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

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

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 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

House Speaker Mike Johnson (R-La.) plans to pursue a stopgap spending measure that would fund some parts of the federal government through January 19 and others through February 2. Under this “two-step continuing resolution (CR),” appropriations for Military Construction-Veterans Affairs, Transportation-Housing and Urban Development, Agriculture-Rural Development-Food and Drug Administration, and Energy-Water Development would be extended through January 19, while funding for the remaining eight appropriations measures would face the later deadline. The stopgap would not include any supplemental funding. Johnson is aiming to avoid “the absurd holiday-season omnibus tradition of massive, loaded up spending bills introduced right before the Christmas recess.” His plan, however, was received with some internal criticism, with conservative Rep. Chip Roy (R-Texas) expressing opposition to a clean CR that does not include additional spending cuts and policy riders. The House GOP can only afford four defections on a party-line vote. Lawmakers face a deadline of November 17 to fund the federal government and avoid a government shutdown when the current CR expires.

Senate Confirms Monica Bertagnolli as NIH Director

The Senate confirmed Monica Bertagnolli, M.D. as director of the National Institutes of Health (NIH) in a 62-36 vote last week. Nearly every Democrat joined 13 Republicans in support of her nomination. Sens. Bernie Sanders (I-Vt.) and John Fetterman (D-Pa.) were the only members of the Democratic caucus to vote no, with Fetterman echoing concerns previously voiced by Sanders that Bertagnolli is not “prepared to take on the greed and power of the drug companies.” Bertagnolli becomes the second woman to serve as permanent head of the medical research agency. She replaces principal deputy director Lawrence Tabak, D.D.S. who has worked as NIH acting director since the departure of long-time director Francis Collins, M.D. nearly two years ago. Bertagnolli is an oncologist who most recently served as the director of the National Cancer Institute.

Senate Finance Advances Mental Health, PBMs, Medicare Physician Fee Schedule Relief Extension Package

The Senate Finance Committee unanimously advanced the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act last week. The bill would mitigate the impending Medicare physician fee schedule cut by extending the relief from last year at the 2.5% level, rather than letting it drop to 1.25%. The package would expand eligibility for workforce shortage incentive programs for mental health and substance use disorder clinicians, support the use of licensed clinical social workers in the Medicare program, and require Medicare Advantage plans to have up-to-date and accurate provider directories. Additionally, the draft would mandate that prescription drug plan sponsors with preferred pharmacy networks have a minimum share of in-network pharmacies in underserved areas not tied to a pharmacy benefit manager or the sponsor. The bill also directs the U.S. Department of Health and Human Services to collect data on drug acquisition costs, and would require plans to include certain discount-eligible drugs in their formularies.

Finance Leadership Requests Artificial Intelligence Briefing

Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) have sent a letter to the U.S. Department of Health and Human Services requesting staff briefings to learn more about how the department plans to adapt to the evolving artificial intelligence (AI) landscape. The lawmakers ask about any existing gaps in regulatory authority and about how the Centers for Medicare and Medicaid Services will monitor application of AI in the Medicare, Medicare Advantage, and Medicaid programs. “As agencies, providers, manufacturers, and insurers scale up their adoption of these types of tools across diverse health care settings,” the letter states, “the Senate Finance Committee seeks to strengthen our understanding of the relevant regulatory and statutory landscape, as well as engage on plans for adapting as the technology evolves.”

HELP Chair Continues Push for Reasonable Pricing and Access Standards

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) sent a letter to Ambassador Pamela Hamamoto urging her to push for the inclusion of reasonable pricing and access standards in the new World Health Organization Pandemic Accord. “The U.S. should champion including reasonable pricing and technology sharing requirements into all funding agreements with pharmaceutical companies,” Sanders argues. “That is not just the right thing to do. It is the smart thing to do to protect the American people from viruses that respect no borders.”

Warren Comments on Amgen Acquisition of Horizon Therapeutics

Sen. Elizabeth Warren (D-Mass.) has sent a letter to the Federal Trade Commission (FTC) Chair Lina Khan expressing her disappointment with the agency’s decision to allow Amgen’s acquisition of Horizon Therapeutics to move forward. She expresses concerns about the potential impact of the merger on the price and availability of medicine. The letter urges the FTC to “vigorously challenge consolidation and anticompetitive behavior in the health care industry, consistent with its proposed merger guidelines.”

Congressional Retirements

Sen. Joe Manchin (D-W.Va.) has announced that he will not run for reelection next year. Manchin has served in the Senate since 2010. He currently sits on the Appropriations Committee and the Committee on Veterans’ Affairs. Manchin’s decision complicates Democrats’ hope to hold on to the Senate majority in 2025. Democrats and Democrat- aligned independents currently only hold a 51-seat majority in the chamber, and nearly all competitive seats up for reelection next year are held by Democrats. West Virginia Governor Jim Justice, who switched parties in 2017, and Rep. Alex Mooney (R-W.Va.) are running for the GOP nomination for Manchin’s Senate seat.

In the House, Rep. Brad Wenstrup, D.P.M. (R-Ohio) announced last week that he will be retiring from Congress at the end of next year. Wenstrup has served in Congress since 2013. He currently sits on the House Ways and Means Committee and is chairman of the Select Subcommittee on the Coronavirus Pandemic and co-chair of the GOP Doctors Caucus. Rep. Derek Kilmer (D-Wash.), House Appropriations Committee member, also announced that he will not seek reelection next year. Wenstrup and Kilmer join nearly two dozen other members of Congress who have already announced their plans to retire or seek other offices in 2024. Additionally, Rep. Brian Higgins (D-N.Y.) announced that after serving 19 years in the House, he will resign in February. He serves on the House Ways and Means Committee and Budget Committee. He also co-chairs the Bipartisan Cancer Caucus.

Ways and Means Republicans Criticize NSA Implementation

Republicans on the House Ways and Means Committee have sent a letter to the Biden administration criticizing its implementation of the No Surprises Act (NSA). The letter expresses concerns that some patients still receive a balance bill following the independent dispute resolution (IDR) process, and urges agencies to enforce the patient protections established by the law. But even worse, the letter states, are the “challenges when grouping IDR claims, the growing backlog of cases, and cases in which large health insurers fail to pay medical providers any amount after arbitration combine to place a significant financial burden on medical providers, forcing them to reduce available staff and services for patients.” The lawmakers also highlight the administration’s failure to issue rulemaking on the advanced explanation of benefits provision of the law.

E&C Republicans Probe SAMHSA Expenditures

House Energy and Commerce Committee Republicans have sent a “final notice” to the Substance Abuse and Mental Health Services Administration (SAMHSA) informing Administrator Miriam E. Delphin-Rittmon, Ph.D. that they will issue a subpoena if she fails to provide requested accounting details about how SAMHSA spent COVID-19 related supplemental money and 9-8-8 crisis care funding. The lawmakers are seeking “to get full accountability for SAMHSA funds,” stating that the agency “has repeatedly not provided requested information about expenditures, nor have any legal reasons been provided for not yet providing the requested information and documents.” Dr. Delphin-Rittmon is asked to produce the requested documents by November 27, 2023.

House Releases 2024 Legislative Calendar

House Majority Leader Steve Scalise (R-La.) released the chamber’s schedule for calendar year 2024 last week. The House’s schedule for the second session of the 118th Congress has 113 legislative days. It features similar recesses to prior years, including two weeks in February and the month of August, along with a week off in July for the Republican National Convention. The House plans to recess all October ahead of the 2024 elections and is scheduled to return after Veterans Day for a lame duck session. The Senate has not yet released its 2024 calendar.

House GOP Leadership Update

Rep. Blake Moore (R-Utah) has been elected the new vice chair of the House Republican Conference. He will fill the position formerly held by the new Speaker of the House Mike Johnson (R-La.). Moore was first elected to the House of Representatives in 2020 And currently serves on the Ways and Means and Budget committees. The role of conference vice chair is one of seven elected leadership positions in the House GOP and is responsible for focusing on political messaging.

President Acts to Expand Veterans’ Health Care Coverage

The White House announced several changes that will expand health care coverage for the nation’s veterans. Beginning this month, all living World War II veterans will be able to access health care services, including nursing home care, from the Department of Veterans Affairs at no cost. The administration will also work to accelerate PACT Act enrollment for veterans applying for benefits following exposure to toxic substances in the line of duty.

CMS Issues 2025 MA, Part D Proposed Rule

The Centers for Medicare and Medicaid Services has released its contract year 2025 policy and technical changes to the Medicare Advantage (MA) Plan Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology Standards proposed rule. The regulation proposes new guardrails for plan compensation to agents and brokers to stop anti-competitive steering, and would fix the amount they can be paid per enrollee – regardless of the plan the beneficiary enrolls in – at $642. The current cap is $611. The rule would also prohibit MA plan organizations from contracting with third-party marketers that offer volume-based bonuses for enrollment into certain plans. CMS expresses concerns that such contract terms may interfere with the ability of agents or brokers to assist enrollees in finding the plan that is best suited to their needs. A fact sheet on the proposed rule can be found here.

Upcoming Congressional Hearings and Markups

House Rules Committee meets on H.R. 5894, the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2024; 4:00 p.m.; November 13

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 2:00 p.m.; November 14

Senate Finance Subcommittee on Health Care hearing “Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency;” 2:30 p.m.; November 14

Senate Foreign Relations Committee hearing “U.S. Leadership on Artificial Intelligence in an Era of Strategic Competition;” 10:00 a.m.; November 15

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: System Uptime;” 12:00 p.m.; November 15

Recently Introduced Health Legislation

H.R.6230 – To prohibit group health plans, health insurance issuers, and Federal health care programs from applying prior authorization requirements, utilization management techniques, and medical necessity reviews. Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Energy and Commerce; Oversight and Accountability

H.R.6227 – To amend the Federal Food, Drug, and Cosmetic Act to expand the tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis. Sponsor: Schweikert, David [Rep.-R- AZ-1]; Committees: House – Energy and Commerce

S.3227 – A bill to amend the Internal Revenue Code of 1986 to provide an alternative manner of furnishing certain health insurance coverage statements to individuals; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

H.R.6243 – To direct the Secretary of Labor to issue an occupational safety and health standard that requires employers to keep opioid overdose reversal drugs onsite and develop and implement training plans to respond to drug overdose emergencies and to amend the Omnibus Crime Control and Safe Streets Act of 1968 to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House – Education and the Workforce; Judiciary

H.R.6251 – To establish a grant program to provide schools with opioid overdose reversal drugs, to direct schools receiving Federal funds to report to certain Federal information systems any distribution of an opioid overdose reversal drug, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Education and the Workforce

S.3233 – A bill to amend title XVIII of the Social Security Act to reduce the occurrence of diabetes in Medicare beneficiaries by extending coverage under Medicare for medical nutrition therapy services to such beneficiaries with pre- diabetes or with risk factors for developing type 2 diabetes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Finance

S.3236 – A bill to amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Finance

S.3244 – A bill to amend the Medicare Improvements for Patients and Providers Act of 2008 to extend funding outreach and assistance for low-income programs; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

S.3245 – A bill to amend title XIX of the Social Security Act to require the Secretary of Health and Human Services to conduct surveys of non-retail pharmacy drug prices, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

H.R.6257 – To amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Ways and Means

H.R.6258 – To amend the Child Abuse Prevention and Treatment Act to disqualify any State that discriminates against parents or guardians who oppose medical, surgical, pharmacological, psychological treatment, or clothing and social changes related to affirming the subjective claims of gender identity expressed by any minor if such claimed identity is inconsistent with such minor’s biological sex from receiving funding under such Act; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Education and the Workforce

H.R.6270 – To amend title I of the Patient Protection and Affordable Care Act to authorize the establishment of, and provide support for, State-based universal health care systems that provide comprehensive health benefits to State residents, and for other purposes; Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Oversight and Accountability; Education and the Workforce

H.R.6275 – To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce; Judiciary

H.R.6279 – To amend the Internal Revenue Code of 1986 to allow certain wearable devices to be purchased using health savings accounts and other spending arrangements and reimbursement accounts; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means

S.3254 – A bill 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: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Finance

S.3258 – A bill to amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis, and for other purposes; Sponsor: Coons, Christopher A. [Sen.-D-DE]; Committees: Senate – Finance

S.3259 – A bill to amend the Public Health Service Act to reauthorize and expand technical assistance and support for recovery community organizations and peer support networks, and for other purposes; Sponsor: Collins, Susan M. [Sen.- R-ME]; Committees: Senate – Health, Education, Labor, and Pensions

S.3260 – A bill to direct the Secretary of Health and Human Services to establish a working group to formulate recommendations for standardizing the measurements of loneliness and isolation, and for other purposes; Sponsor: Ricketts, Pete [Sen.-R-NE]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.6283 – To improve services provided by pharmacy benefit managers; Sponsor: Miller-Meeks, Mariannette [Rep.- R-IA-1]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Oversight and Accountability

H.R.6284 – To direct the Secretary of Health and Human Services to establish a working group to formulate recommendations for standardizing the measurements of loneliness and isolation, and for other purposes; Sponsor: Flood, Mike [Rep.-R-NE-1]; Committees: House – Energy and Commerce

H.R.6288 – To amend the Federal Food, Drug, and Cosmetic Act to provide for a Pediatric Brain Tumor Real-World Data Registry Program, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce

H.R.6296 – To provide for an emergency increase in Federal funding to State Medicaid programs for expenditures on home and community-based services; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

H.R.6301 – To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider; Sponsor: Grothman, Glenn [Rep.-R-WI-6]; Committees: House – Education and the Workforce

H.R.6302 – To amend title XXVII of the Public Health Service Act to establish requirements for the disclosure of certain information relating to health care sharing ministries, and for other purposes; Sponsor: Huffman, Jared [Rep.-D-CA-2]; Committees: House – Energy and Commerce

H.R.6305 – To amend title III of the Public Health Service Act to impose a limitation on regulations relating to the control of communicable diseases, and for other purposes; Sponsor: Luna, Anna Paulina [Rep.-R-FL-13]; Committees: House – Energy and Commerce; Rules

H.R.6310 – To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models under the Medicare program; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

