Weekly Spotlight
CBO Explores the Impact of NIH Funding Cuts and FDA Review Delays on Drug Development.
The CBO evaluated the impact of a hypothetical 10% reduction in NIH funding, specifically focusing on external preclinical research. It is estimated that such a reduction would lead to a decrease of approximately 4.5% in the number of new drugs introduced to the market over time, equating to about two fewer drugs per year. This effect is projected to grow over a 30-year period, with the full
impact realized in the third decade after the funding cut begins. CBO has not yet analyzed the effects of more drastic funding cuts, upwards of 35%, to the NIH that may yet be implemented, leaving uncertainty about the broader implications of such changes.
The CBO also assessed the consequences of a nine-month increase in the FDA’s review times for new drug applications (NDAs). Initially, this would lead to a delay in drug approvals, with most approvals shifting to the subsequent year. Over time, the increased costs associated with longer review periods would deter drug approvals, resulting in an estimated 2% reduction annually, translating to about one fewer drug approved each year in the second decade after the increase.
The projected reductions in drug approvals highlight the long-term consequences of these fiscal policies, which could hinder medical advancements and public health outcomes. The findings suggest that maintaining adequate funding and efficient regulatory processes is crucial for fostering innovation in the pharmaceutical industry.
Articles Used
- Trump Administration’s N.I.H. and F.D.A. Cuts Could Curtail New Drug Development, Budget Office Says
- CBO: How Changes to Funding for the NIH and Changes in the FDA’s Review Times Would Affect the Development of New Drugs
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS Publishes Outpatient Hospital and Physician Payment Proposed Regs
Proposed changes to the Physician Fee Schedule aim to adjust payment rates, with implications for various medical practices and specialties. For 2026, CMS has proposed a 3.6% pay increase for physicians, with two separate conversion factors for qualifying alternative payment model participants and non-participants. This adjustment is part of ongoing discussions about the sustainability and adequacy of the Medicare payment model, which many providers deem outdated and underfunded.
The Centers for Medicare & Medicaid Services (CMS) proposed cuts to payments for specialists, particularly those perceived as overpaid for certain procedures. This move is part of a broader strategy to increase payments for primary care doctors while reducing compensation for specialists. Proposed changes include a 2.5% reduction in payments for thousands of procedures primarily performed by specialists, as well as a new “efficiency adjustment”
The proposed cuts are seen as an effort to balance the compensation landscape between primary care providers and specialists. Historically, specialists have been compensated at higher rates, which has raised concerns about the sustainability of primary care practices. The American Medical Association has criticized the proposed changes, arguing they could undermine care quality and access.
Provider groups have expressed dissatisfaction with the proposed payment models, emphasizing the need for comprehensive reform to address systemic issues within the Medicare fee schedule. They argue that without significant changes, the current model will continue to threaten the viability of independent practices and the quality of care provided.
In conjunction with payment changes, CMS is expanding coverage for remote patient monitoring (RPM) services, which have seen significant growth in spending—from $15 million in 2019 to over $300 million in 2022. However, there are calls for regulatory guardrails to prevent potential abuses in this rapidly growing area. The expansion of remote patient monitoring services represents a modernization effort but also raises concerns about regulatory oversight.
In the outpatient hospital and ASC proposed rule for 2026, key changes include a proposed 2.4% payment increase, significant modifications to the inpatient-only list, and a controversial plan to recoup $7.8 billion in overpayments related to the 340B drug program. The American Hospital Association (AHA) has expressed strong opposition to some of these proposals, labeling them as “illegal and unwise.”
CMS has proposed a 2.4% increase in outpatient payment rates for hospitals and ASCs. This increase is derived from a projected market basket update of 3.2%, adjusted by a 0.8% productivity cut. AHA representatives have criticized this adjustment as insufficient, especially for hospitals in financially strained rural and underserved areas.
The proposed rule also includes a plan to phase out the inpatient-only list over three years, beginning with 285 procedures primarily related to musculoskeletal care. This change aims to provide more flexibility for physicians in determining the appropriate setting for procedures, allowing them to be conducted in outpatient facilities.
