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, HHS released proposed rules to enhance coverage of birth control and preventive services, and OIG released a report on questionable use of Medicare Advantage (MA) health risk assessments.
I. Regulations, Notices & Guidance
- On October 21, 2024, the Food and Drug Administration (FDA) released a noticed entitled, Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period. FDA is extending the comment period for the notice that appeared in the Federal Register on September 20, 2024. In the notice, FDA requested comments on the draft guidance for industry and FDA staff entitled Chemical Analysis for Biocompatibility Assessment of Medical Devices. The agency is taking this action in response to a request for an extension to allow interested entities additional time to submit comments.
- On October 21, 2024, FDA released draft guidance entitled, Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-- Content and Format; Draft Guidance for Industry; Availability. This draft guidance is intended to assist applicants in developing the drug interactions section of labeling as described in FDA regulations for the content and format of labeling for human prescription drug and biological products. The purpose of the draft guidance is to provide recommendations on what information to include in and how to present and organize the information within the drug interactions section of labeling for human prescription drug and biological products. The goal of these recommendations is to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.
- On October 21, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Notice of Request for Public Comments on Draft Recommendations for the HRSA Supported Women’s Preventive Services Guidelines Relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening. This notice seeks comment on draft recommendations for the HRSA-supported Women’s Preventive Services Guidelines (“Guidelines”) relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening. These draft recommendations have been developed by the Women's Preventive Services Initiative (WPSI), through which clinicians, academics, and expert health professionals develop draft recommendations for HRSA’s consideration. 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, the Department of Health and Human Services (HHS), and Treasury have issued regulations and policy guidance which describe how group health plans and health insurance issuers apply the coverage requirements.
- On October 23, 2024, HHS released a final rule entitled, Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations. In this final rule, HHS is amending its regulations that govern the protection of human subjects for conformity with 2018 revisions made to the Federal policy for protection of human research subjects (the “Common Rule”), as well as to maintain consistency with the prior version of the Common Rule for research that remain subject to those requirements. Amendments include updating citations that were renumbered, adding updated descriptions of the applicability of exemptions, and correcting a technical error. No substantive amendments are included in this final rule.
- On October 23, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a notice entitled, HHS Approval of Entities that Certify Medical Review Officers. This notice publishes a list of HHS-approved Medical Review Officers (MROs) certification entities. The most recent HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 10, 2023 (Oral Fluid) and February 1, 2024 (Urine), address the role and qualifications of MROs and HHS approval of entities that certify MROs.
- On October 24, 2024, HHS released a proposed rule entitled, Enhancing Coverage of Preventive Services Under the Affordable Care Act. This document sets forth proposed rules that would amend the regulations regarding coverage of certain preventive services under the Public Health Service Act. Specifically, this document proposes rules that would provide that medical management techniques used by non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage with respect to such preventive services would not be considered reasonable unless the plan or issuer provides an easily accessible, transparent, and sufficiently expedient exceptions process that would allow an individual to receive coverage without cost sharing for the preventive service that is medically necessary with respect to the individual, as determined by the individual’s attending provider, even if such service is not generally covered under the plan or coverage. These proposed rules also contain separate requirements that would apply to coverage of contraceptive items that are preventive services under the Public Health Service Act. Specifically, these proposed rules would require plans and issuers to cover certain recommended over-the-counter contraceptive items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed rules would require plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost-sharing requirements, unless a therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. Finally, this document proposes to require a disclosure pertaining to coverage and cost-sharing requirements for over-the-counter contraceptive items in plans’ and issuers’ Transparency in Coverage internet-based self-service tools or, if requested by the individual, on paper. These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans, and issuers.
- On October 25, 2024, HHS and the Centers for Medicare & Medicaid Services (CMS) released a rule correction entitled, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program; Correcting Amendment. This document corrects technical and typographical errors in the final rule that appeared in the April 15, 2024 issue of the Federal Register entitled, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program. The effective date of the final rule was June 4, 2024.
- On October 25, 2024, the Administration for Children and Families (ACF) released a notice entitled, Request for Information: Administration for Children and Families Development of Interoperability Standards for Human Service Programs. ACF, an agency within HHS, invites public comments to inform the use or adoption of interoperability standards for human services programs. ACF and state, local, and tribal governments all provide a number of health and human services programs for children, youth, families, communities, and individuals. ACF seeks public comment on the most effective approaches, technical standards, and technological tools that currently or could promote interoperability between health and human services programs. ACF has authority under the Title IV of the Social Security Act to designate use of interoperable data standards for several of its programs (e.g., Temporary Assistance for Needy Families (TANF), child support, child welfare, and foster care). The purpose of this RFI is to understand how ACF, in collaboration with ASTP/ONC, can better support interoperability between human services within and across states and local community resources, between states, and ACF.
Event Notices
October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.
October 31, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a hybrid meeting open to the public.
November 6, 2024: the Centers for Disease Control and Prevention (CDC) announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
November 12, 2024: the National Institutes of Health (NIH) announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: CDC announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting that is open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
November 20, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is an in-person meeting open to the public.
November 20, 2024: CDC announced a meeting of the Board of Scientific Counselors, Office of Readiness and Response. This is a virtual meeting open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
November 22, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
December 3, 2024: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 3, 2024: SAMHSA announced a meeting of the Center for Substance Abuse Prevention’s Drug Testing Advisory Board. This is a virtual meeting open to the public.
December 4, 2024: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open for public comment.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
December 11, 2024: CDC announced a meeting of the Lead Exposure and Prevention Advisory Committee. This is a virtual meeting open to the public.
