Cassidy Releases FDA Modernization Recommendations

Cassidy Releases FDA Modernization Recommendations – Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy, MD has released a new report that makes legislative and regulatory recommendations for modernizing the Food and Drug Administration (FDA). The 20-page report, titled “Patients and Families First: Building the FDA of the Future,” recommends:

  • Congress and FDA should apply the “least burdensome” approach beyond medical devices to other product categories.
  • To reshore early-stage clinical research, FDA should launch a voluntary program in which FDA pilots a notification pathway for eligible Phase 1 clinical trials.
  • As clinical trials continue to evolve from three-phase, site-based studies towards more decentralized and innovative designs, FDA should continue supporting the use of digital health technologies, while ensuring that validation requirements for these tools are tailored to their relative risks.
  • To ensure that AI standards and frameworks do not conflict, and that FDA grows its talent pipeline, FDA should further its partnerships across U.S. Department of Health and Human Services agencies while expanding external fellowships.
  • FDA should consider how to improve predictability in the drug review process, which should include more judicious use of clinical holds and greater transparency in its dialogue with sponsors.
  • Congress should codify recent agency actions to tailor chemistry, manufacturing, and controls (CMC) requirements for therapies intended for small populations.
  • To accelerate rare disease drug development, FDA should more consistently use tools like accelerated approval and better coordinate reviews across its divisions and offices.
  • Congress should create a new streamlined intermediate pathway for biologics through which more innovative and affordable products can get to patients.
  • Congress should simplify the current requirements for new biologics, including simplifying the outdated interchangeability designation and streamlining the studies needed to obtain biosimilar approval.
  • Congress should pass bills advanced by the HELP Committee to address abuses in the health care system that permit FDA to reject frivolous citizen petitions aimed at delaying generic entry and tackling exclusivity “parking” to incentivize timely market entry of competitive generic products.
  • Congress could require FDA to provide clearer guidance on the clinical data and evidence needed to support premarket submissions, especially for novel, complex health technologies.
  • Congress should consider ways to change or supplement the existing medical device review pathways to properly evaluate software, so these new products have an efficient and appropriate pathway to market.
  • Congress should ensure that FDA implements guidance on clinical decision support (CDS) in the spirit of what it directed in the 21st Century Cures Act.

 

NIH Director Bhattacharya to Lead CDC in Acting Capacity – Director of the National Institutes of Health (NIH) Jay Bhattacharya, MD has been tapped to serve as Centers for Disease Control and Prevention (CDC) acting director. Bhattacharya replaces previous CDC acting director and U.S. Department of Health and Human Services deputy director Jim O’Neill, who was recently removed from those positions as a part of a broader restructuring across the Department. The administration reportedly plans to nominate O’Neill to lead the National Science Foundation. Bhattacharya will continue in his role leading the NIH while at the helm of the CDC.

 

Senate Republicans Urge Recovery of Fraudulent ACA Subsidy Payments – A group of Senate Republicans are requesting that the Department of Justice (DOJ) investigate and pursue civil remedies to recover Affordable Care Act (ACA) marketplace subsidies paid to insurance companies due to fraudulent, unauthorized, or improper enrollment in insurance plans. The letter, signed by 17 lawmakers, highlights that the Government Accountability Office could not identify evidence of reconciliation for over $21 billion in ACA marketplace subsidies in tax year 2023. The lawmakers praise the recent reconstitution of the False Claims Act Working Group, while underscoring DOJ’s “responsibility to ensure taxpayer funds are not misused and to enforce federal civil fraud remedies, when necessary.”

 

New GAO Reports on Impact of No Surprises Act, Gain-of Function Research – The Government Accountability Office (GAO) has published a new report examining provider participation and payments for selected services before and after the enactment of the No Surprises Act (NSA). Among the specialties most likely to be affected by the law – emergency medicine, radiology, anesthesiology, and air ambulances – the GAO found that the percentage of in-network claims increased for three of the four specialties since the NSA was implemented. The report also details how payment changes for the selected services largely reflect continuations of trends that existed prior to the NSA taking effect. The full report can be found here.

 

The GAO also released a report on high-risk, gain of function research. The agency found that the U.S. Department of Health and Human Services does not consistently disclose important details about its process for weighing the risks and benefits of this research or reveal how many projects involve these potentially dangerous pathogens, and recommends that the Department address this issue to ensure public trust in federally funded research. The report was requested by Republicans on the House Energy and Commerce Committee.

