What’s Ahead: This Week

Notable Policy Events –

  • Monday, October 31
    • Bipartisan Policy Center, “What Should President Biden Do if Congress Changes Hands?” Additional information
  • Tuesday, November 1
    • CMS, “National Stakeholder Call with CMS Administrator Chiquita Brooks-LaSure.” Additional information
    • Fierce Healthcare, “Make EHR Your Brand’s Super Power.” Additional information
    • Health Affairs, “Policy Spotlight: One-On-One With AHRQ Director Robert Otto Valdez.” Additional information
    • HHS Office for Civil Rights, “Webinar with HHS Office for Civil Rights Director Melanie Fontes Rainer on President Biden’s Executive Order on Securing Access to Reproductive and Other Health Care Services.” Additional information
    • NIHCM Foundation, “Food Insecurity and Health: Strategies to Address Community Needs.” Additional information
    • S. Chamber of Commerce Foundation, “Path Forward: Preparing for the Next Wave of COVID-19.” Additional information
    • Urban Institute, “Partnering for Vaccine Equity.” Additional information
  • Wednesday, November 2 – Thursday, November 3
  • Wednesday, November 2
    • Alliance of Community Health Plans, “Coordinating a Strong 988 Crisis Response.” Additional information
    • CMS, “Technical Expert Panels and Public Comments: Ways for Stakeholders to Provide Input on Quality Measures.” Additional information
    • Fiscal Note, “2023 State Sessions Look Ahead: The Biggest Issues You Need to Watch.” Additional information
    • Phreesia, “Modernizing Patient Intake and Reducing Staff Burden.” Additional information
  • Thursday, November 3 – Friday, November 4
  • Thursday, November 3
  • Friday, November 4
    • Institute for Medicaid Innovation (IMI), 2022 Annual Medicaid Managed Care Organization Survey Release.” Additional information

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

Medicare –

  • On October 24, the HHS Office of Inspector General (OIG) released a report which found that payments made to providers under the COVID-19 accelerated and advance payments program were generally in compliance with the Coronavirus Aid, Relief, and Economic Security (CARES) Act and other federal requirements. Report in Brief Report
  • On October 25, HHS OIG released a report which found that ineligible providers rendered services and wrote prescriptions for some Medicare Part C and Part D beneficiaries, but that CMS generally ensured sponsors complied with federal requirements. Report in Brief Report
  • On October 27, CMS announced that the 2020 Medicare Current Beneficiary Survey (MCBS) public use file (PUF) is available. MCBS PUF
  • Also on October 27, HHS OIG released a report that summarized the results of 12 previous hospital compliance audits to determine if hospitals are billing appropriately for certain claims, including the appeals status of any improperly paid claims and what actions CMS has taken with respect to the recommendations made. Report in Brief Report
  • On October 28, CMS issued a final rule that implements certain provisions of the Consolidated Appropriations Act, 2021 that will simplify Medicare enrollment rules and extend coverage of immunosuppressive drugs for certain beneficiaries. The rule creates Medicare special enrollment periods, allows certain eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty, and allows beneficiaries to have Medicare coverage immediately the month after their enrollment. Final Rule Press Release Fact Sheet
  • Also on October 28, CMS announced an additional three-month extension in the timeline for the publication of the Medicare Advantage Risk Adjustment Data Validation (MA-RADV) final rule. CMS was unable to meet the November 1, 2022 timeline for publication of the RADV-audit related provisions because of “ongoing exceptional circumstances.” Notice

