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 released the FY2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Proposed Rule, and Congress held hearings on chronic care and telehealth proposals.
I. Regulations, Notices & Guidance
- On April 8, 2024, the Food and Drug Administration (FDA) released a notice entitled, 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments. FDA is announcing the availability of the Agency’s annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since its establishment, it has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act.
- On April 9, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule correction entitled, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024; Corrections. This document corrects technical errors in the final rule that appeared in the August 7, 2023, Federal Register, entitled “Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024”. The effective date of the rule was October 1, 2023.
- On April 10, 2024, the Administration of Children and Families (ACF) released a notice entitled, Privacy Act of 1974; System of Records. In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the ACF, Office of Child Support Services (OCSS): System No. 09-80-0381, entitled “OCSS National Directory of New Hires, HHS/ACF/OCSS.”
- On April 10, 2024, FDA released a notice entitled, Determination That KEMSTRO (Baclofen) Orally Disintegrating Tablets, 10 Milligrams and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that KEMSTRO (baclofen) orally disintegrating tablets, 10 milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for baclofen orally disintegrating tablets, 10 mg and 20 mg, if all other legal and regulatory requirements are met.
- On April 10, 2024, FDA released a notice entitled, Determination That VISTARIL (Hydroxyzine Pamoate) Oral Suspension, 25 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. FDA has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.
- On April 10, 2024, FDA released a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; DUVYZAT (givinostat). FDA announced the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria and requires FDA to publish notice of the award of the priority review voucher. FDA has determined that DUVYZAT (givinostat), approved on March 21, 2024, manufactured by Italfarmaco S.p.A., meets the criteria for a priority review voucher.
- On April 10, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Availability of Draft Health Center Program Policy Guidance Regarding Services To Support Transitions in Care for Justice-Involved Individuals Reentering the Community. The purpose of the draft Policy Information Notice (PIN) is to propose Health Center Program policy guidance for all health centers that apply for and receive federal award funds under the Health Center Program, as authorized by section 330 of the Public Health Service (PHS) Act (including sections 330(e), (g), (h), and (i)), as well as section 330 subrecipient organizations and Health Center Program look-alikes, to clarify the conditions under which they may provide certain health services as part of the Health Center Program scope of project to certain incarcerated/detained individuals. This draft PIN establishes policy guidance that identifies a set of health services that a health center may provide, the locations at which such services may be provided, the target population for such services (specifically, incarcerated/detained individuals who are scheduled for release from a carceral setting within 90 days), and other pertinent circumstances under which the health center may, on its own behalf and subject to all section 330 requirements, provide such services to justice-involved individuals reentering the community to support their care transition from the carceral setting to the community within the scope of their Health Center Program project.
- On April 12, 2024, CMS released a notice entitled, Medicare Program: Application by the Accreditation Commission for Health Care for Continued Approval of its Home Infusion Therapy Accreditation Program. This final notice announces the agency’s decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.
- On April 12, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Requests for Nominations: Healthcare Infection Control Practices Advisory Committee. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Healthcare Infection Control Practices Advisory Committee (HICPAC). HICPAC consists of 14 experts in fields including, but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical and environmental microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related fields.
- On April 12, 2024, CDC released a notice entitled, Requests for Nominations: Advisory Council for the Elimination of Tuberculosis. In accordance with the Federal Advisory Committee Act, 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.
Event Notices
April 17, 2024: The National Institutes of Health (NIH) announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.
April 17, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This is a hybrid meeting open to the public.
April 17, 2024: CDC announced a meeting of the Community Preventative Services Task Force. This is a virtual meeting open to the public.
April 30, 2024: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
May 6, 2024: CDC announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a virtual meeting open to the public.
May 7, 2024: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting open to the public.
May 9, 2024: FDA announced a meeting of the Blood Products Advisory Committee. This is a virtual meeting open to the public.
May 9-10, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a hybrid meeting open to the public.
May 21, 2024: CMS announced a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). This is a virtual meeting open to the public.
May 21-22, 2024: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a hybrid meeting open to the public.
June 3, 2024: FDA announced a meeting of the AIDS Research Advisory Committee. This is a hybrid meeting open to the public.
June 4, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Dose Reconstruction Review, National Institute for Occupational Safety and Health. This meeting is open to the public.
June 6, 2024: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a virtual meeting open to the public.
