Weekly Spotlight
A National Kidney Plan: Prevention, Dialysis Competition, and Transplant Reform
HHS released the Kidney Care National Plan on Oct. 20. The plan sets three priorities: preventing kidney failure, improving dialysis care while expanding patient choice, and reforming transplantation. HHS estimates that 37 million American adults have kidney disease and that most of them do not know it (HHS).
Dialysis. Two chains, DaVita and Fresenius Medical Care, hold roughly 74% of the dialysis market, up from about 59% in 2006. HHS said it would consider streamlining certification requirements that raise upfront costs for new dialysis suppliers and would investigate anti-competitive tactics by the largest firms (Becker’s Hospital Review).
Prevention. The plan proposes a CMS Innovation Center payment model that would reward earlier diagnosis and treatment of early-stage kidney disease, with the ACCESS Model as a template (Becker’s Hospital Review). A KidneyX prize of up to $4.67 million, run with the American Society of Nephrology, targets earlier identification of cardiovascular-kidney-metabolic risk (HHS).
Transplantation. A National Transplant Expansion Strategy would make living donation easier to pursue. The plan also calls for stronger oversight of organ procurement organizations and a shift to a multi-vendor transplant network (HHS, Becker’s Hospital Review). DaVita said the plan reflects many of its priorities but disputed the view that kidney care lacks innovation (Fierce Healthcare).
Tags: #PAYER #PROVIDER #PATIENT
From Savage Health Policy
The Final Rule Is Out. Whose Argument Won?
The 2027 final payment rules are coming. Each preamble will answer the comments the agency received and say what it adopted. The preamble will not tell you whose argument carried.
A final rule scorecard will. I code the comment record against the rule’s own proposals, then set the final rule against that record. You see what the agency adopted and whose language the final text tracks.
The scorecard also sets up next year. Your next letter starts from what the agency adopted, not from what everyone asked for.
The Rule Summary is free and covers the final rule the week it publishes. To see how your issue fared, start at the Comment Intelligence page or email me at csavage@shpconsulting.llc.
Centers for Medicare and Medicaid Services (CMS)
Medicaid Work Requirements: A Court Hearing, State Planning, and Eligibility System Warnings
A federal judge in Boston heard the states’ challenge to the Medicaid work requirement rule on Oct. 22, as state Medicaid directors met to plan implementation ahead of the Jan. 1, 2027, start. Democratic Senators Ron Wyden, Elizabeth Warren, and Raphael Warnock asked CMS to set mandatory standards for the contractors that run state Medicaid eligibility systems. Their interim report says they have no confidence the systems will be error-free by Jan. 1 and calls for independent audits. Georgetown’s Center for Children and Families is tracking each state’s approach.
- Anxiety builds over Medicaid work requirements
- Senate Dems Demand Reforms To Eligibility Tech Contracts Ahead Of Work Reqs
- Democrats Demand Tougher Standards For Companies Running Medicaid Systems
- How are States Handling Work Reporting Requirements?
Tags: #PAYER #PATIENT #PROVIDER
Medicaid Financing: Provider Taxes and Rural Hospitals
The HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) projects that the Medicaid provider tax limits in the 2025 reconciliation law could lower employer-sponsored insurance premiums by 2.2%, as CMS warns states against workarounds. The American Hospital Association estimates the law will cut federal Medicaid spending in rural areas by nearly $140 billion and puts more than 300 rural hospitals at risk of closure, conversion, or service cuts.
- ASPE Projects ESI Premium Savings From Provider Tax Limits As CMS Warns States Against Workarounds
- Medicaid cuts put 300+ rural hospitals at risk of closure: AHA
Tags: #HOSPITAL #PAYER
Coverage Costs: Higher Worker Premiums and a Rising Uninsured Rate
KFF’s 2026 Employer Health Benefits Survey finds workers pay an average of $7,471 a year toward family coverage, up 9% ($621) from 2025, while average family premiums rose 5% to $28,303. The uninsured rate among working-age adults is already rising before next year’s expected coverage losses.
