Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS finalizes Ambulatory Specialty Model. Here’s what to know.

The Centers for Medicare and Medicaid Services (CMS) has finalized a mandatory five-year Ambulatory Specialty Model starting 2027 for chronic heart failure and lower back pain management. The Medicare payment model adjusts provider reimbursements up to 12% based on Merit-based Incentive Payment System performance, impacting hospitals, specialty practices, and potentially pharmaceutical and device utilization for these conditions.
Source(s):
CMS finalizes Ambulatory Specialty Model. Here’s what to know. (modernhealthcare.com)
Tags: #ALL

AHIP Report Says MA Plans are Better than Traditional Medicare

An analysis by Wakely Consulting Group for health insurers found Medicare Advantage plans are more cost-effective than traditional Medicare, with fee-for-service costs potentially 9.8% higher under equivalent CMS regulatory requirements. The findings have significant implications for Medicare policy decisions affecting millions of seniors, healthcare providers, hospitals, and pharmaceutical coverage under federal health programs.
Source(s):
In Apples-to-Apples Comparison, the Facts are Clear: Medicare (ahip.org)
Tags: #ALL

OBBBA Sparks Anxiety, Innovation for Health System Strategic Leaders

The One Big Beautiful Bill Act (OBBBA) will restructure Medicaid eligibility and CMS financing in 2026, creating financial pressures for hospital systems through reduced Medicare and Medicaid reimbursements. Healthcare leaders anticipate increased uncompensated care burdens, forcing innovation in care delivery models, particularly affecting rural hospitals and potentially impacting pharmaceutical and device procurement strategies under new CMS guidelines.
Source(s):
OBBBA Sparks Anxiety, Innovation for Health System Strategic Leaders (Becker’s Hospital Review)
Tags: #ALL

Medicare finalizes dialysis pay increase

Medicare’s CMS has finalized increased payment rates for dialysis services, significantly impacting hospital-based and independent providers serving kidney disease patients. This Medicare policy adjustment aims to ensure sustainable facility operations while maintaining access to essential renal care services amid rising healthcare costs.
Source(s):
Medicare finalizes dialysis pay increase (Modern Healthcare News)
Tags: #HOSPITAL, #PROVIDER, #PAYER

Opinion: Trump’s regressive deal on GLP-1s misses the mark for patients like me

An opinion piece critiques the Trump administration’s pharmaceutical deal with GLP-1 manufacturers to reduce Medicare and Medicaid copays for weight loss medications. The author argues this CMS-negotiated initiative inadequately addresses comprehensive obesity treatment access and affordability across all patient populations, highlighting gaps in federal drug pricing policy that leave many Americans without sufficient coverage for these costly treatments.
Source(s):
Opinion: Trump’s regressive deal on GLP-1s misses the mark for patients like me (Stat)
Tags: #PATIENT, #PAYER, #DRUG

PrEP access increased during Medicaid expansion, but disparities remain, study shows

A study found Medicaid expansion increased PrEP access nationwide, but racial and gender disparities persist in HIV prevention. Despite pharmaceutical advances and CMS coverage improvements, structural barriers limit equitable access for vulnerable populations, highlighting gaps in federal policy implementation across healthcare systems and requiring targeted interventions.
Source(s):
PrEP access increased during Medicaid expansion, but disparities remain, study shows (Managed Healthcare Executive)
Tags: #PAYER, #PATIENT, #PROVIDER

Trade groups call on CMS to broaden pharmacists’ scope of practice

In a November 14 letter, pharmaceutical trade groups urged CMS Administrator Mehmet Oz to expand pharmacists’ scope of practice under Medicare Part B, enabling reimbursement for complex clinical services and pharmacist-initiated prescriptions. The policy change would enhance healthcare access for Medicare beneficiaries while potentially reducing hospital burden through expanded community pharmacy services, representing a significant shift in CMS reimbursement policy for pharmaceutical care delivery.
Source(s):
Trade groups call on CMS to broaden pharmacists’ scope of practice (Becker’s Hospital Review)
Tags: #DRUG, #PROVIDER, #PAYER

CFRB Floats PFS Reforms As Potential Offsets For Physician Pay Overhaul

The Committee for a Responsible Federal Budget (CFRB) has proposed Medicare Physician Fee Schedule (PFS) reforms including efficiency gains and improved billing transparency for nurse practitioners and physician assistants as financial offsets for CMS physician payment restructuring. The reforms would impact Medicare reimbursements, potentially affecting hospitals and healthcare providers while addressing federal budget concerns through systematic payment modifications.
Source(s):
CFRB Floats PFS Reforms As Potential Offsets For Physician Pay Overhaul (InsideHealthPolicy Daily News)
Tags: #PROVIDER, #HOSPITAL, #PAYER

Medicare premiums set to rise 10% next year, CMS says

The Centers for Medicare & Medicaid Services (CMS) announced a 10% Medicare premium increase affecting millions of seniors and beneficiaries. This policy change will strain healthcare affordability for elderly populations while increasing financial pressures on the Medicare program amid rising pharmaceutical and hospital costs.
Source(s):
Medicare premiums set to rise 10% next year, CMS says (Healthcare Dive)
Tags: #PATIENT, #PAYER, #PROVIDER