H.R.6313 – To amend title XVIII of the Social Security Act to improve the accuracy of geographic adjustment factors under the Medicare program and to permanently extend certain adjustments to such factors for certain localities, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.6315 – To amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to waive the requirement of certain veterans to make copayments for hospital care and medical services in the case of an error by the Department of Veterans Affairs, and for other purposes; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Veterans’ Affairs

S.3282 – A bill to amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to waive the requirement of certain veterans to make copayments for hospital care and medical services in the case of an error by the Department of Veterans Affairs, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Veterans’ Affairs

S.3284 – A bill to amend title 38, United States Code, to modify the limitation on reimbursement for emergency treatment of amounts owed to a third party or for which the veteran is responsible under a health-plan contract; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Veterans’ Affairs

H.Res.860 – Expressing support for raising awareness about the growing population of young adults living with chronic health conditions in the United States; Sponsor: Raskin, Jamie [Rep.-D-MD-8]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.6330 – To direct the Secretary of Veterans Affairs to carry out a pilot program to collect and analyze data regarding suicides and attempted suicides by veterans on the property of the Department of Veterans Affairs, and for other purposes; Sponsor: Crow, Jason [Rep.-D-CO-6]; Committees: House – Veterans’ Affairs

H.R.6331 – To require the Secretary of Veterans Affairs to establish a pilot program to furnish doula services to veterans; Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Veterans’ Affairs

H.R.6333 – To amend title 38, United States Code, to modify the limitation on reimbursement for emergency treatment of amounts owed to a third party or for which the veteran is responsible under a health-plan contract; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Veterans’ Affairs

H.R.6338 – To direct the Secretary of Veterans Affairs to establish a pilot program for gynecologic cancer care coordination at the Department of Veterans Affairs, and for other purposes; Sponsor: Garcia, Sylvia R. [Rep.-D-TX-29]; Committees: House – Veterans’ Affairs

H.R.6340 – To direct the Under Secretary for Health of the Department of Veterans Affairs to provide certain information to Department of Veterans Affairs medical center staff and homelessness service providers regarding the Coordinated Entry program, and for other purposes; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Veterans’ Affairs

H.R.6344 – To amend titles XVIII and XIX of the Social Security Act to require providers of services and health maintenance organizations under the Medicare and Medicaid programs to provide for certain policies to be in place relating to do-not-resuscitate orders or similar physician’s orders for unemancipated minors receiving services; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; Committees: House – Energy and Commerce; Ways and Means

H.R.6347 – To limit cost-sharing for prescription drugs, and for other purposes; Sponsor: Manning, Kathy E. [Rep.-D- NC-6]; Committees: House – Energy and Commerce

H.R.6353 – To direct the Secretary of Veterans Affairs to conduct a review on opioid overdose deaths among veterans, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Veterans’ Affairs

H.R.6360 – To amend title 38, United States Code, to assign the highest priority status for hospital care and medical services provided through the Department of Veterans Affairs to veterans who are former prisoners of war; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Veterans’ Affairs

CMS released the CY 2024 Physician Fee Schedule (PFS) final rule on November 2. According to CMS, the finalized CY 2024 PFS conversion factor is $32.74, a decrease of $1.15 or 3.37% relative to CY 2023. Also note that CMS finalized maintaining a Merit-Based Incentive Payment System (MIPS) performance threshold of 75 points for 2024, rather than increasing it to 82 points, as proposed, which would have made it more challenging for physicians to avoid a penalty in 2026.

FY 2024 Appropriations Update

While both the House and Senate are making progress on their respective fiscal year (FY) 2024 spending bills, appropriators have yet to open any bicameral discussions to reconcile the two chambers’ very different approaches to government funding. Congress currently faces a November 17 deadline to avoid a government shutdown. The House of Representatives has passed seven of the 12 annual appropriations measures (Military Construction-Veterans Affairs (VA), Defense, Homeland Security, State-Foreign Operations, Energy-Water, Legislative Branch, Interior-Environment), while the Senate passed the chamber’s first minibus package containing appropriations for Agriculture-Food and Drug Administration, Military Construction-VA, and Transportation-Housing and Urban Development in a bipartisan 82-15 vote last week. The two chambers’ approaches to FY 2024 government funding vary significantly, however, with the House bills containing steeper spending cuts and contentious policy riders.

During his first meeting with Senate Republicans since being elected House Speaker, Mike Johnson (R-La.) argued in support of another continuing resolution (CR) extending government funding through January 15. House Majority Leader Steve Scalise (R-La.) has said that any stop-gap spending bill will contain both spending cuts and policy changes. Congress faces an effective April 30 deadline to pass FY 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.

The House also passed a $14.3 billion Israel aid package in a 226-196 vote last week. Most Democrats opposed the measure, which includes cuts to the Internal Revenue Service, and the White House has already threatened to veto the bill. Senate Majority Leader Chuck Schumer (D-N.Y.) has pledged that the Senate will consider a broader package including emergency spending for Israel, Gaza, and Ukraine. Speaker Johnson stated that the House will vote on aid to Ukraine as soon as this week as a part of a package that also contains border enforcement measures. Sens. Bernie Sanders (I-Vt.), Mazie Hirono (D-Hawaii), Ed Markey (D-Mass.), Jeff Merkley (D-Ore.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.) sent a letter to Senate leadership last week calling for any emergency supplemental appropriations bill for Ukraine, Israel, and Gaza to contain equal funding for “major crises” domestically, including the state of the U.S. primary health care system and the opioid crisis. The White House has requested $106 billion in emergency aid for Ukraine, Israel, and Gaza.

Republican appropriators in the House of Representatives released a revised version of their FY 2024 Labor-Health and Human Services-Education legislation last week. Similar to other spending bills being advanced by the House, the revised HHS appropriations measure includes a number of contentious policy riders, including a provision to prevent any funding from going toward postgraduate physician training programs that mandate abortion training or penalize students who opt out of such training. The bill also includes language to block the declaration of a public health emergency related to gun violence, along with a measure to prevent funding to implement President Joe Biden’s executive order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation. Speaker Johnson plans to bypass a full committee markup and instead bring the bill to the floor for a vote the week of November 13.

Senate Finance to Mark Up Mental Health, PBMs, Medicare Physician Fee Schedule Relief Extension Package This Week

Senate Finance Committee leadership released a bipartisan discussion draft of legislation containing measures related to the pharmacy benefit manager (PBM) industry as well as provisions aimed at increasing access to mental health care. The package would expand eligibility for workforce shortage incentive programs for mental health and substance use disorder clinicians, support the use of licensed clinical social workers in the Medicare program, and require Medicare Advantage plans to have up-to-date and accurate provider directories. Additionally, the draft would add to the Modernizing and Ensuring PBM Accountability Act advanced by the panel in July by mandating that prescription drug plan sponsors with preferred pharmacy networks have a minimum share of in-network pharmacies in underserved areas not tied to a PBM or the sponsor. The bill also directs the U.S. Department of Health and Human Services to collect data on drug acquisition costs, and would require plans to include certain discount-eligible drugs in their formularies. The package also mitigates the impending Medicare physician fee schedule cut by extending the relief from last year at the 2.5% level, rather than letting it drop to 1.25%. The panel plans to markup the package on Wednesday.

Senate to Hold NIH Director Confirmation Vote

The Senate plans to vote early this week on the nomination of Monica Bertagnolli to serve as the next director of the National Institutes of Health. A vote to end debate on the Senate floor is scheduled for Monday, which could set the stage for a final confirmation vote on Tuesday. The Senate Committee on Health, Education, Labor and Pensions advanced her nomination in a bipartisan vote late last month.

Pallone, Neal Push for MA Broker Compensation Oversight

House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) and Ways and Means Committee Ranking Member Richard Neal (D-Mass.) are urging the Centers for Medicare and Medicaid Services (CMS) to increase oversight of broker participation and compensation in the Medicare Advantage (MA) market. The lawmakers raise concerns that misaligned incentives have led to broker and marketing practices that may push seniors away from the insurance plans best suited to their needs. They request that CMS move to require MA plans to report total broker compensation amounts, inclusive of any bonus or incentive payments. They also ask the agency to change the total amount brokers can receive in compensation per enrollee.

Additional GOP Leaders Question Proposed Changes to Nursing Home Standards

Republican leadership of the House Energy and Commerce Committee, House Ways and Means Committee, and Senate Finance Committee have sent a letter to the U.S. Department of Health and Human Services arguing that the administration’s proposed nursing home staffing requirements will jeopardize access to care, particularly for Americans in rural and underserved areas. The new rule from CMS would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers ask that the agency withdraw the rule and work on tailored solutions “addressing the severe health care workforce shortages” across the nation.

Warner, Cassidy Launch Health Care Cybersecurity Working Group

Senate Intelligence Committee Chairman Mark Warner (D-Va.) and Health, Education, Labor and Pensions Ranking Member Bill Cassidy (R-La.) announced the creation of a health care cybersecurity working group last week. The lawmakers, joined by Sens. John Cornyn (R-Texas) and Maggie Hassan (D-N.H.), plan to examine proposals to address the cybersecurity of the nation’s health care system. Sen. Warner released a report last year entitled Cybersecurity is Patient Safety which considered the establishment of minimum cyber hygiene practices for health care organizations.

COVID Panel Probes Global Biosafety Standards, Pandemic Origins

Reps. Brad Wenstrup (R-Ohio) and Raul Ruiz (D-Calif.) have sent a letter to the Government Accountability Office requesting a report on G-20 member nations’ biosafety and biosecurity standards. The Select Subcommittee on the Coronavirus Pandemic leadership ask for a comprehensive assessment of how the current biosafety and biosecurity standards of the foreign nations compare to those existing in the United States. “As we saw during the COVID-19 pandemic, biosafety and biosecurity issues have the potential to affect the international community,” the letter states. “While the United States evaluates its own biosafety and biosecurity standards, precautions taken by other nations remain highly relevant to the Select Subcommittee’s work.”

Chair Wenstrup, along with House Oversight and Accountability Chairman James Comer (R-Ky.) and Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.), also informed the U.S. Department of Health and Human Services of their decision to subpoena Assistant Secretary for Legislation Melanie Egorin last week. The committee leaders argue that she has spent months evading lawmakers’ questions related to the origins of COVID-19. Egorin must now testify at a deposition on November 16.

President Issues AI Executive Order

President Joe Biden issued an executive order on artificial intelligence last week. The move charges the National Institute of Standards and Technology with the creation of standards to ensure that AI tools are safe and effective, and will require AI developers to share safety test results and other information with the federal government. Additionally, the order directs the U.S. Department of Health and Human Services to establish a safety program to address harms or unsafe health care practices involving AI. Measures laid out by the order are set to be implemented over the next year.

Bipartisan Veterans Task Force Recommends Improvements for Women’s Care

Abipartisan congressional Women Veteran Task Force submitted a report to the House Committee on Veterans’ Affairs last week making recommendations on issues that uniquely affect women veterans. The Task Force recommends more gender specific training for practitioners administering VA disability exams. The report also highlights the potential need to develop national or regional gender-specific cancer support programs, and suggests that the VA consider updating their guidelines for screening women who have heterogeneous dense breasts.

Upcoming Congressional Hearings and Markups

Senate Finance Committee markup of discussion draft of mental health/PBM package; time TBA; November 8

Senate Appropriations Committee hearing “A Review of the President’s Supplemental Request for the Departments of Health and Human Services and Homeland Security;” 9:00 a.m.; November 8

Senate Homeland Security and Governmental Affairs Committee hearing “The Philosophy of AI: Learning from History and Shaping Our Future;” 9:30 a.m.; November 8

Senate Judiciary Subcommittee on Intellectual Property hearing “Reforming the Patent Trial and Appeal Board – The PREVAIL Act and Proposals to Promote U.S. Innovation Leadership;” 2:30 p.m.; November 8

Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Retirement Security hearing “Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care;” 2:30 p.m.; November 8

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 2:00 p.m.; November 14

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: System Uptime;” 12:00 p.m.; November 15

Recently Introduced Health Legislation

S.3162 – A bill to improve the requirement for the Director of the National Institute of Standards and Technology to establish testbeds to support the development and testing of trustworthy artificial intelligence systems and to improve interagency coordination in development of such testbeds, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Commerce, Science, and Transportation

S.3165 – A bill to help persons in the United States experiencing homelessness and significant behavioral health issues, including substance use disorder, by authorizing a grant program within the Department of Health and Human Services to assist State and local governments, continuums of care, community-based organizations that administer both health and homelessness services, and providers of services to people experiencing homelessness, better coordinate health care and homelessness services, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3167 – A bill to amend the Employee Retirement Income Security Act of 1974 to clarify the treatment of certain association health plans as employers, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.6122 – To require the Secretary of Health and Human Services and the Secretary of Labor to conduct a study and issue a report on grant programs to support the nursing workforce; Sponsor: Nunn, Zachary [Rep.-R-IA-3]; Committees: House – Energy and Commerce; Education and the Workforce

S.3171 – A bill to amend the Public Health Service Act to promote healthy eating and physical activity among children; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

S.3172 – A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products and foods for special dietary uses as qualified medical expenses; Sponsor: Cramer, Kevin [Sen.-R-ND]; Committees: Senate – Finance

S.3175 – A bill to establish a grant program to support schools of medicine and schools of osteopathic medicine in underserved areas; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3193 – A bill to amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Health, Education, Labor, and Pensions

S.3196 – A bill to amend title XIX of the Social Security Act to provide a State option to extend Medicaid coverage for foster care children while receiving treatment from a qualified residential treatment program; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

H.R.6144 – To amend the Omnibus Crime Control and Safe Streets Act of 1968 to authorize grant programs to combat fentanyl poisonings; Sponsor: Garcia, Mike [Rep.-R-CA-27]; Committees: House – Judiciary

H.R.6160 – To amend the Public Health Service Act to reauthorize a lifespan respite care program; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

H.R.6161 – To amend the Internal Revenue Code of 1986 to allow amounts paid for over-the-counter naloxone to be taken into account in determining the deduction for medical expenses; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Ways and Means

