Category: Weekly Policy Briefing

Trump Names NIH, HHS Deputy Secretary Nominees President Donald Trump has nominated Jay Bhattacharya to serve as the next Director of the National Institutes of Health (NIH). Bhattacharya is a Stanford University physician, economist, and professor of health policy. His research focuses on the health and well-being of vulnerable populations, with a particular emphasis on the role of government programs, biomedical innovation, and economics.  He was one of the main authors of the Great Barrington Declaration, a document that called for an end to COVID-19 lockdowns in October 2020. Bhattacharya has also been critical of other aspects of the U.S. response to the pandemic, accusing former NIH leaders of suppressing scientific debate and research, and calling for an overhaul of the biomedical research agency.

The President-elect has also nominated Jim O’Neil to serve as Deputy Secretary of Health and Human Services. O’Neill is a science and technology investor. He previously served as U.S. Department of Health and Human Services (HHS) principal associate deputy secretary during the George W. Bush administration and is the former acting CEO of the Thiel Foundation. During his first term in office, Trump considered O’Neill to serve as Commissioner of Food and Drugs. O’Neill has previously argued that medicines should be approved once their safety is confirmed by the Food and Drug Administration, and that a review of efficacy data should take place after a drug has gone to market.  If confirmed, O’Neill would be second in command to nominee Robert F. Kennedy, Jr. at HHS.

House COVID Panel to Release Final Report This Week – The House Select Subcommittee on the Coronavirus Pandemic will hold a markup of the panel’s final report this week. The final report will include investigative materials, findings, and recommendations related to:

• COVID-19 origins
• Taxpayer funded COVID-19 relief programs
• Laws enacted in reaction to COVID-19
• COVID-19 vaccine development and implementation
• Economic impact of COVID-19 on individuals, communities, businesses, states, and governments
• Societal impacts of COVID-19
• Executive branch COVID-19 related decisions
• Executive branch cooperation with Congress to prevent a future pandemic

The report will be released to the public ahead of Wednesday’s markup.

DeSantis Announces Special Election Dates to Replace Gaetz, Waltz in House – Governor Ron DeSantis (R) has set the special election to fill Florida’s 1^st Congressional District seat in the House of Representatives for April 1. The seat was recently vacated by former Rep. Matt Gaetz (R). The front runner in the Republican primary, which will take place on January 28, is Jimmy Patronis, the state’s Chief Financial Officer. The special primary and election to fill the seat of Florida’s 6^th District Rep. Michael Waltz (R) will be held on the same dates. Waltz, who was tapped to serve as President Trump’s national security adviser, is resigning effective January 20. Former Florida state House member Randy Fine has announced his candidacy to succeed Waltz and has already won the endorsement of President-elect Trump.

CMS Proposes Medicare Coverage of Anti-Obesity Medications – The Biden administration has taken the first step to expanding access to popular new weight-loss drugs for patients covered by Medicare and Medicaid. The proposed rule from the Centers for Medicare and Medicaid Services (CMS) would require the programs to cover anti-obesity drugs. Congress banned Medicare from covering the popular weight-loss drugs known as GLP-1s solely for weight loss purposes in 2003, though the treatments can be covered for other indications like diabetes and heart conditions. CMS’ proposal involves the classification of obesity as a chronic, complex disease, which will allow the recognition of GLP-1 drugs as anti-obesity treatments under Part D. The proposal is estimated to cost $40 billion over the next decade. Concerns about the impact of the regulation on health care costs were highlighted by a number of Democrats on Capitol Hill. Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) praised the administration’s recognition of the importance of anti-obesity medications, but highlighted that “unless Medicare demands that Novo Nordisk and Eli Lilly substantially reduce the prices for these anti-obesity drugs, Medicare premiums for all seniors would skyrocket.” It is unlikely that the rule, which must still complete the notice and comment rulemaking process, will be finalized in the next two months, and it is unclear how the proposal will be handled by the incoming Trump administration. Nominee for Secretary of Health and Human Services Robert F. Kennedy Jr. has expressed skepticism about weight-loss drugs in the past.

Upcoming Congressional Hearings and Markups

House Select Subcommittee on the Coronavirus Pandemic business meeting to consider the report on “After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward;” 10:30 a.m.; December 4

Senate Environment and Public Works Committee hearing “Examining the Public Health Impacts of PFAS Exposures;”  9:30 a.m.; December 5

Recently Introduced Health Legislation

S.Res.908 — A resolution expressing support for the goals of Stomach Cancer Awareness Month; Sponsor: Young, Todd [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.909 — A resolution designating November 21, 2024, as “National Rural Health Day”; Sponsor: Barrasso, John [Sen.-R-WY]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.910 — A resolution designating November 2024 as “National Hospice and Palliative Care Month”; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Judiciary

S.Res.912 — A resolution designating November 2024 as “National Lung Cancer Awareness Month” and expressing support for early detection and treatment of lung cancer; Sponsor: Smith, Tina [Sen.-D-MN]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.915 — A resolution designating September 2024 as “National Prostate Cancer Awareness Month”; Sponsor: Crapo, Mike [Sen.-R-ID]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.917 — A resolution recognizing November 2024 as “National Family Caregivers Month”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

S.5367 — A bill to amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits for lung cancer screenings for certain individuals without the imposition of cost sharing; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

S.5368 — A bill to amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

S.5375 — A bill to amend title XXVII of the Public Health Service Act to improve health care coverage under vision and dental plans, and for other purposes; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

S.5380 — A bill to amend title XVIII of the Social Security Act to provide coverage of portable ultrasound transportation and set up services under the Medicare program; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Finance

S.5390 — A bill to require the Secretary of Health and Human Services and the Director of the Cybersecurity and Infrastructure Security Agency to coordinate to improve cybersecurity in the health care and public health sectors, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

S.5394 — A bill to require Federal law enforcement and prison officials to obtain or provide immediate medical attention to individuals in custody who display medical distress; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Judiciary

S.5397 — A bill to amend title XVIII of the Social Security Act to adjust allowable direct and indirect costs for nursing and allied health education programs; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

S.5399 — A bill to amend title 11, United States Code, to provide bankruptcy protections for medically distressed debtors, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Judiciary

S.5400 — A bill to amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test an emergency medical services treatment-in-place model under the Medicare program; Sponsor: Manchin, Joe, III [Sen.-I-WV]; Committees: Senate – Finance

H.Con.Res.133 — Expressing the sense of Congress that public health professionals should be commended for their dedication and service to the United States on Public Health Thank You Day, November 25, 2024; Sponsor: Wittman, Robert J. [Rep.-R-VA-1]; Committees: House – Energy and Commerce

H.Res.1595 — Expressing support for the designation of November 2024 as “National Lung Cancer Awareness Month” and expressing support for early detection and treatment of lung cancer; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Energy and Commerce

Trump Names CMS, CDC, FDA, Surgeon General Nominees – President-elect Donald Trump named several additional nominations for key health-related administration positions last week.

