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.

This Week in Washington: House Energy and Commerce Committee Subcommittee on Health holds hearing on a range of legislation concerning public health programs, patient wellbeing and caregiver support; HHS and FTC request information on group purchasing organization and drug wholesaler business practices.

House

House Energy and Commerce Committee Subcommittee On Health Holds Hearing on Multiple Patient and Caregiver Proposals

On Feb. 14, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss proposals aimed at improving public health, emergency medical services, maternal and pediatric health, disease research and prevention, support for family caregivers and access to care for patients.

The proposals were:

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. 7208, To reauthorize the Traumatic Brain Injury program: Reauthorizes certain Traumatic Brain Injury (TBI) programs aimed at improving TBI prevention, patient advocacy systems and access to TBI rehabilitation.

H.R. 7251, To amend the Public Health Service Act to reauthorize certain poison control programs: 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. 7153, To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes: 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 Secretary of the Department of Health and Human Services (HHS) to prioritize the allocation of resources for healthcare professional mental health and substance use disorder services.

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. 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. 7213, Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2024: Reauthorizes the Autism Coordination Committee, the Developmental Disabilities Surveillance and Research Program and other programs concerning autism education, early detection and intervention for fiscal years 2025 through 2029.

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. 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. 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. 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. 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. 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. 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 has address other issues related to human trafficking.

H.R. 7300, Reauthorization of the Family-to-Family Health Information Centers: Reauthorizes funding for family-to-family health information centers through fiscal year 2029.

H.R. 7268, DeOndra Dixon INCLUDE Project Act of 2024: Reauthorizes the NIH Investigation of Co-Occurring Conditions Across the Lifespan to Understand Down Syndrome Project and requires the NIH to report on the program’s progress and related research.

H.R. 5012, SHINE for Autumn Act of 2023: Allows 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. It would also require HHS to establish a perinatal pathology fellowship program within an existing training program.

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. 4534, Women and Lung Cancer Research and Preventive Services Act of 2023: Requires HHS to conduct an interagency review on the status of women with lung cancer and to identify research and education opportunities.

For more information, click here.

House Committee on Veterans Affairs Subcommittee on Health Holds Hearing on VA Use of Artificial Intelligence

On Feb. 15, the House Committee on Veterans Affairs Subcommittee on Health held a hearing to examine the current and potential future uses of artificial intelligence at the Department of Veterans Affairs. Announced witnesses were:

  • Charles Worthington, Chief Technology Officer and Chief Artificial Intelligence Officer at the Department of Veterans Affairs
  • Gil Alterovitz, Ph.D., Director of the Department of Veterans Affairs National Artificial Intelligence Institute
  • Carolyn Clancy, M.D., Assistant Under Secretary for Health at the Department of Veterans Affairs Office of Discovery, Education and Affiliate Networks
  • Prashant Natarajan, Author
  • Gary Velasquez, Chief Executive Officer of Cogitativo
  • Charles Rockefeller, Co-Founder and Head of Partnerships at CuraPatient
  • David Newman-Toker, M.D., Ph.D., Director of the Johns Hopkins School of Medicine Armstrong Institute Center for Diagnostic Excellence

For more information, click here.

House Energy and Commerce Committee Chairmen Request GAO Study on Sales of Lab Equipment

On Feb. 12, 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 Comptroller General Gene Dodaro, requesting the Government Accountability Office (GAO) examine the sale of used and excess laboratory equipment and protective clothing by the Department of Health and Human Services and the Department of Agriculture.

The chairmen are warning that the sale of this equipment could facilitate biological terrorism or warfare and are requesting the GAO investigate how federal agencies oversee the sales and exports of dual-use biological equipment.

For more information, click here.

Editor’s Note: The House is in recess until Feb. 28 and the first appropriations deadline is March 1.

Senate

Senate Finance Committee Chairman Sends Letter Concerning Data Broker Sale of Personal Information

On Feb. 13, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Federal Trade Commission (FTC) Chair Lina Khan and U.S. Securities and Exchange Commission (SEC) Chair Gary Gensler concerning the sale of personal information by data broker Near Intelligence, Inc.

The chairman is concerned about the Near Intelligence, Inc. sale of location and device data it obtained from individuals without first obtaining their informed consent. Sen. Wyden is requesting the FTC to intervene in the company’s bankruptcy proceedings to ensure that all personal data is destroyed and is also requesting the SEC to examine whether misleading statements made by the company to investors constitute securities fraud.

For more information, click here.

