Policy Digest — February 9, 2026

Introduction
This week: Congress ended a partial government shutdown with legislation extending Medicare telehealth flexibilities and enacting sweeping PBM reforms. The FDA moved to crack down on compounded GLP-1 drugs as Novo Nordisk sued Hims & Hers. ACA Marketplace enrollment declined for the first time since 2020 following the expiration of enhanced premium subsidies, while hospitals began preparing for Medicaid cuts under the One Big Beautiful Bill Act.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

ACA Marketplace Enrollment Declines for First Time Since 2020 as Subsidy Expiration Takes Hold

ACA Marketplace plan selections fell 5% for 2026, with over 1 million fewer sign-ups—the first decline since 2020. New enrollees dropped 14% and returning consumers fell 3%, according to CMS data analyzed by KFF and Health Management Associates. State variation was significant: New Mexico saw a 14% increase due to state-funded subsidies, while Ohio and North Carolina declined 20% and 22% respectively. The decline follows the December 31, 2025 expiration of enhanced premium tax credits, with subsidized enrollees facing an estimated 114% average premium increase. State-based marketplaces report higher-than-usual cancellation and disenrollment rates. Separately, Americans are increasingly selecting higher-deductible plans, raising concerns about care avoidance. KFF’s latest polling shows overall ACA favorability continues to exceed unfavorability—a trend since 2017—though deep partisan divides persist. Effectuated enrollment data will not be available until July 2026.

Source(s):
KFF
Health Management Associates
NPR
KFF ACA Tracker

Tags: #PAYER #PATIENT

Medicaid Challenges Mount as Cuts Approach and Doctor Participation Falls Short

Hospitals are using 2026 to strengthen margins before approximately $1 trillion in Medicaid cuts under the One Big Beautiful Bill Act begin in 2027, with three-quarters of cuts back-loaded to the final five years. Fitch Ratings forecasts median not-for-profit hospital operating margins improving from 1.5% to 2% through expanded AI use, supply cost management, and rapid-cycle revenue assessments. Sens. Warren, Sanders, and Wyden sent a letter warning Equifax CEO Max Begor against price gouging states that will need to verify Medicaid beneficiaries’ compliance with new work requirements—mandating 80 hours of work, training, education, or community service for able-bodied adults ages 19-64 covered under ACA Medicaid expansion. Separately, Health Affairs research found that 25% of physicians enrolled in Medicaid do not actually treat Medicaid patients, with mental health practitioners showing particularly low participation rates—raising additional concerns about beneficiary access as the program contracts.

Source(s):
HFMA
The Hill
Healthcare Dive

Tags: #HOSPITAL #PAYER #PROVIDER

ACO Participation Reaches Record Highs

CMS reported 14.3 million Medicare beneficiaries are now receiving ACO-coordinated care as of January 2026, a 4.4% increase from 2025. The Medicare Shared Savings Program grew to 511 ACOs serving 12.6 million beneficiaries—the largest number ever—a 12.3% increase. In performance year 2024, MSSP ACOs earned $4.1 billion in shared savings and saved Medicare $2.5 billion relative to benchmarks. ACO REACH has 74 ACOs serving 1.7 million beneficiaries. Becker’s separately published its annual list of 50 ACOs driving value-based care, highlighting organizations like ACO West Virginia, which saved Medicare more than $20 million in 2024 while serving 37,000 beneficiaries.

Source(s):
Becker’s Payer
Becker’s Hospital Review

Tags: #PROVIDER #PAYER #HOSPITAL

AI-Powered Prior Authorization Gains Traction

Optum launched an AI-powered prior authorization system that it says reduces manual touches by 45%, cuts review time by 56%, and achieves a 96% first-pass approval rate. Allina Health, a Minneapolis-based nonprofit with 12 hospitals, will be among the first to deploy the provider-facing component, powered by physician-led AI startup Humata Health, which embeds directly into EHRs. The payer-facing InterQual Auth Accelerator is also available. CMS requires payers to authorize urgent requests within 72 hours and standard requests within seven days. The launch comes as regulatory scrutiny of AI in prior authorization intensifies, with industry observers arguing that understanding nuanced differences between AI approaches is essential for payers and providers navigating compliance requirements.