- Workers Now Pay $7,471 on Average Annually for Family Health Coverage (KFF)
- Health insurance premiums jump 9%, and more Americans don’t have access to coverage
- ‘Back to the Future’: Uninsured rate backslide stirs pre-ACA comparisons
Tags: #PAYER #PATIENT
Physician Fee Schedule: Cuts by Specialty and a Remote Monitoring Limit
Under the proposed 2027 physician fee schedule, most physicians outside qualifying alternative payment models face a 1.68% cut to the conversion factor, with steeper drops for some specialties. The proposal would also end traditional Medicare payment for remote patient monitoring delivered through outside vendors, and critics warn rural patients would lose the most access.
Becker’s Hospital Review KFF Health News
Tags: #PROVIDER #PAYER #PATIENT
Also in CMS
CMS released a rule Oct. 23 implementing the pre-enrollment verification system every Affordable Care Act marketplace must have in place by August 2027 (Inside Health Policy). A second trade association sued HHS and CMS over the freeze on new agents and brokers for 2027 open enrollment (Healthcare Dive). CMS says it already investigates certified independent dispute resolution entities but has not disclosed the status of those probes (Inside Health Policy). UnitedHealthcare and Humana Medicare Advantage plan cancellations will affect about 1 million enrollees, mostly in discontinued PPO plans (The Hill). NCQA research finds accredited Medicare Advantage plans perform better on CMS Star Ratings (NCQA). Amazon, Google, Meta, Oracle, and Axon asked the insurers and administrators of their self-funded plans to expand electronic prior authorization upgrades, in an employer statement CMS and the Labor Department announced Oct. 21 (Becker’s Hospital Review). CMS Administrator Mehmet Oz said the ACCESS digital technology model could draw more providers into accountable care organizations (Inside Health Policy). CMS will use the MAHA ELEVATE and GUIDE Innovation Center models in HHS’s updated national Alzheimer’s strategy (Inside Health Policy). Medicare Payment Advisory Commission (MedPAC) commissioners voiced strong interest in replacing the Merit-based Incentive Payment System (Inside Health Policy). Health Management Associates outlines what the 2025 reconciliation law’s Medicaid provisions mean for drug manufacturers (Health Management Associates).
Tags: #ALL
Food and Drug Administration (FDA)
Generative AI Devices: Who Answers for Safety
Physicians, hospitals, and digital health groups told FDA that developers, not clinicians, should carry responsibility for the safety and performance of generative AI-enabled devices. The American Medical Association (AMA) urged risk-based oversight and warned that lighter premarket testing could deter adoption over liability concerns. The American Hospital Association said in an Oct. 19 letter that hospitals lack the technical visibility to evaluate the tools. Digital health groups backed developer liability and federal-state sandboxes but differed on how rigorous requirements should be. Rick Abramson, director of FDA’s Digital Health Center of Excellence, said draft guidance is expected in the coming months and that such tools may need to be assessed more like a physician than like a heart valve.
- AMA Urges FDA To Hold Manufacturers Liable For GenAI Device Safety
- AMA Calls for Risk-Based GenAI Oversight to Protect Patients and Support Responsible Innovation
- Hospitals can’t see inside AI tools, AHA tells FDA
- Digital Health Groups Urge FDA To Hold AI Developers Liable, Create Fed-State Sandboxes
- Developers, not doctors, should be held accountable for generative AI medical devices, providers say
- Gen AI policy is a White House priority, CDRH digital health leader says
- FDA Official Believes GenAI-enabled Tools Will Need to Be Assessed Like a Physician
Tags: #DEVICE #PROVIDER #HOSPITAL
Edwards Wins FDA Approval for Pascal Precision in Tricuspid Repair
FDA approved Edwards’ Pascal Precision system for transcatheter edge-to-edge repair in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy who are at intermediate or greater surgical risk. Pascal was previously approved for degenerative mitral regurgitation.
Tags: #DEVICE #PROVIDER #PATIENT
CDRH Rebuilds Its Staff
Michelle Tarver, director of FDA’s Center for Devices and Radiological Health (CDRH), said the center is hiring after losing large numbers of clinical reviewers and AI and digital health experts.
