Bipartisan Privacy Rights Draft Released

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

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

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
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 (effective March 22, 2024)
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 (effective April 19, 2024)
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP
Kuster (D), NH

 

Upcoming Congressional Hearings and Markups

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

GAO Releases Report on Federal Improper Payments

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

 

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

 

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

 

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

 

 

 

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

 

 

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

 

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

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
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 (effective March 22, 2024)
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 (effective April 19, 2024)
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP
Kuster (D), NH

 

 

Upcoming Congressional Hearings and Markups

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

 

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

 

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

Congress Wraps Up FY2024 Appropriations

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

 

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

 

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

 

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

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

 

 

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

 

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
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 (effective March 22, 2024)
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 (effective April 19, 2024)
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

President Releases FY 2025 Budget Proposal

President Releases FY 2025 Budget Proposal-The Biden administration released its fiscal year (FY) 2025 budget proposal last week. The $7.3 trillion budget calls for more than $1.6 trillion in base discretionary spending, including $621 billion for non-defense related programs, and would reduce the deficit by $3 trillion over the next decade. The budget request would increase discretionary spending at the U.S. Department of Health and Human Services by $5 billion over FY 2023 for a total of $133.8 billion. The budget keeps in place for FY 2025 the discretionary spending caps agreed to with Congress in last year’s debt ceiling deal.

 

The President’s budget represents the White House’s current priorities and a vision for a potential second term, with most proposals standing little chance of becoming law in the currently divided Congress. Notable health-related proposals contained in the budget include:

  • Raising the Medicare tax rate on those earning more than $400,000 from 3.8% to 5% to extend the solvency of the Medicare program;
  • Expanding the number of drugs subject to Medicare price negotiation, and speeding the price negotiation process;
  • Extending Medicare’s $2,000 per year out of pocket cap on drug spending and the $35 insulin cap to commercial insurance;
  • Limiting Medicare Part D cost-sharing for expensive generic drugs to $2;
  • Expanding domestic manufacturing capacity of medical countermeasures;
  • Expanding end-to-end supply chain visibility to prepare for and mitigate potential drug shortages;
  • Permanently expanding the Affordable Care Act’s enhanced premium tax credits;
  • Providing “Medicaid-like” coverage for eligible individuals in the 10 states that have yet to expand their programs;
  • Allowing states to expand continuous Children’s Health Insurance Program (CHIP) eligibility from 12 months to 36 months, and prohibiting premiums and enrollment fees in CHIP;
  • Providing new funding to support states in enforcing current mental health parity requirements;
  • Mandating that insurers cover three behavioral health visits and three primary care visits annually without cost-sharing;
  • Expanding access to the HIV prevention drug PrEP for uninsured individuals and those on Medicaid;
  • Prohibiting facility fees for telehealth services;
  • Penalizing hospitals that do not adopt minimum cybersecurity standards, while providing incentives for cybersecurity upgrades and support for low-resourced hospitals to increase their cybersecurity;
  • Recategorizing funding for nursing home surveys from discretionary to mandatory beginning in 2026 and increasing funding to cover the full cost of statutorily mandated surveys; and
  • Expanding the Title X family planning program.

 

HHS FY 2024 Funding Deadline Approaches-Congress has through Friday, March 22 to pass the remaining six appropriations bills for FY 2024. Funding for the departments of Homeland Security, Defense, State, Treasury, Health and Human Services, Education, and Labor was not included in the $460 billion appropriations package passed by Congress earlier this month. The most recent reports indicate that the next government funding package will not include health care policy riders addressing issues likes pharmacy benefit manager reform or hospital transparency. The Congressional Budget Office (CBO) stated its prediction last week that nondefense discretionary spending will not be subject to sequestration even if lawmakers fail to pass the six remaining appropriations bills for FY 2024 by the end of April because nondefense funding in the Consolidated Appropriations Act, 2024 and the continuing resolution is $3 billion below the section 102 nondefense cap. Defense programs could still face a 1% spending cut, which could amount to a reduction totaling $11 billion. The debt limit agreement reached between the President and House Republican leadership last year included a provision to subject defense and nondefense programs to a 1% across-the-board cut to all discretionary spending if Congress did not complete FY 2024 appropriations by an April 30 deadline. Lawmakers have successfully passed six of the annual 12 government funding bills. CBO predicts that those funding bills, along with the specifics of the current stopgap spending measure funding the remaining parts of the federal government, equate to more than a 1% cut to base nondefense discretionary spending, which could shield nondefense programs from sequestration. The agency qualified that the authority to determine whether sequestration is required ultimately lies with the Office of Management and Budget.

 

Lankford Blocks VA IVF Legislation-Sen. James Lankford (R-Okla.) blocked legislation that would expand veterans’ access to in vitro fertilization last week. Sen. Patty Murray (D-Wash.) sought to pass her bill (S. 2801), which would have removed a requirement that veterans must have a service-related injury or illness to access the procedure, by unanimous consent. Lankford expressed concerns about the legislation’s “overly broad definitions,” including its definition of infertility, and noted his support for moving the bill through the committee process. The Department of Veterans Affairs recently announced that it would lift a requirement that veterans be married to receive in vitro fertilization.

 

E&C Health Subcommittee Advances 19 Bills-The House Energy and Commerce Subcommittee on Health advanced 19 bipartisan bills during a markup on Tuesday.

  • H.R. 619, theNAPA Reauthorization Act was advanced, as amended, by a roll call vote of 26-0.
  • H.R. 620, theAlzheimer’s Accountability and Investment Act was advanced by a roll call vote of 26-0.
  • H.R. 7218, theBuilding Our Largest Dementia Infrastructure for Alzheimer’s Act of 2024 was advanced by a roll call vote of 25-0.
  • H.R. 4581, theMaternal and Child Health Stillbirth Prevention Act of 2023 was advanced by a roll call vote of 25-0.
  • H.R. 4646, theSIREN Reauthorization Act was advanced by a roll call vote of 24-0.
  • H.R. 6160, to amend the Public Health Service Act to reauthorize a lifespan respite care program, was advanced by a roll call vote of 25-0.
  • H.R. 6960, theEmergency Medical Services for Children Reauthorization Act of 2024 was advanced by a roll call vote of 23-0.
  • H.R. 7153, theDr. Lorna Breen Health Care Provider Protection Reauthorization Act was advanced by a roll call vote of 25-0.
  • H.R. 7251, thePoison Control Centers Reauthorization Act of 2024 was advanced by a roll call vote of 23-0.
  • H.R. 7224, to amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program, was advanced by a roll call vote of 24-0.
  • H.R. 6829, theCardiomyopathy Health Education, Awareness, Research, and Training in the Schools Act of 2023 was advanced by a roll call vote of 24-0.
  • H.R. 7189, theCongenital Heart Futures Reauthorization Act of 2024 was advanced by a roll call vote of 24-0.
  • H.R. 3916, theSCREENS for Cancer Act of 2023 was advanced by a roll call vote of 24-0.
  • H.R. 2706, theCharlotte Woodward Organ Transplant Discrimination Prevention Act was advanced by voice vote.
  • H.R. 5012, theSHINE for Autumn Act of 2023 was advanced by voice vote.
  • H.R. 7208, theTraumatic Brain Injury Program Reauthorization Act of 2024 was advanced by voice vote.
  • H.R. 7406, theDeOndra Dixon INCLUDE Project Act of 2024 was advanced by voice vote.
  • R. 5074, theKidney PATIENT Act, was advanced by a roll call vote of 16-10. Full committee Ranking Member Frank Pallone (D-N.J.) expressed concerns that the legislation, which would delay implementation of the inclusion of oral-only end-stage renal disease (ESRD) related drugs in the Medicare ESRD prospective payment system, would negatively impact access to care and increase costs.
  • R. 5526, theSeniors’ Access to Critical Medications Act of 2023, was advanced by a roll call vote of 19-6. Ranking Member Pallone was joined by several other panel Democrats in voting against the bill, which would permanently allow independent doctors to send prescriptions via mail, due to concerns about the risk of fraud.

 

Hassan Urges UnitedHealth to Better Support Providers Impacted by Cyberattack-Sen. Maggie Hassan (D-N.H.) has sent a letter urging UnitedHealth Group and Optum to take immediate steps to better support health care providers impacted by the February 21 cyberattack on Change Healthcare. She asserts that the structure of the current funding assistance program in place has discouraged providers from applying, and makes recommendations to address the Temporary Funding Assistance Program’s (TFAP) calculation for financial assistance and loan agreement. “As this weeks-long disruption continues, many providers are approaching a financial cliff that could endanger the availability of care,” the letter states. “In order to fulfill its obligation to its clients and the patients they serve, I urge UnitedHealth Group to immediately expand and revise its TFAP.”

 

Finance, HELP Leadership Push Agencies to Address Surprise Costs Related to Preventive Services-Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) have sent a letter to federal agencies urging them to issue guidance for insurers to protect patients against surprise cost-sharing. The letter follows reports of individuals with private health insurance plans receiving surprise bills for equipment and facility fees for certain preventive services that should be, under law, covered by their insurance. The lawmakers urge the U.S. departments of Health and Human Services, Treasury, and Labor to issue clarifying guidance to protect patients from being charged cost-sharing when they receive recommended preventive services and to address inappropriate charges for services that are integral to their care. “Health plans should be accountable for ensuring that preventive services are covered without cost sharing in accordance with the law,” Wyden and Sanders wrote. “Patients should not have to appeal these charges and be deterred from seeking preventive services.” The lawmakers also encourage the Biden administration to investigate and audit health insurers participating in the federal marketplace and employer-sponsored plans to ensure that the appropriate preventive services are covered without cost-sharing.