 

ACIP Delays February Meeting – The Advisory Committee on Immunization Practices (ACIP) will delay its next meeting amidst an ongoing lawsuit brought by public health and medical groups questioning the legality of recent changes to the nation’s vaccine policy and recommendation processes by the U.S. Department of Health and Human Services. ACIP had been scheduled to meet February 25-27. While an agenda for the meeting had not yet been published, the panel typically discusses the effectiveness of upcoming seasonal influenza vaccines during its February meeting. ACIP now plans to meet in March, with an exact date yet to be determined.

 

Upcoming Congressional Hearings and Markups

House Ways and Means Subcommittee on Health hearing “Advancing the Next Generation of America’s Health Care Workforce;” 10:00 a.m.; February 24

 

Senate Health, Education, Labor, and Pensions (HELP) Committee hearing on the nomination of Casey Means to be Medical Director in the Regular Corps of the Public Health Service and Surgeon General of the Public Health Service; 10:00 a.m.; February 25

 

Senate HELP Committee markup of legislation including S. 1782, Charlotte Woodward Organ Transplant Discrimination Prevention Act; S. 1552, Living Donor Protection Act of 2025; and S. 3315, Health Care Cybersecurity and Resiliency Act of 2025; 10:00 a.m.; February 26

 

Senate Special Committee on Aging hearing “From Regulator to Roadblock: How FDA Bureaucracy Stifles Innovation;” 9:30 a.m.; February 26

 

Recently Introduced Health Legislation

H.R.7590 – To promote minimum State requirements for the prevention and treatment of concussions caused by participation in school sports, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Education and Workforce

 

Judiciary Republicans Subpoena Insurance Providers for Documents About ACA Marketplace Fraud

Judiciary Republicans Subpoena Insurance Providers for Documents About ACA Marketplace Fraud – House Judiciary Committee Chair Jim Jordan (R-Ohio) and panel Republicans are subpoenaing health insurers participating in the Affordable Care Act (ACA) marketplace citing allegations of fraudulent use of federal subsidies. The eight insurers subpoenaed include Blue Shield of California, Centene Corporation, CVS Health, Elevance Health, GuideWell, Health Care Service Corporation, Kaiser Permanent, and Oscar Health. The lawmakers reference a recent Government Accountability Office report which found billions of dollars in unreconciled ACA subsidies per year and examples of tens of thousands of Social Security Numbers subject to potential fraud. The subpoenas demand details about each company’s fraud protection measures, requesting a response by February 23.

 

Banks Asks FDA to Detail Plan for Enforcement Against Certain GLP-1 Compounders – Sen. Jim Banks (R-Ind.) has written to Marty Makary, MD urging the commissioner of Food and Drugs to take enforcement against compounded weight-loss medications that are being marketed by telehealth and online pharmacy platforms. Sen. Banks suggests the agency consider the feasibility of requiring more explicit warnings on those websites in violation of federal drug law. He also asks the commissioner to expound on a recent statement that the Food and Drug Administration would work to limit the active ingredients used to make “non-FDA-approved compounded drugs that are being mass-marketed by companies… as similar alternatives to FDA-approved drugs.” The letter follows Banks’ introduction of the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act (S. 3794), which would impose new restrictions on compounding pharmacies to prevent the mass marketing of non-FDA- approved drugs.

 

HELP Chair Cassidy Requests Details on Cyberbreach – Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy, MD (R-La.) is investigating a recent data exposure that took place within the Illinois Department of Human Services (IDHS). Sen. Cassidy’s letter to Gov. JB Pritzker (D) requests detailed records from the exposure. “Protecting the privacy and security of sensitive health information is essential to ensure that patients receive the best care and that their information is not misused,” Sen. Cassidy wrote. “Despite IDHS’ role in helping vulnerable communities, its repeated failures to implement basic security processes highlight IDHS’ disregard of its responsibility to over 4.6 million Illinois residents.”

 

HHS Personnel Changes – Several notable personnel changes were announced at the U.S. Department of Health and Human Services (HHS) last week.

  • HHS Deputy Secretary Jim O’Neill and General Counsel Mike Stewart will not remain in their current positions, but are reportedly being offered other jobs within the administration.
  • Arman Sharma has been hired as the Deputy Chief Artificial Intelligence Officer. Sharma is a recent Stanford University graduate. During his time in school, he co-authored a book on the economics of medicine with current National Institutes of Health Director Jay Bhattacharya.
  • Director of the Center for Medicare Chris Klomp is the new chief counselor at HHS and in charge of overseeing all Department operations. He will retain his current role as well while reporting to Secretary Robert F. Kennedy Jr. HHS Chief of Staff Matt Buckham will become Senior Counselor for Operations and Personnel, and HHS Chief Policy Adviser Ken Callahan will become Senior Counselor for Policy. Both will report to Klomp.
  • At the Food and Drug Administration, Deputy Commissioner for Human Foods Kyle Diamantas and Deputy Commissioner for Policy, Legislation, and International Affairs Grace Graham have been appointed senior counselors. They will also remain in their current roles.
  • Centers for Medicare and Medicaid Services Chief Policy and Regulatory Officer John Brooks will also serve as senior counselor while remaining in his current role.

