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, CMS proposed four major facility payment rules and issued the Medicare Advantage Part D Final Rule. Plus, NIH released a National Cancer Plan to reduce cancer deaths and advance treatments. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On April 3, 2023, the Food and Drug Administration (FDA) issued a request for information (RFI) entitled, In-Home Disposal Systems for Opioid Analgesics. FDA is announcing the establishment of a docket to obtain information and comments that will assist the Agency in assessing whether in-home disposal products can be expected to meet the public health goal of mitigating the risk of nonmedical use or overdose if the Agency were to require drug manufacturers to make in-home disposal products available to patients under a risk evaluation and mitigation strategy (REMS). The Agency would like information and comments on the issues to be discussed at the public workshop convened by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation entitled “Defining and Evaluating In-Home Disposal Systems for Opioid Analgesics” on June 26 and 27, 2023. Comments must be received by August 28, 2023.
- On April 3, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Requests for Nominations: Organizations to Serve as Non-Voting Liaison Representatives to the Advisory Committee on Women's Services Subcommittee on Maternal Mental Health. SAMHSA is soliciting nominations from qualified organizations to be considered for non-voting liaison representative positions on a subcommittee of the Advisory Committee for Women’s Services (ACWS) focused on maternal mental health. The ACWS subcommittee will consist of five non-voting liaison representatives who are nominated by their organizations to serve as the representatives of their organizations and selected by the ACWS Designated Federal Officer (DFO). The ACWS’s role is to advise the Associate Administrator for Women’s Services (AAWS) on appropriate activities to be undertaken by the agencies of the Administration with respect to women’s substance use and mental health services, including services which require a multidisciplinary approach. These may include discussion on the development of policies and programs regarding women’s issues; plans to standardize and enhance the collection of data on women’s health, and other emerging issues concerning women’s substance use and mental health services. In particular, this subcommittee will focus on maternal mental health issues (which includes substance use) including prevention, screening, diagnosis, treatment, equity and community-based interventions. Nominations must be received no later than 5 p.m. ET on April 10, 2023.
- On April 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program: Fiscal Year 2024 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice Quality Reporting Program Requirements, and Hospice Certifying Physician Provider Enrollment Requirements. This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for fiscal year (FY) 2024. This rule includes information on hospice utilization trends and solicits comments regarding information related to the provision of higher levels of hospice care; spending patterns for non-hospice services provided during the election of the hospice benefit; ownership transparency; equipping patients and caregivers with information to inform hospice selection; and ways to examine health equity under the hospice benefit. This rule also proposes conforming regulations text changes related to the anticipated expiration of the COVID-19 public health emergency (PHE). In addition, this rule proposes updates to the Hospice Quality Reporting Program; discusses the Hospice Outcomes and Patient Evaluation tool; provides an update on Health Equity and future quality measures; and provides updates on the Consumer Assessment of Healthcare Providers and Systems (CAHPS), Hospice Survey Mode Experiment. This rule also proposes to codify hospice data submission thresholds and discusses updates to hospice survey and enforcement procedures. Additionally, the rule proposes to require hospice certifying physicians to be Medicare-enrolled or to have validly opted-out.
- On April 3, 2023, CMS issued a proposed rule entitled, Medicare Program: Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program. This proposed rule proposes updates to the prospective payment rates for inpatient rehabilitation facilities (IRFs) for FY 2024. As required by statute, this proposed rule includes the proposed classification and weighting factors for the IRF prospective payment system’s case-mix groups and a description of the methodologies and data used in computing the proposed prospective payment rates for FY 2024. It also proposes to rebase and revise the IRF market basket to reflect a 2021 base year. It also would modify the regulation regarding when IRF units can become excluded and paid under the IRF PPS. This proposed rule also includes updates for the IRF Quality Reporting Program (QRP). Comments on the proposed rule must be received by June 2, 2023
- On April 4, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Laboratory Recommendations for Syphilis Testing in the United States. CDC announces the opening of a docket to obtain comment on the proposed Laboratory Recommendations for Syphilis Testing in the United States. The proposed recommendations for syphilis testing include laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results. The recommendations are intended to aid laboratorians and clinicians in the diagnosis of syphilis. These proposed recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients in the U.S. Comments on the proposed recommendations are due June 4, 2023.
