As mandated by §4009 of the 21st Century Cures Act (P.L. 114-255), which requires more transparency in the Local Coverage Determination (LCD) process, CMS has changed the manner in which Medicare administrative contractors (MACs) make their determinations as well as how and when such determinations are communicated to the public. CMS has revised Chapter 13 of the Medicare Program Integrity Manual (Pub. 100-08) clarifying and simplifying the LCD process to increase transparency and ensure that Medicare beneficiaries are included in the process. CMS will accept feedback on the changes and will consider additional revisions based on the feedback.
The LCD process. MACs issue an LCD when a national determination does not exist or when a national determination needs further definition. MACs determine which health care items and services meet requirements for Medicare coverage accounting for local variations in the practice of medicine.
The changes. According to CMS Administrator Seema Verma, coverage decisions will be made more transparently and the redesigned LCD process will expand access to new medical technologies. The revision provides a step-by-step description of the LCD process in language that is understandable to all interested parties. MACs are required to follow the full LCD process for valid requests. Specifically, the changes:
- require a consistent, standardized summary of the clinical evidence supporting LCD decisions;
- include a beneficiary representative and other health care professionals in addition to physicians (e.g. nurses, social workers) on Contactor Advisory Committees that inform LCDs;
- ensure that Contractor Advisory Committee meetings are open to the public;
- allow patients to have an informal meeting with the MAC to request new LCDs; and
- allow for broader participation by holding open meetings virtually (e.g., by webinar) instead of in-person meetings.
In addition, the LCD reconsideration process must be consistent with the National Coverage Determination reconsideration process and proposed policies must be retired if not finalized within one year of the original posting date.
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