Health Care Policy Update – Weekly Wrap-up and What’s Ahead – May 1, 2023


What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, May 2
    • Senate HELP Committee, “Markup of Legislation to Lower Prescription Drug Prices: S. 1067, S, 1114, S. 1214, and Pharmacy Benefit Manager Reform Act.” Additional information
  • Wednesday, May 3
    • Senate Finance Committee, “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks.” Additional information
    • Senate Veterans’ Affairs Committee, “Examining the Effectiveness of the Office of Integrated Veteran Care.” Additional information
  • Thursday, May 4
    • Senate Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, “A Review of the President’s FY 2024 Funding Request and Budget Justification for the National Institutes of Health.” Additional information
    • Senate HELP Committee, “Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act.” Additional information

Notable Policy Events –

  • Monday, May 1 – Wednesday, May 3
  • Tuesday, May 2
    • CMS, “Home and Community-Based Settings Compliance Post-March 2023.” Additional information
    • S. News & World Report, “Confronting the Crisis of Inequitable Maternal and Infant Health Outcomes.” Additional information
  • Wednesday, May 3
  • Thursday, May 4
    • HHS, “Mental Health Summit.” Additional information
    • Policy Center for Maternal Mental Health, “Congressional Briefing: Unveiling the New Maternal Mental Health State Report Cards and Policy Roadmap.” Additional information
    • Yale New Haven Hospital, Johns Hopkins Medicine, and University of Maryland Medical System, “Telehealth Symposium,” featuring Sirona Strategies VP Chris Adamec. Additional information
  • Friday, May 5
    • Johns Hopkins Bloomberg School of Public Health, “Fireside Chat with Michelle Lujan Grisham, Governor, State of New Mexico.” Additional information

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

Medicare & Medicaid–

  • On April 24, the Government Accountability Office (GAO) released a report on Medicaid and its role supporting beneficiaries with intellectual or developmental disabilities, describing characteristics and health care expenditures of beneficiaries enrolled in Medicaid home and community-based services (HCBS) programs in 2019. Report
  • Also on April 24, the HHS Office of Inspector General (OIG) released a report which found that Medicare spent up to $128 million over five years in duplicate payments for individuals with Medicare and Veterans Health Administration benefits. Report
  • On April 25, CMS released a notice soliciting comments on the data validation process for Medicare Part C and Part D reporting requirements. Validated plan-reported data may be used for Star ratings, display measures, and other performance measures. Comments are due by June 26, 2023. Notice
  • Also on April 25, HHS released an analysis on the impact that Medicaid work requirements would have should proposals by Congressional Republicans be implemented, concluding that 21 million people nationwide would be at risk of losing Medicaid coverage. Press Release Fact Sheet
  • On April 27, CMS issued a frequently asked questions (FAQ) document on CMS waivers, flexibilities, and the end of the COVID-19 public health emergency (PHE). FAQs
  • Also on April 27, CMS issued a proposed rule on ensuring access to Medicaid services, proposing requirements intended to increase transparency and accountability, standardize data and monitoring, and create opportunities for states to promote active beneficiary engagement. Comments are due by June 22, 2023. Proposed Rule Fact Sheet Press Release
  • Also on April 27, CMS issued a proposed rule on Medicaid Managed Care which would strengthen standards for timely access to care and states’ monitoring and enforcement efforts; enhance quality, fiscal, and program integrity standards; and better address health-related social needs, among other changes. Comments are due by June 22, 2023. Proposed Rule Fact Sheet Press Release
  • Also on April 27, Sen. Johnson (R-WI) and House Committee on Oversight and Accountability Chair Comer (R-TN) sent a letter to CMS Administrator Brooks-LaSure raising concerns about improper payments in the Medicaid program and what safeguards CMS has in place to address them. Letter Press Release
  • Also on April 27, the Congressional Budget Office (CBO) released a report, “The Medicare and Medicaid Improvement Funds: Budgetary History and Projections.” Report
  • On April 28, CMS released a notice soliciting comments on the implementation of a survey on reasons for beneficiary disenrollment from Medicare Prescription Drug Plans and Medicare Advantage plans. Comments are due by May 30, 2023. Notice
  • Also on April 28, CMS released the latest enrollment figures for Medicare, Medicaid, and CHIP. As of January 2023, 65,545,616 people are enrolled in Medicare and 93,008,246 people are enrolled in Medicaid and CHIP. Enrollment Figures
  • Also on April 28, CMS released a blog, “The Transplant Eco-System: The Role of Data in CMS Oversight of The Organ Procurement Organizations,” outlining CMS’ strategy for Organ Procurement Organizations (OPOs) and transplant programs. Blog
  • Also on April 28, CMS released a notice announcing a policy extension of the Medicare Diabetes Prevention Program (MDPP) expanded model that was issued during the COVID-19 PHE. The notice specifies an effective date of the regulations December 31, 2023, through which in-person delivery of MDPP services can be suspended. Notice