December 12, 2024: FDA announced a hearing of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
II. Reports, Studies, & Analyses
- On October 24, 2024, the HHS Office of the Inspector General (OIG) released a report entitled, Medicare Advantage (MA): Questionable Use of Health Risk Assessments Continues to Drive Up Payments to Plans by Billions. The report revealed significant issues with the use of health risk assessments (HRAs) by MA companies, resulting in an estimated $7.5 billion in inflated risk-adjusted payments for 2023. The report indicated that many diagnoses were recorded solely through HRAs or HRA-linked chart reviews, without any corresponding records of services to confirm these diagnoses. According to the report, 1.7 million MA enrollees had diagnoses that appeared only on HRAs or HRA-linked chart reviews, suggesting either that the diagnoses may be inaccurate or that patients did not receive adequate follow-up care. Twenty MA companies were responsible for 80 percent of the inflated payments, notably for serious and chronic health conditions such as diabetes and congestive heart failure. In response to these findings, OIG issued three recommendations to CMS. First, OIG recommended CMS impose additional restrictions on the use of diagnoses reported only from in-home HRAs or those linked to HRA chart reviews for risk-adjusted payments. Second, OIG recommended that CMS conduct audits to validate the accuracy of the diagnoses reported through these assessments and third, OIG recommended CMS investigate whether certain health conditions that resulted in higher payments might be more susceptible to misuse by MA companies. While CMS agreed to the third recommendation, it did not concur with the first two.
- On October 22, 2024, the HHS OIG released a report entitled, Medicare Part D Paid Millions for Drugs for Which Payment Was Available Under the Medicare Part A Skilled Nursing Facility Benefit. This investigation was a follow up from a 2009 study that found that Medicare Part D paid for drugs covered under Medicare Part A. OIG found that up to $465.1 million worth of drugs were paid for by Part D for patients during their Part A-covered skilled nursing facility (SNF) stay. Due to Part D’s cost-sharing requirements, this meant Part D enrollees inappropriately paid for approximately $21 million worth of drugs, causing unnecessary financial strain. OIG recommended that CMS work with plan sponsors to adjust or delete inappropriate prescription drug events, as well as similar instances of noncompliance from before and after the audit period, and assess the impact it had on the federal government. It also recommended that CMS provide plan sponsors with timely and accurate information on Part A SNF stays and instruct SNFs to cooperate with plan sponsors to prevent improper Part D payments of this nature.
III. Other Health Policy News
- On October 21, 2024, the Biden Administration proposed new rules to expand access to birth control and preventive services under the Affordable Care Act (ACA). These rules would require most health plans to cover over-the-counter (OTC) contraceptives without cost-sharing or prescriptions, giving more people affordable access to birth control. The rules also strengthen coverage for FDA-approved contraceptives and address reports of insurers placing unnecessary barriers such as administrative hurdles and cost-sharing requirements. In addition to contraceptive coverage, the rules expand access to other preventive services, including medications like pre-exposure prophylaxis (PrEP) and breast reconstruction after mastectomies. The proposal aims to remove financial and procedural obstacles, ensuring people can access critical healthcare services without burdens. The Administration also plans to improve transparency by requiring health plans to clearly explain their coverage of contraceptives through online tools, along with providing contact information for further inquiries. The proposed rules are available here. A press release with more information is available here.
- On October 22, 2024, HHS, through the Office of Assistant Secretary for Planning and Evaluation (ASPE), released new data reporting that the IRA has saved nearly 1.5 million Medicare Part D enrollees approximately $1 billion in out-of-pocket prescription drug costs in the first half of 2024. The IRA capped out-of-pocket drug costs at around $3,500 for 2024, with this limit set to decrease to $2,000 in 2025. Data in the report indicate that over 500,000 beneficiaries saved an average of $1,802 each. States like California, Florida, New York, and Texas saw the most people reach the cap, with high-cost drugs like cancer treatments contributing significantly. The issue brief is available here. A press release with more information is available here.
- On October 18, 2024, Senate Finance Committee Chair, Ron Wyden (D-OR), wrote a letter to CMS Administrator Chiquita Brooks-LaSure and Deputy Administrator Dan Tsai, urging the agency to address the critical shortage of addiction medicine specialists in the U.S. to improve access to substance use disorder (SUD) services for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries, particularly in rural and underserved areas. In the letter, Chair Wyden noted that fewer than 4,600 physicians are certified in addiction medicine, and only about 1,500 are certified in addiction psychiatry. Furthermore, residency match data shows that only 51 percent of addiction psychiatry fellowship programs and 60 percent of addiction medicine slots were filled this year. Chair Wyden’s request comes as CMS prepares to release guidance—mandated by the Consolidated Appropriations Act,2024—that is aimed at enhancing the mental health and SUD provider workforce for Medicaid and CHIP. In the letter, he urges CMS to include education, training, recruitment, and retention strategies to support addiction specialists in these programs, with a focus on bolstering access to SUD services in rural and underserved communities. These are part of ongoing efforts to address workforce shortages in rural and underserved areas. Earlier this year, Chair Wyden and the Medicare Graduate Medical Education (GME) Working Group outlined proposals aimed at expanding Medicare-supported residency programs in rural areas. In August 2024, Chair Wyden, along with Senator Marsha Blackburn (R-TN), introduced S. 4957, the Health Workforce Innovation Act to support education and training for health care workers in underserved regions. The letter is available here. A press release with more information is available here.
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