What’s Ahead: This Week

Hearings and Markups – No notable hearings this week. Senate only in session.

Notable Policy Events – 

  • Wednesday, May 31 to Friday, June 2
    • America’s Physician Groups, “APG Annual Spring Conference 2023: Going the Distance.” Additional Information
  • Wednesday, May 31
    • American Medical Association (AMA), “Future of Health Immersion Program: Digitally Enabled Care for Women’s Health.” Additional Information
    • Bipartisan Policy Center, “Integrating Behavioral Health and Primary Care in Rural America.” Additional Information
  • Thursday, June 1
    • Health Affairs, “Policy Spotlight: One-on-One with Carrie H. Colla, Director of Health Analysis at the Congressional Budget Office.” Additional Information

Weekly Wrap-Up: Notable Health Care Developments from Last Week

Medicare & Medicaid –

  • On May 23, CMS issued a proposed rule seeking to improve and promote efficient operation of the Medicaid Drug Rebate Program (MDRP), and increase transparency in payment arrangements between pharmacy benefit managers (PBMs) and Medicaid-managed care plans. Comments are due July 25. Press Release General Fact Sheet PBM Transparency Fact Sheet  Proposed Rule
  • Also on May 23, CMS Office of Minority Health (OMH) released the Disparities in Health Care in Medicare Advantage Associated with Dual Eligibility or Eligibility for a Low-Income Subsidy and Disability report, summarizing information on the performance of Medicare Advantage (MA) plans on specific measures of quality of health care reported in 2021. Report
  • Also on May 23, CMS released the sixth annual evaluation report for the Home Health Value-Based Purchasing (HHVBP) Model. In the first six years of the model, Medicare spending was reduced by $1.38 billion and quality of care improved. Report
  • On May 25, HHS released a report providing an overview of MA, highlighting that enrollment is now about half of the Medicare market. The report states that federal spending per beneficiary is higher in MA compared to fee-for-service, and that margins are higher in MA than other markets. Report

Health IT –

  • On May 23, the Biden Administration announced new efforts that will advance the research, development, and deployment of responsible artificial intelligence (AI). These efforts include the release of a National AI R&D Strategic Plan by the Office of Science and Technology Policy (OSTP) and a Request for Information (RFI) from OSTP on national priorities for mitigating AI risks. Fact Sheet National AI R&D Strategic Plan RFI
  • On May 24, CMS released an Informational Bulletin on the Medicaid Enterprise Systems compliance and re-approval process for state systems with operational costs claimed at the 75 percent federal match rate. Bulletin

Mental Health & Substance Use Disorder Policy –

  • On May 23, the White House announced actions to protect youth mental health, safety, and privacy online, including an interagency Task Force on Kids Online Health & Safety. The U.S. Surgeon General also released an advisory that describes current evidence on the impacts of social media on the mental health of children and adolescents. WH Press Release Surgeon General Advisory Summary Press Release
  • On May 25, SAMHSA awarded 13 grants to communities to create new and enhance existing mobile crisis response teams, including the 988 Suicide and Crisis Lifeline. Press Release
  • Also on May 25, HHS released its initial report on a demonstration project that aims to increase the treatment capacity of Medicaid providers to deliver substance use disorder treatment and recovery services, as required of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act (Pub. L. No. 115-271). Initial Report to Congress Demonstration Project

Prescription Drugs – On May 22, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) issued a report to Congress regarding the impact of prescription drug shortages on consumer costs. The report also highlighted potential policies that could be pursued to address cost increases when there are shortages and to ensure sufficient supply of generic drugs. Report in Brief Report

Food and Drug Administration

  • On May 22, the FDA’s Center for Drug Evaluation and Research published two Guidance Snapshots on the agency’s 2020 guidance titled, “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs”. This guidance presents recommendations sponsors can apply to diversify participation in clinical trials. Guidance Snapshot for Patients Guidance Snapshot for Industry
  • On May 25, Senate Homeland Security and Governmental Affairs Committee Chair Peters (D-MI), Sen. Stabenow (D-MI), and Rep. Slotkin (D-MI) wrote to FDA Commissioner Califf to ask what the agency is doing to mitigate nationwide shortages of cancer drugs. Press Release Letter
  • Also on May 25, the FDA released draft guidance to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus and/or type 2 diabetes mellitus. Press Release Draft Guidance

