Health Care Policy Update – Weekly Wrap-up and What’s Ahead – November 20, 2023


What’s Ahead: This Week

Hearings and Markups –

  • There are currently no hearings or markups scheduled for this week.

Notable Policy Events – 

  • Monday, November 20
    • CATO Institute, “We’ve Got You Covered: Rebooting American Health Care.” Additional Information – In-Person in Washington, DC and Virtual; Free.
  • Tuesday, November 21
    • Office of the National Coordinator for Health IT (ONC), Trusted Exchange Framework and Common Agreement (TEFCA), Recognized Coordinating Entity (RCE), “Monthly Informational Call.” Additional Information

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

 

Medicare & Medicaid –

  • On November 14, CMS released an Informational Bulletin with the 2024 Supplemental Security Income (SSI), Spousal Impoverishment, and Medicare Savings Program Resource Standards. Bulletin
  • On November 15, CMS released a rule that will require the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities and Medicaid nursing facilities. Press Release Fact Sheet HHS Report Rule
  • On November 16, CMS released an informational bulletin, “Supports to Address Health-Related Social Needs in Medicaid and CHIP.” This guidance outlines a framework of services and supports to address health-related social needs (HRSNs) that CMS considers allowable under specific Medicaid and CHIP authorities. Bulletin
  • Also on November 16, Senate Help Ranking Member Cassidy (R-LA) requested information from two community health center systems as part of his ongoing investigation into how health care providers use revenue generated from the 340B Drug Pricing Program. Press Release Letter
  • Also on November 16, Senate HELP Committee Chair Sanders (I-VT), Sen. Warren (D-MA), and Sen. Blumenthal (D-CT) released a report, “Residents at Risk: Quality of Care Problems in Understaffed Nursing Homes and the Need for a New Federal Nursing Home Staffing Standard.” The report finds that nursing homes with higher staffing levels provide higher quality care than homes with lower staffing levels. Press Release Report

Marketplaces – On November 15, HHS released the Notice of Benefit and Payment Parameters for 2025 proposed rule, proposing standards for issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, direct enrollment entities, and assisters that help Marketplace consumers. Fact Sheet Letter to Issuers CMS Guidance Proposed Rule

Payment & Delivery System Models – 

  • On November 15, CMS released the request for applications (RFA) for the Guiding an Improved Dementia Experience (GUIDE) Model, which aims to support people living with dementia and their caregivers. The application deadline is January 30, 2024. RFA
  • On November 16, CMS released the notice of funding opportunity (NOFO) for the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. The application for the first cohort is due March 18, 2024. NOFO

Public Health Prevention, Preparedness, & Surveillance –

  • On November 15, HHS published a readout of HHS Secretary Becerra’s meeting with public health officials regarding COVID-19, flu, and RSV vaccines. Press Release
  • On November 16, CDC issued a press release about a report indicating concerns about measles rates as vaccinations continue to decrease. Press Release Report
  • Also on November 16, the CDC and FDA expedited the availability of additional RSV immunizations for infants. Press Release

Health IT, Privacy, & Digital Health – 

  • On November 13, ONC published a blog on a recent study the office conducted in which it explored the digital divide to better understand the relationship between interoperable exchange and measures of hospitals that served marginalized populations. Blog
  • On November 14, CDC issued a notice with comment period on a proposed information collection project titled, “National Notifiable Diseases Surveillance System”. This data collection provides the official source of statistics in the U.S. for nationally notifiable disease conditions. Comments are due January 16, 2024. Notice
  • Also on November 14, CDC issued a notice with comment period on a proposed information collection project titled, “OD2A—LOCAL Linkage to and Retention in Care Surveillance”. This project is designed to help standardize data processes that drive data-to-action decision-making and improve intra-jurisdictional comparisons over time. Comments are due January 16, 2024. Notice

