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.