Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare, Medicaid & Marketplaces –
- On November 14, Reps. Bucshon (R-IN) and Bera (D-CA) published an op-ed warning that Medicare cuts to physicians threaten patient access and physician stability. Op-Ed
- Also on November 14, the HHS Office of Inspector General (OIG) released a report on long-term trends of psychotropic drug use in nursing homes, finding that from 2011 through 2019, about 80 percent of Medicare’s long-stay nursing home residents were prescribed a psychotropic drug. Report in Brief Report
- Also on November 14, Sens. Castro (D-TX), Booker (D-NJ), and Jayapal (D-WA) led 83 colleagues in a letter calling on HHS to remove barriers that prevent Deferred Action for Childhood Arrivals (DACA) recipients from accessing affordable health insurance through the ACA marketplace and CHIP. Press Release Letter
- On November 15, CMS released a data brief that includes a snapshot of selected metrics from various data sources in three areas: access to Medicaid and CHIP coverage, access to services, and beneficiary experiences in managed care. Data Brief
- Also on November 15, CMS released an Informational Bulletin that describes the 2023 and 2024 updates to the Core Set of children’s health care quality measures for Medicaid and CHIP (Child Core Set) and of health care quality measures for adults enrolled in Medicaid (Adult Core Set). Informational Bulletin
- Also on November 15, Senate Finance Committee Democrats sent a letter to HHS Secretary Becerra and CMS Administrator Brooks-LaSure urging additional consumer protections in Medicare Advantage. Press Release Letter
- Also on November 15, CMS announced that the first improper payment rate for the Federally-facilitated Exchange (FFE) program was less than one percent for Benefit Year 2020. CMS also released a corresponding Fiscal Year (FY) 2022 Improper Payments fact sheet. Press Release Fact Sheet
- Also on November 15, Rep. Schakowsky (D-IL) co-authored an opinion piece in Newsweek, “How Medicare Advantage Scams Seniors.” Article
- On November 16, HHS OIG released a report of a Medicare Advantage compliance audit, finding that with respect to the nine groups of high-risk diagnosis codes covered by a Medicare Advantage plan for 2016 and 2017, most of the selected diagnosis codes submitted to CMS for use in CMS’ risk adjustment program did not comply with Federal requirements. Report in Brief Report
- On November 17, HHS OIG released a report finding that CMS contractors conducted Medicaid Fee-for-Service claim reviews for selected states under the Payment Error Rate Measurement (PERM) program in accordance with Federal and State requirements. Report in Brief Report
- On November 18, CMS released an Informational Bulletin with the 2023 Supplemental Security Income (SSI) and Spousal Impoverishment Standards. Informational Bulletin
- Also on November 18, CMS announced California’s amendment to the state’s Medicaid section 1115 demonstration is open for federal comment from November 18 to December 18, 2022. California is proposing county-based plan model changes in the Medi-Cal Managed Care Program. Pending Application Public Comments
- Also on November 18, HHS announced a nearly 40 percent increase in new sign-ups for health insurance coverage on HealthCare.gov. Press Release
Payment & Delivery System Models –
- On November 14, CMS released the Medicare Diabetes Prevention Program (MDPP) Expanded Model second evaluation report, which found that immediate goals of the program are being met but low participation has limited the program’s impact. Report
- On November 18, CMS published the fifth evaluation report and associated materials for the Next Generation Accountable Care Organization (ACO) Model. Model Webpage Report Technical Appendices
Public Health Prevention, Surveillance & Data –
- COVID-19 Data: To date, there are 98,174,364 total COVID-19 cases and 1,073,115 COVID-19 deaths in the United States. Also, 911,216,095 COVID-19 vaccines have been delivered and 650,810,290 individual COVID-19 vaccine doses have been administered. Data
- FDA Action Update: To date, FDA has authorized 445 tests under Emergency Use Authorizations (EUAs), including 307 molecular tests, 85 antibody tests and 53 antigen tests. FDA also continues to update COVID-19 FAQs.
