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 the Notice of Benefit and Payment Parameters for 2026 and CMS selected fifteen new drugs for the second round of Medicare price negotiations.
I. Regulations, Notices & Guidance
- On January 13, 2025, the Consumer Financial Protection Bureau (CFPB) released a rule entitled, Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V). CFPB is issuing a final rule amending Regulation V, which implements the Fair Credit Reporting Act (FCRA), concerning medical information. The FCRA prohibits creditors from considering medical information in credit eligibility determinations. The CFPB is removing a regulatory exception that had permitted creditors to obtain and use information on medical debts notwithstanding this statutory limitation. The final rule also provides that a consumer reporting agency generally may not furnish to a creditor a consumer report containing information on medical debt that the creditor is prohibited from using.
- On January 13, 2025, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on The Performance of Fusion Procedures for Degenerative Disease of the Lumbar Spine, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On January 13, 2025, AHRQ released a notice entitled, Supplemental Evidence and Data Request on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review. is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review, which is currently being conducted by the AHRQ’s EPC Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On January 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee. This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of CMS concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC’s fundamental purpose is to support the principles of an evidence-based determination process for Medicare’s coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.
- On January 13, 2025, CMS released a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program. This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS’ authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS’ Exchange standards and requirements; HHS’ system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; permissible plan-level adjustment to the index rate to account for cost-sharing reductions (CSRs); reconsideration standards for certification denials; changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a policy to publicly share aggregated, summary-level Quality Improvement Strategy (QIS) information on an annual basis; and revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.
- On January 14, 2025, FDA released a proposed rule entitled, Food Labeling: Front-of-Package Nutrition Information. FDA proposes to require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label. This action, if finalized, would require the display of a compact informational box containing certain nutrient information on the principal display panel. The box would provide consumers, including those who have lower nutrition knowledge, with standardized, interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet. We also propose to amend certain nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies.
- On January 14, 2025, HHS released a notice entitled, Enhancing Coverage of Preventive Services Under the Affordable Care Act. This document withdraws a notice of proposed rulemaking that appeared in the Federal Register on October 28, 2024, regarding coverage of certain preventive services under the Affordable Care Act (ACA).
- On January 14, 2025, the Occupational Safety and Health Administration (OSHA) released a notice entitled, Occupational Exposure to COVID-19 in Healthcare Settings. This document states that OSHA is terminating its COVID-19 rulemaking.
- On January 15, 2025, HHS and the Drug Enforcement Agency (DEA) released a final rule entitled, Continuity of Care via Telemedicine for Veterans Affairs Patients. This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.
- On January 15, 2025, HHS and DEA released a final rule entitled, Expansion of Buprenorphine Treatment via Telemedicine Encounter. HHS and DEA amending their regulations to expand the circumstances under which practitioners registered by the DEA are authorized to prescribe schedule III-V controlled substances approved by FDA for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. Under these new regulations, after a practitioner reviews the patient’s prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, the practitioner may prescribe an initial six-month supply of such medications (split amongst several prescriptions totaling six calendar months) through audio-only means. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This regulation also requires the pharmacist to verify the identity of the patient prior to filling a prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires an in-person medical evaluation prior to issuance of a controlled substance prescription. However, this regulation falls under one of the exceptions found within the Ryan Haight Act. Additionally, this regulation does not affect practitioner-patient relationships in cases where an in-person medical evaluation has previously occurred. The purpose of this regulation is to prevent lapses of care by continuing some of the telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder.
- On January 15, 2025, HHS and DEA released a proposed rule entitled, Special Registrations for Telemedicine and Limited State Telemedicine Registrations. The Ryan Haight Act generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the “practice of telemedicine” within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion.
- On January 15, 2025, FDA released a proposed rule entitled, Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products. FDA is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.
- On January 15, 2025, HHS released a notice entitled, Mandatory Guidelines for Federal Workplace Drug Testing Programs –Authorized Testing Panels. HHS herein publishes the panels of Schedule I and II drugs and biomarkers authorized for testing in Federal workplace drug testing programs. HHS has revised the drug testing panels for both urine and oral fluid, and revised required nomenclature for laboratory and Medical Review Officer Reports.
- On January 15, 2025, HHS released a final rule entitled, Privacy Act; Implementation. HHS is issuing this final rule to make effective the exemptions that were previously proposed for a new Privacy Act system of records, NIH Police Records, maintained by the National Institutes of Health (NIH), from certain requirements of the Privacy Act. The new system of records covers criminal and non-criminal law enforcement investigatory material maintained by the NIH Division of Police, a component of NIH which performs criminal law enforcement as its principal function. The exemptions are necessary and appropriate to protect the integrity of law enforcement proceedings and records compiled during the course of NIH Division of Police activities, prevent disclosure of investigative techniques, and protect the identity of confidential sources involved in those activities.