June 26, 2024: CDC announced a meeting of the Meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
II. HEARINGS & MARKUPS
- On April 9, 2024, the Senate Committee on Finance Subcommittee on Health Care held a hearing entitled, Closing Gaps in the Care Continuum: Opportunities to Improve Substance Use Disorder Care in the Federal Health Programs. Witnesses included: Brendan Saloner, Ph.D., Bloomberg Professor Of American Health, Johns Hopkins Bloomberg School Of Public Health, Johns Hopkins University; Malcolm Horn, Ph.D., LCSW, MAC, SAP, Chief Behavioral Health Officer, Rimrock Foundation; Sarah Bagley, MD, MSc; Associate Professor Of Medicine And Pediatrics, Associate Program Director, Grayken Fellow in Addiction Medicine, Boston Medical Center and Boston University Chobanian & Avedisian School of Medicine; and Paul J. Christine, MD, Ph.D., Assistant Professor Of Medicine, University of Colorado School of Medicine and Denver Health.
- On April 10, 2024, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Legislative Proposals to Support Patient Access to Telehealth Services. Witnesses included: Ms. Jeanette Ashlock, Patient Advocate, National Multiple Sclerosis Society; Mr. Fred Riccardi, President, Medicare Rights Center; Dr. Lee Schwamm, MD, Volunteer, American Heart Association; Associate Dean for Digital Strategy and Transformation, Yale School of Medicine; Senior Vice President and Chief Digital Health Officer, Yale New Haven Health System; Dr. Eve Cunningham, MD, MBA, Group Vice President and Chief of Virtual Care and Digital Health, Providence; and Dr. Ateev Mehrotra, MD, MPH, Professor of Health Care Policy and Medicine, Harvard Medical School; Hospitalist, Beth Israel Deaconess Medical Center.
- On April 11, 2024, the Senate Committee on Finance held a hearing entitled, Bolstering Chronic Care through Medicare Physician Payment. Witnesses included: Amol Navathe, MD, Ph.D., Professor of Health Policy and Medicine, University of Pennsylvania; Steven P. Furr, MD, FAAFP, President, American Academy of Family Physicians; Patricia L. Turner, MD, MBA, FACS, Executive Director and Chief Executive Officer, American College of Surgeons; and Melanie Matthews, Chief Executive Officer, Physicians of Southwest Washington (PSW).
- On April 11, 2024, the House Committee on Oversight and Accountability held a hearing entitled, Oversight of the U.S. Food and Drug Administration. The sole witness was Dr. Robert Califf, FDA Commissioner.
III. Reports, Studies, & Analyses
- On April 9, 2024, the HHS Office of the Inspector General (OIG) released a report entitled, Ohio Generally Completed Medicaid Eligibility Actions During the Unwinding Period in Accordance With Federal and State Requirements. OIG conducted an audit to evaluate whether Ohio complied with federal and state requirements while completing Medicaid eligibility actions during the unwinding period, following the end of the continuous enrollment condition mandated by the Families First Coronavirus Response Act. The audit focused on renewals, post-enrollment verifications, and redeterminations for all enrollees, including disenrolling those who were no longer eligible. Out of 1,211,991 enrollees covered during the audit period (April 1 through August 31, 2023), a sample of 140 enrollees was examined. OIG found that 9 enrollees had their Medicaid enrollment incorrectly determined. Based on this sample, it was estimated that Ohio either incorrectly renewed or terminated Medicaid eligibility for 78,486 of the 1,211,991 Medicaid enrollees during the audit period. In response, the OIG recommended that Ohio take appropriate corrective actions for the identified incorrect determinations, implement periodic training for caseworkers on verifying and documenting enrollees’ income during the renewal process, and provide additional training on using current information for enrollee eligibility determinations. Ohio concurred with all the recommendations and detailed actions it has taken or plans to take to address the issues identified.
- On April 10, 2024, the Kaiser Family Foundation (KFF) released a report entitled, Gaps in Medicare Advantage Data Remain Despite CMS Actions to Increase Transparency. The report examined recent steps by CMS to enhance transparency in Medicare Advantage (MA) plans and the effective of these efforts. Recent efforts include the expansion of reporting requirements for MA insurers concerning supplemental benefits, making this information accessible to researchers and other stakeholders within a few years. Additionally, starting in 2026, CMS will mandate that MA insurers post summary data on the timeliness and use of prior authorizations on their websites. According to the report, substantial data gaps persist. In 2024, the Medicare Payment Advisory Commission (MedPAC) estimated that Medicare will spend 22 percent more per MA enrollee than for those in traditional Medicare. The report stated that current research indicates few differences in beneficiary experience, affordability, service utilization, and quality between MA and traditional Medicare despite these higher costs. The report highlighted key areas lacking comprehensive data, including the use of supplemental benefits like dental, vision, and hearing, and the associated out-of-pocket spending.
