What’s Ahead: This Week

Hearings and Markups –

  • Tuesday, April 18
    • House Energy & Commerce Committee, Innovation, Data, and Commerce Subcommittee, “Hearing on the Fiscal Year 2024 Federal Trade Commission Budget.” Additional information
    • House Energy & Commerce Committee, Oversight and Investigations Subcommittee, “Insights from the HHS Inspector General on Oversight of Unaccompanied Minors, Grant Management, and the Centers for Medicare and Medicaid Services (CMS).” Additional information
    • House Veterans’ Affairs Committee, Health Subcommittee, “Combatting a Crisis: Providing Veterans Access to Life-saving Substance Abuse Disorder Treatment.” Additional information
    • House Veterans’ Affairs Committee, Health Subcommittee, “Markup of Pending Health Legislation.” Additional information
  • Wednesday, April 19
    • House Appropriations Committee, Labor, HHS, Education, and Related Agencies Subcommittee, “Budget & Oversight Hearing: FY2024 Request for the Centers for Disease Control and Prevention (CDC), Administration for Strategic Preparedness and Response (ASPR), and National Institutes of Health (NIH).” Additional information
    • House Energy & Commerce Committee, Health Subcommittee, “Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care.” Additional information
    • House Energy & Commerce Committee, Oversight and Investigations Subcommittee, “Who is Selling Your Data: A Critical Examination of the Role of Data Brokers in the Digital Economy.” Additional information
    • House Committee on Oversight and Accountability, Subcommittee on Cybersecurity, Information Technology, and Government Innovation, “Data Breach at the D.C. Health Exchange.” Additional information
    • Senate Committee on Agriculture, Nutrition, and Forestry, Subcommittee on Food and Nutrition, Specialty Crops, Organics, and Research, “SNAP and Other Nutrition Assistance in the Farm Bill.” Additional information

Notable Policy Events –

  • Monday, April 17 to Friday, April 21
  • Monday, April 17
    • HHS Center for Faith-Based and Neighborhood Partnerships, “Black Maternal Health Outcomes Matter: Keeping Hope Alive!”
  • Tuesday, April 18
    • Moving Health Home, “In-Person Congressional Briefing: The Future of the Care in the Home.” Additional information
    • Bipartisan Policy Center, “Obesity in the US: Increasing Access to Treatment.” Additional information
    • Brookings Institution, “The Economic Impact of the Opioid Epidemic: Labor Supply and the Workplace.” Additional information
    • Urban Institute, “Prison Research Meets Practice: A Conversation on Correctional Staff Wellness.” Additional information
  • Wednesday, April 19
    • Duke Margolis Center for Health Policy, “The Next Generation of Risk Adjustment: Policy Opportunities to Advance Reform.” Additional information
  • Thursday, April 20
  • Friday, April 21
    • Bipartisan Policy Center, “State of U.S. Mental Health Featuring Dr. Jerome Adams.” Additional information

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

Medicare & Medicaid –

  • On April 10, CMS issued a proposed rule for the calendar year (CY) 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) and long-term care hospital prospective payment system (LTCH PPS), which makes payment and policy updates for inpatient hospitals and LTCHs participating in Medicare. CMS projects a 2.8 percent increase in operating payment rates for general acute care hospitals paid under the IPPS. Fact Sheet Press Release Proposed Rule
  • Also on April 10, HHS released a report on state-level estimates of the share of Medicaid beneficiaries who are currently working. The intersection between Medicaid and employment has implications for the end of the pandemic-related Medicaid continuous enrollment provision. Report State-Level Estimates
  • On April 11, CMS issued a notice with proposed revisions to the Healthcare Common Procedure Coding System Level II code set. The notice also announced the extension of the exception to the Medicare beneficiary signature requirement for emergency and nonemergency ambulance transport services when the beneficiary is incapable. Comments are due May 11, 2023. Notice
  • On April 12, House Committee on Oversight and Accountability Chair Comer (R-KY) requested that the Government Accountability Office (GAO) Comptroller Dodaro initiate a review of the improper payments in the Medicaid program. Press Release Letter
  • Also on April 12, CMS announced that Arizona requested to amend its Section 1115 demonstration to allow the state to annually renew Medicaid eligibility for individuals who were in the state’s foster care system between ages 18 to 26. The federal public comment period is open from April 12 through May 12, 2023. Application Comments
  • Also on April 12, the HHS Office of Inspector General (OIG) released a report which found that CMS did not accurately report one or more deficiencies related to health, fire safety, and emergency preparedness on Care Compare for an estimated two-thirds of nursing homes. Report in Brief Report
  • Also on April 12, CMS released updated information on telehealth use by Medicare fee-for-service (FFS) beneficiaries. Report
  • On April 13, CMS released the 2023 Medicaid and CHIP Beneficiary Profile and Infographic, which provides an overview of the enrollment, expenditures, characteristics, health status, and experience of beneficiaries. Infographic
  • On April 14, CMS released a notice announcing the final Federal share of disproportionate share hospital (DSH) allotments for fiscal year (FY) 2020 and FY 2021, and the preliminary DSH allotments for FY 2022 and FY 2023. Notice
  • Also on April 14, CMS released a notice acknowledging the receipt of an application from the Accreditation Commission for Healthcare for continued recognition as a national accrediting organization for hospitals participating in Medicare or Medicaid. Comments are due May 14, 2023. Notice

