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