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 finalized rules on minimum nursing home staffing standards, as well as access and quality standards in Medicaid, and the Federal Trade Commission (FTC) banned private employers from utilizing most noncompete clauses in employee contracts.
I. Regulations, Notices & Guidance
- On April 22, 2024, the Food and Drug Administration (FDA) released a notice entitled, PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications. FDA is withdrawing approval of 23 new drug applications (NDAs) from multiple applicants. The applicants notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
- On April 22, FDA released a notice entitled, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants are required to, or have agreed to, conduct is on the FDA’s website entitled Postmarketing Requirements and Commitments: Reports.
- On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Medicaid Program; Ensuring Access to Medicaid Services. This final rule takes a comprehensive approach to improving access to care, quality and health outcomes, and better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These improvements increase transparency and accountability, standardize data and monitoring, and create opportunities for States to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
- On April 22, 2024, CMS released a final rule entitled, Medicaid Program; Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality. This final rule will advance CMS’s efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees. The final rule addresses standards for timely access to care and States’ monitoring and enforcement efforts, reduces State burdens for implementing some State directed payments (SDPs) and certain quality reporting requirements, adds new standards that will apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and that specify the scope and nature of ILOSs, specifies medical loss ratio (MLR) requirements, and establishes a quality rating system for Medicaid and CHIP managed care plans.
- On April 22, 2024, CMS released a final rule entitled, Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting. This final rule establishes minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration’s nursing home reform initiative to ensure safe and quality care in long-term care facilities. In addition, this final rule requires States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff.
- On April 22, 2024, the Department of Health and Human Services (HHS) released a final rule entitled, HIPAA Privacy Rule to Support Reproductive Health Care Privacy. HHS is issuing this final rule to modify the Standards for Privacy of Individually Identifiable Health Information 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). HHS is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the HIPAA Privacy Rule to Support Reproductive Health Care Privacy and public comments received on proposals to revise provisions of the HIPAA Privacy Rule in the NPRM for the Confidentiality of Substance Use Disorder (SUD) Patient Records.
- On April 24, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Announcement of Requirements and Registration for The REACH Lark Galloway-Gilliam Award for Advancing Health Equity Challenge (REACH Lark Award Challenge). CDC is announcing the 2024 Racial and Ethnic Approaches to Community Health (REACH) Lark Galloway-Gilliam for Advancing Health Equity Award Challenge (REACH Lark Award Challenge). This biennial challenge was established in 2019 to recognize extraordinary individuals, organizations, or community coalitions associated with the REACH program whose work has contributed to the implementation of culturally tailored interventions that advance health equity, reduce health disparities, and increase community engagement to address preventable risk behaviors (e.g., tobacco use, poor nutrition, and physical inactivity).
- On April 24, 2024, CMS released a notice entitled, Announcement of the Re-Approval of AABB (Association for the Advancement of Blood and Biotherapies) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988. This notice announces the application of the Association for the Advancement of Blood and Biotherapies (AABB) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program. CMS has determined that AABB meets or exceeds the applicable CLIA requirements. The agency is announcing the re-approval and grant AABB deeming authority for a period of 6 years.
- On April 24, 2024, FDA released a notice entitled, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability. FDA is issuing this revised draft guidance to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA agreed to publish a draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products, as described in the document titled Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027. The revised draft guidance is consistent with this commitment and replaces the draft guidance for industry entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers issued on February 4, 2020.
- On April 25, 2024, CMS released a notice entitled, Application: Medicare Program; Continued Approval of the National Association of Boards of Pharmacy's Home Infusion Therapy Accreditation Program. This notice acknowledges the receipt of an application from the National Association of Boards of Pharmacy (NABP) for continued approval by CMS of NABP’s national accrediting organization program for suppliers providing home infusion therapy (HIT) services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
- On April 25, 2024, FDA released a notice entitled, Petition: Food Additive Petition from Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Working Group, Tom Neltner, and Maricel Maffini. FDA is announcing that it has filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene.
- On April 25, 2024, FDA released a notice entitled, Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability. This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants.
- On April 25, 2024, FDA released a notice entitled, Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability. This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions.
- On April 25, 2024, FDA released a notice entitled, Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration’s Office of Clinical Pharmacology; Request for Comments. The purpose of this notice is to solicit input from interested parties on specific and actionable policy topics that could be prioritized, developed, and implemented by the staff of CDER’s Office of Clinical Pharmacology (OCP) to support effective drug development programs.
- On April 25, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Proposed Inclusion of Terrain Factors in the Definition of Rural Area for Federal Office of Rural Health Policy Grants. HRSA’s Federal Office of Rural Health Policy (FORHP) utilizes clear, consistent, and data-driven methods of defining rural areas in the U.S. for determining eligibility for its rural health grant programs. FORHP monitors ongoing national research and, as appropriate, considers updates to its definition. Because access to needed health care is likely to be reduced when roads are most difficult to traverse, with this notice, FORHP proposes to modify the definition of rural areas by integrating the new Road Ruggedness Scale (RRS) released in 2023 by the Economic Research Service (ERS) of the U.S. Department of Agriculture, which characterizes topographic variability, or ruggedness, of roads. This proposal does not impact rural areas included in the current FORHP definition. This notice seeks public comment on FORHP’s proposal. This notice also includes a technical clarification explaining how FORHP will use census data to identify outlying Metropolitan Statistical Area counties that qualify as rural in future updates given the U.S. Census Bureau’s 2020 Census terminology changes that removed the categories of Urban Clusters and Urbanized Areas.
