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