Health Care Policy Update – Weekly Wrap-up and What’s Ahead: May 9, 2022


 

 

What’s Ahead: This Week

Hearings & Markups –

  • Wednesday, May 11
    • House Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, “FY2023 Budget Request for the National Institutes of Health.” Additional information
    • Senate Veterans’ Affairs Committee, “Examining Quality of Care in VA and the Private Sector.” Additional information
    • House Appropriations Committee, Subcommittee on Military Construction, Veterans Affairs, and Related Agencies, “Impacts of VA’s Research Efforts on Veterans.” Additional information
    • Senate Appropriations Committee, Subcommittee on Interior, Environment, and Related Agencies, “A Review of the Fiscal Year 2023 President’s Budget for the Indian Health Service.” Additional information
    • House Veterans’ Affairs Committee, Subcommittee on Economic Opportunity, “Reviewing President Biden’s Strategy to Reduce Veteran Suicide by Addressing Economic Risk Factors.” Additional information
  • Thursday, May 12
    • House Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, “Healthy Aging: Maximizing the Independence, Well-being, and Health of Older Adults.” Additional information
    • House Homeland Security Committee, Subcommittee on Border Security, Facilitation, and Operations, “Examining DHS’s Efforts to Combat the Opioid Epidemic.” Additional information
    • House Veterans’ Affairs Committee, Subcommittee on Health, “Innovative Care Delivery at VA: Partnering to Improve Infrastructure and Operational Efficiency.” Additional information

Notable Policy Events –

  • Monday, May 9
  • Tuesday, May 10
    • Bipartisan Policy Center, “Shoring Up the Nursing Workforce: What Policies Can Get Us Back on Track?” Additional information
  • Wednesday, May 11
  • Thursday, May 12
    • Center for Health Care Strategies, “Increasing Investment in Primary Care through Medicaid Managed Care.” Additional information
  • Friday, May 13

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

COVID-19 Surveillance, Funding, Oversight and Data –

  • Data: To date, there are 80,440,151 total COVID-19 cases and 986,042 COVID-19 deaths in the United States. Also, 718,074,545 COVID-19 vaccines have been delivered and 569,397,972 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 431 tests under Emergency Use Authorizations (EUAs), including 297 molecular tests, 84 antibody tests and 50 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On May 3, HHS released a report that describes workforce shortages both prior to and during the pandemic, and the impact of COVID-19 on the mental and physical health of the health care workforce. Overview Report
  • On May 4, Sens. Brown (D-OH), Grassley (R-IA), Casey (D-PA), Barrasso (R-WY) and Luján (D-NM) sent a letter to CMS Administrator Brooks-LaSure urging the agency to provide clear guidance on ways the Agency will support pharmacists who provide essential services such as vaccinations to Medicare beneficiaries once the COVID-19 public health emergency (PHE) designation ends. Press release Letter
  • On May 5, FDA limited the authorized use of the Janssen COVID-19 Vaccine to individuals for whom other COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who would not otherwise receive a COVID-19 vaccine. After conducting an updated analysis, FDA has determined that the of a potentially life-threatening syndrome warrants limiting the authorized use of the vaccine. Press release
  • Also on May 5, Reps. Gohmert (R-TX), Posey (R-FL) and Duncan (R-SC), were joined by Sen. Cruz (R-TX) and thirteen other Republican Senators in a letter to the FDA and CDC requesting the FDA set ahigh safety and efficacy standard before considering granting EUA status to Pfizer and Moderna for use of the COVID vaccine in children 6 months of age and older. Press release
  • On May 6, HHS released a new toolkit about Coverage and Reimbursement of COVID-19 Vaccines, Vaccine Administration and Cost-Sharing under Medicaid, the Children’s Health Insurance Program, and Basic Health Program. Press release

