Health Care Week In Review: HRSA Releases List of Health Professional Shortage Areas, Biden Bolsters HHS Authority to Address Drug Shortages

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, HRSA released its list of designated mental, primary, medical, and dental health professional shortage areas (HPSAs) and President Biden gave HHS greater authority to address drug shortages under the Defense Production Act (DPA).

I. Regulations, Notices & Guidance

• On December 26, 2023, the Food and Drug Administration (FDA) released a notice entitled, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability. FDA is issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule” (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads), present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met.
• On December 26, 2023, the National Institutes of Health (NIH) released a notice entitled, Government Owned Inventions. The invention is directed to a T cell receptor (TCR) that specifically targets the Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1). This TCR may be used to develop novel immunotherapies against several common and aggressive epithelial cancers. It may also be possible to use portions of the KK-LC-1 TCR in chimeric proteins for cancer therapy and/or for antigen detection assays. This technology was discovered and is being developed by the National Cancer Institute (NCI). The NCI is currently seeking a licensee and/or collaborator to further develop this technology.
• On December 27, 2023, FDA released a notice entitled, Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability. FDA is issuing this draft guidance to provide recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, the guidance describes how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, the guidance describes requirements for potency assurance, including testing required for lot release.
• On December 27, 2023, FDA released a notice entitled, Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability. This revised draft guidance discusses certain quality considerations for ophthalmic drug products intended for topical delivery in and around the eye. Specifically, this revised draft guidance discusses microbiological considerations; approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. This guidance revises the draft guidance for industry of the same name issued in October 2023.
• On December 27, 2023, FDA released a notice entitled, Reformulating Drug Products That Contain Carbomers Manufactured With Benzene; Guidance for Industry; Availability. The purpose of this guidance is to provide recommendations to applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to support the reformulation of drug products that use carbomers manufactured with benzene. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid use of these carbomers. This guidance provides recommendations for tests and documentation related to reformulation based on various routes of administration and dosage forms of affected drug products and provides recommendations for application holders on the appropriate submission types to notify FDA of reformulation changes.
• On December 27, 2023, the Office of Medicare Hearings and Appeals (OMHA) released a notice entitled, Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances—July Through September 2023. This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from July through September 2023. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
• On December 29, 2023, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Application from the Community Health Accreditation Program (CHAP) for Continued Approval of Its Home Health Agency Accreditation Program. This notice announces CMS’s decision to approve the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs.
• On December 29, 2023, the Health Resources and Services Administration (HRSA) released a notice entitled, Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas. This is the second of two planned notices informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of December 2, 2023. The lists are available on the shortage area topic page on HRSA’s data.hrsa.gov website.
• On January 2, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF). Nominations must be received electronically by March 15th of a given year to be considered for appointment to begin in January of the following year.
• On January 2, 2024, FDA released a notice entitled, Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance; Availability. This draft report responds to the Consolidated Appropriations Act of 2023 (CAA, 2023), which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices. It also directs FDA to publish a draft report and plan no later than one year after enactment of the CAA, 2023 and to consult with stakeholders in developing the report and implementation plan.
• On January 2, 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. The notice serves to notify 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 using Urine or Oral Fluid (Mandatory Guidelines).
• On January 2, 2024, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule entitled, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing. This final rule implements the Electronic Health Record (EHR) Reporting Program provision of the 21st Century Cures Act by establishing new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program). This final rule also makes several updates to certification criteria and standards recognized by the Program. The Program updates include revised certification criteria for “decision support interventions,” “patient demographics and observations,” and “electronic case reporting,” as well as a new baseline version of the United States Core Data for Interoperability (USCDI) standard to Version 3. Additionally, this final rule provides enhancements to support information sharing under the information blocking regulations. The implementation of these provisions advances interoperability, improves algorithm transparency, and supports the access, exchange, and use of electronic health information (EHI). This final rule also updates numerous technical standards in the Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs for health IT developers and users of health IT.
• On January 3, 2024, HRSA released a notice entitled, National Vaccine Injury Compensation Program, List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service Act (PHS Act), as amended. While the Secretary of the Department of Health and Human Services (HHS) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
• On January 3, 2024, HRSA released a notice entitled, Update to the Health Resources and Services Administration-Supported Women’s Preventive Services Guidelines Relating to Screening for Urinary Incontinence. A Federal Register notice published on September 29, 2023, detailed and sought public comment on recommendations under development by the Women’s Preventive Services Initiative (WPSI), regarding updates to the HRSA-supported Women’s Preventive Services Guidelines (Guidelines). The proposed updates specifically related to Screening for Urinary Incontinence. WPSI convenes health professionals to develop draft recommendations for HRSA’s consideration. On December 28, 2023, HRSA accepted as final WPSI’s recommended updates to the Screening for Urinary Incontinence guideline.
• On January 4, 2024, HRSA released a notice entitled, Update to the Bright Futures Periodicity Schedule as Part of the HRSA-Supported Preventive Services Guidelines for Infants, Children, and Adolescents. A Federal Register notice published on October 24, 2023, detailed and sought public comment on recommendations under development by the Infant, Child, and Adolescent Preventive Services (ICAPS) Program, regarding updates to the HRSA-supported preventive services guidelines for infants, children, and adolescents in the Bright Futures Periodicity Schedule footnotes. The proposed updates are related to six existing footnotes. The ICAPS Program convenes health professionals to develop draft recommendations for HRSA’s consideration. Twenty-five respondents provided comments which were received and considered as detailed below. On December 29, 2023, HRSA accepted as final the ICAPS Program’s recommended update to the six footnotes. None of the footnote updates change the HRSA-supported clinical recommendations and therefore none of these updates make any changes to coverage without cost-sharing, as each of the footnotes merely update references to the supporting evidence base for existing recommendations or adds additional descriptive text.
• On January 5, 2024, NIH released a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention listed 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.

