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 negotiated legislation to avoid a government shutdown on October 1, but a resolution remains unclear, and the Congressional Budget Office released a report projecting CMMI activities will continue to increase net federal spending over the next decade. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On September 25, 2023, the Food and Drug Administration (FDA) issued a final rule entitled, Requirements for Additional Traceability Records for Certain Foods; Technical Amendment. FDA is correcting the final rule on requirements for additional traceability records for certain foods that published in the Federal Register of November 21, 2022. The final rule was published with some editorial and inadvertent errors. This document corrects those errors.
• On September 25, 2023, ACF issued a proposed rule entitled, Parentage Establishment in the Child Support Services Program. The Office of Child Support Services (OCSS) proposed to replace the gender specific term “paternity” with the gender-neutral term “parentage” throughout the Child Support Services Program to be inclusive of all family structures served by the child support services program. While title IV-D (Child Support and Establishment of Paternity) requires States and Tribes to have laws permitting the establishment of paternity and requiring genetic testing in contested paternity cases, OCSS also recognizes that title IV-D does not preclude States and Tribes from having parentage establishment laws and procedures for all families. The proposed changes to chapter III of the child support regulations recognize developments in State laws regarding parentage establishment and provide States and Tribes optional flexibility to establish parentage for all children in accordance with their laws, regardless of the gender of their parents or family structure.
• On September 26, 2023, FDA issued guidance entitled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. As more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system. This final guidance supersedes the final guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.
• On September 26, 2023, FDA issued guidance entitled, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry. This draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk based preventive controls under FDA’s regulation entitled, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The newly available draft chapters are entitled Chapter 11—Food Allergen Program” and “Chapter 16--Acidified Foods. This draft guidance is not final nor is it in effect at this time.
• On September 26, 2023, FDA issued a request for information (RFI) entitled, Artificial Intelligence in Drug Manufacturing. FDA is reopening the comment period for the notice, published in the Federal Register on March 1, 2023, establishing a public docket, and requesting information and comments. FDA is reopening the comment period to update comments and to receive any new information.
• On September 26, 2023, the National Institutes of Health (NIH) issued a notice of a prospective grant entitled, Prospective Grant of an Exclusive Patent License, Development and Commercialization of Engineered T Cell Therapies for the Treatment of Cancer. NIH is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the supplementary information section of this notice to Moonlight Bio, Inc. (“Moonlight”), headquartered in Seattle, WA.
• On September 26, 2023, the Administration for Community Living (ACL) issued an intent to award a single source supplement entitled, the Link Center: Bridging Intellectual and/or Developmental Disabilities (I/DD) and Mental Health Systems Cooperative Agreement. ACL announced the intent to award a single-source supplement to the current cooperative agreement held by the National Association for State Directors of Developmental Disabilities Services (NASDDDS) for the Link Center: Bridging I/DD and Mental Health Systems cooperative agreement. The purpose of this project is to improve the quality of life for people with intellectual and/or developmental disabilities (I/DD) and mental health conditions by supporting state agencies with policy development, service design, and service coordination resources, and sharing resources to individuals, families, direct support professionals, clinicians, and other policymakers. The administrative supplement for fiscal year (FY) 2023 will amount to $540,000, bringing the total award for FY 2023 to $1,214,978.
• On September 27, 2023, the Department of Health and Human Services (HHS) issued a proposed rule comment period extension entitled, Requirements Related to the Mental Health Parity and Addiction Equity Act; Extension of Comment Period. This document extends the comment period for the proposed rules entitled, Requirements Related to the Mental Health Parity and Addiction Equity Act that were published in the August 3, 2023, issue of the Federal Register. The comment period for the proposed rules, which had been scheduled to close on October 2, 2023, is extended 15 days to October 17, 2023.
• On September 27, 2023, NIH issued an RFI entitled, Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research. The purpose of this RFI is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.
