Policy Update – July 14, 2025

Introduction

This Week: Kennedy weighs in on prevention and vaccines, more BBB and Prior Auth news, and FDA opens the vault on its drug decisions.

Weekly Spotlight

On the heels of the Supreme Court’s verdict on Braidwood, which affirmed the role of the United States Preventive Services Task Force (USPSTF) in defining what preventive services should be covered by all health plans, Health Secretary Robert F. Kennedy Jr. cancelled planned USPSTF meeting. The response from health organizations was swift and underscores the tension between health policy and governance.

On July 9, 2025, Health Secretary Robert F. Kennedy Jr. abruptly canceled a scheduled meeting of the USPSTF, which was set to discuss important topics such as dietary guidelines and cardiovascular health. This decision came shortly after a Supreme Court ruling that affirmed Kennedy’s authority over the panel, raising questions about his potential influence on preventive health recommendations. The cancellation was communicated via email, which did not provide a specific reason for the decision. However, the Department of Health and Human Services (HHS) expressed a desire to engage with the Task Force in the future.

In response to the cancellation, over 100 health organizations have urged Congressional leaders to protect the integrity of the USPSTF. These organizations emphasized the importance of maintaining the key elements of the Task Force, particularly in light of its postponed discussions on cardiovascular disease and innovative child health strategies. This collective action reflects widespread concern regarding the potential impact of political decisions on public health initiatives.

The cancellation of the USPSTF meeting by Secretary Kennedy raises significant alarms about the future of preventive health care recommendations in the U.S. The swift response from health organizations underscores the vital role that the Task Force plays in shaping health policy. As stakeholders advocate for the protection of the USPSTF, the situation highlights the intersection of health governance and political authority, with potential implications for public health outcomes.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

The Centers for Medicare & Medicaid Services (CMS) has introduced a new model aimed at enhancing prior authorization processes within traditional Medicare. This initiative, known as the Wasteful and Inappropriate Service Reduction (WISeR) model, seeks to combat healthcare fraud and improve the efficiency of authorization procedures by integrating advanced technologies such as artificial intelligence (AI) and machine learning. The new model is being rolled out in select states and targets specific medical services that are prone to misuse.

Overview of the WISeR Model: The WISeR model was unveiled by CMS as part of efforts to streamline prior authorizations for certain traditional Medicare services. It will be implemented in states including Arizona, Washington, New Jersey, Texas, and Oklahoma, starting January 1, 2026, and will run until December 31, 2031. The model focuses on 17 services identified as vulnerable to fraud and waste, including procedures like deep brain stimulation and cervical fusion.

Technological Integration: CMS plans to partner with companies specializing in AI and machine learning to enhance the efficiency of the prior authorization process. Providers involved in the initiative will be compensated based on the savings generated by reducing unnecessary services, thus aligning financial incentives with patient care quality.

Goals and Benefits: The primary aim is to reduce wasteful healthcare spending, which CMS estimates accounted for up to 25% of U.S. healthcare costs, with Medicare alone spending approximately $5.8 billion on low-value care in 2022. CMS Administrator Mehmet Oz emphasized that the model will help streamline processes while safeguarding beneficiaries from unnecessary procedures that can incur high costs and potential harm.

Stakeholder Reactions: While the initiative has garnered support for its potential to reduce fraud, there are concerns among some politicians and experts regarding its implementation and impact on patient care. The model retains clinician authority to deny services that do not meet Medicare coverage criteria, ensuring that decisions are made by healthcare professionals rather than solely by algorithms.

The introduction of the WISeR model by CMS represents a significant step towards modernizing the Medicare prior authorization process. By leveraging technology and focusing on high-risk services, the initiative aims to reduce fraud, lower healthcare spending, and improve the overall experience for providers and beneficiaries alike. However, as with any new model, careful monitoring and evaluation will be crucial to address concerns and ensure that patient care remains a priority.

