assessed for comprehensiveness. ACA aimed to
take steps to address these issues by including a series of five provisions focusing on the
development of a national strategy, priorities, and strategic plan to improve health care quality;
coordination of health care quality activity at the federal level; measure development and
endorsement; public reporting of quality data; and the coordinated selection of measures for use
in federal quality programs through a pre-rulemaking process.
Regarding the second mechanism, ACA includes provisions that aim to support both quality
improvement and patient safety activities. Specifically, ACA includes a provision tasking an
existing center at AHRQ with carrying out research on best practices in a number of areas and
establishing a grant program to assist entities with implementation and adoption of the research
findings of this center. The ACA also includes patient safety related provisions that aim to
enhance the education of health care providers in this area and that establish an effort to publicly
report on measures for hospital acquired conditions (HACs) that are currently utilized by CMS
for the adjustment of payment to hospitals based on rates of hospital-acquired infections;104 and
through provisions that aim to improve the quality and safety of care delivered to nursing home
residents. For more information on these provisions, see the section “Nursing Homes and Other
Long-Term Care Facilities and Providers.”
Regarding the third mechanism, health care delivery reforms have often sought to improve the
efficiency of the delivery of services, as well as improving the quality or value of service
delivery. ACA includes a number of provisions that aim to improve the coordination of the
delivery of health care across settings. Many of these provisions specifically focus on patientcentered models of care, such as medical homes, and on improving care for chronic conditions.
Specifically, the ACA authorizes funding for several types of programs aimed at enhancing the
coordination of care. Some programs seek to improve the delivery of health care services by
supporting medical homes, medication management services, primary care extension programs,
the co-location of mental and other health services, or community-based collaborative care
networks. Others aim to empower patients by facilitating shared decisionmaking among patients,
caregivers and providers, or modifying requirements for patient navigator services. The ACA care
coordination-related provisions incentivize the improvement of the coordination of care by
broadly encouraging reforms in various settings, with different patient populations, with different
payer sources, and by attempting to educate and empower patients to improve coordination of
their care. Specifically, ACA includes numerous provisions that expand value-based purchasing in
the Medicare program;105 that target improvements in the quality of care provided through the
Medicaid program;106 and which extend to private insurers’ quality reporting requirements
relating to both covered benefits and reimbursement structures that improve health outcomes and
patient safety.107 The application of health care quality requirements to private health plans
governed by the PHSA, ERISA and the IRC, and not as a condition of participation in a public
program, is a noteworthy departure from law prior to ACA.
104
Hospital-acquired infections are a type of a hospital-acquired condition.
ACA, Title III, Subpart A, Part I, Secs. 3001-3008.
106
ACA, Title II, Subtitle I, Secs. 2701-2707.
107
The private market reforms added by ACA directly amend the PHSA, and thus apply to all health insurance issuers
offering coverage in the individual and group markets, and to nonfederal government plans (ACA Sec. 1001). In
addition, through conforming amendments, ACA extends the application of these reforms to all employer-sponsored
group health plans regulated by ERISA and the IRC (Sec. 1563(e) and (f), respectively).
105
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The following sections provide an overview of the specific provisions related to developing and
coordinating health care quality activities at the national level, quality improvement/patient safety
related reforms, and health care service delivery reforms related to care coordination.108
National Strategy to Improve Health Care Quality and Quality
Measurement
Sec. 3011. National Strategy
Sec. 3011, as amended by ACA Sec. 10302, creates in Title III a new PHSA Part S, Health Care
Quality Programs, Subpart I, National Strategy for Quality Improvement in Health Care. It
includes a new Sec. 399HH, National Strategy for Quality Improvement in Health Care, which
required the Secretary to establish a national strategy for healthcare quality improvement to
improve the delivery of health care services, outcomes, and population health, and to identify
national priorities for quality improvement by January 1, 2011. This section requires the Secretary
to ensure that the national priorities would address health care provided to patients with high-cost
chronic diseases; improve federal payment policy to emphasize quality and efficiency; have the
greatest potential for improving health outcomes, efficiency, and patient-centeredness of care;
reduce health disparities; and address gaps in quality and health outcomes measures, comparative
effectiveness information, and data aggregation techniques, among others. The national strategy
must include a comprehensive strategic plan to achieve the national priorities for quality
improvement and will be required to address a number of issues, including coordination among
agencies within the Department and strategies to align public and private payers with regard to
quality and patient safety efforts, among others. The Secretary is also required to create a health
care quality website to make public the national priorities and other information the Secretary
deems appropriate.
Sec. 3012. Interagency Working Group on Health Care Quality
This section requires the President to convene a working group to be known as the Interagency
Working Group on Health Care Quality. The goals of this group include achieving collaboration,
cooperation, and consultation between federal departments and agencies with respect to quality
improvement activities; avoiding duplication of quality improvement efforts; developing a
streamlined process for quality reporting and compliance requirements; and assessing alignment
of quality efforts in the public sector with private sector initiatives. The working group is
composed of senior level representatives of specified federal agencies and departments; the
Secretary serves as the chair; and members serve as vice chair on a rotating basis. The Working
Group was required to submit a report describing its progress and recommendations to relevant
committees of Congress and to make this report publicly available.
108
For more information about value-based purchasing provisions under Medicare and new patient care models, see
CRS Report R41196, Medicare Provisions in the Patient Protection and Affordable Care Act (PPACA): Summary and
Timeline, coordinated by Patricia A. Davis. For more information about Medicaid quality provisions, see CRS Report
R41210, Medicaid and the State Children’s Health Insurance Program (CHIP) Provisions in ACA: Summary and
Timeline, by Evelyne P. Baumrucker et al. Finally, for more information about private health insurance reform
provisions, see CRS Report R42069, Private Health Insurance Market Reforms in the Patient Protection and
Affordable Care Act (ACA), by Annie L. Mach and Bernadette Fernandez.
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Sec. 3013. Quality Measure Development
Subsection 3013(a) creates in PHSA Title IX Part D, Health Care Quality Improvement,
Subpart I, Quality Measure Development. It includes a new PHSA Sec. 931, Quality Measure
Development, which requires the Secretary, in consultation with AHRQ and CMS, to identify
gaps where no quality measures exist or where existing measures need improvement, updating or
expansion consistent with the national strategy under Sec. 399HH. In identifying these gaps, the
Secretary is to consider the gaps identified by the entity with a contract under SSA Sec. 1890(a)
and other stakeholders. The Secretary must make a report on any gaps identified, and the process
used to identify the gaps, available to the public. The section further requires the Secretary to
fund or enter into agreements with eligible entities to develop, improve, update, or expand quality
measures in areas identified as gap areas. The Secretary is to give priority to the development of
quality measures that allow for the assessment of health outcomes and functional status of
patients; the management and coordination of health care across episodes of care and care
transitions; the meaningful use of health information technology; the safety, effectiveness,
efficiency, patient-centeredness, and timeliness of care; and health disparities, among other
things. An entity receiving funds under this section is required to use the funds to develop quality
measures that allow, to the extent practicable, data on measures to be collected using health
information technology, that are free of charge to users, and that are publicly available, among
other things. The Secretary may use funds under this section to update and test quality measures
endorsed by the entity with a contract under SSA Sec. 1890(a). As amended by ACA Sec.
10303(a), the section requires the Secretary to develop, and periodically update, provider-level
outcome measures for hospitals and physicians, and other providers as determined appropriate.
The measures must include outcome measurement for acute and chronic disease and primary and
preventive care. In developing the outcome measures, the Secretary is required to seek to address
risk adjustment, accountability, and sample size issues; and include the full scope of services that
comprise a cycle of care.
Subsection 3013(b) amends new SSA Sec. 1890A, as added by ACA Sec. 3014(b), discussed
below, by requiring CMS, in consultation with AHRQ, through contracts, to develop quality and
efficiency measures as determined appropriate for use under the SSA. The subsection also
requires the Secretary to publicly report on measures for hospital-acquired conditions (see ACA
Sec. 10303(b), discussed below).
Subsection 3013(c) authorizes to be appropriated $75 million for each of FY2010 through
FY2014, to remain available until expended, to carry out the provisions in this section. At least
50% of the amounts appropriated must be used for the activities authorized under subsection (b).
Sec. 3014. Quality Measurement
Subsection 3014(a), as amended by ACA Sec. 10304, amends SSA Sec. 1890(b) by expanding
the duties of the consensus-based entity under contract with CMS pursuant to this section
(currently the National Quality Forum). The entity is required to convene multi-stakeholder
groups to provide input on the national priorities for health care quality improvement developed
under ACA. In addition, the multi-stakeholder groups are required to provide input on the
selection of quality measures for use in various specified Medicare payment systems for hospitals
and other providers, as well as in other health care programs, and for use in reporting
performance information to the public. The entity is required to transmit to the Secretary the input
of multi-stakeholder groups no later than February 1 of each year, beginning in 2012. The
subsection amends SSA Sec. 1890(b)(5)(A) to require the consensus-based entity to submit a
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report to Congress and the Secretary describing gaps in endorsed measures and areas where
evidence is insufficient to support endorsement of quality measures in priority areas identified
under the national strategy.
Subsection 3014(b), as amended by ACA Sec. 10304, adds a new SSA Sec. 1890A, Quality and
Efficiency Measurement. This section requires the Secretary to establish a multi-step prerulemaking process and timeline for the adoption, dissemination, and review of measures by the
Secretary. The steps include gathering multi-stakeholder input; making measures under
consideration available to the public; transmission to, and consideration by the Secretary of, the
input of multi-stakeholder groups; and the publication of the rationale for the use of any quality
measure in the Federal Register. The subsection also requires the Secretary to establish a process
for disseminating quality measures used by the Secretary and to periodically review quality
measures and determine whether to maintain the use of the measure or to phase it out.
To carry out the provisions above, the Secretary must provide for the transfer of $20 million from
the Medicare Part A and Part B trust funds to the CMS Program Management Account for each of
FY2010 through FY2014.
Sec. 3015. Data Collection; Public Reporting
This section amends PHSA Title III by adding at the end the following new PHSA Sec. 399II,
Collection and Analysis of Data for Quality and Resource Use Measures. This section, as
amended by Sec. 10305 of ACA, requires the Secretary to establish and implement an overall
strategic framework to carry out the public reporting of performance information, as described in
new PHSA Sec. 399JJ, as added by this act. In addition, the Secretary is required to collect and
aggregate consistent data on quality and resource use measures, and may award grants or
contracts for this purpose, and to ensure that data collection, aggregation and analysis systems
involve an increasingly broad range of patient populations, providers, and geographic areas over
time. This section allows the Secretary to award grants or contracts to eligible entities to support
new, or improve existing, efforts to collect and aggregate quality and resource use measures. The
Secretary, under this section, is only permitted to award grants or contracts to entities that enable
summary data that can be integrated and compared across multiple sources. There are authorized
to be appropriated SSAN for FY2010 through FY2014.
The section also adds a new PHSA Sec. 399JJ, Public Reporting of Performance Information,
which requires the Secretary to make available to the public, through standardized websites,
performance information summarizing data on quality measures. This performance information is
required to include information regarding clinical conditions to the extent such information is
available, and the information would, where appropriate, be provider-specific and sufficiently
disaggregated and specific to meet the needs of patients with different clinical conditions. The
Secretary is required to consult with the entity with a contract under SSA Sec. 1890(a) and other
entities as appropriate to determine the type of information that is useful to stakeholders. In
addition this section requires the entity with a contract under Sec. 1890(a) to convene multistakeholder groups to review the design and format of each website and to transmit the views of
these groups to the Secretary. There are authorized to be appropriated SSAN for FY2010 through
FY2014.
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Quality Improvement and Patient Safety
Sec. 3501. Health Care Delivery System Research; Quality Improvement
This section creates a new Subpart II, Health Care Quality Improvement Programs, and includes
a new PHSA Sec. 933, Health Care Delivery System Research, to enable the Director of AHRQ
to identify, develop, evaluate, and disseminate innovative strategies for quality improvement
practices in the delivery of health care services that represent best practices, and to require The
Center for Quality Improvement and Patient Safety of AHRQ (hereinafter referred to as the
“Center”), or another relevant agency or department designated by the Director, to carry out
several specified functions. The general functions of this Center include, among others (1)
identifying providers that deliver consistently high-quality, efficient health care services and
employ best practices that are adaptable and scalable to diverse health care settings; (2) assessing
research, evidence, and knowledge about what strategies and methodologies are most effective in
improving health care delivery; (3) finding ways to translate such information rapidly and
effectively; (4) creating strategies for quality improvement through the development of tools,
methodologies, and interventions that can successfully reduce variation in the delivery of health
care; and (5) building capacity at the state and community level to lead quality and safety efforts
through education, training and mentoring programs. The center is required to support research
on health care delivery system improvement and the development of tools to facilitate the
adoption of best practices. This section requires the Director to make the research findings of the
center available to the public, ensures that research findings and results generated by the center
are shared with the Office of the National Coordinator of Health Information Technology, and
requires the center to coordinate its activities with the Center for Medicare and Medicaid
Innovation established by ACA. The Director is required to identify a list of processes or systems
on which to focus research and dissemination activities, and is required to take into account a
number of factors, including the cost to federal health programs and provider assessment of such
processes or systems, among others. This section authorizes to be appropriated $20 million for
FY2010 through FY2014.
This section also adds a new PHSA Sec. 934, Quality Improvement Technical Assistance and
Implementation, which requires the Director, through the center, to award technical assistance
funding to specified eligible entities. Funds provide technical support to institutions that deliver
health care so that such institutions understand, adapt, and implement the models and practices
identified by the research conducted by the center. Funds also support implementation awards to
eligible entities to implement these models and practices. Sec. 3511 of ACA authorizes the
appropriation of SSAN to carry out the activities in this section.
Sec. 3508. Quality and Patient Safety Training in Clinical Education
This section allows the Secretary to award grants to eligible entities or consortia to carry out
demonstration projects to develop and implement academic curricula that integrate quality
improvement and patient safety into the clinical education of health professionals. A grant may be
awarded under this section only if the receiving entity or consortium agrees to make available
non-federal contributions toward the costs of the program in an amount that is not less than $1 for
each $5 of federal funds. This section also requires the Secretary to evaluate the projects funded
under this section and publish, make publicly available, and disseminate the results of such
evaluations on as wide a basis as is practicable. Finally, this section requires the Secretary to
submit a report to specified congressional committees that would describe the specific projects
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supported under this section and provide recommendations to Congress. Sec. 3511 of ACA
authorizes the appropriation of SSAN to carry out the activities in this section.
Sec. 10303(b). Hospital-Acquired Conditions
Medicare pays acute care hospitals using the inpatient prospective payment system (IPPS), where
each patient is classified into a Medicare severity adjusted diagnosis-related group (MS-DRG).
Generally, except for outlier cases, a hospital receives a predetermined amount for a given MSDRG regardless of the services provided to a patient. In some instances, Medicare patients may
be assigned to a different MS-DRG with a higher payment rate based on secondary diagnoses.
Starting October 1, 2008, hospitals did not receive additional Medicare payment for
complications that were acquired during a patient’s hospital stay for certain select conditions.
These hospital-acquired conditions (HACs) are (1) high-cost, high-volume, or both; (2) identified
though a secondary diagnosis that will result in the assignment to a different, higher paid MSDRG; and (3) reasonably preventable through the application of evidence-based guidelines.
Sec. 10303(b) amends SSA Sec. 1890A, as added by Sec. 3014(b), and as amended by Sec.
3013(b), to require the Secretary, to the extent practicable, to publicly report on measures for
HACs that are currently utilized by CMS for the adjustment of payment to hospitals based on
rates of hospital-acquired infections.109
Sec. 10303(c). Clinical Practice Guidelines
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Sec. 304(b))
required the Secretary to enter into a contract with the IOM to conduct a study on the best
methods used in developing clinical practice guidelines in order to ensure that organizations
developing such guidelines have information on approaches that are objective, scientifically
valid, and consistent. The IOM is required to submit to the Secretary, and the appropriate
committees of jurisdiction of Congress, a report containing the results of this study and
recommendations for legislation and administrative action. Finally, stakeholders with expertise in
making clinical recommendations are required to participate on the panel responsible for
conducting this study and preparing the report.
Sec. 10303(c) requires the Secretary, following receipt of the report required under MIPPA Sec.
304(b), and not less than every three years thereafter, to contract with the IOM to employ the
results of the study and the best methods identified for the purpose of identifying existing and
new clinical practice guidelines that were developed using such best methods, including
guidelines listed in the National Guideline Clearinghouse. This section requires the Secretary, in
carrying out this identification process, to allow for consultation with professional societies,
voluntary health care organizations, and expert panels.
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Hospital-acquired infections are a type of a hospital-acquired condition.
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Care Coordination
Sec. 3502. Community Health Teams to Support Medical Homes
This section requires the Secretary to implement a grant program for the purpose of establishing
health teams to provide support to primary care providers, and providing capitated payments to
these providers. Eligible grantees are a state (or designee), Indian tribe, or tribal organization that
submits a plan for financial sustainability and for incorporating prevention initiatives, patient
education, and care management resources into care delivery; ensures that the health team
includes a multi-disciplinary team of specified providers; and agrees to provide services to
Medicaid beneficiaries with chronic conditions, as described in SSA Sec. 1945 (as added by Sec.
2703 of ACA), in accordance with the payment methodology established under that section.
“Medical home” is defined as a mode of care that includes (1) personal physicians; (2) wholeperson orientation; (3) coordinated and integrated care; (4) safe and high quality care though
evidence-informed medicine, appropriate use of health information technology, and continuous
quality improvements; (5) expanded access to care; and (6) payment that recognizes added value
from additional components of patient-centered care. A health team is required to carry out 10
specific activities, including establishing contractual agreements with primary care providers to
provide support services; developing plans that integrate preventive services for patients;
providing 24-hour care management and support during transitions in care settings; and others.
Primary care providers who contract with these teams are required to provide care plans for
patient participants, provide access to participant health records and primary care practices, and
meet regularly with the care team to ensure integration of care. Sec. 3511 of ACA authorizes the
appropriation of SSAN to carry out the activities in this section.
Sec. 3503. Medication Management Services in Treatment of Chronic Disease
This section adds a new PHSA Sec. 935, Grants or Contracts to Implement Medication
Management Services in Treatment of Chronic Diseases, which requires the Secretary, acting
through the Patient Safety Research Center established in PHSA Sec. 933 (as added by Sec. 3501
of ACA), to provide grants to support medication therapy management (MTM) services provided
by licensed pharmacists. Grantees are required to provide various specified MTM services to
targeted individuals, such as (1) assessing patients’ health and functional status; (2) formulating a
medical treatment plan; (3) administering appropriate medication therapy; (4) monitoring and
evaluating patient response to therapy; (5) documenting the care delivered and communicating
essential aspects to appropriate care providers; (6) providing education and training to enhance
the appropriate use of medications; and (7) coordinating and integrating MTM services in broader
health care management. MTM services provided by licensed pharmacists under this program are
targeted at individuals who take four or more prescribed medications, take high-risk medications,
have two or more chronic diseases, or have undergone a transition of care or other factors that are
likely to create a high risk of medication-related problems. The Secretary is required to assess and
evaluate specified aspects of the program and report to Congress. Sec. 3511 of ACA authorizes
the appropriation of SSAN to carry out the activities in this section.
Sec. 3506. Program to Facilitate Shared Decisionmaking
This section adds a new PHSA Sec. 936, Program to Facilitate Shared Decisionmaking, to
facilitate shared decision making between patients and caregivers and their clinicians by engaging
the patient in clinical decision making, providing information on trade-offs among treatment
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options, and incorporating patient preferences and values into the medical plan. The Secretary is
required to enter into a contract with the consensus-based organization with a contract under SSA
Sec. 1890 to develop and identify standards for patient decision aids, to review patient decision
aids, and develop a certification process for determining whether patient decision aids meet those
standards. The Secretary, acting through the Director of AHRQ, is required to award grants or
contracts to develop, update, and produce patient decision aids, to test such materials to ensure
they are balanced and evidence-based, and to educate providers on their use. The Secretary is
required to award grants for establishing Shared Decision Making Resource Centers to develop
and disseminate best practices to speed adoption and effective use of patient decisions aids and
shared decision making. The Secretary also is required to award grants to providers for the
development and implementation of shared decision-making techniques. Providers receiving a
grant are required to report to the Secretary data on those quality measures, and the Secretary is
required to provide feedback to those providers. This section authorizes to be appropriated SSAN
for FY2010, and each subsequent fiscal year.
Sec. 3510. Patient Navigator Program
This section amends PHSA Sec. 340A to prohibit the Secretary from awarding a grant to an
entity under this section unless the entity provides assurances that patient navigators recruited,
assigned, trained, or employed using these grant funds meet certain minimum core proficiencies.
These proficiencies are defined by the entity that submits the application and would be tailored
for the main focus or intervention of the navigator involved. The section authorizes an
appropriation of $3.5 million for FY2010, and SSAN for each of FY2011 through FY2015.
Sec. 5405. Primary Care Extension Program
This section, as amended by Sec. 10501(f) of ACA, adds a new PHSA Sec. 399V-1, Primary
Care Extension Program, requiring the Secretary to establish a Primary Care Extension Program.
The program is to provide support and assistance to primary care providers (as defined) to
educate providers about preventive medicine, health promotion, chronic disease management,
mental health services, and evidence-based therapies in order to enable providers to incorporate
such matters into their practice and to improve community health by working with communitybased health connectors (referred to in this section as “Health Extension Agents”). A Health
Extension Agent is any local, community-based health worker who facilitates and provides
assistance to primary care practices by implementing quality improvement or system redesign,
incorporating the principles of the patient-centered medical home to provide guidance to patients
in culturally and linguistically appropriate ways, and linking practices to diverse health system
resources.
The Secretary is required to award competitive grants to states to establish Primary Care
Extension Program State Hubs, consisting of the state health department and other specified
entities. Hubs established under a grant must contract with and provide grant funds to county or
local entities to serve as Primary Care Extension Agencies and organize statewide or multistate
networks of such agencies to share information. Primary Care Extension Agencies established by
a Hub are required to (1) assist primary care providers to implement a patient-centered medical
home; (2) develop and support primary care learning communities; (3) participate in a national
network of hubs and proposed how best practices can be shared; and (4) develop a plan for
financial sustainability after the initial six-year period of funding under this section is completed.
