What’s Ahead: This Week

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

Notable Policy Events – 

  • Tuesday, October 3
    • Duke Margolis Center for Health Policy, “Medicare Accountable Care in 2023 – The Path to 100%” Additional Information
    • Health Affairs, “Health Affairs Briefing: Tackling Structural Racism in Health.” Additional Information
  • Wednesday, October 4 – Thursday, October 5
    • Patient-Centered Outcomes Research Institute (PCORI), “2023 PCORI Annual Meeting.” Additional Information
  • Thursday, October 5

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

Medicare & Medicaid –

  • On September 25, CMS announced new reporting requirements for Medicare Advantage (MA) plans regarding supplemental benefits. Starting in 2024, CMS will require plans to report more detail on supplemental benefits, including the categories of benefits offered and utilization of benefits. Medicare Advantage Reporting Requirements
  • Also on September 25, CMS announced 2024 premiums and deductibles for MA and Medicare Part D prescription drug plans. The average monthly plan premium for all MA plans is projected to increase $0.64 from 2023 to 2024. Press Release
  • On September 26, the Government Accountability Office (GAO) released a report which found gaps in the data collected by CMS to identify private equity and other owners in nursing homes. Report
  • Also on September 26, the HHS Office of Inspector General (OIG) released a report which found that states did not meet all of the requirements to receive the increased COVID-19 federal medical assistance percentage (FMAP). All four states reviewed by OIG terminated Medicaid enrollees’ coverage for unallowable or potentially unallowable reasons. Report
  • On September 28, CMS sent a State Medicaid Director Letter with guidance on Medicaid transportation policy, providing a resource for states on federal requirements and state flexibilities. Letter
  • Also on September 28, House Energy and Commerce Committee Ranking Member Pallone (D-NJ) and Senate Finance Committee Chair Wyden (D-OR) sent a series of letters to Medicaid Managed Care Organizations (MCOs) as part of an investigation into prior authorization denials for Medicaid patients. Press Release
  • On September 29, Senate HELP Committee Ranking Member Cassidy (R-LA) opened an investigation as to how hospital systems may spend revenue generated from the 340B Drug Pricing Program. Press Release
  • Also on September 29, CMS released a request for information (RFI) regarding processes for assessing compliance with mental health parity and addiction equity requirements in Medicaid and CHIP. Comments are due by December 4th, 2023. RFI
  • Also on September 29, CMS sent a letter to state health officials reinforcing that states must provide 12 months of continuous coverage for children under the age of 19 on Medicaid and the CHIP beginning January 1, 2024. Letter

Marketplaces – On September 27, CMS released a document with frequently asked questions (FAQs) on ACA implementation of the Transparency in Coverage Final Rules (TiC Final Rules). FAQs

Payment & Delivery System Models –

  • On September 25, CMS announced the 2024 participants in the MA Value-Based Insurance Design (VBID) Model. The estimated number of MA enrollees covered by the model will increase by 47 percent compared to 2023. Press Release
  • On September 28, the Congressional Budget Office (CBO) released a report on the federal budgetary effects of the Center for Medicare & Medicaid Innovation (CMMI). CBO estimates that CMMI’s activities increased direct spending by $5.4 billion between 2011 and 2020 and will increase spending by $1.3 billion from 2021 to 2030. Report

Public Health Prevention, Preparedness, & Surveillance –

  • On September 26, HHS Office of Inspector General (OIG) found that CDC’s Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) program recipients encountered challenges expending school funding and implementing screening programs. Press Release Report
  • Also on September 26, Senate HELP Ranking Member Cassidy (R-LA) issued an RFI on ways to reform the CDC and its practices to modernize public health data, and improve core public health activities. Comments are due October 20. Press Release RFI
  • On September 27, CDC issued the second part of its “Annual Report to the Nation,” which focuses on the decreasing date of cancer diagnoses during the COVID-19 pandemic. Press Release Report

Health IT, Privacy, & Digital Health – 

  • On September 26, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report that summarizes 15 considerations and 14 opportunities for the implementation of HHS’s trustworthy AI principles in patient-centered outcomes research projects that incorporate AI technology. Report in Brief Report
  • On September 27, the Federal Trade Commission (FTC) announced that it is seeking research for its annual PrivacyCon event which will take place virtually on March 6, 2024. FTC is seeking research on data security topics such as artificial intelligence and health-related privacy. Submissions are due December 6, 2023. Press Release