CMS is accelerating a repayment plan that requires hospitals to return $7.8 billion in overpayments made under the 340B drug program. Instead of a gradual repayment over 14 years, hospitals would face a 2% annual cut through 2031. AHA has condemned this plan, claiming it penalizes hospitals for CMS’s own mistakes and citing a Supreme Court ruling that deemed the previous policy unlawful.
Other proposed changes include updates to hospital price transparency rules and the introduction of a new drug acquisition cost survey. CMS is also revising the criteria for procedures covered in ASCs, aiming to enhance safety and efficiency. The AHA’s strong opposition to the clawback plan and the proposed adjustments to the inpatient-only list highlight the ongoing tensions between healthcare providers and regulatory bodies.
(See below for articles consulted)
Two insurers dominate most Medicare Advantage markets, report find
A report reveals that over 97% of U.S. counties experience high levels of consolidation in Medicare Advantage markets, predominantly led by UnitedHealthcare and Humana. These two insurers have significant control over the plans available to Medicare beneficiaries nationwide.
#All
Disabled Americans Fear What Medicaid Cuts Could Do to Them
NYT explores the apprehensions of disabled Americans regarding proposed Medicaid cuts amounting to roughly $1 trillion. While the White House claims these cuts will not affect home- and community-based care, health care experts disagree, fearing that such reductions will significantly impact the services available to disabled individuals. The potential consequences of these cuts could lead to reduced access to essential healthcare services for vulnerable populations.
#Patient
US health department hands over Medicaid personal data to ICE
The article reports on the controversial decision by the U.S. health department to provide Medicaid personal data to Immigration and Customs Enforcement (ICE). This action has raised significant concerns about privacy and the potential implications for Medicaid recipients, particularly among immigrant communities. The transfer of such sensitive information could deter individuals from seeking necessary healthcare services due to fear of repercussions.
#Patient, #Hospital
CMS Launches Value-Based Gene Therapy Program for Sickle Cell Disease
The Centers for Medicare & Medicaid Services (CMS) has initiated a value-based gene therapy program specifically for sickle cell disease, establishing outcomes-based agreements on behalf of Medicaid programs. This program has been adopted by 33 states, Washington, D.C., and Puerto Rico, collectively covering approximately 84% of Medicaid enrollees affected by the disease. The initiative aims to improve access to innovative therapies for patients suffering from sickle cell disease.
#Patient, #Provider
Food and Drug Administration (FDA)
The FDA clearances for medical devices you need to know
The article discusses recent FDA clearances for various medical devices, although specific details about the devices and their implications were not provided in the excerpt. The focus is on keeping healthcare professionals informed about important regulatory updates that could impact clinical practice and patient care.
#Device
EtO for Device Sterilization: Executive Order
On July 17, President Donald Trump issued an executive order regarding the use of ethylene oxide for sterilizing medical equipment. The Environmental Protection Agency’s new emissions-control requirements, known as the EtO Rule, are argued to impose severe burdens on commercial sterilization facilities, potentially disrupting the supply of critical medical devices. To address this concern, Trump has exempted certain facilities from compliance with the EtO Rule for an additional two years, allowing them to continue operating under previous emissions standards to maintain national security and healthcare outcomes.
#Device
FDA floats fast-track incentives for drugmakers that lower prices
The FDA is considering offering fast-track reviews for pharmaceutical companies that commit to lowering drug prices in the U.S. to match those in other countries. This initiative, discussed by FDA Commissioner Marty Makary, would allow companies to receive priority review vouchers, significantly reducing the time for drug approval from about 10 months to as little as 1-2 months. However, concerns have been raised regarding the vagueness of the program’s guidelines, which some experts fear could lead to political favoritism.
#Drug
FDA taps biotech veteran George Tidmarsh to lead drug center
The FDA has appointed George Tidmarsh as the new director of its Center for Drug Evaluation and Research. Tidmarsh, a seasoned biotech executive with experience in oncology and pediatrics, has played a significant role in the development of various approved drugs. His appointment is expected to bring extensive scientific and regulatory expertise to the FDA, enhancing its ability to evaluate and approve new medications effectively.