Mehmet Oz, M.D., the celebrity physician and TV personality known as Dr. Oz, was selected to serve as the Administrator of the Centers for Medicare and Medicaid Services (CMS). Oz is a well-known supporter of alternative and unconventional remedies and holistic care.  As an informal health advisor to President Trump during his first term in office, Oz supported unproven COVID-19 therapies, including the use of hydroxychloroquine for the treatment of COVID-19. Oz’s experience as a physician and cardiothoracic surgeon has been highlighted as a potential strength for the role of CMS Administrator. Senate Health, Education, Labor, and Pensions Committee Chair Bill Cassidy, M.D. (R-La.), who also serves on the Senate Finance Committee, expressed support for Oz’s nomination on X, stating “It has been over a decade since a physician has been at the helm of CMS, and I look forward to discussing his priorities. This is a great opportunity to help patients and implement conservative health reforms.” Oz unsuccessfully ran for the U.S. Senate in Pennsylvania in 2022, losing to now-Sen. John Fetterman (D). While most Democrats on Capitol Hill have raised concerns about Oz’s lack of government experience and endorsement of questionable health supplements, Fetterman stated that he would support his previous opponent if Oz “is about protecting and preserving Medicare and Medicaid.” Oz supports expansion of the Medicare Advantage (MA) program, having proposed a “Medicare Advantage for All” plan funded by a 20% payroll tax during his campaign for Senate. Oz co-founded a digital health company, Sharecare, in 2010, and has since called for making COVID-19-era telehealth flexibilities permanent. Oz’s nomination will be voted on by the Senate Finance Committee. Incoming Finance Chair Mike Crapo (R-Idaho) has praised Oz “for providing consumers with the necessary information to make their own health care decisions,” while current Chair Ron Wyden (D-Ore.) has already stated his plans to question Oz about MA plans’ use of prior authorization.

Trump has nominated former Congressman Dave Weldon, M.D. as the Director of the Centers for Disease Control and Prevention (CDC). Weldon is a board-certified internist who served in the House of Representatives from 1995 through 2009. He is currently a professor of biomedical engineering at the Florida Institute of Technology. Weldon’s medical career has focused on the management of hypertension, elevated cholesterol, diabetes, arthritis, cancer screening, preventive care, and general illnesses of the elderly. In the House, Weldon sponsored a provision known as the “Weldon Amendment,” which prevents federal funds from being made available to Federal agencies and programs, and State and local governments, that “subject any institutional or individual health care entity to discrimination” on the basis of not providing, paying for, providing coverage of, or referring for abortions.

Marty Makary, M.D. has been tapped to lead the Food and Drug Administration (FDA). Makary is a Johns Hopkins professor and surgeon. He is also a health policy researcher and adviser at the Paragon Health Institute. Makary’s work has focused on the high costs and overtreatment present in the U.S. health care system. He has been a frequent critic of many aspects of the nation’s response to the COVID-19 pandemic, including COVID vaccine use in children.

Trump also tapped Janette Nesheiwat, M.D. to serve as the next Surgeon General. Nesheiwat is a Fox News medical contributor and the medical director at CityMD, a group of urgent care centers in New York. She is board certified in family/emergency medicine.

House Democratic Leadership Elections – Democratic leadership in the House of Representatives will remain largely unchanged next Congress after caucus-wide elections last week. Democratic leader Hakeem Jeffries (D-N.Y.), Whip Katherine Clark (D-Mass.), Caucus Chair Pete Aguilar (D-Calif.), Vice Chair Ted Lieu (D-Calif.), and Assistant Leader Joe Neguse (D-Colo.) will continue to serve in their current positions during the 119^th Congress. The remaining results of the House Democratic leadership elections are as follows:

• Debbie Dingell (D-Mich.) defeated Rep. Jasmine Crockett (D-Texas) in the race for Democratic Policy and Communications Committee (DPCC) Chair.
• Lauren Underwood, R.N. (D-Ill.), Lori Trahan (D-Mass.), and Maxwell Frost (D-Fla.) were elected to serve as DPCC co-chairs.
• Robert Garcia (D-Calif.) was elected Caucus Leadership Representative.
• Susie Lee (D-Nev.) defeated Reps. Kim Schrier, M.D. (D-Wash.) and Greg Landsman (D-Ohio) to serve as the next Battleground Leadership Representative.

Leader Jeffries is responsible for appointing the next Democratic Congressional Campaign Committee (DCCC) Chair. Current DCCC Chair Suzan DelBene (D-Wash.) has declined to say whether she is interested in serving another term.

Congress Considers Biden’s Emergency Supplemental Funding Request – Lawmakers’ focus during the lame duck period so far has been on electing leadership for the 119^th Congress and negotiating an emergency supplemental relief bill. House Speaker Mike Johnson (R-La.) has indicated that there is bipartisan interest in passing a supplemental relief package, and that the President’s request for $98.6 billion in disaster aid in response to recent hurricanes is currently being evaluated.  The administration’s emergency supplemental funding request sent to Congress last week calls for $40 billion for the Federal Emergency Management Agency’s Disaster Relief Fund and $3 billion for the U.S. Department of Health and Human Services (HHS) to support health care needs in areas impacted by the hurricanes, among other funding requests. It remains unclear if the aid will be passed as a standalone measure or be attached to government funding legislation. Congress faces a December 20 deadline to avoid a federal government shutdown. House Republican leadership is expected to push for a stopgap spending bill that funds the government through March 2025, which would allow the GOP to implement their own budget priorities under Republican control of the White House, Senate, and Congress in the new year.

Senate Judiciary Advances Patent Reform Bill – The Senate Judiciary Committee advanced the PREVAIL Act (S. 2220) last week in an 11-10 vote. The bipartisan legislation, which was introduced by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.), aims to reform the Patent Trial and Appeal Board (PTAB) and ensure the U.S. Patent and Trademark Office (USPTO) has the resources it needs to effectively administer the nation’s patent system. The legislation would also end USPTO fee diversion. The panel agreed to a manager’s amendment addressing Democratic concerns that the bill could impede access to PTAB by advocates for patient and generic drug manufacturers.

Senators Push for Doc Fix and Long-Term Physician Payment Reform – A bipartisan group of 41 senators led by Sens. John Boozman, OD (R-Ark.) and Peter Welch (D-Vt.) have sent a Dear Colleague letter to Majority Leader Chuck Schumer (D-N.Y.) and Minority Leader Mitch McConnell (R-Ky.) urging leadership to address the 2.8% cut to Medicare payments set to go into effect on January 1. “Persistent instability in the health care sector – due, in part, to consistent payment cuts – impacts the ability of physicians and clinicians to provide the highest quality of care,” the lawmakers argue. “These continued payment cuts undermine the ability of independent clinical practices – especially in rural and underserved areas – to care for their communities.” The letter also underscores the need for long-term legislative solutions to reform the Medicare Access and CHIP Reauthorization Act, such as reforms to statutory budget neutrality requirements and payment updates reflective of inflation.

Senators Introduce Health Care Cybersecurity Legislation – Members of the Senate Bipartisan Cybersecurity Working Group introduced legislation last week to strengthen cybersecurity in the nation’s health care sector and better protect Americans’ health data. The Health Care Cybersecurity and Resiliency Act of 2024 (S. 5390) was introduced on Friday by Sens. Bill Cassidy, M.D. (R-La.), Mark Warner (D-Va.), John Cornyn (R-Texas), and Maggie Hassan (D-N.H.). The bill would:

• Provide grants to health entities to improve cyberattack prevention and response;
• Provide training to health entities on cybersecurity best practices;
• Provide best practices to rural health clinics and other providers on cybersecurity breach prevention, resilience, and coordination with federal agencies;
• Improve coordination between HHS and the Cybersecurity and Infrastructure Security Agency;
• Modernize regulations so entities covered under HIPAA use the best cybersecurity practices; and
• Require the HHS Secretary to develop and implement a cybersecurity incident response plan.

Warren, Grassley Request IRS Briefing on Tax Exempt Hospitals – Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) have written to the Internal Revenue Service urging the agency to increase oversight of tax-exempt hospitals. The letter specifically requests clarification around requirements for hospital patient financial assistance programs. “While the promotion of health is an exempt purpose, not every entity that promotes health is entitled to a tax exemption. Instead, to qualify for a federal tax exemption based on the promotion of health, an organization must ‘primarily benefit the community.’ We are concerned that some nonprofit hospitals may fall short on this measure,” the lawmakers state. They request a staff-level briefing on the subject by December 10.

