(ace) consensus conference on glucos

(ace) consensus conference on glucos
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (AACE)
AMERICAN COLLEGE OF ENDOCRINOLOGY (ACE)
CONSENSUS CONFERENCE ON GLUCOSE MONITORING
George Grunberger, MD, FACP, FACE, Chair
Timothy Bailey, MD, FACE
Pauline Camacho, MD, FACE
Daniel Einhorn, MD, FACP, FACE
Alan J. Garber, MD, PhD, FACE
Yehuda Handelsman, MD, FACP, FACE, FNLA
R. Mack Harrell, MD, FACP, FACE, ECNU
Howard M. Lando, MD, FACP, FACE
Bill Law Jr., MD, FACE, FACP
Jonathan D. Leffert, MD, FACP, FACE, ECNU
Eric A. Orzeck, MD, FACP, FACE
1
2014 AACE/ACE Consensus Conference on Glucose Monitoring
INTRODUCTION
Glucose monitoring is mandatory for modern diabetes care. While glucose monitoring is
necessary, it is not adequate by itself to promote optimal diabetes management. Action based
on glucose monitoring data is required to affect change. Only an educated patient working with
health care professionals can act together to prevent or delay debilitating, and even deadly,
complications of this disease. Glucose monitoring is complex, costly, and complicated,
surrounded by issues of access, reimbursement, and quality. Cost control measures
implemented throughout health care in the United States have created a renewed interest in the
most efficient and effective uses of blood glucose monitoring (BGM) and continuous glucose
monitoring (CGM) technology to optimize health outcomes for patients with diabetes.
Recognizing the need to address these issues and to build consensus on glucose monitoring,
the American Association of Clinical Endocrinologists (AACE)/American College of
Endocrinology (ACE) convened a conference to debate these points on September 28th and
29th, 2014, at the Hyatt Regency at Capitol Hill in Washington, DC. Participants included
members of health care associations, insurance companies, government, patient advocacy,
pharmaceutical and equipment manufacturing companies, health care systems, physicians,
educators, and allied health care professionals.
Specifically, four questions were asked:
What data support glucose monitoring (as distinct from glycemic control) as a means to
prevent diabetic macro- and microvascular complications?
a)
Does frequency of glucose monitoring correlate with better outcomes?
b) Which patients benefit the most from structured glucose monitoring?
c) Do glucose strip and CGM accuracy correlate with better outcomes?
Should the FDA improve post-approval surveillance of glucose strip, glucose meter, and
CGM quality?
a) Does sub-standard glycemic monitoring technology harm patients? If so, what
data exist to support such a claim? Are all manufacturers required to report this
data to the FDA?
b) What is the current state of affairs at the FDA in post marketing meter and CGM
surveillance?
c) What enforcement options are available to the FDA, and how are they
implemented?
3. Do current private insurance and Medicare policies balance the need to provide patient
access to high quality care and effective glucose monitoring and, if not, what policy
changes are needed with respect to:
a) Patient Access to BGM supplies
i. Competitive Bidding Program
ii. Limiting glucose strip brand or meter type
2
b) Patient access to CGM technology
c) Limited or lack of coverage for sensor-augmented insulin pump therapy and
emerging semi-automated CGM/pump combinations
4. What is the most effective way for the key stakeholders (physicians, allied health care
professionals, patients, professional associations, educators, investigators, payors,
industry, employers, health care systems, regulators) to achieve appropriate, evidencebased, cost-effective regulation of glucose (blood, continuous) monitoring technology?
METHODS AND SCOPE OF CONFERENCE
The goal of the AACE-ACE Glucose Monitoring Consensus Conference was to develop the
evidence base for a comprehensive action plan and to identify points of consensus along with
alternative interpretations among constituencies within our four pillars, representing the major
stakeholders in glucose monitoring in the U.S. The intention was to have the broad range of
stakeholders jointly examine the evidence from different perspectives and with different
emphases on priorities. In this sense, the conference was emergent in nature and a process of
joint discovery based in terms of the totality of viewpoints. This approach was critical since the
action plan will ultimately require concerted action and cooperation among stakeholders based
on a consensus interpretation of evidence.