- On April 4, 2023, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the federal advisory committee, ACBTSA. This announcement is to solicit nominations of qualified candidates to five public member positions on the ACBTSA. Qualified individuals will be nominated to the Secretary of HHS for consideration of appointment as members of the ACBTSA. Members are invited to serve on the Committee for up to four-year terms. The Committee was established to provide advice to the Secretary on a range of policy issues related to blood, blood products, and tissues. The functions of the Committee are solely advisory in nature. Nominations for membership on the ACBTSA must be received no later than 5:00 pm ET on May 5, 2023.
- On April 4, 2023, HHS issued a notice entitled, Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council also provides feedback on a National Plan to Address Alzheimer's disease. HHS is soliciting nominations for six new non-federal members of the Advisory Council to replace the six members whose terms will end September 30, 2023. Non-federal members of the council represent six categories of people impacted by dementia: 12 non-federal members selected by the Secretary who represent 6 categories of people impacted by dementia: (1) dementia caregivers; (2) health care providers; (3) representatives of State or local health departments; (4) researchers with dementia-related expertise in basic, translational, clinical, or drug development science; (5) voluntary health association representatives; and (6) dementia patient advocates, including one advocate who is currently living with dementia. Nominations must be received by 5:00 pm ET on April 28, 2023.
- On April 4, 2023, CMS issued a proposed rule entitled, Medicare Program: FY 2024 Inpatient Psychiatric Facilities Prospective Payment System - Rate Update. This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These proposed changes would be effective for IPF discharges occurring during FY 2024. In addition, this proposed rule discusses proposals on quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program with proposed changes beginning with the FY 2024 payment determination through changes beginning with the FY 2028 payment determination. Comments on the proposed rule must be received by June 5, 2023.
- On April 4, 2023, CMS issued a proposed rule entitled, Medicare Program: Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024. This proposed rule would update payment rates, including implementing the second phase of the Patient Driven Payment Model (PDPM) parity adjustment recalibration. This proposed rule also proposes updates to the diagnosis code mappings used under PDPM, the SNF QRP, and the SNF Value-Based Purchasing (VBP) Program. CMS is also proposing to eliminate the requirement for facilities to actively waive their right to a hearing in writing, instead treating the failure to submit a timely request for a hearing as a constructive waiver. Comments on the proposed rule must be received by June 5, 2023.
- On April 5, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents. AHRQ is seeking scientific information submissions from the public to inform AHRQ’s review on Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Specifically, the Agency is looking for studies that report on psychosocial and pharmacologic interventions for disruptive behavior in children and adolescents, including those that describe adverse events. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On April 5, 2023, FDA issued draft guidance entitled, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making. This draft guidance is the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.
- On April 5, 2023, FDA issued draft guidance entitled, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its efforts to prevent or mitigate shortages. The draft guidance also explains how FDA communicates information about products in shortage to the public. This draft guidance is not final nor is it in effect at this time.
- On April 5, 2023, FDA issued a notice entitled, List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the FD&C Act. FDA is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients (APIs)) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the FD&C Act provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and is including on the list at this time: quinacrine hydrochloride (HCl) to compound drug products for oral use only. This notice also identifies 10 bulk drug substances that FDA has considered and is not including on the list at this time: hydroxyzine HCl, mannitol, methacholine chloride, metoclopramide HCl, nalbuphine HCl, potassium acetate, procainamide HCl, sodium bicarbonate, sodium nitroprusside, and verapamil HCl. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.
- On April 5, 2023, CMS issued a final rule entitled, Medicare Program: Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly. This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021 (CAA, 2021), section 11404 of the Inflation Reduction Act (IRA), and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.