Casey Concedes PA Senate Race – Sen. Bob Casey (D-Pa.) has conceded the Pennsylvania Senate race to his Republican opponent David McCormick. The race recently underwent a state-ordered recount because McCormick’s margin of victory was less than 0.5%. McCormick is the former CEO of Bridgewater Associates. He previously served in the Bush administration as the Under Secretary of Commerce for Industry and Security and later as the Under Secretary of the Treasury for International Affairs. Casey’s concession puts the Senate balance of power in the 119^th Congress at 53 Republicans and 47 Democrats.

Sherrill to Run for NJ Governor – Rep. Mikie Sherrill (D-N.J.) announced her bid for governor of New Jersey last week. Sherrill, who just won reelection to the House of Representatives, will run to succeed term-limited Governor Phil Murphy (D) in November 2025. She joins a field of at least five other Democrats, including Rep. Josh Gottheimer, and four Republicans vying for the position.

Recently Introduced Health Legislation

H.Res.1575 — Expressing support for designating the week of November 4 through November 10, 2024, as “Forensic Nursing Week”; Sponsor: Ross, Deborah K. [Rep.-D-NC-2]; Committees: House – Energy and Commerce

H.R.10131 — To amend the Patient Protection and Affordable Care Act to include fertility treatment and care as an essential health benefit; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

H.R.10135 — To improve the quality, appropriateness, and effectiveness of diagnosis in health care, and for other purposes; Sponsor: Beyer, Donald S. [Rep.-D-VA-8]; Committees: House – Energy and Commerce

H.R.10136 — To amend title XVIII of the Social Security Act to align payment under Medicare for specified surgical procedures with high-cost supplies furnished in office-based facilities, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

H.R.10137 — To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to provide health care for family members and other individuals who resided at or worked at locations where there is a presumption of service-connection for certain illnesses and conditions, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

S.5339 — A bill to authorize the collection of supplemental payments to increase congressional investments in medical research, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.1580 — Supporting the designation of July as Uterine Fibroids Awareness Month; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House – Energy and Commerce

H.R.10153 — To designate Regional Breast and Gynecologic Cancer Care Coordinators to expand the work of the Breast and Gynecologic Oncology System of Excellence at the Department of Veterans Affairs, and for other purposes; Sponsor: Garcia, Sylvia R. [Rep.-D-TX-29]; Committees: House – Veterans’ Affairs

S.Res.896 — A resolution expressing support for the designation of the week beginning on November 11, 2024, as “National School Psychology Week”; Sponsor: Padilla, Alex [Sen.-D-CA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.899 — A resolution designating November 2024 as “American Diabetes Month”; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.5346 — A bill to amend title XIX of the Social Security Act to establish a minimum Medicaid disproportionate share hospital allotment for States; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

S.5348 — A bill to amend title II of the Public Health Service Act to include as an additional right or privilege of commissioned officers of the Public Health Service (and their beneficiaries) certain leave provided under title 10, United States Code to commissioned officers of the Army (or their beneficiaries); Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.1581 — Expressing support for the designation of “Prematurity Awareness Month”; Sponsor: McClellan, Jennifer L. [Rep.-D-VA-4]; Committees: House – Energy and Commerce

H.R.10172 — To amend title XIX of the Social Security Act to prohibit payments under the Medicaid program for conversion therapy, and for other purposes; Sponsor: Thanedar, Shri [Rep.-D-MI-13]; Committees: House – Energy and Commerce

H.R.10173 — To amend the Toxic Substances Control Act to authorize grants for toxic substances remediation in schools, to reauthorize healthy high-performance schools, and for other purposes; Sponsor: McClellan, Jennifer L. [Rep.-D-VA-4]; Committees: House – Energy and Commerce

H.R.10175 — To authorize United States participation in the Davos Alzheimer’s Collaborative; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Foreign Affairs

H.R.10182 — To amend the Internal Revenue Code of 1986 to waive the 10-percent additional tax on early distributions from qualified retirement plans in the case of withdrawals for family caregiving expenses; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Ways and Means

H.R.10187 — To amend title XVIII of the Social Security Act to modify Medicare rural hospital flexibility program grants; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means

H.R.10188 — To expand cost-sharing reductions with respect to qualified health plans offered through an Exchange, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce; Ways and Means

S.5349 – A bill to amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes; Sponsor: Young, Todd [Sen.-R-IN]; Committees: Senate – Finance

S.5353 — A bill to establish a national plan to coordinate research on epilepsy, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions

S.5356 — A bill to establish clear and consistent biological definitions of male and female; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Judiciary

S.Res.907 — A resolution to authorize representation by the Senate Legal Counsel in the case of Dr. Ralph de la Torre v. Bernard Sanders, et al; Sponsor: Schumer, Charles E. [Sen.-D-NY]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

H.Res.1591 — Recognizing November 2024 as “National Family Caregivers Month”; Sponsor: Evans, Dwight [Rep.-D-PA-3]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

H.Res.1594 — Supporting the goals and ideals of “National Rural Health Day”; Sponsor: Tokuda, Jill N. [Rep.-D-HI-2]; Committees: House – Energy and Commerce

H.R.10193 — To amend the Public Health Service Act to authorize grants to provide treatment for diabetes in minority communities; Sponsor: Waters, Maxine [Rep.-D-CA-43]; Committees: House – Energy and Commerce

H.R.10197 — To direct the Secretary of Health and Human Services to enter into an arrangement with the National Academies of Sciences, Engineering, and Medicine to conduct a comprehensive study on the health care impacts of the use of kinetic impact projectiles in the United States, and for other purposes; Sponsor: Beatty, Joyce [Rep.-D-OH-3]; Committees: House – Energy and Commerce

H.R.10202 —  To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits for lung cancer screenings for certain individuals without the imposition of cost sharing; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Energy and Commerce

H.R.10210 — To establish a national plan to coordinate research on epilepsy, and for other purposes; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House – Energy and Commerce

H.R.10214 — To require the Secretary of Health and Human Services to carry out a public awareness campaign to increase awareness of the importance of father inclusion and engagement in improving overall health outcomes during pregnancy, childbirth, and postpartum, and for other purposes; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House – Energy and Commerce

H.R.10225 — To amend title XVIII of the Social Security Act to adjust allowable direct and indirect costs for nursing and allied health education programs; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Ways and Means

H.R.10238 — To authorize the collection of supplemental payments to increase congressional investments in medical research, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

H.R.10239 — To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes; Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House – Energy and Commerce

H.R.10240 — To amend title XVIII of the Social Security Act to provide coverage of portable ultrasound transportation and set up services under the Medicare program; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Energy and Commerce; Ways and Means

Republicans Secure Majority in House for 119^th Congress-Republicans have officially won enough seats to retain majority control of the House of Representatives for the 119^th Congress. While five races remain uncalled, the balance of power currently stands at 218 seats for Republicans and 212 seats for Democrats. On the Senate side, Pennsylvania party officials are preparing for a recount in the race between Democratic incumbent Sen. Bob Casey and Republican challenger David McCormick. The state-mandated recount must begin by November 20, and Pennsylvania counties must submit their recount results by November 27.

