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.

For more information, click here.

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.

For more information, click here.

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.

This Week in Washington: House Energy and Commerce Committee markup includes 19 healthcare bills; Senate HELP Committee to mark up SUPPORT Act Reauthorization and three other bills; House to vote on Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Comments sought on march-in rights.

Congress

House

House Energy and Commerce Committee Marks Up 19 Healthcare Bills

On Dec. 5 and 6, the House Energy and Commerce Committee marked up and reported out of committee 44 bills, including 19 healthcare bills. The bills were:

H.R. 2365, National Plan to End Parkinson’s Act
This legislation would direct the Department of Health and Human Services Secretary (HHS Secretary) to coordinate and improve federal prevention, treatment and cure strategies for Parkinson’s disease. It would also require HHS to form an advisory council to assess current national Parkinson’s disease recommendations and strategies.

H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
This legislation would allow changes in insurance plan formularies for biosimilar products to be made mid-year beginning in 2025.

H.R. 2880, Protecting Patients Against PBM Abuses Act
This legislation would ban PBM spread pricing and would delink PBM compensation from the cost of medications. It would also prohibit PBMs from compensating network pharmacies less than affiliated pharmacies and would increase data transparency of PBM rebates and administrative fees.

H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare Part D, and for other purposes
This legislation would require prescription drug plans (PDPs) to only use pharmacy performance measures that are established by the HHS Secretary. It would also establish a process to allow PDPs to submit information about pricing prescription drug claims to their network pharmacies.

H.R. 5385, Medicare PBM Accountability Act
This legislation would strengthen reporting requirements for PBMs and would require them to submit information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs to the HHS Secretary.

H.R. 5386, Cutting Copays Act
This legislation would set copays for generic drugs to $0 for low-income patients in the Medicare Low-Income Subsidy program.

H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program
This legislation would limit patient cost-sharing for Medicare Part D drugs beginning in 2027 and would limit beneficiary out-of-pocket costs to no more than what an insurance company pays for highly rebated drugs once all discounts are accounted for.

H.R. 5389, National Coverage Determination Transparency Act
This legislation would require the HHS Secretary to determine whether a request for a National Coverage Determination (NCD) is complete within 30 days of receiving a request. It would also require the Secretary to make all NCD applications public on the Centers for Medicare and Medicaid Services (CMS) website and would allow the Secretary to work directly with entities that submit NCD applications.

H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
This legislation would clarify that NCDs for Medicare-covered drugs and biologics must be made with respect to each drug or biologic and not the class of the drug or biologic.

H.R. 5396, Coverage Determination Clarity Act of 2023
This legislation would prohibit Local Coverage Determinations (LCDs) from being more restrictive than NCDs and would require the HHS Secretary to review LCDs annually to evaluate their consistency.

H.R. 5371, Choices for Increased Mobility Act of 2023
This legislation would clarify that expenses for titanium or carbon fiber materials used in the construction of wheelchair bases are not covered under Medicare Part B. It would also clarify that Medicare Part B beneficiaries may pay out of pocket for wheelchair upgrades if they wish.

H.R. 5388, Supporting Innovation for Seniors Act
This legislation would expand a flexibility under the Medicare Advantage (MA) Value-Based Insurance Design Model that allows MA plans to expand access to innovative medical devices and technologies using their existing supplemental benefit funds.

H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
This legislation would require MA plans to report on the utilization of supplemental benefits by enrollees.

H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
This legislation would require the Center for Medicare and Medicaid Innovation to test a model covering virtual diabetes outpatient self-management training services and would remove patient cost-sharing and deductible requirements for Medicare Part B diabetes outpatient self-management training services.

H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
This legislation would codify a proposed CMS durable medical equipment (DME) policy that clarifies coverage of an external infusion pump under the Medicare DME benefit.

H.R. 5555, DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to make payment adjustments to certain Medicare items and durable medical equipment included in the 2021 Durable Medicare Equipment, Prosthetics/Orthotics and Supplies competitive bidding program.

H.R. 6545, Physician Fee Schedule Update and Improvements Act
This legislation would increase the Medicare payment add-on adjustment made in the 2024 Physician Fee Schedule from 1.25 percent to 2.5 percent and extend incentive payments for participation in alternative payment models. It would also extend the floor for the work geographic index.

H.R. 6364, Medicare Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from publicly disclosing the addresses of physician and practitioner residences from which telehealth services are provided.