Marketplaces & Health Care Coverage –

  • On April 13, House and Senate Health Committee leaders wrote to 12 insurers and trade associations requesting information regarding how they plan to respond to the Braidwood Management Inc. v. Becerra ruling, which struck down the provision of the ACA that requires health plans to cover preventive services with no cost sharing for beneficiaries. Press Release Letter
  • Also on April 13, the White House announced plans to extend health coverage to Deferred Action for Childhood Arrivals (DACA) recipients through a forthcoming CMS proposed rule which would amend the definition of “lawful presence,” for purposes of Medicaid and ACA coverage, to include DACA recipients. White House Fact Sheet HHS Statement What They Are Saying
  • Also on April 13, the Departments of Labor (DOL), HHS, and the Treasury, along with the Office of Personnel Management, released updated Frequently Asked Questions that seek to clarify the impact of the recent court decision in Braidwood Management Inc. v. Becerra on private health insurance coverage of preventive services. FAQs

Payment & Delivery System Models –

  • On April 12, CMS announced that Washington’s Savings Report for the Medicaid-Medicare Financial Alignment Initiative was available. In demonstration year six, total Medicare savings were $54.3 million. Preliminary total Medicare savings in demonstration year seven were calculated as $34.1 million. Savings Report

Public Health Preparedness, Surveillance & Data –

  • COVID-19 Data: To date, there are 104,348,746 total COVID-19 cases and 1,128,404 COVID-19 deaths in the United States. Also, 976,711,975 COVID-19 vaccines have been delivered and 674,711,945 individual COVID-19 vaccine doses have been administered. Data
  • FDA Action Update: To date, FDA has authorized 452 tests under Emergency Use Authorizations (EUAs), including 307 molecular tests, 84 antibody tests and 61 antigen tests. FDA also continues to update COVID-19 FAQs.
  • On April 11, HHS posted a new funding opportunity to multidisciplinary clinics that care for people with Long COVID to expand access to comprehensive, coordinated, and person-centered care, particularly for underserved, rural, vulnerable, or minority populations that are disproportionately impacted. The letter of intent is due May 5, and applications are due by June 12, 2023. Press Release Funding Announcement
  • Also on April 11, House Committee on Oversight and Accountability Chair Comer (R-KY) and Rep. Langworthy (R-NY) sent a letter to HHS launching an investigation following reports indicating HHS misallocated COVID-19 relief funds intended to help low-income hospitals. Press Release Letter
  • On April 14, HHS Secretary Becerra announced that he will issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19 in the coming weeks. HHS Secretary Becerra sent a letter to U.S. Governors on the intention to amend the PREP Act declaration to extend certain important protections. Press Release Letter
  • Also on April 14, CDC updated its HHS Vaccination Operational Planning Guide to help jurisdictions and providers plan for a potential transition in guidance for COVID-19 vaccines. The guide addresses the impact of potentially having the bivalent mRNA COVID-19 vaccines authorized (by FDA) and recommended (by CDC) as primary doses in the COVID-19 vaccination series. Guidance

