Health Care Week in Review July 7, 2023

Health Care Week in Review: Leqembi Approval, Administration Issues Proposed Rules

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, FDA fully approved the Alzheimer’s drug Leqembi, CMS issued a 340B remedy proposed rule, and HHS issued a proposed rule on short term/limited duration insurance plans. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

  • On July 3, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request: Breastfeeding and Health Outcomes for Infants and Children. AHRQ is seeking scientific information submissions from the public to inform the agency’s review on Breastfeeding and Health Outcomes for Infants and Children, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information is designed to improve the quality of this review. Submissions must be received by August 4, 2023.
  • On July 3, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Request for Nominations: Board of Scientific Counselors (BSC), National Center for Injury Prevention and Control (NCIPC). The BSC, NCIPC consists of up to 18 experts in relevant disciplines involved in injury and violence prevention. Nominees will be selected based on expertise in the fields of pertinent disciplines involved in injury and violence prevention, including, but not limited to, epidemiology, statistics, trauma surgery, rehabilitation medicine, behavioral science, health economics, program evaluation, political science, law, criminology, and other aspects of injury management. Nominations for membership on the BSC, NCIPC must be received no later than September 15, 2023.
  • On July 6, 2023, the National Institutes of Health (NIH) issued a notice entitled, Government-Owned Inventions; Availability for Licensing. A safe and effective HIV-1 vaccine has remained elusive due to the extreme difficulty in eliciting broadly neutralizing antibodies (bNAbs), which recognize and block HIV-1 from entering healthy cells. Only rare natural HIV-1 envelopes (Envs) promote the activation and expansion of naïve B cells expressing unmutated germline antibodies of various bNAb lineages, but they typically do so for a single lineage for the same neutralization site. The National Institute of Allergy and Infectious Diseases (NIAID) overcame this barrier by designing and characterizing two chimeric HIV-1 Env immunogens capable of simultaneously engaging multiple germline bNAb lineages. Both chimeric Env immunogens maintain native-like folding and engage two lineages of germline bNAbs directed against two independent sites of HIV-1 vulnerability. This technology is available for licensing for commercial development, as well as for further development and evaluation under a research collaboration. The dual-germline engager HIV-1 immunogens could serve as an alternative to current anti-retrovirals or incorporated into current HIV treatment strategies.
  • On July 7, 2023, the Department of Health and Human Services (HHS), along with the Department of Labor (DOL) and Department of the Treasury, issued a proposed rule entitled, Short-Term, Limited-Duration Insurance; Independent, Non-coordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance. This proposed rule sets forth provisions that would amend the definition of short-term, limited-duration insurance (STLDI), which is excluded from the definition of individual health insurance coverage under the Public Health Service Act (PHSA). The proposed rule also sets forth proposed amendments to the requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets. Further, the proposed rule includes amendments to clarify the tax treatment of certain benefit payments in fixed amounts received under employer-provided accident and health plans. Finally, this proposed rule solicits comments regarding coverage only for a specified disease or illness that qualifies as excepted benefits, and comments regarding level-funded plan arrangements.
  • On July 7, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to serve on the Advisory Committee on Organ Transplantation. HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT). ACOT provides advice and recommendations to the HHS Secretary on proposed Organ Procurement and Transplantation Network (OPTN) policies and other relevant matters. Nominees sought are individuals involved in organ procurement, organ transplantation (including, but not limited to, transplant candidates, recipients, living organ donors, and families of deceased organ donors), bioethics, and other medical specialties involved in organ transplantation and in the identification and referral of donors. Written nominations for ACOT membership will be received on a continuous basis.
  • On July 7, 2023, Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022. This proposed rule describes the agency’s proposed actions to comply with the remand from the district court to craft a remedy in light of the United States Supreme Court’s decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.