Source(s):
Healthcare Finance News
MedCity News

Tags: #PAYER #PROVIDER #HOSPITAL

Updated Documentation Requirements in Medicare Could Add Burden on Healthcare Providers

CMS issued a regulatory update effective April 13 that expands face-to-face encounter and written-order requirements for eight oxygen equipment codes and adds prior authorization for seven DMEPOS items including orthoses and pneumatic compression devices. Pneumatic compression devices had improper payment rates of 61%-79% from 2021 through 2024; orthoses ranged from 35.2% to 57.5%. CMS estimates the increased oversight will reduce unnecessary payments by 20% and save $32 million per year, adding 18 codes to its Master List for a total of 512 items.

Source(s):
Updated Documentation Requirements in Medicare Could Add Burden on Healthcare Providers

Tags: #DEVICE #PROVIDER #HOSPITAL

Reimbursement Is ‘the Biggest Challenge’ to Medtech Innovation

Stanford Biodesign co-founder Josh Makower warned that reimbursement has become the largest source of downstream risk for medical device companies, calling the situation “dire” and “getting worse, not better.” Emerging medtech companies without clear coding or coverage pathways face adoption delays that can persist long after FDA clearance, as lack of a payment framework stalls market uptake.

Source(s):
Josh Makower warns of the ‘biggest challenge’ to medtech innovation: ‘It is dire.’

Tags: #DEVICE

Heads Up: HEDIS® Public Comment Opens Next Week

NCQA’s annual public comment period for proposed HEDIS Volume 2 changes opens February 13 and runs through March 13. This year’s comment period covers seven new HEDIS measures and revisions to three existing measures.

Source(s):
Heads Up: HEDIS® Public Comment Opens Next Week

Tags: #PAYER #HOSPITAL

CMS Adds Cardiac Ablation to ASC-Covered Procedures List

CMS will cover key cardiac ablation procedures in ambulatory surgery centers beginning January 1, expanding outpatient treatment options for patients requiring cardiac rhythm management interventions.

Source(s):
CMS adds cardiac ablation to ASC-covered procedures list

Tags: #PROVIDER #DEVICE

Medicare 3-Day Rule Adds Extra Costs for Hospitals Without Reducing Spending

A JAMA Internal Medicine study found that Medicare’s reinstated 3-day hospitalization rule for SNF care increased the likelihood of three-day inpatient stays by 1.13 percentage points overall and by 5.57 percentage points among patients discharged to SNFs. Using data from more than 600,000 traditional Medicare hospitalizations, the study found no significant changes in SNF discharge probability, 30-day rehospitalization, mortality, or Medicare spending. The authors concluded the policy imposes additional costs on hospitals while failing to lower Medicare spending.

Source(s):
Medicare 3-Day Rule Adds Extra Costs for Hospitals: 4 Study Notes

Tags: #HOSPITAL #PROVIDER

3 Insurers Reporting Medicare Advantage Growth

Several insurers reported Medicare Advantage membership gains during the annual enrollment period for 2026 coverage. However, the Medicare Advantage market continues experiencing payer exits, benefit cuts, and payment concerns amid rising medical costs.

Source(s):
3 insurers reporting Medicare Advantage growth

Tags: #PAYER #PATIENT

Food and Drug Administration (FDA)

FDA Moves to Restrict Compounded GLP-1s as Novo Nordisk Sues Hims & Hers

The FDA announced on Feb. 6 its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients used in non-FDA-approved compounded drugs, naming Hims & Hers and other compounding pharmacies specifically. The agency is also cracking down on misleading direct-to-consumer advertising, stating companies cannot claim compounded products are generic versions of FDA-approved drugs or that they use the same active ingredient. Novo Nordisk simultaneously filed a patent infringement lawsuit against Hims & Hers over compounded semaglutide, with Novo’s chief counsel warning that compounders should be “very much on notice.” Hims & Hers retreated from its planned launch of a knockoff oral weight loss pill, and its stock fell as much as 27%, bringing year-to-date losses to roughly 50%.