 

 

Recently Introduced Health Legislation

S.3809 — A bill to authorize the Director of the National Science Foundation to identify grand challenges and award competitive prizes for artificial intelligence research and development; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Commerce, Science, and Transportation

 

H.Res.1043 — Expressing support for the designation of February 2026 as “American Heart Month”; Sponsor: Beatty, Joyce [Rep.-D-OH-3]; Committees: House – Energy and Commerce

 

H.R.7417 — To amend the Public Health Service Act to reauthorize the WISEWOMAN program; Sponsor: Beatty, Joyce [Rep.-D-OH-3]; Committees: House – Energy and Commerce

 

H.R.7434 —To authorize the Director of the National Science Foundation to identify grand challenges and award competitive prizes for artificial intelligence research and development; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Science, Space, and Technology

 

H.R.7444 —To amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7451 — To amend the Immigration and Nationality Act to discontinue the H-1B program, and for other purposes; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Judiciary

 

H.R.7453 — To amend the Internal Revenue Code of 1986 to make sex offenders ineligible for the refundable credit for coverage under a qualified health plan and to amend title XIX of the Social Security Act to make sex offenders ineligible for Federally funded medical assistance under the Medicaid program; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Ways and Means; Energy and Commerce

 

S.3812 — A bill to require the Secretary of Labor to issue guidance and regulations regarding opioid overdose reversal medication and employee training; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3816 —A bill to amend title XVIII of the Social Security Act to permit a private cause of action for damages in the case of a group health plan which fails to provide for primary payment or appropriate reimbursement; Sponsor: Scott, Tim [Sen.- R-SC]; Committees: Senate – Finance

 

S.3822 — A bill to prohibit pharmacy benefit managers, insurers, and prescription drug or medical device wholesalers from being under common ownership with certain medical service providers, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Judiciary

 

H.Res.1050 — Expressing support for the designation of September 19, 2026, as “Black Autism Acceptance and Awareness Day”; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Energy and Commerce

 

H.R.7465 — To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish a demonstration program to award grants to States to improve the provision of recommended immunizations for children, adolescents, and adults through the use of mobile vaccination units, and for other purposes; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Energy and Commerce

 

H.R.7478 — To amend title XVIII of the Social Security Act to establish certain standards and requirements with respect to financial assistance and medical debt collection for hospitals participating in the Medicare program, and to amend title III of the Public Health Service Act to establish a grant program for purposes of medical debt relief; Sponsor: Vasquez, Gabe [Rep.-D-NM-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7479 — To require the Secretary of Labor to issue guidance and regulations regarding opioid overdose reversal medication and employee training; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Education and Workforce

 

S.Res.604 — A resolution recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic security; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Judiciary

 

S.3826 — A bill to amend title 28, United States Code, to increase transparency and oversight of third-party litigation funding in certain actions, and for other purposes; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Judiciary

 

S.3829 — A bill to prevent exploitative private equity practices, and for other purposes; Sponsor: Warren, Elizabeth [Sen.- D-MA]; Committees: Senate – Finance

 

S.3834 — A bill to amend title XVIII of the Social Security Act to expand the scope of practitioners eligible for payment for telehealth services under the Medicare program, and for other purposes; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Finance

 

S.3840 — A bill to provide for the designation of areas as Health Investment Zones to reduce health disparities and improve health outcomes in such areas, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Finance

S.3848 — A bill to amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to publish information on expenditures under the Medicare program, and for other purposes; Sponsor: Scott, Tim [Sen.-R- SC]; Committees: Senate – Finance

 

S.3853 — A bill to amend the Public Health Service Act to end the liability shield for vaccine manufacturers, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.1058 — Recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic security; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House

– Judiciary; Education and Workforce; Energy and Commerce; Financial Services; Oversight and Government Reform; Armed Services; Veterans’ Affairs; House Administration

 

H.Res.1060 — Expressing support for the designation of April 5, 2026, as “Barth Syndrome Awareness Day”; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.7482 — To authorize the Secretary of Health and Human Services to fund prize competitions to accelerate innovation in the prevention, diagnosis, and treatment of Lyme disease, and for other purposes; Sponsor: Smith, Christopher H. [Rep.- R-NJ-4]; Committees: House – Energy and Commerce

