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The LCD Reconsideration Process is a mechanism by which interested parties can request a revision of an LCD. In order to be considered a valid request, the following requirements must be met:
- Requestor must be qualified
- Subject must be appropriate
- Information submitted must be adequate
- Process for submission must be followed
Any request for LCD reconsideration that, in the judgment of the DME MAC, does not meet these requirements is invalid.
Requestor
The DME MAC will consider all LCD reconsideration requests from:
- Beneficiaries residing in our jurisdiction; or
- Suppliers doing business in our jurisdiction.
We may consider LCD reconsideration requests from any other interested party doing business in our jurisdiction.
Subject
The LCD Reconsideration Process is available only for final LCDs. The whole LCD or any part of the LCD may be reconsidered. Requests are not accepted for other documents including:
- National Coverage Decisions (NCD) - for example, Coverage Issues Manual;
- Coverage provisions in interpretive manuals - for example, Medicare Carrier Manual;
- Draft LCDs;
- Retired LCDs;
- Individual claim determinations;
- Bulletins, articles, training materials;
- Any instance in which no LCD exists, i.e. requests for development of an LCD.
If modification of the LCD would conflict with an NCD, the request is not valid. Refer to the NCD reconsideration process at http://www.access.gpo.gov/nara/index.html
Information to be Submitted
The request must identify the language that the requestor wants added to or deleted from an LCD. Requests must include a justification supported by new evidence, which may materially affect the LCDs content or basis. When articles or textbooks are cited, copies of the published documents must be included.
The level of evidence required for LCD reconsideration is the same as that required for new/revised LCD development. As described in the Medicare Program Integrity Manual, LCDs are to be based on the strongest evidence available. In order of preference, LCDs are based on:
- Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies
- General acceptance by the medical community (standard of practice), as supported by sound medical evidence based on:
- Scientific data or research studies published in peer-reviewed medical journals; or
- Consensus of expert medical opinion (i.e., recognized authorities in the field); or
- Medical opinion from medical associations or other health care experts.
Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with financial interest in the outcome, are not sufficient evidence of general acceptance by the medical community. The broad range of available evidence will be considered and its quality will be evaluated before a conclusion is reached.
Submission Process
In order to be valid, the request for LCD reconsideration must be in writing and must include the name and mailing address of the requestor. Inclusion of a telephone number and/or email address is optional. If the requestor is a supplier, the supplier number must be included. If the requestor is neither a beneficiary nor a supplier, the requestor must identify the nature of their business and who they are representing (if applicable).
Requests may be submitted by mail, email, or fax to:
Paul J. Hughes, MD
Medical Director
DME MAC Jurisdiction A
75 Sgt. William Terry Dr
Hingham, MA 02043
or
NHICDMELCDRecon@examhub.exch.eds.com
or
Fax 781-741-3991
DME MAC Response
Within 30 days after the request is received, the DME MAC will determine whether the request is valid or invalid and will notify the requestor of that determination. If the request is invalid, we will explain why it was invalid.
If the request is valid, within 90 days after the request is received, the DME MAC will make a reconsideration decision and will notify the requestor of the decision with its rationale. Decision options include: no revision, revision to a less restrictive policy, revision to a more restrictive policy, or retiring the policy.
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06/20/2008 |