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The section authorizes six-year program grants for entities that submit a fully developed Hub
implementation plan, and two-year planning grants for entities to develop such a plan. Recipients
of program grants are to be evaluated at the end of the grant period by an evaluation panel
appointed by the Secretary, and may receive additional support if their program and sustainability
plan receive a satisfactory evaluation. There are authorized to be appropriated $120 million for
each of FY2011 and FY2012, and SSAN for FY2013 and FY2014.
Sec. 5604. Co-locating Care in Community-Based Mental Health Settings
This section creates a new PHSA Sec. 520K, Grants for Co-Locating Primary and Specialty
Care in Community-Based Mental Health Settings, requiring the Secretary to fund demonstration
projects for providing coordinated care to special populations, which are defined as individuals
with mental illness and co-occurring primary care conditions and chronic diseases. The Secretary
is to award grants to eligible entities to establish demonstration projects for the provision of
coordinated and integrated services to special populations through the co-location of primary and
specialty care services in community-based mental and behavioral health settings. Grantees are
required to use grant funds to provide specific services such as primary care services, diagnostic
and laboratory services, and screenings for the defined special populations, and certain specialty
care services. Not more than 15% of the funds may be used for information technology or facility
improvements or modifications. Within 90 days of expiration of the grant, grantees are required to
submit to the Secretary an evaluation of the effectiveness of the activities carried out under the
grant. There is authorized to be appropriated $50 million for FY2010 and SSAN for each of
FY2011 through FY2014 to carry out this section.
Sec. 10333. Community-Based Collaborative Care Networks
This section adds a new PHSA Sec. 340H,110 Community-Based Collaborative Care Networks,
authorizing the Secretary to award grants to eligible entities to support community-based
collaborative care networks (CCNs). An eligible CCN is a consortium of health care providers
with a joint governance structure that provides comprehensive coordinated and integrated health
care services (as defined by the Secretary) for low-income populations. CCNs must include
(unless such provider does not exist within the community, declines or refuses to participate, or
places unreasonable conditions on their participation) a safety net hospital and all FQHCs in the
community. Grant funds may be used to assist low-income individuals, as described; provide case
management and care management; perform health outreach; provide transportation; expand
capacity; and provide direct patient care services. The Secretary is authorized to limit the percent
of grant funding that may be spent on direct care services provided by HRSA grantees or to
impose other requirements on such grantees deemed necessary. There is authorized to be
appropriated SSAN for each of FY2011 through FY2015.
Sec. 10410. Centers of Excellence for Depression
This section adds a new PHSA Sec. 520B, Centers of Excellence for Depression, requiring the
Secretary, acting through the SAMHSA Administrator, to award five-year grants on a competitive
basis to eligible entities to establish national centers of excellence for depression. These centers
110
Note that ACA created two new PHSA Sec. 340H. This summary refers to 42 U.S.C. § 256i. The other new PHSA
Sec. 340H (42 U.S.C. § 256h) is described in “Sec. 5508(a) and (c). Teaching Health Centers.”
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are required to engage in activities related to the treatment of depressive disorders, as defined. If
funds authorized are appropriated in the amounts provided, the Secretary is required to establish
not more than 20 centers no later than one year after enactment; and not more than 30 centers no
later than September 30, 2016. The Secretary is prohibited from funding an entity unless they
agree to make non-federal contributions toward grant activities equal to $1 for every $5 of federal
grant funds. Each center is required to carry out specified activities, including developing
improved treatment standards, clinical guidelines, diagnostic protocols, and care coordination
practices; and expanding translational research through collaboration of centers and communitybased organizations. One grant recipient is to be designated as the coordinating center, as
specified. The coordinating center is required to establish and maintain a national database. The
Secretary, acting through the SAMHSA Administrator, must establish performance standards for
each center and the network of centers and issue center report cards, as described. Based upon the
report cards, the Secretary is required to make recommendations to (1) the centers regarding
improvements; and (2) Congress for expanding the centers. The Secretary is required to arrange
for an independent third party review to conduct an evaluation of the network of centers. To carry
out this section, there are authorized to be appropriated $100 million for each of FY2011 through
FY2015, and $150 million for each of FY2016 through FY2020. Of the amount appropriated for
a fiscal year, the Secretary is required to determine the allocation for each center, which may not
be more than $5 million to each center, and no more than $10 million to the coordinating center.
Nursing Homes and Other Long-Term Care
Facilities and Providers
Overview and Impact of ACA
Federal and state governments share responsibility to ensure that nursing homes provide quality
care in a safe environment for the nation’s 1.5 million skilled nursing facilities (SNF) and nursing
facilities (NF) residents. Prior to ACA, Congress established most quality requirements for
Medicare-certified SNFs and Medicaid-certified NFs under the Omnibus Budget Reconciliation
Act of 1987 (OBRA87; P.L. 100-203). OBRA87 defined standards that nursing homes must meet
in order to receive Medicare and Medicaid payment (called conditions of participation). OBRA87
also contained a range of sanctions that state and federal officials could impose on facilities that
failed to meet the federal standards—including civil money penalties (CMPs), payment denial for
new admissions, termination from federal health programs, installation of temporary
management, and directed plans of action. For example, as a condition for participation,
certification, or re-certification, SSA Sec. 1124 requires Medicare and Medicaid entities to
disclose full and complete information for each person with ownership or control interest.111
As part of the shared federal and state responsibility for enforcing SNF and NF quality
requirements, CMS contracts with state survey agencies to conduct periodic inspections and
investigate complaints, both of which contribute to whether or not SNFs and NFs meet federal
standards. Generally, state agencies follow federal regulations for surveying facilities; however,
111
Individuals are considered to have ownership or control interests when directly or indirectly (1) they own 5% or
more of an entity; or they hold a whole or part of any mortgage, deed of trust, note or other obligation secured by the
entity or any property or assets that equal 5% of the total property; (2) they are officers or directors of the entity, if the
entity is organized as a corporation; or (3) they are partners in the entity if it is organized as a partnership.
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some survey activities and policies are determined by state survey agencies, including hiring and
retaining a surveyor workforce, training surveyors, reviewing deficiency citations, and managing
regulatory interactions with the industry and public . State surveyors generally first propose
sanctions based on deficiencies identified during inspections. CMS regional office officials will
then review and implement the state surveyor recommendations.
Prior to ACA enactment, there were no provisions in law requiring use of a standardized
complaint form. However, there were mechanisms to ensure nursing facilities met certain
minimum patient safety and quality standards—standard surveys and complaint investigations.
Every SNF or NF undergoes a standard survey at least every 15 months, and the statewide
average interval for these surveys must not exceed 12 months. During a standard survey, surveyor
teams assess how well SNFs and NFs meet comprehensive federal quality-of-care and fire safety
requirements. In contrast, complaint investigations generally focus on specific allegations of
substandard resident care or safety violations. Complaint investigations provide an opportunity
for state surveyors to intervene promptly if problems arise between standard surveys. Complaints
may be filed against a home by a resident, the resident’s family, or a nursing home employee
verbally, via a complaint hotline, or in writing, but there were not standard reporting forms that
helped document the complaint for investigators or helped in collecting comparable data.
Surveyors generally follow state procedures when investigating complaints, but must comply
with certain federal guidelines and time frames. In resident abuse cases, such as pushing,
slapping, beating, or otherwise assaulting residents by individuals to whom their care has been
entrusted, state survey agencies may notify state or local law enforcement agencies that can
initiate criminal investigations. States must maintain a registry of qualified nurse aides, the
primary caregivers in nursing homes. The registry contains any findings where aides were
responsible for abuse, neglect, or theft of residents’ property, which constitutes a ban from further
nursing home employment ban.
Overall, ACA’s nursing home transparency, enforcement, and staff training provisions expand
federal quality and accountability requirements for SNFs and NFs. These provisions require SNFs
and NFs to disclose ownership and organizational relationships, implement ethics and compliance
programs, and report direct care staff expenditures. ACA also requires the Secretary, among other
activities, to develop and disseminate a standardized complaint form, refine and update
Medicare’s Nursing Home Compare website, and implement a national independent monitor
demonstration program. In addition, GAO is required to conduct a study and report to Congress
on CMS’s Five-Star Quality Rating System. ACA authorizes the Secretary and states to impose
CMPs on SNFs and NFs found to provide deficient care that jeopardizes residents’ safety and
health.
Further, ACA’s nursing home transparency and accountability changes establish new
requirements for SNF and NF administrators to inform residents, their representatives, the
Secretary, states, and other stakeholders of planned facility closures. ACA requires the Secretary
to conduct demonstration projects on best practices for culture change and use of information
technology in SNFs and NFs. Moreover, ACA requires the Secretary to expand initial nurse aide
training, competency, and evaluation requirements to include dementia and abuse prevention.
Sec. 6101. Disclosure of Owners and Other Parties
ACA Sec. 6101 amended SSA Sec. 1124 to require the Secretary, within two years of enactment
(by March 23, 2012), to issue regulations or amend contracts mandating SNFs and NFs supply
the Secretary or state agency complete information on ownership or control interests (owner,
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governance, management, officer, etc.) for each SNF or NF where there was least a 5%
ownership interest. ACA Sec. 6101 also required facilities to disclose each facility’s
organizational structure as well as relationships where subcontractors have at least a 5% control
interest in the facility. In implementing these requirements, the Secretary was to ensure SNF and
NFs reported disclosable party and other accountability information in standard formats.
Sec. 6102. Compliance and Ethics Requirements for Nursing Facilities
Prior to ACA, Medicare and Medicaid law did not require SNFs and NFs to develop and
implement compliance and ethics training programs. ACA Sec. 6102 required the Secretary, by
March 23, 2012, and in collaboration with the HHS Office of Inspector General (OIG), to issue
regulations specifying requirements for SNFs and NFs to follow in developing and implementing
compliance and ethics programs. Within three years after date by which facilities had to comply
with ethics program regulations are issued (by March 23, 2015), the Secretary is to submit a
report to Congress on whether these requirements reduced deficiency citations, increased quality
performance, or affected other patient quality-of-care metrics.
Sec. 6103. Nursing Home Compare Medicare Website
CMS developed the Nursing Home Compare (NH Compare) website to improve SNF and NF
quality of care and to improve access to nursing home quality information for long-term care
(LTC) consumers and their families. Since its launch in November 2002, CMS has enhanced the
website by adding or improving quality measures and website navigation. Medicare’s NH
Compare website includes national data on all nursing facilities that participate in Medicare and
Medicaid. The data include facility ratings, selected results from survey and certification
inspections, and staffing information on Medicare SNFs and Medicaid NFs.
Sec. 6103 requires the Secretary to enhance the information on SNFs and NFs available on the
NH Compare website, and to ensure that the information is prominent, easily accessible,
searchable, and readily understandable to LTC consumers.
Sec. 6104. Reporting of Expenditures
This section requires SNFs to report expenditures for wages and benefits for direct care staff on
facility cost reports. The reports must be broken out into categories including registered nurses,
licensed professional nurses, certified nurse assistants, and other medical and therapy staff.
Within one year of enactment (by March 23, 2011) the Secretary was required to consult with
private sector accountants experienced with cost reports to assist in redesigning those reports to
separately capture direct care staff wage and benefit expenditures. In addition, the Secretary was
required to consult with the Medicare Payment Advisory Commission (MedPAC), the HHS OIG,
the Medicaid and CHIP Payment Access Commission (MACPAC), and other experts in
categorizing direct care wages and benefits into functional areas. SNFs were required to report
expenditures for direct care staff on cost reports submitted two years after ACA’s enactment date
(by March 23, 2012). The Secretary was required to categorize the first year’s expenditure data
within 30 months of enactment (by September 23, 2012) and on an annual basis thereafter. The
Secretary is further required to establish procedures for making expenditure reports readily
available to interested parties upon request.
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Sec. 6105. Standardized Complaint Form
ACA Sec. 6105 requires the Secretary to develop a standardized form to be used by SNF and NF
residents and their representatives in submitting quality-of-care complaints. The new standard
complaint form is not to prevent SNF and NF residents from submitting complaints in other
ways, including orally. States are required to establish a complaint resolution process that
includes (1) procedures to ensure accurate tracking of received complaints, including notifications
to the complainant (or his/her representative) that the complaint was received; (2) procedures to
determine the complaint’s likely severity, and for the investigation of the complaint; and (3)
deadlines for responding to the complaint and for notifying the complainant of the outcome of the
investigation. Such processes are required to ensure that legal representatives or other responsible
parties are not denied access to a resident or otherwise retaliated against if they complain about
the facility’s quality of care or safety issues. The changes in this section became effective on
March 23, 2011.
Sec. 6106. Ensuring Staffing Accountability
This section amends SSA Sec. 1128I requiring the Secretary, in consultation with stakeholders, to
establish specifications for SNFs and NFs to electronically report direct staffing information to
the Secretary. These regularly reported staffing data are to include agency and contract staff, by
staff position categories (based on payroll and other verifiable and auditable data). The reporting
requirements are to include the category of work employees perform, resident census data,
information on employee turnover and tenure, and the hours of care provided per resident per day.
The reporting process is required to be electronic and data are to be reported in a uniform format.
Facilities were required to begin submitting uniform staffing information electronically within
two years of enactment (by March 23, 2012).
Sec. 6107. GAO Study and Report on Five-Star Quality Rating System
The Medicare NH Compare website includes data from the quality rating system that gives
facilities a rating of between one and five stars. Nursing homes with five stars are considered to
provide superior quality and nursing homes with one star are considered to provide lower quality
care. NH Compare gives each nursing home an overall rating as well as separate ratings for the
following three areas: health inspections, staffing, and quality measures. ACA Sec. 6107 required
GAO to conduct a study and submit a report to Congress on the CMS nursing home Five-Star
Quality Rating System. GAO’s report was due by March 23, 2012, and was to include the
following analyses: (1) how the Five-Star Quality Rating System was being implemented; (2) any
problems associated with implementation of the system; and (3) how the Five-Star Quality Rating
System can be improved. GAO’s report also was to offer recommendations for legislative and
administrative action.
Sec. 6111. Civil Money Penalties
ACA Sec. 6111 authorizes the Secretary and states to impose additional CMPs on SNFs and NFs
with deficiencies and quality-of-care issues that jeopardize residents’ safety and health. This
section also requires the Secretary to issue regulations establishing an independent, informal
dispute resolution process that produces a written record. The dispute hearing is to occur within
30 days of the penalty citation. In instances where deficiencies are cited at the level of actual
harm and immediate jeopardy, the Secretary may place CMPs in an escrow account following
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completion of the informal dispute resolution process, or up to 90 days after the date of the CMP,
whichever is earlier. Monetary amounts collected and placed in escrow are to be kept in interest
bearing escrow accounts pending the resolution of appeals. The Secretary and states may reduce
CMPs if deficiencies were self-reported and corrected within 10 calendar days after imposition.
Reductions are to be made for self-reported deficiencies cited at the immediate jeopardy level, at
the actual harm level if the harm were found to be a “pattern” or “widespread,” or for deficiencies
that result in a resident’s death. Facilities cited for repeat deficiencies during the past year are
ineligible for reductions, even if the deficiencies were self-reported.
The Secretary also is required to issue regulations that, in the case where such appeals are
unsuccessful, authorize a portion of CMPs to fund activities that benefit residents. These
activities include projects that strengthen and support resident and family councils, offset the
costs of relocating residents to home and community-based settings or another facility, and
support and protect residents in situations where a facility closes or is decertified. CMP funds
used to benefit patients also may be used for facility improvement initiatives approved by the
Secretary, including joint training of facility staff and surveyors; technical assistance for facilities
implementing quality assurance programs; and appointment of temporary management firms. The
changes in this section became effective March 23, 2011.
Sec. 6112. National Independent Monitor Demonstration Program
This section required the Secretary within one year of enactment (by March 23, 2011) to develop,
test, and implement a two-year national independent monitoring demonstration program to
oversee interstate and large intrastate chains of SNFs and NFs. The Secretary is required to select
chains for participation in the demonstration and evaluate them for evidence of serious safety and
quality-of-care deficiencies. The facilities in those chains are subject to review, oversight, and
root-cause quality and deficiency analyses by an independent monitor under contract to the
Secretary.
Chains that receive a report containing findings and recommendations from the independent
monitor are required, within 10 days, to submit a report outlining corrective actions that will be
taken. If a chain declines to implement the independent monitor’s recommendations, the chain is
required to submit reasons why it will not do so. After receiving the chain’s response, the
independent monitor is required to finalize recommendations and to submit a report to the chain
and the facilities of the chain, the Secretary, and relevant state or states, as appropriate. Chains are
responsible for a portion of the costs associated with appointment of independent monitors. The
Secretary has authority to waive Medicare and Medicaid laws to carry out the independent
monitor pilot program. Within six months of the end of the independent monitor demonstration,
(by September 23, 2013) the HHS OIG will evaluate the independent monitor program to
determine the feasibility of establishing a permanent program, as well as appropriate procedures
and mechanisms to implement the program permanently and to submit the evaluation report to
Congress and the Secretary. There are authorized to be appropriated SSAN to carry the section.
Sec. 6113. Notification of Facility Closure
This section requires the administrator of a SNF or NF that is preparing to close to provide
written notification to residents, legal representatives of residents or other responsible parties, the
state, the Secretary, and the LTC ombudsman program. This notification is to be made at least 60
days before closure. Facilities are required to prepare a plan for closing the facility by a specified
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date and submit the plan to the state where the facility is located. States are required to approve
the plan and ensure the safe transfer of residents to another facility or alternative setting that the
state finds appropriate in terms of quality, services and location, and takes into consideration the
needs and best interests of each resident. In cases where the Secretary terminates a facility’s
participation, the Secretary is required to provide written notification to stakeholders by the date
that the Secretary determines appropriate. Facilities are not permitted to admit new residents on
or after the date on which written notification is submitted. The Secretary is to continue making
payments to a facility to support residents until they are relocated, as the Secretary determines
appropriate. SNF and NF administrators who fail to comply with the closure notice requirements
could be subject to sanctions of up to $100,000 and exclusion from federal health program
participation. The requirements for SNF and NF administrators to notify stakeholders of pending
facility closures take effect one year after enactment.
Sec. 6114. Culture Change and Information Technology Demonstrations
This section requires the Secretary to conduct the following two demonstration projects for SNFs
and NFs: (1) to develop best practices for facilities involved in culture change (developing
patient-centric models of care); and (2) to develop SNF and NF best practices for the use of
information technology to improve resident care. The demonstration projects are required to take
into consideration the special needs of facility residents with cognitive impairments. The
Secretary was to award one or more grants three-year duration under each demonstration project
by March 23, 2011. The Secretary is required to submit a report to Congress within nine months
of the completion of the demonstration projects that evaluates the projects and makes
recommendations for legislation and administrative actions. There are authorized to be
appropriated SSAN to carry out the projects.
Sec. 6121. Dementia and Abuse Prevention Training
This section amends SSA Secs. 1819 (Medicare) and 1919 (Medicaid) by requiring SNFs and
NFs, respectively, to include dementia and abuse prevention training as part of pre-employment
initial training for permanent and contract or agency staff and, if the Secretary determines
appropriate, as part of ongoing in-service nurse aide training. These new training requirements
took effect on March 23, 2011.
Sec. 6201. Background Checks on Employees of Long-Term Care Facilities
This section requires the Secretary to establish a nationwide program for background checks on
direct patient access employees of long-term care (LTC) facilities or providers (as defined), and to
provide federal matching funds to states to conduct these activities. The Secretary is required to
carry out the nationwide program under terms and conditions similar to those used for the
Background Check Pilot program, authorized by Sec. 307 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA, P.L. 108-173). From January 2005 through
September 2007, CMS administered the Background Check Pilot program, in consultation with
the Department of Justice (DOJ), in seven states (Alaska, Idaho, Illinois, Michigan, Nevada, New
Mexico, and Wisconsin) selected to participate.
Under the nationwide program, the Secretary is required to enter into agreements with newly
participating states and previously participating states. Certain LTC providers are required to
obtain state and national criminal history background checks on their prospective employees as
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the Secretary determines appropriate, efficient, and effective. The section requires the Secretary
of the Treasury to transfer to HHS an amount specified by the HHS Secretary as necessary (not to
exceed $160 million) to carry out the nationwide program for the period of FY2010 through
FY2012. Such amounts are required to remain available until expended. The Secretary is
authorized to reserve no more than $3 million of the amount transferred to conduct an evaluation.
Comparative Effectiveness Research
Overview and Impact of ACA
ACA builds on provisions included in ARRA
that expanded the federal government’s role in
the oversight and funding of comparative
effectiveness research. ARRA provided a total
of $1.1 billion for comparative effectiveness
research, instructed the Secretary to contract
with the IOM to produce a report with
recommendations on national comparative
effectiveness research priorities, and created
the Federal Coordinating Council for
Comparative Effectiveness Research
(FCCCER), an interagency advisory group.
FCCCER was required to report to the
President and the Congress annually on
federal comparative effectiveness research
activities.112
Comparative Effectiveness Research
U.S. Government Accountability Office, PatientCentered Outcomes Research Institute: Review of the
Audit of Financial Statements for 2012 and 2011, 13-390,
March 29, 2013, http://www.gao.gov/products/GAO-13390R.
U.S. Government Accountability Office, PatientCentered Outcomes Research Institute: Review of the
Audit of Financial Statements for 2011 and 2010,12663R, May 10, 2012, http://www.gao.gov/products/GAO12-663R.
U.S. Government Accountability Office, Agency for
Healthcare Research and Quality's Process for Awarding
Recovery Act Funds and Disseminating Results, 12-332,
February 29, 2012, http://www.gao.gov/products/GAO12-332.
U.S. Government Accountability Office, Use of Recovery
Act and Patient Protection and Affordable Care Act Funds for
Comparative Effectiveness Research, 11-712m R, June 14,
2011, http://www.gao.gov/products/GAO-11-712R.
