Health Care Policy Update – Weekly Wrap-up and What’s Ahead – April 10, 2023


What’s Ahead: This Week
Hearings and Markups –
  • Congress is not in session this week
Notable Policy Events – 
  • Monday, April 10
    • National Telecommunications and Information Administration (NTIA), “NTIA Public Virtual Listening Session: Digital Equity Request For Comment.” Additional information
    • The Washington Post, “Declining Life Expectancy in the U.S.” Additional information
  • Tuesday, April 11
    • American Enterprise Institute, “The Future of Medical Device Regulation: The Final Frontier.” Additional information
    • Brookings Institution, “Wall Street Comes to Washington Health Care Roundtable.” Additional information
    • Urban Institute, “Strengthening Social Security for Older Adults, People with Disabilities, and Their Families.” Additional information
  • Wednesday, April 12
    • Duke Margolis Center for Health Policy, “The Next Generation of Risk Adjustment Discussing Policy Options to Advance Reform.” Additional information
    • Health IT Advisory Committee (HITAC), “Committee Meeting.” Additional information
  • Thursday, April 13 to Friday, April 14
  • Thursday, April 13
    • Civitas Networks for Health, “Collaboratives in Action: The Health Data Utility Framework, A Milestone in the Health Data Utility Movement.” Additional information
    • Hudson Institute, “How Health Security Strengthens National Security.” Additional information
    • U.S. News & World Report, “Hospitals as Community Care Hubs for Autism.” Additional information
  • Friday, April 14
    • Office of the National Coordinator for Health IT (ONC), “Clinical Decision Support Series: What to Know About Clinical Decision Support: Introduction to the Basics.” Additional information
Weekly Wrap-Up: Notable Health Care Developments from Last Week
Medicare – 
  • On April 3, CMS issued a proposed rule to update Medicare payment policies and rates under the Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) and the IRF Quality Reporting Program for fiscal year (FY) 2024. CMS is proposing to update the IRF PPS payment rates by three percent. Fact Sheet Proposed Rule
  • On April 4, CMS released a notice soliciting comments on the Notice of Denial of Medical Coverage (or Payment) under Medicare and the scheduled non-emergent ambulance transport prior authorization process. Comments are due by June 5, 2023.  Notice
  • Also on April 4, CMS issued a proposed rule to update Medicare payment policies and rates for the Inpatient Psychiatric Facility Prospective Payment System (IPF PPS) for FY 2024. Total estimated payments to IPFs are estimated to increase by 1.9 percent in FY 2024 relative to IPF payments in FY 2023. Proposed Rule Fact Sheet
  • Also on April 4, CMS issued a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for FY 2024. The proposed rule also includes proposals for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program for FY 2024 and future years. Proposed Rule Fact Sheet
  • On April 5, HHS released a notice listing the Office of Medicare Hearings and Appeals (OMHA) Case Processing Manual (OCPM) instructions that were published from October through December 2022.  Notice
  • Also on April 5, CMS issued the Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly Final Rule. The rule implements changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, network adequacy, and other programmatic areas. Final Rule Fact Sheet Press Release
  • On April 6, CMS Administrator Brooks-LaSure wrote a blog on the basics of Medicare coverage, including when and how to apply for Medicare, options to consider, and the tools available to help make Medicare coverage decisions. Blog
  • On April 7, CMS announced the availability of the calendar year 2024 Plan Benefit Package (PBP), Bid Pricing Tool (BPT), and plan creation functionality in the Health Plan Management System (HPMS). Announcement
Medicaid – 
  • On April 3, the HHS Office of Inspector General (OIG) released a report on its 2022 inspection of the Rhode Island Medicaid Fraud Control Unit (MFCU). The inspection found that the MFCU maintained strong working relationships and investigated cases jointly with OIG and the U.S. Attorney’s Office. Report in Brief Report
  • On April 4, CMS released a notice soliciting comments on information collected by CMS regarding Medicaid managed care programs, grievances and appeals, enrollment broker contracts, and organizational capacity. CMS is also soliciting comments on annual reports submitted by applicable manufacturers of drugs, devices, biologics, or medical supplies covered under Medicare, Medicaid, and CHIP. Comments are due May 4, 2023. Notice
  • Also on April 4, CMS approved Arizona’s state plan amendment to provide 12 months of postpartum coverage to Medicaid-eligible pregnant individuals. State Plan Amendment
