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, Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released a statement announcing an inquiry into high rates of prior authorization denials by Medicaid managed care health insurance plans. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On August 15, 2023, the Food and Drug Administration (FDA) reopened the comment period for the notice of availability that published in the Federal Register of June 8, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled, Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting. The agency is taking this action in response to a request for an extension to allow interested persons additional time to develop and submit comments.
• On August 15, 2023, FDA announced the availability of a final guidance for industry entitled, Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors. The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency’s recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,” issued on July 15, 2014, and supersedes FDA’s guidance entitled “A Guide to Informed Consent,” issued on September 1998.
• On August 15, 2023, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making to establish standards and procedures by which it may require acceptance and priority performance of certain contracts or orders to promote the national defense over other contracts or orders with respect to health resources. This proposed rule also sets new standards and procedures by which HHS may allocate materials, services, and facilities to promote the national defense.
• On August 17, 2023, CMS issued a notice entitled, Medicare and Medicaid Programs: Application from the Joint Commission for Continued CMS Approval of its Critical Access Hospital Accreditation Program. This notice announces the agency’s decision to approve the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
• On August 17, 2023, the Drug Enforcement Administration (DEA) issued a final order entitled, Schedules of Controlled Substances: Placement of Metonitazene in Schedule I. With the issuance of this final order, the DEA Administrator is permanently placing N,N-diethyl-2-(2-(4- methoxybenzyl)-5-nitro-1H-benzimidazol-1-yl) ethan-1-amine (metonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States’ obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle metonitazene.

Event Notices

• September 6, 2023: National Institutes of Health (NIH) announced a public meeting of the of the National Cancer Advisory Board. The meeting agenda will include program reports and presentations and attention to business of the Board.
• September 6-8, 2023: Health Resources and Services Administration (HRSA) announced a public meeting of the National Advisory Committee on Rural Health and Human Services (NACRHHS). NACRHHS will discuss the availability of disability services in rural areas.
• September 12, 2023: NIH announced a public meeting of the National Heart, Lung, and Blood Advisory Council. The meeting agenda will include discussion of program policies and issues.
• September 12, 2023: NIH announced a public meeting of the National Advisory Council on Drug Abuse. The meeting agenda will include presentations and other business of the council.
• September 18, 2023: FDA announced a public meeting on “Optimizing the Use of Postapproval Pregnancy Safety Studies.” This meeting agenda will include discussions of designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and experiences with implementing these studies. The meeting agenda also will include discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies might optimally be used when it has been determined that this data should be collected.
• September 18, 2023: CMS announced a public meeting of the Advisory Panel on Outreach and Education. The meeting agenda will include presentations on CMS programs, initiatives, and priorities.
• October 4, 2023: FDA announced a public meeting of the Oncologic Drugs Advisory Committee. The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comment on this document.
• October 17, 2023: NIH announced a public meeting of the National Cancer Institute’s President’s Cancer Panel. The meeting agenda will focus on reducing cancer care inequities, specifically leveraging technology to enhance patient navigation.
• October 18, 2023: NIH announced a public meeting of the Advisory Committee on Research on Women’s Health. The meeting agenda will include a Presentation from the Director of the National Institute of General Medical Sciences (NIGMS) and a panel discussion with Institutional Development Award (IDeA) Program participants.
• October 20, 2023: NIH announced a public meeting of the Clinical Center Research Hospital Board. The meeting agenda will include NIH and Clinical Center (CC) leadership announcements and a CC CEO update of recent activities and organizational priorities.
• November 2, 2023: NIH announced a public meeting of the National Cancer Institute’s President’s Cancer Panel. The meeting agenda will focus on reducing cancer care inequities, specifically leveraging technology to enhance patient navigation.

