Health Care Policy Update – Weekly Wrap-up and What’s Ahead – January 17, 2023


What’s Ahead: This Week

Notable Policy Events – 

  • Tuesday, January 17
    • Center for Strategic & International Studies, “Building the CDC the Country Needs.”
      Additional information
    • CMS, “January 2023 CMS Quality Programs Bi-Monthly Forum.” Additional information
    • Office of the National Coordinator for Health IT (ONC), “Trusted Exchange Framework and Common Agreement (TEFCA) Recognized Coordinating Entity (RCE) Monthly Call.” Additional information
    • White House and Health Resources and Services Administration (HRSA), “Building Partnerships to Promote COVID-19 Vaccination.” Additional information
  • Wednesday, January 18
    • Center for Health Care Strategies, “Advancing Trauma- and Resilience-Informed Health Care Systems: Early Lessons from Denver Health.” Additional information
    • Health Affairs, “Journal Club: Medicaid Expansion Led To Reductions In Postpartum Hospitalizations.” Additional information
    • National Nurse-Led Care Consortium, “Social Determinants of Health (SDOH) Screening & Referrals to Support Diabetes Control Webinar.” Additional information
  • Thursday, January 19
    • Center for Health Care Strategies, “Supporting Providers of Color: Practices to Diversify the Workforce and Improve Retention.” Additional information
    • CMS, “Expanded HHVBP Model: First Performance Year Quick Guide Event.” Additional information
    • Health Affairs, “Policy Spotlight: One-on-One with Benjamin Sommers, the Deputy Assistant Secretary in the Office of Health Policy at HHS.” Additional information
    • Milbank Memorial Fund, “Making Health Care More Affordable: Implementing a State Cost Growth Target.” Additional information
    • ONC, “Health IT Advisory Committee (HITAC) Meeting.” Additional information
  • Friday, January 20
    • Alliance for Health Policy, “Federal Funding Streams for Mental Health Services.” Additional information
    • National Academies of Sciences, Engineering, and Medicine, “Forum on Mental Health and Substance Use Disorders: 988 Webinar #1.” Additional information

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

Medicare, Medicaid, Marketplaces & Coverage –

  • On January 9, CMS awarded the first 200 of 1,000 Medicare-funded physician residency slots to enhance the health care workforce and announced it funded additional positions in hospitals serving underserved communities. Press Release
  • Also on January 9, the Government Accountability Office (GAO) released a report on the Federal Employees Health Benefits Program, which included recommendations to the Office of Personnel Management (OPM) to include additional monitoring mechanisms and fraud risk assessment. Report in Brief Report
  • On January 10, the GAO released a notice requesting nominations for the Medicare Payment Advisory Commission (MedPAC). Nominations are due by February 10, 2023 for MedPAC appointments effective May 2023. Notice
  • Also on January 10, CMS released a notice soliciting comments on the collection of provider network coverage data, qualified health plan (QHP) issuer data, and the bid pricing tool for Medicare Advantage plans and prescription drug plans. Comments are due by February 9, 2023 Notice
  • On January 11, CMS released a memo outlining key dates and information on how CMS will approach implementation of the Medicare Drug Price Negotiation Program of the Inflation Reduction Act for initial price applicability year 2026. Press Release Timeline Memo
  • Also on January 11, HHS announced that about 15.9 million people have selected an ACA Marketplace plan since the start of the 2023 Marketplace Open Enrollment Period on November 1, 2022.  Press Release Fact Sheet 
  • Also on January 11, GAO released a report examining CMS requirements for reporting and responding to abuse and neglect allegations which identified gaps in the requirements for hospices, compared with requirements for extended care provided in hospitals and nursing homes. Report
  • On January 13, CMS issued a notice on updates to the Healthcare Common Procedure Coding System (HCPCS) codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List. Comments are due by March 18, 2023. Notice
  • Also on January 13, CMS announced that Utah submitted a request to amend its Medicaid 1115 Demonstration to provide long-term services and supports to behaviorally complex individuals. The comment period is open through February 12, 2023. Pending Application Comments
  • Also on January 13, CMS released an extension request regarding the Delaware Diamond State Health Plan section 1115 demonstration. The comment period is open through February 12, 2023. Notice Pending Application
  • Also on January 13, CMS released the 2021 Drug Utilization Review (DUR) fee-for-service (FFS) National and Individual State DUR Summary Reports and the National, Individual and Abbreviated State Managed Care Organization (MCO) DUR Summary Reports, which show practitioners’ prescribing habits and cost savings generated from DUR programs. Reports
  • Also on January 13, HHS released an issue brief which examines the composition of the population that is uninsured and highlights changes in uninsured rates by geography and demographic factors from 2019 to 2021. Report Press Release
  • Also on January 13, CMS announced that Utah submitted a request to amend the Medicaid Reform 1115 Demonstration to provide state plan covered physical and behavioral health services in an integrated model through a contracted local mental health authority. The comment period is open through February 12, 2023.  Comments Pending Applications