Marketplaces & Coverage–

  • On April 26, CMS issued a proposed rule that would expand access for Deferred Action for Childhood Arrivals (DACA) recipients to subsidized coverage through the Health Insurance Marketplaces and Basic Health Program, in addition to some Medicaid and CHIP programs. Comments are due by June 23, 2023. Proposed Rule Press Release
  • Also on April 26, CDC released a report on health insurance coverage, highlighting that uninsurance rates ranged from 8.0 to 8.8 percent from October 2021–December 2022. The data is part of an early release of selected estimates from the 2022 National Health Interview Survey. Data Report
  • On April 27, HHS released an initial report from the fourth quarter of 2022 and a status update on the Federal Independent Dispute Resolution (IDR) process for the period from April 15, 2022 through March 31, 2023, as required by the No Surprises Act. 2022 Q4 Initial Report Status Update

Payment & Delivery System Models –

Public Health Preparedness, Prevention, Surveillance & Data –

  • COVID-19 Data: To date, there are 104,538,730 total COVID-19 cases and 1,130,662 COVID-19 deaths in the United States. Also, 979,617,855 COVID-19 vaccines have been delivered and 675,442,636 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 438 tests under Emergency Use Authorizations (EUAs), including 301 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On April 24, House Committee on Oversight and Accountability, Select Subcommittee on the Coronavirus Pandemic Chair Wenstrup (R-OH) led Republican members of the Subcommittee in a letter requesting the Embassy of the People’s Republic of China make five Chinese scientists available for in-person, transcribed interviews related to the origins of COVID-19. Press Release Letter
  • Also on April 24, HHS released a press release highlighting HHS’ nationwide vaccination day event intended to bring health-related resources to Black communities, partnering with seven organizations to provide free COVID vaccines in 17 cities. Press Release
  • On April 25, the FDA announced the issuance of an Emergency Use Authorization (EUA) for the BioSynchronicity Corporation’s C-Sync COVID–19 Antigen Test, a medical device related to the COVID-19 public health emergency. Notice
  • On April 28, CDC released a notice seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). The HICPAC consists of 14 experts in fields including infectious diseases, infection prevention, health care epidemiology, public health, and related medical fields. Nominations are due September 29, 2023. Notice
  • Also on April 28, the White House Office of Science and Technology Policy (OSTP) published a blog on the role of research in the response to Mpox and how this process for research gathering can be applied to other diseases and future outbreaks. Blog

Health IT, Privacy, & Digital Health –

  • On April 24, HHS OIG released a toolkit which provides detailed information on methods to analyze telehealth claims to identify program integrity risks associated with telehealth services. Toolkit

Mental Health and Substance Use Disorder Policy –

  • On April 24, the Substance Abuse and Mental Health Services Administration (SAMHSA) posted an Executive Summary of the August 2022 Recovery Now! Summit that the agency hosted for 200 in-person and virtual participants to collaborate on the Office of Recovery’s National Recovery Agenda. Summary
  • Also on April 24, SAMHSA announced a notice of funding opportunity (NOFO) for the Minority AIDS Initiative. The program aims to provide substance use and HIV prevention services to racial and ethnic minority populations at high-risk for substance use disorders (SUDs) and HIV infection. Applications are due June 20, 2023. NOFO
  • On April 25, CDC released a report on working conditions and serious psychological stress among working aged adults in 2021. Report
  • On April 28, President Biden declared May 2023 as National Mental Health Awareness Month and encouraged stakeholders to take action to strengthen mental health in the U.S. Proclamation
  • Also on April 28, SAMHSA released a notice announcing it is providing up to $2,817,614 for one grant recipient funded in the fiscal year (FY) 2020 Suicide Prevention Resource Center. Notice
  • Also on April 28, SAMHSA released a notice announcing it is providing up to $747,646 in additional support to the University of North Carolina to support a grant originally funded in FY 2018 under the National Center of Excellence for Eating Disorders. Notice