- On April 25, 2024, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention listed in the notice, human monoclonal antibodies that target the RH5 complex of blood-stage plasmodium falciparum, is owned by an agency of the U.S. government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
- On April 26, 2024, CMS released a notice entitled, Medicare Program; Application by The Compliance Team (TCT) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program. This notice acknowledges the receipt of an application from The Compliance Team (TCT) for continued approval by CMS of TCT’s national accrediting organization program for suppliers providing HIT services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
- On April 26, 2024, FDA released a technical amendment to a final rule entitled, Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product. FDA is amending the food additive regulations to update the production organism Corynebacterium lilium that has been scientifically reclassified to corynebacterium glutamicum. This action is being taken to improve the accuracy and clarity of the regulations.
- On April 26, 2024, FDA released a notice entitled, Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability. FDA is announcing the availability of a guidance for industry entitled Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with FDA’s regulations after FDA revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance.
- On April 26, 2024, FDA released a notice entitled, Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability. This guidance is intended to assist NDA and ANDA applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly.
- On April 26, 2024, FDA released a notice entitled, Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability. This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine’s (CVM’s) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes FDA’s recommendations for submitting raw data.
- On April 26, 2024, CMS released a final rule entitled, Nondiscrimination in Health Programs and Activities. CMS is issuing this final rule regarding section 1557 of the Affordable Care Act (ACA) (section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the HHS Secretary to promulgate regulations to implement the nondiscrimination requirements of section 1557. CMS is also revising its interpretation regarding whether Medicare Part B constitutes Federal financial assistance for purposes of civil rights enforcement. Additionally, CMS is revising provisions prohibiting discrimination on the basis of sex in regulations issued by CMS governing Medicaid and the Children’s Health Insurance Program (CHIP); Programs of All-Inclusive Care for the Elderly (PACE); health insurance issuers and their officials, employees, agents, and representatives; States and the Exchanges carrying out Exchange requirements; agents, brokers, or web-brokers that assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees; issuers providing essential health benefits (EHB); and qualified health plan issuers.
Event Notices
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 15-16, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. 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.
May 24, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a virtual 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 3, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual 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 4, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory Board (DTAB). This is a hybrid meeting open to the public.
June 6, 2024: CDC announced a meeting of the Advisory Committee to the Director, CDC. This is a virtual meeting open to the public.
June 6, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting 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 7, 2024: FDA announced a meeting of the National Advisory Eye Council. 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. Reports, Studies, & Analyses
- On April 25, 2025, the Office of the Inspector General (OIG) released a report entitled, West Virginia Lacked Effective Oversight of Its Opioid Response Grants. OIG conducted an audit to assess whether West Virginia and its subrecipients complied with federal regulations and met program goals in implementing the SAMHSA Opioid State Targeted Response (STR) and State Opioid Response (SOR) grants. The audit covered the periods from May 1, 2017, to April 30, 2020, for the STR grant, and from September 30, 2020, to September 29, 2021, for the fiscal year (FY) 2020 SOR grant. The audit found that West Virginia did not adhere to federal regulations, failing to support its annual progress reports, adequately monitor subrecipient spending, and establish procedures to determine if SOR grant goals were met. Additionally, West Virginia lacked effective control and accountability for federal funds, not safeguarding them appropriately and inaccurately reflecting expenditures in its Federal financial report. In the report, OIG recommended several corrective actions, including revising procedures to maintain documentation for progress reports, conducting periodic reviews of supporting documentation for subrecipient expenditures, and providing training to program managers on approving advanced payments closer to actual disbursements. West Virginia concurred with and implemented changes to address recommendations.
- On April 24, 2024, the Kaiser Family Foundation (KFF) released a report entitled, A New Use for Wegovy Opens the Door to Medicare Coverage for Millions of People with Obesity. The analysis found that 3.6 million of the 13.7 million Medicare beneficiaries that are diagnosed with obesity or overweight could be eligible for Wegovy coverage. While Medicare is prohibited by covering drugs that are prescribed for obesity, FDA recently approved Wegovy for use to reduce the risk of stroke and heart attacks for certain high-risk populations. The 3.6 million beneficiaries KFF identified had established diagnoses cardiovascular disease in addition to obesity/overweight in 2020. This represents 7 percent of 2020 Medicare beneficiaries. The impact on Medicare spending will depend on how many beneficiaries utilize the drug, negotiated plan prices, the number of plans that cover Wegovy, and the extent of utilization management tools, such as prior authorization. KFF estimates that, assuming 10 percent of eligible beneficiaries use Wegovy and the rebate is 50 percent of its list price, Medicare would incur nearly $3 billion in net Part D spending in one year for coverage of Wegovy.
