Health Care Week in Review | DOL Finalizes PBM Fee and Compensation Transparency Requirements; Federal Court Blocks CMS Medical Frailty Standard for Medicaid Community Engagement Requirements

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.

This week, the Department of Labor (DOL) finalized new compensation disclosure requirements for pharmacy benefit managers (PBMs) and affiliated service providers, and a federal court struck down part of the Center for Medicare & Medicaid Services (CMS's) Medicaid community engagement requirements interim final rule governing medical frailty determinations.

Regulations, Notices & Guidance

* On October 26, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Requirement For Attestation for All Airline Or Other Aircraft Passengers Arriving In The United States From Any Foreign Country And Controlled Free Pratique For Airlines Confirming That Such Passengers Have Not Been In The Democratic Republic Of The Congo In The Past 21 Days. CDC is announcing the issuance of an order under Sections 361, 365, 368, and 369 of the Public Health Service Act, and associated implementing regulations, prohibiting the boarding of any passenger who is not otherwise subject to an exemption on any aircraft destined to the U.S. from a foreign country unless the passenger presents a signed attestation confirming the passenger has not been present in the Democratic Republic of the Congo (DRC) during the 21 days prior to boarding a flight to the U.S. This order goes into effect on November 3, 2026, and will remain in effect through December 18, 2026.

* On October 26, 2026, the National Institutes of Health (NIH) released a notice entitled, Government-Owned Inventions; Availability for Licensing. NIH is announcing an invention available for licensing to achieve expeditious commercialization of results of federally funded research and development. The new technology addresses the limitation of cross-reactivity with antibodies directed towards other parasites when testing for active infection of Lymphatic filariasis.

* On October 27, 2026, the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a final rule entitled, Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity. This final rule focuses on deregulatory actions identified in HHS regulations regarding health information technology standards, implementation specifications, and certification criteria and regarding certification programs for health information technology. ONC states that this final rule reduces burden, offers flexibility to both developers and providers, and supports innovation through the removal and revision of certain certification criteria and regulatory provisions. This final rule is effective on December 28, 2026, except for amendatory instructions 7, 10, and 12 which are effective January 1, 2027.

* On October 27, 2026, the Food and Drug Administration (FDA) released a notice entitled, Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability. FDA is announcing the availability of draft guidance for sponsors submitting Investigational Drug Exemption (IDE) applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). The guidance presents current publicly available resources and associated content developed to support IDE electronic submissions to FDA. Comments must be received by December 28, 2026, to be considered.

* On October 27, 2026, FDA released a notice entitled, Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability. FDA is announcing the availability of draft guidance to provide recommendations for how an individualized human genome editing (GE) product that includes multiple product variants can be submitted in a single Biologics License Application (BLA). When finalized, this guidance will describe FDA's current thinking on individualized GE products with respect to how to specify the extent of GE component variation in a BLA, how to add new product variants to the BLA after licensure, and related topics. Comments must be received by November 27, 2026, to be considered.

* On October 28, 2026, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a proposed revision to mandatory guidelines entitled, Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG). SAMHSA is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), published in the Federal Register on October 12, 2023. This proposal includes revisions that would: clarify the types of laboratories that may be certified to conduct testing for federal agency workplace drug testing programs; reflect HHS's decision to publish the Authorized Drug Testing Panels only when revised rather than each year; revise the initial test batch quality control requirements for laboratories; and allow a split testing laboratory to test for any HHS-authorized biomarker to reconfirm substitution based on a biomarker test. Comments must be received by December 29, 2026, to be considered.

* On October 28, 2026, SAMHSA released a proposed revision to mandatory guidelines entitled, Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG). SAMHSA is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), published in the Federal Register on October 12, 2023. This proposal includes revisions that would: clarify the types of laboratories that may be certified to conduct testing for federal agency workplace drug testing programs; change invalid specimen criteria; reflect HHS's decision to publish the Authorized Drug Testing Panels only when revised rather than each year; revise the initial test batch quality control requirements for laboratories and instrumented initial test facilities (IITFs); allow a Medical Review Officer (MRO) to authorize use of a biomarker test for a specimen with an invalid result based on creatinine and specific gravity; and allow a split testing laboratory to test for any HHS-authorized biomarker to reconfirm substitution based on a biomarker test. Comments must be received by December 29, 2026, to be considered.