Senators Form Medicare Payment Reform Working Group

On Feb. 9, Sens. Blackburn (R-TN), Thune (R-SD), Barrasso (R-WY), Stabenow (D-MI), Warner (D-VA) and Cortez Masto (D-NV) announced that they would form a Medicare payment reform working group to explore and propose long-term reforms to the physician fee schedule and make updates to the Medicare Access and CHIP Reauthorization Act.

For more information, click here.

Editor’s Note: When senators return after the Presidents Day recess, they will have to address the impeachment of Secretary of Homeland Security Alejandro Mayorkas. No other business can be done on the senate floor while the impeachment trial is ongoing.

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

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs.

House

House Budget Committee Favorably Reports Dr. Michael C. Burgess Preventive Health Savings Act

On Feb. 6, the House Budget Committee marked up and reported out of committee the Doctor Michael C. Burgess Preventive Health Savings Act. The legislation would require the Congressional Budget Office (CBO) to calculate the budgetary effects for two additional 10-year periods, for healthcare policies that result in reductions to budget outlays. The CBO currently limits its cost estimates to a single 10-year period.

House Committee On Ways And Means Holds Hearing On Chronic Drug Shortages

On Feb. 6, the House Committee on Ways and Means held a hearing to examine and discuss chronic drug shortages. Announced witnesses were:

  • Stephen Schleicher, M.D., MBA, Chief Medical Officer at Tennessee Oncology
  • Eugene Cavacini, Senior Vice President and Chief Operating Officer at McKesson Pharmaceutical Solutions and Services (PSaS)
  • Allan Coukell, BSc, Senior Vice President for Public Policy at Civica Rx
  • Stephen Schondelmeyer, PharmD, Ph.D., Director of the University of Minnesota College of Pharmacy PRIME Institute
  • Julie Gralow, M.D., Chief Medical Officer and Executive Vice President at ASCO
  • Jeromie Ballreich, Ph.D., Associate Research Professor at the Johns Hopkins Bloomberg School of Public Health

For more information, click here.

House Energy And Commerce Committee Oversight And Investigations Subcommittee Holds Hearing on FDA Foreign Drug Inspection Program

On Feb. 6, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss the Food and Drug Administration Drug Inspection Program and evaluate its current status, challenges and shortcomings. Announced witnesses were:

  • Dinesh S. Thakur, Public Health Activist at the Thakur Family Foundation, Inc.
  • John W.M. Claud, Counsel at Hyman, Phelps and McNamara
  • Mary Denigan-Macauley, Director of Public Health at the Government Accountability Office

For more information, click here.

House Passes Bill Banning QALYs

On Feb. 7, the House passed the Protecting Health Care for All Patients Act on a 211-208 vote. The legislation would ban quality-adjusted life years (QALYs) from being used in coverage and payment determinations for federal health programs including Medicare. QALYs are a measure used to assess disease burden and evaluate how well medical treatments lengthen or improve a patient’s life.

For more information, click here.

FDA Modernization Act 3.0 Introduced

On Feb. 6, Rep. Carter (R-GA) introduced the Food and Drug Administration Modernization Act 3.0. The legislation aims to reduce the use of animals in nonclinical testing by improving the predictivity of nonclinical testing methods, decreasing the development time for biological products and drugs and facilitating the development, qualification and adoption of testing methods.

For more information, click here.

Ensuring Pathways to Innovative Cures Act Introduced

On Feb. 1, Reps. Guthrie (R-KY), Murphy (R-NC) and Davis (D-NC) introduced the Ensuring Pathways to Innovative Cures Act. The legislation seeks to clarify that small-molecule drugs can stay on the market for 11 years before the Centers for Medicare and Medicaid Services could consider them for price negotiation.

For more information, click here.

Chair Cathy McMorris Rodgers Announces Retirement

On Feb. 8, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced that she will retire at the end of her term. Her retirement is notable as the committee is already set to lose a large number of senior Republican members including Reps. Burgess (TX), Bucshon (IN), Duncan (SC), Curtis (UT), Pence (IN) and Armstrong (ND).