The IOM released its report on June 30,
2009.113 Reflecting broad stakeholder input,
the report identified 100 health topics as highpriority areas for comparative effectiveness research. FCCCER also released its initial report in
June 2009. The report’s recommendations focused on (1) the importance of disseminating
comparative effectiveness research findings to doctors and patients; (2) targeting comparative
effectiveness research to the needs of priority populations such as racial and ethnic minorities,
and persons with multiple chronic conditions; (3) researching high-impact health arenas such as
medical and assistive devices, surgical procedures, and behavioral interventions and prevention;
and (4) electronic data networks and exchange.114
In ACA, Congress terminates FCCCER and replaces it with a new private, non-profit corporation
called the Patient-Centered Outcomes Research Institute (PCORI). PCORI is responsible for
112
For more information on ARRA’s comparative effectiveness research provisions, see CRS Report R40181, Selected
Health Funding in the American Recovery and Reinvestment Act of 2009, coordinated by C. Stephen Redhead.
113
Institute of Medicine, Initial National Priorities for Comparative Effectiveness Research, (Washington, DC: The
National Academies Press, 2009), http://www.iom.edu/Reports/2009/
ComparativeEffectivenessResearchPriorities.aspx.
114
HHS, Federal Coordinating Council for Comparative Effectiveness Research, Report to the President and the
Congress, June 30, 2009, http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf.
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coordinating and supporting comparative clinical effectiveness research, which is broadly defined
in the law to mean “research evaluating and comparing health outcomes and the clinical
effectiveness, risks, and benefits of 2 or more ... health care interventions, protocols for treatment,
care management and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals ...
integrative health practices, and any other strategies or items being used in the treatment,
management, and diagnosis of, or prevention of illness or injury.”115 ACA creates a 10-year,
multi-billion dollar trust fund to support such research.
Secs. 6301 and 10602. Patient-Centered Outcomes Research
This section adds a new SSA Title XI Part D, Comparative Clinical Effectiveness Research,
comprising new SSA Secs. 1181-1183. New SSA Sec. 1181,Comparative Clinical Effectiveness
Research, authorizes the establishment of a private, nonprofit, tax-exempt (by amending IRC Sec.
501(l)) corporation called the Patient-Centered Outcomes Research Institute (the Institute). The
Institute is to “assist patients, clinicians, purchasers, and policy-makers in making informed
health decisions by advancing the quality and relevance of [clinical] evidence ... through research
and evidence synthesis.” The Institute is to identify national priorities for research, including
attention to chronic conditions, gaps in evidence, quality of care, patient health and well-being,
and the effect on national expenditures associated with interventions or conditions, among other
concerns. The section requires the Institute to enter into contracts with federal agencies as well as
with appropriate academic, private sector research, or study-conducting entities for the
management of funding and conduct of research.
The Institute’s 19-member board includes the directors (or their designees) of AHRQ and NIH,
along with others appointed by the U.S. Comptroller General to include representation of a broad
range of groups, including patients and health care consumers; physicians and providers; private
payers; pharmaceutical, device, and diagnostic manufacturers; quality improvement or
independent health services researchers; and government representatives. The Institute is to, as
appropriate, appoint expert advisory panels to assist in identifying research priorities and
establishing the research project agenda. The section directs the appointment of panels for clinical
trials and rare diseases.
The law required the Institute to establish a methodology committee, consisting of no more than
15 members appointed by the Comptroller General plus the directors of AHRQ and NIH, which is
to have responsibility for developing and improving the science and methods of comparative
clinical effectiveness research. The methodology committee is to establish, with outside input and
with public comment, and periodically update research design standards regarding clinical
outcomes measures, risk-adjustment, subpopulation analysis, and other aspects of research and
assessment. The methodology committee is to be able to consult and contract with the IOM and
other private and governmental entities.
The section also includes extensive procedures regarding conflict-of-interest, data privacy, peerreview, and the public availability of information.
A new PHSA Sec. 937, Dissemination and Building Capacity for Research, requires AHRQ to
broadly disseminate research findings that are published by the Institute and other governmentfunded comparative effectiveness research entities; create information tools; and develop a
115
New SSA Sec. 1181(a)(2), as added by ACA Sec. 6301(a).
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publicly available database of government-funded evidence. Dissemination materials are to
identify researchers; describe research methodology, limitations, and subpopulation-specific
considerations; and must not include practice guidelines, or recommendations for payment,
coverage, or treatment. This section also requires training of researchers and building of data
capacity in coordination with other federal health programs, and authorizes federal agencies to
contract with the Institute for the conduct and support of relevant research.
New SSA Sec. 1182, Limitations on Certain Uses of Comparative Clinical Effectiveness
Research, limits certain uses of evidence and findings from comparative effectiveness research.
The Secretary may only use the findings to make coverage determinations if the use is through an
iterative and transparent process that includes public comment and considers the effect on
subpopulations. The Secretary is prohibited from using these research findings in determining
Medicare coverage in a manner that treats extending the life of an elderly, disabled, or terminally
ill individual as of lower value than extending the life of an individual who is younger,
nondisabled, or not terminally ill; or that would preclude or discourage an individual from
choosing a health care treatment based on how the individual values the tradeoff between
extending the length of their life and the risk of disability. Also, the Institute is prohibited from
using values that discount the value of life because of an individual’s disability or to use such
measures in determining coverage.
New IRC Sec. 9511, Patient-Centered Outcomes Research Trust Fund, establishes a new PatientCentered Outcomes Research Trust Fund (PCORTF) in the U.S. Treasury to fund the Institute and
its activities. The fund will receive the following amounts: (1) specified annual appropriations
over the period FY2010-FY2019 totaling $1.26 billion (new IRC Sec. 9511); (2) additional
annual appropriations over the period FY2013-FY2019 equal to the net revenues from a new fee
levied on health insurance policies (new IRC Sec. 4375) and self-insured health plans (new IRC
Sec. 4376) through FY2019; and (3) transfers from the Medicare trust funds through FY2019
(new SSA Sec. 1183, Trust Fund Transfers to Patient-Centered Outcomes Research Trust Fund).
The new health insurance fee is to equal $2 multiplied by the average number of covered lives in
a policy/plan year ($1 in the case of policy/plan years ending during FY2013), updated annually
by the rate of medical inflation. Similarly, the transfers from the Medicare trust funds are to equal
$2 multiplied by the average number of Part A and Part B beneficiaries in a given fiscal year ($1
in FY2013), updated annually by the rate of medical inflation.
Sec. 6302. Federal Coordinating Council for Comparative Effectiveness
Research
This section terminates the FCCCER upon enactment. This is in keeping with the assignment of
coordinating activities to the new Patient-Centered Outcomes Research Institute.
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Health Data Collection
Overview and Impact of ACA
Prior to the ACA, the federal government collected data on health disparities through a number of
systems administered by various agencies within HHS,116 but much of this effort was not
coordinated. For example, since 1999, HHS-funded and sponsored surveys and data collection
systems have been required to collect health disparities data in accordance with the department’s
Inclusion Policy.117 The policy mandates the inclusion of information on race and ethnicity and
encourages (but does not require) the collection of socioeconomic or cultural background
characteristics. It specifies that OMB’s standards for racial and ethnic data collection are to be
used; however, the requirement for collecting race and ethnicity data may be waived under certain
circumstances.118
Medicare for many years has obtained race
Health Data Collection
and ethnicity information about its
Centers for Disease Control and Prevention, Health
beneficiaries from the Social Security
Disparities: CDC Health Disparities and Inequalities Report-Administration (SSA). The SSA provides
United States, 2011, Morbidity and Mortality Weekly
CMS with copies of the SS-5 (“Application
Report, Supplement Vol. 60, Atlanta, GA, January 14,
2011, http://www.cdc.gov/mmwr/pdf/other/su6001.pdf.
for a Social Security Card”) form, which
includes information about race and ethnicity. U.S. Government Accountability Office, Key Indicators
While the SS-5 information is supposed to be
Systems: Experience of Other National and Subnational System
Offer Insights for the United States, GAO-11-396, March 31,
OMB-compliant, there are deficiencies in the
119
2011, http://www.gao.gov/assets/320/317346.pdf.
accuracy and completeness of the data.
Section 185 of MIPPA instructed the
Secretary to evaluate approaches for collecting disparities data on Medicare beneficiaries and to
provide a report to Congress, within 18 months of enactment, including recommendations for
reporting nationally recognized quality measures, such as Healthcare Effectiveness Data and
Information Set (HEDIS) measures, on the basis of race, ethnicity, and sex. MIPPA further
instructed the Secretary to implement the approaches identified in the initial report and, four years
after enactment and every four years thereafter, report back to Congress with recommendations
for improving the identification of health care disparities among Medicare beneficiaries based on
an analysis of those efforts.
116
For example, the National Center for Health Statistics, part of the CDC, collects and reports data on the health and
nutrition status of the U.S. population through the National Health and Nutrition Examination Survey (NHANES).
117
The Inclusion Policy may be found at http://aspe.hhs.gov/datacncl/inclusn.htm.
118
The OMB standards are officially OMB Directive 15, revised in 1997, and are available at
http://www.whitehouse.gov/omb/rewrite/fedreg/ombdir15.html. The OMB standards require a minimum of five racial
categories (White, Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian or Other
Pacific Islander). When ethnicity information is gathered, a dichotomous identification question with the choices—
Hispanic or Latino, or not Hispanic or Latino—must be used. Data collection instruments may include additional
categories such as Mexican-American, Chicano, Puerto Rican, Cuban, or Filipino, as long as these categories can be
aggregated to the standard categories. When individuals are asked to self-identify (which is OMB’s preferred method),
respondents must be given the opportunity to report multiple races in response to a single question. Including
“multiracial” as an option is not acceptable.
119
See, for example, “Medicare Race and Ethnicity Data,” by Marshall McBean, prepared for the National Academy of
Social Insurance, 2004, available at http://www.nasi.org/sites/default/files/research/McBean.pdf.
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The Medicaid Statistical Information System (MSIS) is the primary source of state-reported data
on Medicaid enrollees and expenditures. The MSIS required data set includes information on
eligibility, including racial and ethnic data. States have the discretion to choose whether or how to
collect racial and ethnic information; if they do collect this information CMS requires that it be
reported in a standardized format. There is considerable variation in the quantity and quality of
the data that is reported.120
Regarding the collection of data on key national indicators, there are a number of current efforts,
some mandated in the PHSA, to collect and disseminate health statistics on the U.S. population.
The National Center for Health Statistics (NCHS), part of the CDC, collects statistics on (1) the
extent and nature of illness and disability in the U.S. population; (2) the impact of illness and
disability of the population on the U.S. economy; (3) environmental, social, and other health
hazards; (4) determinants of health; (5) health resources; (6) utilization of health care; (7) health
care costs and financing; and (8) family formation, growth, and dissolution.
NCHS also has responsibility, under PHSA Sec. 306, for compiling national vital statistics from
records of births, deaths, marriages, and divorces. That section also establishes the National
Committee on Vital and Health Statistics (NCVHS) to assist and advise the Secretary on issues
related to the collection of vital and health statistics in the United States. In addition, it directs the
Secretary to ensure comparability and reliability of health statistics, requiring the Secretary to
provide adequate technical assistance to assist state and local jurisdictions in the development of
model laws dealing with issues of confidentiality and comparability of data.
The ACA includes three sets of provisions that aim to enhance the completeness, accuracy, and
uniformity of health data. First, in the area of health disparities, the law mandates the collection
and reporting of data on race, ethnicity, sex, primary language, and disability status by all
federally conducted and supported health care and public health programs (e.g., Medicare,
Medicaid), activities, and surveys (including surveys conducted by the Bureau of Labor Statistics
and the Bureau of the Census). It specifies that the existing Office of Management and Budget
(OMB) standards must be used, at a minimum, for recording race and ethnicity, and instructs the
Secretary to issue new standards for measuring the other three factors (i.e., sex, primary language,
and disability status). Second, the law requires the development of a system to collect data on key
national indicators, to be determined by the Secretary (notably, the nature of the data to be
collected under this system is not addressed by the statutory language, with the term “health”
never appearing in the provision). Finally, the ACA seeks to improve states’ collection of vital
statistics by educating providers about the importance of standardized birth and death certificate
data, among other things. Additional background on each of these topics is provided below.
Sec. 4302. Health Disparities Data Collection and Analysis
Subsection 4302(a) creates a new PHSA Title XXXI—Data Collection, Analysis, and Quality.
It requires the Secretary to ensure that, by no later than two years after enactment, all federally
conducted or supported health care and public health programs, activities, and surveys collect and
report, to the extent practicable, data on race, ethnicity, sex, primary language, and disability
status. Such data must be aggregated at the smallest practicable geographic level. The collected
data must be sufficient to generate statistically reliable estimates of racial, ethnic, sex, primary
120
See, for example, “A Brief Overview of Medicaid Data Sources,” Kaiser Commission, Medicaid Facts, 2004,
available at http://www.kff.org/kaiserpolls/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=32735.
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language, and disability status subgroups. The Secretary may require the collection of other
demographic data regarding health disparities.
The subsection establishes uniform standards for the measurement and collection of health
disparities data, requiring that OMB’s standards must be used, at a minimum, for recording race
and ethnicity. The Secretary is instructed to develop standards for the measurement of sex,
primary language, and disability status. In addition, the Secretary must develop standards for
collecting health disparities data, whether by self-report or from a parent or legal guardian. The
Secretary is also required to ensure that federal health care programs that report quality measures
include data on individuals receiving health care items and services by race, ethnicity, sex,
primary language, and disability status. Finally, the Secretary is instructed to develop data
management, interoperability, and security standards for the collected information on health
disparities.
The subsection requires the Secretary to analyze the data collected on health disparities; provide
for the public reporting and dissemination of the data and analyses; and safeguard the privacy of
the information. The subsection authorizes the appropriation of SSAN for each of FY2010
through FY2014 for the above data collection, analysis, and reporting activities. However, data
may not be collected unless funds are directly appropriated for such purpose.
Subsection 4302(b)(1) amends the Medicaid statute (i.e., SSA Sec. 1902) to require that any
health disparities data collected under a Medicaid state plan meet all the requirements established
above. The subsection also amends the CHIP statute (i.e., SSA Sec. 2108) to require states to
include in their annual report health disparities data collected and reported in accordance with the
same requirements.
Subsection 4302(b)(2) amends the Medicaid statute by adding the language in MIPPA Sec. 185
(discussed in the preamble above) as a new SSA Sec. 1946, with the following two revisions.
First, all references to Medicare are replaced by referencing both Medicaid and CHIP. Second,
whereas the original MIPPA language addressed the collection of data on race, ethnicity, and
gender, the new provision in the Medicaid statute addresses data collection on the basis of race,
ethnicity, sex, primary language, and disability status (in accordance with the subsection 4302(a)
above). Thus, this subsection requires the Secretary to evaluate approaches for collecting
disparities data on Medicaid and CHIP beneficiaries and report to Congress on improving the
identification of health care disparities among those beneficiaries.
Sec. 5605. Key National Indicators
This section establishes the Commission on Key National Indicators (“Commission”) composed
of eight members appointed equally by the majority and minority leaders of the Senate and the
Speaker and minority leader of the House of Representatives. The Commission has the following
responsibilities: (1) conduct comprehensive oversight of the newly established key national
indicator system; (2) make recommendations on how to improve the key national indicator
system; (3) coordinate with federal government users and information providers to assure access
to relevant and quality data; and (4) enter into contracts with the National Academy of Sciences
(“Academy”).
The Commission is required to enter into an arrangement with the Academy to review available
public and private sector research on key national indicator set selection and determine how to
best establish a key national indicator system. The Academy must establish the key national
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indicator system by either creating its own institutional capability, or partnering with an
independent, private, non-profit organization as an Institute. The Academy is required to identify
and select all criterion and methodologies to establish and operate the key national indicator
system. The Academy is further required to design, publish, and maintain a website for public
access to key national indicators. Also, the Academy is to develop a quality assurance framework
to ensure rigorous and independent processes and quality data selection, and is required to submit
a report not later than 270 days after enactment, and annually thereafter, to the Commission
outlining the findings and recommendations of the Academy. The U.S. Comptroller General is
required to conduct a study of previous work conducted by a range of entities with respect to best
practices for a key national indicator system, and is required to submit this study to the
appropriate authorizing committees of Congress.
This section authorizes to be appropriated $10 million for FY2010, and $7.5 million for each of
FY2011 through FY2018, with amounts appropriated to remain available until expended.
Sec. 10407(c). Vital Statistics
This subsection requires the Secretary, acting through the CDC Director, to promote the education
and training of physicians on the importance of birth and death certificate data, encourage state
adoption of the latest standard revisions of birth and death certificates (including the collection of
such data for diabetes and other chronic diseases), and work with states to re-engineer their vital
statistics systems. (Note: Sec. 10407 in its entirety is discussed earlier in this report under
“Prevention and Wellness”)
Health Information Technology
Overview and Impact of ACA
To promote the growth of electronic record keeping and claims processing in the nation’s health
care system, HIPAA’s Administrative Simplification provisions (SSA Secs. 1171-1179) instructed
the Secretary to adopt electronic format and data standards for nine specified administrative and
financial transactions between health care
Administrative Simplification
providers and health plans. Those transactions
Center for American Progress, Paper Cuts: Reducing
include patient eligibility inquiry and
Health Care Administrative Costs, June 2012,
response, reimbursement claims, claims status
http://www.americanprogress.org/wpinquiry and response, and payment and
content/uploads/issues/2012/06/pdf/papercuts_final.pdf.
remittance advice, among others. In addition,
HHS, National Committee on Vital and Health Statistics,
HIPAA directed the Secretary to adopt a
Update on Health Care Administrative Transactions: Findings
standard for transferring standard data
from June 2012 NCVHS Hearings, September 21, 2012,
elements among health plans to improve the
http://www.ncvhs.hhs.gov/120921lt.pdf.
coordination of benefits and the sequential
processing of claims.
In 2000, CMS issued an initial set of standards for seven of the nine transactions and for the
coordination of benefits, and listed the codes sets that must be used in the transactions to identify
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specific diagnoses and clinical procedures.121 The code sets include the International
Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes that are used
for diagnoses and inpatient procedures. As required under HIPAA, the Secretary published
updated standards in early 2009 to replace the existing versions. The compliance deadline for the
updated standards was January 1, 2012. CMS also set a deadline of October 1, 2013, for providers
to switch from using the ICD-9-CM codes to report diagnoses and clinical procedures to using the
greatly expanded ICD, 10th Revision (ICD-10) code set. CMS has since extended the ICD-10
deadline by one year to October 1, 2014, in response to providers’ concerns.122
The HIPAA standard for the payment and remittance advice transaction, which is a
communication from a health plan to a provider that includes an explanation of the claim and
payment for that claim, can accommodate an electronic funds transfer (EFT), in which payment is
electronically deposited into a designated bank account. EFT is common in the health care
sector—health plan contracts often require it—but at the time of ACA’s enactment there was no
EFT mandate in federal law for Medicare, Medicaid, or private health insurance.
The HIPAA electronic transactions standards, which are the result of a consensus-based
development process, include optional data/content fields that can accommodate plan-specific
information. Providers often are faced with a multiplicity of companion guides and plan-specific
requirements and must customize transactions on a plan-by-plan basis. ACA seeks to address this
variability by requiring the adoption of operating rules for each HIPAA transaction for which
there is an existing standard, with the goal of creating as much uniformity in the implementation
and use of the transactions standards as possible.
HIPAA does not mandate that providers conduct the transactions electronically, though health
plans typically require it. However, providers that elect to submit one or more of the HIPAA
transactions electronically must comply with the standard for those transactions. In 2001,
Congress enacted the Administrative Simplification Compliance Act, which mandated that
Medicare claims be submitted electronically in the HIPAA standard format, with the exception of
those from small providers and in other limited circumstances. In September 2005, CMS
proposed a standard for health care claims attachments, one of the two remaining HIPAAspecified transactions for which a standard must be adopted. A claims attachment transaction is
used to request and provide additional clinical data necessary to adjudicate a claim.
HIPAA also instructed the Secretary to adopt unique identifiers for health care providers, health
plans, employers, and individuals for use in standard transactions. Unique identifiers for
providers and employers were adopted prior to ACA, while the health plan identifier was still
under review at the time of the law’s enactment. Congress has blocked the development of a
unique individual identifier through language added to the annual Labor-HHS appropriations bill.
121
Electronic standards were adopted for the following seven HIPAA-specified administrative and financial
transactions: health care claim submission; patient eligibility inquiry and response; prior authorization and patient
referral; health care claim status inquiry and response; plan enrollment and disenrollment; claim payment and
remittance advice; and premium payments. Electronic standards have not yet been adopted for the following two
transactions: health care claims attachments; and first report of injury.
122
For more information, see http://www.cms.gov/icd10.
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Sec. 1104. Administrative Simplification: Operating Rules
This ACA section123 amends SSA Sec. 1173 to establish a timeline for the development, adoption
and implementation of a single set of operating rules for each HIPAA transaction for which there
is an existing standard. The standards and associated operating rules must meet certain
requirements. They have to (1) enable determination of an individual’s eligibility and financial
responsibility for specific services prior to or at the point of care; (2) be comprehensive, requiring
minimal augmentation with paper; and (3) provide for timely acknowledgment, response, and
status reporting that supports a transparent claims and denial management process. Operating
rules are defined as the necessary business rules and guidelines for the electronic exchange of
information that are not defined by the electronic standards themselves. In adopting the operating
rules, the Secretary is required to consider the recommendations of a qualified nonprofit entity
that uses a multi-stakeholder, consensus-based process for developing such rules. Also, the
section adds EFT for the payment of health claims as a HIPAA transaction and requires the
Secretary to adopt an EFT standard no later than January 1, 2012, to take effect by January 1,
2014.
Operating rules for eligibility and health claims status transactions had to be adopted by July 1,
2011, and were to take effect by January 1, 2013. Operating rules for claims payment/remittance
and EFT had to be adopted by July 1, 2012, and are to take effect by January 1, 2014. The
Secretary must adopt operating rules for the remaining HIPAA transactions (i.e., health claims,
plan enrollment and disenrollment, health plan premium payments, and prior authorization and
referral) by July 1, 2014, to take effect by January 1, 2016.
By January 1, 2014, the Secretary must establish a committee to review and provide
recommendations for updating and improving the HIPAA standards and operating rules. By April
1, 2014, and biennially thereafter, the committee must conduct hearings to evaluate the adopted
standards and operating rules, and by July 1, 2014, and biennially thereafter, the committee must
submit its recommendations to the Secretary. The Secretary must adopt the recommendations
through promulgation of an interim final rule within 90 days of receipt of the committee’s report.
