This Week in Washington: House appropriators release FY2025 topline appropriations levels; Senate Finance Committee releases white paper on Medicare physician payment reforms; House Energy and Commerce Committee Subcommittee on Health marks up 21 bills.

House

House Appropriators Release FY2025 Topline Funding Amounts

On May 16, House appropriators released topline funding amounts for the fiscal year (FY) 2025 appropriations bills. The proposed funding levels total roughly $1.6 trillion and would increase defense spending by 1 percent and decrease non-defense spending by 6 percent. The funding levels are lower than the spending caps agreed to in the debt limit deal from last year.

House appropriators are proposing to allocate:

  • $25.9 billion to the Food and Drug Administration and related agencies; and
  • $184. 6 billion to the Department of Health and Human Services and related agencies.

In addition, House appropriators released the markup schedule of bills and announced they are aiming to approve them by mid-July.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Marks Up 21 Bills

On May 16, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 21 bills that extend Medicare telehealth flexibilities, facilitate rare pediatric disease innovation, improve the Medicaid enrollment process for out-of-state providers and strengthen Medicaid fraud prevention.

The bills are:

H.R. 3433, Give Kids a Chance Act: Amends the Federal Food, Drug and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations.

H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act: Requires the Department of Health and Human Services Secretary (HHS Secretary) to conduct a national, evidence-based education campaign to increase public and healthcare provider awareness regarding the potential risks and benefits of human cell and tissue products transplants.

H.R. 6033, Supporting Patient Education and Knowledge (SPEAK) Act of 2023: Requires the HHS Secretary to establish a task force to improve access to healthcare information technology for non-English speakers.

H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024: Establishes a Medicare incident to modifier for mental health services furnished through telehealth.

H.R. 7623, Telehealth Modernization Act of 2024: Makes certain telehealth flexibilities under the Medicare program permanent.

H.R. 1406, Sustainable Cardiopulmonary Rehabilitation Services in the Home Act: Permanently extends certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19.

H.R. 7856, PREVENT DIABETES Act: Provides for coverage of the Medicare Diabetes Prevention program.

H.R. 5394, Expanding Remote Monitoring Access Act: Ensures appropriate access to remote monitoring services furnished under the Medicare program.

H.R. 1199, Facilitating Innovative Nuclear Diagnostic Act of 2023: Ensures equitable payment and preserves Medicare beneficiary access to diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system.

H.R. 6020, Honor Our Living Donors Act: Eliminates consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals.

H.R. 455, To amend the Controlled Substances Act to fix a technical error in the definitions: Amends the Controlled Substances Act to fix a technical error in the definitions.

H.R. 7213, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2024: Enhances activities of the National Institutes of Health with respect to research on autism spectrum disorder and reauthorizes programs relating to autism.

H.R. 670, Think Differently Database Act: Directs the HHS Secretary to establish a clearinghouse on intellectual disabilities.

H.R. 8084, LIVE Beneficiaries Act: Requires States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly.

H.R. 8089, Medicare and Medicaid Fraud Prevention Act of 2024: Requires certain additional provider screening under the Medicaid program.

H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Ensures the reliability of address information provided under the Medicaid program.

H.R. 8112, To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 4758, Accelerating Kids’ Access to Care Act: Streamlines enrollment under the Medicaid program of certain providers across State lines.

H.R. 3227, Ensuring Seniors’ Access to Quality Care Act: Amends titles XVIII and XIX of the Social Security Act with respect to nursing facility requirements.

H.R. 468, Building America’s Health Care Workforce Act: Extends the COVID-19 Emergency Declaration Blanket Waiver relating to training and certification of nurse aides.

H.R. 4534, Women and Lung Cancer Research and Preventive Services Act: Requires the HHS Secretary and Secretaries of Defense and Veterans Affairs, to conduct an interagency review to evaluate the status of and identify opportunities related to research on women and lung cancer.

For more information, click here.

House Committee on Oversight and Accountability Marks Up BIOSECURE Act

On May 15, the House Committee on Oversight and Accountability marked up and reported out of committee nine bills, including H.R. 8333, the BIOSECURE Act. The legislation would prohibit federal agencies from contracting with or procuring equipment or supplies from certain foreign-owned biotechnology providers after 2032.

In March, the Senate Homeland Security and Governmental Affairs Committee reported out of committee a version of the bill with a shorter timeline.

For more information, click here.

Senate

Senate Finance Committee Chairman and Ranking Member Release White Paper on Medicare Doctor Payment Reform

On May 17, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a white paper on Medicare Doctor Payment Reform. The white paper outlines potential policy reforms to streamline clinician payment systems that include:

  • Creating sustainable payment updates to ensure clinicians can own and operate their practices;
  • Incentivizing alternative payment models that reward providing better care at a lower cost;
  • Rethinking how Medicare measures quality care;
  • Improving primary care;
  • Supporting chronic care benefits in Medicare fee-for-service; and
  • Ensuring continued access to telehealth.

For more information, click here.

Senate HELP Committee Majority Staff Release Report Concerning Weight Loss Drug Spending

On May 15, the Senate Health, Education, Labor and Pensions Committee majority staff released a report concerning the impact weight loss drugs could have on prescription drug spending. The majority staff used data on drug net pricing and uptake percentage to assess potential impacts.

The majority staff found that if 50 percent of adults with obesity took weight loss drugs, total spending could equal $411 billion per year and cost the Medicare and Medicaid programs $166 billion per year. The majority staff also found that lower weight loss drug prices could significantly reduce total spending.

For more information, click here.

Senate HELP Committee Schedules Markup of Seven Healthcare Bills

On May 23, the Senate Health, Education, Labor and Pensions Committee will mark up seven healthcare bills that will reauthorize programs relating to Alzheimer’s disease, child emergency medical services, poison control programs and lifespan respite care. The bills are:

S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Act through fiscal year 2029 to promote the use of mental health and substance use disorder services by healthcare providers.

S. 3765, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children program through fiscal year 2029.

S. 4351, A bill to amend the Public Health Service Act to reauthorize certain poison control programs: Reauthorizes certain poison control programs through fiscal year 2029.

S. 3775, BOLD Infrastructure for Alzheimer’s Reauthorization Act of 2024: Reauthorizes the Building Our Largest Dementia Infrastructure for Alzheimer’s Act through fiscal year 2029.

S. 4325, A bill to amend the Public Health Service Act to reauthorize the program relating to lifespan respite care, and for other purposes: Reauthorizes the Lifespan Respite Care program through fiscal year 2029.

S. 3757, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes the Centers for Disease Control and Prevention’s Congenital Heart Disease, Research, Surveillance and Awareness Program through fiscal year 2029.

S. 4045, East Palestine Health Impact Monitoring Act of 2024: Requires the Secretary of Health and Human Services to award a grant, contract or cooperative agreement to an eligible entity to study the public health impacts resulting from the February 2023 train derailment in East Palestine, OH.

For more information, click here.

Senate AI Working Group Releases Roadmap for AI Policy

On May 15, the Senate Bipartisan Artificial Intelligence (AI) Working Group released the Roadmap for Artificial Intelligence Policy. The roadmap outlines considerations for committees of jurisdiction that are developing legislation concerning AI.

The roadmap encourages committees to:

  • Ensure appropriate guardrails and safety measures are implemented to protect patients from fraud and abuse;
  • Support the National Institutes of Health in developing and improving AI technologies;
  • Make healthcare and biomedical data available for machine learning and data science research;
  • Ensure that the Department of Health and Human Services and other healthcare agencies have the tools to weigh the benefits and risks of AI-enabled products; and
  • Promote innovation of AI systems and examine Centers for Medicare and Medicaid Services’ reimbursement mechanisms to strengthen accountability, appropriate use and broad application of AI in all populations.

For more information, click here.

Senate Judiciary Committee Announces Hearing on Prescription Drug Access and Affordability

On May 21, the Senate Judiciary Committee will hold a hearing on prescription drug market competition, accessibility and affordability. Witnesses are:

  • William Feldman, MD, DPhil, MPH, Associate Physician at the Brigham and Women’s Hospital Division of Pulmonary and Critical Care Medicine
  • David Mitchell, President and Founder of Patients for Affordable Drugs
  • Adam Mossoff, Professor of Law at the George Mason University Antonin Scalia Law School
  • Arti Rai, Elvin R. Latty Duke Law Distinguished Professor of Law
  • Jocelyn Ulrich, Vice President of Policy and Research at PhRMA

For more information, click here.

Senate HELP Committee Holds Hearing on Dental Care

On May 16, the Senate Health, Education, Labor and Pensions Committee held a hearing on dental care. Committee members discussed factors that could be exacerbating dental care issues, including the lack of affordable dental insurance, oral health workforce pipelines and incentives for providers to offer rural dental care services. Witnesses were:

  • Lisa Simon, Associate Physician of Brigham and Women’s Hospital and Member of the Harvard Medical School Faculty
  • Myechia Minter-Jordan, MD, MBA, President and CEO of CareQuest Institute for Oral Health
  • Brian Jeffrey Swann, DMD, MPH, Co-Chair of the National Dental Association Global Oral Health Outreach and Member of the Remote Area Medical Board of Directors
  • Gordon Roswell Isbell, III, DMD, MAGD, Past Trustee of the Academy of General Dentistry

For more information, click here.

Senate Finance Committee Holds Hearing on Rural Healthcare

On May 16, the Senate Finance Committee held a hearing to discuss rural healthcare challenges. During the hearing, Chairman Ron Wyden (D-OR) stated that the committee could begin working on permanently extending telehealth flexibilities. Witnesses were:

  • Michael Topchik, Executive Director of the Chartis Center for Rural Health
  • Jeremy P. Davis, MHA, President and Chief Executive Officer of Grande Ronde Hospital
  • Lori Rodefeld, MS, Director of GME Development at the Wisconsin Collaborative for Rural Graduate Medical Education
  • Keith J. Mueller, Ph.D., Gerhard Hartman Professor of Health Management and Policy and Director of the Rural Policy Research Institute

For more information, click here.