  • Also on April 4, CMS released a notice soliciting comments on the Notice of Denial of Medical Coverage (or Payment) under Medicare and the scheduled non-emergent ambulance transport prior authorization process. Comments are due by June 5, 2023.  Notice
  • Also on April 4, the HHS Office for Civil Rights sent a letter to state Medicaid directors reminding states of their legal obligations under federal civil rights laws as states transition from Medicaid continuous enrollment coverage under the Public Health Emergency. The letter outlines the requirement to provide meaningful language access for individuals with limited English proficiency and ensure effective communication with individuals with disabilities. Letter Press Release
  • On April 6, House Oversight and Accountability Committee Chair Comer (R-KY) sent a letter to CMS Administrator Brooks-LaSure requesting documents and communications related to CMS’ handling of Medicaid redeterminations after the unwinding Medicaid continuous enrollment provisions. Press Release Letter 
  • On April 7, CMS released a notice with proposed revisions to the Medicaid Managed Care Rate Development Guide, which outlines standards and expectations for documentation such as projected benefit costs and other considerations or adjustments used when setting capitation rates. Comments are due April 24, 2023. Notice
Payment & Delivery System Models  – 
  • On April 4, CMS released a survey to collect information from participants of the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model measurement year three. The survey must be completed by April 14, 2023. Survey
  • On April 5, CMS announced additional details on the Medicare Advantage Value-Based Insurance Design (VBID) Model Extension. The model, which is extended from 2025 to 2030,will include several new policies intended to more fully address the health-related social needs of patients, advance health equity, and improve care coordination for patients with serious illness. Additional Information
  • On April 6, CMS announced it is extending the timeline to review data for the Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model participants, in response to stakeholder feedback. The period for data review is extended to at least eight weeks after distribution of baseline data and preliminary Target Prices. Timeline
Public Health Preparedness, Prevention, Surveillance, & Data – 
  • COVID-19 Data: To date, there are 104,242,889 total COVID-19 cases and 1,127,104 COVID-19 deaths in the United States. Also, 974,987,545 COVID-19 vaccines have been delivered and 674,375,206 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 446 tests under Emergency Use Authorizations (EUAs), including 300 molecular tests, 84 antibody tests, 61 antigen tests, and one diagnostic breath test. FDA also continues to update COVID-19 FAQs.
  • On April 4, Senate Special Committee on Aging Chair Casey (D-PA) and Senate Finance Committee Chair Wyden (D-OR) led a letter to HHS Secretary Becerra, urging HHS to continue providing Medicare coverage for rapid, at-home COVID-19 tests after the public health emergency expires on May 11. Press Release Letter
  • On April 5, Rep. Miller-Meeks (R-IA) released a request for information (RFI) to health care industry stakeholders seeking insight to reform and improve the CDC. The RFI seeks specific guidance, feedback, and information on how best to reform, improve, and authorize the CDC and its programs to rebuild trust and ensure the agency is nimble in addressing public health threats. Comments are due by April 23, 2023. RFI Press Release
  • Also on April 5, HHS released a fact sheet outlining progress made in responding to Long COVID and actions moving forward. Fact Sheet
Health IT, Privacy, & Digital Health –
  • On April 3, ONC published a blog on the work of the standards division in the Office of Technology at ONC. The standards division is responsible for providing technical subject matter expertise to ONC and health IT partners to encourage the adoption and use of health IT standards. Blog
  • Also on April 3, the Sequoia Project, the Recognized Coordinating Entity (RCE) for the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA) released two draft standard operating procedures (SOPs): The “Draft Health Care Operations: Limited Exchange Purpose Implementation SOP” and the “Draft Payment: Risk Adjustment Exchange Purpose Implementation SOP.” Stakeholder feedback on these draft documents is due May 3, 2023. Draft Health Care Operations: Limited Exchange Purpose Implementation SOP Draft Payment: Risk Adjustment Exchange Purpose Implementation SOP
  • On April 6, ONC published a blog on physician access to state Prescription Drug Monitoring Program (PDMP) data and how physician participation in interstate data sharing remains limited. Blog
Mental Health and Substance Use Disorder Policy –