By December 31, 2013, health plans are required to file a certification statement with the
Secretary that their data and information systems comply with the most current published
standards and associated operating rules, for the following transactions: eligibility, health claims
status, claims payment/remittance and EFT. By December 31, 2015, health plans are required to
certify to the Secretary that their data and information systems comply with the most current
published standards and operating rules for the remaining completed HIPAA transactions. The
Secretary is permitted to designate an outside entity to verify that health plans have met the
certification requirements and must conduct periodic audits of plans to ensure that they maintain
compliance with the standards and operating rules.
The section requires the Secretary, no later than April 1, 2014, and annually thereafter, to assess a
penalty fee against health plans that fail to meet the certification requirements. By May 1, 2014,
and annually thereafter, the Secretary must provide the Treasury Secretary with a list of health
plans that have been assessed a penalty fee for noncompliance, and by August 1, 2014, and
123
HCERA also includes a section 1104, which addresses Medicare Disproportionate Share Hospital (DSH) payments.
That provision is discussed in CRS Report R41196, Medicare Provisions in the Patient Protection and Affordable Care
Act (PPACA): Summary and Timeline, coordinated by Patricia A. Davis.
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annually thereafter, the Treasury Secretary must provide notice to all such plans. The deadline for
health plans to pay the penalty fees is November 1, 2014, and annually thereafter. The Secretary
of the Treasury, acting through the Financial Management Service, is responsible for the
collection of penalty fees. Unpaid penalty fees are to be increased by an interest payment
determined in a manner similar to underpayment of income taxes and considered debts owed to
federal agencies, which may offset and reduce the amount of tax refunds otherwise payable to a
health plan.
The section requires the Secretary to issue a rule to establish a unique health plan identifier. The
rule was to take effect no later than October 1, 2012. In addition, the Secretary is required to
adopt a transaction standard and single set of associated operating rules for health claims
attachments no later than January 1, 2014, to take effect by January 1, 2016.
In addition to the above provisions, the section amends SSA Sec. 1862(a) to require that as of
January 1, 2014, no Medicare payment may be made for benefits delivered under Part A or Part B
other than by EFT or an electronic remittance in a form specified in the HIPAA
payment/remittance advice standard.
Sec. 10109. Administrative Simplification: Additional Standards; ICD-10
This section further amends SSA Sec. 1173 to require the Secretary, by January 1, 2012, and not
less than every three years thereafter, to solicit input from the NCVHS, the Health Information
Technology Policy and Standards Committees and other stakeholders on whether standards and
operating rules should be developed for other administrative and financial transactions. The
Secretary was to solicit input on the following specified areas by January 1, 2012: (1) whether
enrollment of health care providers by health plans could be made electronic and standardized;
(2) whether the HIPAA standards and operating rules should apply to the health care transactions
of automobile insurance, worker’s compensation, and other programs not covered under HIPAA;
(3) whether standardized forms could apply to financial audits required by health plans and
government agencies; (4) whether there could be greater transparency and consistency in the
methods used to establish claim edits used by health plans; and (5) whether health plans should be
required to publish their timeliness of payment rules.
The section also required the Secretary to convene a meeting of the ICD-9-CM Coordination and
Maintenance Committee by January 1, 2011, to receive stakeholder input and make
recommendations about revisions to the crosswalk between the ICD-9 and ICD-10 codes. The
Secretary must make appropriate revisions and post the revised crosswalk on the CMS website.
For subsequent versions of the ICD codes, the Secretary is required, after consultation with
appropriate stakeholders, to post on the CMS website a crosswalk between the previous and
subsequent versions of the codes no later than the date on which the subsequent version is
implemented.
Sec. 1561. Standards for Enrollment in Federal and State Programs
This section adds a new PHSA Title XXX, Subtitle C, Other Provisions, comprising Sec. 3021.
The Secretary, within 180 days of enactment and in consultation with the HIT Policy Committee
and the HIT Standards Committee, was required to develop interoperable and secure standards
that facilitate enrollment of individuals in federal and state health and human services programs.
The standards and protocols must allow for the following functions: (1) electronic matching
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against existing federal and state data that provide evidence of eligibility; (2) simplification and
submission of electronic documentation, digitization of documents, and systems verification of
eligibility; (3) reuse of stored eligibility information; (4) capability of individuals to manage their
eligibility information online; (5) ability to expand the enrollment system to integrate new
programs; (6) notification, including by e-mail and phone, of eligibility, recertification, and other
information regarding eligibility; and (7) other functionalities to streamline the enrollment
process. The Secretary is required to notify states upon approval of the standards and protocols
and may require that states and other entities incorporate such standards and protocols as a
condition of receiving federal HIT funds.
The Secretary is required to award grants to states and localities to develop new or upgrade
existing IT systems to implement the enrollment standards and protocols. Eligible grantees are
required to submit an adoption and implementation plan that includes, among other things,
demonstrated collaboration with other grantees. The Secretary also is required to ensure that the
enrollment IT adopted by grantees be shared at no cost to other qualified states, localities, and
others.
Emergency Care
Overview and Impact of ACA
Amid concerns of an overburdened emergency care system, the IOM in 2006 issued three reports
examining the state of the U.S. emergency medical system. The reports focused on the hospitalbased emergency system (i.e., emergency departments); the emergency medical system including
trauma care, ambulances, and other forms of transport; and emergency care for children.124 Each
report discussed deficiencies with the current emergency care system, including overcrowded
hospital emergency departments, local and regional variation in the availability of services, an
insufficient workforce to provide necessary care, limited financial or personnel resources, and
other deficiencies that may strain the systems’ ability to handle a disaster. The IOM reports made
a number of recommendations to address those deficiencies.
ACA amends existing and creates new emergency and trauma care provisions in Title XII of the
PHSA. These provisions address a number of the IOM recommendations to improve the U.S.
emergency and trauma care system. They include designating the Assistant Secretary for
Preparedness and Response as the lead office within HHS for emergency and trauma care;
authorizing grants to create regionalized systems for trauma care; allocating additional funds to
facilities with large uncompensated care burdens; and improving the emergency care workforce,
among other provisions.
In addition to these specific provisions, ACA may impact the emergency medical system through
its changes to the private health insurance system and the expansion of Medicaid that are intended
to reduce the number of uninsured. Some of the challenges that the emergency care system—and
hospital emergency departments in particular—face are associated with, or exacerbated by,
124
Institute of Medicine, Emergency Medical Services at the Crossroads (Washington, DC: The National Academies
Press, 2006); Institute of Medicine, Hospital-Based Emergency Care At the Breaking Point, (Washington, DC: The
National Academies Press, 2006); and Institute of Medicine, Emergency Care for Children: Growing Pains,
(Washington, DC: The National Academies Press, 2006).
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having to provide care to the uninsured. Under the Emergency Medical Treatment and Labor Act
(EMTALA), hospital emergency departments must examine and treat any individual who comes
to the hospital with an emergency medical condition, and any woman who is in labor. EMTALA
requires hospitals to offer treatment, within their capacity and with the individual’s consent, to
stabilize the emergency condition, or transfer the individual to another medical facility, subject to
certain restrictions. The act prohibits discrimination and delay in examining or treating
emergency patients, and provides protections to whistleblowers who report violations of its
provisions.125 Uncompensated care provided to the uninsured in emergency departments can place
a financial burden on hospitals, which can hinder access to emergency care overall.126
Sec. 3504. Regionalized Systems for Emergency Care
This section amends PHSA Sec. 1203, which provides grants to states and localities to improve
access to and enhance the development of trauma care systems, by renaming the section,
Competitive Grants for Trauma Systems for the Improvement of Trauma Care, and by transferring
administration of the program from HRSA to the Assistant Secretary for Preparedness and
Response.
In addition, the section adds a new PHSA Sec. 1204, requiring the Secretary, acting through the
Assistant Secretary for Preparedness and Response, to award no fewer than four multiyear
contracts or competitive grants for pilot projects to improve regional coordination of emergency
services. Eligible grantees (including states and Indian tribes) must propose a pilot project to
design, implement, and evaluate certain emergency medical and trauma systems. Grants must be
matched with cash or in-kind at a rate of $1 for every $3 of federal funds, and priority is to be
given to entities in medically underserved areas. Within 90 days of completing a pilot project, the
grantee is required to submit to the Secretary a detailed evaluation of the program’s
characteristics and impact. The Secretary is further required, as appropriate, to disseminate that
information to the public and to Congress. In addition, the section authorizes to be appropriated
for Title XII Parts A and B trauma care grant programs $24 million for each of FY2010 through
FY2014, and transfers authority for administering those grants and related authorities to the
Assistant Secretary for Preparedness and Response.
Finally, the section adds a new PHSA Sec. 498D, directing the Secretary to expand and accelerate
basic science, translational and service delivery research on emergency medical care systems and
emergency medicine, including pediatric emergency medical care. The Secretary also is required
to support research on the economic impact of coordinated emergency care systems. There are
authorized to be appropriated SSAN for each of FY2010 through FY2014 to carry out the new
section.
Sec. 3505. Trauma Care Centers
This section amends PHSA Secs. 1241-1245 by replacing the existing provisions with new
language requiring the Secretary to establish three programs to award grants to qualified public,
nonprofit Indian Health Service, Indian tribal, and urban Indian trauma centers to (1) help defray
125
For more information, see CRS Report RS22738, EMTALA: Access to Emergency Medical Care, by Edward C. Liu.
Institute of Medicine, Hospital-Based Emergency Care At the Breaking Point, (Washington, DC: The National
Academies Press, 2006).
126
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substantial uncompensated care costs, (2) further the core missions of such centers, and (3)
provide emergency relief to ensure the continued availability of trauma services. In states with a
trauma care system, a trauma center is not eligible for a grant unless it is part of the trauma care
component of the state plan for the provision of emergency care services. The maximum grant
amount is $2 million per fiscal year.
To receive a substantial uncompensated care grant, qualified trauma centers are categorized based
on the percentage of emergency department visits that are charity, self-pay, and Medicaid
patients. Trauma centers in each category are eligible for grants up to some specified percentage
of their uncompensated care costs. For example, category A centers—those with the highest
percentage of charity or self-pay patient visits—are eligible for grants covering 100% of their
uncompensated care costs.
The section specifies the distribution of funding allocated for core mission grants among the
different levels of trauma centers. Preference in awarding emergency relief grants is to be given
to applications from trauma centers in areas in which the availability of trauma care is declining
or would significantly decrease if the center was forced to scale back or close. The Secretary is
authorized to require that grantees (1) maintain access to trauma care services at comparable
levels to the prior year during the grant program; and (2) provide data to a national and
centralized registry of trauma cases, in accordance with American College of Surgeons (ACS)
guidelines.
The section authorizes $100 million to be appropriated for FY2009, and SSAN for each of
FY2010 through FY2015 to carry out the three grant programs. Seventy percent of the total
amount appropriated for a fiscal year is for substantial uncompensated care awards unless the
appropriation is less than $25 million, in which case all the funding will be used for such awards.
The Secretary is required to submit a biennial report to Congress on the status of the grant
programs. The section also adds a new PHSA Sec. 1246 that defines the term “uncompensated
care costs.”
Additionally, this section adds a new PHSA Sec. 1281, requiring the Secretary to award grants to
states for the purpose of supporting trauma-related physician specialties and broadening access to
and availability of trauma care services. Distribution of grant funds among the states is based on
the program’s annual appropriation level. The lower the appropriation amount, the more the
distribution of funds is restricted to those states with trauma centers that provide a substantial
amount of uncompensated care. If the appropriation is less than $10 million, the lowest amount
specified, then the funds are distributed among only those states with one or more category A
centers. The section adds a new PHSA Sec. 1282 that authorizes $100 million to be appropriated
for each of FY2010 through FY2015 to provide for the state grants.
Sec. 5603. Emergency Medical Services for Children
This section amends PHSA Sec. 1910, which authorizes demonstration grants to expand
emergency services for children, by lengthening the grant period to four years (with an optional
fifth year). It also authorizes to be appropriated $25 million for the program for FY2010, $26.3
million for FY2011, $27.6 million for FY2012, $28.9 million for FY2013, and $30.4 million for
FY2014.
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Pain Care Management
Overview and Impact of ACA
Under general authorities in PHSA Title III and Title IV, NIH established the Pain Consortium to
enhance pain research and promote collaboration among researchers across various NIH Institutes
and centers that have programs and activities addressing pain. In addition, PHSA Sec. 403
requires the NIH Director to submit to the President and Congress a biennial report that includes,
among other things, a summary of the research activities throughout the agency organized by
category; the chronic disease category includes pain and palliative care.
ACA addresses several issues with the goal of
advancing research and treatment for pain care
management. For the purpose of recognizing
pain as a national public health problem, the
Secretary is required to convene an IOM
Conference on Pain. The act also encourages
the NIH Director to continue and expand pain
research through the Pain Consortium and
establishes a health professionals training
program in pain care. The following describes
these provisions in greater detail.
Pain Care Management
Institute of Medicine: Relieving Pain in America: A Blueprint
for Transforming Prevention, Care, Education, and Research,
June 29, 2011,
http://www.iom.edu/Reports/2011/Relieving-Pain-inAmerica-A-Blueprint-for-Transforming-Prevention-CareEducation-Research.aspx. See, also,
http://www.iom.edu/Activities/PublicHealth/PainResearch.
aspx (IOM’s web-site about this activity).
Sec. 4305. Advancing Research and Treatment for Pain Care Management
This section requires the Secretary to seek an agreement with the IOM (or another appropriate
entity if the IOM declines) to convene a Conference on Pain, no later than one year after the
appropriation of funds, for the purposes of increasing the recognition of pain as a significant
public health problem in the United States, among other purposes. It also requires a report
summarizing the Conference’s findings to be submitted to Congress. For the purpose of carrying
out this section, ACA authorizes to be appropriated SSAN for each of FY2010 and FY2011.
The section adds a new PHSA Sec. 409J, which encourages the NIH Director to continue and
expand an aggressive program of research on the causes of and potential treatment for pain
through the Pain Consortium. The Pain Consortium, no less than annually, develops and submits
to the NIH Director recommendations on appropriate pain research initiatives that could be
undertaken with funds reserved under the NIH Common Fund or otherwise available for such
initiatives. The Secretary also is required to establish, no later than one year after enactment, and
as necessary maintain, the Interagency Pain Research Coordinating Committee to coordinate all
efforts within HHS and other federal agencies that relate to pain research, among other duties.
The section adds a new PHSA Sec. 759, authorizing the Secretary to establish a program to train
health professionals in pain care. The Secretary may fund health professions schools, hospices,
and other entities for the development and implementation of education and training programs to
health care professionals in pain care. Award applicants must agree to include information and
education on the following topics: (1) recognized means for assessing, diagnosing, treating, and
managing pain and related signs and symptoms; (2) applicable laws, regulations, rules, and
policies on controlled substances; (3) interdisciplinary approaches to the delivery of pain care; (4)
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cultural, linguistic, literacy, geographic, and other barriers to care in underserved populations; and
(5) recent findings, developments, and improvements in the provision of pain care. The Secretary
also is required to provide for an evaluation of the implemented programs. For the purposes of
carrying out this section, there are authorized to be appropriated SSAN for each of FY2010
through FY2012 with amounts remaining available until expended.
Elder Justice
Overview and Impact of ACA
ACA represents Congress’s first attempt at
comprehensive legislation to address abuse,
neglect, and exploitation of the elderly at the
federal level by incorporating the Elder Justice
Act into health reform legislation. The
enactment of elder justice provisions not only
brings greater national attention to the issue,
but emphasizes various public health and
social service approaches to the prevention,
detection, and treatment of elder abuse. At the
federal level, the enactment of the Elder
Justice Act places the issue of elder abuse on
par with similar legislation Congress has
enacted with respect to child abuse and
neglect, under the Child Abuse Prevention and
Treatment Act (CAPTA), and domestic
violence, under the Violence Against Women’s
Act (VAWA).
Elder Justice
U.S. Government Accountability Office, Stronger Federal
Leadership Could Enhance National Response to Elder Abuse,
GAO-11-208, Mar 2, 2011,
http://www.gao.gov/assets/320/316224.pdf
U.S. Government Accountability Office, National Strategy
Needed to Effectively Combat Elder Financial Exploitation,
GAO-13-110, Nov 15, 2012,
http://www.gao.gov/products/GAO-13-110
U.S. Government Accountability Office, Strengthening
Efforts to Combat Elder Financial Exploitation, GAO-13140T, Nov 15, 2012, http://www.gao.gov/products/GAO13-140T
U.S. Government Accountability Office, Survey of Adult
Protective Services Program Administrators (GAO-11-129SP,
March 2011), an E-supplement to GAO-11-208, GAO11-129SP, Mar 2, 2011,
http://www.gao.gov/products/GAO-11-129SP.
Abuse, neglect, and exploitation of older individuals in domestic and institutional settings, such
as nursing homes, affects hundreds of thousands of older Americans every year according to
national experts.127 Precisely how many older individuals are mistreated by someone on whom
they depend for care or protection is unknown. Efforts to collect data on elder abuse, neglect, and
exploitation at the national level are hampered by variation in state statutory definitions of elder
abuse that make it difficult to identify actions that constitute abuse and neglect, and by the
absence of a uniform reporting system across states. In 2003, a National Research Council Study
estimated that between 1 and 2 million Americans age 65 and older had been injured, exploited,
or mistreated.128 Other evidence and anecdotal reports indicate that the problem is serious and that
many incidents are never reported.129
127
U.S. Government Accountability Office, Stronger Federal Leadership Could Enhance National Response to Elder
Abuse, GAO-11-208, Mar 2, 2011, http://www.gao.gov/assets/320/316224.pdf. Reissued on March 22, 2011.
128
Richard J. Bonnie and Robert B. Wallace, eds., Elder Mistreatment: Abuse, Neglect and Exploitation in an Aging
America, National Research Council (Washington, DC: National Academy Press, 2003).
129
Ibid.
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Congressional interest in the issue of elder abuse, neglect, and exploitation spans more than a
quarter of a century with numerous hearings and reports concerning the need for a federal
response to abuse, neglect, and exploitation of the elderly. Prior to enactment of ACA, Congress
took a number of modest steps towards addressing elder abuse, including federal assistance to
state Adult Protective Services programs through the Social Security Block Grant (SSBG)
program and amendments to the Older Americans Act (OAA) to provide separate funding for
elder abuse prevention and vulnerable elder rights protection activities, including establishment of
the Long-Term Care Ombudsman Program (LTCOP). Provisions regarding elder justice were also
incorporated in the OAA reauthorization of 2006 (P.L. 109-365).
The Elder Justice Act, first introduced in 2002 and periodically re-introduced since that time,
represents an effort to produce a coordinated federal effort with a multidisciplinary approach that
combines law enforcement, public health, and social services to combat abuse, neglect, and
exploitation of the elderly.130 The following summarizes the Elder Justice Act provisions enacted
under ACA.
Sec. 6703. Elder Justice
This section includes the following provisions divided into three subsections: (a) elder justice
provisions amending Title XX of the SSA; (b) various provisions related to protecting residents
of long-term care facilities; and (c) establishing a national nurse aide registry.
Elder Justice
Subsection (a) of Sec. 6703 renames SSA Title XX as Block Grants to States for Social Services
and Elder Justice, places the existing sections (i.e., Secs. 2001-2007) under a new Subtitle A,
Block Grants to States for Social Services, and adds a new Subtitle B, Elder Justice, composed of
the following two parts.
Part I—National Coordination of Elder Justice Activities and Research
Title XX, Subtitle B, Part I is divided into two subparts—Subpart A establishes an Elder Justice
Coordinating Council and Advisory Board on Elder Abuse, Neglect, and Exploitation comprised
of new SSA Secs. 2021-2024; Subpart B adds a new Sec. 2031 awarding grants to establish and
operate stationary and mobile forensic centers. These sections and activities are described in
further detail below.131
Subpart A—Elder Justice Coordinating Council and Advisory Board on Elder Abuse,
Neglect, and Exploitation. Subpart A adds a new Sec. 2021, Elder Justice Coordinating Council,
establishing such a Council in the Office of the Secretary. The Council includes the Secretary as
130
Congress first introduced the Elder Justice Act of 2002 in the 107th Congress (S. 2933). The Elder Justice Act has
been introduced subsequently in the 108th Congress (S. 333; H.R. 2490), 109th Congress (S. 2010; H.R. 4993), and
110th Congress (S. 1070; H.R. 1783). In the 111th Congress, Senator Orrin Hatch introduced the Elder Justice Act of
2009 (S. 795). A companion bill (H.R. 2006) was introduced in the House by Representative Peter T. King. S. 795 was
incorporated into the Senate Finance Committee’s health reform bill (S. 1796) and subsequently adopted in the Senate
health reform bill, ACA (H.R. 3590).
131
Prior to Part I, new Subtitle B begins with Secs. 2011 (Definitions) and 2012 (General Provisions), which are not
discussed here.
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chair and the U.S. Attorney General, as well as the head of each federal department or agency,
identified by the chair, as having administrative responsibility or administering programs related
to elder abuse, neglect, and exploitation. The council is required to submit a report to the
appropriate committees of Congress within two years of enactment and every two years thereafter
that describes its activities and challenges; and make recommendations for legislation, model
laws, and other actions deemed appropriate. There are authorized to be appropriated SSAN to
carry out the Council’s functions.
Subpart A also adds a new Sec. 2022, Advisory Board on Elder Abuse, Neglect, and Exploitation,
establishing an Advisory Board to create a short- and long-term multidisciplinary plan for
development of the field of elder justice and make recommendations to the Elder Justice
Coordinating Council. The Advisory Board must be composed of 27 members from the general
public appointed by the Secretary and must have experience and expertise in prevention of elder
abuse, neglect, and exploitation. The Advisory Board is required to submit a report to the Elder
Justice Coordinating Council and the appropriate committees of Congress within 18 months of
enactment and annually thereafter that contains information on the status of federal, state, and
local elder justice activities; and make specified recommendations. There are authorized to be
appropriated SSAN to carry out the functions of the Advisory Board.