Pay PCPs Act Introduced

On May 15, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Whitehouse (D-RI) introduced the Pay PCPs Act. This legislation would:

  • Establish a hybrid Medicare payment system that would reward primary care providers based on patient health outcomes;
  • Reduce cost-sharing for patients who participate in certain primary care activities and services; and
  • Create a new technical advisory committee to help the Centers for Medicare and Medicaid Services (CMS) determine Medicare fee schedule rates.

In addition, the senators have issued a request for information on what the structure and makeup of the advisory committee should be and how CMS can strengthen its role in setting fee-for-service payment rates.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH reforms.

House

House Ways and Means Committee Marks Up Telehealth Legislation

On May 8, the House Ways and Means Committee marked up and reported out of committee six bills that preserve telehealth and health-at-home service flexibilities, prevent rural hospital closures, strengthen ambulance service access and expand the number of doctors and nurses in rural communities.

The bills are:

H.R. 8261, Preserving Telehealth, Hospital and Ambulance Access Act: Expands Medicare telehealth flexibilities for two years, Hospital-at-Home flexibilities for five years and Medicare supplemental payments for rural hospitals and ambulance services.

H.R. 7931, Preserving Emergency Access in Key Sites (PEAKS) Act: Permanently expands Medicare emergency ambulance coverage for mountainous communities.

H.R. 8245, Rural Hospital Stabilization Act: Establishes grants to help rural hospitals stabilize their finances and carry out minor renovations, care delivery training and equipment acquisition.

H.R. 8244, Ensuring Seniors’ Access to Quality Care Act: Allows nursing homes to continue operating their certified nurse assistant training program if they incur fines, so long as the fines are unrelated to direct resident care.

H.R. 8235, Rural Physician Workforce Preservation Act: Ensures 10 percent of the 1,200 Medicare Graduate Medical Education slots reserved for rural hospitals are appropriately distributed.

H.R. 8246, Second Chances for Rural Hospitals Act: Expands Rural Emergency Hospital (REH) eligibility by allowing hospitals that have been closed since 2014 to become a REH and receive additional funding.

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Concerning ASPR Management of SNS Funding

On May 9, House Energy and Commerce Committee Chairman Cathy McMorris Rogers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Assistant Secretary for Preparedness and Response Dawn O’Connell, concerning the Administration for Strategic Preparedness and Response’s (ASPR) management of supplemental funding for the strategic national stockpile (SNS).

The chairmen are concerned that ASPR has:

  • Inadequately managed SNS funding;
  • Awarded few vendor-managed inventory contracts to resupply SNS products; and
  • Granted SNS warehouse contracts to companies lacking technical expertise.

For more information, click here.

Forty Representatives Send Letter Concerning Hospice Benefit Integrity Issues

On May 7, Rep. Blumenauer (D-OR) and 39 other representatives sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure regarding deficiencies, fraud and abuse among hospice providers enrolled in the Medicare program.

The members are concerned that fraudulent hospice providers are enrolling in and receiving payments from the Medicare program and are urging CMS to strengthen its oversight of hospice programs.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Announces Hearing with FDA Officials

On May 22, the House Energy and Commerce Committee Subcommittee on Health will hold a hearing to discuss the Food and Drug Administration’s (FDA) regulation of drugs, biologics and medical devices. The directors of the FDA Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research and Center for Devices and Radiological Health will testify.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Releases White Paper Outlining Possible NIH Reforms

On May 9, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) released a white paper on the National Institutes of Health (NIH), outlining proposals to modernize and reform NIH transparency, research integrity and grant management.

The ranking member is urging the NIH to:

  • Facilitate biomedical competition and innovation;
  • Utilize artificial intelligence to prioritize grants;
  • Reorganize the Intramural Research Program;
  • Address inconsistencies in research claims; and
  • Implement new oversight tools to identify grant compliance violations.

For more information, click here.

Sen. Marshall to Reintroduce Improving Seniors’ Timely Access to Care Act

On May 8, Sen. Marshall (R-KS) announced that he will reintroduce the Improving Seniors’ Timely Access to Care Act. This legislation would shift Medicare Advantage prior authorization to an electronic system and establish a real-time decision process.

The bill passed the House in Sept. 2022 but did not pass the Senate due to a Congressional Budget Office (CBO) cost estimate that predicted the bill would cost $16 billion to implement. However, the release of a Centers for Medicare and Medicaid Services final rule establishing an electronic prior authorization system resulted in the CBO reducing the bill’s cost estimate to zero.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for Childhood Arrivals (DACA) recipients.

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Medicaid Proposals

On April 30, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals aimed at improving Medicaid program access and integrity. One of the proposals would prohibit the Centers for Medicare and Medicaid Services’ (CMS) minimum nursing home staffing rule from being implemented.

The proposals are:

H.R. 124, Byron Nash Renal Medullary Carcinoma Awareness Act of 2023: Supports education on the risk of renal medullary carcinoma for individuals with sickle cell disease eligible to receive care under Medicaid.

H.R. 468, Building America’s Health Care Workforce Act: Extends nursing home waivers to retain temporary nurse aides for more than 120 days and allows competency requirement evaluations to be conducted at nursing homes that employ temporary nurse aides.

H.R. 670, Think Differently Database Act: Establishes a publicly available clearinghouse within the Department of Health and Human Services (HHS) to improve accessibility of health service information and resources for individuals with intellectual disabilities.

H.R. 3227, Ensuring Seniors’ Access to Quality Care Act: Modifies requirements that prohibit nursing homes subject to civil monetary penalties from running nurse aide training and competency evaluations, so long as the facility has addressed deficiencies and has not been found to have deficiencies related to patient harm or quality of care for more than two years.

H.R. 7513, Protecting America’s Seniors Access to Care Act: Prohibits the Secretary of HHS from finalizing regulations that would require long-term care facilities to adhere to minimum staffing standards.

H.R. 7573, Stop Unfair Medicaid Recoveries Act: Repeals the requirement that States establish a Medicaid Estate Recovery Program and limits the ability of States to place liens on a Medicaid beneficiary’s property.

H.R. 8084, To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly, and for other purposes: Requires States to perform quarterly verifications of the Social Security Administration’s Death Master File and disenroll deceased individuals enrolled for medical assistance under the State plan.

H.R. 8089, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires certain additional provider screening under the Medicaid program.

H.R. 8094, To amend title XIX of the Social Security Act to modify certain asset recovery rules: Modifies asset recovery under a State plan and allows States to choose to not pursue adjustments or recoveries of medical assistance through property liens, if after the death of an individual, the individual’s home would be transferred to another individual who is eligible for Medicaid or has an income that is 138 percent of the Federal Poverty Level or below.

H.R. 8106, To amend title XIX of the Social Security Act to remove the requirement that an individual need an institutional level of care in order to qualify for home and community-based services under a Medicaid waiver: Amends waivers to allow States to provide home and community-based services (HCBS) to beneficiaries who do not meet an institutional level of care and requires States to report on the state of waiting lists for HCBS care.

H.R. 8107, To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities: Amends the Medicaid buy-in program to repeal the eligibility pathway age limit of 65 to allow current beneficiaries to continue to be able to retain coverage through the program.

H.R. 8108, To amend title XIX of the Social Security Act to require medical assistance under the Medicaid program for certain home and community-based services for military families: Requires States that currently provide Medicaid coverage for HCBS to dependents of military families to maintain the coverage for care in the event that the family moves out of state for active duty.

H.R. 8109, To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration: Permanently extends the Money Follows the Person rebalancing demonstration to support the transition from living in an inpatient facility to HCBS, for long-term services and supports-eligible individuals.

H.R. 8110, To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid: Permanently extends spousal impoverishment protections for beneficiaries receiving HCBS.

H.R. 8111, To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program: Streamlines processes for States and managed care organizations to update address information for currently enrolled beneficiaries to ensure that beneficiaries reside in the State.

H.R. 8112, To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program: Requires states to check the CMS Data Exchange database to identify providers who have been removed from participating in the Medicaid program.

H.R. 8113, To amend title XIX of the Social Security Act to require reporting on certain directed payments under the Medicaid program: Requires States to report on provider-level data from amounts paid by the State through state-directed payments.

H.R. 8114, To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare and Medicaid Services to place certain limitations on Medicaid payments for home and community-based services: Prohibits the Secretary of HHS from finalizing regulations that would require pass-through payment requirements for HCBS.

H.R. 8115, To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid: Establishes enforcement mechanisms for the Secretary of HHS to make partial deferrals of payments to Medicaid managed care organizations to ensure compliance with federal laws.

For more information, click here.

House Ways and Means Committee To Mark Up Two-Year Telehealth Extension

On May 8, the House Ways and Means Committee will mark up a two-year extension of Medicare telehealth flexibilities that are set to expire at the end of the year. The House and Senate have been discussing whether flexibilities should be extended or made permanent.

House Veterans Affairs Committee Mark Up Includes Six Healthcare Bills

On May 1, the House Veterans Affairs Committee marked up and reported out of committee 21 bills, including six healthcare bills regarding preventative health evaluations, medical facilities and quality management and administrative investigations. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs (VA) drug formulary.

The bills are:

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major VA medical facility projects for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increases access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the VA.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the VA.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

In addition, the committee marked up 15 bills concerning veteran benefits, work study opportunities, employment barriers, claims and appeals processes and fraud prevention efforts.

For more information, click here.

Senate

Senate Finance Committee Releases Discussion Draft Concerning Generic Drug Shortages

On May 3, the Senate Finance Committee released a discussion draft to address and mitigate generic drug shortages. The draft would establish a voluntary Medicare Drug Shortage Prevention and Mitigation Program that would require participants to meet minimum standards and requirements to receive Medicare incentive payments. They include:

  • Minimum three-year contracts with generic drug manufacturers;
  • Purchase volume and stable pricing commitments;
  • Contingency contracts with alternate manufacturers;
  • Prohibition of exclusive provider contracting requirements; and
  • Transparency standards to address quality control issues.

In addition, the draft would modify the Medicaid Drug Rebate Program to allow for reductions or waivers to the inflation rebate for certain generic drugs in the event of a shortage.

The committee is requesting comments on the proposal. Comments are due by June 6.

For more information, click here.

Twenty-Two Senators Send Letter Concerning VA Access to Non-Opioid Pain Alternatives

On April 16, Sen. Jeanne Shaheen (D-NH) and 21 other senators sent a letter to Department of Veterans Affairs (VA) Secretary Denis McDonough concerning access to non-opioid pain alternatives throughout the VA healthcare system.

