The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to established, older products and technologies.
Technology companies can mitigate these risks and increase opportunities by better understanding the process and preparing response strategies early. In 10 Strategic Considerations for Tackling Medicare’s Revised National Coverage Determination Process, Latham & Watkins partner Stuart Kurlander, counsel Esther Scherb and associate Chris Koepsel offered advice on navigating the new process.
10. Get to know the Medicare Coverage Database. CMS utilizes a web-based tracking system called the “Medicare Coverage Database,” which contains various NCD information, including: all active NCDs, proposed NCD decisions, National Coverage Analyses and Medicare coverage guidance documents.
9. Understand the NCD removal process. CMS plans to periodically publish a list of NCDs proposed for removal, along with rationale explaining why that particular NCD is being considered for removal. CMS will solicit public comments for 30 days, after which, the agency will either retain the NCD, follow the proposal to remove the NCD or formally reconsider the NCD.
8. Take inventory of older NCDs. Companies interested in existing NCDs should gather information to understand which older NCDs CMS may target, collect data in preparation of positions to either remove or retain the NCD, and monitor the CMS website for a possible 30 day public comment window.
7. Stay abreast of changes. Remain vigilant of changing circumstances and opportunities for new NCDs, and removals or reconsiderations of existing NCDs. CMS may internally generate or reconsider any policy or an entire NCD, regardless of its age, if the agency identifies evidence supporting a new NCD or becomes aware of new evidence that could support a material change in coverage to an existing NCD.
6. Be prepared before requesting. Companies should evaluate fully the opportunities for new NCDs and reconsideration of any existing NCDs before making requests. The two processes are the same, and CMS will consider accepting a formal request for a new NCD or reconsideration of an existing NCD at any time.
5. Schedule face time first. Informal discussions with CMS are encouraged under the 2013 Notice for two main reasons. First, informal contacts allow companies to crystallize the issues to be considered and avoid delays. Second, the informal discussions often clarify whether the request will be successful, saving you from wasted time and money.
4. Missing information can mean long delays. Submit complete information with any formal request. A single missing piece of required information may render the request incomplete, and delay timelines for CMS action.
3. FDA ≠ CMS. Understand the differences between FDA and CMS requirements. While FDA approvals or clearances are a prerequisite for a technology receiving Medicare coverage, meeting these requirements alone does not entitle a technology to Medicare coverage.
2. Find your benefit category. Ensure your product or related service fits a recognized benefit category.
1. Data is king. Obtain data to demonstrate your relevancy to the Medicare population. Companies should ensure that evidence supporting their technologies includes data either directly addressing individuals covered by Medicare or must otherwise demonstrate how existing data impacts this population.