What’s Ahead: This Week

Notable Policy Events –

  • Tuesday, August 16
    • Washington Post Live, “The Path Forward: Health Care with Kate Ryder, Founder & CEO, Maven Clinic.” Additional information
    • The Government Executive Media Group, “Enhancing the Health Care Experience with a Human-Centered Approach.” Additional information
  • Wednesday, August 17
    • Health Affairs, “Alcohol-Attributable Deaths Help Drive Growing Socioeconomic Inequalities In U.S. Life Expectancy.” Additional information
    • Washington Post Live, “The State of Youth Mental Health.” Additional information

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

Inflation Reduction Act –

  • On August 12, the House passed the Inflation Reduction Act of 2022 (H.R. 5376) by a vote of 220-207. This follows the Senate passage of the bill on August 7 by a vote of 51-50. The bill provides funding, establishes programs, and otherwise modifies provisions related to health care, taxes, and the environment. Notably, the bill will allow Medicare to negotiate drug prices, cap the amount Medicare beneficiaries pay out-of-pocket on prescription drugs at $2,000 annually, extends through 2025 ACA Marketplace premium tax credits, and more. The bill now goes to the President for signature. Bill Text Press Release One-Pager CBO Score White House Remarks

Medicare, Medicaid & Marketplaces –

  • On August 9, the HHS Office of Inspector General (OIG) released a report that explored possible incentives created by Medicare Part D’s programmatic structure that may be influencing use of higher-cost hepatitis C drugs in Medicare. Report in Brief Report
  • Also on August 9, CMS Administrator Brooks-LaSure sent a letter to the state of Georgia suspending implementation of part of a Georgia Access Model. CMS suggested that implementation could be delayed a year if the state provides the requested information and alters its plan to avoid a federally projected drop in enrollment. Letter
  • On August 10, Rep. Murphy (R-NC) published an op-ed on the potential impact of the Inflation Reduction Act on available funding for Medicare. Press Release Full Op-ed
  • Also on August 10, CMS published a blog citing ways in which the Inflation Reduction Act federal premium tax credits for consumers enrolled in ACA qualified health plans could improve health care coverage and affordability for middle-income Americans. Blog

Payment & Delivery System Models –

  • On August 8, CMS published a blog in Health Affairs on the lessons learned from five years of CMS’ Accountable Health Communities (AHC) Model. The blog outlines key evaluation findings to-date, promising practices that providers and payers can implement to address health-related social needs in their patient populations, and how lessons learned are being embedded across CMS. Blog

Public Health Prevention

  • COVID-19 Data: To date, there are 92,560,911 total COVID-19 cases and 1,031,426 COVID-19 deaths in the United States. Also, 799,444,535 COVID-19 vaccines have been delivered and 606,162,842 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 9, Republican leaders of the House Energy & Commerce Committee wrote a letter to HHS Secretary Becerra requesting information regarding the Biden Administration’s current response to the nationwide monkeypox outbreak. Press Release Letter
  • Also on August 9, HHS Secretary Becerra took action that allowed the FDA Commissioner to grant Emergency Use Authorization (EUA) for monkeypox vaccines. Specifically, Secretary Becerra issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C) that circumstances justify emergency use authorization of vaccines. Press Release Determination
  • Also on August 9, the FDA issued an EUA for the JYNNEOS vaccine to allow health care providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. Press Release
  • Also on August 9, the Biden Administration announced key actions and an implementation plan to increase monkeypox vaccine supply, including granting EUA for the JYNNEOS vaccine to be administered intradermally. Fact Sheet
  • On August 10, House Committee on Oversight & Reform Chairwoman Maloney (D-NY) sent a letter to HHS Secretary Becerra requesting HHS to take all steps necessary to ensure patients can safely and easily access the antiviral medication TPOXX (tecovirimat) for the treatment of monkeypox. Press Release Letter
  • Also on August 10, 17 governors sent a letter to President Biden requesting to lift the COVID-19 vaccine mandate for international travel to the U.S. Letter
  • On August 11, the White House Monkeypox Response Team held a press briefing with public health officials including HHS Secretary Becerra, FDA Commissioner Califf, and CDC Director Walensky. Press Briefing
  • Also on August 11, the CDC issued updated guidance on COVID-19 to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to COVID-19, and what actions to take if they are sick or test positive for the virus. Press Release Guidance
  • Also on August 11, the FDA issued guidance advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, whether COVID-19 symptoms are present or not. Safety Communication
  • Also on August 11, House Committee on Oversight & Reform Chairwoman Maloney (D-NY) and Select Subcommittee on the Coronavirus Crisis Chair Clyburn (D-SC) released new evidence that 135 million COVID-19 vaccine doses manufactured at Emergent BioSolutions’ Bayview facility between August 2021 and February 2022 were designated for destruction following the discovery of quality deficiencies. Press Release

