What’s Ahead: This Week

Notable Policy Events –

  • Thursday, September 8
    • S. News & World Report, “Improving Mental Health on Campus: How Colleges Are Responding.” Additional information
  • Friday, September 9
    • National Academies of Sciences, Engineering, and Medicine, “Review of Federal Policies that Contribute to Racial and Ethnic Health Inequities.” Additional information
    • Office of the National Coordinator for Health IT (ONC), “2022 ONC Virtual Tech Forum: Health IT Standards Driving Modernization in Healthcare and Public Health.” Additional information

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

Medicare, Medicaid & Marketplaces –

  • On August 29, CMS released an update to its COVID-19 Emergency Declaration Blanket Waivers for Specific Providers guidance, which extends the deadline for nursing aides to complete training requirements until the end of the PHE. The deadline was previously October 6. Guidance
  • On August 30, CMS announced that the Medicare Shared Savings Program (MSSP), through its work with Accountable Care Organizations (ACOs), saved Medicare $1.66 billion in 2021 compared to spending targets, marking the fifth consecutive year the program has generated overall savings. CMS Press Release HHS Press Release
  • On August 31, CMS issued a proposed rule, entitled “Streamlining the Medicaid, CHIP, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes,” to simplify the processes for eligible individuals to enroll and retain eligibility in Medicaid, CHIP, and the Basic Health Program. Fact Sheet Press Release Proposed Rule
  • On September 1, CMS released its first quarterly Medicaid and CHIP Modified Adjusted Gross Income (MAGI) application processing time report that shows the average number of days it takes states to complete MAGI eligibility determinations at application. The data released reflects MAGI determination for the period January-March 2022. Report
  • Also on September 1, CMS awarded the Contact Center Operations (CCO) contract to accept and respond to customer inquiries to Maximus Federal Services, Inc. (Maximus) under a full and open competition that began in November 2019. Fact Sheet

Payment & Delivery System Models –

  • On September 2, CMS released the Expanded Home Health Value-Based Purchasing (HHVBP) Model August 2022 Newsletter, which provides home health agencies with the latest information about the expanded HHVBP Model. Newsletter

Public Health Prevention –

  • COVID-19 Data: To date, there are 94,487,185 total COVID-19 cases and 1,041,816 COVID-19 deaths in the United States. Also, 809,924,135 COVID-19 vaccines have been delivered and 610,012,616 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 302 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On August 29, HHS announced it will provide approximately $11 million to support the first U.S.-based fill and finish manufacturing of JYNNEOS – a vaccine approved to prevent smallpox and monkeypox. Press Release
  • Also on August 29, Republicans on the Senate HELP Committee and Armed Services Committee sent a letter to President Biden asking the Administration to re-establish Operation Warp Speed to develop new vaccines and medical products that can counter the ongoing COVID-19 pandemic. Press Release Letter
  • On August 30, the White House Monkeypox Response Team held a press conference with public health officials promoting upcoming programs to reach LGBTQI+ communities and other groups disproportionately impacted by the monkeypox outbreak. Press Briefing
  • On August 31, HHS released a report on COVID-19 vaccines and treatments and preventing gaps in coverage. The report provides potential next steps for payers as they navigate the coverage and payment process to prevent gaps in availability of COVID-19 vaccines and treatments. Report
  • Also on August 31, the FDA amended the emergency use authorizations (EUAs) of the Moderna and the Pfizer-BioNTech COVID-19 vaccines to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Press Release
  • Also on August 31, 12 Senate Democrats sent a letter to HHS Secretary Becerra and CDC Director Walensky asking the agencies to track and address racial disparities in the nation’s public health response to the monkeypox virus. Press Release Letter
  • On September 1, the CDC recommended the first updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 and older, now covering Omicron BA.4 and BA.5 Press Release
  • Also on September 1, the White House Office of Science and Technology Policy (OSTP) and National Science and Technology Council released the First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness Plan, which details crucial advancements towards pandemic preparedness, including providing priority areas for investment and additional efforts needed in the years ahead. Report Fact Sheet
  • On September 2, the Biden Administration issued guidance to Congress on a short-term continuing resolution (CR) that would provide funding and legislative adjustments to avoid disruptions to certain public services. As part of the CR, the Administration is calling on Congress to provide funding for support for Ukraine, COVID-19, monkeypox, and natural disaster recovery. Blog