Articles used:

Opinion: STAT+: How to Evaluate GLP-1s and Medicare Costs? Here’s One Idea

Experts argue that covering GLP-1 medications for weight loss under Medicare could yield significant savings, potentially lowering annual costs per beneficiary. However, current evidence on the cost-effectiveness of GLP-1s is inconclusive, with adherence issues and high drug prices posing challenges to their widespread adoption in treating obesity.

#PAYER

Some Hospitals Charge Commercial Insurers Much More Than Medicare

A recent study indicates that hospitals charge commercial insurers over double the rates they charge Medicare, with price variations influenced by local market dynamics such as hospital concentration and insurer competition. This disparity raises questions about healthcare costs and the financial burden on patients with private insurance.

#All

Physician group, cities sue CMS over ACA final rule

A coalition of physician groups and cities has filed a lawsuit against the Centers for Medicare & Medicaid Services (CMS) regarding a final rule related to the Affordable Care Act (ACA). The details of the lawsuit and the implications for healthcare policy were not provided in the content.

#Provider

Food and Drug Administration (FDA)

FDA Publishes Hundreds of Drug Rejection Letters

Allegedly aiming to provide clearer insights into the decision-making processes behind drug approvals and rejections, the Food and Drug Administration (FDA) published more than 200 complete response letters (CRLs) that detail the agency’s rejections of drug applications.

Publication of Complete Response Letters: On July 10, 2025, the FDA released more than 200 CRLs as part of a broader transparency campaign. These letters were sent to drug manufacturers whose applications were ultimately approved, highlighting the agency’s commitment to openness in the often opaque drug review process. The letters cover decisions made between 2020 and 2024 and include redactions to protect sensitive business information. Notably, at least 14 of these letters were published for the first time.

Implications of the Transparency Initiative: The FDA’s move is seen as a significant effort to demystify the drug approval process, which has often been criticized for its lack of transparency. By compiling these letters in one accessible location, the agency intends to provide stakeholders with more information about the factors influencing drug approvals Critics, however, raise questions about the effectiveness of this transparency initiative, suggesting that while it is a step forward, it may not fully address the complexities and challenges within the drug review process and could give the public a mistaken impression of the safety and effectiveness of a drug product.

In conjunction with the publication of CRLs, the FDA also faced scrutiny for its recent decision to reject Capricor Therapeutics’ marketing application for a cell therapy aimed at treating Duchenne muscular dystrophy. This case exemplifies the ongoing challenges faced by biotech companies in navigating FDA approvals.

Articles used:

Vaccines in the News

Recent developments in the realm of COVID-19 vaccine recommendations and approvals have sparked significant controversy and legal action. The approval of Moderna’s pediatric COVID-19 vaccine, changes in vaccination recommendations by HHS Secretary Robert F. Kennedy Jr., and lawsuits from medical groups highlight a contentious landscape in public health policy.

Moderna’s Pediatric Vaccine Approval: The FDA has granted full approval to Moderna’s COVID-19 vaccine for children, marking it as the first such vaccine in the U.S. to transition from emergency use authorization (Article 2). However, this approval is limited to children with certain medical conditions, raising questions about its implications for broader pediatric vaccination efforts. However, some suggest that the media portrayal of this approval may be misleading, indicating that the approval might not be as comprehensive as reported. Under Secretary Kennedy’s directive, HHS has altered COVID-19 vaccine recommendations, stating that the vaccine would no longer be recommended for healthy children and pregnant individuals. This shift has been met with backlash from six major medical groups, which argue that such changes are unlawful and undermine public trust in healthcare. The lawsuit filed by these groups asserts that the decision violates established vaccine review and recommendation policies, further complicating the public health response to COVID-19 .

