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Congress Extends Government Funding
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 7th 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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Butler (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Bishop (R), NC |
Schiff (D), CA | Lesko (R), AZ |
Slotkin (D), MI | Granger (R), TX |
Allred (D), TX | Buck (R), CO |
Trone (D), MD | Burgess, MD (R), TX |
Blunt Rochester (D), DE | Wenstrup, DPM (R), OH |
Napolitano (D), CA | McHenry (R), NC |
Wexton (D), VA | McCarthy (R), CA (effective Dec. 31, 2023) |
Kim, Andy (D), NJ | Johnson (R), OH (effective Jan. 21, 2024) |
Jackson, Jeff (D), NC | Ferguson, IV, DMD, PC (R), GA |
Sarbanes (D), MD | Curtis (R), UT |
Blumenauer (D), OR | Luetkemeyer (R), MO |
Kilmer (D), WA | Lamborn (R), CO |
Spanberger (D), VA | Bucshon, MD (R), IN |
Kildee (D), MI | Pence (R), IN |
Phillips (D), MN | Duncan (R), SC |
Cardenas (D), CA | Armstrong (R), ND |
Eshoo (D), CA | McMorris Rodgers (R), WA |
Manning (D), NC | Gallagher (R), WI |
Higgins (D), NY (effective Feb. 2, 2024) | |
Nickel (D), NC | |
Ruppersberger (D), MD | |
Sablan (D), MP |
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
Health on the Hill Podcast: Grass is Always Greener Edition
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Agencies Prepare for Partial Shutdown as March 1 Deadline Approaches
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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Butler (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Bishop (R), NC |
Schiff (D), CA | Lesko (R), AZ |
Slotkin (D), MI | Granger (R), TX |
Allred (D), TX | Buck (R), CO |
Trone (D), MD | Burgess (R), TX |
Blunt Rochester (D), DE | Wenstrup (R), OH |
Napolitano (D), CA | McHenry (R), NC |
Wexton (D), VA | McCarthy (R), CA (effective Dec. 31, 2023) |
Kim, Andy (D), NJ | Johnson (R), OH (effective Jan. 21, 2024) |
Jackson, Jeff (D), NC | Ferguson (R), GA |
Sarbanes (D), MD | Curtis (R), UT |
Blumenauer (D), OR | Luetkemeyer (R), MO |
Kilmer (D), WA | Lamborn (R), CO |
Spanberger (D), VA | Bucshon (R), IN |
Kildee (D), MI | Pence (R), IN |
Phillips (D), MN | Duncan (R), SC |
Cardenas (D), CA | Armstrong (R), ND |
Eshoo (D), CA | McMorris Rodgers (R), WA |
Manning (D), NC | Gallagher (R), WI |
Higgins (D), NY (effective Feb. 2, 2024) | Green (R), TN |
Nickel (D), NC | |
Ruppersberger (D), MD | |
Sablan (D), MP |
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
Health on the Hill Podcast: bipArtIsan Edition
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Health on the Hill Podcast: Supplemental Stalemate Edition
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Senate Passes Supplemental Appropriations Measure
Senate Passes Supplemental Appropriations Measure-The Senate passed a $95 billion bipartisan national security supplemental appropriations package last week including $60 billion in aid for Ukraine, $14 billion in aid for Israel, and $10 billion in humanitarian assistance to the Gaza Strip and Ukraine. The package also includes the FEND Off Fentanyl Act, which would provide $1.2 billion to curb fentanyl trafficking and allow for the sanctioning of fentanyl cartels. House Speaker Mike Johnson (R-La.) has stated that he will not bring the bill for consideration before the House of Representatives.
