What’s Ahead: This Week

Hearings and Markups – There are currently no relevant hearings or markups scheduled for this week.

Notable Policy Events – 

  • Monday, October 9 to Wednesday, October 11
  • Tuesday, October 10 to Wednesday, October 11
  • Tuesday, October 10
    • American Medical Association (AMA), “National Health Equity Grand Rounds: Creating Accountability Through Data.” Additional Information
    • U.S. News & World Report, “Remodeling Pediatric Mental Healthcare to be a Community Resource Multiplier.” Additional Information
  • Wednesday, October 11
    • American Enterprise Institute (AEI), “Are We Looking for Health Care Competition in All the Wrong Places?” Additional Information
    • Trust for America’s Health (TFAH), “The State of Obesity: Creating Pathways to a Healthier America.” Additional Information
  • Thursday, October 12

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

Medicare & Medicaid –

  • On October 2, CMS announced measure removals from the Quality Reporting Programs (QRPs) for Inpatient Rehabilitation Facilities (IRFs), Long-Term Care Hospitals (LTCHs) and Skilled Nursing Facilities (SNFs). The changes will go into effect on January 1, 2024. IRF Notice LTCH Notice SNF Notice
  • On October 3, HHS announced that the 10 companies selected for the Medicare Drug Price Negotiation program have decided to participate. The negotiations with participating drug companies for the selected drugs will occur in 2023 and 2024 with the negotiated prices effective beginning in 2026. CMS Statement Press Release 
  • Also on October 3, Senate Special Committee on Aging Chair Casey (D-PA) sent a letter to CMS Administrator Brooks-LaSure regarding oversight of coverage denials by Medicaid managed care organizations (MCOs). Press Release Letter

Payment & Delivery System Models –

  • On October 5, CMS posted reports on the Medicare-Medicaid Financial Alignment Initiative in Ohio, New York, and Washington. Through the Financial Alignment Initiative, CMS partners with states to test two new models for their effectiveness in accomplishing these goals. Financial Alignment Initiative Ohio New York Washington
  • Also on October 5, CMS released updated Home Health (HH) Outcome and Assessment Information Set (OASIS) and HH QRP claims-based measures. Announcement

Public Health Prevention, Preparedness, & Surveillance – On October 3, the FDA updated the Novovax COVID-19 vaccine formula to better address current variants. Press Release

Health IT, Privacy, & Digital Health – 

  • On October 3, the Advanced Research Projects Agency for Health (ARPA-H) announced awardees of the DIGIHEALS project. DIGIHEALS supports innovative research that aims to protect the U.S. health care system’s electronic infrastructure against hostile threats. Press Release
  • On October 6, the Drug Enforcement Administration (DEA) released a second temporary extension of COVID-19 telemedicine flexibilities for prescription of controlled medications. The second temporary rule extends these flexibilities to December 31, 2024. Second Temporary Extension

Mental Health and Substance Use Disorder Policy – 

  • On October 4, the Agency for Healthcare Research and Quality (AHRQ) published a request for supplemental evidence and data submissions on its review “Mental Health and Occupational Stress in the Emergency Medical Service and 911 Workforce.” Comments are due November 3, 2023. Notice
  • Also on October 4, the Department of Labor (DOL) published a blog, which outlined the importance of mental health parity and plans to address discriminatory practices. Blog
  • Also on October 4, CMS released a request for information (RFI) on processes for assessing compliance with mental health parity and addiction equity in Medicaid and CHIP. RFI Medicaid Mental Health Parity
  • Also on October 4, Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $35 million in grant funding for essential behavioral health services and HIV prevention and care to historically underserved populations. Press Release

