National Coverage Determinations Proposed for Removal (March 2015)

On August 7, 2013, the Centers for Medicare & Medicaid Services (CMS) published a Federal Register notice, (78 FR 48164-69), updating the process used for opening, deciding or reconsidering national coverage determinations (NCDs) under the Social Security Act (the Act). The notice replaced the September 26, 2003 Federal Register notice (68 FR 55634) and further outlined an expedited administrative process, using specific criteria, to remove certain NCDs older than 10 years since their most recent review.

This is the March 2015 list of NCDs proposed for removal, along with the relevant portion of the FR notice containing the CMS criteria. CMS is soliciting public comment for 30 calendar days on whether any or all of these NCDs should be removed or retained. Your comment may be entered here.

CMS expects to publish a finalized list by fall 2015. Local Medicare Administrative Contractors (MACs) will be able to determine coverage for items and services that were previously determined by removed NCDs.

Process as described in the Federal Register notice.

E. Expedited Process to Remove an NCD Using Certain Criteria
We recognize the need to periodically review our policies and processes to ensure that we remain effective and efficient as well as open and transparent. We are aware that clinical science and technology evolve and that items and services that were once considered state-of-the-art or cutting edge may be replaced by more beneficial technologies or clinical paradigms. Therefore, we are announcing an administrative procedure to periodically review the inventory of NCDs that are older than 10 years since their most recent review and evaluate the continued need for those policies to remain active on a national scale. We are administratively simplifying the Medicare program by removing NCDs in circumstances described below. This process of removal would not result in an NCD as that term is defined in sections 1869(f) and 1862(l) of the Act because there would be no uniform national decision about whether or not the particular item or service would be covered under Title XVIII of the Act. Rather, the initial coverage decision under section 1862(a)(1)(A) of the Act for the particular item or service would be made by local contractors. We believe that allowing local contractor discretion in these cases better serves the needs of the Medicare program and its beneficiaries since we believe the future utilization for items and services within these policies will be limited.

This expedited procedure allows us to regularly identify and remove NCDs that no longer contain clinically pertinent and current information or that involve items or services that are used infrequently by beneficiaries. As the scientific community continues to pursue research in certain areas, the evidence base we previously reviewed may have evolved to support other policy conclusions. Alternatively, in some circumstances, removing an NCD has the effect of striking national noncoverage and may permit access to technologies that may be beneficial for some limited uses.

Under this process, we will periodically publish on our Web site, a list of NCDs proposed for removal along with our rationale for their proposed removal. We will solicit public comment for 30 calendar days. This will invite the public to comment on whether any or all of these NCDs should be removed or retained. In addition, we will ask the commenters to include a rationale to support their comments. We use the public comments to help inform our decision to do one of the following:

• Follow the proposal to remove the NCD.
• Retain the policy as an NCD.
• Formally reconsider the NCD and post a tracking sheet to that effect on the Coverage website.

We consider all the public comments when developing a final NCD list for removal. When the final NCD list for removal is posted to our Coverage Web site, we summarize the comments and briefly explain our rationale as to why a specific NCD remained active, was removed from active national status, or qualified for reconsideration. The final list will be effective upon posting it to the Web site.

Currently, an existing NCD must undergo a formal reconsideration process to be removed or amended and the process generally takes 9 to 12 months. We expect this new administrative procedure to reduce that time significantly. We believe that this streamlined process is more efficient and helpful to the public because it instills confidence that national policies are being monitored to ensure health benefits for Medicare beneficiaries remain current.

We may consider an older NCD for removal if, among other things, any of the following circumstances apply:

• We believe that allowing local contractor discretion better serves the needs of the Medicare program and its beneficiaries.
• The technology is generally acknowledged to be obsolete and is no longer marketed.
• In the case of a noncoverage NCD based on the experimental status of an item or service, the item or service in the NCD is no longer considered experimental
• The NCD has been superseded by subsequent Medicare policy.
• The national policy does not meet the definition of an “NCD” as defined in sections 1862(l) or 1869(f) of the Act.
• The benefit category determination is no longer consistent with a category in the Act.

National Coverage Determinations for Possible Removal