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, President Biden issued an Executive Order on securing access to reproductive and other health care services and HHS announced a public health emergency in response to the ongoing monkeypox outbreak. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On August 1, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Policy Regarding N-acetyl-L-cysteine; Guidance for Industry; Availability. This guidance explains FDA’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) and are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and that are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- On August 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare 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 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation. This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; and update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition, it will establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; and update policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital-Acquired Condition (HAC) Reduction Program, PPS-Exempt Cancer Hospital Reporting (PCHQR) Program, and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP). It will also revise the hospital and CAH conditions of participation (CoPs) for infection prevention and control and antibiotic stewardship programs; and codify and clarify policies related to the costs incurred for qualified and non-qualified deferred compensation plans. Lastly, this final rule will provide updates on the Rural Community Hospital Demonstration Program and the Frontier Community Health Integration Project (FCHIP).
- On August 2, 2022, the National Institutes of Health (NIH) issued a request for information (RFI) entitled, NIH RFI on NIH-Wide Strategic Plan for Research on the Health of Women. NIH’s Office of Research on Women’s Health (ORWH) is updating the NIH Strategic Plan for Research on the Health of Women. NIH is soliciting input from the basic, clinical, and translational scientists; advocacy and patient communities; and the public on topics under consideration for the next strategic plan. Responses to the RFI are due on September 29, 2022.
- On August 2, 2022, FDA issued draft and revised guidance entitled, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability. The guidances in this notice represent FDA’s current thinking on and provide product-specific recommendations regarding, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
- On August 2, 2022, FDA issued draft guidance entitled, Electronic Submission of Expedited Safety Reports from Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability. This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/BE studies through the FDA Adverse Event Reporting System (FAERS) database.
- On August 4, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the Safety and Occupational Health Study Section (SOHSS). SOHSS consists of 20 experts in fields associated with occupational medicine and nursing, industrial hygiene, occupational safety and engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, economic science, psychology, pulmonary pathology/physiology, and social science. Nominations for membership on SOHSS must be received no later than September 1, 2022.
- August 23, 2022: CDC announced a public meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). The agenda will include updates on the following: the Healthcare Personnel Guideline Workgroup; Isolation Precautions Guideline Workgroup; Neonatal Intensive Care Unit Guideline Workgroup; and Neonatal Pediatric Surveillance Workgroup.
- August 30-31, 2022: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The agenda will include a presentation on phase one of the Krabbe disease evidence review, a presentation and Committee discussion on the infant formula shortage, a presentation and Committee discussion on advancing the newborn screening system, a presentation on the Long-term Follow-up for Severe Combined Immunodeficiency and Other Newborn Screening Conditions Program, and Workgroup updates.
- September 7, 2022: FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The committee will discuss new drug application (NDA) 216660, for sodium phenylbutyrate/taurursodiol (AMX0035) powder for oral suspension, submitted by Amylyx Pharmaceuticals Inc., for the treatment of amyotrophic lateral sclerosis.
- September 8-9, 2022: NIH announced a public meeting of the Council of Councils. The agenda will include an NIH program update, scientific talks, and updates regarding other business of the Committee.
- September 21-22, 2022: NIH announced a public meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). The agenda will include discussions of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAMs) accomplishments in 2022; implementation of the strategic roadmap: incorporation of alternatives and associated metrics; and validation and establishing scientific confidence in new approach methodologies.
- September 22, 2022: NIH announced a public meeting of the National Center for Advancing Translational Sciences Advisory Council. The agenda will include discussions regarding a report from the Institute director, program updates, and Clearance of Concepts.
II. Congressional Hearings
- On August 3, 2022, the Senate Committee on Homeland Security and Governmental Affairs Subcommittee on Emerging Threats and Spending Oversight held a hearing entitled, Revisiting Gain of Function Research: What the Pandemic Taught Us and Where Do We Go From Here. Witnesses present included: Dr. Richard Ebright, Laboratory Director, Waksman Institute of Microbiology, Rutgers University; Dr. Steven Quay, Chief Executive Officer, Atossa Therapeutics, Inc.; and Dr. Kevin Esvelt, Assistant Professor of Media Arts and Sciences, MIT Media Lab.
- On August 3, 2022, the Senate Committee on Finance held a hearing entitled, A System in Need of Repair: Addressing Organizational Failures of the U.S.’s Organ Procurement and Transplantation Network. Witnesses present included: Brian Shepard, Chief Executive Officer, United Network for Organ Sharing (UNOS); Diane Brockmeier, RN, President And CEO, Mid-America Transplant; Barry Friedman, RN, Executive Director, AdventHealth Transplant Institute; Calvin Henry, Region 3 Patient Affairs Committee Representative, Organ Procurement and Transplantation Network (OPTN); and Dr. Jayme Locke, Director, Division of Transplantation, Heersink School of Medicine, University of Alabama at Birmingham.