- On November 15, the White House released a Statement of Administration Policy, stating that if Congress passes Senate Joint Resolution 63, which would terminate the national emergency declared on March 13, 2020, and unnecessarily and abruptly curtail the ability of the Administration to respond to COVID-19, the President will veto it. Statement
- Also on November 15, the FDA issued an Emergency Use Authorization (EUA) to Roche Molecular Systems, Inc. for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection. Letter of Authorization
- Also on November 15, White House Office of Management and Budget (OMB) Director Young sent a letter to Speaker of the House Pelosi (D-CA) providing the President’s request for FY 2023 emergency supplemental funding for critical assistance to Ukraine and critical response activities to address COVID-19. Press Release Letter
- On November 18, CDC released a report on sociodemographic variation in uptake of COVID-19 vaccine and parental attitudes toward vaccination of children. Report
Health IT, Privacy, & Digital Health –
- On November 15, the Office of the National Coordinator for Health IT (ONC) published a blog on the Pediatric Health Information Technology: Neonatal Abstinence Syndrome Informational Resource and how this new resource supports pediatric care and practice settings specific to neonatal abstinence syndrome. Blog
- Also on November 15, the White House Office of Science and Technology Policy (OSTP) announced that Asad Ramzanali will succeed Dr. Marc Aidinoff as OSTP Chief of Staff. Press Release
- On November 17, the FDA published a blog on the agency’s Cybersecurity Modernization Action Plan. Blog
Mental Health and Substance Use Disorder Policy –
- On November 14, HHS released a report on the national and state estimates of children living with parents engaged in problematic substance use, including past-year substance use and substance use disorder (SUD) by substance type and child demographics. Report
- Also on November 14, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a request for comments of SAMHSA’s Publications and Digital Products website Registration Survey, which aims to improve customer service and lessen the burden on the public to locate mental and substance use disorder resources. Comments are due by January 13, 2023. Request for Information
- Also on November 14, SAMHSA published a request for comments on the Fast Track process, which allows agencies to obtain timely feedback on service delivery. These collections will allow for ongoing, collaborative and actionable communications between SAMHSA and its customers and stakeholders. Comments are due by January 13, 2023. Request for Information
- On November 15, CDC released a data brief on suicide rates by race and ethnicity which found that age-adjusted suicide rates for non-Hispanic White individuals declined from 2018 to 2020 while rates increased for non-Hispanic Black and Hispanic individuals. Data Brief
- On November 16, the CDC released updated provisional counts for drug overdose deaths based on a current flow of mortality data in the National Vital Statistics System. Data
- Also on November 16, SAMHSA launched the new disparity impact statement (DIS) for discretionary grantees. The new DIS aids both the grantee and the agency in gaining a greater understanding of how SAMHSA funding is being used to reduce behavioral health disparities across the nation. Statement
- On November 17, SAMHSA released 10 assistance collaborative papers, which provide important resources on 988 implementation. Report
- Also on November 17, CMS extended the request for comments regarding the medical necessity and contract amendments under mental health parity. Comments are due by December 19, 2022. Request for Comments
- On November 18, CDC released updated death rates for drug overdose among persons aged 25-44 years and by race and ethnicity. Data
Prescription Drugs, Medical Devices, and Biomedical Research –
- On November 15, the FDA issued a notice on Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, to help facilitate the development and approval of certain nonprescription naloxone drug products. Press Release Notice
- Also on November 15, HHS OIG released a report comparing average sales prices and manufacturer prices for Medicare Part B drugs, finding that in the second quarter of 2022, seven drug codes met CMS’ price substitution criteria by exceeding the five percent threshold for two consecutive quarters or three of the previous four quarters. Report in Brief Report
- On November 17, the FDA approved Tzield injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. Press Release
Veterans Health and Military Health –
- On November 14, the Government Accountability Office (GAO) released a report on how the Veterans Administration (VA) can enhance its oversight of state veterans homes. Report in Brief Report
- On November 15, GAO released a report on a two-year pilot from the VA MISSION Act of 2018 that directed the VA to increase the use of medical scribes and assess what impact this would have on provider efficiency. Report in Brief Report