Health IT, Privacy, & Digital Health –

  • On August 9, the Office of the National Coordinator for Health IT (ONC) provided an update on ProjectUS@, an effort to standardize patient addresses to improve patient matching. Version 2.0 of the Project US@ Technical Specification is expected to be released in 2023 and will include recommendations from consumer engagement subject matter experts. Blog
  • Also on August 9, the FDA published a blog on the potential impact of a European data law, the General Data Protection Regulation (GDPR), on FDA’s future ability to receive non-public health information from the EU. Blog
  • On August 11, ONC published a blog on the Department of Emergency Medicine at the University of Michigan Medical School’s development of an EHR-derived health equity dashboard that allows for the exploration of disparities in emergency department care. Blog
  • Also on August 11, the Federal Trade Commission (FTC) released an Advanced Notice of Proposed Rulemaking, which seeks public comment to inform rules that would address harmful commercial surveillance and loose data security to protect people’s privacy and information. Press Release Advanced Notice
  • Also on August 11, Sen. Bob Casey (D-PA) led a bipartisan group of Senators in requesting the U.S. Government Accountability Office (GAO) to investigate the federal government’s compliance with Section 508 of the Rehabilitation Act, which mandates that the government make its electronic and information technology accessible to people with disabilities. Press Release Letter
  • Also on August 11, the Biden Administration announced $146 million in awards to bring high-speed internet to Tribal communities in New Mexico through the Tribal Broadband Connectivity Program. Fact Sheet Remarks

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On August 9, HHS released a report on opioid use in long-term care settings. Using pharmacy claims data from IQVIA, this report tracked the use of pain medications across retail and long-term care pharmacy settings. Report in Brief Report
  • Also on August 9, the FDA announced its intent to issue three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, in violation of the FD&C Act. There are currently no FDA approved over-the-counter drug products for this purpose. Press Release
  • On August 10, HHS OIG released a report that examined whether South Carolina complied with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs and found that South Carolina did not always comply. Report in Brief Report

Veterans Health and Military Health  –

  • On August 9, the Department of Veterans Affairs (VA) OIG released a report that reviewed quality assurance programs as they relate to disability compensation for eligible veterans. Report in Brief Report
  • Also on August 9, Senate Veterans’ Affairs Committee Chair Tester (D-MT) hosted a roundtable discussion with committee members and Veterans Service Organizations (VSOs) to discuss ongoing legislative priorities following passage of the PACT Act of 2022. Press Release
  • On August 11, GAO published a report that assesses the extent to which VA acquisitions are following the current Acquisition Program Management Framework for purchasing of goods and services, including medical supplies. GAO recommended several steps be taken prior to implementing the new framework. Report in Brief Report
  • Also on August 11, GAO published a report addressing Department of Defense (DOD) medical facilities’ and the Defense Health Agency’s (DHA) adherence to and monitoring of clinical quality management procedures. GAO recommended that the DHA clarify its clinical quality management procedures and conduct monitoring to better ensure facilities adhere to these procedures. Report in Brief Report