Tags: #DEVICE
Also in FDA
FDA issued guidance Oct. 20 on how drug companies can develop, distribute, and label software apps used with prescription drugs (Medscape). AdvaMed CEO Scott Whitaker named four policy priorities: tariffs, FDA user fees, payment and coverage, and cybersecurity (MedCity News). A September forum took up the transition to 12-digit National Drug Codes (Health Management Associates).
Tags: #DRUG #DEVICE
Department of Health and Human Services (HHS)
NIH: Fewer Grants, a Women’s Health Division, and a Vaccine Injury Clinic
The National Institutes of Health (NIH) awarded about 56,600 grants in fiscal year 2026, about 7,400 (nearly 12%) fewer than in fiscal year 2024, according to an Association of American Medical Colleges analysis. President Trump signed an executive order creating a White House task force and an NIH division for women’s health. NIH Director Jay Bhattacharya invited prospective participants as the agency finalizes the protocol for its vaccine injury clinic, which is expected to enroll hundreds of patients. Polling for the United for Cures coalition shows bipartisan opposition in key Senate races to a proposed Office of Management and Budget rule giving political appointees more control over federal grantmaking.
- NIH Sees 7,400 Fewer Grants During Fiscal Year 2026 Than In Previous Year
- Trump Signs Order Creating NIH Division, Task Force for Women’s Health
- NIH Director: Vaccine Injury Clinic Will Enroll Hundreds Of Patients
- Battleground Polling Data Shows Opposition To OMB Grantmaking Proposal
Tags: #ALL
Calley Means Leaves the Administration
Calley Means, a leading voice of the Make America Healthy Again movement who moved from advising Secretary Robert F. Kennedy Jr. to a White House role, resigned less than two weeks before the midterm elections, reportedly amid frustration over delays in the MAHA food agenda.
Tags: #ALL
Also in HHS
Gallup finds Americans rate the Centers for Disease Control and Prevention (CDC) and FDA worse than ever, with 26% and 25% rating each agency’s performance excellent or good (Fierce Healthcare). CDC leaders told staff a hiring plan to replenish the workforce is nearly finished (Government Executive). HHS posted a notice of intent Oct. 19 to award Anthropic a sole-source contract to keep its workforce on Claude AI tools (Becker’s Hospital Review). Rare disease advocates see the ARPA-H SURPASS program as a sign of openness to alternatives to randomized trials in small populations (Inside Health Policy).
Tags: #ALL
Heard on the Hill
On the Hill
The House Oversight Committee chair opened an investigation into whether Optum Rx, CVS Caremark, and Express Scripts retaliated against independent pharmacies through audits (Fierce Healthcare). Democrats on the Joint Economic Committee estimate seniors will pay more out of pocket for certain oncology and immunotherapy drugs because the 2025 reconciliation law bars all orphan drugs from Medicare price negotiation (Inside Health Policy). A poll finds 89% of voters want Congress to act on hospital prices (Fierce Healthcare).
Tags: #ALL
Notable Notes
An Adjustable Pulmonary Valve for Children: A Surgeon on Why It Matters
Surgeon Emile Bacha explained why the newly FDA-approved adjustable pulmonary valve for children should reduce the open-heart operations children with congenital heart disease need as they grow.
Tags: #DEVICE #PATIENT
Transcatheter Aortic Valves in the Mitral Position
A study links transcatheter aortic valves placed in the mitral position inside failed surgical valves to high technical success and low in-hospital mortality in high-risk patients.
Tags: #DEVICE #PROVIDER
Also Notable
Median net launch prices for new drugs now exceed $250,000 a year, according to an Oct. 20 report from the Institute for Clinical and Economic Review and West Health (ICER). For the first time, the American Heart Association and three partner groups released shared guidance defining four stages of heart health for girls and women (American Heart Association). A pain physician argues that new Medicare contractor coverage policies will put peripheral nerve procedures for chronic pain out of reach for some patients (STAT).
Tags: #ALL