Notable Policy Events –

  • Wednesday, August 24
    • Kaiser Family Foundation, “The Health Wonk Shop: Health Care Inflation in the US.” Additional information
    • White House, “Conference on Hunger, Nutrition, & Health Bi-Weekly Stakeholder Check-In.” Additional information
    • CMS, “Medicaid and CHIP Continuous Enrollment Unwinding: What to Know and How to Prepare, A Partner Education Monthly Series.” Additional information
  • Thursday, August 25
    • CMS, “National Stakeholder Call with the CMS Administrator on the Inflation Reduction Act.” Additional information

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

Inflation Reduction Act –

  • On August 16, the President signed the Inflation Reduction Act of 2022 (H.R. 5376) into law. The bill has provisions on prescription drug pricing reform and extended ACA subsidies. Bill Text Fact Sheet Press Release Remarks

Medicare, Medicaid & Marketplaces –

  • On August 16, HHS approved the extension of Medicaid and CHIP coverage for 12 months after pregnancy in Hawaii, Maryland, and Ohio. HHS Press Release  CMS Press Release
  • On August 17, CMS issued an informational bulletin to remind states of existing federal requirements relevant to payment for Ground Emergency Medical Transportation (GEMT) services in Medicaid to assist them in developing state plan amendments that are consistent with such federal requirements. Informational Bulletin
  • On August 18, CMS released a roadmap for the eventual end of the Medicare COVID-19 Public Health Emergency (PHE) waivers and flexibilities and shared information on what health care facilities and providers can do to prepare for future events. CMS released fact sheets to help the health care sector transition to operations once the PHE ends. Press Release Roadmap Fact Sheets
  • Also on August 18, CMS issued guidance on the funding, documentation, and expansion of Medicaid-covered school-based services, prompting states to work with schools to deliver on-site health care services to children enrolled in the Medicaid program. Press Release Guidance
  • Also on August 18, CMS issued an informational bulletin encouraging state Medicaid programs to participate in a new demonstration that would allow the US Department of Agriculture (USDA) to use Medicaid eligibility data in its free and reduced meals programs for schools. Informational Bulletin
  • Also on August 18, CMS issued guidance reminding State Medicaid Agencies of the federal requirements for the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit. CMS provided examples on ways that Medicaid and CHIP funding can be used in the provision of high-quality behavioral health services to children and youth. Press Release Guidance
  • Also on August 18, CMS released the Mandatory Medicaid and CHIP Core Set Reporting proposed rule to promote consistent use of nationally standardized quality measures in Medicaid and CHIP. The rule proposes requirements for mandatory annual state reporting of three different quality measure sets designed to measure the overall national quality of care for beneficiaries, monitor performance at the state level, and improve quality care. Press Release Proposed Rule
  • On August 19, HHS released a report on current projections of the number of individuals predicted to lose Medicaid coverage at the end of the COVID-19 PHE due to a change in eligibility or administrative churning. Report in Brief Report

Payment & Delivery System Models –

  • On August 15, CMS announced a list of provisionally accepted ACO REACH applicants and Implementation Period #3 (IP3) ACOs. The new cohort will begin participation in the ACO REACH Model on January 1, 2023.  Press Release
  • On August 19, CMS officials published a Viewpoint piece in JAMA Health Forum on addressing challenges in primary care.  The article discusses key lessons on how the CMS Innovation Center’s primary care models are informing the next generation of advanced primary care model development. Article

Public Health Prevention

  • COVID-19 Data: To date, there are 93,240,120 total COVID-19 cases and 1,034,668 COVID-19 deaths in the United States. Also, 803,252,035 COVID-19 vaccines have been delivered and 607,588,353 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 15, HHS announced that it is making up to 442,000 doses of the JYNNEOS vaccine available for states and jurisdictions to order under an accelerated Phase 3 of the National Vaccine Strategy (NVS) to combat the current monkeypox outbreak. Press Release
  • On August 16, the White House announced resources and guidance available for K-12 grade schools to prevent COVID-19 spread and stay safely open throughout the school year. Fact Sheet
  • On August 17, CDC Director Walensky announced an agency reorganization in the wake of the CDC’s handling of the COVID-19 pandemic. The CDC announced recommendations and next steps throughout the coming months to move the agency forward. Fact Sheet
  • Also on August 17, the Government Accountability Office (GAO) released a report describing medical surge challenges selected hospitals faced in responding to the COVID-19 pandemic, how health care coalitions have supported their efforts, and selected HHS programs and activities underway to support medical surge readiness. Report in Brief Report
  • Also on August 17, the CDC announced its assistance in Michigan and Ohio with an E. coli outbreak from an unknown food source. Media Statement
  • On August 18, Reps. Comer (R-KY), Scalise (R-LA), and Jordan (R-OH) wrote a letter to District of Columbia Mayor Bowser asking her to stop the enforcement of the District’s vaccine mandate for students ages 12 and older before the school year begins. Press Release Letter
  • Also on August 18, the White House National Monkeypox Response team announced a series of actions the Biden Administration is taking to further its response to the monkeypox outbreak and mitigate the spread of the virus. Fact Sheet Press Briefing
  • Also on August 18, HHS announced an agreement between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM) to establish the first fill and finish line for the JYNNEOS vaccine in the U.S. Press Release
  • On August 19, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted, for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. The agency previously authorized the vaccine for individuals 18 years and older. Fact Sheet for Healthcare Providers Fact Sheet for Recipients and Caregivers