Senate

Senate HELP Committee Holds Hearing on Prescription Drug Costs

On Feb. 8, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to examine the cost of prescription drugs. Announced witnesses were:

  • Joaquin Duato, Johnson and Johnson Chief Executive Officer
  • Robert Davis, Merck Chief Executive Officer
  • Chris Boerner, Bristol Myers Squibb Chief Executive Officer
  • Peter Maybarduk, J.D., Access to Medicines Director at Public Citizen
  • Tahir Amin, LL.B., Chief Executive Officer at Initiative for Medicines, Access and Knowledge
  • Darius Lakdawalla, Ph.D., Director of Research at the University of Southern California Schaeffer Center

In addition, HELP committee majority staff released a report concerning the profits Johnson and Johnson, Merck and Bristol Meyer Squibb made in 2022 and the median price they charged for certain medications in the U.S. compared to other countries over the last two decades.

For more information on the hearing, click here.

For more information on the report, click here.

Senate Finance Committee Holds Hearing on Role of AI in Healthcare

On Feb. 8, the Senate Finance Committee held a hearing to discuss the use of artificial intelligence algorithms and systems in healthcare. Announced witnesses were:

  • Peter Shen, Head of Digital and Automation for North America at Siemens Healthineers
  • Mark Sendak, M.D., MPP, Co-Lead of the Health AI Partnership
  • Michelle M. Mello, J.D., Ph.D., Professor of Health Policy and Law at Stanford University
  • Ziad Obermeyer, M.D., Associate Professor and Blue Cross of California Distinguished Professor at the University of California – Berkeley
  • Katherine Baicker, Ph.D., University of Chicago Provost

For more information, click here.

Senate 340B Working Group Releases Sustain 340B Act Discussion Draft

On Feb. 2, the Senate 340B Working Group released a legislative discussion draft of the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act. The discussion draft outlines proposed changes to the 340B program concerning contract pharmacies, child sites, discount duplications, user fees and the definition of a 340B patient.

The working group is seeking feedback from 340B stakeholders on the proposals, and comments will be accepted until April 1.

For more information, click here.

MACPAC Releases Policy Brief On Medicaid Spending On High-Cost Drugs

On Feb. 6, the Medicaid and Children’s Health Insurance Program Payment and Access Commission released a policy brief concerning Medicaid spending on high-cost drugs. The brief outlines how much the Medicaid program spent per claim on brand name and generic drugs from 2018 to 2021 and includes recommendations on how states can address the growing costs of specialty drugs and ensure that beneficiaries can access them.

For more information, click here.

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

This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual prescribing of buprenorphine permanent; Biogen pulls Aduhelm from market; Supreme Court to hear mifepristone case oral arguments on March 26.

Congress

House

House Budget Committee to Mark Up Preventive Health Savings Act

This week, the House Budget Committee is expected to mark up the Preventive Health Savings Act. The legislation would alter the manner in which the Congressional Budget Office (CBO) provides cost estimates for preventive healthcare policies. It would require the CBO to calculate the budgetary effects for two additional 10-year periods for healthcare policies that result in reductions to budget outlays. CBO currently limits its cost estimates to a window of 10 years.

House Energy and Commerce Committee Health Subcommittee Holds Hearing on Healthcare Costs

On Jan. 31, the House Energy and Commerce Committee Health Subcommittee held a hearing on healthcare spending and discussed how Congress could work toward lowering cost growth and improving transparency. Announced witnesses were:

  • Chapin White, Ph.D., Director of Health Analysis at the Congressional Budget Office
  • Sophia Tripoli, MPH, Senior Director of Health Policy at Families USA
  • Kevin Lyons, Plan Administration at the New Jersey State Policemen’s Benevolent Association, Inc.
  • Benedic Ippolito, Ph.D., M.S., Senior Fellow at the American Enterprise Institute
  • Katie Martin, MPA, President and CEO of the Health Care Cost Institute

For more information, click here.

House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Holds Hearing on HHS Compliance

On Jan. 31, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing to discuss the Department of Health and Human Services’ compliance with the subcommittee’s requests for documents and information concerning its response to the COVID-19 pandemic. Announced witnesses were:

  • The Honorable Melanie Egorin, Department of Health and Human Services Assistant Secretary for Legislation

For more information, click here.

Biogen Pulls Aduhelm from Market Citing CMS and FDA Decisions

On Jan. 31, Biogen announced that it would pull its Alzheimer’s drug Aduhelm (aducanumab) from the market due to limited Centers for Medicare and Medicaid Services (CMS) coverage and additional Food and Drug Administration (FDA) study requirements needed for full approval. The FDA had granted Aduhelm accelerated approval in June 2021.

Long-term critic of CMS’ coverage policy Rep. Guthrie (R-KY) stated at an Alzheimer’s event on Jan. 30 that he was disappointed with the announcement. In 2022, CMS issued a national coverage determination that blocked Aduhelm and other Alzheimer’s drugs that target amyloid beta plaque from receiving Medicare coverage except for when they are administered in clinical trials.