#Drug
A ‘Culture Change’ Is Needed in Academic Medicine, FDA Commissioner Says
FDA Commissioner Marty Makary emphasized the need for a cultural shift in academic medicine during an event hosted by The Hill. He criticized the current environment shaped by the National Institutes of Health (NIH), suggesting that it is time for a transformation to improve the field.
#All
Health and Human Services (HHS)
RFK Jr. gives vaccine skeptics plum HHS posts
Health and Human Services Secretary Robert F. Kennedy Jr. has appointed several vaccine skeptics to influential positions within the department, raising concerns about the politicization of public health. These appointments include roles typically held by career staff, which experts worry could undermine the integrity of health policy. Additionally, a recent Danish study has reaffirmed the safety of aluminum in vaccines, countering claims made by some anti-vaccine advocates.
#All
Opinion: I worked for 20 years for the HHS office that safeguarded people in research studies. DOGE gutted it
In an opinion piece, Ivor Pritchard reflects on his 20 years at the Office for Human Research Protections (OHRP) and the importance of protecting individuals participating in clinical research. He expresses concern over the potential erosion of safeguards designed to prevent coercion in research participation, particularly following recent changes within the HHS. Pritchard emphasizes the need for stringent regulations to ensure ethical practices in clinical trials.
#All
HHS formally lays off thousands of employees following SCOTUS ruling
Following a Supreme Court decision that lifted a lower court injunction, the U.S. Department of Health and Human Services has officially terminated around 10,000 employees. This significant reduction in workforce follows a legal ruling impacting the agency’s operations and employment policies.
#All
Kennedy dismisses two top HHS aides
Health and Human Services Secretary Robert F. Kennedy Jr. has dismissed two senior aides, Heather Flick Melanson and Hannah Anderson, after only a few months in their positions. The changes signal a leadership shakeup within the department, with Matt Buckham stepping in as the acting chief of staff. The dismissals come as Kennedy aims to further his agenda, which includes a commitment to improving public health initiatives.
#All
The NIH Undergoes More Shake-Ups
The National Institutes of Health (NIH) is experiencing significant organizational changes, including the dismissal of advisory council scientists and the disbandment of the Advisory Committee to the Director. Reports indicate that some research deemed risky has been paused, reflecting a broader shift in the agency’s operational focus. These alterations are part of ongoing efforts to reshape the NIH’s approach to research and public health initiatives.
#All
As Past USPSTF Chairs, We Fear for the Future of the Task Force
In an open letter, former USPSTF Chairs express concern over the cancellation of a scheduled meeting of the U.S. Preventive Services Task Force (USPSTF) by the Secretary of Health and Human Services. This cancellation has raised alarms among primary care clinicians, who fear it may signal a diminishing role for the task force in shaping preventive health guidelines. The implications of this change could negatively impact public health initiatives and the delivery of preventive care.
#All
340B Health pushes back on CMS plan for steeper hospital cuts
340B Health has raised objections to the Centers for Medicare & Medicaid Services (CMS) plans to implement deeper cuts to outpatient payments and potentially reduce drug reimbursements for 340B hospitals. These proposed cuts are part of a strategy to recoup funds following a Supreme Court ruling that found previous cuts to drug payments unlawful. The organization warns that using cost survey data to set future payment rates could undermine the benefits of the 340B program for hospitals serving vulnerable populations.
#Hospital, #Drug
Hill Happenings
Congress has Passed the Big Beautiful Bill, Now What?
Senator Josh Hawley (R-MO) has introduced a bill aimed at repealing federal Medicaid cuts. This initiative follows his support for the “One Big, Beautiful Bill Act,” which had a narrow passage in the Senate. The proposed legislation seeks to bolster funding for rural hospitals and restore funding to safety-net healthcare programs, indicating a proactive approach to address healthcare accessibility issues in underserved areas. At the same time, House GOP Budget Chair Jodey Arrington is advocating for a reduction in Medicaid federal matching funds for expansion states and the introduction of site-neutral payment for hospitals in a forthcoming reconciliation bill. This proposal aligns with broader Republican efforts to reform Medicaid, although it may face opposition from Democrats who support maintaining funding levels.
