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 announced a record level of Marketplace enrollments, and the White House issued a memorandum on protecting access to reproductive healthcare services. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On January 23, 2023, the Food and Drug Administration (FDA) issued a notice entitled, Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra. FDA is publishing this notification in light of the recent decision by the U.S. Court of Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra. The Catalyst decision addressed the orphan-drug exclusivity provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Orphan Drug Act and subsequent amendments, and concluded that FDA’s approval of Jacobus Pharmaceutical Company’s (Jacobus’s) drug (the drug at issue in the litigation) must be set aside. Consistent with the court’s decision, FDA has set aside its approval of Jacobus’s drug. This notification announces that, at this time, while complying with the court’s order in Catalyst, FDA intends to continue to apply its regulations tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved to matters beyond the scope of that order.
- On January 23, 2023, FDA issued final guidance entitled, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research; general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, intermediates, drug substances, and drug products to determine their control status. This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs. This guidance finalizes the draft guidance of the same title issued on July 22, 2020.
- On January 23, 2023, FDA issued final guidance entitled, Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This guidance describes FDA’s regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems. This guidance document is being implemented immediately to bolster access to ibuprofen oral suspension products in hospitals and health systems during the current surge in respiratory infections.
- On January 24, 2023, the Department of Health and Human Services (HHS) issued a final rule entitled, National Institutes of Health Loan Repayment Programs. HHS, through the National Institutes of Health (NIH), is updating the existing regulation for NIH Loan Repayment Programs (LRPs) to reflect the consolidation of NIH LRPs into two programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers); the direct authority of the NIH Director to administer the NIH LRPs (formerly the duty of the Secretary, HHS); and the increase in the annual loan repayment amount from a maximum of $35,000 to a maximum of $50,000.
- On January 25, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Request for Nominations and Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting. This notice invites all interested parties to submit nominations to fill vacancies on the APOE. This notice also announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of HHS and the Administrator of CMS on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public and will be held on February 9, 2023.
- On January 26, 2023, the Centers for Disease Control and Prevention (CDC) issued a request for information entitled, Proposed Update to the CDC Framework for Program Evaluation in Public Health; Extension of Comment Period. CDC announces the extension of the comment period for the update to the CDC Framework for Program Evaluation in Public Health (CDC Evaluation Framework) and associated resources (e.g., checklists, self-study guide). Comments are now due February 17, 2023.
- On January 27, 2023, FDA issued draft guidance entitled, Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry. The draft guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. This draft guidance, when finalized, will supersede the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry” dated April 2020 and updated August 2020.
Event Notices
- February 2-3, 2023: HHS announced a meeting of the National Vaccine Advisory Committee (NVAC). During this meeting, NVAC will hear presentations to support the recent charges on innovation and safety from Admiral Rachel L. Levine, MD, the Assistant Secretary for Health and Director of the National Vaccine Program. NVAC will also hear presentations on COVID-19, RSV, meningitis, and measles.
- February 7-8, 2023: NIH announced a partially open meeting of the National Advisory Mental Health Council (NAMHC). The open agenda will include a presentation of the National Institute of Mental Health (NIMH) Director's Report; discussion of NIMH programs; and a presentation of the Mental Health Board of Scientific Counselors (MHBSC) Report. The closed agenda will be for review and evaluation of grant applications.
- February 9, 2023: NIH announced a partially open meeting of the National Cancer Institute (NCI), National Cancer Advisory Board (NCAB). The open agenda will include NCAB Subcommittee Meetings; Director's and program reports and presentations; and business of the board. The closed agenda will be for review and evaluation of grant applications.
- February 22-24, 2023: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on mpox vaccines, influenza vaccines, pneumococcal vaccine, rotavirus vaccines, varicella vaccines, meningococcal vaccines, Polio vaccine, respiratory syncytial virus vaccine pediatric/maternal, respiratory syncytial virus vaccine adult, dengue vaccines, Chikungunya vaccine, and COVID-19 vaccines. Recommendation votes on mpox vaccine are scheduled. A Vaccines For Children vote on rotavirus vaccines is scheduled.
- March 7-8, 2023: CDC announced a meeting of the ICD-10 Coordination and Maintenance (C&M) Committee. The tentative agenda will include discussions on several topics related to the International Classification of Diseases, Tenth Revision (ICD-10) Clinical Modification (CM) and ICD-10 Procedure Coding System (PCS).
- March 9, 2023: HHS announced a public meeting of the National Biodefense Science Board (NBSB). The NBSB provides expert advice and guidance to HHS regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response. NBSB also will hear from members of the public, including experts from relevant biomedical, biodefense, or health industries; faculty or researchers at academic institutions; health professionals, health system experts, or those who work in health care consumer organizations; or experts in state, Tribal, territorial, or local government agencies.
