Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS Unveils ‘App Library’ To Boost Medicare Beneficiaries’ Use Of Health Apps
CMS announced Feb. 23 it is launching a “Medicare app library” that will recommend health apps vetted for HIPAA-like and other standards through paid accreditation programs managed by the Digital Medicine Society (DiMe) or the CARIN Alliance and DirectTrust. The initiative aims to boost Medicare beneficiaries’ adoption of digital health tools by creating a curated, standards-based marketplace.
Source(s): CMS Unveils ‘App Library’ To Boost Medicare Beneficiaries’ Use Of Health Apps
Tags: #PATIENT #PROVIDER
Medicare Advantage Roundup
Several developments this week shaped the Medicare Advantage (MA) landscape for 2027 and beyond.
- It’s about to get harder for many Medicare patients to see a cardiologist
- Outlook 2026: Medicare Advantage Advance Notice—What It Means for the 2027 Market
Tags: #PAYER #PATIENT #PROVIDER
Trump Administration Launches Multi-Pronged Healthcare Fraud Crackdown
CMS published a Federal Register Request for Information on its Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative, seeking stakeholder feedback on regulatory changes to combat fraud. The agency is exploring AI tools to improve the accuracy of Medicare Advantage coding and hospital billing. As part of the crackdown, CMS deferred $260 million in Medicaid funds to Minnesota, citing fraud in state social service programs including bogus daycare centers. CMS Administrator Dr. Oz has taken fraud-busting efforts on the road in a media campaign, while federal law enforcement agencies have stepped up prosecutions, forcing providers to spend more on defense.
Source(s):
Request for Information (RFI) Related to Comprehensive Regulations to Uncover Suspicious Healthcare
CMS eyes AI to tackle coding under CRUSH anti-fraud plan
CMS Defers $260M in Medicaid Funds as Part of Major Crackdown on Healthcare Fraud
CMS unveils new initiatives aimed at cracking down on healthcare fraud
Lights, camera, fraud: Dr. Oz takes fraud-busting on the road
DOJ healthcare fraud crackdown pushes providers to spend more on defense
Tags: #HOSPITAL #PAYER #PROVIDER
Medicaid Under Pressure: Funding Freeze, OBBBA Cuts, Work Requirements, and Coverage Rollbacks
A RAND study found state Medicaid budgets will shrink by $664 billion through 2034 under the One Big Beautiful Bill Act (OBBBA), with federal savings of $714 billion and state general fund losses of $87 billion over the decade. New work requirements take effect January 1, 2027, but states face millions in IT costs to verify compliance. More than three dozen states now cover dental services under Medicaid, but expected cuts could roll back that coverage. The Trump administration also deferred $259.5 million in quarterly Medicaid funding to Minnesota, citing fraud concerns, creating confusion among providers who rely on those payments. KFF notes comprehensive managed care accounts for about 78% of Medicaid beneficiaries (over 66 million individuals) and 50% of total spending.
Source(s):
State Medicaid budgets to lose $664B under OBBBA: Study
OBBBA Medicaid cuts: State budget impact
Trump’s Medicaid work mandates meant to save money, but states face millions in costs
Medicaid dental care threatened by GOP cuts
Medicaid service providers say federal funding freeze is cause for concern
HHS defers $259.5 million in Medicaid funding to Minnesota
Vance fraud war risks
Medicaid managed care: Reporting and transparency
Medicaid work requirements could push patients off coverage
Tags: #ALL
Medicare Payment Models Roundup
This week brought several developments in Medicare payment policy, from digital health reimbursement to ACO design and MA coding rules.
- ACO Groups Urge CMS To Incorporate REACH Model Framework Into MSSP
- Insurers back Medicare coding rule ahead of looming pay overhaul
- Capstone analysts warned that low reimbursement rates in CMS’s ACCESS Model will pressure digital health vendor margins, while a separate report cautioned that some AI implementations may actually increase healthcare costs and reduce workflow efficiency. Sources: Low pay rates in Medicare’s ACCESS Model will pressure digital health margins: Capstone, Some AI may actually increase healthcare costs and lower workflow efficiency
Tags: #PROVIDER #PAYER #HOSPITAL
GAO Examines No Surprises Act Payment and Network Trends
A Government Accountability Office (GAO) report found the No Surprises Act (NSA) appears to have driven a moderate increase in providers going in-network for some services. This trend could counter concerns that the large share of NSA arbitration decisions favoring providers would diminish incentives to join insurance networks.
