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 awarded $100 million to strengthen the nursing workforce, $88 million for behavioral health programs, and $30 million to expand developmental screening for children. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On August 7, 2023, the Drug Enforcement Administration (DEA) issued a final rule entitled, Dispensing of Narcotic Drugs to Relieve Acute Withdrawal Symptoms of Opioid Use Disorder. DEA is revising existing regulations to expand access to medications for the treatment of opioid use disorder (OUD) pursuant to the Easy Medication Access and Treatment for Opioid Addiction Act (the Act). The Act directed DEA to revise its regulations to allow practitioners to dispense no more than a three-day supply of narcotic drugs to one person or for one person’s use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both). The goal of the Act is to significantly expand immediate and emergency access to medications for individuals suffering from acute withdrawal symptoms while the individual awaits further, long-term treatment. DEA believes that allowing a practitioner to supply three days’ worth of narcotic drugs at one time may help reduce overdose deaths by providing a short-term maintenance level of medications while arrangements are made for further, more permanent treatment.
• On August 7, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, QTc Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability. This guidance is intended to assist applicants with incorporating corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling.
• On August 9, 2023, the National Institutes of Health (NIH) issued a notice entitled, Interagency Coordinating Committee on the Validation of Alternative Methods: Request for Comment on Draft Report on Validation, Qualification, and Acceptance of New Approach Methodologies. NIH’s Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announced the availability of a draft document entitled, Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies. This document presents key concepts of validation, qualification, and regulatory acceptance as they apply to new approach methodologies (NAMs) that include testing in a biological system (e.g., in vitro, certain in chemico, small model organisms). ICCVAM welcomes submission of innovative test methods that may be acceptable for specific regulatory uses. Acceptability for regulatory use is generally demonstrated by completion of adequate validation studies to characterize the usefulness and limitations of a test method in accordance with ICCVAM test method submission guidelines. ICCVAM will accept public comments on the document through September 5, 2023.
• On August 9, 2023, NIH issued a notice entitled, National Institutes of Health (NIH) Office of Science Policy (OSP): Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). NIH is seeking input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMO) in contained research settings. NIH is proposing to update the NIH Guidelines to clarify minimum containment requirements, propose considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biosafety Officers (BSOs). The proposed revisions are specific to GDMO research subject to the NIH Guidelines, conducted in contained settings and are consistent with the recommendations of the NIH Novel and Exceptional Technology Research Advisory Committee (NExTRAC) report, Gene Drives in Biomedical Research.
• On August 9, 2023, FDA issued a notice entitled, Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for Comments. FDA is seeking stakeholder comments on the development of a technology and software assessment that examines the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. FDA would like to obtain information regarding issues to be addressed in the assessment related to the accessibility of the necessary software and hardware to such dispensers; whether the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and if the necessary hardware and software can be integrated into business practices to maintain drug supply chain security.
• On August 10, 2023, FDA issued draft guidance entitled, Classification Categories for Certain Supplements Under the Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; Availability. This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.
• On August 10, 2023, FDA issued draft guidance entitled, Formal Meetings between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.
• On August 10, 2023, FDA issued draft guidance entitled, Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials; Draft Guidance for Industry; Availability. The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the post-marketing setting in historically under-represented patient populations in clinical trials. The draft guidance discusses mechanisms by which FDA can require or request that information on safety and effectiveness be collected in the post-marketing setting; design and statistical considerations for subpopulation analyses; and post-marketing approaches to obtain information on the benefit-risk profile in underrepresented clinical trial populations. FDA is also seeking dialogue from stakeholders on collaborative efforts to explore methods to enhance representation in clinical trials.

Event Notices

• September 7, 2023: NIH announced a public meeting of its Council of Councils (COC). The meeting agenda will include announcements, NIH program updates, strategic planning discussions, and other COC business.
• September 7, 2023: NIH announced a public meeting of the National Advisory Child Health and Human Development (NACHHD) Council. The meeting agenda will include opening remarks and a discussion of administrative matters.
• September 7-8, 2023: NIH announced a public meeting of the National Institute of Mental Health (NIMH) National Advisory Mental Health Council (NAMHC). The meeting agenda will include a report from the NIMH Director and a discussion of NIMH programs.
• September 7-8, 2023: FDA announced a public meeting of the Microbiology Devices Panel (MDP) of the Medical Devices Advisory Committee (MDAC). The MDP will meet to discuss and provide advice to FDA on in vitro diagnostic devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA).
• September 11, 2023: NIH announced a public meeting of the National Institute of Allergy and Infectious Diseases (NIAID) National Advisory Allergy and Infectious Diseases Council. The meeting agenda will include reports from the acting NIAID Director, a Division Director, and Division staff.
• September 11, 2023: NIH announced a public meeting of the NIAID AIDS Research Advisory Committee. The meeting agenda will include a report from a NIAID Division Director and from Division staff.
• September 12, 2023: NIH announced a public meeting of the National Institute of Nursing Research (NINR) National Advisory Council for Nursing Research (NACNR). The meeting agenda will include a report from the NINR Director, as well as discussions regarding the Community Partnerships to Advance Science for Society (ComPASS) Initiative and the Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) Program.
• September 12-13, 2023: NIH announced a public meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). The meeting agenda will include opening remarks, consideration of June 2023 meeting minutes, and reports from various program directors.
• September 14-15, 2023: NIH announced a public meeting of the National Institute on Deafness and Other Communication Disorders (NIDCD) National Deafness and Other Communication Disorders Advisory Council (NDCDAC). The meeting agenda will include NIDCD staff reports on divisional, programmatical, and special activities.
• September 19, 2023: The Department of Health and Human Services (HHS) announced a joint public meeting of the National Advisory Committee on Seniors and Disasters (NACSD) and the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). NACSD and NACIDD provide expert advice and guidance to HHS regarding the specific needs of older adults and people with disabilities, respectively, related to disaster preparedness and response.
• October 11, 2023: NIH announced a public meeting of the Interagency Autism Coordinating Committee (IACC). The meeting agenda will include discussion of business, updates, and issues related to autism research and services activities.

