CMS has codified in a recent final rule how it defines equal and adequate protections for goods and services that could be provided under Sections A and B of Medicare. The definition has a trio of main elements, according to the final rule, so that an item or service is 1) safe and secure, 2) not for inquiry or experimentation, and 3) suitable for Medicare patients.

The agency anticipates that the codification of the definition will provide the coverage policy processes with clarity and consistency for the goods and services covered under Sections A and B.

CMS and Medicare Administrative Contractors have traditionally taken decisions depending on each case, requiring representations to be appropriate, or by local and national coverage legislation, such as Local Coverage Determinations and National Coverage Determinations, to decide if services offered are just.

The final rule stated that, to the extent that the services are offered by the majority of commercial insurers, CMS must determine the coverage of the services or products which have insufficient evidence to meet the appropriateness criteria. However, in the final regulation, CMS did not entirely replace the appropriateness criteria and decided to later issue guidance for how it would determine when and how commercial coverage could be extended to Medicare program coverage.

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