- On November 17, VA OIG released a report on the Veterans Health Administration’s (VHA) lethal means safety (LMS) training, firearms access and safe storage discussions within suicide risk assessments and safety plans, and clinicians’ perspectives on lethal means interventions. VA OIG made seven recommendations related to training oversight and evaluation of staff barriers. Report in Brief Report
Health Systems, Public Health & Health Equity –
- On November 15, CDC released a data brief on death rates for leading causes of death by race and ethnicity, which found that death rates for non-Hispanic White, non-Hispanic Black, and Hispanic people increased from 2013 through 2020. Data Brief
- Also on November 15, CMS released a report on rural-urban disparities in health care among Medicare beneficiaries, which identified noteworthy variation in patterns of rural-urban differences by race and ethnicity. Report
- Also on November 15, CMS released the Advancing Rural Health Equity Year in Review, which details CMS efforts to serve people in rural, tribal, and geographically isolated communities in FY 2022. Year in Review
- Also on November 15, the Health Resources and Services Administration (HRSA) highlighted a series of approaches to expand care and treatment for people with HIV supported by the Ryan White HIV/AIDS Program in FY 2022. Press Release
- Also on November 15, the Agency for Healthcare Research and Quality (AHRQ) requested that the White House OMB reapprove AHRQ’s collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home and Community Based Services (HCBS) Survey Database. Notice
- On November 16, the FDA issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products packaged to likely promote use by youth. Press Release
- Also on November 16, HHS released a report finding that unstably housed domestic violence survivors who received Domestic Violence Housing First (DVHF) model services – including housing-related advocacy and/or flexible financial assistance – reported a number of positive changes within 24-months after seeking services. Report
- Also on November 16, HHS released the FY 2023 Ending the HIV Epidemic – Primary Care HIV Prevention (PCHP) notice of funding opportunity (NOFO), which will make approximately $50 million available for up to 140 health centers located in the targeted geographic locations where there is a substantial amount of new HIV infections. NOFO
- On November 17, the US Department of Agriculture (USDA) issued a proposed rule proposing changes to the foods prescribed to participants in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Press Release Proposed Rule
- On November 18, Senate Finance Committee Chair Wyden (D-OR) and Sens. Grassley (R-IA), Cardin (D-MD), and Young (R-IN) raised concerns in a letter about conflicts of interest at the National Academy for Science, Engineering and Medicine (NASEM) after it published a report on the organ procurement and transplantation system that mirrored recommendations supported by industry groups. Press Release Letter
Reproductive, Maternal, & Infant Health –
- On November 14, the FDA provided an update on steps taken to increase the availability of safe, nutritious infant formula. Press Release
- On November 15, the FDA released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. Press Release Outline
- On November 16, HHS released the 2022 Maternal Health Vignette, detailing how the Office of the Secretary’s Patient Centered Outcomes Research Trust Fund (OS-PCORTF) cross-agency projects are working to improve maternal health. Report
- On November 18, Sen. Warren (D-MA) and eight Senate Democrats sent a letter to FDA Commissioner Califf encouraging the agency to defend reproductive rights and to consider steps to protect and expand access to medication abortion. Press Release Letter
Misc. –
- On November 15, the FDA finalized a rule to trace contaminated food more effectively through the food supply. Press Release Final Rule
- Also on November 15, HHS released the Agency Financial Report for FY 2022 which provides fiscal and summary performance results to assess HHS accomplishments between October 1, 2021 and September 30, 2022. Report Press Release
- On November 16, HHS OIG released the 2022 Top Management and Performance Challenges Facing HHS, identifying six top management and performance challenges (TMCs) that HHS faces as it strives to fulfill its mission to enhance the health and well-being of all Americans. Report
- Also on November 16, HHS OIG released its November 2022 Work Plan items. Work Plan Items
- On November 17, the FDA issued warning letters to seven companies for violating the Federal Food, Drug, and Cosmetic Act, by illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions. Press Release
- On November 18, House Ways & Means Committee Republicans released a one-pager outlining planned areas for oversight of the Biden Administration, to include expansions of the ACA, protecting medical innovation, and nursing home deaths. Press Release One-Pager
Legislative Activity
Votes and Committee Activity –