- On January 16, 2025, FDA released a notice entitled, Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal. On September 20, 2024, FDA published a direct final rule amending the Scope section of its regulation that provides for a regulatory hearing before FDA. FDA is withdrawing this direct final rule because it received significant adverse comment.
- On January 16, 2025, FDA released a notice entitled, Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments. The purpose of this docket to solicit input from interested parties on this topic.
- On January 16, 2025, FDA released a notice entitled, Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period. FDA is extending the comment period for the draft guidance for industry entitled Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics that appeared in the Federal Register of December 6, 2024. The new deadline for public comments is March 6, 2025.
- On January 16, 2025, FDA released draft guidance for industry entitled, Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology. This guidance provides recommendations to sponsors for the clinical development of drug and biological products intended for the prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN) in oncology patient populations.
- On January 16, 2025, HHS released a notice entitled, Annual Update of the HHS Poverty Guidelines. This notice provides an update of the HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index.
- On January 17, 2025, HHS released its semiannual regulatory agenda detailing an inventory of rulemaking actions under development throughout the Department.
Event Notices
January 7, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 7, 2025: The Small Business Administration (SBA) announced a meeting of the National Women’s Business Council. This is an in-person meeting open to the public.
January 13, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
January 16, 2025: HHS announced a meeting of the Advisory Committee on Minority Health. This is a virtual meeting open to the public.
January 23, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting with one session open to the public.
January 23, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the Secretary’s Advisory Council on Blood Stem Cell Transplantation (ACBSCT). This is a virtual meeting open to the public.
January 27, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.
January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.
January 29-39, 2025: HRSA announced a meeting of the Advisory Commission on Childhood Vaccines. This is a virtual meeting open to the public.
February 5, 2025: FDA announced a joint public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid meeting open to the public.
February 6, 2025: CMS announced a meeting of the Advisory Panel on Outreach and Education (APOE). This is a virtual meeting open to the public.
February 10, 2025: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a virtual meeting open to the public.
February 11-12, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Association of Public Health Laboratories (APHL) entitled, Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States. This is a virtual meeting open to the public.
February 13-14, 2025: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
February 25, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
February 25, 2025: FDA announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.
February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
March 5-6, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
March 27-28, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
May 14, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
August 6-7, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
December 4-5, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
II. Reports, Studies, & Analyses
- On January 14, 2025, the HHS Office of Inspector General (OIG) released a report entitled, How FDA Used Its Accelerated Approval Pathway Raised Concerns in 3 of 24 Drugs Reviewed. OIG examined whether FDA’s use of its accelerated approval pathway for drugs that treat serious and life-threatening conditions led to the approval of drugs that provided no clinical benefit for patients. OIG found that three out of twenty-four drugs approved under the accelerated pathway had concerns: for two of these three drugs, FDA reviewed analyses not in the sponsor’s original analysis plans, which is a deviation from recommended practices. For all three drugs, FDA issued an approval despite concerns from FDA reviewers and/or advisory committees. Additionally, FDA had meetings missing from the administrative file or not fully documented for one drug. Two of the three drugs are now off the market, while the third has had its confirmatory trial delayed. OIG recommended FDA define specific factors that would require the accelerated approval council to advise on certain drug applications, as well as take steps to ensure appropriate documentation of meetings is included in drug approval administrative files. FDA concurred with the second recommendation, but not the first.
III. Other Health Policy News
- On January 13, 2025, CMS released a final rule entitled, Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program. The final rule includes payment parameters and provisions related to the HHS-RADV programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program. It also includes the 2026 benefit year user fee rates for issuers offering QHPs through FFEs and SBE-FPs, as well as requirements related to modifications to the calculation of the BHP payment and changes to the IVA sampling approach and SVA pairwise means test for HHS-RADV.
- In addition, the final rule addresses:
- HHS’ authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS’ Exchange standards and requirements;
- HHS’ system suspension authority to address noncompliance by agents and brokers;
- An optional fixed-dollar premium payment threshold;
- Permissible plan-level adjustment to the index rate to account for cost-sharing reductions (CSRs);
- Reconsideration standards for certification denials;
- Changes to the approach for conducting ECP certification reviews;
- A policy to publicly share aggregated, summary-level QIS information on an annual basis; and
- Revisions to MLR reporting and rebate requirements for qualifying issuers that meet certain standards.
- The final rule can be viewed here.