II. Reports, Studies & Analyses

• On August 9, 2023, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicare Advantage in 2023: Premiums, Out-of-Pocket Limits, Cost Sharing, Supplemental Benefits, Prior Authorization, and Star Ratings. The issue brief provides background information about Medicare Advantage (MA) plans in 2023, including premiums, cost sharing, out-of-pocket limits, supplemental benefits, prior authorization, and star ratings, as well as trends over time. Of note, KFF found that 73 percent of enrollees in individual MA plans offering prescription drug coverage do not pay a premium other than the Medicare Part B premium. Further, the issue brief illustrates how MA-Part D (MA-PD) premiums have declined from an average of $36 per month in 2015 to $15 per month in 2023. Additionally, KFF found that nearly all MA plan enrollees have access to benefits that are not available to enrollees in Traditional Medicare. For example, between 98 and 99 percent of MA enrollees have access to eye exams and/or glasses, hearing exams and/or aids, a fitness benefit, telehealth services, and dental care. The issue brief also highlights how approximately 99 percent of MA enrollees are covered by plans that require prior authorization for some services. Finally, KFF’s analysis shows that 70 percent of MA enrollees are in plans that have scored a 4 stars or higher rating in 2023 (1-5 scale).
• On August 9, 2023, Alston & Bird published the latest edition of its Healthy Byte series entitled, Healthy Byte: How the New CMS Clarifications Will Affect Your RPM and RTM Services. Alston & Bird’s Tania Khan and Sean Sullivan discussed how in the 2024 Physician Fee Schedule (PFS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) provided some clarifications on coverage and reimbursement for various types of remote patient monitoring, including remote physiologic monitoring (RPM), and remote therapeutic monitoring (RTM). Further, they examined how CMS reinforced existing guidelines and billing requirements for RPM and RTM services, as well as what aspects of CMS regulations remain unclear. They also discussed how stakeholders can submit comments before CMS finalizes the PFS proposed rule later this year. Comments are due on September 11, 2023.
• On August 9, 2023, the Congressional Research Service (CRS) published a report entitled, Medicare Secondary Payer: Coordination of Benefits. While Medicare is typically the primary payer for its enrollees, there are instances where the program is considered the secondary payer. In these cases, federal Medicare Secondary Payer (MSP) law prohibits Medicare from making payments for an item or service when payment has been made, or can reasonably be expected to be made, by another insurer such as a liability plan. Typically, Medicare is the secondary payer for beneficiaries who are also covered through: (1) a group health plan (GHP), based on their own or their spouse’s current employment; (2) auto and other liability insurance; (3) no-fault liability insurance; and (4) workers’ compensation programs, including the Federal Black Lung Program. The Medicare program is also prohibited from making payments for items or services paid for by a different government entity, such as the Department of Veterans Affairs (VA). In this report, CRS examined the MSP system, reporting requirements, beneficiary responsibility, payer liability issues, and issues for Congress. Specifically, CRS assessed who takes on the role of primary payer in certain scenarios between the Medicare Program and other payers such as GHPs, MA plans, TRICARE, and the VA. CRS also identified bills since 1980 that have had an impact on the MSP program, including the Medicare, Medicaid & SCHIP Extension Act of 2007, which implemented new reporting requirements MSP services.
• On August 11, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Medicare Paid Independent Organ Procurement Organizations Over Half a Million Dollars for Professional and Public Education Overhead Costs That Did Not Meet Medicare Requirements. Organ procurement organizations (OPOs) perform or coordinate the procurement and preservation of organs, such as kidneys, as well as transportation of organs to hospitals for transplantation into patients on the transplant waiting list. OIG conducted this audit to assess whether independent OPOs’ professional and public education overhead costs met Medicare requirements. OIG assessed 300 sampled professional and public education overhead costs, with 264 costs meeting federal requirements. The remaining 36 costs, totaling $15,852 (with Medicare payments of $6,423), did not meet Medicare requirements and were therefore unallowable. After extrapolating the sample data, OIG estimated that $664,295 of the $50.9 million paid for professional and public education overhead costs was unallowable. OIG found that the OPOs reported unallowable expenses because they misunderstood Medicare requirements and staff made administrative errors. OIG is recommending that CMS: (1) instruct the Medicare administrative contractor (MAC) to recover $72,208 in unallowable Medicare payments by adjusting the applicable OPOs’ Medicare cost reports to correct the $148,750 of unallowable professional and public education overhead costs reported; and (2) update applicable Medicare requirements to clarify which types of professional and public education overhead costs are unallowable, which could have saved Medicare an estimated $664,295 for professional and public education overhead costs during its audit period.

