What’s Ahead: This Week

Notable Policy Events –

  •  Monday, August 29
  • Tuesday, August 30
    • Center for Strategic and International Studies, “A Fireside Chat with Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention.” Additional information
    • Health Affairs, “Lunch & Learn: The 25th Anniversary of CHIP: A Checkup.” Additional information
    • Primary Care Collaborative, “Addressing Inequities with Whole-Person Primary Care.” Additional information
  • Thursday, September 1 – Friday, September 2


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

No Surprises Act –

  • On August 24, the Departments of Labor, HHS and Treasury published the Requirements Related to Surprise Billing final rules in the Federal Register. The final rules concern standards related to the arbitration process for implementing the No Surprises Act, a bipartisan law to protect consumers against surprise medical bills. These final rules are effective on October 25, 2022. Press Release Final Rules

Medicare, Medicaid & Marketplaces –

  • On August 22, HHS awarded approximately $25 million in planning grants to five new states and territories to expand access to home and community-based services (HCBS) through Medicaid’s Money Follows the Person (MFP) demonstration program. HHS Press ReleaseCMS Press Release
  • Also on August 22, CMS released the Money Follows the Person: Updated State Transitions annual report for calendar years 2017 to 2020. The brief shows how MFP transitions varied by state and target population over time. Annual Report
  • Also on August 22, CMS issued an informational bulletin detailing actions that states can take using existing Medicaid authorities to drive better health outcomes for nursing home residents and to improve staff pay, training, and retention efforts. HHS Press Release CMS Press Release Informational Bulletin
  • Also on August 22, CMS published a blog providing an update on the launch of a multi-faceted approach to determine the minimum level and type of staffing needed to enable safe and quality care in nursing homes. Information obtained through efforts, including a study and RFI, will inform future proposed rulemaking on minimum staffing requirements, which CMS plans to issue in Spring 2023. Blog
  • On August 23, Senate Finance Committee Chair Wyden (D-OR) launched an inquiry into the marketing tactics of Medicare Advantage plans. Chair Wyden sent letters to 15 state insurance commissioners and state health insurance assistance programs requesting data about Medicare Advantage marketing complaints and other information. Press Release Letter
  • On August 25, CMS released the latest enrollment data highlights for Medicare, Medicaid and CHIP for May 2022. Enrollment Data
  • On August 26, HHS announced an investment of $98.9 million in grant funding to 59 returning Navigator organizations for the 2023 Open Enrollment Period to help consumers navigate enrollment through the Marketplace, Medicaid, and CHIP. Press Release
  • Also on August 26, CMS released a report on Medicaid Beneficiaries Who Use Long-Term Services and Supports (LTSS), which explores use of LTSS across different HCBS and institutional categories during calendar year 2019. Report

Payment & Delivery System Models –

  • On August 23, CMS released the first evaluation report for the Integrated Care for Kids (InCK) Model, which describes findings from the pre-implementation period activities (2020-2021). Model Webpage Report At-a-Glance Report
  • On August 25, CMS issued the Radiation Oncology Model final rule, announcing its decision to delay the start date of the model to a date yet to be determined through future rulemaking. Model Webpage Final Rule
  • On August 26, CMS announced the availability of new Research Identifiable Files (RIFs) for six CMS Innovation Center (CMMI) models through the CMMI Model Data Sharing (CMDS) Initiative. Additional Information

Public Health Prevention

  • COVID-19 Data: To date, there are 93,880,573 total COVID-19 cases and 1,037,953 COVID-19 deaths in the United States. Also, 806,829,135 COVID-19 vaccines have been delivered and 608,937,334 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 439 tests under Emergency Use Authorizations (EUAs), including 302 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On August 22, CDC recommended the use of Novavax’s COVID-19 vaccine as another primary series option for adolescents ages 12 through 17. Press Release
  • On August 23, HHS Secretary Becerra announced more than $20 million in funding to expand HIV prevention, testing, and treatment services at health centers nationwide. Press Release
  • On August 24, Senate HELP Committee Chair Murray (D-WA) sent a letter to the head of the HHS Administration for Strategic Preparedness and Response (ASPR), asking the Administration for a strategy to improve the availability and distribution of monkeypox vaccines—particularly within the LGBTQ+ community. Press Release Letter
  • Also on August 24, the House Select Subcommittee on the Coronavirus Crisis released a staff report that examined interactions between senior Trump Administration officials and the FDA around COVID-19 vaccine and treatment authorizations. Press Release Report
  • On August 25, members of the White House Monkeypox and COVID-19 response teams, as well as representatives from the CDC, met virtually with colleges and universities from across the country to discuss best practices and measures to curb the spread of Monkeypox and COVID-19. Meeting Readout
  • Also on August 25, the CDC launched a new landing page for colleges and universities and students with resources around Monkeypox. Landing Page
  • Also on August 25, House Committee on Oversight & Reform Ranking Member Comer (R-KY), House Education & Labor Committee Ranking Member Foxx (R-NC), and other Republican House members sent a letter to Department of Education Secretary Cardona requesting all documents and information about learning loss resulting from pandemic school closures, policies governing the use of COVID-19 relief funds for K-12 students, and the Department’s communications with teachers’ unions. Press Release Letter
  • On August 26, the White House Office of National AIDS Policy (ONAP) released the National HIV/AIDS Strategy for the United States 2022-2025. The Strategy sets forth targets for ending the HIV epidemic in the U.S. by 2030, including a 75 percent reduction in new HIV infections by 2025 and a 90 percent reduction by 2030. Report in Brief Report
  • Also on August 26, the FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Press Release Guidance

