The Advanced Medical Technology Association, known as AdvaMed, has formally called upon the Centers for Medicare & Medicaid Services (CMS) to broaden the scope of its newly proposed "Regulatory Alignment for Predictable and Immediate Device" (RAPID) coverage pathway. In a comprehensive response to the agency’s latest regulatory framework, the industry’s leading lobbyist group emphasized that while the RAPID program represents a significant step toward bridging the gap between federal authorization and patient access, it remains too restrictive in its current form. Specifically, AdvaMed is advocating for the inclusion of breakthrough diagnostics, the establishment of firm timelines for national coverage determinations, and a more inclusive eligibility criteria for Class II medical devices.
The RAPID proposal is the latest iteration in a decade-long effort to solve the "valley of death" in medical technology—the period between Food and Drug Administration (FDA) authorization and the securement of a Medicare reimbursement code. For many innovative startups and established medtech firms, this gap can last anywhere from three to seven years, often stifling innovation and preventing Medicare beneficiaries from accessing life-saving technologies that have already been deemed safe and effective by the FDA.
The Evolution of Breakthrough Device Coverage: A Decade of Policy Shifts
The struggle to harmonize FDA and CMS processes has seen several dramatic shifts over the last two presidential administrations. To understand the significance of the RAPID proposal, one must look at the chronology of the "Breakthrough Devices Program." Established under the 21st Century Cures Act, the FDA’s breakthrough designation is intended for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Since its inception, the FDA has granted this designation to nearly 1,300 devices, yet only a fraction of these have reached widespread clinical use due to reimbursement hurdles.
In early 2021, under the first Trump administration, the CMS proposed the Medicare Coverage of Innovative Technology (MCIT) final rule. This rule would have granted automatic, nationwide Medicare coverage for four years to any breakthrough device immediately upon FDA marketing authorization. While the medtech industry lauded the move, the rule was quickly finalized and then subsequently repealed by the Biden administration in late 2021. CMS leadership at the time cited "significant concerns" regarding the clinical evidence used by the FDA, noting that the FDA’s "safe and effective" standard does not always align with the CMS’s "reasonable and necessary" standard for the Medicare population, which often includes older adults with multiple comorbidities.
Following the repeal of MCIT, the CMS introduced the Transitional Coverage for Emerging Technologies (TCET) pathway. However, TCET was criticized by industry stakeholders for its limited scale, as the agency suggested it would only be able to process five new breakthrough technologies per year. The RAPID program, published in late 2026, serves as a middle-ground successor, aiming to increase the volume of covered devices while maintaining more rigorous evidence requirements than the original MCIT proposal.
Technical Mechanics of the RAPID Proposal
The RAPID pathway introduces a tiered eligibility structure based on the FDA’s classification of medical devices. Under the current CMS proposal, Class III devices—those that support or sustain human life or present a high risk of illness or injury—are eligible for the RAPID pathway regardless of their participation in other federal programs. However, Class II devices—which include a vast array of technologies from infusion pumps to specialized imaging software—must participate in the FDA’s Total Product Life Cycle Advisory Program (TAP) to qualify for RAPID.
The CMS estimates that approximately 40 new devices would currently qualify for the RAPID program under these constraints, with the potential for that number to grow to 60 in the coming years. Notably, the current proposal excludes in vitro diagnostics (IVDs). This exclusion has become a primary point of contention for AdvaMed and its member companies.
AdvaMed’s Core Arguments for Expansion
In a statement following the submission of formal comments, AdvaMed CEO Scott Whitaker underscored the urgency of the situation. "Medicare beneficiaries shouldn’t have to wait for FDA-authorized breakthrough technologies that could improve their health and even save their lives," Whitaker stated. "CMS has taken an important step toward that goal with RAPID, but we must ensure no patient is left behind because of arbitrary category exclusions."
The Case for Diagnostics
AdvaMed’s primary critique involves the exclusion of diagnostics. The group argues that diagnostics are the cornerstone of modern personalized medicine. From blood-based tests for early cancer detection to advanced genomic sequencing, breakthrough diagnostics allow for earlier intervention, which often results in lower long-term costs for the Medicare program. By excluding these tools from the RAPID pathway, AdvaMed contends that the CMS is effectively slowing the adoption of preventative care.
Eligibility and Class II Restrictions
The requirement for Class II devices to participate in the FDA’s TAP program is seen by industry experts as a bottleneck. While the TAP program is designed to facilitate communication between the FDA, manufacturers, and payers, it has limited capacity. AdvaMed is calling for broader eligibility that does not tie CMS coverage so strictly to a voluntary FDA advisory program that may not be accessible to all innovators.
Predictable Timelines and Funding
A recurring theme in AdvaMed’s feedback is the need for "firm timelines." Currently, even within specialized pathways, the National Coverage Determination (NCD) process can be opaque and open-ended. The lobbyist group is requesting that the CMS commit to specific deadlines for making coverage decisions once a device enters the RAPID program. Furthermore, AdvaMed has called for adequate congressional funding to ensure the CMS has the staff and resources to manage the increased workload without creating new backlogs.
Data Analysis: The Impact of Coverage Delays
Supporting data suggests that the "coverage gap" has tangible consequences for the American healthcare system. According to a study of breakthrough-designated devices, those that do not receive immediate national coverage see a significantly slower rate of adoption in hospital systems that serve high volumes of Medicare patients.
Research indicates that for every year a breakthrough cardiovascular device is delayed in reaching the Medicare population, thousands of potential "life-years" are lost due to the continued use of legacy technologies that are less effective. Additionally, the lack of a predictable reimbursement pathway has a chilling effect on venture capital investment in the medtech sector. Investors are increasingly hesitant to fund the expensive clinical trials required for Class III devices if there is no guarantee of a timely "return on innovation" via Medicare reimbursement.
Broader Implications for the Healthcare Ecosystem
The outcome of the RAPID proposal will have far-reaching implications for the future of medical innovation. If the CMS adopts AdvaMed’s recommendations, it could signal a new era of "regulatory harmony" where the FDA and CMS work in tandem rather than in silos.
For healthcare providers, a streamlined RAPID pathway would mean more certain access to the latest tools. Currently, many hospitals are forced to utilize "local coverage determinations" (LCDs), which vary by region. This creates a "zip code lottery" where a Medicare beneficiary in Maryland might have access to a breakthrough neurological implant that a beneficiary in Florida does not. A nationalized, predictable RAPID program would eliminate these regional disparities.
Furthermore, the inclusion of transition protections—another of AdvaMed’s requests—would ensure that technologies currently being evaluated under the TCET or other legacy pathways are not lost in the shuffle as the CMS shifts its focus to RAPID. This "grandfathering" of evidence-building efforts is seen as essential for maintaining the trust of the manufacturing community.
Conclusion and Next Steps
As the CMS reviews the feedback from AdvaMed and other stakeholders, the medtech industry remains cautiously optimistic. The transition from the limited scope of TCET to the more robust framework of RAPID suggests an agency that is listening to the needs of the innovation community, even if it remains wary of the fiscal and clinical risks associated with automatic coverage.
The finalization of the RAPID rule will be a landmark event for the Department of Health and Human Services. Whether it becomes the gold standard for medical device reimbursement or another bureaucratic hurdle will depend on the agency’s willingness to incorporate industry feedback regarding diagnostics, timelines, and eligibility. For now, the message from AdvaMed is clear: a breakthrough in the lab is only a victory if it reaches the patient’s bedside without delay. The medtech industry now waits to see if the CMS will bridge the final gap in the regulatory journey of life-saving technology.