 

Cassidy Issues RFI on Regulation of Clinical Tests-Senate HELP Committee Ranking Member Bill Cassidy (R-La.) has requested information from stakeholders on ways to improve the regulation of clinical tests in the United States. Cassidy poses a series of 20 questions covering both the Food and Drug Administration’s proposed regulatory framework for diagnostics and the Clinical Laboratory Improvement Amendments regulatory framework for laboratory developed tests. The feedback received will be used to determine how Congress can modernize current regulations to support innovation while ensuring clinical tests are safe and effective to use. Responses should be submitted to [email protected] by April 3, 2024.

 

 

Bucshon Aims to Enact Medicare Reforms Before Year’s End-Rep. Larry Bucshon, M.D. (R-Ind.) believes reforms to the Medicare physician payment system are possible before the end of the year. In remarks made at POLITICO’s Health Care Summit last week, Bucshon stated that it was his goal to “address the reimbursement issues at CMS” before he retires at the end of this Congress. Potential reforms include changes to how physicians are reimbursed by the Medicare program and additional transparency requirements aimed at lowering prices across the health care system.

 

MedPAC, MACPAC Release March Reports to Congress-The Medicare Payment Advisory Commission (MedPAC) has released its annual March report to Congress. In addition to the Commission’s recommended provider payment updates for 2025, the report contains a recommendation on providing additional resources to Medicare safety-net hospitals and to clinicians who furnish care to fee-for-service Medicare beneficiaries with low incomes. The report also contains chapters describing recent trends in enrollment, plan offerings, and payments to Medicare Advantage (MA) plans and discusses related MA issues such as coding intensity, favorable selection, and market concentration.

 

The Medicaid and CHIP Payment and Access Commission (MACPAC) also released its March report to Congress last week containing recommendations on ways to improve Medicaid and the Children’s Health Insurance Program (CHIP). This year’s report focuses on how state Medicaid agencies can improve beneficiary engagement on Medical Care Advisory Committees (MCACs) and actions the federal government can take to aid states, recommending the Centers for Medicare and Medicaid Services issue guidance focused on specific state concerns related to implementation challenges. The recommendations also call on state Medicaid agencies to develop a plan to recruit beneficiary members from historically marginalized communities as well as to develop and implement policies that reduce beneficiary participation barriers. The report also focuses on the monitoring and oversight of denials and appeals in Medicaid managed care and makes recommendations to improve the transparency of denials and appeals as well as the beneficiary experience with the appeals process.

 

USPSTF Appoints New Chair, Vice Chair-The U.S. Preventive Services Task Force (USPSTF) has announced the appointments of a new chair and vice chair, Wanda Nicholson, M.D., M.P.H., M.B.A., and John Wong, M.D., MACP, respectively. Dr. Nicholson is a senior associate dean for diversity, equity, and inclusion, director of the Office of Inclusive Excellence, and professor of prevention and community health at the Milken Institute School of Public Health at the George Washington University. She is an obstetrician-gynecologist with expertise in perinatal and women’s population health and health equity. Dr. Wong is vice chair for academic affairs, chief of the Division of Clinical Decision Making, and a primary care clinician in the Department of Medicine at Tufts Medical Center. He is also director of comparative effectiveness research for the Tufts Clinical Translational Science Institute and a distinguished professor of medicine at Tufts University School of Medicine and the Tufts University Graduate School of Biomedical Sciences.

 

Congressional Retirements and Resignations-Rep. Ken Buck (R-Colo.) will retire from Congress effective March 22. Buck, who had already announced that he would not be running for reelection in November, did not give a reason for resigning early. Buck is a member of the Foreign Affairs and Judiciary committees. The June 25 special election to fill Buck’s vacant seat will coincide with the Republican primary for the full two-year term.

 

Rep. John James (R-Mich.) has filled the open seat on the House Energy and Commerce Committee following the retirement of Rep. Bill Johnson (R-Ohio) in January. “I congratulate Rep. James on becoming the newest member of the Energy and Commerce Committee-the best Committee on Capitol Hill,” Chair Cathy McMorris Rodgers (R-Wash.) stated. “I welcome his experience and perspective as a veteran and businessman as we continue working to deliver solutions to improve the lives of the American people.”

 

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
Sinema (I), AZ
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 (effective March 22, 2024)
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

House Ways and Means Committee field hearing “Access to Health Care in America: Ensuring Resilient Emergency Medical Care;” 2:00 p.m.; Denton, TX; March 18

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, hearing “Fiscal Year 2025 Budget Request for the Department of Health and Human Services;” 10:00 a.m.; March 20

 

House Ways and Means Committee hearing with Health and Human Services Secretary Becerra; 2:00 p.m.; March 20

 

House Energy and Commerce Subcommittee on Health hearing “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule;” 10:00 a.m.; March 21

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation hearing “White House Overreach on AI;” 10:00 a.m.; March 21

 

House Select Subcommittee on the Coronavirus Pandemic hearing “Assessing America’s Vaccine Safety Systems, Part 2;” 2:00 p.m.; March 21

 

House Veterans’ Affairs Subcommittee on Health hearing on pending legislation; 2:00 p.m.; March 21

 

Recently Introduced Health Legislation

H.R.7591-To establish the National Patient Safety Board; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce; Veterans’ Affairs

 

H.R.7596-To direct the Secretaries of Defense and of Veterans Affairs to take certain steps regarding research related to menopause, perimenopause, or mid-life women’s health, and for other purposes; Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House-Armed Services; Veterans’ Affairs

 

H.R.7599-To amend title XVIII of the Social Security Act to expand the eligibility for designation as a rural emergency hospital under the Medicare program; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; Committees: House-Ways and Means

 

H.R.7605-To address the worsening long-term care workforce crisis and increase access to and affordability of long-term care; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House-Education and the Workforce; Energy and Commerce

 

S.Res.586-A resolution supporting the goals and ideals of “Deep Vein Thrombosis and Pulmonary Embolism Awareness Month”; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.7618-To amend title XVIII of the Social Security Act to include physical therapists and occupational therapists as health professionals for purposes of the annual wellness visit under the Medicare program, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.7619-To require the Secretary of Health and Human Services to issue guidance to States on strategies under Medicaid and CHIP to increase mental health and substance use disorder care provider education, training, recruitment, and retention; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House-Energy and Commerce

 

S.3921-A bill to amend title XIX of the Social Security Act to provide a higher Federal matching rate for increased expenditures under Medicaid for behavioral health services (including those related to mental health and substance use), and for other purposes; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate-Finance

 

S.3932-A bill to prohibit the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury from finalizing a rule proposing restrictions on short-term limited duration insurance, and to amend title XXVII of the Public Health Service Act to define such insurance; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate-Health, Education, Labor, and Pensions

 

H.R.7623-To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.7635-To amend title III of the Social Security Act to ensure the accessibility of drugs furnished under the 340B drug discount program; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House-Energy and Commerce

 

H.R.7641-To prohibit the inclusion of mandatory predispute arbitration clauses and clauses limiting class action lawsuits in health insurance contracts; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House-Energy and Commerce; Ways and Means; Education and the Workforce

 

H.Res.1078-Recognizing the 75th anniversary of the National Institute of Dental and Craniofacial Research and its critical role in improving the dental, oral, and craniofacial health of the United States through research, training, and the dissemination of health information; Sponsor: Babin, Brian [Rep.-R-TX-36]; Committees: House-Energy and Commerce

 

H.R.7647-To direct the Secretary of Health and Human Services to provide guidance to State Medicaid agencies, public housing agencies, Continuums of Care, and housing finance agencies on connecting Medicaid beneficiaries with housing-related services and supports under Medicaid and other housing resources, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House-Energy and Commerce; Financial Services

 

H.R.7652-To increase oversight and transparency with respect to Medicare billing codes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House-Ways and Means; Energy and Commerce

 

H.R.7657-To direct the Secretary of Veterans Affairs to revise a certain directive of the Veterans Health Administration of the Department of Veterans Affairs; Sponsor: Finstad, Brad [Rep.-R-MN-1]; Committees: House-Veterans’ Affairs

 

H.R.7665-To amend title XVIII of the Social Security Act to improve the way beneficiaries are assigned under the Medicare shared savings program by also basing such assignment on primary care services furnished by nurse practitioners, physician assistants, and clinical nurse specialists; Sponsor: Kilmer, Derek [Rep.-D-WA-6]; Committees: House-Ways and Means; Energy and Commerce

 

H.R.7669-To make States ineligible for funding through the State Maternal and Child Health Services Block Grant program if the States prohibit a licensed physician from performing in vitro fertilization for an individual experiencing medical hardship in conceiving a child, and for other purposes; Sponsor: Luna, Anna Paulina [Rep.-R-FL-13]; Committees: House-Energy and Commerce

 

H.R.7677-To prohibit the Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury from finalizing a rule proposing restrictions on short-term limited duration insurance, and to amend title XXVII of the Public Health Service Act to define such insurance; Sponsor: Self, Keith [Rep.-R-TX-3]; Committees: House-Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.7681-To amend the Internal Revenue Code of 1986 to extend the exemption for telehealth services from certain high deductible health plan rules, to establish a safe harbor for high deductible health plans with no deductible for certain primary care services, and to direct the Comptroller General of the United States to conduct a study on the effects of such safe harbor; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House-Ways and Means

 

H.R.7682-To amend title XIX of the Social Security Act to increase under the Medicaid program the minimum monthly personal needs allowance for institutionalized individuals and couples, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House-Energy and Commerce

 

S.Res.588-A resolution recognizing March 14, 2024, as “Black Midwives Day”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.Res.590-A resolution designating March 15, 2024, as “Long COVID Awareness Day”; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate-Judiciary

 

S.J.Res.65-A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Environmental Protection Agency relating to “Reconsideration of the National Ambient Air Quality Standards for Particulate Matter”; Sponsor: McConnell, Mitch [Sen.-R-KY]; Committees: Senate-Environment and Public Works

 

S.3934-A bill to require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Finance

 