Source(s): GAO examines No Surprises Act payment and network trends
Tags: #PROVIDER #PAYER #HOSPITAL
Food and Drug Administration (FDA)
Generic Drug Industry Pushes Onshoring Incentives and FDA Reform
At the Association for Accessible Medicines conference, a top HHS official urged generic manufacturers to provide feedback on incentivizing domestic production as part of a whole-of-government onshoring effort that includes a recent CMS initiative. Industry lobbyists from both parties expressed optimism about codifying FDA regulatory reforms into law as part of a broader affordability agenda.
Source(s):
HHS official: Whole-of-government effort needed to onshore essential medical products
Generic drug advocates seek to codify FDA reforms
Tags: #DRUG
FDA Approves Swallowable Weight-Loss Balloon as Court Rejects Obesity Disability Claim
The FDA granted premarket approval to Allurion’s swallowable gastric balloon system for short-term weight loss. The device uses a “smart capsule” ingested during a 15-minute office visit without surgery or endoscopy. In the AUDACITY trial of 550 participants, 58% receiving treatment lost more than 5% of body weight by week 48, with a 3.1% serious adverse event rate. Separately, the 1st U.S. Circuit Court of Appeals ruled that a worker did not plausibly establish obesity as a disability in her lawsuit against Cigna for refusing to cover weight-loss medications, finding her allegations too general under the ACA’s Section 1557 anti-discrimination protections.
Source(s):
FDA Approves Swallowable Gastric Balloon for Weight Loss
Cigna obesity disability lawsuit dismissed by 1st Circuit
Tags: #DEVICE #DRUG #PATIENT
FDA Clears AI-Powered Platform for TAVR and Cardiac Pacing Procedures
The FDA cleared the CARA System from Cara Medical, an AI-powered platform that provides a personalized 3D map of the patient’s cardiac conduction system and overlays it onto live fluoroscopic images during transcatheter aortic valve replacement (TAVR) and cardiac pacing procedures.
Source(s): FDA clears AI-powered platform that personalizes care during TAVR, cardiac pacing procedures
Tags: #DEVICE #PROVIDER
FDA Approves Next-Generation CardioMEMS Reader for Heart Failure Monitoring
The FDA approved an updated CardioMEMS reader that is 60% smaller than its predecessor and offers built-in WiFi connectivity. The device works with an implantable sensor to monitor pulmonary artery pressure in heart failure patients.
Source(s): FDA approves next-generation CardioMEMS reader for heart failure monitoring
Tags: #DEVICE #PROVIDER
Prasad Under Probe for Promoting Workplace Toxicity, Staffers Say
The FDA is investigating complaints that Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), fosters a toxic workplace. The agency enlisted outside investigator Professional EEO Services for a wide-ranging probe that has been ongoing for months. Prasad has been accused of berating staff and retaliating against reviewers who questioned his decisions.
Source(s): Prasad Under Probe for Promoting Workplace Toxicity, Staffers Say
Tags: #DRUG #DEVICE
Department of Health and Human Services (HHS)
USPSTF Sidelined: No Meetings in Nearly a Year, Founding Members Warn of Dismantlement
The U.S. Preventive Services Task Force (USPSTF) has not convened in nearly a year, with five of 16 member terms expired since Dec. 31, no replacements announced, and no new meetings scheduled. Two original USPSTF members warned in an Annals of Internal Medicine commentary that HHS Secretary Kennedy could effectively dismantle the task force by cutting its budget, replacing members with specialists, or revising its evidence standards. Four draft guidelines remain unfinalized, covering alcohol screening, cervical cancer self-swabs, perinatal depression, and vitamin D supplementation. Under the ACA, USPSTF A/B-rated recommendations must be covered by insurers at no cost to patients, meaning politically motivated changes could affect coverage of mammograms, colonoscopies, and other preventive services for millions of Americans.