H.R. 1352, Increasing Access to Biosimilars Act of 2023
This legislation would create a pilot program to evaluate the benefits of providing additional shared savings payments to Medicare biosimilar providers.

In addition, the committee marked up bills related to energy and manufacturing infrastructure, consumer protections, internet broadband and technology innovation and safety. 

For more information, click here.

House to Vote on Lower Costs, More Transparency Act and Support for Patients and Communities Reauthorization Act

This week, the House plans to vote on the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act. The vote will be held under suspension of the rules. This prohibits amendments from being offered.

The Lower Costs, More Transparency Act is a legislative package that includes provisions seeking to increase healthcare pricing transparency by implementing site-neutral payments for off-campus hospital outpatient departments, extending funding for health programs, banning pharmacy benefit manager spread pricing and requiring hospitals and other providers to publish the prices they charge for services.

The Support for Patients and Communities Reauthorization Act will reauthorize community-based opioid use disorder prevention, treatment and recovery programs. The legislation was not considered earlier because Republicans sought to include a provision that would reclassify xylazine as a Schedule III drug under the Controlled Substances Act.

House Energy and Commerce Committee Chairman Announces Hearing on AI

On Dec. 6, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) announced that the committee will hold a hearing to discuss the projected impacts of artificial intelligence on supply chains, energy, healthcare and emerging technologies. The hearing will be held on Dec. 13. Announced witnesses are:

  • Director Helena Fu, Director of Critical and Emerging Technology of the Department of Energy Office of the Undersecretary for Science
  • Micky Tripathi, National Coordinator for Health Information Tech at the U.S. Department of Health and Human Services
  • Saif Khan, Senior Advisor to the Department of Commerce Secretary for Critical and Emerging Technologies

For more information, click here.

House Energy and Commerce Committee Chairmen Threaten to Subpoena CDC Over Lab Safety Practices

On Dec. 7, 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 Centers for Disease Control and Prevention (CDC) Director Mandy Cohen, warning that the committee could subpoena the CDC if it does not provide documents regarding laboratory safety practices at CDC facilities.

For more information, click here.

Innovation in Pediatric Drugs Act of 2023 Introduced

On Dec. 7, Reps. Eshoo (D-CA) and McCaul (R-TX) introduced the Innovation in Pediatric Drugs Act of 2023. The legislation would require rare disease drugs to be studied in children, grant the Food and Drug Administration additional authority to penalize companies that fail to complete required pediatric studies and increase funding for the National Institutes of Health Best Pharmaceuticals for Children Act Program.

For more information, click here.

Senate

Senate HELP Committee to Mark Up SUPPORT Act Reauthorization and Three Other Bills

On Dec. 12, the Senate Health, Education, Labor and Pensions Committee will mark up the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Reauthorization Act. The bipartisan legislation would reauthorize programs that provide community-based prevention, treatment and recovery services for individuals with substance use and behavioral health disorders.

The markup is also scheduled to include 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.

For more information, click here.

Senate HELP Committee Ranking Member Sends Letter Concerning Patient Access to Gene Therapies

On Dec. 5, Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) sent a letter to gene therapy stakeholders, requesting feedback on how access to gene therapies for patients with ultra-rare diseases could be improved.

The ranking member is seeking responses to questions concerning gene therapy insurance coverage, pricing strategies, supply chain contract designs and physician prescribing methods. The ranking member is also seeking input on how the federal government could play a role in overseeing access to gene therapies in the commercial market. Responses are due by Jan. 22.

For more information, click here.

Senate Finance Committee Reports Final Legislative Text of Better Mental Health Care, Lower-Cost Drugs and Extenders Act

On Dec. 7, the Senate Finance Committee reported the final legislative text of the Better Mental Health Care, Lower-Cost Drugs and Extenders Act, which was marked up and reported out of committee on Nov. 8. The legislation seeks to increase Medicare reimbursement rates for doctors and providers, expand mental health and substance use disorder services, lower prescription drug costs and extend Medicare and Medicaid programs that are set to expire.

For more information, click here.