Lawmakers are advancing spending bills for FY26, with House Republicans proposing significant cuts while largely rejecting President Trump’s most drastic reductions. The House’s appropriations measures are divided along party lines, with notable cuts to federal staffing, including a 26% reduction in the Department of Housing and Urban Development. The Senate’s approach is more bipartisan, with funding bills that maintain or slightly increase spending levels, particularly for essential programs like international food aid. Key concerns include the impact of cuts on public services, with Democrats warning that reductions to agencies like the Environmental Protection Agency could harm public health and safety.
Senator Susan Collins, chair of the Appropriations Committee, faces internal party challenges as GOP leaders prioritize President Trump’s budget proposals over her concerns about safety-net cutbacks. Despite her efforts to maintain bipartisan cooperation, Collins finds herself at odds with party leadership, which could jeopardize her political future as she considers running for a sixth term. Polling indicates declining support for Collins among Maine voters, raising questions about her re-election prospects amidst a potential Democratic challenge.
While Congress grapples with spending bills that reflect differing priorities between Republicans and Democrats, individual lawmakers like Senator Collins navigate complex party dynamics that may influence their electoral futures. The outcomes of these legislative efforts and the political landscape will shape the next fiscal year and beyond.
(See below for articles consulted)
Senate clears amended bill to claw back billions in foreign aid and public media funding
The Senate passed legislation to rescind $9 billion in previously approved government funding, targeting foreign assistance and public media. The bill, which now moves to the House, faced opposition from some moderates and Democrats concerned about the lack of transparency in proposed cuts to vital programs.
#All
The Appropriations Process Was Already Broken. The Rescission Bill May Have Just Shattered It.
This article discusses the deteriorating state of the government appropriations process, exacerbated by a recent rescission bill. With a history of failing to pass all appropriations bills since 1997, the current political climate is characterized by deep partisan divides, making it increasingly unlikely that a comprehensive appropriations package will be achieved before the upcoming funding deadline. The article reflects on the challenges and implications of this dysfunction in Congress.
#All
What the GOP’s cuts to public broadcasting have to do with health care policy
While these cuts do not directly affect domestic health care programs, they may hinder bipartisan efforts on health care legislation, as Democrats could become more reluctant to collaborate with Republicans after witnessing their willingness to retract previously agreed-upon funding. The White House’s plans for further rescissions could exacerbate this partisan divide.
#All
The White House is frustrated with Susan Collins. She might be the GOP’s best option.
President Trump is reportedly frustrated with Senator Susan Collins due to her critical votes affecting his agenda, leading to discussions about potential replacements if she does not seek reelection. Despite her moderate stances causing tension, local Republicans believe she is the best chance to retain the seat in a state trending blue, as no other Republican is seen as viable against strong Democratic challengers.
#All
Republicans are ready to revive stalled health care legislation. Dems want the GOP to pay a price.
The article outlines the Republican party’s efforts to revive a bipartisan health care package, following significant cuts to Medicaid in their recent legislation. However, Democrats are hesitant to engage in negotiations, citing a lack of trust after Republicans retracted previously agreed-upon funding. The article discusses the complexities of potential bipartisan cooperation, including demands from Democrats for the extension of ACA tax credits as a condition for collaboration.
#All
Democrats wrestle with shutdown strategy
This article details the frustrations of Democrats in Congress as they face challenges in negotiating government funding with Republicans, who are pushing for deep spending cuts and conservative policy changes. With a potential government shutdown looming, Democrats are struggling to unify their strategy to counter the GOP’s actions, which have included significant funding clawbacks. The piece highlights the difficulties in maintaining effective bipartisan negotiations amid a contentious political environment.
Opinion: Doctors in Elected Office Are Turning Their Backs on Science
There are reportedly growing frustrations among health professionals that elected officials with medical and science backgrounds appear to support policies that contradict scientific findings, undermining the role of science in public health and medical practice. This trend raises concerns about the future of health policy and its alignment with scientific research.