H.R.6168 – To amend the Violent Crime Control and Law Enforcement Act of 1994 to ensure that healthcare providers can assist survivors of domestic violence, and for other purposes; Sponsor: Sykes, Emilia Strong [Rep.-D-OH-13]; Committees: House – Judiciary

S.3200 – A bill to reauthorize the loan repayment program for the substance use disorder treatment workforce; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

S.3202 – A bill to amend the Internal Revenue Code of 1986 to provide an alternative manner of furnishing certain health insurance coverage statements to individuals; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

S.3204 – A bill to amend Internal Revenue Code of 1986 to streamline and improve the employer reporting process relating to health insurance coverage and to protect dependent privacy; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

S.3206 – A bill to provide for a study on the accessibility of substance use disorder treatment and mental health care providers and services for farmers and ranchers, and for other purposes; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

S.3211 – A bill to enhance our Nation’s nurse and physician workforce by recapturing unused immigrant visas; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Judiciary

S.3215 – A bill to conduct or support further comprehensive research for the creation of a universal influenza vaccine or preventative; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.3219 – A bill to protect against seasonal and pandemic influenza, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

S.3220 – A bill to expand the tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Health, Education, Labor, and Pensions

S.3224 – A bill to codify Internal Revenue Service guidance relating to treatment of certain services and items for chronic conditions as meeting the preventive care deductible safe harbor for purposes of high deductible health plans in connection with health savings accounts; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

H.R.6171 – To amend the Internal Revenue Code of 1986 to provide a refundable credit to individuals who donate certain life-saving organs; Sponsor: Wilson, Joe [Rep.-R-SC-2]; Committees: House – Ways and Means; Energy and Commerce

H.R.6176 – To prohibit Federal funding of Planned Parenthood Federation of America; Sponsor: Aderholt, Robert B. [Rep.-R-AL-4]; Committees: House – Energy and Commerce

H.R.6177 – To prohibit Federal funding for researchers who have conducted a study or experiment relating to gender identity, and for other purposes; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Natural Resources

H.R.6184 – To conduct or support further comprehensive research for the creation of a universal influenza vaccine or preventative; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

H.R.6204 – To provide for a grant program to support access to free eye care services for students attending public elementary schools and secondary schools; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.6205 – To enhance our Nation’s nurse and physician workforce by recapturing unused immigrant visas; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Judiciary

Republicans in the House of Representatives elected Rep. Mike Johnson (R-La.) to serve as the next Speaker of the House on Wednesday, ending a three-week impasse that stalled all legislative work in the chamber. Johnson was first elected to the House in 2016, having previously worked as a senior counsel for the Alliance Defending Freedom and as a former state legislator. The Alliance Defending Freedom was involved in the recent legal case that overturned Roe v. Wade, and is now leading the push to restrict access to abortion medication. Johnson himself has sponsored a bill that would ban all abortions past 15 weeks, and has signed on as a cosponsor of legislation to codify the Hyde amendment which prohibits the use of federal funds to pay for abortion, except to save the life of the mother, or if the pregnancy is the result of incest or rape. Johnson previously served as chair of the conservative Republican Study Committee. During this time, he backed a budget proposal to raise the Medicare eligibility age to 67 and to endorse site neutral payments in the Medicare program. In 2019, he led an effort to replace Obamacare with high-risk pools, to roll back Medicaid expansion in favor of per-capita caps on the program, and to expand the use of health savings accounts. Johnson is a longstanding opponent of gender affirming care for children, and has been critical of the Centers for Disease Control and Prevention’s handing of the COVID-19 pandemic. Johnson was one of former President Donald Trump’s top allies on the Hill during his efforts to overturn Joe Biden’s 2020 presidential election victory.

The new Speaker is a strong advocate of cutting government spending. While he voted against the most recent continuing resolution (CR), Johnson has indicated that he is open to the next stopgap spending bill extending government funding for as long as five months. Johnson plans to pursue votes on eight spending bills ahead of the November 17 deadline to fund the federal government. If a CR is needed, Johnson has stated his intent to propose one that expires on January 15 or April 15 “to ensure the Senate cannot jam the House with a Christmas omnibus.”

Congress faces an effective April 30 deadline to pass fiscal year (FY) 2024 funding, 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. The House successfully passed its Energy-Water spending bill (H.R. 4394) by a 210-199 vote last week. The House is expected to vote on Legislative Branch, Interior-Environment, and Transportation-Housing and Urban Development (HUD) appropriations the week of October 30; Financial Services and Commerce-Justice-Science the week of November 6; and Labor-Health and Human Services (HHS)-Education and Agriculture-Food and Drug Administration (FDA) the week of November 13. This plan would involve skipping committee markup of the Commerce-Justice-Science and Labor-HHS-Education bills and bringing them straight to the floor. Johnson’s plans also involve the establishment of a working group to negotiate the Agriculture-FDA bill, which was pulled from floor consideration earlier this year due to Republican in-fighting over total spending levels and a restriction that would prevent the abortion medication mifepristone from being dispensed via the mail.

Senate appropriators have marked up all 12 of their annual spending bills with bipartisan support, and aim to pass their first three-bill minibus comprised of Agriculture-FDA, Military Construction-Veterans Affairs, and Transportation-HUD measures (H.R. 4366) in the coming days.

HELP Advances NIH Nominee

The Senate Health, Education, Labor and Pensions (HELP) Committee voted to advance the nomination of Dr. Monica Bertagnolli to serve as the Director of the National Institutes of Health (NIH) in a bipartisan 15-6 vote last week. Chairman Bernie Sanders (I-Vt.) voted against the nomination, stating that he was not convinced she is prepared “to take on the greed and power of the drug companies and health care industry.” Earlier in the week, Sanders sent a letter to Christi Grimm, U.S. Department of Health and Human Services Inspector General, asking her office to investigate an exclusive patent license granted by the NIH to for a cervical cancer treatment. “I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders states. He suggests that the NIH should instead offer nonexclusive licenses so that more companies can manufacture the treatment at a lower cost to patients.

Budget Panel Task Force Considers Changes to CBO’s Scoring Methods

The House Budget Committee Health Care Task Force held its inaugural member roundtable last week to discuss the Congressional Budget Office’s (CBO) methods for analyzing policies that impact drug development in the U.S. Participants discussed how the agency developed its estimates of the Inflation Reduction Act’s impact on patient access to cures. The Task Force aims to ensure that CBO’s future analyses capture additional factors and subsequent real-world effects of policies impacting medical innovation across the nation.

House Members Urge Administration to Reconsider Nursing Home Staffing Rule

Agroup of 100 bipartisan members of the House of Representatives are urging the Biden administration to reconsider its proposed nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers, led by Rep. Greg Pence (R-Ind.), assert that the regulation would result in “limited access to care for seniors, mandatory increases in state Medicaid budgets, and could most consequentially lead to widespread nursing home closures.”

Lawmakers Push for Marijuana Descheduling

Abipartisan group of lawmakers have sent a letter urging the Drug Enforcement Administration (DEA) to pursue a full descheduling of marijuana. The policymakers highlight the federal-state policy gap on cannabis faced by medical practices and other stakeholders. “While Congress works to send the President comprehensive cannabis legislation, the urgency of full descheduling should inform DEA’s position on overall cannabis reform and appropriate enforcement centered on advancing public safety, not unjust criminalization,” the letter states. “Marijuana’s continued inappropriate scheduling is both arcane and out-of-touch with the will of the American people.”

Comer Probes FTC Move to Block Illumina’s Acquisition of Grail

House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the Federal Trade Commission (FTC) regarding the agency’s handling of Illumina Inc.’s attempted acquisition of Grail, a cancer test provider. The European Union ordered Illumina to unwind its acquisition of Grail earlier this month, following a similar move by the FTC to block the deal earlier this year. Comer argues that the “collusion” between the FTC and EU deserves further scrutiny, and requests records of communication between the U.S regulatory agency and its European counterparts. “The FTC’s actions set a bad precedent that emboldens foreign governments to attack American businesses,” the letter states. “By deferring to foreign entities’ approaches to certain transactions, the FTC is improperly denying U.S. businesses the due process rights they are entitled to before the FTC and American courts.”

AAP Releases New Medicaid/CHIP Policy Statement

The American Academy of Pediatrics (AAP) released a proposal last week to overhaul how Medicaid and the Children’s Health Insurance Program (CHIP) provide health care for the nation’s children. The recommendations are aimed at providing more consistent and equitable health insurance coverage under the programs across all 50 states. The proposal would combine Medicaid and CHIP into a single program, automatically enrolling all newborns and extending program eligibility to include individuals up to the age of 26, regardless of immigration status. It would also increase the income threshold for eligibility to 400% of the federal poverty level. AAP also suggests “an end to undervalued Medicaid payment, with rates at least comparable to prevailing Medicare rates and that support the full range of services needed to provide comprehensive care to children.”

Recently Introduced Health Legislation

H.Res.806 – Expressing support for the recognition of October 2023, as “World Menopause Awareness Month” and expressing the sense of the House of Representatives regarding global awareness and access to care during the menopausal transition and post-menopause; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]

H.Con.Res.74 – Expressing support for the Geneva Consensus Declaration on Promoting Women’s Health and Strengthening the Family and urging that the United States rejoin this historic declaration; Sponsor: Banks, Jim [Rep.-R- IN-3]

H.R.6020 – To amend the Public Health Service Act to eliminate consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R- CA-23]

H.R.6023 – To amend title 38, United States Code, to provide for the retroactive payment of benefits for veterans with covered mental health conditions based on military sexual trauma, and for other purposes; Sponsor: Carbajal, Salud O. [Rep.-D-CA-24]

H.R.6028 – To amend the Controlled Substances Act regarding marihuana, and for other purposes; Sponsor: Mace, Nancy [Rep.-R-SC-1]

H.R.6029 – To provide Medicaid assistance to individuals and families affected by a disaster or emergency, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]

H.R.6030 – To amend title XVIII of the Social Security Act to provide an option for first responders age 50 to 64 who are separated from service due to retirement or disability to buy into Medicare; Sponsor: Phillips, Dean [Rep.-D-MN-3]

H.R.6033 – To require the Secretary of Health and Human Services to establish a task force to improve access to health care information technology for non-English speakers; Sponsor: Steel, Michelle [Rep.-R-CA-45]

H.R.6038 – To amend the Public Health Service Act to provide for a Reducing Youth Use of E-Cigarettes Initiative; Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]

S.3130 – A bill to amend the Indian Health Care Improvement Act to improve the recruitment and retention of employees in the Indian Health Service, restore accountability in the Indian Health Service, improve health services, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Indian Affairs

S.3131 – A bill to amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

H.Res.813 – Supporting the designation of October 23, 2023, as “AADC Deficiency Awareness Day”; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce

H.R.6040 – To prohibit the use of Federal funds for gender transition in minors; Sponsor: Boebert, Lauren [Rep.-R- CO-3]; Committees: House – Education and the Workforce

H.R.6045 – To direct the Comptroller General of the United States to conduct a study and submit a report on the efficacy of Federal drug surveillance systems, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

S.3136 – A bill to amend title XIX of the Social Security Act to extend the requirement for State Medicaid plans to provide coverage for medication-assisted treatment; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

S.3137 – A bill to allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.3138 – A bill to amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children’s Health Insurance Program; Sponsor: Brown, Sherrod [Sen.-D- OH]; Committees: Senate – Finance

S.3143 – A bill to establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

S.3144 – A bill to protect survivors from brain injury by authorizing the Secretary of Health and Human Services to collect data on the prevalence of brain injuries resulting from domestic and sexual violence; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

S.3145 – A bill to amend the Public Health Service Act to authorize fellowships under the Minority Fellowship Program to be awarded for training for professionals in the addiction medicine field; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

S.3157 – A bill to amend title XVIII of the Social Security Act to expand eligibility for incentives under the Medicare health professional shortage area bonus program to practitioners furnishing mental health and substance use disorder services; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

S.3158 – A bill 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: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

H.Res.815 – Expressing support for the recognition of October 26, 2023, as “Intersex Awareness Day”, and supporting the goals and ideals of Intersex Awareness Day; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Education and the Workforce

H.Res.821 – Supporting the goals and ideals of “Creutzfeldt-Jakob Disease (CJD) Awareness Day;” Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House – Energy and Commerce

H.R.6078 – To amend the Public Health Service Acts to make community colleges eligible to participate in the Nurse Education, Practice, Quality, and Retention-Pathway to Registered Nurse Program, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Energy and Commerce. A press release can be found here.

H.R.6088 – To require the National Academy of Sciences to establish a grant program to develop safe AI models and safe AI research, and for other purposes; Sponsor: Kiley, Kevin [Rep.-R-CA-3]; Committees: House – Science, Space, and Technology. A press release can be found here.

H.R.6094 – To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

H.R.6103 – To allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability; Judiciary

H.R.6109 – To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Ways and Means

H.R.6110 – To amend title XVIII of the Social Security Act to restore physician judgment to prescribe the appropriate mix of skilled modalities that constitute an intensive rehabilitation therapy program in an inpatient rehabilitation hospital or unit; Sponsor: Thompson, Glenn [Rep.-R-PA-15]; Committees: House – Ways and Means

H.R.6112 – To establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Energy and Commerce; Ways and Means

The House of Representatives remains without a Speaker following a closed- door Republican conference vote on Friday to drop Rep. Jim Jordan (R-Ohio) as the party’s nominee. Jordan was unable to secure the support necessary to be elected over the course of three failed floor votes last week. The House GOP is expected to meet on Monday to hear from the new candidates seeking the position, and to vote as early as Tuesday on its next speaker- designate. The members currently running for the position include House Majority Whip Tom Emmer (R-Minn.), Republican Study Committee chairman Rep. Kevin Hern (R-Okla.), House Republican Vice Conference chairman Rep. Mike Johnson (R-La.), Rep. Pete Sessions (R-Texas), Rep. Austin Scott (R-Ga.), Rep. Byron Donalds (R-Fla.), Rep. Jack Bergman (R-Mich.), Rep. Dan Meuser (R-Pa.), and Rep. Gary Palmer (R-Ala.). The chamber has a significant agenda of items to tackle whenever a speaker is elected. The current continuing resolution (CR) funding the federal government expires November 17. Federal funding for community health centers and health workforce programs were also temporarily extended by the CR. Both the Pandemic All Hazards Preparedness Act (PAHPA) and the President’s Emergency Plan for AIDS Relief (PEPFAR) program authorizations expired on September 30, with only certain PAHPA authorities temporarily extended by the CR.

