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, Senate Democrats released draft legislation aimed at preventing labor and delivery unit closures, and CMS announced the upcoming closure of the AAP Program that addressed Medicare funding issues resulting from Change Healthcare cyber-attack.
I. Regulations, Notices & Guidance
- On June 17, 2024, the Food and Drug Administration (FDA) released a final rule entitled, Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases. The final rule revises the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017. This rule is effective December 18, 2025, except for the amendments to §§ 4.2 (amendatory instruction 2), 4.3 (amendatory instruction 3), and 4.4 (amendatory instruction 4) (21 CFR 4.2, 4.3, and 4.4), which are effective February 2, 2026. The incorporation by reference of certain material listed in this rule has been approved by the Director of the Federal Register as of February 2, 2026.
- On June 17, 2024, FDA issued guidance entitled, Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability. FDA announced the availability of a final guidance for industry entitled Facility Readiness: Goal Date Decisions Under GDUFA. This guidance provides information to applicants on how FDA will use information related to a facility’s readiness for inspection as certified on Form FDA 356h to set a goal date for an original abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance finalizes the draft guidance of the same title issued on October 7, 2022.
- On June 17, 2024, the National Institutes of Health (NIH) released a Request for Information (RFI) entitled, Request for Information on the National Institutes of Health Draft Public Access Policy. NIH is soliciting comments from the public on the NIH Draft Public Access Policy and two supplemental draft guidance documents regarding government use license and rights and costs for publications. The NIH Draft Public Access Policy builds upon NIH’s long history of providing public access to scholarly publications resulting from the research it supports and proposes additional steps to accelerate access.
- On June 20, 2024, FDA issued a final rule technical amendment entitled, Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address. FDA is amending the regulations for medicated feed mill applications and for veterinary feed directive drugs to update addresses and simplify notification procedures. These technical amendments are being made to improve the accuracy of the agency’s regulations and are non-substantive.
- On June 20, 2024, FDA issued guidance entitled, Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability. FDA is announcing the availability of a final guidance entitled, Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection. The FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) so that, as is the case with a drug, a device is deemed to be adulterated if the owner, operator, or agent of the factory, warehouse, or establishment at which the device is manufactured, processed, packed, or held delays, denies, or limits an FDA inspection. This final guidance describes, for both drugs and now devices, the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection. This guidance finalizes the draft guidance of the same title issued on December 16, 2022, and supersedes the October 2014 final guidance entitled, Circumstances That Constitute Delaying, Limiting, or Refusing a Drug Inspection.
- On June 20, 2024, FDA issued guidance entitled, Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft guidance for industry entitled, Considerations in Demonstrating Interchangeability With a Reference Product: Update. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). After considering any comments received in the docket for this draft guidance, FDA intends to revise the final guidance for industry entitled, Considerations in Demonstrating Interchangeability With a Reference Product issued on May 14, 2019, to amend sections in that document regarding the subject addressed in this draft guidance.
- On June 20, 2024, FDA issued guidance 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; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry (GFI) #279 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. This final guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.
- On June 20, 2024, FDA issued guidance entitled, Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry (GFI) #278 entitled, Human User Safety in New and Abbreviated New Animal Drug Applications. This guidance is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs (including new generic animal drugs). This guidance addresses general principles of human user safety (HUS) assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to address HUS concerns, and how HUS information should be submitted to the Center of Veterinary Medicine (CVM).
- On June 20, 2024, FDA released a notice entitled, Request for Nominations from Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees. FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER’s public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
- On June 21, 2024, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting; Correction. This document corrects typographical and technical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled, Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting. The effective date of the Minimum Staffing final rule is June 21, 2024.
- On June 21, 2024, CMS released a notice entitled, Medicaid Program; Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality; Correction. This document corrects typographical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled Medicaid Program; Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality. The effective date of the Managed Care final rule is July 9, 2024.
- On June 21, 2024, FDA released a notice entitled, Determination That INVEGA (Paliperidone) Extended-Release Tablet, 1.5 Milligrams, Was not Withdrawn from Sale for Reasons of Safety or Effectiveness. FDA has determined that INVEGA (paliperidone) extended-release tablet, 1.5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
- On June 21, 2024, FDA released a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062. This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
- On June 21, 2024, FDA released a notice entitled, Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles. Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed.
- On June 21, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF); Corrections. On March 1, 2024, HHS published a final rule to improve child care access, affordability, and stability in the Child Care and Development Fund. Some amendments in the final rule could not be incorporated due to technical inaccuracies in the instructions. Additionally, that document inadvertently failed to update certain amended cross-references. This document makes technical changes to correct the final regulations.
Event Notices
June 26, 2024: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
June 26, 2024: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
June 26-28, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
June 28-29, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a hybrid meeting open to the public.
July 1-2, 2024: HHS announced a meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders. This is a hybrid meeting open to the public.
July 10, 2024: NIH announced a meeting of the Frederick National Laboratory Advisory Committee to the National Cancer Institute. This is a virtual meeting open to the public.
July 11-12, 2024: FDA announced a meeting entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. This is a hybrid meeting open to the public.
July 22, 2024: FDA announced a public workshop entitled, Best Practices for Meeting Management. This is a hybrid workshop open to the public.
July 25, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This meeting is open to the public.
June 26, 2024: NIH announced a meeting of the National Cancer Institute Council of Research Advocates. This is a virtual meeting open to the public.