Health IT, Privacy, & Digital Health –

  • On August 16, Sen. Warner (D-VA) sent a letter to the Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) requesting information about the agencies’ plan to ensure continuity of care for patients being prescribed controlled substances via COVID-19 PHE telemedicine flexibilities once the PHE ends. Press Release Letter
  • On August 18, the Office of the National Coordinator for Health IT (ONC) released a data brief on physicians’ readiness to electronically support public health activities in the year prior to the pandemic. The report does not report on physicians’ overall levels of public health reporting, nor does it reflect recent levels of electronic public health reporting. Blog Data Brief Overview Data Brief
  • Also on August 18, the inaugural PandemicX 2022 cohort, which was comprised of 15 health technology startups, showcased their tech innovations in a special PandemicX finale webinar. The startup’s proposed solutions align with federal health challenges and address health equity barriers and other disparities exacerbated by COVID-19 using data and innovation. Press Release
  • On August 19, ONC released a blog on the upcoming deadlines for availability of standards-based FHIR APIs. The 21st Century Cures Act Final Rule required that certified health IT developers update and provide their customers with FHIR-based application programming interfaces, also known as certified API technology, by December 31, 2022. Blog

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On August 16, the FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. Press Release Final Rule President Biden Remarks
  • On August 17, the HHS Office of Inspector General (OIG) released a report on if the National Institutes of Health (NIH) ensured that NIH-funded Intramural and Extramural clinical trials complied with federal reporting requirements. OIG found that NIH did not ensure compliance with federal reporting requirements for these trials. Report in Brief Report
  • Also on August 17, CMS announced it will discontinue the use of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) for claims with dates of service on or after January 1, 2023. CMS suppliers must continue to submit CMN and DIF information for claims with dates of service before January 1, 2023 if it is required. News Alert

Veterans Health and Military Health  –

  • On August 17, the VA OIG released a report on allegations at the VA Greater Los Angeles Health Care System that nursing staff failed to (i) assess a resident who was complaining of pain; (ii) properly document assessments, reassessments, treatments, or interventions; and (iii) implement a provider’s order related to transferring the resident to a higher level of care. Report in Brief Report
  • On August 18, House Committee on Veterans’ Affairs Committee Chair Takano (D-CA) and Subcommittee on Health Chairwoman Brownley (D-CA) announced a new Committee effort focused on reproductive health care access for America’s veterans. Press Release

Health Systems & Public Health–

  • On August 15, the Federal Trade Commission (FTC) issued a policy paper highlighting the pitfalls of using Certificates of Public Advantage (COPAs), which purport to shield hospital mergers from antitrust laws in favor of state oversight. The paper details research showing that these COPAs are often detrimental for patient costs, patient care, and health care worker wages. Press Release Fact Sheet Policy Paper
  • On August 18, the FDA issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. Press Release Letter

Reproductive & Maternal Health –

  • On August 17, Health Resources and Services Administration (HRSA) Administrator Johnson and Rep. Davis (D-IL) visited the Primo Center for Women and Children in Chicago to highlight the need for reauthorization of the HRSA Maternal, Infant, and Early Childhood Home Visiting Program. Press Release
  • Also on August 17, Rep. Cloud (R-TX) sent a letter to the Walt Disney Company, Warner Bros. Discovery Inc., Alphabet Inc., and Meta with concerns that Big Tech companies may be pressuring women to take advantage of abortion coverage rather than paid family leave policy. Press Release Walt Disney Co. Letter Warner Bros. Discovery Letter Alphabet Inc. Letter Meta Letter

Misc. –

  • On August 15, the FDA issued a consumer update to warn the public about certain spray sunscreens that have been recalled because of benzene contamination. Consumer Update
  • Also on August 15, the FDA launched a new external webpage to highlight the Operation Lascar Initiative which, with the United Kingdom (U.K.), is the FDA’s first bilateral initiative focused on the movement of illicit FDA-regulated products. Webpage
  • On August 17, the Agency for Healthcare Research and Quality (AHRQ) released an issue brief on distributed cognition and the role of nurses in diagnostic safety in the emergency department. Issue Brief
  • Also on August 17, the FDA approved Zynteglo, the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Press Release

Legislative Activity –

Votes and Committee Activity –

  • On August 16, the President signed the TBI and PTSD Law Enforcement Training Act (H.R. 2992) into law. The bill requires the Bureau of Justice Assistance (BJA) to consult with relevant agencies to establish crisis intervention training tools for first responders to address individuals with traumatic brain injuries, acquired brain injuries, and post-traumatic stress disorder. Bill Text Press Release
  • Also on August 16, the President signed the Inflation Reduction Act of 2022 (H.R. 5376) into law. The bill has provisions on prescription drug pricing reform and affordable care act subsidies. Bill Text Fact Sheet Press Release

Introduced Legislation –

  • On August 16, Reps. Lee (D-NV) and Fitzpatrick (R-PA) introduced the Expanding Access to Mental Health Training Act (H.R. 8722), which would reauthorize the program for mental health awareness training grants. Press Release One-Pager