The senators are urging the VA to stop utilizing opioid treatments for acute pain and are requesting information on the:

  • Number of non-opioid pain alternatives currently on the VA National Formulary;
  • Steps the VA has taken to transition away from opioids to treat acute pain;
  • Frequency at which VA facilities and community care sites dispense and use non-opioid pain alternatives; and
  • Actions Congress could take to help facilitate VA efforts.

For more information, click here.

Senate HELP Committee Holds Hearing on Minority Healthcare Professional Shortages and Maternal Mortality

On May 2, the Senate Health, Education, Labor and Pensions Committee held a hearing to discuss the shortage of minority healthcare professionals and maternal mortality. During the hearing, Ranking Member Bill Cassidy (R-LA) urged the Senate Finance Committee to expand and allocate graduate medical education residency slots in underserved communities. Witnesses were:

  • The Honorable Laphonza Butler, United States Senator, California
  • The Honorable Michael C. Burgess, MD, United States Congressman, Twenty-Sixth Congressional District of Texas
  • Yolanda Lawson, MD, President of the National Medical Association
  • Samuel Cook, MD, Resident at the Morehouse School of Medicine
  • Michael Galvez, MD, Valley Children’s Hospital, Co-Creator of National Latino Physician Day
  • Jaines Andrades, DNP, AGACNP-BC, Nurse Practitioner at Baystate Health
  • Brian Stone, MD, FACS, President of Jasper Urology Associates

For more information, click here.

Senate Armed Services Committee Subcommittee on Personnel Holds Hearing on DOD Prescription Drug Shortage Capabilities

On April 30, the Senate Armed Services Committee Subcommittee on Personnel held a hearing to examine Department of Defense (DOD) biomedical research and development capabilities and discuss how the department addresses prescription drug shortages. Members also discussed the possibility of granting DOD authority to manufacture prescription drugs to combat shortages. Witnesses were:

  • The Honorable Lester Martínez-López, Assistant Secretary of Defense for Health Affairs, Department of Defense
  • David J. Smith, Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, Department of Defense
  • Mark Dertzbaugh, Principal Assistant for Research and Technology, United States Army Medical Research and Development Command
  • Matthew R. Beebe, Director of Acquisition (J7), Defense Logistics Agency
  • Melissa Barber, Postdoctoral Fellow, Yale Law School, Yale School of Medicine and Affiliate, Yale Collaboration for Regulatory Rigor, Integrity and Transparency
  • Bryce H. P. Mendez, Specialist in Defense Health Care Policy, Congressional Research Service
  • Colonel Victor A. Suarez, USA (Ret.), Founder and Principal Growth Partner, Blu Zone Bioscience and Supply Chain Solutions, LLC.

For more information, click here.

MACPAC Chair and Appointed Members Announced

On May 2, Government Accountability Office Comptroller General Gene L. Dodaro announced the appointment of a new chairman and two members, in addition to the reappointment of four members, to the Medicaid and Children’s Health Insurance Program Payment and Access Commission (MACPAC). They are:

  • Verlon Jones, MPA, Executive Vice President and Chief Safety Officer at Acentra Health and MACPAC Chair
  • Robert Duncan, MBA, Executive Vice President and Chief Operating Officer at Connecticut Children’s Hospital-Hartford, MACPAC Vice Chair
  • Doug Brown, RPh, MBA, Senior Vice President of Value and Access at COEUS Consulting
  • Michael Nardone, MPA, Former Director of the Disabled and Elderly Health Program Group at the Centers for Medicare and Medicaid Services Center for Medicaid and CHIP Services
  • Heidi Allen, PhD, MSW, Associate Professor at Columbia University School of Social Work
  • John McCarthy, MPA, Founding Partner at Speire Healthcare Strategies

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: CMS releases SNF minimum staffing standards final rule; Senate HELP Committee chairman requests information on Ozempic and Wegovy pricing; HHS OCR releases final rule concerning HIPAA reproductive healthcare privacy.

House

House Budget Committee Chairman Requests GAO Investigation of CMMI

On April 25, House Budget Committee Chairman Jodey Arrington (R-TX) and House Budget Committee Healthcare Task Force Chairman Michael Burgess (R-TX) sent a letter to Government Accountability Office (GAO) Comptroller General Gene L. Dodaro, requesting the GAO investigate whether Center for Medicare and Medicaid Innovation (CMMI) payment models will decrease net federal spending for Medicare.

The chairmen are concerned that the models will increase federal spending despite initial estimates that they would decrease spending. A September 2023 Congressional Budget Office report revealed that CMMI activities increased spending by $5.4 billion between 2011 and 2020 despite projections that they would save $2.8 billion.

For more information, click here.

House Members Urge HHS to Ensure Coverage of CDC-Recommended Vaccines Without Cost-Sharing

On April 19, Reps. Eshoo (D-CA), Bucshon (R-IN), Trone (D-MD) and Garamendi (D-CA) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, concerning commercial coverage of vaccines recommended by the Centers for Disease Control and Prevention (CDC).

The members state that final regulations issued by HHS and the Departments of Labor and Treasury that limit health insurance coverage of vaccines to those that are considered “routine,” defy congressional intent and the Public Health Services Act requirement that all CDC-recommended vaccines be covered without cost-sharing. The members are urging HHS to align the final regulations with the statutory requirement.

For more information, click here.

House Energy and Commerce Committee Oversight and Investigations Subcommittee to Hold Hearing on Change Healthcare Cyberattack

On May 1, the House Energy and Commerce Committee Oversight and Investigations Subcommittee will hold a hearing to examine the Change Healthcare cyberattack. The UnitedHealth Group Chief Executive Officer will testify.

For more information, click here.

Senate

Senate HELP Committee Chairman Requests Information on Ozempic and Wegovy Pricing

On April 24, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) sent a letter to Novo Nordisk Chief Executive Officer Lars Fruergaard Jørgensen, concerning the list and net prices of Ozempic and Wegovy.

The chairman is requesting information on the:

  • Costs and volumes of the drugs sold;
  • Prices paid by government payers;
  • Revenue Novo Nordisk has made from selling the drugs;
  • Manner in which prices are determined; and
  • Research and development expenditures linked to the drugs.

For more information, click here.

Sanders Long COVID Proposal Receives Mixed Comments

On April 9, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) released a draft proposal concerning Long COVID and requested stakeholder feedback. The proposal has received mixed comments from stakeholders who are divided over the proposal’s funding levels and on whether other chronic conditions should be addressed in the bill.

The Long COVID Moonshot Advocacy Group has requested that the proposal’s funding be used to study infection-associated chronic conditions and illnesses but the Long COVID Foundation has expressed concern that the funding is inadequate. The Long COVID Action Project and the Long COVID Foundation have requested that these conditions be addressed by separate legislation.

Senate Finance Committee to Hold Hearing on Change Healthcare Cyberattack

On May 1, the Senate Finance Committee will hold a hearing to examine the Change Healthcare cyberattack. The UnitedHealth Group Chief Executive Officer will testify.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing concerning improper payments.

Congress

House

House Energy and Commerce Committee Chairmen and Ranking Members Request Information on Impacts of Change Healthcare Cyberattack

On April 15, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), in addition to Ranking Member Frank Pallone (D-NJ) and two subcommittee ranking members Anna Eshoo (D-CA) and Kathy Castor (D-FL) sent a letter to UnitedHealth Group Chief Executive Officer Sir Andrew Witty concerning the Change Healthcare cyberattack.

The chairmen and ranking members are requesting information on the actions UnitedHealth took to address and resolve the attack and on the outreach it conducted to inform the healthcare community of potential disruptions.

For more information, click here.

House Veterans Affairs Committee Subcommittee on Health Marks Up 11 Healthcare Bills

On April 16, the House Veterans Affairs Committee Subcommittee on Health marked up and reported out of committee 11 healthcare bills, including bills related to emergency transportation, maternal health and hyperbaric oxygen therapy. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs drug formulary.

The bills are:

H.R. 3584, Veterans CARE Act: Directs the Secretary of Veterans Affairs (VA Secretary) to conduct and support research on the efficacy and safety of medicinal cannabis.

H.R. 3644, ACT for Veterans Act: Extends the authorization period for emergency treatment in non-Department of Veterans Affairs medical facilities under the Veterans Community Care Program.

H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act: Directs the VA Secretary to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder.

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 5530, VA Emergency Transportation Access Act: Prohibits the VA Secretary from making changes to the Department of Veterans Affairs rate of payment or reimbursement provided for transportation of veterans and other eligible individuals on special modes of transportation.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major medical facility projects for the Department of Veterans Affairs for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the Department of Veterans Affairs.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

H.R. 3303, Maternal Health for Veterans Act: Supports programs of the Department of Veterans Affairs relating to the coordination of maternity healthcare.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Health Sector Cybersecurity

On April 16, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss healthcare cybersecurity practices and vulnerabilities. Subcommittee members also discussed the possibility of amending HIPAA to give healthcare entities more clearinghouse options following a cyberattack. The Change Healthcare cyberattack prompted the subcommittee to look into this. Witnesses were:

  • Greg Garcia, Executive Director for Cybersecurity at the Healthcare Sector Coordinating Council
  • Robert Sheldon, Senior Director of Public Policy and Strategy at CrowdStrike
  • John Riggi, National Advisor for Cybersecurity and Risk at the American Hospital Association
  • Scott MacLean, Board Chair for the College of Healthcare Information Management Executives (CHIME)
  • Adam Bruggeman, MD, Orthopedic Surgeon at Texas Spine Center

For more information, click here.

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing Concerning Improper Payments

On April 16, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss improper Medicare and Medicaid payments. The hearing focused on the fiscal implications of improper payments and ways to strengthen their oversight. Witnesses were:

  • The Honorable Gene Dodaro, Comptroller General of the Government Accountability Office
  • The Honorable Christi Grimm, Inspector General of the Department of Health and Human Services
  • Timothy Hill, MPA, Medicaid and CHIP Payment and Access Commission Member
  • Michael Chernew, Ph.D, Medicare Payment Advisory Commission Chair

For more information, click here.