Senate Finance Committee Holds Hearing on Prescription Drug Shortages

On Dec. 5, the Senate Finance Committee held a hearing to examine the causes of prescription drug shortages and supply chain challenges. The committee also discussed the impacts of shortages on patients and providers and potential policy solutions. Announced witnesses were:

  • Inmaculada Hernandez, PharmD., Ph.D., Professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Division of Clinical Pharmacy
  • Marta E. Wosińska, Ph.D., Senior Fellow at the Brookings Institution Schaeffer Initiative on Health Policy
  • Allan Coukell, Senior Vice President of Public Policy at Civica Rx
  • Jason Westin, M.D., M.S., FACP, Director of the Clinical Research Program and Section Chief of Aggressive Lymphoma at the M.D. Anderson Cancer Center Department of Lymphoma and Myeloma

For more information, click here.

Senators Send Letters Concerning Private Equity Ownership of Hospitals

On Dec. 6, Sens. Whitehouse (D-RI) and Grassley (R-IA) sent letters to four private equity firm chief executive officers, requesting that they provide information concerning their ownership of hospitals. The senators are concerned that private equity ownership in healthcare is negatively impacting quality of care and resources among hospitals and resulting in facility staffing shortages, closures and debt.

In addition, the senators sent a letter to the chief executive officer of the Ottumwa Regional Health Center, seeking information on whether the health center experienced operational and financial hardships after it was acquired by a private equity firm in 2010.

For more information, click here.

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

This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements.

Congress

House

House Energy and Commerce Committee Oversight and Investigations Subcommittee Holds Hearing on CDC Respiratory Disease Preparedness

On Nov. 30, the House Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing to discuss Centers for Disease Control and Prevention (CDC) readiness and preparedness plans for future public health crises and the spread of influenza, COVID-19 and respiratory syncytial virus.

The subcommittee also evaluated efforts the CDC has taken to resolve decision-making, health department coordination and data collection and analysis challenges it experienced during the COVID-19 pandemic. Witnesses included:

  • The Honorable Mandy Cohen, M.D., Director of the Centers for Disease Control and Prevention

For more information, click here.

House Energy and Commerce Committee Subcommittee on Health Holds Hearing on Role of AI in Healthcare

On Nov. 29, the House Energy and Commerce Committee Subcommittee on Health held a hearing to discuss how artificial intelligence (AI) is being implemented in medical devices, and how it could reduce administrative burden for physicians. The subcommittee also discussed the risks and benefits of using AI technology and the implications it could have on patient and consumer data privacy, cybersecurity and drug development. Witnesses included:

  • Michael Schlosser, M.D., MBA, Senior Vice President of Care Transformation and Innovation at HCA Healthcare
  • Benjamin Nguyen, Senior Product Manager at Transcarent
  • Peter Shen, Head of Digital Health in North America for Siemens Healthineers
  • Christopher Longhurst, M.D., Chief Medical Officer, Chief Digital Officer and Association Dean at UC San Diego Health
  • David Newman-Toker, M.D., Ph.D., Professor of Neurology and Director of the Johns Hopkins University School of Medicine Department of Neurology Division of Neuro-Visual and Vestibular Disorders

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Regarding Rise of Respiratory and Pneumonia Cases in China

On Nov. 29, 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 Centers for Disease Control and Prevention (CDC) Director Mandy Cohen in response to the rise of respiratory disease and pneumonia cases in China. The chairmen are requesting that the CDC provide information on any communications it has had with Chinese health officials and federal agencies concerning the recent virus outbreak.

For more information, click here.

Senate

Senators Send Letter Concerning Attempts by Insurers to Evade Medical Loss Ratio Requirement

On Nov. 22, Sens. Warren (D-MA) and Braun (R-IN) sent a letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, requesting that the HHS Office of Inspector General investigate whether health insurance companies, including Cigna, CVS, Aetna and United Health Group, are attempting to evade the Medical Loss Ratio (MLR) statutory requirement by increasing the cost of generic drug prices at specialty pharmacies that they own. The MLR requires insurance companies to spend a minimum of 80 or 85 percent of consumers’ premium dollars on medical claims and quality improvements.

The senators are concerned over the findings of a report that revealed that insurers are charging significantly more for generic drugs dispensed by specialty pharmacies they own compared to generic drugs dispensed by independent pharmacies.

For more information on the letter, click here.

Senate Majority Whip Sends Letter Regarding New Medicare Coverage for Dental Care Services

On Nov. 28, Senate Majority Whip Dick Durbin (D-IL) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to notify states about changes made to Medicare coverage and billing practices for oral healthcare services in the 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule.

In addition, the majority whip is requesting that the CMS Medicaid Director send a letter to states to encourage them to expand coverage and billing practices for dental care services for Medicaid enrollees.