- March 9, 2023: FDA announced a meeting of the Oncologic Drugs Advisory Committee (ODAC). The committee will discuss supplemental biologics license application (BLA) 761121/S-008, for POLIVY (polatuzumab vedotin-piiq) for injection, submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This product was approved under 21 CFR 601.41 (subpart E, accelerated approval regulations) for use in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, after at least two prior therapies. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a product after it receives accelerated approval. Based on the results of the POLARIX study, the committee will discuss the benefit-risk profile of POLIVY in patients with previously untreated DLBCL.
- March 20, 2023: FDA announced a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). The committees will discuss new drug application 217722, for naloxone hydrochloride nasal spray, 3 mg/0.1 mL, submitted by Harm Reduction Therapeutics, Inc. The product is proposed for nonprescription use as an opioid reversal agent in the emergency treatment of opioid overdose. The issues for discussion will be on the adequacy of the data supporting the nonprescription application. This product represents a potential first in class product in a new therapeutic category for nonprescription drugs.
- March 22, 2023: FDA announced a meeting of the Peripheral and Central Nervous System Drugs (PCNS) Advisory Committee. The committee will discuss new drug application (NDA) 215887, for tofersen (BIIB067) intrathecal injection, submitted by Biogen Inc., for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
II. Reports, Studies & Analyses
- On January 23, 2023, the Kaiser Family Foundation (KFF) published an issue brief entitled, State Policies for Expanding Medicaid Coverage of Community Health Worker (CHW) Services. Research indicates community health worker (CHW) services can greatly improve health outcomes, reduce health disparities, expand access to health care, promote health equity, and provide culturally appropriate health promotion and education to communities. As such, KFF conducted a Medicaid budget survey to understand states’ CHW coverage policies in place as of July 1, 2022 and planned for fiscal year (FY) 2023. The survey found that 29 of the 48 responding states allowed for some Medicaid payment for services provided by CHWs in 2022 and that many states also reported plans to expand Medicaid coverage of CHW services through other mechanisms (e.g., Section 1115 authorities) in 2023. States also reported efforts to implement new certification and training for CHWs and to work with stakeholders to identify best practices for expanding CHW services.
- On January 24, 2023, HHS released a report entitled, Insulin Affordability and the Inflation Reduction Act: Medicare Beneficiary Savings by State and Demographics. This report assessed the potential cost savings to Medicare beneficiaries as a result of the $35/month cap on insulin enforced by the Inflation Reduction Act (IRA). Prior to the IRA, in 2019, the national average out-of-pocket cost for Medicare beneficiaries was $63 per insulin fill. The report estimates that if the $35/month cap had been effective in 2020, total savings would have been approximately $734 million in Part D and $27 million in Part B, leading to an average savings of $500 on insulin for the year per beneficiary. The report also provides information on savings by state and by demographic characteristics (e.g., gender, race and ethnicity, age).
- On January 24, 2023, the Government Accountability Office (GAO) released a report entitled, COVID-19: HHS Funds Allocated to Support Disproportionately Affected Communities. GAO issued this study to review how HHS allocated pandemic relief funds from its Public Health and Social Services Emergency Fund (the Fund) to support communities disproportionately affected by COVID-19. Pandemic relief laws allocated nearly $75 billion of the Fund to four HHS agencies: the Centers for Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA), Indian Health Service (HIS), and Office of Minority Health (OMG). GAO found that the agencies directed $29 billion (over 35 percent) of funding to programs specifically supporting communities disproportionately affected by COVID-19 and $33 billion to programs with a recommendation that awardees support such communities with the funds. Additionally, GAO found that states reported the following challenges in utilizing distributed funds to support a range of COVID-19 response efforts in disproportionately affected communities – (1) delays in state acceptance of federal funds and (2) capacity challenges, including hiring and workload capacity issues.
- On January 24, 2023, the Congressional Research Service (CRS) published a report entitled, Health Care Provisions of the Budget Reconciliation Measure P.L. 117-169. P.L. 117-169, otherwise known as the IRA, was signed into law on August 16, 2022. This report provides an overview of the budget reconciliation process and details provisions of the IRA related to health (e.g., Medicare, Medicaid, CHIP, and private health insurance). For example, the report discusses the process in which the Secretary of HHS will now be authorized to negotiate prices for certain drugs covered under Medicare Part B and Part D, starting with 10 high-spending, single-source drugs for 2026 and increasing to 20 drugs by 2029. Additionally, the report describes that in 2023, cost-sharing for certain vaccines will be eliminated and by 2025, CMS will redesign the Part D benefit to include an annual $2,000 out-of-pocket spending cap for enrollees. The report provides both an abbreviated and detailed summary of provisions.
- On January 24, 2023, KFF published an issue brief entitled, What Happens When COVID-19 Emergency Declarations End? Implications for Coverage, Costs, and Access. There are numerous implications for the emergency declarations issued during the pandemic when the COVID-19 public health emergency (PHE) ends. This brief provides an overview of the major health-related COVID-19 federal emergency declarations and flexibilities that have been made and describes any resulting implications for their termination in the following areas: (1) coverage, costs, and payment for COVID-19 testing, treatments, and vaccines; (2) Medicaid coverage and federal match rates; (3) telehealth flexibilities offered under Medicaid and CHIP, Medicare, and cross-payers; (4) various Medicaid and CHIP flexibilities; (5) various Medicare payment and coverage flexibilities; (6) private insurance coverage flexibilities through the Consolidated Omnibus Budget Reconciliation Act (COBRA); (7) FDA emergency use authorization (EUA); and (8) liability immunity for providers to administer medical countermeasures.