Health IT, Privacy, & Digital Health –

  • On August 22, the Office of the National Coordinator for Health IT (ONC) announced that registration is open for the 2022 ONC Tech Forum. This year’s event will be held virtually over three consecutive “Forum Fridays” on September 9, 16 and 23. Blog
  • On August 23, ONC released a blog on the use of health IT integration to address the drug overdose crisis in the U.S. Blog
  • Also on August 23, HHS announced a settlement with New England Dermatology P.C., d/b/a New England Dermatology and Laser Center (“NDELC”), over the improper disposal of protected health information, a potential violation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Press Release

Mental Health & Substance Abuse –

  • On August 23, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the finalists of the Recovery Innovation Challenge, which seeks to identify innovative practices in behavioral health that advance recovery on the ground and in the community. Finalists
  • On August 25, Republican members of the House Energy &Commerce Committee and the House Republican Big Tech Task Force unveiled a proposal examining the harms of Big Tech on children mental health and well-being and outlining several proposals to equip parents and protect children from such harms. Press Release One Pager

Prescription Drugs, Medical Devices, & Biomedical Research –

  • On August 25, Rep. Hern (R-OK) published an op-ed in the Daily Signal on the potential impact of drug pricing controls on the cost of insulin. Press Release Op-Ed
  • Also on August 25, the HHS Office of the Inspector General (OIG) released a memo comparing average sales prices (ASPs) with average manufacturer prices (AMPs) of Medicare Part B drugs. OIG found in the first quarter of 2022, eight drug codes met CMS’ price substitution criteria by exceeding the five percent threshold for two consecutive quarters or three of the previous four quarters. Memo in Brief Complete Memo
  • On August 26, the FDA announced the removal of N95 respiratorsfrom the agency’s medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. Press Release
  • Also on August 26, the FDA released a report on the state of pharmaceutical quality in 2021. The report presents recent findings from the Office of Pharmaceutical Quality (OPQ) that reveal insights about pharmaceutical manufacturers and their products, adherence to manufacturing compliance standards, and opportunities for improvement. Report

Veterans Health & Military Health  –

  • On August 23, House Committee on Veterans’ Affairs Chair Takano (D-CA) unveiled the Veterans Reproductive Healthcare Survey as part of the Committee’s larger effort focused on reproductive health care access for America’s veterans. Press Release Survey
  • On August 25, the Department of Veterans Affairs (VA) OIG released a report on whether Veterans Benefits Administration (VBA) staff followed regulations when processing and deciding claimed conditions potentially associated with contaminated water exposure at Camp Lejeune, a military training facility. VA OIG found that VBA staff incorrectly processed 21,000 claims. Report in Brief Report

Health Systems, Public Health & Health Equity –

  • On August 22, the Agency for Healthcare Research and Quality (AHRQ) released a blog on the agency’s efforts to expand tools to eliminate diagnostic errors. AHRQ’s newest clinical tool – Measure Dx – offers guidance and scalable strategies to detect and learn from diagnostic safety events. Blog Measure DX
  • On August 23, the Task Force on Hunger, Nutrition, and Health released its report to inform the upcoming White House Conference on Hunger, Nutrition, and Health being held in September 2022. Press Release Report in Brief Report
  • On August 25, Reps. Khanna (D-CA) and Tlaib (D-MI) held a field hearing in Detroit, Michigan to examine the gaps in current laws and regulations that leave communities vulnerable to pollution, and the policy changes necessary to safeguard public health and the environment. Press Release Field Hearing

Reproductive & Maternal Health –

  • On August 26, HHS Secretary Becerra and CMS Administrator Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are restricted and where women may be denied medical care. HHS also issued a report and plan of action in response to the Dobbs Supreme Court decision.HHS Press Release CMS Press Release Letter Report

Infant Formula

  • On August 25, the Biden Administration announced the twentieth Fly Formula Mission to deliver approximately 68,000 pounds of Nestlé specialty formula product, the equivalent of over 862,000 eight-ounce bottles, from Switzerland and the Netherlands to New York, NY. Press Release

Misc. –

  • On August 25, the White House Office of Science and Technology Policy (OSTP) updated U.S. policy guidance to make the results of taxpayer-supported research immediately available to the American public at no cost. Press Release
  • Also on August 25, the FDA and its regulatory counterparts in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alimentary Health, Safety and Quality (SENASICA) – held the second annual Food Safety Partnership Meeting to help ensure the safety of food imported from Mexico and to advance protections for consumers in both countries. Press Release
  • Also on August 25, the FDA posted additional FAQs for stakeholders for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF). FAQs
  • On August 26, the FDA issued final guidance to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report). Press Release Guidance

Legislative Activity –

Introduced Legislation –

  • On August 23, Rep. Holmes Norton (D-DC) introduced the Congress Leads by Example Act (H.R. 8743), which would provide enhanced enforcement authority for occupational safety and health protections applicable to the legislative branch, to provide whistleblower protections and other antidiscrimination protections for employees of the legislative branch. Press release
  • On August 26, Rep. Courtney (D-CT) introduced the Access to Inpatient Rehabilitation Therapy Act of 2022 (H.R. 8746), which would restore physician judgment to prescribe the appropriate mix of skilled modalities that constitute an intensive rehabilitation therapy program in an inpatient rehabilitation hospital or unit. Bill text Press release