Having secured majority control, the House GOP is now considering passage of a continuing resolution (CR) that extends government funding through March to provide President-elect Donald Trump with more control over fiscal year 2025 federal spending. This plan could allow Republicans to secure significant spending cuts but would put pressure on President Trump to avoid a government shutdown early in his administration. While House Republicans may favor a CR, the Democratic-controlled Senate would like to see an omnibus spending package.

Trump Taps RFK Jr. for HHS Secretary-President-elect Trump has named Robert F. Kennedy Jr. as his choice for Secretary of the U.S. Department of Health and Human Services. Kennedy is an environmental lawyer and well-known vaccine skeptic. He is a former Democrat who ran as an Independent in this year’s presidential race before dropping out and endorsing Donald Trump. Kennedy has recently spearheaded the ‘Make America Healthy Again’ movement, calling for a reform of pesticide, food additive, and vaccine regulations. Democrats are widely opposed to the selection, while many Republicans have not yet weighed in on the choice. The nomination will be voted upon by the Senate Finance Committee, but Kennedy will appear before both the Finance and Health, Education, Labor, and Pensions (HELP) Committees for confirmation hearings. Incoming HELP Chair Bill Cassidy, MD (R-La.) has acknowledged bipartisan support for Kennedy’s stance on food additives, while Finance Chair Mike Crapo (R-Idaho) has complimented Kennedy’s focus on chronic disease prevention. Kennedy’s position on vaccines, however, has largely drawn criticism from senators on both sides of the aisle, though some members-including Sens. Rand Paul, MD (R-Ky.) and Tommy Tuberville (R-Ala.)-have expressed support.

Trump Draws from Elected Officials for Other White House Positions-Amongst the other individuals tapped by Trump for Cabinet posts and administration jobs include several current members of Congress. President Trump has nominated Rep. Matt Gaetz (R-Fla.) as Attorney General. Gaetz resigned from Congress following Trump’s nomination announcement. The House Ethics Committee had been set to meet last week to vote on its report examining allegations of sex trafficking, acceptance of improper gifts, and illicit drug use by Gaetz, but lost jurisdiction over the former Congressman upon his resignation. While Ethics Committee Chair Michael Guest (R-Miss.) has indicated that he does not plan to allow the report to be released, Democrats on the panel are reportedly considering what avenues are available for them to release the information themselves. Gaetz’s nomination would be considered before the Judiciary Committee in the Senate. Current Judiciary Chair Dick Durbin (D-Ill.) was joined by a number of Senate Republicans-including Judiciary Committee member John Cornyn (R-Texas)-in pressing House Ethics to turn over the report. They have also expressed openness to subpoenaing the panel for the information. Rep. Mike Waltz (R-Fla.) is President Trump’s nominee for National Security Adviser. Florida Gov. Ron DeSantis (R) is acting quickly to schedule special elections to fill the two Florida seats. Former House Republican Conference Chair Elise Stefanik (R-N.Y.) has been nominated as U.N. Ambassador. Her confirmation would trigger a special election, which would likely take place sometime in the spring. The nomination of House members could temporarily impact Republican’s narrow majority in the chamber, though House Speaker Mike Johnson (R-La.) has stated that he does not expect Trump to select any additional House members for his administration. Trump also tapped Florida Sen. Marco Rubio (R) to serve as Secretary of State. DeSantis is responsible for appointing a replacement to fill Rubio’s seat until the next general election. Sen. Rick Scott (R-Fla.) has called on the Governor to appoint Lara Trump, current co-chair of the Republican National Committee, to replace Rubio in the Senate.

President-elect Pushes for Use of Recess Appointments-Donald Trump has repeatedly asserted his plans to use the president’s ability to make recess appointments to effectively bypass the normal Senate confirmation process for executive nominations. While recess appointments used to be common, a 2014 Supreme Court decision has since curbed its use. Neither President Trump during his first term nor President Biden made use of recess appointments. Recess appointments can be made while the Senate is adjourned for periods of two weeks or longer. Both chambers of Congress would need to pass a concurrent adjournment resolution-which can be done with simple majority votes-to put the Senate into a recess long enough to open the recess appointment window. While incoming Senate Majority Leader John Thune (R-S.D.) has expressed a preference for confirming presidential nominees “the regular way” he also stated that he remains open to the idea of recess appointments should Democrats block nominations through procedural means. There are more than 1,200 presidential appointments that require Senate confirmation. The last cabinet nomination to be formally rejected by the Senate was President George H.W. Bush’s defense secretary nominee John Tower, a former senator who faced allegations of alcohol abuse. Other nominees, such as Andrew Puzder-nominated for Secretary of Labor during Trump’s first term-have withdrawn their nomination before a formal vote. With an expected 53-47 seat majority, the Senate GOP can only afford to lose four Republicans in a nomination vote on the Senate floor.

Thune to Replace McConnell as Senate Republican Leader-Sen. John Thune (R-S.D.) was elected Republican Senate leader in a closed-door vote last week, beating Sens. John Cornyn (R-Texas) and Rick Scott (Fla.) to replace Sen. Mitch McConnell (R-Ky.). McConnell, who has led the Senate GOP for nearly 20 years, announced earlier this year that he would be stepping down from Senate leadership. Thune was first elected to the House of Representatives in 1996, where he served until being elected to the Senate in 2004. He has served as the Senate GOP whip, the second ranking Republican in the chamber, since 2019. During his time in Congress, Thune has been a champion of telehealth and pharmacy benefit manager reform. He is also a member of the bipartisan working group on Medicare physician payment reform, and opposes the Inflation Reduction Act’s Medicare drug price negotiation program. Starting in January, Thune will control the Senate’s procedures and schedule, and manage negotiations with Senate Democrats. Thune has stated that the Senate filibuster will stay intact during his leadership tenure. The incoming Senate majority leader has said that his priority will be confirmation of the President’s executive nominees, telling senators to expect “an aggressive schedule” until nominations are confirmed. The remaining results of Senate Republican leadership elections are as follows:

• Senate GOP Conference Chair John Barrasso, MD (R-Wy.) was elected the next Senate Majority Whip.
• Tom Cotton (R-Ark.) defeated Sen. Joni Ernst (R-Iowa) to replace Barrasso as Senate GOP Conference Chair.
• Shelley Moore Capito (R-W.Va.) was elected GOP Policy Committee Chair.
• James Lankford (R-Okla.) was elected GOP Conference Vice Chair.
• Tim Scott (R-S.C.) was elected Republican Senatorial Committee Chair.

Democrats have not yet held their leadership elections but are unlikely to see any major changes in rank.

Cassidy to Chair HELP in the 119^th Congress-Sen. Bill Cassidy, MD (R-La.) will lead the Senate Health, Education, Labor, and Pensions (HELP) Committee next Congress. Sen. Rand Paul, MD (R-Ky.), who has seniority on the panel, announced that he will take the helm of the Senate Homeland Security and Governmental Affairs Committee (HSGAC) instead. As HSGAC chair, Paul has stated his intent to build upon the panel’s biosecurity-related investigations. Sen. Cassidy, a gastroenterologist/hepatologist, will be the first medical doctor to serve as HELP chair since 1933. During his time as HELP Ranking Member during the 118^th Congress, Cassidy has worked with members on both sides of the aisle to lower the cost of health care and reform the pharmacy benefit manager industry. He also released an NIH white paper, and earlier this month released a bipartisan legislative framework for site neutral payment reform with Sen. Maggie Hassan (D-N.H.).