Payment & Delivery System Models –

  • On January 9, CMS released the financial and quality results for Performance Year 5 (2020) of the Comprehensive ESRD Care (CEC) Model. Results Model Webpage

Public Health Preparedness, Prevention, Surveillance, & Data – 

  • COVID-19 Data: To date, there are 101,518,229 total COVID-19 cases and 1,095,149 COVID-19 deaths in the United States. Also, 947,249,345 COVID-19 vaccines have been delivered and 666,511,603 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 443 tests under Emergency Use Authorizations (EUAs), including 298 molecular tests, 85 antibody tests and 59 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On January 9, the National Institutes of Health (NIH) awarded eight research grants to refine new technologies for early diagnosis of severe illnesses resulting from SARS-CoV-2 infection in children. Press Release
  • On January 10, the White House released a fact sheet of key deliverables for the 2023 North American Leaders’ Summit to address shared challenges, including strengthening public health approaches to substance use and developing public policies to protect against current and future public health crises. Press Release
  • Also on January 10, Sen. Sanders (I-VT), who is expected to be the incoming chairman of the Senate HELP Committee, sent a letter to Moderna’s CEO asking the company to reconsider its decision to increase its price for the COVID-19 vaccine in light of the role the federal government has played in the development of the vaccine. Press Release Letter
  • Also on January 10, Secretary of Defense Austin released a memorandum rescinding the COVID-19 vaccine mandate for members of the Armed Forces. Memo Press Release
  • On January 11, HHS Secretary Becerra renewed the COVID-19 Public Health Emergency (PHE) until April 11, 2023. PHE Renewal
  • Also on January 11, FDA announced the issuance of an Emergency Use Authorization (EUA) for an in vitro diagnostic device in response to an outbreak of mpox. The authorization is effective as of December 13, 2022. Notice
  • Also on January 11, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA) issued a statement after the Biden Administration further extended the COVID-19 PHE declaration. Statement
  • On January 12, the Administration for Children and Families (ACF) released a request for comments on the COVID-19 mitigation policy in Head Start. Notice
  • Also on January 12, Nirav Shah was announced as the new Principal Deputy Director for CDC. Press Release 
  • On January 13, CDC released a report on routine vaccination coverage against 14 diseases by age 24 months among children born between 2018–2019, finding that vaccination coverage for this age group has remained high and stable for most vaccines, although disparities persist. Report
  • Also on January 13, CDC released a report on vaccination coverage with state-required vaccines among children in kindergarten during the 2021-2022 school year, finding a decline from 95 to 94 percent. Report
  • Also on January 13, CDC and the FDA identified a preliminary COVID-19 vaccine safety signal for ischemic stroke in persons aged 65 years and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. To date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal. Press Release