* On October 28, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, CMS is providing notice of a computer matching program between CMS and participating State-Based Administering Entities (AEs) entitled, Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs Under the Patient Protection and Affordable Care Act. The matching program supports eligibility determinations for enrollment in applicable state health subsidy programs under the Patient Protection and Affordable Care Act (ACA), including Qualified Health Plans (QHPs), Medicaid, the Children's Health Insurance Program (CHIP), and Basic Health Programs (BHPs). The matching program also supports implementation of statutory requirements concerning Medicaid community engagement and the prevention of concurrent Medicaid enrollment in more than one state through the Multi-State Enrollment Prevention (MSEP) system.

* On October 28, 2026, ACF released a notice of proposed rulemaking entitled, Reducing Bureaucracy and Burden for Block Grants. ACF is proposing to amend its block grant regulations to modernize requirements, reduce administrative burden on states and tribal grantees, and improve the clarity and efficiency of program administration. The current regulations include outdated provisions and procedural requirements that no longer reflect statutory authority or agency practice. The proposed revisions are intended to streamline grantee obligations, eliminate unnecessary requirements, and align the regulations with current law and policy. Comments must be received by November 28, 2026, to be considered.

* On October 28, 2026, CMS released a final rule entitled, Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Payment, and ESRD Quality Incentive Program. This final rule updates and revises payment rates and policies for renal dialysis services under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for Calendar Year (CY) 2027. This final rule also includes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by an ESRD facility to individuals with AKI. In addition, this final rule updates the requirements for the ESRD Quality Incentive Program. This final rule is effective on January 1, 2027.

* On October 28, 2026, HHS released a notice entitled, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. HHS is announcing the availability of a document that describes the HHS Secretary's enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) while the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act is developed through rulemaking.

* On October 29, 2026, CDC released a notice entitled, Notice of Amended Order Requirement For Attestation By All Persons Arriving In The United States From Any Foreign Country Via Transportation By Aircraft And Controlled Free Pratique For Airlines and Other Aircraft Operators Confirming That Such Persons Have Not Been In The Democratic Republic Of The Congo In The Past 21 Days. CDC is announcing the issuance of an amended order under Sections 361, 365, 368, and 369 of the Public Health Service Act, and associated implementing regulations, prohibiting the boarding of any person who is not otherwise subject to an exemption on any aircraft destined to the U.S. from a foreign country unless the person presents a signed attestation confirming the person has not been present in the DRC during the 21 days prior to boarding a flight to the U.S. This amended order was issued on October 28, 2026, to become effective on November 3, 2026, and will remain in effect through December 18, 2026.

* On October 29, 2026, CDC released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices. In accordance with the Federal Advisory Committee Act, CDC is seeking nominations for membership on the Advisory Committee on Immunization Practices (ACIP). ACIP consists of up to 19 experts that collectively represent a balanced range of scientific, clinical, and public health expertise relevant to the Committee's mission, including person(s) knowledgeable about consumer perspectives and/or social and community aspects of immunization programs. Nominations for membership within ACIP must be received no later than December 31, 2026. Submissions received after this time will not be considered for the current membership cycle.

* On October 29, 2026, FDA released a notice entitled, Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability. FDA is announcing the availability of a revised draft guidance for industry that revises and replaces the draft guidance entitled Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products, published in the Federal Register on July 1, 2024. This draft guidance addresses key aspects of drug delivery performance information for devices and combination products that include device constituent parts intended for delivery of a human drug, including a biological product. This draft guidance provides recommendations for development and organization of device drug-delivery performance information and data to improve the consistency of this information in applications and to facilitate transparency and predictability in development and regulatory review. The draft guidance is intended to facilitate and streamline development and lifecycle management of drug delivery devices. Comments must be received by January 28, 2027, to be considered.

* On October 30, 2026, FDA released a proposed rule entitled, Infant Formula Nutrient Requirements. FDA is proposing to amend the regulations on nutrient specifications and labeling for infant formula as part of a phased, comprehensive review of infant formula nutrients. This proposed rule, if finalized, would amend the minimum and/or maximum levels of four required nutrients, change the unit of measure for certain nutrients, change the permitted source to meet one of the nutrient requirements, and amend the content of the required labeling. This proposed rule also includes a comprehensive assessment of four additional nutrients for which FDA concludes that the current required levels remain appropriate and reflect the best available scientific evidence on infant nutritional requirements and safe intake levels. Comments must be received by March 2, 2027, to be considered.