House Republican Leadership Elections-Republicans in the House of Representatives unanimously nominated Mike Johnson (R-La.) to continue to serve as House Speaker. While Johnson only needed the support of a simple majority of his conference to become the party’s nominee, he will need a majority of the full House in January to secure the speakership. The speaker election is slated for January 3. Majority Leader Steve Scalise (R-La.) and Majority Whip Tom Emmer (R-Minn.) will continue to serve in their positions during the 119^th Congress. The remaining results of the House Republican leadership elections are as follows:

• Lisa McClain (R-Mich.) defeated Rep. Kat Cammack (R-Fla.) for the position of Republican Conference Chair.
• Erin Houchin (R-Ind.) was selected to replace McClain as GOP Conference Secretary.
• Richard Hudson (R-N.C.) won a second term as National Republican Congressional Committee Chair.
• Oklahoma Rep. Kevin Hern (R-Okla.) defeated Rep. Gary Palmer (R-Ala.) in the race for Policy Committee Chair.

The House Republican Steering Committee had planned to meet to decide contested races for committee chairmanships in the 119^th Congress, including the Energy and Commerce Committee, but the meeting was rescheduled. House Democrats will hold their leadership elections on November 19^th and 20^th.

Freshmen members of Congress have also been on the Hill in recent days for new member orientation. The Republican freshman class selected Rep.-elect Brandon Gill (R-Texas) to serve as the freshman class president. Gill is a former investment banker who will fill the seat of retiring Rep. Michael Burgess, MD (R-Texas) next Congress.

GOP Doctors Caucus Announces Co-Chairs for the 119th Congress-The House GOP Doctors Caucus has elected Rep. John Joyce, MD (R-Pa.), a dermatologist, to serve as co-chair alongside Rep. Greg Murphy, MD (R-N.C.), a urologist, for the 119^th Congress. “Our country faces many great challenges, and now more than ever, we need thoughtful solutions to expand access to affordable, high-quality care,” Joyce and Murphy said in a statement. “With a majority in the House of Representatives, we look forward to working with President Trump and the Republican Conference as we consider much-needed reforms.”

Gottheimer to Run for NJ Governor-Rep. Josh Gottheimer (D-N.J.) announced his bid for governor of New Jersey last week. Gottheimer, who just won reelection to the House of Representatives, will run to succeed term-limited Governor Phil Murphy (D) in November 2025. He joins a field of at least four other Democrats and four Republicans vying for the position.

E&C Republicans Ask GAO to Assess Structure of Lab Safety Offices-House Energy and Commerce Committee Republicans are asking the Government Accountability Office (GAO) to examine laboratory safety programs at the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health. “This committee remains concerned about the effectiveness of the oversight the U.S. Department of Health and Human Services and its agencies provide to the laboratories they own and operate,” the letter states. “In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk.” The letter was signed by Committee Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.).

DEA Extends COVID-Era Telehealth Flexibilities-On Friday, the Drug Enforcement Administration (DEA) released a temporary rule titled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” This regulation extends, through December 31, 2025, the pandemic-era telemedicine flexibilities that have been in place since March 2020 for prescribing controlled medications via the practice of telemedicine. The flexibilities allow Schedule II-V substances to be prescribed without an in-person visit. The final rule extends regulations with no substantive changes to the current rules. DEA previously received a record 38,000 comments after proposing to rein in the flexibilities due to concerns about overprescribing and substance misuse. The agency states that its latest decision will provide more time to finalize regulations that both mitigate the risk of diversion while also avoiding disruptions in access to care.

GAO Outlines Ongoing Cybersecurity Challenges at HHS-The Government Accountability Office (GAO) has released a new report outlining the steps the U.S. Department of Health and Human Services (HHS) could take to address the increasing number of cyberattacks against health care organizations. The report highlights that HHS has failed to implement past GAO recommendations related to supporting health care cyber risk management, assessing sector cybersecurity risks, and coordinating and collaborating for sector cybersecurity. The full GAO report can be found here.

CBO Releases FY 2024 Budget Review Summary-The federal budget deficit increased eight percent, or $138 billion, according to the Congressional Budget Office’s (CBO) budget review summary for fiscal year (FY) 2024. CBO found that Medicare outlays rose by nine percent, or $78 billion, because of higher enrollment and health care service payment rates. Medicaid outlays rose less than one percent, or $2 billion. While state Medicaid programs disenrolled millions of individuals in FY 2024, per-person Medicaid enrollee costs increased since FY 2023.

Upcoming Congressional Hearings and Meetings

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing on the National Institutes of Health; 10:00 a.m.; November 19

House Appropriations Committee oversight hearing “Assessing the Veterans Health Administration Fiscal Year 2025 Potential Shortfall;” 10:00 a.m.; November 20

House Foreign Affairs Subcommittee on Global Health, Global Human Rights, and International Organizations hearing “Meeting the Challenges of Global Brain Health: Diagnosis and Treatment for the 21st Century;” 2:00 p.m.; November 20

House Veterans’ Affairs Subcommittee on Health hearing “Life After Limb Loss: Examining VA Amputee Prosthetics Care;” 2:30 p.m.; November 20

Recently Introduced Health Legislation

H.R.10106-To require the Secretary of Veterans Affairs to enter into a contract or other agreement with a third party to review appointees in the Veterans Health Administration who had a license terminated for cause by a State licensing board for care or services rendered at a non-Veterans Health Administration facility and to provide individuals treated by such an appointee with notice if it is determined that an episode of care or services that they received was below the standard of care, and for other purposes; Sponsor: Norman, Ralph [Rep.-R-SC-5]; Committees: House-Veterans’ Affairs

S.5297-A bill to amend the Internal Revenue Code of 1986 to increase the limitations on contributions to health savings accounts, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate-Finance

S.5298-A bill to amend the Employee Retirement Income Security Act of 1974 to allow health marketplace pools to be deemed an employer under section 3(5) of such Act for purposes of offering a group health plan or group health insurance coverage, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate-Health, Education, Labor, and Pensions

H.Res.1569-Expressing support for the designation of the week beginning on November 11, 2024, as “National School Psychology Week”; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House-Education and the Workforce

S.5308-A bill to amend title XVIII of the Social Security Act to reauthorize the Rural Flex program, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate-Finance

S.5311-A bill to require the public release of all research supported by the National Institutes of Health; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate-Health, Education, Labor, and Pensions

H.J.Res.220-Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Bureau of Consumer Financial Protection relating to “Debt Collection Practices (Regulation F); Deceptive and Unfair Collection of Medical Debt”; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House-Financial Services

S.5326-A bill to fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States healthcare system; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions

S.5330-A bill to direct the Secretary of Defense to establish a pilot program regarding treating pregnancy as a qualifying event for enrollment in TRICARE Select; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate-Armed Services

H.R.10124-To direct the Secretary of Agriculture to establish and administer a pilot program to provide grants to support Food is Medicine programs, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House-Agriculture; Energy and Commerce

H.R.10126-To fully fund the Prevention and Public Health Fund and reaffirm the importance of prevention in the United States healthcare system; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House-Energy and Commerce

House Republicans Release CR-Only 13 legislative days remain before lawmakers are scheduled to recess and return to the campaign trail until after election day. During that short time, Congress must pass a continuing resolution (CR) to avoid a government shutdown, with lawmakers also hoping to tackle the defense authorization, farm bill, and a slate of China-focused legislation. On Friday, House Republicans released the Continuing Appropriations and Other Matters Act, 2025 which would provide funding at fiscal year 2024 levels through March 28, 2025. The CR also includes the Safeguard American Voter Eligibility (SAVE) Act (H.R.8281) requiring voters to show documentation of U.S. citizenship. The House Rules Committee is scheduled to meet on Monday afternoon to consider the rule for the legislation which is planned to be considered by the full House later this week. Democrats are united in support of a clean, short-term CR that extends into the post-election lame duck session.