Lawmakers Consider Potential of Short and Long-Term Physician Fee Schedule Reform-Lawmakers are going on the record regarding the chances of a Medicare physician reimbursement fix this year. A 3.37% reduction to Medicare physician payments went into effect on January 1, 2024. Reps. Ami Bera (D-Calif.) and Robin Kelly (D-Ill.) told an American Medical Association conference last week that their current priority is at least partial reversal of the cut that took place at the beginning of this year. At the same event, Rep. Larry Bucshon (R-Ind.) stated that a doctor pay fix could be included in a government funding package next month. While there is bipartisan agreement that broader reforms to the Medicare Physician Fee Schedule (MPFS) are necessary, such work is not likely until 2025 given the slow-down in legislative activity during presidential election years. This effort will also be complicated by the retirement from Congress of several physician lawmakers and other champions of Medicare physician payment reform. In related news, Sens. Catherine Cortez Masto (D-Nev.), Marsha Blackburn (R-Tenn.), John Thune (R-S.D.), John Barrasso (R-Wyo.), Debbie Stabenow (D-Mich.), and Mark Warner (D-Va.) recently announced the formation of a working group to investigate and propose long-term reforms to the MPFS and make necessary updates to the Medicare Access and CHIP Reauthorization Act. The working group plans to reach out to stakeholders in the coming weeks to seek feedback and to begin developing policies that will address Medicare physician payment in the long-term.
Durbin, Braun Call on FDA to Address Rx Drug Promotion on Social Media-Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) have sent a letter the Food and Drug Administration (FDA) calling on Commissioner Robert Califf to take action to address the “alarming proliferation of dangerous and misleading content promoting prescription drugs.” The lawmakers specifically request that the FDA modernize its draft guidance on prescription drug promotion, which has not been updated since 2014, to clarify that platforms like Instagram, Snapchat, X, and TikTok are subject to FDA regulation and requirements. They highlight the social media promotion of prescription drugs by telehealth companies as a perceived gap in the FDA’s jurisdiction. Durbin and Braun also argue that prescription drug promotion by social media influencers warrants particular attention. “The threats to children from misleading and unsubstantiated advertisements necessitate action, “The letter argues. “You have called health misinformation and disinformation a leading cause of death in the United States-and it is time the FDA addresses this challenge.”
E&C Leaders Ask GAO to Assess Risks of Selling Excess Laboratory Equipment-Republicans on the House Energy and Commerce Committee are calling for an investigation into how well the U.S. Department of Health and Human Services (HHS) and the Department of Agriculture manage the resale of laboratory equipment and protective gear. “The availability of both biological laboratory equipment and protective clothing on the commercial market provides access to materials needed to conduct legitimate scientific research, but also increases the chances this equipment could be used for malicious purposes, such as biological terrorism or warfare,” Committee Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight Subcommittee Chair Morgan Griffith (R-Va.) write. The lawmakers request that the Government Accountability Office (GAO) examine the extent to which these items are resold or exported and the controls in place to limit the risk they are used to create biological weapons both within and outside the U.S.
Sanders Urges Strong Warning Labels to Combat Diabetes Epidemic and Obesity-Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) has sent a letter to the FDA urging Commissioner Califf to require the food and beverage industry to place strong warning labels on products high in sugar, salt, and saturated fats. Sanders points out the direct relationship between the nation’s diabetes epidemic and obesity crisis, and argues that the FDA “can and must do more to ensure that Americans, especially children, teens, and their parents understand the health risks associated with the consumption of these unhealthy and ultra-processed foods.” Sanders’ letter notes his plans for the HELP Committee to hold a hearing in the near future to consider what the FDA can do to ensure that the food and beverages Americans consume are not harming them.
Lawmakers Express Concerns About Private Equity in Health Care-The Massachusetts congressional delegation has written to Ceberus Capital Management expressing concerns about the private equity firm’s role in the finances of Steward Health Care-owned hospitals across the state. “We have long been concerned about the nefarious role of private equity in our economy. Ownership by private equity investors increases health care costs and reduces quality of care, and private equity firms have played a role in the collapse of hospitals around the country, hurting communities and the health care workers and other staff that serve them,” the letter argues. “The dire threat of Steward’s collapse appears to be a textbook example of the grave risks posed by a private equity takeover of the health care system.”