* On October 30, 2026, HHS released a final rule entitled, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance. This final rule revises the regulation implementing section 504 of the Rehabilitation Act of 1973 as it applies to recipients of HHS funding, entitled Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance, published on May 9, 2024. This final rule clarifies that HHS interprets the statutory exclusion of "gender identity disorders not resulting from physical impairments" from the terms "individual with a disability" and "disability" set forth in HHS regulations to encompass "gender dysphoria not resulting from a physical impairment" for purposes of the regulation. HHS states that this clarification is necessary to resolve ambiguity introduced in the preamble to the 2024 final rule and to ensure compliance with the best reading of the governing statute. This final rule is effective January 2, 2027.

* On October 30, 2026, CMS released a final rule entitled, Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage. This final rule revises the Conditions for Coverage for Organ Procurement Organizations to clarify outstanding procedural questions and provide additional operational flexibility for organ procurement organizations (OPOs) to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving organs. This final rule revises definitions, revises the designation requirements for OPOs, clarifies when an OPO's service area is open for competition, and updates the process for appeals. This final rule is effective January 2, 2027.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event.

* November 1-3, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences (ESBSC). This is a hybrid meeting with some sessions open to the public.

* November 2-3, 2026: CMS announced the second biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026. This is a hybrid meeting open to the public.

* November 4, 2026: NIH announced a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). This is a virtual meeting with some sessions open to the public.

* November 5, 2026: ONC announced a meeting of the Health IT Advisory Committee (HITAC). This is a virtual meeting open to the public.

* November 5, 2026: NIH announced a meeting of the President's Cancer Panel. This is a virtual meeting open to the public.

* November 9, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a hybrid meeting open to the public.

* November 16, 2026: NIH announced a meeting of the Sickle Cell Disease Advisory Committee. This is a virtual meeting open to the public.

* November 18, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting open to the public.

* November 19, 2026: FDA announced a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. This is a hybrid meeting open to the public.

* November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.

* December 2, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with some sessions open to the public.

* December 2, 2026: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.

* December 2, 2026: NIH announced a meeting of the NCI. This is a virtual meeting with some sessions open to the public.

* December 3, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board (SDRAB). This is a virtual meeting open to the public.

* **December 6-7, 2027: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD). This is a hybrid meeting open to the public.

* December 7-8, 2026: NIH announced a meeting of the NICHD. This is a hybrid meeting open to the public.

* December 8, 2026: The Internal Revenue Service (IRS) announced a hearing on the proposed regulations amending an individual taxpayer's eligibility for a Premium Tax Credit (PTC). This is a telephonic meeting open to the public.

* December 8-9, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.

* December 9-10, 2026: CMS announced a town hall meeting to discuss FY 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). This is a virtual meeting open to the public.

* January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a virtual meeting open to the public.

* January 20, 2027: NIH announced a meeting of the NIDDK Advisory Council. This is a virtual meeting with some sessions open to the public.

* **January 21, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a virtual meeting with some sessions open to the public.

* January 25-26, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.

* **January 26-27, 2027: NIH announced a meeting of the National Institute of Aging. This is a virtual meeting with some sessions open to the public.

* February 8-9, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.

* **February 19, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.

* **May 3-4, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.

* **May 11-12, 2027: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with some sessions open to the public.

* **May 12, 2027: NIH announced a meeting of NIDDK. This is a hybrid meeting with some sessions open to the public.

* **May 18, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a hybrid meeting with some sessions open to the public.

* **June 4, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.

* **June 7, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.

* **June 7-8, 2027: NIH announced a meeting of the NICHD. This is an in-person meeting with some sessions open to the public.

* **June 25, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.

* **September 7-8, 2027: NIH announced a meeting of the NICHD. This is an in-person meeting with some sessions open to the public.

* **September 9-10, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.

* **September 14, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a hybrid meeting with some sessions open to the public.

* **September 14-15, 2027: NIH announced a meeting of the National Institute of Aging. This is a hybrid meeting with some sessions open to the public.

