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, House members introduced legislation aimed at enhancing 340B Drug Pricing Program transparency, and the Department of Health and Human Services (HHS) released a new framework for a national plan on aging.

I. Regulations, Notices & Guidance

• On May 29, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform AHRQ’s review on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
• On May 29, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee to the Director, Centers for Disease Control and Prevention; Notice of Extension. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Advisory Committee to the Director (ACD), CDC (ACD, CDC). The ACD, CDC consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.
• On May 29, 2024, the Food and Drug Administration (FDA) released a notice entitled, Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal from List of Standing Committees. FDA is announcing the termination of the Science Advisory Board to the National Center for Toxicological Research (NCTR). This document announces the reasons for termination and removes the Science Advisory Board to the NCTR from FDA’s list of standing advisory committees.
• On May 29, 2024, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. The inventions listed in this notice are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
• On May 30, 2024, FDA released a notice entitled, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period. FDA is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled Hazard Analysis and Risk-Based Preventive Controls for Human Food which were announced in the Federal Register of February 2, 2024. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
• On May 31, 2024, AHRQ released a notice entitled, CDS Connect – Designing the Future of a National Hub for Clinical Decision Support: Request for Information. Clinical decision support (CDS) enables providers and others to implement up-to-date research findings quickly into their practice. In 2016, AHRQ supported the development of CDS by establishing CDS Connect, a platform to assist the healthcare community in creating and disseminating CDS artifacts. In 2023, AHRQ conducted a CDS Connect Challenge Competition to identify business models and platform enhancements that will allow CDS Connect to evolve its role as a national CDS hub. Based on the results of this Challenge Competition, AHRQ has issued the following Request for Information (RFI) to solicit ideas and identify possible collaborators for creating a new sustainment model (such as a Public Private Partnership (PPP) between AHRQ and a third-party organization) that ensures CDS Connect’s future operations.
• On May 31, 2024, FDA released a notice entitled, Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation. FDA has determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import-related food testing covered by the LAAF regulation for mycotoxins. As sufficient capacity is reached for additional analytes covered under the import-related food testing provisions of the LAAF regulation, those specific analytes and compliance dates will be posted on the LAAF Dashboard. Owners and consignees of imported food subject to the LAAF regulation must use a LAAF-accredited laboratory to conduct covered import-related food testing starting on the applicable compliance date, which is six months from the date a specific analyte is listed on a public registry, based on FDA’s determination that sufficient laboratory capacity has been achieved for such analyte. FDA has not yet made a capacity determination for the other food testing circumstances covered by the LAAF regulation.
• On May 31, 2024, FDA released a notice entitled, Pfizer, 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 FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
• On May 31, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies. HHS notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
• On May 31, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs and the Children’s Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes; Correction. This document corrects technical and typographical errors in the proposed rule that appeared in the May 2, 2024 Federal Register titled Medicare and Medicaid Programs and the Children’s Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes.

Event Notices

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. This meeting is open to the public.

June 4, 2024: 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 5, 2024: HHS announced a meeting of the National Committee on Vital and Health Statistics. This is a virtual meeting open to the public.

June 5-6, 2024: HHS announced a meeting of the Presidential Advisory Council on HIV/AIDS. 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 10, 2024: SAMHSA announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee. This is a virtual meeting open to the public.

June 13-14: HHS announced a meeting of the National Vaccine Advisory Committee. This is a hybrid meeting open to the public.

June 20, 2024: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a virtual meeting open to the public.

June 26, 2024: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.

June 26, 2024: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.

June 26, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Infant and Maternal Mortality. This is a hybrid meeting open to the public.

June 26-28, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.

June 28-29, 2024: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a hybrid meeting open to the public.

July 11-12, 2024: FDA announced a meeting entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. This is a hybrid meeting open to the public.