Source(s):
Federal panel behind cancer screening recommendations hasn’t met in nearly a year
RFK Jr. May Eliminate the USPSTF, Original Task Force Members Warn
Tags: #PROVIDER #PATIENT #PAYER
Vaccine Policy Upheaval: 15 States Sue, CDC Panel Reshuffled, Medical Groups Sound Alarm
Fifteen states filed a federal lawsuit challenging the CDC’s January decision to strip seven childhood vaccines of their universally recommended status. HHS Secretary Kennedy announced two new ACIP members and set new meeting dates to discuss long COVID and mRNA shot safety. At least six states are moving independently to ensure childhood vaccines remain free and accessible. The American College of Obstetricians and Gynecologists (ACOG) withdrew as an ACIP liaison organization, citing cherry-picked data and exclusion from workgroups. A MedPage Today analysis argued the White House reversal of an FDA refuse-to-file decision on Moderna’s flu vaccine was driven by midterm election politics, while STAT profiled Stanley Plotkin, the 93-year-old “godfather of vaccines,” watching his field’s achievements erode under the current administration.
Source(s):
15 states sue over new vaccine policy
States Sue Over Childhood Vaccine Rollback
CDC vaccine changes: States work to keep childhood shots accessible
Two new members added to CDC vaccine advisory committee (ACIP)
After delay, Kennedy’s CDC vaccine panel sets new date for meeting over long COVID and mRNA shot safety
ACOG Withdraws From ACIP
RFK Jr.’s anti-vaccine stance infiltrated the FDA. Trump is reining it in.
Stanley Plotkin, godfather of vaccines, watches his life’s work under threat
Tags: #PATIENT #PROVIDER #DRUG
Casey Means Surgeon General Nomination Faces Bipartisan Scrutiny
Casey Means, MD, faced skeptical questioning at her Feb. 25 Senate HELP Committee hearing, sidestepping questions on vaccines, birth control, and pesticides. Sen. Collins (R-Maine) pressed her on past endorsement of psychedelic mushrooms; Means said her views as a private citizen differ from what she would say as a public official. Former Surgeon General Jerome Adams published a STAT op-ed calling the nomination “incomprehensible,” noting Means would be the first surgeon general without a completed residency or active medical license. MedPage Today’s editorial board called her hearing performance unconvincing, and NBC News reported she softened her social media persona during testimony, distancing herself from prior criticisms of traditional medicine.
Source(s):
Casey Means faces tough confirmation questions on vaccines, qualifications, and psychedelics
Senate Republican calls past Casey Means magic mushroom recommendation ‘a red herring’
Trump ex-surgeon general Jerome Adams: Casey Means nomination ‘incomprehensible’
DC Diagnosis: The nation’s ‘MAHA mom,’ Casey Means
The Senate should not confirm Casey Means as surgeon general
Casey Means surgeon general nomination: Editorial
Casey Means softened social media persona during surgeon general testimony
Tags: #ALL
HRSA Extends 340B Rebate Model Comment Period to 60 Days
HRSA extended the comment period on its proposed 340B rebate model pilot program from 30 to 60 days, with comments now due April 20. The extension came after the American Hospital Association (AHA) and other groups argued the original March 19 deadline was insufficient for hospitals to compile the operational and financial data HRSA requested. HHS had planned to implement a 340B rebate model on January 1, 2026, but federal courts blocked the proposal and the agency subsequently issued a request for information on a pilot program.
Source(s):
HRSA extends comment period on 340B rebate proposal
Request for Information: 340B Rebate Model Pilot Program Extension
Tags: #HOSPITAL #DRUG
HIV Research Advances at CROI 2026 as Ryan White Program Faces Existential Threat
Several studies at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026 showed promising HIV treatment advances. Gilead’s single-tablet bictegravir/lenacapavir regimen maintained virological suppression in Phase 3 ARTISTRY switch trials. Injectable cabotegravir-rilpivirine (Cabenuva) maintained suppression in 94.4% of adolescents through 96 weeks. A Phase I trial found very early antiretroviral therapy (ART) initiation in children could lead to ART-free remission, with three children remaining aviremic for up to 52 months after stopping treatment. However, a simulation study warned that ending the Ryan White HIV/AIDS Program would cause a 73% increase in new infections across 30 states over five years, amounting to an additional 117,431 cases.