House Appropriations Committee Agriculture, Rural Development and FDA Subcommittee Holds Hearing on President’s FY2025 FDA Budget Request

On April 18, the House Appropriations Committee Agriculture, Rural Development and Food and Drug Administration (FDA) Subcommittee held a hearing to discuss the president’s fiscal year 2025 budget request for the FDA. The FDA Commissioner testified.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Sends Letter Concerning FDA Classification of CDS Software

On April 17, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf concerning the September 2022 final guidance, which seeks to regulate clinical decision support (CDS) software as a medical device.

The ranking member believes that the FDA’s categorization of CDS as a medical device disregards congressional intent and may jeopardize access to advanced tools used to improve patient care. Congress excluded CDS software from being categorized as a medical device in the 21st Century Cures Act.

For more information, click here.

Senate Finance Committee Majority Staff Release Report on State Attorneys General Misusing Authority to Obtain Transgender Care Records

On April 16, the Senate Finance Committee majority staff released a report concerning transgender healthcare record requests by state attorneys general in Tennessee, Indiana, Missouri and Texas. The majority staff reviewed information on such requests and how medical providers responded to them.

The majority staff discovered that some state attorneys general are misusing their Medicaid investigative and consumer protection authorities to obtain sensitive health records of teens and adults seeking gender-affirming care. The staff also found that some providers complied with the request for health records while others refused, citing patient privacy concerns.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care Hospital Prospective Payment System proposed rule.

Congress

House

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Telehealth Service Proposals

On April 10, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals concerning telehealth service access, reimbursement and geographic restrictions. The proposals were:

H.R. 134, To amend Title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services: Allows any location in the United States, including a beneficiary’s home, to be considered an originating site for the purpose of furnishing telehealth services under Medicare.

H.R. 1110, KEEP Telehealth Options Act of 2023: Requires the Department of Health and Human Services Secretary (HHS Secretary) to publish a report on the provision of telehealth services under Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) during the COVID-19 emergency and requires the Medicare Payment and Medicaid and CHIP Payment Advisory Commissions to study the risk of fraudulent activities related to the expansion of telehealth.

H.R. 3432, Telemental Health Care Access Act of 2023: Eliminates certain geographic restrictions and in-person Medicare coverage requirements to promote access to mental and behavioral telehealth services.

H.R. 3875, Expanded Telehealth Access Act: Permanently expands practitioner eligibility for payment for telehealth services under Medicare to include physical therapists, speech-language pathologists, audiologists and occupational therapists and assistants.

H.R. 4189, CONNECT for Health Act of 2023: Removes the geographic requirements for telehealth originating sites, expands the scope of originating sites, allows more practitioners to furnish telehealth services and removes geographic restrictions on telehealth services furnished by Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) to improve Medicare reimbursement of telehealth services.

H.R. 5541, Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act: Temporarily allows authorized healthcare professionals to provide mental health telehealth services across state lines during a declared national emergency.

H.R. 5611, Helping Ensure Access to Local Telehealth (HEALTH) Act of 2023: Allows Medicare coverage of telehealth services to include audio-only communications, implements a permanent payment system for telehealth services furnished by FQHCs and RHCs and eliminates originating site requirements for telehealth services furnished by them.

H.R. 6033, Supporting Patient Education and Knowledge (SPEAK) Act of 2023: Directs the HHS Secretary to convene a task force to assess barriers and develop recommendations to improve access to health information systems for non-English speakers.

H.R. 7149, Equal Access to Specialty Care Everywhere (EASE) Act of 2024: Requires the Center for Medicare and Medicaid Innovation to conduct a pilot program that would assess the impact of furnishing certain specialty healthcare services through telehealth and other remote technologies.

H.R. 7623, the Telehealth Modernization Act of 2024: Makes certain telehealth flexibilities permanent under Medicare by removing geographic restrictions, expanding eligibility for practitioners, retaining the waiver process for modifying telehealth services covered under Medicare, implementing a permanent payment system for telehealth services furnished by RHCs and FQHCs, allowing clinically appropriate use of telehealth for hospice care and home dialysis and allowing the use of audio-only telecommunications technology.

H.R. 7711, Advancing Access to Telehealth Act: Removes Medicare telehealth geographic restrictions, allows the use of audio-only telecommunications technology and eliminates in-person requirements for certain services furnished through telehealth.

H.R. 7858, Telehealth Enhancement for Mental Health Act of 2024: Directs the HHS Secretary to implement a coding modifier to identify telehealth claims for services that are key components of the care process and furnished by non-physician clinicians or support staff.

H.R. 7856, the PREVENT DIABETES Act: Establishes a diabetes prevention program under Medicare and sunsets the Medicare Diabetes Prevention Program Expanded Model.

H.R. 7863, To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program: Requires the HHS Secretary to issue guidance for providers on best practices for furnishing behavioral health services via telehealth to Medicare beneficiaries with limited English proficiency.

H.R. , Hospital Inpatient Services Modernization Act: Extends regulatory flexibilities associated with the Hospital at Home programs to allow acute hospitals to provide certain inpatient services outside of the hospital setting.

For more information, click here.

House Republican Appropriators Announce Subcommittee Assignment Changes

On April 11, House Republican appropriators announced new subcommittee chair assignments, a day after the House Republican Conference elected Rep. Cole (R-OK) to become the next chairman of the House Appropriations Committee. They are:

  • Valadao (R-CA) as Legislative Branch Subcommittee Chairman;
  • Womack (R-AR) as Transportation-HUD Subcommittee Chairman; and
  • Joyce (R-OH) as Financial Services Subcommittee Chairman.

In addition, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced changes to the committee’s subcommittee assignments. They include:

  • Pence (R-IN) to join the Subcommittee on Environment, Manufacturing and Critical Materials and to leave the Subcommittee on Innovation, Data and Commerce;
  • Weber (R-TX) to serve as Vice Chair of the Subcommittee on Communications and Technology;
  • Allen (R-GA) to join the Subcommittee on Energy, Climate and Grid Security and to leave the Subcommittee on Innovation, Data and Commerce;
  • Balderson (R-OH) to join the Subcommittee on Health and to leave the Subcommittee on Communications and Technology;
  • Miller-Meeks to join the Subcommittee on Communications and Technology;
  • Obernolte (R-CA) to join the Subcommittee on Innovation, Data and Commerce and to leave the Subcommittee on Environment, Manufacturing and Critical Materials; and
  • James (R-MI) to join the Subcommittee on Innovation, Data and Commerce and the Subcommittee on Environment, Manufacturing and Critical Materials.

Senate

Senate HELP Committee Chairman Requests Comments on Long COVID Draft Proposal

On April 9, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) released a draft proposal concerning Long COVID. The draft proposal would:

  • Provide $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH) to respond to and address Long COVID;
  • Create a centralized coordinating entity for Long COVID research activities at the NIH;
  • Require the NIH to establish a new grant process for clinical trials related to Long COVID;
  • Establish an NIH Long COVID research advisory board and Long COVID database; and
  • Require federal entities to provide continued education and support on Long COVID risks.

The chairman is seeking comments on the proposal. Comments are due by April 23, 2024.

For more information, click here.

Senate Finance Committee Chairman Issues Statement on CMS MA and Part D Final Rule

On April 5, Senate Finance Committee Chairman Ron Wyden (D-OR) issued a statement in response to the release of a Centers of Medicare and Medicaid Services final rule concerning Medicare Advantage (MA) and Part D. The rule contains several policy changes recommended by the chairman.

In his statement, the chairman announced that the rule will strengthen protections against deceptive and high-pressure marketing practices for seniors, prohibit middlemen selling of seniors’ personal information, and ensure that MA plans provide access to mental health professionals.

For more information, click here.

Senate Finance Committee Holds Hearing on Medicare Physician Payment

On April 11, the Senate Finance Committee held a hearing to discuss Medicare physician payment and chronic care coverage. This hearing is considered a step towards considering physician payment reform. Witnesses were:

  • Amol Navathe, MD, Ph.D., Professor of Health Policy and Medicine at the University of Pennsylvania
  • Steven P. Furr, MD, FAAFP, President of the American Academy of Family Physicians
  • Patricia L. Turner, MD, MBA, FACS, Executive Director and Chief Executive Officer at the American College of Surgeons
  • Melanie Matthews, Chief Executive Officer of Physicians of Southwest Washington (PSW)

For more information, click here.

Senate Finance Committee Subcommittee on Health Care Holds Hearing on Federal Health Programs’ SUD Care

On April 9, the Senate Finance Committee Subcommittee on Health Care held a hearing to discuss how substance use disorder care in federal health programs can be improved. Witnesses were:

  • Brendan Saloner, Ph.D., Bloomberg Professor of American Health at the Johns Hopkins University Bloomberg School of Public Health
  • Malcolm Horn, Ph.D., LCSW, MAC, SAP, Chief Behavioral Health Officer at Rimrock Foundation
  • Sarah Bagley, MD, MSc, Associate Professor of Medicine and Pediatrics, Associate Program Director, Grayken Fellow in Addiction Medicine at the Boston Medical Center and Boston University Chobanian and Avedisian School of Medicine
  • Paul J. Christine, MD, Ph.D., Assistant Professor of Medicine at the University of Colorado School of Medicine and Denver Health

For more information, click here.

Preserving Emergency Access in Key Sites Act Introduced

On April 10, Sens. Machin (D-WV) and Capito (R-WV) introduced the Preserving Emergency Access in Key Sites (PEAKS) Act. The legislation would:

  • Allow Critical Access Hospitals (CAHs) in rural, mountainous areas to operate ambulatory services under a special enhanced Medicare payment model;
  • Reimburse CAHs for ambulatory services if there is no other ambulatory base within 15 miles of the facility; and
  • Ensure that a CAH located in a mountainous area does not lose its designation if a new facility is constructed within 15 miles.

A companion bill was introduced in the House by Reps. Miller (R-WV) and Caraveo (D-CO).

For more information, click here.