Medicaid –

  • On October 24, CMS announced that Nevada is requesting authority for a new five-year section 1115 demonstration to expand access to oral health services for Medicaid beneficiaries over the age of 21. Pending Application Public Comments
  • On October 25, CMS announced that Medicaid and CHIP coverage of the updated COVID-19 vaccines is available for eligible covered children following the CDC’s expanded use of updated COVID-19 vaccines to children ages five through 11 years. Press Release
  • Also on October 25, HHS OIG released a report which found that Colorado did not report and return the correct federal share of Medicaid overpayments identified during the period October 1, 2014, through December 31, 2020. Report in Brief Report
  • On October 26, CMS approved North Carolina’s state plan amendment to provide qualifying community-based mobile crisis intervention services to Medicaid beneficiaries. Announcement
  • On October 27, CMS announced that more than half of all states have expanded access to 12 months of Medicaid and CHIP coverage after pregnancy, with Georgia and Pennsylvania becoming the 25th and 26th states to be approved for extended coverage. Press Release
  • Also on October 27, HHS OIG released a report which found California made nearly $16 million in unallowable capitation payments for Medicaid beneficiaries with multiple client index numbers. Report in Brief Report
  • Also on October 27, CMS announced that Tennessee submitted an amendment to the TennCare III demonstration proposing to continue to provide the enhanced home and community-based services (HCBS) supports beyond the expiration of the public health emergency (PHE). Application Comments
  • On October 28, HHS OIG released a report which found that Mississippi did not always comply with federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs. Report in Brief Report
  • Also on October 28, CMS released July 2022 Medicaid and CHIP enrollment data for 50 states and the District of Columbia. Data Highlights Enrollment Trends Snapshot

Marketplaces –

  • On October 25, HHS released a report which found that enrollment in Marketplace coverage via HealthCare.gov for all racial and ethnic groups increased from 2020 to 2022, with the number of Black and Latino enrollees experiencing the largest increases in enrollment. Report Press Release
  • On October 26, the Biden-Harris Administration announced outreach efforts to connect Americans to coverage ahead of the Open Enrollment period, including a new “window shopping” feature allowing consumers to browse all health care coverage options and costs. Press Release

Payment & Delivery System Models –

  • On October 24, the Government Accountability Office (GAO) announced that Dr. Lindsay Botsford, Market Medical Director at One Medical and Dr. James Walton, President and Chief Executive Office at Genesis Physicians Group, were appointed to the Physician-Focused Payment Model Technical Advisory Committee (PTAC). Press Release
  • Also on October 24, CMS released a notice announcing organizational changes within the CMS Innovation Center (CMMI). Notice

Public Health Prevention, Surveillance & Data –

  • COVID-19 Data: To date, there are 97,329,787 total COVID-19 cases and 1,066,351 COVID-19 deaths in the United States. Also, 890,758,935 COVID-19 vaccines have been delivered and 636,871,557 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 435 tests under Emergency Use Authorizations (EUAs), including 298 molecular tests, 85 antibody tests and 51 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On October 25, President Biden announced additional efforts to get Americans their updated COVID-19 vaccine, so that they have the protection they need heading into Thanksgiving. Fact Sheet
  • Also on October 25, CDC released a data brief, “COVID-19 Death Rates in Urban and Rural Areas: United States, 2020,” finding that a more detailed measure of urbanicity can result in a more precise analysis of COVID-19 death rates than is possible with the typical urban–rural dichotomy. Data Brief
  • On October 26, CDC released a Morbidity and Mortality Weekly Report (MMWR) which found that patients with HIV and AIDS are at an elevated risk of developing severe monkeypox infections. MMWR
  • On October 27, the Senate HELP Committee Minority oversight staff released an interim report titled, “An Analysis of the Origins of the COVID-19 Pandemic,” summarizing a review to date of publicly available, open-source information related to the potential origin of SARS-CoV-2. Press Release Report
  • Also on October 27, the FDA announced the issuance of an Emergency Use Authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) of an in vitro diagnostic device for detection of monkeypox virus, in response to a recent outbreak. Notice

