What’s Ahead: This Week

Hearings and Markups –

  • Wednesday, October 25
    • House Energy & Commerce Committee, Health Subcommittee, “Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care.” Additional Information
    • Senate HELP Committee, “Nomination of Monica Bertagnolli to be Director of the National Institutes of Health (NIH).” Additional Information
  • Friday, October 27
    • Senate HELP Committee, “Field Hearing: Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?” Additional Information

Notable Policy Events –

  • Tuesday, October 24
    • Centers for Disease and Office of Pandemic Preparedness and Response Policy Control and Prevention, “White House Briefing on COVID-19 Vaccines.” Additional Information
    • CMS Innovation Center (CMMI), “Making Care Primary (MCP) Office Hour.” Additional Information
  • Wednesday, October 25
    • Aspen Institute, “Dr. Mandy Cohen, Public Health Grand Rounds.” Additional Information
    • CMS, “Medicaid and CHIP Renewals: What to Know and How to Prepare, A Partner Education Monthly Series.” Additional Information
    • National Press Club, “Newsmaker Program: America’s Looming Physician Shortage.” Additional Information
    • Office of the National Coordinator for Health Information Technology (ONC), “ONC Health IT Certification Program Developer Roundtable.” Additional Information
    • White House, “Conference on Hunger, Nutrition, and Health Monthly Update Call.” Additional Information
  • Thursday, October 26
    • National Academy for State Health Policy, “Considering the AHEAD Model: Lessons from States on Hospital Global Budgets and Investing in Primary Care.” Additional Information
    • Primary Care Collaborative, “Health is Primary: Charting a Path to Equity & Sustainability.” Additional Information
  • Thursday, October 26 – Friday, October 27
    • American Health Information Management Association (AHIMA), “AHIMA23 Virtual Conference.” Additional Information

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

Medicare & Medicaid –

  • On October 17, Reps. Bucshon (R-IN), Bera (D-CA), Ruiz (D-CA), and Miller-Meeks (R-IA) published an op-ed advocating for the Strengthening Medicare for Patients and Providers Act (H.R. 2474), which would provide a permanent inflation-based update to the Medicare Physician Fee Schedule. Article
  • On October 20, CMS published an article in Journal of the American Medical Association (JAMA), “The CMS Strategy to Promote Equity in Quality and Value Programs.” The article highlights CMS’ efforts to incentivize excellent care for underserved populations through the Rewarding Excellence for Underserved Populations (REUP). Article

Payment & Delivery System Models – On October 17, CMS released the final evaluation report for the Million Hearts Model which found that the model reduced the incidence of first-time heart attacks and strokes by three to four percent without impacting Medicare spending. Report At-A-Glance Report

Public Health Prevention, Preparedness, Surveillance –

  • On October 16, HHS Office of Inspector General (OIG) published a report, which found that the Strategic National Stockpile (SNS) was not effectively positioned to respond to the COVID-19 pandemic. Press Release Report
  • On October 17, HHS’s Office of Disease Prevention and Health Promotion solicited comments on current Healthy People 2030 objectives. Comments are due November 20. Notice
  • On October 19, the Government Accountability Office (GAO) issued a report outlining COVID-19 fraud prevention actions. Press Release Report
  • Also on October 19, FDA issued a notice that it will withdraw two COVID-19-realted guidance documents related to drug manufacturing and monoclonal antibody information. The guidelines will expire on November 7. Action
  • Also on October 19, FDA announced the availability of a revised guidance for industry entitled “Development and Licensure of Vaccines to Prevent COVID–19.” Press Release Guidance
  • On October 20, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA), along with Reps. Guthrie (R-KY) and Griffith (R-VA) sent a letter to NIH Acting Director Tabak warning the issuance of a subpoena if NIH does not fulfill document requests related to Mpox. Press Release Letter

Health IT, Privacy, & Digital Health –

Mental Health and Substance Use Disorder Policy –

  • On October 17, House Education & the Workforce Chair Foxx (R-NC) submitted a comment letter to Department of Labor Acting Secretary Su, HHS Secretary Becerra, and Department of the Treasury Secretary Yellen opposing the Tri-Agencies’ proposed mental health parity rules. Press Release Letter
  • On October 18, House Education & the Workforce Committee Ranking Member Scott (D-VA) and HELP Subcommittee Ranking Member DeSaulnier (D-CA) applauded the Biden administration’s proposed rule to strengthen parity requirements for mental health and substance use disorder care. Press Release Letter