Subpart A adds a new Sec. 2023, Research Protections, requiring the Secretary to promulgate
guidelines to assist researchers working in the areas of elder abuse, neglect, and exploitation with
issues relating to human research subject protections. For the purposes of the application of
certain specified federal regulations to research conducted under Subpart A it defines “legally
authorized representative” to mean, unless otherwise provided by law, the individual, or judicial
or other body authorized under the applicable law to consent to medical treatment on behalf of
another person.
To carry out the functions under Subpart A, a new Sec. 2024, Authorization of Appropriations,
authorizes to be appropriated $6.5 million for FY2011, and $7.0 million for each of FY2012
through FY2014.
Subpart B—Elder Abuse, Neglect, Exploitation Forensic Centers. Subpart B adds a new Sec.
2031, Establishment and Support of Elder Abuse, Neglect, and Exploitation Forensic Centers,
requiring the Secretary, in consultation with the U.S. Attorney General, to award grants to eligible
entities to establish and operate both stationary and mobile forensic centers and to develop
forensic expertise pertaining to elder abuse, neglect, and exploitation. It authorizes to be
appropriated $4 million for FY2011, $6 million for FY2012, and $8 million for each of FY2013
and FY2014 to carry out these activities.
Part II—Programs to Promote Elder Justice
Title XX, Subtitle B, Part II establishes several grant programs and other activities to promote
elder justice. These provisions are established in the following new Secs. 2041-2046 and are
described below.
Sec. 2041. Enhancement of Long-Term Care. This section requires the Secretary, in
coordination with the Secretary of Labor, to carry out activities that provide incentives for
individuals to train for, seek, and maintain employment providing direct care in LTC. The
Secretary is required to award grants to eligible entities to conduct programs that offer direct care
employees continuing training and varying levels of certification. It also authorizes the Secretary
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to make grants to LTC facilities for specified activities that would assist such entities in offsetting
costs related to purchasing, leasing, developing, and implementing certified EHR technology
designed to improve patient safety and reduce adverse events and health care complications
resulting from medication errors. This section also requires the Secretary to adopt electronic
standards for the exchange of clinical data by LTC facilities and, within 10 years of enactment, to
have in place procedures to accept the optional electronic submission of clinical data by LTC
facilities pursuant to such standards. The standards adopted must be compatible with standards
established under current law, as specified, and with general HIT standards. The section
authorizes to be appropriated $20 million for FY2011, $17.5 million for FY2012, and $15 million
for each of FY2013 and FY2014 to carry out the activities under this section.
Sec. 2042. Adult Protective Service Functions and Grant Program. This section requires the
Secretary to ensure that the Department (1) provides authorized funding to state and local adult
protective services (APS) offices that investigate reports of elder abuse, neglect, and exploitation;
(2) collects and disseminates data in coordination with DOJ; (3) develops and disseminates
information on best practices regarding, and provides training on, carrying out APS; (4) conducts
research related to the provision of APS; and (5) provides technical assistance to states and other
entities that provide or fund APS. To carry out these functions, the section authorizes to be
appropriated $3 million for FY2011, and $4 million for each of FY2012 through FY2014.
The section also requires the Secretary to establish two grant programs. The first it to enhance
APS programs provided by states and local governments. The second is grants to states for APS
demonstration programs. Annual grants awarded to states to enhance APS programs are to be
distributed to states based on a formula. For each of FY2011 through FY2014, the section
authorizes to be appropriated $100 million for annual grants to enhance APS programs and $25
million for the APS demonstration grants.
Sec. 2043. Long-Term Care Ombudsman Program Grants and Training. This section
requires the Secretary to award grants to eligible entities with relevant expertise and experience in
abuse and neglect in LTC facilities or state LTC ombudsman programs to (1) improve the
capacity of state LTC ombudsman programs to respond to and resolve abuse and neglect
complaints; (2) conduct pilot programs with state or local LTC ombudsman offices; and (3)
provide support for such state LTC ombudsman programs and such pilot programs. It authorizes
to be appropriated $5 million for FY2011, $7.5 million for FY2012, and $10 million for each of
FY2013 and FY2014. The section also requires the Secretary to establish programs to provide
and improve ombudsman training with respect to elder abuse, neglect, and exploitation for
national organizations and state LTC ombudsman programs. It authorizes to be appropriated $10
million for each of FY2011 through FY2014.
Sec. 2044. Provision of Information Regarding, and Evaluation of, Elder Justice Programs.
To be eligible to receive a grant under Part II, this section requires an applicant to (1) agree to
provide the required information to eligible entities conducting an evaluation of the activities
funded through the grant; and (2) in the case of an applicant for a certified EHR technology grant,
to provide the Secretary with such information as the Secretary may require. It requires the
Secretary to reserve a portion of the funds appropriated in each program under Part II (no less
than 2%) to be used to provide assistance to eligible entities to conduct validated evaluations of
the effectiveness of the activities funded under each program under Part II. This provision does
not apply to the certified EHR technology grant program; instead, the Secretary is required to
conduct an evaluation of the activities funded under this grant program and appropriate grant
audits.
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Sec. 2045. Report. This section requires the Secretary to submit a report to the Elder Justice
Coordinating Council and the appropriate committees of Congress, no later than October 1, 2014,
compiling, summarizing, and analyzing state reports submitted under the APS grant programs and
recommendations for legislative or administrative action, as the Secretary determines appropriate.
Sec. 2046. Rule of Construction. This section states that nothing in Subtitle B should be
construed as (1) limiting any cause of action or other relief related to obligations under this
subtitle that are available under the state law; or (2) creating a private cause of action for a
violation of this subtitle. The section also amends SSA Sec. 402(a)(1)(B) to require a state’s
TANF state plan to indicate whether the state intends to assist individuals to train for, seek, and
maintain employment providing direct care in a LTC facility or in other occupations related to
elder care. States that add this option are required to provide an overview of such assistance. The
amendment took effect on January 1, 2011.
Protecting Residents of Long-Term Care Facilities
Subsection (b) of Sec. 6703 establishes (1) a National Training Institute for Surveyors and grants
to state survey agencies; and (2) requirements for reporting crimes in federally funded LTC
facilities.
Specifically, this subsection requires the Secretary to enter into a contract to establish and operate
the National Training Institute for federal and state surveyors to carry out specified activities that
provide and improve training of surveyors investigating allegations of abuse, neglect, and
misappropriation of property in programs and LTC facilities that receive payments under
Medicare or Medicaid. It authorizes to be appropriated $12 million for the period of FY2011
through FY2014 to carry out these activities. The HHS Secretary is also required to award grants
to state survey agencies that perform surveys of Medicare or Medicaid participating facilities to
design and implement complaint investigation systems. It authorizes $5 million for each of
FY2011 through FY2014 to carry out these activities.
This subsection amends SSA Title XI, Part A (as amended by ACA Sec. 6005) by adding a new
Sec. 1150B, Reporting to Law Enforcement of Crimes Occurring in Federally Funded Long-Term
Care Facilities, requiring the reporting of crimes occurring in federally funded LTC facilities that
receive at least $10,000 during the preceding year. It requires the owner or operator of these
facilities to annually notify covered individuals that they are required to report any reasonable
suspicion of a crime against a resident or individual receiving care from the facility. Failure to
report suspicion of a crime would result in a civil money penalty and the Secretary may make a
determination to exclude the covered individual from participation in any federal health care
program. If an individual is classified as an “excluded individual,” a LTC facility that employs
that person is not eligible to receive federal funds under the SSA. It prohibits a LTC facility from
retaliating against an employee for making a report. If retaliation occurs, the LTC facility may be
subject to a civil money penalty or the Secretary may exclude them from participation in any
federal health care program for a period of two years, or both. In addition, each LTC facility is
required to post conspicuously, in an appropriate location, a sign specifying the rights of
employees under this section.
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National Nurse Aide Registry
Subsection (c) of Sec. 6703 requires the Secretary, in consultation with appropriate government
agencies and private sector organizations, to conduct a study on establishing a national nurse aide
registry. No later than 18 months after the date of enactment, the Secretary is required to submit a
report to the Elder Justice Coordinating Council and appropriate congressional committees
containing the findings and recommendations of the study. It authorizes to be appropriated SSAN
to carry these activities, with funding for the study not to exceed $500,000.
Biomedical Research and Medical Products
Overview and Impact of ACA
ACA contains provisions that impact various stages of the medical product development pipeline,
including basic biomedical research, premarket and postmarket review of medical products by the
Food and Drug Administration
(FDA), and revenue generation via
Biomedical Research and Medical Products
products already on the market.
CRS Report R42130, FDA Regulation of Medical Devices, by Judith A.
Johnson.
Basic biomedical research supported CRS Report R42680, The Food and Drug Administration Safety and
by the National Institutes of Health
Innovation Act (FDASIA, P.L. 112-144), coordinated by Susan Thaul.
(NIH) and other federal agencies
can sometimes result in the
development of medical products. ACA contains two provisions designed to facilitate biomedical
research and help translate promising research findings into new medical products. One creates a
two-year temporary tax credit equal to 50% of investment in certain types of therapeutic research.
Another authorizes NIH funding for the Cures Acceleration Network (CAN) to speed treatment
development not likely to occur through market incentives.
FDA is responsible for ensuring medical product safety and effectiveness; it derives most of its
authorities from the Federal Food, Drug, and Cosmetic Act (FFDCA).132 Adding FDA
requirements may increase the quality of medical products but may also raise the cost or delay
consumer access to those products. Three ACA provisions affect FDA regulation of medical
products. One requires that, if certain conditions are met, additional health benefit and risk
information about a prescription drug must be included in its labeling and in advertisements. A
second makes it easier for a generic drug to continue to seek FDA approval if the associated
brand-name drug changes its labeling within 60 days of the generic’s approval. A third provision
will enable biosimilar biological products to reach the marketplace for the first time. Because of
its significance, the biosimilar provision is discussed in its own section below.
Medical products comprise 14% of health care expenditures.133 The implementation of ACA may
increase the demand for medical products as more individuals obtain health insurance. ACA
132
21 USC §§ 301 et seq.
This percentage is based upon CMS data from 2011. It was generated by dividing $349 billion (Retail Outlet Sales
of Medical Products) by $2,547 billion (Health Consumption Expenditures). The number does not reflect all of the
costs of FDA regulated medical products associated with health care spending, because it does not include those
purchased by hospitals (such as pacemakers and other implantable devices), dentists offices (such as fillings), or other
(continued...)
133
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contains provisions designed to generate tax revenue from the sale of prescription drugs and
medical devices. It also contains a provision that taxes (and may deter) the use of another product
regulated under the FFDCA: ultraviolet lamps used for indoor tanning. (Note that ACA provisions
that affect Medicare and Medicaid reimbursement for medical products are discussed in separate
CRS reports, which are listed at the beginning of this report.)
Biomedical Research
Sec. 9023. Qualifying Therapeutic Discovery Project Credit
This section inserts a new Sec. 48D, Qualifying Therapeutic Discovery Project Credit, into the
IRC, Chapter 1, subchapter A, part IV, Subpart E and makes other conforming and clerical
amendments. The new provision creates a two-year temporary tax credit program for small
companies with 250 or fewer employees that invest in qualifying therapeutic discovery projects.
Companies may apply for one or more tax credits, each covering 50% of the cost of qualifying
research investments made in 2009 or 2010. However, the total amount of tax credits any one
company receives may not exceed $5 million. Overall, the tax credit program is capped at $1
billion.
There are three types of qualifying therapeutic discovery projects for which investments may be
eligible for the new tax credit. The first consists of studies designed to treat or prevent diseases or
conditions for the purpose of securing FDA approval of a new drug (under FFDCA Sec. 505(b))
or licensure of a new biological product (under PHSA Sec. 351(a)). The second includes projects
to diagnose diseases or conditions or to determine molecular factors related to diseases or
conditions by developing molecular diagnostics to guide therapeutic decisions. The third includes
projects to develop a product, process, or technology to further the delivery or administration of
therapeutics.
In addition, when determining which investments to certify as qualified for the tax credit (as
described below), the Secretary of the Treasury, in consultation with the Secretary is directed to
consider:
•
only projects that have both a reasonable potential to (1) result in new therapies
to treat areas of unmet medical need or to prevent, detect, or treat chronic or
acute diseases and conditions; (2) reduce long-term health care costs in the
United States, or (3) significantly advance the goal of curing cancer within the
30-year period; and
•
projects that have the greatest potential to create and sustain (directly or
indirectly) high-quality, high-paying jobs in the United States, and to advance
U.S. competitiveness in the fields of life, biological, and medical sciences.
Within 60 days of enactment, the Treasury Secretary, in consultation with the Secretary, must
establish a qualifying therapeutic discovery project program to consider and award certifications
for qualified investments eligible for the new credit to qualifying therapeutic discovery project
(...continued)
health care facilities. “Table 4 - National Health Expenditures by Source of Funds and Type of Expenditures: Calendar
Years 2005-2011,” CMS website, at http://www.cms.hhs.gov/NationalHealthExpendData/downloads/tables.pdf.
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sponsors. Those wishing to obtain the required certification for the new tax credit will have to
make an application to the Secretary of the Treasury, who must respond with a determination
within 30 days of receipt.
In lieu of the tax credit for investments in 2009 or 2010, companies may elect to receive one or
more grants, subject to the same restrictions (i.e., grants may cover up to 50% of the amount of
qualifying investments made in 2009 and 2010, and the total amount of grants any one company
receives for the two years may not exceed $5 million). The section appropriates SSAN to carry
out the grant program. An application for certification for the new tax credit is also considered by
the Secretary of the Treasury to be an application for the new grant program.
Certain types of expenditures are excluded from the eligibility for the credit and the grant, such as
facility maintenance and employee remuneration. Certain other restrictions apply related to the
use of tax deductions or other tax credits for project expenses claimed for the new tax credit or
grant.
Sec. 10409. Cures Acceleration Network
ACA amends PHSA Sec. 402(b) to require the NIH Director (Director) to implement a new
Cures Acceleration Network (CAN), to facilitate the development of “high need cures,” as
described below. It also amends PHSA Sec. 499(c)(1) to enable the Foundation for the National
Institutes of Health to accept charitable gifts to support the CAN. If funded, CAN will help
support the development of treatments for diseases or conditions that are rare, or for which
market incentives are inadequate.
ACA adds a new PHSA Sec. 402C, Cures Acceleration Network, containing definitions,
establishing CAN within the Office of the Director, specifying CAN’s functions, establishing
CAN’s Board, and requiring the Director to award grants, contracts, or cooperative agreements to
carry out the purposes of the section.
ACA defines a “high need cure” as a medical product (a drug, device, or biological product) that
the NIH Director determines: (1) is a priority to diagnose, prevent, or treat harm from a disease or
condition; and (2) that the incentives of the commercial market are unlikely to result in its
adequate or timely development. The Director must award, as specified, grants, contracts, or
cooperative agreements to accelerate the development of high need cures. Each Cures
Acceleration Partnership Award is to, among other things, provide up to $15 million for the first
year, payable in a lump sum, with a matching requirement. The Cures Acceleration Grant Awards
are similar but have no matching requirement. The Cures Acceleration Flexible Research Awards
will be available if the Director determines that the goals of the section could not be met
otherwise, and will consist of awards not to exceed 20% of the total funds appropriated under this
section (see below).
The CAN is directed to conduct and support revolutionary advances in basic research, facilitate
FDA review for CAN-funded cures, as specified, and carry out other specified functions. A CAN
Review Board is to be established to advise the Director on CAN activities. The board is also to
advise the Director on significant barriers to the translation of basic science into clinical
applications, among other things, and must submit to the Secretary reports regarding any barrier
that is identified. The Director must then respond to such recommendations in writing.
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There are authorized to be appropriated $500 million for FY2010, and SSAN for subsequent
fiscal years. Other funds appropriated under the PHSA may not be allocated to the CAN.
FDA Requirements for Medical Products
Sec. 3507. Presentation of Prescription Drug Benefit and Risk Information
This section requires the Secretary, acting through the FDA Commissioner, to determine whether
the addition of information about the health benefits and risks of a prescription drug to that drug’s
labeling and advertising would improve health care decision-making by clinicians, patients, and
consumers. Such information would be presented in a standard format such as a “Drug Facts
Box.” To reach this determination, the Secretary must review all available scientific evidence and
research on decision-making and social and cognitive psychology and consult with a wide range
of stakeholders. Within one year of enactment, the Secretary must submit to Congress a report
that includes the determination and the reasoning behind it. If the determination is that decisionmaking would be improved, the Secretary must propose implementation regulations not later than
three years after the report’s submission. Sec. 3511 of ACA authorizes the appropriation of SSAN
to carry out the activities in this section.
Sec. 10609. Labeling Changes
To receive FDA approval, a generic drug must, in addition to other requirements in an
abbreviated new drug application (ANDA), use the same labeling that FDA had approved for the
listed referent (usually brand-name) drug. This provision addresses the situation in which the
labeling of the listed referent drug is changed within 60 days of its generic product ANDA
approval. ACA amends FFDCA Sec. 505(j) to allow the Secretary to approve an otherwise
qualified generic application with the existing (unrevised) labeling if (1) the revisions did not
involve the “Warning” section, (2) the generic sponsor submits revised labeling (to put it in
accord with the listed referent drug’s revised labeling) within 60 days, and (3) the Secretary has
not determined that sale of the product with the existing (unrevised) labeling adversely impacts
the safe use of the drug.
Revenue Provisions Related to FDA-Regulated Products
Sec. 9008. Annual Fee for Brand Name Pharmaceuticals
This section, as amended by HCERA Sec. 1404, imposes an annual fee on covered entities; that
is, certain manufacturers and importers of branded prescription drugs (including biological
products and excluding orphan drugs).134 Effective in 2011, a covered entity must pay an annual
134
The FDA designates products (or combinations of products) that are used to treat rare diseases or conditions as
orphan drugs. To meet this designation, a manufacturer must request this designation and must meet certain criteria.
The orphan drug designation qualifies the manufacturer for a tax credit and certain marketing incentives. For more
information, see U.S. Department of Health and Human Services, U.S. Food and Drug Administration, "Designating an
Orphan Product: Drugs and Biologics," December 11, 2012,
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesigna
tion/default.htm.
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fee to the Secretary of the Treasury. The total fee amounts authorized per year are as follows: $2.5
billion for 2011; $2.8 billion for each of 2012 and 2013; $3 billion for each of 2014 through 2016;
$4 billion for 2017; $4.1 billion for 2018; and $2.8 billion for 2019 and each year thereafter. Fees
amounts are to be transferred to the Medicare Part B trust fund.
The annual fee amount that each covered entity must pay is based on its share of the total
prescription drug sales to specified government programs. Each entity must pay a proportion of
the annual fee total equal to the entity’s proportion of all such sales for the previous year.
However, only specified amounts of such drug sales are taken into account when calculating
entities’ annual fees; for sales of not more than $5 million, none will be taken into account. For
sales of more than $5 million and not more than $125 million, 10% will be taken into account.
For sales of more than $125 million and not more than $225 million, 40% will be taken into
account. For sales of more than $225 million and not more than $400 million, 75% will be taken
into account. For sales of more than $400 million, 100% will be taken into account. In the event
that more than one person is liable for a fee with respect to a single covered entity, all such
persons are jointly and severally liable for payment.
The Secretary of the Treasury is required to calculate the proportion to be paid by each covered
entity based upon annual reports made by the Secretaries of HHS, Veterans Affairs, and Defense.
Reports are required to contain the total branded prescription drug sales for each covered entity
with respect to Medicare Parts B and D, Medicaid, the Department of Veterans Affairs programs,
and the Department of Defense programs and TRICARE. The Secretary of the Treasury is
required to publish guidance necessary to carry out the purposes of this section.
HCERA Sec. 1405 (repeals ACA Secs. 9009, 10904). Medical Device Tax
This provision creates a new IRC Sec. 4191 in new Subchapter E – Medical Devices.
Beginning in 2013, the law imposes a 2.3% sales tax on the sale of a medical device by a
manufacturer, producer, or importer. Taxable devices include those defined in FFDCA Sec.
201(h), excluding eyeglasses, contact lenses, hearing aids, and any other devices determined by
the Secretary to be of a type the general public typically buys at retail for individual use. Tax
exemptions listed under IRC Sec. 4221(a)(3)-(6) and Sec. 6416(b)(2)(B)-(E) do not apply,
including those for state and local governments, nonprofit educational entities, and certain others.
This provision also repeals ACA Sec. 9009, as amended by ACA Sec.10904 (imposition of annual
fee on medical device manufacturers and importers).
Sec. 10907 (nullifies Sec. 9017). Excise Tax on Indoor Tanning Services
This section adds a new IRC Sec. 5000B (in a new Chapter 49), imposing a 10% tax on amounts
paid for indoor tanning services performed on or after July 1, 2010. Phototherapy services
performed by licensed medical professionals are not subject to this tax. The person receiving
payment for the service must collect the amount of the tax from the individual on whom the
procedure is performed, and is responsible for the tax amount if the client does not submit the
payment. The provider must submit the tax to the Treasury Secretary on a quarterly basis.
This section also nullifies ACA Sec. 9017 (Excise Tax on Elective Cosmetic Medical Procedures).
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Biosimilars
Overview and Impact of ACA
ACA establishes a new FDA regulatory authority by creating a licensure pathway for biosimilars
and authorizing the agency to collect associated fees. A biosimilar, often called a “follow-on”
biologic, is similar to a brand-name biologic while a generic drug is the same as a brand-name
chemical drug. Chemical drugs are small molecules for which the equivalence of chemical
structure between the brand-name drug and a generic version is relatively easy to determine. In
contrast, comparing the structure of a biosimilar and the brand-name biologic is far more
scientifically challenging. A biologic is a preparation, such as a drug or a vaccine, that is made
from living organisms. Most biologics are complex proteins that require special handling (such as
refrigeration) and are usually administered to patients via injection or infused directly into the
bloodstream. In many cases, current technology will not allow complete characterization of
biological products. Additional clinical trials may be necessary before the FDA would approve a
biosimilar.135
Biosimilars
Congressional interest in an expedited
pathway for the licensure of biosimilars is the
CRS Report RL34045, FDA Regulation of Follow-On
Biologics, by Judith A. Johnson.
same as it was for generic chemical drugs in
1984; namely, cost savings. The pathway for
biosimilars is analogous to the FDA’s authority for approving generic chemical drugs under the
Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417). Often referred to
as the Hatch-Waxman Act, this law allows the generic company to establish that its drug product
is chemically the same as the already approved innovator drug, and thereby relies on the FDA’s
previous finding of safety and effectiveness for the approved innovator drug.