 

H.R.7486 — To amend title XI of the Social Security Act to provide for support to facility-based providers through contracts with quality improvement organizations; Sponsor: Beyer, Donald S. [Rep.-D-VA-8]; Committees: House – Ways and Means

 

H.R.7496 — To provide for the designation of areas as Health Investment Zones to reduce health disparities and improve health outcomes in such areas, and for other purposes; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Energy and Commerce; Ways and Means; Education and Workforce

 

H.R.7497 — To amend the SUPPORT for Patients and Communities Act to improve trauma support services and mental health care for children and youth in educational settings, and for other purposes; Sponsor: Hayes, Jahana [Rep.-D-CT- 5];Committees: House – Education and Workforce

 

H.R.7514 — To authorize rural health facilities to use certain Federal agricultural credit assistance for the purpose of refinancing debt obligations, updating necessary services, technology, and equipment, and supporting ancillary needs; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Agriculture

 

S.Con.Res.27 — A concurrent resolution celebrating the 125th Anniversary of the Army Nurse Corps; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate – Armed Services

 

S.3869 — A bill to allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3872 — A bill to amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

S.3883 — A bill to remove linguistic barriers to participation in Gun Violence Prevention Strategies; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Judiciary

 

S.3886 — A bill to establish total nurse staffing hours per resident day, to require 24-hour use of registered professional nurses in nursing homes, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

 

H.J.Res.149 — Recognizing the 125th anniversary of the Army Nurse Corps, expressing gratitude for members of the Army Nurse Corps for their service to the Nation, and for other purposes; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Armed Services

 

H.R.7520 — To amend title XVIII of the Social Security Act to delay the implementation of an efficiency adjustment to work relative value units under the Medicare physician fee schedule; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Energy and Commerce; Ways and Means

H.R.7528 — To amend section 503B of the Federal Food, Drug, and Cosmetic Act to enhance the ability of outsourcing facilities to mitigate drug shortages by allowing a short-term period to continue supplying the market after a drug is in shortage; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.7531 — To allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Education and Workforce; House Administration; Oversight and Government Reform

 

H.R.7535 — To amend title XIX of the Social Security Act to require coverage of 12 mental health telehealth visits per calendar year for certain previously incarcerated individuals under the Medicaid program; Sponsor: Foushee, Valerie P. [Rep.-D-NC-4]; Committees: House – Energy and Commerce

 

H.R.7537 — To prevent exploitative private equity practices, and for other purposes; Sponsor: Goodlander, Maggie [Rep.- D-NH-2]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

 

H.R.7546 — To amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7558 — To direct the Secretary of Defense and the Secretary of Veterans Affairs to jointly adopt and use interoperable image-sharing software technology for the purpose of sharing medical images and related data at medical facilities of the Department of Defense and Department of Veterans Affairs, and for other purposes; Sponsor: Schweikert, David [Rep.-R- AZ-1]; Committees: House – Armed Services; Veterans’ Affairs

Partial Shutdown Ends with Most Federal Agencies Funded Through Sept. 30

Partial Shutdown Ends with Most Federal Agencies Funded Through Sept. 30 – Congress approved a spending package (H.R. 7148) on Tuesday to end the partial government shutdown that had commenced January 31, completing the fiscal year (FY) 2026 appropriations process for nearly all federal agencies. The $1.2 trillion funding package was passed in a bipartisan 217-214 vote. The bill included funding for Defense, Financial Services, Labor-Health and Human Services-Education, National Security-State, and Transportation-Housing and Urban Development through September 30, along with funding for the Department of Homeland Security (DHS) through February 13. The agreement provides lawmakers with additional time to negotiate reforms to the DHS bill in light of recent events in Minneapolis involving Immigration and Customs Enforcement.

 

The package contains nearly $117 billion in discretionary funding for the U.S. Department of Health and Human Services (HHS), in line with FY 2025 funding levels and rejecting the deeper cuts to HHS proposed by the President’s budget request. The legislation also includes provisions to reform the pharmacy benefit manager industry and extensions of key health care programs, such as the Medicare dependent hospital program, Medicare telehealth flexibilities, the Acute Hospital Care at Home waiver, and virtual cardiopulmonary rehabilitation services. The package also contains approximately $16 billion in congressionally directed spending, with health care related earmarks set to receive $986 million.