HELP to Vote on NIH Nominee This Week

President Joe Biden’s nominee to serve as Director of the National Institutes of Health (NIH) Dr. Monica Bertagnolli declined to specify what steps she would take to lower drug prices during her confirmation hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee last week. Chairman Bernie Sanders (I-Vt.) asked the nominee whether she would commit to reinstating and expanding the reasonable pricing clause in NIH contracts. While Bertagnolli agreed that taxpayers deserve a fair return on their investment, she did not explicitly commit to whether she would, or would not, use the reasonable pricing clause if confirmed. The HELP Committee is scheduled to vote on Bertagnolli’s nomination on Wednesday.

Senators Launch Mental Health Caucus

Sens. Alex Padilla (D-Calif.), Thom Tillis (R-N.C.), Tina Smith (D-Minn.), and Joni Ernst (R-Iowa) announced the launch of a new bipartisan Mental Health Caucus last week. The 10-member caucus will focus on addressing health care workforce issues, raising awareness of the 988-crisis hotline, and effectively implementing the Bipartisan Safer Communities Act. The other members of the caucus include Sens. Cory Booker (D-N.J.), Shelley Moore Capito (R-W.Va.), Susan Collins (R-Maine), John Fetterman (D-Pa.), Amy Klobuchar (D-Minn.), and Lisa Murkowski (R-Alaska).

Lawmakers Comment on Biden Administration’s Proposed Changes to Mental Health Parity Requirements

Leadership of the House Education and Workforce Committee have weighed in on the Biden administration’s proposed expansion of mental health parity requirements. The regulation builds on the Mental Health Parity and Addiction Equity Act by mandating that insurers analyze the outcomes of their coverage policies. In her comments submitted on the proposed rule, Chair Virginia Foxx (R-N.C.) argued that the regulation “will serve only to weaken parity compliance by given prominence to bureaucratic reporting, paperwork, and audits.” Ranking Member Bobby Scott (D-Va.) and Health Subcommittee Ranking Member Mark DeSaulnier (D-Calif.), however, expressed support for the proposed rule and urged the administration to further limit the exceptions to the non-quantitative treatment limitation requirements contemplated by the proposal.

CA Sen. Butler Will Not Seek a Full Term

Sen. Laphonza Butler (D-Calif.) has confirmed that she will not run for a full Senate term in 2024. Butler, a labor leader and consultant, was recently appointed to fill the seat of the late Dianne Feinstein. Senate Majority Leader Chuck Schumer (D-N.Y.) confirmed last week that Sen. Butler will take the late Feinstein’s seat on the Judiciary Committee. Sen. Kyrsten Sinema (I-Ariz.) will take her place on the Appropriations Committee and Sen. Mark Kelly (D-Ariz.) will fill her seat on the Intelligence panel.

CMS Rejects More than 300 Misleading MA Ads

The Centers for Medicare and Medicaid Services (CMS) rejected more than 300 misleading advertisements for Medicare Advantage (MA) plans in the lead-up to this year’s open enrollment period. For the first time, and in response to complaints about MA ads, the agency reviewed more than 1,700 ads between May and September. Of the more than 250 ads submitted by third-party marketing organizations, 192 were rejected. Plans were permitted to start advertising on October 1st ahead of open enrollment, which runs from October 15 through December 7. The Senate Finance Committee convened a hearing on the subject of deceptive MA marketing practices on Wednesday and heard testimony from the Ohio Department of Insurance, Security Health Plan, and Chapter, a technology-enabled Medicare and retirement navigation platform.

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic “Reforming the WHO: Ensuring Global Health Security and Accountability;” 10:00 a.m.; October 24

Senate Health, Education, Labor, and Pensions Committee executive session to consider the nomination of Monica Bertagnolli to be Director of the National Institutes of Health; 10:00 a.m.; October 25

House Energy and Commerce Subcommittee on Health hearing “Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care;” 2:00 p.m.; October 25

Senate Veterans’ Affairs Committee hearing “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans;” 3:30 p.m.; October 25

Senate Specialty Committee on Aging hearing “Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases;” 10:00 a.m.; October 26

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

Recently Introduced Health Legislation

H.R.5958 – To amend title XI of the Social Security Act to require that direct-to-consumer advertisements for drugs and biologicals include an appropriate disclosure of pricing information. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

H.R.5957 – To amend the Public Health Service Act to establish a program of research regarding the risks posed by the presence of dioxins, phthalates, pesticides, chemical fragrances, and other components of menstrual products and intimate care products. Sponsor: Meng, Grace [Rep.-D-NY-6]

H.Res.784 – Supporting the designation of October 15, 2023, as “National Pregnancy and Infant Loss Remembrance Day” and recognizing the people who have lost a pregnancy or an infant. Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]

S.3048 – A bill to amend the Family and Medical Leave Act of 1993 to prohibit an employer from recovering any health care premium paid by the employer for an employee if the employee fails to return to work due to the birth of a child, and for other purposes; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Health, Education, Labor, and Pensions

S.3059 – A bill to amend title XVIII of the Social Security Act to establish provider directory requirements, and to provide accountability for provider director accuracy, under Medicare Advantage; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

S.3060 – A bill to establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.792 – Expressing support for the designation of October 17, 2023, as “National Vitiligo Awareness Day”; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]

H.R.5975 – To authorize grants to implement school-community partnerships for preventing substance use and misuse among youth; Sponsor: Sánchez, Linda T. [Rep.-D-CA-38]

H.R.5976 – To establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]

S.3069 – A bill to amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast protheses following a mastectomy; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Finance

S.3070 – A bill to amend the SUPPORT for Patients and Communities Act to reauthorize the youth prevention and recovery initiative; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.5984 – To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for expanding, modernizing, or streamlining emergency room operations; Sponsor: Lawler, Michael [Rep.-R-NY-17]

S.3085 – A bill to establish a program for purposes of carrying out programs to prevent adverse childhood experiences and promoting positive childhood experiences, and to require the Secretary of Health and Human Services to conduct studies, evaluations, and research to address adverse childhood experiences, including through the promotion of positive childhood experiences; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

S.3090 – A bill to amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

S.3091 – A bill to amend title XVIII of the Social Security Act to permit certain clinics to qualify as a rural emergency hospital under the Medicare program; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Finance

S.3098 – A bill to amend title XIX of the Social Security Act to make permanent the Medicaid option to remove the IMD exclusion to provide medical assistance for certain individuals who are patients in an institution for mental diseases; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

S.3103 – A bill to amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Banking, Housing, and Urban Affairs

H.R.6003 – To amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-47]

H.R.6004 – To amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]

The House of Representatives remains without a speaker following the ousting of Kevin McCarthy (R-Calif.) on October 3. On Friday, Rep. Jim Jordan (R-Ohio) became the House GOP’s new nominee for speaker following a closed- door 124-81 vote. Speaker designate Steve Scalise (R-La.) dropped out of the race on Thursday after it became clear that he did not have enough support amongst Republican lawmakers to be elected on the floor. Scalise had previously beat out Jordan to earn the GOP conference nomination in a 113-99 vote earlier in the week. Any nominee will need to receive 217 votes to win the speakership on the floor. House Minority Leader Hakeem Jeffries (D-N.Y.) stated over the weekend that “informal conversations” are taking place regarding a bipartisan solution to the chamber’s current speaker situation. Over the weekend, House Republican Leadership announced plans to vote on the election of the Speaker on Tuesday afternoon.

A group of centrist House Democrats have sent a letter to House Speaker Pro Tempore Patrick McHenry (R-N.C.) stating that they would back the temporary expansion of McHenry’s authority to allow the chamber to take up urgent legislative matters, including government funding and foreign aid. The current continuing resolution expires on November 17, and the House is unable to vote on a government funding plan until a new speaker is elected. “In light of our nation’s pressing issues, a looming government shutdown, and the attacks on our key ally, Israel, we strongly support an immediate vote to expand the Speaker Pro Tempore’s authorities to all for the consideration of a legislative agenda limited to the most pressing issues,” the lawmakers said. They suggest the expansion of the speaker pro tempore’s authorities in 15-day increments until the election of a new speaker. The letter was signed by four leaders of the bipartisan Problems Solvers Caucus: Reps. Josh Gottheimer (D-N.J.), Ed Case (D-Hawaii), Susie Lee (D-Nev.), and Jared Golden (D-Maine).

GOP Doctors Caucus Release Proposal to Reform MPFS

The GOP Doctors Caucus released a discussion draft of legislation last week that would overhaul Medicare’s physician fee schedule (MPFS). The proposal would provide more flexibility around how much the Centers for Medicare and Medicaid Services can spend. The agency is currently restrained by a budget neutrality requirement. The bill would also update how the Medicare program calculates practice expense relative value units (RVUs). Practice expense RVUs have been on the decline since they were last addressed by Congress in 2015.

Blackburn Urges HHS to Affirm Parameters Around Patient Cost-Sharing

Sen. Marsha Blackburn (R-Tenn.) has sent a letter urging the U.S. Department of Health and Human Services (HHS) to affirm that patients’ prescription drug payments, including when financed through copay assistance, constitute cost- sharing, and should be treated as such. Blackburn cites data finding that manufacturer-funded copay assistance reduced Americans’ prescription drug costs by nearly $19 billion last year, and that forgone or delayed care due to accumulators and other comparable tools likely total between $1.3 billion and $2.5 billion annually. “By clarifying that cost-sharing, even when financed through a copay assistance program, still comprises cost-sharing, HHS could correct the legal defects of the 2021 Notice of Benefit and Payment Parameters and save patients tens of billions in out-of-pocket costs,” Blackburn argues.

HELP Dems Release Staff Report on Nonprofit Charity Care

Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.) has released a majority staff report asserting that major non-profit hospitals are prioritizing profits over spending on charity care. The Affordable Care Act requires nonprofit hospitals to establish financial assistance policies to care for patients who are unable to afford treatment. According to the report, between 2012 and 2019 nonprofit hospitals increased their average operating profits by 36% and nearly doubled their cash reserves, while their average spending on charity care decreased from $6.7 million to $6.4 million over the same period. Of the 16 largest nonprofit hospitals, 12 of them dedicated less than 2% of their total revenue to charity care, and half of those dedicated less than 1%. The report recommends mandating that tax-exempt hospitals provide a minimum level of charity care and suggests reforms to increase transparency around the reporting of community benefit data to the Internal Revenue Service.

Doc Caucus Comments on Proposed Nursing Home Staffing Requirements

The GOP Doctors Caucus is asking the Biden administration to reconsider its proposed rule regarding nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers express concerns that the “one-size-fits-all approach to staffing long-term care facilities, especially those in rural areas, is tone deaf to challenges they face.”

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Strengthening Biosafety and Biosecurity Standards: Protecting Against Future Pandemics;” 10:00 a.m.; October 18

House Science, Space, and Technology Subcommittee on Investigations and Oversight hearing “Balancing Knowledge and Governance: Foundations for Effective Risk Management of Artificial Intelligence;” 10:00 a.m.; October 18

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Safeguarding Data and Innovation: Building the Foundation for the Use of Artificial Intelligence;” 10:00 a.m.; October 18

Senate Committee on Health, Education, Labor, and Pensions hearing to examine the nomination of Monica M. Bertagnolli, of Massachusetts, to be Director of the National Institutes of Health; 10:00 a.m.; October 18

Senate Finance Committee hearing “Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences;” 10:00 a.m.; October 18 Senate Budget Committee hearing “Improving Care, Lowering Costs: Achieving Health Care Efficiency;” 10:00 a.m.; October 18

House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials hearing “Exposing EPA Efforts to Limit Chemicals Needed for Life-Saving Medical Devices and Other Essential Products;” 10:30 a.m.; October 18

House Energy and Commerce Subcommittee on Health hearing “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors;” 10:00 a.m.; October 19

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 1:30 p.m.; October 19

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

Recently Introduced Health Legislation

H.R.5910 – To prioritize educating and training for existing and new environmental health professionals. Sponsor: Thanedar, Shri [Rep.-D-MI-13]

H.R.5909 – To amend title XXVII of the Public Health Service Act to limit cost sharing for prenatal services in certain circumstances. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

H.R.5906 – To amend title XI of the Social Security Act to exclude expenditures attributable to a State medicaid fraud control unit from the payment limits under Medicaid for Guam, the Northern Mariana Islands, and American Samoa. Sponsor: Sablan, Gregorio Kilili Camacho [Del.-D-MP-At Large]

H.R.5901 – To amend the Public Health Service Act to encourage programs to address college athlete mental health. Sponsor: Hudson, Richard [Rep.-R-NC-9]

H.R.5894 – Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes. Sponsor: Aderholt, Robert B. [Rep.-R-AL-4]

H.Res.766 – Supporting the designation of October 7, 2023, as National Ostomy Awareness Day. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]

H.Res.780 – Expressing support for the goals of “World Sight Day” by promoting the importance of accessible, affordable, and inclusive eye care; Sponsor: Veasey, Marc A. [Rep.-D-TX-33]

H.R.5924 – To amend title XVIII of the Social Sec

urity Act with respect to the timing of changes to the annual out-of- pocket threshold for the Medicare prescription drug benefit, and to amend title XI of such Act with respect to the timing of the Medicare drug price negotiation program; Sponsor: Magaziner, Seth [Rep.-D-RI-2]

H.Res.782 – Thanking and promoting the professions of perinatal nurses by encouraging participation in National Perinatal Nurses Week; Sponsor: Joyce, David P. [Rep.-R-OH-14]

H.R.5935 – To amend title XVIII of the Social Security Act to extend the Quality Payment Program-Small Practice, Underserved, and Rural Support program; Sponsor: Stansbury, Melanie Ann [Rep.-D-NM-1]

H.R.5938 – To amend the Veterans’ Benefits Improvements Act of 1996 and the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 to improve the temporary licensure requirements for contract health care professionals who perform medical disability examinations for the Department of Veterans Affairs, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]

H.R.5948 – To terminate the Office of Gun Violence Prevention in the Executive Office of the President and prohibit the establishment of any similar successor office, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]

Last week, eight conservative critics of Rep. Kevin McCarthy (R-Calif.) were joined by the House Democratic caucus in successfully ousting McCarthy as Speaker of the House in a 216-210 vote. The motion to vacate was brought to the floor by Rep. Matt Gaetz (R-Fla.) and supported by Republican Reps. Andy Biggs (Ariz.), Ken Buck (Colo.), Tim Burchett (Tenn.), Eli Crane (Ariz.), Bob Good (Va.), Nancy Mace (S.C.), and Matt Rosendale (Mont.). McCarthy is the first House speaker in history to be removed from the job. The GOP dissidents cited McCarthy’s support for the latest continuing resolution to prevent a government shutdown as the main reason for their campaign against him. Rep. Patrick McHenry (R-N.C.) has been tapped to serve as speaker pro-tempore, having been on the top of McCarthy’s secret list of successors, a practice initiated after 9/11 to protect the continuity of government. While the chamber cannot vote on legislation until a new speaker has been elected, McHenry now has the full power of speaker to sign enrolled bills and joint resolutions and usher the House through votes to elect a permanent replacement.