Health IT, Privacy, & Digital Health –

  • On August 29, the Office of the National Coordinator for Health IT (ONC), in collaboration with the Health Resources and Services Administration (HRSA), announced an initiative to launch a new United States Core Data for Interoperability (USCDI+) that would support HRSA’s Uniform Data System (UDS) reporting through the UDS Modernization Initiative. Press Release UDS Modernization Initiative
  • Also on August 29, the HHS Office of Inspector General (OIG) released a report to determine if HRSA implemented selected cybersecurity controls over the Organ Procurement and Transplantation Network (OPTN) to protect the confidentiality, integrity, and availability of transplant data, in accordance with Federal requirements. OIG recommended that HRSA develop additional oversight controls and procedures. Report in Brief Report
  • On August 31, The Sequoia Project, the Recognized Coordinating Entity (RCE) that supports the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA), released final Common Agreement Standards Operating Procedures (SOPs) and the Qualified Health Information Network (QHIN) application. Press Release

Mental Health and Substance Use Disorder Policy –

  • On August 30, the FDA introduced the FDA Overdose Prevention Framework, which aims to prevent drug overdoses and reduce death. The framework focused on four priorities including primary prevention, harm reduction, development of evidence-based treatments for substance use disorders, and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks. Press Release Framework
  • On August 31, the CDC National Center for Injury Prevention and Control, National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA), and CMS published a study finding the expansion of telehealth services during the COVID-19 pandemic was associated with individuals staying in treatment for opioid use disorders longer and reducing their risk of medically treated overdose. NIDA Press Release CDC Press Release CMS Press Release Study
  • Also on August 31, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $79.1 million in overdose prevention grants, as part of President Biden’s National Drug Control Strategy, the HHS Overdose Prevention Strategy, and the Biden-Harris Unity Agenda to address the opioid and overdose epidemic. SAMHSA Press Release HHS Press Release
  • Also on August 31, SAMHSA released a request for information on SAMHSA’s role regarding mental health and substance use wellbeing in the context of climate change and health equity. SAMHSA seeks input about how it can best address the behavioral health impacts of climate change and health equity considerations. Additional Information
  • Also on August 31, SAMHSA released a blog on International Overdose Awareness Day that included an analysis of overdose deaths from 2019 to 2020 and recent efforts by SAMHSA to advance prevention, evidence-based treatment, and recovery support programs. Blog
  • On September 1, SAMHSA announced it awarded $40.22 million in youth mental health grants throughout the month of August, plus $47.6 million in new grant funding opportunities for school-based mental health programs developed from the Bipartisan Safer Communities Act. Press Release
  • On September 2, HHS awarded $2 million in funding to the American Academy of Pediatrics to establish a National Center of Excellence on Social Media and Mental Wellness to develop and disseminate information, guidance, and training on the impact social media has on children and young people. Press Release

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On August 29, the FDA alerted patients, caregivers, and health care providers that Philips Respironics recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. Press Release
  • Also on August 29, House Ways & Means Committee Ranking Member Brady (R-TX) and House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) sent a letter to HHS Secretary Becerra, requesting information on plans to execute government prescription drug price controls in the Medicare program and the impact those decisions will have on seniors’ access to innovative medicines. Press Release Letter
  • On August 31, the FDA approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Press Release
  • On September 1, the FDA announced a whole-of-government approach to combating illicit health products from entering the U.S. This approach is based on a series of investigations that determined the best way to address this problem is to cast a wide net by soliciting the help of other parts of the FDA, other U.S. government agencies, and officials in other countries. Press Release
  • On September 2, HHS OIG released a report on if the Administration for Strategic Preparedness and Response (ASPR) monitored contracts for the production of ventilators in accordance with federal requirements. OIG found that ASPR did not establish responsibilities for communication with other emergency response teams, did not always report contract data, or monitor contractor performance. Report in Brief Report