S.3939-A bill to amend title XVIII of the Social Security Act to improve the way beneficiaries are assigned under the Medicare shared savings program by also basing such assignment on primary care services furnished by nurse practitioners, physician assistants, and clinical nurse specialists; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate-Finance

 

S.3949-A bill to amend title V of the Public Health Service Act to ensure protections for lesbian, gay, bisexual, and transgender youth and their families; Sponsor: Butler, Laphonza R. [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.3950-A bill to provide States with support to establish integrated care programs for individuals who are dually eligible for Medicare and Medicaid, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

 

S.3951-A bill to amend title XVIII of the Social Security Act to provide for adjustments to the Medicare part D cost-sharing reductions for low-income individuals; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

 

S.3953-A bill to make demonstration grants to eligible local educational agencies or consortia of eligible local educational agencies for the purpose of increasing the numbers of school nurses in public elementary schools and secondary schools; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.3958-A bill to require the Interagency Working Group on Toxic Exposure to conduct research on the diagnosis and treatment of health conditions of descendants of individuals exposed to toxic substances while serving as members of the Armed Forces, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate-Veterans’ Affairs

President Biden Delivers State of the Union Address

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

 

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

 

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

 

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

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

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
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

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

 

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

 

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

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

H.R.7535-To require the Comptroller General of the United States to conduct a study and submit a report on price-related compensation and payment structures in the prescription drug supply chain; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce; Ways and Means

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

Congress Extends Government Funding

Congress 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

 

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

 

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

 

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

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

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

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

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Lawmakers return to session this week after congressional leadership on Sunday announced bipartisan agreement on topline spending amounts which provide a path to avoid a January 20 partial government shutdown. House Speaker Mike Johnson (R-La.) communicated the development in a Dear Colleague letter stating “The topline constitutes $1.590 trillion for FY24 – the statutory levels of the Fiscal Responsibility Act. That includes $886 billion for defense and $704 billion for nondefense.” Senate Majority Leader Chuck Schumer (D-N.Y.) and House Minority Leader Hakeem Jeffries (D-N.Y.) released a joint statement on the agreement stating that “The bipartisan topline appropriations agreement clears the way for Congress to act over the next few weeks in order to maintain important funding priorities for the American people and avoid a government shutdown.” Office of Management and Budget Director Shalanda Young characterized the work to pass funding for the Departments of Agriculture, Veterans Affairs, Energy, Agriculture-Food and Drug Administration, Transportation, and Housing and Urban Development ahead of the first government funding deadline on January 20 as “daunting,” with House Speaker Mike Johnson (R-La.) standing by his pledge to not pass another continuing resolution. No decisions have been reached regarding which health care related riders could be attached to the January spending vehicle. A Medicaid disproportionate share hospital cut delay and funding for several programs, including the community health center program, face a January 19 expiration. Other potential policy riders include a partial Medicare physician reimbursement fix, health transparency legislation, pharmacy benefit manager reforms, and site neutrality proposals. Congress has until February 2 to pass the Labor-Health and Human Services funding legislation and the other remaining annual appropriations bills.

 

Senators Comment on Co-pay Assistance Lawsuit

A bipartisan group of 19 senators led by Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) are urging the Biden administration to drop its appeal of a court decision that struck down a regulation allowing insurers to avoid counting manufacturer co-pay assistance toward patients’ maximum out-of-pocket costs and deductibles. Patient advocacy groups, who brought the lawsuit against the U.S. Department of Health and Human Services (HHS), argued that the rule contradicts the statutory definition of cost sharing and would result in increased costs for patients. The lawmakers characterize the court decision as “an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines.” The letter also expresses support for the Help Ensure Lower Patient Copays Act (S. 1375/H.R. 830) that would prohibit the use of copay accumulators.

 

E&C GOP Launches Probe into Internal Scientific Disagreements at FDA

Republicans on the House Energy and Commerce Committee are investigating the handling of internal scientific disagreements related to regulatory decisions at the Food and Drug Administration (FDA). The lawmakers specifically cite the events surrounding the departure of several agency vaccine regulators following updated coronavirus vaccine recommendations in August 2021. Their letter seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials. It requests a written response from the agency by January 24.

 

FDA Approves FL Request to Import Drugs from Canada

The FDA has approved a plan from the state of Florida to allow the importation of prescription drugs from Canada. Before drug importation can commence, the state will first need to submit specific medications for FDA review and approval and ensure the products have been tested for authenticity and safety. In its letter authorizing the proposal, the agency stated that Florida has demonstrated that its plan “will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.” The agency has already denied a citizen petition from PhRMA to block the importation plan. Other states, including Colorado and New Hampshire, along with American Indian tribes have expressed interest in submitting similar applications to the FDA.

 

Congressional Retirements and Resignations

Reps. Doug Lamborn (R-Colo.) and Blaine Luetkemeyer (R-Mo.) each announced last week that they will not be seeking reelection this year. Lamborn has served in Congress since 2006 and is a member of the Armed Services and Natural Resources committees. Luetkemeyer was first elected to the House in 2008. He currently serves on the Financial Services and Small Business committees.

 

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
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

 

Upcoming Congressional Hearings and Markups

 

Senate Homeland Security and Governmental Affairs hearing “Harnessing AI to Improve Government Services and Customer Experience;” 10:00 a.m.; January 10

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Lowering Costs and Increasing Access to Health Care with Employer-Driven Innovation;” 10:15 a.m.; January 11

 

House Veterans’ Affairs Committee oversight hearing “Rural Access: Is VA Meeting All Veterans Where They Live?;” immediately following committee business meeting; 10:15 a.m.; January 11

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

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

 

Ways and Means Chair Comments on NSA Implementation

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

 

Administration Extends IDR Flexibilities Following Portal Reopening

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

 

IRA Medicare Reforms Effective Jan. 1

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

 

Former Texas Congresswoman Eddie Bernice Johnson Dies at 88

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

 

Congressional Retirements and Resignations

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

 

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

 

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 after March 2024)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA
Spanberger (D), VA
Kildee (D), MI
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

House Adjourns for Holiday Recess

House Speaker Mike Johnson (R-La.) sent the House of Representatives home for the holidays last week following the chamber’s passage of the fiscal year 2024 National Defense Authorization Act (H.R. 2670) by a vote of 310-118. The $886 billion defense policy bill was passed over the objection of 73 hardline conservative members of his caucus, who rejected the package negotiated with Democrats, which preserves the Pentagon’s abortion travel policy. The House is scheduled to reconvene on January 9, 10 days before Congress’ first government funding deadline. The Senate has delayed its holiday recess to continue negotiations on aid for Ukraine. Senate Majority Leader Chuck Schumer (D-N.Y.) has stated that the chamber will vote on aid this week whether or not a deal has been reached.

 

House Passes Health Transparency Bill, SUPPORT Act Reauthorization

The House of Representatives passed the Lower Costs, More Transparency Act (H.R. 5378) in a bipartisan 320-71 vote last week. The package is focused on increasing transparency in the hospital, insurer, and pharmacy benefit manager (PBM) industries. It includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Centers Graduate Medical Education program. The Congressional Budget Office estimates that the package would cut $715 million from the deficit over the next decade. The bill’s fate in the Senate remains unclear. The Senate Finance Committee and Senate Health, Education, Labor, and Pensions (HELP) Committee have each advanced their own PBM- related measures out of committee this year.

 

The House also passed the Support for Patients and Communities Reauthorization Act (H.R. 4531) last week in a 386-37 vote. The package would reauthorize the 2018 law’s substance use disorder treatment and recovery support services, prevention programming, and long-term recovery services through fiscal year 2028. The programs expired at the end of September. The Senate HELP Committee advanced its own version of the reauthorization bill (S. 644, as amended) out of committee last week in a 19-1 vote.

 

Democrats Probe Pharmacies Protection of Patient Privacy

Sen. Ron Wyden (D-Ore.), Rep. Pramila Jayapal (D-Wash.), and Rep. Sara Jacobs (D-Calif.) have sent a letter to the U.S. Department of Health and Human Services (HHS) regarding federal health privacy regulations. The lawmakers detail the findings of an oversight inquiry into the privacy practices of pharmacies related to law enforcement demands for patient records which found that none of the eight major pharmacy chains surveyed require a warrant prior to sharing pharmacy records with law enforcement agents. The letter urges HHS to consider further strengthening its HIPAA regulations “to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles.”

 

Carter, Barragan Lead Comments on Co-pay Assistance Lawsuit

Abipartisan group of 48 members of Congress are urging the U.S. Department of Health and Human Services to drop its appeal of a court decision that struck down a regulation allowing insurers to avoid counting manufacturer co- pay assistance toward patients’ maximum out-of-pocket costs and deductibles. Patient advocate groups, who brought the lawsuit against the department, argued that the rule contradicts the statutory definition of cost sharing and would result in increased costs for patients. The letter, led by Reps. Buddy Carter (R-Ga.) and Nanette Barragan (D-Calif.), expresses support for the court decision as “an important step in the right direction for patients who rely on manufacturer copay assistance to alleviate affordability and access challenges for their medicines.”

 

E&C GOP Demands Answers on FDA Foreign Drug Inspection Program

Republican leadership of the House Energy and Commerce Committee are threatening to subpoena Food and Drug Administration (FDA) leadership if they do not cooperate with an investigation into the agency’s inspection of foreign drug facilities. The lawmakers reiterate their concerns, originally shared in a July letter to the agency, about the quality of drugs produced in India and China and the impact of subsequent drug shortages on patients. “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions,” the letter argues. Lawmakers are prepared to issue a subpoena by January 5 should the FDA fail to provide the requested documentation.