Health IT, Privacy, & Digital Health –

  • On April 8, Office of the National Coordinator for Health IT (ONC) officials released a report in JAMA finding that over 40 percent of hospitals observed practices they perceived to constitute information blocking in 2021. Study
  • On April 11, ONC issued a proposed rule titled, “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1). The rule would implement certain provisions of the 21st Century Cures Act and includes proposals on the movement of health information electronically, new data standards that help ensure information can be understood when it enters and leaves a system, electronic case reporting that supports public health and emergency response, and algorithm transparency. Comments are due by June 20, 2023. Proposed Rule Information Page Press Release General Overview Fact Sheet At-a-Glance Fact Sheet ONC Blog Post
  • Also on April 11, the HHS Office for Civil Rights (OCR) announced that the Notifications of Enforcement Discretion issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act during the COVID-19 public health emergency will expire at 11:59 pm on May 11, 2023, due to the expiration of the COVID-19 public health emergency. Press Release Notice
  • Also on April 11, CMS updated its Risk Adjustment and Telephone Services During COVID-19 FAQs. FAQs
  • Also on April 11, ONC released the Leading Edge Acceleration Projects (LEAP) in Health IT notice of funding opportunity (NOFO) to address well-documented and fast emerging challenges that inhibit the development, use, and/or advancement of well-designed, interoperable health IT. Applications are due by June 12, 2023. NOFO
  • On April 12, ONC published a blog on its recently released FAQs that address information on how ONC’s information blocking regulations and HHS’ OCR HIPAA Privacy, Security, and Breach Notification Rules (HIPAA Rules) interact with one another. Blog
  • Also on April 12, HHS OCR issued a proposed rule titled “HIPAA Privacy Rule to Support Reproductive Health Care Privacy.” The proposed rule would modify existing standards permitting uses and disclosures of protected health information (PHI) by limiting uses and disclosures of PHI for certain purposes where the use or disclosure of information is about reproductive health care that is lawful under the circumstances in which such health care is provided. Comments are due by June 16, 2023. Proposed Rule Press Release Fact Sheet
  • On April 13, ONC published a blog on current and potential uses of predictive models and machine learning algorithms in health care and how ONC’s understanding of this landscape connects with ONC’s HTI-1 proposed rule. Blog
  • Also on April 13, CDC announced the 2022 Data Modernization Initiative (DMI) Snapshot that details the accomplishments of the DMI in 2022 and includes a suite of materials that showcase DMI’s progress. 2022 DMI Snapshot Overview of Data Modernization Visual Booklet

Mental Health and Substance Use Disorder Policy –

  • On April 10, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a NOFO for the Behavioral Health Partnership for Early Diversion of Adults and Youth program. The program aims to establish or expand programs that divert adults and youth with a mental illness or a co-occurring disorder (COD) from the criminal or juvenile justice system to community-based mental health and substance use disorder services (SUD) and other supports prior to arrest and booking. Applications are due June 9, 2023. NOFO
  • On April 11, SAMHSA requested public comments on the agency’s draft 2023-2026 Strategic Plan. The four-year plan presents a new person-centered mission and vision highlighting key guiding principles and presenting five key priorities and their associated goals and objectives. Comments are due April 27, 2023. Press Release Strategic Plan Comment Form
  • On April 13, the Health Resources and Services Administration (HRSA) released the funding applications for the FY 2023 Rural Communities Opioid Response Program Child and Adolescent Behavioral Health (RCORP-CABH). Applications are due May 24, 2023. Funding Information

Prescription Drugs, Medical Devices, Biomedical Research, & Health Innovation   –

  • On April 12, FDA announced the availability of a final guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers.” This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. Notice
  • Also on April 12, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA), House Ways & Means Committee Chair Smith (R-MO), and Senate Finance Committee Ranking Member Crapo (R-ID) sent a letter to HHS Secretary Becerra and CMS Administrator Brooks-LaSure raising concerns with the Biden Administration’s initial drug price-setting program implementation guidance. Press Release Letter