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

  • On October 17, FDA’s Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. Press Release
  • On October 18, FDA announced the availability of final guidance intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware of remote monitoring devices used to support patient monitoring. Final Guidance
  • On October 19, FDA added 171 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the United States by 510(k) clearance, granted De Novo request, or premarket approval. Press Release

Veterans Health and Military Health – On October 19, the Department of Veterans Affairs (VA) announced a new partnership with the Department of Defense (DoD) to increase access to world-class surgical care for approximately 37,000 Gulf Coast-area Veterans. Press Release

SDOH & Health Equity –

  • On October 17, the House Ways and Means Committee issued a blog post detailing its conclusions from recent roundtables on challenges to accessing health care in rural areas. Blog
  • On October 18, the Agency for Healthcare Research and Quality (AHRQ) issued a request for evidence to inform its review and update of a report on health care quality and disparities. Submissions are due by November 17. Request

Misc. – On October 17, FDA released a blog on its work to develop a front-of-package labeling system to quickly communicate and provide context to certain nutrition information to combat the epidemic of diet-related disease. Blog

Legislative Activity –

Introduced Legislation –

  • On October 17, Rep. Sánchez (D-CA) and 10 bipartisan cosponsors introduced the Keeping Drugs Out of Schools Act of 2023 (H.R. 5975), which would authorize grants to implement school-community partnerships for preventing substance use and misuse among youth. Bill Text Press Release
  • Also on October 17, Rep. Watson Coleman (D-NJ) and 24 bipartisan cosponsors introduced the Youth Mental Health Research Act (H.R. 5976), which would establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health. Sens. Klobuchar (D-MN) and Britt (R-AL) introduced the companion legislation in the Senate (S. 3060). Bill Text Press Release
  • Also on October 17, Sens. Vance (R-OH) and Rubio (R-FL) introduced the Fairness for Stay-At-Home Parents Act (S. 3048), which would prohibit an employer from recovering any health care premium paid by the employer for an employee if the employee fails to return to work due to the birth of a child. Bill Text Press Release
  • Also on October 17, Sens. Bennet (D-CO), Tillis (R-NC), and Wyden (D-OR) introduced the Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act (S. 3059), which would establish provider directory requirements, and provide accountability for provider director accuracy, under Medicare Advantage. Bill Text One Pager Press Release
  • On October 18, Reps. Lawler (R-NY) and Espaillat (D-NY) introduced the Streamline Emergency Care Act (H.R. 5984), which would award grants for expanding, modernizing, or streamlining emergency room operations. Press Release
  • Also on October 18, Sens. Duckworth (D-IL) and Murkowski (R-AK) introduced the Breast Cancer Patient Equity Act (S. 3069), which would provide coverage for custom fabricated breast protheses following a mastectomy. Bill Text Press Release
  • Also on October 18, Sens. Peters (D-MI) and Capito (R-WV) introduced the Youth Prevention and Recovery Reauthorization Act (S. 3070), which would amend the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act to reauthorize the youth prevention and recovery initiative. Press Release
  • On October 19, Rep. Porter (D-CA) and 23 cosponsors introduced the Medical Debt Relief Act (H.R. 6003), which would prohibit the inclusion of medical debt on a consumer report. Sens. Merkley (D-OR), Menendez (D-NJ), Fetterman (D-PA), and Blumenthal (D-CT) introduced the companion legislation in the Senate (S. 3103). Press Release
  • Also on October 19, Rep. Pressley (D-MA) and 15 cosponsors introduced the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act (H.R. 6004), which would improve Medicaid and the Children’s Health Insurance Program for low-income mothers. Sen. Booker (D-NJ) and 6 cosponsors introduced the companion legislation in the Senate (S. 3090). Bill Text Press Release Summary
  • Also on October 19, Sens. Thune (R-SD), Hassan (D-NH), and Blackburn (R-TN) introduced the Securing Advances and a Variety of Evidence-Based (SAVE) Institutions for Mental Disease (IMD) Options Act (S. 3098), which would make permanent the Medicaid option to remove the IMD exclusion to provide medical assistance for certain individuals who are patients in an institution for mental diseases. Bill Text Press Release