Category: Weekly Policy Briefing

Greene, Massie to Trigger Motion to Vacate Vote-Reps. Marjorie Taylor Greene (R-Ga.) and Thomas Massie (R-Ky.) announced plans to force a vote this week on Greene’s motion to vacate in an attempt to oust Mike Johnson (R-La.) as Speaker of the House. Their decision follows Johnson’s work with Democrats to fund the federal government and pass $95 billion in foreign aid. House Democratic leadership have pledged to join with Johnson’s GOP backers to table the motion.

House Passes Congressional Budget Office Data Sharing Act-The House of Representatives passed legislation last week that will speed the rate at which data is shared between federal agencies, including the U.S. Department of Health and Human Services, and the Congressional Budget Office (CBO). H.R. 7032, the bipartisan Congressional Budget Office Data Sharing Act, passed by voice vote. The bill clarifies and expands the CBO Director’s authority to request and receive data from executive branch agencies, and would require CBO to maintain the same level of confidentiality protections as the agency providing the data.

Senate Passes Minority Health Resolution, Considers Health Professional Shortages-Last week, the Senate passed S. Res. 675, a resolution promoting minority health awareness and supporting the goals and ideals of National Minority Health Month, including bringing attention to the health disparities faced by minority populations of the United States. The bipartisan resolution was sponsored by Sen. Ben Cardin (D-Md.) and cosponsored by seven other members of the Senate. The resolution was passed the same day the Senate Health, Education, Labor, and Pensions Committee convened a hearing about the shortage of minority health care workers and the nation’s high maternal mortality rate. During the hearing, Chairman Bernie Sanders (I-Vt.) argued in favor of canceling student debt and making public colleges and universities tuition free in order to address health workforce shortages. He also urged the expansion of programs like the National Health Service Corp as well as the size of Historically Black Colleges and Universities. Witnesses spoke to the importance of access to health care providers that reflect the racial and ethnic background of the patient population for improving health outcomes.

Senate Finance Leaders Release Proposal Aimed at Drug Shortages-Bipartisan leadership of the Senate Finance Committee have released a draft legislative proposal to address prescription drug shortages and stabilize the supply of generic medications. The Committee is accepting comments on the proposal at [email protected] through June 6, 2024.The draft from Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries, and drug manufacturers to meet standards in securing a sustainable, high-quality supply of essential medicines for all patients. Requirements for program participants include:

• Minimum three-year contracts with manufacturers for generic drugs that present high shortage risks;
• Meaningful purchase volume commitments and stable pricing;
• Requirements for contingency contracts with alternate manufacturers to strengthen competition and prevent shortages from supply-chain disruptions;
• Prohibitions against anticompetitive practices; and
• Transparency around manufacturer quality control issues.

The proposal would also change the Medicaid Drug Rebate Program to enable reductions or waivers of the inflation rebate for certain generic drugs in the event of shortage risk.

Ways and Means Expected to Markup Telehealth Legislation-The House Ways and Means Committee is expected to mark up a two-year extension of the Medicare telehealth flexibilities first instituted in response to the COVID-19 pandemic. It remains unclear what temporary extension legislation the committee will vote on. Both the CONNECT for Health Act (H.R. 4189), introduced by Ways and Means member Mike Thompson (D-Calif.), and the Telehealth Modernization Act (H.R. 7623), introduced by Rep. Buddy Carter (R-Ga.), would make the pandemic-era rules permanent. Despite significant support from advocates and many lawmakers for making the telehealth regulations permanent, concerns remain about the high Congressional Budget Office score of such policy.

Klobuchar Requests Investigation into Health Data Analytics Firm-Sen. Amy Klobuchar (D-Minn.) is asking the Federal Trade Commission and the Department of Justice to investigate potentially anticompetitive behavior by MultiPlan, a health care data analytics firm. Recent reports have revealed MultiPlan’s role in helping health insurers determine medical payments for out-of-network claims and raised questions about possible price fixing. “While it is common for patients to pay different rates for out-of-network care, I am concerned that-rather than competing for business from employers by reducing these costs to employees-algorithmic tools are processing data gathered across numerous competitors to subvert competition among insurance companies,” Klobuchar writes. “The result is that instead of competing with each other, insurance companies are pushing additional hidden costs onto employees and patients.” Sen. Klobuchar introduced legislation earlier this year, the Preventing Algorithmic Collusion Act (S. 3686), which would prohibit the use of pricing algorithms that can facilitate collusion through the use of nonpublic competitor data.

United CEO Testifies on Change Healthcare Cyberattack-UnitedHealth Group’s CEO Andrew Witty testified before both the Senate Finance Committee and the Energy and Commerce Subcommittee on Oversight and Investigations last Wednesday to discuss the February Change Healthcare cyberattack and United’s response to the attack. Lawmakers questioned Witty about how the attack occurred, the number of Americans impacted by the resulting data breach, and the lessons learned in coordinating with federal agencies following the attack. The Change server infiltrated by the hackers was not protected by multifactor authentication, and the criminals accessed data potentially covering one-third of all Americans. Some lawmakers used the opportunity to argue against consolidation in the health care market, while others spoke in favor of minimum cybersecurity and data standards for the industry. Finance Chairman Ron Wyden (D-Ore.) stated that his panel is currently drafting legislation that would require larger health care companies to meet stronger cybersecurity standards, noting that his committee also has jurisdiction over issues impacting the Health Insurance Portability and Accountability Act (HIPAA).

Several days prior to Witty’s appearance before lawmakers, Sens. Elizabeth Warren (D-Mass.), Bill Cassidy (R-La.), and Richard Blumenthal (D-Conn.) sent a letterto the Cybersecurity and Infrastructure Security Agency (CISA) urging the agency to assess the cybersecurity landscape leading up to, and after, the Change attack. The lawmakers also requested details about CISA’s role in responding to the Change data breach, the broader risks posed by ransomware, and current efforts to combat it. Meanwhile, a group of congressional Democrats are also asking the Securities and Exchange Commission (SEC) to investigate the timing of stock sales by United’s chair and three executives. The sales in question occurred between October, when the company learned of an antitrust investigation, and February, when the antitrust probe was made public. The lawmakers ask SEC to review whether the antitrust investigation was material to investors and, if so, whether disclosures were sufficient.

Cassidy Urges White House to Detail Avian Flu Research Priorities-Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy, MD (R-La.) has sent a letterto the White House urging the Biden administration to issue a plan detailing its research priorities related to the H5N1 influenza (Avian Flu) outbreak. Cassidy highlights the importance of coordination across federal agencies, transparent communication about the spread and behavior of the virus, and the risks of jeopardizing public trust in the nation’s agriculture and food sectors. He calls on the President “to swiftly publish a prioritized list of research activities, including target timelines for generating results and communicating findings to the public” and to “make all relevant data and methodologies available to nonfederal scientists in an appropriate manner for validation.”

FDA Releases Final LDT Rule-The Food and Drug Administration (FDA) has finalized a rule to regulate laboratory-developed tests (LDTs) as medical devices. The regulation, which is aimed at ensuring the accuracy and reliability of LDTs, will be phased in over a four-year period. Lawmakers in Congress, including House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), had previously called on the agency to rescind the proposed rule due to concerns about its impact on patient access to innovative diagnostics. “While the final rule is a slight improvement to the proposed rule, it will still increase costs and decrease access to diagnostics and medical tests that provide information crucial for doctors to treat their patients effectively…Moreover, finalizing this rule is inconsistent with President Biden’s goal of reducing cancer deaths. The FDA should abandon the rule, as it lacks the clear statutory authority to implement it,” Chair Rogers stated.

FSMB Adopts Guidance on Clinical Use of AI-The Federation of State Medical Boards (FSMB) has released a new report on Navigating the Responsible and Ethical Incorporation of Artificial Intelligence into Clinical Practice. The guidance suggests that physicians are ultimately responsible for their use of AI and should be held accountable for any harms that occur because of its use. FSMB discusses best practices for regulating the clinical use of AI, and recommends that state medical boards set accountability measures based on a tool’s risk to patients. “With focused efforts on the current and future state of the use of AI by licensees, state medical boards may sustain regulatory efficiency, achieve consistency across jurisdictions in the regulation of AI in clinical practice, help secure the benefits of AI, and proactively safeguard patients while upholding professional standards,” the report states.

Congressional Retirements and Resignations-New York state senator Timothy Kennedy (D) won the special election for New York’s 26^th congressional district last week. Kennedy will fill the seat vacated by former Rep. Brian Higgins (D), who resigned in February. Democrats now control 213 seats in the House of Representatives to Republicans’ 217 seats, with five vacancies remaining.

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

Upcoming Congressional Hearings and Markups

House Committee on Small Business hearing “Stifling Innovation: Examining the Impacts of Regulatory Burdens on Small Businesses in Healthcare;” 10:00 a.m.; May 8

Senate Budget Committee hearing “Reducing Paperwork, Cutting Costs: Alleviating Administrative Burdens in Health Care;” 10:00 a.m.; May 8

Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee hearing “A Review of the President’s Fiscal Year 2025 Budget Request for the Food and Drug Administration;” 10:00 a.m.; May 8

Senate Health, Education, Labor, and Pensions Committee hearing “Feeding a Healthier America: Current Efforts and Potential Opportunities for Food is Medicine;” 2:30 p.m.; May 21

Recently Introduced Health Legislation

H.R.8128-To require health insurance coverage for scalp cooling items; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House-Energy and Commerce; Ways and Means; Education and the Workforce; Armed Services; Veterans’ Affairs; Oversight and Accountability

H.R.8134-To promote the leadership of the United States in global innovation by establishing a robust patent system that restores and protects the right of inventors to own and enforce private property rights in inventions and discoveries, and for other purposes; Sponsor: Massie, Thomas [Rep.-R-KY-4]; Committees: House-Judiciary

H.R.8137-To provide for an exception to the restrictions described in the Assisted Suicide Funding Restriction Act of 1997 with respect to certain States; Sponsor: Pettersen, Brittany [Rep.-D-CO-7]; Committees: House-Energy and Commerce; Ways and Means; Judiciary; Education and the Workforce; Oversight and Accountability; Natural Resources; Foreign Affairs

H.R.8144-To amend title III of the Public Health Service Act to include rural emergency hospitals in the definition of a covered entity for purposes of the 340B drug discount program; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House-Energy and Commerce

H.R.8154-To amend title XVIII of the Social Security Act to extend telehealth services for federally qualified health centers and rural health clinics; Sponsor: Murphy, Gregory F. [Rep.-R-NC-3]; Committees: House-Energy and Commerce; Ways and Means

S.4204-A bill to amend title XIX of the Social Security Act to codify value-based purchasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements, and for other purposes; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate-Finance

S.4215-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

H.Res.1180-Recognizing the importance of diversity, equity, and inclusion efforts in medical education; Sponsor: Beatty, Joyce [Rep.-D-OH-3]; Committees: House-Energy and Commerce

H.Res.1181-Expressing support for designation of April as “National Donate Life Month” and expressing gratitude to all Americans who have registered to be organ and tissue donors; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House-Energy and Commerce

H.Res.1185-Designating the month of May as “National First Responder Month”; Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House-Transportation and Infrastructure

H.R.8165-To amend title 38, United States Code, to establish qualifications for the appointment of a person as a marriage and family therapist, qualified to provide clinical supervision, in the Veterans Health Administration; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House-Veterans’ Affairs

H.R.8167-To require the Secretary of Defense to award grants to fund research on orthotics and prosthetics; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House-Armed Services

H.R.8168-To require the Secretary of Veterans Affairs to award grants to establish, or expand upon, master’s degree programs in orthotics and prosthetics, and for other purposes; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House-Veterans’ Affairs

S.4223-A bill to establish certain duties for pharmacies to ensure provision of Food and Drug Administration-approved contraception, medication related to contraception, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

S.4226-A bill to decriminalize and deschedule cannabis, to provide for reinvestment in certain persons adversely impacted by the War on Drugs, to provide for expungement of certain cannabis offenses, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Finance

S.4229-A bill to amend title XVIII of the Social Security Act to require that coinsurance for drugs under Medicare part D be based on the drug’s net price and not the drug’s list price; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate-Finance

S.4230-A bill to improve the tracking and processing of security and safety incidents and risks associated with artificial intelligence, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate-Commerce, Science, and Transportation

S.4231-A bill to provide for the establishment of Medicare part E public health plans, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate-Finance

S.4232-A bill to amend title 18, United States Code, to prohibit former employees of covered health agencies from serving on the board of entities involved in development and research of a drug, biological product, or device and from profiting from a drug, biological product, or device, and for other purposes; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate-Judiciary

S.4236-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.R.8200-To amend title III of the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants to eligible entities to carry out construction or modernization projects designed to strengthen and increase capacity within the specialized pediatric health care infrastructure, and for other purposes; Sponsor: Cardenas, Tony [Rep.-D-CA-29]; Committees: House-Energy and Commerce

H.R.8202-To amend title 38, United States Code, to provide for a presumption of service-connection under the laws administered by the Secretary of Veterans Affairs for certain diseases associated with the COVID-19 vaccine that become manifest during the one-year period following the receipt of the vaccine, and for other purposes; Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House-Veterans’ Affairs; Armed Services

H.R.8207-To provide for the establishment of Medicare part E public health plans, and for other purposes; Sponsor: Gomez, Jimmy [Rep.-D-CA-34]; Committees: House-Energy and Commerce; Education and the Workforce; Ways and Means

H.R.8211-To amend title 18, United States Code, to prohibit former employees of covered health agencies from serving on the board of entities involved in development and research of a drug, biological product, or device and from profiting from a drug, biological product, or device, and for other purposes; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House-Judiciary

H.R.8217-To amend part B of title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House-Energy and Commerce; Ways and Means; Education and the Workforce

H.R.8220-To clarify coverage of occupational therapy under the Medicare program; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House-Ways and Means; Energy and Commerce

S.Res.675-A resolution promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2024, which include bringing attention to the health disparities faced by minority populations of the United States such as American Indians, Alaska Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians and other Pacific Islanders; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.J.Res.76-A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to “Short-Term, Limited-Duration Insurance and Independent, Noncoordinated Excepted Benefits Coverage”; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate-Health, Education, Labor, and Pensions

S.4238-A bill to amend title III of the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants to eligible entities to carry out construction or modernization projects designed to strengthen and increase capacity within the specialized pediatric health care infrastructure, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

S.4246-A bill to improve menopause care and mid-life women’s health, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate-Health, Education, Labor, and Pensions

H.R.8223-To improve menopause care and mid-life women’s health, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House-Energy and Commerce

H.R.8227-To amend title XVIII of the Social Security Act to remove in-person requirements under Medicare for mental health services furnished through telehealth and telecommunications technology; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House-Energy and Commerce; Ways and Means

H.R.8235-To amend title XVIII of the Social Security Act to modify the distribution of certain additional graduate medical education positions under the Medicare program; Sponsor: Murphy, Gregory F. [Rep.-R-NC-3]; Committees: House-Ways and Means; Energy and Commerce

Budget Leadership Requests GAO Review of CMMI–House Budget Committee Chairman Jodey Arrington (R-Texas) and Budget Committee Health Care Task Force Chair Michael Burgess (R-Texas) are requesting that the Government Accountability Office (GAO) investigate the effectiveness of the Center for Medicare and Medicaid Innovation (CMMI). Arrington and Burgess argue that CMMI has failed to deliver on its mandate to test new payment models that address health care costs and quality. CMMI spending is set to increase by $1.3 billion by 2030, while only six of the more than 50 models it has tested have resulted in statistically significant savings. “We must conduct budgetary oversight of mandatory health care programs such as CMMI that are adding to our national debt and not delivering for taxpayers or patients,” Arrington and Burgess stated. The lawmakers ask GAO to review the agency’s dedicated funding and performance and to evaluate which of the payment models tested by CMMI have saved money or increased spending.

Sanders Opens Investigation into Weight-Loss Drug Pricing–Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) is opening a new investigation into the price of weight-loss drugs Ozempic and Wegovy. The products currently sell for approximately $1,000 a month. “The unjustifiably high prices of Ozempic and Wegovy are already straining the budgets of Medicare and Medicaid and severely limiting access for patients who need these drugs,” the HELP Chairman argued. Sanders sent a letter to Novo Nordisk’s CEO requesting that the drug company substantially reduce the list price and the net price of both Ozempic and Wegovy, and provide detailed information regarding the pricing, cost, and sale of each product. “The scientists at Novo Nordisk deserve great credit for developing these drugs that have the potential to be a game changer for millions of Americans struggling with type 2 diabetes and obesity. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them,” Sanders wrote.

Cole Announces Appropriations Deadline and Updates to Earmarking Process–House Appropriations Committee Chairman Tom Cole (R-Okla.) announced a change to the congressional earmarking process for fiscal year (FY) 2025 last week. The new policy will restrict the House of Representatives from earmarking funds for nonprofits, including health care facilities, under the latest Transportation-Housing and Urban Development appropriations bill. House Republicans had previously banned earmarks under Defense, Financial Services, and Labor-Health and Human Services-Education appropriations ahead of FY 2024 spending bills. Cole also announced a deadline of May 3, 2024, for members to submit their earmark requests.

NJ Rep. Donald Payne Dies Following Heart Attack–Six-term Congressman Donald Payne Jr. (D-N.J.) died last week at the age of 65. Payne had been hospitalized since suffering a cardiac episode related to complications from diabetes earlier this month. Payne succeeded his father, New Jersey’s first-ever Black representative in Congress, in representing the state’s 10^th congressional district. During his time in the House of Representatives he sponsored legislation to promote screening for colorectal cancer and peripheral arterial disease. He was a member of the Homeland Security and Transportation and Infrastructure committees. House leadership announced that votes are no longer expected May 2 to accommodate his funeral service. Payne’s death leaves the House with a 217-212 Republican-Democratic split, with six vacancies.

WHO Finds Widespread Overuse of Antibiotics During COVID Pandemic–The World Health Organization (WHO) released new findings last week revealing extensive, world-wide overuse of antibiotics during the COVID-19 pandemic. While only 8% of hospitalized patients with COVID-19 had bacterial co-infections requiring antibiotics, 75% of patients were treated with antibiotics just in case they help. Antibiotic use ranged from 33% in the Western Pacific Region to 83% in the Eastern Mediterranean and the African Regions. “These findings underscore the important need to adequately resource the efforts to improve antibiotic prescribing globally, and are particularly relevant to discuss ahead of the upcoming UN General Assembly High-Level Meeting on Antimicrobial Resistance (AMR) to take place this September,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for AMR.