Welcome Back to the Health Care Workforce Act Introduced

On April 9, Sen. Kaine (D-VA) introduced the Welcome Back to the Health Care Workforce Act. The bill would direct the Health Resources and Services Administration to establish a grant program to:

  • Support communities in local- and state-level partnerships with healthcare organizations to connect internationally educated healthcare professionals with resources they need to enter the healthcare workforce;
  • Address barriers internationally educated healthcare professionals face when trying to enter the healthcare workforce;
  • Assist with obtaining overseas academic or training records and provide support throughout the U.S. licensing and credentialing process;
  • Develop work-force readiness, peer support, mentoring and career counseling opportunities; and
  • Create opportunities to complete prerequisite courses, education training and English-language learning.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress passes remaining appropriations bills; House Energy and Commerce Committee marks up 17 healthcare bills; CMS announces coverage for some Wegovy prescriptions.

Congress

House

Congress Passes Remaining Appropriations Bills

On March 22, Congress passed a $1.2 trillion funding package that included the Defense, Financial Services, Homeland Security, Labor-HHS-Education, Legislative Branch and State-Foreign Operations appropriations bills.

The Department of Health and Human Services will receive $117 billion, a $955 million dollar increase compared to last year. $48.6 billion will go towards the National Institutes of Health to improve Alzheimer’s, cancer, mental health and diabetes research. The funds will:

  • Support the 9-8-8 Suicide and Crisis Lifeline Program;
  • Bolster Organ Procurement and Transplantation Network Modernization Initiative reforms;
  • Strengthen Health Resources and Services Administration telehealth efforts;
  • Expand rural health grants; and
  • Increase efforts to counter the flow of illicit fentanyl.

Funding for the Advanced Research Projects Agency for Health and tuberculosis activities will remain flat and funding for family planning, global health and COVID-19 programs will be cut. The agreement includes a legacy ban on using federal funds to match patients to their health records with a unique ID and a requirement for HHS to report on COVID-19 countermeasure claims that have not been resolved in the vaccine injury compensation program.

Not included in the appropriations package were proposals addressing pharmacy benefit managers, healthcare transparency and community health center funding increases.

House Energy and Commerce Committee Marks Up 17 Healthcare Bills

On March 20, the House Energy and Commerce Committee marked up and reported out of committee 17 healthcare bills concerning emergency medical services, Alzheimer’s caregiver and patient support, poison control centers, cancer screening programs and lifespan respite care.

The bills were:

H.R. 619, NAPA Reauthorization Act: Reauthorizes the National Alzheimer’s Project through 2035, updates the project’s purpose and expands the membership and reporting requirements of the Advisory Council on Alzheimer’s Research, Care and Services.

H.R. 620, Alzheimer’s Accountability and Investment Act: Requires the National Institutes of Health (NIH) to continue to submit an annual budget estimate to Congress to achieve the initiatives and goals included in the National Plan to Address Alzheimer’s Disease.

H.R. 7218, Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act of 2024: Reauthorizes programs focused on improving Alzheimer’s disease and other related dementia education, early detection, diagnosis, patient and caregiver support, risk reduction and other activities at currently appropriated levels for fiscal years 2025 through 2029.

H.R. 4581, Maternal and Child Health Stillbirth Prevention Act of 2024: Clarifies that evidence-based activities and research focused on reducing the incidence of stillbirth are permissible uses of the Maternal and Child Health Services Block Grant.

H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act: Prohibits healthcare providers from denying or restricting an individual’s access to organ transplants solely on the basis of the individual’s disability, except in limited circumstances.

H.R. 4646, SIREN Reauthorization Act: Reauthorizes and modifies the Rural Emergency Medical Services Training and Equipment Assistance Program for fiscal years 2024 through 2028.

H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program: Reauthorizes the Lifespan Respite Care Program through fiscal year 2028. The Lifespan Respite Care Program empowers coordinated state systems to provide accessible, community-based respite care services for family caregivers of children and adults.

H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children Program for fiscal years 2024 through 2029.

H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Protection Act which works to prevent suicide and burnout, as well as address mental and behavioral health conditions among healthcare professionals. The legislation would direct the HHS Secretary to prioritize the allocation of resources for healthcare professional mental health and substance use disorder services.

H.R. 7251, Poison Control Centers Reauthorization Act of 2024: Reauthorizes certain poison control programs including the maintenance of the national toll-free phone number, the promotion of poison control center utilization and the maintenance of a program that awards grants to accredited poison control centers.

H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask and Respond to Health and Wellness Training Program: Reauthorizes the Stop, Observe, and Respond to Health and Wellness Training Program through fiscal year 2029. The program trains healthcare and social service providers to identify potential human trafficking victims and work with law enforcement as well as address other issues related to human trafficking.

H.R. 7208, Dennis John Beningo Traumatic Brain Injury Program Reauthorization Act: Reauthorizes certain Traumatic Brain Injury (TBI) programs aimed at improving TBI prevention, patient advocacy systems and access to TBI rehabilitation.

H.R. 6829, Cardiomyopathy Health Education, Awareness, and Research, and AED Training in the Schools (HEARTS) Act of 2024: Directs HHS to develop and distribute educational materials regarding cardiomyopathy, automated external defibrillators and cardiopulmonary resuscitation to school administrators, educators, health professionals and families. It would also direct the Centers for Disease Control and Prevention to report on its national cardiomyopathy surveillance and research activities to Congress.

H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes a national congenital heart disease research, surveillance and awareness program through fiscal year 2029.

H.R. 7406, DeOndra Dixon INCLUDE Project Act of 2024: Authorizes the NIH Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome Project and requires the NIH to report to Congress on the program’s progress and related research.

H.R. 3916, SCREENS for Cancer Act of 2024: Reauthorizes the National Breast and Cervical Cancer Early Detection Program through fiscal year 2028 and modifies and updates program reporting requirements.

H.R. 5074, Kidney PATIENT Act: Delays the implementation of the inclusion of oral-only End Stage Renal Disease (ESRD) drugs in the Medicare ESRD Prospective Payment System.

In addition, the committee marked up 11 bills concerning energy, infrastructure and communication technologies.

For more information, click here.

House Veterans’ Affairs Committee Subcommittee on Health Holds Hearing on Pending Healthcare Legislation

On March 21, the House Committee on Veterans’ Affairs held a legislative hearing to discuss pending healthcare bills. One of the bills concerns the inclusion of psychiatric drugs in the Department of Veterans Affairs drug formulary.

The bills were:

H.R. 3584, Veterans CARE Act: Directs the Secretary of Veterans Affairs (VA Secretary) to conduct and support research on the efficacy and safety of medicinal cannabis.

H.R. 3644, ACT for Veterans Act: Extends the authorization period for emergency treatment in non-Department of Veterans Affairs medical facilities under the Veterans Community Care Program.

H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act: Directs the VA Secretary to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder.

H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act: Directs the VA Secretary to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era.

H.R. 5530, VA Emergency Transportation Access Act: Prohibits the VA Secretary from making changes to the Department of Veterans Affairs rate of payment or reimbursement provided for transportation of veterans and other eligible individuals on special modes of transportation.

H.R. 6324, Fiscal Year 2024 Veterans Affairs Major Medical Facility Authorization Act: Authorizes major medical facility projects for the Department of Veterans Affairs for fiscal year 2024.

H.R. 6373, Veterans STAND Act: Directs the VA Secretary to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies.

H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs: Directs the VA Secretary to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs.

H.R. 3225, BUILD for Veterans Act of 2023: Improves the management and performance of the capital asset programs of the Department of Veterans Affairs.

H.R. 5794, Veterans Affairs Peer Review Neutrality Act of 2023: Eliminates conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration.

H.R. 5247, Expedited Hiring for VA Trained Psychiatrists Act of 2023: Improves the authority of the VA Secretary to hire psychiatrists.

H.R. 3303, Maternal Health for Veterans Act: Supports programs of the Department of Veterans Affairs relating to the coordination of maternity healthcare.

For more information, click here.

House Passes Bill to Extend CBO Cost Estimate Period for Preventive Healthcare Legislation

On March 19, the House passed H.R. 766, the Dr. Michael C. Burgess Preventive Health Savings Act. The legislation would require the Congressional Budget Office (CBO) to calculate the budgetary effects for 30 years for healthcare policies related to preventive care. The CBO currently limits its cost estimates to a single 10-year period. The reason for this move is that the CBO often scores preventive health policies as costing funds, which makes passage difficult because the provisions usually need to be paid for meaning that other services must be reduced. It is believed that a longer budget window estimate would show that in the out years the policies would save federal funds. It is unclear whether the Senate will take up the legislation.

House Energy and Commerce Committee Chairmen Request GAO Investigation of 9-8-8 Funding

On March 20, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro, requesting the GAO investigate funding for the 9-8-8 Suicide and Crisis Lifeline Program.

The chairmen are interested in knowing the extent to which states and grantees have used Substance Abuse and Mental Health Administration COVID-19 supplemental funding for the 9-8-8 program and are looking for information on how remaining funds will be used.

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Regulation of Clinical Tests

On March 21, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss diagnostic test regulation and the potential impacts of a proposed Food and Drug Administration rule that would classify in-vitro diagnostic products as devices and subject them to oversight under medical device authorities. Witnesses were:

  • Susan Van Meter, President of the American Clinical Laboratory Association (ACLA)
  • Zach Rothstein, JD, Executive Director of AdvaMedDx
  • Donald S. Karcher, MD, FCAP, President of the College of American Pathologists (CAP)
  • Jeff Allen, PhD, President and CEO of Friends of Cancer Research
  • Dara L. Aisner, MD, PhD, Medical Director at the Colorado Molecular Correlates Laboratory, Professor of Pathology at the University of Colorado and Representative of the Academic Coalition for Effective Laboratory Developed Tests

For more information, click here.

House Ways and Means Committee Holds Hearing on President’s FY2025 Budget Request for HHS

On March 20, the House Committee on Ways and Means held a hearing to discuss the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services. The Secretary of the Department of Health and Human Services testified.

For more information, click here.

House Appropriations Committee Holds Hearing on President’s FY2025 Budget Request for HHS

On March 20, the House Appropriations Committee held a hearing to discuss the President’s Fiscal Year 2025 Budget Request for the Department of Health and Human Services. The Secretary of the Department of Health and Human Services testified.

For more information, click here.