Mental Health and Substance Use Disorder Policy – 

  • On September 25, Substance Abuse and Mental Health Services Administration (SAMHSA), the Health Resources and Services Administration (HRSA), and the Administration for Children and Families (ACF), announced $206 million in grant awards towards youth mental health. SAMHSA announced $131.7 of the $206 million total. Press Release
  • Also on September 25, SAMHSA published, “National Substance Use and Mental Health Services Survey (N-SUMHSS) 2022: Data on Substance Use and Mental Health Treatment Facilities,” a voluntary annual survey of all active substance use and mental health facilities in the United States, its territories, and D.C. The report presents findings on the key operational characteristics of substance use and mental health treatment facilities, use of pharmacotherapies, language assistance services, and suicide prevention assistance services. Press Release Report
  • On September 26, HHS OIG published a report finding that one-third of the 1.5 million Medicaid enrollees with opioid use disorder did not receive medication treatment (referred to as MOUD) in 2021. Report in Brief Report
  • On September 27, SAMHSA awarded $232.2 million in grants for suicide prevention and behavioral health care for at-risk communities, including more than $200 million in new funding for states, territories, and Tribal nations and organizations to build local capacity for the 988 Suicide & Crisis Lifeline and related crisis services. Press Release
  • On September 28, SAMHSA awarded $42.6 million in Strategic Prevention Framework – Partnerships for Success (SPF-PFS) grants to 17 states and 60 communities (located across 33 states). Press Release
  • On September 29, the Biden Administration declared October 2023 as National Youth Substance Use Prevention Month. Press Release
  • Also on September 29, SAMHSA published a blog about the tenth anniversary of the national campaign “Talk. They Hear You,” which helps parents and caregivers, educators, and community members get informed, be prepared, and take action to prevent underage drinking and other substance use. Blog
  • Also on September 29, SAMHSA released a blog discussing tools to prevent suicide. Blog

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

  • On September 26, FDA issued final guidance that provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions. Announcement Final Guidance
  • On September 29, FDA announced a proposed rule regarding laboratory developed tests and in vitro diagnostic products (IVDs). The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Press Release Proposed Rule
  • Also on September 29, FDA granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. Press Release
  • Also on September 29, FDA announced the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing clinical development issues. Press Release Notice

Veterans Health and Military Health – 

  • On September 29, Department of Veterans Affairs (VA) announced that, starting on October 1, veterans will have access to maternity care coordinators from the beginning of their pregnancy to 12 months postpartum — an expansion from the previous end-date of 8 weeks postpartum. Press Release
  • On September 28, the VA OIG conducted a national review of Veterans Health Administration’s (VHA) reproductive health services, finding that facilities were generally able to provide reproductive health services. For the most part, the concerns reported were not unique to the provision of reproductive health care and were consistent with recognized broader challenges for health care, including provision of rural health care, community care provider availability and coordination, and shortages in VHA staffing. Report in Brief Report

SDOH & Health Equity – 

  • On September 25, Ways and Means Committee Chair Smith (R-MO) and Rep. LaHood (R-IL) sent a letter to the GAO requesting the agency to conduct an investigation into the use of Temporary Assistance for Needy Families (TANF) funds. Press Release Letter
  • On September 26, the National Institutes of Health (NIH) designated people with disabilities as a population with health disparities. Press Release
  • Also on September 26, the Administration for Community Living’s (ACL) Disability Information and Access Line (DIAL) launched a new tool to help people with disabilities find local services and resources to support community living. Press Release
  • On September 28, HHS announced $24.5 million in new awards to 34 tribes and tribal organizations to implement culturally grounded, evidence-based home visiting programs. Press Release
  • On September 29, HHS announced it has awarded two organizations $4 million to support its Center for Indigenous Innovation and Health Equity (CIIHE). The awards will support a five-year initiative to advance sustainable solutions that address Indigenous health disparities and advance health equity in American Indian and Alaska Native (AI/AN) and Native Hawaiian and Pacific Islander (NHPI) communities. Press Release

Health Systems & Health Care Workforce – On September 29, HHS released a report summarizing lessons learned from the governmental public health workforce at state, tribal, local, and territorial public health agencies during the COVID-19 pandemic. Report