Mental Health and Substance Use Disorder Policy –

  • On November 13, HHS released the results of the 2022 National Survey on Drug Use and Health (NSDUH). The report shows how people living in the United States reported about their experience with mental health, substance use, and treatment-related behaviors in 2022. Press Release Report  Brief  HHS Statements
  • On November 16, HHS announced notices of funding opportunities this week for grant programs that address behavioral health challenges in local communities by preventing substance use initiation, reducing the progression of substance use, and addressing other related concerns. The grant opportunities total about $74.4 million and are part of the Biden-Harris Administration’s priorities to beat the overdose epidemic and tackle the mental health crisis – two key pillars of the President’s Unity Agenda for the nation. Press Release

Prescription Drugs, Medical Devices, Biomedical Research, & Health Innovation – On November 15, FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. Press Release

Veterans Health and Military Health –

  • On November 15, the Department of Veterans Affairs (VA) announced that the Million Veteran Program (MVP) welcomed the one-millionth Veteran into the program, making it the first research program in the world to include extensive health and genetic data for this many participants. Press Release
  • On November 16, the Department of Veterans Affairs (VA) released the National Veteran Suicide Prevention Annual Report, the largest national analysis of Veteran suicides through 2021 (the latest year for which we have data). The report shows that 6,392 Veterans died by suicide in 2021, which is 114 more than in 2020. The number of non-Veteran suicides also increased to 40,020 deaths in 2021, which is 2,000 more than in 2020. Press Release Report

SDOH & Health Equity –

  • On November 15, HHS unveiled its updated Language Access Plan which sets forth guidance, best practices, and action steps for HHS offices to develop their own, agency-specific language access plans. Press Release Language Access Plan
  • On November 16, the White House released its Playbook to Address Social Determinants of Health (SDOH). Playbook
  • Also on November 16, HHS issued a press release highlighting the White House SDOH Playbook. Press Release
  • Also on November 16, the Assistant Secretary for Planning and Evaluation (ASPE) issued a call to action to address HRSNs. Press Release
  • Also on November 16, the Office of Science and Technology Policy (OSTP) penned a blog post discussing climate change as an SDOH. Blog
  • On November 17, the Administration for Community Living (ACL) published a blog discussing new opportunities in addressing HRSNs, as discussed in the White House SDOH Playbook. Blog

Health Systems & Health Care Workforce – On November 15, CMS announced 200 new graduate medical education (GME) residency slots awarded to 99 qualifying hospitals to enhance the health care workforce and fund additional positions in hospitals serving underserved communities. Announcement

Reproductive & Maternal Health – On November 13, the White House announced the first-ever initiative on Women’s Health and Research, led by the First Lady and the White House Gender Policy Council. Press Release