Health IT, Privacy, & Digital Health –

  • On January 10, ONC published a blog announcing the release of the annual Interoperability Standards Advisory (ISA) Reference Edition, a catalog of curated standards and implementation specifications for health information interoperability. Blog ISA Reference Edition
  • On January 11, President Biden published an op-ed in the Wall Street Journal on Big Tech. The op-ed focuses on the protection of privacy, competition, and American children. Op Ed
  • Also on January 11, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA) released a statement in response to President Biden’s Wall Street Journal op-ed on Big Tech, calling on the Administration to work with Congress to enact comprehensive privacy protections through one national privacy standard that protects all Americans. Statement
  • On January 12, ONC published the Draft United States Core Data for Interoperability (USCDI) Version 4. Draft USCDI Version 4 includes USCDI Version 3 and 20 new data elements for interoperable health information exchange. Draft USCDI Version 4 ONC Health IT Standards Bulletin USCDI Website

Mental Health and Substance Use Disorder Policy –

  • On January 9, HHS awarded nearly $245 million in Bipartisan Safer Communities Act funding to support youth mental health, help the health care workforce address mental health needs, and fund other critical mental health supports. Press Release
  • Also on January 9, the Substance Abuse and Mental Health Services Administration (SAMHSA) requested approval from the Office of Management and Budget (OMB) for changes and updates to the Protection and Advocacy for Individuals with Mental Illness (PAIMI) revised annual program performance report (PPR). Information Collection
  • Also on January 9, SAMHSA requested OMB approval for extension of the Federal Drug Testing Custody and Control Form (CCF) for federal agency and federally regulated drug testing programs. Proposed Collection
  • Also on January 9, SAMHSA reinstated the Projects for Assistance in Transition from Homelessness (PATH) program, which funds services for people with serious mental illness (SMI) experiencing homelessness. SAMHSA also submitted revisions to the approved PATH program annual report. PATH Program Reinstatement Revisions
  • Also on January 9, the White House Office of National Drug Control Policy (ONDCP) released the Performance Measures for Medication-assisted Treatment in Correctional Settings report, which details substance use treatment in correctional settings. Press Release Report
  • On January 10, Reps. Kuster (D-NH), Fitzpatrick (R-PA), and Trone (D-MD) met to highlight the Bipartisan Addiction and Mental Health Task Force wins during the 117th Congress and to recommit to its bipartisan mission of addressing the issues of mental health and substance use disorder. Statement
  • Also on January 10, FDA launched a campaign on youth cigarette prevention, which will focus on the negative mental health effects of cigarette smoking and withdrawal. Press Release
  • On January 11, CDC released the most recent provisional drug overdose death counts, which showed 107,477 predicted overdose deaths in the 12-month period ending in August 2022. Data
  • Also on January 11, White House ONDCP Director Dr. Rahul Gupta issued a statement on the CDC’s release of provisional drug overdose death data, which showed a 2.57 percent decrease from the 110,315 fatal drug overdoses provisionally estimated for the 12-month period ending in March 2022. Statement Data
  • Also on January 11, the House Energy & Commerce Committee held a roundtable on America’s fentanyl crisis. Roundtable Highlights
  • On January 12, the Congressional Mental Health Caucus announced Rep. Stewart (R-UT) as the new co-chair for the 118th Congress. Press Release
  • On January 13, SAMHSA announced Notices of Funding Opportunities (NOFOs) for five grant programs aimed at preventing substance misuse and treating substance use disorder (SUD). The grant opportunities total about $73.4 million and align with the Biden-Harris Administration’s efforts to address the nation’s addiction and overdose crises. Press Release

Prescription Drugs, Medical Devices, & Biomedical Research –

  • On January 10, FDA issued a statement regarding two warning letters to a leading manufacturer of endoscopes, Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd., concerning violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes. Statement Olympus Medical Systems Corporation Letter Aizu Olympus Co., Ltd. Letter
  • Also on January 10, the FDA announced it is partnering with Health Canada to launch a joint eSTAR pilot. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. Press Release
  • Also on January 10, FDA published a blog on the approval of 37 new drugs and therapies in 2022. Blog
  • Also on January 10, Sens. Warren (D-MA), King (I-ME), and Rep. Doggett (D-TX) led a bicameral letter to HHS Secretary Becerra asking the Administration to combat high prescription drug prices by protecting taxpayer investments in the development of the prostate cancer drug enzalutamide (Xtandi), through exercising the federal government’s taxpayer protection rights under the Bayh-Dole Act. Press Release Letter
  • On January 11, the FDA issued the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022, which highlights the goal of advancing model-informed drug development (MIDD). Notice
  • On January 12, Reps. Pressley (D-MA), Trahan (D-MA), Clark (D-MA), and Sen. Warren (D-MA) sent a letter to the CEO of Johnson & Johnson asking for answers on the manufacturer’s efforts to address and resolve the shortage of infant and children’s Tylenol and Motrin in Massachusetts and across the country. Press Release Letter

