Biden repeals Trump-era Medicare ‘breakthrough’ coverage policy

Biden repeals Trump-era Medicare ‘breakthrough’ coverage policy


The Centers for Medicare and Medicaid Services finalized its decision to repeal a rule that would have created an expedited Medicare coverage pathway for medical devices considered “breakthrough technology.”

The rule would have allowed Medicare to cover devices deemed “breakthrough” by the Food and Drug Administration for four years once they received market authorization. But the Biden CMS worried this would lead to coverage of devices without evidence they would adequately serve Medicare beneficiaries in particular.

“Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions,” CMS Chief Medical Officer Lee Fleisher said in a news release.

CMS proposed repealing the rule in September after first delaying its implementation in March and again in May. Without Friday’s final rule, the policy would have gone into effect in December.

The final rule says CMS still wants to improve access to breakthrough technologies and may do this through existing pathways or future rulemaking.


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