• On September 28, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2024. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2024. The calendar year 2024 AIC threshold amounts are $180 for ALJ hearings and $1,840 for judicial review.
• On September 28, 2023, the Health Resources and Services Administration (HRSA) issued a notice of supplemental award entitled, Notice of Supplemental Award; Emergency Medical Services for Children Innovation and Improvement Center. For FY 2023, HRSA will provide additional supplemental funds for the Emergency Medical Services for Children Innovation and Improvement Center to continue to provide assistance to a Pediatric Mental Health Care Access (PMHCA) award recipient so that they can improve access to PMHCA program activities in emergency departments.
• On September 28, 2023, HRSA issued a request for public comments entitled, Notice of Request for Public Comments on a Draft Recommendation to Update the HRSA-Supported Women’s Preventive Services Guideline Relating to Screening for Urinary Incontinence. This notice seeks comments on a draft recommendation to update the HRSA-supported Women’s Preventive Services guidelines relating to screening for urinary incontinence. This draft recommendation has been developed through a cooperative agreement, known as the Women’s Preventive Services Initiative (WPSI), with the American College of Obstetricians and Gynecologists (ACOG), through which they convene health professionals to develop draft recommendations. Under applicable law, non-grandfathered group health plans and health insurance issuers must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor (DOL), HHS, and Treasury have previously issued regulations, which describe how group health plans and health insurance issuers apply the coverage requirements.
• On September 28, 2023, HRSA issued a notice of supplemental award entitled, National Center for Newborn Screening Systems Excellence Funding Supplement. HRSA will provide supplemental funding to the National Center for Newborn Screening Systems Excellence in FY 2023.
• On September 28, 2023, FDA issued guidance entitled, Antimicrobial Susceptibility Test System Devices--Updating Breakpoints in Device Labeling; Guidance for Industry. This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria website (STIC Website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.
• On September 28, 2023, FDA issued a notice entitled, Fee Rate for Using a Priority Review Voucher in Fiscal Year 2024. This notice establishes the FY 2024 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, or tropical disease priority review voucher and outlines the payment procedures for such fees.
• On September 28, 2023, FDA issued guidance entitled, Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff. This draft guidance introduces submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guidance submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation currently.
• On September 28, 2023, FDA issued guidance entitled, Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff. This guidance provides technical considerations for physiologic closed-loop control (PCLC)technology to promote development and availability of safe and effective PCLC medical devices.
• On September 29, 2023, FDA issued a proposed rule entitled, Medical Devices; Laboratory Developed Tests. The proposed rule amends its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.
• On September 29, 2023, The Centers for Disease Control and Prevention (CDC) issued a notice entitled, Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention; Request for Comment and Informational Presentation. CDC opened a docket to obtain comment on proposed guidelines for the use of doxycycline post-exposure prophylaxis (PEP) for prevention of bacterial sexually transmitted infections (STI). The purpose of the proposed guidelines is to provide updated clinical guidance for healthcare providers to inform the use of doxycycline PEP for preventing bacterial STI infections.
• On September 29, 2023, CMS issued a notice entitled, Medicare and Medicaid Programs; Application from the Center for Improvement in Healthcare Quality for Initial CMS Approval of its Psychiatric Hospital. This notice announces CMS’s decision to approve the Center for Improvement in Healthcare Quality (CIHQ) as a national accrediting organization (AO) for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
• On September 29, 2023, FDA issued guidance entitled, Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”; Guidance for Industry. This guidance is intended to assist applicants in incorporating dose banding information, based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA), into the proposed labeling of injectable drug products that are the subject of certain marketing applications submitted to FDA. This guidance finalizes the draft guidance of the same title issued on July 21, 2022.
• On September 29, 2023, FDA issued a notice entitled, Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program. The FDA CBER Office of Therapeutic Products (OTP) and Center for Drug Evaluation and Research’s (CDER) Office of New Drugs are announcing the opportunity for a limited number of development programs to participate in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, with the goal of further accelerating the pace of development of certain CBER- and CDER- regulated products (novel drug and biological products) that are intended to treat a rare disease.