 

Cassidy Probes 340B Prime Vendor Apexus – Senate Health, Education, Labor, and Pensions Committee Chair Bill Cassidy, MD is requesting details about the business and revenue generation practices of 340B drug pricing program prime vendor Apexus. The letter is the latest step in Sen. Cassidy’s investigation into the 340B program. Apexus has held an exclusive contract with the Health Resources and Services Administration as the sole 340B prime vendor since 2004. The letter highlights the rapid growth of the 340B program since that time, raising questions about where revenue is generated and whether it is being used for the original intent of the program. Cassidy poses questions to the company regarding its revenue and compensation structure, “share back” practices, organizational structure and internal access controls for 340B data, relationship with parent company Vizient, engagement with regulators, and role in increasing 340B utilization.

 

Latest Congressional Retirements – Rep. Barry Loudermilk (R-Ga.) announced that he will not seek reelection this year. Rep. Loudermilk has served in Congress for more than a decade. He currently sits on the House Finance Services Committee and the Committee on House Administration. Rep. Mark Amodei (R-Nev.) also announced his plans to retire at the end of his term. Rep. Amodei has served in Congress since 2011. He is a senior member of the House Appropriations Committee. The House of Representatives Press Gallery casualty list tallying members who are retiring or seeking other office can be found here.

 

Christian Menefee Sworn in to House of Representatives – Texas Democrat Christian Menefee was sworn in to the House of Representatives last week. Menefee recently won a special election to represent Texas’ 18th congressional district, a seat that has been vacant since Sylvester Turner died in March 2025. He campaigned on a progressive platform that included support for the establishment of a Medicare for All single-payer health care system. Rep. Menefee’s swearing in brings the balance of power in the House to 218 Republicans and 214 Democrats.

 

New GAO Report on FDA Staffing Struggles – The Government Accountability Office (GAO) has released a new report detailing the Food and Drug Administration’s (FDA) struggle to recruit, retain, and train staff, and the subsequent impact on the agency’s ability to conduct inspections. The staffing issues have arisen despite an increase in FDA funding from 2008 through 2024, money largely stemming from user fees paid by regulated industries. Nevertheless, GAO reports that in 2024, for example, FDA was not able to complete as many drug inspections as it had in prior years. The agency has also faced challenges managing other resources, such as its information technology systems for collecting safety and quality complaints.

 

GAO to Review ACIP’s Hep B Vaccine Recommendation Change – The GAO has agreed to conduct a review of the recent Advisory Committee on Immunization Practices (ACIP) decision to no longer recommend a universal hepatitis B birth dose vaccine. The agency stated that it will examine “matters relating to public-health, economic, and equity impacts” in its acceptance letter to lawmakers. The GAO report was requested by Reps. Judy Chu (D-Calif.), Kim Schrier, MD (D-Wash.), and 108 other Democratic lawmakers who argue that ACIP’s decision was “rooted in reckless conspiracy theories, not science.”

 

Moolenaar Highlights Chinese Control of U.S. Medical Technology – Rep. John Moolenaar (R-Mich.) has sent a letter to Treasury Secretary Scott Bessent regarding a Chinese pharmaceutical company’s investment in FastWave Medical, a U.S. developer of laser-based intravascular lithotripsy technology. Rep. Moolenaar chairs the House Select Committee on the Chinese Communist Party. He expresses concerns related to national security and urges the Committee on Foreign Investment in the United States, led by Secretary Bessent, to take immediate action. “Grand Pharma’s predatory investment in FastWave jeopardizes dozens of U.S. engineering and manufacturing jobs, undermines the availability of this life-saving technology for American patients, and weakens U.S. competitiveness in medical innovation,” Moolenaar’s letter states.

 

Grassley Urges More Timely  Suicide-Related Followup Care – Sen. Chuck Grassley (R-Iowa) has written to the Centers for Medicare and Medicaid Services (CMS) urging Administrator Mehmet Oz, MD to address the findings contained in the Office of the Inspector General (OIG) report entitled, Most Children Enrolled in Medicaid Did Not Receive Timely Suicide-Related Followup Care. The OIG discovered that in half of the 258,458 unique hospitalizations or child emergency department visits for suicidal ideations or behaviors in 2023, children did not receive a follow-up visit in the week following being discharged. He requests a response by February 28 detailing what steps CMS has taken in response to the report, whether CMS will require Medicaid programs to ensure children are seen for a follow-up within seven days of treatment for suicide ideations, whether there are systems in place for hospitals to communicate their need for additional assistance with these issues, and whether CMS plans to develop or promote training models for providers to recognize and manage suicidal risk among children while they await specialist care.