Concerns Over Transparency and Oversight

The HHS has faced scrutiny for its handling of conflicts of interest related to new members of the Advisory Committee on Immunization Practices (ACIP). The agency initially promised to release ethics forms for these new members, appointed by Kennedy, but has since failed to do so, raising concerns about transparency. Additionally, the abrupt cancellation of preventive care meetings by Kennedy has alarmed health researchers, who fear potential biases in the composition of advisory panels.

The recent actions and decisions made by the HHS under Secretary Kennedy have ignited legal challenges and public concern regarding the safety and efficacy of COVID-19 vaccinations, particularly for vulnerable populations such as children and pregnant individuals. The controversies surrounding the approval of Moderna’s vaccine and the subsequent changes in vaccination recommendations reflect a broader struggle over public health policy, transparency, and trust. As these issues unfold, they will likely continue to influence public perception and health practices regarding COVID-19 vaccinations in the United States.

Articles Used:

FDA Approves Label Change for Alzheimer’s Amyloid Drug

The FDA has approved a label update for donanemab (Kisunla), an anti-amyloid drug intended for early symptomatic Alzheimer’s disease. The update includes a new titration schedule aimed at reducing potential side effects and improving patient outcomes, as announced by the drug’s manufacturer, Eli Lilly.

#DRUG, #PATIENT

Makary’s big promises at FDA get a closer inspection

In his first 100 days as FDA commissioner, Marty Makary has made several ambitious announcements aimed at increasing transparency and efficiency in the agency’s operations. While some proposals, like releasing complete response letters, are seen as beneficial, others, such as the promise of expedited drug reviews to lower prices, have drawn skepticism regarding their feasibility. The article suggests that Makary’s media-savvy approach might not align with the realities of the pharmaceutical industry, potentially affecting morale within the FDA.

https://www.inoreader.com/article/3a9c6e771266f3e7

#Device, #DRUG

What to Know About the Collapse of the F.D.A.

The FDA is facing significant challenges under the direction of a health secretary who is perceived as antagonistic to its mission. This shift is raising concerns about the agency’s future effectiveness and regulatory capabilitie

#Device, #Drug

Inside the Collapse of the F.D.A.

#Device, #Drug

FDA should judge drugs on what they do in real life, not just in companies’ clinical trials

The article argues that the FDA should evaluate drugs based on their real-world effectiveness rather than solely relying on data from clinical trials conducted by pharmaceutical companies. This perspective highlights the importance of understanding how medications perform in diverse populations and everyday settings, suggesting that real-life outcomes should play a critical role in regulatory decisions.

#Drug

Inside the staff exodus and tanking morale that threaten Makary’s FDA

FDA employees are reportedly disillusioned and leaving the agency due to its increasing politicization and the loss of experienced staff. The article discusses how recent leadership changes and policy decisions, particularly under Health Secretary Robert F. Kennedy Jr., have contributed to declining morale and concerns about the agency’s ability to maintain its high standards in product reviews and inspections. The situation poses risks to the agency’s reputation as a gold standard in public health oversight.

#Drug, #Device

FDA Accepts NDA for Investigational HIV Regimen, Doravirine/Islatravir

Merck’s investigational HIV regimen combining doravirine and islatravir has been accepted by the FDA for review. If approved, this would mark the first two-drug treatment for HIV that does not include an integrase inhibitor, potentially offering a new option for patients.

#Drug, #Patient

Health and Human Services (HHS)

NIH to cap fees for publicly funded research

The National Institutes of Health (NIH) plans to implement a cap on article processing charges that publishers can impose on NIH-funded researchers starting in fiscal 2026. This initiative aims to enhance public trust in health communications by ensuring that research funded by taxpayers remains accessible. Currently, some researchers face fees as high as $13,000 to publish their work, and the NIH also spends millions on subscription fees for access to this research. The cap is part of broader NIH policies designed to promote transparency and maximize the public benefit from research investments.

