Weekly Spotlight: CMS Publishes the RAPID Procedural Notice
CMS published the procedural notice for its new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway (CMS-3487-NC). National Medicare coverage could begin as soon as 60 days after FDA Breakthrough Device authorization. A comment period is open.
The notice follows commentary CMS made on RAPID in its own FY2027 IPPS final rule (issued July 31, effective October 1). That rule repeals the alternative pathway letting breakthrough-designated devices skip the usual evidence bar for new technology add-on payments and outpatient device pass-through payments. It phases in October 2026 for outpatient and fiscal year 2028 for inpatient. CMS considered whether RAPID would offset that change and said no, stating that coverage and payment are “separate processes with different standards and purposes.” Six of the 16 device approvals under the repealed pathway were cardiac or structural heart. That is $130.5 million of the $417.7 million paid out under it, roughly 31% of the total.
The payment-side repeal is already final. The RAPID notice is now published. The open question for device makers is whether a faster coverage pathway can offset the narrower one CMS already closed.
Centers for Medicare and Medicaid Services (CMS)
CJR-X Goes Mandatory Nationwide as CMS Finalizes FY2027 Inpatient Rules
CMS finalized a 2.3% FY2027 base payment increase for inpatient and long-term care hospitals. It also replaced the voluntary Comprehensive Care for Joint Replacement model with CJR-X, the first mandatory nationwide Medicare bundled-payment model, beginning January 2028. The rule also pushes hospitals to adopt and attest to certified health IT under the Promoting Interoperability program. The American Hospital Association says the savings targets built into CJR-X are unachievable for participating hospitals, which have 17 months to prepare.
Healthcare Dive Becker’s Hospital Review CMS Announces Expansion of Proven Joint… HFMA Inside Health Policy healthmanagement.com
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Medicaid Work Requirements: A Narrower Frailty Exemption and Compounding State Choices
CMS’s interim final rule on Medicaid work requirements adopted a narrower definition of medical frailty than states had expected, and KFF’s analysis lays out the operational problems states face applying the exemption. Supplemental Security Income applicants covered through Medicaid expansion or certain waiver programs face heightened risk of losing coverage because of the verification burden. CBPP argues state legislative choices are compounding the reconciliation law’s Medicaid cuts, with states splitting between protecting coverage and deepening reductions.
The Medical Frailty Exemption from Medicaid… What Could Medicaid Work Requirements Mean for…Medicaid Changes Continue to Deepen the Harm of…
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Medicaid Provider-Tax Rule: What It Could Mean Beyond Medicaid
Health Management Associates breaks down CMS’s proposed rule implementing the reconciliation law’s Medicaid provider-tax limits. It flags open questions for states, Medicaid managed care plans, ACA marketplaces and other insurers about financing exposure that reaches beyond Medicaid itself.
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Hospital Finance: A DSH Court Win Offsets a Fiscal Year of Converging Cuts
A U.S. District Court judge in Northern Texas vacated a 2023 CMS regulation that excluded certain Medicaid Section 1115 waiver patients from the Medicare disproportionate-share hospital (DSH) payment formula. The ruling could return millions of dollars a year to safety-net hospitals. It arrives as hospital finance leaders face 340B payment cuts, site-neutral reimbursement and Medicaid rollbacks landing in the same fiscal year for the first time, per Becker’s.
Modern Healthcare: Medicare DSH Ruling Could… Becker’s Hospital Review
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ACA Marketplace Enters 2027 Renewal Sicker, Pricier, and in Court
ACA marketplace insurers filed a median proposed premium increase of about 15% for 2027, the second consecutive year at that level, per KFF’s analysis of complete rate filings across all 50 states and DC. A separate report finds marketplace enrollees are 6.3% sicker on average as the risk pool shrinks. Small-group insurers separately proposed a median 14% increase. Twenty-two states have sued to block the 2027 ACA marketplace rule over eligibility verification and enrollment period changes.
healthsystemtracker.org How Much and Why ACA Marketplace Premiums Are… Becker’s Payer How Much and Why Premiums Are Going Up for… beckerspayer.com
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Rare-Disease Carve-Out Fights Intensify Across CMS’s Drug Pricing Pilots
A Harvard analysis finds that exempting rare disease treatments from the Medicare drug price negotiation pilot would eliminate much of the program’s projected savings. A rare disease industry coalition is separately asking CMS to exempt orphan drugs from the forthcoming most-favored-nation (MFN) pricing model, arguing international licensing terms leave those drugs unfairly exposed. A Yale study suggests drugmakers could evade both the GLOBE and GUARD Medicare pilots, which key off the lowest prices charged abroad, by simply raising international prices for novel drugs.