* **October 15, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

* On October 28, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Potential Vulnerabilities in CMS's Oversight of Medicare Providers' Billing of Selected Outpatient Drugs. OIG conducted an analysis of CMS claims data with dates of service from April 1, 2024, through March 31, 2025, to highlight providers' billing trends and patterns and identify any vulnerabilities in CMS's oversight of these billings. Through the analysis, OIG found that providers billed 160,918 Part B claim lines for outpatient drugs with 577 unique procedure codes that did not match the procedure codes associated with the drug codes included on the claim lines. Among those claim lines, OIG stated that six procedure codes were associated with 62 percent of these outpatient drugs and two provider types (critical access hospitals and short-term acute-care hospitals) billed for 99 percent of these outpatient drugs. From these results, OIG identified two potential vulnerabilities related to CMS's and Medicare Administrative Contractors' oversight of providers' billing of drugs. First, CMS did not have system edits to ensure providers used the correct procedure code when billing for outpatient drugs. Second, provider education activities did not address billing for drugs using procedure codes that match those associated with the drug codes in CMS crosswalk files.

* On October 30, 2026, KFF released a report entitled, Medicare Part D Premiums and Cost Sharing in 2027. KFF conducted an analysis of premium and cost-sharing requirements for Medicare Part D coverage in stand-alone prescription drug plans (PDPs) and found that the average monthly premium for these stand-alone plans is projected to increase to $51 in 2027, up 50 percent from $34 in 2026, if current enrollees do not switch into lower-premium plans during open enrollment, which runs through December 7, 2026. The analysis also found that the projected average monthly premium of $51 for PDPs is more than five times higher than the drug coverage premium in Medicare Advantage (MA) plans that offer Part D coverage (MA-PDs), which is projected to average $9 per month next year. Deductibles are also projected to increase, averaging $643 for PDP enrollees and $489 for MA-PD enrollees, while most Part D enrollees will face coinsurance rather than fixed copayments for preferred brand and non-preferred drugs, which may result in less predictable out-of-pocket costs.

Other Health Policy News

* On October 27, 2026, Senate Finance Committee Ranking Member Ron Wyden (D-OR), Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bernie Sanders (I-VT), and 11 other Senate Democrats opened an inquiry into ten of the largest health insurers participating in the federal marketplace regarding their disenrollment of certain enrollees. In letters to the companies' chief executives, the senators raised questions about the criteria and processes used to identify potentially unauthorized enrollments, including the use of zero-dollar premiums and a lack of claims as indicators of possible fraud. The letters also state that insurers assisted CMS in contacting enrollees, in some cases requesting verification of Social Security numbers, and that coverage was terminated for individuals who did not respond. The senators emphasized that the companies carried out these communications months before CMS attempted to change its guidance to support the request, bypassing the established process for mid-year eligibility determinations.

The senators have requested additional information from the insurers to better understand the scope of the issue and their response, including when CMS first contacted them about evaluating unauthorized enrollments and whether the agency provided a legal basis for its request; why the companies conducted mid-year eligibility redeterminations that conflicted with the federal exchange manual in effect at the time; whether zero-dollar net premiums, a lack of claims, or missed unsolicited communications are reliable indicators of fraud; how many terminated enrollees subsequently filed a health care claim or sought reinstatement; and whether the companies are participating in a second phase of terminations.

The text of the letter may be found here. The press release from the Office of Senator Wyden may be found here.

* On October 27, 2026, HHS, through the Office on Women's Health (OWH), announced coordinated efforts with the Agency for Healthcare Research and Quality (AHRQ) and DenseBreast-info.org (DBI) to establish the OWH-AHRQ Breast Cancer Screening and Diagnostic Follow-up Initiative. This initiative is intended strengthen breast cancer screening, expand breast density education, and improve timely diagnostic follow-up, with a focus on the wellbeing of midlife women. Specifically, participants will analyze national screening and follow-up patterns to identify areas of opportunity, while a collaborative of more than 40 health systems will expand evidence-based practices and address delays in care. Additionally, through a Memorandum of Understanding (MOU), OWH and DenseBreast-info.org (DBI) will collaborate to expand access to evidence-based educational resources that improve breast density awareness, support informed discussions between women and their healthcare providers, and promote understanding of breast cancer screening and diagnostic follow-up options. These efforts follow the October 19, 2026, Executive Order (EO), Advancing Women's Health to Improve Outcomes in All Phases of Life.

The HHS press release may be found here.