CMS releases Medicare premiums, deductibles for 2026

CMS has released updated Medicare premiums and deductibles for 2026, reflecting ongoing program adjustments that will directly impact beneficiaries’ out-of-pocket costs for pharmaceutical coverage, hospital services, and healthcare access. These CMS policy changes affect millions of Medicare enrollees and healthcare providers nationwide.
Source(s):
CMS releases Medicare premiums, deductibles for 2026 (Seeking Alpha)
Tags: #ALL

‘Push Back on Orthodoxy,’ Dr. Oz Tells AMA’s House of Delegates

At a recent AMA meeting, Dr. Mehmet Oz, CMS administrator overseeing Medicare policy, urged physicians to challenge medical orthodoxy in healthcare advocacy. His remarks addressed stakeholders including hospitals, pharmaceutical companies, and device manufacturers, emphasizing physician courage in navigating FDA regulations and CMS policies that impact patient care and healthcare delivery systems.
Source(s):
‘Push Back on Orthodoxy,’ Dr. Oz Tells AMA’s House of Delegates (MedPageToday.com – medical news for physicians)
Tags: #ALL

Food and Drug Administration (FDA)

FDA Commissioner Makary Faces Mounting Pressure from White House and HHS Leadership Amid Agency Turmoil

FDA Commissioner Marty Makary is under increasing pressure as the White House has requested the resignation of his senior aide while HHS Secretary Robert F. Kennedy Jr. reportedly considers reducing Makary’s authority amid internal agency tensions. The leadership conflicts threaten to disrupt FDA oversight of pharmaceutical regulations, medical device approvals, and vaccine policies, with potential downstream effects on CMS Medicare programs and hospital compliance standards. The turmoil could significantly impact regulatory decisions affecting healthcare stakeholders, hospitals, and public health policy implementation across federal agencies.
Source(s):
The White House Has Asked for the Resignation of a Top Aide to FDA Chief (POLITICO – Health Care)
Report: Kennedy Considered Sidelining Makary’s Leadership At FDA (InsideHealthPolicy Daily News)
Tags: #ALL

Novo Nordisk’s semaglutide fails to slow Alzheimer’s progression

Novo Nordisk announced FDA-monitored trials of semaglutide failed to slow Alzheimer’s progression, potentially impacting Medicare coverage decisions for off-label use. The pharmaceutical company’s results raise regulatory questions about expanding drug approvals beyond metabolic conditions, affecting healthcare stakeholders and CMS reimbursement policies.
Source(s):
Novo Nordisk’s semaglutide fails to slow Alzheimer’s progression (Stat)
Tags: #DRUG, #PAYER, #PROVIDER

The FDA Commissioner Is Missing the Point of Advisory Committees

Recent controversies surrounding antidepressant safety during pregnancy and hormone therapy for menopause have raised questions about the decision-making processes at the FDA. HHS officials have highlighted the need for improved communication and transparency regarding advisory committee recommendations.
Source(s):
The FDA Commissioner Is Missing the Point of Advisory Committees (MedPageToday.com – medical news for physicians)
Tags: #DRUG, #PROVIDER

US FDA Tests Faster Follow-Up Process for Drug Reviews

The FDA is piloting an accelerated follow-up process for pharmaceutical drug reviews to streamline regulatory pathways and expedite patient access to medications. This efficiency initiative could reduce approval timelines, benefiting drug manufacturers, healthcare providers, and Medicare beneficiaries while potentially influencing CMS coverage decisions and hospital formulary planning.
Source(s):
US FDA Tests Faster Follow-Up Process for Drug Reviews (Reuters)
Tags: #DRUG, #HOSPITAL, #PAYER

ACLU Sues FDA Over Unanswered Freedom of Information Act Request

The ACLU is suing the FDA for failing to respond to a FOIA request regarding abortion pill legality and interstate prescribing practices, seeking judicial enforcement of pharmaceutical transparency laws. This lawsuit highlights regulatory oversight tensions affecting reproductive healthcare access, patient rights, and provider prescribing authority under FDA jurisdiction.
Source(s):
ACLU Sues FDA Over Unanswered Freedom of Information Act Request (Health Exec)
Tags: #DRUG, #PROVIDER, #PATIENT

Function Health has won over consumers. When will it publish evidence?

Function Health raised $298 million for personalized health services using extensive lab testing, but faces FDA scrutiny over limited evidence supporting testing efficacy for low-risk individuals. The company’s direct-to-consumer model bypasses traditional healthcare systems, potentially impacting how Medicare and CMS evaluate preventive testing reimbursement policies.
Source(s):
Function Health has won over consumers. When will it publish evidence? (Stat)
Tags: #PATIENT, #PAYER, #PROVIDER

Opinion: The Trump administration is turning drug review into make-a-deal

Opinion article raises concerns that the Trump administration’s FDA drug review process prioritizes deal-making over rigorous pharmaceutical safety standards. Authors argue this shift could compromise regulatory integrity, potentially impacting patient safety and Medicare beneficiaries while affecting hospital formulary decisions and device approval timelines.
Source(s):
Opinion: The Trump administration is turning drug review into make-a-deal (Stat)
Tags: #ALL

FDA panel to review first heart failure device of its kind

An FDA advisory panel will review a novel cardiac shunt device for heart failure patients, showing 52% reduced hospitalizations and improved mortality outcomes. The device review represents potential Medicare coverage implications and could influence CMS reimbursement policies for innovative cardiovascular devices, impacting hospitals and pharmaceutical companies developing heart failure therapies.
Source(s):
FDA panel to review first heart failure device of its kind (Cardiovascular Business)
Tags: #DEVICE, #HOSPITAL, #PAYER