HHS, FTC Issue RFI on Generic Drug Shortages-HHS and the Federal Trade Commission (FTC) have issued a request for information (RFI) on generic drug shortages and the impact of group purchasing organizations (GPOs) and drug wholesalers on access to generic pharmaceuticals. The agencies are requesting public input on:
- Whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act and the Robinson-Patman Act.
- Whether and to what extent the available protections for GPOs under the Federal Anti-Kickback Statute affect market concentration and contracting practices by GPOs, as well as drug shortages.
- Whether and to what extent market concentration among GPOs and drug wholesalers has impacted smaller health care providers and rural hospitals.
- Whether and to what extent concentration among GPOs and drug wholesalers has disincentivized suppliers from competing in generic drug markets.
- The impact of the prevailing GPO compensation model, which may rely on rebates, chargebacks, and administrative fees from manufacturers and suppliers in exchange for favorable treatment, on generic manufacturers and other suppliers.
The RFI is a part of the administration’s effort to promote competition in pharmaceutical markets and ensure access to high-quality, affordable care. This latest announcement notes another forthcoming joint RFI from the FTC, HHS, and Department of Justice seeking input on how private equity and other corporations’ control of health care is impacting Americans.
HHS OIG Releases Telehealth Report-The HHS Office of the Inspector General (OIG) released a report last week finding that health care providers largely complied with Medicare requirements when billing for evaluation and management (E/M) services provided via telehealth during the first nine months of the COVID-19 pandemic. The agency found that for 105 of the 110 sampled E/M services provided via telehealth, providers complied with Medicare requirements; the Medicare program paid $446 for the five sampled E/M services for which providers did not document or insufficiently documented the services. Investigators determined that unallowable payments identified resulted primarily from clerical errors or the inability to access records.
FDA Approves First Cell Therapy for Solid Tumors-The FDA has approved Iovance Biotherapeutics’ Amtagvi to treat advanced melanoma that either cannot be removed from the body or has spread throughout the body and was previously treated with other therapies. It is the first cell therapy to be approved for the treatment of solid tumors. Iovance is currently working to complete a confirmatory trial to ensure Amtagvi has a clinical benefit to cancer patients.
Congressional Retirements and Resignations-Rep. Matt Rosendale (R-Mt.) has dropped his bid to unseat Sen. Jon Tester (D-Mont.) less than a week after launching his campaign for the Senate. Rosendale has not yet decided whether he will run for reelection to the House of Representatives. The filing deadline for Montana is March 11.
Rep. Mark Green (R-Tenn.) has announced his decision to retire at the end of the year. Green was first elected to Congress in 2018. He currently serves as the chair of the House Homeland Security Committee.
Former Rep. Tom Suozzi (D) defeated Republican candidate Mazi Pilip to succeed ousted Rep. George Santos (R-N.Y.) in the House of Representatives. His victory flips the state’s third congressional district back to Democrats and further narrows the GOP’s majority in the House.
Rep. James Clyburn (D-S.C.) has stepped down from his role as assistant Democratic leader, a position he has held for just over a year. He previously served as the House Majority Whip. His decision follows similar moves by former House Speaker Nancy Pelosi (D-Calif.) and former Majority Leader Steny Hoyer (D-Md.) to step down from their respective leadership roles after the 2022 election. Rep. Joe Neguse (D-Colo.), chair of the Democratic Policy and Communications Committee, plans to run for assistant leader, according to two Democratic leadership aides.