* On October 27, 2026, CMS issued new guidance to QHP issuers regarding agent- and broker-of-record changes for Marketplace enrollments. This guidance provides that issuers should not allow agents or brokers to claim credit for enrollments if their National Producer Number (NPN) was not included in the original enrollment data provided by CMS, including through post-enrollment agent-of-record or broker-of-record forms. CMS said the policy is intended to reduce unauthorized changes to consumers' agent-of-record information and related enrollment fraud. Issuers may continue to work with agents, brokers, and CMS on legitimate book-of-business transfers consistent with the FFE Enrollment Manual.

The CMS guidance may be found here.

* On October 28, 2026, HHS published the Health Data, Technology, and Interoperability: ONC Deregulatory Actions to Unleash Prosperity (HTI-5) final rule, which removes or revises certain federal health IT certification requirements and advances ONC's transition toward a certification framework centered on Fast Healthcare Interoperability Resources (FHIR)-based application programming interfaces (APIs). The final rule aligns with President Trump's Executive Order (EO) 14192, Unleashing Prosperity through Deregulation, and EO 14267, Reducing Anti-Competitive Regulatory Barriers. HHS estimates the final rule will generate more than $1.5 billion in regulatory cost savings.

The final rule removes 14 health IT certification criteria and revises seven, a narrower approach than initially proposed, which would have eliminated 34 of the Certification Program's 60 certification criteria. The finalized revisions include eliminating certain transparency requirements for the decision support interventions certification criterion, including AI-related "model card" requirements for source attribute support and source attribute access and modification. The final rule also revises and removes several Conditions and Maintenance of Certification requirements. However, ONC is retaining privacy and security certification safeguards and certain public health-related reporting requirements. Implementation dates for the certification changes vary, with some provisions taking effect 60 days after publication, others on January 1, 2027, and one on January 1, 2030.

Notably, ONC did not address proposed changes to existing information blocking definitions and exceptions, including changes affecting the manner and infeasibility exceptions and the treatment of automated access to electronic health information. The current information blocking requirements therefore remain in place. ONC indicated that proposals not addressed in the final rule remain under consideration and could be addressed through future rulemaking.

The HTI-5 final rule may be found here. The HHS press release may be found here. The ONC fact sheet may be found here and ONC's summary of certification criteria removals and revisions may be found here.

* On October 28, 2026, CMS released the CY 2027 Changes to the End-Stage Renal Disease Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Payment, and ESRD Quality Incentive Program final rule. The final rule increases the ESRD PPS base rate to $297.52. CMS expects this will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7 percent, which is reflective of a 1.9 percent market basket update. The final rule also makes routine annual updates to the ESRD PPS-specific wage index to adjust payments based on geographic area and to the fixed dollar loss (FDL) and Medicare allowable payment (MAP) amounts for CY 2027.

The final rule also doubles the Low-Volume Payment Adjustment (LVPA) volume threshold, increasing the threshold from 4,000 to 8,000 facilities, and extends the attestation deadline to December 31, 2026, for an ESRD facility to attest that it meets the requirements of the LVPA for CY 2027. Further, the final rule updates the case-mix adjusters for pediatric patients and finalizes the proposal to begin applying the LVPA to treatments furnished to pediatric ESRD beneficiaries by ESRD facilities that meet the low-volume criteria. Additionally, the final rule includes an increase to the payment adjustment amount for home and self-dialysis training from $95.60 to $138.00 beginning in CY 2027 and finalizes proposals relating to the onset period and onset adjustment factor.

CMS is also finalizing several changes to better align payment adjustment amounts for the transitional drug add-on payment adjustment (TDAPA) and post-TDAPA add-on payment adjustment with the actual costs of drugs. CMS is further finalizing removals, replacements, and revisions of certain measures within the ERSD Quality Incentive Program (QIP).

The ERSD PPS final rule may be found here. The CMS fact sheet may be found here.

* On October 29, 2026, the Department of Labor's (DOL) Employee Benefits Security Administration (EBSA) issued a final rule requiring pharmacy benefit managers (PBMs) and affiliated brokers and consultants to disclose certain information about their fees and compensation to fiduciaries of large, self-insured employer-sponsored group health plans. The final rule implements transparency provisions enacted by Congress as part of the Consolidated Appropriations Act, 2026 and is intended to provide plan fiduciaries with information to assess the reasonableness of PBM compensation and fulfill their obligations under the Employee Retirement Income Security Act (ERISA).

Under the final rule, PBMs must disclose rebates and other payments received from drug manufacturers; compensation received when the amount paid by a health plan for a prescription drug exceeds the amount reimbursed to the pharmacy; and payments recouped from pharmacies in connection with prescription drugs dispensed to plan participants. The final rule also allows plan fiduciaries to audit the accuracy of PBM disclosures and provides additional relief for plan fiduciaries if a PBM fails to comply with its disclosure requirements.