III. Other Health Policy News
- On April 23, 2024, the Federal Trade Commission (FTC) issued a final rule that prohibits for-profit companies from utilizing noncompete agreements for most employees. Once the rule goes into effect, for-profit employers will no longer be able to enter into new noncompete agreements or enforce existing noncompete agreements for most employees. Non-profit entities, including non-profit hospitals, are beyond FTC’s jurisdiction and are not subject to this rule. FTC said that the rule is “expected to lower health care costs by up to $194 billion over the next decade.” The U.S. Chamber of Commerce promptly filed a lawsuit to block the rule on April 24, 2024, stating that FTC is overstepping its authority in implementing this broad rule. Other legal challenges, including from hospitals and health care entities, are expected to follow. The rule is available here. A press release is available here. For additional analysis, read the Alston & Bird advisory alert.
- On April 22, 2024, CMS released a final rule entitled, Minimum Staffing Standard for Nursing Homes. The rule aims to enhance access to quality care and support for families and care workers. This final rule establishes national minimum staffing requirements for nursing homes, requiring a minimum of 3.48 hours of nursing care per resident per day and 24/7 on-site availability of a registered nurse. A $75 million national nursing home staffing campaign will also be developed to increase nurse numbers and provide financial incentives. A fact sheet is available here. The final rule is available here.
- On April 22, 2024, CMS released a final rule entitled, Ensuring Access to Medicaid Services. Key provisions in this final rule include the renaming and expansion of states’ Medical Care Advisory Committees to Medicaid Advisory Committees (MAC) with an expanded scope, establishment of a Beneficiary Advisory Council (BAC) comprising Medicaid beneficiaries, their families, and/or caregivers, and public disclosure requirements for MAC and BAC activities. The final rule strengthens oversight of HBCS, requiring states to meet nationwide incident management system standards, establish a grievance system for HCBS, and ensure a minimum of 80 percent of Medicaid payments for certain HCBS services are spent on compensation for direct care workers. Additionally, the final rule mandates transparency in fee-for-service (FFS) Medicaid Physician Fee Schedule (PFS) payment rates, comparison with Medicare rates, and the establishment of an advisory group for direct care workers and beneficiaries to advise on payment rates. A fact sheet is available here. The final rule is available here.
- On April 22, 2024, CMS released a final rule entitled, Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (Managed Care Rule). This final rule aims to improve timely access to care through the establishment of maximum appointment wait time standards and requires states to use independent entities for secret shopper surveys and annual enrollee experience surveys. Additionally, the final rule enhances transparency by requiring states to maintain a single, easily accessible web page for public information and to submit annual payment analyses comparing managed care plans’ payment rates with Medicare’s and the state’s Medicaid state plan payment rate. The Managed Care Rule also strengthens standards for state directed payments, specifies the scope of in lieu of services and settings to address health-related social needs, and establishes a quality rating system for Medicaid and CHIP managed care plans. Other notable regulatory revisions include the removal of barriers to use state directed payments for value-based purchasing payment arrangements, the establishment of submission timeframes for state directed payment preprints and rate certifications, and requirements for provider level reporting on actual state directed payment expenditures. The final rule also requires Medicaid managed care plans to submit actual expenditures and revenues for state directed payments as part of their medical loss ratio reports, specifies contractual requirements for provider incentive payments, and establishes a quality rating system for Medicaid and CHIP managed care plans, among other provisions. A fact sheet is available here. The final rule is available here.
- On April 24, 2024, Senator Bernie Sanders (I-VT), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, launched an investigation into the pricing of Novo Nordisk’s drugs, Ozempic and Wegovy, in the U.S. In a letter to the company’s CEO, Senator Sanders criticized the high costs of these medications, pointing out that Americans are charged $969 a month for Ozempic and $1,349 a month for Wegovy, while the same drugs are significantly cheaper in other countries, costing as little as $155 and $59 respectively. Sanders cited a Yale University report indicating that the drugs could be manufactured for less than $5 a month, emphasizing that the high prices are preventing millions of Americans from accessing these potentially life-changing medications. He highlighted that these high prices are straining Medicare and Medicaid budgets. The letter demands that Novo Nordisk substantially reduce the prices of Ozempic and Wegovy and requests detailed information on the company’s pricing strategy, including its expenditures on research and development for these drugs and the company’s profits from selling the products to commercial insurers and government programs. The full letter is available here. A press release is available here.
- On April 26, 2024, CMS released a final rule entitled, Nondiscrimination in Health Programs and Activities. This final rule is aimed at enhancing protections against discrimination in health care and reinforces safeguards against discrimination based on race, color, national origin, sex, age, and disability. Key provisions include holding HHS health programs to the same nondiscrimination standards as recipients of federal financial assistance, extending protections to Medicare Part B payments, mandating proactive communication of language assistance and accessibility services, clarifying nondiscrimination requirements for telehealth, safeguarding against discriminatory health insurance benefit designs, and addressing discrimination in the use of artificial intelligence (AI) in health care. A press release with more information is available here. The final rule is available here.
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