House Majority Leader Steve Scalise (R-La.) and Rep. Jim Jordan (R-Ohio), who both supported Speaker McCarthy in last week’s vote, have formally announced their candidacies to be the next Speaker. Both members are seen as ideologically to the right of McCarthy, with Jordan being considered the more conservative of the two. Jordan currently serves as chair of the House Judiciary Committee and is leading the GOP’s investigations into the current administration and Biden family. He recently voted against the continuing resolution to keep the government running through November 17, while Scalise voted in favor of it. Both candidates have focused on the need to address the fentanyl crisis and have criticized the Biden administration’s response to the COVID-19 pandemic. Jordan has been endorsed by former president Donald Trump. Gaetz has expressed support for both bids for speaker while emphasizing that a plan to reduce government spending is more important than the individual speaker themself.

The House GOP plans to hold a party conference on Tuesday to provide rank-and-file members the opportunity to ask questions of the candidates. The conference would then vote on their nominee for speakership. If a strong candidate emerges, McHenry plans to hold a floor vote to elect a new speaker on Wednesday. The next speaker faces a possible government shutdown when the current continuing resolution expires on November 17, as well as reauthorization of key health programs like the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Children’s Hospital Graduate Medical Education program, the Pandemic and All-Hazards Preparedness Act, and the SUPPORT Act, which expired last month.

GOP Senators Pledge to Block Bills Unrelated to Government Funding

Agroup of 20 Republican senators have sent a letter to Senate Majority Leader Chuck Schumer (D-N.Y.) pledging to withhold their support for any vote to proceed to items unrelated to the fiscal year 2024 appropriations process. “We urge you to present a plan to the Republican Conference for how you intend to pass the remaining appropriations bills and conference them with the House in a manner that respects an open amendment process and which does not end in a December omnibus spending package,” the letter states. The lawmakers highlight that limited time remains until government funding once again expires on November 17th.

Ways and Means Members Probe Implementation of Hospice Special Focus Program

Abipartisan group of House Ways and Means Committee members have sent a letter to the Biden administration regarding the Hospice Special Focus Program (SFP). The lawmakers assert that the Centers for Medicare and Medicaid Services’ (CMS) proposal for identifying poorly performing hospices is based on incomplete survey data and would “not adequately identify hospices that are truly struggling with performance.” The letter also encourages CMS to ensure Medicare-certified hospices get a preview of their performance under the SFP before the program is formally launched. The letter was signed by Reps. Beth Van Duyne (R-Texas), Earl Blumenauer (D-Ore.), Brad Wenstrup (R-Ohio), and Jimmy Panetta (D-Calif.).

Warren, Jayapal Urge Scrutiny of UnitedHealth, Amedisys Merger

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have requested that antitrust regulators examine UnitedHealth Group’s proposed acquisition of home health and hospice provider Amedisys Inc. The letter characterizes the deal as the “latest example of massive health care conglomerates using anti-competitive mergers to increase their market dominance, reducing competition, hurting patients, and increasing health care costs.” The lawmakers urge the Department of Justice to closely scrutinize the deal and to “oppose the growing trend of insurers buying up health care providers to reduce competition.”

Laphonza Butler Sworn in as Senator

California Governor Gavin Newsom (D) tapped Laphonza Butler, president of EMILY’s List, to fill the seat of the late Sen. Dianne Feinstein. EMILY’s List advocates for the election of Democratic, pro-choice women to political office. Butler previously served as president of SEIU Local 2015 in California, and has also worked as a partner at political consulting firm SCRB Strategies. Butler was sworn in by Vice President Kamala Harris on Tuesday, becoming only the third Black female senator in history. She is one of three LGBTQ senators currently in office. She has not yet indicated whether she will seek the office in the 2024 election.

CBO Issues Call for New Obesity Research

The Congressional Budget Office (CBO) is requesting new research to inform its analysis of obesity treatment policies, including the use of new anti-obesity medications. Medicare is currently prohibited from covering weight-loss drugs like Ozempic and Trulicity, but legislation – including the Treat and Reduce Obesity Act (S. 2407/H.R. 4818) – has been introduced to change that policy. CBO’s blog on the issue states that were Medicare to pay for these drugs some of the cost would be captured through higher premiums and patient cost sharing, but that the drugs’ net cost to the Medicare program would still be “significant” over the next decade.

DEA Extends COVID Telehealth Rules for Remote Prescribing

The Drug Enforcement Administration (DEA) has extended COVID-era flexibilities for the prescription of controlled substances via telemedicine through the end of 2024. The agency’s second temporary rule will allow all patients to be prescribed controlled substances without an in-person visit. DEA plans to issue new standards by fall 2024 that will “most effectively expand access to telemedicine encounters” while also preventing misuse.

Recently Introduced Health Legislation

S.Res.389 – A resolution expressing support for the annual designation of October 1st as “National Latino/a Physician Day”. Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

H.R.5864 – To amend title XIX of the Social Security Act to provide for coverage under the Medicaid program of non- invasive prenatal genetic screening; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

H.R.5866 – To ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

S.3006 – A bill to ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.405 – A resolution expressing support for the designation of September 30, 2023, as “National Veterans Suicide Prevention Day;” Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.3010 – A bill 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: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

S.3021 – A bill to amend title XVIII of the Social Security Act to permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19, and for other purposes; Sponsor: Sinema, Kyrsten [Sen.-I- AZ]; Committees: Senate – Finance

S.3022 – A bill to amend the Indian Health Care Improvement Act to allow Indian Health Service scholarship and loan recipients to fulfill service obligations through half-time clinical practice, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Indian Affairs

Congress narrowly averted the threat of a federal government shutdown over the weekend following passage of a clean continuing resolution (CR) that funds the government through November 17. House Speaker Kevin McCarthy (R-Calif.) brought the bipartisan stopgap spending bill (H.R. 5860) to the floor on Saturday. It passed by a vote of 335-91, with 90 Republicans and one Democrat voting in opposition. The legislation extends fiscal year (FY) 2023 funding for 45 days. It also extends funding for several programs that were set to expire at the end of September, including the Community Health Center program, National Health Service Corps, Teaching Health Center Graduate Medical Education program, Special Diabetes Program, Special Diabetes Program for Indians, pandemic preparedness authorities, and delays scheduled cuts to Medicaid payments for disproportionate share hospitals. The bill reauthorizes animal drug user fees through FY 2028. The bill also includes the full $16 billion in disaster relief funding requested by the Biden administration, but does not include supplemental aid to Ukraine. It also struck a pay raise for Members of Congress that had been included in the Senate’s version of the temporary spending bill. The Senate voted 88-9 to concur with the House amendments to the CR. The Senate vote was reportedly delayed over concern regarding the elimination of funding for Ukraine. In calling up the vote, Senate Majority Leader Chuck Schumer (D-N.Y.) said that he and Minority Leader Mitch McConnell (R-Ky.) have “agreed to continue fighting for more economic and security aid for Ukraine.” President Joe Biden signed the measure into law late Saturday. Speaker McCarthy is expected to face a motion to vacate the chair this week from a small group of House Republicans seeking to oust him as speaker. The group, headed by Rep. Matt Gaetz (R-Fla.), opposed a bipartisan approach to government funding and sought to enact steep budgetary cuts.

Wyden, Pallone to Investigate Medicaid MCOs’ Use of Prior Authorization

Senate Finance Committee Chairman Ron Wyden (D-Ore.) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) sent a series of letters to the nation’s largest Medicaid managed care organizations (MCOs) regarding their high rates of care denials. The lawmakers are requesting details about the insurance carriers’ use of prior authorization, including any algorithms and reliance on artificial intelligence used to make prior authorization coverage decisions. The lawmakers highlight a recent finding from the Health and Human Services Office of the Inspector General which found that one in eight MCO prior authorization requests were denied, double the rate in the Medicare Advantage program. “It is critical that MCOs are not improperly denying access to care in an effort to maximize profits given that they are obligated by statute, regulation, and contracts with states to pay network providers for furnishing covered services to enrollees,” Pallone and Wyden write. “MCOs should not be prioritizing corporate or shareholder profits ahead of the health and well-being of American families.”

MA Premiums to Increase $0.64

The average premium for Medicare Advantage (MA) plans will increase from $17.86 to $18.50 per month in 2024, according to the latest estimates from the Centers for Medicare and Medicaid Services. The total number of MA plans will also increase, from 5,674 to 5,700. The agency projects that MA will account for more than half of all Medicare enrollment next year, with 33.8 million people expected to choose an MA plan during the upcoming open enrollment period, which opens on October 15 and closes December 7.

Cassidy Issues RFIs on Reforming CDC, NIH

Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) is soliciting comments to inform potential legislation to modernize the Centers for Disease Control and Prevention (CDC). Cassidy specifically seeks input on four high-level topics – fostering innovation and collaboration, making data work for everyone, improving upon what works well, and mechanisms to modernize – as well as other relevant information. Cassidy’s request for information (RFI) mirrors a similar request for feedback issued by the House Energy and Commerce Committee in April. Comments should be submitted no later than October 20th via email to [email protected].

Cassidy also issued an RFI on ways to reform the National Institutes of Health (NIH). Specifically, the HELP Ranking Member is seeking information on how the NIH could improve its process for approving federal research grants, better support the biomedical research workforce, bolster collaboration across academia and industry, and increase transparency into agency activities. The deadline to submit feedback to [email protected] is October 27th.

FDA Proposes LDT Enforcement Rule

The Food and Drug Administration (FDA) released a proposal last week that would result in most laboratory developed tests (LDTs) being subject to agency review as medical devices. The rule is aimed at ensuring the safety, accuracy, and effectiveness of LDTs. It seeks to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including LDTs, are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs through a five-stage, multi-year phaseout of its current general enforcement discretion approach. The FDA estimates that the proposed rule would save the health care system more than $22.3 billion and the FDA $5.6 billion annually. Comments on the proposed rule are due by December 1, 2023.

Administration to Begin Enforcement of Drug Price Reporting Requirements

The departments of Health and Human Services, Labor, and Treasury have issued joint guidance regarding the enforcement of drug price reporting requirements for health insurers. The departments announced their decision to rescind a 2021 regulation that had delayed enforcement of the drug pricing provisions of the Trump-era transparency in coverage rule. That regulation requires health insurers to publicly disclose the negotiated rates of covered prescription drugs in machine readable files. Going forward, the Biden administration plans to address enforcement of the requirements on a case-by-case basis, and does not plan to issue further rulemaking in the near future.

Medicare Drug Price Negotiations to Proceed

Federal Judge Michael J. Newman denied a request to halt Medicare drug price negotiations while litigation challenging the process is ongoing. The lawsuit, brought by the U.S. Chamber of Commerce and other local and state chambers of commerce, argued that the Inflation Reduction Act violates the First, Fifth, and Eighth amendments of the Constitution. In its defense of the law, the Justice Department asserted that the Chamber and its members cannot show imminent harm and questioned whether the Chamber had standing to bring its case. “The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,” Newman wrote in his opinion. “Any economic harm – which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis – will not occur for years in the future.” Pharmaceutical manufacturers of the 10 drugs selected for the first round of negotiation had until October 1st to agree to participate in the process, to withdraw their products from the Medicare program, or to face excise taxes. While companies are not required to announce their decision to opt into the program, Merck, Boehringer Ingelheim, AstraZeneca and Bristol Myers Squibb have publicly confirmed that they will participate in negotiations.

CBO Issues Report on CMMI

The Center for Medicare and Medicaid Innovation (CMMI) spent $7.9 billion operating care models that reduced spending by $2.6 billion, according to a new analysis by the Congressional Budget Office (CBO). Previous CBO forecasts had projected that CMMI would save $2.8 billion in its first decade of work, since its inception as a part of the Affordable Care Act in 2010. CBO now projects that CMMI will increase net federal spending by $1.3 billion over its second decade. CBO attributes CMMI’s performance to the slow pace at which successful models are scaled up and the voluntary nature of most pilot programs.

ARPA-H Announces Cambridge, Dallas as Latest Hubs

The Advanced Research Projects Agency for Health (ARPA-H) announced the selection of its next two headquarters last week. ARPA-H’s customer experience hub will be in Dallas and its investor catalyst hub will be in Cambridge, Mass. Dallas and Cambridge join Washington, D.C., which will serve as the stakeholder and operations hub, as a part of the new agency’s hub-and-spoke model. ARPA-H continues to recruit a network of regional private, public, and nonprofit organizations to serve as spokes, with 10 spokes having been announced so far.

Earlier in the week, ARPA-H announced the award of almost $115 million for three new cancer research programs. Rice University will receive up to $45 million for the development of an implant to sense and deliver specific doses of medicine to increase cancer therapy response rates. The University of Missouri will receive up to $9 million for the development of a cancer therapy that uses engineered bacteria to target tumors’ immune cells to treat cancer without the traditional side effects of cancer treatment. The Georgia Institute of Technology and Emory University will receive up to $50 million to develop biosensor tools to recognize cancer-specific biomarkers, with the goal of identifying cancers when they are at their most treatable.