DOL estimates the final rule could reduce prescription drug costs for health plans and participants by as much as $22 billion over 10 years on an undiscounted basis. According to DOL, employer-sponsored self-insured group health plans affected by PBM practices cover approximately 90 million Americans.

The final rule may be found here. The DOL press release may be found here.

* On October 29, 2026, the U.S. District Court for the District of Massachusetts struck down part of CMS's interim final rule implementing the Medicaid community engagement requirements under H.R. 1, the One Big Beautiful Bill (OBBB) (also referred to as the Working Families Tax Cut (WFTC) legislation). The court held that CMS could not require individuals in one of the five statutory "medically frail" categories to also prove that their condition significantly impairs their ability to satisfy the community engagement requirement. The court concluded that CMS lacked authority to impose that second condition. Congress's use of "including" established a statutory floor, meaning CMS could expand the definition but could not remove individuals who fall within the enumerated categories. The additional work capacity limitation was therefore ultra vires and contrary to law under the Administrative Procedure Act (APA). The court vacated that portion of the rule and permanently enjoined CMS from enforcing it.

The court upheld the interim final rule's 12-month limit on claims and encounter data used to verify medical frailty, as well as the limitation allowing only one self-attestation per continuous enrollment period. The January 1, 2027 implementation deadline remains in place, but the court ordered a six-month stay of enforcement for determinations of whether an individual qualifies as medically frail, giving states additional time to revise their eligibility systems and processes.

The summary judgement may be found here. The interim final rule may be found here.

* On October 29, 2026, HHS, the Treasury Department, and the Office of Personnel Management (OPM) released guidance entitled, Federal Independent Dispute Resolution (IDR) Operations Final Rules Batching and Bundling Guidance for Certified IDR Entities and Disputing Parties. This guidance explains how to implement the finalized batching requirements, identifies the permissible Current Procedural Terminology (CPT) code ranges for anesthesiology, radiology, pathology, and laboratory items and services eligible for batching because they relate to the treatment of a similar condition, and defines a bundled payment arrangement. It also provides practical examples to clarify how disputing parties and certified IDR entities should apply the finalized batching and bundled payment provisions.

The guidance may be found here.

* On October 29, 2026, Senate HELP Chairman Bill Cassidy (R-LA) released a legislative discussion draft to improve patient access to Artificial Intelligence (AI)-based health technologies. The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care (PATIENT AI) Act aims to create a more predictable and consistent framework to review and reimburse for AI-based technologies to allow novel products to come to market without unnecessary barriers while retaining oversight of patient safety.

The PATIENT AI Act would expand the use of AI across HHS while directing the department to issue guidance protecting patient privacy and security. It would also clarify FDA and ONC oversight of AI-based technologies, give FDA authority to review software updates on a rolling basis, and establish a payment pathway to encourage adoption of AI-enabled tools.

The discussion draft text may be found here and the section-by-section summary may be found here. The press release from Chairman Cassidy's office may be found here.

* On October 30, 2026, the HHS Office for Civil Rights (OCR) released a final rule clarifying that, under HHS regulations, gender dysphoria not resulting from physical impairments does not qualify as a disability under Section 504 of the Rehabilitation Act of 1973. This final rule revises the Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance final rule, published on May 9, 2024, in which the preamble suggested that gender dysphoria may qualify as a disability without providing explicit regulatory guidance on the issue. This new final rule clarifies that HHS interprets the statutory exclusion of "gender identity disorders not resulting from physical impairments" to encompass "gender dysphoria not resulting from a physical impairment" for purposes of determining who qualifies as an individual with a disability under the regulation. HHS stated that the change is intended to resolve ambiguity created by the preamble to its May 2024 final rule, which had stated that gender dysphoria did not fall within the statutory exclusions for gender identity disorders, while the regulatory text itself did not address whether gender dysphoria could constitute a disability under Section 504.

This final rule applies to all programs and activities that receive HHS funding.

The final rule follows an April 2025 notice clarifying that the 2024 rule did not establish gender dysphoria as a disability and a December 2025 proposed rule addressing the issue. The final rule will go into effect on January 2, 2027.

The final rule may be found here. The HHS press release may be found here.