#All

Trump administration cuts undocumented immigrants’ access to range of federally funded programs

The Trump administration has announced a significant reduction in access for undocumented immigrants to federally funded programs such as health care, early childhood education, and nutritional support, effective July 14. This policy change reverses longstanding federal practices and is expected to instill fear within immigrant communities, potentially worsening health outcomes not only for undocumented individuals but also for their legal citizen children. Additionally, the new rules may impact authorized immigrants, including asylees, refugees, and DACA recipients, as well as those with temporary protected status or work and student visas.

#All

Hill Happenings

The recent passage of President Donald Trump’s “One Big Beautiful Bill Act,” which includes significant cuts to Medicaid and food assistance programs, has sparked widespread concern among state governors and health policy experts. This legislation is projected to create substantial budgetary challenges for states, particularly those with high populations of low-income residents. The articles reviewed highlight the implications of these cuts, the potential for political fallout, and the mixed responses from various stakeholders in the healthcare system.

Impact on State Budgets: The legislation is causing significant financial strain on state budgets as governors face a loss of federal funds, particularly affecting education, public safety, and disaster relief. Democratic governors like Kathy Hochul of New York and Katie Hobbs of Arizona are bracing for budget gaps, with Hochul facing an $11 billion shortfall due to Medicaid cuts. Republican governors also confront challenges in justifying tax cuts while managing the fallout from reduced Medicaid funding.

Political Ramifications: As many governors face reelection in 2026, the cuts provide a political opportunity for Democrats to criticize Republicans for their handling of healthcare and social safety nets. Polling indicates that the cuts are unpopular, with a Quinnipiac survey showing 55% opposition to the law, suggesting potential electoral consequences for Republicans.

Healthcare System Strain: Health policy experts warn that the Medicaid cuts could lead to increased costs for states and higher rates of uninsured individuals, with estimates suggesting over 51,000 preventable deaths could occur due to reduced access to healthcare. Rural hospitals, already under financial pressure, are particularly vulnerable, with experts suggesting that a newly introduced $50 billion rural health fund may not adequately offset the impending losses.

Lobbying and Industry Response: The health care industry’s influence appears diminished, as evidenced by the inability of lobbyists to significantly alter the legislation. Drug manufacturers have received a mixed outcome, with provisions in the bill allowing more medications to be exempt from Medicare price negotiations, potentially costing the government $5 billion in savings.

Future Implications: While some provisions of the bill may not take effect immediately, they pose long-term challenges for state healthcare systems and the populations they serve. The potential for backlash against the cuts to Medicaid and food assistance could shape future political landscapes and healthcare policy discussions.

The “One Big Beautiful Bill Act” represents a significant shift in federal healthcare policy, with far-reaching implications for state budgets, political dynamics, and the healthcare system’s capacity to serve vulnerable populations. As states grapple with the fallout from these cuts, the political and social ramifications will likely unfold in the lead-up to the 2026 elections, highlighting the delicate balance between fiscal policy and public health.

Articles used:

Senate Confirms New Office of Personnel Management Head in Mostly Party-Line Vote

Scott Kupor, nominated by President Trump, has been confirmed as the director of the Office of Personnel Management (OPM) in a 49-46 Senate vote. While some praised his private sector experience, concerns remain regarding his stance on the administration’s workforce reduction initiatives, which have faced criticism for potentially politicizing federal jobs.

#ALL

California Has an Idea to Counter Trump’s Megabill: Roll Back Environmental Laws

In response to President Trump’s budget “megabill,” California lawmakers are considering slashing environmental permitting to expedite clean energy projects. This controversial move could heighten tensions between clean energy advocates and environmentalists, as lawmakers seek to meet strict construction deadlines to retain federal subsidies for renewable energy initiatives.

#ALL

Senate Committee Advances Susan Monarez to Be Trump’s CDC Director

The Senate health committee has advanced Susan Monarez’s nomination as the director of the CDC in a narrow party-line vote. Supporters highlight her extensive public health experience, while critics, including Democrats, raise concerns about her previous actions regarding vaccine safety during her tenure as acting director.

#ALL

Senate GOP plots how to move Trump’s $9.4B clawbacks request

Senate Republicans are strategizing on how to manage President Trump’s $9.4 billion request to cut funding for foreign aid and public broadcasting, with a deadline approaching. Majority Leader John Thune indicated that the bill’s final form is still undecided, as GOP senators discuss potential amendments to protect funding for crucial programs like AIDS prevention and public radio. The urgency is heightened by the looming expiration of the request, which, if not acted upon, would require the administration to allocate the funds as originally intended.

#All

Trump hands Congress a weapon he once warned would do grave damage to presidency

President Donald Trump is compelling Joe Biden’s former aides to provide testimony to congressional investigators regarding Biden’s health, waiving executive privilege to do so. This action mirrors his previous warnings about the dangers of such tactics, raising concerns among constitutional experts about the potential erosion of presidential privilege norms. The investigation, led by Rep. James Comer, aims to explore whether Biden’s health was concealed from the public during his presidency.

#All

AHA backs bill to expand physician residencies

The American Hospital Association (AHA) has endorsed a bipartisan bill aimed at increasing the number of Medicare-supported medical residency positions, which have remained stagnant for nearly three decades. The Resident Physician Shortage Reduction Act proposes adding 14,000 residency slots over seven years, alongside grants for rural hospitals to establish new programs. This legislative effort seeks to address physician shortages and ensure that healthcare providers reflect the communities they serve.

#Provider

Notable Notes

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

The Centers for Medicare & Medicaid Services (CMS) has finalized a national coverage determination for transcatheter tricuspid valve repair (T-TEER) procedures, specifically for Abbott’s TriClip device, which is currently the only FDA-approved option. This decision is expected to enhance treatment options for patients suffering from symptomatic tricuspid regurgitation.

#DEVICE, #PROVIDER, #PATIENT

Cardiac procedure reimbursement: Inpatient vs outpatient

A report on Medicare reimbursement illustrates significant differences in payment rates for cardiovascular procedures across various clinical settings. For example, the reimbursement for a femoropopliteal stent is $11,341 in hospital outpatient departments compared to $7,579 in ambulatory surgical centers (ASCs). Such disparities underscore the financial implications for healthcare facilities and patients.

#HOSPITAL, #PROVIDER, #PATIENT

What’s driving cardiology’s outpatient migration?: 4 things to know

The trend towards outpatient care is driven by factors such as increased physician autonomy, technological advancements, lower costs, and improved patient experiences. Research indicates that the volume of procedures performed in ASCs is expected to grow significantly, with a notable shift towards outpatient settings for peripheral vascular interventions.

#HOSPITAL, #PROVIDER, #PATIENT

Training Gaps in Cardiogenetic Testing

A survey by the American College of Cardiology revealed that 40% of cardiologists lack training in cardiogenetic testing. Despite a high interest in further education, barriers such as the perceived cost and limited access to genetic counselors hinder the integration of genetic testing into cardiovascular care.

#PROVIDER, #PATIENT

Cardiology still No. 2 in FDA-cleared clinical AI algorithms, trailing only radiology

Cardiology ranks second only to radiology in the number of FDA-cleared clinical AI algorithms, indicating the specialty’s growing reliance on technology to enhance diagnostic and treatment capabilities.

#PROVIDER, #PATIENT

Myval TAVR valve associated with positive durability data after 4 years

Research on the Myval TAVR valve has shown promising durability data after four years, although the device is not yet available in the U.S. This highlights ongoing innovations in cardiac devices that could potentially improve patient outcomes.

#DEVICE, #PROVIDER, #PATIENT

New TAVR valve from MiRus linked to positive early outcomes

The Siegel TAVR valve, developed by MiRus, has shown promising early outcomes in clinical trials. Unlike traditional valves, this new device is constructed from specialized alloys that do not contain nickel or cobalt. This innovation aims to enhance patient safety and comfort during transcatheter aortic valve replacement procedures.

#Device, #Provider, #Patient

Federal Workers Brace for the End After Supreme Court Ruling

Federal employees are expressing anxiety and exhaustion following a Supreme Court ruling that could jeopardize their jobs. Many are holding out hope that legal avenues may still protect their positions amid ongoing uncertainty.

#ALL

When Defending Science, Fight with Composure

The article discusses the challenges faced by scientific institutions amid budget cuts and workforce reductions. It emphasizes the need for the medical community to advocate for science with composure and resilience in the face of political pressures.

#ALL

AMA Continues Fight Against Scope of Practice Creep

The American Medical Association (AMA) has achieved 180 victories in limiting the scope of practice for various healthcare professionals, emphasizing the importance of proper training and background in medical practices. However, the organization faces ongoing challenges as it seeks to maintain these standards against growing pressures.

#PROVIDER

Trump extends hiring freeze for 3 more months

President Trump has extended the hiring freeze for federal civilian positions for an additional three months, maintaining restrictions on hiring across federal agencies. The freeze, which has been in place since his inauguration, includes exemptions for certain positions related to national security and public safety. This extension reflects the administration’s ongoing efforts to reduce the federal workforce through attrition rather than layoffs.

#All

Opinion: A patient told me that I hadn’t listened closely enough. I’m glad she did

In a reflective piece, Dr. Jeffrey Millstein discusses a recent encounter with a patient who expressed concern about his listening skills during a prior visit. He appreciates the feedback as it highlights the importance of patient comfort in communication, emphasizing that such openness can lead to better health discussions and outcomes.

#All

Modern HIV Rapid Test Similar to COVID Rapid Test | IAS 2025

The article discusses the A-0 test, a widely used HIV antibody blood test available at low cost in many low- and middle-income countries. This test is highlighted for its affordability and accessibility, drawing parallels to the rapid testing methods developed during the COVID-19 pandemic. The emphasis on cost-effective testing solutions underscores an ongoing effort to improve public health responses to infectious diseases.

#All

Gilead to provide HIV prevention drug to 2 million people in lower-income countries at cost

Gilead has announced an agreement to supply its HIV prevention drug, lenacapavir, to up to 2 million individuals in low- and middle-income countries at a no-profit price. The Global Fund to Fight AIDS, Tuberculosis and Malaria will oversee the purchase and distribution of the drug, which was recently approved for sale in the U.S. This initiative aims to enhance access to vital HIV prevention resources in economically disadvantaged regions.

#Drug, #Patient, #Provider

29 physician specialties gaining, losing ground on pay

A report indicates that diabetes and endocrinology specialists have seen the highest pay increase this year, while several specialties, such as cardiology and dermatology, have experienced pay cuts. The data, gathered from over 7,000 physicians, reflects trends in compensation across various medical fields and raises discussions about the factors influencing these changes.

#Provider

Opinion: Loneliness Is A Public Health Crisis. And It’s Everywhere In Connecticut

Dr. Phil Roland, market medical executive, Cigna Healthcare for Connecticut and the Northeast, writes about loneliness as a “growing public health crisis.” Data from The Cigna Group’s “Loneliness in America” report indicate “57% of Americans say they feel lonely, a number that has remained at epidemic levels for years.” Roland discusses how healthcare providers, nonprofits, and government agencies are addressing loneliness, and shares that Cigna Healthcare is “exploring something called ‘social prescriptions’ — intentional referrals to local resources that help patients form relationships, build routines and strengthen their support systems — as way to take on loneliness head on.”

#PATIENT, #PAYER

Policy Update – July 14, 2025

Introduction

Weekly Spotlight

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Food and Drug Administration (FDA)

FDA Publishes Hundreds of Drug Rejection Letters

Vaccines in the News

What to Know About the Collapse of the F.D.A.

Health and Human Services (HHS)

Hill Happenings

Notable Notes

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