In a 2025 JACC Advances systematic review and meta-analysis of 18 US atrial fibrillation catheter ablation studies, non-Hispanic Black patients were 35 percent less likely to receive catheter ablation than non-Hispanic white patients (adjusted odds ratio 0.65, 95 percent confidence interval 0.58 to 0.74; Nosair et al., PMID 40857826). Secondary reporting describes the Centers for Medicare and Medicaid Services' new RAPID Coverage Pathway, announced April 22, as compressing Medicare coverage decisions on FDA Breakthrough Devices from 12 or more months to as little as two; the CMS primary-source text was not reachable from multiple cms.gov paths at the time of this writing.
RAPID is coverage-speed reform. The peer-reviewed evidence on device utilization for Black Medicare beneficiaries says the gaps live downstream of coverage-decision timing. Here is what RAPID appears to change, what it does not, and the specific Black-beneficiary group it most clearly helps.
What RAPID appears to change, per secondary reporting
Per coverage from the Kaiser Family Foundation CMS tracker and Fierce Healthcare, the RAPID Coverage Pathway is a replacement for the earlier Transitional Coverage for Emerging Technologies (TCET) mechanism. Devices that receive FDA Breakthrough Device Designation would be eligible for an expedited Medicare National Coverage Determination, with the pathway reducing the decision window from the roughly 12 to 18 months the standard NCD process typically runs to as short as two months. The CMS primary-source announcement, FDA joint statement, and Federal Register notice with the docket number and public-comment window end date are on this piece's update list; readers tracking the specific procedural details will see those populated as the federal sources become reachable.
The pathway affects manufacturer timelines and therefore the window in which a newly approved Breakthrough Device is commercially available to Medicare beneficiaries. That is a real improvement for the specific patient who would have received the device in months 13 through 18 of the standard process and will now receive it in months 3 through 6. It is not a guarantee that a given Medicare-eligible Black beneficiary will see the device prescribed, covered by their specific Medicare Advantage plan, or delivered through a nearby facility.
The utilization gaps the peer-reviewed evidence documents are downstream of timing
Three peer-reviewed studies published in the last 18 months document Black-beneficiary gaps in utilization of the device categories most likely to flow through RAPID, and each gap operates mechanisms that a coverage-speed reform does not change.
The Nosair 2025 meta-analysis cited above synthesizes 18 US AFib catheter ablation studies. The 35 percent reduced ablation odds in Black patients (OR 0.65) comes with a 22 percent reduction for Hispanic patients and a 26 percent reduction for Asian patients. The authors flag that none of the 18 studies explicitly defined disparity or the source of race and ethnicity data, which means the mechanism driving the gap is underspecified in the literature. What the evidence does say is that Black patients receive ablation less often when they are eligible for it under current coverage rules.
A 2024 JAMA Network Open analysis of continuous glucose monitor prescribing at 275 federally qualified health centers found that Black Type 2 diabetes patients had 24 percent lower multivariable odds of receiving a CGM prescription than white patients (OR 0.76, 95 percent CI 0.59 to 0.98; Wallia et al., PMID 39576644). The gap operates in the primary-care setting where the prescription would originate, not at the CMS coverage-determination level.
A 2025 Diabetes Spectrum paper on automated insulin delivery adoption among youth with Type 1 diabetes found that 47 percent (60 of 129) of Black youth used AID systems compared with 70 percent (341 of 483) of white youth (P less than 0.001); Black youth who did use AID achieved a median A1C of 8 percent versus 9.6 percent in Black youth without AID (P less than 0.001; Yilmaz et al., PMID 41522278). The glycemic benefit is real. The adoption gap is also real, and it closes only when Black youth actually receive the devices.
Sickle cell gene therapy aligns RAPID timing with a majority-Black patient population
One device category has a specific Black-beneficiary alignment with RAPID's timing reform. Casgevy, the first FDA-approved CRISPR gene therapy for severe sickle cell disease, reached 97 percent vaso-occlusive-crisis-free status at 12 months in 30 evaluable patients in the pivotal trial (Frangoul et al., NEJM 2024, PMID 38661449). Approximately 90 percent of US sickle cell disease patients are Black, and as patients from the expanded Casgevy-eligible population age into Medicare, the coverage-determination timeline for Casgevy and the forthcoming Lyfgenia and other approvals becomes directly consequential for a majority-Black patient group.
Our earlier reporting on the ex-vivo SCD gene therapy pipeline and its access constraints is at /articles/crispr-aav-sickle-cell-access-gap/. The RAPID framework would not change the bone-marrow-harvest or myeloablative-conditioning requirements that determine which patients can complete the therapy; it would change how quickly the Medicare coverage determination for gene therapies published under Breakthrough Device Designation reaches an NCD.
Named voice on the evidence
Dr. Amisha Wallia, MD, MS, is an endocrinologist in the Division of Endocrinology at Northwestern University Feinberg School of Medicine and lead author of the 2024 JAMA Network Open CGM disparities paper. Her research documents the primary-care-setting mechanisms that produce the Black-patient CGM prescribing gap across a 275-FQHC-site sample. Her institutional page is at Northwestern Feinberg Endocrinology.
Wallia has not been interviewed for this piece; the citation above is the primary-source record under her institutional affiliation. The CGM findings are what an interview would expand into clinical and patient-coaching recommendations.
What you can do before a Breakthrough Device prescription
Three specific actions map to the evidence.
"Has this device received FDA Breakthrough Device Designation, and is Medicare covering it under the RAPID pathway?" Ask the specialist who proposes the device. The RAPID pathway is the new mechanism; asking whether a specific device is flowing through it clarifies both the FDA-approval status and the coverage-billing category the prescription will use.
"Does the device have a National Coverage Determination, a Local Coverage Determination, or is it covered under RAPID?" Ask the provider or the device manufacturer's reimbursement support line. The answer determines billing and prior-authorization routing and affects whether out-of-pocket costs show up.
Submit a public comment on the RAPID pathway during the 60-day Federal Register window. The docket number and comment-window end date are on this piece's update list. Beneficiaries, providers, and advocacy organizations all have standing to submit comments. The coverage-pathway design decisions that affect future Breakthrough Device access are the comments' practical stakes.
For Medicare-age sickle cell disease patients specifically: ask whether the participating state Medicaid program is enrolled in the CMS Cell and Gene Therapy Access Model and whether RAPID changes the Casgevy or Lyfgenia treatment-center referral options.
Update plan
We will update this piece when the CMS April 22 RAPID press release URL and exact text are sourced from cms.gov directly, when the FDA joint RAPID statement is pulled from the FDA CDRH newsroom, when the Federal Register docket number and the 60-day comment-window end date are confirmed, when Tamara Syrek Jensen's post-CMS affiliation is verified, and when the current CMS Coverage and Analysis Group director's name is confirmed.