- On November 14, the House Committee on Rules marked up and held a committee vote on a draft report on the Ending Hunger in America initiative, which included testimony and documents to offers solutions to hunger and ways to improve the nation’s health. The Committee voted to release the report to the full House for consideration. Press release Draft report
- On November 15, the Senate passed S.J. Res 63 by a vote of 62-36. The resolution seeks to end the COVID-19 national emergency declared by the President on March 13, 2020. Resolution text Congressional record
- On November 16, the Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454) passed the Senate by voice vote. The bill would expand research on cannabidiol and marijuana. The bill now heads to the President for consideration. Bill text Press release
- On November 17, the Department of Veterans Affairs Information Technology Reform Act of 2021 (H.R. 2250) passed the House by a vote of 414-2. The bill would improve the management of information technology projects and investments of the Department of Veterans Affairs. The bill now heads to the Senate for consideration. Bill text Press release
- Also on November 17, the Lymphedema Treatment Act (H.R. 3630) passed the House by a vote of 402-13. The bill would provide for coverage of certain lymphedema compression treatment items under the Medicare program. The bill now heads to the Senate for consideration. Bill text Press release
- Also on November 17, the Ensuring Phone and Internet Access Through Lifeline and Affordable Connectivity Program Act of 2022 (H.R. 4275) passed the House as amended. The bill would provide for certain reports on enrollment in the Lifeline program. The bill now heads to the Senate for consideration. Bill text Press release
- Also on November 17, the Improving Oversight of the Veterans Community Care Providers Act of 2022 (H.R. 7277) passed the House as amended. The bill would improve the methods by which the Secretary of Veterans Affairs identifies health care providers that are not eligible to participate in the Veterans Community Care Program. The bill now heads to the Senate for consideration. Bill text Press release
Introduced Legislation –
- On November 15, Reps. Guthrie (R-KY), Eshoo (D-CA), Griffith (R-VA), Peters (D-CA), Burgess (R-TX), and Matsui (D-CA) introduced the Pre-Approval Information Exchange Act of 2022 (H.R. 9297), which would facilitate the exchange of certain product information. Bill text Press release
- Also on November 15, Sens. Blumenthal (D-CT) and Booker (D-NJ) introduced the Stop Subsidizing Childhood Obesity Act of 2022 (S. 5086), which would protect children’s health by denying any deduction for advertising and marketing directed at children to promote the consumption of food of poor nutritional quality. Bill text Press release
- Also on November 15, Sens. Smith (D-MN) and Wyden (D-OR) introduced the Behavioral Health Network and Directory Improvement Act (S. 5093), which would protect patients and improve the accuracy of provider directory information by eliminating ghost networks. Press release
- On November 16, Reps. Speier (D-CA), Nadler (D-NY), and Porter (D-CA) introduced the Independent Drug Value Assessment Act (H.R. 9321), which would provide for the development and publication of independent value assessments for drugs. Bill text Press release
- Also on November 16, Sens. Carper (D-DE) and Cassidy (R-LA) introduced the PACE Part D Choice Act (S. 5106), which would ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare part D. Bill text Press release
- Also on November 16, Sens. Brown (D-OH), Grassley (R-IA), Durbin (D-IL), Cassidy (R-LA), Padilla (D-CA), Wicker (R-MS), Tester (D-MT), Markey (D-MA), and Peters (D-MI) introduced the Prevent Exposure to Narcotics and Toxins (PREVENT) Act of 2022 (S. 5114), which would provide training for Department of Homeland Security personnel regarding the use of containment devices to prevent exposure to potential synthetic opioids. Bill text Press release
- On November 17, Reps. Boyle (D-PA) and Brown (D-OH) introduced the Mental and Physical Health Care Comorbidities Act (H.R. 9328), which would establish a demonstration program to promote collaborative treatment of mental and physical health comorbidities under the Medicare program. Bill text Press release
- Also on November 17, Sens. Carper (D-DE) and Barrasso (R-WY) introduced legislation to provide greater accessibility to physical and occupational therapy (S. 5), which would ensure appropriate supervision requirements for outpatient physical therapy and outpatient occupational therapy. Bill text Press release
- Also on November 17, Sen. Bennet (D-CO) introduced the Mental and Physical Health Care Comorbidities Act (S. 8), which would establish a demonstration program to promote collaborative treatment of mental and physical health comorbidities under the Medicare program. Bill text Press release
- Also on November 17, Sens. Booker (D-NJ) and Paul (R-KY) introduced the Breakthrough Therapies Act (S. 5123), which would amend the Controlled Substances Act to modify the registration requirements relating to research. Bill text Press release