Health Care Week In Review: CMS and HHS Issue Proposed Rules

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Week in Review Highlight of the Week:

This week, CMS issued its annual Inpatient Prospective Payment System (IPPS) proposed rule and HHS issued proposed rules that would implement health IT provisions and increase HIPAA protections for reproductive care. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On April 10, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Proposed Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership. This proposed rule would: revise the Medicare hospital Inpatient Prospective Payment Systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy-related changes.
• On April 11, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, A Risk-Based Approach to Monitoring of Clinical Investigations--Questions and Answers; Guidance for Industry; Availability. This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on previous guidance for industry by providing additional information to facilitate sponsors’ implementation of risk-based monitoring.
• On April 11, 2023, FDA issued a notice entitled, Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program. FDA’s Center for Devices and Radiological Health (CDRH) announced its Radiation Sterilization Master File Pilot Program (Radiation Pilot Program). The Radiation Pilot Program is voluntary and intends to allow companies that terminally sterilize single-use medical devices (sterilization providers) using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, methods, or processes under the specific conditions outlined in this notice. Under this voluntary pilot program, manufacturers of class III devices subject to premarket approval (PMA holders) who have been granted a right of reference by a sterilization provider may, upon notification from FDA, include references to Master File(s) accepted into the Radiation Pilot Program in post-approval reports. These references may describe the particular changes noted above affecting the sterilization sites, methods, or processes of their class III devices, in lieu of submitting premarket approval application (PMA) supplements for such changes. By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices. Additionally, through evaluation of data from pilot participants, the Radiation Pilot Program seeks to provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts and facilitate supply chain resiliency.
• On April 11, 2023, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. This proposed rule would implement the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program (Program). This proposed rule would also make several updates to certification criteria and implementation specifications recognized by the Program, including a revised certification criterion for decision support and revised certification criteria for patient demographics and observations and electronic case reporting. This proposed rule would establish a new baseline version of the United States Core Data for Interoperability (USCDI). Additionally, this proposed rule would provide enhancements to support information sharing under the information blocking regulations. These provisions intend to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information (EHI). The proposed rule would also update the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.
• On April 12, 2023, FDA issued a request for information (RFI) entitled, Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments. FDA announced an RFI on the development of an FDA Data and Technology Strategic Plan. As part of FDA’s User Fee Program commitments and other federal requirements, the Agency will develop and publish an FDA Data and Technology Strategic Plan by September 30, 2023. This plan will define and shape the future course of FDA’s data and technology capabilities, building on the existing FDA Modernization Framework. This plan will also integrate Agency and center strategies.
• On April 12, 2023, FDA issued a notice entitled, Exemption of Certain Categories of Biological Products from Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act. FDA is issuing a final order to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. However, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. This final order exempts two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health. The two categories are: (1) blood and blood components for transfusion; and (2) cell and gene therapy products, where one lot treats a single patient.
• On April 12, 2023, the Drug Enforcement Agency (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I. DEA is proposing to place nine substances in schedule I of the Controlled Substances Act (CSA). These nine substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. This temporary order was subsequently extended multiple times, most recently on December 29, 2022, through the Consolidated Appropriations Act, 2023 (CAA, 2023), which extended the order until December 31, 2024. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these nine specific controlled substances.
• On April 12, 2023, the HHS Office for Civil Rights (OCR) issued a proposed rule entitled, HIPAA Privacy Rule to Support Reproductive Health Care Privacy. HHS is issuing this notice of proposed rulemaking (NPRM) to solicit comment on its proposal to modify the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The proposal 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. The proposal would modify existing standards by prohibiting uses and disclosures of PHI for criminal, civil, or administrative investigations or proceedings against individuals, covered entities or their business associates (collectively, “regulated entities”), or other persons for seeking, obtaining, providing, or facilitating reproductive health care that is lawful under the circumstances in which it is provided.
• On April 14, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. CDC and the Health Resources and Services Administration (HRSA) are seeking nominations for membership on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). CHAC consists of 18 experts who advise CDC and HRSA officials on issues related to HIV, viral hepatitis, and sexually transmitted disease (STD) prevention. Nominations for membership on CHAC must be received no later than October 1, 2023.
• On April 14, 2023, CDC issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis. CDC is seeking nominations for membership on the Advisory Council for the Elimination of Tuberculosis (ACET). ACET consists of 10 experts including the Chair in fields associated with public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, and preventive health care delivery. The Advisory Council for the Elimination of Tuberculosis (ACET) provides advice and recommendations regarding the elimination of tuberculosis (TB) to CDC and HHS. Nominations for membership on ACET must be received no later than August 31, 2023.
• On April 14, 2023, the National Institutes of Health (NIH) issued an RFI entitled, Request for Information (RFI): Inviting Feedback on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2024–2028. NIH’s Office of Disease Prevention (ODP) is requesting public comment on its draft strategic plan for Fiscal Years 2024–2028 (FY24–28) entitled, Prevention Research: Creating a Healthier Future for All. ODP invites feedback on its proposed priorities from prevention researchers in academia and industry, health care providers, patient advocacy organizations, community-based organizations (CBOs), health service organizations, scientific or professional organizations, trainees and early-stage investigators, federal agencies, those employed by NIH or at institutions receiving NIH support, and the general public.

