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, HHS finalized a rule that strengthens protections against disability discrimination in programs that receive HHS funding, FDA finalized a rule regulating LDTs as medical devices, and Senate Finance Committee leadership released a discussion draft on drug shortages.
I. Regulations, Notices & Guidance
- On April 29, 2024, the Food and Drug Administration (FDA) released a final rule entitled, Medical Devices; Laboratory Developed Tests. FDA issued this final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.
- On April 29, 2024, FDA released a notice entitled, Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability. In the context of emergent situations involving chemical, biological, radiological, or nuclear (CBRN) threats, there may be a public health need for certain IVDs to be available for immediate response purposes. When finalized, this guidance will describe FDA’s enforcement policy for certain laboratory manufacturers offering certain unauthorized IVDs for immediate response to CBRN agents in the absence of a declaration applicable to IVDs under the FD&C Act. This draft guidance is not final nor is it for implementation at this time.
- On April 29, 2024, FDA released a draft guidance entitled, Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved tests and unapproved uses of approved tests during a declared emergency. This draft guidance is not final nor is it for implementation at this time.
- On April 29, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Application by the Community Health Accreditation Partner (CHAP) for Continued CMS Approval of its Home Infusion Therapy (HIT) Accreditation Program. This notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued approval by CMS of CHAP’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 29, 2024, FDA released a draft guidance entitled, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry; Availability. Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. The draft guidance provides sponsors of allogeneic cell-based medical products recommendations for determining the appropriate cell safety testing to support an investigational new drug application (IND) or a biologics license application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.
- On April 30, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Notice of Publication of Common Agreement for Nationwide Health Information Interoperability (Common Agreement) Version 2.0. This notice fulfills an obligation under the Public Health Service Act (PHSA) that requires the Office of the National Coordinator for Health Information Technology (ONC) to publish on the ONC public website, and in the federal register, the trusted exchange framework and common agreement (TEFCA) developed under the PHSA. This notice is for publishing an updated version of the Common Agreement (Version 2.0).
- On April 30, 2024, CMS released a notice entitled, Medicare and Medicaid Programs: Application from the Joint Commission for Initial CMS-approval of its Rural Health Clinic (RHC) Accreditation Program. This final notice announces CMS’s decision to approve The Joint Commission (TJC) for initial recognition as a national accrediting organization (AO) for rural health clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
- On May 1, 2024, FDA released a notice entitled, Request for Nominations of a Nonvoting Representative of the Interest of Tobacco Growers on the Tobacco Products Scientific Advisory Committee. FDA is requesting nominations for a nonvoting representative of the interests of the tobacco growers to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encouraged nominations of appropriately qualified candidates from these groups. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco growers industry to serve on the TPSAC and notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.
- On May 1, 2024, the Administration for Community Living (ACL) released a notice entitled, Announcing the Intent To Award a Single-Source Supplement for the Puerto Rico Disaster Assistance Grant Program. ACL announced its intent to award a single-source supplement to the current cooperative agreement held by the Puerto Rico Ombudsman Office for the Elderly (PROOE) for the project Puerto Rico Disaster Assistance Grant which is through the Older Americans Act, Disaster Assistance for State Units on Aging (SUAs) and Tribal Organizations in Major Disasters Declared by the President and the Consolidated Appropriations Act, 2023 (CAA, 2023).
- On May 2, 2024, the Agency for Toxic Substances and Disease Registry (ATSDR) released a notice entitled Availability of Three Draft Toxicological Profiles. ATSDR announced the opening of a docket to obtain comments on drafts of three updated toxicological profiles: acrolein, n-hexane, and naphthalene. ATSDR believes this action is necessary as this is the opportunity for members of the public and organizations to submit comments on drafts of the profiles. The intended effect of this action is to ensure that the public can note any pertinent additional information or reports on studies about the health effects caused by exposure to the substances covered in these three profiles for review.
- On May 2, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, Formation of a Subcommittee of the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council. SAMHSA gave notice of the formation of a subcommittee of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC) that will be known as the Substance Use Prevention Workforce. The subcommittee reports to the CSAP NAC, and of its findings, which are further deliberated by the CSAP NAC. The expected lifespan of the subcommittee is approximately one year. It is estimated that subcommittee meetings will occur approximately on a monthly basis via web conference.
- On May 3, 2024, CMS issued a final rule entitled, Clarifying the Eligibility of Deferred Action for Childhood Arrivals (DACA) Recipients and Certain Other Noncitizens for a Qualified Health Plan through an Exchange, Advance Payments of the Premium Tax Credit, Cost-Sharing Reductions, and a Basic Health Program. This final rule makes several clarifications and updates the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for Medicaid and Children’s Health Insurance Programs (CHIPs). Specifically, Deferred Action for Childhood Arrivals (DACA) recipients and certain other noncitizens will be included in the definitions of “lawfully present” that are used to determine eligibility to enroll in a QHP through an Exchange, for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs), or for a BHP.