Vaccine makers have reason for alarm in proposals to reformulate shots

The Trump administration is considering major FDA-regulated changes to vaccine formulations, including removing aluminum and separating MMR vaccines into individual doses. Pharmaceutical manufacturers warn these proposals could disrupt markets, cost billions, pose public health risks, and require years of FDA approval processes to implement safely.
Source(s):
Vaccine makers have reason for alarm in proposals to reformulate shots (Stat)
Tags: #DRUG, #PATIENT, #PROVIDER

Health and Human Services

RFK Jr. Orders CDC to Revise Vaccine-Autism Website Language, Sparking Medical Community Backlash Amid Broader Agency Turmoil

Health Secretary Robert F. Kennedy Jr. personally directed the CDC to remove website claims that vaccines do not cause autism, contradicting FDA-approved vaccine safety research and scientific consensus, while the agency faces internal criticism over leadership vacancies and poor communication. Major medical organizations including the AMA strongly opposed the policy shift, warning it could undermine public trust in immunizations and impact Medicare vaccination coverage decisions across hospital systems. The controversial changes come as the Trump administration simultaneously announced 16 new CDC initiatives including enhanced disease surveillance and hepatitis B screening programs, highlighting tensions between evidence-based public health messaging and political directives affecting pharmaceutical industry confidence and CMS reimbursement policies.
Source(s):
Inside the CDC Whiplash (POLITICO – Health Care)
RFK Jr. Says He Instructed CDC to Change Vaccines and Autism Language on Website (The New York Times)
RFK Jr. says he directed CDC to remove claim that vaccines do not cause autism (POLITICO – Health Care)
RFK Jr. Says He Personally Directed CDC’s New Guidance on Vaccines and Autism (MedPageToday.com – medical news for physicians)
‘Dangerous’: Medical Groups Slam CDC Changes on Vaccines and Autism (MedPageToday.com – medical news for physicians)
RFK Jr. confirms he ordered CDC website changes on vaccines and autism (Stat)
CDC Website No Longer Rejects Autism-Vaccine Link (MedPageToday.com – medical news for physicians)
Trump administration lists 16 new CDC initiatives, from hepatitis B testing to bolstering workforce (Stat)
Vaccines aren’t linked to autism, despite CDC website change (Stat)
Tags: #ALL

Senate Republicans Navigate Complex Political Dynamics as RFK Jr.’s HHS Leadership Raises Questions About Vaccine Policy Commitments

Reports indicate that Health Secretary Robert F. Kennedy Jr. has not honored specific vaccine policy commitments made to Senate Republicans, including Senator Bill Cassidy, prior to his confirmation vote, raising concerns about FDA oversight accountability and potential impacts on Medicare coverage and CMS programs. Despite affirming vaccine safety, Senator Cassidy declined to publicly criticize RFK Jr. in recent interviews, reflecting broader political tensions around pharmaceutical regulations and federal health agency leadership. The situation highlights ongoing uncertainty for healthcare stakeholders monitoring potential shifts in vaccine policy and regulatory approaches under the new HHS administration.
Source(s):
Cassidy Got Pledges From RFK Jr. on Vaccines. They Haven’t Stuck. (The New York Times)
Vaccine-supporting Cassidy declines to speak against RFK Jr. (POLITICO – TOP Stories)
Tags: #ALL

RFK Jr.’s Health Leadership Sparks Science vs. Policy Tensions Across Federal Agencies

Health Secretary RFK Jr.’s tenure has created significant friction between scientific integrity and policy implementation, with investigations revealing his reliance on misinformation to guide FDA and health policy decisions while promoting ‘Make America Healthy Again’ reforms. His influence spans across CMS policies, pharmaceutical oversight, and device regulations, drawing concerns from hospitals, Medicare stakeholders, and industry executives about undermining trust in health institutions. These developments echo broader public health challenges, including the 2019 measles outbreak response tensions, highlighting ongoing conflicts between federal health mandates and community resistance that affect CDC, FDA vaccine policy enforcement, and healthcare delivery systems.
Source(s):
How RFK Jr. is steamrolling science as health secretary (Stat)
MAHA Idealism Meets Political Reality as RFK Jr. Seeks to Wrangle Growing Movement (MedPage Today Primary Care)
The Civil War Inside Public Health (MedPageToday.com)
A revelatory profile of RFK Jr. (Stat)
Tags: #ALL

Trump and RFK Jr. are mulling their most disruptive vaccine policies yet — alarming manufacturers

The Trump administration, with HHS Secretary Robert F. Kennedy Jr., is considering significant vaccine policy changes that could restrict FDA-approved childhood vaccines, disrupt pharmaceutical manufacturing, and impact Medicare coverage. These potential regulatory shifts may impose substantial costs on device and vaccine manufacturers.
Source(s):
Trump and RFK Jr. are mulling their most disruptive vaccine policies yet — alarming manufacturers (Stat)
Tags: #ALL