Health Systems, Public Health & Health Equity –

  • On August 8, HHS awarded nearly $90 million in American Rescue Plan funding to nearly 1,400 community health centers across the country to advance health equity through better data collection and reporting. Press Release
  • Also on August 8, HHS announced investments of nearly $60 million to grow the health workforce and increase access to quality health care in rural communities, including nearly $46 million in funding from the American Rescue Plan. Press Release
  • On August 10, the CDC, the Agency for Toxic Substances and Disease Registry (ATSDR) and HHS’ Office of Environmental Justice announced the release of the Environmental Justice Index (EJI). The EJI provides a single environmental justice score for local communities to identify and map areas most at risk for the health impacts of environmental burden. Press Release Environmental Justice Index (EJI)

Reproductive & Maternal Health

  • On August 9, Vice President Harris held a roundtable discussion with higher education leaders on reproductive health. Meeting Readout
  • On August 10, members of the House Committee on Oversight and Reform sent a letter asking the GAO to review the accessibility and availability of menstrual products to inform legislative efforts to advance health and economic equity in the U.S. Press Release Letter
  • On August 11, Sen. Cardin (D-MD) and colleagues sent a letter asking the U.S. Agency for International Development (USAID) to clarify the continuation of International Family Planning and Health programs post-Dobbs. Press Release Letter
  • Also on August 11, Vice President Harris held meetings with Nevada and California state legislators and advocates on reproductive rights. NV Meeting Readout CA Meeting Readout

Infant Formula

  • On August 8, HHS announced two Operation Fly Formula flights currently scheduled for the week of August 8, projected to import more than five million eight-ounce bottle equivalents of infant formula to the U.S. Press Release
  • On August 10, the FDA announced a shipment of 331,000 pounds of Reckitt Nutrition/Mead Johnson Nutrition PurAmino Hypoallergic Infant Formula base powder which will be used to produce about 469,000 cans or about six million full-size, eight-ounce bottles. Press Release

Misc. –

  • On August 9, the CDC released a new Vital Signs report, which stated that too few people diagnosed with hepatitis C are being treated, despite availability of medications capable of curing this viral infection. Media Statement Report
  • Also on August 9, Rep. Garcia (D-TX) led a bipartisan group of 22 House members in a letter to President Biden requesting he prioritize multicancer early detection technologies (MCED) within the Administration’s Cancer Moonshot Program and the Cancer Cabinet. Press Release Letter
  • On August 10, President Biden announced his intent to appoint Dr. Monica Bertagnolli as the 16th  – and first woman – Director of the National Cancer Institute (NCI). Press Release
  • On August 11, HHS and the American Society of Nephrology (ASN) announced a new prize competition from the Kidney Innovation Accelerator (KidneyX) that seeks to further the development of a fully functional bioartificial kidney. Up to $10.5 million in funding will be split among up to nine prize winners. Press Release
  • Also on August 11, GAO released a report that examined the effects of the National Science Foundation’s (NSF) program on jurisdictions’ competitiveness in obtaining NSF and other federal research funding, and NSF’s efforts to assess the effects of the program and identify opportunities for improvement. GAO recommended that NSF include more information in its reports to Congress on whether program goals are being met. Report in Brief Report

Legislative Activity –

Votes and Committee Activity –

  • On August 10, the President signed the Honoring our PACT Act of 2022 (S. 3373) into law. The bill addresses health care, presumption of service-connection, research, resources, and other matters related to veterans who were exposed to toxic substances during military service. Bill text Press release

Introduced Legislation –

  • On August 9, Reps. Steube (R-FL) and Fitzpatrick (R-PA) introduced the Protecting Dogs Subjected to Experiments Act (H.R. 8699), which would prohibit the provision of Federal funds to the National Institutes of Health for the purposes of conducting biological, medical, or behavioral research involving the testing of dogs. Bill text Press release