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, Congress passed a bill raising the nation’s debt limit to avoid a potential default and CMS issued a final rule rescinding COVID-19 vaccine requirements for facilities participating in Medicare and Medicaid. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On May 30, 2023, the Food and Drug Administration (FDA) issued a proposed rule entitled, Medication Guides: Patient Medication Information. FDA is proposing to amend its human prescription drug product labeling regulations for Medication Guides (FDA-approved written prescription drug product information distributed to patients). This rule, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and contnt that would be submitted to FDA for approval. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

• On May 31, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) to Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements. This final rule removes expired language addressing staff and patient COVID-19 testing requirements for long-term care (LTC) facilities issued in the interim final rule (IFR) with comment entitled, Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, published in the September 2, 2020 Federal Register. The rule also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff. In addition, the rule withdraws the regulations in the IFR with comment entitled, Omnibus COVID-19 Health Care Staff Vaccination, published in the November 5, 2021 Federal Register, and finalizes certain provisions of the COVID-19 Vaccine Requirements for LTC Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff IFR, published in the May 13, 2021 Federal Register.

• On June 1, 2023, FDA issued draft guidance entitled, Migraine: Developing Drugs for Preventive Treatment; Draft Guidance for Industry; Availability. This draft guidance is intended to assist sponsors in the clinical development of drugs for the preventive treatment of migraines. The draft guidance is intended to complement, not replace, the guidance for industry “Migraine: Developing Drugs for Acute Treatment,” and focuses on specific drug development and trial design issues that are unique to the study of drugs for the preventive treatment of migraines. This draft guidance is intended to serve as a focus for continued discussions among FDA’s Division of Neurology, sponsors, the academic community, and the public.

• On June 2, 2023, FDA issued final guidance entitled, Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals; Guidance for Industry; Availability. The purpose of this guidance is to assist sponsors in the nonclinical safety evaluation of the immunotoxic potential of pharmaceuticals, which for purposes of the guidance is defined to encompass drug products, including small molecule drugs, and oligonucleotides, as well as certain biological products, such as biotechnology-derived therapeutic proteins. Immunotoxicity is any adverse unintended immunosuppression or stimulation, which can be the result of off-target effects or exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators.

• On June 2, 2023, FDA issued revised draft guidance entitled, Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised Draft Guidance for Industry; Availability. This draft guidance provides recommendations for drug development programs for drugs intended to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS). As with the prior 2019 draft guidance, this draft guidance incorporates advice FDA received at a December 2017 advisory committee meeting on appropriate patient selection criteria and trial design features, including enrollment criteria and acceptable efficacy endpoints for drugs intended to treat IC/BPS. This draft guidance encourages sponsors to assess dosing strategies, explore multiple efficacy endpoints, and collect safety information during early drug development to inform design strategy and selection of clinically meaningful endpoints for later clinical trials. This draft guidance also provides advice on enrollment criteria, efficacy endpoints, and other considerations for clinical trials to support an IC/BPS indication. This draft guidance provides recommendations based on the agency’s current thinking on the development of patient-reported outcomes to evaluate patient symptoms to demonstrate a clinically meaningful change with treatment for this condition.

• On June 2, 2023, FDA issued final guidance entitled, Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry; Availability. With the continued market growth and increased clinical use of therapeutic proteins, FDA believes it is important to understand the nature of and the potential for drug-drug interactions (DDIs) with these products. The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologics license applications (BLAs) determine the need for DDI studies for a therapeutic protein by providing a systematic, risk-based approach. This guidance finalizes the draft guidance of the same title issued on August 10, 2020.

• On June 2, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices (ACIP). CDC is seeking nominations for the Advisory Committee on Immunization Practices (ACIP). ACIP consists of up to 20 experts in fields associated with immunization practices and public health, use of vaccines and other immune-biologic agents in clinical practice or preventive medicine, clinical or laboratory vaccine research, assessment of vaccine efficacy and safety, or have knowledge about consumer perspectives and/or social and community aspects of immunization programs. Nominations for membership on ACIP must be received no later than August 1, 2023.