STAT Inside Health Policy Inside Health Policy
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No Surprises Act Arbitration: New Batching Rules, a Timeline Guide, and Losses in Court
CMS will rename the Federal Independent Dispute Resolution portal the IDR Gateway and change how batched disputes are handled starting November 1. Separately, DOL, HHS, Treasury and OPM released an implementation timeline guide for certified IDR entities and disputing parties, including new standalone coding guidance. Health plans, meanwhile, are on a losing streak in federal court over the arbitration process that sets out-of-network payment between plans and providers.
Coming Soon: Changes to Batching Disputes CMS MedPage Today: Health Plans Losing Court…
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CMS Reworks the Value-Based Care Machinery: LEAD, Digital Quality, and MA Demos
CMS’s updated LEAD Model methodology changes the financial case for participating ACOs, and actuaries are walking organizations through what to recalculate for performance year 2027. The CY2027 Physician Fee Schedule proposed rule separately lays out CMS’s first roadmap for moving Medicare Shared Savings Program ACOs to FHIR-based digital quality measurement. CMMI may also be eyeing new Medicare Advantage demonstrations on Star Ratings, risk adjustment and value-based contracting. ACHP says CMS still has not clarified which measures will govern 2027 Star Ratings in light of the Clover Health case.
healthmanagement.com healthmanagement.com Inside Health Policy Inside Health Policy
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Also in CMS
KFF’s updated Medicare spending interactive covers a program serving 70 million people that accounts for 14% of the federal budget and 21% of national health spending. California’s first cardiac ablation in an ambulatory surgery center marks the site-of-service shift Medicare is encouraging to lower costs. A STAT progress reportfinds Medicare is promoting its ACCESS chronic care pilot but not telling patients which providers offer it. And a Los Angeles Times opinion column argues the administration is letting Medicare Part D insurers raise premiums after ending a temporary stabilization subsidy.
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Food and Drug Administration (FDA)
MDUFA VI Reauthorization Draws Broad Support as FDA Sets a September Device-Science Meeting
Industry, patient and consumer stakeholders broadly backed FDA’s draft MDUFA VI commitment letter at an August 5 public meeting, citing gains on review consistency, digital health oversight and breakthrough-device coordination. AdvaMed says the deal emphasizes consistency and domestic manufacturing priorities. FDA will separately hold a September 25 public meeting, “Regulatory Science Innovations Catalyzing Medical Device Development,” with registration open through September 10.
Inside Health Policy MDUFA VI emphasizes consistency, domestic… Public meeting on Innovations Catalyzing Device…
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Department of Health and Human Services (HHS)
CDC Leadership Change Lands Amid a Widening Vaccine-Trust Gap
The Senate confirmed Dr. Erica Schwartz as CDC director on a mostly party-line vote, filling a nearly yearlong vacancy. She will be the first Black woman to run the agency and faces an uphill battle amid continued distrust of CDC vaccine guidance. Pediatricians and health departments are increasingly turning to non-CDC sources for immunization guidance. The White House is separately drafting an executive order on the childhood vaccine schedule and autism, timed just after Schwartz’s confirmation. A national study of more than 2.5 million children found no association between MMR vaccination before age 2 and autism. CDC has confirmed 2,371 measles cases in 2026, the highest since 1991, with Secretary Kennedy urging vaccination while repeating other disputed vaccine claims.
STAT The Washington Post Pediatricians And Health Departments Sidestep… CIDRAP RFK Jr. Encourages Measles Vaccination As Cases…
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HHS Decertifies Second Organ Procurement Group Over Patient Safety Failures
HHS began decertifying Network for Hope, the Kentucky-based organ procurement organization serving parts of Indiana, Ohio and West Virginia, after CMS and HRSA reviews found persistent patient safety failures. The move comes a year after federal investigators found the group had prepared dozens of still-living patients for organ recovery. The House Ways and Means Committee, which had the group under investigation, confirmed the decertification.
The New York Times Healthcare Dive waysandmeans.house.gov
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HRSA Revives Its 340B Rebate Pilot After Court Challenge
HRSA released a revised 340B Rebate Model Program on July 31 after an earlier version drew a court challenge, giving qualifying manufacturers a voluntary retrospective-rebate pathway for a limited set of covered drugs. Hospital groups are criticizing the revised pilot, arguing a rebate structure strains cash flow at safety-net providers compared with upfront discounts.
healthmanagement.com Revised 340B Drug Rebate Pilot Sparks Criticism…
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CDC to Route HIV Prevention Funding Through States as Community Groups Lose Ground
The CDC is ending direct federal funding for community-based HIV prevention organizations and will route grants through state and local health departments instead. KFF’s analysis of the last grant cycle finds community organizations stand to lose substantial funding, concentrated in the South.
