CMS Proposes RAPID Coverage Pathway for Breakthrough Devices

IVDs remain outside scope, while FDA-CMS Parallel Review remains available.

KEY TAKEAWAY RAPID could materially shorten the gap between Food and Drug Administration (FDA) authorization and national Medicare coverage for eligible Breakthrough Devices. The proposed pathway does not include in vitro diagnostics (IVDs), and Parallel Review will remain available.

On August 11, 2026, the Centers for Medicare & Medicaid Services (CMS) published a proposed notice establishing the Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. The framework is intended to accelerate Medicare access to certain FDA-designated Breakthrough Devices. Public comments are due October 13, 2026.

What RAPID Would Do

RAPID would move CMS engagement earlier in the product development lifecycle. CMS and FDA would work with eligible manufacturers during premarket development to align evidence expectations, including clinical outcomes relevant to Medicare beneficiaries, before FDA market authorization.

For qualifying technologies, CMS proposes to:

• Release a proposed National Coverage Determination (NCD) on the same day as FDA market authorization.
• Issue a final NCD approximately 60 days later for eligible Class II devices.
• Issue a final NCD approximately 90 days later for eligible Class III devices.

This approach could provide greater coverage predictability at launch than the traditional NCD process, which CMS notes generally takes 9 to 12 months or longer.

Which Technologies Would Qualify?

The proposed pathway would apply to:

• FDA-designated Class III Breakthrough Devices.
• Certain FDA-designated Class II Breakthrough Devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP).

Eligible technologies would need to address unmet needs relevant to Medicare beneficiaries and generate clinical health outcomes evidence that can support both FDA review and CMS coverage decision-making.

An Important Distinction for Diagnostics

While RAPID represents a significant step toward accelerating Medicare coverage for innovative medical technologies, IVDs are not included in the proposed pathway. As drafted, RAPID would apply to certain FDA-designated Breakthrough Devices but would not create a comparable expedited pathway for molecular diagnostics, companion diagnostics, genomic assays, or other in vitro diagnostic technologies.

For laboratories and diagnostic developers, existing Medicare coverage pathways remain unchanged. Coverage strategies will continue to rely on established mechanisms such as MolDX, local and national coverage determinations, claim-by-claim adjudication, and other available coverage pathways.

Parallel Review Remains Available

It is important to note that RAPID does not replace the FDA-CMS Parallel Review Program. CMS has indicated that Parallel Review will remain available, preserving an existing mechanism for coordinated FDA and CMS engagement.

This distinction is particularly important because diagnostics are excluded from RAPID. While device manufacturers may gain access to a new accelerated coverage framework, diagnostic developers will continue to operate within the current coverage landscape unless CMS chooses to expand the pathway in the future.

Why This Comment Period Matters

Currently, Medicare serves nearly 70 million beneficiaries and is the largest single health care purchaser in the United States. As CMS evaluates how to accelerate coverage, laboratory and diagnostics stakeholders have a unique opportunity to help shape the policies that could soon positively affect beneficiaries’ access to clinically meaningful healthcare innovations. The current comment period offers an important forum to discuss whether IVDs that demonstrate strong evidence of validity and utility should be part of that future framework.

For laboratory owners, diagnostic manufacturers, providers, Medicare beneficiaries and their families, patient advocacy organizations, and investors, the comment period presents an important opportunity to engage CMS on a fundamental policy question:

If CMS is seeking to accelerate Medicare access to innovative technologies that meet rigorous standards for clinical validity, clinical utility, and patient benefit, why do IVDs not have a place alongside medical devices in future iterations of the pathway?

Diagnostics increasingly drive treatment selection, disease monitoring, risk stratification, and precision medicine decision-making across Medicare populations. As CMS evaluates how best to modernize coverage processes for innovative technologies, stakeholders may wish to consider whether the principles underlying RAPID could also apply to diagnostic technologies that demonstrate strong analytical validity, clinical validity, and clinical utility.

CONSIDER THIS YOUR CALL TO ACTION

ADVI encourages laboratory owners and other diagnostics stakeholders to review the proposal and submit comments by October 13, 2026. This is an opportunity to explain why IVDs that meet rigorous validity and utility standards deserve a place alongside devices as CMS refines and optimizes the timing of Medicare coverage for innovation. Comments should reference file code CMS-3487-NC and may be submitted through Regulations.gov dMS-2026-2674.

How to submit your comments:

Sources

• Federal Register notice, CMS-3487-NC: https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16368.pdf
• Federal Register public comment page: https://www.federalregister.gov/documents/2026/08/11/2026-16368/medicare-program-regulatory-alignment-for-predictable-and-immediate-device-rapid-coverage-pathway
• CMS RAPID fact sheet: https://www.cms.gov/newsroom/fact-sheets/regulatory-alignment-predictable-immediate-device-coverage-pathway-cms-3487-nc-procedural-notice

This Insight is intended for informational purposes and does not constitute legal advice.

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