Senate

Senate Majority Leader Leads Democrats in Sending Amicus Brief to Supreme Court Concerning Mifepristone Access

On Jan. 30, Senate Majority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jeffries (D-NY) led all 263 Democratic members of Congress in sending an amicus brief to the U.S. Supreme Court. The amicus brief urges the court to reverse rulings by the U.S. Court of Appeals for the 5th Circuit and U.S. District Court for the Northern District of Texas that seek to roll back the Food and Drug Administration’s (FDA) decision to expand access to mifepristone by allowing patients to take the drug later in pregnancy and removing the in-person dispensing requirement.

The members argue that the rulings threaten the health of pregnant patients, exacerbate existing reproductive healthcare challenges and jeopardize the FDA’s drug approval process.

For more information, click here.

Senate Finance Committee Favorably Reports Nomination of HHS Assistant Secretary of Planning and Evaluation Nominee

On Jan. 31, the Senate Finance Committee held an executive session to consider the nominations of Marjorie A. Rollinson, to serve as Chief Counsel for the Internal Revenue Service, and Dr. Rebecca Haffajee, to serve as the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services.

The committee reported both nominations favorably on a 16-11 and 14-13 vote. The senators who opposed Dr. Haffajee’s nomination include Republican Sens. Crapo (ID), Grassley (IA), Cornyn (TX), Thune (SD), Scott (SC), Cassidy (LA), Lankford (OK), Daines (MT), Young (IN), Barrasso (WY), Johnson (WI), Tillis (NC) and Blackburn (TN).

For more information, click here.

Senate Finance Committee Chairman Announces Hearing on AI

On Feb. 1, Senate Finance Committee Chairman Ron Wyden (D-OR) announced that the committee will hold a hearing on Feb. 8 on the use of algorithms and artificial intelligence in healthcare. Announced witnesses are:

  • Peter Shen, Head of Digital and Automation for North America at Siemens Healthineers
  • Mark Sendak, M.D., M.P.P., Co-Lead of the Health AI Partnership
  • Michelle M. Mello, J.D., Ph.D., Professor of Health Policy and Law at Stanford University
  • Ziad Obermeyer, M.D., Associate Professor and Blue Cross of California Distinguished Professor at the University of California – Berkeley
  • Katherine Baicker, Ph.D., Provost at the University of Chicago

For more information, click here.

  • The Honorable Melanie Egorin, Department of Health and Human Services Assistant Secretary for Legislation

For more information, click here.

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

This Week in Washington: Senate Finance Committee chairman sends letters concerning MA marketing practices; Senate Committee on Aging holds hearing on assisted living facilities; CMS requests information on MA prior authorization, beneficiary access and benefits data; Administration touts marketplace enrollment.

Congress

House

House Members Send Letter Concerning Tianeptine

On Jan. 18, Rep. Jackson (D-NC) led Reps. McCormick (R-GA), Rose (R-TN), Boebert (R-CO) and Nickel (D-NC) in sending a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, requesting information on the actions the FDA has taken to address the use of tianeptine.

Tianeptine is an opioid-like antidepressant that has not been approved for medical use and has been shown to be extremely addictive. The FDA recently warned consumers of purchasing and using tianeptine products after it received reports of adverse effects linked to their use, including seizures and hospitalizations.

For more information, click here.

Forty-Six Representatives Send Letter Concerning Surveillance Colonoscopies

On Jan. 10, Rep. Dingell (D-MI) led 45 representatives in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, urging HHS to expand access to preventative care by requiring insurers to cover surveillance colonoscopies without cost-sharing.

The members are requesting that HHS clarify in its federal frequently asked question guidance for insurers regulated by the Affordable Care Act, that follow-up surveillance colonoscopies should be treated as a preventive service. Insurers currently treat an additional colonoscopy screening as a diagnostic service.

For more information, click here.

Rep. Underwood Renews Push to Make ACA Tax Credits Permanent

On Jan. 24, Rep. Underwood (D-IL) renewed her push to make the enhanced tax credits of the American Care Act (ACA) permanent and announced that she is looking at legislative vehicles through which this could be accomplished. ACA tax credits were originally set to expire in 2023 but were extended through 2025 by the Inflation Reduction Act.

House Committee on Education and the Workforce Seeks to Strengthen ERISA

On Jan. 22, House Committee on Education and the Workforce Chairman Virginia Foxx (R-NC) led the committee in sending a letter to employer health benefit stakeholders, requesting they provide feedback on how to strengthen and clarify Employee Retirement Income Security Act preemption.

