American College of Radiology cautions CMS in push to speed up payment for medical innovations
The American College of Radiology is urging the Medicare program to take caution in its push to speed up payment for medical innovations.
Back in August, the agency outlined plans to grant faster coverage for “breakthrough” devices in radiology and other specialties. Dubbed “RAPID,” or Regulatory Alignment for Predictable and Immediate Device coverage, the proposed program would have Medicare work more closely with the FDA to ensure seniors have access to these technologies.
However, in comments submitted to CMS on Oct. 12, the college is urging for cautiousness in these efforts. ACR said it remains concerned that FDA Breakthrough Device designations are often reached with no public insight, due to commercial confidentially clauses.
“As a result, stakeholders may have limited visibility into the rational for device selection and RAPID eligibility determinations,” ACR CEO Dana Smetherman, MD, MBA, MPH, wrote to the head of CMS. “CMS should identify opportunities to enhance transparency while respecting applicable confidentiality requirements,” she added.
The college is recommending requiring that RAPID applicants disclose a minimum set of information, which would be available on a public dashboard once a device is accepted. This could include the intended use, Medicare population treated, clinical health outcomes, and expected public milestones in the process.
ACR also is pushing the agency to create a structured process for specialty medical societies to give their feedback.
“Early input from clinicians who diagnose, treat and manage Medicare beneficiaries can help CMS identify relevant outcomes, appropriate comparators, implementation risks, real-world workflow concerns, coding and payment issues, and patient and safety considerations before the proposed [national coverage determination] is released,” ACR wrote to CMS Administrator Mehmet Oz, MD.
The college also made several other requests in the RAPID process. These included prioritizing “traditional,” more stringent coverage determinations over the alternative RAPID ones. Traditional devices often are focused on high-priority clinical issues, longstanding access barriers and outdated coverage policies. Prioritizing these “RAPID” device applications over traditional ones could unintentionally delay access to services with greater utility and stronger supporting evidence, ACR worries. The college additionally wants CMS to limit RAPID eligibility to certain devices and require Medicare-relevant evidence and clinical input before making coverage determinations.
“These safeguards will help ensure timely access to innovations while preserving the rigorous evidence base needed to support Medicare coverage decisions,” the letter closed.
ACR also promoted its comments in a news update to members, published on Oct. 15.
Back in August, CMS noted that there often is a lag—at a median of nearly six years—between the FDA authorizing new products and Medicare granting payment. The RAPID pathway aims to allow the two agencies to collaborate earlier in product life cycles, generating evidence to more rapidly support decisions. For devices completing the pathway, a coverage determination would be issued the same day as FDA market authorization, CMS noted. This means that national Medicare coverage would begin as soon as 60 days after the Food and Drug Administration made its decision.
Authorities outlined further details on which devices will be eligible for RAPID payment. These include certain Class 2 breakthrough devices partaking in the FDA’s Total Product Life Cycle Advisory Program. Same for Class 3 ones, regardless of their participation.
ACR’s feedback came ahead of authorities closing the 60-day public comment period for the proposal. The agencies are expected to eventually issue a final RAPID rule, potentially incorporating public input.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.