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 “Legislative Proposals to Increase Medicaid Access and Improve Program Integrity;” 10:00 a.m.; April 30

House Appropriations Subcommittee on Labor, Health and Human Services, and Education Member Day Hearing; 10:30 a.m.; April 30

Senate Armed Services Subcommittee on Personnel hearing to examine the Department of Defense’s efforts to ensure servicemembers’ access to safe, high-quality pharmaceuticals; the witness list can be found here; 2:30 p.m.; April 30

Senate Finance Committee hearing “Hacking America’s Health Care: Assessing the Change Healthcare Cyber Attack and What’s Next;” the witness list can be found here; 9:00 a.m.; May 1

House Energy and Commerce Subcommittee on Oversight and Investigation and Subcommittee on Health hearing to discuss gain-of-function research with EcoHealth Alliance President Dr. Peter Daszak; 10:00 a.m.; May 1

House Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss the Change Healthcare Cyberattack with Andrew Witty, CEO, UnitedHealth Group Inc.; 2:00 p.m.;

May 1

Senate Health, Education, Labor, and Pensions Committee hearing “What Can Congress Do to Address the Severe Shortage of Minority Health Care Professionals and the Maternal Health Crisis?” 10:00 a.m.; May 2

Recently Introduced Health Legislation

H.R.8084-To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House-Energy and Commerce

H.R.8089-To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program; Sponsor: Garcia, Mike [Rep.-R-CA-27]; Committees: House-Energy and Commerce

H.R.8094-To amend title XIX of the Social Security Act to modify certain asset recovery rules; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House-Energy and Commerce

S.Res.661-A resolution designating the week of April 15 through April 21, 2024, as “National Osteopathic Medicine Week”; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4201-A bill to amend title XVIII of the Social Security Act to modify the criteria for designation of rural emergency hospitals; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Finance

H.R.8106-To amend title XIX of the Social Security Act to increase transparency and expand coverage options with respect to home and community-based services under a Medicaid waiver; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

H.R.8107-To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Energy and Commerce

H.R.8108-To amend title XIX of the Social Security Act to add a Medicaid State plan requirement with respect to the determination of residency of certain individuals serving in the Armed Forces; Sponsor: Kiggans, Jennifer A. [Rep.-R-VA-2]; Committees: House-Energy and Commerce

H.R.8109-To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce

H.R.8110-To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce

H.R.8111-To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House-Energy and Commerce

H.R.8112-To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program; Sponsor: D’Esposito, Anthony [Rep.-R-NY-4]; Committees: House-Energy and Commerce

H.R.8113-To amend title XIX of the Social Security Act to require reporting on certain directed payments under the Medicaid program; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House-Energy and Commerce

H.R.8114-To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services to place certain limitations on Medicaid payments for home or community-based services; Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House-Energy and Commerce

H.R.8115-To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid; Sponsor: Sarbanes, John P. [Rep.-D-MD-3]; Committees: House-Energy and Commerce

H.R.8116-To amend title 28, United States Code, to limit the use of Federal funds for live tissue training for Department of Justice personnel; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House-Judiciary

H.R.8123-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

E&C Schedule Hearing on Change Healthcare Cyberattack-Bipartisan leadership of the House Energy and Commerce Committee sent a letter to UnitedHealth Group, Inc. last week seeking information about the Change Healthcare cyberattack. “The health care system is rapidly consolidating at virtually every level, creating fewer redundancies and more vulnerability to the entire system if an entity with significant market share at any level of the system is compromised,” the committee leaders wrote. “In order to understand better the steps UnitedHealth has taken to address this situation, we request information about the impact of the cyberattack, the actions the company is taking to secure its systems, and the outreach to the health care community in the aftermath.” UnitedHealth’s CEO Andrew Witty will testify before Energy and Commerce’s Oversight and Investigations Subcommittee in a hearing scheduled for May 1 to discuss the cyberattack and how it has impacted patients and providers.

Cassidy Questions FDA Oversight of Clinical Decision Support Software-Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) has sent a letter to the Food and Drug Administration (FDA) criticizing the agency’s decision in a September 2022 guidance to classify clinical decision support (CDS) software as a medical device and to subject software developers to the FDA’s regulatory process. Cassidy argues that the move is not aligned with the agency’s statutory authority, highlighting that Congress excluded CDS software from being categorized as a medical device in the 21^st Century Cures Act. He expresses concerns about the implications of increased oversight of CDS on patient access to innovative medical technology, and notes that the FDA made the change without providing stakeholders an opportunity to submit feedback on the potential impacts of the policy. “This guidance unnecessarily calls into question the safety of these tools and expands the universe of entities regulated by FDA, many of which are small provider practices who have developed their own CDS tools…FDA’s guidance not only runs contrary to an explicit congressional directive but may jeopardize access to advanced tools that improve patient care,” the letter argues.

Buchanan Asks MedPAC to Rethink Approach to Digital Health Tools-Rep. Vern Buchanan (R-Fla.), Chair of the Ways and Means Subcommittee on Health, has sent a letter to the Medicare Payment Advisory Commission (MedPAC) encouraging the commission to rethink its approach to evaluating digital health tools and the use of artificial intelligence in the Medicare program. Buchanan expresses concerns that MedPAC’s current approach could punish providers for using, and innovators for developing, digital health tools that improve health outcomes and control costs. Buchanan argues that “for Medicare to meaningfully transition to value-based care, payment policies need to maximize efficiencies in care delivery and enhance patient safety using digital health tools.” The letter highlights the “quadruple aim” of digital health tools, and strongly encourages MedPAC to “incorporate digital health tools into future evaluations of Medicare policy recommendations and, in partnership with all stakeholders impacted by Medicare policy, ensure that its evaluations and recommendations related to digital health are inclusive of each of the quadruple aims.”

Democratic Senators Raise Concerns With Levemir Discontinuation-Sens. Jeanne Shaheen (D-N.H.), Raphael Warnock (D-Ga.), and Elizabeth Warren (D-Mass.) have sent a letter to the President and CEO of Novo Nordisk regarding the company’s recent decision to discontinue production of Levemir, one of three long-acting insulin products on the market. The letter highlights that access to affordable, in-demand biosimilar insulins will be further restricted by the discontinuation and the creation of significant barriers to demonstrating biosimilarity without a reference sample. The lawmakers ask Novo Nordisk about the supply chain constraints and issues related to formulary placement that led to the discontinuation of Levemir, and about how the company plans to ensure patient access to similar long-acting insulin products at similar cost-sharing without gaps in coverage.

GAO Releases New Report on State PBM Regulations-The Government Accountability Office (GAO) released a new report last week examining five states’ regulation of pharmacy benefit managers (PBMs). Each of the five states selected for review-Arkansas, California, Louisiana, Maine, and New York-have enacted a variety of laws to regulate PBMs, including fiduciary or duty of care requirements, drug pricing and pharmacy reimbursement requirements, transparency requirements, and pharmacy network and access requirements. The regulators interviewed by GAO generally agreed that broad regulatory authority was more effective than enacting specific statutory provisions, and also stressed the need for robust enforcement of PBM laws and effective penalties to enforce them.

CBO Releases Analysis of Medicare ACOs’ Past Performance and Future Directions-The Congressional Budget Office has released a new report summarizing recent research findings about accountable care organizations (ACOs) and the factors that have contributed to or limited their ability to achieve net budgetary savings for the Medicare program. The analysis found that certain types of ACOs are associated with greater savings, including ACOs led by independent physician groups, ACOs with a larger proportion of primary care providers, and ACOs whose initial baseline spending was higher than the regional average. CBO also outlines the factors that limit the savings from Medicare ACOs, including weak incentives for ACOs to reduce spending, a lack of the resources necessary for providers to participate in ACO models, and providers’ ability to selectively enter and exit the program on the basis of the financial benefits or losses they anticipate from participating.

PAs in Oregon to Rebrand as Physician Associates–Oregon has become the first state in the nation to legally allow physician assistants to use the title physician associate on their license. Other states, including Michigan and South Carolina, are considering similar measures. The change is opposed by the American Medical Association and other physician groups, who have expressed concerns about patient confusion around scope of practice. Oregon’s new law will take effect on June 6, 2024.

Congressional Retirements and Resignations-Rep. Jake LaTurner (R-Kan.) has announced that he will not seek re-election this November. LaTurner has served in Congress since 2021 and currently sits on the Homeland Security, Oversight and Reform, and Science, Space, and Technology committees.

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

Upcoming Congressional Hearings and Markups

House Appropriations Subcommittee on Labor, Health and Human Services, and Education Member Day Hearing; 10:30 a.m.; April 30

House Energy and Commerce Subcommittee on Oversight and Investigation and Subcommittee on Health hearing to discuss gain-of-function research with EcoHealth Alliance President Dr. Peter Daszak; time TBD; May 1

House Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss the Change Healthcare Cyberattack with Andrew Witty, CEO, UnitedHealth Group Inc.; 2:00 p.m.; May 1

Recently Introduced Health Legislation

H.R.7974-To amend the Federal Food, Drug, and Cosmetic Act to require labeling of food products containing insects, and for other purposes; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Energy and Commerce

H.R.7994-To support the direct care professional workforce, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Judiciary; House Administration; Oversight and Accountability

H.R.7996-To amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day; Sponsor: Dunn, Neal P. [Rep.-R-FL-2]; Committees: House-Energy and Commerce

S.Res.647-A resolution recognizing the designation of the week of April 11 through April 17, 2024, as the seventh annual “Black Maternal Health Week”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

S.4131-A bill to reform Federal firearms laws, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate-Judiciary

S.4137-A bill to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate-Finance

S.4147-A bill to continue to fund the IMPROVE initiative through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and for other purposes; Sponsor: Butler, Laphonza R. [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

S.Res.654-A resolution expressing concern about the elevated levels of lead in one-third of the world’s children and the global causes of lead exposure, and calling for the inclusion of lead exposure prevention in global health, education, and environment programs abroad; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate-Foreign Relations

S.4159-A bill to amend the Public Health Service Act to encourage qualified individuals to enter the forensic pathology workforce, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

S.4169-A bill to establish and support primary care team education centers, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate-Health, Education, Labor, and Pensions

S.4174-A bill to amend title IV of the Public Health Service Act to direct the Secretary of Health and Human Services to establish a clearinghouse on intellectual disabilities, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate-Health, Education, Labor, and Pensions

S.4178-A bill to establish artificial intelligence standards, metrics, and evaluation tools, to support artificial intelligence research, development, and capacity building activities, to promote innovation in the artificial intelligence industry by ensuring companies of all sizes can succeed and thrive, and for other purposes; Sponsor: Cantwell, Maria [Sen.-D-WA]; Committees: Senate-Commerce, Science, and Transportation

H.Res.1153-Recognizing the designation of the week of April 11 through April 17, 2024, as the seventh annual “Black Maternal Health Week”; Sponsor: Adams, Alma S. [Rep.-D-NC-12]; Committees: House-Energy and Commerce

H.R.8018-To require the Administrator of the Centers for Medicare & Medicaid Services and the Commissioner of Social Security to review and simplify the processes, procedures, forms, and communications for family caregivers to assist individuals in establishing eligibility for, enrolling in, and maintaining and utilizing coverage and benefits under the Medicare, Medicaid, CHIP, and Social Security programs respectively, and for other purposes. Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.8025-To amend title 10, United States Code, to clarify roles and responsibilities within the Department of Defense relating to subconcussive and concussive brain injuries and to improve brain health initiatives of the Department of Defense, and for other purposes. Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House-Armed Services

H.R.8037-To continue to fund the IMPROVE initiative through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House-Energy and Commerce

H.R.8042-To authorize the Secretary of Health and Human Services to award grants to qualified entities to support community paramedicine programs, and for other purposes; Sponsor: Cleaver, Emanuel [Rep.-D-MO-5]; Committees: House-Energy and Commerce

H.R.8049-To amend the Internal Revenue Code of 1986 to prohibit treatment of certain distributions and reimbursements for certain abortions as qualified medical expenses; Sponsor: Mooney, Alexander X. [Rep.-R-WV-2]; Committees: House-Ways and Means

H.J.Res.129-Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Departments of Labor, the Treasury, and Health and Human Services relating to “Short-Term, Limited-Duration Insurance and Independent, Noncoordinated Excepted Benefits Coverage”; Sponsor: Self, Keith [Rep.-R-TX-3]; Committees: House-Energy and Commerce; Education and the Workforce; Ways and Means

H.R.8064-To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of hearing aids and related hearing services; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House-Energy and Commerce; Ways and Means

H.R.8065-To require the Secretary of Health and Human Services, acting through the Assistant Secretary for Preparedness and Response, to carry out a program under which the Secretary requires each regulated seller of a highly infectious agent to comply with certain logbook requirements, and for other purposes; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House-Energy and Commerce

H.R.8069-To amend the Public Health Service Act to encourage qualified individuals to enter the forensic pathology workforce, and for other purposes; Sponsor: Guest, Michael [Rep.-R-MS-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.8075-To amend title XVIII of the Social Security Act to provide for Medicare coverage of staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients and to ensure all patients are educated on modality options and receive the resources, information, and support to succeed on the modality of their choice, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House-Energy and Commerce; Ways and Means

H.R.8078-To authorize Federal support of States in piloting interoperable State-based repositories of sepsis cases, and for other purposes; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House-Energy and Commerce

H.R.8080-To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish and implement a department-wide after-action program and a risk communication strategy, and for other purposes; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House-Energy and Commerce

Bipartisan Privacy Rights Draft Released-House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Senate Commerce, Science and Transportation Chair Maria Cantwell (D-Wash.) jointlyreleaseda discussion draft for the American Privacy Rights Act. The legislation would set a national standard and minimize the data that companies can collect, keep, and use. It also would provide individuals with the right to opt out of targeted advertising and other data practices. The discussion draft provides enforcement by the Federal Trade Commission, State attorneys general, and consumers. Small businesses that are not selling customers’ personal information would be exempt. The discussion draft includes “health information” under the definition of “sensitive covered data.” Upon release of the draft, House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) said “This is a very strong discussion draft, built on the foundation of years of hard work by the Energy and Commerce Committee to strengthen our nation’s data privacy laws.”

Aderholt Presses for Budget Reforms Before Vote on New Appropriations Leader-Rep. Robert Aderholt (R-Ala.) sent a Dear Colleague letter last week asking the House GOP to delay a vote to select the next chair of the House Appropriations Committee. Aderholt currently leads the Appropriations Subcommittee on Labor-Health and Human Services-Education. Rep. Tom Cole (R-Okla.) is widely considered the frontrunner to replace outgoing Appropriations Committee Chair Kay Granger (R-Texas). The GOP Steering Committee is scheduled to meet April 9 to select a new chair, but Aderholt urges his conference to first conduct an overhaul of the budget process before selecting a new leader. His letter recommends a focus on restoring regular order, strengthening bipartisanship, and promoting fiscal responsibility. “Instead of hastily selecting a new Appropriations chair, I believe that now is the time to focus on correcting the process and developing our theory of government on how we will manage our responsibilities,” Aderholt wrote.

CMS Finalizes 2025 MA Payment Update-The Centers for Medicare and Medicaid Services (CMS) finalized the calendar year 2025 rate announcement for the Medicare Advantage (MA) program last week in line with the agency’s January proposal. Payments to MA plans are projected to increase an average of 3.7%-totaling over $16 billion-from 2024 to 2025. The agency estimates that the federal government will pay between $500 and $600 billion in MA payments to private health plans in 2025. The rate announcement also finalizes updates to MA payment growth rates and changes to the MA payment methodology to improve payment accuracy. CMS also finalized concurrent changes to the structure of the Medicare Part D drug benefit to implement the Inflation Reduction Act’s $2,000 cap on annual out-of-pocket costs for people with Part D in 2025.

HHS Releases Drug Shortages White Paper-The U.S. Department of Health and Human Services (HHS) released a white paper last week outlining steps the administration has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. The paper focuses specifically on generic sterile injectables used in inpatient settings, though HHS acknowledges that the solutions considered in the paper may be applicable to other markets. HHS recommends further collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program. The new programs would be aimed at increasing transparency in the market, linking purchasing and payment decisions to supply chain resilience practices, and incentivizing investments in supply chain resilience and diversification of the supply chain-including domestic manufacturing-to drive impactful change.

HSGAC Chairman Seeks Information on Private Equity Impact on ER Care-Senate Homeland Security and Governmental Affairs Committee (HSGAC) Chairman Gary Peters (D-Mich.) is requesting information from private equity firms about their impact on emergency department operations. Peters cites patient safety issues raised by emergency physicians about private-equity owned staffing companies and hospitals, highlighting that in some cases “physicians reportedly have been responsible for over 20 beds at a given time and patients routinely had a 16-hour wait time in the emergency department.” Peters also expresses concerns that companies “previously engaged in surprise billing may now consider other cost cutting efforts that more directly risk negatively impacting patient safety and care.” Peters sent letters to Team Health, Envision Healthcare, Apollo Global Management, US Acute Care Solutions, and Lifepoint Health.

E&C GOP Requests GAO Report on NIH Handling of National Security Concerns–Republicans on the House Energy and Commerce Committee are requesting that the Government Accountability Office “examine the extent to which the National Institutes of Health (NIH) adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.” The lawmakers highlight recent reports about the agency’s ability to screen for national security issues and vet foreign collaborators. They pose a series of questions aimed at better understanding the extent of current vulnerabilities and NIH’s ability to safeguard federal funding.

Grijalva Announces Cancer Diagnosis–Rep. Raul Grijalva (D-Ariz.) announced last week that he has been diagnosed with cancer. Grijalva had sought treatment several weeks ago for a persistent cough, which was initially diagnosed as pneumonia. “This diagnosis has been difficult to process, but I am confident in the vigorous course of treatment that my medical team has developed, and I’ve begun my journey to fight this cancer,” he stated. Grijalva does not plan to resign from Congress and will continue to work and run for reelection as he undergoes treatment.

Democratic Physicians on the Ballot This November-At least six Democratic doctors are running for the House of Representatives this election cycle, with many of their platforms focused on access to reproductive health and bringing down the cost of health care.

• Minnesota state senator Kelly Morrison, an OB-GYN, is running to replace retiring Rep. Dean Phillips (D-Minn.).
• Arizona state representative Amish Shah, an emergency physician, is running to flip Rep. David Schweikert’s (R-Ariz.) seat.
• Maxine Dexter, a pulmonary and critical care doctor, is running in the Democratic primary to replace retiring Rep. Earl Blumenauer (D).
• Tim Peck, an emergency physician, is running to flip Rep. Erin Houchin’s (R-Ind.) seat.
• Bob Lorinser, a family physician, is running in the Democratic primary for Michigan’s 1^st congressional district, a seat currently held by Rep. Jack Bergman (R-Mich.).
• Kristin Lyerly, an OB-GYN, is unopposed in the Democratic primary in the race to represent Wisconsin’s 8^th congressional district, a seat opened by the retirement of Rep. Mike Gallagher (R-Wis.).