‘It’s Not How a Responsible Scientist Acts’: What We Heard This Week

David Mandell, a public health expert, criticized HHS Secretary Robert F. Kennedy Jr. for his actions regarding CDC vaccine guidance and FDA pharmaceutical oversight, implying such behavior undermines scientific integrity. This highlights tensions between federal health agencies, impacting Medicare beneficiaries, hospital systems, and medical device regulation under CMS policies.
Source(s):
‘It’s Not How a Responsible Scientist Acts’: What We Heard This Week (MedPageToday.com – medical news for physicians)
Tags: #ALL

Federal Health Agencies Face Widespread Operational Disruptions as NIH Hiring Changes, CDC Telework Cuts, and Funding Shortfalls Reshape Medical Research Landscape

Major federal health agencies are experiencing significant operational upheaval as the NIH implements unprecedented expedited director hiring without search committees, the CDC terminates telework agreements for employees including those with medical accommodations, and NIH funding cuts have disrupted hundreds of clinical trials affecting over 11,000 studies. These simultaneous policy shifts at key agencies that oversee pharmaceutical regulations, FDA collaboration, and Medicare-funded initiatives are raising concerns among scientists and healthcare stakeholders about potential impacts on biomedical research priorities, public health operations, and regulatory partnerships across the healthcare sector.
Source(s):
NIH Job Postings Raise Red Flags for Scientists (MedPageToday.com – medical news for physicians)
CDC moves to end telework for employees, including those with medical needs (Stat)
NIH Cuts Disrupted Hundreds of Clinical Trials, Study Finds (MedPageToday.com – medical news for physicians)
Federal employees face lingering uncertainty as some shutdown RIFs are reversed (Government Executive – All Content)
Tags: #ALL

Means Scores Permanent Role At HHS Despite Ethics Questions

Calley Means, a key figure in the “Make America Healthy Again” movement, has been appointed to a permanent position at the Department of Health and Human Services (HHS) as of November 18, 2025. His return to the Trump administration raises ethical concerns due to his previous advisory role under HHS Secretary Robert F. Kennedy Jr., particularly regarding public health policies and vaccine skepticism.
Source(s):
Means Scores Permanent Role At HHS Despite Ethics Questions (InsideHealthPolicy Daily News)
Tags: #ALL

Trump administration touts moves to provide HIV prevention drug, but refuses to include South Africa

The U.S. State Department delivered 1,000 doses of HIV prevention medication to Zambia and Eswatini, excluding South Africa despite high HIV prevalence. This FDA-approved pharmaceutical distribution reflects federal policy decisions affecting access to life-saving treatments across sub-Saharan Africa, impacting public health outcomes and international HIV prevention efforts in underserved populations.
Source(s):
Trump administration touts moves to provide HIV prevention drug, but refuses to include South Africa (Stat)
Tags: #DRUG, #PATIENT

A case study on cravings and a GLP-1

STAT tracks HHS Secretary RFK Jr.’s healthcare reform promises, including new FDA opioid labeling requirements and revised dietary guidelines. These pharmaceutical policy changes impact Medicare beneficiaries and hospital systems under CMS oversight, as the administration pursues broader healthcare transformation affecting key stakeholders.
Source(s):
A case study on cravings and a GLP-1 (Stat)
Tags: #ALL

Heard on the Hill

GOP Scrambles to Address Expiring ACA Subsidies as Premium Increases Loom, White House Prepares Trump Administration Healthcare Proposal

With enhanced ACA premium tax credits set to expire, Republican lawmakers face mounting pressure to address potential premium increases affecting millions of Americans, including Medicare-eligible enrollees and those with employer-sponsored coverage among 165 million Americans. Representative Brian Fitzpatrick is drafting bipartisan legislation to extend subsidies while adding conservative measures like expanded health savings accounts, as the White House prepares a two-year extension proposal with new eligibility limits expected to be announced in coming days. The policy impasse threatens market stability across healthcare sectors, with hospitals anticipating increased uncompensated care costs, pharmaceutical companies facing reduced prescription accessibility, and CMS confronting implementation challenges as stakeholders from insurers to Medicare beneficiaries await resolution.
Source(s):
This House GOP Centrist is Plotting a New Health Care Bill Aimed at Winning Over Trump (POLITICO – TOP Stories)
Republicans left the Obamacare cliff to the last minute. Some are regretting it. (POLITICO – Health Care)
White House to pitch a Trump Obamacare extension with limits (POLITICO – TOP Stories)
Insurers Caution Congress On HSAs, Call For Glide Path To Bipartisan Reforms (InsideHealthPolicy Daily News)
Senators Trade Barbs Over Extending Enhanced Obamacare Subsidies (MedPageToday.com)
Obamacare Customers with Sky-High Premiums Will Get No Help Through Cassidy’s Plan, Democrats and Policy Experts Say (POLITICO)
As health insurance premiums soar, pressure on Republicans mounts (POLITICO – Health Care)
Things aren’t looking good for an extension of ACA premium subsidies (Stat)
White House official promises announcement in ‘coming days’ on healthcare, as Trump preps for nationwide tour (Health Exec)
Tags: #ALL

Cassidy Leads Republican Healthcare Policy Push Amid CDC Vaccine Controversies and ACA Subsidy Debates