III. Reports, Studies & Analyses
- On August 2, 2022, the Department of Health and Human Services (HHS) published a report entitled, National Uninsured Rate Reaches All-Time Low in Early 2022. The report found that the national uninsured rate had reached an all-time low of 8 percent in early 2022. The report, using data from the National Health Interview Survey and American Community Survey, found that 5.2 million people had gained health insurance coverage since 2020. The report identifies Biden Administration policies such as American Rescue Plan (ARP) Act Marketplace subsidies and Medicaid continuous enrollment requirements during the COVID-19 public health emergency (PHE), as well as several recent state Medicaid expansions, as key drivers of increased insurance coverage. Other key findings from the report include a drop in the uninsured rate among adults aged 18-64 from 14.5 percent in late 2020 to 11.8 percent in early 2022. The uninsured rate in children ages 0-17 also fell from 6.4 percent in late 2020 to 3.7 percent in early 2022. Further, there were approximately two million additional adult Marketplace enrollees in early 2022 compared to 2020, which accounts for around half of the four million adults who gained health insurance coverage during that time period.
- On August 3, 2022, the Congressional Budget Office (CBO) published a cost estimate entitled, Estimated Budgetary Effects of H.R. 5376, the Inflation Reduction Act of 2022. In the report, CBO forecasted that the legislation will lead to a net deficit decrease of more than $102 billion over the next ten years. The deficit reduction number calculated by CBO does not include the expected $204 billion tax revenue gained from increased Internal Revenue Service (IRS) enforcement.
- On August 3, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Analysis of Recent National Trends in Medicaid and CHIP Enrollment. This report looks at national and state-by-state Medicaid and Children’s Health Insurance Program (CHIP) enrollment data through April 2022. After declines in enrollment from 2017 through 2019, preliminary data for April 2022 showed that total Medicaid/CHIP enrollment grew to 88.3 million, an increase of 17.0 million from enrollment in February 2020 (23.9 percent), right before the pandemic and when enrollment began to steadily increase. The report found that while enrollment has increased for 26 consecutive months, the monthly increases appear to be slowing compared to early in the pandemic.
IV. Other Health Policy News
- On August 1, 2022, HHS announced guidance on a new Medicaid health home benefit for children with medically complex conditions. This new optional benefit is intended to help state Medicaid programs provide Medicaid-eligible children who have medically complex conditions with person-centered care management, care coordination, and patient and family support. The guidance provides information to states about the new health home benefit, including about payment methodologies, provider standards, provider and state reporting, state monitoring, and state assurance requirements. States with approved Medicaid state plan amendments (SPAs) to cover the new health home benefit will receive a 15-percentage point increase in federal matching for their expenditures on health home services during the first two fiscal year quarters that the SPA is in effect. CMS also has committed to offer ongoing technical assistance to states to implement the new benefit. More information on this announcement can be found here.
- On August 3, 2022, as part of the first meeting of Vice President Harris’ Task Force on Reproductive Healthcare Access, President Biden issued an Executive Order (EO) on Securing Access to Reproductive and Other Healthcare Services. As part of the EO, President Biden directed HHS to consider actions it can take to support access to reproductive health care services for patients who travel out-of-state to receive reproductive care. The President specifically identified Medicaid as an avenue through which HHS could advance access to reproductive health care services. Additionally, the EO directs HHS to ensure health care providers comply with federal non-discrimination laws to prevent delays in individuals’ access to reproductive health care services. The EO states that HHS could ensure health care providers comply with the federal non-discrimination law by issuing guidance to providers on their obligations and pursuing proper enforcement actions in response to complaints or reports of non-compliance. The EO also directs HHS to enhance research, data collection, and data analysis efforts at NIH and CDC to measure the impact that reduced access to reproductive health care services has on maternal health and other health outcomes. More information on this Executive Order can be found here.
- On August 3, 2022, HHS announced the release of two reports in response to President Biden’s April 2022 directive to federal agencies entitled, Memorandum on Addressing the Long-Term Effects of COVID-19. The first report, the National Research Action Plan on Long COVID, provides an overview of current Long COVID research and develops a path for future research to help prevent and treat Long COVID. The report emphasizes several guiding principles to focus the federal government’s Long COVID data analysis work such as: health equity, accelerating and expanding current research, orienting the research effort to improve patient care, and partner engagement. The second report, Services and Supports for Longer-Term Impacts of COVID-19, outlines federal services that address the longer-term effects of COVID-19, including Long COVID. The report provides information on federal resources and supports for those suffering from Long COVID, resources for health care providers treating patients with Long COVID, and available services for those experiencing mental health, substance use, and bereavement challenges. More information on this announcement can be found here.
- On August 4, 2022, HHS announced the declaration of a PHE in response to the ongoing spread of the monkeypox virus in the U.S. The PHE declaration is in concert with FDA’s work to explore new strategies that could help get vaccines to affected communities across the country, including using a new dose-sparing approach that could increase the number of doses available up to five-fold. The PHE also carries important implications for data-sharing with the federal government. Fifty-one jurisdictions have already signed data-use agreements that will provide CDC with information related to vaccine administration. Furthermore, CMS has additional authority to collect testing and hospitalization data. More information on this announcement can be found here.
- On August 4, 2022, HRSA announced the distribution of additional payments from the Provider Relief Fund (PRF) Phase 4 and ARP Rural distributions. HRSA is making nearly $900 million in PRF Phase 4 payments to more than 830 providers, in addition to about $232 million in ARP Rural payments going to approximately 330 providers. The PRF was established to help hospitals, nursing homes and other health care providers pay for COVID-19-related expenses and offset revenue losses from postponing elective procedures. More information on this funding can be found here.
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