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 Appropriations Subcommittee on State, Foreign Operations, and Related Programs hearing “A Review of the President’s Fiscal Year 2025 Budget Request for the U.S. Agency for International Development;” 2:30 p.m.; April 9

Senate Finance Subcommittee on Health Care hearing “Closing Gaps in the Care Continuum: Opportunities to Improve Substance Use Disorder Care in the Federal Health Programs;” 2:30 p.m.; April 9

House Veterans’ Affairs Subcommittee on Technology Modernization oversight hearing “VA Supply Chain Modernization: Ready for Prime Time?” 3:00 p.m.; April 9

Senate Judiciary Committee hearing “Artificial Intelligence and Intellectual Property: Part III-IP Protection for AI-Assisted Inventions and Creative Works;” 10:00 a.m.; April 10

Senate Committee on Environment & Public Works hearing “Examining the State of Air Quality Monitoring Technology;” 10:00 a.m.; April 10

Senate Foreign Relations Committee hearing “FY 2025 United States Agency for International Development Budget Request;” 10::00 a.m.; April 10

House Energy and Commerce Subcommittee on Health hearing “Legislative Proposals to Support Patient Access to Telehealth Services;” 10:00 a.m.; April 10

House Appropriations Subcommittee on Homeland Security budget hearing “Fiscal Year 2025 Request for the Department of Homeland Security;” 10:00 a.m.; April 10

Senate Appropriations Subcommittee on Homeland Security hearing “A Review of the President’s Fiscal Year 2025 Budget Request for the Department of Homeland Security;” 2:30 p.m.; April 10

Senate Finance Committee hearing “Bolstering Chronic Care through Medicare Physician Payment;” 10:00 a.m.; April 11

House Oversight and Accountability Committee hearing “Oversight of the U.S. Food and Drug Administration;” 1:00 p.m.; April 11

House Appropriations Subcommittee on State, Foreign Operations, and Related Programs budget hearing “Fiscal Year 2025 Request for the United States Agency for International Development;” 1:30 p.m.; April 11

House Appropriations Subcommittee on Homeland Security Member Day hearing; 2:00 p.m.; April 11

House Energy and Commerce Committee hearing with EcoHealth Alliance President Dr. Peter Daszak; time TBD; May 1

Recently Introduced Health Legislation

H.R.7848-To update the National Action Plan for Adverse Drug Event Prevention to consider advances in pharmacogenomic research and testing, to improve electronic health records for pharmacogenomic information, and for other purposes. Sponsor: Swalwell, Eric [Rep.-D-CA-14]; Committees: House-Energy and Commerce

H.R.7834-To improve the licensing requirements for the retail sale of firearms, and for other purposes. Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House-Judiciary

H.R.7855-To amend the Public Health Service Act to authorize rural residency planning and development grant programs, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Energy and Commerce

H.R.7856-To amend title XVIII of the Social Security Act to provide for coverage of the Medicare Diabetes Prevention program, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House-Energy and Commerce; Ways and Means

H.R.7858-To amend title XVIII of the Social Security Act to establish a Medicare incident to modifier for mental health services furnished through telehealth; Sponsor: James, John [Rep.-R-MI-10]; Committees: House-Energy and Commerce; Ways and Means

H.R.7863-To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House-Energy and Commerce

GAO Releases Report on Federal Improper Payments-The Government Accountability Office has released a new report on government-wide improper payments made in fiscal year 2023, finding that total improper payments declined by $11 billion from the prior fiscal year. According to the report, programs at the U.S. Department of Health and Human Services accounted for an estimated $100 billion of $236 billion in improper payments across all federal agencies. The Medicare program saw $51.1 billion in improper payments, while the Medicaid program saw $50.3 billion.

Wyden, Grassley Seek Details on UNOS Data Breach-Sens. Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) sent a letter to the United Network for Organ Sharing (UNOS) last week regarding a November 2023 data breach that gave unauthorized access to at least 1.5 million patient records to Organ Procurement and Transplantation Network (OPTN) and DonorNet system users. The lawmakers outline the multiple prior concerns that they have raised regarding UNOS’ data security and its ability to operate critical information technology. Wyden and Grassley criticize UNOS’ “apparent inability to efficiently and effectively operate the OPTN” and request details about the November data breach by April 10.

Markey, Warren Push for Field Hearing on For-Profit Health Companies-Massachusetts Senators Ed Markey (D) and Elizabeth Warren (D) are once again calling on the head of a for-profit health system to testify at a field hearing on April 3^rd in their state about the impact of for-profit companies on patient access to health care. The lawmakers sent a letter to the CEO of Steward Health Care Systems following up on their initial invitation to testify before the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Retirement Security last month. “Investing in and operating a health care system includes a responsibility to the public,” the letter states. “You must answer for Steward’s current financial insecurity and its impact on access to health care.”

Democrats Comment on Abortion, EMTALA in Amicus Brief-More than 250 congressional Democrats have filed an amicus brief ahead of a case in which Supreme Court justices will consider whether Idaho’s near-total abortion ban is subject to the Emergency Medical Treatment and Labor Act’s (EMTALA) requirements that abortion be offered when it constitutes the necessary stabilizing treatment for a pregnant patient experiencing a medical emergency. “If this Court allows Idaho’s near-total abortion ban to supersede federal law, pregnant patients in Idaho will continue to be denied appropriate medical treatment, placing them at heightened risk for medical complications and severe adverse health outcomes,” the brief states. The lawmakers also caution that “health care providers, forced to let Idaho’s abortion law take precedence over their medical judgment about their patients’ best interests, will continue their exile from Idaho, creating maternity-care “deserts” all over the state.” The brief was led by Sens. Chuck Schumer (D-N.Y.), Patty Murray (D-Wash.), Ron Wyden (D-Ore.), and Dick Durbin (D-Ill.); and Reps. Hakeem Jeffries (D-N.Y.), Katherine Clark (D-Mass.), Frank Pallone (D-N.J.), Jerry Nadler (D-N.Y.), Diana DeGette (D-Colo.), and Barbara Lee (D-Calif.).

White House Releases Memo on Use of AI-The White House released the first government-wide memo for federal departments and agencies on the use of artificial intelligence (AI). The memorandum directs agencies to advance AI governance and innovation while managing risks from the use of AI, particularly those affecting the rights and safety of the public, and follows President Joe Biden’s October 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. Agencies will be required to designate a chief AI officer within 60 days to coordinate the use of AI with existing officials and organizations within the agency. The memo also outlines requirements for the creation of publicly reported, annual AI use case inventories, including an identification of which use cases are safety-impacting and rights-impacting, and how agencies are working to manage those risks.

Congressional Retirements and Resignations-Rep. Annie Kuster (D-N.H.) will not seek re-election this year. Kuster has served in Congress since 2013 and currently sits on the House Energy and Commerce Committee and Health Subcommittee. She also chairs the centrist New Democrat Coalition. House Democratic leadership touted Kuster’s leadership in addressing the opioid crisis and lending a voice to survivors of sexual assault following her retirement announcement.

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

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions (HELP) Committee field hearing “When Health Care Becomes Wealth Care: How Corporate Greed Puts Patient Care and Health Workers at Risk;” 11:00 a.m.; April 3

Senate Foreign Relations Committee hearing “FY 2025 United States Agency for International Development Budget Request;” 10::00 a.m.; April 10 

Recently Introduced Health Legislation

S.Res.625-A resolution recognizing the week of March 17 through March 23, 2024, as “National Poison Prevention Week” and encouraging communities across the United States to raise awareness of the dangers of poisoning and promote poison prevention; Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4054-A bill to require entities to meet minimum cybersecurity standards to be eligible for Medicare accelerated and advance payment programs if the reason for the need for such payments is due to a cybersecurity incident; Sponsor: Warner, Mark R. [Sen.-D-VA]; Cosponsors: (0) Committees: Senate-Finance

S.4060-A bill to improve maternal health policies in correctional facilities, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Judiciary

S.4063-A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate-Finance

S.4065-A bill to prohibit discrimination in health care and require the provision of equitable health care, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

H.R.7808-To amend title XIX of the Public Health Service Act to provide for prevention and early intervention services under the Block Grants for Community Mental Health Services program, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House-Energy and Commerce

H.R.7809-To establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House-Energy and Commerce; Ways and Means

H.R.7812-To Direct the Secretary of Health and Human Services to carry out a grant program to support the establishment of a national, toll-free telephone helpline to provide information and assistance to parents, caregivers, and youth to prevent child abuse and strengthen families; Sponsor: Torres, Norma J. [Rep.-D-CA-35]; Committees: House-Education and the Workforce

H.R.7814-To amend the Internal Revenue Code of 1986 to exclude from gross income certain federally subsidized loan repayments for dental school faculty; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House-Ways and Means; Energy and Commerce

H.R.7815-To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants to expand and improve maternal health care services, and for other purposes; Sponsor: Waters, Maxine [Rep.-D-CA-43]; Committees: House-Energy and Commerce

H.R.7820-To amend the Public Health Service Act to direct the Secretary of Health and Human Services to conduct a public health education, awareness, and outreach campaign to enhance access to abortion and related health services. Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House-Energy and Commerce

H.R.7823-To amend the Federal Food, Drug, and Cosmetic Act to require a warning label advising that the effects of mifepristone can be counteracted, to amend the Public Health Service Act to establish a hotline to provide information to women seeking to counteract the effects of mifepristone, and for other purposes. Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Energy and Commerce

H.R.7827-To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of vaccines to prevent, treat, or mitigate opioid, cocaine, methamphetamine, or alcohol use disorder, to establish an x-prize for the development of such a vaccine, and for other purposes. Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House-Energy and Commerce

H.R.7829-To amend title XVIII of the Social Security Act to improve the payment method for oxygen and oxygen related equipment, supplies, and services, to increase beneficiary access to oxygen and oxygen related equipment, supplies, and services, and for other purposes. Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House-Energy and Commerce; Ways and Means

Congress Wraps Up FY2024 Appropriations-Congress has completed work on fiscal year (FY) 2024 appropriations, passing a $1.2 trillion deal that includes funding for the U.S. Department of Health and Human Services (HHS) and five other spending bills on Friday. The House of Representatives passed the Further Consolidated Appropriations Act, 2024under suspension of the rules by a vote of 286-134. Early Saturday morning, the bill passed the Senate in a 74-24 vote. The measure increases HHS funding by $955 million over FY 2023 for a total of $117.4 billion. The National Institutes of Health would receive a $300 million increase in base funding for a total of $48.6 billion. The Centers for Disease Control and Prevention would receive $9.2 billion, a $4.5 million increase. The Advanced Research Projects Agency for Health (ARPA-H) maintains its current $1.5 billion funding level. The legislation reauthorizes the President’s Emergency Plan for AIDS Relief (PEPFAR) for one year, instead of the traditional five-year reauthorization. The PEPFAR reauthorization does not include the anti-abortion language pushed for by Republicans in the lengthy negotiations that caused the program’s authorization to lapse in October. The spending package includes more than 100 pages of earmarked project funding requested by lawmakers.

Shortly following House passage of the government funding bill, Rep. Marjorie Taylor Greene (R-Ga.) filed a motion to oust House Speaker Mike Johnson (R-La.). It remains unclear whether her motion to vacate has the support of any additional House Republicans. Greene could demand a vote on the motion at any point the House is in session, and if activated, a vote would have to be called within two legislative days. She has signaled that any effort to bring a Ukraine funding bill to the floor for a vote would cause her to act on her motion. The House and Senate currently stand in recess until the week of April 7.

House Passes Preventive Health Savings Act-The House of Representatives passed a bill (H.R. 766) last week that would require the Congressional Budget Office (CBO), when requested by Congress, to consider whether legislative proposals would produce savings over a 30-year budget window instead of 10 years in calculating its cost estimates. The bipartisan bill, introduced by Reps. Michael Burgess (R-Texas) and Diana DeGette (D-Colo.), aims to ensure that the benefits of preventive care are sufficiently accounted for. Rep. Burgess noted that he has worked on this legislation for over 12 years and that the bill “will provide CBO with a mechanism to analyze the long-term benefits of preventive health care measures while ensuring that we make informed decisions on future health care policy.” It was passed by voice vote. It remains unclear whether the legislation will be taken up for consideration by the Senate.

E&C Advances 17 Health Bills-The House Energy and Commerce Committee favorably reported out the following 17 health bills last week.

• R. 619, the NAPA Reauthorization Act was advanced by a vote of 43- 0.
• R. 620, the Alzheimer’s Accountability and Investment Act was advanced by vote of 43-0.
• R. 7218, the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act of 2024 was advanced by a vote of 44-0.
• R. 4581, the Maternal and Child Health Stillbirth Prevention Act of 2024 was advanced by a vote of 44-0.
• R. 2706, the Charlotte Woodward Organ Transplant Discrimination Prevention Act was advanced by a vote of 46-0.
• R. 4646, the SIREN Reauthorization Act was advanced by a vote of 46-0.
• R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program, was advanced by a vote of 46-0.
• R. 6960, the Emergency Medical Services for Children Reauthorization Act of 2024 was advanced by a vote of 48-0.
• R. 7153, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act was advanced by a vote of 48-0.
• R. 7251, the Poison Control Centers Reauthorization Act of 2024 was advanced by a vote of 47-0.
• R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program, was advanced by a vote of 45-0.
• R. 7208, the Dennis John Beningo Traumatic Brain Injury Program Reauthorization Act of 2024 was advanced by a vote of 44-0.
• R. 6829, the Cardiomyopathy Health Education, Awareness, and Research, and AED Training in the Schools (HEARTS) Act of 2024 was advanced by a vote of 42-0.
• R. 7189, the Congenital Heart Futures Reauthorization Act of 2024 was advanced by a vote of 43-0.
• R. 7406, the DeOndra Dixon INCLUDE Project Act of 2024 was advanced by a vote of 45-0.
• R. 3916, the SCREENS for Cancer Act of 2024 was advanced by a vote of 46-0.
• R. 5074, the Kidney PATIENT Act was the only bill to not receive unanimous support, advancing by a vote of 36-10. Ranking Member Frank Pallone (D-N.J.) expressed concerns that the legislation, which would delay implementation of the inclusion of oral-only end-stage renal disease (ESRD) related drugs in the Medicare ESRD prospective payment system, would negatively impact access to care and increase costs.

Democrats Push CFPB to Revise Handling of Medical Debt-A group of Democrats in the Senate have sent a letter to the Consumer Financial Protection Bureau (CFPB) urging the agency to move forward with proposals to protect Americans from predatory medical debt collection practices. “Medical debt does not reflect spending habits or help lenders predict risk; instead, it is evidence of either health issues or a medical emergency,” the letter states. “We ask the CFPB to take concrete steps towards tackling the problems surrounding medical debt through proposing rules to further protect patients’ finances, dignity, and health.” CFPB proposed in September 2023 to remove medical debt from consumer credit reports. The senators also express support for eliminating deferred interest in medical credit products, and prohibiting unfair, deceptive, or abusive practices that target patients who either hold medical debt or need financing for medical care. The letter was signed by Senate Banking, Housing, and Urban Affairs Committee Chair Sherrod Brown (D-Ohio), Jack Reed (D-R.I.), Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.), Raphael Warnock (D-Ga.), John Fetterman (D-Pa.), Laphonza Butler (D-Calif.), Jeff Merkley (D-Ore.), Chris Murphy (D-Conn.), and Ben Ray Lujan (D-N.M.).

Warren, Rubio Press DoD on Pharmaceutical Supply Chain-Sens. Elizabeth Warren (D-Mass.) and Marco Rubio (R-Fla.) sent a letter to Pentagon leadership last week expressing concerns about the nation’s reliance on foreign countries for essential medicines. The lawmakers cite a new report finding that more than one in four U.S.-designated essential medicines are considered very high risk by the military because they are dependent on key ingredients made in China or by unknown sources. Warren and Rubio ask for information about what drug shortages the Department of Defense (DoD) has experienced and efforts to evaluate risks to the supply chain.

Bipartisan Investigation into High-Risk Research Announced-The Senate Homeland Security and Governmental Affairs Committee (HSGAC) is launching a bipartisan investigation into the national security threats posed by high-risk biological research and technology in the U.S. and abroad. The panel plans to hold hearings and conduct government-wide oversight on high-risk life science research, biodefense, synthetic biology, biosafety and biosecurity lapses, early warning capabilities for emerging outbreaks or possible attacks, and the potential origins of the COVID-19 pandemic. Chairman Gary Peters (D-Mich.) and Ranking Member Rand Paul (R-Ky.) aim to identify measures to mitigate existing and emerging risks that could cause serious incidents, whether intentional, accidental, or natural.

Senate Democrats Comment on Pandemic Accord Negotiations-Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) led a group of 12 Democrats in sending a letter to the Biden administration requesting that the White House prioritize equitable access to vaccines, tests, and treatments as a part of ongoing negotiations of the Pandemic Accord at the World Health Organization. The lawmakers express support for the inclusion of pricing-related provisions to apply to any products developed with public funding during a pandemic, and the sharing of intellectual property and technology with other countries during future public health emergencies. “A fairer, more equitable response to the next public health outbreak is in everyone’s interest,” the letter states.

Congressional Retirements and Resignations-Former House Speaker Kevin McCarthy’s (R-Calif.) seat in the House of Representatives will remain vacant for another two months. CA state Rep. Vince Fong (R) failed to receive 50% of the votes in Tuesday’s special election and will face a runoff election in May.

Rep. Kay Granger (R-Texas) announced that she is stepping down as chair of the House Appropriations Committee. She has requested that the House GOP Steering Committee and Conference choose a new chair for the remainder of the 118^th Congress. Rep. Tom Cole (R-Okla.) has said he is seeking to replace Granger as the next committee chair. Reportedly, Rep. Robert Aderholt (R-Ala.), current LHHS Subcommittee chairman, is also expected to run for the position. Rep. Granger will remain on the committee as Chair Emeritus.

Rep. Mike Gallagher (R-Wis.) plans to resign from Congress effective April 19. Gallagher had previously announced that he would not be seeking reelection in November, but his decision to leave the chamber before his term is up further shrinks Republicans’ already narrow majority in the House.

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

Recently Introduced Health Legislation

H.R.7709-To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House-Energy and Commerce

H.R.7708-To amend title XVIII of the Social Security Act to require MA organizations offering network-based plans to maintain an accurate provider directory, and for other purposes. Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House-Ways and Means; Energy and Commerce

H.R.7693-To amend the Internal Revenue Code of 1986 to treat distributions from health savings accounts for funeral expenses of the account beneficiary as qualified distributions. Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House-Ways and Means

H.R.7688-To amend the Public Health Service Act to reauthorize the Project ECHO Grant Program, to establish grants under such program to disseminate knowledge and build capacity to address Alzheimer’s disease and other dementias, and for other purposes. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House-Energy and Commerce

H.Res.1083-Recognizing the longstanding and invaluable contributions of Black midwives to maternal and infant health in the United States. Sponsor: Moore, Gwen [Rep.-D-WI-4]; Committees: House-Energy and Commerce; Armed Services

H.Res.1081-Amending the Rules of the House of Representatives to establish a Committee on Health as a standing committee of the House. Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House-Rules

S.Res.594-A resolution designating April 17, 2024, as “National Assistive Technology Awareness Day”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Judiciary

S.3967-A bill to amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate-Finance

S.3968-A bill to amend the Public Health Service Act to provide community-based training opportunities for medical students in rural areas and medically under-served communities, and for other purposes; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate-Health, Education, Labor, and Pensions

S.3975-A bill to require companies to receive consent from consumers to having their data used to train an artificial intelligence system; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate-Commerce, Science, and Transportation

S.3977-A bill to amend title XVIII of the Social Security Act to protect beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate, safe, effective, patient-centered orthotic and prosthetic care; to reduce fraud, waste, and abuse with respect to orthotics and prosthetics, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate-Finance

S.3979-A bill to amend title 38, United States Code, to make permanent and codify the pilot program for use of contract physicians for disability examinations, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate-Veterans’ Affairs

S.3981-A bill to amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate-Health, Education, Labor, and Pensions

H.Res.1089-Recognizing the seriousness of widespread health care worker burnout in the United States and the need to strengthen health workforce well-being, and expressing support for the designation of March 18, 2024, as the inaugural “Health Workforce Well-Being Day of Awareness”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce

H.Res.1090-Supporting the designation of the first week of April as “Adolescent Immunization Action Week” and recognizing the importance of encouraging vaccination for adolescents and young adults to protect against serious illness; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House-Energy and Commerce

H.Res.1094-Recognizing the significance of Sjogren’s as a serious and systemic autoimmune disease and designating April as “Sjogren’s Awareness Month”; Sponsor: Morelle, Joseph D. [Rep.-D-NY-25]; Committees: House-Energy and Commerce

H.R.7711-To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce; Ways and Means

H.R.7714-To authorize the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to make grants to States to increase awareness and education for colorectal cancer and improve early detection of colorectal cancer in young individuals, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Energy and Commerce

H.R.7715-To authorize additional funding for Food and Drug Administration monitoring and prevention of illicit nicotine products at ports of entry, and for other purposes; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House-Energy and Commerce