- April 25, 2023: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 8, 2022; presentations on substance use prevention priorities and CSAP program developments; and CSAP NAC discussion and public comments.
- May 4-5, 2023: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). During this meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items may include the following topics: (1) ACHDNC committee processes including prioritization and capacity of reviewing initial nominations; (2) criteria for pilot studies related to newborn screening; (3) CDC’s Enhancing Data Driven Disease Detection in Newborns (ED3N) Project; and (4) ACHDNC decision matrix.
- May 9-10, 2023: The National Institutes of Health (NIH) announced a partially open meeting of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Advisory Council (NAC); the National Cancer Institute (NCI) Advisory Board; and the National Institute on Drug Abuse (NIDA) National Advisory Council (NAC). The open agendas will include presentations and other business of the NIAAA, NAC; presentations of the NIAAA, NCI, and NIDA; NIAAA’s director’s update; scientific reports; and other topics within the scope of the Collaborative Research on Addiction at NIH (CRAN). The closed agenda will include review and evaluation of grant applications.
- May 12, 2023: NIH announced a public meeting of the Board of Scientific Counselors (BSC) Chairs Meeting, Office of the Director (OD). The meeting will include a discussion of policies and procedures that apply to the regular review of NIH intramural scientists and their work.
- May 18-19, 2023: NIH announced a partially open meeting of the National Institute on Deafness and Other Communication Disorders (NIDCD) National Advisory Council (NAC). The open agenda will include staff reports on divisional, programmatical, and special activities. The closed agenda will include review and evaluation of grant applications.
- May 31-June 1, 2023: NIH announced a partially open meeting of the National Institute of Neurological Disorders and Stroke (NINDS) National Advisory Council (NAC). The open agenda will include a report by the director of NINDS; a report by the director of the Division of Extramural Activities; and discussion on administrative and program developments. The closed agenda will include review and evaluation of grant applications.
- June 5, 2023: NIH announced a partially public meeting of the National Institute of Allergy and Infectious Diseases (NIAID) National Advisory Council (NAC). The first part of the open agenda will include a report from the Institute Acting Director. The second part of the open agenda include a report from the division’s director and staff. The closed agenda will include review and evaluation of grant applications.
II. Reports, Studies & Analyses
- On April 4, 2023, the Kaiser Family Foundation (KFF) published a report entitled, Explaining Litigation Challenging the ACA’s Preventive Services Requirements: Braidwood Management Inc. v. Becerra. In this case, Braidwood Management v. Becerra, Christian-owned businesses and individuals challenge the Affordable Care Act (ACA) requirement that most private insurance plans cover recommended preventive care services without cost sharing. They assert that: (1) the requirement for the U.S. Preventive Services Task Force (USPSTF), the CDC’s Advisory Committee on Immunization Practices (ACIP), and HRSA to recommend covered preventive services is unconstitutional and (2) that requiring coverage of preexposure prophylaxis (PrEP), medication for HIV prevention, violates the Religious Freedom Restoration Act. The authors discuss potential implications for people’s access to preventative services and PrEP depending on how the court rules. Specifically, the authors express concern that overturning these ACA requirements could create immense barriers to accessing health care and result in a difficult-to-navigate patchwork system of care. The authors note that regardless of how the court rules, both parties are likely to appeal and advance this case to the Supreme Court.
- On April 4, 2023, KFF and the Georgetown University Center for Children and Families (CCF) updated their report entitled, Medicaid and CHIP Eligibility, Enrollment, and Renewal Policies as States Prepare for the Unwinding of the Pandemic-Era Continuous Enrollment Provision. This report reflects KFF’s and CCF’s findings from their 21st annual survey of state Medicaid and Children’s Health Insurance Program (CHIP) program officials. The report describes some of the critical issues facing state Medicaid and CHIP officials, including their programs’ plans to prepare for the end of the Medicaid continuous enrollment provision on March 31, 2023. Most Medicaid and CHIP officials reported that their states are waiting until March or April to initiate their unwinding plans and that they plan to spread renewals over 12 to 14 months. Also, approximately half of the state officials said their states have been flagging individuals who may no longer be eligible or who did not respond to renewal requests. Aside from the Medicaid continuous enrollment discussion, the report also highlighted recent changes in state Medicaid and CHIP eligibility policies. For example, South Dakota recently adopted a ballot initiative to adopt Medicaid expansion under the Affordable Care Act (ACA), and more than two-thirds of states (37) have now extended or plan to extend postpartum coverage for a full 12-months post pregnancy.