Reproductive & Maternal Health –

  • On September 27, HHS announced several new actions to address the nation’s longstanding maternal health crisis, including: awarding more than $103 million to support and expand access to maternal health, forming a new task force to address maternal mental health conditions and co-occurring substance use disorders, and launching a national public education campaign, Talking Postpartum Depression, to provide information about and combat stigmatization associated with this significant public health issue. Press Release
  • Also on September 27, HHS announced that it has awarded more than $13 million in grants to 11 organizations for its Healthy Families Community-Based Perinatal Health Initiative (COPHI) to develop innovative models for integrating community-based maternal support services into perinatal systems of care. Press Release

Misc. – 

  • On September 29, the Biden Administration declared October 2, 2023 as Child Health Day. Press Release
  • Also on September 29, the Biden Administration declared October 2023 as National Breast Cancer Awareness Month Press Release

Legislative Activity 

Votes and Committee Activity –

  • On September 30, the President signed H.R. 5860 into law, which provides fiscal year appropriations to Federal agencies through November 17, 2023, for continuing projects of the Federal Government and extends several expiring authorities. Bill text Press Release

Introduced Legislation – 

  • On September 26, Rep. Van Duyne (R-TX) introduced the HSA Modernization Act of 2023 (H.R. 5687), which would modernize health savings accounts. Press Release Section-By-Section Summary
  • Also on September 26, Reps. Smucker (R-PA) and Blumenauer (D-OR) introduced the Bipartisan HSA Improvement Act of 2023 (H.R. 5688), which would improve health savings accounts. Press Release
  • Also on September 26, Reps. Moore (R-UT) and Tenney (R-NY) introduced the Advancing Health Savings Act (H.R. 5690), which would allow for certain distributions from a health savings account for medical expenses incurred during the 60-day period before the account was established. Press Release
  • Also on September 26, Reps. Casar (D-TX), Pingree (D-ME), and Pressley (D-MA) introduced the No Photo for Food Act (H.R. 5701), which would prohibit the placement of a photograph of any household member on an electronic benefit card used by such household to purchase food with supplemental nutrition assistance program benefits provided under such Act. Bill Text Press Release
  • Also on September 26, Rep. Fischbach (R-MN) introduced the Hardworking Seniors Act (H.R. 5709), which would allow individuals entitled to Medicare Part A to make contributions to health savings accounts. Press Release
  • Also on September 26, Reps. Van Duyne (R-TX) and Hern (R-OK) introduced the Elevating HSA Limits Act of 2023 (H.R. 5737), which would increase the maximum contribution limit for health savings accounts. Press Release
  • Also on September 26, Reps. Wild (D-PA), Fitzpatrick (R-PA), and Trone (D-MD) introduced the Enhancing Mental Health and Suicide Prevention Through Campus Planning Act (H.R. 5740), which would promote comprehensive campus mental health and suicide prevention plans. Bill Text One Pager Press Release
  • Also on September 26, Sens. Booker (D-NJ) and Mullin (R-OK) introduced the Prescription Information Modernization Act (S. 2916), which would provide for digital communication of prescribing information for drugs (including biological products). Bill Text Press Release
  • Also on September 26, Sens. Markey (D-MA), Baldwin (D-WI), and Young (R-IN) introduced the Eliminating Opioid-Related Infectious Diseases Act (S. 2918), which would reauthorize the program of surveillance and education regarding infections associated with illicit drug use and other risk factors. Bill Text Press Release
  • Also on September 26, Sens. Hassan (D-NH) and Cornyn (R-TX) introduced the Advancing Lifesaving Efforts with Rapid Test Strips (ALERT) for Communities Act (S. 2919), which would require research with respect to fentanyl and xylazine test strips and authorize the use of grant funds for such test strips. Press Release
  • Also on September 26, Sens. Markey (D-MA), Padilla (D-CA), Blumenthal (D-CT), Booker (D-NJ), and Merkley (D-OR) introduced the Housing Alignment and Coordination of Critical and Effective Supportive Health Services (ACCESS) Act (S. 2932), which would provide guidance to State Medicaid agencies, public housing agencies, Continuums of Care, and housing finance agencies on connecting Medicaid beneficiaries with housing-related services and supports under Medicaid and other housing resources.  Bill Text Press Release