 

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Committee hearing “Opportunities with VHA Reorganization;” 10:15 a.m.; February 11

 

House Energy and Commerce Subcommittee on Health hearing “Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain;” 10:15 a.m.; February 11

 

Senate Special Committee on Aging “Hearings to Examine How Washington’s Rules Drove Physicians Out of Medicine;” 3:00 p.m.; February 11

 

Senate Veterans’ Affairs Committee “Hearings to Examine Building a 21st Century VA Health Care System, Focusing on Assessing the Next Generation of VA’s Community Care Network;” 4:00 p.m.; February 11

 

Recently Introduced Health Legislation

H.R.7277 — To amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7279 — To provide for a wage differential program to support new nursing school faculty members; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce

 

H.R.7286 — To amend the Internal Revenue Code of 1986 to revoke the tax-exempt status of organizations that provide, or provide funding for, abortion; Sponsor: Hageman, Harriet M. [Rep.-R-WY-At Large]; Committees: House – Ways and Means

 

H.R.7289 — To amend the Public Health Service Act to establish an advisory committee on training in community health centers, and for other purposes; Sponsor: Johnson, Julie [Rep.-D-TX-32]; Committees: House – Energy and Commerce

 

H.R.7291 — To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to establish a board to review certain designations that a substance used in food is generally recognized as safe, with respect to the intended use of such substance, and for other purposes; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Energy and Commerce

 

S.3758 — A bill to direct the Secretary of Veterans Affairs to make opioid overdose rescue medications available to veterans and their caregivers, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Veterans’ Affairs

 

S.3757 — A bill to amend the Higher Education Act of 1965 to establish fair and consistent eligibility requirements for graduate medical schools operating outside the United States and Canada; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3762 — A bill to amend part C of title XVIII of the Social Security Act to provide for prior authorization reforms under the Medicare Advantage program; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Finance

 

S.3763 — A bill to amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis, and for other purposes; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Finance

 

S.3767 — A bill to amend the Indian Health Care Improvement Act to elevate the position of Director of the Indian Health Service within the Department of Health and Human Services to Assistant Secretary for Indian Health, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Indian Affairs

 

H.R.7324 — To amend title XVIII of the Social Security Act to expand eligibility for incentives under the Medicare health professional shortage area bonus program to practitioners furnishing mental health and substance use disorder services; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7335 — To require U.S. Immigration and Customs Enforcement and U.S. Customs and Border Protection to perform an initial health screening on detainees, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Judiciary; Homeland Security

 

H.R.7336 — To amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce; Ways and Means

 

S.3771 — A bill to amend title 38, United States Code, to codify the requirements for appointment, qualifications, and pay for the therapeutic medical physicists of the Department of Veterans Affairs, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Veterans’ Affairs

 

H.Res.1037 — Expressing support for the designation of February 4, 2026, as “National Cancer Prevention Day”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.Res.1039 — Supporting the goals and ideals of “National Black HIV/AIDS Awareness Day”; Sponsor: Waters, Maxine [Rep.-D-CA-43]; Committees: House – Energy and Commerce

 

H.R.7351 — To amend the Immigration and Nationality Act to provide nonimmigrant status to nurses working in certain facilities; Sponsor: Beyer, Donald S. [Rep.-D-VA-8]; Committees: House – Judiciary

 

H.R.7352 — To amend the Public Health Service Act to establish a program to develop innovative antimicrobial drugs targeting the most challenging pathogens and most threatening infections, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Budget

 

H.R.7366 — To amend the Federal Food, Drug, and Cosmetic Act to clarify and affirm the preemptive authority of the Food and Drug Administration over dietary supplement regulation, and for other purposes; Sponsor: Langworthy, Nicholas A. [Rep.-R-NY-23]; Committees: House – Energy and Commerce

 

H.R.7385 — To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to establish a grant program related to pre-exposure prophylaxis, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

S.3783 — A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to establish a Mental and Behavioral Health Career Promotion Grant Program, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3788 — A bill to amend the Federal Food, Drug, and Cosmetic Act to require drug labeling to include original manufacturer and supply chain information; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Banking, Housing, and Urban Affairs

 

S.3794 — A bill to amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes; Sponsor: Banks, Jim [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3797 — A bill to amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3799 — A bill to amend the Public Health Service Act to reauthorize the Healthy Start Initiative; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.7391 — To amend title III of the Public Health Service Act to ensure that Federally-qualified health centers are not required to pay more than the 340B ceiling price for covered outpatient drugs at the time of purchase; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House – Energy and Commerce

 