Prescription Drugs, Medical Devices, Biomedical Research, & Health Innovation –

  • On October 2, FDA issued minor updates to the final guidance entitled, “Electronic Submissions Template for Medical Devices 510(k) Submissions”. The updates are to support the use of the Electronic Submission Template and Resource (eSTAR) through the Center for Devices and Radiological Health (CDRH) portal. Final Guidance
  • On October 4, FDA published draft guidance, which would assist sponsors in developing treatments for stimulant use disorders. Comments on the draft guidance are due December 4, 2023. Announcement Draft Guidance 
  • Also on October 4, HHS released an RFI regarding coverage of over-the-counter (OTC) preventive services, requesting input on the potential benefits and costs of requiring health plans and issuers to cover OTC preventive items and services without cost sharing and without a prescription. Comments are due December 4, 2023. RFI
  • On October 6, HHS released a report on the changes in list prices of prescription drugs from 2017 to 2023. The average drug price increase over the course of the period was 15.2 percent, which translates to $590 per drug product. Report

Veterans Health and Military Health – On October 6, the Department of Veterans Affairs (VA) announced a pledge with 13 health care systems to share data to improve the Veteran experience regardless of where Veterans receive their health care. Press Release

Health Systems & Health Care Workforce – On October 3, Sen. Warren (D-MA) and Rep. Jayapal (D-WA) sent a letter to Assistant Attorney General Kanter and Federal Trade Commission Chair Khan raising concerns about health care consolidation and urging robust oversight. Press Release Letter

Misc. – On October 5, AHRQ published a blog in support of whole-person care delivery in primary care practice. Blog

Legislative Activity 
Introduced Legislation – 

  • On October 2, Reps. Fitzpatrick (R-PA) and Clarke (D-NY) introduced the Expanded Genetic Screening Act (H. R. 5864), which would provide for coverage under the Medicaid program of non-invasive prenatal genetic screening. Bill Text Press Release
  • Also on October 2, Reps. Lee (D-CA), Trone (D-MD), Mullin (D-CA), Schiff (D-CA), and Tonko (D-NY) introduced the Substance Use Disorder and Family Engagement (SAFE) in Recovery Act (H.R. 5866), which would ensure comprehensive wraparound services for families impacted by substance use disorders. Sen. Markey (D-MA) introduced the companion legislation in the Senate (S. 3006) on October 3. Bill Text Press Release
  • On October 3, Reps. Buck (R-CO) and Boebert (R-CO) introduced the No Federal Tax Dollars for Illegal Aliens Health Insurance Act (H.R. 5875), which would ensure that taxpayer funds for health insurance coverage are available only to authorized individuals. Bill Text Press Release
  • Also on October 3, Rep. Kelly (D-IL) introduced the Promoting Access to Broadband Act of 2023 (H.R. 5886), which would direct the Federal Communications Commission to establish a program to make grants available to States to inform Medicaid enrollees, SNAP participants, and low-income residents of potential eligibility for the Affordable Connectivity and Lifeline programs of the Commission. Sen. Durbin (D-IL) and six cosponsors introduced the companion legislation in the Senate (S. 3024) on October 4. Press Release
  • On October 4, Sens. Hassan (D-NH) and Murkowski (R-AK) introduced the Nutrition CARE Act (S. 3010), which would provide coverage of medical nutrition therapy services for individuals with eating disorders under the Medicare program. Press Release
  • Also on October 4, Sens. Sinema (I-AZ), Blackburn (R-TN), and Klobuchar (D-MN) introduced the Sustainable Cardiopulmonary Rehabilitation Services in the Home Act (S. 3021), which would permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19. Rep. Joyce (R-PA) and 29 bipartisan cosponsors introduced the companion legislation in the House (H.R. 1406) on March 7. Bill Text Press Release
  • Also on October 4, Sens. Cornyn (R-TX), Padilla (D-CA), and Murphy (D-CT) introduced the Meals for At-Risk Americans Act (S. 3034), which would provide guidance and enhanced technical assistance for States seeking to establish a restaurant meals program under the supplemental nutrition assistance program. Press Release
  • On October 6, Rep. Aderholt (R-AL) introduced H.R. 5894, which would make appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024.
  • Also on October 6, Reps. Spanberger (D-VA) and Miller-Meeks (R-IA) introduced the Caring for Grieving Families Act (H.R. 5909), which would limit cost sharing for prenatal services in certain circumstances. Bill Text Press Release