PROGRESS ON NCD REQUEST

In November 2016 we submitted A FORMAL REQUEST FOR A NATIONAL COVERAGE DETERMINATION— COVERAGE OF LYMPHEDEMA COMPRESSSION TREATMENT ITEMS AS PROSTHETIC DEVICE BENEFITS

The purpose was to remove ambiguities and to clarify the use of these medical items in the treatment of lymphedema, and to determine whether these items meet the Medicare coverage requirements for prosthetic device benefits. The complete formal request met the Medicare conditions stated in the Medicare guidance document “Factors CMS Considers in Opening a National Coverage Determination”, briefly:

• A formal request letter and supporting documentation submitted electronically (unless there is good cause for only a hardcopy submission).
• The request is identified as a "formal request for an NCD."
• The request states the benefit category or categories of the Medicare program to which the requestor believes the item or service applies.
• The requestor should submit adequate supporting documentation along with the formal letter, including a full compilation of the supporting medical and scientific information currently available that measures the medical benefits of the item or service.

CMS Describes the NCD process on their Web site “Upon acceptance of a complete, formal, request, posting of the tracking sheet on our Web site facilitates the ability of interested individuals to participate in, and monitor, the progress of our review. This is a key element in making our NCD process more efficient, open, and accessible to the public.

“We then undertake a formal evidence review to determine whether or not an unbiased interpretation of the available evidence base supports or refutes the requested coverage in whole or in part.” [Ref Medicare Program; Revised Process for Making National Coverage Determinations, Federal Register Vol. 78, No. 152, August 7, 2013]

No such analysis was made by CMS and a letter was received 23 months later which stated briefly that compression garments were not like Foley catheters so they do not meet the coverage requirements as prosthetic devices. There was no indication that CMS had analyzed the extensive evidence submitted, let alone even read it. No tracking sheet was ever posted, public and expert comment solicited, or decision made on the basis of the available evidence. Disputed denials continue to be made by DME MACs, appealed, and a significant percentage overturned by ALJs.

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Lymphedema Treatment is Good Business as well as Good Medicine
© 2002 Robert Weiss, Porter Ranch, CA