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 released its Skilled Nursing Facility and Inpatient Prospective Payment System final rules and HHS announced the establishment of the Office of Long COVID Research and Practice. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On July 31, 2023, the Department of Health and Human Services (HHS) issued a notice entitled, Establishment of the Office of Long COVID Research and Practice. HHS announced the establishment of the Office of Long COVID Research and Practice within the Office of the Assistant Secretary for Health (OASH). The Office will be charged with the implementation of the National Research Action Plan on Long COVID, and coordinating the whole-of-government response to the longer-term effects of COVID-19, including Long COVID and associated conditions. HHS believes coordination efforts led by the new office will strengthen the federal government’s current work and identify and fill needs in areas such as clinical guidance, partner engagement, and public education and communications.
- On July 31, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final 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 final rule updates payment rates, including implementing the second phase of the Patient Driven Payment Model (PDPM) parity adjustment recalibration. This final rule also updates the diagnosis code mappings used under PDPM, the Skilled Nursing Facility (SNF) Quality Reporting Program (QRP), and the SNF Value-Based Purchasing (VBP) Program. CMS is also eliminating the requirement for facilities to actively waive their right to a hearing in writing, treating it as a constructive waiver when the facility does not submit a request for hearing. This rule is effective October 1, 2023.
- On August 1, 2023, 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 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction. This final rule will: revise the Medicare Hospital Inpatient Prospective Payment System (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; 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); and make other policy-related changes. This final rule also revises CMS’ regulations on counting days associated with individuals eligible for certain benefits provided by section 1115 demonstrations in the Medicaid fraction of a hospital’s disproportionate patient percentage (DPP) used in the disproportionate share hospital (DSH) calculation.
- On August 2, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability. The draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver under the Prescription Drug User Fee Act (PDUFA) for certain new drug applications (NDAs) for single-entity (SE), antiretroviral (ARV), and fixed-combination (FC) ARV drug products for the treatment or prevention of human immunodeficiency virus-one (HIV-1). The draft guidance is also intended to help applicants request a barrier-to-innovation waiver under those circumstances.
- On August 2, 2023, FDA issued draft guidance entitled, Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability. This draft guidance provides recommendations for applications for single-entity ARV and ARV FC drug products for the treatment or prevention of HIV-1 infection that are intended for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR). Specifically, this draft guidance addresses versions of ARV drug products for which the individual ARV drug product components are already FDA-approved and for which substantial evidence of safety and efficacy of the specific drug product or combination drug product already exists.
- On August 3, 2023, FDA issued final guidance entitled, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Availability. This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance also details the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the process FDA intends to follow once every two years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable.
- On August 4, 2023, FDA issued final guidance entitled, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities; Guidance for Industry; Availability. This guidance provides applicants and manufacturers of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential of Nitrosamine Drug Substance-Related Impurities (NDSRIs) that could be present in drug products and recommends acceptable intake (AI) limits for NDSRIs. NDSRIs, which are a subcategory of nitrosamine impurities that share structural similarity to the active pharmaceutical ingredient (API) in drug products, typically lack compound-specific mutagenicity and carcinogenicity data to inform safety assessments. This guidance provides a recommended methodology for AI determination that uses structural features of NDSRIs to generate a predicted carcinogenic potency categorization and corresponding recommended AI limit that manufacturers and applicants can apply, in the absence of other FDA-recommended AI limits, in their evaluation of potential impurities in their drug products.
Event Notices
- August 29, 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 April 25, 2023; planned CSAP activities and programming for Fiscal Year 2024; presentations on substance use prevention priorities; and CSAP NAC discussion and public comments.
- August 29, 2023: The National Institutes of Health (NIH) announced a public meeting of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). The meeting agenda presentation, discussion, and possible finalization of the Draft Report of the Working Group on Data Science and Emerging Technology and will include discussion of next steps for NExTRAC.
- September 6-7, 2023: NIH announced a public meeting of the National Advisory Neurological Disorders and Stroke (NANDS) Council. The meeting agenda will include a report from the Director of the National Institute of Neurological Disorders And Stroke (NINDS) and updates on administrative and program developments.
- September 7, 2023: NIH announced a public meeting of the National Cancer Institute (NCI) President's Cancer Panel. The meeting agenda will feature stakeholder feedback to the President’s Cancer Panel National Cancer Plan.