Event Notices

• October 4, 2023: NIH announced that the National Cancer Institute Council of Research Advocates will hold a meeting to discuss National Cancer Institute updates. This meeting is virtual and open to the public.
• October 11, 2023: FDA announced that the Office of Women’s Health Office of Clinical Pharmacology will hold a public workshop entitled, Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research. The purpose of the public workshop is to discuss the current understanding of the impact of menopause on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response relationships of FDA regulated drugs and biologics used by menopausal women for non-menopause-related indications.
• October 13, 2023: NIH announced that the National Advisory Eye Council will hold a public in-person meeting to discuss the National Eye Institute (NEI) Director’s report, various NEI programs, and concept clearances.
• October 17 and 18, 2023: CDC announced that it will hold public information sessions entitled, World Trade Center Health Program; Notices of Funding Opportunities Public Information Sessions. These sessions will provide information on current research funding opportunities published by the World Trade Center (WTC) Health Program and will provide information to members of the public who may be interested in submitting applications for funding.
• October 18, 2023: HHS announced that the Secretary’s Advisory Committee on Health Research Protections will hold a virtual meeting open to the public.
• October 18, 2023: NIH announced a meeting of the Advisory Committee on Research on Women's Health. This is a virtual meeting open to the public.
• October 25, October 26, and October 27, 2023: CDC announced it will hold a meeting of the Advisory Committee on Immunization Practices. This meeting is open to the public and time will be available for public comment.
• October 26, 2023: NIH announced a meeting of the Office of AIDS Research Advisory Council that will focus on focus on HIV and health disparities, guest speakers and a discussion panel. This is a virtual meeting open to the public.
• October 31 and November 1, 2023: CMS announced a meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the DOL, HHS, and the Treasury, and relevant States, and the prevention of balance billing to consumers. This is a virtual meeting that is open to the public.
• November 14, 2023: CDC announced a meeting of the Advisory Committee to the Director, CDC. This is a hybrid meeting that is open to the public. There will be an opportunity for public comment.
• November 16, 2023: NIH announced that the Diabetes Mellitus Interagency Coordinating Committee will hold a public online meeting entitled, The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities.
• November 29, 2023: NIH announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This meeting will be held virtually and is open to the public.
• November 30, 2023: FDA announced it will hold a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting of the Sleep Disorders Advisory Board. This is a virtual public meeting that requires registration to attend.
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for FY 2024. This is a virtual public meeting that requires registration to attend.
• December 13 and December 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.

II. Hearings and Markups

U.S. Senate

• On September 27, 2023, the Senate Committee on Budget held a hearing entitled, Medicare Forever: Protecting Seniors by Making the Wealthy Pay Their Fair Share. Witnesses present included Marilyn Moon, Visiting Scholar, Center for Medicare Advocacy, and Former Public Trustee of the Medicare and Social Security Trust Funds; Chye-Ching Huang, Executive Director, Tax Law Center, New York University School of Law; and James C. Capretta, Senior Fellow and Milton Friedman Chair, American Enterprise Institute.

III. Reports, Studies & Analyses

• On September 26, 2023, the Government Accountability Office (GAO) released a report entitled, Nursing homes: Limitations of Using CMS Data to Identify Private Equity and Other Ownership. GAO was asked to review CMS’s nursing home ownership data for information about private equity owners. This report 1) estimates the percentage of Medicare-enrolled nursing homes in 2022 that were private equity-owned and 2) describes the limitations of using CMS’s data to identify private equity and other owners of nursing homes.
• On September 28, 2023, the Congressional Budget Office (CBO) released a report entitled, Federal Budgetary Effects of the Activities of the Center for Medicare & Medicaid Innovation. In this report, CBO presents findings from its analysis of the Center for Medicare & Medicaid Innovation’s (CMMI’s) activities during the first decade of operation and uses those findings to update its projections of CMMI’s effects on federal spending. The report explains changes to CBO’s analytic method based on those findings and discusses the agency’s revised approach to estimating the effects of legislative proposals that would change CMMI’s models or operations.
• On September 28, 2023, CBO released a report entitled, Federal Subsidies for Health Insurance: 2023 to 2033. This report presents the latest projections of federal costs associated with subsidies for health insurance from the federal government. For the first time, projections in the report reflect the entire population instead of only the civilian noninstitutionalized population younger than 65, giving a more accurate estimate of projections. CBO found in 2023, federal subsidies for health insurance are estimated to be $1.8 trillion, and subsidies will reach $3.3 billion in 2033.
• On September 29, 2023, the Office of Inspector General (OIG) released a report entitled, Many Medicaid Enrollees with Opioid Use Disorder Were Treated with Medication; However, Disparities Present Concerns. OIG stated Medicaid covers an estimated 40 percent of nonelderly adults with opioid use disorder. Individuals seeking treatment often face barriers accessing medication for opioid use disorder (MOUD), and demographic groups such as adolescents or people of certain races may be less likely to receive MOUD. In this data brief, OIG examined the extent to which Medicaid enrollees with opioid use disorder received medication for opioid use disorder (MOUD) in 2021.

