DOTmed September 4, 2020
John R. Fischer

The Centers for Medicare and Medicaid Services (CMS) has proposed a new rule that would enable medical devices approved under the FDA’s “breakthrough” designation to be covered by Medicare immediately, effectively eliminating delays in patient access.

The move would permit Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 and 2020, thereby allowing Medicare beneficiaries to use them for life-threatening illnesses and conditions, according to Policy and Medicine, a publication by Rockpointe Corporation.

“Too often, innovative devices are approved by the FDA but aren’t covered by Medicare until sufficient evidence has been collected,” said Patrick Hope, executive director of MITA, in a statement. “This creates a ‘Catch-22’ scenario in which, without adequate coverage or reimbursement,...

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Topics: CMS, FDA, Govt Agencies, Insurance, Medical Devices, Medicare
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