The four pillars and the constituencies that comprise each pillar who participated in the AACEACE Glucose Monitoring Consensus Conference are delineated in Table 1. The
Medical/Scientific/Professional/ Educational Societies pillar comprises professional
organizations representing multidisciplinary health care professionals participating in the care of
patients with diabetes. The Government/Regulatory/Payors/Employers pillar includes groups
that set policy for health care and disease prevention. The Industry pillar encompasses
pharmaceutical companies developing glucose monitoring devices and testing strips, large
employers concerned with the adverse health impact of diabetes among their employees, and
major payors or health care insurance companies. The Patient/Lay Organizations pillar includes
lay and professional organizations advocating for diabetes patients.
Table 1: Glucose Monitoring Consensus Conference Pillar Participants
PILLAR
PILLAR PARTICIPANTS
Medical/Scientific
Professional/Educational
Societies Pillar
Jo Jo Dantone, MS, RDN, LDN, CDE
Diabetes Care and Education Practice
Group Academy of Nutrition and Dietetics
Helena Duncan
College of American Pathologists
Marion Franz, MS, RDN
Guido Freckmann, MD
CDE Academy of Nutrition and Dietetics
Institut für Diabetes-Technologie
Forschungs- und
Entwicklungsgesellschaft mbH an der
Universität Ulm
Diabetes Technology Consultants
American Osteopathic Association
JDRF
Diabetes Care and Education Practice
Group, Academy of Nutrition and
Dietetics
Diabetes Translational Research Center,
Indiana University
American Association of Diabetes
Educators
Barry Ginsberg, MD, PhD
Louis C. Haenel, IV, DO, FACE, FACOI
Aaron J. Kowalski, PhD
Betty A. Krauss, RDN, CDE
o David Marrero, PhD
Molly McElwee-Malloy, RN, CDE
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Gerardo Moreno, MD, MSHS
Jerry Penso, MD, MBA
Gary Puckrein, PhD
Robert Ratner, MD, FACP, FACE
David Sacks, MB, ChB, FRCPath
Mitchel Scott, PhD
Krishnaswami Vijayaraghavan, MD,
MS, FACP, FACC, FNLA
Phyllis Zimmer, MN, FNP, FAANP, FAAN
Richard Bergenstal, MD
Government/Regulatory/
Payors/Employers
Irl B. Hirsch, MD
Pamela Allweiss, MD, MPH
Guillermo Arreaza, MD
Helene D. Clayton-Jeter, OD
Sanford Cohen, MD
Alberto Gutierrez, PhD
David Knowlton
Todd Prewitt, MD
William Rogers, MD, FACEP
Kimberly Jinnett, PhD, MSPH
Courtney H. Lias, PhD
Industry
Patient/Lay
Organizations
Kenneth Snow, MD, MBA
Chris Arapoff
Alan Cariski, MD, JD, FACP, FACE
Nathan Carrington, PhD
Jacob Drapkin
Claudia Graham, PhD, MPH
Brian Levy, MD, FACE
Robert Morin, MD, FACE
David Price, MD
Melissa Dobson Schooley, JD
Steve Scott
Mark Swinton, MBA
Bruce T. Taylor
Ramakrishna Venugopalan, PhD, MBA
Duncan Williams
Bennet Dunlap, MSHC
Larry Ellingson, RPh
Manny Hernandez
Jeff Hitchcock
Cynthia Rice, MPP
Larry Smith
Kelly Close
American Geriatrics Society
American Medical Group Association
National Minority Quality Forum
American Diabetes Association
American Association for Clinical Chemistry
Clinical Chemistry, Washington University
American College of Cardiology
Nurse Practitioner Healthcare Foundation
Park Nicollet International Diabetes Center,
Keynote Speaker
University of Washington, Keynote Speaker
Centers for Disease Control and Prevention,
Division of Diabetes Translation
National Institute of Diabetes, Digestive, and
Kidney Diseases, National Institutes of Health
US Food and Drug Administration
United Healthcare
US Food & Drug Administration, Division of
Chemistry and Toxicology Devices
New Jersey Healthcare Quality Institute
Humana
Centers for Medicare and Medicaid Services
Integrated Benefits Institute, Keynote
Speaker
US Food & Drug Administration, Division of
Chemistry and Toxicology Devices, Keynote
Speaker
Aetna, Keynote Speaker
Medtronic Diabetes
LifeScan, Inc.