Health IT, Privacy, & Digital Health –

  • On October 25, the Office of the National Coordinator for Health IT (ONC) published a blog on how policies finalized by CMS in the Fiscal Year (FY) 2023 Inpatient Prospective Payment System (IPPS) final rule are advancing the use of interoperable health IT. Blog
  • On October 26, House Energy & Commerce Committee Chair Pallone (D-NJ) sent letters to 13 internet service providers expressing concerns over reports of providers engaging in predatory behaviors through the Emergency Broadband Benefit (EBB) Program and the Affordable Connectivity Program (ACP). Press Release Altice USA AT&T Charter Comcast Cox Communication Dish Network Excess Wireless Frontier Lumen/CenturyLink Maxsip Q Link T-Mobile Verizon
  • Also on October 26, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA) and Rep. Bilirakis (R-FL) sent letters to six toy manufacturers asking how they plan to ensure children and their information is protected online following reports that manufacturers are moving their marketing efforts to Big Tech companies. Press Release Bandi Namco Hasbro Mattel MGA Entertainment The Lego Group Toy Association
  • On October 27, ONC published a blog on the launch of the Gravity Project Pilots Affinity Group that will pilot the Social Determinants of Health (SDOH) Clinical Care FHIR Implementation Guide (SDOH CC IG) as a way to further the development and adoption of SDOH standards. Blog
  • Also on October 27, Senate Homeland Security & Government Affairs Committee Chair Peters (D-MI) participated in a fireside chat during this year’s annual Michigan Cyber Summit to discuss collaboration between the federal government and state and local governments to combat evolving cybersecurity threats. Press Release

Mental Health and Substance Use Disorder Policy –

  • On October 24, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the Disaster Distress Helpline can provide immediate crisis counseling to people affected by the recent mass shooting in a St. Louis school. Press Release
  • On October 26, SAMHSA released a notice informing the public that the agency intends to award $47 million for up to one year to Vibrant Emotional Health for the 988 Suicide and Crisis Lifeline Access Improvement Project. Notice
  • On October 27, GAO released a report on behavioral health workforce and federal actions to help recruit and retain providers. Report in Summary Report

Prescription Drugs, Medical Devices, and Biomedical Research –

  • On October 25, the FDA released a safety communication warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC. Safety Communication
  • Also on October 25, the White House Office of Science and Technology Policy (OSTP) released a Request for Information (RFI) on clinical research infrastructure and emergency clinical trials. The RFI seeks comments on how to build the clinical research capacity needed to appropriately respond in the event of an emergency. Comments are due by December 27, 2022. Notice of RFI Press Release
  • On October 26, House Energy & Commerce Committee Ranking Member McMorris Rodgers (R-WA), along with Reps. Guthrie (R-KY) and Griffith (R-VA), sent a letter to Boston University President Robert Brown, requesting information related to reports that researchers at Boston University are conducting gain-of-function research with coronaviruses. Press Release Letter
  • Also on October 26, Reps. Cloud (R-TX) and Comer (R-KY) sent a letter to Department of Homeland Security Secretary Mayorkas requesting documents and communications to examine the Department’s response to the perceived threat of “rainbow fentanyl.” Press Release Letter
  • On October 27, the FDA published a blog on the agency’s efforts to-date to increase the availability of safe and effective medicines for children and the FDA’s plans for continued collaboration with stakeholders to advance treatment options for children. Blog
  • Also on October 27, the White House OSTP released an RFI on Data Collection for Emergency Clinical Trials Interoperability Pilot. The RFI seeks input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs), in the pre-emergency phase as well as in emergency settings. Comments are due by December 27, 2022. Notice of RFI
  • On October 28, the FDA updated the list of Breakthrough Devices that have been authorized for marketing. The Breakthrough Devices Program provides patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review. Press Release List