Source(s):
Gilead’s single-tablet regimen of bictegravir/lenacapavir maintained virological suppression in HIV
Injectable cabotegravir-rilpivirine maintains suppression in adolescents at CROI
Very early ART in children may lead to remission at CROI
Ending Ryan White program would spike HIV infections: CROI simulation
Tags: #DRUG #PATIENT #PROVIDER
Robert F Kennedy Jr: One Year of Failure
The Lancet published an editorial assessing HHS Secretary Kennedy’s first year, arguing his approach has undermined rather than restored public trust in federal health agencies. The piece examines how his tenure has affected the CDC, FDA, and broader public health infrastructure.
Source(s): Robert F Kennedy Jr: 1 year of failure
Tags: #ALL
CDC’s New Acting Director Draws Unexpected Praise From Agency Staff
Dr. Jay Bhattacharya, the NIH director now also serving as acting CDC director, has drawn unexpected praise from agency staff after offering to publicly endorse vaccination, particularly the measles vaccine. His willingness to support immunization has won over some employees wary of new leadership.
Source(s): C.D.C.s New Acting Director Draws Unexpected Praise From Agency Staff
Tags: #ALL
How Can HHS Drive Clinical AI Adoption? The Industry Wish List Is Taking Shape
Health tech firms and AI startups have submitted feedback to HHS on accelerating clinical AI adoption. The department solicited input in December, and an industry wish list is taking shape around regulatory clarity, reimbursement pathways, and integration standards.
Source(s): How can HHS drive clinical AI adoption? The industry wish list is starting to take shape
Tags: #PROVIDER #HOSPITAL #DEVICE
More Pregnant Americans Are Skipping Prenatal Care, CDC Finds
CDC data show first-trimester prenatal care declined from 78.3% of U.S. births in 2021 to 75.5% in 2024, reversing years of progress. Late or no care increased in at least 36 states and D.C., rising from 6.3% to 7.3% nationally across every age group and nearly all racial and ethnic groups. Growing maternity care deserts, rural hospital closures, and Medicaid enrollment barriers are among the suspected drivers.
Source(s): More pregnant Americans are skipping prenatal care, CDC finds
Tags: #PATIENT #PROVIDER
AHA Urges ONC to Slow Health IT Certification Overhaul
The AHA is urging the Office of the National Coordinator for Health IT (ONC) to scale back and delay portions of a proposed interoperability overhaul. In a February 27 letter, AHA warned that eliminating key certification requirements could threaten patient safety and strain hospitals, particularly rural facilities.
Source(s): AHA urges ONC to slow health IT certification overhaul
Tags: #HOSPITAL #PROVIDER
HHS’ Claude, FDA’s Elsa May Be Hung Up By Trump Order That Agencies Stop Using Anthropic AI
President Trump issued a February 27 directive ordering federal agencies to cease using Anthropic AI technology, which would affect HHS’s “Claude for Government” and the FDA’s “Elsa” chatbots. Trump contradicted himself in the same Truth Social post by referencing a six-month phase-out period for certain agencies.
Source(s): HHS’ Claude, FDA’s Elsa May Be Hung Up By Trump Order That Agencies Stop Using Anthropic AI
Tags: #ALL
Heard on the Hill
ACA Marketplace Enrollees Face Soaring Costs After Enhanced Subsidy Expiration
The expiration of enhanced ACA marketplace subsidies at the end of 2025 has forced difficult financial choices for millions of enrollees. KFF estimates premiums more than doubled on average for the roughly 22 million people who received the subsidies, and early CMS data shows at least 1.5 million dropped coverage in 2026. Adults ages 50-64 are disproportionately affected: a 60-year-old earning $65,000 pays an estimated $10,389 more per year in premiums, and unsubsidized benchmark premiums rose 26% on average. The return of the “subsidy cliff” has hit self-employed workers and small business owners particularly hard, with 88% of marketplace enrollment growth since 2020 concentrated in states Trump won in 2024. The Trump administration has also proposed new ACA plan designs that could raise family deductibles to $31,000, drawing criticism that care would become unaffordable.