The generic drug industry achieves cost savings by avoiding the expense of clinical trials, as well
as the initial drug research and development costs that were incurred by the brand-name
manufacturer. The cost of brand-name biologics is often prohibitively high. For example, the
rheumatoid arthritis and psoriasis treatment Enbrel costs about $15,000 per year.136 A pathway
enabling the FDA approval of biosimilars may allow for market competition and reduction in
prices, though perhaps not to the same extent as occurred with generic chemical drugs under
Hatch-Waxman. Based on its analysis of published studies of the impact of follow-on biologics
on health care spending, CBO estimates that establishing a regulatory pathway for approving such
products would result in a net savings to the federal government of $9.2 billion over a 10-year
period.137
135
For additional information, see CRS Report RL34045, FDA Regulation of Follow-On Biologics, by Judith A.
Johnson.
136
Carter, C.T., Chongolkar, A.K., and Scott McKenzie, R., "Adalimumab, Etanercept, and Infliximab Utilization
Patterns and Drug Costs Among Rheumatoid Arthritis Patients," Journal of Medical Economics, vol. 15, no. 2 (January
6, 2012), pp. 332-339. Enbril is the commercial name for etanercept.
137
Congressional Budget Office, Budget Options Volume 1: Health Care, December 2008, at http://www.cbo.gov/
ftpdocs/99xx/doc9925/12-18-HealthOptions.pdf.
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Sec. 7001. Short Title
This section provides the title, “Biologics Price Competition and Innovation Act of 2009,” and the
sense of the Senate that a biosimilars pathway balancing innovation and consumer interests
should be established.
Sec. 7002. Approval Pathway for Biosimilar Biological Products
This section amends PHSA Sec. 351 to create a new regulatory pathway for the FDA approval of
biosimilars. A biosimilar is defined as a biological product that is highly similar to the reference
(brand-name) product such that there is no clinically meaningful difference between the
biological product and the reference product. A biological product is defined as a protein (except
any chemically synthesized polypeptide).
The section allows the Secretary to determine that elements (such as clinical studies) in the
application for the licensure of a biological product as biosimilar or interchangeable may be
unnecessary. The Secretary will determine if the reference product and a biosimilar biological
product are interchangeable according to specified criteria. Interchangeable means that the
biological product may be substituted for the reference product without the intervention of the
health care provider who prescribed the reference product.
The section provides a 12-year data exclusivity period (from the date on which the reference
product was first approved) for the reference product during which time the FDA cannot approve
a follow-on version of the innovator biologic drug. If a reference product has been designated an
orphan drug, an application for a biosimilar or interchangeable product may not be filed until the
later of (1) the seven-year period of orphan drug exclusivity described in the FFDCA, or (2) the
12-year period established by this section. The section also allows for a period of exclusive
marketing for the biological product that is the first to be established as interchangeable with the
reference product.138
The Secretary is authorized to publish proposed guidance as specified for public comment prior to
publication of final guidance on the licensure of a biological product. If guidance is to be
developed, a process must be established to allow for public input regarding priorities for issuing
guidance. The issuance or non-issuance of guidance does not preclude the review of, or action on,
an application.
The section sets forth a process governing patent infringement claims against an applicant or
prospective applicant for a biological product license. It also establishes new processes for
identifying patents that might be disputed between the reference product company and the
company submitting a biosimilar application.
The section further requires that all biological product applications be submitted under PHSA
Sec. 351. For the small number of biological products that have been approved under FFDCA
Sec. 505, the approved application will be deemed to be a license for the biological product under
Sec. 351 as of 10 years after enactment.
138
For more information on exclusivity and patents, see CRS Report RL33901, Follow-On Biologics: Intellectual
Property and Innovation Issues, by Wendy H. Schacht and John R. Thomas.
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The section allows for the collection of user fees for the review of applications for approval of
biosimilars. The Secretary is required to develop recommendations regarding goals for the review
of biosimilar product applications for FY2013 through the end of FY2017 and present them to
Congress. The recommendations must be published in the Federal Register with a 30-day public
comment period, and a public meeting must be held. The revised recommendations must be
presented to Congress by January 15, 2012. Based on those recommendations, it is the sense of
the Senate that Congress will authorize a user fee program effective October 1, 2012. Through
October 1, 2010, the Secretary must collect data on the cost of biosimilar product application
review as conducted according to the prescription drug user fee program. Two years after
receiving the first user fee for a biosimilar product application, and every two years thereafter
until October 1, 2013, the Secretary must perform an audit of the application review costs. An
alteration of the user fee will occur depending on results of the audit, as specified in this section.
The section authorizes the appropriation of SSAN for each of FY2010 through FY2012 to cover
the costs of developing recommendations for a user fee program and for auditing the costs of
reviewing biosimilar product applications.
An extra six months of data (market) exclusivity will be provided for a new biologic drug if
pediatric studies are conducted prior to FDA approval of the drug. An extra six months of data
(market) exclusivity is provided for a biologic drug already on the market if pediatric studies are
conducted and the request for the extension is made not less than nine months before the
expiration of the original exclusivity period. The section requires an IOM study to be conducted
that will review and assess the number and importance of biological products for children that are
being tested as a result of amendments made by this ACA title, as well as biological products that
are not being tested for pediatric use, and offer recommendations for ensuring pediatric testing of
biological products.
Sec. 7003. Savings
This section requires that the Secretary and the Treasury Secretary determine for each fiscal year
the amount saved to the federal government as a result of enactment of the approval pathway for
biosimilar biological products. Notwithstanding any other provision, the savings to the federal
government as a result of enactment of the biosimilars approval pathway will be used for deficit
reduction.
Nutrition Labeling
Overview and Impact of ACA
Concern about the rising rates of obesity and the resulting effect on individuals’ health and health
care costs has prompted Congress to consider a number of options in an effort to reduce obesity
levels in the U.S. population. ACA
Nutrition Labeling
includes one such option. The law
CRS
Report
R42825,
Nutrition Labeling of Restaurant Menus, by
requires nutrition labeling for foods sold
Amalia K. Corby-Edwards.
in chain restaurants and vending
machines, which were previously
exempted from FDA’s nutrition labeling regulations.
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Sec. 4205. Nutrition Labeling of Restaurant Menus and Food Sold in Vending
Machines
This section inserts a new paragraph H into FFDCA Sec. 403(q)(5), requiring nutrition labeling
for standard menu items offered for sale in chain restaurants or similar retail food establishments
with 20 or more locations. These establishments must disclose on the menu and the menu board,
as specified, for standard menu items: (1) the number of calories contained in the item; and (2)
the suggested daily caloric intake, as specified by the Secretary by regulation. Such
establishments must also make available at the premises upon request certain detailed written
nutritional information. The establishments must have a reasonable basis for their nutrient content
disclosures. The Secretary must establish by regulation standards for determining and disclosing
the nutrient content for standard menu items that come in different flavors, varieties, or
combinations, but that are listed as a single menu item.
The section also requires certain vending machine operators that own or operate 20 or more
machines to provide specified signs disclosing the number of calories contained in each article of
food, so that the information is accessible to consumers before they make their purchases.
The Secretary must promulgate proposed regulations as specified to carry out the requirements of
the section, and to provide quarterly reports to Congress describing progress toward promulgating
final regulations.
The section amends FFDCA Sec. 403A to preempt states and localities from establishing or
continuing in effect any requirement for nutrition labeling of a food that is not identical to the
requirements of FFDCA Sec. 403(q), including the new requirements for foods sold in certain
restaurants and similar retail food establishments. The section also prohibits the amendments it
made from being construed as (1) preempting any provision of state or local law unless the state
or local law creates or continues nutrition disclosures of the type that would be required by this
section and those disclosures would be expressly preempted; (2) applying to any state or local
requirement about food labeling that provides for safety warnings concerning the food or a
component of the food; or (3) applying to any restaurant or similar retail food establishment other
than those described in this proposal and offering for sale substantially the same menu items,
except if the restaurant or retail food establishment is not part of a chain of 20 or more locations
but elects to comply with requirements for such restaurants.
340B Drug Pricing
Overview and Impact of ACA
Under PHSA Sec. 340B, pharmaceutical
drug manufacturers that participate in the
Medicaid drug rebate program are
required to enter into pharmaceutical
pricing agreements that provide discounts
on covered outpatient drugs purchased by
certain public health facilities (covered
Congressional Research Service
340B Drug Pricing
U.S. Government Accountability Office, Drug Pricing:
Manufacturer Discounts in the 340B Program Offer Benefits, but
Federal Oversight Needs Improvement, 11-836, September 23,
2011, http://www.gao.gov/assets/330/323702.pdf.
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entities). HRSA, the agency that administers the 340B program, indicates that approximately
14,000 covered entities and 800 pharmaceutical manufacturers participate in the program.139
Covered entities are eligible to receive discounts on outpatient prescription drugs from
participating manufacturers. These entities include hospitals owned or operated by state or local
government that serve a higher percentage of Medicaid beneficiaries, as well as federal grantees
such as FQHCs, FQHC look-alikes, family planning clinics, state-operated AIDS drug assistance
programs, Ryan White CARE Act grantees, family planning and sexually transmitted disease
clinics, and others, as identified in the PHSA. Covered entities do not receive discounts on
inpatient drugs under the 340B program.
Participating 340B covered entities are prohibited from diverting drugs purchased under the
program to other organizations and from obtaining multiple discounts, including participation in
outpatient group purchasing arrangements. The 340B discount is determined by dividing the
average total Medicaid rebate percentage of 15.1% for single source and innovator multiple
source drugs, and 11% for non-innovator multiple source drugs by the average manufacturer price
(AMP) for each dose and strength. Medicaid statute defines AMP as the average price paid to
manufacturers by wholesalers for drugs distributed to the retail pharmacy class of trade.
Manufacturers are required to report AMP and their best price to the Secretary, but subject to
verification, manufacturers calculate the maximum price (“ceiling price”) they may charge 340B
entities. Manufacturers are permitted to audit covered entity records if they suspect product
diversion or multiple discounts are taking place.
Sec. 6004 of the Deficit Reduction Act of 2005 (DRA, P.L. 109-171) amended SSA Sec. 1927(a)
to require prescription drug manufacturers to add certain qualifying children’s hospitals (those
that are exempt from the Medicare prospective payment system) to the entities entitled to receive
discounts under the 340B program. DRA Sec. 6004 also required the children’s hospitals to meet
all other 340B participation requirements. A final rule for participation of children’s hospitals in
the 340B program was issued on September 1, 2009.140 The ACA further expanded the types of
entities that could participate in the program. It also included two provisions related to improving
program integrity and oversight.
Sec. 7101. Expanded Participation in 340B Program
This section, as amended by HCERA Sec. 2302, amends PHSA Sec. 340B to add the following to
the list of covered entities entitled to discounted drug prices under the 340B program: (1) certain
children’s and free-standing cancer hospitals excluded from the Medicare prospective payment
system; (2) critical access hospitals; and (3) certain rural referral centers and sole community
hospitals. These new 340B-eligible facilities also must meet other specified 340B participation
requirements. In addition, the changes in this section and Sec. 7102 (described below) are to be
used to determine whether drug manufacturers meet the pricing requirements under Sec. 340B
and SSA Sec. 1927. The provisions in this section and Sec. 7102, as amended by HCERA,
became effective on January 1, 2010, and were applicable to drug purchases beginning January 1,
2010.
139
See HRSA, “2009 Quarter 3 Statistics for 340B Covered Entities, Record Counts as of 7/01/2009,” at
ftp://ftp.hrsa.gov/bphc/pdf/opa/Stats_2009_QTR_3.pdf.
140
74 Federal Register, 45206 (September 1, 2009), available at http://edocket.access.gpo.gov/2009/pdf/E9-21109.pdf.
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Sec. 7102. Improvements to 340B Program Integrity
This section further amends PHSA Sec. 340B to require the Secretary to develop systems to
improve manufacturer and covered entity compliance and program integrity activities, as well as
administrative procedures to resolve disputes. The compliance and program integrity systems are
to include a number of specifications to increase transparency and strengthen monitoring,
oversight, and investigation of the prices that manufacturers charge covered entities, as well as
additional improvements to ensure covered entities do not divert drugs or obtain multiple
discounts. The Secretary is required to establish a new administrative dispute resolution process
to mediate and resolve covered entity overpayment claims and manufacturer claims against
covered entities for drug diversion or multiple discounts. Civil money penalty sanctions up to
$5,000 per instance for manufacturer overcharges are authorized under this section. The Secretary
is required to establish standards and issue regulations for assessing CMPs on drug manufacturers
for overcharge violations by September 19, 2010. The Secretary also is required to issue
regulations within 180 days of enactment (by September 19, 2010) to implement a dispute
resolution process by which covered entities can report instances where they suspect they have
been overcharged. The section authorizes the appropriation of SSAN for FY2010 and each
succeeding fiscal year to carry out the improvements to the 340B program.
Finally, this section amends the PHSA Sec. 340B to require that pricing agreements stipulate that
drug makers will report to the Secretary quarterly ceiling prices for each covered drug and to
offer these drugs to covered entities at or below these prices. HCERA Sec. 2302 amends ACA
Sec. 7102 to exclude orphan drugs, as designated by FFDCA Sec. 526, from 340B discounts for
the newly added hospital entities.141
Sec. 7103. GAO Study on Improving the 340B Program
This section requires GAO to submit a report to Congress that examines whether individuals
receiving services through 340B-covered entities are receiving optimal health care services. The
report was due within 18 months of enactment (by September 23, 2011) and is to at least make
recommendations on (1) whether the 340B program should be expanded; (2) whether mandatory
340B sales of certain products could hinder patients’ access to those therapies through any
provider; and (3) whether 340B income is being used by covered entities to further program
objectives.
Medical Malpractice and Liability Reform
Overview and Impact of ACA
Although medical malpractice liability reform has attracted congressional attention over the
years, ACA is the first law enacted with provisions on the topic. One provision expresses the
Sense of the Senate that Congress should consider establishing a state demonstration program to
evaluate alternatives to tort litigation. The second establishes such an initiative that will be in
effect for five years. Since before ACA was enacted, various states have regulated and
141
These entities are certain children’s and free-standing cancer hospitals excluded from the Medicare prospective
payment system, (2) critical access hospitals, and (3) certain rural referral centers and sole community hospitals.
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implemented tort reform for medical malpractice lawsuits. In states that have done so, tort reform
laws include statutes of limitation and caps on non-economic damages or punitive damages, for
example. It is unclear whether, or by how much, such reforms have reduced costs on the health
care system.142 ACA does not create a federal medical liability reform law as prior congressional
bills have sought to do, but rather gives states a financial incentive to develop their own
alternatives to tort litigation aimed at meeting specific goals. Furthermore, ACA extends Federal
Tort Claims Act liability protection to members, employees, and contractors of free clinics.
Secs. 6801 and 10607. Medical Malpractice and Liability Reform
Sec. 6801 expresses the Sense of the Senate that (1) health care reform presents an opportunity to
address issues related to medical malpractice and medical liability insurance; (2) states are
encouraged to develop and test litigation alternatives while preserving an individual’s right to
seek redress in court; and (3) Congress should consider establishing a state demonstration
program to evaluate alternatives to the existing civil litigation system with respect to medical
malpractice claims.
Sec. 10607 creates a new PHSA Sec. 933V-4, that authorizes the appropriation of $50 million for
a five-year period beginning in FY2011 for the Secretary to award demonstration grants to states
for the development, implementation, and evaluation of alternatives to current tort litigation for
resolving disputes over injuries allegedly caused by health care providers or organizations. These
grants will exist for no more than five years. States that receive a grant are required to develop an
alternative that (1) allows for the resolution of disputes caused by health care providers or
organizations; and (2) promotes a reduction of health care errors by encouraging the collection
and analysis of patient safety data related to the resolved disputes.
Prior to receiving a grant, a state will have to demonstrate that its alternative: (1) increases the
availability of prompt and fair resolutions of disputes; (2) encourages the efficient resolution of
disputes; (3) encourages the disclosure of health care errors; (4) enhances patient safety by
reducing medical errors and adverse events, (5) improves access to liability; (6) informs the
patient about the differences between the alternative and tort litigation; (7) allows the patient to
opt out of the alternative at any time; (8) does not conflict with state law regarding tort litigation;
(9) does not abridge a patient’s ability to file a medical malpractice claim.
Each state will be required to identify the sources from and methods by which compensation will
be paid, which can include public and private funding sources. In addition, each state will be
required to establish a scope of jurisdiction to whom the alternative will apply so that it is
sufficient to evaluate the effects of the alternative. The Secretary will provide to the states that are
applying for the grants technical assistance, including guidance on common definitions, noneconomic damages, avoidable injuries, and disclosure to patients of health care errors and adverse
events.
When reviewing states’ grant applications, the Secretary will consult with a newly established
review panel that will be composed of relevant experts appointed by the Comptroller General.
There are various reporting requirements that must be completed. First, states that receive a grant
must submit a report to the Secretary covering the impact of the activities funded on patient safety
142
For more information, see CRS Report R40862, Medical Malpractice Insurance and Health Reform, by Baird
Webel, Vivian S. Chu, and Bernadette Fernandez.
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Public Health, Workforce, Quality, and Related Provisions in ACA
and on the availability and price of medical liability insurance. Second, the Secretary must submit
an annual compendium to Congress that examines any differences that may result in the areas of
quality of care, number and nature of medical errors, medical resources used, length of time for
dispute resolution, and the availability and price of liability insurance. Third, the Secretary, in
consultation with the review panel, must contract with a research organization to conduct an
overall evaluation of the effectiveness of grants awarded. This evaluation must be submitted to
Congress no later than 18 months following the date of implementation of the first funded
program. Fourth, MedPAC and the Medicaid and CHIP Payment and Access Commission
(MACPAC) must each conduct an independent review of the impact of state-implemented
alternatives on their programs and beneficiaries. These reports must be submitted no later than
December 31, 2016.
The section would not limit any prior, current, or future efforts of any state to establish any
alternative to tort litigation.
Sec. 10608. Liability Protection for Free Clinics
The Federal Tort Claims Act (FTCA) waives sovereign immunity to make the United States
liable, in accordance with the law of the state where a tort occurs, for “injury or loss of property,
or personal injury or death caused by the negligent or wrongful act or omission of any employee
of the government while acting within the scope of his office or employment.”143 Congress can
choose to immunize a private organization, or its employees or volunteers, from tort liability by
enacting a statute that specifically deems them federal employees for purposes of the FTCA. In
1996, Congress granted FTCA liability protection to volunteer health professionals at free
clinics.144 In other words, such individuals have been deemed federal employees such that they
are immunized from liability under the FTCA if medical malpractice claims are brought against
them.
ACA Sec. 10608 amends PHSA Sec. 224(o)(1) to extend FTCA liability protection to officers,
governing board members, employees, and contractors of free clinics. Under this, free clinics that
qualify for such protection have the option of not purchasing medical malpractice insurance to
cover the organization, members, employees, or contractors.
143
28 U.S.C. § 1346(b).
42 U.S.C. § 233(o)(1). It is worth noting that in 1992 Congress deemed federally funded health centers, their
officers, members, employees, and contractors employees of the federal government for purposes of the FTCA. 42
U.S.C. § 233(g).
144
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Public Health, Workforce, Quality, and Related Provisions in ACA
Appendix A. ACA Provisions Amended or Struck
by ACA Title X and/or HCERA
Table A-1. ACA Provisions Amended or Struck by ACA Title X and/or HCERA
Topic
Underlying ACA
Section
Amending (or Striking) Section
ACA Title X
National health care quality strategy
3011
10302
Quality measure development
3013
10303(a)
Quality measurement selection/dissemination
3014
10304
Public reporting of performance information
3015
10305
National Prevention and Health Promotion
Council
4001
10401(a)
School-based health centers
4101
10402(a)
Medicare personalized prevention plan
4103
10402(b)
Medicare preventive services cost-sharing
4104
10406
Community transformation grants
4201
10403
Employer-sponsored wellness program grants
4303
10404
CBO scoring of prevention and wellness
programs
4401
10405
National Health Care Workforce Commission
5101
10501(a)
Community health workforce grants
5313
10501(c)
Primary care extension program
5405
10501(f)
GME rules for counting resident time
5505
10501(j)
5508(b)
10501(n)(5)
6301
10602
NHSC rules for counting teaching time
Patient-centered outcomes research
340B drug program
HCERA
7101-7103
2302
Prescription drug tax
9008
1404
Medical device tax
9009
10904
Elective cosmetic procedure/indoor tanning bed
tax
9017
10907(a)
Community health center/NHSC funding
10503
1405(d)
2303a
Source: Prepared by the Congressional Research Service based on a review of the Patient Protection and
Affordable Care Act (ACA), P.L. 111-148, as amended by the Health Care and Education Reconciliation Act of
2010, P.L. 111-152.
a.
ACA Sec. 10503 appropriates a total of $8.5 billion for community health centers over the five-year period
FY2011 through FY2015; $7.0 billion for center operations and patient services, and $1.5 billion for
construction and renovation. HCERA Sec. 2303 increases the amount for center operations and patient
services to $9.5 billion. Note that Sec. 10503 also appropriates $1.5 billion for the NHSC.
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Appendix B. Timeline of Public Health, Workforce,
Quality, and Related ACA Provisions
In some instances, ACA, as amended by HCERA, specifies dates for key administrative or
programmatic activities or requirements. The following timeline (see Table B-1) lists provisions
summarized in this report that include dates for the following:145
•
final report deadlines, including reports to Congress;
•
implementation or termination of new or existing grant programs;
•
rulemaking or guidance;
•
new or expiring authorities, activities, or requirements; and establishment or
termination of entities.
Other activities or requirements that have no date specified in ACA and are implicitly effective
upon enactment (March 23, 2010) are not included in this timeline.
