Documentation – Development Letters from TrustSolutions
TrustSolutions, the Program Safeguard Contractor (PSC) for Jurisdiction C, performs
both Medical Review and Benefit Integrity (Fraud) audits. These audits may be either
widespread (focusing on specific HCPCS codes and/or geographic areas) or supplierspecific. The audits may be conducted either at the time of claim submission (prepayment) or at a later time (post-payment).
For pre-payment audits, CIGNA Government Services (CGS) sends a development letter
to the supplier on behalf of TrustSolutions. For post-payment audits, TrustSolutions
directly sends the notification letter requesting records. The development/notification
letter provides general directions on the type of documentation that must be submitted.
However, many suppliers do not provide all of the information that has been requested.
This results in denial of the claim or recoupment of an overpayment. This article gives
additional guidance on the documentation that must be sent to the PSC in response to a
development/notification letter. More information on each of the elements discussed
below can be found in the DME MAC Jurisdiction C Supplier Manual, Chapter 3,
Supplier Documentation.
Detailed written order
The detailed written order must contain either:
• A narrative description of the item including all significant options and features
that are described in the base code or that will be separately billed using an addon code; or
• The manufacturer name and product name/number.
For items that are provided on a periodic basis (e.g., supplies, accessories, dressings,
ostomy/urological products, drugs, nutrients, etc.), the detailed written order must contain
appropriate information concerning the quantity used at one time and the frequency of
use/replacement. Some Local Coverage Determinations (LCDs) provide specific
information on the type of documentation required for items addressed by those medical
policies.
The detailed written order must be signed and dated by the ordering physician.
Individual LCDs specify whether the detailed written order must be signed and dated
prior to claim submission or prior to delivery of the item.
Dispensing order
If the detailed written order is not obtained prior to delivery of the item, there must be a
separate dispensing order. A more general description of the item is sufficient on the
dispensing order. This may be either a written order signed and dated by the physician or
supplier documentation of a verbal order from the physician which is signed and dated by
the supplier.
A copy of the dispensing order must be submitted only when it is specifically requested
in the development letter. If the development letter doesn’t specify a dispensing order,
the detailed written order is sufficient for purposes of that audit.
Certificate of Medical Necessity
If the item requires a CMN, a copy of the CMN must be submitted. The CMN can serve
as the detailed written order if it contains all of the information specified for a detailed
written order.
Patient Medical Records
This is the element that is most often missing in the response to development letters.
Suppliers must provide a copy of documentation from the patient’s medical record that
identifies the condition/diagnosis for which the item is being ordered and other pertinent
information relating to the medical necessity for the item. The ICD-9 code submitted on
the claim should reflect this condition/diagnosis.
The medical record may be:
• A physician office note; or
• A hospital, nursing home, or home health note; or
• A note from a nonphysician practitioner, such as a physical therapist or
occupational therapist. This person must be someone who is practicing within
his/her scope of practice, who can bill Medicare for his/her services (i.e., is a
Medicare-enrolled provider), and who has no financial relationship with the
supplier.
The date of the visit must be noted in the record and must be prior to the date of service
on the claim. For items that are being newly provided, the date of the visit must
generally be within 3 months prior to the initial dispensing of the item.
For items addressed in LCDs, there must be information to document that all coverage
criteria specified in the medical policy have been met. This may include copies or
laboratory or other diagnostic test results or x-ray reports. For items that are provided on
a rental basis, this may include documentation of continued medical necessity – e.g., the
continued presence of an ulcer for patients on a Group 2 support surface.
The medical record must be in the usual format for that physician’s/provider’s medical
records. Supplier-created forms, attestations or similar documents are not
sufficient to document medical necessity, even if completed and signed by the
physician.
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If the development letter lists specific information that is needed, suppliers must include
that in their response.
Supplier Records
Suppliers may submit any other information that they think would be helpful in
documenting the medical necessity for the specific item that was provided. This is
optional.
Delivery Slips
Another element that is frequently missing, or incomplete, is documentation proving that
the patient received the items ordered by the physician. Proof of delivery includes the
following documentation:
•
When items are delivered by the supplier directly to the patient
The delivery slip should include:
1) Patient’s name
2) Detailed description of the items being delivered or the brand name
3) Serial numbers, if applicable
4) Quantity delivered
5) Signature of the patient or designee. A designee is any person who can
sign and accept delivery of the item on behalf of the patient. If it is a
designee, the relationship of that person to the patient should be noted on
the delivery slip – e.g., spouse, neighbor, etc. The signature of the
designee should be legible. If it is not, the supplier should print the name
of the designee on the delivery slip.
6) Date of the signature. This must be the date that the items were received
by the patient or designee.
It is unacceptable for the supplier to leave or hand over the items without
first obtaining the required signature. Audits have indicated that often
packages have been delivered to the wrong address or have been left at the
door or on the porch of the patient's residence. Patients often indicate that they
did not receive the items that were shipped by the supplier. In situations in
which the patient denies receipt of the items, the claim will be denied or an
overpayment will be requested unless the supplier proves delivery with the
detailed documentation described above.
•
When items are delivered by a shipping service (e.g., UPS)
The following documents are required:
1) Supplier’s shipping invoice. This should include:
a) Patient’s name
b) Detailed description of the items being delivered or the brand name
c) Serial numbers, if applicable
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d) Quantity delivered
2) Shipping service tracking slip. This should reference each individual
package, the delivery address, the corresponding package identification
number give by the service, and if possible, the date delivered.
or
Instead of the shipping service tracking slip, suppliers may have the
patient or designee sign and date the shipping invoice and return it to them
postage-paid.
If the patient or designee is not available to sign for the items delivered by a
shipping service, it is acceptable for the service to leave the package at the
door.
•
Alternative documentation when items are delivered to a nursing facility on
behalf of the patient
Suppliers should work with the nursing facility staff to implement an
inventory control procedure that ensures the following:
1) Items are identified and retained for use only by the specific patient for
which they are intended;
2) Items are utilized by the patient for which they are issued;
3) The medical records in the nursing home document the use of all items
billed to Medicare. The documentation may be in the nurse's notes or in a
special treatment record or form.
For patients in a nursing facility, documentation in the medical records of
usage by the patient may substitute for the signature of the patient/ designee
(for directly delivered items) or shipping service tracking slip (when a
shipping service is used). However, the supplier must still have a shipping
invoice with:
a) Patient’s name
b) Detailed description of the items being delivered or the brand name
c) Serial numbers, if applicable
d) Quantity delivered
Both the supplier’s shipping invoice and the medical records to document
usage by the patient must be submitted upon request from the DME PSC.
If the supplier does not provide proof of delivery when requested by the DME PSC, the
claim for the item will be denied or an overpayment will be recovered.
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