  • On April 3, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced a notice of funding opportunity (NOFO) for the Strategic Prevention Framework. The program aims to reduce the onset and progression of substance misuse and its related problems by supporting the development and delivery of community-based substance misuse prevention and mental health promotion services. Applications are due June 5, 2023. NOFO
  • Also on April 3, SAMHSA announced a NOFO for the Strategic Prevention Framework – Partnerships for Success for States. The program aims to promote substance use prevention throughout a state jurisdiction for individuals and families by building and expanding the capacity of local community prevention providers to implement evidence-based programs. Applications are due June 5, 2023. NOFO
  • On April 4, House Energy & Commerce Committee Chair Rodgers (R-WA) and Reps. Guthrie (R-KY) and Griffith (R-VA) sent a letter to HHS, requesting information related to SAMHSA COVID-19 supplemental funding, its implementation of the 9-8-8 suicide hotline, to what extent it provides support for treatment for serious mental illness, and its new Office of Recovery. Press Release Letter
  • On April 5, the FDA issued a notice with a RFI to all manufacturers of opioid analgesics used in outpatient settings, outlining requirements to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. FDA requests information on whether in-home disposal products can be expected to mitigate the risk of nonmedical use or overdose if drug manufacturers were required to make in-home disposal products available. Comments are due August 28, 2023. Notice Press Release
  • Also on April 5, the Agency for Healthcare Research and Quality (AHRQ) requested supplemental evidence and data submissions on psychosocial and pharmacologic interventions for disruptive behavior in children and adolescents. Submissions are due by May 8, 2023. Notice
  • Also on April 5, SAMHSA released a notice of intent to award supplemental funding for recipients of the Prevention Technology Transfer Centers (PTTCs) Cooperative Agreements. The supplemental funding will extend the project period by one-year. Notice
  • Also on April 5, SAMHSA released a notice of intent to award supplemental funding for recipients of the Addiction Technology Transfer Centers (ATTC) Cooperative Agreements. The supplemental funding will extend the project period by one-year. Notice
  • Also on April 5, SAMHSA released a notice of intent to award supplemental funding to recipients of the Mental Health Technology Transfer Centers (MHTTCs) Cooperative Agreements. The supplemental funding extends the project period by one-year. Notice
  • Also on April 5, Rep. Harder (D-CA) sent a letter to Drug Enforcement Agency (DEA) Administrator Milgram requesting resources to address the spread of xylazine. Letter Press Release
  • On April 6, SAMHSA announced a notice of information collection for the National Survey on Drug Use and Health (NSDUH). NSDUH data helps to identify the extent of substance use and mental illness among different subgroups, estimate trends over time, and determine the need for treatment services. Notice
  • On April 7, SAMHSA announced a SAMHSA Emergency Response Grant (SERG) funding to Pennsylvania to support community wellness and resilience following the freight train derailment and related chemical spill in East Palestine, Ohio. Announcement
Prescription Drugs, Medical Devices, & Biomedical Research & Health Innovation–
  • On April 3, the Federal Trade Commission (FTC) issued an Opinion and Order requiring DNA sequencing provider, Illumina, Inc., to divest GRAIL, Inc., which makes a multi-cancer early detection test, finding that the deal would stifle competition and innovation in the market for life-saving cancer tests. Press Release FTC Opinion FTC Final Order
  • Also on April 3, the FDA published an article on pharmacodynamic biomarkers and their role in biosimilar product development. Article 
  • On April 5, the FDA announced the availability of draft guidance entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” This draft guidance describes how stakeholders can collect and submit patient experience data to be used for medical product development and regulatory decision-making. Notice Draft Guidance
  • Also on April 5, CDC and HHS announced the opening of a docket to obtain comment on the proposed Laboratory Recommendations for Syphilis Testing in the United States. Notice
  • Also on April 5, the National Institutes of Health (NIH) released a RFI entitled, “Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials (DCTs).” NIH is seeking comment on how DCTs may be designed to be more effective, efficient, and equitable, including ways to enable participants from diverse backgrounds and underserved communities. Comments are due May 12, 2023. RFI
Veterans Health and Military Health –
  • On April 3, the Department of Veterans Affairs (VA) announced that eligible American Indian and Alaska Native Veterans are no longer required to make copayments for health care and urgent care received through the VA. Press Release 