- On May 3, 2024, CMS released a notice entitled, Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance; Comment Request. CMS announced an opportunity for the public to comment on CMS’ draft guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturer effectuation of the maximum fair price for 2026 and 2027 for the implementation of the Inflation Reduction Act (IRA). This and other IRA-related guidance can be viewed on the dedicated IRA section of the CMS website.
- On May 3, 2024, FDA issued a final rule entitled, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water. The final rule amends the agricultural water provisions of the produce safety regulation. Specifically, the final rule replaces the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with a regulatory approach that incorporates recent science and FDA outbreak investigation findings to achieve improved public health protections as compared to the earlier requirements. The final rule requires systems-based assessments, with required testing in certain circumstances, that focus on key risk factors for contamination by pre-harvest agricultural water and will enable farms to implement effective preventive measures. The final rule requires farms to take timely action based on risk and includes a new requirement for expedited mitigation for certain hazards. The requirements are adaptable to future scientific advancements and provide sufficient flexibility to be practicable for all sizes and types of farms to implement across the wide variety of agricultural water systems, uses, and practices. These revisions to the produce safety regulation will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.
- On May 3, 2024, FDA released a notice entitled, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft guidance for industry (GFI) #290 (VICH GL61) entitled “Pharmaceutical Development.” This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance describes the suggested contents for the Pharmaceutical Development section, which provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.
Event Notices
May 6, 2024: The Centers for Disease Control and Prevention (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: The National Institutes of Health (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: The Health Resources and Services Administration (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 20, 2024: HHS announced a meeting of the National Advisory Committee on Seniors and Disasters. 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 23, 2024: CDC announced a meeting entitled, National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in People. This is a virtual 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.
May 30, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating 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: 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 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.
II. Hearings & Markups
- On April 30, 2024, the House Energy and Commerce (E&C) Health Subcommittee held a hearing entitled, Legislative Proposals to Increase Medicaid Access and Improve Program Integrity. The witness was Daniel Tsai, Deputy Administrator and Director of the Center for Medicaid and CHIP Services, CMS.
- On May 1, 2024, the Senate Finance Committee held a hearing entitled, Hacking America’s Health Care: Assessing the Change Healthcare Cyber Attack and What’s Next. The witness was Andrew Witty, Chief Executive Officer (CEO), UnitedHealth Group.
- On May 1, 2024, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing entitled, A Hearing with the President of EcoHealth Alliance, Dr. Peter Daszak. The witness was Dr. Peter Daszak, President, EcoHealth Alliance, Inc.
- On May 1, 2024, the E&C Health Subcommittee held a hearing entitled, Examining the Change Healthcare Cyberattack. The witness was Andrew Witty, CEO, UnitedHealth Group.
- On May 2, 2024, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, What Can Congress Do to Address the Severe Shortage of Minority Health Care Professionals and the Maternal Health Crisis. The witnesses present included: Senator Laphonza Butler; Representative Michael Burgess; Yolanda Lawson, President, National Medical Association; Dr, Samuel Cook, MD, Resident, Morehouse School of Medicine; Dr. Michael Galvez, MD, Co-Creator of National Latino Physician Day, Valley Children's Hospital; Jaines Andrades, DNP, AGACNP-BC, Nurse Practitioner, Baystate Health; and Brian Stone, MD, FACS, President, Jasper Urology Associates.
III. Reports, Studies, & Analyses
- On May 2, 2024, the Government Accountability Office (GAO) released a report entitled Public Health Preparedness: HHS Should Address Strategic National Stockpile Coordination Challenges. GAO surveyed 62 jurisdictions to assess the Strategic National Stockpile (SNS) resources provided to them, the challenges jurisdictions had when accessing SNS resources during the COVID-19 pandemic the mpox outbreak from 2022 to 2023, and jurisdictional SNS coordination issues that could impact future responses. Jurisdictions reported struggles with understanding the SNS resource inventory, coordinating with HHS on requesting and receiving SNS assets, and navigating outdated SNS guidance. GAO noted that the main SNS guidance document has not been updated since 2014. Other coordination issues that were identified that may affect future outbreak responses included jurisdictional public health officials being unaware or unfamiliar with HHS response plans, and necessary federal efforts to keep managing the stockpile which expanded during the COVID-19 pandemic. GAO recommended that (1) CDC and the Administration for Strategic Preparedness and Response (ASPR) collaborate to clearly define each agency’s roles and responsibilities related to the SNS, (2) ASPR develop standard operating procedures for how and when guidance documents are updated, and (3) ASPR formally designate an entity to regularly engage with Tribes and other relevant stakeholders to address unique challenges that Tribes may experience when accessing the SNS.