Medicare, Medicaid & Marketplaces –

  • On May 4, HHS released a report that found estimated savings of about $2.6 billion from reduced Medicare hospitalizations associated with COVID-19 vaccinations in early 2021. These cost savings reflect 107,000 fewer Medicare (FFS and Medicare Advantage) COVID-19 hospitalizations, compared to projections if no COVID-19 vaccines were available during that period. Overview Report
  • Also on May 4, FCC is seeking public comment on a letter from CMS to the FCC requesting its opinion on whether text messages and automated pre-recorded telephone calls to individuals’ cell phones with reminders to update their contact information, return their renewal forms, and follow up with the Marketplace if their enrollment needs to transition, are permissible under the Telephone Consumer Protection Act (TCPA). Comments are due by May 17, 2022. Request for information Letter
  • On May 6, House Energy & Commerce Committee Chair Pallone (D-NJ) and Senate Finance Committee Chair Wyden (D-OR) wrote to companies contracting with states to assist in determining who is eligible for Medicaid and Children’s Health Insurance Program (CHIP) coverage at the end of the COVID-19 PHE. Press release
  • Also on May 6, CMS approved Tennessee and South Carolina’s state plan amendments to expand Medicaid and CHIP coverage to 12 months postpartum to an estimated 22,000 and 16,000 parents, respectively. HHS Press release CMS Press release
  • Also on May 6, CMS released the HHS risk adjustment model coefficients for the 2023 benefit year. As noted in the HHS Notice of Benefit and Payment Parameters for 2023 final rule, the

2023 benefit year final HHS risk adjustment model coefficients are based on blended coefficients separately solved from the 2017, 2018, and 2019 enrollee-level EDGE data. Risk Adjustment Coefficients

 

Payment and Delivery System Models –

Mental Health and Substance Use Disorder Policy –

  • On May 2, HHS released a series of reports about how to sustain gains from achieved Coordinated Specialty Care (CSC) early intervention programs once clients are no longer receiving intensive services. Environmental scan Final report Issue brief
  • On May 3, HHS Secretary Becerra and Department of Labor Secretary Walsh met with health insurance and business leaders to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic. Press release
  • Also on May 3, HHS released a fact sheet about actions the agency was taking around Mental Health Awareness Month 2022. Secretary Becerra also kicked off the HHS National Tour to Strengthen Mental Health to address the mental health challenges that have been exacerbated by the COVID-19 pandemic, including substance use, youth mental health, and suicide. Fact sheet Statements from Sec. Becerra and other HHS leaders on Mental Health Awareness Month
  • On May 4, HHS announced $55 million in funding for its Tribal Opioid Response (TOR) grant program. The TOR grant program addresses the overdose crisis in tribal communities by increasing access to FDA-approved medications for the treatment of opioid misuse, and supporting prevention, harm reduction, treatment, and recovery support services for opioid and stimulant misuse and co-occurring mental and substance use conditions. Press release Notice of funding opportunity
  • On May 6, HHS announced the launch of the Maternal Mental Health Hotline, a new, confidential, toll-free hotline for expecting and new moms experiencing mental health challenges. Press release

Prescription Drug and Medical Device Policy –

  • On May 2, Senate Finance Committee Ranking Member Crapo (R-ID), Senate HELP Committee Ranking Member Burr (R-NC), House Ways & Means Committee Ranking Member Brady (R-TX) and House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) sent a letter to CMS Administrator Brooks-LaSure raising concerns with a recent decision to restrict coverage of an FDA approved Alzheimer’s treatment and any similar future treatments. Press release Letter
  • Also on May 2, the Healthy Future Task Force Treatment Subcommittee laid out its agenda for increasing access to affordable treatments at a roundtable. Press release House Minority Leader McCarthy (R-CA) Statement Treatment Subcommittee objectives
  • Also on May 2, Sen. Grassley (R-IA) sent a letter to the HHS OIG asking for an update on seven drug manufacturer referrals for 340B Drug Pricing Program non-compliance. Press release
  • On May 3, Senate HELP Chair Murray (D-WA), Senate Finance Committee Chair Wyden (D-OR), Special Committee on Aging Chair Casey (D-PA) and Sen. Hassan (D-NH) sent a letter to the three largest PBMS, CVS Caremark, OptumRx, and Express Scripts amid ongoing reports that they are illegally delaying or denying patient insurance coverage for birth control. Press release CVS Caremark Letter Optum Rx Letter Express Scripts Letter
  • On May 4, FDA announced it will permit marketing for a new test that improves diagnosis of Alzheimer’s Disease for adults aged 55 years and older, who are presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Press release
  • On May 6, HHS completed its review of Merck’s policy, which places restrictions on 340B pricing for certain covered entities dispensing medications through pharmacies. HHS determined that Merck’s actions have resulted in overcharges and are in direct violation of the 340B statute. Letter