Ways and Means Passes Legislation to Expand Use of HSAs

The House Ways and Means Committee advanced the Bipartisan HSA Improvement Act (H.R. 5688) last week. The bill passed the committee in a 28-14 vote, with four Democrats joining Republicans in voting in support of the measure. The legislation would allow individuals who utilize direct primary care arrangements and worksite health clinics to contribute to a health savings account (HSA). The panel also advanced the HSA Modernization Act (H.R. 5687) along a party line vote. The bill would expand eligibility for HSAs to Medicare beneficiaries who are still working and veterans, allow spouses to make catch-up contributions to the same HSA, and increase the limits on contributions.

Senate Committee Advances SAFER Banking Act

The Senate Banking Committee advanced legislation last week that would enable the nation’s cannabis businesses to access banking services more easily. The SAFER Banking Act (S. 2860) would create a safe harbor for banks, credit unions, and payment processors that provide services to state-sanctioned businesses. The legislation aims to promote public safety by reducing cannabis businesses’ reliance on cash and increasing access to deposit accounts, insurance, other financial services.

Democrats Push for Opioid Settlement Fund Oversight

Agroup of 12 congressional Democrats have sent a letter to the Office of National Drug Control Policy regarding oversight of the more than $50 billion states will receive in opioid settlement money over the next 15 years. The letter, spearheaded by Sen. Ed Markey (D-Mass.) and Rep. David Trone (D-Md.), argues that the funds must be spent on substance use disorder treatment and prevention, not on other general state expenditures. “This funding, drawn from the profits that pharmaceutical companies made by overprescribing opioids and underselling their potential dangers, presents a significant opportunity to redistribute ill-gained earnings to the people who the opioid epidemic harmed,” the lawmakers state. “We must take full advantage of these settlements to combat this crisis, therefore we urge the Biden administration to closely track opioid settlement fund spending, to ensure that populations in need of additional support receive it and to avoid duplicative federal efforts.”

Sen. Dianne Feinstein Dies at 90

Six-term California Democratic Senator Dianne Feinstein, 90, passed away at her home in Washington on Friday. She was the chamber’s longest serving female senator. Feinstein sat on four committees prior to her death: Appropriations, Judiciary, Intelligence, and Rules. Senate Democrats are expected to select a member to replace her in the coming days to maintain their majority on each panel. Feinstein had already announced that she would not be running for a seventh term in 2024. California Governor Gavin Newsom will be responsible for appointing Feinstein’s successor. Newsom has stated that he will appoint a Black woman, but that he will not appoint anyone already running for the position so as not to interfere in the primary race. He has also confirmed that his appointee will be free to run for a full Senate term in 2024, should they choose to do so. Reps. Barbara Lee (D-Calif.), Katie Porter (D-Calif.), and Adam Schiff (D-Calif.), along with former Google executive Lexi Reese, have announced their candidacies for the 2024 Senate race.

POLICY BRIEFINGS

NJ Democrat to Challenge Menendez for Senate Seat

Rep. Andy Kim (D-N.J.) plans to challenge Sen. Bob Menendez (D-N.J.) for his seat in the upper chamber next year. Kim’s announcement follows the indictment of the three-term Senator on charges of corruption. Menendez will step down as chair of the Foreign Relations Committee, but has pleaded not guilty to charges that he accepted bribes in exchange for helping the Egyptian government. Menendez has stated that he will not resign, but it is unclear whether he would cooperate with a Senate ethics investigation. He faces mounting calls from both Republicans and Democratic colleagues in Congress to step down.

Insurers Commit to COVID Shot Coverage With No Cost Sharing

Representatives of the nation’s major health insurance carriers sent a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra last week assuring him that Americans can access the latest COVID-19 booster without any out-of-pocket costs. “Throughout this transition to traditional public and private reimbursement, our members prepared and have been working tirelessly to overcome system challenges and increase access. We value the collaboration with your teams as we work together to continue to expand access to the updated COVID vaccines through more routine channels,” the letter states. “You have our commitment that health insurers are fully covering the new COVID-19 shots, as required, with no cost sharing when consumers access them from a network provider or receive them through an out-of-network provider when in-network options are unavailable.”

Upcoming Congressional Hearings and Markups

Senate Veterans’ Affairs Committee hearing “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans;” 3:00 p.m.; October 4

Recently Introduced Health Legislation

S.Res.367 – A resolution designating September 2023 as “National Spinal Cord Injury Awareness Month”; Sponsor: Rubio, Marco [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.368 – A resolution supporting the designation of the week of September 17 through September 23, 2023, as “Telehealth Awareness Week”; Sponsor: Schatz, Brian [Sen.-D-HI]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.369 – A resolution expressing support for the designation of September 2023 as “Sickle Cell Disease Awareness Month” in order to educate communities across the United States about sickle cell disease and the need for research, early detection methods, effective treatments, and preventative care programs with respect to complications from sickle cell disease and conditions related to sickle cell disease; Sponsor: Scott, Tim [Sen.-R-SC]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.2916 – A bill to provide for digital communication of prescribing information for drugs (including biological products), and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

S.2918 – A bill to reauthorize the program of surveillance and education regarding infections associated with illicit drug use and other risk factors; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.2922 – A bill to advance population research for chronic pain; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

S.2932 – A bill 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: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

S.2933 – A bill to reauthorize the program of first responder training; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.725 – Expressing support for the designation of September 30, 2023, as “Rare Cancer Day” to highlight the challenges patients with rare cancers face and to raise awareness and support efforts to improve early diagnosis and treatment; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Energy and Commerce

H.Res.728 – Expressing support for the designation of September 2023 as “Peripheral Artery Disease Awareness Month”; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

H.R.5687 – To amend the Internal Revenue Code of 1986 to modernize health savings accounts; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means

H.R.5688 – To amend the Internal Revenue Code of 1986 to improve health savings accounts; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means

H.R.5690 – To amend the Internal Revenue Code of 1986 to allow for certain distributions from a health savings account for medical expenses incurred during the 60-day period before the account was established; Sponsor: Moore, Blake D. [Rep.-R-UT-1]; Committees: House – Ways and Means

H.R.5697 – To direct the Secretary of Veterans Affairs to ensure veterans may obtain a physical copy of a certain form by mail or at medical facilities of the Department of Veterans Affairs, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Veterans’ Affairs

H.R.5699 – To provide programs to assist diagnosis, awareness, and education of blood clot conditions, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

H.R.5708 – To amend the Federal Food, Drug, and Cosmetic Act to extend a priority review program to encourage treatments for agents that present national security threats; Sponsor: Finstad, Brad [Rep.-R-MN-1]; Committees: House – Energy and Commerce

H.R.5709 – To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A to make contributions to health savings accounts; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Ways and Means

H.R.5713 – To amend the Controlled Substances Act to authorize Homeland Security Investigations to perform certain drug enforcement functions, and for other purposes; Sponsor: Higgins, Clay [Rep.-R-LA-3]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

H.R.5716 – To amend the Internal Revenue Code of 1986 to allow contributions to a health savings account when a spouse has a health flexible spending account; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Ways and Means

H.R.5737 – To amend the Internal Revenue Code of 1986 to increase the maximum contribution limit for health savings accounts; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means

H.R.5740 – To amend the Higher Education Act of 1965 to promote comprehensive campus mental health and suicide prevention plans, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Education and the Workforce

S.2939 – A bill to amend title XVIII of the Social Security Act to require reporting on enforcement and oversight of pharmacy access requirements under Medicare part D; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Finance

S.2941 – A bill to amend title XVIII of the Social Security Act to provide coverage of preventative home visits under Medicare, and for other purposes; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Finance

S.2942 – A bill to amend title XVIII of the Social Security Act to improve the annual wellness visit under the Medicare program; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Finance

S.2946 – A bill to amend the Public Health Service Act to provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

S.2948 – A bill to require the Secretary of Labor to issue guidance and regulations regarding opioid overdose reversal medication and employee training; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

S.2954 – A bill to apply the Medicaid asset verification program to all applicants for, and recipients of, medical assistance in all States and territories, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

H.Res.732 – Expressing support for the designation of September 30, 2023, through October 7, 2023, as “National Student Athlete Mental Health Week”; Sponsor: Carl, Jerry L. [Rep.-R-AL-1]; Committees: House – Education and the Workforce

H.Res.734 – Expressing support for the designation of October 1 as “National Latino and Latina Physician Day”; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

H.R.5746 – To amend title XVIII of the Social Security Act to expand the availability of supplemental benefits to certain Medicare Advantage enrollees; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Ways and Means; Energy and Commerce

H.R.5749 – To amend the Public Health Service Act with regard to research on asthma, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

H.R.5752 – To amend the Internal Revenue Code of 1986 to allow first-dollar coverage of mental health services for purposes of health savings accounts; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Ways and Means

H.R.5762 – To direct the Secretary of Health and Human Services to research and design a graphic symbol to indicate when linguistic access materials and services are available for a health program, product, or service, and for other purposes; Sponsor: Kim, Young [Rep.-R-CA-40]; Committees: House – Energy and Commerce

H.R.5773 – To amend the Public Health Service Act to remove certain liability protections for certain biological products and other drugs if the sponsor thereof fails to disclose to the public all non-exempt data within the biological product file or drug application, and for other purposes; Sponsor: Posey, Bill [Rep.-R-FL-8]; Committees: House – Energy and Commerce

H.R.5774 – To amend the Internal Revenue Code of 1986 to clarify the treatment of distributions from health savings accounts for long-term care services; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means

H.R.5777 – To amend the Internal Revenue Code of 1986 improve health savings accounts; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Ways and Means

S.Res.381 – A resolution supporting the designation of the week of August 28 through September 1, 2023, as “National Community Health Worker Awareness Week”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.384 – A resolution recognizing the seriousness of polycystic ovary syndrome (PCOS) and expressing support for the designation of September 2023 as “PCOS Awareness Month”; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.2966 – A bill to amend the Public Health Service Act to encourage programs to address college athlete mental health; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate – Health, Education, Labor, and Pensions

S.2973 – A bill to amend titles XVIII and XIX of the Social Security Act to establish requirements relating to pharmacy benefit managers under the Medicare and Medicaid programs, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

S.2978 – A bill to authorize funding for the establishment and implementation of infant mortality pilot programs in standard metropolitan statistical areas with high rates of infant mortality, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

S.2993 – A bill to amend the Social Security Act and the Public Health Service Act to permanently authorize certified community behavioral health clinics, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

H.Res.740 – Expressing support for the designation of September 30, 2023, as “National Veterans Suicide Awareness and Prevention Day”; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Oversight and Accountability

H.R.5782 – To ensure access to cost-free rabies postexposure prophylaxis; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Ways and Means

H.R.5787 – To amend the Internal Revenue Code of 1986 to allow, without regard to disability, individuals eligible for veterans benefits to contribute to health savings accounts; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means

H.R.5788 – To amend the Public Health Service Act to promote healthy eating and physical activity among children; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

H.R.5789 – To authorize funding for the creation and implementation of infant mortality pilot programs in standard metropolitan statistical areas with high rates of infant mortality, and for other purposes; Sponsor: Cohen, Steve [Rep.-D- TN-9]; Committees: House – Energy and Commerce

H.R.5794 – To amend title 38, United States Code, to eliminate conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Veterans’ Affairs

H.R.5796 – 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: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce; Ways and Means

H.R.5804 – To authorize the Secretary of Health and Human Services to make loans and loan guarantees for planning, constructing, or renovating pediatric or adult mental health treatment facilities and pediatric or adult substance use disorder treatment facilities, and for other purposes; Sponsor: Kilmer, Derek [Rep.-D-WA-6]; Committees: House – Energy and Commerce

H.R.5806 – To amend title 18, United States Code, to prohibit chemical abortions, and for other purposes; Sponsor: Ogles, Andrew [Rep.-R-TN-5]; Committees: House – Judiciary

H.R.5818 – To amend title XVIII of the Social Security Act to expand coverage of the in-home administration of intravenous immune globulin under the Medicare program; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.5819 – To amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Energy and Commerce; Ways and Means

H.R.5821 – To amend the Internal Revenue Code of 1986 to provide for a credit against tax for expenses for translational research regarding neurodegenerative diseases and psychiatric conditions; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Ways and Means

The Biden administration released the list of the first 10 Part D drugs subject to the price negotiation process established by the 2022 Inflation Reduction Act:

• Bristol-Pfizer’s Eliquis, used as a blood thinner;
• Eli Lilly’s Jardiance, used for diabetes and heart failure;
• Johnson & Johnson’s Xarelto, used as a blood thinner;
• Merck’s Januvia, used for diabetes;
• AstraZeneca’s Farxiga, used for diabetes and heart failure;
• Novartis’ Entresto, used for heart failure;
• Amgen’s Enbrel, used for autoimmune diseases;
• AbbVie-J&J’s Imbruvica, used for blood cancers;
• J&J’s Stelara, used for autoimmune diseases; and
• Novo Nordisk’s NovoLog, used for diabetes.

The Centers for Medicare and Medicaid Services plans to hold a public patient- focused listening session for each of the selected drugs between October 30, 2023, and November 15, 2023. The listening sessions will provide an opportunity for patients and other interested parties to share input on therapeutic alternatives to the selected drugs, how the selected drugs address unmet medical needs, and the impact of selected drugs on specific populations. Registration to apply to be a speaker opened on September 1, 2023, and will close on October 2, 2023. The public is also invited to submit data on selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical needs, and data on impacts on specific populations by October 2, 2023.

Majority Leader Steve Scalise Undergoing Treatment for Blood Cancer

House Majority Leader Steve Scalise (R-La.) has been diagnosed with multiple myeloma, “a very treatable blood cancer,” according to a statement released last week. Scalise has already begun treatment, which will last several months. He plans to return to Washington when the House of Representatives reconvenes later this month, and announced that he expects to continue his work as Majority Leader during this period.