Veterans’ Health and Military Health –

  • On August 29, the Department of Veterans Affairs (VA) extended its financial hardship suspension on benefit debts through December 31, 2022. Beginning in September, debt notification letters will be mailed to affected Veterans advising them of the extended hardship suspension option, as well as extended debt repayment plans, waivers, and compromises. Press Release
  • On August 30, the VA published a new guidebook entitled “Whole Health System Approach to Long COVID,” outlining how to care for veterans with Long COVID. Press Release Guidebook
  • On September 1, the VA OIG released a report that assessed the oversight and stewardship of funds by the VA Cincinnati Healthcare System. VA OIG found that the health care system did not comply with VA policy for three of the 36 sampled transactions. Report in Brief Report
  • Also on September 1, the VA OIG released a report on the results of an evaluation of Veterans Health Administration (VHA) facilities’ medication management for remdesivir use. VA OIG found that VHA did not consistently provide patient/caregiver education for remdesivir or report adverse events to the FDA in accordance with Emergency Use Authorization requirements. Report in Brief Report
  • Also on September 1, the Government Accountability Office (GAO) released a report on VA’s efforts to provide benefits to Vietnam veterans for certain conditions associated with Agent Orange exposure. Report in Brief Report
  • On September 2, VA issued an interim final rule that will allow VA to provide access to abortion counseling and — in certain cases — abortions to pregnant Veterans and VA beneficiaries. Press Release Interim Final Rule

Health Systems, Public Health, SDOH & Health Equity –

  • On August 29, the White House announced it will host the White House Conference on Hunger, Nutrition, and Health on September 28, 2022 in Washington, DC and via livestream. The White House also released a toolkit for partner-led satellite events held in parallel with the Conference. Statement Toolkit Conference Webpage
  • On August 30, the White House released a fact sheet on the Monkeypox Response Team’s plans to support large LGBTQI+ events and equity interventions to reach communities at highest risk of contracting the virus. Fact Sheet
  • Also on August 30, the White House Office of Management & Budget (OMB) announced it will launch new public listening sessions and solicit public input on the review of OMB’s Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity. This Directive provides minimum standards that ensure the government’s ability to compare race and ethnicity information and data across federal agencies. Blog
  • On September 1, Sen. Booker (D-NJ) sent a letter to Ambassador Susan Rice, Director of the White House Domestic Policy Council, outlining his top policy objectives for the White House Conference on Hunger, Nutrition, and Health. Letter Press Release

Reproductive & Maternal Health –

  • On August 29, HHS announced investments of over $20 million to improve maternal and infant health and implement the White House Blueprint for Addressing the Maternal Health Crisis. Press Release
  • On August 31, House Energy & Commerce Committee Democratic leaders wrote to Meta CEO Mark Zuckerberg to seek answers following recent reporting on the company releasing users’ sensitive data, including private communications, related to abortion in state criminal proceedings. Press Release Letter

Misc. –

  • On August 29, HHS announced that HHS Secretary Becerra has appointed new members to the Board of Directors of the National Fitness Foundation. Press Release
  • On September 2, House Oversight & Reform Committee Chair Maloney (D-NY) and Subcommittee on Economic & Consumer Policy Chair Krishnamoorthi (D-IL) sent a letter to the Consumer Product Safety Commission (CPSC) requesting information about how the Commission is working to protect babies from harmful inclined products. Press Release Letter
  • Also on September 2, President Biden announced the 21 winners of the $1 billion Build Back Better Regional Challenge. Funding supports projects that will develop workforce training programs, rebuild pharmaceutical supply chains in the U.S., build advanced manufacturing centers for testing and training, and more. Press Release
  • Also on September 2, the Biden Administration announced the twenty-first Operation Fly Formula mission that will deliver approximately 333,338 pounds of Aptamil Gold Plus, the equivalent of five million eight-ounce bottles. Press Release

Legislative Activity –

Introduced Legislation –

  • On August 30, Rep. Budd (R-NC) introduced the Critical Health Careers Act of 2022 (H.R. 8753), which would require the Secretary of Education to prioritize Innovation and Modernization program grant applications that focus on developing and credentialing students in health and biotechnology careers. Bill text Press release
  • On September 2, Rep. Ralph (R-SC) introduced the Fighting Cancer in Children Act (H.R. 8768), which would rescind and transfer funds available for the Office of the Director of the National Institutes of Health to accounts for pediatric cancer research, awareness, and survivorship, to reduce the deficit, and for other purposes. Bill text Press release