  • On April 4, the Government Accountability Office (GAO) released a report on actions the Coast Guard can take to ensure its active duty personnel and their families have access to health care. GAO recommended that the Coast Guard and Defense Health Agency (DHA) agree to share access data and that the Coast Guard monitor access to TRICARE for beneficiaries. Report in Brief Report
  • Also on April 4, the Department of Defense (DoD) issued a final rule amending TRICARE reimbursement of ambulatory surgery centers and outpatient services provided in Cancer and Children’s Hospitals. Notice Final Rule
  • On April 6, the VA OIG released a report on an audit that was conducted to determine if the Veterans Health Administration (VHA) provided oversight of the installation and deployment of its high-frequency radio network to ensure communication capabilities during crises. The VA OIG substantiated that the network was not functioning as intended. Report in Brief Report
  • Also on April 6, House Committee on Veterans’ Affairs Chair Bost (R-IL) and Rep. Rosendale (R-MT) issued a joint statement in response to the announcement from the VA that it will continue a pause on future deployments of the Oracle Cerner electronic health record system. Press Release
  • On April 7, the VA announced it reached a tentative agreement with the American Federation of Government Employees (AFGE) on a master bargaining agreement to help the VA continue hiring staff and delivering care and benefits to veterans. The union represents more than 291,000 VA employees. Press Release
Population Health, Public Health & Health Equity –
  • On April 3, HHS released a National Cancer Plan, providing a framework to collaborate in ending cancer and to realize the vision laid out by the Cancer Moonshot. Plan Press Release
  • On April 4, the U.S. Department of Agriculture (USDA) Food and Nutrition Service released a notice soliciting comments on a study that will examine coordination between the Supplemental Nutrition Assistance Program (SNAP) and Medicaid in up to five states. Comments are due by June 5, 2023. Notice
  • On April 5, HHS released a notice requesting nominations for the Advisory Council on Alzheimer’s Research. HHS is soliciting nominations for six new non-federal members to serve a four-year term, replacing members whose terms will end September 30, 2023. Notice
  • Also on April 5, HHS released a notice seeking nominations for membership on the Advisory Committee on Blood and Tissue Safety and Availability. Members are invited to serve on the Committee for up to four-year terms. Nominations are due by May 5, 2023. Notice
  • Also on April 5, FDA released a blog, “FDA Actions are Reducing Exposure to Contaminants in Our Most Vulnerable Populations,” outlining FDA’s work to help safeguard the food supply by evaluating the use of chemicals as food ingredients. Blog
  • On April 6, FDA released a notice announcing it is reopening the comment period for the draft guidance entitled “Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry.” Comments are due by May 8, 2023. Notice
  • On April 7, CDC released a notice soliciting comments on a project, “Focus groups among adults with or caring for individuals with congenital heart defects, muscular dystrophy, and spina bifida.” Comments are due June 6, 2023. Notice
  • Also on April 7, the Health Resources and Services Administration (HRSA) released a notice soliciting comments on proposed revisions to information collected from the Ryan White HIV/AIDS Program (RWHAP) participants. Comments are due May 10, 2023. Notice
  • Also on April 7, the Office of Management and Budget (OMB) released a notice announcing that the public comment period for the “Initial Proposals for Updating OMB’s Race and Ethnicity Statistical Standards” has been extended and will remain open until April 27, 2023. Notice
Health Systems & Health Care Workforce –
  • On April 4, CMS Chief Medical Officer Dr. Lee Fleisher published an article on patient safety and quality in the New England Journal of Medicine. The article outlines the current state of patient safety and shares CMS’ perspective on how to support and drive the nation’s health care system toward improved safety for patients. Article
  • On April 5, HRSA released a notice soliciting comments on proposed revisions to the Interest Capture Form for the National Health Service Corps (NHSC) and the Nurse Corps Scholarship and Loan Repayment Programs. Comments are due by May 5, 2023. Notice
Reproductive, Maternal, & Infant Health  –
  • On April 3, House Energy & Commerce Committee Ranking Member Pallone (D-NJ), House Education & the Workforce Committee Ranking Member Scott (D-VA), and House Ways & Means Committee Ranking Member Neal (D-MA) submitted comments to the Departments of HHS, Labor, and Treasury in support of the proposed rules to ensure access to no-cost coverage for contraceptive services under the ACA. Press Release Letter