Digital Health, Health IT and Privacy –

Veteran Health and Military Health –

  • On May 3, Senate Finance Committee Ranking Member Crapo (R-ID) and Sen. Risch (R-ID) sent a letter to Secretary of Defense Austin raising questions about the number and nature of military discharges for not receiving a COVID-19 vaccine. Press release
  • On May 4, VA OIG released a report about the Connected Care Program which purchased 10,000 iPhones with unlimited prepaid data plans for the homeless veterans. The report found that 8,544 of the 10,000 iPhones remained in storage as of July 2021, as demand for the iPhones was much lower than anticipated, resulting in an estimated $1.8 million in wasted data plan costs. Overview Report
  • Also on May 4, Rep. Walorski (R-IN) urged VA Secretary McDonough to provide improved care to U.S. veterans seeking long-term care, including ensuring quality care facilities close to veterans’ homes and family support. Press release
  • Also on May 4, Rep. Roy (R-TX) sent a letter opposing VA Secretary McDonough’s decision to mandate the COVID-19 vaccine for VA employees. Press release
  • On May 5, the Department of Defense and VA released a joint audit that assessed internal controls and compliance with legal requirements, as well as actions by DoD, VA, and their joint Federal Electronic Health Record Modernization (FEHRM) Program Office. The joint audit found that DoD and VA took some actions to achieve system interoperability, but there are remaining challenges. Overview Report

Public Health and Health Equity–

  • On May 2, HHS Secretary Becerra and Ambassador Tai released a joint statement in celebration of Asian American, Native Hawaiian, and Pacific Islander Heritage Month. Press release Fact sheet
  • On May 3, HHS awarded nearly $25 million to improve and strengthen access to school-based health services in communities across the country. Awards will support local partnerships between schools and health centers to provide children and youth the comprehensive physical and mental health care they need. Press release
  • Also on May 3, HHS Secretary Becerra released a statement about the inaugural National Adolescent Health Month. This month-long observance will address the following weekly themes: 1) empower youth with sexual and reproductive health information and services, 2) support mental health and well-being, 3) encourage physical health and healthy decision-making, and 4) sustain equitable, accessible, and youth-friendly services. Press release
  • On May 4, President Biden announced that the White House will host a Conference on Hunger, Nutrition and Health this September. The Conference will launch a national plan around combatting hunger in the U.S. Press release HHS Secretary Becerra and Department of Agriculture Secretary Vilsack statements