Senator Bill Cassidy (R-LA) is championing multiple healthcare initiatives, criticizing the CDC’s revised autism webpage that he says amplifies debunked vaccine-autism links while advocating for hepatitis B vaccination protocols ahead of December’s ACIP meeting. Simultaneously, Cassidy is proposing Republican alternatives to ACA tax credit extensions targeting Medicare-eligible populations through CMS marketplace mechanisms, positioning himself as a key GOP voice on vaccination policy and healthcare funding negotiations affecting pharmaceutical manufacturers, hospital systems, and public health messaging standards.
Source(s):
Cassidy: CDC’s Revamped Autism Page Fuels Doubt, Hurts Disease Prevention (InsideHealthPolicy Daily News)
Cassidy and other Republicans have little to say about change to CDC’s position on vaccines and autism (Stat)
Cassidy Concerned About Hep B Vaccines Ahead Of ACIP Meeting (InsideHealthPolicy Daily News)
Cassidy pitches his alternative to extending extra ACA subsidies (Stat)
Tags: #ALL

Under Mike Johnson, a rarely used House tool has gone mainstream

Speaker Mike Johnson’s tenure has seen increased utilization of discharge petitions in the House, allowing lawmakers to force votes on blocked legislation. This shift reflects a growing frustration among Republicans with leadership and the desire for greater legislative action on key issues.
Source(s):
Under Mike Johnson, a rarely used House tool has gone mainstream (POLITICO – TOP Stories)
Tags: #ALL

Bill seeks to expand Medicare’s drug price negotiation program

On November 20, House lawmakers introduced “The Lowering Drug Costs for American Families Act,” expanding Medicare’s pharmaceutical price negotiation authority from 10 to 50 medications by January 2026. The CMS-administered program would include private insurers and eliminate rare disease exemptions, potentially reducing costs for Medicare beneficiaries, hospitals, and healthcare stakeholders while impacting pharmaceutical manufacturers’ pricing strategies.
Source(s):
Bill seeks to expand Medicare’s drug price negotiation program (Becker’s Hospital Review)
Tags: #ALL

House Dems urge Trump administration to act on health insurance claim denials

House Democrats urged the Labor Department to address improper health insurance claim denials affecting Medicare beneficiaries and hospital patients, recommending enhanced data collection on pharmaceutical and device coverage denials and improved consumer appeals. They cited Trump administration staffing cuts that weakened CMS and FDA oversight capabilities, leading to significant patient health and financial hardships across healthcare stakeholders.
Source(s):
House Dems urge Trump administration to act on health insurance claim denials (Government Executive – All Content)
Tags: #ALL

Democrats try again to reestablish legal deference to agencies on regulations

Congressional Democrats have reintroduced the EXPERTS Act to restore “Chevron deference,” which allows courts to defer to federal agencies’ expertise in ambiguous legal interpretations. This legislation aims to counteract the deregulatory measures of the Trump administration, limit private sector influence in rulemaking, and enhance public participation in regulatory processes.
Source(s):
Democrats try again to reestablish legal deference to agencies on regulations (Government Executive – All Content)
Tags: #ALL

Lawmakers To CMS: Insulate ACOs From Fraud They Didn’t Commit

GOP lawmakers led by House Ways & Means health subcommittee Chair Vern Buchanan are pressing CMS to shield accountable care organizations from Medicare fraud penalties when ACOs are not directly responsible. The policy push aims to protect hospital systems and healthcare providers from unfair financial liability while CMS continues broader Medicare fraud enforcement efforts that impact pharmaceutical and device reimbursements across the healthcare system.
Source(s):
Lawmakers To CMS: Insulate ACOs From Fraud They Didn’t Commit (InsideHealthPolicy Daily News)
Tags: #HOSPITAL, #PROVIDER, #PAYER

Gallego Asks Companies For More Details On GLP-1 Deal

Senator Ruben Gallego is requesting details from pharmaceutical companies regarding GLP-1 drug pricing agreements with the Trump administration, citing concerns over potential Medicare cost increases and patient access implications. The FDA-regulated diabetes medications inquiry highlights ongoing CMS reimbursement policy scrutiny and pharmaceutical pricing transparency issues affecting healthcare stakeholders.
Source(s):
Gallego Asks Companies For More Details On GLP-1 Deal (InsideHealthPolicy Daily News)
Tags: #ALL

MedPAC Payment Basics Resource

The Medicare Payment Advisory Commission (MedPAC) has published comprehensive “Payment Basics” resources detailing Medicare’s complex reimbursement mechanisms across healthcare services including hospital, pharmaceutical, and device payments. These CMS-focused guides inform policymakers, providers, and industry stakeholders about Medicare payment reforms, rate-setting methodologies, and regulatory impacts on healthcare delivery and access for beneficiaries.
Source(s):
MedPAC Payment Basics Resource (medpac.gov)
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Notable Notes

Abbott’s $21B Acquisition of Exact Sciences Signals Major Shift in Cancer Diagnostics Market with Potential Policy Implications

Abbott announced a $21 billion acquisition of cancer screening company Exact Sciences at $105 per share, representing a 50% premium, to strengthen its diagnostic capabilities in the growing early detection market. The deal enhances Abbott’s colorectal cancer screening portfolio with innovative at-home testing solutions, potentially expanding access to critical diagnostics while requiring FDA approval processes for integrated technologies. The acquisition could significantly impact Medicare reimbursement policies for cancer screening devices and affect healthcare providers, patients, and payers as the consolidated entity navigates regulatory approval and market integration.
Source(s):
Abbott acquires cancer diagnostic company Exact Sciences for $21B (Health Exec)
Abbott to buy cancer screening test maker Exact Sciences in $21B deal (Stat)
Tags: #DEVICE, #PROVIDER, #PATIENT