 

GAO Details Challenges of NSA Implementation

The Government Accountability Office released a new report last week on the implementation of the No Surprises Act (NSA). The report reviews the more than 490,000 payment disputes initiated between providers and insurers from April 2022 through June 2023, which is nearly 20 times more than regulators’ expectation. While 61% of these disputes remain unresolved, providers have prevailed in 77% of disputes in which a payment determination has been reached. The report attributes the large number of unresolved disputes to the complexity of determining whether disputes are eligible for the independent dispute resolution process.

 

Missouri Implements First PDMP

On December 13th, Missouri launched a statewide prescription drug monitoring program (PDMP) to help pharmacists, doctors, and other health professionals reduce abuse and misuse of Schedule II, III, and IV controlled substances in the state. The Missouri legislature approved the establishment of a statewide PDMP in 2021. For years, Missouri was the only state without a statewide PDMP; instead, the St. Louis County Department of Public Health operated a PDMP that served 75 jurisdictions within the state. The St. Louis PDMP plans to cease operations as a result of the new statewide program.

 

Congressional Retirements and Resignations

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

 

Recently Introduced Health Legislation

S.3458 – A bill to amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Finance

 

S.3462 – A bill to require the Secretary of Health and Human Services to issue draft guidance to address non-addictive analgesics for chronic pain; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6693 – To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6705 – To require the Secretary of Health and Human Services to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, to require certain establishments that perform donor screening or testing to screen or test for active and latent tuberculosis, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Energy and Commerce

 

H.R.6716 – To amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant women, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Oversight and Accountability

 

S.3464 – A bill to support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6731 – To support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes; Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House – Energy and Commerce

 

H.R.6732 – To amend title XI of the Social Security Act to clarify parameters for model testing and add accountability to model expansion under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means; Rules

 

S.Res.496 – A resolution designating September 2023 as “National Cholesterol Education Month” and September 30, 2023, as LDL-C Awareness Day; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Judiciary

 

S.3481 – A bill to amend title XVIII of the Social Security Act to expand and expedite access to cardiac rehabilitation programs and pulmonary rehabilitation programs under the Medicare program, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Finance

 

S.3482 – A bill to establish a multi-stakeholder advisory committee tasked with providing detailed recommendations to address challenges to transmitting geolocation information with calls to the 988 Suicide and Crisis Lifeline, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Commerce, Science, and Transportation

 

S.3490 – A bill to prohibit the Secretary of Veterans Affairs from providing health care to, or engaging in claims processing for health care for, any individual unlawfully present in the United States who is not eligible for health care under the laws administered by the Secretary; Sponsor: Tuberville, Tommy [Sen.-R-AL]; Committees: Senate – Veterans’ Affairs

 

S.3498 – A bill to amend title XVIII of the Social Security Act to provide for coverage of peer support services under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.3501 – A bill to provide greater support for grandfamilies and older caregiver relatives; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.3503 – A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Finance

 

S.3509 – A bill to amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant persons, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance

 

H.R.6742 – To establish a pilot program to provide an add-on payment to certain plans offering benefits designed to address the needs of dual-eligible individuals related to social determinants of health, and to provide administrative flexibility to improve integration for certain dual-eligible individuals; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6743 -To amend the Public Health Service Act to include public awareness about menopause and related chronic conditions, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.6744 – To prohibit the Secretary of Veterans Affairs from providing health care to, or engaging in claims processing for health care for, any individual unlawfully present in the United States who is not eligible for health care under the laws administered by the Secretary; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs

 

H.R.6746 – To amend the Public Health Service Act to provide for a public awareness campaign with respect to iron deficiency; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

H.R.6748 – To amend title XVIII of the Social Security Act to provide for coverage of peer support services under the Medicare program; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6749 – To require the Director of the National Institutes of Health to evaluate the results and status of completed and ongoing research related to menopause, perimenopause, or mid-life women’s health, to conduct and support additional such research, and for other purposes; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.6763 – To establish a multi-stakeholder advisory committee tasked with providing detailed recommendations to address challenges to transmitting geolocation information with calls to the 988 Suicide and Crisis Lifeline, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.6764 – To direct the Secretary of Health and Human Services to modify the HIPAA privacy regulation with respect to the disclosure of certain protected health information; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.6768 – To amend the Public Health Service Act to require the Secretary of Health and Human Services to carry out activities to establish, expand, and sustain a public health nursing workforce, and for other purposes; Sponsor: Stansbury, Melanie Ann [Rep.-D-NM-1]; Committees: House – Energy and Commerce

 

S.Res.507 – A resolution designating September 25, 2023, as “National Ataxia Awareness Day”, and raising awareness of ataxia, ataxia research, and the search for a cure; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.510 – A resolution expressing the sense of the Senate that the scientific judgement of the Food and Drug Administration that mifepristone is safe and effective should be respected, and law and policy governing access to lifesaving, time-sensitive medication abortion care in the United States should be equitable and based on science; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3519 – A bill to direct the Secretary of Health and Human Services to issue guidance on whether hospital emergency departments should implement fentanyl testing as a routine procedure for patients experiencing an overdose, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3525 – A bill to require the Secretary of Health and Human Services to maintain a peer-to-peer support line to provide emotional support, information, brief intervention, and mental health resources to youth who are experiencing stress or who are at risk of, or affected by, mental health disorders, and to establish a grant program for local educational agencies to employ school-based mental health coordinators; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3532 – A bill to amend the Public Health Service Act to provide for the establishment of a Task Force on Youth Mental Health Data Integration; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3545 – A bill to amend the Public Health Service Act with respect to public health data accessibility, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3546 – A bill to require a study on the quality of care difference between mental health and addiction therapy care provided by health care providers of the Department of Veterans Affairs compared to non-Department providers, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Veterans’ Affairs

 

S.3548 – A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3550 – A bill to clarify training requirements for prescribers of controlled substances; Sponsor: Bennet, Michael F. [Sen.- D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3552 – A bill to amend the Taxpayer Certainty and Disaster Tax Relief Act of 2020 to allow qualified tax-exempt organizations to claim the employee retention credit for employers affected by qualified disasters against Medicare hospital insurance taxes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

H.Res.937 – Raising awareness for the sarcoma cancer chordoma; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]; Committees: House – Energy and Commerce

 

H.R.6780 – To amend title XVIII of the Social Security Act to establish a Medically Tailored Home-Delivered Meals Demonstration Program to test a payment and service delivery model under part A of Medicare to improve clinical health outcomes and reduce the rate of readmissions of certain individuals; Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Ways and Means

 

H.R.6790 – To amend the Public Health Service Act with respect to preventing end-stage kidney disease, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6791 – To amend the Digital Equity Act of 2021 to facilitate artificial intelligence literacy opportunities, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.6794 – To amend title XVIII of the Social Security Act to extend the Medicare independence at home medical practice demonstration program; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6800 – To amend title 38, United States Code, to codify the requirements for appointment, qualifications, and pay for therapeutic medical physicists of the Department of Veterans Affairs, and for other purposes; Sponsor: Cherfilus- McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Veterans’ Affairs

 

H.R.6801 – To amend title XVIII of the Social Security Act to ensure that remote physiologic monitoring services are not subject to cost sharing under the Medicare program; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6802 – To improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies; Sponsor: Craig, Angie [Rep.-D-MN-2]; Committees: House – Energy and Commerce

 

H.R.6803 – To provide greater support for grandfamilies and older caregiver relatives; Sponsor: Davis, Danny K. [Rep.-D- IL-7]; Committees: House – Ways and Means; Education and the Workforce; Energy and Commerce; Financial Services

 

H.R.6804 – To amend the Public Health Service Act to establish a grant program to provide self-harm and suicide prevention services in primary care offices, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Energy and Commerce

 

H.R.6807 – To increase funding for cancer research by the National Cancer Institute to be more in proportion to the mortality rates of cancer; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Appropriations; Energy and Commerce

 

H.R.6815 – To require the Nuclear Regulatory Commission to revise its regulations to protect patients from unintended exposure to radiation during nuclear medicine procedures, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R- VA-9]; Committees: House – Energy and Commerce

 

H.R.6829 – To amend the Public Health Service Act to authorize and support the creation and dissemination of cardiomyopathy education, awareness, and risk assessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy, and for other purposes; Sponsor: Pallone, Frank, Jr. [Rep.-D-NJ-6]; Committees: House – Energy and Commerce

 

H.R.6835 – To amend the Older Americans Act of 1965 to establish a grant program for multigenerational activities for long-term care facilities; Sponsor: Strickland, Marilyn [Rep.-D-WA-10]; Committees: House – Education and the Workforce

Health Transparency Bill to be Considered Under Suspension of the Rules

The House of Representatives is scheduled to vote on the Lower Costs, More Transparency Act (H.R. 5378) under suspension of the rules this week. The package is focused on increasing transparency in the hospital, insurer, and pharmacy benefit manager (PBM) industries. It includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Centers Graduate Medical Education Program. Since being pulled from floor consideration earlier this year, the bill now reportedly has the bipartisan support of leadership from both the Energy and Commerce and Education and Workforce committees. The chamber is also scheduled to consider H.R. 4531, the Support for Patients and Communities Reauthorization Act, under suspension of the rules. The bill would reauthorize substance use disorder treatment and recovery support services, prevention programming, and long-term recovery services.

 

Energy and Commerce Advances 19 Health Bills

The House Energy and Commerce Committee advanced a slate of health care related bills last week, including legislation to reform the pharmacy benefit manager (PBM) industry, lower the cost of prescription drugs, and increase stability in the Medicare payment system.

