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.

This Week in Washington: Congress passes continuing resolution; CMS releases final rule concerning prior authorization.

Congress

House

The House is in district work week.

Congress Passes Continuing Resolution

On Jan. 18, the House and Senate passed a continuing resolution (CR) and averted a partial government shutdown. The CR will maintain staggered funding deadlines and will extend funding to March 1 and 8. Funding had originally been scheduled to expire on Jan. 19 and Feb. 2.

Funding for the departments of Agriculture, Energy, Veterans Affairs, Transportation and Housing and Urban Development has been extended to March 1 and funding for the departments of Commerce, Justice, Defense, Homeland Security, Interior, Labor, Education and Health and Human Services has been extended to March 8. The CR notably extends healthcare extenders such as funding for community health centers, teaching hospitals and diabetes programs and a delay of Medicaid disproportionate hospital share cuts.

House Budget Committee Favorably Reports Fiscal Commission Act of 2024

On Jan. 18, the House Budget Committee marked up and reported out of committee H.R. 5779, the Fiscal Commission Act of 2024. The legislation would create a bipartisan debt commission, which would be tasked with addressing the national debt and making spending and revenue reform recommendations. Some Democrats and Medicare advocates argue that the bill will fast-track cuts to Social Security, Medicare and Medicaid.

In addition to H.R. 5779, the committee also reported H.R. 6952, the Fiscal State of the Nation Act and H.R. 6957, the Debt to GDP Transparency and Stabilization Act out of committee.

For more information, click here.

Senate

Senate HELP Committee to Vote on Issuing Subpoenas to Pharmaceutical Company CEOs

On Jan. 18, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) announced that the committee will vote on Jan. 31 on whether to issue subpoenas for Johnson and Johnson chief executive officer (CEO) Joaquin Duato and Merck CEO Robert Davis to testify before the committee concerning the higher prices they charge for medicine in the U.S. compared to other countries.

For more information, click here.

Senate HELP Committee Ranking Member Seeks Information on Pharmacy 340B Revenue

On Jan. 17, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent letters to president and chief executive officer (CEO) of CVS Health Karen Lynch and Walgreens CEO Tim Wentworth, requesting they submit information on CVS Health’s and Walgreens’ participation in the 340B Drug Discount Program.

The ranking member has been investigating how healthcare providers use revenue generated from the 340B program and is interested in understanding how major contract pharmacies generate revenue and whether that revenue is directly benefiting patients.

For more information, click here.

Senate HELP Committee Holds Hearing on Long COVID

On Jan. 18, the Senate Health, Education, Labor and Pensions Committee held a hearing on Long COVID and discussed how Long COVID research and patient care could be improved. Witnesses included:

  • Angela Meriquez Vázquez, M.S.W., Long COVID Patient
  • Rachel Beale, M.B.A., Long COVID Patient
  • Nicole Heim, Parent of Long COVID Patient
  • Michelle Harkins, M.D., University of New Mexico Professor of Medicine
  • Ziyad Al-Aly, M.D., Clinical Epidemiologist at Washington University in St. Louis
  • Charisse Madlock-Brown, Ph.D., University of Iowa Associate Professor of Health Informatics
  • Tiffany Walker, M.D., Emory University School of Medicine Assistant Professor

For more information, click here.

Health Care PRICE Transparency Act 2.0 Introduced

On Jan. 10, Sens. Braun (R-IN), Grassley (R-IA), Smith (D-MN) and Hickenlooper (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) introduced the Health Care PRICE Transparency Act 2.0.

The legislation seeks to strengthen the transparency of healthcare pricing by:

  • Requiring machine-readable files of all negotiated rates and cash prices between plans and providers;
  • Requiring actual prices for 300 shoppable services to be published, with all services by 2025;
  • Increasing maximum annual penalties to $10,000,000;
  • Codifying the Transparency in Coverage rule; and
  • Providing group health plans the right to access, audit and review claims encounter data.

For more information, click here.

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

This Week in Washington: House Speaker and Senate Majority Leader reach topline appropriations deal; OCR releases final rule on conscience rights; Senate HELP Committee Democrats launch investigation into cost of asthma inhalers; State of the Union scheduled for March 7.

Congress

House

House Speaker and Senate Majority Leader Reach Topline Appropriations Deal

On Jan. 7, House of Representatives Speaker Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) reached an agreement on topline appropriations levels for fiscal year 2024. The Speaker and Senate Majority Leader agreed to a topline amount of $1.59 trillion, of which $886 billion would go to defense and $704 billion would go to non-defense discretionary spending.

Due to the tight turnaround before the approaching Jan. 19 funding deadline, the Senate Majority Leader has already taken the first procedural step on creating a short-term continuing resolution (CR) to allow for more time to work on the specifics of the agreement and avoid a partial government shutdown. However, it remains unclear whether the House would pass a CR.