  • Also on April 3, House Education & the Workforce Committee Chair Foxx (R-NC) and Rep. Good (R-VA) sent a comment letter to the Departments of HHS, Labor, and Treasury in opposition to the proposed rules to ensure access to no-cost coverage for contraceptive services under the ACA. Press Release Letter
  • On April 4, SAMHSA released a notice soliciting nominations for the Advisory Committee for Women’s Services. Nominations are due by April 10, 2023. Notice
  • On April 6, FDA released a notice extending the comment period for draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.” Comments are due by May 15, 2023. Notice
  • Also on April 6, FDA announced the final decision to withdraw approval of Makena, an accelerated approval pathway drug that was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Press Release
  • On April 7, HRSA released a notice for public comment on its Rural Maternity and Obstetrics Management Strategies (RMOMS) Program. Comments are due June 6, 2023. Notice
  • Also on April 7, the Administration for Children and Families (ACF) released a notice requesting comments on proposed revisions to the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Tribal Home Visiting Program Data Reports. Comments are due June 9, 2023. Notice
  • Also on April 7, CDC released a notice for comment on a proposed information collection project titled “The National Survey of Family Growth (NSFG),” designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive health. Notice
  • Also on April 7, U.S. District Judge Matthew Kacsmaryk, who presided over the Alliance for Hippocratic Medicine vs. FDA case, suspended the FDA’s approval of mifepristone. Ruling
  • Also on April 7, the Biden Administration appealed the 5th Circuit Court ruling of Judge Matthew Kacsmaryk against the FDA’s approval of mifepristone. White House Statement Appeal
Misc. –

  • On April 3, NIH published a study identifying rare genetic variants that could point to one of the general mechanisms driving age-related macular degeneration (AMD), a common cause of vision loss in older adults. Press Release
  • On April 4, the White House released a new resource, “Guidebook to the Inflation Reduction Act’s Clean Energy and Climate Investments in Indian Country,” which provides clear descriptions of the law’s tax incentives and funding programs for which Tribes are eligible. Press Release Guidebook
  • On April 6, the White House released an Executive Order on Modernizing Regulatory Review, which seeks to improve the effectiveness of the regulatory review process; establish inclusive regulatory policy and public participation; and improve regulatory analysis. Executive Order
  • On April 7, the FDA issued a notice seeking comments on the collection of information which allows the submission of individual generic requests for obtaining qualitative data to support social and behavioral research for food, dietary supplements, cosmetics, and animal food and feed. Notice
  • Also on April 7, OMB released a notice requesting nominations of experts to peer-review draft guidance on conducting analyses of federal regulations. Nominations are due by April 28, 2023. Notice

Legislative Activity –

Votes and Committee Activity –

  • On April 6, the President vetoed H.J. Res. 27, a resolution that would disapprove the revised definition of “Waters of the United States”. The definition sets rules for protecting water quality and public health. The President vetoed the resolution because the revised definition was not clear. Press Release H.J.Res.27
Introduced Legislation –
  • On April 3, Reps. Ruiz (D-CA), Bucshon (R-IN), Bera (D-CA), and Miller-Meeks (R-IA) introduced the Strengthening Medicare for Patients and Providers Act (H.R. 2474), which would provide for an update to a single conversion factor under the Medicare physician fee schedule that is based on the Medicare economic index. Bill text Press release
  • Also on April 3, Rep. Weber (R-TX) introduced the Securing Our Schools Act (H.R. 2479), which would provide for safe schools and safe communities. Bill text Press release
  • On April 6, Reps. Buchanan (R-FL), Scott (D-VA), Kiggans (R-VA), and Pettersen (D-CO) introduced the Treating Invisible Wounds on Base Act (H.R. 2482), which would conduct a study on the accessibility of mental health care providers and services for members of the Armed Forces serving on active duty. Press release
  • Also on April 6, Rep. Kim (D-NJ) introduced the Protecting Americans from Unsafe Drugs Act (H.R. 2500), which would expand certain authorities with respect to the recall of controlled substances to apply with respect to all drugs. Press release
  • Also on April 6, Reps. Spanberger (D-VA) and Johnson (R-SD) introduced the Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act (H.R. 2534), which would ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program. Bill text Press release