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

  • On April 25, the FDA approved Qalsody to treat patients with amyotrophic lateral sclerosis (ALS). Press Release
  • Also on April 25, Senate HELP Committee Chair Sanders (I-VT) and Ranking Member Cassidy (R-LA) issued a statement announcing a bipartisan deal on legislation to lower drug prices by reforming pharmacy benefit managers and expanding the availability of low-cost generic drugs. Press Release
  • On April 26, the FDA approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI. Press Release
  • On April 27, GAO released a report on the actions taken by federal agencies to combat antibiotic resistance and how these actions address previous recommendations made by GAO in a March 2020 report in which GAO made eight recommendations. Report in Brief Report
  • Also on April 27, the CDC’s National Institute for Occupational Safety and Health (NIOSH) announced the availability of final documents for developing hazardous drugs and managing exposure to hazardous drugs in health care settings. Notice Procedures Additional Information
  • Also on April 27, the FDA issued a letter to health care providers informing them and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service (UCS) software in certain medical devices. Letter
  • Also on April 27, the FDA approved the vaccine Prevnar 20 for the prevention of disease caused by the 20 different serotypes of Streptococcus pneumoniae contained in the vaccine, and for the prevention of ear infection caused by seven of the serotypes of Streptococcus pneumoniae contained in the vaccine. Approval Letter

Veterans Health and Military Health –

  • On April 25, Military Officers Association of America (MOAA) awarded Senate Veterans’ Affairs Committee Chair Tester (D-MT) the 2023 Colonel Arthur T. Marix Congressional Leadership Award for his commitment to serving the nation’s veterans and their families. Press Release
  • On April 26, the Department of Veterans Affairs (VA) OIG released a report on a review that was conducted to assess implementation and use of VA Video Connect (VVC) prior to and during the COVID-19 pandemic. Report in Brief Report
  • Also on April 26, President Biden issued a statement on outcomes from the passing of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act, including the submittal of 500,000 PACT Act-related claims to the VA and three million veterans receiving toxic exposure screenings since August. Statement
  • Also on April 26,  Joshua Jacobswas confirmed as VA’s Under Secretary for Benefits. Press Release
  • On April 27, VA OIG released a report on the results of a focused evaluation of the inpatient and outpatient care provided at the VA Long Beach Healthcare System in California. VA OIG noted opportunities for improvement and issued three recommendations in medical staff privileging and environment of care. Report in Brief Report
  • Also on April 27, House Committee on Veterans’ Affairs Chair Bost (R-IL), along with Reps. Luttrell (R-TX) and Van Orden (R-WI), sent a letter to VA Inspector General Missal regarding allegations that a Tomah, Wisconsin VA Medical Center neurologist provided incomplete disability exams to hundreds of veterans over an 18-year period. Press Release Letter

Population Health, Public Health & Health Equity –

  • On April 25, HHS Secretary Becerra released a statement against Missouri’s emergency regulation restricting access to gender-affirming care as an attack on bodily autonomy and interference with the practice of medicine by dedicated and trained professionals. Statement
  • On April 26, the U.S. Department of Agriculture (USDA) Food and Nutrition Service (FNS) released a notice soliciting comments on states’ customer service strategies for the Supplemental Nutrition Assistance Program (SNAP). Comments are due by June 26, 2023. Notice
  • Also on April 26, USDA FNS released a notice soliciting comments on a study examining how states have shifted SNAP operations due to the COVID-19 pandemic. Comments are due by June 26, 2023. Notice
  • Also on April 26, HHS announced the availability of $2.5 million in funding for Native communities to support the development of produce prescription programs, which help individuals and families who are experiencing food insecurity and/or diet‑related health problems more easily obtain fresh fruits and vegetables. Press Release
  • Also on April 26, the Department of Housing and Urban Development (HUD) awarded nearly $15 million through the Older Adults Home Modification Program (OAHMP) to fund programs that make safety and functional home modifications to meet the needs of low-income elderly homeowners that allow them to age in place. OAHMP Grants Press Release
  • On April 27, HHS announced it had awarded $147 million to 49 recipients to advance the Ending the HIV Epidemic in the U.S. initiative, providing support to states and metropolitan areas with the highest levels of HIV transmission. Press Release
  • Also on April 27, USDA released a blog post, “Easier Enrollment in WIC Leads to Healthier Moms and Kids,” highlighting steps USDA is taking to help more eligible families connect to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Blog
  • On April 28, CDC released the Youth Risk Behavior Surveillance Report for 2021, which includes data on a broad range of health-related behaviors among high school students. Report
  • Also on April 28, the Biden Administration released a multi-year Alternatives, Rehabilitation, and Reentry Strategic Plan aimed at strengthening public safety and reducing unnecessary criminal justice system interactions. The Strategic Plan supports justice-involved persons and promotes public safety by utilizing a whole-of-government approach, including by expanding access to health care, food and subsistence benefits, and affordable housing. Strategic Plan Fact Sheet
  • Also on April 28, President Biden declared May 2023 as National Physical Fitness and Sports Month, calling upon the American people to make daily physical activity a priority, to support efforts to increase access to sports opportunities in their communities, and to pursue physical fitness as an essential part of healthy living. Proclamation
  • Also on April 28, FDA issued a final guidance titled, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,” which replaces the draft guidance of the same name published in February 2019. Press Release Final Guidance