Senate

Senate HELP Committee Democrats Launch Investigation into Cost of Asthma Inhalers

On Jan. 8, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) and Sens. Baldwin (D-WI), Luján (D-NM) and Markey (D-MA) sent letters to the chief executive officers of AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva, concerning the prices they charge for asthma inhalers.

The chairman and senators are concerned over the tactics used on inhaler product patents and are seeking information on the costs involved in inhaler manufacturing and asthma and chronic obstructive pulmonary disease research and development. This investigation piggybacks on the Federal Trade Commission’s work on improperly listed patents in the Food and Drug Administration’s Orange Book.

For more information, click here.

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

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final rule concerning clinical use of AI.

Congress

House

House Passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization

Last week, the House passed the Lower Costs, More Transparency Act, a legislative package that includes provisions seeking to increase hospital and other provider price transparency, implement site-neutral payments for off-campus hospital outpatient departments, ban pharmacy benefit manager spread pricing and extend funding for health programs.

The House also passed the Support for Patients and Communities Reauthorization Act. The legislation reauthorizes opioid-use disorder prevention, treatment and recovery programs; permanently extends Medicaid coverage for medication-assisted treatments; improves overdose response training programs; and places xylazine in Schedule III of the Controlled Substances Act.

In addition, the House passed the Dr. Emmanuel Bilirakis and Honorable Jennifer Wexton National Plan to End Parkinson’s Act. The legislation would require the Department of Health and Human Services to develop a national plan to prevent and cure Parkinson’s disease.

Forty-Eight Members Send Letter Concerning Manufacturer Copay Accumulators

On Dec. 12, Rep. Carter (R-GA) led 48 members in sending a letter to the Secretaries of HHS, Labor and Treasury—Xavier Becerra, Julie Su and Janet Yellen—concerning copay accumulators and the recent decision by the U.S. District Court for the District of Columbia that vacated the 2021 Notice of Benefit and Payment Parameters (NBPP) Final Rule that permitted the use of copay accumulator adjustment programs.

The members believe HHS should notify beneficiaries and reaffirm the 2020 NBPP Final Rule that states group health plans and health insurers must count copay assistance toward a patient’s maximum annual limitation on cost-sharing (MOOP) for drugs that do not have a medically appropriate generic equivalent available.

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena FDA Over Foreign Drug Inspection Program

On Dec. 14, 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 follow-up letter to Food and Drug Administration (FDA) Commissioner Robert Califf, warning that the committee could subpoena the FDA if it does not submit documents and information concerning the FDA foreign drug inspection program.

The chairmen are concerned about the effectiveness of the program after reports indicated a reduction in the total number of FDA foreign inspections and an increase in drug manufacturing facility citations in 2022.

For more information, click here.

Senate

Senate HELP Committee Marks Up SUPPORT Act Reauthorization and Three Other Bills

On Dec. 12, the Senate Health, Education, Labor and Pensions Committee marked up and reported out of committee four bills. Among them was the SUPPORT for Patients and Communities Reauthorization Act, which would reauthorize programs that provide substance use disorder prevention, treatment and recovery services, and increase funding for mental and behavioral health training and the National Child Traumatic Stress Initiative.

In addition, the committee reported out of committee the Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023, which would reauthorize the National Breast and Cervical Cancer Early Detection Program, the Advancing Research in Education Act, which would reauthorize the Education Science Reform Act and the Modernizing Opioid Treatment Access Act, which would allow certain providers to prescribe methadone for opioid use disorder.

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Senate Finance Committee Chairman Sends Letter Concerning Pharmacy Prescription Record Sharing Practices

On Dec. 12, Senate Finance Committee Chairman Ron Wyden (D-OR) and Reps. Jayapal (D-WA) and Jacobs (D-CA) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, expressing their concern over the practice by some pharmacies to provide patient prescription records to law enforcement agencies without requesting a warrant.

The chairman and members have been investigating pharmacy prescription record-sharing practices and discovered through inquiries with pharmacy companies that several do not require a warrant prior to sharing records with law enforcement agencies. The chairman and members are urging HHS to address pharmacy privacy practices and revise Health Insurance Portability and Accountability Act regulations to require a warrant for law enforcement to access prescription records.

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MACPAC Releases 2023 Medicaid and CHIP Data Book

On Dec. 15, the Medicaid and Children’s Health Insurance Program (CHIP) Payment and Access Commission (MACPAC) released the 2023 MACStats: Medicaid and CHIP Data Book. The data book contains the latest data and information on the Medicaid and CHIP programs and is divided into the following six sections:

  • Key statistics on Medicaid and CHIP;
  • Trends in Medicaid spending, enrollment and share of state budgets;
  • Medicaid and CHIP enrollment and spending;
  • Medicaid and CHIP eligibility;
  • Measures of beneficiary health, use of services and access to care; and
  • A technical guide regarding data sources and methods.

 For more information, click here.

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