For more information, click here.

Senate HELP Committee Chairman Announces Hearing on Prescription Drug Costs

On Nov. 21, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) announced that the HELP committee will hold a hearing on Jan. 25 to discuss the cost of prescription drugs. The hearing will focus on the impacts high prescription drug prices are having on public health.

For more information, click here.

Senate Finance Committee Chairman Announces Hearing on Prescription Drug Shortages

On Nov. 21, Senate Finance Committee Chairman Ron Wyden (D-OR) announced that the Finance committee will hold a hearing on prescription drug shortages on Dec. 5. The committee will examine supply chain challenges and impacts and will discuss potential policy solutions. Announced witnesses are:

  • Inmaculada Hernandez, PharmD., Ph.D., Professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences Division of Clinical Pharmacy
  • Marta E. Wosińska, Ph.D., Senior Fellow at the Brookings Institution Schaeffer Initiative on Health Policy
  • Allan Coukell, Senior Vice President of Public Policy at Civica Rx
  • Jason Westin, M.D. M.S., FACP, Director of the Clinical Research Program and Section Chief of Aggressive Lymphoma at the M.D. Anderson Cancer Center Department of Lymphoma and Myeloma

For more information, click here.

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

This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth flexibilities; White House launches Women’s Health Research initiative.

Congress

House

House and Senate Pass Continuing Resolution

Last week, the House and Senate passed a “laddered” continuing resolution (CR) that will extend funding at current levels through early next year. The CR, which was proposed by the Speaker of the House, will extend funding for Agriculture, Military Construction-VA, Energy-Water and Transportation-HUD appropriations until Jan. 19.

In addition, it will extend funding for Commerce-Justice-Science, Defense, Financial Services, Homeland Security, Interior-Environment, Labor-HHS-Ed., Legislative Branch and State-Foreign Ops appropriations until Feb. 2. If no long-term funding is approved, a 1 percent across-the-board cut will occur. This was agreed to as part of the deal reached to avoid the government defaulting earlier in the year.

House Considers Labor-HHS Appropriations Bill But Postpones Vote on Final Passage

On Nov. 15, the House was scheduled to vote on the Labor-HHS appropriations bill after it considered several amendments to the bill. However, House Republican leadership determined they would not vote on final passage and decided to recess early for the Thanksgiving break because it was unclear whether the bill would pass.

The Labor-HHS bill would cut social spending programs by $60 billion by implementing reductions to 50 programs and eliminating 60.

House Energy and Commerce Committee Subcommittee on Health Reports Out 21 Healthcare Bills

On Nov. 15, the House Energy and Commerce Committee Subcommittee on Health marked up and reported out of committee 21 healthcare bills. Among them were three bills concerning pharmacy benefit managers (PBMs) and one bill regarding home infusion drugs. They are:

H.R. 2880, Protecting Patients Against PBM Abuses Act
This legislation would ban PBM spread pricing and would delink PBM compensation from the cost of medications. It would also prohibit PBMs from compensating a network pharmacy less than affiliated pharmacies and would increase data transparency of PBM rebates and administrative fees.

H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes
This legislation would require prescription drug plans (PDPs) to only use pharmacy performance measures that are established by the Secretary of the Department of Health and Human Services (HHS Secretary). It would also establish a process to allow PDPs to submit information about pricing prescription drug claims to their network pharmacies. 

H.R. 5385, Medicare PBM Accountability Act
This legislation would strengthen reporting requirements for PBMs and would require them to submit to the HHS Secretary information on drug costs and pricing, generic and biosimilar formulary placement, PBM affiliates, conflicts of interest, drug dispensing and Part D drugs.

H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
This legislation would codify a proposed Centers for Medicare and Medicaid Services (CMS) durable medical equipment (DME) policy that clarifies coverage of an external infusion pump under the Medicare DME benefit.

The other bills are:

H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
This legislation would allow changes in insurance plan formularies for biosimilar products to be made mid-year beginning in 2025.

H.R. 5386, Cutting Copays Act
This legislation would set copays for generic drugs to $0 for low-income patients in the Medicare Low-Income Subsidy program. 

H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program
This legislation would limit patient cost-sharing for Medicare Part D drugs beginning in 2027 and would limit beneficiary out-of-pocket costs to no more than what an insurance company pays for highly rebated drugs once all discounts are accounted for.