Population Health, Public Health & Health Equity

  • On May 23, CDC announced that estimated annual new HIV infections were 12 percent lower in 2021 compared to 2017, with declines among young people driving the decrease. Press Release
  • On May 24, HHS Office for Civil Rights (OCR) released a report summarizing progress on improving the provision of meaningful access to language assistance services to persons with limited English proficiency. Press Release Report
  • Also on May 24, the Congressional Budget Office (CBO) published data highlighting that, in 2023, 248 million people under age 65 have health insurance coverage and 23 million people (8.3 percent) are uninsured, with variations in coverage by income, race and ethnicity. Article
  • On May 25, HHS released a report reviewing the community impacts of use of force and other police activities on physical, mental, and public health in support of President Biden’s May 2022 Executive Order (EO) on Advancing Effective, Accountable Policing and Criminal Justice Practices to Enhance Public Trust and Public Safety. The White House also released a fact sheet detailing additional actions and progress on the EO. Report White House Fact Sheet

Legislative Activity –

Debt Ceiling Negotiations –

  • On May 27, President Biden issued a statement on a budget agreement in principle made with Speaker of the House McCarthy (R-CA). White House Statement

Votes and Committee Activity –

  • On May 24, the House Energy & Commerce Committee marked up several health care bills. The bills now go to the floor for consideration. Markup Details Markup Memo
    • The Animal Drug User Fee Amendments of 2023 (H.R. 1418) passed, without amendment, by a vote of 49-0. The bill would reauthorize user fee programs relating to new animal drugs and generic new animal drugs. Bill Text
    • The Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) passed, without amendment, by a vote of 48-0. The bill would improve the Organ Procurement and Transplantation Network. Bill Text
    • The Medicaid VBPs for Patients (MVP) Act (H.R. 2666) passed, as amended, by a vote of 31-19. The bill would codify value-based purchasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements. Bill Text
    • The Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (H.R. 3261) passed, as amended, by a vote of 49-0. The bill would promote hospital and insurer price transparency. Bill Text
    • The Providers and Payers COMPETE Act (H.R. 3284) passed, as amended, by a vote of 49-0. The bill would require the Secretary of Health and Human Services to submit an annual report on the impact of certain Medicare regulations on provider and payer consolidation. Bill Text
    • H.R. 3290 passed, as amended, by a vote of 29-22. The bill would ensure transparency and oversight of the 340B drug discount program. Bill Text
  • On May 25, the House passed the Halt All Lethal Trafficking (HALT) of Fentanyl Act (H.R. 467) by a vote of 289-133. The bill would amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances. The bill now heads to the Senate for consideration. Bill Text Press Release

Introduced Legislation –

  • On May 22, Rep. Lee (D-CA) and 31 cosponsors introduced the Real Education and Access for Healthy Youth Act (REAHYA) (H.R. 3583), which would provide for the overall health and well-being of young people, including the promotion and attainment of lifelong sexual health and healthy relationships. Press Release
  • On May 24, Reps. Underwood (D-IL), Bonamici (D-OR), and Horsford (D-NV) introduced the Educating Future Nurses Act (H.R. 3623), which would establish a national graduate nurse education program. Press Release
  • Also on May 24, Reps. Castor (D-FL), Letlow (R-LA), and Schrier (D-WA) introduced the Promoting Resources to Expand Vaccination, Education and New Treatments for (PREVENT) HPV Cancers Act (H.R. 3633), which would provide for a public awareness campaign with respect to human papillomavirus. Additional Information Press Release
  • Also on May 24, Rep. Ferguson (R-GA) and seven bipartisan cosponsors introduced the Save Rural Hospitals Act of 2023 (H.R. 3635), which would ensure fairness in Medicare hospital payments by establishing a floor for the area wage index applied with respect to certain hospitals. Bill Text Press Release
  • Also on May 24, Rep. Lee (D-PA) and 31 cosponsors introduced the Hazard Pay for Health Care Heroes Act (H.R. 3645), which would establish emergency grants to safeguard essential health care workers. Press Release
  • Also on May 25, Rep. Bera (D-CA) and 11 bipartisan cosponsors introduced the Helping Emergency Responders Overcome (HERO) Act (H.R. 3671), which would improve the detection, prevention, and treatment of mental health issues among public safety officers. Press Release
  • Also on May 25, Reps. Kamlager-Dove (D-CA), Moore (D-WI), and Cleaver (D-MO) introduced the Foster Youth Dental Act (H.R. 3701), which would strengthen coverage under the Medicaid program for certain foster youth individuals. Bill Text Press Release
  • Also on May 25, Reps. Smith (R-NE), Blumenauer (D-OR), Armstrong (R-ND), and Tokuda (D-HI) introduced the Rural Health Clinic (RHC) Burden Reduction Act (H.R. 3730), which would modernize provisions relating to rural health clinics under Medicare. Press Release