  • On September 27, Reps. Bilirakis (R-FL) and Blumenauer (D-OR) introduced the Addressing Whole Health in Medicare Advantage Act (H.R. 5746), which would expand the availability of supplemental benefits to certain Medicare Advantage enrollees. Press Release
  • Also on September 27, Reps. Fitzpatrick (R-PA) and Trone (D-MD) introduced the Opening Plans to Individuals and Offering New Services (OPTIONS) for Mental Health Act (H.R. 5752), which would allow first-dollar coverage of mental health services for purposes of health savings accounts. Bill Text Press Release
  • Also on September 27, Rep. Hayes (D-CT) and 57 cosponsors introduced the Women, Infants, and Children (WIC) for Kids Act (H.R. 5757), which would extend certain certification periods for the special supplemental nutrition program for women, infants, and children. Bill Text Press Release
  • Also on September 27, Reps. Kim (R-CA) and Meng (D-NY) introduced the Health Communication Access and Resources for Everyone (CARE) Act (H.R. 5762), which would research and design a graphic symbol to indicate when linguistic access materials and services are available for a health program, product, or service. Bill Text Press Release
  • Also on September 27, Sen. King (I-ME) introduced the Preventive Home Visits Act (S. 2941), which would provide coverage of preventative home visits under Medicare. Press Release
  • Also on September 27, Sen. King (I-ME) introduced the WELL Seniors Act (S. 2942), which would improve the annual wellness visit under the Medicare program. Press Release
  • Also on September 27, Sens. Merkley (D-OR) and Scott (R-FL) introduced the School Access to Naloxone Act (S.2946), which would provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose. Bill Text One Pager Press Release
  • On September 28, Reps. Carey (R-OH), Golden (D-ME), Kelly (R-PA), Feenstra (R-IA), and Malliotakis (R-NY) introduced the Veterans HSA Access Act (H.R. 5787), which would allow, without regard to disability, individuals eligible for veterans benefits to contribute to health savings accounts. Bill Text Press Release
  • Also on September 28, Reps. Cohen (D-TN), Doggett (D-TX), Cherfilus-McCormick (D-FL), and Del. Norton (D-DC) introduced the Reducing Obesity in Youth Act (H.R. 5788), which would promote healthy eating and physical activity among children. Press Release
  • Also on September 28, Reps. Cohen (D-TN), Graves (R-LA), Barragan (D-CA), Blunt Rochester (D-DE), Grijalva (D-AZ), and Kilmer (D-WA) introduced the Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now (NEWBORN) Act (H.R. 5789), which would authorize funding for the creation and implementation of infant mortality pilot programs in standard metropolitan statistical areas with high rates of infant mortality. Press Release
  • Also on September 28, Reps. Fischbach (R-MN) and Pence (R-IN) introduced the Protecting Rural Seniors Access to Care Act (H.R. 5796), which would prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the nursing home workforce. Press Release
  • Also on September 28, Reps. Kilmer (D-WA) and Bacon (R-NE) introduced the Mental Health Infrastructure Improvement Act (H.R. 5804), which would make loans and loan guarantees for planning, constructing, or renovating pediatric or adult mental health treatment facilities and pediatric or adult substance use disorder treatment facilities. Bill Text Press Release
  • Also on September 28, Rep. Steel (R-CA) and 6 bipartisan cosponsors introduced the Connecting Our Medical Providers with Links to Expand Tailored and Effective (COMPLETE) Care Act (H.R. 5819), which would provide incentives for behavioral health integration under the Medicare program. Press Release
  • Also on September 28, Reps. Williams (D-GA) and Mace (R-SC) introduced the Care is an Economic Development Strategy (CEDS) Act (H.R. 5825), which would require eligible recipients of certain grants to develop a comprehensive economic development strategy that directly or indirectly increases the accessibility of affordable, quality care-based services. Press Release
  • Also on September 28, Sens. Boozman (R-AR), Booker (D-NJ), Blackburn (R-TN), Blumenthal (D-CT), and Wicker (R-MS) introduced the Targeting Emotional Mental Stability (TEAMS) Act (S. 2966), which would encourage programs to address college athlete mental health. Press Release
  • Also on September 28, Sen. Wyden (D-OR) introduced the Modernizing and Ensuring PBM Accountability (MEPA) Act (S. 2973), which would establish requirements relating to pharmacy benefit managers under the Medicare and Medicaid programs. Press Release
  • On September 29, Rep. Larsen (D-WA) introduced the Protecting America from Seasonal and Pandemic Influenza Act (H.R. 5846), which would protect against seasonal and pandemic influenza. Press Release