Event Notices

• April 19, 2023: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines. No recommendation votes are scheduled.
• May 2-3, 2023: CMS announced a public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage; consumer protection and enforcement authorities of the Departments of Labor (DOL), HHS, and the Treasury Department, as well as states; and the prevention of balance billing to consumers. The recommendations shall address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by state legislatures, state insurance regulators, state attorneys general, and other state officials as appropriate, consistent with current legal authorities regarding consumer protection; and legislative options for Congress to prevent balance billing. This notice also updates the GAPB Advisory Committee membership roster.
• May 3, 2023: HHS announced a stakeholder listening session in preparation for the 76th World Health Assembly. The stakeholder listening session is designed to seek input from stakeholders and subject matter experts to help inform and prepare for U.S. government engagement with the World Health Assembly (WHA). The listening session will discuss resolutions and other decisions to be covered at the 76th World Health Assembly.
• May 4, 2023: HHS announced a public meeting of its Office of Global Affairs (OGA). HHS is charged with leading the U.S. delegation to the Group of 7 (G7) Health Ministers’ Meeting and will convene an informal stakeholder listening session. The G7 is an informal grouping of Canada, France, Germany, Italy, Japan, the U.S., and the United Kingdom, and it also includes participation by the European Commission. The stakeholder listening session is designed to seek input from stakeholders to help inform and prepare for U.S. government engagement in the G7 Health Ministers’ Meeting.
• May 10, 2023: HHS and the Department of Agriculture (USDA) announced a public meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). The agenda will include presentations by each subcommittee, deliberation by the full Committee regarding the prioritization of scientific questions, and initial draft protocol development and discussion of plans for future Committee work.
• May 11, 2023: NIH announced a public hearing of the NIH Office of the Director Council of Councils (the Council). The meeting agenda will include a call to order and introductions, announcements, NIH program updates, discussion of strategic plans, and other business of the Council.
• May 12, 2023: FDA announced a public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss the Biologics License Application (BLA) 125781 from Sarepta Therapeutics, Inc. for delandistrogene moxeparvovec with the requested indication for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
• May 18, 2023: FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee will discuss the biologics license application (BLA) 125768 from Pfizer, Inc. for ABRYSVO (Respiratory Syncytial Virus Vaccine) with the requested indication for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through six months of age by active immunization of pregnant individuals.
• May 18-19, 2023: NIH announced a public meeting of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM, a congressionally mandated committee, coordinates the development and validation of alternative testing strategies that protect human health and the environment while replacing, reducing, or refining animal use. The meeting will allow NIH to share information and facilitate direct communication of ideas and suggestions from stakeholders. Also, ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches.
• May 23, 2023: NIH announced a public meeting of the National Advisory Council on Minority Health and Health Disparities (NACMHD). The meeting agenda will include opening remarks, administrative matters, a Director’s report, presentations, and other NACMHD business.
• May 25, 2023: NIH announced a public meeting of the National Center for Advancing Translational Sciences Advisory Council (NCATSAC) The meeting agenda will include a report from the NCATS Director, discussion of the NCATS strategic plan, and other program updates.
• May 30-June 1, 2023: CMS announced a public meeting for new revisions to the Healthcare Common Procedure Coding System (HCPCS) coding system. The meeting is being held to discuss CMS’ preliminary coding, Medicare benefit categories, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and non-biological products, as well as how to register for those meetings.
• June 7-8, 2023: FDA announced a public workshop entitled, Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development. Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will include discussions of the Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development.
• June 8, 2023: FDA announced a public meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. The meeting will include presentations from FDA on: (1) the five-year plan for the Prescription Drug User Fee Act (PDUFA) VII, Biosimilar User Fee Act (BsUFA) III, and Generic Drug User Fee Amendments (GDUFA) III; and (2) the Agency’s progress in implementing resource capacity planning and modernized time reporting.
• June 9, 2023: HHS announced a public listening session on Amendments to the International Health Regulations (2005). HHS is charged with leading U.S. participation in the Working Group on the Amendments to the International Health Regulations (2005) and will convene a stakeholder listening session on June 9, 2023. The listening session is designed to seek input from stakeholders and subject-matter experts on these proposals and to help inform and prepare the U.S. government for engagement with the Working Group on the Amendments to the International Health Regulations (2005).
• June 9, 2023: FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss supplemental BLA 761269/s-001, for LEQEMBI (lecanemab) solution for intravenous infusion, submitted by Eisai, Inc., for the treatment of early Alzheimer’s disease. This product was approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) for the treatment of Alzheimer’s disease. Confirmatory studies are studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The committee will discuss the confirmatory study, BAN2401-G000-301, conducted to fulfill post-marketing requirement 4384-1.
• June 14, 2023: CDC announced a public meeting of the Advisory Board on Radiation and Worker Health (ABRWH). The agenda will include discussions on the following: work group and subcommittee reports; an update on the status of Special Exposure Cohort (SEC) petitions; and plans for the August 2023 ABRWH meeting.
• June 16, 2023: NIH announced a public meeting of the Clinical Center Research Hospital Board (CCRHB). The meeting agenda will include NIH and Clinical Center (CC) leadership announcements, updates on recent CC activities and organizational priorities, and other CCRHB business.
• June 22, 2023: CMS announced a public meeting regarding new and reconsidered clinical diagnostic laboratory test codes for the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2024. The purpose of the meeting is for CMS to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised HCPCS codes being considered for Medicare payment under the CLFS for CY 2024. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
• June 23, 2023: HHS announced a public meeting of OGA. The meeting is a stakeholder listening session for the Intergovernmental Negotiating Body (INB) to draft and negotiate a World Health Organization (WHO) convention, agreement, or other international instrument on pandemic prevention, preparedness, and response. The stakeholder listening session is designed to seek input from stakeholders and subject matter experts to help inform and prepare for U.S. government engagement with the INB.