• On June 2, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Challenge Competition: Announcement of AHRQ Challenge on the Impact of AHRQ’s Patient Safety Tools. AHRQ announced a challenge competition to better understand how using an AHRQ patient safety tool has resulted in safer care, as evidenced by associated process and/or outcome measures. AHRQ would like to use this information as an example of the type of return on investment (ROI) an organization might expect when using the tool. This challenge competition will be completed in one phase, with a cash prize awarded to up to 10 winners. All submissions will be reviewed by at least two AHRQ patient safety subject matter expert staff who will score them based on the review criteria and provide a brief comment about the submission. The scores/comments on submissions will be compiled and a ranked summary provided to AHRQ Challenge staff. Submission are due by October 5, 2023.

• On June 2, 2023, CMS issued a notice entitled, Request for Nominations of Members to Serve on the Air Ambulance Quality and Patient Safety Advisory Committee. The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021 (CAA, 2021), requires the Secretary of HHS and the Secretary of the Department of Transportation (DOT) to establish and convene an advisory committee for the purpose of reviewing options to establish quality, patient safety, and clinical capability standards for each clinical capability level of air ambulances. This notice announces the establishment of the Air Ambulance Quality and Patient Safety Advisory Committee and solicits nominations for membership on the Advisory Committee.

Event Notices

• June 13-15, 2023: The National Institutes of Health (NIH) announced a public meeting of the National Cancer Institute (NCI) Board of Scientific Advisors (BSA) and National Cancer Advisory Board (NCAB). The meeting agenda will include a discussion on population science, epidemiology, and disparities; a joint NCAB and NCI BSA meeting; a report from the NCI Director; and NCI BSA presentations.

• June 22, 2023: CMS announced a public meeting of the Advisory Panel on Outreach and Education (APOE). APOE advises and makes recommendations to 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). The meeting agenda will include opening remarks, a recap of the last APOE meeting, presentations on CMS programs, discussion of APOE recommendations, and public comment.

II. Hearings & Markups

U.S. Senate

• On May 31, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Solving the Child Care Crisis: Meeting the Needs of Working Families and Child Care Workers. Witnesses present included: Elizabeth Groginsky, Cabinet Secretary, New Mexico Early Childhood Education and Care Department; Lauren Hogan, Managing Director of Policy and Professional Advancement, National Association for the Education of Young Children (NAEYC); Cheryl Morman, Family Child Care Provider and President, Virginia Alliance for Family Child Care Associations; Carrie Lukas, President, Independent Women's Forum; and Kathryn Larin, Director in Education, Workforce, and Income Security, Government Accountability Office (GAO).

III. Reports, Studies & Analyses

• On May 31, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Medicare Paid Millions More for Physician Services at Higher Non-facility Rates Rather Than at Lower Facility Rates While Enrollees Were Inpatients of Facilities. OIG’s objective in conducting this review was to determine whether Medicare paid the proper rate for physician services furnished to enrollees while they were inpatients of a skilled nursing facility (SNF) or hospital. OIG found that Medicare sometimes paid higher non-facility rates rather than lower facility rates for physician services while enrollees were Medicare Part A SNF or hospital inpatients. During the two-year audit period, Medicare made overpayments that totaled over $22.4 million across over 1.1 million claims by paying the non-facility rate for services coded as furnished in a nursing facility or SNF setting without Part A coverage while enrollees were Part A SNF inpatients. Among its recommendations to address overpayments, OIG advised that CMS: (1) direct its Medicare contractors to recover the $22.4 million in overpayments identified in the review; (2) take the necessary steps, including seeking legislative authority, if necessary, to revise its regulations, to ensure that Medicare appropriately pays for the physician services; and (3) provide additional education to practitioners on the appropriate use of place-of-service codes.

• On June 1, 2023, the Kaiser Family Foundation (KFF) published a report entitled, A Closer Look at the Remaining Uninsured Population Eligible for Medicaid and CHIP. This issue brief assesses the characteristics of the nonelderly uninsured population that is eligible for Medicaid and CHIP. KFF first gave an overview of the Medicaid continuous enrollment provision, saying that the ongoing unwinding of the provision will likely increase the number of individuals who are uninsured. KFF found that over 50 percent of the people who remain uninsured are eligible for some form of financial assistance either through Medicaid/CHIP or the Marketplace. Of that number, 7.4 million (27 percent) are eligible for Medicaid or CHIP. KFF found that uninsured individuals who are eligible for Medicaid/CHIP are more likely to be adults, more likely to be people of color, and more likely to live in a Medicaid expansion state.