III. Other Health Policy News

• On August 9, 2023, HHS announced that its Office of Climate Change and Health Equity (OCCHE), in partnership with the National Highway Traffic Safety Administration (NHTSA), was launching an online information portal called the Heat-Related Illness EMS Activation Surveillance Dashboard (EMS HeatTracker). The EMS HeatTracker will map emergency medical services (EMS) responses to heat-related illness across the country in order to help facilitate the delivery of outreach and medical aid to populations with the most need. When implemented, the EMS HeatTracker will be used to help state, regional, and local government officials, such as city and regional planners, determine where to prioritize heat mitigation strategies, like street trees, parks, and cool roofs. It will also help public officials plan where to construct heat interventions such as cooling centers. In addition to showing state and county-level heat-related EMS activations, the dashboard will break down patient characteristics by age, race, gender, and urbanicity (e.g., urban, suburban, rural, and frontier). The information on the EMS HeatTracker will be updated every Monday morning with a two-week lag behind real time. More information on this announcement can be found here.
• On August 9, 2023, the Health Resources and Services Administration (HRSA) announced that it had awarded $30 million in funding to 151 community health centers (CHCs). Notably, in 2022, CHCs furnished care for more than 30 million patients, including 20 percent of residents in rural areas. The funding is intended to improve developmental outcomes for children ages 0-5 through increased health screenings and more comprehensive follow-up services. HRSA emphasized that supporting a strengthened CHC screening infrastructure for children is critical to reducing gaps in school readiness and improving a child’s ability to succeed. HRSA noted that when providers combine developmental surveillance and developmental screening, the likelihood of identifying a developmental delay or behavioral concern increases by up to 90 percent. Additionally, development health promotion can help avoid or mitigate factors that could negatively influence childhood development, such as adverse childhood experiences in the home, financial instability, unhealthy neighborhoods, or housing conditions. CHCs will utilize HRSA-funding in the following four areas: (1) workforce recruitment, retention, development, and engagement; (2) patient/caregiver experience; (3) access and affordability; and (4) population health and health-related social needs. More information on this announcement can be found here.
• On August 10, 2023, HRSA announced that it had awarded over $100 million in funding to expand the nursing workforce. The funding will be directed towards meeting the growing need for registered nurses (RNs), nurse practitioners (NPs), certified nurse midwives, and nurse faculty. Specifically, HRSA is allocating $8.7 million for the Nurse Education, Practice, Quality and Retention-Pathway to Registered Nurse Program, which facilitates training for licensed practical nurses and licensed vocational nurses to become registered nurses. Further, $34.8 million was awarded through the Advanced Nursing Education Workforce Program, which aims to increase the number of primary care NPs, clinical nurse specialists, and certified nurse midwives trained to furnish primary care, mental health and SUD, and/or maternal health care services. An additional $30 million was awarded to the Advanced Nursing Education-Nurse Practitioner Residency and Fellowship Program, in order to support residency and fellowship programs for nurses trained in primary care. Finally, HRSA awarded $26.5 million through the Nurse Faculty Loan program to help recipient schools offer low-interest loans and loan cancellation to incentivize careers as nursing school faculty. More information on this funding can be found here.
• On August 11, 2023, HHS announced that it had awarded more than $88 million in funding for various behavioral health programs, varying from efforts to develop and support school-based mental health programs and services, to multiple grant programs that will expand access to substance use disorder (SUD) treatments. The awards include $42.2 million for Project Advancing Wellness and Resiliency in Education (AWARE), which aims to develop and support school-based programs and treatments that address youth mental health. Project AWARE also provides training for education professionals and other adults who interact with school-aged youth, to help them detect and respond to mental health challenges, and help connect children and their families to needed services. Additionally, this announcement includes $17.5 million for the National Child Traumatic Stress Initiative, which is designed to upgrade treatment and services for youth who have experienced traumatic events. $4.6 million was also allocated to the Transforming Lives Through Supported Employment program, which helps individuals with co-occurring mental and SUDs find employment. Further, funds were allocated to other programs with specific focuses on getting transition-aged youth, adults with a serious mental illness or serious emotional disturbance, and homeless individuals connected to support services. More information on this funding can be found here.

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