Biden Administration Sends Funding Requests for CR-The Office of Management and Budget (OMB) has sent Congress the President’s list of requested changes-or anomalies-for any CR that will otherwise extend government funding at current levels beyond the end of the fiscal year on September 30. The White House’s request includes the provision of an additional $50 million for the Centers for Disease Control and Prevention’s (CDC) respiratory virus preparedness and response efforts, $20 million for the CDC’s wastewater surveillance program, and $13 million to support the restructuring of the nation’s organ transplant system. The administration also requests $12 billion in mandatory funding for the Cost of War Toxic Exposures Fund at the Department of Veterans Affairs to address a budgetary shortfall.

House to Vote on China Bills This Week-The House of Representatives is scheduled to vote this week on the BIOSECURE Act (H.R.8333) under suspension of the rules. The legislation would prohibit Chinese biotechnology companies of concern, or companies that use equipment or services from biotechnology companies of concern, from receiving federal contracts, grants, or loans and is aimed at blocking foreign governments from accessing Americans’ health and genomic data. BIOSECURE, which was advanced by the House Oversight Committee in a 40-1 vote, would initially impact BGI Group, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics.

Consideration of BIOSECURE is part of a large series of votes by the chamber on legislation relating to China. The House is also scheduled to vote of the-No WHO Pandemic Preparedness Treaty Without Senate Approval Act (H.R.1425) this week. The bill would deem the World Health Organization’s (WHO) pending agreement on pandemic preparedness as a treaty and subject it to a Senate vote prior to implementation in the U.S. Republicans have raised concerns relating to the nation’s financial obligations and U.S. sovereignty in opposing WHO’s global pandemic response efforts.

Steward CEO to Defy HELP Subpoena-The Senate Health, Education, Labor, and Pensions (HELP) Committee will move forward with a hearing on the bankruptcy of Steward Health Care and the subsequent impact on patient care despite Steward CEO Ralph de la Torre’s refusal to comply with a bipartisan subpoena compelling his testimony. De la Torre has asked for a postponement of the hearing until after legal proceedings related to Steward’s bankruptcy are resolved. “Dr. de la Torre will be held accountable for his greed and the damage he has caused the American people and our nation’s health care system,” HELP Chairman Bernie Sanders (I-Vt.) said in a statement. “With or without him, this hearing is going forward. We will expose his fraud, and put his greed on display. I look forward to hearing from patients, medical professionals, and community members whose lives have been upended by Dr. de la Torre and his private equity cronies.” The hearing is scheduled to take place on Thursday; the witness list has yet to be announced.

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health legislative hearing “Evaluating FDA Human Foods and Tobacco Programs;” 10:00 a.m.; September 10

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “ERISA’s 50^th Anniversary: The Value of Employer-Sponsored Health Benefits;” 10:15 a.m.; September 10

House Select Subcommittee on the Coronavirus Pandemic hearing with former New York Governor Andrew Cuomo; 2:00 p.m.; September 10

House Veterans’ Affairs Subcommittee on Economic Opportunity hearing “Mission Transition: Evaluating Mental Health Support Programs for Separating Servicemembers;” 3:00 p.m.; September 10

House Veterans’ Affairs Subcommittee on Health legislative hearing including a DRAFT bill to include a representative of the National Association of State Veterans Homes on the Geriatrics and Gerontology Advisory Committee of the Department of Veterans Affairs (VA); DRAFT, Veterans’ Mental Health Access Act; DRAFT, To amend title 38, U.S.C., to require that non-citizen appointees to positions in the Veterans Health Administration are subjected to background investigations prior to employment; DRAFT, Enhancing Faith-Based Support for Veterans Act of 2024; DRAFT, No Wrong Door for Veterans Act; H.R.9324, Protecting Veteran Access to Telemedicine Services Act; DRAFT, Safeguarding VA’s Healthcare Workforce Act; DRAFT, The Veterans Supporting Prosthetics Opportunities and Recreational Therapy Act; DRAFT, Service Dogs Assisting Veterans Act; H.R.9146, Ensuring Continuity in Veterans Health Act; H.R.7504, Rural Veterans Transportation to Care Act; H.R.6330, Veterans Sentinel Act; H.R.8562, Parity for Native Hawaiian Veterans Act; H.R.6291, Have You Served Act; H.R.9301, To direct the Secretary of VA to include two counties in New Mexico in a certain Veterans Integrated Service Network; DRAFT, Conflict of Interest Waiver for VA Researchers; 10:00 a.m.; September 11

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation;” 10:30 a.m.; September 11

House Judiciary Subcommittee on Administrative State, Regulatory Reform, and Antitrust hearing “The Role of Pharmacy Benefit Managers;” 2:00 p.m.; September 11

Senate HELP Committee hearing to examine the bankruptcy of Steward Health Care, focusing on how management decisions have impacted patient care; 10:00 a.m.; September 12

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” 10:00 a.m.; September 24

Recently Introduced Health Legislation

H.Res.1418-Supporting the designation of March 2024 as Endometriosis Awareness Month; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House-Energy and Commerce

H.Res.1419-Supporting the goals of Overdose Awareness Day and strengthening efforts to combat the opioid crisis in the United States; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House-Energy and Commerce

H.R.9425-To amend the Federal Food, Drug, and Cosmetic Act to authorize tobacco user fee assessments for all regulated tobacco products, and for other purposes; Sponsor: McClellan, Jennifer L. [Rep.-D-VA-4]; Committees: House-Energy and Commerce

H.R.9426-To direct the Secretary of Veterans Affairs to carry out a pilot program under which the Secretary may fill vacant shifts at medical facilities of the Department of Veterans Affairs with non-Department health care providers; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House-Veterans’ Affairs

H.R.9427-To direct the Secretary of Veterans Affairs to carry out a pilot program to provide grants to outpatient mental health facilities for the provision of culturally competent, evidence-based mental health care for veterans, and for other purposes; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House-Veterans’ Affairs

H.R.9436-To establish a National Science Foundation grant program to provide and strengthen opportunities for peer-led research regarding autism spectrum disorder and its characteristics in women, and for other purposes; Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House-Science, Space, and Technology Latest

H.R.9438-To amend and reauthorize the Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program of the Department of Veterans Affairs; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House-Veterans’ Affairs

H.R.9439-To authorize proceeds from any sale or any moneys forfeited under the Controlled Substances Act to be used for the Substance Use Prevention, Treatment, and Recovery Services Block Grant, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House-Judiciary; Energy and Commerce

H.R.9443-To amend the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to share food safety information with State, local, Tribal, and Territorial authorities, and for other purposes; Sponsor: Ross, Deborah K. [Rep.-D-NC-2]; Committees: House-Energy and Commerce

H.R.9445-To direct the Secretary of Defense to replace certain syringes of the Department of Defense; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House-Armed Services

H.Res.1421-Supporting the goals of “Blood Cancer Awareness Month”; Sponsor: Fong, Vince [Rep.-R-CA-20]; Committees: House-Energy and Commerce

H.R.9446-To provide payment for patient navigator services under title XIX of the Social Security Act, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House-Energy and Commerce

H.R.9449-To direct the Secretary of Veterans Affairs to establish a list of covered providers that complete annual training on the prevention of suicide among veterans and to make such list available to veterans; Sponsor: Huizenga, Bill [Rep.-R-MI-4]; Committees: House-Veterans’ Affairs

Hoyer Recovers from Mild Stroke-Rep. Steny Hoyer (D-Md.), 85, experienced a stroke on August 11, the congressman’s office announced last week. He is not experiencing any lingering symptoms following treatment for the mild ischemic stroke. Hoyer, the former House majority leader, is expected to resume his normal schedule this week.