II. Reports, Studies & Analyses

• On August 15, 2023, the U.S. Government Accountability Office (GAO) issued a report entitled Public Health Preparedness: HHS Reserve Funding for Emergencies. In the report, GAO found that HHS can use a variety of funding options to help address a public health emergency or threat. For example, HHS may use annual or supplemental appropriations that were made for specific agency programs and activities. HHS also has two reserve funds to address immediate needs that arise in the first days or weeks of an emergency. The Public Health Emergency Fund, established in 1983, is a reserve fund to help HHS agencies, such as the Administration for Strategic Preparedness and Response and the Centers for Disease Control and Prevention (CDC), to rapidly respond to any kind of public health emergency or threat. Such threats include extreme weather; diseases; radiological or nuclear incidents; or acts of terrorism. However, the fund has not received appropriations or been used in over 25 years. The Infectious Diseases Rapid Response Reserve Fund, established in 2018, is another reserve fund to allow CDC to rapidly respond to infectious disease threats. This fund received $800 million in appropriations from 2019 through 2023, including $600 million in 2020 after the beginning of the COVID-19 pandemic. From fiscal year 2020 through May 2023, CDC used $211 million from the fund for activities such as diagnostic testing and airport screening to help control the spread and severity of three infectious diseases: COVID-19, Ebola, and mpox (formerly known as monkeypox).
• On August 15, 2023, the Kaiser Family Foundation (KFF) published an updated Medicaid Enrollment and Unwinding Tracker. The Medicaid Enrollment and Unwinding Tracker presents the most recent data on monthly Medicaid enrollment, renewals, disenrollments, and other key indicators reported by states during the unwinding of the Medicaid continuous enrollment provision. The unwinding data are pulled from state websites, where available, and from CMS. For background, the Medicaid continuous enrollment provision, which had halted Medicaid disenrollments since March 2020, ended on March 31, 2023. Primarily due to the continuous enrollment provision, more than 94 million people were enrolled in Medicaid/the Children’s Health Insurance Program (CHIP) in March 2023, the month before the unwinding period began, an increase of over 22 million from February 2020. As states unwind the continuous enrollment provision over the following 12 months, they will redetermine eligibility for all Medicaid enrollees and will disenroll those who are no longer eligible or who may remain eligible but are unable to complete the renewal process. Millions of people are expected to lose Medicaid coverage during this unwinding period.

III. Other Health Policy News

• On August 14, 2023, the CMS released a Request for Applications (RFA) detailing model payment, care delivery, quality, and other policies for the Making Care Primary (MCP) Model. On June 8, 2023, CMS announced the MCP Model, which is a new voluntary primary care model that will be tested in eight states. Launching July 1, 2024, the 10.5-year model is intended to improve care management and care coordination, equip primary care clinicians with tools to form partnerships with health care specialists, and leverage community-based connections to address patients’ health needs as well as their health-related social needs (HRSNs) such as housing and nutrition. CMS is working with State Medicaid Agencies in eight states and plans to engage private payers in the coming months. The initial eight states are: Colorado, North Carolina, New Jersey, New Mexico, New York, Minnesota, Massachusetts, and Washington. Interested applicants may apply to the MCP Model later this month when the Application Portal opens on the CMS website. To be eligible to apply to participate in MCP, an organization must: (1) be a legal entity formed under applicable state, federal, or Tribal law authorized to conduct business in each state in which it operates; (2) be Medicare-enrolled; (3) bill for health services furnished to a minimum of 125 attributed Medicare beneficiaries; and, (4) have the majority (at least 51 percent) of their primary care sites located in an MCP state. Information on the MCP Model and RFA can be found here. CMS is offering RFA Office Hours from 2-3 PM ET on August 21, 2023. Questions about the RFA can be sent to: MCP@cms.hhs.gov.
• On August 17, 2023, Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released a statement announcing an inquiry into high rates of prior authorization denials by Medicaid managed care health insurance plans. He shared that he is deeply troubled by reports that Medicaid managed care plans denied an average of one out of every eight requests for treatment, which he added is more than double the rate of service denials in Medicare Advantage. Congressman Pallone referenced a report released by the Health and Human Services Office of the Inspector General (OIG) that indicated that some people enrolled in Medicaid managed care may not be receiving all medically necessary health care services due to high rates of prior authorization denials by insurance plans. Congressman Pallone commended the OIG for this releasing this report and explained that he will be contacting each of the health insurance companies included in the report to ask for additional information and pose questions regarding prior authorization practices. Congressman Pallone’s press release is available here. The OIG report is available here.
• On August 16, 2023, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra released a statement on the U.S. Court of Appeals for the Fifth Circuit’s ruling on mifepristone. He stated that, “Today’s decision undermines our nation’s entire system of drug approval by overriding the scientific, evidence-based decision-making of the FDA. This decision threatens Americans’ right to access the medications they need and, if it stands, would have a devastating impact on women’s health by restricting their access to reproductive health care.” The Fifth Circuit ordered that access to mifepristone should be sharply curtailed. If this decision takes effect, it will roll back actions the federal government has taken since 2016 to make mifepristone more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. The holding would inhibit access from the current 10 weeks of pregnancy to seven and would reimpose a requirement that only physicians can prescribe the pills. In his statement, Secretary Becerra added that, “The most important thing to know is that mifepristone remains approved and available while we fight this decision in the courts. We remain confident the law is on our side, and we will continue to vigorously defend the FDA’s independent, science-based drug approval process, and Americans’ right to access the health care they need.” Secretary Becerra’s press release is available here.

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