Roche Diabetes Care
J & J Diabetes Solutions Companies
Dexcom, Inc.
J & J Diabetes Solutions Companies
Bayer HealthCare, LLC
Dexcom, Inc.
Medtronic
Abbott Diabetes Care
Abbott Diabetes Care
Roche Diagnostics Diabetes Care
Animas Corporation, a J&J Company
Abbott Diabetes Care
StripSafely
National Diabetes Volunteer Leadership
Council
Diabetes Hands Foundation
Children with Diabetes
JDRF
National Diabetes Volunteer Leadership
Council
diatribe.org, Keynote Speaker
The AACE-ACE Glucose Monitoring Consensus Conference took place September 28-29, 2014
in Washington, DC at the Hyatt Regency on Capitol Hill. The conference agenda is outlined in
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Figure 1.
Figure 1: AACE-ACE Glucose Monitoring Consensus Conference Agenda
SUNDAY, SEPTEMBER 28, 2014
General Session - Keynote Speakers | Moderator: Dr. George Grunberger
1:00 pm – 1:10 pm
Welcome
Dr. R. Mack Harrell, AACE President
1:10 pm – 1:20 pm
AACE Perspective
Dr. George Grunberger, AACE President Elect
Chair, Consensus Conference on Glucose Monitoring
1:20 pm – 1:40 pm
State of the Art of Glucose Monitoring Technology
Dr. Richard Bergenstal, Park Nicollet International Diabetes Center
1:40 pm – 2:00 pm
Clinical Applications of Glucose Monitoring
Dr. Irl Hirsch, University of Washington School of Medicine
2:00 pm – 2:20 pm
Post-Marketing Surveillance
Dr. David Klonoff, Diabetes Technology Society
2:20 pm – 2:40 pm
Overall Economic Impact of Glucose Monitoring
Dr. William Herman, Michigan Center for Diabetes Translational Research
2:40 pm – 2:55 pm
Break
2:55 pm – 3:15 pm
Regulator’s Viewpoint
Dr. Courtney Lias, Division of Chemistry and Toxicology Devices, FDA
3:15 pm – 3:25 pm
3:35 pm – 3:55 pm
3:55 pm – 4:15 pm
4:15 pm – 4:35 pm
Payors’ Viewpoint:
Private Insurance – Dr. Kenneth Snow, Aetna
Large Employers - Dr. Kimberly Jinnett, Integrated Benefits Institute
Regency C
Regency C
Industry Viewpoint
Ms. Khatereh Calleja, AdvaMed
Mr. Richard Price, AdvaMed
Patients’ Viewpoint
Mrs. Kelly Close, Close Concerns
4:35 pm – 5:00 pm
Conclusion and Monday Agenda
Dr. George Grunberger, Chair
5:00 pm – 6:00 pm
Reception
6:00 pm
Dinner on your own
Regency B
The conference began with introductory remarks from the AACE president, Dr. Harrell, a
summary of AACE’s perspective on glucose monitoring, and several keynote talks giving the
perspectives of different stakeholders. Pillar breakout sessions were scheduled on the morning
of the second day. During these breakout sessions, participants within each pillar individually
presented their answers to each of the 4 questions using oral statements, hardcopy handouts,
and/or slide presentations. Every participant was given 5 minutes to respond to each question.
This was followed by general discussion and debate, moderated by the co-chairs. For each
question, an effort was made to establish points of consensus among participants, as well as to
identify alternative viewpoints and knowledge gaps requiring additional research. The
proceedings were recorded. To capture salient aspects and conclusions in real time, a team of
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medical writers and conference leaders integrated information and discussions.
On the afternoon of the second day, the pillars met together for “among-pillar discussions” so
that all participants could evaluate and debate the conclusions reached by the individual pillars.
