Health Care Week in Review May 31, 2024

Health Care Week in Review: House Members Introduced Legislation Intended to Enhance 340 Program Transparency; HHS Released Strategic Framework for a National Plan on Aging

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

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.

View our Health Care Legislative & Public Policy team.

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