  • H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 was passed by a vote of 48-0.
  • H.R. 2880, Protecting Patients Against PBM Abuses Act, was passed by a vote of 46-0.
  • H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes, was passed by a vote of 44-0.
  • H.R. 5385, Medicare PBM Accountability Act, was passed by a vote of 44-0.
  • H.R. 5386, Cutting Copays Act, was passed by a vote of 41-1.
  • H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program, was passed by a vote of 45-0.
  • H.R. 5389, National Coverage Determination Transparency Act, was passed by a vote of 46-0.
  • H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act, was passed by a vote of 42-0.
  • H.R. 5396, Coverage Determination Clarity Act of 2023, was passed by a vote of 44-0.
  • H.R. 5371, Choices for Increased Mobility Act of 2023, was passed by a vote of 41-0.
  • H.R. 5388, Supporting Innovation for Seniors Act, was passed by a vote of 43-0.
  • H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage, was passed by a vote of 43-0.
  • H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023, was passed by a vote of 44-0.
  • H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023, was passed by a vote of 46-0.
  • H.R. 5555, DMEPOS Relief Act of 2023, was passed by voice vote.
  • H.R. 2365, National Plan to End Parkinson’s Act, was passed by a vote of 47-0.
  • H.R. 6545, Physician Fee Schedule Update and Improvements Act, was passed by a vote of 46-0.
  • H.R. 6364, Medicare Telehealth Privacy Act of 2023, was passed by a vote of 44-0.
  • H.R. 1352, Increasing Access to Biosimilars Act of 2023, was passed by a vote of 44-0.

 

Rep. Murphy Introduces Legislation to Fully Avert Medicare Physician Cut

Abipartisan group of lawmakers led by Rep. Greg Murphy (R-N.C.) introduced legislation last week that would eliminate the impending 3.37% Medicare reimbursement cut for physicians scheduled to go into effect on January 1. Original cosponsors of the Preserving Seniors’ Access to Physicians Act (H.R. 6683) include Reps. Danny Davis (D-Ill.), Brad Wenstrup (R-Ohio), Jimmy Panetta (D-Calif.), Larry Bucshon (R-Ind.), and Michael Burgess (R-Texas). The version of the Physician Fee Schedule Update and Improvements Act (H.R. 6545) advanced by the House Energy and Commerce Committee last week (see above) would increase support for physicians and other practitioners by changing the add-on adjustment from 1.25% to 2.5%, while also extending incentive payments for participating in eligible alternative payment models (APMs), updating the budget neutrality threshold from $20 million to $53 million, and ensuring timely updates to direct costs used to calculate practice expense relative value units.

 

House Passes TRANQ Research Act, VA Home Care Legislation

The House of Representatives passed the Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act (H.R. 1734), as amended by the Senate in June, by voice vote last week. The bill requires the National Institute of Standards and Technology to support research and other activities related to identifying xylazine (a compound used in veterinary medicine as a nonopioid tranquilizer), novel synthetic opioids, and other new psychoactive substances, and will now be sent to President Joe Biden for his signature. The chamber also passed the Elizabeth Dole Home Care Act (H.R. 542) in a 414-5 vote. The bill expands community-based services for aging veterans and aims to improve VA support for veterans and caregivers of all ages.

 

Budget Committee Leaders to Investigate Private Equity Hospital Ownership

Sens. Sheldon Whitehouse (D-R.I.) and Chuck Grassley (R-Iowa) have launched an investigation into the involvement of private equity in the nation’s hospitals. The lawmakers are requesting information from hospital system executives about the impact of their financial arrangements on patients, clinicians, and profits. The probe centers on Lifepoint Health and its owner Apollo Global Management. The lawmakers highlight the significant staffing reductions and substandard health care that has resulted in many hospitals following private equity acquisition. They are requesting details about related-party transactions and the degree to which private equity firms “are calling the shots” at these hospitals.

 

HELP Ranking Member Issues RFI on Gene Therapies

Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) is requesting information from stakeholders on ways to improve and protect access to gene therapies for Americans with ultra-rare diseases. Cassidy intends to use the feedback received to inform future legislation to modernize and improve the market structure for gene therapies to ensure that it supports the continued development of innovative treatments for Americans with ultra-rare diseases. Responses should be submitted to [email protected] by January 22, 2024.

 

FDA Approves Groundbreaking CRISPR Drug for Treatment of Sickle Cell

The Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. The agency approved both Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia, from Bluebird Bio., for the treatment of SCD on Friday. Casgevy is the FDA-approved treatment to use the genome-editing technology CRISPR. Lyfgenia is a cell-based gene therapy which uses a lentiviral vector (gene delivery vehicle) for genetic modification. The treatments are intended for patients with history of SCD related pain crises that can damage organs – a patient population estimated to include 10 to 20 percent of the approximately 100,000 individuals in the U.S. with SCD.

 

DEA Telehealth Regulations Forthcoming

The Drug Enforcement Administration (DEA) will propose new regulations for the prescription of controlled substances via telehealth this month, according to the Biden administration’s updated regulatory agenda. The agency’s COVID-era flexibilities permitting physicians to prescribe controlled substances without an in-person visit were extended through the end of 2024 earlier this year. The extension came in response to a mass of comments expressing concern with the DEA’s prior proposal to reinstate limitations around the remote prescribing of controlled substances and a requirement that an in-person visit occur prior to the prescription of controlled drugs via telehealth. The extra time was intended to give patients and providers time to adapt to the new rules once DEA promulgated a final set of regulations.

 

Congressional Retirements and Resignations

Former House Speaker Kevin McCarthy (R-Calif.) has announced plans to leave Congress later this month. McCarthy has served as a member of Congress since 2007. He was elected House Speaker in January 2023, but was ousted less than 10 months later by hardline conservatives displeased with a government funding deal brokered by McCarthy with the Biden administration and Senate Democrats. His departure from the House of Representatives will narrow the GOP’s majority in the chamber by one more vote least temporarily. California Governor Gavin Newsom’s office has stated that they are awaiting specifics around the timing of McCarthy’s departure to determine the next step toward filling his seat. In announcing his decision to resign, McCarthy stated that his political work was “only getting started” and that he “will continue to recruit our country’s best and brightest to run for elected office.”

 

Rep. Patrick McHenry (R-N.C.) will retire when his current term ends in January 2025. McHenry currently chairs the Financial Services Committee. He rose to prominence during his tenure of House speaker pro tempore following the ousting of former speaker Kevin McCarthy in October. He has served in the House since 2005.

 

Rep. Kathy Manning (D-N.C.) also announced that she will not seek reelection next year. Her decision follows North Carolina’s approval of new congressional maps that would have made winning reelection more difficult. “I won’t file for re-election in the egregiously gerrymandered Congressional districts,” Manning wrote on X, formerly known as Twitter. Manning has served two terms in Congress and currently sits on the Education and Workforce Committee.

 

In related election news, former congressional health policy staffer Kyle Hill announced his campaign for Congress last week. During his time on Capitol Hill in the offices of Reps. Steve Israel (D-N.Y.) and Suzan DelBene (D-Wash.), Hill helped craft the Seniors’ Timely Access to Care Act. He is a former registered dietitian and current volunteer emergency medical technician. He joins incumbent Rep. Nick LaLota (R), James Gaughran (D), Craig Herskowitz (D), Nancy Goroff (D), and Andy DeCecco (D) vying to represent New York’s 1st Congressional District.

 

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


 

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions (HELP) Committee executive session to consider S. 1840, SCREENS for Cancer Act of 2023; S. 3392, Advancing Research in Education Act; S. 3393, SUPPORT for Patients and Communities Reauthorization Act; and S. 644, Modernizing Opioid Treatment Access Act; 10:00 a.m.; December 12

 

House Homeland Security Subcommittee on Cybersecurity and Infrastructure Protection hearing “Considering DHS’ and CISA’s Role in Securing Artificial Intelligence;” 10:00 a.m.; December 12

 

House Veterans’ Affairs Subcommittee on Health hearing “Staff Sergeant Parker Gordon Fox Suicide Prevention Grants: Saving Veterans’ Lives Through Community Connection;” 10:30 a.m.; December 12

 

Senate Special Committee on Aging hearing “Understanding a Growing Crisis: Substance Use Trends Among Older Adults;” 9:30 a.m.; December 14

 

Senate HELP Committee hearing “What is Fueling the Diabetes Epidemic?;” 10:00 a.m.; December 14

 

Recently Introduced Health Legislation

H.Res.904 – Supporting the goals of World AIDS Day. Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Foreign Affairs

 

H.R.6545 – to amend title XVIII of the Social Security Act to make improvements to the physician fee schedule under the Medicare program. Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.483 – A resolution commending the officers of the Commissioned Corps of the United States Public Health Service for 225 years of work protecting, promoting, and advancing the health and safety of the United States; Sponsor: Wyden, Ron [Sen.-D-OR]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.3385 – A bill to prohibit contracting with certain biotechnology providers; Sponsor: Hagerty, Bill [Sen.-R-TN]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.3387 – A bill to direct the Secretary of Health and Human Services to update and clarify its rule on substances generally recognized as safe and to establish within the Food and Drug Administration the Office of Food Chemical Safety, Dietary Supplements, and Innovation, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3388 – A bill to amend the Public Health Service Act to authorize grants to States, Indian Tribes, Tribal organizations, and political subdivisions thereof to hire, employ, train, and dispatch mental health professionals to respond in lieu of law enforcement officers in emergencies involving one or more persons with a mental illness or an intellectual or developmental disability, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3393 – A bill to reauthorize the SUPPORT for Patients and Communities Act, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6571 – To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

S.3394 – A bill to amend title XVIII of the Social Security Act to expand the eligibility for designation as a rural emergency hospital under the Medicare program; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Finance

 

S.3398 – A bill to amend the Public Health Service Act to establish an Office of Drug Manufacturing; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3403 – A bill to amend title XVIII of the Social Security Act to establish a Medicare payment option for patients and eligible professionals to freely contract, without penalty, for Medicare fee-for-service items and services, while allowing Medicare beneficiaries to use their Medicare benefits; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Finance

 

S.3410 – A bill to prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the nursing home workforce; Sponsor: Fischer, Deb [Sen.-R-NE]; Committees: Senate – Finance

 