- On January 25, 2023, CRS released a report entitled, The Strategic National Stockpile: Overview and Issues for Congress. The report provides background information on the Strategic National Stockpile (SNS), which consists of many health care ancillary supplies, drugs, vaccines, and medical products that can be deployed in response to a threat to public health. The report also discusses issues that may be of Congressional interest, such as: (1) the scope and purpose of the stockpile, (2) how the stockpile inventory is managed, and (3) the role of the Public Health and Emergency Medical Countermeasure Enterprise (PHEMCE), which is an interagency workgroup that makes decisions of the SNS.
- On January 25, 2023, KFF released an issue brief entitled, What Happens After People Lose Medicaid Coverage? The pandemic-era requirement that Medicaid programs keep beneficiaries continuously enrolled (for which they received enhanced federal funding) will end on March 31, 2023, as directed by the Consolidated Appropriations Act (CAA), 2023. It is expected that anywhere between five and 14 million people could lose their Medicaid coverage when the continuous enrollment provision ends. Thus, this issue brief uses data from the 2016-2019 Medical Expenditure Panel Survey (MEPS) to understand the rates of individuals who are able to enroll in alternate coverage options during the first 12 months following disenrollment from Medicaid/CHIP. KFF found that in the 12 months following disenrollment from Medicaid/CHIP, about 65 percent of people experienced a period of uninsurance and only 35 percent of people were able to secure continuous coverage. Other those 65 percent who were uninsured for some time, 17 percent were uninsured for the full year. Of the 35 percent who maintained continuous coverage, most people had a period of overlapping coverage with both Medicaid/CHIP and private health insurance before being disenrolled from their Medicaid/CHIP coverage. KFF also found that about 41 percent of people who were disenrolled from Medicaid/CHIP re-enrolled into the program within a year. KFF concluded that when the Medicaid continuous enrollment provision ends, past patterns reflect that most people who are disenrolled from the program will become uninsured for all or part of the next year.
III. Other Health Policy News
- On January 22, 2023, the White House issued a memorandum on further efforts to protect access to reproductive healthcare services. The memorandum describes FDA’s recent updates to the Risk Evaluation and Mitigation Strategies (REMS) for mifepristone, including: (1) allowing telehealth visits for prescriptions, (2) mailing options to send mifepristone to patients, (3) permanently removing a requirement that mifepristone must be dispensed in-person, and (4) allowing pharmacies to become certified to dispense mifepristone. The memorandum then highlights actions the Biden Administration has taken to further protect access abortion care, including medication abortion, through Executive Order 14076, the Department of Justice’s (DOJ) formation of a Reproductive Rights Task Force, and HHS actions to ensure non-discrimination in healthcare. More information on this memorandum can be found here.
- On January 25, 2023, HHS, through the Indian Health Service (HIS), awarded $139 million in funding for the FY 2023 Special Diabetes Program for Indians (SDPI) to provide diabetes prevention and treatment services for American Indian and Alaska Native (AI/AN) communities. The awards were made to 302 tribal, urban, and IHS sites (11 of which are being funded for the first time) in 35 states under a new five-year grant cycle that began on January 1, 2023. Research finds that programs like SDPI are able to cut rates of diabetes-related kidney failure and diabetic eye disease by half. More on this announcement can be found here.
- On January 25, 2023, the Biden Administration announced that a record-breaking 16.3 million people have signed up for coverage under an Affordable Care Act (ACA) Marketplace health plan during the 2023 Marketplace Open Enrollment Period (OEP) that ran from November 1, 2022 to January 15, 2023. This marks a 13 percent increase in the number of people signing up for health insurance from this time in 2022. 22 percent of these enrollees are new to the Marketplaces in 2023 (a 21 percent increase from 2022). These record-breaking numbers may be in part due to a competitive marketplace, with 92 percent of enrollees having three or more options when shopping for plans and four out of five enrollees being able to access plans for $10 or less after tax credits. More on this announcement can be found here.
- On January 26, 2023, the White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders (WHIAANHPI) announced a series of regional economic summits to connect Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) community members directly with federal leaders and resources. The series aims to empower the AA and NHPI communities by fostering collaboration to advance economic equity. The series will be held in collaboration with federal agencies such as the Small Business Administration (SBA), the Department of the Treasury, the HHS Office of Small and Disadvantaged Business Utilization's (OSDBU), and the National Asian/Pacific Islander American Chamber of Commerce and Entrepreneurship (National ACE). More on this announcement can be found here.
Click here to view the members of our Health Care Legislative & Public Policy team.