Healthcare Workforce Crisis Intensifies as Job Satisfaction Plummets Amid Rising Costs and Staffing Shortages

Healthcare workers are experiencing unprecedented levels of exhaustion and job dissatisfaction, with many considering leaving the field due to inadequate hospital staffing and low pay, while the sector added only 42,800 jobs in September despite an 8.5% decline in job postings indicating severe recruitment challenges. Mercer projects healthcare benefit costs will surge 6.7% in 2026—the highest increase in 15 years—creating additional pressure on Medicare systems and CMS reimbursement strategies while threatening employment stability across pharmaceutical and medical device companies dependent on a stable healthcare workforce.
Source(s):
Health care workers say their jobs feel “unsustainable,” Indeed report finds (medicaleconomics.com)
The healthcare workforce in 12 numbers (Becker’s Hospital Review)
Tags: #ALL

Opinion: The definitional problems at the heart of the neurodiversity movement

The growing visibility of the neurodiversity movement and its implications for understanding neurodiverse individuals are discussed. It highlights the importance of inclusivity and informed conversations about neurodiversity in societal contexts.
Source(s):
Opinion: The definitional problems at the heart of the neurodiversity movement (Stat)
Tags: #PATIENT, #PROVIDER

More Lung Cancer Screening Could Prevent Over 60,000 U.S. Deaths by 2030

Researchers indicate that increasing lung cancer screening to 100% among eligible individuals could prevent over 60,000 deaths in the U.S. by 2030. Currently, only 18.7% of eligible individuals are screened. Enhanced Medicare and CMS coverage policies for screening devices could drive hospital adoption and improve public health outcomes through FDA-approved diagnostic technologies.
Source(s):
More Lung Cancer Screening Could Prevent Over 60,000 U.S. Deaths by 2030 (MedPageToday.com)
Tags: #PAYER, #PATIENT

21 Joint Commission Moves in 2025

The Joint Commission’s 2025 accreditation overhaul cuts hospital regulatory standards by 50%, reducing compliance burdens for healthcare facilities. New 2026 mandate requiring dedicated nurse executives for staffing oversight will impact hospital operations, Medicare reimbursement eligibility, and CMS quality reporting requirements, affecting pharmaceutical and device implementation protocols.
Source(s):
21 Joint Commission Moves in 2025 (Becker’s Hospital Review)
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Early TAVR for Asymptomatic Severe AS Cuts Costs, Improves Outcomes

A study found that early transcatheter aortic valve replacement (TAVR) leads to significant lifetime savings, with costs reduced by approximately $2,334 in the U.K. and up to $19,607 in Switzerland. This suggests that early intervention could enhance patient outcomes while also being cost-effective.
Source(s):
Early TAVR for Asymptomatic Severe AS Cuts Costs, Improves Outcomes (Cardiovascular Business)
Tags: #ALL

Medical Groups Outraged by Anthem Payment Policy Change

Anthem Blue Cross Blue Shield will penalize hospitals 10% for out-of-network physician services across 11 states starting January 2026, potentially disrupting hospital-physician partnerships and independent practice viability. Medical groups claim the policy undermines No Surprises Act protections and threatens patient access to care, particularly affecting Medicare beneficiaries and hospital network stability.
Source(s):
Medical Groups Outraged by Anthem Payment Policy Change (MedPageToday.com)
Tags: #HOSPITAL, #PROVIDER, #PAYER

Maryland PDAB To Use MFP If Board Moves Forward With UPL

The Maryland Prescription Drug Affordability Board plans to utilize CMS’ negotiated Medicare maximum fair prices as upper payment limits for diabetes drugs including Jardiance and Farxiga, if implementing price limitations. Pharmaceutical manufacturers oppose the policy, citing concerns over drug pricing impacts and market access restrictions affecting patient care and industry revenue.
Source(s):
Maryland PDAB To Use MFP If Board Moves Forward With UPL (InsideHealthPolicy Daily News)
Tags: #DRUG, #PAYER, #PATIENT

Elevated BMI should not routinely be listed as a formal diagnosis

The authors argue against routine BMI-over-25 diagnoses, citing healthcare stigma that delays patient care and worsens outcomes. This impacts hospital protocols, Medicare reimbursement practices, and CMS quality metrics. Policy implications include revised diagnostic coding standards and healthcare provider training to reduce weight bias in clinical settings.
Source(s):
Elevated BMI should not routinely be listed as a formal diagnosis (Stat)
Tags: #PROVIDER, #HOSPITAL, #PAYER

Former FDA commissioner Scott Gottlieb joins UnitedHealth’s board

Scott Gottlieb, former FDA commissioner, joins UnitedHealth Group’s board, bringing pharmaceutical and medical device regulatory expertise. His appointment signals UnitedHealth’s strategic focus on navigating FDA oversight, CMS Medicare policies, and regulatory challenges affecting healthcare innovation and hospital partnerships.
Source(s):
Former FDA commissioner Scott Gottlieb joins UnitedHealth’s board (Healthcare Finance News)
Tags: #ALL