- September 12-13, 2023: The Drug Enforcement Agency (DEA) announced a public listening session to receive additional input concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. Specifically, DEA is inviting all interested persons, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, and other third parties to express their views at the listening sessions concerning the advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all, the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported, and specific additional safeguards that could be placed around the prescribing of schedule II controlled substances via telemedicine.
- September 14, 2023: NIH announced a public meeting of the National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB). The meeting agenda will include a report from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), as well as reports from NIBIB staff and NACBIB members.
- September 21-22, 2023: NIH announced a public meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. The meeting agenda will include an update on progress toward implementing the recommendations of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Strategic Roadmap in the areas of replacing acute toxicity tests and advancing validation approaches; a discussion regarding the role of new approach methodologies in improving environmental health protection; and an update on National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) computational resources.
- October 18-19, 2023: FDA announced a public meeting entitled, Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies. This public meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated in response to the COVID-19 pandemic. The public meeting will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI) to bring the clinical research community together to discuss a variety of topics related to mitigating disruptions of clinical studies of medical products during disasters and public health emergencies (PHEs). The meeting format will include presentations and panel discussions.
- October 26, 2023: NIH announced a public meeting of the National Library of Medicine (NLM) Board of Scientific Counselors (BSC). The meeting will include program discussion and the presentation of an investigator report.
II. Reports, Studies & Analyses
- On July 31, 2023, the Congressional Research Service (CRS) published a report entitled, Public Health Funding and the Fiscal Responsibility Act of 2023. This report assesses the impact that the Fiscal Responsibility Act of 2023 (FRA) will have on public health funding. Within HHS, there are nine operating divisions that make up the Public Health Service (PHS), including the Administration for Strategic Preparedness and Response (ASPR) and the Centers for the Disease Control and Prevention (CDC). PHS agencies received roughly $415 billion from the five COVID-19 supplemental appropriations measures enacted in 2020 and the American Rescue Plan Act of 2021 (ARPA) budget reconciliation measure. The FRA rescinded unobligated balances across a number of agencies and federal accounts. Specifically, CRS estimated the following recissions: $9.9 billion from the Public Health and Social Services Emergency Fund Account (PHSSEF), $1.5 billion from CDC, $500 million from NIH, and $300 million from the Health Resources and Services Administration (HRSA). Overall, CRS is projecting that a number of PHS entities will see sharp decreases in funding as COVID-19 supplemental funding expires or is rescinded.
- On August 1, 2023, CRS issued a report entitled, Xylazine: Considerations for Federal Control. Xylazine is a sedative drug used in veterinary medicine and is not intended for human use. However, xylazine has been increasingly used by some individuals in combination with illicit fentanyl in order to increase its potency. Further, xylazine is not currently controlled under the Controlled Substances Act (CSA). The drug can increase the risk of fatal overdose because it can lead to respiratory depression, low blood pressure, and slowed heart rate. Further, because it is not an opioid, opioid overdose-reversal drugs like naloxone are ineffective in reversing xylazine overdoses. Since xylazine is not scheduled under the CSA, DEA does not currently have the authority to regulate it. Discussions in Congress have centered on whether to schedule xylazine, as well as what level it should be scheduled at. CRS explained that since xylazine has an accepted use in veterinary medicine, it is unlikely DEA would take steps to emergency schedule it in Schedule I. CRS added that placement in Schedule II would affect the availability and handling of xylazine, but, unlike a Schedule I placement, it would still be available for its accepted medical uses.
- On August 1, 2023, the HHS Office of Inspector General (OIG) published a report entitled, Telehealth During 2020 Helped Ensure End-Stage Renal Disease Patients Received Care, But Limited Information Related to Telehealth Was Documented. In response to the COVID-19 PHE, CMS implemented numerous waivers and flexibilities to ease access to health care services, including telehealth. OIG conducted this audit of end-stage renal disease (ESRD)-related telehealth services provided during the first year of the PHE to verify whether providers complied with Medicare requirements, determine what telehealth-related information was documented in the medical records, and further inform policymakers and other stakeholders as they consider permanent changes to telehealth policies. OIG sought to determine: (1) what information related to ESRD-related telehealth services was documented in medical records during the PHE audit period; and (2) whether the claims met certain Medicare requirements. After review, OIG found that providers documented limited information in medical records related to telehealth services, but the ESRD-related telehealth service claim lines generally met certain Medicare requirements. OIG found that in general, the only telehealth information documented in the medical records was that the service was provided via telehealth. Of 100 sampled claims, OIG found that 93 percent were billed properly, and the effect of any mistakes were minimal.