Source(s):
STAT
Fierce Pharma
FDA
Yahoo Finance

Tags: #DRUG #PATIENT #PROVIDER

FDA and J&J Issue Alerts on Impella Heart Pump Sensor Malfunction

FDA issued an Early Alert and J&J’s Abiomed division issued an urgent medical device correction for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pump devices. The differential pressure sensor may malfunction, causing values to drift over time and potentially creating high-risk situations including inaccurate pump flow readings, incorrect P-level adjustments, and unnecessary pump exchanges. The issue has been linked to 22 reports of serious injuries. This is the latest in a series of recalls and corrections for Abiomed’s Impella devices throughout 2025 and into 2026.

Source(s):
FDA
MedTech Dive

Tags: #DEVICE #PROVIDER

Eli Lilly to Buy Orna Therapeutics for $2.4 Billion

Eli Lilly will pay up to $2.4 billion to acquire Orna Therapeutics, which is developing circular RNA technology to create in vivo CAR-T cell therapies that edit immune cells without removing them from the body. Orna’s lead product, ORN-252, targets CD19 for autoimmune disease treatment. The deal is part of Lilly’s string of science-focused acquisitions over the past 12 months.

Source(s):
Eli Lilly to Buy Orna Therapeutics for $2.4 Billion

Tags: #DRUG

FDA Publishes Final Cybersecurity Guidance for Medical Devices

FDA published final guidance in February 2026 providing recommendations for cybersecurity device design, labeling, and documentation required in premarket submissions for devices with cybersecurity risk. The guidance from CDRH and CBER aims to promote consistency and facilitate efficient review of quality management system considerations.

Source(s):
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

Tags: #DEVICE

FDA Breakthrough Program Starts FY2026 at Steady Pace

The FDA granted 42 breakthrough device designations in the first quarter of FY2026, consistent with the 164-166 annual designations seen from FY2022 through FY2025. Orthopedics was the most active area in the second half of calendar 2025 with 13 new designations. CMS Administrator Mehmet Oz expressed support for speedier Medicare coverage of breakthrough devices during his confirmation hearing; Medicare currently provides national coverage for up to five breakthrough devices per year. As of Dec. 31, the FDA had authorized 185 breakthrough devices since the program’s inception.

Source(s):
FDA Breakthrough Program Starts FY2026 at Steady Pace

Tags: #DEVICE

Winding Down Animal Testing

The Trump administration is advancing efforts to wind down animal testing, according to POLITICO Pulse. Limited detail is available beyond the headline summary.

Source(s):
Winding down animal testing

Tags: #DRUG #DEVICESenior FDA Official Under OIG Investigation Over Divorce, Assets

The HHS inspector general is investigating whether a senior FDA official used a fraudulent divorce to circumvent federal conflict-of-interest rules regarding financial assets.

Source(s):
Senior FDA official under OIG investigation over divorce, assets

Tags: #DRUG #DEVICE

Department of Health and Human Services (HHS)

HHS Drops Controversial 340B Rebate Pilot

HHS is dropping its 340B Rebate Model Pilot following a federal court’s preliminary injunction that found the agency failed to meet Administrative Procedure Act requirements. In a Feb. 5 court filing, the government requested vacatur and remand, but indicated HHS could restart the administrative process with a new notice, comment solicitation, and an effective date no earlier than 90 days after any new approvals. AHA President Rick Pollack said the association appreciates HHS’ decision to go back to the drawing board.

Source(s):
HHS Drops Controversial 340B Rebate Pilot

Tags: #HOSPITAL #DRUG

HHS Unveils $100 Million Program to Address Homelessness and Addiction

HHS Secretary Robert F. Kennedy Jr. announced $100 million for a pilot program addressing homelessness and substance abuse in eight cities, building on President Trump’s executive order launching the “Great American Recovery Initiative.” HHS will also make faith-based organizations eligible for addiction-related grants and expand states’ ability to use federal health funding for substance abuse treatment involving children. The announcements come amid uncertainty for treatment providers, as roughly one-third of SAMHSA’s 900 employees have been laid off over the past year.

Source(s):
HHS Unveils Program to Address Homelessness and Addiction

Tags: #PATIENT #PROVIDER

NIH Chief Details Plans for FDA Modernization at Senate Hearing

NIH Director Jay Bhattacharya testified at a Senate hearing that NIH requires structural overhaul to deliver more cures, spend taxpayer dollars more wisely, and regain public trust.