Icahn Mount Sinai rethinks premed path to widen physician pipeline

The Icahn School of Medicine at Mount Sinai is transforming medical education policy through innovative admissions pathways like FlexMed, bypassing traditional MCAT requirements to diversify the physician workforce. This hospital-affiliated initiative addresses healthcare workforce shortages while potentially impacting Medicare provider networks and CMS physician supply planning through expanded recruitment of underrepresented candidates from military and diverse academic backgrounds.
Source(s):
Icahn Mount Sinai rethinks premed path to widen physician pipeline (Becker’s Hospital Review)
Tags: #PROVIDER, #HOSPITAL

US drug expenditure far outpaces other countries: Report

A report by IQVIA reveals that U.S. pharmaceutical spending in 2022 averaged approximately $2,000 per capita, significantly higher than other countries ($656-$1,337). This disparity stems from elevated hospital costs, physician payments, and administrative expenses, highlighting critical challenges for Medicare, CMS policy reforms, and FDA pricing oversight in managing drug expenditures across healthcare systems and impacting patient access.
Source(s):
US drug expenditure far outpaces other countries: Report (Becker’s Hospital Review)
Tags: #ALL

Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in

Boston Scientific halted sales of its Acurate TAVR devices after FDA approval failure and poor clinical trial performance. The decision impacts hospital procurement strategies, Medicare coverage decisions, and physician treatment options. Cardiologists debate whether premature withdrawal limits patient access to alternative transcatheter aortic valve replacement technologies, potentially affecting CMS reimbursement policies and competitive device market dynamics.
Source(s):
Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in (Cardiovascular Business – Cardiovascular Business is a leading news website that focuses on the business and economics behind quality clinical care.)
Tags: #ALL

South Africa urged to issue compulsory license for Gilead HIV prevention drug

Patient advocates urge South African government to issue compulsory pharmaceutical license for Gilead’s HIV prevention drug, enabling domestic production to reduce costs and improve accessibility. This policy move would enhance government control over essential medication access and health outcomes, potentially serving as precedent for other developing nations seeking affordable drug manufacturing alternatives.
Source(s):
South Africa urged to issue compulsory license for Gilead HIV prevention drug (Stat)
Tags: #ALL

How Mark Cuban plans to ‘f— up’ health care

Mark Cuban’s Cost Plus Drugs platform bypasses traditional pharmaceutical supply chains, potentially disrupting Medicare Part D and commercial insurance models. His support for the Trump administration’s TrumpRx initiative signals broader FDA and CMS policy shifts toward direct-to-consumer drug purchasing, impacting hospitals, device manufacturers, and pharmaceutical pricing structures while expanding patient access to medications.
Source(s):
How Mark Cuban plans to ‘f— up’ health care (Stat)
Tags: #ALL

Is a pediatric care crisis brewing?

A significant decline in pediatric services has been observed in U.S. hospitals, with nearly 30% of inpatient pediatric units closed between 2008 and 2022. This trend is exacerbated by workforce shortages and insufficient Medicare/Medicaid reimbursement rates, creating financial pressures that threaten hospital sustainability of pediatric care. CMS payment policies disproportionately impact children’s hospitals, while FDA device approvals lag for pediatric populations. Without policy intervention addressing reimbursement gaps and regulatory barriers, access to high-quality pediatric care will be severely limited, affecting vulnerable populations and hospital systems nationwide.
Source(s):
Is a pediatric care crisis brewing? (Becker’s Hospital Review)
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Current Lung Cancer Screening Guidelines Miss Most Tumors, Study Suggests

A recent cohort study indicates that only 35.1% of lung cancer patients met USPSTF screening criteria, suggesting current guidelines miss most cases. This finding has significant implications for Medicare coverage decisions, CMS reimbursement policies, and FDA device approval standards for screening technologies. Healthcare systems and hospitals may need to reassess screening protocols, while pharmaceutical companies developing early detection methods could benefit from expanded criteria. The gap highlights urgent need for revised guidelines to improve patient outcomes and reduce healthcare costs through earlier intervention.
Source(s):
Current Lung Cancer Screening Guidelines Miss Most Tumors, Study Suggests (MedPage Today Oncology/Hematology)
Tags: #ALL

Transcaval access a safe, effective alternative during Impella implants

Researchers have identified transcaval access as a viable FDA-regulated alternative for cardiologists treating high-risk heart failure patients during Impella device implants at hospitals. This approach could potentially improve patient outcomes and Medicare reimbursement considerations in complex cases where traditional access methods may pose risks for CMS-covered procedures.
Source(s):
Transcaval access a safe, effective alternative during Impella implants (Cardiovascular Business)
Tags: #DEVICE, #PROVIDER, #HOSPITAL

Heart Rhythm Advocates town hall to review key EP policies

Leaders from the Heart Rhythm Society (HRS) and Heart Rhythm Advocates will discuss critical electrophysiology (EP) policy updates affecting device regulations, Medicare reimbursement, and CMS guidelines. The town hall focuses on FDA approval processes, pharmaceutical access, and hospital implementation strategies to enhance stakeholder engagement and address current EP field challenges.
Source(s):
Heart Rhythm Advocates town hall to review key EP policies (Cardiovascular Business)
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Breast Cancer and Birth Control: A Huge New Study Shows How Science Can Be Distorted

A significant study has emerged highlighting the complexities surrounding the risks associated with hormonal birth control in relation to breast cancer. As misinformation proliferates, healthcare professionals emphasize the importance of nuanced communication to combat misconceptions, particularly in the era of social media.
Source(s):
Breast Cancer and Birth Control: A Huge New Study Shows How Science Can Be Distorted (MedPage Today Oncology/Hematology)
Tags: #PATIENT, #PROVIDER

Large-scale policy changes fail to boost heart failure outcomes—what else is needed?

