On August 7, the Centers for Medicare & Medicaid Services (CMS) published a notice (Notice) that it was revising the process for approving national coverage determinations (NCDs) which had been in place since 2003, and superseding the 2003 Federal Register notice of the prior process.1 The Notice was effective on the date of publication.
NCDs are described as "[g]enerally applicable rules to ensure that similar claims [under Part A or Part B] for items or services are covered in the same manner."2 The term "national coverage determination" is defined by statute as a determination made by the Secretary of the U.S. Department of Health & Human Services with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Act.3 NCDs are controlling authorities for Medicare contractors, administrative law judges, and the Medicare Appeals Council.4 The NCD request process can be initiated by an individual (including a beneficiary), an entity (including a medical professional society or business interest), or by CMS.
Among the most important provisions in the Notice are the following:
Starting the NCD Request Process with Informal Contact
CMS recommends that those interested in submitting a request for an NCD first have informal contact with the CMS Coverage and Analysis Group (CAG) within the Center for Clinical Standards and Quality before submitting a formal request. This will allow CAG staff to identify additional information that might be needed or helpful for the NCD request, and to identify clinical trial protocols for results which will be submitted to support the NCD request.
What Constitutes a Complete, Formal Request for an NCD or a Complete, Formal Request for Reconsideration
In the Notice, CMS set forth several conditions it requires before it will consider an NCD request complete, including that the request be in writing and clearly identify the statutorily defined Medicare benefit category into which the item or service fits (and include enough information for CMS to make a benefit category determination). Among other factors, the process also requires that the information provided address relevance, usefulness, or the medical benefits of the item or service to the Medicare population.
Requests for Reconsideration of an Existing NCD by External Parties
CMS will only consider requests for reconsideration if one of the specified criteria supports the request, such as a "sound premise" that new evidence may change the NCD decision or "plausible arguments" that CMS' previous conclusion materially misinterpreted the existing evidence at the time the NCD was decided.
Reviews of NCDs Generated by CMS
CMS itself will initiate the NCD review process, when there are significant questions about the health outcomes for the Medicare beneficiary population; when new evidence suggests that a review may be warranted; when local coverage policies vary in language or interpretation; when health technology represents a substantial clinical advance and is likely to have a significant improvement in patient health outcomes or a positive impact on the Medicare program; or when rapid diffusion of an item or service is anticipated and the evidence previously considered may inadequately address questions regarding impact on the Medicare population, target subgroup populations, practitioner or facility qualifications, or on beneficiary health outcomes.
Expedited Process to Remove an NCD Using Certain Criteria
CMS will periodically review the inventory of NCDs which are more than 10 years beyond their most recent review to evaluate the continued need for these NCDs. If an NCD is removed, the initial coverage decision would be made by the local Medicare contractor. This differs from current policy, which requires a formal reconsideration process for the NCD to be removed or revised.
In the Notice, CMS also discussed the importance of public commentary during the process, and described the various steps and timing of the review process.
Copyright 2013, American Health Lawyers Association, Washington, D.C. Reprint permission granted.
178 Fed. Reg. 48164 (Aug. 7, 2013), superseding 68 Fed. Reg. 55634 (Sept. 26, 2003).
278 Fed. Reg. at 48165.
3Soc. Sec. Act § 1862(l)(6)(A); 42 U.S.C. § 1395y(l)(6)(A).
442 C.F.R. § 405.1060.