• On June 2, 2023, Alston & Bird issued a Health Care Advisory entitled, Health Care Advisory: Provider Relief Fund Audit Season Is Here – Are You Ready? Alston & Bird’s Brian Lee and Christopher J. “CJ” Frisina analyzed why the Health Resources & Services Administration (HRSA) is planning to enhance oversight for entities that received money through the Provider Relief Fund (PRF) and American Rescue Plan Act (ARPA) Rural payments during the COVID-19 pandemic. The Advisory notes that HRSA is hiring accounting firms to conduct PRF and ARPA Rural payment audits, indicating that oversight will be extensive. While the upcoming round of audits is only for funds received prior to June 30, 2021, the Advisory warns that more audits are likely because there were nine reporting periods, and many providers received significant PRF and ARPA Rural payments after June 30, 2021 (which comprises reporting periods five through nine). Further, the Advisory highlights that these HRSA audits mark the beginning of a broader federal oversight effort, which is expected to escalate with HHS OIG and other entities also planning to conduct oversight.

IV. Other Health Policy News

• On June 1, 2023, the Senate passed H.R. 3746, the Fiscal Responsibility Act of 2023 by a vote of 63-36, only 24 hours after the House passed the bill by a vote of 314 to 117. The bill will now be sent to the President for his signature, meaning it will be enacted before Treasury Secretary Janet Yellen’s announced default date of June 5, 2023. Passage of the bill moved quickly after the original agreement on the bill’s provisions was reached on May 28, 2023 by President Joe Biden, House Speaker Kevin McCarthy (R-CA), and the other congressional leaders. For health care providers, the biggest impact in the short term will be the downward pressure on discretionary spending due to the spending caps contained in the package, and the rescission of nearly $10 billion from the federal public health emergency fund and $1.7 billion from the CDC’s COVID-19 fund. The agreement contains no changes to Medicare or Medicaid spending. In addition, some providers will have employees impacted by the return of obligatory student loan payments. More information on this action can be found here.

• On June 1, 2023, CMS announced the process by which Medicare beneficiaries will be able to access Alzheimer’s treatments in scenarios where FDA grants a treatment traditional approval. Currently, there are two Alzheimer’s treatments that have received accelerated approval from FDA, meaning they are covered by CMS with restrictions, but neither have received traditional FDA approval. However, FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) will meet to discuss confirmatory trial results for the Alzheimer’s drug, Leqembi, on June 9, 2023, which could result in traditional FDA approval for the drug shortly thereafter. CMS is accounting for this possibility by establishing the process by which traditionally approved Alzheimer’s drugs will be covered. The agency announced that Medicare will cover Alzheimer’s drugs with traditional approval as long as the physician and clinical team involved participate in a registry, which essentially collects evidence on how drugs perform in the real world. Clinicians will be able to submit information through a CMS-operated portal that CMS assured stakeholders will adhere to strict privacy laws under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). For individuals to have their Alzheimer’s treatment covered by CMS, they will have to: (1) be enrolled in Medicare Part B; (2) be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease; and (3) have a qualified physician participating in a registry. More information on this announcement can be found here.

• On June 1, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $5.9 million to states, tribes, and college campuses for youth suicide prevention programs. Of the nearly $6 million, $3.6 million was awarded to states and tribes under the Garrett Lee Smith (GLS) State/Tribal Youth Suicide Prevention and Early Intervention Program. This program supports states and tribes with implementing youth suicide prevention and early intervention strategies in schools, institutions of higher education, juvenile justice systems, substance use and mental health programs, foster care systems and other child and youth-serving organizations. The remaining $2.3 million was allocated to college campuses through the GLS Campus Suicide Prevention Program, which enhances mental health services for all college students. The program also helps to prevent and reduce suicide, mental and substance use disorders (SUDs), promotes help-seeking behavior and improves the identification and treatment of at-risk college students so they can successfully complete their studies. More information on this funding can be found here.

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