Health Systems & Health Care Workforce –

  • On April 26, CMS announced updates to enforcement processes for the Hospital Price Transparency Rule, including imposing penalties earlier and automatically and streamlining the compliance process. Press Release
  • Also on April 26, GAO released a report on the Internal Revenue Service (IRS) oversight of nonprofit hospitals’ tax-exempt status. GAO recommends Congress consider specifying what services and activities demonstrate sufficient community benefit. Report
  • Also on April 26, CDC released a notice announcing the opening of a docket to obtain comment on several draft guidelines regarding infection prevention and control in health care personnel, including pregnant health care personnel. Notice

Misc. –

Legislative Activity –

Votes and Committee Activity –

  • On April 26, the House passed the Limit, Save, Grow Act of 2023 (H.R. 2811) by a vote of 217-215. The bill would provide for a responsible increase to the debt ceiling, and includes health care related proposals such as implementing Medicaid work requirements. The bill now heads to the Senate for consideration. Bill text Press release

Introduced Legislation –

  • On April 24, Rep. Castor (D-FL) introduced the Kids Protecting the Information of our Vulnerable Adolescents, Children and Youth (PRIVACY) Act (H.R. 2801), which would amend the Children’s Online Privacy Protection Act of 1998 to update and expand the coverage of such Act. Press release
  • Also on April 24, Rep. Espaillat (D-NY) introduced the Harm Reduction Through Community Engagement Act of 2023 (H.R. 2804), which would amend the Controlled Substances Act with respect to the registration of opioid treatment programs to increase stakeholder input from relevant communities and to ensure such programs are treating patients in need. Bill text
  • On April 25, Reps. Harshbarger (R-TN), Spanberger (D-VA), Miller-Meeks (R-IA), and Krishnamoorthi (D-IL) introduced the PBM Sunshine and Accountability Act (H.R. 2816), which would strengthen transparency requirements with respect to pharmacy benefit managers. Bill text Press release Summary
  • Also on April 25, Reps. Buschon (R-IN) and Ruiz (D-CA) introduced the Good Samaritan Health Professionals Act of 2023 (H.R. 2819), which would limit the liability of health care professionals who volunteer to provide health care services in response to a disaster. Press release
  • Also on April 25, Reps. Connolly (D-VA), Mace (R-SC), Norton (D-DC), and Wasserman Schultz (D-FL) introduced the Family Building FEHB Fairness Act (H.R. 2828), which would require Federal employee health benefit plans to include assisted reproductive treatment benefits. Sen. Duckworth (D-IL) introduced the companion legislation in the Senate (S. 1262). Bill text Press release
  • Also on April 25, Reps. Duncan (R-SC) and DelBene (D-WA) introduced the Chronic Care Management Improvement Act (H.R. 2829), which would remove cost-sharing responsibilities for chronic care management services under the Medicare program. Press release
  • Also on April 25, Reps. Smith (R-NE) and Dingell (D-MI) introduced the Expanding Care in the Home Act (H.R. 2853), which would expand access to clinical care in the home. Press release
  • Also on April 25, Reps. Trone (D-MD), Rogers (R-KY), Lamborn (R-CO), and Peltola (D-AK) introduced Bruce’s Law (H.R. 2867), which would establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Drugs, and to provide community-based coalition enhancement grants to mitigate the effects of drug use. Bill text Press release One pager
  • Also on April 25, Reps. Walberg (R-MI), Foxx (R-NC), Good (R-VA), Allen (R-GA), Crenshaw (R-TX), and Burgess (R-TX) introduced the Association Health Plans Act (H.R. 2868), which would clarify the treatment of certain association health plans as employers. Press release
  • Also on April 25, Reps. Wasserman Schultz (D-FL), Hayes (D-CT), and McBath (D-GA) introduced the School Shooting Safety and Preparedness Act (H.R. 2869), which would require the Secretary of Education, in consultation with the Attorney General and the Secretary of Health and Human Services, to publish an annual report on indicators of school crime and safety that includes data on school shootings. Press release
  • Also on April 25, Sen. Klobuchar (D-MN) and 23 cosponsors introduced the Strengthening Medicare and Reducing Taxpayer (SMART) Prices Act (S. 1264), which would strengthen the drug pricing reforms in the Inflation Reduction Act. Press release