White House Calls on Congress to Pass Continuing Resolution

The Biden administration formally asked Congress to pass a short-term spending bill to prevent a government shutdown at the end of the fiscal year on September 30. The White House is also seeking $40 billion in emergency spending as a part of the stopgap package. Conservatives in the House Freedom Caucus have already expressed opposition to any clean continuing resolution that does not include the Secure the Border Act, address the “unprecedented weaponization of the Justice Department and FBI,” and “end the Left’s cancerous woke policies in the Pentagon.” Both Democrat and Republican leaders of the Senate have signaled their support for a stopgap spending measure, and Senate Majority Leader Chuck Schumer (D-N.Y.) stated that the Senate’s focus will be on government funding when the chamber returns from August recess this week.

Doc Caucus Members Ask Appropriators to Act on Abortion Training Programs

The GOP Doctors Caucus sent a letter to House Appropriations Labor-Health and Human Services-Education Subcommittee Chairman Robert Aderholt (R-Ala.) in support of a change to physician training requirements that would result in medical residents having to opt-in to learn about abortion services, rather than the current process of allowing them to opt-out of such lessons. Several Doc Caucus members and former practicing OB/GYN Rep. Michael Burgess (R-Texas) raised concerns that the current opt-out process “is fundamentally unjust and places undue pressure on [residents] to partake in training that may conflict with their beliefs.” The letter encourages appropriators to prohibit federal funds from being used to implement opt-out curricula.

House Budget Panel Launches Health Care Task Force

House Budget Committee Chairman Jodey Arrington (R-Texas) recently announced the formation of a task force on health care. The task force will focus on bending the cost curve of health care, and will work to examine key drivers of health care costs and proposals to reduce health care spending. Rep. Michael Burgess (R-Texas) will serve as the chair of the task force, whose members include Reps. Drew Ferguson (R-Ga.), Buddy Carter (R-Ga.), Lloyd Smucker (R-Pa.), Blake Moore (R-Utah), and Rudy Yakym (R-Ind.). According to Arrington, the Task Force “will be guided by the principles that health care in America should be affordable, accessible, and personalized.” It plans to explore the Congressional Budget Office’s modeling and projection capabilities of health care policies “to ensure policymakers can access the best data when evaluating potential impacts on the federal budget and patients.” The task force issued a request for information (RFI) seeking comments by October 15 “on solutions to improve outcomes and reduce federal health care spending in the budget.”

NIH Nominee Reaches Agreement with Warren on Ethics Demands

Sen. Elizabeth Warren (D-Mass.) will support the confirmation of Monica Bertagnolli to serve as the Director of the National Institutes of Health (NIH) after the Biden administration nominee agreed to a pair of ethics demands. Bertagnolli agreed to not seek employment or compensation from any pharmaceutical company with an annual revenue of $10 billion or more for four years after leaving her government post. She also agreed to recuse herself from NIH decisions related to companies with which she has had a prior relationship for four years. The standard recusal period is two years. Bertagnolli’s path to confirmation is still complicated by Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sander’s (I-Vt.) refusal to schedule a hearing on her nomination. Sanders has pledged to oppose all administration health nominees until the White House takes unilateral action to cut drug prices. The NIH has been without a permanent leader since Dr. Francis Collins stepped down in December 2021.

Warren, Jayapal Urge FDA to Address Orange Book-Related Problems

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) sent a letter to the Food and Drug Administration (FDA) urging the agency to close alleged regulatory loopholes which they assert delay the entry of generic competition to the market and enable manufacturers of brand pharmaceuticals to keep high prices in place for longer periods of time. The lawmakers specifically recommend that the FDA narrow the patents allowed to be listed in the Orange Book, which is used by generic drug companies to determine when they can file a generic drug for approval. The letter also calls for increased information sharing between the FDA and the U.S. Patent and Trademark Office to help determine whether manufacturers are using the patent system in an anti-competitive manner.

New HHS OIG Strategy on Medicare, Medicaid Managed Care

The U.S. Department of Health and Human Services Office of the Inspector General (OIG) published a coordinated oversight plan for managed care in the Medicare and Medicaid programs last week. The strategy will be used to align OIG’s audits, evaluations, investigations, and enforcement of managed care. It aims to promote access to care for people enrolled in managed care, provide comprehensive financial oversight, promote data accuracy, and encourage data driven decisions. OIG’s work will be guided by the following managed care life cycle and the unique risks and vulnerabilities associated with each stage: plan establishment and contracting, enrollment, payment, and the provision of services.

POLICY BRIEFINGS

Department of Labor Proposes to Extend Overtime Protections

The Biden administration has proposed to revive an Obama-era regulation to require employers to pay overtime to salaried workers earning less than $55,000 a year. The regulation, which would increase the salary threshold for overtime from $35,668, would impact a total of 3.6 million employees, including approximately 600,000 individuals working in the nation’s health care and social services sectors. The notice of proposed rulemaking will be open for public comment for 60 days.

Recently Introduced Health Legislation

H.R.5269 – To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment and maintenance of a Pediatric Research Site Network; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Energy and Commerce

H.R.5287 – To direct the Secretary of Veterans Affairs to establish a pilot program to provide veteran health savings accounts to allow veterans to receive primary care furnished under non-Department direct primary care service arrangements, and for other purposes. Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Veterans’ Affairs

H.R.5299 – To amend title XVIII of the Social Security Act to establish a demonstration program for international coverage under the Medicare program; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Ways and Means; Energy and Commerce

H.R.5308 – To reauthorize the Distance Learning and Telemedicine Program of the Department of Agriculture; Sponsor: Langworthy, Nicholas A. [Rep.-R-NY-23]; Committees: House – Agriculture

H.R.5312 -To amend the Child Nutrition Act of 1966 to support women, infants, and children impacted by substance use disorder, and for other purposes; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Education and the Workforce

H.R.5317 – To amend the Internal Revenue Code of 1986 to allow distributions from a health flexible spending arrangement or health reimbursement arrangement directly to a health savings account in connection with establishing coverage under a high deductible health plan; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means

President Joe Biden plans to request additional funding from Congress for new COVID-19 vaccines. It is unclear whether the money would go toward research and development of an updated vaccine beyond the one already in development, or whether the administration will seek to restart the federal program providing free coronavirus shots for all Americans. In either case, the request is likely to meet opposition from Republicans on Capitol Hill. The Centers for Disease Control and Prevention is scheduled to meet on September 12 to discuss the latest round of COVID-19 vaccines to be deployed this fall.

Freedom Caucus to Oppose Clean CR

The House Freedom Caucus released a statement last week in anticipation of the use of a continuing resolution to fund the federal government beyond the end of the fiscal year on September 30. The Caucus stresses their support for reining in “reckless inflationary spending,” stating their refusal to support any stopgap spending measure that “continues Democrats’ bloated COVID-era spending.” The Freedom Caucus will oppose any clean, short-term funding bill that does not include the Secure the Border Act, address the “unprecedented weaponization of the Justice Department and FBI,” and “end the Left’s cancerous woke policies in the Pentagon.”

CBO Announces 2023 Panel of Health Advisers

The Congressional Budget Office (CBO) has announced the members of its Panel of Health Advisers for the coming year. The panel advises CBO on its cost analyses and provides assistance to support CBO’s understanding of “cutting edge research and the latest real-world developments in health care delivery and financing.” The complete list of advisers and their affiliations can be found here.

CMS Releases First Guidance on OOP Smoothing Program

The Centers for Medicare and Medicaid Services (CMS) released the first of two draft guidance documents last week to implement the Medicare Prescription Payment Plan Program. The program, which was established under the Inflation Reduction Act, will permit seniors to spread (or ‘smooth’) out their out-of-pocket (OOP) drug costs over a 12-month period. It is set to begin on January 1, 2025. The guidance instructs Part D plans on how to identify patients who may benefit from the program, how such patients should be notified via their pharmacy, and how insurers should reimburse pharmacies for the cost-sharing patients would otherwise pay upfront. Comments on the guidance are due September 20, 2023. A second guidance, planned for release early next year, will shed light on how the program will impact plan bids for 2025.

First Medicare Price Negotiation Drugs to Be Announced This Week

The Biden administration will announce the first 10 prescription drugs selected for the first round of the Inflation Reduction Act’s Medicare price negotiation policy early this week. The announcement is expected to precede a Tuesday event at the White House on lowering health care costs scheduled for 2 p.m. Eastern. Under the law, CMS is required to publish the list of up to 10 Medicare Part D drugs it selects for negotiation by September 1.

FDA Issues Warning Letters on Unapproved Skin Infection Treatments

The Food and Drug Administration (FDA) has issued six warning letters, including several to the nation’s major retailers, about the selling of unapproved products labeled to treat molluscum contagiosum. There are currently no over-the-counter products approved to treat the viral skin infection, which is common in children. The letters require the companies to respond within 15 days with evidence that they are no longer selling the products or that their sale is not in violation of FDA regulations, or risk further action by the agency.

Conservative Think Tanks Prepare Health Plans Ahead of 2024 Election

Paragon Health, the Heritage Foundation, and America First Policy Institute are at work drafting health policies in anticipation of the 2024 presidential election. Axios reported last week on work by the conservative think tanks to prepare health care policies and consider potential appointees should a Republican retake the White House next year. The plans include a focus on the use of association health plans, Medicaid block grants, site neutral payments, and an expansion of Trump-era transparency regulations.

WaPo Explores Geographic Distribution of Physician Income

The Washington Post published a recent article exploring the geographic distribution of physician income and why the nation’s highest paid doctors work in the Dakotas. While the nationwide average is $405,000, the average physician in their prime earning years (age 40 to 55) made $524,000 annually in South Dakota, while in North Dakota they made $468,000. Other rural states – Alaska, Wyoming, and Nebraska – round out the top five states for physician pay. The article suggests that the lack of competition in rural America may be responsible in part for these disparities in doctor pay, along with Medicare’s subsidization of seniors’ health care costs and the lack of variation in the program’s reimbursement rates for physician work from state-to-state.

Recently Introduced Health Legislation

H.R.5237 – To require the Comptroller General of the United States to submit a report on the effects of the fentanyl crisis, and for other purposes; Sponsor: Fry, Russell [Rep.-R-SC-7]; Committees: House – Energy and Commerce

H.R.5247 – To amend title 38, United States Code, to improve the authority of the Secretary of Veterans Affairs to hire psychiatrists; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Veterans’ Affairs

H.R.5256 – To amend title XVIII of the Social Security Act to provide payment under part A of the Medicare Program on a reasonable cost basis for anesthesia services furnished by an anesthesiologist in certain rural hospitals in the same manner as payments are provided for anesthesia services furnished by anesthesiologist assistants and certified registered nurse anesthetists in such hospitals, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Ways and Means

H.R.5259 – To direct the Secretary of Defense to include in periodic health assessments of members of the Armed Forces an evaluation of whether the member has been exposed to perfluoroalkyl substances and polyfluoroalkyl substances, and for other purposes; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

H.R.5261 – To direct the Secretary of Defense to provide to each health care provider of the Department of Defense training regarding the potential health effects of perfluoroalkyl or polyfluoroalkyl substances; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

Senate Majority Leader Chuck Schumer (D-N.Y.) has expressed support for a continuing resolution (CR) extending through early December to fund the federal government and avoid a government shutdown when current funding runs out at the end of the fiscal year (FY) on September 30. The Senate is scheduled to be in session only 17 days before the FY 2024 appropriations bills need to be passed, and the House will be in session only 12 days. Schumer stated that he has already spoken with House Speaker Kevin McCarthy (R-Calif.) about the passage of a stopgap spending measure as government funding negotiations continue. McCarthy himself recognized the need for such a temporary measure during a GOP conference call last week. The Speaker underscored the importance of the short-term bill lasting no later than early December.

Congress has used CRs to extend government funding through December in each of the last three years. This year, the House of Representatives has passed just one of the 12 annual appropriations bills, legislation to fund Military Construction, Veterans Affairs, and related agencies, while the Senate has passed none but reported all 12 bills out of committee before the August recess. Republicans in the House continue to have internal disagreements regarding overall spending levels and policy riders, such as those related to the politicization of the Department of Justice, abortion, and border security. Government funding negotiations could be further complicated by the need to attach the administration’s supplemental funding request – which is expected to be increased to account for growing disaster aid costs to respond to destructive wildfires in Hawaii – to a CR.

The latest debt limit deal included a provision to trigger a 1% across the board discretionary spending cut if the government is not fully funded by January 1. Senators are scheduled to return from August recess on September 5 and House members on September 12. Congress must also reauthorize by September 30 the SUPPORT Act, the Pandemic and All-Hazards Preparedness Act, the Children’s Hospitals Graduate Medical Education Program, and extend funding for the Community Health Center Fund.

WH Outlines R&D Priorities for FY 2025 Budget

The Biden administration is asking federal agencies to prioritize achieving better health outcomes in any research and development projects they might propose for funding in fiscal year (FY) 2025. The White House Office of Science and Technology Policy and the Office of Management and Budget (OMB) sent a memo on Thursday outlining R&D priorities for FY 2025 budget requests to OMB. The guidance includes funding activities related to the President’s Cancer Moonshot Initiative (with a focus on early detection, novel therapies, and prevention), antibiotic resistance and infectious outbreaks, preventing exposure to harmful chemicals, and mitigating the health effects of climate change.

Senate Democrats Comment on FDA’s Proposed Opioid Disposal Requirements

Agroup of ten Senate Democrats have sent a letter urging the Food and Drug Administration (FDA) to expand upon its proposed prescription opioid disposal policies. The agency’s April proposal, aimed at preventing abuse of and exposure to prescription opioids, would require patients be provided with mail-back envelopes and safe-disposal education when they are prescribed opioids in the outpatient setting. The lawmakers suggest that the FDA include a requirement for an at-home disposal option as well, highlighting that rural patients may not have regular access to the mail. The letter was led by Sens. Martin Heinrich (D-N.M.), Jon Tester (D-Mont.), and Patty Murray (D-Wash.). Comments on the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy are due by August 28.