George Helmy Tapped to Fill Menendez’s Senate Seat-New Jersey Governor Phil Murphy (D) has appointed his former chief of staff George Helmy to fill the seat of Sen. Bob Menendez (D) until early next year. Menendez was convicted on federal corruption charges last month and will resign from the Senate effective August 20. Helmy is an executive vice president at the New Jersey health system RWJ Barnabas Health and is on the Board of Commissioners of the Port Authority of New York and New Jersey. Rep. Andy Kim (D) is heavily favored to win the full six-year term in the November election, in which Menendez has filed to run as an independent. It remains unclear whether Menendez will remain on the ballot.

White House Announces First 10 Negotiated Medicare Drug Prices-On Thursday, the Biden administration announced the maximum fair prices of the first 10 drugs selected for the Medicare price negotiation process established by the Inflation Reduction Act in 2022. The new prices will go into effect for people with Medicare Part D prescription drug coverage starting January 1, 2026.

The White House estimates that if the new prices had been in effect last year, Medicare would have saved an estimated $6 billion, or 22%, across the 10 selected drugs. Approximately nine million people with Medicare use at least one of the 10 selected drugs, and these individuals are expected to see aggregated estimated savings of $1.5 billion in out-of-pocket costs in 2026. Throughout the negotiation process, the Centers for Medicare and Medicaid Services (CMS) raised its offers for each drug following discussions with the pharmaceutical manufacturer, while many of the manufacturers lowered their counteroffers. CMS will select up to 15 more Part D drugs for negotiation for 2027 by February 1, 2025. The agency will select up to 15 more drugs covered by Part B or Part D for 2028, and up to 20 more Part B or Part D drugs for each year after that.

President Announces New Cancer Moonshot Research Awards-President Joe Biden announced $150 million in new Advanced Research Projects Agency for Health awards as a part of his Cancer Moonshot initiative last week. The new grants will support eight teams of researchers at Tulane University; Dartmouth College; Johns Hopkins University; Rice University; the University of California, San Francisco; the University of Illinois Urbana-Champaign; the University of Washington; and Cision Vision in Mountain View, California working to improve tumor removal technologies for people with cancer. The President has stated that the Cancer Moonshot will be a priority of his final months in office. Biden’s Cancer Moonshot, originally authorized as part of the 21^st Century Cures Act while Biden was Vice President, aims to ultimately reduce the nation’s cancer death rate by 50% over the next 25 years.

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” 10:00 a.m.; September 24

Recently Introduced Health Legislation

H.R.9328-To amend title 38, United States Code, to establish additional presumptions of service connection for certain diseases that occur in veterans who suffered toxic exposure while serving at Karshi Khanabad Air Base, Uzbekistan; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House-Veterans’ Affairs

H.R.9333-To amend the Internal Revenue Code of 1986 to provide an income tax credit for the costs of certain fertility treatments; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House-Ways and Means

H.R.9335-To direct the Secretary of Defense to carry out a pilot program to provide services from midwives to covered beneficiaries under the TRICARE program; Sponsor: Kilmer, Derek [Rep.-D-WA-6]; Committees: House-Armed Services

H.R.9350-To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to revise part 71 of title 42, Code of Federal Regulations, to allow for the import of certain dogs without rabies vaccination documentation or an import form, and for other purposes; Sponsor: Kennedy, Timothy M. [Rep.-D-NY-26]; Committees: House-Energy and Commerce

H.R.9351-To amend title XIX of the Social Security Act to modify certain limitations on disproportionate share hospital payment adjustments under the Medicaid program; Sponsor: LaLota, Nick [Rep.-R-NY-1]; Committees: House-Energy and Commerce

H.R.9352-To amend title XXVII of the Public Health Service Act and title 5, United States Code, to require group health plans, health insurance issuers offering group or individual health insurance coverage, and Federal Employees Health Benefits Program health benefits plans to meet certain requirements with respect to medical child support orders, and for other purposes; Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House-Energy and Commerce; Ways and Means; Oversight and Accountability

HELP Committee Advances OAA Reauthorization-The Senate Health, Education, Labor, and Pensions (HELP)Committee voted 20-1 to reauthorize the Older Americans Act (OAA) last week. Sen. Rand Paul (R-Ky.) was the sole vote in opposition to the reauthorization. Under S. 4776, the Older Americans Act Reauthorization Act of 2024, OAA programs would receive an almost 5% increase in authorized funding through fiscal year 2029. The Committee also advanced the Autism Collaboration, Accountability, Research, Education, and Support (Autism CARES) Act of 2024 (S.4762) and the Traumatic Brain Injury Program Reauthorization Act (S.4755) on a bipartisan basis.

HSGAC Advances Healthcare Cybersecurity Act-The Senate Homeland Security and Governmental Affairs Committee (HSGAC) advanced the Healthcare Cybersecurity Act (S.4697) in a 10-1 vote last week with Sen. Rand Paul (R-Ky.) voting against the bill. This legislation directs the Cybersecurity and Infrastructure Security Agency (CISA) and the U.S. Department of Health and Human Services (HHS) to collaborate on improving cybersecurity and make resources available to non-federal entities relating to cyber threat indicators and appropriate defense measures. It would also create a special liaison to HHS within CISA to coordinate during cybersecurity incidents and collaborate to support health care and public health sector entities.

Senate Appropriators Advance FY25 LHHS Bill-The Senate Appropriations Committee approved its fiscal year (FY) 2025 Labor-Health and Human Services (LHHS) spending measure last week in a bipartisan 25-3 vote. Sens. Deb Fischer (R-Neb.), Marco Rubio (R-Fla.), and Bill Hagerty (R-Tenn.) voted in opposition the legislation and Sen. John Hoeven (R-N.D.) did not vote. The bill provides $122.8 billion in discretionary funding for HHS. The National Institutes of Health would receive $50.2 billion, an increase of $2.05 billion over current levels. The bill sustains $1.5 billion in funding for the Advanced Research Projects Agency for Health. The Centers for Disease Control and Prevention would see a funding increase of $173 million over FY24 levels. The bill includes $3.82 billion for the Administration for Strategic Preparedness and Response, an increase of $200 million over FY24. More information can be found in the bill summary, bill text, and report.

The Senate’s bill stands in stark contrast to the House of Representative’s FY25 LHHS spending bill, which would cut HHS funding by 7% and provide flat funding for the NIH while proposing structural reforms. The House had planned to bring their version of the bill to the floor for a vote, but instead adjourned early for August recess when it became clear the measure did not have enough support for passage. Lawmakers are expected to begin negotiations on a stopgap spending measure when both chambers return from recess in September.

Comer Requests CMS Briefing on OPO Guidance-House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the administration regarding its failure to issue guidance on the future of low performing organ procurement organizations (OPOs). The Centers for Medicare and Medicaid Services (CMS) finalized a rule in 2020 that would decertify the lowest performing-Tier 3-OPOs in 2026 based on their 2024 performance if they have failed to show improvement. CMS has yet to release guidance outlining how this decertification process would proceed or how higher performing OPOs should prepare to take over additional service areas. Approximately 42% of OPOs operated at the Tier 3 level in 2021, the most recent year with available data. “CMS’ inaction has created lack of clarity, increased uncertainty for Americans who need a transplant, and threatens to erode accountability for OPOs,” Comer writes. He requests a briefing from the agency that includes a description of the steps CMS is taking to ensure the final rule is implemented “without dilution or delay.”