Veterans Health and Military Health  –

  • On April 10, House Committee on Veterans’ Affairs Chair Bost (R-IL) and Rep. Obernolte (R-CA) sent a letter to Department of Veterans Affairs (VA) Secretary McDonough requesting answers on a situation at the Loma Linda VA Medical Center where a supervisory employee continues to be employed despite creating a hostile work environment. Press Release Letter
  • On April 11, VA OIG released a report that found the Audie L. Murphy Memorial Veterans’ Hospital in San Antonio, Texas acquired more ventilators from March 1, 2020, through November 30, 2021 than were needed for veteran care. Report in Brief Report
  • On April 12, VA OIG released a report that summarizes OIG reviews of non-pharmaceutical proposals conducted during FY 2021. The VA OIG found that commercial sales practices disclosures were accurate, complete, and current for nine of the 26 proposals. Report in Brief Report

Population Health, Public Health & Health Equity –

  • On April 11, CDC released a report finding that reported cases of the sexually transmitted infections (STIs) chlamydia, gonorrhea, and syphilis all increased between 2020 and 2021 – reaching a total of more than 2.5 million reported cases. Press Release Surveillance Data
  • On April 12, the U.S. Department of Agriculture (USDA) Food and Nutrition Service released a notice on proposed information collection from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program participants. Comments close June 12, 2023. Notice
  • Also on April 12, FDA Commissioner Califf released a blog announcing that FDA is working to combat the epidemic of diet-related chronic disease through nutrition efforts. Blog
  • Also on April 12, HHS announced the release of $375 million in Community Services Block Grant (CSBG) funding to help reduce poverty through community-based programming by creating opportunities for health and wellness that would not be available otherwise. Press Release
  • On April 14, NIH released a notice requesting public comment on its draft strategic plan for fiscal years 2024–2028, “Prevention Research: Creating a Healthier Future for All.” Responses are due by May 22, 2023. Notice
  • Also on April 14, CDC released a notice requesting nominations to the Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. Nominations are due by October 1, 2023. Notice
  • Also on April 14, CDC released a notice requesting nominations to the Advisory Council for the Elimination of Tuberculosis. Nominations are due by August 31, 2023. Notice

Health Systems & Health Care Workforce –

  • On April 14, HRSA released a notice on an evaluation of the Nurse Corps Loan Repayment Program (LRP) and Scholarship Program (SP). Comments are due by June 13, 2023. Notice

Reproductive & Maternal Health –

  • On April 10, President Biden proclaimed April 11-17 as Black Maternal Health Week. Proclamation
  • Also on April 10, House Energy & Commerce Committee Chair McMorris Rodgers (R-WA) and Subcommittee on Health Chair Guthrie (R-KY) issued a statement regarding two federal court rulings on the abortion pill mifepristone, stating that the FDA’s job is to ensure safety and maintain this directive while the courts review the cases. Press Release
  • On April 12, the White House released fact sheets on the work the Administration has done, and is planning to do, in protecting access to medication abortion. Fact Sheet on Administration’s Record Fact Sheet on Administration’s Plans
  • Also on April 12, House Energy & Commerce Committee Democrats sent a letter to Chair McMorris Rodgers (R-WA) and Health Subcommittee Chair Guthrie (R-KY) requesting an immediate hearing on the decision in Alliance for Hippocratic Medicine v. FDA staying the approval of mifepristone. Press Release Letter
  • On April 13, Vice President Harris gave remarks at the Interagency Task Force on Reproductive Healthcare Access to discuss the work that the Administration has done and will continue to do in support of reproductive rights. The Vice President also provided a statement on the Fifth Circuit’s decision regarding mifepristone. Press Release Statement
  • On April 14, 253 Members of Congress submitted an amicus brief to the U.S. Supreme Court in the case of Alliance for Hippocratic Medicine v. FDA, in support of the Biden Administration’s appeal of a federal district court ruling that suspends the FDA’s approval of mifepristone as well as the decision by the Court of Appeals for the Fifth Circuit which significantly restricts access to the drug nationwide and ultimately overrides FDA’s scientific judgement. Press Release Supreme Court Amicus Brief Fifth Circuit Amicus Brief
  • Also on April 14, the Department of Justice (DOJ) requested a stay seeking emergency relief from the U.S. Supreme Court in the Court of Appeals for the Fifth Circuit case involving limited access to mifepristone. Application to Stay the Order
  • Also on April 14, Supreme Court Justice Alito temporarily froze the lower court’s ruling that would restrict access to mifepristone, preserving the status quo for the next five days. Order