Source(s):
The ACA health coverage subsidy lapse hit 22 million people. Here are some of their stories
How will the loss of enhanced premium tax credits affect older adults?
New A.C.A. Plans Could Increase Family Deductibles to $31,000
Tags: #PATIENT #PAYER
More Residency Slots Needed in Rural Areas, Lawmakers and Health Experts Say
At a House Ways and Means Health Subcommittee hearing, lawmakers and witnesses said placing more residency training slots in rural areas is critical for addressing healthcare workforce shortages. Rep. Adrian Smith (R-Neb.) noted that large urban hospitals have collected 97% of the 800 recently distributed graduate medical education (GME) slots despite 10% being reserved for rural areas, while only 2% of residencies are located in rural communities. Witness Jennifer Trilk, PhD, urged integrating lifestyle medicine into medical training, noting chronic disease accounts for 90% of the nation’s $4.9 trillion in annual healthcare spending.
Source(s): More Residency Slots Needed in Rural Areas, Lawmakers and Health Experts Say
Tags: #PROVIDER #HOSPITAL
White House Stalls Release of Approved US Science Budgets
Weeks after Congress rejected the Trump administration’s sweeping cuts to science agencies for 2026, funding to the NIH, NSF, and NASA is still not flowing freely. The White House budget office has not authorized release of congressionally approved research funds.
Source(s): White House stalls release of approved US science budgets
Tags: #DRUG #PROVIDER
Notable Notes
TrumpRx: What’s the Value for Customers?
KFF analysis finds the TrumpRx discount program may have limited value for the roughly 66% of Americans under 65 with private insurance. Because TrumpRx purchases don’t count toward deductibles or out-of-pocket maximums, insured patients could pay more over the course of a year compared to using their plan benefits. About half of the 43 TrumpRx drugs have generic equivalents, at least 17 of which are cheaper via GoodRx or Cost Plus Drugs than the TrumpRx brand-name price. Some advertised prices, such as Wegovy at $149/month, reflect limited-time introductory offers that rise to $299/month after two fills.
Source(s): TrumpRx: What’s the Value for Customers?
Tags: #DRUG #PATIENT #PAYER
Novo Nordisk Slashes Wegovy and Ozempic List Prices by Up to 50%
Novo Nordisk announced it will cut the list price of Wegovy, Ozempic, and Rybelsus to $675/month effective January 1, 2027, representing approximately 50% and 35% reductions for Wegovy and Ozempic respectively. The new pricing applies to all doses and aims to reduce costs for patients whose out-of-pocket expenses are tied to list price, such as those with high-deductible plans or coinsurance. Self-pay channels, including NovoCare Pharmacy and telehealth partnerships, are unaffected by the change.
Source(s):
Novo Nordisk Announces Significant Reduction in US List Price of Wegovy, Ozempic, Rybelsus
Novo to knock down Ozempic, Wegovy list prices; self-pay channels unaffected
Tags: #DRUG #PATIENT #PAYER
AdvaMed Urges Tailored Tariff Approach for MedTech After Supreme Court Ruling
AdvaMed CEO Scott Whitaker urged the Trump administration to tailor tariff policy for the medtech sector after the Supreme Court struck down broad IEEPA-based tariffs and the president imposed a 10% surcharge under Section 122. Whitaker noted that 70% of medtech products used in the U.S. are manufactured domestically, with more than $340 billion invested in U.S.-based manufacturing and research since 2017. He pointed to the ongoing Section 232 national security investigation into medical equipment as a more targeted, evidence-based approach to addressing supply chain vulnerabilities without disrupting a net-exporting American industry.