Event Notices

  • July 19-20, 2023: HHS announced a public meeting of the National Committee on Vital and Health Statistics (NCVHS). The meeting agenda will include the introduction of six new members recently appointed to serve on the Committee, discussion of activities outlined in the NCVHS 2023 workplan, and discussions on several health data policy topics, including a briefing on conversational artificial intelligence (AI).
  • August 1, 2023: The Food and Drug Administration (FDA) announced a public meeting of the Medical Imaging Drugs Advisory Committee (MIDAC). MIDAC will discuss dosimetry data needed to support the initial clinical study in an original investigational new drug (IND) application for certain new positron emission tomography (PET) drugs. FDA would like to obtain MIDAC’s input on the following: (1) the sufficiency of available data from animal or human studies involving certain positron emitting radionuclides (e.g., C11, F18) to allow a reasonable calculation of radiation-absorbed dose to the whole body and critical organs upon administration of a new PET drug containing certain radionuclides to a human subject in first-in-human studies; and (2) the logic of a proposed list of numerical radioactivity thresholds for new PET drugs containing these radionuclides, such that Phase 1 studies that will both: (a) administer sub-threshold activities; and (b) obtain sufficient human data for dosimetry calculations may be found safe-to-proceed in the absence of dosimetry data based on prior animal administration of the new PET drug under investigation.
  • August 16, 2023: CDC announced a public hearing of the Advisory Board on Radiation and Worker Health (ABRWH). The meeting agenda will include updates from the National Institute for Occupational Safety and Health (NIOSH), DOL, the Department of Energy (DOE), and the Interactive Radio-Epidemiological Program (IREP). Additionally, there will be procedure reviews and document approvals, as well as updates from the Savannah River Site Workgroup and the Metals & Control (M&C) Workgroup.

II. Reports, Studies & Analyses

  • On July 6, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Part D Plans Generally Include Drugs Commonly Used By Dual-Eligible Enrollees: 2023. Dual-eligible enrollees are defined as individuals enrolled in both Medicare and Medicaid. These enrollees tend to have very low incomes, be in poorer health than other Medicare enrollees, and utilize a high volume of health care services. Accessing critical and necessary prescription drugs can be difficult for dual-eligible beneficiaries. As such, OIG assessed whether the 445 unique formularies used by the 5,619 Medicare Part D plans operating in 2023 cover the drugs most commonly used by dual-eligible enrollees. OIG found that, consistent with previous years, a majority of Part D plan formularies covered at least 97 percent of the 200 drugs most commonly used by dual-eligible beneficiaries. However, OIG found that while dual-eligible have alternate options to receiving their prescriptions if their formularies do not cover specific drugs, the options may be burdensome and do not always guarantee access to the drugs.
  • On July 7, 2023, the Kaiser Family Foundation (KFF) published a report entitled, Overview of Health Coverage and Care for Individuals with Limited English Proficiency (LEP). HHS identifies individuals with LEP as those who do not speak English as their primary language and who have a limited ability to read, write, speak, or understand English. Individuals with LEP disproportionately face gaps in health insurance coverage and poor health outcomes, in part because of linguistic barriers to information or communication. In this brief, KFF provided an overview of the LEP population and their access to health coverage and care based on 2021 American Community Survey (ACS) data. KFF found that most U.S. individuals with LEP are Hispanic, Spanish-speaking adults (62 percent). Additionally, Texas, California, Florida, and New York are home to 60 percent of the overall LEP population. Individuals with LEP were found to be more likely to be uninsured, low-income, and have low education attainment compared to their English-proficient counterparts. KFF concluded that language assistance (e.g., oral interpretation, either in-person or remote via phone or video, and written translations), can help LEP individuals access health care and improve the quality of care that they receive.