Foxx Opposes Mental Health Parity Regulations-House Education and the Workforce Committee Chair Virginia Foxx (R-N.C.) sent a letter to the White House urging the administration to drop its proposed mental health parity rule. The rule is aimed at improving mental health coverage in commercial insurance plans by requiring parity between physical and mental health care in “non-quantitative treatment limitations” such as prior authorization. Foxx asserts that the rule lacks clarity and fails to consider workforce shortages amongst mental health professionals, arguing that it would actually decrease access to mental health treatment by disincentivizing employers from offering coverage. She also questions whether the rule exceeds agency authority in light of the Supreme Court’s overturning of the Chevron Deference.

Bucshon Remarks on VALID Act Status-Rep. Larry Bucshon, M.D. (R-Ind.) commented on the future of diagnostics reform legislation last week, appearing optimistic about the chances for bill passage in the next several years. The Food and Drug Administration (FDA) finalized a regulation earlier this year to provide greater oversight of laboratory developed tests (LDTs) within the agency’s existing medical device framework. Bucshon is the co-author of the bipartisan VALID Act (H.R.2369), which would create a new risk-based framework for the review of diagnostics and LDTs. Bucshon stated that many stakeholders’ opposition to the FDA rule has brought more parties back to the negotiating table on the VALID Act, and that the Supreme Court’s recent Chevron decision could result in litigation challenging the rule. Bucshon, who is retiring at the end of this year, has not yet secured a Republican to replace him alongside VALID Act co-lead Rep. Diana DeGette (D-Colo.).

Release of Senate 340B Bill Delayed-The release of legislation in the Senate to reform the 340B drug pricing program has been stalled, with the bill now not expected to be introduced until after the August recess. Sen. John Thune (R-S.D.) had previously expressed hopes that the bill would be rolled out last week, but its release was delayed by unspecified disagreements between Republican and Democratic members of the chamber’s bipartisan 340B working group. “It’s clear that we need a little more time to get this across the finish line,” GOP members of the working group-Sens. Thune, Jerry Moran (Kan.), and Shelley Moore Capito (W-Va.)-said in a statement.

CMS Releases FY25 IPPS Final Rule-Hospital payments will increase by $3.2 billion next year under the FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule released by CMS last week. The 2.9% increase will take effect October 1 and is in line with CMS’ initial proposed rule. The regulation also finalizes a separate IPPS payment for small, independent hospitals to establish and maintain a buffer stock of essential medicines. The agency asserts that such facilities are particularly vulnerable to supply disruptions, and that buffer stocks will help guard against future shortages. CMS’ fact sheet on the final rule can be found here.

Congressional Retirements and Resignations-Rep. Bob Good (R-Va.) was defeated by former Navy SEAL officer John McGuire in the Republican primary following a recount for Virginia’s 5^th congressional district. Good was first elected to Congress in 2020 and serves on the Education and Workforce and Budget committees. He is currently the chairman of the House Freedom Caucus.

A running list of members of Congress who are retiring or seeking other office can be found below.

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?”10:00 a.m.; September 24

Recently Introduced Health Legislation

H.R.9179-To amend title 38, United States Code, to establish the Office of Falls Prevention of the Department of Veterans Affairs, and for other purposes; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House-Veterans’ Affairs; Education and the Workforce

S.4827-A bill to improve transparency and the availability of information regarding dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to list dietary supplements with the Food and Drug Administration; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions

S.4829-A bill to direct the Administrator of the Centers for Medicare & Medicaid Services to clarify that implanted active middle ear hearing devices are prosthetics and are not subject to the hearing aid coverage exclusion under the Medicare program; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Finance

S.Res.775-A resolution expressing support for the designation of July 15, 2024, as “National Leiomyosarcoma Awareness Day”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate-Health, Education, Labor, and Pensions

S.4831-A bill to amend the Older Americans Act of 1965 to include peer supports as a supportive service within the National Family Caregiver Support Program, to require States to consider the unique needs of caregivers whose families have been impacted by substance use disorder, including opioid use disorder, in providing services under such program, and for other programs; Sponsor: Budd, Ted [Sen.-R-NC]; Committees: Senate-Health, Education, Labor, and Pensions

S.4835-A bill to amend the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide for 3 primary care visits and 3 behavioral health care visits without application of any cost-sharing requirement; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate-Health, Education, Labor, and Pensions

S.4845-A bill to lower the cost of all drugs for all Americans; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

S.4847-A bill to require the Secretary of Defense to conduct a study on active military-civilian partnerships at trauma centers of military medical treatment facilities within the Defense Health Agency; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Armed Services

S.4855-A bill to amend the Older Americans Act of 1965 to authorize the provision of appropriate training, resources, and best practices to the aging network under grants for projects that address negative health effects associated with social isolation among older individuals; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions

S.4860-A bill to amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

S.4862-A bill to ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes; Sponsor: Rounds, Mike [Sen.-R-SD]; Committees: Senate-Health, Education, Labor, and Pensions

H.R.9184-To amend title XI of the Social Security Act to exclude from antikickback and other sanctions certain travel and lodging arrangements between manufacturers of drugs and individuals being administered such drugs, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House-Energy and Commerce; Ways and Means

H.R.9186-To amend title 10, United States Code, to ensure that medical records of the Department of Defense indicate the organizational affiliation of certain health care providers; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Armed Services

H.R.9194-To amend the Research and Development, Competition, and Innovation Act to support nucleic acid screening, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Science, Space, and Technology

H.R.9218-To establish a clear and consistent biological definition of male and female; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Judiciary

H.R.9232-To amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House-Ways and Means

H.R.9233-To amend the Public Health Service Act to require the Secretary of Health and Human Services to establish a program for the conduct and support of research, training, and health information dissemination with respect to environmental risk factors of neurodegenerative diseases, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House-Energy and Commerce

S.4878-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions

S.4879-A bill to prioritize funding for an expanded and sustained national investment in biomedical research; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Appropriations

S.4905-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: Reed, Jack [Sen.-D-RI]; Committees: Senate-Health, Education, Labor, and Pensions

S.4918-A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Health, Education, Labor, and Pensions

S.Res.794-A resolution designating September 25, 2024, as “National Ataxia Awareness Day”, and raising awareness of ataxia, ataxia research, and the search for a cure; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Judiciary

S.Res.799-A resolution supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2024; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4923-A bill to amend title IV of the Social Security Act to require States to provide information about available benefits and services to kinship caregivers; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

S.4935-A bill to amend title XVIII of the Social Security Act to update the budget neutrality threshold under the Medicare physician fee schedule; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate-Finance

S.4937-A bill to require Senate approval before the United States assumes any obligation under a WHO pandemic agreement and to suspend funding for the WHO until such agreement is ratified by the Senate; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate-Foreign Relations

S.4942-A bill making appropriations for the Departments of Labor, Health and human Services, and Education, and related agencies for the fiscal year ending September 30, 2025, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate-Appropriations

S.4949-A bill to improve end-of-life care; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions

S.4957-A bill to amend the Public Health Service Act to provide for a health care workforce innovation program; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Health, Education, Labor, and Pensions

S.4964-A bill to provide for a comprehensive Federal response to Long COVID, including research, education, and support for affected individuals, to direct the National Institutes of Health to establish a Long COVID research program, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate-Health, Education, Labor, and Pensions

S.4968-A bill to improve the Institutional Development Award program of the National Institutes of Health; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Health, Education, Labor, and Pensions

S.4984-A bill to amend the Controlled Substances Act to require regulated persons to identify tableting machines and encapsulating machines by serial number; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

S.4987-A bill to codify Chevron deference; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Homeland Security and Governmental Affairs