Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program

Area of Science:

• Medical device regulation
• Health economics
• Clinical evidence evaluation

Background:

• The US Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have distinct roles in medical device approval and reimbursement.
• CMS has introduced policies to accelerate coverage for devices designated as 'Breakthrough' by the FDA, including a new Transitional Coverage for Emerging Technologies pathway.

Purpose of the Study:

• To analyze the implications of the FDA's Breakthrough Devices Program (BDP) on medical device market authorization and reimbursement.
• To evaluate the evidence standards used for BDP-designated devices and their representativeness of the Medicare beneficiary population.

Main Methods:

• Review of publicly available information on the FDA's Breakthrough Devices Program.
• Case examples of cardiovascular devices authorized through the BDP were examined.
• Analysis of evidence requirements, trial designs, and postmarket study outcomes for selected devices.

Main Results:

• The BDP may permit FDA authorization with less rigorous evidence, including single-arm trials and surrogate endpoints, often not representative of Medicare beneficiaries.
• Some devices authorized via BDP have shown initial findings that were later unverified or contradicted by postmarket studies.
• Manufacturers have leveraged BDP designation to increase device pricing, leading to higher costs for CMS and healthcare systems.

Conclusions:

• The BDP may grant accelerated reimbursement for costly devices despite limited or unverified clinical evidence.
• Recommendations include increased FDA selectivity for BDP eligibility, objective criteria for designation revocation, and timely postmarket evidence generation.
• CMS should independently review clinical evidence, guide manufacturers on coverage standards, and link reimbursement to demonstrated clinical outcomes.