A running list of members of Congress who are retiring or seeking other office can be found below.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Butler (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Bishop (R), NC |
Schiff (D), CA | Lesko (R), AZ |
Slotkin (D), MI | Granger (R), TX |
Allred (D), TX | Buck (R), CO |
Trone (D), MD | Burgess (R), TX |
Blunt Rochester (D), DE | Wenstrup (R), OH |
Napolitano (D), CA | McHenry (R), NC |
Wexton (D), VA | McCarthy (R), CA (effective Dec. 31, 2023) |
Kim, Andy (D), NJ | Johnson (R), OH (effective Jan. 21, 2024) |
Jackson, Jeff (D), NC | Ferguson (R), GA |
Sarbanes (D), MD | Curtis (R), UT |
Blumenauer (D), OR | Luetkemeyer (R), MO |
Kilmer (D), WA | Lamborn (R), CO |
Spanberger (D), VA | Bucshon (R), IN |
Kildee (D), MI | Pence (R), IN |
Phillips (D), MN | Duncan (R), SC |
Cardenas (D), CA | Armstrong (R), ND |
Eshoo (D), CA | McMorris Rodgers (R), WA |
Manning (D), NC | Gallagher (R), WI |
Higgins (D), NY (effective Feb. 2, 2024) | Green (R), TN |
Nickel (D), NC | |
Ruppersberger (D), MD | |
Sablan (D), MP |
Recently Introduced Health Legislation
H.R.7317-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to nursing homes, assisted living facilities, and other long-term care facilities to improve their preparedness for power outages. Sponsor: Wilson, Frederica S. [Rep.-D-FL-24]; Committees: House – Energy and Commerce
H.R.7312-To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Judiciary
H.R.7307-To amend the Public Health Service Act to establish a grant program to expand the number of allied health professionals in underserved communities and rural areas, and for other purposes. Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce
S.3797-A bill 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: Rounds, Mike [Sen.-R-SD]; Committees: Senate-Indian Affairs
S.3799-A bill to require the Secretary of Health and Human Services to evaluate how the frequency of summary notices provided to patients can be increased, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Finance
S.3800-A bill to increase the penalties for health care fraud, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Judiciary
S.Res.560-A resolution designating February 2024 as “American Heart Month”; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.
H.R.7327-To amend title XIX of the Social Security Act to ensure adequate consideration of payment rates for multimission hospitals under the Medicaid program, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce
H.R.7346-To amend the Public Health Service Act to provide for the continued implementation of the Climate and Health program by the Centers for Disease Control and Prevention; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce
H.R.7347-To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs; Sponsor: Van Orden, Derrick [Rep.-R-WI-3]; Committees: House – Veterans’ Affairs
H.R.7354-To establish an Interagency Task Force to examine the conditions and experiences of Black women and girls in education, economic development, healthcare, labor and employment, housing, justice and civil rights, to promote community-based methods for mitigating and addressing harm and ensuring accountability, and to study societal effects on Black women and girls, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Judiciary; Education and the Workforce; Energy and Commerce; Financial Services
H.R.7368-To amend title XVIII of the Social Security Act to provide for the application of Medicare secondary payer rules to certain workers’ compensation settlement agreements and qualified Medicare set-aside provisions; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce
H.R.7373-To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to include alpha-gal syndrome on the list of nationally notifiable diseases; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Energy and Commerce
H.R.7379-To amend title XXX of the Public Health Service Act to establish standards and protocols to improve patient matching; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Energy and Commerce; Ways and Means