S.3411 – A bill to prohibit contracting with certain biotechnology providers; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

 

H.R.6590 – To improve access to the Program of All-Inclusive Care for the Elderly, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6596 – To end the epidemic of gun violence and build safer communities by strengthening Federal firearms laws and supporting gun violence research, intervention, and prevention initiatives; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.- D-GA-4]; Committees: House – Judiciary; Ways and Means; Energy and Commerce

 

H.R.6600 – To direct the Secretary of Health and Human Services to issue guidance on whether hospital emergency departments should implement fentanyl testing as a routine procedure for patients experiencing an overdose, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.6607 – To amend the Public Health Service Act to establish an Office of Drug Manufacturing; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

S.3424 – A bill to reauthorize the program for strengthening communities of recovery for individuals with substance use disorders; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6635 – To prohibit the Department of Health and Human Services from treating pregnancy as an illness for purposes of approving abortion drugs; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

H.R.6636 – 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: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

S.3430 – An original bill to amend titles XVIII and XIX of the Social Security Act to expand the mental health care workforce and services, reduce prescription drug costs, and extend certain expiring provisions under Medicare and Medicaid, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

 

S.3437 – A bill to amend the Social Security Act to authorize grants and training to support area agencies on aging and other community-based organizations in addressing social isolation among older individuals and adults with disabilities; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.3444 – A bill to amend the Communications Act of 1934 to improve the accessibility of 9-8-8, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Commerce, Science, and Transportation

 

S.3447 – A bill to reauthorize the program to support residential treatment programs for pregnant and postpartum women, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3449 – A bill to provide low-income individuals with opportunities to enter and follow a career pathway in the health professions, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Finance

 

S.3450 – A bill to amend title XVIII of the Social Security Act to establish a demonstration program to promote collaborative treatment of mental and physical health comorbidities under the Medicare program; Sponsor: Bennet, Michael F. [Sen.-D-CO];Committees: Senate – Finance

 

S.3451 – A bill to amend titles XIX and XXI of the Social Security Act to provide mental health and substance use services to incarcerated individuals, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.3453 – A bill to establish a grant program to facilitate peer-to-peer mental health support programs for secondary school students, and for other purposes; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3454 – A bill to prohibit the use of Federal funds to purchase at-home tests for SARS-CoV-2 from certain foreign entities; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6663 – To amend the SUPPORT for Patients and Communities Act to authorize the use of certain grants to prevent suicide or overdose by children, adolescents, and young adults, and for other purposes; Sponsor: Craig, Angie [Rep.-D- MN-2]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.6664 – To encourage innovation in the development of pediatric drugs, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.6668 – To prohibit the use of Federal funds to purchase at-home tests for SARS-CoV-2 from certain foreign entities; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.6673 – To amend the Controlled Substances Act to provide for a new rule regarding the application of the Act to marijuana, and for other purposes; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Energy and Commerce; Judiciary; Transportation and Infrastructure

 

H.R.6674 – To provide for the periodic issuance of up-to-date clinical guidance on addressing the health effects of per- and polyfluoroalkyl substances (PFAS), and for other purposes; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Energy and Commerce

 

H.R.6675 – To amend titles XIX and XXI of the Social Security Act to provide mental health and substance use services to incarcerated individuals, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce

 

H.R.6683 – To amend title XVIII of the Social Security Act to increase support for physicians and other practitioners in adjusting to Medicare payment changes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means

House to Consider Two Health Bills this Week

The House of Representatives is scheduled to vote on two health care related bills this week. The Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act (H.R. 1734), as amended by the Senate in June, would require the National Institute of Standards and Technology to support research and other activities related to identifying xylazine (a compound used in veterinary medicine as a nonopioid tranquilizer), novel synthetic opioids, and other new psychoactive substances. The Elizabeth Dole Home Care Act (H.R. 542) would expand community-based services for aging veterans and aims to improve VA support for veterans and caregivers of all ages. Both pieces of legislation are scheduled to be considered under suspension of the rules.

 

White House Announces New Steps to Strengthen Medical Supply Chains

President Joe Biden announced nearly 30 new actions to strengthen the nation’s critical supply chains last week, including the establishment of a White House Council on Supply Chain Resilience. As a part of this effort the President will issue a Presidential Determination broadening the U.S. Department of Health and Human Services’ (HHS) authorities under Title III of the Defense Production Act to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other inputs essential to the national defense. HHS will also designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product supply chains, and to address related shortages.

 

FDA Chief Scientist to Succeed Woodcock at FDA

Namandjé N. Bumpus has been appointed to replace Janet Woodcock as principal deputy commission of the Food and Drug Administration (FDA) when Woodcock retires next year. Bumpus has served as chief scientist of the FDA since June 2022. During her tenure, she has played a key role in the agency’s decision to remove Makena, a medication for preventing premature birth, from the market due to safety concerns, as well as in the agency’s proposal to ban formaldehyde and formaldehyde-releasing chemicals in hair- straightening products marketed in the U.S. Prior to joining the FDA, Bumpus served as Professor and Chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. Her research career focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology. Bumpus will be the first Black woman to serve as principal deputy commissioner at the FDA.

 

Warren, Blumenthal Probe Private Equity-Backed Anesthesia Practice

Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) have sent a letter to U.S. Anesthesia Partners (USAP) raising concerns about reports that USAP is engaging in anticompetitive practices that are reducing patients’ quality of care, increasing prices, and suppressing worker wages. The letter cites an investigation by The Washington Post which found that the private equity (PE) backers of USAP have engaged in a series of small acquisitions to consolidate market power and then use “anticompetitive tactics to maintain its advantage – including restrictive non-compete agreements to prevent physicians from working for other practices in the area, cutting off choices for patients.” The lawmakers assert that USAP “is emblematic of the long-standing problems associated with PE’s involvement in our health care system,” and request a response from USAP by December 11.

 

Fauci to Appear Before Congressional Coronavirus Panel

Former White House medical adviser Anthony Fauci has agreed to testify before the House Select Subcommittee on the Coronavirus Pandemic in January regarding his role in the nation’s response to the COVID-19 pandemic. Fauci will be interviewed by the panel January 8-9 for seven hours per day. “Dr. Fauci was the face of America’s public health response during the COVID-19 pandemic, and his testimony will serve as a crucial component of the Select Subcommittee’s investigations into the origin of COVID-19, coercive mandates, gain-of-function type research, scientific censorship, and more,” Subcommittee Chairman Brad Wenstrup (R-Ohio) said in a statement.

 

George Santos Expelled from the House

The House of Representatives voted to expel Rep. George Santos (R-N.Y.) last week in a 311-114 vote, with nearly half of the chamber’s GOP members supporting his expulsion. Santos becomes only the sixth House lawmaker to be expelled in U.S. history, and the first since former Rep. Jim Traficant (D-OH) was expelled in 2002 following a conviction on federal corruption charges. The Santos decision followed a House Ethics Committee investigation into the lawmaker which found substantial evidence that Santos violated federal criminal laws. Republicans can now only afford to lose three members on party-line votes due to their slim majority. New York Governor Kathy Hochul (D) will call a special election to fill Santos’ seat within the next three months, with party committees nominating candidates to fill the vacancy. Former Rep. Tom Suozzi is one of several Democrats who have declared their intention to run for the seat in the regular 2024 election.

 

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


 

Upcoming Congressional Hearings and Markups

Senate Finance Committee hearing “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective;” 10:00 a.m.; December 5

 

House Energy and Commerce Committee markup of 44 pieces of legislation; December 5

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation hearing “White House Policy on AI;” 2:00 p.m.; December 6

 

House Veterans’ Affairs Subcommittee on Health hearing “Staff Sergeant Parker Gordon (SSG) Fox Suicide Prevention Grants: Saving Veterans’ Lives Through Community Connection;” 10:30 a.m.; December 12

 

Recently Introduced Health Legislation

S.Res.474 – A resolution designating November 2023 as American Diabetes Month; Sponsor: Shaheen, Jeanne [Sen.-D- NH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.478 – A resolution designating November 2023 as “National Hospice and Palliative Care Month”; Sponsor: Rosen, Jacky [Sen.-D-NV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.6483 – To amend the Public Health Service Act to require greater transparency and accountability within the grant- making process of the National Institutes of Health; Sponsor: Huizenga, Bill [Rep.-R-MI-4]; Committees: House – Energy and Commerce

 

H.R.6484 – To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth; Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Energy and Commerce

 

H.R.6487 – 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: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means.