IV. Other Health Policy News

• On September 25, 2023, the Biden-Harris Administration announced over $200 million in grants to support youth mental health. The grants, through ACF and the Substance Abuse and Mental Health Services Administration (SAMHSA), provide funding for programs that connect youth and families to mental health services, expand access to mental health care for young people, and improve the quality of mental health services provided to children involved in the child welfare system. In addition to grants through SAMHSA and ACF, CMS will make more Medicaid funding available for school-based health services in Virginia, including mental health services. A press release with more information is available here.
• On September 26, 2023, Ranking Member on the Senate Health, Education, Labor, and Pensions (HELP) Committee Bill Cassidy (R-LA) released an RFI regarding methods to reform and modernize CDC. In particular, the RFI seeks input on ways to improve coordination with stakeholders, effectively modernize public health data, and improve core public health activities such as epidemiology and training programs. The deadline to submit feedback is October 20, 2023. A press release with more information is available here. Senator Cassidy’s letter to stakeholders is available here.
• On September 26, 2023, CMS announced that average premiums, benefits, and plan choices for Medicare Advantage (MA) and Medicare Part D prescription drug program will remain stable in 2024. The average monthly premium for all MA plans—including Medicare Advantage-Prescription Drug (MA-PD) plans— is projected to change from $17.86 in 2023 to $18.50 in 2024. CMS previously announced that Medicare Part D coverage is expected to be approximately $55.50 in 2024, a 1.8 percent decrease from 2023. CMS stated that stable premiums in the Medicare Part D program are in large part due to improvements made by the Inflation Reduction Act (IRA), which allowed improved access to affordable benefits, including a $35 dost-sharing limit on a month’s supply of insulin product and access to certain adult vaccines. A press release with more information is available here.
• On September 26, 2023, Senate leaders introduced a bipartisan continuing resolution (CR) entitled, the Continuing Appropriations Act, 2024 and Other Extensions Act that would fund the government—including certain public health extenders―through November 17, 2023 to avert a government shutdown. Shortly after the CR was unveiled, the Senate voted 77-19 to begin debate on the package. The CR includes funding for community health centers, the National Health Service Corps (NHSC), teaching health center graduate medical education (GME), and special diabetes programs. The package also delays $8 billion in Medicaid disproportionate share hospital (DSH) payment cuts. It is unclear if the Senate will be able to vote for approval before the October 1 government shutdown deadline. A section-by-section of the legislation is available here. Text of the legislation is available here.
• On September 27, 2023, HHS announced $13 million in grants to 11 organizations across the U.S. to improve access to community-based maternal support services for pregnant and post-partum people. The grants are administered through the Office of Minority Health (OMH) to bolster the Healthy Families Community-Based Perinatal Health Initiative (COPHI). Community-based maternal support services (COMSS) include health literacy, pregnancy, childbirth, and parenting education, housing, food, and transportation. A press release with more information is available here.
• On September 28, 2023, Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) introduced legislation entitled, the Modernizing and Ensuring PBM Accountability Act (MEPA). The legislative text reflects the Chairman’s Mark reported by the Senate Finance Committee in July. The bipartisan bill aims to increase transparency, accountability, and competition of Pharmacy Benefit Managers (PBMs) in the pharmaceutical supply chain. Among other provisions, MEPA prohibits PBM compensation in Medicare from being tied to drug price and creates independent audit and enforcement measures for PBMs. Text of the legislation is available here. A description of the July version of the bill can be found here.
• On September 29, 2023, the House introduced its own CR, entitled, the Spending Reduction and Border Security Act. The legislation would keep the government open until October 31. In addition, funding across most agencies would be cut 30 percent, apart from Defense, Homeland and Veterans Affairs. Of note, the legislation does not include funding for Medicaid DSH and other health care priorities. The legislation failed in a 198-232 vote, with 21 Republicans joining Democrats to defeat the legislation. Text of the legislation is available here.

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