Legislative Activity –

Votes and Committee Activity –

  • On November 14, the House of Representatives passed the Further Continuing Appropriations and Other Extensions Act, 2024 (H.R. 6363), which would provide continuing FY2024 appropriations for federal agencies and extend several expiring programs and authorities. The Senate passed on November 15, and the President signed into law on November 16. Funding for discretionary programs in the Agriculture Appropriation bill (WIC and FDA), community health centers, and some authorizations included in the Pandemic and All-Hazards Preparedness Act (PAHPA) is extended through January 19, 2024 at current levels. Funding for HHS discretionary programs (NIH, CDC, HRSA, SAMHSA) and others are extended through February 2, 2024 at current levels. Bill Text Press Release
  • On November 15, the House Energy & Commerce Committee, Health Subcommittee held a markup and advanced several notable health care bills. The bills now go to the full Committee for consideration. Markup Details Markup Memo
    • The Protecting Patients Against PBM Abuses Act (H.R. 2880) passed by voice vote. The bill would establish certain requirements for pharmacy benefit managers under part D of the Medicare program. Bill Text
    • H.R. 5393 passed by voice vote. The bill would ensure fair assessment of pharmacy performance and quality under Medicare Part D. Bill Text
    • The Medicare PBM Accountability Act (H.R. 5385) passed by voice vote. The bill would establish pharmacy benefit manager reporting requirements with respect to prescription drug plans and MA-PD plans under Medicare part D. Bill Text
    •  The Cutting Copays Act (H.R. 5386) passed by voice vote. The bill would provide for adjustments to the Medicare Part D cost-sharing reductions for low-income individuals. Bill Text
    • H.R. 4881 passed by voice vote. The bill would limit cost sharing for drugs under the Medicare program. Bill Text
    • The National Coverage Determination Transparency Act (H.R. 5389) passed, amended, by voice vote. The bill would ensure transparency in the national coverage determination process under the Medicare program. Bill Text AINS
    • The Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) passed, as amended by voice vote. The bill would clarify the use of the national coverage determination process under the Medicare program. Bill Text AINS
    • The Coverage Determination Clarity Act of 2023 (H.R. 5396) passed by voice vote. The bill would prohibit Medicare local coverage determinations from restricting access to care. Bill Text
    • The Choices for Increased Mobility Act of 2023 (H.R. 5371) passed by voice vote. The bill would clarify payment rules for manual wheelchairs under part B of the Medicare program. Bill Text
    • The Supporting Innovation for Seniors Act (H.R. 5388) passed by a voice vote. The bill would provide coverage of certain technologies and medical devices under the Medicare program. Bill Text
    • H.R. 5380 passed by voice vote. The bill would increase data transparency for supplemental benefits under Medicare Advantage. Bill Text
    • The Expanding Access to Diabetes Self-Management Training Act of 2023 (H.R. 3842) passed by voice vote. The bill would improve access to diabetes outpatient self-management training services and require the Center for Medicare and Medicaid Innovation to test the provision of virtual diabetes outpatient self-management training services. Bill Text AINS
    • The Joe Fiandra Access to Home Infusion Act of 2023 (H.R. 5397) passed by voice vote. The bill would provide coverage of external infusion pumps and non-self-administrable home infusion drugs under the Medicare program. Bill Text AINS
    • H.R. 6366 passed by voice vote. The bill would amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and revise the phase-in of clinical laboratory test payment changes under such program. Bill Text
    • H.R. 6369 passed by voice vote. The bill would amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models. Bill Text
    • The DMEPOS Relief Act of 2023 (H.R. 5555) passed by a vote of 16-12. The bill would provide for certain adjustments to Medicare payment for items of durable medical equipment that were formerly included in round 2021 of the DMEPOS competitive bidding program. Bill Text
    • The Provider Reimbursement Stability Act of 2023 (H.R. 6371) passed by voice vote. The bill would provide for certain adjustments to the physician fee schedule under the Medicare program. Bill Text
    • The Medicare Telehealth Privacy Act of 2023 (H.R. 6364) passed by voice vote. The bill would maintain certain telehealth flexibilities relating to provider privacy under the Medicare program. Bill Text
    • The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) passed by a vote of 21-6. The bill would ensure prompt coverage of breakthrough devices under the Medicare program. Bill Text
    • The Increasing Access to Biosimilars Act of 2023 (H.R. 1352) passed by voice vote. The bill would establish a demonstration project to increase access to biosimilar biological products under the Medicare program. Bill Text