II. Reports, Studies, & Analyses

• On May 28, 2024, the Office of the Inspector General (OIG) released a report entitled, Plans and Enrollment Often Fell Short for Underrepresented Groups in a Sample of NIH-Funded Clinical Trials. OIG reviewed the inclusivity of enrollment plans in NIH-funded clinical trials, focusing on the representation of underrepresented racial and ethnic groups, as well as females, who are disproportionately affected by many diseases. The resulting report revealed that while two-thirds of the sampled clinical trials had inclusive enrollment plans, one-third did not plan to include all racial and ethnic groups. Additionally, over half of the trials lacked required information to justify their target populations, and most completed trials did not meet their enrollment targets for underrepresented groups. Despite NIH’s efforts to monitor enrollment, improvements have been limited. OIG recommended that NIH hold researchers accountable for clearly describing their study populations, develop more support mechanisms to help researchers meet inclusion targets, and align NIH’s data collection and reporting with revised Office of Management and Budget (OMB) requirements for better precision. NIH agreed with these recommendations.
• On May 29, 2024, the Government Accountability Office (GAO) released a report entitled, Medicaid: Managed Care Plans’ Prior Authorization Decisions for Children Need Additional Oversight. The report highlights concerns regarding the oversight of Medicaid managed care plans’ prior authorization decisions for children’s Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services. It finds that while managed care plans have similar processes for reviewing prior authorization requests, they differ on which services require such authorization. States’ oversight practices vary, with some reviewing plans’ policies and collecting data on authorizations, but only a few assess the appropriateness of denied services comprehensively. Moreover, CMS has not clarified whether managed care plans can require prior authorization for EPSDT services if the state Medicaid program does not. To address these issues, GAO recommended that CMS communicate clear expectations for state monitoring of prior authorizations and clarify the rules regarding prior authorization requirements for EPSDT services.
• On May 31, 2024, GAO released a report entitled, People with Disabilities: Information on the Health Care Workforce and Provider Training. GAO conducted this study to examine the prevalence of disabilities in the health care workforce and describe the training providers receive to meet the health needs of people with disabilities. The report found that approximately 13 percent of the U.S. population reported having a disability in 2021, based on data from the U.S. Census Bureau. Disabilities include conditions causing vision or hearing impairments, or significant difficulties in activities like walking, dressing, and remembering. According to the report, people with disabilities are less likely to be employed and are underrepresented in health care occupations. In 2021, they comprised six percent of the employed population, with eight percent in health care support roles and four percent as health care practitioners and technicians. Stakeholders noted that training for health care providers on disability is not widely required or standardized. While there are some disability-related training programs, researchers emphasized the need for more comprehensive training. They identified best practices for training, such as integrating disability content into existing curricula, engaging directly with the disability community, and addressing provider biases and stereotypes.

III. Other Health Policy News

• On May 28, 2024, Representatives Larry Bucshon (R-IN-8), Buddy Carter (R-GA-1), and Diana Harshbarger (R-TN-1) introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). The proposed legislation would establish new 340B eligibility requirements, establish a definition of a covered entity patient, subject contract pharmacies to new rules, and add additional reporting requirements, among other changes. The bill’s introduction coincides with the announcement of a House Energy and Commerce Subcommittee on Oversight and Investigations hearing on the 340B program, which will be held on June 4, 2024. A press release is available here.
• On May 30, 2024, Senate Finance Committee Chair Ron Wyden (D-OR) called on the Federal Trade Commission (FTC) and the U.S. Securities and Exchange Commission (SEC) to investigate cybersecurity practices following a ransomware attack on Change Healthcare on February 21, 2024. Chair Wyden asserted that failure to implement multi-factor authentication (MFA) on a remote access server facilitated the breach. The letter is available here.
• On May 30, 2024, HHS has released a report entitled, Aging in the United States: A Strategic Framework for a National Plan on Aging, aimed at fostering coordinated efforts across public and private sectors to promote healthy aging and age-friendly communities. Developed with input from 16 federal agencies and community partners, the framework outlines goals for improving service delivery, fostering partnerships, and removing barriers to health and independence for older adults. It highlights the need for accessible housing, integrated healthcare, and supportive services. HHS Secretary Xavier Becerra emphasized the administration’s commitment to ensuring dignity for aging Americans through initiatives like reducing prescription drug costs and supporting caregivers. This framework sets the stage for systemic solutions to enhance the wellbeing of the nation’s aging population and will be followed by stakeholder engagement and further development of the national plan. A press release is available here. The framework is available here.

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