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Holds Hearing on Vaccine Safety Systems

On March 21, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing to discuss federal vaccine injury reporting and compensation systems. Witnesses were:

  • Patrick Whelan, M.D., Ph.D., Associate Clinical Professor of Pediatrics at the UCLA Division of Rheumatology
  • David Gortler, Pharm.D., Senior Research Fellow for Public Health Policy and Regulation at the Heritage Foundation
  • Renée Gentry, Director of the George Washington University Vaccine Injury Litigation Clinic
  • Yvonne “Bonnie” Maldonado, M.D., Chief of the Division of Infectious Diseases at the Stanford University School of Medicine Department of Pediatrics

For more information, click here.

Ninety-Six Representatives Send Letter Concerning Change Healthcare Cyberattack

On March 19, Rep. Miller-Meeks (R-IA) and 95 other representatives sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra regarding the Change Healthcare cyberattack.

In the letter, the members state that HHS should:

  • Ensure that timely payments are made to Medicare, Medicaid and Children’s Health Insurance Program providers;
  • Address the inability of patients to receive timely access to medications due to patient identity and eligibility verification disruptions; and
  • Continue its discussions with United Health Group, Change Healthcare and Optum.

For more information, click here.

Thirty-Nine Representatives Send Letter Concerning No Surprises Act Implementation

On March 20, Rep. Wenstrup (R-OH) and 38 other representatives sent a letter to Departments of Health and Human Services, Labor and Treasury Secretaries Xavier Becerra, Julie Su and Janet Yellen, concerning the implementation of the No Surprises Act.

The members are urging the departments to:

  • Enable parties to include or batch all items and services associated with a single patient encounter;
  • Require payors to share additional information with providers, including on whether a claim is eligible for the federal independent dispute process (IDR);
  • Create a process for the government to assist IDR entities to reduce any backlogs in processing disputes; and
  • Require that payors subject to the IDR process register with the departments and provide information concerning the applicability of the IDR process to items or services covered by the plan.

For more information, click here.

Republican Study Committee Releases FY2025 Budget Plan

On March 20, the Republican Study Committee released its fiscal year 2025 Budget Plan. Concerning healthcare reforms, the plan aims to:

  • Repeal the $35 price cap on insulin and the $2000 Inflation Reduction Act out-of-pocket cap;
  • Eliminate Medicare’s authority to negotiate prescription drug costs;
  • Transition the Medicare program to a premium support system;
  • Convert Medicaid, the Affordable Care Act, and the Children’s Health Insurance Program into five block grants and cut funding by $4.5 trillion over the next ten years;
  • Expand Health Savings Accounts and Association Health Plans; and
  • Allow the construction of new Physician Owned Hospitals.

For more information, click here.

Senate

Senate HELP Committee Ranking Member Sends Letter Concerning Change Healthcare Cyberattack

On March 21, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Tuberville (R-AL) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra concerning HHS’ response to the Change Healthcare cyberattack.

The senators are requesting information on the steps HHS has taken to respond to the attack and on how the agency has assisted providers who were unable to process or receive timely payments following the attack.

For more information, click here.

Health Care Cybersecurity Improvement Act of 2024 Introduced

In response to the Change Health cyberattack issues, on March 22, Sen. Warner (D-VA) introduced the Health Care Cybersecurity Improvement Act of 2024. The legislation would modify the Medicare Hospital Accelerated Payment and Medicare Part B Advance Payment programs to allow advance and accelerated payments to be made to healthcare providers in the event of a cyberattack so long as the provider and its vendors meet minimum cybersecurity standards.

For more information, click here.

Senators Send Letter Concerning Essential Health Benefits

On March 19, Sens. Kaine (D-VA), Baldwin (D-WI), Markey (D-MA), Smith (D-MN) and Luján (D-NM) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure concerning essential health benefits (EHB) coverage.

The senators are urging HHS to address EHB coverage gaps by initiating rulemaking to update and revise EHBs. They are urging HHS to institute a minimum standard of coverage that applies to every EHB category, establish a permanent structure for regularly reviewing and updating EHBs and expand the scope of services within the current EHB categories.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: President releases FY2025 Budget; House Energy and Commerce Committee Health Subcommittee marks up 19 healthcare bills; Senate Finance and HELP Committee Chairmen send letter concerning preventive care services cost-sharing; CMS issues guidance on Change Health cyberattack and advanced payments.

Congress

House

House Energy and Commerce Committee Subcommittee on Health Marks Up 19 Healthcare Bills

On March 12, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 19 healthcare bills concerning Alzheimer’s disease, cancer screenings, lifespan respite care, rural emergency services training, pediatric care services, maternal health and mental health and substance use disorder treatment programs.

The bills were:

H.R. 619, NAPA Reauthorization Act: Reauthorizes the National Alzheimer’s Project through 2035, updates the project’s purpose and expands the membership and reporting requirements of the Advisory Council on Alzheimer’s Research, Care and Services.

H.R. 620, Alzheimer’s Accountability and Investment Act: Requires the National Institutes of Health (NIH) to continue to submit an annual budget estimate to Congress to achieve the initiatives and goals included in the National Plan to Address Alzheimer’s Disease.

H.R. 7218, Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act of 2024: Reauthorizes programs focused on improving Alzheimer’s disease and other related dementia education, early detection, diagnosis, patient and caregiver support, risk reduction and other activities at currently appropriated levels for fiscal years 2025 through 2029.

H.R. 5012, SHINE for Autumn Act of 2023: Allows the Department of Health and Human Services (HHS) to award grants for data collection and reporting related to still births and requires HHS to issue guidelines and educational materials regarding proper training and processes for the collection of stillbirth data. The bill also requires HHS to establish a perinatal pathology fellowship program within an existing training program.

H.R. 4581, Maternal and Child Health Stillbirth Prevention Act of 2023: Clarifies that evidence-based activities and research focused on reducing the incidence of stillbirth are permissible uses of the Maternal and Child Health Services Block Grant.

H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act: Prohibits healthcare providers from denying or restricting an individual’s access to organ transplants solely on the basis of the individual’s disability, except in limited circumstances.

H.R. 4646, SIREN Reauthorization Act: Reauthorizes and modifies the Rural Emergency Medical Services Training and Equipment Assistance Program for fiscal years 2024 through 2028.

H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program: Reauthorizes the Lifespan Respite Care Program through fiscal year 2028. The Lifespan Respite Care Program empowers coordinated state systems to provide accessible, community-based respite care services for family caregivers of children and adults.

H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024: Reauthorizes the Emergency Medical Services for Children Program for fiscal years 2024 through 2029.

H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act: Reauthorizes the Dr. Lorna Breen Health Care Provider Protection Act which works to prevent suicide and burnout, as well as address mental and behavioral health conditions among healthcare professionals. The legislation would direct the HHS Secretary to prioritize the allocation of resources for healthcare professional mental health and substance use disorder services.

H.R. 7251, Poison Control Centers Reauthorization Act of 2024: Reauthorizes certain poison control programs including the maintenance of the national toll-free phone number, the promotion of poison control center utilization and the maintenance of a program that awards grants to accredited poison control centers.

H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program: Reauthorizes the Stop, Observe, and Respond to Health and Wellness Training Program through fiscal year 2029. The program trains healthcare and social service providers to identify potential human trafficking victims and work with law enforcement as well as address other issues related to human trafficking.

H.R. 7208, Traumatic Brain Injury Program Reauthorization Act of 2024: Reauthorizes certain Traumatic Brain Injury (TBI) programs aimed at improving TBI prevention, patient advocacy systems and access to TBI rehabilitation.

H.R. 6829, Cardiomyopathy Health Education, Awareness, Research and Training in the Schools (HEARTS) Act of 2023: Directs HHS to develop and distribute educational materials regarding cardiomyopathy, automated external defibrillators and cardiopulmonary resuscitation to school administrators, educators, health professionals and families. It would also direct the Centers for Disease Control and Prevention to report on its national cardiomyopathy surveillance and research activities to Congress.

H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024: Reauthorizes a national congenital heart disease research, surveillance and awareness program through fiscal year 2029.

H.R. 7406, DeOndra Dixon INCLUDE Project Act of 2024: Authorizes the NIH Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome Project and requires the NIH to report to Congress on the program’s progress and related research.

H.R. 3916, SCREENS for Cancer Act of 2023: Reauthorizes the National Breast and Cervical Cancer Early Detection Program through fiscal year 2028 and modifies and updates program reporting requirements.

H.R. 5074, Kidney PATIENT Act: Delays the implementation of the inclusion of oral-only End Stage Renal Disease (ESRD) drugs in the Medicare ESRD Prospective Payment System.

H.R. 5526, Seniors’ Access to Critical Medications Act of 2023: Makes permanent a waiver issued by the Centers for Medicare and Medicaid Services which allows Medicare patients to receive medications by mail and allows family members or caregivers to obtain medications on a patient’s behalf.

For more information, click here.

House Ways and Means Committee Holds Hearing Concerning Home Care Access in Rural and Underserved Communities

On March 12, the House Committee on Ways and Means held a hearing to discuss the challenges patients in rural and underserved communities face when accessing home care services. Announced witnesses were:

  • Bell Maddux, Home Dialysis Patient and Working Mother
  • Roy Underhill, Hospital at Home Patient
  • Nathan Starr, Medical Doctor and Lead Hospitalist of the Intermountain Healthcare Castell Home Services Tele-Hospitalist Program
  • Chris Altchek, Founder and CEO of Cadence
  • Ateev Mehrotra, Professor of Health Care Policy and Medicine at Harvard Medical School and Hospitalist at the Beth Israel Deaconess Medical Center

For more information, click here.

Telehealth Modernization Act of 2024 Introduced

On March 12, Reps. Carter (R-GA), Rochester (D-DE), Steube (R-FL), Sewell (D-AL), Miller-Meeks (R-IA), Van Drew (R-NJ) and Morelle (D-NY) introduced the Telehealth Modernization Act of 2024. The legislation seeks to ensure permanent access to telehealth services for Medicare beneficiaries and extends those flexibilities to federally qualified health centers and rural health clinics.

For more information, click here.