Source(s):
AdvaMed urges tailored tariff approach for medtech
AdvaMed: Trump tariffs ruled illegal
Tags: #DEVICE
Drug Pricing Tensions: Biotech Coalition Forms Against MFN as GoodRx Targets Employers
Ten midsize biotech companies launched the Midsized Biotech Alliance of America to contest the Trump administration’s Most Favored Nation (MFN) drug pricing policy, which they say threatens domestic innovation. Trump’s MFN push is also creating uncertainty across Europe, where countries face questions about whether drugmakers will charge more and how strained health systems will respond. Separately, GoodRx launched GoodRx Employer Direct, allowing employers to subsidize manufacturer-sponsored prices for high-cost brand medications like GLP-1s without adding them to health insurance benefits.
Source(s):
Worried MFN will destroy biotech innovation, midsize biotechs form coalition to fight back
Trump drug prices: MFN deal creates confidential price problem in Europe
GoodRx launches direct-to-employer platform
Tags: #DRUG #PAYER #PATIENT
Heart Valve Research Roundup
Two studies this week explored new frontiers in heart valve intervention.
- Breakable Mechanical Heart Valves Eyed for Future Intervention
- TAVR a safe treatment option for patients who have undergone chest radiation therapy
Tags: #DEVICE #PROVIDER
Patient Access Challenges: Copay Card Pitfalls and the DTC Advertising Debate
KFF Health News reported on a California man with psoriatic arthritis prescribed Otezla whose drugmaker copay card ran out after two months, leaving him with thousands in unexpected costs. Separately, The Conversation examined the role of direct-to-consumer (DTC) drug advertising, noting that while officials blame ads for misleading patients and raising costs, research suggests they also help patients access needed treatment.
Source(s):
Expensive drug copay card discount: Bill of the month, February 2026
Drug company ads are easy to blame for misleading patients and raising costs—but research shows they do help patients get needed treatment
Tags: #PATIENT #DRUG
To Avoid Care Disruptions, Know When the Clock Runs Out on Your Prior Authorization
KFF Health News reports on challenges when prior authorization approvals expire unexpectedly. A Massachusetts woman with multiple sclerosis spent nearly three weeks on phone calls and paperwork to renew her medication approval after discovering it had an expiration date.
Source(s): To Avoid Care Disruptions, Know When the Clock Runs Out on Your Prior Authorization
Tags: #PATIENT #PAYER
NCQA Launches Advanced Primary Care Pilot Program
The National Committee for Quality Assurance (NCQA) launched its Advanced Primary Care Pilot Program, selecting Aledade, Bluegrass Community Health Center, Jefferson Health, and NYC Health + Hospitals to test next-generation primary care standards. Building on the Patient-Centered Medical Home model, the pilot will test scalable standards, electronic clinical quality measures, and digital quality measure feasibility.
Source(s): NCQA Launches Advanced Primary Care Pilot Program—Meet Our Primary Care Partners!
Tags: #PROVIDER #HOSPITAL
Hospitals Accounted for 40% of Spike in Healthcare Spending, Far More Than Any Other Category: KFF
A KFF study found hospitals accounted for 40% of the increase in overall healthcare prices from 2022 to 2024, far more than any other category. The spike reflects both pandemic-delayed care and an increase in prices for hospital services.
Source(s): Hospitals accounted for 40% of spike in healthcare spending, far more than any other category: KFF
Tags: #HOSPITAL #PAYER
Health Insurer Financial Performance in 2024
KFF analysis shows health insurer gross margins per enrollee ranged from $608 in Medicaid managed care to $1,655 in Medicare Advantage at end of 2024. Group market margins were $846, roughly half the MA level. Margins dipped slightly across four markets.
Source(s): Health Insurer Financial Performance in 2024
Tags: #PAYER
AHA: ‘Zero Trust’ Cybersecurity Posture Necessary to Protect Hospital Data
The AHA endorsed adopting the National Security Agency’s two-phase “zero trust” cybersecurity framework for hospitals. The protocols, originally designed for Department of Defense entities, could help protect hospital data from cyber threats.
Source(s): AHA: ‘Zero trust’ cybersecurity posture necessary to protect hospital data
Tags: #HOSPITAL