Introduced Legislation –

  • Also on November 13, Reps. Bergman (R-MI), Dingell (D-MI), Bost (R-IL), and Brownley (D-CA) introduced the Veterans Spinal Trauma Access to New Devices Act (Veterans STAND Act) (H.R. 6373), which would offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies. Press Release
  • Also on November 13, Reps. Burgess (R-TX), Allred (D-TX), Dunn (R-FL), and Crow (D-CO) introduced the Veterans Health Care Stamp Act (H.R. 6374), which would provide for the issuance of a Veterans Health Care Stamp. Press Release
  • Also on November 13, Reps. Molinaro (R-NY), Dingell (D-MI), Fitzpatrick (R-PA), Davis (D-NC), and Lee (D-NV) introduced the Friendly Calls For Our Seniors Act (H.R. 6388), which would carry out a grant program for States to provide telephone reassurance services to certain older adults and to other adults with disabilities. Press Release
  • Also on November 14, Reps. Kelly (D-IL) and Kiggans (R-VA) introduced the Medical Nutrition Therapy Act of 2023 (H.R. 6407), which would expand the availability of medical nutrition therapy services under the Medicare program. Sen. Collins (R-ME) and Peters (D-MI) introduced the companion legislation in the Senate (S. 3297). Press Release
  • Also on November 14, Rep. Tokuda (D-HI) and nine bipartisan cosponsors introduced the Crisis Assistance and Resources in Emergencies (CARE) for First Responders Act (H.R. 6415), which would increase access to mental health, substance use, and counseling services for first responders. Press Release
  • On November 15, Reps. Fitzpatrick (R-PA), Houlahan (D-PA), Salazar (R-FL) introduced the Supporting Innovative Global Health Technologies (SIGHT) Act of 2023 (H.R. 6424), which would provide additional authorities for the leadership of the United States Agency for International Development in health technology innovation for global health in low-resource settings. Bill Text Press Release
  • Also on November 15, Rep. Harshbarger (R-TN) introduced the Immediate Access for the Terminally Ill Act (H.R. 6427), which would allow disabled individuals with incurable terminal illnesses listed on the Compassionate Allowance list to receive disability insurance benefits without a waiting period, to prohibit concurrent receipt of disability insurance benefits and unemployment insurance. Sen. Lee (R-UT) introduced the companion legislation in the Senate (S. 3316).  Bill Text One-Pager Press Release
  • Also on November 15, Rep. Hill (R-AR) introduced the Social Security Disability Insurance (SSDI) Return to Work Act (H.R. 6428), which would help individuals receiving disability insurance benefits under Title II of the Social Security Act obtain rehabilitative services and return to the workforce. Bill Text Press Release
  • Also on November 15, Reps. Miller (R-WV) and Sewell (D-AL) introduced the Assistance for Rural Community Hospitals (ARCH) Act (H.R. 6430), which would extend Medicare-dependent hospital and Medicare low-volume hospital payments, and direct the Comptroller General of the United States to carry out a report on Medicare rural hospital classifications. Bill Text Press Release
  • Also on November 15, Reps. Perez (D-WA) and Finstad (R-MN) introduced the Preserve Access to Rapid Ambulance Emergency Medical Treatment (PARA-EMT) Act (H.R. 6433), which would preserve access to emergency medical services. Bill Text Press Release
  • Also on November 15, Sens. Cortez Masto (D-NV), Cassidy (R-LA), Warren (D-MA), and Blackburn (R-TN) introduced the Encounter Data Enhancement Act (S. 3307), which would require the inclusion of certain information in encounter data under Medicare Advantage. Press Release
  • Also on November 15, Sens. Smith (D-MN) and Cotton (R-AR) introduced the American Made Pharmaceuticals Act (S. 3311), which would conduct a demonstration program to test providing preferential treatment under the Medicare, Medicaid, and CHIP programs for certain drugs and biologicals manufactured in the United States. Press Release
  • Also on November 15, Sens. Thune (R-SD), Klobuchar (D-MN), Wicker (R-MS), Hickenlooper (D-CO), Luján (D-NM), and Capito (R-WV) introduced the Artificial Intelligence (AI) Research, Innovation, and Accountability Act of 2023 (S. 3312), which would provide a framework for artificial intelligence innovation and accountability. Press Release Statement of Support Summary
  • Also on November 15, Sens. Cortez Masto (D-NV) and Fischer (R-NE) introduced the Promoting Digital Privacy Technologies Act (S. 3325), which would support research on privacy-enhancing technologies and promote responsible data use. Press Release
  • Also on November 15, Sens. Collins (R-ME) and Cardin (D-MD) introduced the Supporting Seniors with Opioid Use Disorder Act (S. 3326), which would improve access to opioid use disorder treatment services under the Medicare program. Bill Text Press Release
  • Also on November 15, Sen. Cortez Masto introduced the DATA Privacy Act (S. 3337), which would establish national data privacy standards in the United States. Press Release