ProPublica Reports on Hidden Payment Processing Fees

ProPublica published an article last week shedding light on the payment processing fees charged by insurers when they pay physicians for their work electronically. The creation of these fees follows the shift from paper to electronic processing and the subsequent growth of the payment processing industry. Public records requests made by New York urologist Alex Shteynshlyuger to the Centers for Medicare and Medicaid Services (CMS) revealed federal officials frequently deferring to the payment processing company Zelis, employer of a former CMS staffer and author of current federal standards for paying doctors via electronic funds transfers. In his capacity as vice president of legislative affairs at Zelis, Matthew Albright convinced CMS that a 2000 regulation prohibiting insurers from charging excessive fees for direct transactions did not apply to payment processors. The article details how physicians are often automatically enrolled in higher-fee payment methods without their consent. When they ask to by paid by paper check, insurers often resume electronic payments and the associated fees against the wishes of the provider. Payment processors argue their service offers doctors increased convenience and efficiency, allowing them to be reimbursed by many insurers through a single payment processor. The reporting highlights a survey which found that nearly 60% of medical practices are compelled to pay fees for electronic payment at least some of the time. A separate poll found that these fees can cost larger medical practices as much as $1 million each year.

Recently Introduced Health Legislation

H.R.5183 – To amend title XVIII of the Social Security Act to provide for coverage of cancer care planning and coordination under the Medicare program. Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Energy and Commerce; Ways and Means.

H.R.5206 – To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

H.R.5207 – To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

H.R.5208 – To amend the Internal Revenue Code of 1986 to clarify the treatment of locum tenens physicians and advanced care practitioners as independent contractors to help alleviate physician shortages, including in underserved areas. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Ways and Means

H.R.5212 – To amend the Federal Fire Prevention and Control Act of 1974 to make available under the assistance to firefighters grant program the establishment of cancer prevention programs, and for other purposes. Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Science, Space, and Technology

H.R.5213 – To ensure that prior authorization medical decisions under Medicare are determined by physicians. Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Ways and Means; Energy and Commerce

The Biden administration released its request for $40 billion in supplemental funding for fiscal year 2024 last week. The supplemental budget request to Congress includes approximately $24 billion for continued aid to Ukraine. These emergency funds would not be subject to budget caps, and are likely to meet strong Republican opposition on the Hill. The request to meet critical needs also includes $350 million to support the Substance Abuse and Mental Health Services Administration and the federal response to the overdose epidemic. The money would be directed to states and territories via the State Opioid Response Grant program. The Indian Health Service would receive $50 million for the provision of substance use treatment and prevention services. Approximately $800 million of the $40 billion would be put toward efforts to reduce the supply of illegal fentanyl through the departments of Justice and Homeland Security.

Cassidy Urges Correct Implementation of Surprise Billing Law

Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) has sent a letter to Secretary of Health and Human Services Xavier Becerra urging the administration to correctly implement the No Surprises Act. Cassidy argues that rather “than implement the criteria as written in the statute, the Centers for Medicare and Medicaid Services took artistic license” and “deviated from the criteria,” which has resulted in numerous legal disputes. The letter outlines the adverse patient impacts that have resulted from the administration’s flawed implementation of the 2021 law and highlights the “lack of consistent, standardized information flow between parties and the absence of timely payments once a payment determination has been made.” Cassidy poses a series of over 40 questions covering issues including the qualifying payment amount, ensuring timely and accurate payments, the independent dispute resolution process, batching challenges, the administrative fee, and audit and enforcement authorities, and requests a response from Secretary Becerra by September 15.

Lawmakers Question Nonprofit Hospital Abuse of Tax-Exempt Status

Abipartisan group of senators are asking the Biden administration to investigate nonprofit hospitals’ compliance with community benefit requirements. These hospitals receive tax exemptions in exchange for community benefits – the provision of free or discounted care to low-income individuals. Sens. Elizabeth Warren (D-Mass.), Raphael Warnock (D-Ga.), Bill Cassidy (R-La.), and Chuck Grassley (R-Iowa) sent letters to the Internal Revenue Service and Treasury Department calling for an examination of the approximately $28 billion in nonprofit hospital tax exemptions. The lawmakers highlight concerns that the definition of community benefits is overly broad, allowing “some nonprofit hospitals to avoid providing essential care in the community for those who need it most.” The letter calls for the government to update the forms hospitals file to disclose charity care and to identify hospitals whose tax-exempt status was revoked and those that were audited or deemed at risk for non-compliance with charity care requirements.

Intelligence Chair Warner Comments On Google Medical Language Model

Senate Intelligence Committee Chairman Mark Warner (R-Va.) has sent a letter to the CEO of Google asking him to increase transparency, strengthen privacy, and establish ethical guardrails around the company’s medical language model dubbed Med-PaLM2. Warner cites reports of inaccuracies in the model, arguing that “premature deployment of unproven technology could lead to the erosion of trust in our medical professionals and institutions, the exacerbation of existing racial disparities in health outcomes, and an increased risk of diagnostic and care-delivery errors.” Google, which made Med-PaLM 2 available to a limited number of health care organizations for testing, has previously stated that users of its technology retain complete control of their data.

HHS Announces Funding to Grow Nursing Workforce

The U.S. Department of Health and Human Services (HHS) has announced that it will award more than $100 million to strengthen the nation’s nursing workforce. Nearly $65 million will be put toward advanced nursing education and nurse practitioner residency and fellowship programs. Another $26 million will be used to recruit and retain more nursing faculty. Approximately $9 million will support the training of licensed practice nurses to become registered nurses. The funding announcement is a part of a broader effort at HHS to grow the nation’s health care workforce.

UnitedHealthcare to Scale Back Use of Prior Authorization

Effective September 1 and November 1, UnitedHealthcare will move forward with a plan to reduce its overall volume of prior authorization requirements by 20% for the vast majority of its commercial and Medicaid members. The company has detailed which procedures would no longer be subject to prior authorization, including hundreds of codes for genetic testing. UnitedHealthcare also plans to implement a gold card program starting next year, which would eliminate prior authorization requirements for physicians with high approval rates. Cigna and Aetna have recently announced similar intentions to scale back some of their prior authorization requirements.

New WaPo Analysis of Physician Spread of COVID Misinformation

The Washington Post released a report last week investigating complaints against U.S. doctors for the spread of COVID-19 misinformation. The investigation’s survey of all 50 state medical boards found at least 480 COVID-19 misinformation related complaints. Only 20 doctors were officially sanctioned for their behavior, with five losing their licenses and only one having their license revoked. These providers often promoted unproven treatments like ivermectin and hydroxychloroquine for the treatment of COVID-19, or spread false statements about the use of vaccines and masks.

Recently Introduced Health Legislation

H.R.5138 – To amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Ways and Means; Energy and Commerce

H.R.5142 – To amend the Public Health Service Act to make updates to the Vaccine Injury Compensation Program, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce

H.R.5143 – To amend the Internal Revenue Code of 1986 to provide authority to add additional vaccines to the list of taxable vaccines; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Ways and Means

H.R.5150 – To direct the Secretary of Defense to submit to Congress a report evaluating beneficiary access to TRICARE network pharmacies; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

H.R.5151 – To require responsiveness testing of Defense Logistics Agency pharmaceutical contracts; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

H.R.5159 – To amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means; Energy and Commerce

H.R.5163 – To amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce; Judiciary

H.Res.649 – Calling on the United States to champion a regional artificial intelligence strategy in the Americas to foster inclusive artificial intelligence systems that combat biases within marginalized groups and promote social justice, economic well-being, and democratic values; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Foreign Affairs; Science, Space, and Technology

H.R.5165 – To amend title XIX of the Social Security Act to allow States more flexibility with respect to using contractors to make eligibility determinations and redeterminations on behalf of the State Medicaid plan, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

When Congress returns from recess in September, lawmakers will begin work to reconcile the differences between the two versions of the must- pass $886 billion National Defense Authorization Act (NDAA) advanced by each chamber earlier this summer. The Senate-passed annual defense authorization bill (S. 2226) does not include several contentious provisions attached to the House legislation. The House-passed defense policy bill (H.R. 2670) would prohibit time off and travel allowances for service members seeking abortions. It would also block military health insurance from covering gender hormone treatments or sex reassignment surgeries for transgender individuals.

The Senate is scheduled to reconvene on September 5, and the House is scheduled to return on September 12. In addition to passing the Pentagon spending measure, Congress has a lengthy list of other expiring programs and must-pass legislation to complete before September 30, including fiscal year (FY) 2024 government funding, the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, animal drug user fee reauthorization, President’s Emergency Plan for AIDS Relief (PEPFAR) reauthorization, and funding for public health programs (community health centers, National Health Service Corps, Children’s Hospitals Graduate Medical Education, etc.).

Wyden Issues Letters on ADHD Medication Shortages

Senate Finance Committee Chairman Ron Wyden (D-Ore.) has sent a letter calling on makers of ADHD medication to either increase manufacturing or relinquish their remaining federal quota allotment to permit other manufacturers to produce more than their allotted quota of amphetamine and amphetamine products. According to a joint statement from the Food and Drug Administration and Drug Enforcement Administration (DEA), manufacturers are on track to fall one billion doses below quota. “The following actions are urgently needed,” Wyden argues. “Companies with spare quota allotments should relinquish them to the DEA so the DEA can approve applications from companies that have requested an increase; companies with excess production capacity that have met their quota allotment should apply for an increase; and manufacturers should sufficiently report voluntary and required information on their production, so the agencies have a complete understanding of how the shortage is being resolved and potential future shortages.”

Select Coronavirus Panel to Probe Vaccine Mandates

The House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic has launched an investigation into the development and implementation of vaccination policies and mandates. The panel plans to explore whether regulations stemming from the U.S. Department of Health and Human Services, the Department of Defense, and the Department of Labor stopped the spread and transmission of the coronavirus. According to Chairman Brad Wenstrup, DPM (R-Ohio), the panel will explore how the mandates came to be to inform congressional action in the case of a future pandemic.

Dr. Jeanne Marrazzo Named New Head of NIAID

Dr. Jeanne Marrazzo has been named the new director of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham. She is expected to begin her role as NIAID Director in the fall. She will replace Hugh Auchincloss, Jr., M.D., who has served as acting director of NIAID after long-time director Anthony S. Fauci, M.D., stepped down in December 2022. Dr. Marrazzo’s research has focused on the human microbiome, specifically as it relates to female reproductive tract infections and hormonal contraception; prevention of HIV infection using biomedical interventions; and the pathogenesis and management of bacterial vaginosis, sexually transmitted diseases in HIV-infected persons, and management of antibiotic resistance in gonorrhea. Dr. Marrazzo is a Fellow of the American College of Physicians and of the Infectious Diseases Society of America and is board certified in infectious diseases.

White House Launces New Pandemic Preparedness Office

The White House announced the launch of the Office of Pandemic Preparedness and Response (OPPR) Policy last week. It will be a permanent office in the Executive Office of the President charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the US. OPPR will take over the duties of the current COVID-19 Response Team and Mpox Team at the White House and will continue to coordinate and develop policies and priorities related to pandemic preparedness and response. Major General (ret) Paul Friedrichs has been selected as the office’s inaugural director. Friedrichs previously served as Joint Staff Surgeon at the Pentagon and as medical adviser to the Department of Defense Covid-19 Task Force.

HHS Announces Formation of Long COVID Office

The U.S. Department of Health and Human Services (HHS) has launched a new Office of Long COVID Research and Practice. The office will coordinate the federal government’s response to the long-term effects and associated conditions of COVID-19. The Office of Long COVID Research will be located within HHS’s Office of the Assistant Secretary for Health under the leadership of the HHS Assistant Secretary for Health, Admiral Rachel Levine. The Office is charged with on-going coordination of the whole-of-government response to the longer-term effects of COVID-19, including Long COVID and associated conditions and the implementation of the National Research Action Plan on Long COVID and the Services and Supports for Longer-Term Impacts of COVID-19. Fourteen federal departments currently engage on long COVID, including over a dozen HHS Operating and Staff Divisions with the goal of reducing the impacts of long COVID by improving quality of life for people living with long COVID and reducing disparities related to long COVID.

March of Dimes Releases New Data on Maternal Care Deserts

The nation saw a 4% decline in the number of hospitals offering labor and delivery services between 2019 and 2020, according to new data from the March of Dimes. This figure captures significant disparities across the nation – with Alabama and Wyoming losing nearly 25% of their birthing hospitals during this time, and Idaho, Indiana, and West Virginia losing nearly 10%. Approximately 5.6 million women currently reside in counties with no access to maternity care, while 32 million women are at risk of poor health outcomes because of a lack of nearby maternity care options. The March of Dimes characterizes more than one-third of all U.S. counties as maternal care deserts because of their lack of access to reproductive health services. The problem is particularly acute in rural areas and states that have not expanded their Medicaid programs. The U.S. currently has the worst maternal mortality rate among developed nations. The impact of the Supreme Court’s overturning of Roe v. Wade on maternal health remains unclear, as the report relies on data gathered in 2020 and 2021 prior to the Supreme Court’s ruling.

POLICY BRIEFINGS

Recently Introduced Health Legislation

H.R.5074 – To amend the American Taxpayer Relief Act of 2012 to delay implementation of the inclusion of oral-only ESRD-related drugs in the Medicare ESRD prospective payment system. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

H.R.5076 – To clarify that, in awarding funding under title X of the Public Health Service Act, the Secretary of Health and Human Services may not discriminate against eligible States, individuals, or other entities for refusing to counsel or refer for abortions. Sponsor: Cole, Tom [Rep.-R-OK-4]; Committees: House – Energy and Commerce

H.R.5077 – To establish the National Artificial Intelligence Research Resource, and for other purposes. Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Science, Space, and Technology

H.R.5080 – To amend the Internal Revenue Code of 1986 to exclude certain Nurse Corps payments from gross income. Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Ways and Means

H.R.5093 – To amend title XVIII of the Social Security Act to preserve sole community hospital determinations made by the Secretary of Health and Human Services, and for other purposes. Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Ways and Means

H.Res.639 – Supporting the goals and ideals of “Minority Mental Health Awareness Month” and recognizing the disproportionate impacts of mental health conditions and struggles on minority populations and communities; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

H.Res.640 – Addressing the national crisis of suicide among minority adolescents; Sponsor: Espaillat, Adriano [Rep.-D- NY-13]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.5116 – To amend the Public Health Service Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

H.R.5128 – To amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means; Energy and Commerce