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September 22, 2015

Excluded Genetic Test Reconsideration Requests and Process (CM00006)

Note: This article applies to a specific gene that may include different tests from multiple labs. To reconsider a decision on a specific laboratory test, please follow the Technical Assessment Process outlined on the CGS-MolDX site.

Although the CMS Program Integrity Manual (PIM) 100-08, Chapter 13, Section 13.11.E.2External PDF does NOT allow reconsideration requests for National Coverage Determinations (NCDs), coverage provisions in interpretive manuals, draft, template or retired Local Coverage Determinations (LCDs), individual claims, bulletins, articles, training material, and any instance in which an LCD doesn’t exist, MolDX will continue to accept and consider requests on excluded genetic tests. The following reconsideration requirements have been modeled from the LCD reconsideration PIM language and will be used in support of this excluded service reconsideration process:

  1. Requests shall be submitted in writing with all attachments (email or hardcopy), and shall identify the language the requestor wants added to or deleted from the Excluded Test determination. Requests shall include a justification supported by new evidence, which may materially affect the determination or basis. Copies of published evidence shall be included. The level of evidence required for SE reconsideration is the same as that required for new/revised LCD development. (PIM 100-08, Chapter 13, Section 13.7.1External PDF)
    • Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and
    • 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;
      • Consensus of expert medical opinion (i.e., recognized authorities in the field); or
      • Medical opinion derived from consultations with 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 must be considered and its quality shall be evaluated before a conclusion is reached.
  2. Any reconsideration request for an Excluded Test determination that, in the judgment of the contractor, does not meet these criteria is invalid
  3. Contractor will have the discretion to consolidate valid requests if similar requests are received

Excluded Test Reconsideration Process

  • Submit a valid Excluded Test Reconsideration request by one of the following methods:
    • Email (Preferred): MolDX@palmettogba.com
    • Regular mail:
      Palmetto GBA, Attn: MolDX
      17 Technology Circle, Mail Code AG-315
      Columbia, SC 29203
  • Within 30 days of the request receipt date, MolDX will determine whether the request is valid or invalid
    • If invalid, Palmetto GBA will notify requestor the reason for the invalid determination
    • If valid, Palmetto GBA will make one of the following decisions within 90 days of a valid request receipt date:
      • Continue to exclude coverage
      • Allow coverage and retire article, if applicable
      • Allow limited coverage through the LCD process

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