Misc. –

  • On May 3, House Committee on Oversight and Reform Ranking Member Comer (R-KY) and Oversight Committee Republicans called on Attorney General Garland to launch an investigation into the leaked draft opinion on a matter currently pending before the United States Supreme Court. Press release Letter
  • Also on May 3, HHS Secretary Becerra released a statement on the alleged draft Supreme Court Opinion about Roe v. Wade, reaffirming his support for legal abortion. Press release Becerra reaffirms commitment to legal safe abortion
  • On May 5, HHS released a report, Impact of the COVID-19 Pandemic on People with Disabilities, highlighting the impact of the pandemic on people with disabilities. Press release Report
  • On May 6, HHS launched the first installment of a new public information series called the Climate and Health Outlook (Outlook). This new Outlook series connects weather forecasts to health resources to create actionable data that saves lives and reduces illness and health risks associated with climate-related hazards like extreme heat, wildfires, hurricanes, droughts, and vector-borne diseases that impact human health. Press release Climate and Health Outlook
  • Also on May 6, the White House issued a proclamation on National Women’s Health Week to ensure the health and well-being of women and girls. Press release
  • Also on May 6, HHS is seeking input from individuals and organizations regarding supportive, nutrition, evidence-based disease prevention and health promotion, caregiver, legal, long-term care ombudsman, and other services provided via states, tribes and tribal organizations, area agencies on aging, and local service providers. Comments are due June 6, 2022. Federal register Request for information

Legislative Activity –

Votes and Committee Activity –

  • On May 4, Energy & Commerce Committee Chair Pallone (D-NJ), Ranking Member McMorris Rodgers (R-WA), Health Subcommittee Chair Eshoo (D-CA), and Health Subcommittee Ranking Member Guthrie (R-KY) unveiled a legislative package to reauthorize the FDA user fee agreements. The Food and Drug Amendments of 2022. The legislation is expected to be marked up by the Health Subcommittee this week. Press release GOP Press release Bill text Section-by-section

Introduced Legislation –

  • Also on May 3, Rep. Davids (D-KS) and six cosponsors introduced the Pride in Mental Health Act (H.R. 7644), which would ensure protections for lesbian, gay, bisexual, and transgender youth and their families. Press release
  • Also on May 3, Reps. Mullin (R-OK) and O’Halleran (D-AZ) introduced the Modern Authentication of Pharmaceuticals Act of 2022 (H.R.7653), which would modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain. Bill text Press release
  • Also on May 3, Reps. Mullin (R-OK) and Weber (R-TX) introduced the Mindless Mask Mandate on Planes Act of 2022 (H.R. 7655), which would limit certain authority of the Department of Health and Human Services to require individuals to wear a mask, a face covering, or any other accessory during domestic air travel, to require the refund of civil fines imposed for refusal to wear such an accessory. Bill text Press release
  • Also on May 3, Reps. O’Halleran (D-AZ) and Lesko (R-AZ) introduced the (H.R. 7658), which would reauthorize the Critical Path Public-Private Partnerships. On May 5, Sens. Kelly (D-AZ), Collins (R-ME), and Sinema (D-AZ) introduced the companion legislation in the Senate (S. 4152). Press release
  • Also on May 3, Sen. Lankford (R-OK) and 11 cosponsors introduced the Patient Access to Higher Quality Health Care Act (S. 4130), which would repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals. Bill text Press release
  • Also on May 3, Sen. Blumenthal (D-CT) introduced the Women’s Health Protection Act of 2022 (S.4132), which would protect a person’s ability to determine whether to continue or end a pregnancy, and protect a health care provider’s ability to provide abortion services. Press release
  • On May 5, Sens. Grassley (R-IA), Feinstein (D-CA), Cornyn (R-TX), and Hassan (D-NH) introduced the Stop Pills that Kill Act (S.4151), which would prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances. Press release
  • Also on May 5, Sens. Tester (D-MT) and Boozman (R-AR) introduced the VA Workforce Improvement, Support, and Expansion (WISE) Act of 2022 (S. 4156), which would improve the workforce of the Department of Veterans Affairs. Press release
  • On May 6, Reps. Fletcher (D-TX) and Bilirakis (R-FL) introduced the (H.R.7679), which would amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions. Press release Bill text
  • Also on May 6, Energy & Commerce Committee Chair Pallone (D-NJ) and Ranking Member McMorris Rodgers (R-WA) introduced the Restoring Hope for Mental Health and Well-Being Act of 2022 to reauthorize key programs to address the national mental health and substance use disorder crises. The Health Subcommittee will consider the bipartisan legislation in a markup this week. Press release Bill text Section by section