H.R.7716-To amend title XVIII of the Social Security Act to provide for enforcement of standards for reasonable and relevant contract terms and conditions and essential retail pharmacy protections under the Medicare program; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House-Energy and Commerce; Ways and Means

H.R.7717-To amend title XI of the Social Security Act to enhance pharmacy benefit manager transparency requirements; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House-Energy and Commerce; Ways and Means

H.R.7718-To amend title XVIII of the Social Security Act to assure pharmacy access and choice for Medicare beneficiaries; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House-Energy and Commerce; Ways and Means

H.R.7720-To permit the Byrne JAG grant to be used for the purchase of fentanyl testing kits and opioid reversal agents; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House-Judiciary

H.R.7725-To amend the Higher Education Act of 1965 to prohibit graduate medical schools from receiving Federal financial assistance if such schools adopt certain policies and requirements relating to diversity, equity, and inclusion; Sponsor: Murphy, Gregory F. [Rep.-R-NC-3]; Committees: House-Education and the Workforce

S.Res.605-A resolution recognizing the 75th anniversary of the National Institute of Dental and Craniofacial Research and its critical role in improving the dental, oral, and craniofacial health of the United States through research, training, and the dissemination of health information; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.3983-A bill to amend the Public Health Service Act to authorize a grant program to increase capacity for providing abortion services and other sexual and reproductive health care, and for other purposes; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate-Health, Education, Labor, and Pensions

S.3997-A bill to prioritize funding for an expanded and sustained national investment in basic science research; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions

H.R.7738-To establish the Toxic Exposure Fund of the Department of Veterans Affairs, and for other purposes; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House-Veterans’ Affairs; Rules; Budget

H.R.7742-To amend title XVIII of the Social Security Act to establish a 2-year demonstration program for hospitals to provide outpatient observation services to Medicare beneficiaries at home; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House-Ways and Means; Energy and Commerce

H.R.7745-To prioritize funding for an expanded and sustained national investment in basic science research, and for other purposes; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House-Science, Space, and Technology; Armed Services; Budget

S.4009-A bill to amend title 38, United States Code, to direct the Secretary of Veterans Affairs to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate-Veterans’ Affairs

S.4013-A bill to amend the Public Health Service Act to establish the Firefighter PFAS Injury Compensation Program, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Finance

S.4023-A bill to further protect patients and improve the accuracy of provider directory information by eliminating ghost networks; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate-Health, Education, Labor, and Pensions

S.4031-A bill to authorize the Administrator of the Health Resources and Services Administration to award grants to expand or create health care provider pipeline programs; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate-Health, Education, Labor, and Pensions

S.4035-A bill to require the Director of the Office of Personnel Management to take certain actions with respect to the health insurance program carried out under chapter 89 of title 5, United States Code, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate-Homeland Security and Governmental Affairs

S.4041-A bill to support local educational agencies in addressing the student mental health crisis; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Health, Education, Labor, and Pensions

S.4045-A bill to require a study on public health impacts as a consequence of the February 3, 2023, train derailment in East Palestine, Ohio; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate-Health, Education, Labor, and Pensions

S.4046-A bill to amend title 38, United States Code, to modify authorities relating to the collective bargaining of employees in the Veterans Health Administration, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate-Veterans’ Affairs

H.R.7765-To direct the Secretary of Veterans Affairs to carry out a pilot program to use weapon screening technology at medical centers of the Department of Veterans Affairs; Sponsor: Williams, Brandon [Rep.-R-NY-22]; Committees: House-Veterans’ Affairs

H.R.7788-To amend the Public Health Service Act to establish the Firefighter PFAS Injury Compensation Program, and for other purposes; Sponsor: Soto, Darren [Rep.-D-FL-9]; Committees: House-Ways and Means; Energy and Commerce; Budget

President Biden Delivers State of the Union Address-President Joe Biden delivered his third State of the Union address on Thursday. During his speech, the President touched on a number of health care issues, focusing particularly on the cost of prescription drugs and reproductive health care. He called on Congress to expand the Inflation Reduction Act’s Medicare drug price negotiation program and give Medicare the power to increase the number of drugs eligible for negotiation from the current ten drugs to 500 drugs over the next decade. The President argued that this change “will not only save lives, it will save taxpayers another $200 billion.” He also wishes to cap Medicare co-payments and limit annual out-of-pocket prescription drug spending at $2,000 a year for all Americans, even those with private insurance, and to extend the price cap on insulin to the private insurance market. The President called on Congress to pass federal legislation protecting abortion rights and guaranteeing nationwide access to in vitro fertilization. He also asked lawmakers to support $12 billion for women’s health research, highlighting the White House Initiative on Women’s Health Research that he launched last November, and also called for continued support on Capitol Hill for the Advanced Research Projects Agency for Health (ARPA-H).

President Signs Government Funding Package With Medicare Physician Payment Provision-Congress passed a $460 billion appropriations package last week including fiscal year 2024 funding for Agriculture-Food and Drug Administration; Transportation-Housing and Urban Development; Veterans Affairs; Energy; Commerce-Justice; and the Interior. The measure passed the House of Representatives in a 339-85 vote on Wednesday before being approved by the Senate in a 75-22 vote on Friday, thwarting a partial government shutdown set to occur at midnight. The funding agreement includes a provision addressing the Medicare physician cut that went into effect on January 1. The provision leaves in place the full Medicare physician cut of 3.37% (relative to 2023 payments) from January 1-March 8, and then, from March 9 through December 31, 2024, subjects physicians to a 1.77% cut (relative to 2023 payments). This results in physicians receiving a more than 2% cut in Medicare reimbursements in 2024 (annualized) relative to 2023. Lawmakers continue negotiations on an agreement for the remaining six appropriations bills, including the U.S. Department of Health and Human Services. Congress has until March 22 to fund those remaining portions of the federal government.

CMS Announces Advanced Payments in Response to Clearinghouse Cyberattack-The U.S. Department of Health and Human Services has expanded the types of providers eligible to receive advanced payment under Federal health programs to support them in the wake of the Change Healthcare cyberattack. The Centers for Medicare and Medicaid Services (CMS) had previously announced that it would consider applications for accelerated payments from Medicare Part A providers; on Saturday, CMS expanded their notice to include Part B providers as well. Affected providers can apply to receive 30 days of relief to be repaid at a later date. For more information, please see the CMS Fact Sheet. However, it remains unclear how much money is available for accelerated payments. CMS is also instructing Medicare contractors to accept paper claims and expedite provider requests to switch to a different processing platform, and is encouraging Medicare Advantage and Medicaid managed care plans to also make prospective payments to impacted providers, as well as to relax their prior authorization requirements.

House Passes Seven Health Bills-The House of Representatives passed a slate of health care related legislation last week under suspension of the rules. The following bills have been sent to the Senate for further consideration.

• The Action for Dental Health Act (H.R.3843) passed 391-32.
• The Preventing Maternal Deaths Reauthorization Act (H.R.3838) passed 382-12.
• The END FENTANYL Act (S.206) passed by voice vote.
• The Firefighter Cancer Registry Reauthorization Act (H.R.3821) passed 413-7.
• The Medicaid Primary Care Improvement Act, as amended (H.R.3836) passed by voice vote.
• The Gabriella Miller Kids First Research Act (H.R.3391) passed 384-4.
• The 9-8-8 Lifeline Cybersecurity Responsibility Act of 2023 (H.R.498) passed by voice vote.

Latest Health Legislation Advanced Out of Committee-The House Ways and Means Committee advanced several pieces of health care related legislation last week. The Protecting America’s Seniors’ Access to Care Act (H.R. 7513) blocks the Biden administration’s proposed nursing home staffing mandate. The bill was advanced in a 26-17 vote, largely along party lines. The Kidney PATIENT Act (H.R.5074) would allow end-stage renal disease patients to access oral-only drugs using Medicare Part D. It was advanced in a 41-1 vote. The Real Time Benefit Tool Implementation Act (H.R.7512) would require CMS to implement a prescriber real-time benefit tool by January 1, 2027. It was advanced in a 42-0 vote.

The Senate Homeland Security and Governmental Affairs Committee advanced legislation last week that would limit contracting with certain Chinese biotech companies in an attempt to prevent foreign adversaries from acquiring Americans’ genetic data. The Prohibiting Foreign Access to American Genetic Information Act of 2024(S.3558) would bar biotech companies controlled by a foreign adversary’s government from obtaining federal contracts. It was advanced in an 11-1 vote. Ranking Member Rand Paul (R-KY) voted against the legislation, expressing concerns that it could raise costs for consumers. In related news, Chairman of the House Select Committee on the Chinese Communist Party Mike Gallagher (R-WI) is requesting that Attorney General Merrick Garland review the Biotechnology Innovation Organization’s lobbying on behalf of WuXi Apptec in relation to the Foreign Agent Registration Act. WuXi AppTec is a global pharmaceutical, biopharmaceutical, and medical device company with ties to the Chinese Communist Party. Gallagher suggests that the Attorney General recommend that Congress require trade associations lobbying on behalf of companies posing a national security risk register as foreign agents.

Senate Dems Comment on Medicare Advantage Program-A group of Senate Democrats have sent a letter to the Biden administration highlighting challenges and proposed reforms to strengthen the Medicare Advantage (MA) program. The lawmakers urge CMS to:

• Ensure that insurance companies do not prevent older adults and people with disabilities from getting care by putting up obstacles, including onerous prior authorizations, AI algorithms, or limited networks;
• Strengthen provider encounter and patient data collection and transparency to improve public understanding of the effects of insurer-run MA plans on patients and the Medicare program;
• Rein in overpayments to insurers in MA by adjusting benchmarks to compensate for favorable selection and cracking down on deceptive tactics by private insurance companies, including upcoding;
• Address misleading and deceptive marketing practices; and
• Strengthen Medicare for everyone through administrative action, such as by lowering Medicare premiums, and support legislative efforts to expand Medicare benefits, cap out- of-pocket (OOP) costs in TM, and adjust the physician fee schedule to account for increases in provider costs.

HELP Ranking Member Cassidy Cautions NIH Against Use of March-In Rights-Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) and sixteen Senate Republicans have sent a letter to National Institutes of Health (NIH) Director Monica Bertagnolli detailing concerns with the administration’s proposal to exercise march-in rights under the Bayh-Dole Act to reign in drug prices. “A short-sighted decision to exercise march-in rights would work against your stated goal and jeopardize patient access by discouraging individuals from partnering with NIH to develop new cures and treatments,” the letter states. “Not only will this hurt patients, but it will also diminish the return the public gets on the investments Congress makes in NIH each year-something we should all seek to optimize… Agencies, including NIH, should not abuse their authorities to illegally seize intellectual property, and in the process jeopardize the valuable public-private partnerships that make our biomedical research enterprise the best in the world.” The Senators are also requesting that the Government Accountability Office (GAO) review whether the administration’s proposal meets the definition of a rule under the Congressional Review Act, thus making it possible to be overturned by Congress under a resolution of disapproval.

Stakeholder Input Requested on Older Americans Act-Bipartisan leadership of the Senate HELP Committee issued a request for input from stakeholders as they work to reauthorize the Older Americans Act (OAA). Current authority for the OAA expires on September 30, 2024. The committee is seeking responses on several targeted questions to better understand the impact of the flexibilities granted during the COVID-19 public health emergency. Written responses are due by March 21, 2024 and should be submitted to [email protected].

Republicans Seek HHS Briefing on Medicare Catheter Billing Fraud-Republicans on the House Energy and Commerce, Ways and Means, and Oversight and Accountability committees were joined by the GOP Doctors Caucus leadership in requesting a briefing from U.S. Department of Health and Human Services (HHS) officials regarding the steps that are being taken to address an alleged catheter billing fraud and how to prevent its reoccurrence. The scheme is estimated to have affected over 450,000 Medicare beneficiaries and totaled at least $2 billion. “If public reports about the apparent ease with which this fraud was perpetrated are accurate, they raise questions about the efficacy of current Centers for Medicare and Medicaid Services and the HHS Office of the Inspector General fraud detection and prevention measures,” the letter states. The lawmakers also highlight stakeholder concerns that a similar increase in fraud has occurred in diabetes supplies, which may be evidence of a new fraud against the Medicare program.

Barrasso Announces Bid for Senate GOP Whip-Senate GOP Conference Chair John Barrasso, MD (R-WY), an orthopaedic surgeon, has announced that he will run for Senate Republican whip, the number two spot in Senate GOP leadership. Barrasso was one of the “Three Johns” considered potential candidates to succeed Sen. Mitch McConnell (R-KY) following his announcement that he would step down as Senate GOP leader at the end of this Congress. Former GOP whip John Cornyn (TX) and current GOP whip John Thune (SD) have each confirmed that they will run for the conference’s top post.

GAO Issues Report on Biomedical Research Duplication-The GAO has released a new report on actions that are needed to address biomedical research duplication at different HHS agencies. It is the first in a series of reports examining research activities at the Advanced Research Projects Agency for Health (ARPA-H), NIH, Biomedical Advanced Research and Development Authority, and Food and Drug Administration. The report was mandated by Congress in the Consolidated Appropriations Act, 2023. GAO outlines the practices in place to avoid unnecessary research duplication, including reviewing project and funding information provided by applicants, consulting with experts and other agencies, and using databases to identify potentially overlapping research.

Congressional Retirements and Resignations-Sen. Kyrsten Sinema (I-AZ) announced that she will not run for a second term in the U.S. Senate this November. Her retirement from office leaves Rep. Ruben Gallego (D-AZ) and Kari Lake (R) in the race for the Arizona Senate seat. Sinema currently sits on the Appropriations; Homeland Security and Governmental Affairs; Commerce, Science, and Transportation; and Veterans’ Affairs committees.

According to recent press reports, Sen. Bob Menendez (D-NJ) will not seek reelection this year. Menendez was indicted last week on 12 new felony charges, including bribery and extortion, and has not taken steps to collect the 1,000 petition signatures he needs to get on the ballot ahead of the state’s June 4 Democratic primary. The three-term senator currently serves on the Senate Finance Committee. U.S. Representative Andy Kim (D-NJ-03) and New Jersey First Lady Tammy Murphy are the frontrunners in the race for Menendez’s seat.

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 Health Subcommittee markup of 19 legislative proposals to improve the health and wellbeing of patients and caregivers; 10:00 a.m.; March 12

House Ways and Means Committee hearing “Enhancing Access to Care at Home in Rural and Underserved Communities;” 11:00 a.m.; March 12

Senate Finance Committee hearing to examine the President’s proposed budget request for fiscal year 2025 for the U.S. Department of Health and Human Services; 10:00 a.m.; March 14

Recently Introduced Health Legislation

H.R.7516-To amend the Indian Health Care Improvement Act to address liability for payment of charges or costs associated with provision of purchased/referred care services, and for other purposes. Sponsor: Johnson, Dusty [Rep.-R-SD-At Large]; Committees: House – Natural Resources; Energy and Commerce

H.R.7515-To amend the Fair Credit Reporting Act to delay the inclusion in consumer credit reports and to establish requirements for debt collectors with respect to medical debt information of Native Americans due to inappropriate or delayed billing payments or reimbursements from the Indian Health Service, and for other purposes. Sponsor: Johnson, Dusty [Rep.-R-SD-At Large]; Committees: House – Financial Services

H.R.7513-To prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the skilled nursing facility workforce. Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Ways and Means; Energy and Commerce

H.R.7512-To amend title XVIII of the Social Security Act to ensure implementation of real-time benefit tools under part D of the Medicare program. Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means

H.Res.1050-Supporting the designation of March 2024 as National Colorectal Cancer Awareness Month. Sponsor: Payne, Donald M. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

H.Res.1049-Expressing the need for enhanced public awareness of traumatic brain injury and support for the designation of a National Brain Injury Awareness Month. Sponsor: Pascrell, Bill [Rep.-D-NJ-9]; Committees: House – Energy and Commerce

H.Res.1047-Recognizing the need of Congress to prevent, address, and treat obesity as a disease in the United States on this World Obesity Day, March 4, 2024. Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Energy and Commerce

S.3860-A bill to amend title XVIII of the Social Security Act to provide for patient protection by limiting the number of mandatory overtime hours a nurse may be required to work in certain providers of services to which payments are made under the Medicare Program; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate-Finance

S.3864-A bill to amend the Public Health Service Act to provide for congenital Cytomegalovirus screening of newborns; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.7520-To prohibit data brokers from transferring sensitive data of United States individuals to foreign adversaries, and for other purposes; Sponsor: Pallone, Frank [Rep.-D-NJ-6]; Committees: House – Energy and Commerce

H.R.7535-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: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce; Ways and Means

H.R.7538-To direct the Secretary of Health and Human Services, for the purpose of addressing public health crises, to require the manufacturers of covered products to develop, maintain, and update a plan to mitigate the effects of such products on public health, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Energy and Commerce

H.R.7539-To require the Secretary of the Treasury to guarantee BioBonds in order to provide funding for loans to eligible biomedical companies and universities to carry out clinical trials approved by the Food and Drug Administration, and for other purposes; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

H.R.7542-To amend the Public Health Service Act to provide for congenital Cytomegalovirus screening of newborns; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Energy and Commerce

H.R.7545-To amend title XIX of the Social Security Act to include certified community behavioral health clinic services as a State plan option under the Medicaid program, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

H.R.7546-To amend title XVIII of the Social Security Act to provide for patient protection by limiting the number of mandatory overtime hours a nurse may be required to work in certain providers of services to which payments are made under the Medicare Program; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

H.R.7551-To prohibit any Federal law from making the manufacturer of a COVID-19 vaccine immune from suit or liability, or limiting the liability of such a manufacturer, with respect to claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a COVID-19 vaccine, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House-Judiciary

S.Res.574-A resolution expressing support for starting and growing a family through in vitro fertilization; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.575-A resolution declaring racism a public health crisis; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

S.3882-A bill to amend title XIX of the Social Security Act to provide States with resources to support efforts to integrate or coordinate Medicare and Medicaid benefits for individuals that are eligible for both programs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

S.3885-A bill to expand medical, employment, and other benefits for individuals serving as family caregivers for certain veterans, and for other purposes; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Veterans’ Affairs

H.Res.1060-Expressing support for starting and growing families through in vitro fertilization; Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House – Energy and Commerce

H.Res.1062-Declaring racism a public health crisis; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Energy and Commerce; Judiciary

H.R.7563-To strengthen compliance with the FDA Food Traceability Rule, to enhance the FDA foodborne illness outbreak investigation process, and for other purposes; Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Energy and Commerce

H.R.7573-To amend title XIX of the Social Security Act to repeal the requirement that States establish a Medicaid Estate Recovery Program and to limit the circumstances in which a State may place a lien on a Medicaid beneficiary’s property; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

S.3892-A bill to amend titles XVIII and XIX of the Social Security Act to increase access to community health workers under the Medicare and Medicaid programs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

Congress Extends Government Funding-Congress averted the threat of a partial government shutdown and passed the fourth interim spending measure of fiscal year 2024 on Thursday. The latest stopgap spending bill (H.R. 7463) maintains a laddered approach to government funding-extending appropriations for some departments through March 8 and others through March 22. The bill passed the House of Representatives in a 320-99 vote on Thursday and was approved by the Senate hours later in a 77-13 vote. President Biden signed the legislation into law on Friday.

Congress Reaches Deal on Six Appropriations Bills and Health Provisions-Lawmakers have reached agreement on the Consolidated Appropriations Act, 2024, which includes funding for several appropriations measures (Agriculture-Food and Drug Administration; Transportation-Housing and Urban Development; Veterans Affairs; Energy; Commerce-Justice; Interior) through September 30, the end of the fiscal year. Leadership hopes to finalize and pass the deal, which accounts for approximately 27% of federal agency spending, first in the House and then in the Senate this week-ahead of the March 8 deadline. In the coming days, an agreement is expected to be released for the remaining six appropriations bills, including the U.S. Department of Health and Human Services. Congress has until March 22 to fund those remaining portions of the federal government.