H.R. 5389, National Coverage Determination Transparency Act
This legislation would require the HHS Secretary to determine whether a request for a National Coverage Determination (NCD) is complete within 30 days of receiving a request. It would also require the Secretary to make all NCD applications public on the CMS website and would allow the Secretary to work directly with entities that submit NCD applications.

H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
This legislation would clarify that NCDs for Medicare-covered drugs and biologics must be made with respect to each drug or biologic and not the class of the drug or biologic.

H.R. 5396, Coverage Determination Clarity Act of 2023
This legislation would prohibit Local Coverage Determinations (LCDs) from being more restrictive than NCDs and would require the HHS Secretary to review LCDs annually to evaluate their consistency.

H.R. 5371, Choices for Increased Mobility Act of 2023
This legislation would clarify that expenses for titanium or carbon fiber materials used in the construction of wheelchair bases are not covered under Medicare Part B. It would also clarify that Medicare Part B beneficiaries may pay out-of-pocket for wheelchair upgrades if they wish.

H.R. 5388, Supporting Innovation for Seniors Act
This legislation would expand a flexibility under the Medicare Advantage (MA) Value-Based Insurance Design Model that allows MA plans to expand access to innovative medical devices and technologies using their existing supplemental benefit funds.

H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
This legislation would require MA plans to report on the utilization of supplemental benefits by enrollees.

H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
This legislation would require the Center for Medicare and Medicaid Innovation to test a model covering virtual diabetes outpatient self-management training services and would remove patient cost-sharing and deducible requirements for Medicare Part B diabetes outpatient self-management training services.

H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to revise the phase-in of clinical laboratory test payment changes under such program
This legislation would delay cuts and reporting under the clinical lab fee schedule and would increase the work geographic index to 1.00 for any locality where the index would be less than 1.00, until Jan. 1, 2025.

H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
This legislation would extend incentive payments for participation in eligible alternative payment (APM) models for one year and would adjust the size of payment to the length that a provider has participated in an APM.

H.R. 5555, DMEPOS Relief Act of 2023
This legislation would require the HHS Secretary to make payment adjustments to certain Medicare items and durable medical equipment included in the 2021 Durable Medicare Equipment, Prosthetics/Orthotics and Supplies competitive bidding program.

H.R. 6371, Provider Reimbursement Stability Act of 2023
This legislation would increase the Physician Fee Schedule budget neutrality threshold and require the HHS Secretary to update prices and rates for direct cost inputs for practice expense relative value units no less than every five years. It would also limit year-to-year conversion factor variance.

H.R. 6364, Medicare Telehealth Privacy Act of 2023
This legislation would prohibit the HHS Secretary from publicly disclosing the addresses of physician and practitioner residences from which telehealth services are provided.

H.R. 1352, Increasing Access to Biosimilars Act of 2023
This legislation would create a pilot program to evaluate the benefits of providing additional shared savings payments to Medicare biosimilar providers.

H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act of 2023
This legislation would provide four years of temporary or transitional Medicare coverage to medical breakthrough devices and enable the HHS Secretary to assign coding for approved products.

For more information, click here.

Senate

Senate Finance Committee Subcommittee on Healthcare Holds Hearing on Telehealth Flexibilities

On Nov. 14, the Senate Finance Committee Subcommittee on Healthcare held a hearing to discuss telehealth flexibilities issued during the COVID-19 public health emergency and to evaluate whether flexibilities set to expire next year should be made permanent. Witnesses included:

  • Nicki Perisho, BSN, R.N., Principal Investigator and Program Director of the Northwest Regional Telehealth Resource Center
  • Eric Wallace, M.D., FASN, Professor of Medicine and Medical Director at UAB EMedicine, Co-Director of Home Dialysis and Director of the Division of Nephrology Rare Kidney Disease Clinic at the UAB Department of Medicine
  • Chad Ellimoottil, M.D., M.S., Associate Professor and Medical Director of Virtual Care at the University of Michigan
  • Ateev Mehrotra, M.D., MPH, Professor of Health Care Policy at the Harvard Medical School Department of Health Care Policy

For more information, click here.

Senate HELP Committee Ranking Member Requests Information on Use of 340B Program Revenue

On Nov. 16, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent letters to two federally qualified community health centers, requesting information on how they use the revenue they generate from the 340B Drug Pricing Program. The Ranking Member is concerned over reports that reveal some 340B entities are not passing on the revenue they generate from the 340B program to improve healthcare services for low-income patients.

For more information, click here.

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