Veterans Health and Military Health –

  • On January 11, the Department of Veterans Affairs (VA) issued a proposed rule that would waive copayments incurred on or after Jan. 5, 2022, for eligible American Indian and Alaska Native Veterans. Comments are due by February 13, 2023. Press Release Proposed Rule
  • On January 12, the Department of Defense (DOD) issued an interim final rule to modify the TRICARE regulation by adding freestanding End Stage Renal Disease (ESRD) facilities as a category of TRICARE-authorized institutional provider and establishing reimbursement for such facilities, and by temporarily adopting Medicare’s New COVID-19 Treatments Add-on Payments. Interim Final Rule
  • Also on January 12, the VA Office of Inspector General (OIG) released a report describing the results of a focused evaluation of the outpatient care provided at the El Paso VA Health Care System in Texas. The VA OIG noted opportunities for improvement and issued three recommendations to the System Director and Chief of Staff. Report in Brief Report
  • Also on January 12, the VA OIG released a report on an evaluation of aspects of care delivered at various veteran centers throughout the Midwest. The VA OIG inspection focused on five review areas: leadership and organizational risks; quality reviews; suicide prevention; consultation, supervision, and training; and environment of care. Report in Brief Report
  • Also on January 12, the VA OIG released a report on an evaluation of Veterans Integrated Service Network (VISN) 7 and its oversight of the quality of care delivered in community-based outpatient clinics and through its community care referrals to non-VA providers. Report in Brief Report
  • On January 13, the VA announced that, starting January 17, Veterans in acute suicidal crisis will be able to go to any VA or non-VA health care facility for emergency health care at no cost – including inpatient or crisis residential care for up to 30 days and outpatient care for up to 90 days. Press Release

Health Systems, Public Health, & Health Equity –

  • On January 9, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) wrote to HHS Secretary Becerra urging a quick finalization of the proposed rule to add uterine cancer to the list of World Trade Center (WTC)-related health conditions. Press Release Letter 
  • On January 10, the U.S. Preventive Services Task Force announced the appointment of three new members, Sandra Millon Underwood, R.N., Ph.D.; Goutham Rao, M.D., FAHA; and Joel Tsevat, M.D., M.P.H, to serve a four-year term beginning in January 2023. Press Release
  • Also on January 10, the Equal Employment Opportunity Commission (EEOC) requested public comments on the Draft Strategic Enforcement Plan for 2023 to 2027. EEOC intends to bolster its efforts to protect workers particularly vulnerable to discrimination and implement newly enacted protections for pregnant workers. Comments are due by February 9, 2023. Request for Comments
  • On January 11, the U.S. Department of Agriculture (USDA) announced a Memorandum of Understanding (MOU) to reaffirm and strengthen the relationship between USDA and the National Urban League, who will work collaboratively to promote nutrition and food insecurity, increase access to healthy foods, and ensure equitable service delivery of USDA programs in underserved communities. Press Release
  • Also on January 11, HRSA released a notice on the National Health Service Corps (NHSC) and Nurse Corps Interest Capture Form. The purpose of the form is to enable individuals and clinical sites to ask questions about the NHSC and/or Nurse Corps Scholarship and Loan Repayment Programs. Notice
  • Also on January 11, the White House Office of Science and Technology Policy (OSTP) announced new actions to advance open and equitable research, including new grant funding and expanded opportunities for public engagement. Fact Sheet
  • Also on January 11, HHS Assistant Secretary for Health Admiral Levine posted a blog encouraging the public to donate blood during National Blood Donor Month. Blog
  • On January 12, HHS, along with eight other federal agencies, issued a proposed rule to amend regulations to clarify protections for beneficiaries receiving federally funded social services and the rights and obligations of organizations providing such services. Proposed Rule Press Release
  • Also on January 12, White House Cancer Moonshot Coordinator Dr. Carnival issued a statement on a new report from the American Cancer Society, which shows that overall cancer mortality in the U.S. has dropped 33 percent since 1991. Statement Report
  • On January 13, CDC released a report on the percentage of adults who have ever had hepatitis, stratified by age and sex. Report
  • Also on January 13, HHS released a tool guide on leading practices to advance equity and support of underserved communities through health and human services programs. Tool