The co-chairs assigned to each pillar briefly summarized the points of consensus and alternate
views, followed by robust discussion of the evidence pertinent to each question, involving all
participants. This facilitated the emergence of consensus across pillars.
Immediately after the conference, a primary writing team analyzed the meeting’s transcripts and
completed this document summarizing the conference proceedings, along with points of
consensus and alternative views. The writing committee identified points of affirmation where
the data and related discussions supported previously accepted or validated practices. In
addition, new points of emergence arose from the dynamic and multi-disciplinary nature of the
conference. Both the affirmative and emergent conclusions were sufficient to form the basis for
actionable recommendations.
FOUR QUESTIONS ADDRESSED
QUESTION 1: What data support glucose monitoring (as distinct from glycemic control)
as a means to prevent diabetic macro- and microvascular complications?
a) Does frequency of glucose monitoring correlate with better outcomes?
b) Which patients benefit the most from structured glucose monitoring?
c) Do glucose strip and CGM accuracy correlate with better outcomes?
Several modern studies have demonstrated the importance of glucose control to reduce both
short- and long-term complications. One of the major tools to improve glycemic control is
glucose monitoring. With the advancement of technology, many meters are now available that
allow patients to self-monitor throughout the day. We also now have technology, which allows
continuous glucose monitoring (CGM). New technology enables glucose monitoring to interface
with insulin administration. Although there is a general expert opinion to use frequent glucose
monitoring in most patients with diabetes, many insurance payors, including CMS, deny access
to patients who could benefit due to the cost of such a program. Underscoring the need to form
consensus on these issues, participant experts discussed the available evidence to support
glucose monitoring in people with diabetes.
Consensus participants emphasized that glucose monitoring is only reasonable if it is
actionable. Many of the major diabetes studies have focused on the long-term outcome of
glucose control, in particular micro and macrovascular disease. However, an important aspect
of controlling diabetes is preventing short-term complications, including hypoglycemia and
diabetic ketoacidosis (DKA). Available data support glucose monitoring, CGM, and advanced
technologies to reduce and prevent hypoglycemia. Management plans should be developed
individually with the patient and their clinician to optimize glucose control and should be chosen
according to patient preference and lifestyle.
Some studies failed to demonstrate value for glucose monitoring in obtaining glucose control
due to problems in design as well as a lack of clinical action related to results of glucose
monitoring. More recent trials using structured glucose monitoring coupled with clinical decisionmaking demonstrate a benefit in improving glucose control.
One of the most commonly used measures to monitor glucose control is hemoglobin A1c. In a
large group of people with diabetes, ranging from 14%-25%, A1c is not accurate and should not
be used. For example, A1c levels in people with sickle cell anemia, those of several ethnic
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groups, those with severe kidney disease, and others do not correlate with average glycemia
and may be misleading. For these patients, frequent glucose monitoring is virtually the only way
to assess glucose control over time.
Frequency
People with type 1 diabetes who are engaged in their care should have glucose monitoring
offered at least 8 times daily. Frequency of glucose monitoring reduces hypoglycemia. In a
study of people with type 1 diabetes, increased frequency of glucose monitoring decreased
mean A1c across age groups. Although there was no upper limit to the frequency of daily
monitoring that offers benefit to A1c control, the benefit plateaus around 7-8 per day.
Epidemiologic observational data indicate that self-monitoring of blood glucose (SMBG)
correlates with decreased diabetes-related complications and with all-cause mortality in people
with type 2 diabetes.
People with type 2 diabetes who are on multiple insulin injections, with a high risk of
hypoglycemia, should have glucose monitored at least 8 times daily, similar to type 1 diabetes.
People with type 2 diabetes who are on medications that can cause hypoglycemia (like basal
insulin and sulfonylurea), especially the elderly, are more prone to hypoglycemia and should
have more frequent monitoring. Due to the lack of available robust data, the opinion ranged in
suggesting glucose monitoring from 3-5 times per day in this population. Because of the lack of
controlled trials in people with type 2 diabetes who are being managed with lifestyle modification
or medications with low risk of hypoglycemia are also lacking, it was the participant expert
opinion that these patients should monitor glucose from 1-4 times per day. Similarly, for women
with diabetes who are pregnant, managed with insulin the participant expert opinion was that
glucose should be checked at least 8 times daily and for those managed with lifestyle
modification or medications with low risk of hypoglycemia approximately 4-6 times daily. Large,
randomized trials are needed to validate these expert clinical opinions.