- On April 12, 2024, KFF released an issue brief entitled, Retiree Health Benefits: Going, Going, Nearly Gone?. The report revealed a significant decline in retiree health benefits over the past three decades. In 1988, 66 percent of large employers provided these benefits, but by 2023, this number decreased to 21 percent. This reduction aligns with a growing trend of employers offering retiree benefits through MA plans. The report attributes this decline to increasing healthcare costs and a drop in union membership, placing employers under pressure to prioritize benefits for active workers over retirees. The report underscored the urgency for Medicare to address the financial challenges faced by beneficiaries and to develop sustainable coverage solutions for the future.
IV. Other Health Policy News
- On April 7, 2024, House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-WA-5) and Senate Committee on Commerce, Science and Transportation Chair Maria Cantwell (D-WA) released a discussion draft of federal privacy legislation, entitled the American Privacy Rights Act. They also issued a press release and a section-by-section analysis of the discussion draft. The bill “sets clear, national data privacy rights and protections for Americans, eliminates the existing patchwork of state comprehensive data privacy laws, and establishes robust enforcement mechanisms to hold violators accountable, including a private right of action for individuals.” Specifically, the bill includes definitions for health-related data and information to improve future health technology regulations and sets privacy requirements for business associates that partner with health care entities. The bill does not preempt or displace state laws or regulations for the protection of health information, medical records, or status of HIV testing. Notably, the bill authorizes the Federal Trade Commission (FTC) to enforce the bill’s privacy requirements, including the health care provisions. Recent congressional hearings on the impact of artificial intelligence on patient data and privacy as well as the recent Change Healthcare disruption have added to the debate about whether sufficient safeguards in place to protect individual health data. Federal agencies are also signaling that additional federal rulemaking may be considered.
- On April 10, 2024, CMS released the fiscal year (FY) 2025 Medicare Inpatient Prospective Payment System (IPPS) proposed rule, in which the agency sets forth its proposed payment policies for inpatient acute care hospital services. Among others, CMS proposes to: increase payments made under the IPPS by 2.6 percent for hospitals that participate in the Hospital Inpatient Quality Reporting program and are meaningful electronic health record (EHR) users; continue its policy of temporarily increasing wage index values for certain low-wage index hospitals for at least three more years beginning in FY 2025; provide separate IPPS payment for small, independent hospitals to establish and maintain access to essential medicines; and establish a new mandatory alternative payment model called the Transforming Episode Accountability Model (TEAM) that intends to improve beneficiary care through financial accountability for episode categories that begin with one of the following procedures: coronary artery bypass graft (CABG), lower extremity joint replacement (LEJR), major bowel procedure, surgical hip/femur fracture treatment (SHFFT), and spinal fusion. The proposed rule also includes several requests for information pertaining to maternal care, obstetrical services, and discharge processes. Comments to the proposed rule are due by 5 p.m. EST on June 10, 2024. The text of the rule can be found here; the CMS press release can be found here; and the CMS fact sheet can be found here.
- On April 10, 2024, HRSA announced a new $51 million funding opportunity to support transitions in care for individuals leaving incarceration. This initiative allows HRSA-funded health centers to provide essential health services, including chronic disease management, mental health, and substance use disorder treatment, to individuals in the 90 days prior to their release, aiding their transition back into the community. In a press release, HRSA Administrator Carole Johnson highlighted the significant health care needs of individuals returning from incarceration, particularly those with substance use or mental health conditions, emphasizing the increased risk of overdose and other adverse health outcomes. The funding opportunity will support approximately 51 health centers in implementing approaches that focus on reducing drug overdose risk, addressing mental health and substance use disorder treatment needs, managing chronic conditions, and preventing and treating infectious diseases. Health centers can also use the funds to provide case management services addressing key social determinants of health, such as housing and food insecurity, financial strain, transportation access, and intimate partner violence. A press release with more information is available here.
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