Reproductive, Maternal & Infant Health  –

  • On January 9, FDA issued letters of acknowledgement for the infant formula transition plan, which allows manufacturers to continue marketing their products while they work to meet FDA requirements. Press Release
  • On January 10, CDC released a report on fertility of men and women aged 15-49 from 2015-2019. Report
  • Also on January 10, CDC released a report which found that infants of non-Hispanic Asian women have among the lowest infant mortality rates (IMRs) of all race and Hispanic-origin groups. Report
  • On January 11, CDC requested comments on the Maternal Mortality Review Information Application (MMRIA), which allows Maternal Mortality Review Committees (MMRCs) to develop recommendations for pregnancy-related deaths prevention. Notice
  • On January 12, CDC released a report on fetal mortality in the U.S. from 2019 to 2021. Report

Misc. –

  • On January 9, President Biden declared that an emergency exists in the State of California and ordered Federal assistance to supplement State, tribal, and local response efforts due to the emergency conditions resulting from successive and severe winter storms, flooding, and mudslides that began on January 8, 2023. Declaration
  • On January 10, the Agency for Healthcare Research and Quality (AHRQ) released a newsletter highlighting agency research and program activities. Newsletter
  • On January 12, the Congressional Budget Office (CBO) released a cost estimate of the Consolidated Appropriations Act, 2023, which estimates that Divisions O through MM, which includes health-related provisions, will decrease the deficit by $3.9 billion over the 2023-2032 period. Report
  • Also on January 12, Sen. Gillibrand (D-NY) led a coalition of 16 Senators in a letter calling on the Biden Administration to remain firm in its commitment to paid leave by advancing a national paid family and medical leave program in the FY2024 budget. Press Release Letter
  • Also on January 12, House Education & Workforce Committee Chair Foxx (R-NC) issued a statement to follow up on letters renewing congressional inquiries to federal agency heads. Press Release
  • Also on January 12, the White House OSTP released a framework for federal scientific integrity policy and practice intended to strengthen scientific integrity policies and practices across the federal government. Press Release Framework
  • On January 13, CMS released a document containing its five top tips for selected ground ambulance organizations when they report required cost, utilization, revenue, and other information to CMS. Tips

Legislative Activity –

Votes and Committee Activity –

  • On January 9, the House passed the Adopting the Rules of the House of Representatives for the One Hundred Eighteenth Congress (H. Res. 5) by a vote of 220-213. Notable rule changes that will have implications on health policies include the creation of a select panel to investigate the origins of the COVID-19 pandemic and replacement of pay-go rules with a cut-as-you-go rule, among others. Resolution Section-by-section
  • Also on January 9, Rep. Smith (R-MO) was named as the Chairman of the House Ways & Means Committee. Press release
  • On January 10, Rep. McMorris Rodgers (R-WA) was named as the Chairwoman of the House Energy & Commerce Committee. Press release
  • Also on January 10, Rep. Granger (R-TX) was named as the Chairwoman of the House Appropriations Committee. Press release
  • Also on January 10, Rep. Bost (R-IL) was named as the Chairman of the House Committee on Veterans’ Affairs. Press release
  • Also on January 10, Sens. Murray (D-WA) and Collins (R-ME), the expected incoming Chair and Vice Chair of the Senate Appropriations Committee, respectively, issued a statement on their bipartisan commitment to funding the government and passing the Senate’s appropriations bills through regular order. Statement
  • On January 11, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA) announced nine new members to the House Energy & Commerce Committee. Press release
  • Also on January 11, House Appropriations Committee Chair Granger (R-TX) announced ten new members to the House Appropriations Committee. Press release
  • Also on January 11, House Ways & Means Committee Chair Smith (R-MO) announced ten new members to the House Ways & Means Committee. Press release
  • Also on January 11, the House passed the Born-Alive Abortion Survivors Protection Act (H.R. 26) by a vote of 220-210. The bill would prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion. The bill now heads to the Senate for consideration. Bill text Press release