There was considerable discussion about the frequency of glucose monitoring in different
patient populations, but a consensus was reached that clinical usage must be driven by
clinician-patient agreement on the optimal level of glucose monitoring.
CGM
Usage of CGM has improved outcome through reduction of hypoglycemia. CGM is
recommended in all patients with type 1 diabetes and should be offered to all type 2 diabetes on
multiple insulin injections, basal insulin, or sulfonylureas. CGM should also be used in all
patients who have hypoglycemia unawareness. It was the participant expert opinion that CGM
may be offered to patients with type 2 diabetes who may benefit through lifestyle and specific
changes in their management plan.
Accuracy
Data support the fact that accuracy of glucose monitoring correlates with better outcomes.
Recognizing the importance of accuracy of the glucose meters, participants expressed a
concern that requirement for increased accuracy may affect cost and lead to glucose monitoring
becoming cost-prohibitive. The participant experts accepted the 2013 ISO standards for
accuracy, precision, and bias, with the exception that the standard applied at low glucose levels
may need to be more stringent to avoid clinically inappropriate decisions. Participants also
noted that values that are far out of range are more problematic than meter bias, as these can
affect immediate decision making if no confirmatory testing is performed.
Knowledge Gaps
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More data are needed on the long-term efficacy of frequent monitoring, as well as the data on
the effect of accuracy of glucose meters and strips and CGM on outcomes. Cost is a major
issue in glucose monitoring, particularly as technology advances. Cost-effectiveness of glucose
monitoring in patients with type 2 diabetes who are managed with lifestyle modification or
medications with low risk of hypoglycemia needs to be investigated. Published studies
addressing outcomes related to glucose monitoring lag far behind ongoing technological
advances, and more research is needed. Although there is a dire need to have more data on
the accuracy of glucose monitoring, it would be unethical to conduct large randomized trials
using inaccurate meters. Thus, it is hoped that “big data” may assist in answering those clinical
questions that cannot be addressed in controlled trials.
Conclusion
Glucose monitoring is essential to diabetes care, particularly for reducing hypoglycemia,
provided it is structured. Implementing clinical actions based on data gained during glucose
monitoring is critical for diabetes control. There seems to be a relationship between higher
frequency of glucose monitoring and better glycemic control. The consensus of the participant
experts calls for a wider use of glucose monitoring and CGM and calls for studies that can
address efficacy and cost.
QUESTION 2: Should the FDA improve post approval surveillance of glucose strip,
glucose meter, and CGM quality?
a) Does sub-standard glycemic monitoring technology harm patients? If so, what data
exist to support such a claim? Are all manufacturers required to report this data to
the FDA?
b) What is the current state of affairs at the FDA in post-marketing meter and CGM
surveillance?
c) What enforcement options are available to the FDA and how are they implemented?
Introduction
Shortcomings in the surveillance of glucose strip, glucose meter, and CGM quality have been
clearly recognized. Patients and health care professionals are seeking stricter guidance from
the FDA regarding accuracy of testing and meter standards, along with clearer labels to help
patients understand the results. What constitutes “substandard” monitoring, however, is not
clearly defined. Further, companies producing glucose-monitoring devices are currently
permitted to claim improved clinical outcomes to patients, even if those outcomes have not been
demonstrated. Additional concerns include a lack of consistency in the way that post-market
surveillance (which relies heavily on self-reporting by manufacturers) is applied across
manufacturers and the volume of data to be analyzed.