Source(s):
NIH Chief Details Plans for FDA Modernization at Senate Hearing

Tags: #DRUG #DEVICE

Kennedy’s Vaccine-Promise Report Card

One year after Senate HELP Chair Bill Cassidy (R-La.) supported Robert F. Kennedy Jr. for HHS secretary despite concerns about his anti-vaccine activism, questions remain about how Kennedy has addressed vaccine policy during his tenure.

Source(s):
Kennedy’s vaccine-promise report card

Tags: #PATIENT #PROVIDER

Former FDA Commissioner: HHS Leadership Focused on Policy-Based Evidence, Not Evidence-Based Policy

Former FDA Commissioner Robert Califf criticizes current HHS leadership for pursuing “policy-based evidence” rather than evidence-based policy. Califf responds to new ACIP chair Kirk Milhoan’s suggestion that the polio vaccine may no longer be necessary, arguing Milhoan prioritizes individual clinical experience over population-level data. Califf calls for restoring transparent, rigorous scientific processes for vaccine evaluation, noting that a dozen major professional societies have endorsed AAP vaccination recommendations over recent ACIP positions.

Source(s):
Former FDA commissioner: HHS leadership is focused on policy-based evidence, not evidence-based policy

Tags: #DRUG #PATIENT #PROVIDER

HHS Anti-Fraud Crackdown Sweeps Up Mainly Democratic-Led States

The Trump administration’s healthcare fraud crackdown is disproportionately targeting Democratic-led states, according to STAT. CMS Administrator Mehmet Oz has highlighted fraud concentrated in Los Angeles, accusing Russian and Armenian groups of having “normalized fraud” in areas with dense hospice and medical supply operations.

Source(s):
Inside HHS’ anti-fraud efforts: An aggressive crackdown sweeps up mainly Democratic-led states

Tags: #HOSPITAL #PAYER

HIV Prevention Meds Aren’t Reaching Enough People

The CDC estimates more than 2 million Americans could benefit from PrEP, but only about a quarter are receiving the HIV prevention medication. Barriers include billing mistakes, lingering stigma, and physicians not keeping up with current research.

Source(s):
Effective but Underprescribed: HIV Prevention Meds Aren’t Reaching Enough People

Tags: #PROVIDER #PATIENT

Heard on the Hill

Congress Ends Government Shutdown, Extends Telehealth, Enacts PBM Reform and Eyes GPOs Next

President Trump signed legislation Tuesday ending a partial government shutdown and enacting significant healthcare policy changes. The funding package extends Medicare telehealth flexibilities through 2027, preserves acute hospital-at-home waivers, and enacts pharmacy benefit manager reforms targeting CVS Caremark, Optum Rx, and Express Scripts. The bill did not revive enhanced ACA premium tax credits that expired December 31, 2025. The shutdown had begun Saturday when Senate Democrats held up an HHS funding package bundled with Department of Homeland Security appropriations following fatal shootings by federal immigration agents in Minneapolis. With PBM reform now law, some lawmakers are already looking at group purchasing organizations and their subsidiaries for similar transparency and compensation reforms.

Source(s):
Healthcare Dive
Politico Pulse
Healthcare Finance News
Healthcare Dive
New York Times
Modern Healthcare

Tags: #ALL

Opinion: TrumpRx Has a Fundamental Flaw

University of Washington professors argue that TrumpRx, the administration’s initiative to offer discounted cash prices on brand-name drugs, will not benefit the roughly 85% of Americans with prescription drug insurance coverage. For insured patients, existing pharmacy benefits remain cheaper, and TrumpRx purchases may not count toward deductibles or annual out-of-pocket maximums. The authors contend pharmaceutical manufacturers are the real beneficiaries, as the program allows them to bypass PBM restrictions while maintaining higher prices. They also raise patient safety concerns, warning that cash purchases fragment medication records and reduce pharmacist oversight of drug interactions.

Source(s):
Opinion: TrumpRx has a fundamental flaw

Tags: #DRUG #PATIENT #PAYER

Op-Ed: Health Insurance CEOs Told Congress They Want to Lower Costs. Providers Have Heard This Before

Brandon Edwards, CEO of Unlock Health, writes that insurers testifying before Congress last month again pledged to lower costs, reduce friction, and improve transparency, but argues that sustained follow-through on these commitments has been historically lacking.