II. Reports, Studies & Analyses

• On April 11, 2023, the Congressional Research Service (CRS) published an updated report entitled, Effects of Terminating the Coronavirus Disease 2019 (COVID-19) PHE and NEA Declarations. This report details the effects of terminating the COVID-19 public health emergency (PHE) and the National Emergencies Act (NEA) declaration. CRS stated that it may be difficult to determine the impact that the COVID-19 PHE declaration’s termination will have on a particular waiver, flexibility, program, or agency. For example, the authors note that some impacts on a waiver, flexibility, program, or agency may be specifically dependent on the PHE declaration, while other impacts may be dependent on other factors, such as funding availability, an agency’s interpretation of authority, or authority derived from concurrent emergency declarations. The report then provided an overview of how an NEA declaration permits the President to invoke standby authorities, such as the activation of Ready Reserve units. The report explained that terminating an NEA declaration discontinues the exercise of invoked powers and authorities, although there are exceptions in some cases.
• On April 12, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, CMS Did Not Accurately Report on Care Compare One or More Deficiencies Related to Health, Fire Safety, and Emergency Preparedness for an Estimated Two-Thirds of Nursing Homes. OIG conducted an audit to determine whether CMS accurately reported on Care Compare the deficiencies related to health, fire safety, and emergency preparedness that were identified during inspections of nursing homes. OIG found that for 67 of the 100 nursing homes that were sampled, CMS did not report on Care Compare one or more deficiencies that surveyors identified during yearly and complaint inspections. As a result of the review, OIG estimated that 10,303 nursing homes had one or more deficiencies identified during inspections that were not accurately reported on Care Compare. To address the problem, OIG recommended that CMS: (1) correctly report deficiencies identified in sampled nursing homes; and (2) strengthen its processes for reviewing inspection results reported on Care Compare.
• On April 13, 2023, the Congressional Budget Office (CBO) published a report entitled, Budgetary Effects of Policies to Modify or Eliminate Medicaid’s Institutions for Mental Diseases Exclusion. Under the institutions for mental diseases (IMD) exclusion, the federal government does not make matching payments to states for expenditures for services provided to Medicaid enrollees ages 21 to 64 who are in certain types of inpatient facilities. However, states do take advantage of exceptions within the IMD exclusion in order to secure federal funding. In the report, CBO estimates the budgetary impacts of the following two options related to the IMD exclusion: (1) permanently extending the State Plan Option (allows states to receive federal matching if they meet certain criteria) available under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); and (2) eliminating the IMD exclusion. In assessing both options, and variations of each option, CBO estimated that modifying or eliminating the IMB exclusion would increase federal outlays between $155 million and $38.4 billion between 2024 and 2033 depending on the option.
• On April 13, 2023, the Kaiser Family Foundation (KFF) published a report entitled, Medicaid Financing: The Basics. The report first provides an overview of the Medicaid program, noting that the program is administered with fairly flexible federal rules and is jointly funded by states and the federal government. The authors note that Medicaid represents $1 of every $6 spent on health care in the U.S. and is the major source of financing for states to provide health insurance coverage to low-income residents. The report also addresses the following: (1) how much Medicaid costs and how much is spent; (2) how Medicaid financing works; (3) how Medicaid relates to federal and state budgets; (4) how the COVID-19 pandemic has impacted Medicaid spending; and (5) key issues to monitor moving forward. For example, the authors explained that of the $728 billion spent on the Medicaid program in FY 2021, the federal government covered 69 percent of the costs and states covered the remaining 31 percent.