The 2003 ISO standard minimum accuracy criteria for blood glucose monitors requires that 95%
of glucose results be within 15 mg/dL of reference for glucose <75 mg/dL and within 20% of
reference for glucose ≥75 mg/dL. The 2013 ISO standard requires that 95% of glucose results
<100 mg/dL be within 15 mg/dL of reference and within 15% of reference for glucose ≥100
mg/dL. However, at least six studies evaluating the performance of blood glucose monitoring
devices published between 2010 and 2014 have demonstrated that only 40%-83% met ISO
2003 standards, and only 14-67% met ISO 2013 standards. Most of the less accurate meters
are manufactured outside the US and sold at a lower cost.
8
The FDA agrees that glucose meters that do not perform as designed pose a risk to patients,
since they receive at least 30,000 reports/year of cases of patient harm, including suspected
device-associated deaths, serious injuries, and malfunctions for glucose meters and CGMs.
Despite a requirement to report data on possible patient harm, some lesser known brands
report few or no such data versus the larger branded multinationals. Diabetes Technology
Society public meetings have highlighted substantial accuracy issues observed in currently
available systems. The FDA states that they have tools to effectively assure that meters and
strips perform within labeled levels, including adverse events reports and inspections of
manufacturing facilities. FDA also has multiple enforcement options including recalls, seizures,
safety alerts, warning letters, injunctions, and civil money penalties. However, they do not have
the ability to remove clearance of previously cleared meters on the market, though they can
prevent distribution of such meters.
Ongoing improvements include collaborating with manufacturers to improve AE reporting,
development of new methods to analyze medical device report (MDR) data, drafting new
guidance for manufacturer reporting, and development of a new surveillance program to test
strips and meters in market.
Knowledge Gaps:
• The data to support patient harm are inadequate due to lack of reporting and difficulty in
accurately attributing responsibility for adverse events to the strip manufacturer versus
pharmaceutical company versus patient error.
• Manufacturers are required to report adverse events through the MDR mechanism, but
reporting is done variably and is not standardized.
• Information regarding post-approval quality of blood glucose monitoring strips is lacking,
particularly those obtained from non-US manufacturers of mail order strips and devices.
Conclusions:
• The FDA is to be commended for their recognition of the need for independent and ongoing
pre- and post-marketing testing of blood glucose monitor devices. This could be funded by
industry based on a percentage of total strip sales or other methodology.
• AACE recommends periodic ongoing post-marketing manufacturer inspections and audits,
both within and outside the country.
• AACE believes that the FDA should rigorously apply existing enforcement options and
expeditiously prohibit the sale and marketing of devices that do not meet their ongoing
evaluation of quality, including embargoing products if necessary.
• AACE recommends that requirements and reporting formats for reporting adverse events to
the FDA through MDR mechanisms be harmonized.
• Studies to demonstrate comparative effectiveness should be required.
• ISO 15197:2013 standards should be applied to all blood glucose monitoring devices to
ensure accuracy of SMBG.
• Accuracy results should be part of the product labeling, and manufacturers should be held
to that standard.
• More education for patients and healthcare professionals is necessary for optimal use of
the MedWatch Reporting System.
QUESTION 3: Do current private insurance and Medicare policies balance the need to
provide patient access to high quality care and effective glucose monitoring, and if not,
what policy changes are needed with respect to:
a) Patient access to BGM supplies
9
i. Competitive bidding program
ii. Limiting glucose strip brand or meter type
b) Patient access to CGM technology
c) Limited or lack of coverage for sensor-augmented insulin pump therapy and
emerging semi-automated CGM/pump combinations
Medicare patient access to BGM supplies
CMS views all FDA cleared blood glucose monitoring devices to be of equivalent quality based
on 1976 standards, in spite of the fact that technology has improved dramatically over the last
40 years. Using the Competitive Bidding Program to limit glucose strip costs, Medicare restricts
access to more expensive improved technology devices and limits choice for patients and
health care professionals based primarily on cost. Device manufacturers view this practice as a
barrier to innovation. To the extent that accuracy is improved by new technology, limiting access
to new technology may increase patient risk for adverse events. Additionally, attestation
documentation requirements for patients and health care professionals discourage the utilization
of glucose monitoring, and increase the potential for serious health risks for the patient with
diabetes.