III. Other Health Policy News

  • On July 3, 2023, staff of the Senate Committee on Health, Education, Labor, and Pensions (HELP) Chair Bernie Sanders (I-VT), Ranking Member Bill Cassidy (R-LA), Senator Bob Casey (D-PA), and Senator Mitt Romney (R-UT) released a legislative discussion draft for the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). Among the new measures included in the bill is the creation of a ‘situational awareness system’ through HHS. The department would be required to develop guidance identifying data elements that are indicative of potentially catastrophic disease outbreaks, with the data elements being made publicly available online. Further, the bill would direct HHS to coordinate Long COVID research and response activities between federal agencies. An anonymous, voluntary system at HHS for reporting accidents, near-accidents, or other safety incidents involving biological agents and toxins would also be established under this legislation. While most of the provisions included in the bill were agreed to on a bipartisan basis, there is still work to be done before a deal is reached among Committee leadership. For example, spending amounts for PAHPA’s reauthorization period are bracketed within the bill text to indicate that funding levels have not yet been agreed to by Chair Sanders and Ranking Member Cassidy. Additionally, Chair Sanders is requesting public feedback on a provision that would require all CDC and Biomedical Advanced Research and Development Authority (BARDA)-supported products to be sold to the federal government and in the U.S. commercial market at the lowest price compared to other G7 countries. Ranking Member Cassidy’s office is requesting public comment on a provision that would aim to incentivize the development of medical countermeasures (MCMs) by extending FDA’s priority review voucher program through the duration of the PAHPA reauthorization period. Comments in response to the discussion draft must be submitted to by Monday, July 10, at 10:00am ET. More information on this announcement can be found here.
  • On July 3, 2023, the American Hospital Association (AHA) published two reports entitled, Proposals to Reduce Medicare Payments Would Jeopardize Access to Essential Care and Services for Patients and Setting the Record Straight: Private Equity and Health Insurers Acquire More Physicians than Hospitals. In the Medicare payment report, AHA emphasized that site-neutral payments would negatively affect the ability of hospitals to provide adequate patient care, citing persistent Medicare underpayments that would be exacerbated by site-neutrality. The report also argued that site-neutral payment policies fail to take into account that hospital outpatient departments (HOPDs) treat more complex patients, more underserved patients, and deal with more stringent regulations than other non-hospital settings. The physician acquisition report argues that hospitals are not among the main drivers of physician acquisitions. The report seeks to counteract the belief that site-neutral payments would reduce health care consolidation, especially among independent physician practices, by explaining that private equity (65 percent), physician medical groups (14 percent), and health insurers (11 percent) were the three largest drivers of physician acquisitions between 2019 and 2023. Overall, AHA emphasizes that hospitals and health systems are facing ongoing financial difficulties stemming from the health care workforce shortages, the COVID-19 pandemic, and high inflation. The reports assert that enacting site-neutrality legislation would only worsen Medicare reimbursement for hospitals and reduce access to necessary care for patients. More information on these reports can be found here and here.
  • On July 6, 2023, FDA granted traditional approval for Leqembi (lecanemab-irmb), which is designed to treat adults with Alzheimer’s disease, following a determination that a confirmatory trial verified the drug’s clinical benefit. The drug operates by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease. Leqembi is the first amyloid beta-directed antibody to transition from accelerated approval to traditional approval for the treatment of Alzheimer’s disease. Leqembi was initially approved January 6, 2023, under the Accelerated Approval pathway, which allows FDA to approve drugs that are expected produce a clinical benefit for a significant unmet medical need. However, in order for a drug to transition from FDA’s accelerated approval to its full, traditional approval pathway, FDA requires drug manufactures to conduct a clinical trial, often referred to as a confirmatory study, to verify the anticipated clinical benefit of the drug. The confirmatory study for Leqembi showed statistically significant and clinically meaningful reduction of cognitive decline from baseline to 18 months on the primary endpoint compared to placebo. The most common side effects of Leqembi were headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), a side effect known to occur with the class of antibodies targeting amyloid. More information on this announcement can be found here.
  • On July 6, 2023, HHS Secretary Xavier Becerra highlighted the department’s new Health Workforce Initiative during an event in Cleveland, Ohio. The HHS Health Workforce Initiative aims to support, strengthen, and grow the health care workforce by directing increased federal funds requested in President Biden’s Fiscal Year (FY) 2024 Budget Proposal for HRSA’s workforce training, scholarship, loan repayment, and well-being programs. Programs that will be prioritized for enhanced funding include the National Health Service Corps (NHSC) and the Teaching Health Center Graduate Medical Education Program (THCGME). Additionally, the initiative includes an HHS-wide effort to identify opportunities to improve health workforce recruitment, retention, and career advancement. More information on this initiative can be found here.
  • On July 7, 2023, HHS announced a variety of actions designed to protect consumers from junk health plans, surprise medical bills, and excess health care costs that can lead to medical debt. As part of the announcement, HHS highlighted research from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) that estimated the Inflation Reduction Act’s (IRA’s) Medicare Part D out-of-pocket spending cap of $2,000, going into effect in 2025, will reduce out-of-pocket spending by nearly $400 for more than 18.7 million Medicare enrollees (totaling $7.4 billion annually). Additionally, as included above, HHS, DOL, and the Treasury issued a proposed rule aimed at protecting consumers enrolled in STLDI plans. Further, HHS released a frequently asked questions (FAQs) document further clarifying surprise billing and out-of-pocket cost protections for consumers under the No Surprises Act (NSA) and the Affordable Care Act (ACA), which aims to ensure consumers receive the appropriate protections under each law. The FAQs also reiterate requirements for plans and issuers to make price information available to consumers, including information on facility fees. More information on these announcements can be found here.

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