  • Also on April 25, Sens. Shaheen (D-NH) and Collins (R-ME) introduced the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act of 2023 (S. 1269), which would reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Bill text Press release
  • Also on April 25, Sens. Cruz (R-TX) and Welch (D-VT) introduced the Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act (S. 1280), which would require coordinated National Institute of Standards and Technology science and research activities regarding illicit drugs containing xylazine, novel synthetic opioids, and other substances of concern. Bill text Press release
  • On April 26, Reps. Jayapal (D-WA) and Spartz (R-IN) introduced the Stop Anticompetitive Healthcare Act (H.R. 2890), which would make hospital organizations and cooperative hospital service organizations subject to the law relating to unfair methods of competition. Press release
  • Also on April 26, Reps. Lee (D-NV) and Fitzpatrick (R-PA) introduced the Seniors Securing Access to Vital and Essential (SAVE) Prescription Drugs Act (H.R. 2893), which would provide for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare program. Press release Summary
  • Also on April 26, Rep. Pressley (D-MA) and 43 cosponsors introduced the Anti-Racism in Public Health Act of 2023 (H.R. 2904), which would provide for public health research and investment into understanding and eliminating structural racism and police violence. Sen. Warren introduced the companion legislation in the Senate (S.1317). Bill text Press release Bill summary
  • Also on April 26, Reps. Turner (R-OH), Golden (D-ME), Tenney (R-NY), and Kildee (D-MI) introduced the Health Coverage Tax Credit (HCTC) Reauthorization Act of 2023 (H.R. 2914), which would extend the health coverage tax credit. Press release
  • Also on April 26, Sens. Booker (D-NJ), Padilla (D-CA), and Brown (D-OH) introduced the John Lewis Equality in Medicare and Medicaid Treatment (EMMT) Act (S. 1296), which would improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation. Bill text Press release
  • Also on April 26, Sen. Kaine (D-VA) and seven cosponsors introduced the Supporting Our Direct Care Workforce and Family Caregivers Act (S. 1298), which would award grants for the creation, recruitment, training and education, retention, and advancement of the direct care workforce and to award grants to support family caregivers. Press release
  • Also on April 26, Sens. Menendez (D-NJ), Boozman (R-AR), Schumer (D-NY), and Collins (R-ME) introduced the Resident Physician Shortage Reduction Act (S. 1302), which would provide for the distribution of additional residency positions. Bill text Press release
  • Also on April 26, Sens. Grassley (R-IA), Hassan (D-NH), Wicker (R-MS), and Lujan (D-NM) introduced the Recruiting Families Using Data Act (S. 1313), which would improve foster and adoptive parent recruitment and retention. Bill text Press release One pager Section by section
  • On April 27, Sen. Sanders (I-VT) introduced the Pharmacy Benefit Manager Reform Act (S.1339), which would provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Bill text Press release
  • Also on April 27, Sens. Ossoff (D-GA) and Cramer (R-ND) introduced the Military Families Mental Health Services Act (S.1347), which would waive cost-sharing under the TRICARE program for three mental health outpatient visits per year for certain beneficiaries. Bill text Press release
  • Also on April 27, Reps. Ferguson (R-GA), Peters (D-CA.), LaTurner (R-KS), and Levin (D-CA) introduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (H.R. 2940), which would encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability of antibiotics when needed. Sens. Bennet (D-CO) and Young (R-IN) introduced the companion legislation in the Senate (S. 1355). Bill text Press release
  • Also on April 27, Rep. Smith (D-WA) introduced the Behavioral Health Crisis Care Centers Act (H.R. 2977), which would provide grant funding for states, cities and counties, and tribal governments to build and expand crisis stabilization services with housing assistance and other wrap around services. Bill text Press release
  • On April 28, Rep. Fletcher (D-TX) introduced the Affordable Care Coverage Expansion and Support for States (ACCESS) Act (H.R. 3004)to establish a program at HHS to create a federal Medicaid program for adults in the coverage gap in non-expansion states. Press Release