Table B-1 lists the ACA dates which are grouped alphabetically under headings that correspond
to section headings in the report. Within each heading, table entries are organized alphabetically
by title with key dates in chronological order within each title. Effective dates stated in terms of
days, months, or years after enactment have been converted to calendar dates (e.g., 180 days is
9/19/2010; six months is 9/23/2010, etc.). Table entries for specific implementation requirements
or deadlines that are not tied to a specific calendar date are presented at the end of each title. Each
table entry includes the ACA section number (as amended); a descriptive title for each activity or
requirement; a brief description of the activity or requirement; and the associated start date,
effective date, or deadline. Where applicable, the end date, frequency or duration associated with
specific activities or requirements is noted.
For additional information on provisions that appear in the timeline, refer to the more detailed
section summaries in the report.146 For definitions of acronyms used in the timeline, refer to
Appendix C. Unless otherwise stated, references in the table to “the Secretary” refer to the
Secretary of Health and Human Services (HHS).
145
For a timeline of the ACA provisions regarding Nursing Homes and Other Long-Term Care Facilities and Providers
(i.e., Secs. 6101-6107, 6111-6114, and 6121), see CRS Report R41210, Medicaid and the State Children’s Health
Insurance Program (CHIP) Provisions in ACA: Summary and Timeline, by Evelyne P. Baumrucker et al.
146
In the electronic version of this report, ACA section numbers in the timeline are hyperlinked to corresponding
sections of this report.
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Table B-1. Timeline of Public Health, Workforce, Quality, and Related ACA Provisions
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
340B DRUG PRICING
7101
(amended by
HCERA 2302)
340B: Expanded
Participation in 340B
Program
Adds the following facilities to the list of covered entities eligible
to receive discounts through the PHSA Sec. 340B program: (1)
children’s and free-standing cancer hospitals excluded from the
Medicare prospective payment system; (2) critical access
hospitals; and (3) certain rural referral centers and sole
community hospitals.
1/1/2010
7102a
340B: Improvements to
340B Program Integrity
(Improved compliance)
Requires the Secretary to issue regulations on program integrity,
the dispute resolution process, and a methodology for calculating
ceiling prices.
9/19/2010
7103
340B: GAO Study to Make
Recommendations on
Improving the 340B Program
Requires the U.S. Comptroller General and GAO to submit to
Congress a report that examines at least the following: (1)
whether the 340B program should be expanded; (2) whether
mandatory 340B sales of certain products could hinder patients’
access to those therapies through any provider; and (3) whether
340B income is being used by covered entities to further program
objectives.
9/23/2011
BIOMEDICAL RESEARCH AND MEDICAL PRODUCTS
9023(e)b
Biomedical Research:
Qualifying Therapeutic
Discovery Project Credit
Requires the Secretary of the Treasury to establish a qualifying
therapeutic discovery project program for investments made in
taxable years beginning in 2009 and 2010.
5/22/2010
9023(e)b
Biomedical Research:
Qualifying Therapeutic
Discovery Project Credit
Prohibits Secretary of the Treasury from making any grants for
Qualified Investments in Therapeutic Discovery Projects unless
the application is received before specified date.
1/1/2013
7002
Biosimilars: User fees
Requires the Secretary to collect and evaluate data regarding the
costs of reviewing applications for biosimilar biological products.
3/23/2010
7002a
Biosimilars: Approval
Pathway for Biosimilar
Biological Products
Requires the Secretary to begin to develop recommendations to
present to Congress related to the biosimilar biological product
application review process for the first 5 FYs after FY2012.
10/1/2010
CRS-106
10/1/2010
Frequency
or Duration
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
7002a
Biosimilars: Approval
Pathway for Biosimilar
Biological Products
Requires the Secretary to transmit to Congress the revised
recommendations (developed in consultation with specified
parties and following public review) related to the biosimilar
biological product application review process and associated
material.
1/15/2012
7002
Biosimilars: Approval
Pathway for Biosimilar
Biological Products
Deems an approved application under FFDCA Sec. 505 for a
biological product to be a license under PHSA Sec. 351.
3/23/2020
7002
Biosimilars: Approval
Pathway for Biosimilar
Biological Products
Allows the submission of an approved application under FFDCA
Sec. 505 for a biological product if it belongs to a product class
that is already approved under FFDCA Sec. 505.
7002
Biosimilars: User fees
Requires the Secretary to perform an audit of the costs of
reviewing biosimilar applications and alter user fee amounts if
appropriate.
Two years after
first receiving a
user fee for a
biosimilar
application
6302
Comparative
Effectiveness Research:
Federal Coordinating
Council for Comparative
Effectiveness Research
Notwithstanding any other provision of law, terminates the
FCCCER.
3/23/2010
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to appoint, as specified,
17 members of the Board of Governors of the PCORI.
9/23/2010
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
For each policy year between the specified dates, imposes certain
fees on specified health insurance policies and applicable selfinsured health plans.
10/1/2012
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to review the adequacy
and use of the funding for the PCORI and the activities conducted
under new PHSA Sec. 937, as added by this Act, and to
determine whether the funding sources are appropriate.
3/23/2018
CRS-107
End Date
Frequency
or Duration
3/23/2020
Biennially thereafter
9/30/2019
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Terminates availability for expenditure amounts in PCORTF and
requires that amounts in PCORTF after that date be transferred
to the general fund of the U.S. Treasury.
9/30/2019
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the PCORI methodology committee to, directly or by
contract, develop and periodically update methodological
standards for research and a translation table for reference.
18 months after
establishment of
PCORI
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires PCORI to make research findings available to clinicians,
patients, and the general public.
90 days after
findings
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires PCORI to submit to Congress and the President and to
make available to the public a report describing activities,
research priorities, methodological standards developed, and
other specified items.
Annually
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to provide for financial
audits by a private entity.
Annually
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to report to Congress on
reviews and to recommend legislative and administrative action as
appropriate.
Annually
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to review financial audits
of PCORI.
Not less frequently
than on an annual
basis
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires the U.S. Comptroller General to review specified
processes and activities of PCORI involving, among other items,
research priorities, conduct of research, dissemination, and
training.
Not less frequently
than every five years
CRS-108
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
6301b
Comparative
Effectiveness Research:
Patient-Centered Outcomes
Research
Requires PCORI to review and update, as appropriate, evidence
from research it carries out.
3507
FDA Requirements for
Medical Products:
Presentation of Prescription
Drug Benefit and Risk
Information
Requires the Secretary to report to Congress about whether
adding quantitative summaries of health benefit and risk
information in a standardized format to prescription drug labeling
and advertising would help clinicians, patients, and consumers
make health care decisions.
3/23/2011
3507
FDA Requirements for
Medical Products:
Presentation of Prescription
Drug Benefit and Risk
Information
Requires the Secretary to promulgate regulations if the Secretary
determines that adding quantitative summaries of health benefit
and risk information in a standardized format to prescription drug
labeling and advertising would help clinicians, patients, and
consumers make health care decisions.
Three years
after publication
of report on
health benefit
and risk
information
10907
Revenue Provisions
Related to FDARegulated Products:
Excise Tax on Indoor
Tanning Services
Effective date for 10% excise tax on indoor tanning services.
7/1/2010
HCERA 1405
Revenue Provisions
Related to FDARegulated Products:
Medical Device Tax
Requires certain manufacturers and importers to pay to the
Secretary of the Treasury a 2.3% excise tax on the sale of certain
medical devices.
1/1/2013
9008
(amended by
HCERA 1404)
Revenue Provisions
Related to FDARegulated Products:
Annual Fee for Brand Name
Pharmaceuticals
Requires the Secretaries of HHS, Veterans Affairs, and Defense
to report to the Secretary of Treasury specified information on
prescription drug sales.
Date as
determined by
Treasury
Secretary
9008
(amended by
HCERA 1404)
Revenue Provisions
Related to FDARegulated Products:
Annual Fee for Brand Name
Pharmaceuticals
Requires the Secretary of the Treasury to calculate fees,
according to specified criteria, to be paid by each covered entity
(branded prescription pharmaceutical manufacturers and
importers).
CRS-109
End Date
Frequency
or Duration
On a periodic basis
Annually
Annually
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
ELDER JUSTICE
6703(a)
Elder Justice: Option for
State Plan under TANF
Program
Effective date for a state’s TANF state plan to indicate whether
the state intends to assist individuals to train for, seek, and
maintain employment providing direct care in a LTC facility or in
other related elder care occupations.
1/1/2011
6703(a)a
Elder Justice: Advisory
Board on Elder Abuse,
Neglect, and Exploitation
Requires the Advisory Board on Elder Abuse, Neglect, and
Exploitation to prepare and submit a report to the Elder Justice
Coordinating Council and to Congress containing a report on the
status of federal, state, and local elder justice activities and
recommendations.
9/23/2011
6703(c)a
Elder Justice: National
Nurse Aide Registry
Requires the Secretary to submit to the Elder Justice
Coordinating Council and to Congress a report containing the
findings and recommendations of a study on establishing a
national nurse aide registry.
9/23/2011
6703(a)a
Elder Justice: Coordinating
Council
Requires the Elder Justice Coordinating Council to submit a
report to Congress on the Council’s activities and
recommendations for legislation or other action.
3/23/2012
6703(a)
Elder Justice: Report
Requires the Secretary to submit to the Elder Justice
Coordinating Council and to Congress a report containing
specified information and recommendations regarding state APS
grantee activities.
10/1/2014
6703(a)a
Elder Justice: Adoption of
Standards for Transactions
Involving Clinical Data by
LTC Facilities
Requires the Secretary to have procedures in place to accept the
electronic submission of clinical data by LTC facilities pursuant to
specified standards.
3/23/2020
6703(a)a
Elder Justice: Evaluation
Reports
Requires an eligible entity receiving assistance to conduct
evaluations of funded Elder Justice activities to submit to the
Secretary and to Congress a report containing the results of the
evaluation and recommendations.
Not later than
date specified by
the Secretary
Requires the Secretary to submit to Congress a report on the
status of grant programs for trauma centers.
3/23/2012
Annually thereafter
Every two years
thereafter
EMERGENCY CARE
3505a
CRS-110
Trauma Care Centers:
Grant Programs
Every two years
thereafter
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
HEALTH CARE CENTERS AND CLINICS
10504a
Health Care and the
Uninsured: Access to
Affordable Care
Demonstration
Requires the Secretary to establish a 3-year demonstration
project in up to 10 states to provide access to comprehensive
health care services to the uninsured at reduced fees.
9/23/2010
HEALTH DATA COLLECTION
4302a
Health Disparities Data
Collection and Analysis:
Data Collection
Requires the Secretary to submit to Congress a report on a
specified evaluation of approaches to health care disparities data
collection.
9/23/2011
4302a
Health Disparities Data
Collection and Analysis:
Reporting Requirements
Requires the Secretary to ensure that any federally conducted or
supported health care or public health program, activity or survey
collects and reports data as specified regarding race, ethnicity,
sex, primary language, and disability status.
3/23/2012
4302a
Health Disparities Data
Collection and Analysis:
Improving Disparities in
Medicaid and CHIP
Requires the Secretary to submit to Congress a report with
recommendations for improving the identification of health care
disparities for beneficiaries of Medicaid and CHIP.
3/23/2014
5605a
Key National Indicators:
Commission Appointment
Requires the appointment of members to the Commission on
Key National Indicators by the majority and minority leaders of
the Senate and the Speaker and minority leader of the House of
Representatives.
4/22/2010
5605a
Key National Indicators:
Schedule for Review and
Reports
Requires the Commission on Key National Indicators to develop
and implement a schedule for completion of (1) a certain review
and (2) reports required under this act.
5/22/2010
5605a
Key National Indicators:
National Academy of
Sciences Report
Requires the National Academy of Sciences to submit annually to
the Commission a report with its findings and recommendations.
12/18/2010
5605a
Key National Indicators:
Review and Establishment
Requires the co-chairpersons of the Committee on Key National
Indicators to enter into an arrangement with the National
Academy of Sciences under which the Academy must review and
recommend approaches to selecting and establishing a key set of
national indicators, and enable the establishment of the Key
National Indicator System.
As soon as
practicable after
the selection of
the two cochairpersons
CRS-111
Every year thereafter
ACA
Section
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
Title
Description
5605a
Key National Indicators:
Report to Congress
Requires the Commission to submit annually to Congress and to
the President a report with its findings and recommendations.
Not later than
six months after
the selection of
the two cochairpersons
Every year thereafter
5605a
Key National Indicators:
Commission Report
Requires the Commission to submit annually to the National
Academy of Sciences a report with its findings and
recommendations.
Not later than
one year after
the selection of
the two cochairpersons
Every year thereafter
HEALTH INFORMATION TECHNOLOGY
1561
Standards: Enrollment
Standards for Health and
Human Services Programs
Requires the Secretary to develop interoperable and secure
standards to facilitate enrollment of individuals in federal and
state health and human services programs.
9/19/2010
10109
HIPAA Administrative
Simplification: ICD-10
Codes
Deadline for the Secretary to convene a meeting of the ICD-9CM Coordination and Maintenance Committee to make
recommendations about revisions to the crosswalk between the
ICD-9 and ICD-10 codes.
1/1/2011
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to adopt operating rules for the following
electronic transactions: plan eligibility and health claims status.
7/1/2011
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to adopt a standard for EFT.
1/1/2012
10109
HIPAA Administrative
Simplification: Additional
Standards and Operating
Rules
Deadline for the Secretary to solicit input from NCVHS, the HIT
Policy Committee and other stakeholders on whether to develop
standards and operating rules for other administrative and
financial transactions.
1/1/2012
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to adopt operating rules for the following
electronic transactions: health claims payment/remittance and
EFT.
7/1/2012
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for the unique health plan identifier.
10/1/2012
CRS-112
Every three years
thereafter
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for operating rules for the following electronic
transactions: plan eligibility and health claims status.
1/1/2013
1104
HIPAA Administrative
Simplification: Operating
Rules
Deadline for health plans to certify their compliance with the
standards and operating rules for the following electronic
transactions: plan eligibility, health claims status, claims
payment/remittance, and EFT.
12/31/2013
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for operating rules for the following electronic
transactions: health claims payment/remittance and EFT.
1/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to establish a committee to review, and
provide recommendations for updating and improving electronic
transactions standards and operating rules.
1/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for the EFT standard.
1/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to adopt a standard and associated
operating rules for health claims attachments.
1/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires that Medicare pay for Part A and Part B benefits by EFT
or in a HIPAA-compliant electronic remittance.
1/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to assess a penalty fee against a health
plan that has failed to certify its compliance with any applicable
electronic transactions standards and associated operating rules.
4/1/2014
Annually thereafter
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the electronic transactions review committee to
conduct hearings to evaluate and review the adopted standards
and operating rules.
4/1/2014
No less than
biennially thereafter
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the HHS Secretary to provide the Treasury Secretary
with a list of health plans that have been assessed a penalty fee for
noncompliance with the electronic transactions standards and
associated operating rules.
5/1/2014
Annually thereafter
CRS-113
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Secretary to adopt operating rules for the following
electronic transactions: health claims, plan
enrollment/disenrollment, premium payments, and prior
authorization and referral.
7/1/2014
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the electronic transactions review committee to
provide recommendations for updating and improving the
adopted standards and associated operating rules.
7/1/2014
Not less than
biennially thereafter
1104
HIPAA Administrative
Simplification: Operating
Rules
Requires the Treasury Secretary to provide notice to each health
plan that has been assessed a penalty fee for noncompliance with
the electronic transactions standards and associated operating
rules.
8/1/2014
Annually thereafter
1104
HIPAA Administrative
Simplification: Operating
Rules
Deadline for health plans to pay penalty fees for noncompliance
with the electronic transactions standards and associated
operating rules.
11/1/2014
Annually thereafter
1104
HIPAA Administrative
Simplification: Operating
Rules
Deadline for health plans to certify their compliance with the
standards and operating rules for the following electronic
transactions: health claims, plan enrollment/disenrollment,
premium payments, and prior authorization and referral.
12/31/2015
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for operating rules for the following electronic
transactions: health claims, plan enrollment/disenrollment,
premium payments, and prior authorization and referral.
1/1/2016
1104
HIPAA Administrative
Simplification: Operating
Rules
Effective date for the health claims attachment standard and
associated operating rules.
1/1/2016
HEALTH WORKFORCE
5304a
Dental Workforce:
Alternative Dental Health
Care Provider
Demonstration
Requires alternative dental health care providers demonstration
projects funded under the section to begin and end according to
specified dates.
3/23/2012
5507b
Geriatric and LTC
Workforce: Health
Workforce Demonstrations
Requires the Secretary to award grants to eligible states to
conduct demonstration projects related to personal or home
care aides.
9/23/2011
CRS-114
3/23/2017
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
5507b
Geriatric and LTC
Workforce: Health
Workforce Demonstrations
Requires the Secretary to submit to Congress a report on the
initial implementation of activities conducted under the home
care aide demonstration project.
3/23/2012
5103a
Health Workforce
Evaluation and
Assessment: Health Care
Workforce Program
Assessment
Transfers the responsibilities and resources of the National
Center for Health Workforce Analysis to the National Center
for Health Care Workforce Analysis.
9/19/2010
5104 [added
by ACA
10501(b)]
Health Workforce
Evaluation and
Assessment: Task Force
on Alaska Health Care
Requires the Interagency Access to Health Care in Alaska Task
Force to submit to Congress a report on improving the delivery
of care to federal health care systems beneficiaries in Alaska.
9/19/2010
5101a
Health Workforce
Evaluation and
Assessment: National
Health Care Workforce
Commission
Requires the Comptroller General to make initial appointments
of members to the NHCWC.
9/30/2010
5101a
Health Workforce
Evaluation and
Assessment: National
Health Care Workforce
Commission
Requires the NHCWC to make the first of 2 annual reports to
Congress and to the Administration with recommendations for
meeting the need for health care workers.
4/1/2011
Annually thereafter
5101a
Health Workforce
Evaluation and
Assessment: National
Health Care Workforce
Commission
Requires the NHCWC to make the second of 2 annual reports
to Congress and to the Administration on meeting the need for
health care workers.
10/1/2011
Annually thereafter
5102a
Health Workforce
Evaluation and
Assessment: State Health
Workforce Development
Grants
Requires entities receiving a grant to report on their grant
activities within 1 year of receiving a grant. The administration
will use these reports to develop a report to Congress on the
program.
One year after
grants are
awarded
Annually thereafter
5701
Health Workforce
Evaluation and
Assessment: Reports
Requires the Secretary to submit an annual report to Congress
on the activities carried out under Title V of ACA, as amended.
CRS-115
Annually
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
5503(a)
Medicare GME
Payments: Distribution of
Additional Residency
Positions
Requires the Secretary to permanently reduce the residency caps
of hospitals with unused residency slots. Further requires the
Secretary to redistribute these unused positions, based on a
specified formula, to increase a hospital’s resident limit, provided
that the hospital uses a specified percentage of these residency
positions in primary care and general surgery.
7/1/2011
5503(b)
Medicare GME
Payments: Distribution of
Additional Residency
Positions
Requires that the redistributed residency positions be counted
when determining a hospital’s IME payments.
7/1/2011
5602
NHSC: Designating
Medically Underserved
Populations and HPSAs
Requires the negotiated rulemaking committee for designating
medically underserved populations and HPSAs to deliver a
specified progress report to the Secretary.
4/1/2010
5602
NHSC: Designating
Medically Underserved
Populations and HPSAs
Requires the Secretary to publish a required notice of proposed
negotiated rulemaking for designating medically underserved
populations and HPSAs.
5/7/2010
5602
NHSC: Designating
Medically Underserved
Populations and HPSAs
Requires the Secretary to publish an interim final rule, subject to
revision after public comment, for designating medically
underserved populations and HPSAs.
7/1/2010
5602
NHSC: Designating
Medically Underserved
Populations and HPSAs
Requires the Secretary to publish the final rule, after the public
comment period.
7/1/2011
5309(b)a
Nursing Workforce:
Nurse Retention Grants
Requires the Secretary to submit a report to Congress, before
the end of each fiscal year, containing information about the
nurse retention grants and contracts awarded in this section.
Before
9/30/2010
Nursing Workforce:
Medicare Graduate Nurse
Education Demonstration
Program
Requires the Secretary to submit to Congress a report on the
graduate nurse education demonstration program.
10/17/2017
Physician Workforce:
Rural Physician Training
Grants
Requires the Secretary to define by regulation “underserved rural
community” for purposes of the section.
5/22/2010
5509b
10501(l)a
CRS-116
End Date
Frequency
or Duration
Annually thereafter
ACA
Section
5508(c)b
Title
Physician Workforce:
Teaching Health Centers
Description
Start or
Effective Date
or Deadline
Requires qualified teaching health centers receiving GME
payments under this section to submit a report to the Secretary
that contains certain specified information about the residents
trained by the teaching health center.
One year after
GME funds are
awarded
MATERNAL AND CHILD HEALTH
2951(b)b
Early Childhood Home
Visitations Programs:
Needs Assessment
Requires states receiving FY2011 funding under the Maternal and
Child Health (MCH) Block Grant to conduct a statewide needs
assessment as specified.
9/23/2010
2951(g)b
Early Childhood Home
Visitations Programs:
Advisory Panel
Requires the Secretary to appoint an independent advisory panel
of experts to advise the Secretary on evaluation of the early
childhood home visiting program.
3/23/2011
2951(g)b
Early Childhood Home
Visitations Programs:
Evaluation
Requires the Secretary to submit to Congress a report on its
evaluation of the early childhood home visitation program.
3/31/2015
2951(c)b
Early Childhood Home
Visitations Programs:
State Report on Benchmark
Area Improvements
Requires a state (or other grantee) receiving early childhood
home visitation funds to submit a final report on any
improvements in each of the six specified benchmark areas.
12/31/2015
2951(h)b
Early Childhood Home
Visitations Programs:
Report to Congress
Requires the Secretary to submit a report to Congress regarding
the early childhood home visitation programs.
12/31/2015
2951(c)b
Early Childhood Home
Visitations Programs:
State Report Demonstrating
Benchmark Area
Improvements
Requires states conducting early childhood home visitation
programs to submit a report to the Secretary demonstrating
improvements in at least 4 of 6 benchmark areas.
30 days after the
end of the third
year in which
state conducts
program
2952(b)a
Support, Education, and
Research for Postpartum
Depression: Study Results
Requires the Secretary to submit to Congress the results of a
study on the benefits of screening for postpartum conditions.