II. Reports, Studies, & Analyses
- On June 17, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Older Americans Act: Updated Information on Unmet Need for Services. GAO analyzed data on food insecurity and the receipt of services among older Americans, revealing that in 2021, an estimated 18.1 percent of older adults experienced food insecurity. The report found that approximately nine percent of low-income older adults received either home-delivered or congregate meals, while 22.7 percent received Supplemental Nutrition Assistance Program (SNAP) benefits. Notably, the percentage of older adults receiving home-delivered meals saw a slight increase since 2013, possibly reflecting a shift towards these services during the COVID-19 pandemic due to social distancing measures. Additionally, GAO found a decrease in the percentage of older individuals reporting difficulties with daily activities based on 2020 Health and Retirement Study (HRS) data compared to 2012. However, the 2020 HRS also indicated a reduction in the provision of home-based care services to those experiencing difficulties with daily activities. This reduction may be attributed to the pandemic’s impact on service delivery. GAO explained that it conducted this analysis to provide updated insights into the unmet needs of older Americans under the Older Americans Act and utilized data from the U.S. Census Bureau’s Current Population Survey and the University of Michigan’s Health and Retirement Study to assess the need for and receipt of meal and home-based care services.
- On June 18, 2024, the Congressional Budget Office (CBO) released a blog post entitled, CBO Publishes New Projections Related to Health Insurance for 2024 to 2034. CBO published new projections for federal health insurance subsidies from 2024 to 2034, predicting that net federal subsidies for insured people will rise from $2.0 trillion in 2024 to $3.5 trillion in 2034, equating to 8.5 percent of GDP. Over the 2025–2034 period, these subsidies are expected to total $27.5 trillion, with Medicare accounting for 46 percent, Medicaid and the Children’s Health Insurance Program (CHIP) for 25 percent, employment-based coverage for 21 percent, and subsidies for Affordable Care Act (ACA) Marketplaces or the Basic Health Program for five percent. Other subsidies will account for the remaining two percent. The share of people without health insurance is projected to increase from an all-time low of 7.2 percent in 2023 to 8.9 percent in 2034, primarily due to the expiration of pandemic-related policies like Medicaid’s continuous eligibility and enhanced Marketplace subsidies. Additionally, rising immigration rates are expected to contribute to the increase in uninsured individuals. The largest rise in the uninsured population will be among adults aged 19 to 44. Enrollment in Medicaid and CHIP is projected to decline from 92 million in 2023 to 79 million in 2034, while Medicare enrollment is expected to rise from 60 million in 2023 to 74 million in 2034, with a significant portion of enrollees moving to Medicare Advantage (MA) plans. CBO also adjusted its projections for employment-based and Marketplace enrollments, forecasting higher-than-previously-expected figures due to changes in economic and demographic forecasts, and the effects of pandemic-related policies.
- On June 20, 2024, the Office of Inspector General (OIG) released a report entitled, NIH Did Not Close Contracts in Accordance With Federal Requirements, Resulting in the Increased Risk of Fraud, Waste, and Abuse. OIG reviewed the closure dates of 30 NIH contracts that ended September 30, 2018, or earlier, and totaled $2.1 billion. OIG reviewed the contract documents, including contract awards, closing statements, and payments, and also reviewed NIH policies regarding managing contracts, federal records, and closing contracts. The report found that NIH only met all the administrative closeout requirements for one of 30 contracts, which totaled $140 million. For the other 29 contracts, which totaled over $1.9 billion, NIH failed to meet at least one closeout requirement, such as a contract audit, obtaining a closing statements, or reviewing contract funds. Failing to adhere to contract closeout requirements poses a financial risk to NIH’s funds. OIG recommended that NIH (1) properly closeout the 29 contract that failed to adhere to administrative closeout standards, (2) incorporate administrative closeout requirements into the NIH Policy Manual that are outlined in the Federal Acquisition Regulation and HHS Contract Closeout Directive, and (3) establish performance monitoring activities for personnel compliance with contract closeouts.
III. Other Health Policy News
- On June 17, 2024, Senate Finance Committee Chair Ron Wyden (D-OR) and 15 other Senate Democrats released draft legislation entitled, the Keep Obstetrics Local Act (KOLA). The bill aims to prevent labor and delivery unit closures in rural and underserved hospitals. In a press release, Senator Wyden’s office notes the increase in maternity unit closures, citing that “between 2012 and 2022, approximately one quarter of all rural hospitals stopped providing obstetrics services, impacting 267 communities.” This problem is the result of numerous challenges, including high operating costs of labor and delivery units, low birth volume rates, and challenges with recruiting and retaining trained clinical staff. To address these issues, the legislation would:
- Increase Medicaid reimbursement for labor and delivery services at rural and high-need urban hospitals;
- Provide “standby payments” to low-volume hospitals to assist with the costs of maintaining labor and delivery staff;
- Establish low-volume payment adjustments for hospitals that experience low birth rates; and
- Require that states provide 12 months of postpartum Medicaid covered.
- On June 17, 2024, CMS announced that the Accelerated and Advance Payment (AAP) Program for the Change Healthcare/Optum Payment Disruption (CHOPD) will end on July 12, 2024. The program was launched in response to the February 2024 cyberattack that disrupted Change Healthcare’s electronic data interchange and aimed to mitigate financial disruptions for Medicare providers and suppliers, including hospitals, physicians, and pharmacists. CMS Administrator Chiquita Brooks-LaSure highlighted the agency’s action taken to support health care providers after the attack, including facilitating over $2.55 billion in accelerated payments to Part A providers and $717.18 million in advance payments to Part B suppliers. CMS has recovered over 96 percent of these payments and will stop accepting new applications after July 12, 2024. The press release encourages providers that experience billing or payment issues to contact Change Healthcare or their Medicare Administrative Contractor (MAC) for assistance.
View our Health Care Legislative & Public Policy team.
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