Event Notices

• January 19, 2024: HHS announced a meeting of the 2023 Dietary Guidelines Advisory Committee. This is a virtual meeting open to the public.
• January 19, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). This is a virtual meeting open to the public.
• January 22, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
• January 24, 2024: NIH announced the Interagency Autism Coordinating Committee will hold a meeting to discuss committee business, updates, and issues related to autism research and services activities. This is a hybrid meeting open to the public.
• January 24, 2024: NIH announced the National Advisory Child Health and Human Development Council Stillbirth Working Group Meeting. This is a virtual meeting open to the public.
• January 25, 2024: HRSA announced a meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). This is a hybrid meeting open to the public.
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.
• February 1, 2024: CMS announced a virtual meeting of the Advisory Panel on Outreach and Education (APOE). This meeting is open to the public.
• February 2, 2024: FDA announced the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
• February 6, 2024: FDA announced the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee will hold a meeting that is open to the public.
• February 13-14, 2024: HHS announced a meeting of the Office of Minority Health. The meeting is open to the public. Individuals who wish to attend must register by emailing OMH-ACMH@hhs.gov by 5:00 p.m. EST on January 30, 2024. Each registrant should provide their name, affiliation, phone number, email address, days attending, and if participation is in-person or via webcast.
• February 14, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health. This meeting is open to the public, but without a public comment period. The public can join the meeting by teleconference.
• February 27, 2024: SAMHSA announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held in person.
• March 13, 2024: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.