340B PATIENTS Act Introduced

On March 12, Rep. Matsui (D-CA) introduced the 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (340B PATIENTS) Act. The legislation would:

  • Clarify that manufacturers are required to offer 340B discount prices to covered entities regardless of the manner or location in which a drug is dispensed, including if a covered entity uses a contract pharmacy to dispense 340B drugs to the entity’s patients;
  • Ensure that manufacturers cannot place conditions on the ability of a covered entity to purchase and use 340B drugs, regardless of the manner or location in which the drug is dispensed, including through contract pharmacies; and
  • Impose civil monetary penalties on manufacturers that violate these statutory requirements and prohibitions.

For more information, click here.

Bipartisan Primary and Virtual Care Affordability Act Introduced

On March 13, Reps. Schneider (D-IL) and Wenstrup (R-OH) introduced the Bipartisan Primary and Virtual Care Affordability Act. The legislation seeks to enhance the affordability of primary care and telehealth for patients with high-deductible health plans.

For more information, click here.

Senate

Senate Finance and HELP Committee Chairmen Send Letter Concerning Preventive Care Service Cost-Sharing

On March 11, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) sent a letter to Departments of Health and Human Services, Labor and Treasury Secretaries Xavier Becerra, Julie Su and Janet Yellen, concerning health insurers and providers charging individuals cost-sharing for receiving preventive healthcare services.

The chairmen are concerned that insurers inappropriately charge patients for preventive services such as immunizations and HIV and colon cancer screenings. They urged the departments to issue guidance to address inappropriate cost-sharing and to audit Federally Facilitated Marketplace and employer-sponsored health insurers to ensure that preventative services are fully covered.

For more information, click here.

Senate HELP Committee Ranking Member Requests Information on Regulation of Clinical Tests

On March 13, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) announced that he is requesting information from stakeholders concerning how the regulation of clinical tests could be improved.

Specifically, Sen. Cassidy would like to know how the Food and Drug Administration’s regulatory framework for diagnostics and the Clinical Laboratory Improvement Advisory regulatory framework for laboratory-developed tests could be reformed and improved. Responses are due by April 3.

For more information, click here.

Senate Finance Committee Holds Hearing on the President’s FY2025 Budget Request for HHS

On March 14, the Senate Finance Committee held a hearing to discuss President Biden’s fiscal year 2025 budget request for the Department of Health and Human Services. The Secretary of the Department of Health and Human Services testified.

For more information, click here.

Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024 Introduced

On March 14, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sens. Carper (D-DE), Cornyn (R-TX), Warner (D-VA), Scott (R-SC) and Menendez (D-NJ) introduced the Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024.

The legislation seeks to improve coverage for individuals enrolled in Medicare and Medicaid, known as dual eligibles. The bill would:

  • Require each state to select, develop and implement a comprehensive, integrated health plan for dual-eligible beneficiaries;
  • Require plans to develop and update care coordination plans, establish ombudsman offices and provide a care coordinator for each beneficiary;
  • Reduce “look-alike” plans that target dual-eligible beneficiaries, create a single appeals process and reduce third-party marketing organization incentives to target beneficiaries;
  • Require every state to allow the establishment of the Program of All-Inclusive Care for the Elderly (PACE);
  • Allow enrollment in a PACE program at any time in the month; and
  • Expand PACE coverage to individuals under the age of 55.

For more information, click here.

Senate Committee on Homeland Security and Governmental Affairs Passes the Prohibiting Foreign Access to American Genetic Information Act of 2024

On March 6, the Senate Committee on Homeland Security and Governmental Affairs marked up and reported out of committee the Prohibiting Foreign Access to American Genetic Information Act of 2024. The legislation, sponsored by committee chairman Gary Peters (D-MI) and Sen. Hagerty (R-TN), would:

  • Ban all biotechnology companies that are owned or controlled by a foreign adversary’s government from receiving U.S. taxpayer dollars through federal contracts, grants and loans; and
  • Implement a fast-track ban on biotechnology companies with close ties to the Chinese Communist Party including the BGI Group, MGI, Complete Genomics, WuXi AppTec and their subsidiaries.

Similar legislation was introduced in the House by Reps. Gallagher (R-WI) and Krishnamoorthi (D-IL), the Chairman and Ranking Member of the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party.

For more information, click here.

MACPAC Releases March 2024 Report to Congress

On March 15, the Medicaid and Children’s Health Insurance Program Payment and Access Commission released its March 2024 Report to Congress. The report’s three chapters focus on:

  • Engaging beneficiaries through Medical Care Advisory Committees to inform Medicaid policymaking;
  • Denials and appeals in Medicaid Managed Care; and
  • Annual Analysis of Medicaid Disproportionate Share Hospital Allotments to States.

For more information, click here.

MedPAC Releases March 2024 Report to Congress

On March 15, the Medicare Payment Advisory Commission (MedPAC) released its March 2024 Report to Congress. The report outlines the recommendations MedPAC is making for updating traditional fee-for-service provider payment rates and for providing additional resources to acute care hospitals and clinicians who serve low-income Medicare beneficiaries.

The reports also contains information on the status of ambulatory surgical centers, the Medicare Advantage program and the Part D prescription drug program.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress passes six appropriations bills including skinny health package; House Ways and Means Committee reports bill to block CMS nursing home minimum staffing levels requirement; HHS requests information on private equity and corporate ownership in healthcare.

Congress

House

Congress Passes Six Appropriations Bills and Health Package

Last week, Congress passed the Agriculture-FDA, Commerce-Justice-Science, Energy-Water, Interior-Environment, Military Construction-VA and Transportation-HUD appropriations bills and a health package. The FDA is set to receive $6.72 billion, of which $50 million will go towards helping the agency prioritize cosmetics oversight, alternatives to animal testing and the mitigation of product shortages. The health package addresses several issues but did not include transparency legislation or pharmacy benefit manager reforms. The bill:

  • Reduces the Medicare physician fee cut by increasing payments 1.68 percent;
  • Provides $4.27 billion for community health centers;
  • Makes permanent a state plan amendment to circumvent the IMD exclusion;
  • Requires state Medicaid plans to cover state Medicaid assisted treatments;
  • Increases funding for the Special Diabetes Program, the Special Diabetes Program for Native Americans and graduate teaching medical programs;
  • Establishes behavioral health clinic services as an optional Medicaid benefit; and
  • Requires HHS to issue guidance on how states can improve integrating behavioral health with primary care.

House Ways and Means Committee Favorably Reports Bill that Would Block CMS Nursing Home Minimum Staffing Rule

On March 5, the House Ways and Means Committee marked up and reported out of committee the Protecting America’s Seniors’ Access to Care Act. The legislation would block the Centers for Medicare and Medicaid Services from finalizing a rule that would establish minimum staffing levels for skilled nursing facilities. The committee also reported for the full House to consider two other bills which were:

  • H.R. 5074, the Kidney PATIENT Act of 2023, which would delay the inclusion of oral-only end stage renal disease (ESRD) related drugs in the Medicare ESRD prospective payment system; and
  • H.R. 7512, the Real-Time Benefit Tool Implementation Act, which would implement real-time benefit tools under Part D of the Medicare Program.

For more information, click here.

House Budget Committee Marks Up FY 2025 Concurrent Resolution on the Budget

On March 7, the House Budget Committee marked up and reported out of committee the Fiscal Year 2025 Concurrent Resolution on the Budget. The concurrent resolution contains proposals that support site-neutral payment requirements, Medicaid work requirements and the creation of a bipartisan fiscal commission to address Medicare insolvency. It also contains proposals seeking to eliminate the Medicare Drug Price Negotiation Program and the Affordable Care Act tax credits. For more information, click here.

Protecting Americans’ Data from Foreign Adversaries Act of 2024 Introduced

On March 5, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone (D-NJ) introduced H.R. 7520, the Protecting Americans’ Data from Foreign Adversaries Act of 2024. In many respects, this bill codifies the executive order that President Biden issued on Feb. 28 concerning sensitive personal data. The legislation seeks to ban the sale, transfer or disclosure of Americans’ sensitive data, including health information, to foreign adversary countries or entities controlled by them.

Senate

Senate Finance Committee Chairman Sends Letter Concerning Medicaid and CHIP Unwinding

On March 5, Senate Finance Committee Chairman Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning the unwinding of Medicaid and Children’s Health Insurance Program continuous enrollment in states. The chairman and ranking member are concerned that errors in state eligibility and enrollment systems and operations are resulting in the disenrollment of millions of lower-income individuals and their children. They are jointly recommending that CMS require states to commit to specific plans to adopt sustainable, long-term system fixes and to make public state eligibility and enrollment operations data. For more information, click here.

Senators Send Letter Concerning March-In Rights

On March 4, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) led sixteen senators in sending a letter to National Institutes of Health (NIH) Director Monica Bertagnolli concerning a Biden administration proposal to use march-in rights to lower drug prices. The senators are concerned that the NIH’s use of march-in rights will dissuade drug manufacturers from partnering with the agency to develop new cures and treatments and will jeopardize patients’ access to them. In addition, the ranking member sent a letter to Government Accountability Office (GAO) Comptroller General Gene L. Dodaro, requesting that the GAO investigate whether the proposal meets the definition of a rule under the Congressional Review Act. To read the letter to the NIH Director, click here. To read the letter to the GAO Comptroller General, click here.

Sen. Warren Sends Letter to GlaxoSmithKline CEO Concerning Inhaler

On March 1, Sen. Warren (D-MA) sent a letter to GlaxoSmithKline (GSK) Chief Executive Officer Emma Walmsley concerning GSK’s decision to discontinue marketing its Flovent HFA inhaler and to replace it with its own authorized generic alternative. In the letter, Sen. Warren argues that GSK’s decision to discontinue the marketing of Flovent HFA is an attempt to circumvent provisions in the Inflation Reduction Act that require drug manufacturers to pay new rebates to Medicaid based on historical price increases for their drugs. The senator is requesting that GSK submit information concerning the average list and net prices of Flovent HFA and its generic alternative. For more information, click here.