 

H.R.6490 – To amend title XVIII of the Social Security Act to limit the penalty for late enrollment under part B of the Medicare Program to 15 percent and twice the period of no enrollment, and to exclude periods of COBRA, retiree, and VA coverage from such late enrollment penalty; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.480 – A resolution recognizing November 2023 as “National Family Caregivers Month”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.481 – A resolution expressing support for the goals of Stomach Cancer Awareness Month; Sponsor: Young, Todd [Sen.-R-IN]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.482 – A resolution commemorating and supporting the goals of World AIDS Day; Sponsor: Booker, Cory A. [Sen.- D-NJ]; Committees: Senate – Foreign Relations

 

S.3364 – A bill to amend the SUPPORT for Patients and Communities Act to authorize the use of certain grants to prevent suicide or overdose by children, adolescents, and young adults, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3370 – A bill to reauthorize the program on prenatal and postnatal health of the Centers for Disease Control and Prevention; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3374 – A bill to waive General Schedule qualification standards related to work experience for nurses at military medical treatment facilities, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.3383 – A bill to reform the Centers for Disease Control and Prevention, limit the scope of public health authorities, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.897 – Expressing support for the goals of November National Lung Cancer Awareness Month and for the early detection and treatment of lung cancer; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Energy and Commerce

 

H.Res.898 – Recognizing November 2023 as “National Family Caregivers Month”; Sponsor: Evans, Dwight [Rep.-D- PA-3]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.Res.899 – Recognizing the Suicide Awareness and Remembrance Flag; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.6519 – To amend the Federal Food, Drug, and Cosmetic Act to ban the use of intentionally added perfluoroalkyl or polyfluoroalkyl substances in cosmetics, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.6533 – To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for urban Indian organizations, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

 

H.R.6534 – To establish a home-based telemental health care demonstration program for purposes of increasing mental health and substance use services in rural medically underserved populations and for individuals in farming, fishing, and forestry occupations; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Energy and Commerce

 

H.R.6537 – To waive General Schedule qualification standards related to work experience for nurses at military medical treatment facilities, and for other purposes; Sponsor: Strickland, Marilyn [Rep.-D-WA-10]; Committees: House – Armed Services

Arrington, Burgess Question CBO About Drug Development Analysis

House Budget Committee Chairman Jodey Arrington (R-Texas) and Budget Committee Health Care Task Force Chair Michael Burgess (R-Texas) have sent a letter to the Congressional Budget Office (CBO) regarding CBO’s process for analyzing the impact of policy proposals on U.S. drug development. The lawmakers specifically inquire about CBO’s review of the drug pricing provisions contained in last year’s Inflation Reduction Act (IRA). The letter points out that while CBO’s analysis suggested that the IRA would result in a total of 13 fewer drugs coming to market over the next 30 years, independent assessments and related studies have suggested that number is significantly higher. “With the growing impact of health spending on the federal budget, we appreciate that CBO recognizes the power of innovation to reduce health care costs,” the letter states. “Accordingly, it is increasingly important that CBO’s analysis of policies that impact drug development in the U.S is incorporating the latest and most accurate information to ensure policymakers are fully aware of the impact legislation will have on patient access to new drugs.”

 

Oversight Panel to Probe FTC’s Handling of Amgen Merger

House Oversight Committee Chairman James Comer (R-Ky.) has launched an investigation into the Federal Trade Commission’s (FTC) protection of confidential corporate information. Comer highlighted the FTC’s apparent misuse of confidential information in the premerger process of Amgen’s merger with Horizon Therapeutics. “Left unaddressed, these actions could have a chilling effect on the willingness of companies to engage the Commission in non-adversarial reviews of proposed mergers thereby creating more resource- intensive litigation paid for by taxpayers,” Comer states.

 

AHA Urges CMS to Address MA Plan Violations

The American Hospital Association has sent a letter to the Centers for Medicare and Medicaid Services (CMS) expressing concerns about Medicare Advantage organizations’ (MAO) compliance with Medicare Advantage (MA) coverage regulations. The letter provides examples of plan practices that circumvent the requirements detailed in the calendar year 2024 MA final rule and expresses concerns that these practices “will result in the maintenance of the status quo where MAOs apply their own coverage criteria that is more restrictive than Traditional Medicare proliferating the very behavior that CMS sought to address in the final rule, resulting in inappropriate denials of medically necessary care and disparities in coverage between beneficiaries in MA and those in the Traditional Medicare program.” AHA urges CMS to:

  • Clarify that coverage criteria for inpatient admissions are fully established under Traditional Medicare;
  • Clarify that the flexibility for MA plans to supplement Traditional Medicare rules with additional internal coverage criteria is not applicable for medical necessity reviews of inpatient admissions and level of care decisions and should only be used in certain limited circumstances;
  • Reinforce expectations to MAOs and confirm MAO compliance with public accessibility and evidentiary standards for internal coverage criteria; and
  • Take swift action to correct MA plan policies that do not comply with CMS rules.

 

Congress Retirements and Resignations

Several more lawmakers have added their names to the group of individuals who will not be returning to their elected positions next Congress:

  • Rep. Tony Cardenas (D-Calif.) will retire from Congress at the end of his current term. Cardenas was first elected to the House of Representatives in 2012, and currently serves as a member of the Energy and Commerce Committee.
  • Rep. Anna Eshoo (D-Calif.) also announced plans to retire. Eshoo currently serves as the top Democrat on the Energy and Commerce Subcommittee on Health. During her more than three decades in Congress, Eshoo has played a key role in the development of health care policy. She sponsored the bills that led to the creation of the Biomedical Advanced Research and Development Authority and the Advanced Research Projects Agency for Health. She was also a champion of the original Pandemic and All Hazards Preparedness Act.
  • Rep. Bill Johnson (R-Ohio) will not seek reelection in 2024. He announced last week that he has accepted an offer to become the new president of Youngstown State University. He will continue serving in the House “for several more months.” Johnson is a member of the Energy and Commerce Committee.
  • Rep. Dean Phillips (D-Minn.) will not seek reelection to Congress amidst his 2024 presidential campaign. Phillips was first elected to Congress in 2018 and is a member of the House Problem Solvers Caucus. He has pitched himself as a younger alternative to President Joe Biden in his presidential primary challenge.

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

 

Upcoming Congressional Hearings and Markups

Senate Judiciary Committee hearing “The Gun Violence Epidemic: A Public Health Crisis;” 10:00 a.m.; November 28

 

House Energy and Commerce Subcommittee on Health hearing “Understanding How AI is Changing Health Care;” 10:30 a.m.; November 29

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season;” 10:00 a.m.; November 30

 

Recently Introduced Health Legislation

H.Res.874 – Expressing support for the designation of “Prematurity Awareness Month”. Sponsor: McClellan, Jennifer L. [Rep.-D-VA-4]; Committees: House – Energy and Commerce

 

H.Con.Res.77 – Expressing support for the designation of the week of November 13 through November 19, 2023, as “National Caregiving Youth Week” to raise awareness and encourage national recognition of children and adolescents under 18 years of age who serve as a primary or secondary caregiver for family or household members. Sponsor: Frankel, Lois [Rep.-D-FL-22]; Committees: House – Education and the Workforce

 

H.R.6445 – To amend title XVIII of the Social Security Act to improve coverage of audiology services under the Medicare program, and for other purposes. Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6451 – To amend the Public Health Service Act to authorize grants to States, Indian Tribes, Tribal organizations, and political subdivisions thereof to hire, employ, train, and dispatch mental health professionals to respond in lieu of law enforcement officers in emergencies involving one or more persons with a mental illness or an intellectual or developmental disability, and for other purposes. Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Judiciary

 

H.Con.Res.78 – Expressing the sense of Congress that public health professionals should be commended for their dedication and service to the United States on Public Health Thank You Day, November 20, 2023; Sponsor: Wittman, Robert J. [Rep.-R-VA-1]; Committees: House – Energy and Commerce

 

H.R.6459 -To amend title XI of the Social Security Act to limit demonstration projects related to abortion under Medicaid and CHIP; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce

 

H.R.6460 – To prohibit the Secretary of Health and Human Services from issuing, finalizing, implementing, or enforcing any rule or guidance to facilitate abortions or access to abortions for an unaccompanied alien child; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Judiciary

 

H.R.6461 – To ensure that claims for benefits under the Black Lung Benefits Act are processed in a fair and timely manner, to better protect miners from pneumoconiosis (commonly known as “black lung disease”), and for other purposes; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Education and the Workforce; Ways and Means

 

H.R.6465 – To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6475 – To provide for the designation of areas as Health Disparity Zones to reduce health disparities and improve health outcomes in such areas, and for other purposes; Sponsor: Thanedar, Shri [Rep.-D-MI-13]; Committees: House – Energy and Commerce; Ways and Means

Congress Extends Government Funding Through Early 2024

Congress passed a stopgap spending measure (H.R. 6363) last week that funds some parts of the federal government through January 19 and others through February 2. The “two-step” continuing resolution (CR) was passed by the House of Representatives on Tuesday, with 209 Democrats joining 127 Republicans voting in support of the measure. The temporary funding bill was then approved by the Senate on Wednesday in an 87-11 vote. President Joe Biden signed the agreement into law on Thursday, less than a day before existing funding was set to expire. The package extends appropriations for Military Construction-Veterans Affairs (VA), Transportation-Housing and Urban Development (HUD), Agriculture-Rural Development-Food and Drug Administration (FDA), and Energy-Water Development through January 19, while funding for the remaining eight appropriations measures, including the U.S. Department of Health and Human Services, extends through February 2. Congress faces an effective April 30 deadline to pass fiscal year 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% cut should a CR still be in place past that date. Speaker Johnson stated last week that it would be the last time he supports a short-term government funding measure.

 

The CR was passed as further progress on FY 2024 appropriations bills has stalled. House leadership postponed a vote on their Labor-Health and Human Services-Education spending bill (H.R. 5894) last week after failing to secure enough support for its passage. The bill includes steep funding cuts for domestic agencies, including the National Institutes of Health (NIH). The chamber has also failed to move the Agriculture-FDA, Financial Services, and Transportation- HUD spending bills. The Senate has passed only three of the 12 annual appropriations bills, covering Agriculture-FDA, Military Construction-VA, and Transportation-HUD. The Senate is scheduled to return from Thanksgiving break on November 27, and the House is expected to reconvene on November 28.

 

E&C Health Panel Advances 21 Bills

The House Energy and Commerce Subcommittee on Health advanced 21 bills last week. The bills under consideration were focused on lowering prescription drug costs, improving the Medicare program’s coverage process, and addressing laboratory and physician reimbursement issues. The following legislation was approved by voice vote:

  • H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
  • H.R. 2880, Protecting Patients Against PBM Abuses Act
  • H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and
  • quality under Medicare part D, and for other purposes
  • H.R. 5385, Medicare PBM Accountability Act
  • H.R. 5386, Cutting Copays Act
  • H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program.
  • H.R. 5389, National Coverage Determination Transparency Act
  • H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
  • H.R. 5396, Coverage Determination Clarity Act of 2023
  • H.R. 5371, Choices for Increased Mobility Act of 2023
  • H.R. 5388, Supporting Innovation for Seniors Act
  • H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
  • H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
  • H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
  • H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program
  • H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
  • H.R. 6371, Provider Reimbursement Stability Act of 2023
  • H.R. 6364, Medicare Telehealth Privacy Act of 2023
  • H.R. 1352, Increasing Access to Biosimilars Act of 2023
  • H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act, was advanced 21-6. Several Democrats, including full Committee Ranking Member Frank Pallone (D-N.J.), expressed concerns that the proposal could undermine the Centers for Medicare and Medicaid Services’ process for determining whether a medical product is reasonable and necessary. Democrats also opposed the H.R. 5555, the DMEPOS Relief Act, which advanced 16-12. The bill would maintain the enhanced reimbursement rates for durable medical equipment instituted in response to the COVID-19 pandemic. Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) stated her intention to finalize offsets for the bills and technical assistance from federal agencies before full committee markup.