- On August 3, 2023, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a report entitled, National Uninsured Rate Reaches an All-Time Low in Early 2023. The report examines new National Health Interview Survey (NHIS) data to assess recent changes in health coverage for the population. The report found that the country’s uninsured rate hit an all-time low of 7.7 percent in the first quarter of 2023 following record breaking enrollment during the Affordable Care Act (ACA) open enrollment period. ASPE also found the uninsurance rate for young adults declined from 14.5 percent in late 2020 to 11 percent in 2023, while the uninsured rate for children, which had increased in 2019-2020, decreased from 6.4 percent in late 2020 to 4.2 percent in early 2023. Further, about 5.8 percent of adults 18-64 reported having ACA marketplace coverage in 2023, compared to 4.4 percent in 2020. ASPE did qualify the uninsured rate by explaining that the lowest uninsured rate is usually observed in the first quarter of each year, while individuals transition to new sources of coverage, or periods without insurance coverage, over the remainder of the year. Another factor ASPE noted was the expected decline in Medicaid beneficiaries throughout 2023 following the expiration of continuous enrollment provision in place during the COVID-19 PHE.
III. Other Health Policy News
- On July 31, 2023, the Center for Medicare & Medicaid Innovation (CMMI) announced the creation of the Guiding an Improved Dementia Experience (GUIDE) Model. The model is designed to improve quality of life for patients living with dementia, lessen the burden on their unpaid caregivers (i.e., family members), and enable individuals with dementia to continue living in their homes and communities. CMMI explained that the model is a response to poor health outcomes for many dementia patients, noting high rates of hospitalization, emergency department visits, and post-acute care utilization, as well as elevated rates of depression and behavioral health conditions. CMMI also highlighted that many unpaid caregivers report high levels of stress and depression, which negatively affects their health and increase their risk for serious illness, hospitalization, and mortality. The GUIDE Model will focus largely on care coordination and care management, caregiver education and support, and respite services. Specifically, the model will assign patients with dementia and their caregivers to a care navigator who will help coordinate access to services and supports, including both clinical and non-clinical services, such as meals and transportation through community-based organizations (CBOs). Further, the model will provide education on best practices to caregivers, while also facilitating connections to respite services, which allow caregivers to take short breaks from their caregiving responsibilities. Provider participants in the GUIDE Model will establish dementia care programs (DCPs) to furnish care to their dementia patient populations. Model participants will be allowed to contract with other Medicare providers/suppliers to meet are delivery requirements. The model will last for eight years and will have one track for experienced care teams and another track for inexperienced care teams. The application for the GUIDE Model is expected to be released in Fall 2023, and the model will begin in July 2024. More information on this announcement can be found here.
- On July 31, 2023, the Indian Health Service (IHS) announced that it was allocating $2.5 million in funding to combat food insecurity in tribal communities. The funding will develop the IHS Produce Prescription Pilot Program, which aims to lower rates of food insecurity and improve health care outcomes in American Indian and Alaska Native populations by increasing access to produce and other traditional foods within Native communities. IHS noted that the Produce Prescription Pilot Program is an extension of the Biden Administration’s National Strategy on Hunger, Nutrition, and Health, which has set a goal of eliminating hunger and increasing healthy eating and physical activity by 2030 so fewer Americans experience diet-related diseases. Five tribes and tribal organizations received $500,000 each to establish pilot programs in their communities. More information on this funding can be found here.
- On August 2, 2023, CMS wrote a letter to state Medicaid Directors explaining that states can continue their home-and community-based services (HCBS) Appendix K waivers past November 11, 2023, when the COVID-19 PHE-era waivers are currently set to expire. The Appendix K waivers are valid as long as states apply to fold them into their Section 1915(c) waiver programs. States must only have submitted their extension application by November 11, 2023 in order to continue their HCBS Appendix K waivers, as CMS stated that it is unlikely it will be able to review all state waiver extension applications by that time. Extending Appendix K authority will also mean that states are still responsible for maintaining the temporary changes to HCBS eligibility, covered services, and/or payment rates approved in the applicable Appendix K and in effect on April 1, 2021, in order to comply with maintenance of effort requirements. More information on this action can be found here.
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