- On May 2, 2024, the HHS Office of Inspector General (OIG) released a report entitled, Medicaid Enrollees May Not Be Screened for Intimate Partner Violence Because of Challenges Reported by Primary Care Clinicians. The U.S. Preventive Services Task Force (USPSTF) and the Women’s Preventive Services Initiative (WPSI) recommend that clinicals screen certain women for intimate partner violence (IPV) and refer individuals who screen as positive to support services. The 41 states that have expanded Medicaid are required to cover IPV screening and referral services, as recommended by USPSTF and WPSI. OIG analyzed 1,186 survey responses from primary care clinicians who served patients enrolled in Medicaid. Many clinicians reported a variety of challenges to IPV screenings, including time constraints, worries about patient safety and privacy, and inadequate trainings. Additionally, providers highlighted challenges with making referrals for patients who screened positive, including limited availability of IPV support resources. OIG asserted that the challenges clinicians face with screening patients for IPV and referring them to appropriate services poses a significant health risk. Clinicians noted that enhanced reimbursement for IPV screening and referral services, stronger IPV resources, and more training and guidance could increase the prevalence of IPV screening and referral services for Medicaid beneficiaries.
IV. Other Health Policy News
- On April 29, 2024, HHS released its Plan for Promoting Responsible Use of Artificial Intelligence (AI) in Automated and Algorithmic Systems by State, Local, Tribal, and Territorial Governments (STLT) in the Administration of Public Benefits. This plan offers recommendations to help STLT agencies balance opportunities and risks associated with AI-enabled systems in public benefits programs. While the plan is specific to AI, it also provides best practices applicable to all automated and algorithmic systems. Although these recommendations are voluntary, HHS encourages STLTs to consider incorporating them into their program guidance. The plan emphasizes the importance of protecting rights, ensuring equity, maintaining accountability, and fostering public trust in all automated systems used to administer HHS programs. While not mandatory, HHS supports STLTs in responsible innovation and plans to provide additional resources to support implementation of the plan over the next 12 months. A press release with more information is available here. The plan is available here.
- On April 29, 2024, the Biden Administration announced the allocation of $105 million through HRSA to support over 100 community-based organizations aiming to enhance maternal and infant health across theU.S. HRSA Administrator Carole Johnson announced the funding during a visit to Southside Medical Center in Atlanta, Georgia, marking the second stop of HRSA’s Enhancing Maternal Health Initiative tour. This investment, channeled through the Healthy Start program, aims to address disparities in maternal and infant health outcomes by providing support to communities with disproportionately high rates of infant mortality. The Healthy Start initiative offers services, including culturally responsive healthcare, food assistance, transportation to prenatal care, housing navigation, and other vital social supports. A press release with more information is available here.
- On May 1, 2024, the HHS Office for Civil Rights (OCR) finalized a rule entitled Discrimination on the Basis of Disability in Health and Human Service Programs or Activities. The final rule bolsters protection of individuals with disabilities under Section 504 of the Rehabilitation Act. Specifically, the rule (1) ensures that medical treatment decisions are not negatively impacted by biases or stereotypes about individuals with disabilities; (2) prohibits the use of any measures, tools, or assessments that discount the value of a life extension on the basis of disability to deny or limit a benefit or service; (3) defines accessibility standards for websites and mobile applications; (4) adopts the U.S. Access Board’s standards for accessible medical diagnostic equipment; (5) details requirements to ensure there is not discrimination in services carried out by HHS-funded child welfare agencies; and (6) clarifies obligations to provide services in the integrated settings that are appropriate to meet the needs of people with disabilities. The final rule also updates existing requirements to ensure they are consistent with the American with Disabilities Act (ADA). A press release with more information is available here. The final rule is available here.
- On May 3, 2024, the Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) released draft legislation to address the ongoing prescription drug shortage. The proposal would create a new Medicare program for hospitals and physicians that incentivizes the transparent, reliable, and resilient purchase of prescription drugs across the supply chains, including manufacturers, providers, and intermediaries, such as group purchasing organizations (GPOs). To receive the targeted Medicare incentive payments, key requirements for program participants include (1) minimum three-year contracts with manufacturers for generic drugs at a high risk for shortages; (2) meaningful purchase volume commitments and stable pricing aimed to address market distortions; (3) requirements for contingency contracts with alternative manufacturers to prevent shortages and increase competition; (4) prohibitions against anticompetitive practices in the program, including exclusive contracting requirements for providers; and (5) transparency regarding manufacturer control issues to improve supply-chain visibility and preempt drug shortages. The bill also includes oversight and accountability provisions to protect Medicare and changes the Medicaid Drug Rebate Program (MDRP) by enabling reductions or waivers to the inflation rebate for certain generic drugs if there is a shortage risk. A press release with more information is available here. The discussion draft is available here. A section-by-section summary is available here.
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