H.R.7394 — To amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to establish a Mental and Behavioral Health Career Promotion Grant Program, and for other purposes; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce

 

H.R.7407 — To amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements; Sponsor: Pallone, Frank [Rep.-D-NJ-6]; Committees: House – Energy and Commerce

 

H.R.7409 — To amend title XVIII of the Social Security Act to limit the geographic reclassification of certain hospitals under the Medicare program; Sponsor: Taylor, David J. [Rep.-R-OH-2]; Committees: House – Ways and Means

 

H.R.7411 — To expand the telescreening mammography pilot program of the Department of Veterans Affairs, and for other purposes; Sponsor: Thompson, Glenn [Rep.-R-PA-15]; Committees: House – Veterans’ Affairs

 

Partial Government Shutdown Likely to Continue Into Tuesday

Partial Government Shutdown Likely to Continue into Tuesday – The Senate passed compromise government funding legislation (H.R. 7148) on Friday in a bipartisan 71-29 vote. The deal struck between President Donald Trump and Senate Democrats includes Defense, Financial Services, Labor-Health and Human Services-Education, National Security-State, and Transportation-Housing and Urban Development funding through September 30, along with funding for the Department of Homeland Security (DHS) through February 13. The agreement provides lawmakers with additional time to negotiate reforms to the DHS bill in light of recent events in Minneapolis involving Immigration and Customs Enforcement (ICE).

 

The package contains nearly $117 billion in discretionary funding for the U.S. Department of Health and Human Services (HHS), in line with fiscal year (FY) 2025 funding levels and rejecting the deeper cuts to HHS proposed by the President’s budget request. The legislation also includes provisions to reform the pharmacy benefit manager industry and extensions of key health care programs, such as the Medicare dependent hospital program, Medicare telehealth flexibilities, the Acute Hospital Care at Home waiver, and virtual cardiopulmonary rehabilitation services. The Senate package also contains approximately $16 billion in congressionally directed spending, with health care related earmarks set to receive $986 million.

 

While the deal averts a lengthy government shutdown, a partial shutdown did go into effect early Saturday morning. The House of Representatives will take up the spending package when it returns to session on Monday, but House Democrats informed GOP leadership over the weekend that they will not help fast-track passage of the funding package to reopen the government. As a result, passage of the package through regular order is not expected until Tuesday at the earliest.

 

Bipartisan Talks on ACA Tax Credits Stall – Sens. Bernie Moreno (R-Ohio) and Susan Collins (R-Maine) have presented Democrats with their “best and final offer” to extend and modify the Affordable Care Act’s (ACA) enhanced advance premium tax credits. Sens. Moreno and Collins have led the recent bipartisan negotiations, featuring roughly a dozen other senators, to extend the enhanced subsidies that expired at the end of 2025. The proposal pitched by Moreno and Collins would extend the tax credits for three years, with the first year continuing along the status quo; the credits would then be phased out while providing for an on-ramp to the expansion of a health savings account option during the second and third year. The proposal also includes an across-the-board minimum $5 premium, 700% federal poverty level income cap on eligibility, and funding for cost-sharing reduction payments. It also proposes audits to ensure compliance with the Hyde Amendment, restricting the use of federal dollars for abortion services, and the creation of new fines for insurers that deliberately enroll unqualified individuals. Sen. Angus King (I-Maine), who has helped negotiate on behalf of Democrats, has responded that the proposal does not represent a bipartisan deal and suggested a return to a full, two-year enhanced tax credit extension. Sen. Jeanne Shaheen (D-N.H.), another Democratic negotiator, has also raised concerns about the plan’s failure to recognize that the Hyde Amendment already applies to the ACA market.

 

HELP Republicans Launch Fraud Task Force – Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy, MD (R-La.) and Republican members of the panel Ashley Moody (Fla.), Roger Marshall, M.D. (Kan.), Tommy Tuberville (Ala.), Jon Husted (Ohio), Markwayne Mullin (Okla.), and Tim Scott (S.C.) have announced the formation of a task force to eliminate fraud in federal spending. The new group’s anti-fraud efforts will be based on subject matter, with Sens. Moody and Marshall leading the work in the health care space. The launch of the task force follows reports of fraud and abuse related to federal child care funding in Minnesota, as well as the committee’s creation of an online portal for Americans to report fraud involving taxpayer dollars.

 

Surgeon General Nomination Hearing Expected Later This Month – The Senate HELP Committee will reportedly hold a confirmation hearing for U.S. Surgeon General nominee Casey Means, on February 25. The hearing was originally scheduled for last November but was postponed due to the nominee’s pregnancy. Means is a medical doctor, wellness influencer, and co-founder of the bio wearables and health-tracking company Levels. She graduated medical school but dropped out of her surgical residency in her fifth year, opting to open a functional medicine practice. Means was tapped for the position of surgeon general last May after the White House withdrew the nomination of former Fox News contributor Janette Nesheiwat.

