Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS takes aim at provider taxes in proposed rule
Provider taxes, utilized by 49 states to help finance Medicaid, artificially inflate Medicaid spending to increase federal reimbursement dollars according to a March KFF analysis. While providers maintain these long-standing policies are both legal and necessary, watchdog organizations are advocating for greater transparency in the financial flows between entities. These tax mechanisms, which have existed in some form since the 1980s, represent a significant funding strategy for state Medicaid programs across the country.
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Opinion: STAT+: How Medicaid can innovate in the DOGE era
As policymakers in Washington consider large cuts to Medicaid, provider groups, entrepreneurs, technologists, and investors may feel compelled to turn their efforts away from the program.
Authors, Nate Favini, Andrey Ostrovsky, and Neil Batlivala believe this would be a profound mistake. Favini is chief medical officer for Pair Team. Ostrovsky is former chief medical officer for Medicaid and is managing partner at Social Innovation Ventures. Batlivala is chief executive officer for Pair Team.
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CMS and ASTP make broad health tech info request
The CMS and ASTP have issued an RFI to gather feedback on improving health IT adoption, data interoperability, and supporting digital health in rural areas, amidst ongoing debates over frameworks like TEFCA. Leadership changes at CMS signify a focus on preventive care and technological innovation, with industry investments and new product approvals highlighting rapid health tech progress. Meanwhile, legislative efforts, such as proposed restrictions on AI regulation, could influence the future landscape of digital health, emphasizing ongoing evolution in health technology and policy.
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Intra-annular TAVR valves from Edwards Lifesciences and Abbott deliver similar 1-year outcomes
The study found that both Intra-annular TAVR valves from Edwards Lifesciences and Abbott show comparable one-year outcomes, with each valve offering specific benefits. The findings suggest that while there are differences, the overall efficacy of both devices remains largely similar over the year following implantation. This information may influence clinical decisions regarding valve selection for patients undergoing TAVR procedures.
#Device, #patient, #provider
CMS proposes adding Part B drugs to price negotiation program: 5 notes
On May 12, CMS published draft guidance proposing several changes for the third round of Medicare drug price negotiations, including the potential inclusion of certain Medicare Part B drugs. According to the agency’s news release, the guidance focuses on increasing program transparency, prioritizing drugs with the highest Medicare costs, and ensuring fair pricing without impeding pharmaceutical innovation. These proposed changes represent CMS’s continued efforts to refine the Medicare drug price negotiation process.
#Drug, #Payer, #Patient
Flawed Federal Programs Maroon Rural Americans in Telehealth Blackouts
Rural Americans face challenges in accessing telehealth services due to inadequate internet and technology infrastructure, exemplified by Ada Carol Adkins’s struggles in West Virginia. It critiques federal programs for failing to effectively address these rural healthcare gaps and emphasizes the urgent need for improvements to ensure equitable access. Overall, the piece calls for stronger efforts to enhance rural telehealth infrastructure to reduce health disparities in these communities.
#Patient
Expect More Downside Risk in Medicare’s Payment Models, CMS Official Says
Abe Sutton, director at the Center for Medicare and Medicaid Innovation, has indicated physicians should prepare for an increase in Medicare alternative payment models incorporating downside risk, where providers may face financial penalties for not meeting performance metrics. The strategy emphasizes innovation within Medicare to improve care quality and efficiency while potentially reducing costs through evidence-based prevention, patient empowerment, and driving choice and competition in healthcare markets. This strategic direction aligns with the Innovation Center’s commitment to driving healthcare transformation through payment reform while protecting federal taxpayers and promoting evidence-based prevention.
#Provider, #Hospital, #Patient
CMS Asks: Can digital tools “Make America Healthy Again?”
CMS is seeking public input on how digital technologies can improve healthcare for Americans, especially seniors, by enhancing decision-making, managing chronic conditions, and increasing health data interoperability. The agency emphasizes its role as an innovation facilitator and is focused on advancing digital health tools, secure data exchange, reducing administrative burdens, and promoting value-based care. This proactive approach aims to leverage technology to improve healthcare outcomes and efficiency across the system.
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Food and Drug Administration (FDA)
US FDA approves first at-home test for cervical cancer screening
The U.S. Food and Drug Administration has approved the first at-home test for cervical cancer screening, offering an alternative to Pap smears that need to be undertaken at a doctor’s office.
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STAT+: FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks – Stat
The FDA plans to introduce new guidance for vaccine manufacturers, particularly regarding COVID-19 vaccines, to create a clearer regulatory framework. This initiative aims to enhance transparency and predictability for vaccine developers as the agency seeks to streamline its processes. Details on the guidance are expected to be revealed in the coming weeks.
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Health and Human Services (HHS)
White House unveils sweeping plan to try to lower U.S. drug prices
The Trump administration on Monday unveiled a sweeping plan that aims to lower prescription drug prices — but its impact on the pharmaceutical industry remains to be seen.The plan relies on drugmakers striking deals with the U.S. government to lower their prices, with a threat of new government regulation and legal investigations if they don’t. It calls for basing U.S. drug prices on those paid by other countries, aiming to slash prices in the U.S. and push them up overseas through trade policy. Industry leaders and policy experts have said President Trump’s executive order on Most Favored Drug Pricing is flawed and ignores the basic economics of the global drug marketplace. Experts warn that improper implementation might cause adverse effects on the pharmaceutical industry and innovation efforts.
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The Trump administration’s NIH and FDA cuts will negatively impact patients – Brookings
The Brookings article highlights that budget cuts to the NIH and FDA during the Trump administration are likely to impede medical research and delay the approval of new treatments, adversely impacting patient care and public health. It warns that these reductions could lead to higher healthcare costs and a decline in medical advancements, with long-term consequences for future generations. Overall, the article stresses the risks these funding cuts pose to medical progress and patient well-being.
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HHS recalls some previously laid off worker safety employees
The Department of Health and Human Services has unexpectedly recalled some employees facing layoffs, specifically within the National Institute for Occupational Safety and Health. This decision follows a court ruling that mandated the reinstatement of specific positions, although many employees remain laid off. The situation reflects ongoing tensions and uncertainties regarding staffing within federal health agencies.
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CDC to cut one employee for each it is recalling from layoffs – Government Executive – All Content
The CDC has announced that for every employee it recalls from layoffs, it will implement a corresponding reduction elsewhere, maintaining overall staffing levels. This decision follows recent court rulings impacting public health staffing and reflects the agency’s ongoing challenges in balancing workforce needs amidst federal layoffs. The situation remains fluid, with additional cuts expected to comply with legal requirements.
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These are the regulations the AHA wants RFK Jr. to scrap
The American Hospital Association recommends that the Health and Human Services Department eliminate or ease a slew of regulations on billing, quality reporting, the workforce and other areas in a letter sent to regulators.President Donald Trump has made deregulation a centerpiece of his expansive overhaul of the federal government, including at HHS. The AHA wrote the department Monday offering more than 100 suggestions for policies to scrap in response to an April solicitation from the White House Office of Management and Budget
#Hospital
HIV Testing and Outreach Falter as Trump Funding Cuts Sweep the South
President Donald Trump, in his first term, promised to end America’s HIV epidemic — and he put the resources of the federal government behind the effort. This time, he has deployed the powers of his office to gut funding, abandoning those communities at highest risk of HIV.
#Patient, #Provider
Hill Happenings
Projected number of uninsured from GOP’s bill is nearing levels not seen since ACA repeal effort
Republican health care agenda is likely to increase the number of uninsured Americans, nearing levels seen during failed 2017 ACA repeal efforts. It highlights the lack of a cohesive health care strategy under Trump and emphasizes Medicaid cuts to fund tax reductions, with significant projected costs over the next decade. Overall, there are concerns that the focus on tax cuts may undermine health coverage and reform efforts.
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House GOP unveils plans to reshape Medicaid
House Republicans are proposing to add work requirements for some Medicaid recipients and to reduce federal Medicaid funding for states that cover undocumented immigrants. The policies were included in plans for reducing Medicaid spending released late Sunday by the Energy and Commerce Committee. The proposal, which is to be considered this week by a key House panel, omits some of the furthest-reaching reductions to the health program but would leave millions without coverage or facing higher costs. The House Energy and Commerce Committee advanced the bill proposing $625 billion in Medicaid cuts over ten years to fund broader tax cuts, primarily through work requirements and eligibility checks. The legislation faces uncertain future passage, highlighting deep partisan divisions over Medicaid and health policy priorities. The bill includes $500 million for IT modernization and AI initiatives at the Commerce Department, allowing for upgrades to outdated systems and the deployment of AI
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RFK Jr. Defends HHS Overhaul as Democrats Denounce War on Science
Health Secretary Robert F. Kennedy Jr. defended his extensive restructuring of federal health agencies, which involves significant budget cuts and staff reductions, amid Democratic criticism and concerns over impacts on public health programs. While Kennedy and some Republicans support the reforms, most Americans oppose the proposed cuts due to fears of undermining vital health services, especially in light of recent outbreaks. The controversy underscores deep divisions over health policy, vaccination views, and the future of funding for agencies like the NIH and CDC. Republicans expressed support for Health Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” agenda, while raising concerns on peripheral issues and exercising caution on controversial topics. The hearing revealed a tense atmosphere as Kennedy balanced defending his policies with responding to concerns about their effects on scientific and public health efforts.
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PBM limits could finally pass, if Congress moves its tax-cut bill
New restrictions and transparency rules for pharmacy benefit managers (PBMs) are being considered as part of a larger reconciliation budget advancing in Congress. These changes aim to address compensation practices within the PBM industry, potentially impacting drug pricing and accessibility for patients. The outcome of the tax-cut bill may determine the future of these proposed regulations. In a 160-page bill introduced May 11, House Republicans proposed requiring pharmacy benefit managers to adhere to a transparent pass-through pricing model with states.
If the bill — which aims to cut billions of dollars in Medicaid funds — passes, federal law would require:
- Contracts between PBMs and states to adhere to a drug pricing model limited to a therapy’s ingredient cost and dispensing fee.
- Payments to be passed in their entirety by the PBM to the pharmacy or dispenser.
- PBM administrative fees to reflect fair market value.
#Drug, #Payer, #Patient
Cardiology groups among the many voices asking Congress not to cut Medicaid
A coalition of over 40 U.S. healthcare organizations warns that substantial Medicaid cuts could result in 7.6 million Americans losing health coverage. They emphasize Medicaid’s vital role in supporting vulnerable populations and caution against funding reductions that could harm access to essential healthcare services. The groups are urging Congress to reconsider proposed cuts to protect ongoing access to necessary health care for millions
#Provider
Notable Notes
STAT+: MAHA has a new think tank. The Trump administration is listening
The newly launched MAHA Institute aims to influence federal health and food policy, advocating for significant changes including vaccine availability and dietary reforms. Close allies of Health Secretary Robert F. Kennedy Jr. lead the institute, which seeks to rival established think tanks. The initiative reflects broader political movements and could have implications for public health regulations.
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When valves fail: Surgeons share advice for treating high-risk patients with TAVR explant and SAVR
When a patient’s TAVR valve fails, redo TAVR is not always a feasible option. TAVR explantation and SAVR are typically the answer in these cases, but that approach is associated with certain risks.
#Patient, #Provider, #Device
UnitedHealth under criminal investigation for Medicare fraud
UnitedHealth Group’s stock plummeted by up to 18% amid reports of a Justice Department criminal investigation into potential Medicare fraud, leading to significant market value losses and declines in rival insurer stocks. The company denies being notified of any investigation and emphasizes the integrity of its Medicare Advantage operations, despite ongoing scrutiny of its practices in managing care for sicker patients. With broader regulatory challenges, including antitrust concerns over a recent acquisition, UnitedHealth faces heightened uncertainty about its future prospects in the Medicare sector.
#Payer
Dr. John Whyte to serve as American Medical Association CEO
Dr. John Whyte, an internal medicine specialist, has been appointed as the next CEO and executive vice president of the American Medical Association, effective July 1, according to the physician trade group’s Friday announcement. He will succeed Dr. James Madara, who has served as CEO since 2011. Dr. Whyte brings extensive experience to the role, having previously served as chief medical officer at WebMD and held leadership positions at several federal health agencies including CMS, HHS, and the FDA.
#Provider
Staffing Woes Tied to Physician Burnout
Nearly half of surveyed physicians experience burnout, with 47.9% meeting the criteria and over a quarter experiencing severe burnout. Staffing shortages are identified as a key factor contributing to physician exhaustion and stress. The findings underscore the importance of addressing staffing issues to help reduce burnout and enhance physician well-being.
#Provider