A system-wide initiative in Sweden aimed at improving heart failure outcomes has reportedly failed to significantly impact hospital readmission rates or stays for heart failure patients. The disappointing results raise questions about the effectiveness of broad healthcare policy changes versus targeted interventions involving pharmaceutical treatments, medical devices, and hospital-specific protocols. This challenges assumptions that Medicare and CMS-style system-wide reforms automatically translate to better patient outcomes, suggesting stakeholders may need more focused, evidence-based approaches rather than sweeping policy mandates to address specific cardiovascular conditions.
Source(s):
Large-scale policy changes fail to boost heart failure outcomes—what else is needed? (Cardiovascular Business)
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Interventional cardiology showing more interest in endovascular procedures

At the TCT 2025 conference, Dr. Sahil Parikh noted increasing interest among interventional cardiologists in endovascular procedures for stroke, pulmonary embolism, and peripheral artery disease. This trend toward innovative cardiovascular treatments has implications for device manufacturers, hospital resource allocation, and potential Medicare coverage policies as procedures expand beyond traditional cardiac interventions.
Source(s):
Interventional cardiology showing more interest in endovascular procedures (Cardiovascular Business)
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SCAI: Noncompete contracts unfairly bind cardiologists to hospitals unless they move

The Society for Cardiovascular Angiography and Interventions (SCAI) has expressed concerns to the U.S. Federal Trade Commission regarding hospital-imposed noncompete contracts that restrict cardiologists’ employment mobility. These adhesion contracts limit physician bargaining power and could impact healthcare access, particularly affecting Medicare patients’ access to specialized cardiac interventions and device procedures. SCAI argues these restrictions may concentrate market power among hospital systems, potentially influencing pharmaceutical and medical device procurement while limiting competition in cardiovascular care delivery.
Source(s):
SCAI: Noncompete contracts unfairly bind cardiologists to hospitals unless they move (Cardiovascular Business)
Tags: #PROVIDER, #HOSPITAL, #DEVICE

The Residency Match — Reimagined

The American Academy of Family Physicians (AAFP) is launching a new initiative to transform the residency match process, reducing stress for medical students and improving workforce outcomes for hospitals and healthcare systems.
Source(s):
The Residency Match — Reimagined (MedPage Today Primary Care)
Tags: #PROVIDER, #HOSPITAL

What’s in the New Settlement Against OxyContin-Maker Purdue and the Sackler Family

Purdue Pharma and the Sackler family are required to pay billions to settle numerous lawsuits related to the opioid crisis, following federal court approval. This pharmaceutical industry settlement addresses extensive OxyContin harm and provides resources for addiction treatment programs.
Source(s):
What’s in the New Settlement Against OxyContin-Maker Purdue and the Sackler Family (MedPageToday.com – medical news for physicians)
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AMA Delegates Approve Amended Resolutions On IRA Oncology Impacts, IMG Residency Reform; Adopt Slew Of Other Resolutions Without Debate

On November 17, 2025, the American Medical Association’s House of Delegates adopted resolutions evaluating the Inflation Reduction Act’s pharmaceutical pricing impacts on oncology practices and Medicare beneficiaries, while enhancing IMG residency pathways to address physician workforce shortages. These policy changes affect specialty care access, CMS reimbursement structures, and healthcare delivery for vulnerable populations requiring oncological treatment.
Source(s):
AMA Delegates Approve Amended Resolutions On IRA Oncology Impacts, IMG Residency Reform; Adopt Slew Of Other Resolutions Without Debate (InsideHealthPolicy Daily News)
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Cigna announces new copay-centric insurance model, backed by AI care coordination

Cigna’s AI-powered “Clearity” insurance model introduces tiered health plans expanding provider choice and care coordination. The initiative could influence CMS Medicare Advantage strategies and reshape hospital-payer negotiations, while potentially affecting pharmaceutical coverage decisions and medical device reimbursement across healthcare stakeholders.
Source(s):
Cigna announces new copay-centric insurance model, backed by AI care coordination (Health Exec)
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Opinion: Innovative program gives medical students a fuller view of the health care system’s failings

An opinion piece reflects on a medical student’s experience with an elderly Medicare patient navigating complex healthcare system barriers, emphasizing how medical education must incorporate real-world systemic challenges including hospital inefficiencies and regulatory complexities. This narrative highlights the need for patient-centered care training that prepares future physicians to understand policy implications affecting vulnerable populations and healthcare delivery.
Source(s):
Opinion: Innovative program gives medical students a fuller view of the health care system’s failings (Stat)
Tags: #PROVIDER, #PATIENT

Novo nears release of high-stakes data on Alzheimer’s and GLP-1s

Novo Nordisk awaits pivotal FDA-watched Phase 3 trial results on whether GLP-1 drug semaglutide can slow Alzheimer’s progression. Outcomes will impact pharmaceutical industry strategy, potential Medicare coverage decisions, and CMS reimbursement policies for dual-indication therapies, while reshaping the competitive Alzheimer’s treatment landscape amid ongoing safety evaluations.
Source(s):
Novo nears release of high-stakes data on Alzheimer’s and GLP-1s (Stat)
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