Veterans Health and Military Health –

  • On October 24, the Department of Veterans Affairs (VA) announced the opportunity for public participation in the annual VA Medication Take Back Days, to safely and securely dispose of unused or expired medicine — including controlled substance prescriptions. Press Release
  • Also on October 24, the VA issued a proposed rule to remove the audio-only telehealth exclusion from the Civilian Health and Medical Program of the Department of Veteran’s Affairs (CHAMPVA). Comments are due by November 23, 2022. Proposed Rule
  • On October 25, the VA OIG released a report on Veterans Health Administration (VHA) facilities’ executive leadership position stability, budget and operations, staffing, employee satisfaction, patient experience, accreditation surveys and oversight inspections, factors related to possible lapses in care, and VHA performance data. Report in Brief Report
  • Also on October 25, the VA OIG released a report on findings from health care inspections performed during FY 2021 that focused on facility committees responsible for quality, safety, and value oversight functions, systems redesign and improvement programs, protected peer reviews of clinical care, and medical center surgical programs. Report in Brief Report
  • On October 27, House Committee on Veterans’ Affairs Chair Takano (D-CA) released a staff report on findings from the Committee’s March 2022 investigative hearing examining key factors that place veterans at risk of recruitment by domestic violent extremist groups. Press Release Report
  • Also on October 27, the VA published three grant opportunities for FY 2024 to help Veterans who are experiencing or at risk of homelessness. Press Release
  • Also on October 27, GAO released a report with recommendations on the VA’s Veterans Employment Through Technology Education Courses (VET TEC) pilot program that was created to support veterans who enroll in high-technology education programs through VA-approved training providers. Report in Brief Report
  • Also on October 27, the VA OIG released a report that evaluated VA’s implementation of the Referral Coordination Initiative (RCI) program and found that no VA facility had fully implemented the RCI program almost a full year after VA’s own June 2021 deadline. Report in Brief Report

Health Systems, Public Health & Health Equity –

  • On October 26, the Agency for Healthcare Research and Quality (AHRQ) released a report which found that about 37 percent of Americans had at least one medical and one dental visit in 2019. Hispanic and Black individuals were less likely to have medical and dental visits. Report
  • Also on October 26, the FDA issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). Press Release
  • On October 27, the CMS Office of Minority Health (OMH) announced that it updated Coverage to Care (C2C) resources in additional languages. C2C Website
  • Also on October 27, the CDC released its Annual Report to the Nation on the Status of Cancer that found overall cancer death rates continued to decline among men, women, children, and adolescents and young adults in every major racial and ethnic group in the United States from 2015 to 2019. Press Release Report
  • Also on October 27, HHS published a blog on organizations and initiatives working to improve health outcomes by addressing personal and organizational health literacy. Blog
  • On October 28, the National Institutes of Health (NIH), under its Network for Community-Engaged Primary Care Research (NCPCR), issued two awards to Morehouse School of Medicine and OCHIN. Together, these two NCPCR teams will leverage community-engaged research to advance the prevention and treatment of COVID-19 in primary care settings. Press Release

Reproductive & Maternal Health –

  • On October 25, the House Committee on Oversight and Reform released a staff report, “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private Insurance.” The analysis found that the processes established for patients seeking exceptions to cost-sharing and coverage restrictions can be burdensome for patients and providers, and that from 2015 to 2021, companies denied exceptions requests on average four or more times out of ten. Press Release Report

Legislative Activity –

Introduced Legislation –

  • On October 25, Rep. Griffith (R-VA) introduced the Ensuring Cybersecurity at the NIH Act (H.R. 9228), which would amend the Public Health Service Act with respect to the information security policies and practices of the National Institutes of Health. Bill Text Press Release
  • Also on October 25, Rep. Guthrie (R-KY) introduced the Department of Health and Human Services Cybersecurity Coordination Act (H.R. 9229), which would codify certain recommendations made by the Government Accountability Office with respect to the Department of Health and Human Services and cybersecurity. Bill Text Press Release
  • On October 27, Rep. Maloney (D-NY) introduced the Abortion Care Awareness Act of 2022 (H.R. 9247), which would conduct a public health education, awareness, and outreach campaign to enhance access to abortion and related health services. Bill Text Press Release