Source(s):
Op-Ed: Health Insurance CEOs Told Congress They Want to Lower Costs. Providers Have Heard This Before

Tags: #PAYER #HOSPITAL #PROVIDER

Notable Notes

Structural Heart Roundup

Several studies and developments advanced the structural heart landscape this week.

Tags: #DEVICE #PROVIDER

Cancer Screening Roundup

New developments in cancer screening highlighted both expanding access and persistent limitations.

Tags: #PATIENT #DEVICE #PROVIDER

Health IT Roundup

Health IT developments this week focused on clinical documentation, data integrity, and the clinician-technology relationship.

Tags: #HOSPITAL #PROVIDER

AI in Healthcare Roundup

AI applications across healthcare operations continued to expand this week.

Tags: #HOSPITAL #PROVIDER

Medtronic Roundup

Medtronic made headlines across acquisitions, surgical robotics, and leadership this week.

Tags: #DEVICE #PROVIDER

CABG Surgical Strategy Studies Show No Clear Winner at STS Meeting

Late-breaking studies at the Society of Thoracic Surgeons annual meeting found no clear winner among common coronary artery bypass grafting strategies. One study showed bilateral internal thoracic artery and single internal thoracic artery plus radial artery grafting have similar long-term survival, though patient age may influence the preferred approach. A separate study found off-pump and on-pump CABG showed essentially equivalent intermediate-to-late survival when performed by experienced surgeons, with off-pump approaches showing advantages primarily in 30-day early outcomes.

Source(s):
Cardiovascular Business
MedPage Today

Tags: #PROVIDER #DEVICE

A Look at Amazon’s Healthcare Playbook

Becker’s summarized Amazon’s recent healthcare moves, including WellSpan Health migrating its technology infrastructure to AWS, Amazon One Medical launching an AI chatbot connected to patient health records, and One Medical opening a second collaborative primary care office with Cleveland Clinic. Rush University System for Health also announced a partnership with One Medical to expand primary and specialty care access. Amazon’s healthcare strategy has included both expansion—the 2023 One Medical acquisition, Amazon Pharmacy growth—and pullbacks like the Amazon Care shutdown and Halo health tracker discontinuation.

Source(s):
A look at Amazon’s healthcare playbook

Tags: #HOSPITAL #PATIENT

Reframing Patient Engagement to What Matters Most

Laura Cooley, editor-in-chief of the Journal of Patient Experience, will speak at HIMSS26 about aligning AI and technology investments with actual patient priorities. A survey of 1,800 patients across 66 hospitals found that patients prioritize getting a clear diagnosis, feeling less anxious, and returning home—yet half reported their providers did not know what mattered most to them.

Source(s):
Reframing patient engagement to what matters most

Tags: #HOSPITAL #PATIENT

Men Developed CVD Earlier Than Women, According to 35-Year CARDIA Study

A 35-year analysis from the CARDIA study found that men develop cardiovascular disease earlier than women, suggesting that promoting preventive care among young adult men during critical life periods may help reduce CVD rates.

Source(s):
Men developed CVD earlier than women, according to 35-year CARDIA study

Tags: #PROVIDER #PATIENT

Healthcare Bankruptcies Declined in 2025, Though Providers Remain Hard-Pressed

Chapter 11 bankruptcy filings in healthcare dropped 21% from 2024 to 2025, according to Gibbins Advisors. However, increases in hospital and senior care bankruptcies, combined with ongoing financial pressures, remain causes for concern.

Source(s):
Healthcare bankruptcies declined in 2025, though providers remain hard-pressed

Tags: #HOSPITAL #PROVIDER

When the Doctor Needs a Checkup

As the physician workforce ages rapidly, some hospitals now mandate that older clinicians undergo testing for cognitive decline. Many physicians have resisted these screening requirements, creating tension over patient safety and physician autonomy.