Misc. –

  • On April 10, Senate Special Committee on Aging Ranking Member Braun (R-IN) sent a letter to Senate Budget Committee Chair Whitehouse (D-RI) and Ranking Member Grassley (R-IA) detailing his priorities for the budget, including protecting Medicare and Social Security, reducing the deficit, and balancing the budget. Press Release Letter
  • On April 12, the Biden Administration announced new proposed vehicle pollution standards to protect public health, save consumers money, and increase energy security. Press Release
  • On April 14, HHS released a notice requesting a three-year extension of the Federalwide Assurance (FWA) Form, which provides a simplified procedure for institutions engaged in research conducted or supported by HHS. Comments are due June 13, 2023. Notice

Legislative Activity –

Votes and Committee Activity –

  • On April 10, the President signed H.J. Res. 7 into law, which terminates the national emergency related to the COVID-19 pandemic declared by the President on March 13, 2020. Bill text Press release

Introduced Legislation

  • On April 10, Reps. Bucshon (R-IN) and Kelly (D-IL) introduced the Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544), which would improve the Organ Procurement and Transplantation Network. Press release
  • Also on April 10, Reps. Cole (R-OK) and Ruiz (D-CA) introduced legislation (H.R. 2547), which would extend funding for special diabetes programs for Indians. Press release
  • Also on April 10, Reps. DeGette (D-CO) and Bilirakis (R-FL) introduced legislation (H.R. 2550), which would extend funding for Special Diabetes Programs for Type I diabetes. Bill text Press release
  • Also on April 10, Reps. Joyce (R-PA), Blunt Rochester (D-DE), Stefanik (R-NY), and Fletcher (D-TX) introduced the Strengthening Community Care Act of 2023 (H.R. 2559), which would extend funding for community health centers and the National Health Service Corps. Press release
  • Also on April 10, Reps. Pallone (D-NJ), Vasquez (D-NM), and Ruiz (D-CA) introduced the Doctors of Community (DOC) Act (H.R. 2569), which would reauthorize the program of payments to teaching health centers that operate graduate medical education programs. Bill text Press release
  • Also on April 10, Reps. Pfluger (R-TX) and Hudson (R-NC) introduced the Safeguarding Women’s and Children’s Health Act (H.R. 2570), which would require more accurate reporting of abortion drug prescribing and related adverse events. Press release
  • Also on April 10, Rep. Ryan (D-NY) and 39 cosponsors introduced the Protecting Reproductive Freedom Act (H.R. 2573), which would express the Sense of Congress with respect to Federal preemption of State restrictions on dispensing medication abortion. Press release
  • Also on April 10, Reps. Wild (D-PA), Thompson (R-PA), and Del. Norton (D-DC) introduced the EMS Counts Act (H.R. 2574), which would revise the Standard Occupational Classification System to accurately count the number of emergency medical services practitioners in the United States. Bill text Press release One pager
  • On April 13, Reps. Thompson (D-MS) and Garbarino (R-NY) introduced the DHS Suicide Prevention and Resiliency for Law Enforcement Act (H.R. 2577), which would establish the Law Enforcement Mental Health and Wellness Program. Press release
  • Also on April 13, Reps. Blunt Rochester (D-DE) and Smith (R-NE) introduced the Increasing Access to Quality Cardiac Rehabilitation Act of 2023 (H.R. 2583), which would expand and expedite access to cardiac rehabilitation programs and pulmonary rehabilitation programs under the Medicare program. Press release
  • Also on April 13, Reps. Langworthy (R-NY), Tenney (R-NY), and Williams (R-NY) introduced the Protect Local Taxpayers Act (H.R. 2600), which would ensure the equitable treatment of political subdivisions contributing to State expenditures under the Medicaid program. Bill text Press release
  • Also on April 13, Reps. Wenstrup (R-OH), Ruiz (D-CA), Miller-Meeks (R-IA), McBath (D-GA), Chavez-DeRemer (R-OR), and Blumenauer (D-OR) introduced the Safe Step Act (H.R. 2630), which would require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol. Bill text Press release