The committee, which has jurisdiction over employer-sponsored health coverage, is seeking information concerning transparency, portability, data sharing, quality measures, fiduciary obligations, high-cost specialty drugs and Health Insurance Portability and Accountability Act protections.

For more information, click here.

Senate

Senate Finance Committee Chairman and Ranking Member Release White Paper on Mitigating Generic Drug Shortages

On Jan. 25, Senate Finance Committee Chairman Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released a white paper outlining legislative proposals they may incorporate into legislation to reform the Medicare and Medicaid programs to prevent generic drug shortages. The Finance Committee is considering reforming Medicare payment for generic sterile injectables and implementing incentives for hospitals and pharmacies to engage in shortage prevention and mitigation activities.

The committee is also considering reforming the Medicare Drug Rebate Program and implementing new Part D pilot programs to encourage pharmacies to purchase generic medicines.

For more information, click here.

Senate Finance Committee Chairman Sends Letters Concerning MA Marketing Practices

On Jan. 23, Senate Finance Committee Chairman Ron Wyden (D-OR) sent letters to Medicare Advantage (MA) third-party marketing organizations (TPMOs) eHealth, GoHealth, Agent Pipeline, SelectQuote and TRANZACT, seeking information on how they use insurance agents, lead generators and other data to target, market to and direct seniors towards certain MA plans.

The chairman is concerned that TPMOs are using misleading information to sell Medicare plans and are selling seniors’ personal data to lead generators. Last year, the chairman urged the Centers for Medicare and Medicaid Services to implement stronger marketing rules and the committee held a hearing to evaluate the MA enrollment period and marketing rule developments.

For more information, click here.

Senators Send Letter Concerning FTC Investigation of PBM Business Practices

On Jan. 22, Sens. Grassley (R-IA) and Cantwell (D-WA) led 12 senators in sending a letter to Federal Trade Commission (FTC) Chair Lina Khan, requesting that the FTC complete its investigation of pharmacy benefit manager (PBM) business practices and publicly release a progress report on the status of its investigation.

The FTC launched an inquiry into PBM business practices in June 2023 and has been investigating the impact that vertically integrated PBMs have on the access and affordability of prescription drugs.

For more information, click here.

Senate Committee on Aging Holds Hearing on Assisted Living Facilities

On Jan. 25, the Senate Committee on Aging held a hearing on assisted living facilities and discussed how assisted living care could be expanded and strengthened. Witnesses included:

  • Patricia “Patty” Vessenmeyer, Advocate
  • Jennifer Craft Morgan, Director and Professor at the Georgia State University Gerontology Institute
  • Julie Simpkins, Co-President of Gardant Management Solutions
  • Richard Mollot, Executive Director of the Long Term Care Community Coalition

For more information, click here.

Telemental Health Care Access Act Reintroduced

On Jan. 24, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sens. Smith (D-MN), Thune (R-SD) and Cardin (D-MD) reintroduced the Telemental Health Care Access Act. The legislation would remove the statutory requirement that Medicare beneficiaries be seen in person within six months of being treated for mental health services through telehealth.

For more information, click here.

Medicare Transaction Fraud Prevention Act Introduced

On Jan. 24, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) and Sen. Braun (R-IN) introduced the Medicare Transaction Fraud Prevention Act. The legislation would direct the Centers for Medicare and Medicaid Services to establish a two-year pilot period to oversee Medicare-covered purchasing of durable medical equipment and other diagnostic testing related products.

A companion bill was introduced in the House by Rep. Schweikert (R-AZ).

For more information, click here.

MedPAC and MACPAC Release 2024 Data Book on Dually Eligible Beneficiaries

On Jan. 22, the Medicare Payment Advisory Commission and the Medicaid and Children’s Health Insurance Program Payment and Access Commission jointly released the 2024 data book for beneficiaries dually eligible for Medicare and Medicaid.

The data book is separated into six sections that focus on the following:

  • Overview of dual-eligible beneficiaries;
  • Characteristics of dual-eligible beneficiaries;
  • Eligibility pathways, managed care enrollment and continuity of enrollment;
  • Utilization of and spending on Medicare and Medicaid services for dual-eligible beneficiaries;
  • Medicare and Medicaid spending for dual-eligible beneficiaries by LTSS use; and
  • Trends in dual-eligible population composition, spending and service use.

For more information, click here.

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