CMS Drug Coverage Could Be Driven By Commercial Plan Decisions Under Proposal
Proposed rule would also clarify standard for determining whether coverage of a drug, device, or biologic is ‘reasonable and necessary.’
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Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.
Peter Bach warns against Medicare ceding its scientific authority to FDA and automatically covering all drugs and devices the agency clears, suggesting the Alzheimer’s drug be subject to a CMS Innovation Center trial if FDA-approved. Others say the drug could highlight flaws in Medicare Part B’s payment system.
Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.