- On January 17, 2025, CMS released the list of drugs selected for the second round of Medicare drug price negotiations. The list includes, among others, the GLP-1 weight loss drugs Ozempic, RYBELSUS, and Wegovy. This selection follows a November proposal from the Biden Administration to have Medicare and Medicaid cover GLP-1 drugs, which has drawn criticism due to the large projected cost of doing so – the Congressional Budget Office (CBO) has estimated the cost of the proposal at $35 billion. Both the coverage of GLP-1s and the status of the Medicare drug price negotiations, as well as the drugs selected, may be altered by President-elect Trump’s Administration following his inauguration on January 20, 2025. Until then, the full list of selected drugs is below:
- Ozempic; RYBELSUS; Wegovy
- TRELEGY ELLIPTA
- XTANDI
- POMALYST
- IBRANCE
- OFEV
- LINZESS
- CALQUENCE
- AUSTEDO; AUSTEDO XR
- BREO ELLIPTA
- Tradjenta
- XIFAXAN
- VRAYLAR
- JANUMET; JANUMET XR
- Otezla
- On January 15, 2025, the Drug Enforcement Administration (DEA) released a proposed rule establishing a framework for practitioners to prescribe Schedule II-V controlled substances via telemedicine without a prior in-person medical evaluation entitled, Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation. In the proposed rule, DEA proposes establishing a three-tiered system of “Special Registrations” consisting of: (1) qualified clinician practitioners who can prescribe Schedule III-V controlled substances, (2) qualified specialized clinician practitioners who can prescribe Schedule II-V controlled substances, and (3) qualified covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances. DEA also proposes increased recordkeeping and reporting requirements with these Special Registrations. Public comments on this proposed rule are expected to be due March 18, 2025. The proposed rule can be viewed here.
- In addition to this proposed rule, DEA finalized a rule entitled, Expansion of Buprenorphine Treatment via Telemedicine Encounter. This final rule permits a practitioner to prescribe a patient with a Schedule III-V controlled substance for the treatment of Opioid Use Disorder (OUD) for a period of up to six months following review of the patient’s prescription drug monitoring program (PDMP) data. After six months, the practitioner must use other forms of telemedicine authorized by the Controlled Substances Act or conduct an in-person medical visit. The final rule also requires pharmacists to verify the identity of the individual before filling the prescription. The final rule can be viewed here and is currently scheduled to go into effect on February 16, 2025.
- On January 16, 2025, CMS announced that 24 accountable care organizations (ACOs) will be participating in the ACO Primary Care Flex Model (ACO PC Flex Model) for Performance Year (PY) 2025. These ACOs cover 37 states, with beneficiaries served across all 50 states and the District of Columbia. The ACO PC Flex Model is a voluntary initiative designed to enhance primary care delivery within the Medicare Shared Savings Program (MSSP). Starting in 2025 and running through 2029, the model will test the impact of prospective payments and increased funding for primary care on health outcomes, quality of care, and costs. By offering more flexible payment structures, the ACO PC Flex Model is intended to encourage participating ACOs and their primary care providers to adopt innovative, team-based, person-centered approaches to care, with a particular focus on improving access to high-quality care, especially for underserved populations. Participants will be drawn from ACOs already enrolled in MSSP, which must be low-revenue organizations as defined by Medicare regulations. ACOs interested in joining the ACO PC Flex Model must apply through MSSP, indicating their interest during the application process. More information on the ACO PC Flex Model can be found here.
- On January 15, 2025, SAMHSA released updated National Behavioral Health Crisis Care Guidance. This comprehensive set of documents includes the 2025 National Guidelines for a Behavioral Health Coordinated System of Crisis Care, Model Definitions for Behavioral Health Emergency, Crisis, and Crisis-Related Services, and a draft Mobile Crisis Team Services: An Implementation Toolkit, which is open for public comment. These updates reflect the transition to the 988 Suicide & Crisis Lifeline, which became operational in 2022, and address emerging needs in behavioral health crisis care as the nation faces high rates of suicide and overdose. SAMHSA developed the updated guidance to support state, territorial, tribal, and local governments in developing and sustaining effective crisis care systems, and the resources provide a framework for ensuring individuals facing behavioral health crises have timely access to appropriate care. The guidance emphasizes three foundational elements in building a comprehensive crisis care system: someone to contact (services like the 988 Lifeline), someone to respond (mobile crisis teams offering on-site interventions), and a safe place for help (stabilization services). HHS Secretary Xavier Becerra emphasized that access to crisis care should be universal, while SAMHSA Assistant Secretary for Mental Health and Substance Use Miriam E. Delphin-Rittmon highlighted the role of the updated guidance in helping communities improve their crisis care services to better support individuals in need. A press release with more information is available here.
View our Health Care Legislative & Public Policy team.
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