H.R.7381-To direct the Director of the National Institutes of Health to establish a grant program to facilitate research regarding the use of generative artificial intelligence in health care, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce
H.R.7383-To amend the Federal Food, Drug, and Cosmetic Act to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce
H.R.7384-To amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases; Sponsor: McCaul, Michael T. [Rep.-R-TX-10]; Committees: House – Energy and Commerce
H.R.7397-To amend title XVIII of the Social Security Act to establish a definition of essential health system in statute; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Ways and Means; Energy and Commerce
House Passes Bill to Expand Prohibition on QALYs
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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Feinstein (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Bishop (R), NC |
Schiff (D), CA | Lesko (R), AZ |
Slotkin (D), MI | Granger (R), TX |
Allred (D), TX | Buck (R), CO |
Trone (D), MD | Burgess (R), TX |
Blunt Rochester (D), DE | Santos (R), NY (effective Dec. 1, 2023) |
Napolitano (D), CA | Wenstrup (R), OH |
Wexton (D), VA | McHenry (R), NC |
Kim, Andy (D), NJ | McCarthy (R), CA (effective Dec. 31, 2023) |
Jackson, Jeff (D), NC | Johnson, Bill (R), OH (effective Jan. 21, 2024) |
Sarbanes (D), MD | Ferguson (R), GA |
Blumenauer (D), OR | Curtis (R), UT |
Kilmer (D), WA | Luetkemeyer (R), MO |
Spanberger (D), VA | Lamborn (R), CO |
Kildee (D), MI | Bucshon (R), IN |
Phillips (D), MN | Pence (R), IN |
Cardenas (D), CA | Duncan (R), SC |
Eshoo (D), CA | Armstrong (R), ND |
Manning (D), NC | McMorris Rodgers (R), WA |
Higgins (D), NY (effective Feb. 2, 2024) | Rosendale (R), MT |
Nickel (D), NC | Mike Gallagher (R), WI |
Ruppersberger (D), MD | |
Sablan (D), MP |
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
Health on the Hill Podcast: Scoring Dynamics Edition
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Government Funding Update
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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Feinstein (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Spartz (R), IN |
Schiff (D), CA | Bishop (R), NC |
Slotkin (D), MI | Lesko (R), AZ |
Allred (D), TX | Granger (R), TX |
Trone (D), MD | Buck (R), CO |
Blunt Rochester (D), DE | Burgess (R), TX |
Napolitano (D), CA | Santos (R), NY (effective Dec. 1, 2023) |
Wexton (D), VA | Wenstrup (R), OH |
Kim, Andy (D), NJ | McHenry (R), NC |
Jackson, Jeff (D), NC | McCarthy (R), CA (effective Dec. 31, 2023) |
Sarbanes (D), MD | Johnson, Bill (R), OH (effective Jan. 21, 2024) |
Blumenauer (D), OR | Ferguson (R), GA |
Kilmer (D), WA | Curtis (R), UT |
Spanberger (D), VA | Luetkemeyer (R), MO |
Kildee (D), MI | Lamborn (R), CO |
Phillips (D), MN | Bucshon (R), IN |
Cardenas (D), CA | Pence (R), IN |
Eshoo (D), CA | Duncan (R), SC |
Manning (D), NC | Armstrong (R), ND |
Higgins (D), NY (effective Feb. 2, 2024) | |
Nickel (D), NC | |
Ruppersberger (D), MD | |
Sablan (D), MP |
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
Health on the Hill Podcast: Prescription Parley Edition
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Agreement on Topline Funding Numbers
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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Feinstein (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Spartz (R), IN |
Schiff (D), CA | Bishop (R), NC |
Slotkin (D), MI | Lesko (R), AZ |
Allred (D), TX | Granger (R), TX |
Trone (D), MD | Buck (R), CO |
Blunt Rochester (D), DE | Burgess (R), TX |
Napolitano (D), CA | Santos (R), NY (effective Dec. 1, 2023) |
Wexton (D), VA | Wenstrup (R), OH |
Kim, Andy (D), NJ | McHenry (R), NC |
Jackson, Jeff (D), NC | McCarthy (R), CA (effective Dec. 31, 2023) |
Sarbanes (D), MD | Johnson, Bill (R), OH (effective Jan. 21, 2024) |
Blumenauer (D), OR | Ferguson (R), GA |