Introduced Legislation –

  • On January 9, Rep. Smith (R-NE) and 82 cosponsors introduced the Family and Small Business Taxpayer Protection Act­­ (H.R. 23), which would rescind certain balances made available to the Internal Revenue Service. Press release
  • Also on January 9, Rep. Baird (R-IN) and eight bipartisan cosponsors introduced the VA Same-Day Scheduling Act (H.R. 41), which would ensure the timely scheduling of appointments for health care at medical facilities of the Department of Veterans Affairs. Press release
  • Also on January 9, Rep. Kelly (R-PA) and 62 cosponsors introduced the Heartbeat Protection Act (H.R. 175), which would prohibit abortion in cases where a fetal heartbeat is detectable. Press release
  • Also on January 9, Reps. Levin (D-CA) and Fitzpatrick (R-PA) introduced the Nursing Home Disclosure Act (H.R. 177), which would ensure nursing facilities report information on medical directors of such facilities. Press release
  • Also on January 9, Reps. Massie (R-KY), Miller (R-IL), Norman (R-SC), Perry (R-PA), and Posey (R-FL) introduced legislation to end the COVID-19 vaccine mandate for international air travelers (H.R. 185), which would terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers. Bill text Press release
  • On January 10, Rep. Dingell (D-MI) and six bipartisan cosponsors introduced the Medicare Hearing Aid Coverage Act (H.R. 244), which would remove the exclusion of Medicare coverage for hearing aids and examinations therefor. Press release
  • On January 11, Rep. Estes (R-KS) introduced the Restoring Normalcy in America Act (H.R. 271), which would provide for greater accountability with respect to Federal activities and expenditures relating to COVID-19. Press release
  • Also on January 11, Rep. Escobar (D-TX) and 107 cosponsors introduced the Healthcare Providers’ Safety Act of 2023 (H.R. 286), which would authorize grants to health care providers to enhance the physical and cyber security of their facilities, personnel, and patients. Bill text Press release
  • Also on January 11, Rep. Fitzgerald (R-WI) and 11 cosponsors introduced the Vaccine Discharge Parity Act (H.R. 291), which would ensure that a member of the Armed Forces, granted a general discharge under honorable conditions on the sole basis that such member failed to obey a lawful order to receive a vaccine for COVID-19, is eligible for certain educational assistance administered by the Secretary of Veterans Affairs. Bill text Press release
  • Also on January 11, Rep. Mast (R-FL) and 33 cosponsors introduced the Vaccine Mandate Reenlistment Act (H.R. 297), which would reinstate a member involuntarily separated from the Armed Forces solely on the basis of the refusal of such member to receive a vaccination against COVID-19. Bill text Press release
  • On January 12, Rep. Roy (R-TX) and 15 cosponsor introduced the No Taxpayer Funding for the World Health Organization Act (H.R. 343), which would prohibit United States assessed and voluntary contributions to the World Health Organization. Bill text Press release
  • Also on January 12, Rep. Grothman (R-WI) introduced the Standardizing Thresholds Of Penalties for (STOP) Fentanyl Act (H.R. 335), which would reduce the threshold for mandatory minimum penalties for fentanyl-related offenses under the Controlled Substances Act and the Controlled Substances Import and Export Act. Press release

Also on January 12, Reps. Tenney (R-NY), Gallagher (R-WI), Smith (R-NJ), Issa (R-CA), and LaTurner (R-KS) introduced the Transparency in COVID-19 Expenditures Act (H.R. 348), which would require an audit of COVID-19 relief funding. Bill text Press release