The Consolidated Appropriations Act, 2024 to be considered by Congress this week includes provisions related to Public Health, Medicaid, and Medicare (Division G, Title I). Notably, the agreement includes a provision related to Medicare physician payment. However, the agreement leaves in place the full Medicare physician cut of 3.37% (relative to 2023 payments) from January 1 to March 8, and then, from March 9 through December 31, 2024, subjects them to a cut of 1.69% (relative to 2023 payments).

The package does not include reauthorizations of the Pandemic and All-Hazards Preparedness Act (PAHPA) or the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. Other health programs and policies not addressed in the package include the President’s Emergency Plan for AIDS Relief (PEPFAR), pharmacy benefit manager (PBM) reforms advanced by the Senate Finance Committee earlier this Congress, and extension of telehealth flexibilities which expire on December 31, 2024.

The full list of health provisions included in the agreement follows:

Subtitle A-Public Health Extenders

• 101-Extension for Community Health Centers, National Health Service Corps, and Teaching Health Centers that Operate GME Programs (p. 899)
• 102-Extension of Special Diabetes Programs (p. 902)
• 103-National Health Security Extensions (p. 903)

Subtitle B-Medicaid

• 201-Requirement for State Medicaid Plans to Provide Coverage for Medication-Assisted Treatment (p. 904)
• 202-Collection and Reporting of Comprehensive Data for Specified Populations Enrolled in Medicaid and CHIP (p. 905)
• 203-Monitoring Prescribing of Antipsychotic Medications (p. 916)
• 204-Extension of State Option to Provide Medical Assistance for Certain Individuals in Institutions for Mental Diseases (p. 917)
• 205-Prohibition on Termination of Enrollment Due to Incarceration (p. 922)
• 206-Addressing Operational Barriers to Promote Continuity of Care for Medicaid and CHIP Beneficiaries Following Incarceration (p. 925)
• 207-Guidance Relating to Improving the Behavioral Health Workforce and Integration of Care Under Medicaid and CHIP (p. 936)
• 208-Funding for Implementation and Operations (p. 941)
• 209-Certified Community Behavioral Health Clinic Services Under Medicaid (p. 942)
• 210-Eliminating Certain Disproportionate Share Hospital Payment Cuts (p. 945)
• 211-Promoting Value in Medicaid Managed Care (p. 946)
• 212-Medicaid Improvement Fund (p. 946)

Subtitle C-Medicare

• 301-Extension of Funding for Quality Measure Endorsement, Input, and Selection (p. 946)
• 302-Extension of Funding Outreach and Assistance for Low-Income Programs (p. 947)
• 303-Extension of the Work Geographic Index Floor Under the Medicare Program (p. 950)
• 304-Extending Incentive Payments for Participation in Eligible Alternative Payment Models (p. 950)
• 305-Temporary Payment Increase Under the Medicare Physician Fee Schedule to Account for Exceptional Circumstances and Atypical Timing of Enactment (p. 951)
• 306-Extension of Increased Inpatient Hospital Payment Adjustment for Certain Low-Volume Hospitals (p. 952)
• 307-Extension of the Medicare-Dependent Hospital (MDH) Program (p. 954)
• 308-Extension of Adjustment to Calculation of Hospice Cap Amount Under Medicare (p. 955)
• 309-Medicare Improvement Fund (p. 955)

House to Vote on Health Bills This Week-The House of Representatives plans to consider several health care related bills on the floor this week under suspension of the rules. The chamber is scheduled to vote on:

• S. 206-END FENTANYL Act;
• R. 3838-Preventing Maternal Deaths Reauthorization Act;
• R. 3821-Firefighter Cancer Registry Reauthorization Act;
• R. 3836-Medicaid Primary Care Improvement Act, as amended;
• R. 3843-Action for Dental Health Act;
• R. 3391-Gabriella Miller Kids First Research Act; and
• R. 498 – 9-8-8 Lifeline Cybersecurity Responsibility Act of 2023, as amended.

Mitch McConnell to Step Down from Senate Leadership-Senate Minority Leader Mitch McConnell (R-Ky.) has announced his intention to step down as Republican leader at the end of his two-year term, which concludes at the start of the next Congress in January. He does not plan to retire from the Senate entirely, and is not up for reelection until 2026. With a 17-year tenure as Republican leader, McConnell, 82, is the chamber’s longest serving party leader in history. Minority Whip John Thune (R-S.D.), John Cornyn (R-Texas), and GOP Conference Chair John Barrasso (R-Wyo.) are widely viewed as McConnell’s most likely potential successors. An election for McConnell’s replacement will take place in November.

Lawmakers Respond to Alabama Embryo Ruling-Sen. Cindy Hyde Smith (R-Miss.) blocked consideration of legislation on the Senate floor last week that would have provided federal protections for in vitro fertilization. Sen. Tammy Duckworth (D-Ill.) sought unanimous consent to pass her Access to Family Building Act (S. 3612), which would establish a statutory right to access IVF and other fertility treatments for all Americans. Hyde-Smith argued that the bill’s definition of assisted reproductive technology was too expansive and could legalize cloning and the creation of human-animal chimeras; other Republicans have argued that state legislatures should lead in protecting access to fertility treatments. Duckworth stated that she plans to request a roll call vote on the bill to force members to take a stand on the issue. In the wake of its Supreme Court ruling on frozen embryos, the Alabama state legislature passed measures last week to protect in vitro fertilization patients and providers from criminal or civil liability if embryos they create are subsequently damaged or destroyed. The bills must be reconciled between the state House and Senate before being sent to Gov. Kay Ivey (R), who is expected to sign the bill into law. In related news, Sen. Hyde-Smith, alongside Rep. August Pfluger (R-Texas), led an amicus brief signed by nearly 150 other Republican members of Congress and submitted last week urging the Supreme Court to maintain a lower court’s restrictions around the medication abortion drug mifepristone. Democrats submitted their own amicus brief in January, arguing that the court should not curtail access to the medication.

Grassley Releases Updates on FTC’s PBM Investigation-The Federal Trade Commission (FTC) has informed lawmakers on Capitol Hill that none of the six pharmacy benefit managers (PBMs) contacted as part of the agency’s investigation into PBMs have fully responded to the agency’s orders. “We expect to have all the materials very soon. If, however, some of the companies fail to fully comply with the orders or engage in any actionable delaying tactics, the FTC can take them to court to compel compliance,” FTC Chair Lina Khan stated. The agency’s letter was released by Sen. Chuck Grassley (R-Iowa), who was part of the bipartisan group of senators that initially called for the administration to investigate PBM industry practices. The FTC launched its investigation in June 2022, and expanded it in May and June 2023. Grassley expressed concerns with the FTC’s latest response, highlighting that PBMs had been provided with 90 days to submit requested materials. He called for a “concrete status update” from the FTC and noted his intention to continue to push for “swift and thorough results.”

AI Work Group Considers Role of Medicare/Medicaid Investments-The Senate’s bipartisan Artificial Intelligence Working Group is recommending that the Senate Finance Committee consider how the Medicare and Medicaid programs can be used to fund AI innovations in health care, according to Sen. Mike Rounds (R-S.D.). Rounds, along with Senate Majority Leader Chuck Schumer, Sen. Todd Young (R-Ind.), and Sen. Martin Heinrich (D-N.M.), form the chamber’s bipartisan Artificial Intelligence Working Group, which organized a series of “AI Insight Forums” last year. According to Rounds, the working group plans to issue a report by the end of this month containing ideas and guidelines to inform AI legislation.

Warner, Rubio Push Commerce Department to Better Protect Biotech Sector-Senate Intelligence Committee Chairman Mark Warner (R-Va.) and Ranking Member Marco Rubio (R-Fla.) have sent a letter to the Department of Commerce urging Secretary Gina Raimondo to more sufficiently use its existing authorities to prevent adversary access to U.S. technology, capital, data, and talent in critical technology sectors, including the biotechnology sector. Warner and Rubio argue that China has continuously attempted to “leverage the lack of U.S. controls surrounding access to American innovation, data, and talent to undermine U.S. superiority in critical sectors and related supply chains.” The lawmakers specifically suggest that the Department of Commerce implement an export-control regime targeting the biotechnology sector-as undertaken with the semiconductor industry-and impose controls on the sharing of American data.

Health Sector Coordinating Council Releases Cybersecurity Strategic Plan Amid Fallout From Cyberattack on Major Clearinghouse-The Health Sector Coordinating Council Cybersecurity Working Group published its Five-Year Health Industry Cybersecurity Strategic Plan last week. The document aims to guide C-suite executives, information technology and security leaders, and other relevant stakeholders toward investment and implementation of strategic cybersecurity principles that will measurably reduce risks to patient safety, data privacy, and care operations. The plan was released in the midst of fallout from a cyberattack on UnitedHealth’s Change Healthcare, which has resulted in widespread disruptions for both patients and health care providers. UnitedHealth Group is directing providers facing a liquidity crisis due to the outage to a Temporary Funding Assistance Program administered by its subsidiary Optum Financial Services, though some providers have taken to social media to highlight that the amounts made available fall short of what’s needed to maintain their operations. The White House National Security Council reportedly is considering administrative options to provide short-term financial relief from federal health programs for hospitals impacted by the cyberattack.

CDC Releases New Respiratory Virus Guidance-The Centers for Disease Control and Prevention released new guidelines related to respiratory viruses last week. The agency’s recommendations aim to provide a unified approach to a range of common respiratory viral illnesses, including COVID-19, flu, and RSV. Under the latest guidance, individuals whose COVID-19 symptoms are improving and who have been fever-free for 24 hours without medication no longer need to isolate for a prolonged period. If individuals do choose to return to public places, however, they should take steps such as masking and keeping their distance from others for five days. The CDC’s guidance includes additional recommendations for people who are pregnant, immunocompromised, have disabilities, or are over the age of 65.

Congressional Retirements and Resignations-Rep. Mark Green (R-Tenn.), chairman of the Homeland Security Committee, has reversed his decision to retire from Congress this year. Green will run for reelection to represent the Tennessee’s 7^th congressional district in November. “While my strong desire was to leave Congress at the end of this year, since my announcement, I have received countless calls from constituents, colleagues, and President Trump urging me to reconsider,” he said in a statement.

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

Upcoming Congressional Hearings and Markups

Senate Homeland Security and Governmental Affairs Committee continuation of January 31 markup of legislation, including, S. 3558, a bill to prohibit contracting with certain biotechnology providers; 9:30 a.m.; March 6

Senate Budget Committee hearing to examine how primary care improves health care efficiency; 10:00 a.m.; March 6

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Examining the White House’s Role in Pandemic Preparedness and Response;” 10:00 a.m.; March 6

House Select Committee on the Chinese Communist Party hearing “Growing Stakes: The Bioeconomy and American National Security;” 9:00 a.m.; March 7

Senate Health, Education, Labor, and Pensions Committee hearing “The Older Americans Act: Supporting Efforts to Meet the Needs of Seniors;” 11:00 a.m.; March 7

Recently Introduced Health Legislation

H.R.7442-To direct the Comptroller General of the United States to conduct a study to assess the feasibility and financial effects of expanding coverage under the Medicare program to items and services furnished in the Philippines. Sponsor: Moylan, James C. [Del.-R-GU-At Large]; Committees: House – Ways and Means; Energy and Commerce

H.R.7436-To direct the Comptroller General of the United States to prepare a report on Federal efforts to address antimicrobial resistance. Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

H.R.7434-To ensure that only licensed health care professionals furnish disability examinations under a certain Department of Veterans Affairs pilot program for use of contract physicians for disability examinations, and for other purposes. Sponsor: Finstad, Brad [Rep.-R-MN-1]; Committees: House – Veterans’ Affairs

H.R.7432-To amend title XIX of the Social Security Act to enable State Medicaid programs to provide comprehensive, coordinated care through a health home to individuals with sickle cell disease. Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce

H.Res.1029-Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging. Sponsor: Magaziner, Seth [Rep.-D-RI-2]; Committees: House-Rules

S.Res.566-A resolution designating September 2024 as “National Cholesterol Education Month” and September 30, 2024, as “LDL-C Awareness Day”; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Judiciary

S.3803-A bill to make price gouging unlawful, to expand the ability of the Federal Trade Commission to seek permanent injunctions and equitable relief, and for other purposes. Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Commerce, Science, and Transportation

S.3805-A bill to amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

S.Res.567-A resolution recognizing the seriousness of widespread health care worker burnout in the United States and the need to strengthen health workforce well-being, and expressing support for the designation of March 18, 2024, as the inaugural “Health Workforce Well-Being Day of Awareness”; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3821-A bill to amend title XVIII of the Social Security Act to improve the payment method for oxygen and oxygen related equipment, supplies, and services, to increase beneficiary access to oxygen and oxygen related equipment, supplies, and services, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

H.R.7464-To amend title 38, United States Code, to provide for access standards with respect to the provision by the Department of Veterans Affairs of hospital care, medical services, or extended care services that are applicable to certain veterans with mental disorders; Sponsor: Yakym, Rudy [Rep.-R-IN-2]; Committees: House – Veterans’ Affairs

S.3832-A bill to amend title XVIII of the Social Security Act to ensure appropriate access to non-opioid pain management drugs under part D of the Medicare program; Sponsor: Tillis, Thomas [Sen.-R-NC]; Committees: Senate-Finance

S.3834-A bill to direct the Secretary of Veterans Affairs to ensure veterans may obtain a physical copy of a form for reimbursement of certain travel expenses by mail or at medical facilities of the Department of Veterans Affairs, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs

S.3841-A bill to require the Secretary of Veterans Affairs to submit a report on the impact of a proposed rule submitted by the Centers for Medicare & Medicaid Services on access of veterans to long-term care facilities; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Veterans’ Affairs

S.3847-A bill to authorize the Director of the Centers for Disease Control and Prevention to carry out a Social Determinants of Health Program, and for other purposes; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

S.3849-A bill to promote United States leadership in technical standards by directing the National Institute of Standards and Technology and the Department of State to take certain actions to encourage and enable United States participation in developing standards and specifications for artificial intelligence and other critical and emerging technologies, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Commerce, Science, and Transportation

S.3850-A bill to provide for research and improvement of cardiovascular health among the South Asian population of the United States, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.1036-Expressing support for the designation of February 29, 2024, as “Rare Disease Day”; Sponsor: Carson, Andre [Rep.-D-IN-7]; Committees: House – Energy and Commerce

H.Res.1037-Providing the sense of the House of Representatives that In Vitro Fertilization (IVF) is necessary for women who cannot conceive naturally, and for other purposes; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Energy and Commerce

H.Res.1039-Recognizing the significance of Charcot-Marie-Tooth disease and the need for robust funding of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Energy and Commerce

H.Res.1042-Recognizing the historical contributions and value of the Freedom House Ambulance Service; Sponsor: Lee, Summer L. [Rep.-D-PA-12]; Committees: House – Energy and Commerce

H.Res.1043-Expressing support for continued access to fertility care and assisted reproductive technology, such as in vitro fertilization, in light of the Supreme Court of Alabama’s ruling that has jeopardized access to in vitro fertilization and other assisted reproductive technology; Sponsor: Mace, Nancy [Rep.-R-SC-1]; Committees: House – Energy and Commerce

H.Res.1045-Expressing support for the designation of March 3, 2024, as “National Triple-Negative Breast Cancer Day”; Sponsor: Morelle, Joseph D. [Rep.-D-NY-25]; Committees: House – Oversight and Accountability

H.R.7481-To authorize the Director of the Centers for Disease Control and Prevention to carry out a Social Determinants of Health Program, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce

H.R.7482-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.7489-To increase the recruitment and retention of school-based mental health services providers by low-income local educational agencies; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Education and the Workforce

H.R.7503-To amend the Public Health Service Act to provide health equity for people with disabilities; Sponsor: Payne, Donald M. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce

Agencies Prepare for Partial Shutdown as March 1 Deadline Approaches-The House of Representatives will vote on four separate appropriations bills this week to avert a partial government shutdown as Congress’ first funding deadline approaches on March 1. House Speaker Mike Johnson (R-La.) acknowledged on a call with the GOP conference Friday night that another stopgap spending bill may be necessary to provide lawmakers with additional time to pass the Agriculture-Food and Drug Administration, Military Construction-Veterans Affairs, Energy-Water, and Transportation-Housing and Urban Development spending bills. House members are not scheduled to return to session until Wednesday. Senate Majority Leader Chuck Schumer (D-N.Y.) sent a letter to lawmakers on Sunday reporting that “intense discussions” continue. Although appropriators continue to work toward a compromise on the spending bills, many note that partisan policy riders are presenting hurdles. The federal government once again formally initiated the process of preparing for a partial shutdown, with the Office of Management and Budget instructing agencies to review and update their shutdown plans and providing templates for notifying employees of the status of appropriations. Lawmakers face a March 8 deadline for the remaining eight appropriations bills, including funding for the U.S. Department of Health and Human Services.

Leadership Announces New Bipartisan AI Task Force-House Speaker Mike Johnson (R-La.) and Minority Leader Hakeem Jeffries (D-N.Y.) have launched a new task force on artificial intelligence. The 24-member task force will be chaired by Rep. Jay Obernolte (R-Calif.) and co-chaired by Rep. Ted Lieu (D-Calif.). Membership includes several lawmakers active in the health care policy space, including Reps. Anna Eshoo (D-Calif.), Neal Dunn, MD (R-Fla.), Michelle Steel (R-Calif.), Don Beyer (D-Va.), Ami Bera, MD (D-Calif.), Bill Foster (D-Ill.), Rich McCormick, MD (R-Ga.), and Sara Jacobs (D-Calif.). The group plans to release a report outlining bipartisan proposals for regulating AI technology and spurring investment in AI later this year.

Coons, Tillis Spearhead Letters on March-In Rights, IP Protection-Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) are urging the Biden administration to reconsider its proposal to exercise march-in rights under the Bayh-Dole Act as a means to reduce the price of prescription drugs. The letter, which was signed by more than two dozen lawmakers, highlights the potential unintended consequences of including “reasonable pricing” as a factor in the draft framework for initiating the use of march-in rights. “Entrepreneurial startups and small companies across industries-from green technology and precision agriculture to advanced computing and semiconductors-would be subject to march-in petitions challenging their pricing decisions by rival businesses and even our foreign competitors and adversaries, who could use this tool to cast a cloud over the companies that drive our economy,” the lawmakers warn. They also outline the possible impact of the draft march-in framework on U.S. academic research institutions and efforts to revitalize American manufacturing and technological innovation.

The letter concerning the Bayh-Dole Act follows a letter sent by Sens. Coons and Tillis, along with Sens. Mazie Hirono (D-Hawaii) and James Lankford (R-Okla.), to National Security Adviser Jake Sullivan regarding the proposed global accord on pandemic prevention, preparedness, and response currently being negotiated by members of the World Health Organization. The lawmakers express concerns that the proposed agreement could undermine intellectual property (IP) laws “based on a faulty premise that IP rights impeded the global response to the COVID-19 crisis.” The letter asserts that many factors other than IP were responsible for barriers to treatment access, and that IP protection is “at the core of successful pandemic preparedness.”