Patient access to CGM technology
CGM technology is not covered as a benefit under the current Medicare program as there is no
benefit category for these devices. Successful CGM users with type 1 diabetes, under
commercial insurance, are categorically denied coverage for this technology upon enrollment in
Medicare. Hypoglycemia is especially risky in the Medicare population with associated ER visits,
accidents, seizures, and cardiac events. Several prospective studies have shown improved
glycemic control with fewer hypoglycemic events in patients with type 1 diabetes utilizing CGM
technology. Arbitrary denial of coverage for these devices seems imprudent in these high-risk
patients.
Limited or lack of coverage for sensor augmented insulin pump therapy etc.
The FDA has approved threshold suspend CGM/insulin pump systems, however, all payors
currently deny coverage for this technology deeming it as experimental. In addition, as with
CGM devices, Medicare does not have a benefit category for these emerging technologies.
Knowledge gap:
Technology advances much faster than our ability to plan and complete randomized controlled
trials that assess outcomes. In 2014, the FDA approval process for advanced glucose
monitoring technology is rigorous and should suffice for coverage decisions.
Summary
Contemporary quality standards need to be incorporated into the competitive bidding process.
The bidding process should be modified to ensure the availability of the highest quality products
at the best price.
Diabetes care requires a highly individualized treatment plan. As part of this planning, selection
of glucose monitoring technology demands close collaboration between patients and health
care professionals. Therefore, coverage determination by payors should place a higher priority
on the optimal health needs of the patient as determined by their health care professionals.
Conclusion
Access to glucose monitoring technology is not currently provided to an acceptable degree by
payors. FDA approval should be a reliable indication for benefit coverage. Ongoing randomized
controlled trials or comparative effectiveness studies would be appropriate.
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QUESTION 4: What is the most effective way for the key stakeholders (physicians, allied
health care professionals, patients, professional associations, educators, investigators,
payors, industry, employers, health care systems, regulators) to achieve appropriate,
evidence-based, cost-effective usage of glucose (blood, continuous) monitoring
technology?
The consensus conference provided an opportunity to present the state-of-the-art, highlight
missing data, and problem-solve among groups with varied, and sometimes competing
perspectives, but each with the motivation of improving diabetes patient care. Published
guidelines from medical societies are an excellent source of consensus regarding the best data
available at a point in time. Education for the public and professionals raises awareness and
may create the political will to make improvements in glucose monitoring processes.
Stakeholders were in general agreement that the ideal system would provide just the right
amount of glucose monitoring for a given individual as determined by the individual and their
health care professional. Unfortunately, the current system creates distortions in which some
people who need more monitoring are denied access, while others may be sent supplies in
excess of need in the absence of sufficient controls to prevent fraud and abuse. It is not likely
that we will have randomized clinical trials to answer the question, so we must create a
consensus based on limited data, clinical experience, and expert opinion. Underlying all of these
considerations is the recognition of the reality of finite resources and the need to make hard
choices among competing interests.
It is extremely important to
address diabetes-related
processes at the Federal
government level, since
the government is the
largest payor and its
actions affect every other
payor. The sheer number
of agencies with their own
agendas and complex
reporting structure makes
it difficult to affect
significant change.
An example of a response
to this is the National
Diabetes Clinical Care
Commission Act that
seeks to coordinate all
agencies related to
diabetes and assist them
with the direction of clinical experts as a sanctioned advisory body. All stakeholders would
benefit from streamlining of processes involved in access to glucose monitoring technology.
Innovations that may ease this burden include a single type of form for prescription of glucose
monitoring and documentation of its medical necessity.
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One of the most egregious distortions among stakeholders occurs when people with type 1
diabetes who are stable on CGM are forced to stop CGM when they go on Medicare, leaving
them more vulnerable to hypoglycemia at exactly the stage of life when it is most dangerous.
Stakeholders unanimously agreed that Medicare needs to establish a benefit category for CGM
and advanced medical technologies to come.
In the future, big data can hopefully be harnessed to obtain more definitive answers regarding
the relationship between quality and intensity of BGM and CGM to diabetes outcomes. When
that occurs, the strategies to achieve appropriate, evidence-based, cost-effective usage of
glucose (blood, continuous) monitoring technology will become more apparent.
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