#All
Senators reveal how much Lilly, Pfizer paid telehealth companies
Four U.S. senators, led by Sen. Dick Durbin, have been investigating the financial relationships between telehealth companies and pharmaceutical giants Pfizer and Eli Lilly. Their inquiry revealed that both companies have established direct-to-consumer telehealth platforms to connect patients with healthcare providers for medication-related conditions. While these partnerships aim to enhance access to care, there are concerns among legislators and health policy experts that they may lead to unnecessary prescriptions and elevated healthcare costs.
#Drug
Coalition sends research reimbursement model to Congress
A coalition of research institutions has submitted a new reimbursement model for indirect research costs to Congress, aiming to enhance accountability and efficiency in funding. The proposed model seeks to replace the existing federal cost structure and is designed to accommodate the diverse needs of institutions conducting research. The coalition warns that proposed caps on reimbursements could limit research capabilities and hinder medical advancements.
#Provider
Notable Notes
Advancements in HIV Prevention
Several articles discuss new developments in HIV prevention and treatment coming out of the International AIDS Society 13th Annual Meeting in Kigali, Rwanda. Reports highlighted the investigational oral PrEP agent MK-8527, which appears safe and well-tolerated among low-risk adults and a study showing that adults with HIV reported greater satisfaction after switching to long-acting ART, indicating a positive shift in treatment options. The World Health Organization also announced inclusion of lenacapavir in its PrEP recommendations, despite underutilization issues and barriers to accessing PrEP due to high costs and a lack of federally funded programs. This sentiment is echoed in discussions of the effectiveness of the PEPFAR program in saving lives and the threat it faces from funding cuts. Advocates emphasize the need for partnerships and innovations to overcome these barriers and improve patient-focused care while raising concerns about the future of HIV science and services and suggesting a shift in responsibility to other nations like China.
Reports also stress the importance of integrating HIV care with primary and sexual health services to enhance health outcomes. Experts at IAS 2025 argue that coordinated policies and sustained funding are crucial in achieving this integration, while also addressing the stigma and structural barriers that hinder progress.
Highlighted articles listed below collectively underscore the critical intersection of patient autonomy, advancements in HIV prevention and treatment, and the significant barriers to accessing care. They call for a respectful approach to individual choices in health care while advocating for improved access and integration of services. The future of HIV care hinges on continued innovation, collaboration, and adequate funding to ensure that all individuals can benefit from the latest advancements in treatment and prevention.
(See below for articles consulted)
Trump threatens pharma tariffs this month: 4 notes
President Donald Trump announced the potential imposition of tariffs on pharmaceuticals by the end of July, coinciding with broader tariffs set for August 1. He indicated that these tariffs could start low but escalate significantly, potentially reaching 200% in the future unless pharmaceutical companies relocate manufacturing to the U.S. This announcement follows a cabinet meeting where Trump discussed tariffs on copper and cited national security concerns related to imports. Additionally, he has been negotiating with trading partners to adjust tariff rates, with smaller nations facing a flat 10% tariff while larger partners like the EU could see higher rates.
#Drug
ACC recognizes 400+ hospitals for chest pain, heart attack care
The American College of Cardiology has recognized over 400 hospitals for their excellence in treating acute myocardial infarction, with various levels of achievement awarded. The hospitals met specific performance metrics as part of the ACC’s Chest Pain-MI registry, highlighting their commitment to quality care.
#Hospital
Advancing multi cancer early detection
Experts are focusing on the diagnostic pathways following positive results from multi-cancer early detection (MCED) tests. A recent discussion highlighted the importance of imaging in confirming diagnoses and minimizing patient anxiety. Key findings suggest that imaging-based diagnostic pathways may reduce the number of procedures needed for patients with positive MCED tests, ultimately enhancing patient care and improving outcomes in cancer detection.
#Patient
Do Doctors Profit Off Vaccines? Fact-Checking RFK Jr.’s Claims
An article from The New York Times discusses claims made by Robert F. Kennedy Jr. regarding the profits doctors make from vaccines. Experts emphasize that such statements can undermine trust in healthcare professionals and the medical community, indicating that misinformation can have serious public health implications.