Cassidy Releases White Paper on Health Data Privacy Protections-Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) released a new report last week outlining proposals to improve Americans’ health data privacy. The paper reviews the existing health privacy framework and discusses health data in the Health Insurance Portability and Accountability Act (HIPAA) “gray area” as well as data that falls outside of HIPAA. The white paper follows a request for information issued by Cassidy last year on how to enhance health data privacy protections covered under HIPAA as well as protections for new sources of data. Cassidy argues that Congress “needs to create guardrails around how health data not covered by HIPAA is shared to ensure interoperability does not sacrifice patient privacy” and should “create a more sustainable framework for future information sharing.”

Alabama Supreme Court Issues Ruling on Frozen Embryos-The Alabama Supreme Court ruled last week that couples who lost frozen embryos in an accident at a storage facility can sue under the state’s wrongful death law. The decision reverses a lower court ruling which dismissed the wrongful death claim on the grounds that the embryos were not a person or child. Since the decision, at least three of the state’s in vitro fertilization clinics have announced that they were pausing IVF services as they work to determine the legal implications of the ruling.

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 Budget Committee hearing “No Rights to Speak of: The Economic Harms of Restricting Reproductive Freedom;” 10:00 a.m.; February 28

Senate Armed Services Subcommittee on Personnel hearing to receive testimony on traumatic brain injury and blast exposure care; 3:00 p.m.; February 28

House Energy and Commerce Subcommittee on Health hearing “Legislative Proposals to Support Patients with Rare Diseases;” 10:00 a.m.; February 29

Recently Introduced Health Legislation

H.R.7406-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes. Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

H.R.7405-To amend title 10, United States Code, to prohibit the exclusion of an individual from assignment to a medical personnel position of the Armed Forces on the basis of the amputation of the individual, and for other purposes. Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Armed Services

H.Res.1025-Expressing support for the designation of April 5, 2024, as “Barth Syndrome Awareness Day”; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

H.R.7418-To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

House Passes Bill to Expand Prohibition on QALYs-The House of Representatives passed legislation (H.R. 485) along party lines last week to prohibit the use of quality-adjusted life years (QALYs) and similar metrics in Medicaid and other federal health programs. While supporters of the Protecting Health Care for All Patients Act argue that QALYs discriminate against people with disabilities, congressional Democrats have voiced concerns that the bill’s language is too vague and could impact a broader set of comparative effectiveness analysis used in federal drug price negotiations. Republicans have countered that the legislation mirrors language in the Affordable Care Act, which banned the use of QALYs to determine coverage in the Medicare program.

Oversight Panel Advances PBM Reform Bill-The House Oversight and Accountability Committee advanced the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283) last week. The bipartisan legislation introduced by Reps. Mariannette Miller-Meeks (R-Iowa) and Nanette Diaz Barragan (D-Calif.) would prohibit pharmacy benefit managers (PBMs) from tying fees or other types of remuneration to the price of a medicine and instead require fees to be structured as a flat fee based on the fair market value of PBM services. Additionally, the DRUG Act would ban the practices of spread pricing and patient steering, and prohibit PBMs from paying affiliated pharmacies more than independent community pharmacies for the same services. The bill was favorably reported by a 29-11 vote.

Budget Committee Marks Up Preventive Health Savings Act-The House Budget Committee unanimously advanced the bipartisan Preventive Health Savings Act (H.R. 766) last week in a 30-0 vote. The bill, which was introduced by Reps. Michael Burgess (R-Texas) and Diana DeGette (D-Colo.), directs the Congressional Budget Office (CBO) to more accurately reflect the long term and cost-saving potential of preventive health care initiatives. It also encourages the use of data-informed preventive health measures, and instructs the agency to extend its analysis from the existing 10-year budget window to a 30-year budget window to more sufficiently reflect the potential impact of preventive health policies.

Democrats Urge White House to Finalize March-In Rights Guidance-A group of more than 70 congressional Democrats sent a letter to Biden administration officials last week in support of the White House’s proposal to exercise march-in rights to ensure reasonable prices for taxpayer-funded inventions. The lawmakers offer comments for how the administration’s “Interagency Guidance Framework for Considering the Exercise of March-In Rights” might be strengthened, and urge the administration to finalize the draft framework without delay. “Reining in out-of-control prescription drug prices is one of the most pressing challenges facing the United States, and taxpayers are investing more than ever in biomedical research, sometimes funding 80 to 100 percent of the cost of developing a new medical product,” the letter states. “While we recognize the important role of the private sector in research and development and support the ability to make a reasonable profit, industry interests should not outweigh meeting health and safety needs for all consumers and providing accountability to taxpayers.” In addition to the letter from congressional Democrats, more than 500 comments were received from the public during the notice and comment period for the proposal, which ended on February 6.

E&C Subpoenas NIH for Documents Related to Sexual Harassment Investigation-The House Energy and Commerce Committee is subpoenaing the National Institutes of Health (NIH) for information related to allegations of sexual harassment within the agency and its grantees. An investigation led by Chair Cathy McMorris Rodgers (R-Wash.) found at least 300 cases of harassment since 2018. “As the largest public funder of biomedical research, the NIH is uniquely positioned to transform the culture of science to prevent sexual harassment and mitigate its detrimental impacts,” Chair Rodgers stated. “Unfortunately, the NIH has failed to comply adequately with requests for information and documents related to its handling of sexual harassment complaints.”

CBO Releases Latest Deficit Projections-The Congressional Budget Office (CBO) has released its latest Budget and Economic Outlook, covering the period of 2024 to 2034. CBO estimates that the federal budget deficit will grow by $1 trillion over the next decade, largely driven by federal spending on entitlement programs like Medicare, Medicaid, and Social Security. The agency projects that the deficit will grow from 5.6% of gross domestic product in 2024 to 6.1% in 2034. CBO notes that, since the Great Depression, deficits have exceeded that level only during and shortly after World War II, the 2007-2009 financial crisis, and the coronavirus pandemic.

Congressional Retirements and Resignations-After two decades in Congress, Chairwoman of the House Energy and Commerce Committee Cathy McMorris Rodgers (R-Wash.) announced that she will not run for reelection this year. McMorris Rodgers is a former Republican Conference Vice Chair. During her time as Energy and Commerce Republican leader, she helped advance the latest package of Food and Drug Administration user fee agreement reauthorizations and authored transparency legislation. Rep. Michael Burgess (R-Texas), the second-most-senior Republican on the Committee, previously announced his plan to retire this year. The next most senior Republican, Rep. Bob Latta (R-Ohio), is expected to run for the top seat on the panel. Health Subcommittee Chairman Brett Guthrie (R-Ky.) has also confirmed that he will run to lead the committee.

Rep. Mike Gallagher (R-Wisc.), who was first elected to the House in 2017, announced that he will not seek reelection. Before joining the House of Representatives, Gallagher served in the Marine Corps, staffed the Senate Foreign Relations Committee, and worked in the private sector. Currently, he chairs the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party, and the House Armed Services Subcommittee on Cyber, Information Technologies, and Innovation. He also serves on the Permanent Select Committee on Intelligence.

Rep. Matt Rosendale (R-Mont.) has announced his bid for the GOP nomination to challenge Sen. Jon Tester (D-Mont.) for his seat in the upper chamber. Rosendale has served in the House of Representatives since 2021 and currently sits on the Veterans Affairs Committee. He will face Tim Sheehy, a retired Navy SEAL in the primary.

Rep. Victoria Spartz (R-Ind.) has reversed her decision to retire from Congress and will run for reelection this November.

Former Maryland Governor Larry Hogan (R) announced that he plans to run for the Maryland Senate seat currently held by retiring Senator Ben Cardin (D).

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

Upcoming Congressional Hearings and Markups

House Select Committee on the Chinese Communist Party field hearing “Growing Stakes: The Bioeconomy and American National Security;” 8:30 a.m.; February 13

House Energy and Commerce Subcommittee on Health legislative hearing “Legislative Proposals to Support Patients and Caregivers;” 10:00 a.m.; February 14

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Can the Oracle Pharmacy Software Be Made Safe and Effective?;” 8:00 a.m.; February 15

House Veterans’ Affairs Subcommittee on Health hearing “Artificial Intelligence at VA: Exploring its Current State and Future Possibilities;” 10:00 a.m.; February 15

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Assessing America’s Vaccine Safety Systems, Part 1;” 10:00 a.m.; February 15

Recently Introduced Health Legislation

H.R.7218-To amend title III of the Public Health Service Act to extend the program for promotion of public health knowledge and awareness of Alzheimer’s disease and related dementias, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce

H.R.7222-To amend the Internal Revenue Code of 1986 to allow expenses for parents to be taken into account as medical expenses, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

H.R.7224-To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

H.R.7226-To require research with respect to fentanyl and xylazine test strips, to authorize the use of grant funds for such test strips, and for other purposes; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

H.R.7239-To amend the Controlled Substances Act to enhance the penalties applicable with respect to certain violations involving the use of interactive computer service to distribute a controlled substance, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Judiciary; Energy and Commerce

S.3733-A bill to require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

S.3740-A bill to amend the Omnibus Crime Control and Safe Streets Act of 1968 to reauthorize the residential substance use disorder treatment program, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

S.3741-A bill to prohibit the Secretary of Health and Human Services from restricting funding for pregnancy centers; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.1000-Expressing support for the designation of February 4, 2024, as “National Cancer Prevention Day”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

H.R.7248-To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

H.R.7254-To direct the Administrator of the Centers for Medicare and Medicaid to clarify that fully implanted active middle ear hearing devices are prosthetics and are not subject to the hearing aid coverage exclusion under the Medicare program; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce; Ways and Means

H.R.7258-To amend the Public Health Service Act to provide community-based training opportunities for medical students in rural areas and medically underserved communities, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Energy and Commerce

H.Res.1004-Expressing support for the designation of February 4 through February 10, 2024, as “National Burn Awareness Week”; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Oversight and Accountability

H.R.7265-To authorize the Secretary of Health and Human Services to award grants to establish or expand programs to implement evidence-aligned practices in health care settings for the purpose of reducing the suicide rates of covered individuals, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.7266-To amend the Public Health Service Act to authorize grants to support schools of nursing in increasing the number of nursing students and faculty and in program enhancement and infrastructure modernization, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

H.R.7267-To amend title XIX of the Social Security Act to provide a temporary higher Federal medical assistance percentage for Federal expenditures under the Medicaid program that are associated with the cost of compliance with certain Federal regulations with respect to services furnished in certain intermediate care facilities or home and community-based services furnished to individuals with intellectual and developmental disabilities; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

H.R.7268-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

H.R.7274-To amend title XVIII of the Social Security Act to provide for outreach and education to Medicare beneficiaries to simplify access to information for family caregivers through 1-800-MEDICARE, and for other purposes; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce

H.R.7279-To amend title XVIII of the Social Security Act to reduce the administrative burden on physicians and physical and occupational therapists, with respect to plan of care certification and recertification requirements; Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Energy and Commerce; Ways and Means

H.R.7282-To amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce

H.R.7283-To direct the Comptroller General of the United States to evaluate and report on the inpatient and outpatient treatment capacity, availability, and needs of the United States; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce; Natural Resources

H.R.7292-To amend title XI of the Social Security Act to lower barriers to increase patient access to health care; Sponsor: Moore, Blake D. [Rep.-R-UT-1]; Committees: House – Energy and Commerce; Ways and Means

H.R.7300-To amend title V of the Social Security Act to extend funding for the family-to-family health information centers; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Energy and Commerce

H.R.7301-To amend the Protecting Access to Medicare Act of 2014 to clarify the meaning of psychiatric rehabilitation services under demonstration programs to improve community mental health services, and for other purposes; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Energy and Commerce

H.R.7305-To direct the Secretary of Defense to provide to the Committees on Armed Services of the Senate and House of Representatives a report and briefing on anomalous health incidents affecting members of the Armed Forces and civilian employees of the Department of Defense; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Armed Services

S.3744-A bill to amend title XI of the Social Security Act to lower barriers to increase patient access to health care; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

S.3756-A bill to establish a new pilot program that would test coverage of outpatient observation services furnished outside a hospital under the Acute Hospital Care at Home initiative; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Finance

S.3757-A bill to reauthorize the congenital heart disease research, surveillance, and awareness program of the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.3765-A bill to amend the Public Health Service Act to reauthorize the Emergency Medical Services for Children program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3766-A bill to amend title XVIII of the Social Security Act to provide for outreach and education to Medicare beneficiaries to simplify access to information for family caregivers through 1-800-MEDICARE, and for other purposes; Sponsor: Tillis, Thomas [Sen.-R-NC]; Committees: Senate-Finance

Government Funding Update-The Labor-Health and Human Services (HHS)-Education appropriations bill will face cuts in fiscal year (FY) 2024 under an agreement reached by bicameral appropriations leadership on spending totals for the 12 annual government funding bills. According to Senate Labor-HHS-Education Subcommittee Chair Tammy Baldwin (D-Wis.), the funding will be less than both FY2023 levels ($209.9 billion in base discretionary funding plus $4.2 billion in emergency funds) and the Senate’s FY 2024 bill, which included $224.4 billion in discretionary funding. While the funding allocations are not yet publicly available, House Agriculture-Food and Drug Administration (FDA) Subcommittee Ranking Member Sanford Bishop (D-Ga.) has confirmed that the Agriculture-FDA bill will see a bump in funding. Lawmakers have less than one month to negotiate details of the spending bills, as current funding for federal agencies is set to expire on March 1 for some agencies, including the FDA, and March 8 for the remainder, including HHS. Congress faces an effective April 30 deadline to pass the FY 2024 appropriations bills due to a provision in the most recent debt ceiling law that would impose an automatic spending cut on all discretionary funding should a continuing resolution still be in place at that time. In related news, the White House Office of Management and Budget has confirmed that the President will send Congress his FY 2025 budget proposal on March 11, just days after his March 7 State of the Union address and the FY 2024 funding deadlines.

The Senate will vote this week on $118 billion border deal released on Sunday. The agreement includes $62 billion in aid for Ukraine, $14 billion in aid for Israel, and $10 billion in humanitarian assistance to the Gaza Strip and Ukraine. It also includes the Fentanyl Eradication and Narcotics Deterrence (FEND) Off Fentanyl Act. Majority Leader Chuck Schumer (D-N.Y.) plans to hold a procedural vote on the package Wednesday, though it remains unclear if it has the necessary 60 votes to advance.

CMS Makes First Offers in Drug Price Negotiation Program-Last week, the Centers for Medicare and Medicaid Services (CMS) sent its initial price offers for the 10 products selected for the first round of Medicare prescription drug price negotiations to the affected pharmaceutical manufacturers. The companies have until March 2 to accept the offer or make a counteroffer, and each company will be able to meet with CMS three times during the negotiation process. The administration will publish final prices by September 1. CMS has not released how much the initial price offers, which are not made public, would generate in savings.

Senate Finance Advances ASPE Nominee-The Senate Finance Committee advanced the nomination of Rebecca Lee Haffajee, JD, PhD, MPH to serve as the U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) last week in a 14-13 party line vote. Haffajee has served in this role in an acting capacity since 2021. Her nomination will now be sent to the full Senate for consideration. Prior to joining the administration, Haffajee worked as a policy researcher at the RAND Corporation and an assistant professor at the University of Michigan School of Public Health.

Baldwin Calls for Increased Competition in Asthma-Inhaler Market-Sen. Tammy Baldwin (D-Wis.) has written to the nation’s four largest asthma inhaler manufacturers regarding their use of the Food and Drug Administration’s (FDA) Orange Book to delay the entrance of generic drug products to the market. The letters from Baldwin to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva urge the companies to remove improperly listed patents from the agency’s database of patent and exclusivity information for FDA-approved drugs. Her letters highlight that despite warnings from the Federal Trade Commission challenging more than 100 asthma inhaler patents listed in the Orange Book as inaccurate or improper, the companies have not yet removed the patents.

Senate Dems Urge DEA to Deschedule Marijuana-Twelve Senate Democrats, including Majority Leader Chuck Schumer (D-N.Y.), have sent a letter to Attorney General Merrick Garland and Drug Enforcement Administration (DEA) leader Anne Milgram urging the administration to ease cannabis restrictions. The U.S. Department of Health and Human Services recommended in August that the DEA reschedule marijuana from Schedule I to Schedule III, and the agency’s review of the recommendation is ongoing. The letter, led by Elizabeth Warren (D-Mass.) and John Fetterman (D-Pa.), urges the DEA to “reach the right conclusion” and deschedule marijuana from the Controlled Substances Act altogether “consistent with the clear scientific and public health rationale for removing marijuana from Schedule I, and with the imperative to relieve the burden of current federal marijuana policy on ordinary people and small businesses.”

Lawmakers File Brief in Mifepristone Case-A group of 50 senators and 213 members of the House of Representatives have filed a brief in support of the Biden administration ahead of the Supreme Court’s consideration of Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine. The case will determine whether the Supreme Court should stay the U.S. District Court for the Northern District of Texas’s order blocking the FDA’s approval of mifepristone. The lawmakers argue that the “perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated.” The Supreme Court is scheduled to hear arguments in the case on March 26.

HHS Finalizes OUD Treatment Rule-The U.S. Department of Health and Human Services (HHS) has made permanent certain COVID-era flexibilities impacting the prescription of buprenorphine. The final rule, which applies to certified opioid treatment programs, will allow the opioid use disorder (OUD) treatment to be prescribed via telehealth, including audio-only visits, without an initiating in-person visit with the prescriber. The regulation also allows providers more flexibility around the provision of unsupervised methadone doses.