 

Warnock, Kennedy Report on Insulin Deserts

Sens. Raphael Warnock (D-Ga.) and John Kennedy (R-La.) released a report last week on the urgency of lowering the cost of insulin for all patients across the nation. The lawmakers have proposed to limit the out-of-pocket cost of insulin to $35 a month in the private insurance market and for the uninsured, similar to the insulin out-of-pocket cap for Medicare beneficiaries included in last year’s Inflation Reduction Act. The Congressional Budget Office estimates that the private insurance portion of the bill (S. 954) would cost $629 million over the next decade. The lawmakers point out that this price tag is significantly less than the $410 billion annual cost of diabetes. Warnock is pushing for a vote on the legislation by the end of the year.

 

Bipartisan Group Investigates Health Risks of Meta Platforms

Sens. Elizabeth Warren (D-Mass.), Richard Blumenthal (D-Conn.), Josh Hawley (R-Mo.), Dick Durbin (D-Ill.), and Marsha Blackburn (R-Tenn.) sent a letter to Mark Zuckerberg, CEO of Meta, requesting information related to the mental and physical health risks posed by his company’s products, including Facebook and Instagram. The lawmakers assert that Meta “concealed and misrepresented its extensive knowledge about the threats to young people on its platforms.”

 

Congressional Retirements

Rep. Michael Burgess, MD (R-Texas) announced that he will not seek reelection at the conclusion of his 11th term in Congress next year. Burgess is the second highest ranking Republican on both the House Energy and Commerce Committee and House Rules Committee. He served as the top Republican on the Energy and Commerce Health Subcommittee during both the 115th and 116th Congresses. Burgess also leads the House Budget Committee’s health care task force and is co-chair of the GOP Doctors Caucus. During his time on Capitol Hill, Burgess has focused on health policy issues and has been a champion of Medicare physician payment reform. “It has been the honor of my life to have gone from a small-town doctor delivering babies, with no prior political experience, to elected to represent my friends and neighbors in the United States Congress,” Burgess said in a statement. Several other lawmakers also announced their decisions to leave Congress in recent days:

  • Rep. Abigail Spanberger (D-Va.) is retiring from the House to run for governor of Virginia.
  • Rep. Dan Kildee (D-Mich.) will retire from Congress at the end of his term. Kildee is a member of the House Ways and Means Committee.
  • Rep. George Santos (R-N.Y.) will not seek reelection. The decision follows a recommendation from the House Ethics Committee chairman that Santos be expelled from the House. The panel released the results from an investigation into the lawmaker last week which found substantial evidence that Santos violated federal criminal laws.

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

 

Combined Senate/House 2024 Calendar

The Senate has released a tentative calendar for 2024. The chamber’s schedule includes a two-week Presidents’ Day recess, a two-week recess in late March and early April, another week in late April, two weeks around the Fourth of July, and a five-week August recess, along with an October recess ahead of the 2024 elections. The lame duck session will include two-weeks spent on Capitol Hill in November and another three in December. The combined House and Senate legislative calendar for next year can be found here.

 

Senior FDA Regulator Woodcock to Retire

Janet Woodcock, Principal Deputy Commissioner at the FDA, has announced her plans to retire early next year after nearly four decades at the agency. During her time at the FDA, Woodcock has overseen the approval of numerous critical medical treatments, and played a central role in the government’s pandemic response through her work on COVID-19 therapeutics. Woodcock has also been a strong proponent of reforming the clinical trial system. FDA Commissioner Robert Califf called her “a legend in every sense of the word,” highlighting her “indelible mark” on public health. Woodcock has also been the subject of some controversy in recent years, centering on her role in the opioid epidemic as well her support for the approval of the Alzheimer’s drug Aduhelm and a Duchenne muscular dystrophy drug despite opposition from other agency officials.

 

President Appoints New NCI Director

The White House has appointed W. Kimryn Rathmell, MD, PhD to serve as the next director of the National Cancer Institute. Rathmell succeeds Monica Bertagnolli, who was recently confirmed by the Senate to lead the NIH. Dr. Rathmell is an oncologist and kidney cancer expert who heads the Vanderbilt University Medical Center. She has held key leadership positions at the American Society of Clinical Oncology, the Kidney Cancer Research Foundation, and the American Society for Clinical Investigation.

 

White House Initiative on Women’s Health Research

The White House announced the establishment of an initiative focused on women’s health research last week. The initiative will be led by First Lady Jill Biden, alongside the White House Gender Policy Council, and chaired by Carolyn Mazure, Yale School of Medicine professor of women’s health research, psychiatry, and psychology. It will direct multiple federal agencies to issue recommendations to advance women’s health research within 45 days. The initiative will also engage with the private and philanthropic sectors to identify areas for additional investment.

 

Speaker Johnson Hires New Health Staffer

Drew Keyes has been hired as Senior Policy Advisor for the office of House Speaker Mike Johnson (R-La.). Keyes most recently worked as a senior policy analyst at Paragon Health Institute. Keyes previously served as a professional policy staffer for the Republican Study Committee (RSC), where he was the staff lead for the RSC’s Health Care Task Force. Keyes got his start on Capitol Hill in the offices of Reps. Louie Gohmert (R-Texas) and Tom McClintock (R-Calif.).

 

Recently Introduced Health Legislation

S.3290 – A bill to amend title 38, United States Code, to modify the authority of the Secretary of Veterans Affairs to furnish improvements and structural alterations as part of home health services for disabled veterans; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Veterans’ Affairs

 

H.Res.867 – Expressing support for the designation of November 9, 2023, as “National Microtia and Atresia Awareness Day”; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.6364 – To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6366 – To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6369 – To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6371 – To provide for certain adjustments to the physician fee schedule under the Medicare program; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6373 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies, and for other purposes; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House – Veterans’ Affairs

 

H.R.6374 – To provide for the issuance of a Veterans Health Care Stamp; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Oversight and Accountability; Veterans’ Affairs

 

H.R.6388 – To authorize the Secretary of Health and Human Services, acting through the Administration for Community Living, to carry out a grant program for States to provide telephone reassurance services to certain older adults and to other adults with disabilities, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

S.3297 – A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Finance

 

H.Res.870 – Supporting the goals and ideals of National Rural Health Day; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.6395 – To amend the Energy Act of 2020 to require the Secretary of the Interior to include the Secretary of Health and Human Services in consultations regarding designations of critical minerals, elements, substances, and materials; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Natural Resources

 

H.R.6400 – To amend title XVIII of the Social Security Act to extend eligibility for certain payment increases for biosimilar biological products under the Medicare program; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6403 – To amend the General Education Provisions Act to require the disclosure of student medical and counseling records to parents; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Education and the Workforce

 

H.R.6407 – To amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6412 – To amend title XXVII of the Public Health Service Act to provide certain informational resources related to Down syndrome; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.6415 – To increase access to mental health, substance use, and counseling services for first responders, and for other purposes; Sponsor: Tokuda, Jill N. [Rep.-D-HI-2]; Committees: House – Energy and Commerce; Transportation and Infrastructure

 

S.3304 – A bill to ensure that claims for benefits under the Black Lung Benefits Act are processed in a fair and timely manner, to better protect miners from pneumoconiosis (commonly known as “black lung disease”), and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3307 – A bill to amend title XVIII of the Social Security Act to require the inclusion of certain information in encounter data under Medicare Advantage; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.3311 – A bill to direct the Secretary of Health and Human Services to conduct a demonstration program to test providing preferential treatment under the Medicare, Medicaid, and CHIP programs for certain drugs and biologicals manufactured in the United States; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Finance

 

S.3312 – A bill to provide a framework for artificial intelligence innovation and accountability, and for other purposes; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Commerce, Science, and Transportation

 

S.3326 – A bill to improve access to opioid use disorder treatment services under the Medicare program; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Finance

 

S.3327 – A bill to require the Secretary of Health and Human Services to publish a list of hospitals found to be in noncompliance with the hospital price transparency rule; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3330 – A bill to require the Secretary of Labor to conduct a study on the fiduciary duties of pharmacy benefit managers; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3337 – A bill to establish national data privacy standards in the United States, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Commerce, Science, and Transportation

 

S.Res.470 – A resolution designating November 16th, 2023, as “National Rural Health Day”; Sponsor: Barrasso, John [Sen.-R-WY]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.6424 – To provide additional authorities for the leadership of the United States Agency for International Development in health technology innovation for global health in low-resource settings, and for other purposes; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Foreign Affairs

 

H.R.6428 – To help individuals receiving disability insurance benefits under title II of the Social Security Act obtain rehabilitative services and return to the workforce, and for other purposes; Sponsor: Hill, J. French [Rep.-R-AR-2]; Committees: House – Ways and Means

 

H.R.6430 – To amend title XVIII of the Social Security Act to extend Medicare-dependent hospital and Medicare low- volume hospital payments, and to direct the Comptroller General of the United States to carry out a report on Medicare rural hospital classifications; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means

 

H.R.6433 – To preserve access to emergency medical services; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce; Education and the Workforce