III. Other Health Policy News

• On April 11, 2023, HHS OCR announced that the Notifications of Enforcement Discretion released under HIPAA and the HITECH Act will end on May 11, 2023 concurrently with the expiration of the COVID-19 PHE. The four separate Notifications of Enforcement Discretion released during the COVID-19 PHE outlined how HIPAA Rules would be applied to various violations during the pandemic. For example, one of the Notifications of Enforcement Discretion was related to the utilization of telehealth technology by providers, with OCR deciding to use its enforcement discretion for providers utilizing telehealth in a good faith manner during the PHE. To ensure a smooth return to pre-PHE standards, OCR is providing a 90-calendar day transition period for covered health care providers to come into compliance with HIPAA Rules for the provision of telehealth specifically. More information on this announcement can be found here.
• On April 12, 2023, the Administration for Children and Families (ACF) announced the release of $375 million in Community Services Block Grant (CSBG) funding to help to reduce poverty through community-based programming. This funding is the third installment of CSBG funding for states, territories, and tribes in FY 2023, which brings the total CSBG funding released this fiscal year to more than $750 million in total. The funding is intended to support services that alleviate the causes and conditions of poverty. CSBG-funded services include housing support, food and nutrition programs, transportation assistance, job training, education, disaster response and recovery, community asset building initiatives, and countless other local services aimed at creating pathways out of poverty. CSBG-funded entities also serve as conveners and coordinators in their communities, helping to support broad community-based anti-poverty initiatives. More information about this action can be found here.
• On April 13, 2023, House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Ranking Member Richard Neal (D-MA), House Education and the Workforce Ranking Member Bobby Scott (D-VA), Senate Finance Committee Chair Ron Wyden (D-OR), and Senate Health, Education, Labor, and Pensions (HELP) Chair Bernie Sanders (I-VT) all wrote to health insurers and trade associations requesting information on the insurance industry’s response to the Northern District of Texas’s decision in Braidwood Management Inc. v. Becerra. The ruling struck down the Affordable Care Act’s (ACAs) requirement for most health plans and issuers to cover preventive services as recommended by U.S. Preventive Services Task Force (USPSTF) with an A or B rating without cost-sharing. Services covered under this provision included mammograms, lung cancer and skin cancer screenings, prenatal screenings, and access to HIV pre-exposure prophylaxis (PrEP). The Committee leaders requested that the 12 health insurers and trade associations included in the letter respond by April 19 to indicate whether they (or their members) intend to continue covering these USPSTF-recommended services without cost-sharing until all appellate review in the Braidwood case is concluded. The 12 organization addressed in the letter are: CVS Health Corporation, Alliance of Community Health Plans (ACHP), America’s Health Insurance Plans (AHIP), American Benefits Council, Blue Cross Blue Shield Association (BCBSA), Centene Corporation, Cigna, Elevance Health, Inc., ERISA Industry Committee, Humana Inc., Purchaser Business Group on Health, and UnitedHealth Group. More information on this action can be found here.
• On April 13, 2023, HHS issued an announcement in regard to Black Maternal Health Week 2023. As part of its observance of Black Maternal Health Week, HRSA announced the availability of approximately $468 million in funding related to maternal and child health across several programs. Specifically, HRSA announced up to $435 million in available funding for the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program, up to $23 million through the State Maternal Health Innovation (State MHI) program, and up to $10 million to the Maternal Health Research Collaborative for Minority-Serving Institutions (MH-RC-MSI). HHS Secretary Xavier Becerra also hosted a roundtable to address disparities in Black maternal and infant health, which was organized by the HHS Partnership Center. More information on this announcement can be found here.
• On April 14, 2023, HHS announced that it will issue an amendment in the coming weeks to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19. During the pandemic, the PREP Act declaration has provided liability protection to manufacturers, distributors, and other organizations conducting countermeasure programs and to providers administering COVID-19 countermeasures. This includes COVID-19 countermeasures (such as tests, treatments, and vaccines) purchased by the federal government for administration at pharmacies and other locations. Specifically, through the amendment, HHS will extend liability coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests through December 2024 for pharmacists, pharmacy interns, and pharmacy technicians to administer both vaccines and the test. Once activities are no longer under PREP Act agreement with the federal government, such activities will no longer be protected from liability, such as COVID-19 vaccinations from non-traditional providers such as students and recently retired providers. More information on this expected action can be found here.

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