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 Rules Committee meeting to report a Rule for H.R. 485, Protecting Health Care for All Patients Act; 4:00 p.m.; February 5

House Budget Committee markup of H.R. 766, Preventive Health Savings Act; H.R. 7032, Congressional Budget Office Data Sharing Act; H.R. 5301, Eliminate Useless Reports Act; 10:00 a.m.; February 6

House Ways and Means Committee hearing “Examining Chronic Drug Shortages in the United States;” 10:00 a.m.; February 6

House Oversight and Accountability Committee markup to consider H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act, and other legislation; 10:00 a.m.; February 6

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Protecting American Health Security: Oversight of Shortcomings in the FDA’s Foreign Drug Inspection Program;” 10:30 a.m.; February 6

Senate Health, Education, Labor, and Pensions Committee hearing “Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?;” 10:00 a.m.; February 8

Senate Finance Committee hearing “Artificial Intelligence and Health Care: Promise and Pitfalls;” 10:00 a.m.; February 8

Recently Introduced Health Legislation

H.Res.979-Expressing the sense of the House of Representatives that public health authorities and tobacco control advocates should encourage American innovation and embrace harm reduction as part of the comprehensive United States approach to tobacco control; Sponsor: Reschenthaler, Guy [Rep.-R-PA-14]; Committees: House – Energy and Commerce; Foreign Affairs

H.R.7108-To support States and high-need local educational agencies in increasing the number of mental health services providers in schools; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Education and the Workforce

H.R.7119-To amend titles XVIII and XIX of the Social Security Act to prohibit skilled nursing facilities and nursing facilities from using pre-dispute arbitration agreements with respect to residents of those facilities under the Medicare and Medicaid programs, and for other purposes; Sponsor: Sanchez, Linda T. [Rep.-D-CA-38]; Committees: House – Ways and Means; Energy and Commerce

S.3679-A bill to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3680-A bill to amend the Internal Revenue Code of 1986 to enhance the paid family and medical leave credit, and for other purposes; Sponsor: Fischer, Deb [Sen.-R-NE]; Committees: Senate-Finance

S.3685-A bill to amend the Family and Medical Leave Act of 1993 to permit leave for bone marrow or blood stem cell donation, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3691-A bill to amend title XVIII of the Social Security Act to provide for the application of a cost-of-living adjustment to the non-labor related portion for hospital outpatient department services furnished in Alaska and Hawaii; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate-Finance

H.Res.984-Expressing support for the designation of January 30, 2024, as CTE (chronic traumatic encephalopathy) and RHI (repeated head impacts) Awareness Day; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

H.R.7136-To require the Secretary of Veterans Affairs to establish a comprehensive standard for timing between referrals and appointments for care from the Department of Veterans Affairs and to submit a report with respect to that standard, and for other purposes; Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Veterans’ Affairs

H.R.7140-To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; Sponsor: Horsford, Steven [Rep.-D-NV-4]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

H.R.7141-To amend titles XIX and XXI of the Social Security Act and title XXVII of the Public Health Service Act to require no-cost coverage of human milk fortifier; Sponsor: McGarvey, Morgan [Rep.-D-KY-3]; Committees: House – Energy and Commerce

H.R.7142-To amend title XVIII of the Social Security Act to ensure appropriate access to non-opioid pain management drugs under part D of the Medicare program; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce; Ways and Means

H.R.7147-To amend title XI of the Social Security Act to establish a pilot program for testing the use of a predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests under the Medicare program; Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House – Energy and Commerce; Ways and Means

H.R.7148-To amend title XVIII of the Social Security Act to provide for eligibility for coverage of home health services under the Medicare Program on the basis of a need for occupational therapy; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means; Energy and Commerce

H.R.7149-To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test a model to improve access to specialty health services for certain Medicare and Medicaid beneficiaries; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Energy and Commerce; Ways and Means

H.R.7153-To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce

S.3700-A bill to permit nurse practitioners and physician assistants to furnish necessary services, appliances, and supplies to individuals receiving medical benefits for illnesses; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

S.3701-A bill to establish education partnership programs between public schools and public health agencies to prevent the misuse and overdose of synthetic opioids by youth, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.3713-A bill to prohibit the Federal Government from conducting, funding, approving, or otherwise supporting any research involving human fetal tissue that is obtained pursuant to an induced abortion, and to prohibit the solicitation or knowing acquisition, receipt, or acceptance of a donation of such tissue; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

H.Con.Res.87-Recognizing the need for research, education, and policy development regarding high-potency marijuana; Sponsor: Sessions, Pete [Rep.-R-TX-17]; Committees: House – Energy and Commerce

H.R.7155-To provide for the establishment, within the Food and Drug Administration, of an Abraham Accords Bureau to promote and facilitate cooperation between the Food and Drug Administration and entities in Abraham Accords countries wishing to work with the agency in order to develop and sell products in the United States, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

H.R.7161-To require States to report information on Medicaid payments to abortion providers; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Energy and Commerce

H.R.7164-To advance population research for chronic pain; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

H.R.7174-To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Sponsor: McCormick, Richard [Rep.-R-GA-6]; Committees: House – Energy and Commerce; Ways and Means

S.Con.Res.27-A concurrent resolution recognizing the need for research, education, and policy development regarding high-potency marijuana; Sponsor: Ricketts, Pete [Sen.-R-NE]; Committees: Senate – Health, Education, Labor, and Pensions

S.3722-A bill to require a report on access to maternal health care within the military health system, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Armed Services

S.3725-A bill to amend the Toxic Substances Control Act to codify a Federal cause of action and a type of remedy available for individuals significantly exposed to per- and polyfluoroalkyl substances, to encourage research and accountability for irresponsible discharge of those substances, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Environment and Public Works

H.Res.992-Recognizing February 4, 2024, as “World Cancer Day”, and its theme “Close the Care Gap”, to raise awareness about and launch efforts to eliminate racial and ethnic inequities and disparities in cancer care both in the United States and globally; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce

H.R.7183-To prohibit Federal funds from being used to provide certain gender transition procedures to minors; Sponsor: McCormick, Richard [Rep.-R-GA-6]; Committees: House – Energy and Commerce

H.R.7185-To amend the Office of National Drug Control Prevention Act of 1998 to include new requirements for assessments and reports, and for other purposes; Sponsor: Duarte, John S. [Rep.-R-CA-13]; Committees: House – Oversight and Accountability; Judiciary

H.R.7186-To provide for the integration of participant treatment within the Continuum of Care Program with Certified Community Behavioral Health Clinics, and for other purposes; Sponsor: Calvert, Ken [Rep.-R-CA-41]; Committees: House – Financial Services

H.R.7188-To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Energy and Commerce

H.R.7189-To amend the Public Health Service Act to reauthorize a national congenital heart disease research, surveillance, and awareness program, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

H.R.7194-To amend the Toxic Substances Control Act to codify a Federal cause of action and a type of remedy available for individuals significantly exposed to per- and polyfluoroalkyl substances, to encourage research and accountability for irresponsible discharge of those substances, and for other purposes; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Energy and Commerce; Judiciary

H.R.7207-To amend title XVIII of the Social Security Act to prohibit the Secretary of Health and Human Services from selecting certain activities relating to the development of anti-racism plans as clinical practice improvement activities under the Medicare program; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House – Energy and Commerce; Ways and Means

H.R.7208-To reauthorize the Traumatic Brain Injury program; Sponsor: Pascrell, Bill, Jr. [Rep.-D-NJ-9]; Committees: House – Energy and Commerce

H.R.7212-To address the behavioral health workforce shortages through support for peer support specialists, and for other purposes; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.7213-To amend the Public Health Service Act to enhance activities of the National Institutes of Health with respect to research on autism spectrum disorder and enhance programs relating to autism / reauthorize certain programs with respect to autism spectrum disorder, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce

H.R.7214-To require a report on access to maternal health care within the military health system, and for other purposes; Sponsor: Stefanik, Elise M. [Rep.-R-NY-21]; Committees: House – Armed Services

H.R.7215-To express the sense of Congress that aliens who are present in the United States without lawful status under the immigration laws should not receive any benefit under the Medicare program or under the Medicaid program; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Energy and Commerce; Ways and Means

H.R.7216-To direct the Secretary of Health and Human Services to revise regulations to remove the requirement under the Medicare program that an ambulatory surgical center shall report the COVID-19 vaccination status of health care personnel; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Energy and Commerce; Ways and Means

Agreement on Topline Funding Numbers-House and Senate Appropriations Committee leaders reached an agreement late Friday night on funding totals for the 12 fiscal year (FY) 2024 appropriations bills. The House and Senate now have approximately one month to negotiate details of the spending bills, as current funding for federal agencies is set to expire on March 1 for some agencies and March 8 for the remainder, including the Department of Health and Human Services. Congress faces an effective April 30 deadline to pass the FY 2024 appropriations bills due to a provision in the most recent debt ceiling law that would impose an automatic spending cut on all discretionary funding should a continuing resolution still be in place at that time.

Senate Passes Legislation to Address the Nursing Shortage-The Senate passed the Train More Nurses Act (S. 2853) by unanimous consent last week. The legislation aims to strengthen the nursing workforce and improve pathways for licensed practical nurses to become registered nurses. The bill would require the secretaries of Labor and the U.S. Department of Health and Human Services to conduct a study on federal grant programs that support the nursing workforce.

Administration, Congressional Policymakers Consider MA Program Reforms-The Senate Finance Committee plans to investigate the marketing practices of five Medicare Advantage (MA) third-party marketing organizations: eHealth, GoHealth, Agent Pipeline, SelectQuote, and TRANZACT. Chairman Ron Wyden (D-Ore.) asserts that the sale of beneficiaries’ information has “led to a race to the bottom as unscrupulous actors put their own financial interests ahead of seniors’ health needs.” The panel has sent letters to each of the companies requesting information on their business practices.

The Centers for Medicare and Medicaid Services (CMS) has issued a request for information (RFI) seeking input on the MA program related to “access to care, prior authorization, provider directories, and networks; supplemental benefits; marketing; care quality and outcomes; value-based care arrangements and equity; and healthy competition in the market.” The RFI follows a letter from a bipartisan group of senators including Sens. Bill Cassidy (R-La.), Elizabeth Warren (D-Mass.), Marsha Blackburn (R-Tenn.), and Catherine Cortez Masto (D-Nev.) to the agency in December 2023 urging the administration to improve the data collection and reporting practices of MA plans. Responses to the RFI are due on May 29, 2024.

The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on a series of recommendations during its meeting last week to streamline the appeals process for claims denials made by Medicaid managed care organizations (MCOs). The Commission proposed to allow third-party doctors to conduct external medical reviews of MCO claims denials. Similar policies are already in place in 14 states across the nation. The recommendation follows a 2023 report from the U.S. Department of Health and Human Services which found high rates of prior authorization denials by MCOs. The same report found that external medical reviewers made decisions in beneficiaries’ favor more often than when MCOs oversaw the claims adjudication process. MACPAC also voted to recommend that CMS issue guidance on MCO denial forms, and that states conduct audits of denials made by MCOs. MACPAC’s recommendations will be published in the Commission’s March 2024 Report to Congress.

Finance Leaders Consider Policies to Prevent Generic Drug Shortages-Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) have released a white paper outlining policy proposals the Committee is exploring to address generic drug shortages through modifications to the Medicare and Medicaid programs. The panel is considering the following areas for legislative development this year:

• Medicare Part A and B payment reforms to stabilize the supply of generic sterile injectable medicines;
• New incentives for providers and other prescription drug supply chain stakeholders to engage in shortage prevention and mitigation activities;
• Reforms or new pilot programs in Medicare Part D to bolster incentives for pharmacies to purchase generic medicines from drug manufacturers that invest in shortage mitigation, quality, and drug supply chain resilience; and
• Potential reforms to the Medicaid Drug Rebate Program targeting generic medicines in shortage.

Lawmakers to Launch Digital Health Caucus; HHS Releases Goals for Cybersecurity-Reps. Troy Balderson (R-Ohio) and Robin Kelly (D-Ill.) plan to launch the Congressional Digital Health Caucus during an event hosted by the Consumer Technology Association on Thursday. The caucus will focus on ensuring access to the benefits of digital health tools for all Americans. The event on February 1 will feature speakers from Google, Microsoft, Amazon Web Services, and Hippocratic AI to discuss artificial intelligence in digital health care.

In related news, a bipartisan group of senators have sent a letter to Majority Leader Chuck Schumer (D-N.Y.) calling for the creation of a federal agency responsible for regulating the technology industry. “Congress must create a new agency with the resources and meaningful enforcement authority to regulate these firms in a comprehensive, considered, and continuous manner,” the letter states. “We can successfully mitigate the risks of AI while simultaneously addressing the harms American families and businesses experience every day in our digital world.” The Majority Leader has recently convened a series of AI Insight Forums underscoring the need for a comprehensive approach to artificial intelligence. The letter, which was signed by Sens. Michael Bennet (D-Colo.), Lindsey Graham (R-S.C.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), also endorses the Digital Platform Commission Act (S. 1671) and the Digital Consumer Protection Commission Act (S. 2597) to establish a new enforcement authority to oversee the tech sector.

The U.S. Department of Health and Human Services (HHS) released a set of voluntary cybersecurity performance goals for the health care sector on Wednesday. The measures include both essential goals to strengthen basic cybersecurity as well as enhanced goals to protect against sophisticated cyber-attacks. The goals were accompanied by a new gateway website to help the health care and public health sector implement these practices.

Pharmaceutical Manufacturers Agree to Testify in Feb. 8 Hearing-The CEOs of Johnson & Johnson and Merck have agreed to testify before the Senate Health, Education, Labor and Pensions (HELP) Committee, alongside the CEO of Bristol Meyers Squibb, on the issue of prescription drug pricing during a hearing to be held of February 8. Chairman Bernie Sanders (I-Vt.) had planned to hold a vote this week on issuing subpoenas for the CEOs but canceled the Executive Session explaining that “The use of a subpoena was clearly a last resort and I’m delighted that these CEOs will be coming into our committee voluntarily.”

Lawmakers Urge White House to Oppose WTO COVID-19 IP Waiver-A bipartisan group of senators sent a letter to President Joe Biden last week urging the administration to oppose a World Trade Organization (WTO) proposal to waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics. “Waiving rules meant to incentivize the discovery and production of life-saving medicines will cause investors and innovators to shift their efforts elsewhere,” the lawmakers argue. “What is more, allowing foreign competitors to disregard IP protections for made-in-the-USA biomedical technologies would undercut U.S. businesses and undermine the efforts of the workers who brought those technologies to market.” The issue will be discussed at a WTO ministerial conference next month. The letter was led by Sens. Mike Crapo (R-Idaho), Chris Coons (D-Del.), Tom Carper (D-Del.), and Thom Tillis (R-N.C.) and signed by 10 other senators.

Congressional Retirements and Resignations-Rep. Kelly Armstrong (R-N.D.) announced his candidacy for Governor of North Dakota last week. Armstrong was first elected to the House of Representatives in 2018 and currently serves on the Energy and Commerce Committee. Rep. Dutch Ruppersberger (D-Md.) announced that he would retire at the end of his term. Ruppersberger has served in the House since 2003 and currently sits on the House Appropriations Committee.

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

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “The Future of Data Privacy and Artificial Intelligence at VA;” 3:30 p.m.; January 29

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Overseeing the Department of Health and Human Services’ Compliance with Congress;” 10:00 a.m.; January 31

House Energy and Commerce Subcommittee on Health hearing “Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers;” 10:00 a.m.; January 31

Senate Homeland Security and Governmental Affairs Committee Executive Session to consider nominations and legislation including S. 3558, to prohibit contracting with certain biotechnology providers; 10:15 a.m.; January 31

Senate Veterans’ Affairs Committee hearing “Vet Centers: Supporting the Mental Health Needs of Servicemembers, Veterans and their Families;” 3:30 p.m.; January 31

House Judiciary Committee field hearing “Artificial Intelligence and Intellectual Property: Part II-Identity in the Age of AI; 9:00 a.m. PT; Los Angeles, CA; February 2

Senate Health, Education, Labor, and Pensions Committee hearing on the high costs of prescription drugs for patients; 10:00 a.m.; February 8

Recently Introduced Health Legislation

H.R.7059-To amend the Public Health Service Act to authorize a grant program to increase capacity for providing abortion services and other sexual and reproductive health care, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

H.R.7063-To prohibit Federal funds from being made available to any pregnancy center that diverts people from accessing comprehensive and timely medical care from licensed medical professionals; Sponsor: Landsman, Greg [Rep.-D-OH-1]; Committees: House – Energy and Commerce

H.R.7068-To amend the Controlled Substances Act to provide for the scheduling of tianeptine as a schedule III substance, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Energy and Commerce; Judiciary

S.Res.530-A resolution designating January 23, 2024, as “Maternal Health Awareness Day”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Judiciary

S.3638-A bill to allow health plan policyholders to obtain information about controlled substances prescribed to adult children enrolled in such plan; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Health, Education, Labor, and Pensions

S.3641-A bill to require the Secretary of Defense to establish a pilot program for evidence-based perinatal mental health prevention for pregnant and postpartum members of the Armed Forces and dependents, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

S.3651-A bill to amend title XVIII of the Social Security Act to ensure coverage of mental health services furnished through telehealth; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

S.3653-A bill to apply user fees with respect to tobacco products deemed subject to the requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.532-A resolution recognizing and supporting the goals and ideals of National Medicolegal Death Investigation Professionals Week; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

S.3663-A bill to provide funding for programs and activities under the SUPPORT for Patients and Communities Act; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.7085-To prohibit contracting with certain biotechnology providers, and for other purposes; Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House – Oversight and Accountability

H.R.7087-To direct the Secretary of Defense to establish a pilot program for evidence-based perinatal mental health prevention for pregnant and postpartum members of the Armed Forces and beneficiaries, and for other purposes; Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House – Armed Services

H.R.7090-To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

H.R.7091-To amend title 38, United States Code, to require medical facilities of the Department of Veterans Affairs to share certain data with State cancer registries, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Veterans’ Affairs; Energy and Commerce

H.R.7093-To provide for Congressional approval of public health emergency declarations, and for other purposes; Sponsor: Moore, Barry [Rep.-R-AL-2]; Committees: House – Energy and Commerce; Rules

Congress Passes CR, Averting Government Shutdown Until March-Congress successfully passed another two-step stopgap spending bill (H.R. 2872) last week. The measure extends funding deadlines for federal agencies from January 19 and February 2 to March 1 and March 8. The Senate passed the bill in a 77-18 vote on Thursday. The CR was approved by the House of Representatives in a 314-108 vote hours later, and signed by President Joe Biden on Friday. House Speaker Mike Johnson (R-La.) had previously pledged to not pass any additional temporary spending measures, and nearly half the House Republican caucus voted against the bill in opposition to the Speaker’s dealmaking with congressional Democrats and in demand of immigration and border security policy changes. Last week, prior to passage of the CR, Congressional leadership announced bipartisan agreement on a $1.66 trillion topline spending cap for fiscal year (FY) 2024, and lawmakers hope the latest CR will provide enough time to negotiate the details of the 12 annual appropriations bills. Congress faces an effective April 30 deadline to pass appropriations for FY 2024 due to a provision included in the most recent debt ceiling compromise which would impose an automatic across the board spending cut should a CR still be in place at that time. House GOP leadership have announced a change to the chamber’s schedule for next month, deciding to cut their February recess short and hold votes February 28 through March 1.

CMS Releases Final Interoperability and E-Prior Authorization Regulation-The Centers for Medicare and Medicaid Services (CMS) released its final rule on advancing interoperability and improving prior authorization processes last week. The regulation would impose new requirements aimed at enhancing the electronic exchange of health care data and improving prior authorization processes. Provisions in the final rule apply to Medicare Advantage organizations, state Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally Facilitated Exchanges. The rule requires impacted payers to implement an HL7 FHIR Patient Access application programming interface (API), a provider access API, a payer-to-payer API, and a prior authorization API. It also includes provisions to require impacted payers to send prior authorization decisions within 72 hours for urgent requests and seven calendar days for standard requests, to provide a specific reason for denied prior authorization decisions, and to publicly report certain prior authorization metrics on an annual basis. The regulation also adds a new “Electronic Prior Authorization” measure for Merit-based Incentive Payment System eligible clinicians and hospitals, including critical access hospitals. The regulation was praised by the congressional champions of the Improving Seniors’ Timely Access to Care Act, who stated that the regulation will “make a big difference in helping seniors access the medical care they are entitled to without unnecessary delays and denials.” Rep. Suzan DelBene (D-Wash.) explained that although the rule address many of the things that were in the bill, there are areas where CMS “could have gone further, especially in terms of speed of decision-making.” She and the other bill sponsors plan to review the final rule and “see what else we can do legislatively to not only solidify and codify what is in the rule, but also look at what we can do to try to increase speed of responses.”

HELP to Vote on Prescription Drug Pricing Investigation-The Senate Health, Education, Labor, and Pensions (HELP) Committee is set to vote on January 31 to authorize an investigation into the high costs of prescription drugs. The panel will also vote on subpoenaing the CEOs of Johnson & Johnson and Merck to testify about why the manufacturers charge “substantially higher prices for medicine in the U.S. compared to other countries.” Chairman Bernie Sanders (I-Vt.) will need a majority of his panel to vote in support of the subpoenas. If he is successful, it will be the first time the committee has subpoenaed anyone in more than 40 years.

Biden Administration Drops Appeal on the Copay Accumulator Decision-The Biden administration has dropped its previous appeal of an October U.S. District Court decision to strike down a 2021 rule allowing copay accumulators. The decision was praised by many lawmakers on Capitol Hill, including Sens. Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) and Reps. Buddy Carter (R-Ga.), Nanette Barragan (D-Calif.), and Mariannette Miller-Meeks (R-Iowa), who had urged the administration to drop its appeal and introduced the HELP Copays Act (S. 1375/H.R. 830), which would prohibit the use of copay accumulator programs. Nineteen states have already acted to ban copay accumulator adjustment programs.