II. Reports, Studies, & Analyses

• On December 21, 2023, the Government Accountability Office (GAO) released a report entitled, Medical Device Cybersecurity: Agencies Need to Update Agreement to Ensure Effective Coordination. GAO found that while medical device cybersecurity vulnerabilities are not often compromised, these vulnerabilities do pose a threat to hospitals and patients. While the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) are responsible for managing medical device cybersecurity, their interagency collaboration agreement has not been updated since 2018. The report highlights challenges patients, providers, and other stakeholders have in utilizing federal support to address cybersecurity threats because there is a lack of awareness of these resources and challenges understanding the government’s communication on their vulnerabilities. The report notes that FDA has recently taken greater steps to protect medical devices from cyber security risks, but recommends that FDA and CISA create a more updated agreement that reflect organization and procedural changes since 2018.
• On December 29, 2023, the HHS Office of the Inspector General (OIG) released a report entitled, Ohio Could Better Ensure That Nursing Homes Comply With Federal Requirements for Life Safety, Emergency Preparedness, and Infection Control. OIG audited 20 of the 949 nursing homes in Ohio that participate in Medicare or Medicaid to assess their compliance with CMS requirements for life safety, emergency preparedness, and infection control. The report found deficiencies at 18 of the 20 nursing homes for a total of 160 deficiencies. Of the 160 deficiencies, 47 were related to life safety, 47 were related to emergency preparedness, and 66 were related to infection control. The report cites the deficiencies as being largely due to frequent staff and management changes, limited state resources to conduct nursing home services, and lack of state requirements for nursing home staff to participate in life safety training programs.
• On January 3, 2024, the Congressional Budget Office (CBO) released a cost estimate for H.R. 3884, Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023. The bipartisan bill would authorize $8 million in annual appropriations to CDC from 2024 to 2028 to conduct research on sickle cell disease and other similar blood disorders. Comparatively, $4 million was appropriated for this work in 2023. The report estimates that the bill would cost $37 million from 2024 to 2028 and $4 million after 2028, for a total 10-year prediction of $41 million.
• On January 5, 2024, the Kaiser Family Foundation (KFF) released a report entitled, A Look at Nursing Facility Characteristics Between 2015 and 2023. KFF used public data from Nursing Home Compare to examine changes in the characteristics of nursing facilities and their residents over the years. Key findings from the report include that from 2013 to 2023, the number of nursing facilities decreased by 4 percent and the number of residents decreased by 12 percent; while acuity levels have increased, the average number of hours of care given to residents per day declined from 4.13 hours to 3.77 hours (9 percent); and the percent of nursing facilities with serious deficiencies rose by 17 percent to 26 percent, likely due to workforce issues. The report also analyzed CMS’s proposed rule on nursing staffing requirements, finding that only 19 percent of facilities currently meet the required hours for nurses and nurse aids.

III. Other Health Policy News

• On December 27, President Joe Biden issued a new presidential determination in a memorandum to the Secretary of HHS, Xavier Becerra. The determination gives HHS more authority to utilize the Defense Production Act (DPA) to increase manufacturing of essential medical projects. The determination also waives DPA’s requirement of the president to notify Congress of a shortage before taking actions address it. HHS previously announced in November 2023 that it would invest $35 million into the domestic production of materials for sterile injectables.
• On January 2, 2024, the Court of Appeals for the Fifth Circuit affirmed the District Court for the Northern District of Texas ruling in Texas v. Becerra. The Fifth Circuit found, in part, that the Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA), does not mandate physicians to provide abortions in Texas when that is the necessary stabilizing treatment for an emergency medical condition. The lawsuit was initiated after HHS issued guidance and a supporting letter stating that EMTALA requires providers to offer necessary stabilizing care for patients suffering emergency medical conditions, which might include abortion care in certain situations. In addition, the Fifth Circuit found HHS’s guidance “exceeds the statutory language” and “goes beyond EMTALA by mandating abortion.” Because the “guidance establishes or changes a substantive legal standard” the Medicare Act requires such guidance to be subject to notice and comment rulemaking. The Fifth Circuit also upheld an injunction from the district court barring enforcement of HHS’s guidance and a supporting letter in Texas and against the two groups that joined Texas in the lawsuit. Although HHS sought to narrow the injunction, claiming that the language is overbroad, the Fifth Circuit found the injunction is not overbroad, affirming the district court’s decision.

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