Senate Budget Committee Holds Hearing on Primary Care

On March 12, the Senate Budget Committee held a hearing to discuss how primary care can improve the efficiency of healthcare. Announced witnesses were:

  • Christopher Koller, President of the Milbank Memorial Fund
  • Amol Navathe, Associate Professor at the University of Pennsylvania Perelman School of Medicine and the Wharton School
  • Bob Rauner, President of the Partnership for a Healthy Nebraska and Representative of the American Academy of Family Physicians
  • Lisa M. Grabert, Visiting Research Professor at the Marquette University College of Nursing
  • Christina Taylor, Chief Medical Officer of Clover Health Value Based Care and President-elect of the Iowa Medical Society

During the hearing, committee Chairman Sheldon Whitehouse (D-RI) introduced a discussion draft of a bill that would encourage the Centers for Medicare and Medicaid Services (CMS) to establish hybrid primary care payments under the Medicare program, provide Medicare beneficiaries with cost-sharing relief for certain primary care services and create a new technical advisory committee to help CMS more accurately determine Fee Schedule rates. For more information on the hearing, click here. For more information on the discussion draft, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.

This Week in Washington: Congress averts government shutdown; President issues executive order concerning foreign exploitation of health data; Sen. McConnell announces he is stepping down as leader at the end of the term; State of the Union on Thursday.

House

Congress Passes CR and Averts Government Shutdown

On Feb. 29, the House and Senate passed a continuing resolution (CR), averting a partial government shutdown. The CR pushes back the deadlines of the Agriculture-FDA, Commerce-Justice-Science, Energy-Water, Interior-Environment, Military Construction-VA and Transportation-HUD appropriations bills to March 8.

The CR also pushes back the deadlines of the Defense, Financial Services, Legislative Branch, Homeland Security, Labor-HHS-Ed and State-Foreign Operations appropriations bills to March 22. It remains unclear what policy riders, if any, the Agriculture-FDA and HHS funding bills will contain.

On March 3, the legislative text of six funding bills was posted. Among them was funding for the FDA. The language calls for the FDA to reallocate at least $50 million to prioritize cosmetics oversight, alternatives to animal testing and mitigation of product shortages. It is expected that this legislation will be acted on by the House this week.

Skinny Health Package Announced

On March 3, the text of a healthcare spending package was released. It includes a 1.68 percent payment increase to the Medicare Fee Physician Schedule, partially mitigating a 3.4 percent cut that went into effect January 1. The package also includes $4.27 billion for community health centers (CHCs), less than the House passed in the Lower Costs, More Transparency Act but higher than the roughly 4 billion dollar cost of current continuing funding levels. The bill funds CHCs from October 2023 to the end of calendar year 2024. It also makes permanent a state plan amendment option to circumvent the IMD exclusion and permanently requires state Medicaid plans to cover state Medicaid assisted treatment.

Notably, this would establish behavioral health clinic services as an optional Medicaid benefit and requires HHS to issue guidance on how states can improve integrating behavioral health with primary care. In addition, there is increased funding for the Special Diabetes Program and the Special Diabetes Program for Native Americans and an increase in funding for graduate teaching medical programs. Left behind are several health priorities including hospital site-neutral policies, pharmacy benefit manager reforms and full reauthorization of the Pandemic and All Hazards Preparedness Act. However, some of these policies could be addressed later this year.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Multiple Rare Disease Proposals

On Feb. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals concerning patient access to rare disease treatments and care. The proposals discussed include:

H.R. 1092, Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act: Modifies the new drug approval process by requiring the Food and Drug Administration (FDA) to utilize patient-experience data as part of the benefit-risk assessment framework.

H.R. 3433, Give Kids a Chance Act: Authorizes the FDA to require pediatric cancer trials for new drugs that are used in combination with active ingredients that meet the standard of care for targeting pediatric cancer or have been approved to treat adult cancer and are directed at molecular targets.

H.R. 4758, Accelerating Kids Access to Care Act: Permits enrollment under Medicaid for eligible out-of-state providers by enabling providers to enroll in state Medicaid programs without additional screening requirements.

H.R. 5539, Optimizing Research Progress Hope and New (ORPHAN) Cures Act: Expands and clarifies the exclusion for orphan drugs under the Drug Price Negotiation Program, allowing drugs that treat multiple rare diseases to maintain their orphan drug status and remain exempt from Medicare drug negotiations.

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act: Modifies the criteria for certain single source drugs to qualify for the Drug Price Negotiation Program after being approved for 11 years instead of 7 years.

H.R. 5663, ALS Better Care Act: Expands Medicare coverage to include relevant services for people diagnosed with amyotrophic lateral sclerosis and establishes a supplemental facility-based payment system that would cover outpatient services administered by a qualified provider.

H.R. 6020, Honor Our Living Donors Act: Prevents an organ recipient’s income from being considered when providing reimbursement for qualifying expenses incurred by a living organ donor during the donation process.

H.R. 6094, Providing Realistic Opportunity to Equal and Comparable Treatment (PROTECT) for Rare Act: Expands the definition of medically accepted indications in Medicare Part D and Medicaid to include treatments for rare diseases that are supported in peer-reviewed literature and clinical guidelines and do not otherwise have unfavorable reviews. The legislation also expedites coverage reviews for such treatments by private health insurers.

H.R. 6465, Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act: Modifies how plasma derived products are treated in relation to the Part D cost-sharing structure by phasing-in the increase in manufacturer rebates over five years under the existing pathway for small biotechnology manufacturers.

H.R. 6664, Innovation in Pediatric Drugs Act: Removes the existing exemption for orphan drugs to be studied in children after approval and authorizes the FDA to penalize companies that have not completed required pediatric studies on time. This legislation also increases funding for the National Institutes of Health Best Pharmaceuticals for Children’s Act program from $25 to $50 million through fiscal year (FY) 2027.

H.R. 6705, Effective Screening and Testing for Tuberculosis Act: Requires the Secretary of the Department of Health and Human Services (HHS) to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, and requires certain donor screening or testing to screen or test for active and latent tuberculosis.

H.R. 7188, Shandra Eisenga Human Cell and Tissue Product Safety Act: Requires the Secretary of HHS to conduct a national, evidence-based education campaign to increase public and healthcare provider awareness of the potential risks and benefits of human cell and tissue products transplants. This legislation also establishes civil monetary penalties for any person who violates human cell and tissue product requirements and requires the Secretary to submit a report on how the safety of such products could be improved.

H.R. 7248, FDA Modernization Act 3.0: Establishes a process for the qualification of nonclinical testing methods to replace the use of animals in nonclinical research.

H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act: Clarifies the FDA’s interpretation of limiting orphan drug exclusivity to the approved indication rather than the potentially broader designation.

H.R. 7384, Creating Hope Reauthorization Act of 2024: Extends the FDA priority review voucher program from FY 2024 through FY 2028 to incentivize the development of drugs for rare pediatric diseases.

H.R. 7436, Antimicrobial Resistance Research Assessment Act: Requires the Government Accountability Office to report on the efforts of the federal government to address antimicrobial resistance, including the roles of each federal program in these efforts and recommendations to improve coordination.

H.R. , Patient Access Act: Prevents antikickback penalties from being applied to certain travel and lodging arrangements made between a drug manufacturer and an individual who is prescribed such a drug.

H.R. , Sickle Cell Disease Comprehensive Care Act: Allows state Medicaid programs to establish health homes for eligible beneficiaries with sickle cell disease.

For more information, click here.

House to Vote on Healthcare Bills Under Suspension of the Rules

This week, the House is expected to vote on several healthcare bills under suspension of the rules, which prohibits amendments from being introduced, limits floor debate and requires a two-thirds majority vote for legislation to pass. The bills include:

H.R. 498, 9-8-8 Lifeline Cybersecurity Responsibility Act of 2023: Strengthens cybersecurity protections for the 9-8-8 suicide prevention hotline.

H.R. 3838, Preventing Maternal Deaths Reauthorization Act of 2023: Reauthorizes through fiscal year (FY) 2028, federal support for state-based efforts aimed at reducing disparities in maternal health outcomes and improving maternal mortality review committees.

H.R. 3821, Firefighter Cancer Registry Reauthorization Act of 2023: Reauthorizes the National Firefighter Registry for Cancer through FY 2028.

H.R. 3836, Medicaid Primary Care Improvement Act: Clarifies that Medicaid programs are authorized to provide primary care services through direct primary care arrangements.

H.R. 3843, Action for Dental Health Act of 2023: Reauthorizes state grants that support dental health workforce activities in areas that face dental health provider shortages, through FY 2028.

H.R. 3391, Gabriella Miller Kids First Research Act 2.0: Reauthorizes the National Institutes of Health pediatric research initiative through FY 2028 and requires the Department of Health and Human Services to report to Congress about research funded through the initiative.

H.R. 4510, NTIA Reauthorization Act: Reauthorizes the National Telecommunications and Information Administration through FY 2025 and supports the expansion of broadband, which is used extensively in telehealth.

S. 206, END FENTANYL Act: Requires the Commissioner of U.S. Customs and Border Protection to update and review policies and manuals used during inspections at ports of entry to improve the discovery of drug and human smuggling.

Senate

Senate Minority Leader Announces He is Stepping Down as Leader at End of Term

On Feb. 28, Senate Minority Leader Mitch McConnell (R-KY) announced that he will be stepping down from his role as leader of the Senate Republican Conference at the end of this term. McConnell has been leading Senate republicans since 2007.

Sen. Grassley Requests Floor Vote on PBM Bills

Sen. Grassley (R-IA) recently urged Senate Majority Leader Chuck Schumer (D-NY) to schedule floor votes on a series of pharmacy benefit manager (PBM) bills that Senate committees favorably reported last year, after he received an update from the Federal Trade Commission (FTC) considering its ongoing investigation of PBM business practices.

The FTC reported that it has been unable to conclude its ongoing investigation because six major PBMs have failed to submit documents and data concerning their use of drug manufacturer rebates and fees, creation of drug formularies and pharmacy reimbursements. The PBMs include CVS Caremark, Express Scripts, OptumRx, Humana Pharmacy Solutions, Prime Therapeutics and MedImpact Healthcare Systems.

Sen. Duckworth’s Attempt to Seek Unanimous Consent on IVF Bill Fails

On Feb. 28, in response to the Alabama Supreme Court’s ruling concerning in vitro fertilization (IVF), Sen. Duckworth (D-IL) sought to pass by unanimous consent the Access to Family Building Act, a bill she introduced in 2022 which would establish a federal protection for IVF access. However, the bill was blocked by Sen. Hyde-Smith (R-MS).

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.