Schatz Leads Bipartisan Letter on Permanent Telehealth Flexibilities-A bipartisan group of senators led by Sen. Brian Schatz (D-Hawaii) have sent a letter to the U.S. Department of Health and Human Services (HHS) urging the administration to work with Congress to ensure that all Medicare beneficiaries have permanent access to telehealth services. Temporary COVID-era waivers expanding access to telehealth are currently set to expire on December 31, 2024. The letter urges Secretary Xavier Becerra to communicate to Congress and the public the authorities, appropriations, resources, and other supports needed to enact permanent telehealth legislation. The lawmakers also encourage HHS to solicit information from stakeholders to address any outstanding implementation questions related to permanent policy.

ARPA-H to Solicit Rural Care Proposals-The Advanced Research Projects Agency for Health (ARPA-H) has launched a program to increase access to early disease detection and hospital level care in rural areas of the country. The Platform Accelerating Rural Access to Distributed & Integrated Medical care (PARADIGM) program aims to support the development of mobile health units to extend the reach of rural hospitals. A forthcoming PARADIGM program solicitation will solicit proposals from a wide range of applicants with proposals for bringing advanced medical services to underserved rural populations throughout the country. More information about the PARADIGM program and the scheduled Proposers’ Day to be held the week of February 12 can be found here.

FDA, CMS Issue Joint Statement on Regulation of LDTs-The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) issued a joint statement last week reiterating mutual support for FDA oversight of the analytical and clinical validity of laboratory developed tests (LDTs). The statement acknowledges the concerns that have been raised about the safety and effectiveness of LDTs, and responds to the suggestion that these concerns should be addressed through the expansion of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). “The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs,” the statement reads. “Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.”

Congressional Retirements and Resignations-Rep. Jeff Duncan (R-S.C.) announced his retirement last week. Duncan was first elected to Congress in 2010, and currently sits on the Energy and Commerce Committee.

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) announced the selection of Rep. Buddy Carter (R-Ga.) to replace Rep. Bill Johnson (R-Ohio) as Chair of the Environment, Manufacturing, and Critical Materials Subcommittee. Johnson resigned from Congress effective this week to start as President at Youngstown State University.

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

Upcoming Congressional Hearings and Markups

Senate Judiciary Subcommittee on Intellectual Property hearing to examine the Patent Eligibility Restoration Act, focusing restoring clarity, certainty, and predictability to the U.S. patent system; 2:30 p.m.; January 23

Senate Committee on Environment and Public Works oversight hearing to examine the Toxic Substances Control Act amendments implementation; 10:00 a.m.; January 24

Senate Special Committee on Aging hearing “Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults;” 10:00 a.m.; January 25

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “The Future of Data Privacy and Artificial Intelligence at VA;” 3:30 p.m.; January 29

Senate Health, Education, Labor, and Pensions Committee executive session to authorize an investigation into the high costs of prescription drugs for patients in the United States compared to other countries; 11:00 a.m.; January 31

Recently Introduced Health Legislation

H.R.6986-To address patent thickets; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Judiciary

H.R.6992-To require the Secretary of Health and Human Services to establish a list of essential medicines, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

H.R.6993-To allow individuals to choose to opt out of the Medicare part A benefit; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House – Ways and Means

S.3597-A bill to reauthorize programs relating to oral health promotion and disease prevention; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.3598-A bill to require the Secretary of Veterans Affairs to establish a comprehensive standard for timing between referrals and appointments for care from the Department of Veterans Affairs and to submit a report with respect to that standard, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs

S.3607-A bill to amend the Internal Revenue Code of 1986 to provide that amounts paid for an abortion are not taken into account for purposes of the deduction for medical expenses; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance

S.3608-A bill to amend the Internal Revenue Code of 1986 to prohibit treatment of certain distributions and reimbursements for certain abortions as qualified medical expenses; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance

H.R.7002-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.7014-To amend title XIX of the Social Security Act to prohibit Federal Medicaid funding for the administrative costs of providing health benefits to individuals who are unauthorized immigrants; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

H.R.7017-To amend the Internal Revenue Code of 1986 to take certain Medicare premiums of household members into account in determining the health care insurance premiums tax credit; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Ways and Means

S.3609-A bill to ensure that women seeking an abortion are informed of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child, before giving their informed consent to receive an abortion; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

S.3612-A bill to prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.3621-A bill to amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.3628-A bill to amend title XVIII of the Social Security Act to improve mobility crisis under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Finance

S.3630-A bill to amend title XI of the Social Security Act to establish a pilot program for testing the use of a predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests under the Medicare program; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate-Finance

H.Res.976-Recognizing the roles and the contributions of Americas Certified Registered Nurse Anesthetists (CRNAs) and their critical role in providing quality health care for the public and the Nations Armed Forces for more than 150 years, through multiple public health emergencies, and beyond; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

H.R.7044-To ensure that women seeking an abortion are notified, before giving informed consent to receive an abortion, of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Energy and Commerce

H.R.7049-To repeal the Department of Veterans Affairs directive relating to the COVID-19 vaccination program for Veterans Health Administration health care personnel, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Veterans’ Affairs

H.R.7050-To amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means; Energy and Commerce

H.R.7056-To prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce

Leaders Agree to Extend Laddered Short-Term Funding Plan-Congressional leadership have reached an agreement on a second two-step continuing resolution (CR) to avoid January 20 and February 2 partial government shutdowns. Leaders have coalesced around a CR that maintains House Speaker Mike Johnson’s (R-La.) laddered government funding approach, extending appropriations for federal agencies to March 1 and March 8. A section-by-section is available here, and the legislative text is available here.

Johnson had previously pledged to not pass another stopgap spending bill. The change of course follows an initial bipartisan agreement reached last week on topline spending amounts. Johnson insists that he is standing by the deal struck with Senate Majority Leader Chuck Schumer (D-N.Y.), despite criticism from far-right members of the House GOP, who have pressured him to abandon it. The deal includes $1.59 trillion in spending for fiscal year 2024 – $886 billion in defense and $704 billion in non-defense spending.

MedPAC Votes on Payment Update Recommendations-The Medicare Payment Advisory Commission (MedPAC) voted on its latest payment update recommendations for physicians, hospitals, and the post-acute care sector during its January meeting last week. The Commission recommends updating 2025 Medicare payments for physicians and other health professional services by the amount specified in current law plus half the Medicare Economic Index increase, and reiterated a prior recommendation to create a non-budget-neutral add-on payment under the Medicare physician fee schedule for services provided to low-income beneficiaries. MedPAC also voted to recommend a positive update for hospitals – current law amount plus 1.5% for 2025. Commissioners voted in support of lower base pay rates for skilled nursing facilities, home health agencies, and inpatient rehabilitation facilities, and recommended that Congress eliminate the 2024 update for hospices in 2025. MedPAC also recommended that Congress update the Medicare end-stage renal disease prospective payment system by the amount under current law.

HELP Chair Launches Investigation Into Pricing of Asthma Inhalers-Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and Sens. Tammy Baldwin (D-Wis.), Ben Ray Lujan (D-N.M.), and Ed Markey (D-Mass.) have sent letters to AstraZeneca, Boehringer Ingelheim, GSK, and Teva to request details about the “extremely high prices” of the manufacturers’ asthma inhaler products. The letters ask for information on internal strategic communications, patient assistance programs, and the costs involved in the manufacturing of inhalers. “There is no reason for these products to be so expensive,” the lawmakers assert. “The devices have been available since the 1950s and most of the drugs they use have been on the market for more than 25 years.”

Fauci Completes Two Days of Interviews Before House Panel-Dr. Anthony Fauci provided two days of closed-door testimony before the House of Representatives Select Subcommittee on the Coronavirus Pandemic last week. According to reports, panel Republicans focused much of their questioning on the definition of gain of function research funded by the National Institutes of Health (NIH). Fauci was also questioned about the origins of COVID-19 and issues related to the federal government’s pandemic response, including federal records violations, conflicts of interest, and conflicting guidance. While the meetings produced few surprises or new information, Fauci has agreed to testify in a future open session before the committee.

ARPA-H to Solicit Preventive Care Proposals-The Advanced Research Projects Agency for Health (ARPA-H) has launched a program to increase investments in solutions to preventable health challenges in underserved communities. The Health care Rewards to Achieve Improved Outcomes  (HEROES) program aims to strengthen investment in community-level preventive care resources, particularly in places that have historically lacked access to medical and health care breakthroughs. A forthcoming HEROES program solicitation will solicit proposals from “Health Accelerators” – groups or organizations such as health consortiums or community health centers – aimed at health challenges in parts of the country where the associated health outcome is worse than the national average. More information about the HEROES program and the scheduled February 13-14 Proposers’ Day can be found here.

HHS Appoints First Ever Chief Competition Officer-Stacy Sanders has been appointed to serve as the first-ever Chief Competition Officer at the U.S. Department of Health and Human Services (HHS). The newly created position will be responsible for coordinating, identifying, and elevating opportunities across HHS to promote competition in health care markets, and will work with the Federal Trade Commission and Department of Justice to address concentration in health care markets through data-sharing, reciprocal training programs, and the further development of additional health care competition policy initiatives. Sanders most recently worked as a counselor to HHS Secretary Xavier Becerra, overseeing the Department’s implementation of the Inflation Reduction Act. Earlier in her career, Sanders worked as staff director for the Senate Special Committee on Aging and as federal policy director of the Medicare Rights Center.

OMB Clears CMS Prior Authorization Regulation-The Office of Management and Budget (OMB) has cleared a final rule from the Centers for Medicare and Medicaid Services (CMS) on prior authorization. The regulation will place new requirements on Medicare Advantage organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally facilitated Exchanges to improve the electronic exchange of health care data and streamline processes related to prior authorization. The proposed rule, which was first published in December 2022, would also add a new measure for eligible hospitals and critical access hospitals, under the Medicare Promoting Interoperability Program, and for Merit-based Incentive Payment System (MIPS) eligible clinicians, under the Promoting Interoperability performance category of MIPS, to encourage providers to adopt the electronic prior authorization processes. Once the final rule is implemented, it should make it easier for Congress to advance the Improving Seniors’ Timely Access to Care Act – bipartisan prior authorization legislation which passed the House during the 117^th Congress.

Congressional Retirements and Resignations-Rep. Larry Bucshon, MD (R-Ind.) has announced plans to retire at the end of this year. Bucshon, a cardiothoracic surgeon, has served in the House of Representatives since 2011. He is a member of the GOP Doctors Caucus. During his time in Congress, Bucshon has been a champion of diagnostics reform legislation (the VALID Act) as well as other bipartisan health measures, including proposals to related to the Medicare physician reimbursement system. He is a member of the Energy and Commerce Committee. Rep. Greg Pence (R-Ind.) has also determined that he will not seek reelection to the House this year. Pence was first elected to represent Indiana’s 6^th Congressional District in 2018, filling the same seat held by former Vice President Mike Pence before he was elected Indiana governor. He currently serves on the Energy and Commerce Committee. Currently, the number of members who are retiring from Capitol Hill next year currently stands only slightly higher than the average of 34 retirements per election cycle.

California Governor Gavin Newsom (D) has set a special election to fill the seat of retired former House Speaker Kevin McCarthy (R). The all-parties special primary election will take place on March 19, several weeks following the primary scheduled to fill McCarthy’s seat for the full two-year term. If no candidate wins a majority of the votes in the March 19^th primary, the top two finishers will compete in a May 21 runoff election.

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

Upcoming Congressional Hearings and Markups

Senate Homeland Security & Governmental Affairs Committee hearing “The Cyber Safety Review Board: Expectations, Outcomes, and Enduring Questions;” 10:00 a.m.; January 17

Senate Health, Education, Labor, and Pensions hearing “Addressing Long COVID: Advancing Research and Improving Patient Care;” 10:00 a.m.; January 18

Recently Introduced Health Legislation

S.3560 – A bill to amend title 38, United States Code, to authorize pre-enrollment of certain combat service members of the Armed Forces in the system of annual patient enrollment of the Department of Veterans Affairs; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Veterans’ Affairs

S.3573 – A bill to amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate-Finance

S.3575 – A bill to amend the Public Health Service Act to give a preference, with respect to project grants for preventive health services, for States that allow all trained individuals to carry and administer epinephrine, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.6936 – To require Federal agencies to use the Artificial Intelligence Risk Management Framework developed by the National Institute of Standards and Technology with respect to the use of artificial intelligence; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Oversight and Accountability; Science, Space, and Technology

S.3578 – A bill to amend title XIX of the Social Security Act to prohibit Federal Medicaid funding for the administrative costs of providing health benefits to individuals who are unauthorized immigrants; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

S.3583 – A bill to address patent thickets; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Judiciary

H.R.6956 – To amend title XIX of the Social Security Act to prohibit the Secretary of Health and Human Services from treating any Medicaid-related funds recovered from one or more pharmaceutical companies or drug distributors with respect to opioid litigation as an overpayment under such title, and for other purposes; Sponsor: Kaptur, Marcy [Rep.-D-OH-9]; Committees: House – Energy and Commerce

H.R.6960 – To amend the Public Health Service Act to reauthorize the Emergency Medical Services for Children program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

H.R.6961 – To amend title XVIII of the Social Security Act to provide coverage of medical nutrition therapy services for individuals with eating disorders under the Medicare program; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Ways and Means

H.R.6963 – To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

H.R.6965 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to establish requirements with respect to cost sharing for epinephrine injectors under group health plans and group and individual health insurance coverage; Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

H.R.6968 – To direct the Secretary of Health and Human Services to give marriage and family therapists participating in the National Health Service Corps Loan Repayment Program the option of completing a postgraduate degree clinical training program that is accredited by the State in which the program is located in lieu of such a program that is accredited by the Commission on Accreditation for Marriage and Family Therapy Education; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Energy and Commerce

H.R.6977 – To amend the Public Health Service Act to provide for a demonstration project for the development and publication of independent value assessments for drugs, and for other purposes; Sponsor: Nadler, Jerrold [Rep.-D-NY-12]; Committees: House – Energy and Commerce

H.R.6979 – To amend the Internal Revenue Code of 1986 to provide a credit to small businesses for research activities related to the mitigation of certain drug threats; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Ways and Means

H.R.6980 – To amend the Immigration and Nationality Act to provide for the reallocation of unused waivers of the foreign residency requirement for certain J-visa holders; Sponsor: Nehls, Troy E. [Rep.-R-TX-22]; Committees: House – Judiciary

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

According to guidance released on December 22, the Office of Management and Budget (OMB) has instructed federal agencies to not prepare for sequestration cuts at this time. The federal government is currently operating under a continuing resolution (CR) that funds some parts of the government through January 19 and others through February 2. Congress faces an effective April 30 deadline to pass fiscal year 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% automatic cut should a stopgap spending measure still be in place past that date. The OMB guidance sought to provide clarification around the April 30 date, given that the law states that the 1% cut will be required if Congress relies on a CR beyond December 31; OMB, however, is not required to issue a sequestration order until the end of April. The guidance also confirms that cuts will be negated once lawmakers reach a full-year funding deal, even if that occurs after the April 30 deadline. The sequestration spending cuts would only apply during the period in which a CR is in place beyond April 30.

Ways and Means Chair Comments on NSA Implementation

House Ways and Means Committee Chairman Jason Smith (R-Mo.) has released a statement on the administration’s “bungled” implementation of the No Surprises Act, following the release of a Government Accountability Office (GAO) report outlining the challenges with implementation of the 2020 law. “GAO’s report is further evidence that the Biden administration is failing to deliver this law’s promised benefits to patients and providers,” Smith states. “While I’m pleased the bipartisan advocacy of members of the Ways and Means Committee has contributed to a reduction of the dispute resolution process administrative fee, there’s much more that needs to be fixed. We will continue our efforts to hold the Biden administration accountable for ignoring the law’s clear Congressional intent.”

Administration Extends IDR Flexibilities Following Portal Reopening

On December 21, the U.S. Departments of Health and Human Services, Labor, and the Treasury announced an extension of the deadline for parties to complete certain independent dispute resolution (IDR) activities that were impacted by the temporary suspension of IDR operations due to litigation surrounding the implementation of the No Surprises Act. Parties for whom the IDR initiation deadline under applicable regulations fell on any date between August 3, 2023, and December 14, 2023, will have until March 14, 2024, to initiate a new batched dispute or a new single dispute involving air ambulance services. For disputes initiated between August 3, 2023, and January 21, 2024, the administrative fee amount is $50 per party per dispute. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute. Certified IDR entity fees for disputes initiated on or after January 22, 2024, may be updated to fall within the ranges finalized in the December 21, 2023, final rules to establish the new administrative fee amount and certified IDR entity fee ranges. The administration previously reopened the federal IDR portal to process all dispute types on December 15.

IRA Medicare Reforms Effective Jan. 1

Several Medicare reforms passed as a part of the 2022 Inflation Reduction Act are now in effect, including an expansion of the federal Low-Income Subsidy (LIS) program. There will no longer be a partial LIS program providing a lower level of financial support for certain individuals. Effective January 1, 2024, anyone who qualifies for the LIS program will get full program benefits, covering the majority, if not all, out-of-pocket costs for prescription medications. The new year also brings the elimination of the 5% coinsurance for Medicare Part D beneficiaries who have entered the catastrophic phase of their coverage.

Former Texas Congresswoman Eddie Bernice Johnson Dies at 88

Former Congresswoman Eddie Bernice Johnson (D) passed away on Sunday at the age of 88. Johnson was a nurse before entering politics, first serving as a Texas state lawmaker before being elected to the House of Representatives in 1992. She was the first African American and woman to serve as chair of the House Committee on Science, Space and Technology. She retired in 2021 after serving nearly 30 years in Congress.

Congressional Retirements and Resignations

Rep. John Curtis (R-Utah) is planning to announce his candidacy for the U.S. Senate early this month. Curtis was first elected to Congress in 2017 and currently serves as a member of the House Energy and Commerce Committee. Sen. Mitt Romney (R-Utah) previously announced his decision to not seek a second Senate term in September.

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

Recently Introduced Health Legislation

H.R.6903 – To direct the Secretary of Defense to develop a plan to ensure an adequate supply of medications for the military health system. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

H.R.6897 – To require the Secretary of Defense to establish a pilot program to evaluate novel pharmaceutical manufacturing technologies to reduce the reliance of the Department on foreign manufacturers for active pharmaceutical ingredients and key starting materials. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

H.R.6895 – To amend the National Defense Authorization Act for Fiscal Year 2023 to extend Federal support for bioindustrial manufacturing processes to include support for the manufacturing of certain pharmaceutical ingredients. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

H.R.6892 – To provide for the coverage of medically necessary food and vitamins and individual amino acids for digestive and inherited metabolic disorders under Federal health programs and private health insurance, to ensure State and Federal protection for existing coverage, and for other purposes. Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means; Oversight and Accountability; Armed Services

H.R.6884 – To increase the minimum levels of financial responsibility for transporting property, and to index future increases to changes in inflation relating to medical care. Sponsor: Garcia, Jesus G. “Chuy” [Rep.-D-IL-4]; Committees: House – Transportation and Infrastructure

H.R.6881 – To direct the Federal Trade Commission to establish standards for making publicly available information about the training data and algorithms used in artificial intelligence foundation models, and for other purposes. Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Energy and Commerce