Kilmer (D), WA | Curtis (R), UT |
Spanberger (D), VA | Luetkemeyer (R), MO |
Kildee (D), MI | Lamborn (R), CO |
Phillips (D), MN | Bucshon (R), IN |
Cardenas (D), CA | Pence (R), IN |
Eshoo (D), CA | Duncan (R), SC |
Manning (D), NC | Armstrong (R), ND |
Higgins (D), NY (effective Feb. 2, 2024) | |
Nickel (D), NC | |
Ruppersberger (D), MD |
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
Health on the Hill Podcast: A Generic Plan Edition
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Congress Passes CR, Averting Government Shutdown Until March
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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Feinstein (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES |
|
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Spartz (R), IN |
Schiff (D), CA | Bishop (R), NC |
Slotkin (D), MI | Lesko (R), AZ |
Allred (D), TX | Granger (R), TX |
Trone (D), MD | Buck (R), CO |
Blunt Rochester (D), DE | Burgess (R), TX |
Napolitano (D), CA | Santos (R), NY (effective Dec. 1, 2023) |
Wexton (D), VA | Wenstrup (R), OH |
Kim, Andy (D), NJ | McHenry (R), NC |
Jackson, Jeff (D), NC | McCarthy (R), CA (effective Dec. 31, 2023) |
Sarbanes (D), MD | Johnson, Bill (R), OH (effective Jan. 21, 2023) |
Blumenauer (D), OR | Ferguson (R), GA |
Kilmer (D), WA | Curtis (R), UT |
Spanberger (D), VA | Luetkemeyer (R), MO |
Kildee (D), MI | Lamborn (R), CO |
Phillips (D), MN | Bucshon (R), IN |
Cardenas (D), CA | Pence (R), IN |
Eshoo (D), CA | Duncan (R), SC |
Manning (D), NC | |
Higgins (D), NY (effective Feb. 2, 2024) | |
Nickel (D), NC |
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
Health on the Hill Podcast: Prior Authorized Edition
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ICYMI: 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. House and Senate members urged the administration to drop its appeal, including via introduction of bipartisan, bicameral legislation, the HELP Copays Act. 19 States have banned copay accumulator programs.
DOJ Drops Appeal In Copay Accumulator Suit https://t.co/mB6SejOIta
— InsideHealthPolicy (@InHealthPolicy) January 17, 2024
Health on the Hill Podcast: Extendable Ladder Edition
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ICYMI – Alliance of Specialty Medicine Calls on Congress to Reverse Medicare Reimbursement Cuts
#Medicare cuts to providers went into effect on Jan. 1. This needs to be addressed ASAP. READ our letter to Congress. https://t.co/WV0dkycrIT pic.twitter.com/emGIGte7Hd
— Specialty Docs (@SpecialtyDocs) January 16, 2024
Leaders Agree to Extend Laddered Short-Term Funding Plan
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 117th 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 6th 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 19th 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.
SENATE | |
Stabenow (D), MI | Braun (R), IN |
Cardin (D), MD | Romney (R), UT |
Carper (D), DE | |
Feinstein (D), CA | |
Manchin (D), WV | |
HOUSE OF REPRESENTATIVES | |
Porter (D), CA | Mooney (R), WV |
Lee (D), CA | Banks (R), IN |
Gallego (D), AZ | Spartz (R), IN |
Schiff (D), CA | Bishop (R), NC |
Slotkin (D), MI | Lesko (R), AZ |
Allred (D), TX | Granger (R), TX |
Trone (D), MD | Buck (R), CO |
Blunt Rochester (D), DE | Burgess (R), TX |
Napolitano (D), CA | Santos (R), NY (effective Dec. 1, 2023) |
Wexton (D), VA | Wenstrup (R), OH |
Kim, Andy (D), NJ | McHenry (R), NC |
Jackson, Jeff (D), NC | McCarthy (R), CA (effective Dec. 31, 2023) |
Sarbanes (D), MD | Johnson, Bill (R), OH (effective Jan. 21, 2023) |
Blumenauer (D), OR | Ferguson (R), GA |
Kilmer (D), WA | Curtis (R), UT |
Spanberger (D), VA | Luetkemeyer (R), MO |
Kildee (D), MI | Lamborn (R), CO |
Phillips (D), MN | Bucshon (R), IN |
Cardenas (D), CA | Pence (R), IN |
Eshoo (D), CA | |
Manning (D), NC | |
Higgins (D), NY (effective Feb. 2, 2024) | |
Nickel (D), NC |
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
Health on the Hill – Now Available on YouTube
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