CMS RAPID pathway: AdvaMed seeks wider device eligibility

Medtech lobby group AdvaMed wants the Centres for Medicare and Medicaid Services (CMS) to widen the CMS RAPID pathway. The proposed route would bring faster Medicare coverage for certain breakthrough devices. Public comments on it close on 13 October.

What AdvaMed is asking for

AdvaMed wants more breakthrough devices to qualify, including diagnostics. It also wants firm timelines for national coverage determinations.

The group also asked for transition protections. They would cover technologies already planned under earlier CMS coverage pathways. AdvaMed also wants adequate funding for the programme, plus transparency and alignment with the Food and Drug Administration (FDA).

Earlier this year, AdvaMed called the pathway a "positive step" towards wider access to breakthrough devices. Even then, it asked for clearer timelines and broader eligibility.

How the CMS RAPID pathway works

RAPID stands for Regulatory Alignment for Predictable and Immediate Device. CMS announced the plan earlier this year. Certain breakthrough devices would receive a proposed national coverage determination as soon as the FDA authorises them.

Eligibility is slightly narrower than in past efforts. Class II devices must take part in theFDA'ss Total Product Life Cycle Advisory Program. Class III devices qualify whether or not they take part. The CMS RAPID pathway will leave out in vitro diagnostics, as CMS has no plan to cover them.

CMS expects 40 new devices would qualify today. About 20 more could follow later.

Earlier attempts at faster coverage

RAPID has gone through several rounds of back-and-forth on reimbursement for breakthrough devices. The FDA has given breakthrough designation to nearly 1,300 devices. These may treat or diagnose life-threatening or debilitating conditions more effectively.

During the first Trump administration, CMS proposed automatic four-year coverage for breakthrough devices with FDA authorisation. CMS dropped the plan soon after. CMS leadership had""significant concern"" over the clinical evidence for Medicare patients. The Biden administration then set up a pathway covering five breakthrough technologies a year.

What the AdvaMed CEO said

“Medicare beneficiariesshouldn'tt have to wait for FDA-authorized breakthrough technologies that could improve their health and even save their lives”, AdvaMed CEO Scott Whitaker said in a statement.

He added: “CMS has taken an important step toward that goal with RAPID”

Why it matters

For makers of breakthrough devices, the comment window shuts on 13 October. The CMS RAPID pathway is still a proposal. Medigear.uk will follow the CMS RAPID pathway as CMS reviews the comments.

Source: MedTech Dive