 

Florida Rep. Buchanan to Retire After Two Decades in Congress – Rep. Vern Buchanan (R-Fla.), 74, has announced that he will not seek reelection this year. Rep. Buchanan has served in the House of Representatives for 20 years. He currently serves as the vice chair of the House Ways and Means Committee and as the chair of its Subcommittee on Health.

 

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions Committee hearing “Modernizing the National Institutes of Health: Faster Discoveries, More Cures;” 10:00 a.m.; February 3

 

House Education and Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Building an AI-Ready America: Adopting AI at Work;” 10:15 a.m.; February 3

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Common Schemes, Real Harm: Examining Fraud in Medicare and Medicaid;” 10:30 a.m.; February 3

 

Senate Veterans’ Affairs Committee hearing “Independent Spirits: Veteran Health & Healing through Adaptive Sports;” 4:00 p.m.; February 4

 

Recently Introduced Health Legislation

H.Res.1019 – Recognizing the roles and the contributions of America’s Certified Registered Nurse Anesthetists (CRNAs) and their critical role in providing quality health care for the public and our Nation’s Armed Forces, for more than 150 years and through multiple public health emergencies and beyond; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.7237 – To amend the Public Health Service Act to ensure that a woman seeking a chemical abortion is made aware of the risks involved, and for other purposes; Sponsor: Stutzman, Marlin A. [Rep.-R-IN-3]; Committees: House – Energy and Commerce

 

S.J.Res.103 — A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Veterans’ Affairs

 

S.3690 — A bill to amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Finance

 

S.3692 — A bill to provide for the inclusion of virtual diabetes prevention program suppliers in the Medicare Diabetes Prevention Program Expanded Model, and for other purposes; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Finance

 

S.3697 — A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs, to prohibit investigational use exemptions for abortion drugs, and to impose additional regulatory requirements with respect to previously approved abortion drugs, and for other purposes; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3698 — A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require that group health plans and health insurance issuers offering group or individual health insurance that provide coverage for mental health services and substance use disorder services provide such services without the imposition of cost-sharing from the diagnosis of pregnancy through the 1-year period following such pregnancy, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3703 — A bill to amend the Veterans’ Benefits Improvements Act of 1996 and the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 to improve the temporary licensure requirements for contract health care professionals who perform medical disability examinations for the Department of Veterans Affairs, and for other purposes; Sponsor: Husted, Jon [Sen.-R-OH]; Committees: Senate – Veterans’ Affairs

 

S.3706 — A bill to amend title 38, United States Code, to authorize the provision of produce prescriptions to veterans, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Veterans’ Affairs

 

S.3707 — A bill to provide for a wage differential program to support new nursing school faculty members; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.J.Res.144 — Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.7267 — To amend title 38, United States Code, to authorize the provision of produce prescriptions to veterans, and for other purposes; Sponsor: Pingree, Chellie [Rep.-D-ME-1]; Committees: House – Veterans’ Affairs

 

S.Res.590 — A resolution designating January 23, 2026, as “Maternal Health Awareness Day”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.3712 — A bill to direct the Secretary of Health and Human Services to conduct, and submit to Congress a report describing the results of, a study on the use of home cardiorespiratory monitors for infants, and for other purposes; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3714 — A bill to amend title V of the Social Security Act to extend funding for the family-to-family health information centers; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3716 — A bill to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3729 — A bill to require the Medicare Payment Advisory Commission (MedPAC) submit to Congress two reports on agreements with pharmacy benefit managers with respect to prescription drug plans and MA-PD plans; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.3730 — A bill to amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Finance

 

S.3739 — A bill to direct the Secretary of Veterans Affairs to carry out a demonstration project on coverage by the Department of Veterans Affairs of over-the-counter hearing aids, and for other purposes; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Veterans’ Affairs

 

S.3741 — A bill to require the Secretary of Commerce to promulgate regulations to improve nucleic acid synthesis security, and for other purposes; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Commerce, Science, and Transportation

 

S.3750 — A bill to amend title XVIII of the Social Security Act to establish provider directory requirements, and to provide accountability for provider directory accuracy, under Medicare Advantage; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

 

S.3751 — A bill to require the Comptroller General of the United States to conduct a study and submit a report on price-related compensation and payment structures in the prescription drug supply chain; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance