Breakthrough Device Changes Needed: Research

Researchers from several academic medical centers say FDA should consider making some changes to its Breakthrough Devices Program (BDP) to prevent it from triggering Centers for Medicare and Medicaid Services (CMS) supplemental payments for many costly, new devices. Writing in a JAMA Cardiology Special Communication, the researchers say (article purchase required) recent CMS policies automatically provide supplemental reimbursement for devices designated in FDA’s BDP. And, they say, CMS published a notice in June for a new Transitional Coverage for Emerging Technologies pathway, accelerating coverage for BDP devices.

The researchers say FDA awards the breakthrough designation early in a device’s development to expedite market authorization. They say the agency is willing to accept greater uncertainty in benefit and risk, contingent on postmarket studies.

The article presents three examples of cardiovascular devices that the authors say illustrate that the BDP may allow for FDA authorization based on less rigorous evidence. “The BDP may qualify new, costly devices for higher and automatic Medicare reimbursement despite evidence not being representative of CMS beneficiaries and persistent uncertainty of benefit and risk,” the article says. “To ensure that best evidence is generated to inform clinical care, FDA could apply more selectivity to BDP eligibility, specify objective criteria for revoking breakthrough designation when appropriate, and ensure timely postmarket evidence generation, whereas CMS could independently review clinical evidence, advise manufacturers about standards for coverage review, and make supplemental payments and long-term device reimbursement contingent on clinical outcome benefit and postmarket evidence generation.”