Source(s):
When the Doctor Needs a Checkup

Tags: #PROVIDER #HOSPITAL

Healthcare Workers Still Not Exempt From H-1B Visa Fee

More than four months after the Trump administration imposed a $100,000 fee on H-1B visa applications, healthcare workers have not received an exemption. Concerns persist about the fee’s impact on filling critical healthcare workforce shortages.

Source(s):
Healthcare Workers Still Not Exempt From H-1B Visa Fee

Tags: #PROVIDER #HOSPITAL

Kaiser Increased Its Operating Income in 2025, Despite Rising Expenses

Kaiser Permanente nearly tripled its operating income to $1.4 billion in 2025, up from $569 million in 2024, while doubling its operating margin from 0.5% to 1.1%. Expenses rose by more than $11 billion driven by rising medication costs. Kaiser’s portfolio grew to 55 hospitals and over 840 medical offices through its Risant Health subsidiary, which added Geisinger Health and Cone Health. The system is navigating a strike by more than 30,000 workers in California and Hawaii now in its third week.

Source(s):
Kaiser Increased Its Operating Income in 2025, Despite Rising Expenses

Tags: #HOSPITAL #PAYER

Otsuka Awareness Campaign Urges HCPs to See ‘All of ADHD’

Otsuka launched a new awareness campaign aimed at educating healthcare professionals about the broader impacts of ADHD on patients’ lives beyond core diagnostic symptoms.

Source(s):
Otsuka Awareness Campaign Urges HCPs to See ‘All of ADHD’

Tags: #DRUG #PROVIDER

U.S., Australia Lead the World on Kids’ Food Allergy Rates

A meta-analysis in JAMA Pediatrics found that 4.7% of children globally develop at least one food allergy by age 6, with U.S. and Australian children facing elevated risk at 6.7% and 10.2% respectively. Major risk factors included early-life antibiotic use, Black race, early onset of atopic conditions, delayed solid food introduction, and family history. The study assessed 342 risk factors across 190 studies involving 2.75 million participants.

Source(s):
U.S., Australia Lead the World on Kids’ Food Allergy Rates

Tags: #PATIENT #PROVIDER

Science Communication Should Be a Core Competency in Medical Training

A MedPage Today opinion argues that formal science communication training should be embedded in medical education, citing declining public trust in expertise. The authors propose required courses, GME requirements, and community-facing presentations, noting physicians remain highly trusted by personal patients but medical schools treat communication as an informal skill.

Source(s):
Science Communication Should Be a Core Competency in Medical Training

Tags: #PROVIDER

Primary Care Physicians’ EHR Work Persists After Reducing Patient Visits

A Health Affairs study analyzing national Epic data from 2019-2022 found that primary care physicians who reduced visit volume by 32.6% saw only a 21.2% decrease in EHR time, meaning per-visit EHR time increased over 20%. EHR time outside scheduled hours per visit rose nearly 40%, with patient message management time per visit increasing over 29%. Researchers suggested payment models that reimburse work outside of visits and AI tools could help address the burden.

Source(s):
Primary care physicians’ EHR work persists after reducing patient visits: study

Tags: #PROVIDER #HOSPITAL

Medtech Companies Share New Electrophysiology Data at AF Symposium 2026

AF Symposium 2026 in Boston featured late-breaking electrophysiology data from major medtech companies including Johnson & Johnson MedTech, Abbott, Atraverse Medical, Field Medical, Pulse Biosciences, Arga Medtech SA, and CardioFocus.

Source(s):
Boston EP Party: Medtech Companies Share New Electrophysiology Data at AF Symposium 2026

Tags: #DEVICE

How AI Is Reshaping Clinical Trials and Market Access

H1 CEO Ariel Katz discusses how AI, evolving regulation, and pricing shifts are changing the landscape for clinical trial design and drug commercialization.

Source(s):
How AI Is Reshaping Clinical Trials and Market Access

Tags: #DRUG

Pioneer Heart Surgeon Vinay Badhwar Elected STS President

Vinay Badhwar, a world leader in robotic cardiac surgery technologies, was elected president of the Society of Thoracic Surgeons. Badhwar and his team recently launched a 40-part video series to teach other clinicians about robotic-assisted cardiac surgery techniques.

Source(s):
Pioneer heart surgeon Vinay Badhwar elected STS president

Tags: #PROVIDER #DEVICE

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