19thnews.org The Future of CDC HIV Prevention Funding for…
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Also in HHS
HRSA-funded health centers served more than 32.7 million patients in 2025, the highest in program history. A GAO report finds HHS and partner agencies could strengthen emerging infectious disease detection through better interagency collaboration and data quality. FDA and CMS officials held closed-door meetings with health tech companies on clinical AI last month, per STAT. HHS announced a new behavioral health quality initiativewith commitments from health systems and providers. And NIH plans to close off a funding pathway for international researchers on visas, restricting a key avenue for building a biomedical research career in the U.S.
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Heard on the Hill
Bipartisan Senate Bill Would End HHS’s 340B Rebate Pilot
A bipartisan group of senators introduced the SUSTAIN 340B Act. It would create a clearinghouse to handle improper 340B discounts, codify longstanding gray areas in the program, and repeal HRSA’s contested rebate pilot within a year, replacing it with a national data clearinghouse. The bill would also lock in hospitals’ use of contract pharmacies and add transparency and compliance rules.
Inside Health Policy Fierce Healthcare medcitynews.com HFMA
Tags: #DRUG #HOSPITAL
Senate Budget Committee Hearing Previews the Medicaid Spending Fight
At an August 4 Senate Budget Committee “Medicaid the Reality” hearing, conservative policymakers argued federal Medicaid spending cuts streamline the program without hurting providers, while Georgetown CCF’s Andy Schneider testified on the other side. All 47 members of the Senate Democratic caucus separately asked CMS Administrator Mehmet Oz to withdraw the June interim final rule on Medicaid work requirements.
HFMA ccf.georgetown.edu Becker’s Hospital Review
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Also on the Hill
A Senate continuing resolution advanced Aug. 2 would extend government funding through Dec. 11 and block OMB’s proposed rule giving political appointees final say over federal grant decisions. Site-neutral payment legislation is the health policy change most likely to clear Congress this year, per HFMA, with roughly six weeks of legislative calendar remaining. Senate Finance Committee members separately introduced a companion bill to stabilize year-to-year Medicare physician pay. Three Republican senators are reviving a push for a chief pharma trade negotiator at USTR. Sen. Andy Kim (D-N.J.) is proposing Medicaid coverage for everyone up to age 26. Senate Republicans have scheduled a contempt vote against Anthony Fauci, part of a broader effort to constrain the federal health bureaucracy. More than 60 House Democrats demanded answers from the VA on strained veterans’ mental health care.
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Notable Notes
Structural Heart, in Brief
Transcatheter-valve and structural-heart evidence relevant to Edwards Lifesciences and its peers this week, spanning cost-effectiveness data, procedural best practices, and a workforce fight over volume-reporting requirements.
- Early TAVR for patients with asymptomatic severe AS may save money in the long run
- Improvement in Paravalvular Regurgitation Over Time With a Self-Expanding Supra-Annular Transcatheter Aortic Valve
- Redo-TAVR (TAV-in-TAV) Best Practices Part 1: Short-in-Short and Short-in-Tall: A Heart and Valve Collaboratory Document
- Why SCAI Is Calling for an End to Volume Reporting
- The fight for safer cath labs continues: ‘We have to fix the work environment’
- Implementation of cardiac computed tomography in everyday practice: A clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI) of the ESC and the ESC Council for Cardiology Practice
Tags: #DEVICE #PROVIDER
Medical Device Firms Urge California To Ease EtO Cancer Risk Level
Medical device and chemical manufacturers are urging California to scale back proposed ethylene oxide cancer risk exposure levels, which would affect device sterilization capacity.
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Hospital and Payer Notes
Six months after enhanced ACA premium subsidies expired, hospitals report rising uninsured volumes beginning to weigh on their finances. Fitch says fiscal 2025 may prove ‘a brief operational peak’ for nonprofit hospitalsahead of delayed OBBBA provisions taking effect. Hospital price caps are gaining momentum in multiple states, with some systems already restructuring in response. And physicians on RVU-based compensation often cannot verify whether their conversion factor is competitive, with rates ranging from $36 to $95 per work RVU.
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Also Worth Noting
A 100% tariff on patented drug imports took effect July 31 for several major pharmaceutical companies. Prescription drugs drove more than 40% of fully insured cost growth last year, per UnitedHealth. Researchers are proposing a single, publicly owned PBM as a check on pharmacy benefit manager market power. NCQA released HEDIS Measurement Year 2027 changes for standard measures and for long-term services and supports. A New York Times feature reports that millions of U.S. children are serving as unpaid family caregivers. A GAO technology assessment finds wearables, increasingly AI-augmented, show potential and risk in clinical decision-making. And contract research organization Icon announced a partnership with Anthropic to deploy Claude across clinical trial operations.
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