#Patient, #Provider
AMA President: Healthcare Cuts Have Left Us With Few Options
The President of the American Medical Association discusses the dire situation in Flint, Michigan, where a significant portion of the population struggles with healthcare access due to budget cuts. The commentary reflects on the challenges faced by healthcare providers and the community in meeting essential health needs.
#Provider
Spotlight Articles – Sources Consulted
CMS Publishes Outpatient Hospital and Physician Payment Proposed Regs
- Medicare pits primary care doctors against specialists
- STAT+: CMS proposes more remote patient monitoring coverage without heeding warnings about abuse
- CMS pitches Medicare SSP changes for 2026: 8 things to know
- Remote patient monitoring gets boost in CMS proposal
- Doc Groups Say Proposed Medicare Payment Increase Is Inadequate
- CMS proposal includes cardiologist pay bump—cuts to high-value services still a concern
- CMS to bump physician pay 3.62% in proposed rule
- CMS proposes rule aligning Medicare physician payment with ‘Big Beautiful Bill, MACRA
- Providers slam ‘outdated’, ‘underfunded’ Medicare pay
- CMS Proposes 2.5-Percent MD Pay Increase; Provider Associations Respond
- CMS Floats New RPM And Telehealth Codes, Expanded DTx Codes In Draft Physician Rule
- CMS Proposes First Medicare Pay Hike For Physicians In Five Years While Cracking Down On Skin Graft Overspending, Chronic Disease Care Gaps
- CMS Aims For Stability In QPP, Proposes 2-Year, Feedback-Only Period For Cost Measures
- Physicians set for Medicare pay hike under draft regulation
- CMS proposes 2026 Medicare rule: 6 notes
- CMS pitches 3.6% bump in Medicare physician pay rule: 8 things to know
- CMS proposes 3.6% pay bump for docs, takes aim at chronic conditions in physician fee schedule
- CMS’ $7.8B hospital clawback plan ‘illegal and unwise’: AHA
- CMS floats 2.4% annual outpatient, ASC pay bump alongside price transparency, site neutrality
- STAT+: Trump’s Medicare agency to speed up clawback of $7.8 billion in hospital drug payments
- STAT+: Medicare plans to cover more than a thousand new procedures in outpatient settings, despite concerns about safety
- CMS pitches 2.4% outpatient pay bump for hospitals in 2026: 5 things to know
- Medicare outpatient rates to rise under proposed rule
Congress has Passed the Big Beautiful Bill, Now What?
- GOP senator introduces bill to repeal federal Medicaid cuts
- Congress is advancing FY26 spending bills, including some with dramatic staffing cuts
- Arrington Still Wants FMAP, Site-Neutral Changes
- Susan Collins finally got her dream job. Fellow Republicans are making it a nightmare.
Advancements in HIV Prevention
- Once-Monthly Oral PrEP Option Appears Safe, Tolerable in Adults at Low Risk of HIV
- Adults With HIV Report Greater Satisfaction After Switching to Long-Acting ART
- Federal, Pharmaceutical Barriers to PrEP Access
- PEPFAR keeps millions of people with HIV alive and may be spared from Trump spending cuts
- Integrating People-Centered HIV Care With Primary Healthcare | IAS 2025
- Zambia HIV Leader Calls Long-Acting PrEP a Big Step, But Warns Funding Cuts Could Slow Progress | IAS 2025
- The HIV Prevention Pipeline | IAS 2025
- STAT+: ViiV expands licensing deal for its HIV drug in low-income countries
- AI Set to Speed Up HIV Vaccine Research and Trials, Focusing on Fair Access
- Without Reliable U.S. Funding, What Might the Future of HIV Science and Services Look Like | IAS 2025
- People, Partnerships and Innovation Are Key to Ending the HIV Epidemic | IAS 2025
- Sexual Health and HIV Care Integration Key to Better Care | IAS 2025
- WHO Adds Lenacapavir to Its HIV PrEP Recommendations Amid Underutilization of PrEP and Severe PEPFAR Funding Cutbacks | IAS 2025
- Study Participants Happy They Switched from Oral PrEP to Long-Acting Injections