3/23/2012
2952(a)a
Support, Education, and
Research for Postpartum
Depression: Report to
Congress
Authorizes the Director of the National Institute of Mental
Health to submit to Congress the first periodic report on the
findings of an authorized study on the relative mental health
consequences for women of resolving a pregnancy in various
ways.
3/23/2015
CRS-117
End Date
Frequency
or Duration
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
MEDICAL MALPRACTICE AND LIABILITY REFORM
10608
Medical Malpractice
Coverage: Liability
Protection for Free Clinics
Extends malpractice coverage to certain persons providing
services for free clinics.
3/23/2010
10607a
Medical Liability Reform:
State Demonstration
Programs to Evaluate
Alternatives to Tort
Litigation
Requires MedPAC and the Medicaid and CHIP Payment and
Access Commission to report to Congress on the impact of
medical liability alternatives and provide recommendations.
12/31/2016
NURSING HOMES AND OTHER LTC FACILITIES AND PROVIDERSc
6201b
LTC Background
Checks: Nationwide
Program on Criminal
Background Checks for
Employees of LTC Facilities
and Providers
Requires Inspector General to submit a report to Congress
containing results of evaluation of the nationwide program for
background checks to employees of LTC facilities.
180 days after
program’s
completion
NUTRITION LABELING
4205
Chain Restaurant Menus
and Vending Machines:
Nutrition Information
Requires the Secretary to publish a Federal Register notice with
information for retail food establishments seeking to voluntarily
provide nutrition information to consumers.
7/21/2010
4205
Chain Restaurant Menus
and Vending Machines:
Nutrition Labeling
Recommendations
Requires the Secretary to promulgate proposed nutrition labeling
regulations.
3/23/2011
PAIN CARE MANAGEMENT
4305(a)a
IOM Conference on Pain:
Report
Requires a report to Congress summarizing the Conference on
Pain’s findings and recommendations.
6/30/2011
4305(a)a
IOM Conference on Pain:
Conference Agreement
Requires Secretary to seek an agreement with IOM (or another
appropriate entity if the IOM declines) to convene a Conference
on Pain.
One year after
funds
appropriated
4305(b)
Pain Research: Interagency
Pain Research Coordinating
Committee
Requires the Secretary to establish, and as necessary maintain,
the Interagency Pain Research Coordinating Committee.
3/23/2011
CRS-118
Review necessity
every two years
thereafter
ACA
Section
4305(b)
Title
Pain Research:
Recommendations
Description
Start or
Effective Date
or Deadline
End Date
Requires the Pain Consortium to develop and submit to the NIH
Director recommendations on pain research initiatives.
Frequency
or Duration
Not less than
annually thereafter
PREVENTION AND WELLNESS
10413a
Community-Based
Prevention Programs:
Young Women’s Breast
Health Awareness
Requires the Secretary to establish an advisory committee to
assist in creating and conducting required education campaigns
regarding young women’s breast health.
5/22/2010
4001
[amended by
ACA
10401(a)]
Community-Based
Prevention Programs:
National Prevention, Health
Promotion and Public Health
Council
Requires the National Prevention, Health Promotion and Public
Health Council to submit to the President and the relevant
committees of Congress, an annual report on prevention, health
promotion, and public health activities, goals, and progress.
7/1/2010
1/1/2015
Annually thereafter
Sec. 4004
[amended by
ACA
10401(c)] a
Community-Based
Prevention Programs:
Education and Outreach
Regarding Preventive
Benefits
Requires the Secretary to report to Congress on outreach efforts
for states and providers regarding obesity-related services for
Medicaid beneficiaries
1/1/2011
1/1/2017
Triennially
3509a
Community-Based
Prevention Programs:
Offices on Women’s Health
Requires the Secretary to submit a report to Congress describing
projects related to improving women's health.
3/23/2011
4001
[amended by
ACA
10401(a)]
Community-Based
Prevention Programs:
National Prevention, Health
Promotion and Public Health
Council
Requires the Secretary to publish a national prevention, health
promotion and public health strategy.
3/23/2011
4004
[amended by
ACA
10401(c)]a
Community-Based
Prevention Programs:
Education and Outreach
Campaign Regarding
Preventive Benefits
Requires the Secretary to establish a national media campaign on
health promotion and disease prevention.
3/23/2011
10334a
Community-Based
Prevention Programs:
Offices of Minority Health
Requires the Secretary to submit to Congress reports describing
the activities of the Office of Minority Health and agencies
regarding minority health.
3/23/2011
CRS-119
Biennially thereafter
Biennially thereafter
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
4204b
Community-Based
Prevention Programs:
Immunizations
Requires GAO to submit a report to Congress on Medicare
beneficiary access to vaccines.
6/1/2011
4102a
Community-Based
Prevention Programs:
Oral Health Activities
Requires the Secretary to implement a 5-year oral health care
prevention and education campaign.
3/23/2012
4203
Community-Based
Prevention Programs:
Wellness for Individuals with
Disabilities
Requires the Architectural and Transportation Barriers
Compliance Board to issue regulatory standards for medical
diagnostic equipment, to improve disabled access.
3/23/2012
Community-Based
Prevention Programs:
Better Diabetes Care
Requires the Secretary to submit to Congress a report on a
required study on the appropriate level of diabetes medical
education.
3/23/2012
4202b
Community-Based
Prevention Programs:
Community Wellness Pilot;
Medicare Wellness
Evaluation
Requires the Secretary to submit a report to Congress on
programs that promote healthy lifestyles and reduce risk factors
for the Medicare population based on an evidence review and
evaluation of programs.
9/30/2013
4204a
Community-Based
Prevention Programs:
Immunizations
Requires the Secretary to submit a report to Congress on the
demonstration program to improve the provision of
recommended immunizations.
3/23/2014
1302
[amended by
HCERA 1004]
Prevention in Private
Health Insurance:
Essential Health Benefits
Requirement
Effective date for inclusion of the “essential health benefits
package," including preventive and wellness services, in plans
offered by qualified health plans that participate in insurance
exchanges.
Plan years
beginning on or
after 1/1/2014
4107
[amended by
ACA
10201(c)]
Prevention Under
Medicaid: Medicaid
Tobacco Cessation Services
for Pregnant Women
Requires states to provide Medicaid coverage to pregnant women
for counseling and drug therapy for tobacco cessation.
10/1/2010
4108b
Prevention Under
Medicaid: Incentives for
Chronic Disease Prevention
Under Medicaid
Requires the Secretary to award grants to states to provide
incentives to Medicaid beneficiaries to participate in healthy
lifestyle programs.
1/1/2011
10407(d)a
CRS-120
End Date
1/1/2016
Frequency
or Duration
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
4106
Prevention Under
Medicaid: Medicaid
Preventive Services for
Adults
Provides states an enhanced federal match if they provide
Medicaid coverage of recommended preventive services for
eligible adults.
1/1/2013
4108b
Prevention Under
Medicaid: Incentives for
Chronic Disease Prevention
Under Medicaid
Requires the Secretary to submit an initial report and a final
report to Congress on the Medicaid healthy lifestyle initiatives
implemented through the state grant program.
1/1/2014
4103
[amended by
ACA
10402(b)]
Prevention Under
Medicare: Medicare Annual
Visit and Personalized
Prevention Plan
Effective date of coverage of Medicare personalized prevention
plan services.
1/1/2011
4104
[amended by
ACA 10406]
Prevention Under
Medicare: Removal of
Cost-Sharing for Medicare
Preventive Services
Effective date of waiver of cost-sharing for Medicare covered
preventive services.
1/1/2011
Prevention Under
Medicare: Preventive
Services Furnished at
FQHCs
Effective date for FQHCs to receive reimbursement for Medicare
covered preventive services.
1/1/2011
4103(b)
[amended by
ACA
10402(b)]
Prevention Under
Medicare: Medicare Annual
Visit and Personalized
Prevention Plan
Requires the Secretary to publish guidelines for health risk
assessments, to support Medicare coverage of personalized
prevention plan services.
3/23/2011
4103(b)
[amended by
ACA
10402(b)]
Prevention Under
Medicare: Medicare Annual
Visit and Personalized
Prevention Plan
Requires the Secretary to establish standards for interactive
telephonic or web-based programs used to furnish health risk
assessments.
3/23/2011
4103
[amended by
ACA
10402(b)]
Prevention Under
Medicare: Medicare Annual
Visit and Personalized
Prevention Plan
Requires the Secretary to publish a health risk assessment model,
to support Medicare coverage of personalized prevention plan
services.
9/23/2011
10501(i)
CRS-121
End Date
1/1/2016
Frequency
or Duration
ACA
Section
Start or
Effective Date
or Deadline
Title
Description
1001
Wellness Programs:
Reporting Requirements for
Group Health Plans
Requires the Secretary to develop reporting requirements for
group health plans and health insurance issuers related to benefits
and reimbursement that implement, among other things,
“wellness and health promotion activities."
3/23/2012
1001
Wellness Programs:
Reporting Requirements for
Group Health Plans
Requires the Secretary to promulgate regulations providing
criteria for determining whether a reimbursement structure
meets specified reporting elements for, among other things,
“wellness and health promotion activities."
3/23/2012
4303
Wellness Programs: CDC
Grants for Employer Based
Wellness Programs
Requires the CDC Director to conduct a national survey of
employer-based health policies and programs.
3/23/2012
1201
Wellness Programs:
Regarding Prohibiting
Discrimination Based on
Health Status
Requires the Secretary to submit a report to Congress regarding
the impact and effectiveness of wellness programs and incentives.
3/23/2013
1201
Wellness Programs:
Regarding Prohibiting
Discrimination Based on
Health Status
Requires the Secretary to establish a 10-state pilot program in
which participating states are required to apply the wellness
program provisions to health insurers in the individual market.
7/1/2014
1001
Wellness Programs:
Reporting Requirements for
Group Health Plans
Requires GAO to submit a report to Congress regarding the
impact of the reporting requirement for group health plans have
had on the quality and cost of health care.
180 days after
regulations
published
4303
Wellness Programs: CDC
Grants for Employer Based
Wellness Programs
Requires the CDC Director to submit a report to Congress with
recommendations for the implementation of effective employerbased health policies and programs.
Upon
completion of
the employerbased health
policies survey
Care Coordination:
Medication Management
Services in Treatment of
Chronic Disease
Requires the Secretary to commence as specified a program to
provide grants or contracts to eligible entities to implement
medication management services provided by licensed
pharmacists.
5/1/2010
QUALITY
3503a
CRS-122
End Date
Frequency
or Duration
Regular intervals
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
10410(b)a
Care Coordination:
Centers of Excellence for
Depression
Requires the Secretary to establish no more than 20 depression
centers of excellence.
3/23/2011
10410(b)a
Care Coordination:
Centers of Excellence for
Depression
Requires the Secretary to make recommendations to: (1)
depression centers of excellence regarding improvements, and (2)
Congress regarding expanding the centers to serve individuals
with other types of mental disorders.
9/30/2015
10410(b)a
Care Coordination:
Centers of Excellence for
Depression
Requires the Secretary to establish no more than 30 depression
centers of excellence.
9/30/2016
3012
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Interagency
Working Group on Health
Care Quality
Requires the Interagency Working Group on Health Care Quality
to submit to Congress and make public on an Internet website a
report on its progress and recommendations.
12/31/2010
3011
National Strategy to
Improve Health Care
Quality and Quality
Measurement: National
Strategy
Requires the Secretary to submit to Congress the first annual
report on the national strategy to improve the delivery of health
care services, patient health outcomes, and population health.
1/1/2011
3011
National Strategy to
Improve Health Care
Quality and Quality
Measurement: National
Strategy
Requires the Secretary to create an Internet website to make
public information regarding the national priorities, agencyspecific strategic plans for quality, and other information.
1/1/2011
3014(b)
[amended by
ACA 10304]b
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measurement
Requires the Secretary, as part of a required pre-rulemaking
process, to make publicly available a list of quality and efficiency
measures being considered for use in health care programs or in
reporting performance information to the public.
12/1/2011
CRS-123
End Date
Frequency
or Duration
Annually updated
thereafter
Annually thereafter
ACA
Section
Title
Description
Start or
Effective Date
or Deadline
End Date
Frequency
or Duration
3014(a)
[amended by
ACA 10304]b
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measurement
Requires the entity with a contract with the Secretary under SSA
Sec. 1890 to transmit to the Secretary the input of multistakeholder groups on the selection of quality measures and the
national priorities (identified under ACA Sec. 3011).
2/1/2012
3014(b)
[amended by
ACA 10304]b
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measurement
Requires, as part of a required pre-rulemaking process, the
consensus-based entity with a contract with the Secretary under
SSA Sec. 1890 to transmit to the Secretary the input of multistakeholder groups on the selection of quality and efficiency
measures.
2/1/2012
Annually thereafter
3014(b)
[amended by
ACA 10304]b
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measurement
Requires the Secretary to conduct and make public, as part of a
required pre-rulemaking process, an assessment of the quality and
efficiency impact of using endorsed measures.
3/1/2012
Every three years
thereafter
3013(a)
[amended by
ACA
10303(a)]a
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measure Development
Requires the Secretary to develop at least 10 outcome quality
measures on acute and chronic diseases.
3/23/2012
3013(a)
[amended by
ACA
10303(a)]a
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measure Development
Requires the Secretary to develop at least 10 outcome quality
measures for primary and preventive care.
3/23/2013
3014(b)
[amended by
ACA 10304]b
National Strategy to
Improve Health Care
Quality and Quality
Measurement: Quality
Measurement
Requires the Secretary to periodically review quality and
efficiency measures to determine whether to phase out or
maintain the use of the measures.
Quality Improvement
and Patient Safety:
Quality and Patient Safety
Training in Clinical Education
Requires the Secretary to submit to specified committees of
Congress a report on demonstration projects to develop and
implement academic curricula that integrates quality
improvement and patient safety in the clinical education of health
professionals.
3508a
CRS-124
In no case less often
than once every
three years
3/23/2012
Annually thereafter
Source: Prepared by the Congressional Research Service based on a review of the Patient Protection and Affordable Care Act (ACA), P.L. 111-148, as amended by the
Health Care and Education Reconciliation Act of 2010, P.L. 111-152.
a.
For the specified new and/or existing program or activity, ACA authorizes appropriations. For further information on ACA’s discretionary provisions for which
appropriations are authorized, see CRS Report R41390, Discretionary Spending in the Patient Protection and Affordable Care Act (ACA), coordinated by C. Stephen Redhead.
b.
For the specified new and/or existing program or activity, ACA mandates an appropriation or requires the Secretary to transfers funds. For further information on
ACA’s mandated appropriations and fund transfers, see CRS Report R41301, Appropriations and Fund Transfers in the Patient Protection and Affordable Care Act (ACA), by
C. Stephen Redhead.
c.
For a timeline of information associated with ACA Secs. 6101-6107, 6111-6114, and 6121, regarding Nursing Homes and Other Long-Term Care Facilities and
Providers, see CRS Report R41210, Medicaid and the State Children’s Health Insurance Program (CHIP) Provisions in ACA: Summary and Timeline, by Evelyne P. Baumrucker
et al.
CRS-125
Public Health, Workforce, Quality, and Related Provisions in ACA
Appendix C. Acronyms Used in the Report
ACA
Patient Protection and Affordable Care Act
ACF
Administration for Children and Families
ACIP
Advisory Committee on Immunization Practices
AFL
Adolescent Family Life
AHEC
Area Health Education Center
AHRQ
Agency for Healthcare Research and Quality
AMP
average manufacturer price
APS
adult protective services
ARRA
American Recovery and Reinvestment Act
CAN
Cures Acceleration Network
CBO
Congressional Budget Office
CCN
collaborative care networks
CDC
Centers for Disease Control and Prevention
CFCIP
Chafee Foster Care Independence Program
CHC
Community Health Center
CHIP
Children’s Health Insurance Program
CHIPRA
Children’s Health Insurance Program Reauthorization Act of 2009
CHW
community health worker
CMP
civil monetary penalty
CMS
Centers for Medicare and Medicaid Services
COE
Center of Excellence
DOJ
Department of Justice
EFT
electronic funds transfer
EIS
Epidemic Intelligence Service
EHR
electronic health record
ERISA
Employee Retirement Income Security Act
FACA
Federal Advisory Committee Act
FCCCER
Federal Coordinating Council for Comparative Effectiveness Research
FDA
Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
FLSA
Fair Labor Standards Act
FQHC
Federally Qualified Health Center
FTCA
Federal Tort Claims Act
GAO
Government Accountability Office
GEC
Geriatric Education Center
HCERA
Health Care and Education Reconciliation Act
HELP
Senate Committee on Health, Education, Labor, and Pensions
HHS
Health and Human Services
Congressional Research Service
126
Public Health, Workforce, Quality, and Related Provisions in ACA
HIT
Health Information Technology
HIPAA
Health Insurance Portability and Accountability Act
HITECH
Health Information Technology for Economic and Clinical Health Act
HRSA
Health Resources and Services Administration
HPSA
Health Professional Shortage Area
IHS
Indian Health Service
IOM
Institute of Medicine
IPPE
initial preventive physical examination (Medicare)
IRC
Internal Revenue Code
LTC
long term care
MA
Medicare Advantage
MCH
Maternal and Child Health
MACPAC
Medicaid and CHIP Payment Access Commission
MedPAC
Medicare Payment Advisory Commission
MEPS
Medical Expenditure Panel Survey
MIPPA
Medicare Improvements for Patients and Providers Act of 2008
MTM
medication therapy management
NCHS
National Center for Health Statistics
NCHWA
National Center for Health Workforce Analysis
NCVHS
National Committee on Vital and Health Statistics
NF
nursing facility
NHSC
National Health Service Corps
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NHANES
National Health and Nutrition Examination Survey
NMHC
Nurse-Managed Health Clinic
NOHSS
National Oral Health Surveillance System
OAA
Older Americans Act
OIG
Office of Inspector General
OMB
Office of Management and Budget
ONCHIT
Office of the National Coordinator for Health Information Technology
PCORTF
Patient-Centered Outcomes Research Trust Fund
PDP
prescription drug plan
PHSA
Public Health Service Act
PQRI
Physician Quality Reporting Initiative
PRAMS
Pregnancy Risk Assessment Monitoring System
QHBP
Qualified Health Benefits Plan
RHQDAPU
Reporting Hospital Quality Data for Annual Payment Update
SAMHSA
Substance Abuse and Mental Health Services Administration
SBHC
School-Based Health Clinic
Congressional Research Service
127
Public Health, Workforce, Quality, and Related Provisions in ACA
SG
U.S. Surgeon General
SNF
skilled nursing facility
SSA
Social Security Act
SSAN
such sums as may be necessary
TANF
Temporary Assistance for Needy Families
TFCPS
Task Force on Community Preventive Services
USPHS
U.S. Public Health Service
USPSTF
U.S. Preventive Services Task Force
Author Contact Information
C. Stephen Redhead, Coordinator
Specialist in Health Policy
[email protected], 7-2261
Judith A. Johnson
Specialist in Biomedical Policy
[email protected], 7-7077
Elayne J. Heisler, Coordinator
Analyst in Health Services
[email protected], 7-4453
Sarah A. Lister
Specialist in Public Health and Epidemiology
[email protected], 7-7320
Cliff Binder
Analyst in Health Care Financing
[email protected], 7-7965
Amanda K. Sarata
Specialist in Health Policy
[email protected], 7-7641
Kirsten J. Colello
Specialist in Health and Aging Policy
[email protected], 7-7839
Carmen Solomon-Fears
Specialist in Social Policy
[email protected], 7-7306
Amalia K. Corby-Edwards
Analyst in Public Health and Epidemiology
[email protected], 7-0423
Jennifer Staman
Legislative Attorney
[email protected], 7-2610
Acknowledgments
Vivian S. Chu, Legislative Attorney; Bernice Reyes-Akinbileje, Analyst in Health Resources and Services;
Christine Scott, Specialist in Social Policy; Emilie Stolzfus, Specialist in Social Policy; Susan Thaul,
Specialist in Drug Safety and Effectiveness; and Erin Williams, former CRS specialist in Public Health and
Bioethics co-authored sections of the original version of this report. Elicia J. Herz, Kathleen S. Swendiman,
Annie L. Mach also contributed to this report.
Congressional Research Service
128
Public Health, Workforce, Quality, and Related Provisions in ACA
Key Policy Staff
Area of Expertise
Name
Phone
E-mail
Health Centers and Clinics
Elayne J. Heisler
7-4453
[email protected]
Primary Care and Nursing Workforce;
NHSC
Elayne J. Heisler
7-4453
[email protected]
Bernice Reyes-Akinbileje
7-2260
[email protected]
Long-Term Care Workforce
Kirsten J. Colello
7-7839
[email protected]
Elayne J. Heisler
7-4453
[email protected]
Prevention and Wellness; Public Health
Workforce; Commissioned Corps
Sarah A. Lister
7-7320
[email protected]
Maternal and Child Health
Amalia Corby-Edwards
7-0423
[email protected]
Teen Pregnancy Prevention and
Adoption Support
Carmen Solomon-Fears
7-7306
[email protected]
Quality
Amanda K. Sarata
7-7641
[email protected]
Nursing Homes and Other Long-Term
Care Facilities and Providers
Cliff Binder
7-7965
[email protected]
Comparative Effectiveness Research
Amanda K. Sarata
7-7641
[email protected]
Jim Hahn
7-4914
[email protected]
Health Data Collection
Amalia Corby-Edwards
7-0423
[email protected]
Health Information Technology
C. Stephen Redhead
7-2261
[email protected]
Emergency Care
Elayne J. Heisler
7-4453
[email protected]
Pain Care Management; Elder Justice
Kirsten J. Colello
7-7839
[email protected]
Biomedical Research; Medical Products
Judith A. Johnson
7-7077
[email protected]
Biosimilars
Judith A. Johnson
7-7077
[email protected]
Wendy H. Schacht
7-7066
[email protected]
John R. Thomas
7-0975
[email protected]
Nutrition Labeling
Amalia Corby-Edwards
7-0423
[email protected]
340B Drug Pricing
Cliff Binder
7-7965
[email protected]
Medical Malpractice Liability Reform
Baird Webel
7-0652
[email protected]
Vivian S. Chu
7-4576
[email protected]
Amanda K. Sarata
7-7641
[email protected]
Congressional Research Service
129
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