Yesterday, the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published its revised process for external requests and internal reviews for new national coverage determinations (NCDs) or for reconsideration of existing NCDs.  Today’s guidance supersedes CMS’s previous process issued in 2003.

Prior to formally requesting an NCD or reconsideration, CMS encourages requesters to contact CMS staff in the Coverage and Analysis Group (CAG).  The CAG staff may identify additional needed information and supporting documentation.  The requester may also find that a formal request is not needed.  For example, CAG staff could determine that coverage of the item or service is already available or that the item or service falls outside the scope of an NCD.

If the requester decides to move forward with requesting an NCD review, the requester must provide the following, which would constitute a “complete, formal request”:

1. A final letter of request that is clearly identified as “A Formal Request for A National Coverage Determination.”

2. A full and complete description of the item or service in the request.

3. The scientific evidence supporting the clinical indications for the item or service, including the proposed use of the item or service, the target Medicare population, the medical indication(s) for which the item or service can be used, and whether the item or service is used by health care providers or beneficiaries.

4. The Medicare Part A or B benefit category or categories in which the item or service falls.

5. Additional information if the item or service is currently under FDA review.

Once CMS receives the complete formal request, it will add the request to its tracking sheet on the CMS website and permits public comments on the request.  CMS will also initiate a formal evidence review and will generally issue a proposed decision within six months of opening the NCD review.  CMS will accept public comments for 30 days after issuing the proposed decision.  CMS will then issue a final NCD within 60 days of the end of the public comment period.  These timeframes could be extended, however, if CMS commissions a third party technology assessment, convenes the Medicare Evidence Development and Coverage Advisory Committee, or requests a clinical trial.

Today’s guidance also provides the process for requesting reconsideration of an NCD.  The reconsideration must be in writing and clearly identified.  The requester must also provide documentation meeting one of the following:

1. Additional scientific evidence not considered at the most recent review and a “sound premise” that the evidence may change the NCD decision.

2. Arguments that CMS’s conclusion materially misinterpreted the existing evidence at the time the NCD was decided.

CMS will generally accept or reject an external NCD reconsideration request within 60 days of receiving the request.

In certain circumstances, CMS may internally initiate review of an NCD.  CMS will also periodically review NCDs that have not been reviewed in the past 10 years.  CMS will publish a list of NCDs proposed for removal and rationale for removal and provide a 30 day public comment period.  CMS anticipates that this process will reduce the timeframe for removal or amendment of an NCD.  Currently, removal or amendment takes 9 to 12 months.

For more information, please see the guidance at this link.