III. Other Health Policy News
- On April 3, 2023, the Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the NIH’s NCI. The plan provides a framework for achieving the Cancer Moonshot goal of reducing the cancer death rate by 50 percent within 25 years. The plan includes eight goals and strategies that outline strategies to prevent cancers, reduce deaths, and improve the lives of patients after a diagnosis of cancer. The eight goals are: (1) prevent cancer, (2) detect cancers early, (3) develop effective treatments, (4) eliminate inequities, (5) deliver optimal care, (6) engage every person, (7) maximize data utility, and (8) optimize the workforce. The plan calls for collaboration across all sectors of society and government to work together to address and improve cancer incidence and outcomes. More information on this announcement can be found here.
- On April 4, 2023, it was announced that the National Institute on Aging (NIA), part of NIH, is providing up to $300 million to fund a six-year project to build an Alzheimer's disease research database. The database will enable researchers to access long-term health information of 70 to 90 percent of the U.S. population – before and after patients may be diagnosed – to advance scientific understanding of Alzheimer’s disease and related dementias. The database may also help identify early risk factors and mitigate disparities related to the underrepresentation of certain populations in clinical trials and treatments. More information on this announcement can be found here.
- On April 5, 2023, HHS released a fact sheet outlining the progress made by the Long COVID Coordination Council, compromised of members from 14 federal agencies, in its efforts to coordinate a whole-of-government response to the longer-term effects of COVID-19. The fact sheet identifies progress made and future goals related to: (1) delivering high-quality care for individuals experiencing Long COVID; (2) promoting provider and public education on Long COVID; (3) identifying workplace supports for workers experiencing Long COVID; (4) raising awareness of Long COVID as a potential cause of disability; (5) leveraging federal data collection and analysis efforts to understand and track Long COVID; (6) and continually learning from patients, providers, and caregivers about Long COVID. The whole-of-government approach will help advance understanding, awareness, and treatment for everyone affected by Long COVID. More information on this announcement can be found here.
- On April 5, 2023, HHS’ Office for Civil Rights (OCR) reminded states of their obligations under federal civil rights laws as the COVID-19 public health emergency (PHE) comes to an end and states restart Medicaid and CHIP eligibility reviews (i.e., the redetermination process). Specifically, under certain provisions in the Civil Rights Act of 1964, the Rehabilitation Act of 1973, the Americans with Disabilities Act (ADA), and the ACA, entities receiving federal financial assistance are prohibited from discriminating on the basis of, among other things, race, color, national origin, and disability. This means people of different backgrounds must be able to fully participate in federal programs (i.e., Medicaid or Medicare). As such, OCR emphasized the importance of states prioritizing language access and effective communication to prevent people of color, individuals with limited English proficiency, or people with disabilities, from being disenrolled as a result of inaccessible communications. More information on this announcement can be found here.
- On April 6, 2023, President Biden issued an executive order (E.O.) entitled, Executive Order on Modernizing Regulatory Review. This E.O. modernizes the Office of Information and Regulatory Affairs’ (OIRA) processes to promote public interest and address national priorities by: (1) improving the effectiveness of the regulatory review process, (2) promoting inclusive regulatory policy and public participation, and (3) improving regulatory analysis. Specifically, the E.O. more stringently defines “significant regulatory action;” requires OIRA to solicit increased public participation, specifically from underserved communities, in the regulatory process; and encourages the regulatory process to assess distributive impacts and implications for equity. More information on this E.O. can be found here.
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