Health Care Week in Review | Tri-Agencies Finalize Transparency in Coverage Rules; Rep. Pallone Proposes No Surprises Act Reforms

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. 

Regulations, Notices & Guidance

• On October 5, 2026, the Departments of Health and Human Services (HHS), Labor (DOL), and the Treasury (hereinafter “Departments”) released final rules entitled, Transparency in Coverage. Consistent with the President’s Executive Order 14221, Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information, the Departments jointly finalized changes to the Transparency in Coverage regulations to improve the accessibility of pricing disclosures to health plan participants, beneficiaries, and enrollees, and the standardization and reliability of the public pricing disclosures from non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage.
• On October 5, 2026, the Food and Drug Administration (FDA) released a final order entitled, Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry. FDA is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device.
• On October 5, 2026, FDA released a final order entitled, Medical Devices; Exemptions from Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems. This order sets forth FDA’s final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption is immediately in effect for such devices, it will decrease regulatory burdens on the medical device industry, and it will eliminate private costs and expenditures required to comply with certain federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On October 5, 2026, FDA released a final order entitled, Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation. FDA is classifying the focused ultrasound system for non-thermal, mechanical tissue ablation into class II. The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the focused ultrasound system for non-thermal, mechanical tissue ablation. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device.
• On October 5, 2026, FDA released a final order entitled, Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System. FDA is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system into class II. The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the high throughput DNA sequencing for hereditary cancer predisposition assessment test system.
• On October 6, 2026, the Centers for Medicare & Medicaid Services (CMS) released guidance entitled, New State Plan Option to Cover Certified Community Behavioral Health Clinic Services (SMD 26-004). This guidance establishes an optional Medicaid state plan benefit for Certified Community Behavioral Health Clinics (CCBHCs), giving states a new pathway to cover comprehensive behavioral health services through their Medicaid programs. The guidance builds on the longstanding CCBHC demonstration model and requires participating clinics to meet state certification standards, provide a broad range of mental health and substance use disorder services, and coordinate care across community providers. States adopting the option must cover nine core service categories, including crisis response, outpatient behavioral health treatment, case management, psychiatric rehabilitation, peer supports, and specialized services for veterans, while maintaining quality reporting and governance requirements. Unlike the existing CCBHC demonstration, the new state plan option gives states greater flexibility in how they reimburse providers and does not include an enhanced federal Medicaid match or a required prospective payment system.
• On October 7, 2026, CMS released a proposed rule entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other. This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages.
• On October 8, 2026, FDA released a final order entitled, Medical Devices: Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-The-Counter Use. FDA is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II. The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the infant pulse rate and oxygen saturation monitor for over-the counter use.
• On October 8, 2026, FDA released a final order entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit. FDA is classifying the hematopoietic cell enrichment kit into class II. The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device.
• On October 8, 2026, FDA released a final order entitled, Medical Devices: Immunology and Microbiology; Classification of the System for Detection of Nucleic Acid from Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens. FDA is classifying the system for detection of nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens into class II. The special controls that apply to the device type are identified in this final order and will be part of the codified language for classification of the system for detection of nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens.
• On October 9, 2026, HHS released a notice entitled, Announcing Solicitation of Written Comments to inform the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle Strengthening Guidance. HHS seeks public comments to inform the development of the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance (2027 Steps and Muscle-Strengthening Guidance). The Physical Activity Guidelines for Americans provide science-based recommendations on how physical activity can help promote health and reduce the risk of chronic disease. The guidelines serve as the benchmark and primary, authoritative voice of the federal government for providing science-based guidance on physical activity, fitness, and health in the U.S. Comments are due November 12, 2026.
• On October 9, 2026, FDA released final guidance entitled, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability. This final guidance provides answers to commonly asked questions from applicants and other interested parties regarding post-approval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This final guidance finalizes the draft guidance of the same title issued on July 23, 2024.na 

Event Notices

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

• October 14, 2026: The National Institutes of Health (NIH) announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• **October 15, 2026: NIH announced a meeting of the President's Cancer Panel. This is a virtual meeting open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• **October 19, 2026: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
• October 19-20, 2026: NIH announced two Tribal Consultations and one Tribal listening session at the National Congress of American Indians (NCAI) Annual Convention. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Office of AIDS Research Advisory Council. This is a hybrid meeting open to the public. 
• October 22, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• October 26, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act. This is a hybrid meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting open to the public.
• October 29, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute on Aging. This is a virtual meeting with some sessions open to the public.
• October 30, 2026: FDA announced a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. This is a hybrid meeting 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: The Office of the National Coordinator for Health IT (ONC) announced a meeting of HITAC. 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, NIDDK. This is a virtual meeting with some sessions open to the public.
• December 1, 2026: NIH announced a meeting of the NCI. This is an in-person 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 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid 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.

Reports, Studies & Analyses

GAO Examines Medicare Part D Vertical Integration and Pharmacy Payments

On October, 5, 2026, the Government Accountability Office (GAO) released a report entitled, Medicare Part D: Payments and Contracts Between Pharmacies and Plan Sponsors That Are Vertically Integrated. GAO examined how vertical integration among Medicare Part D plan sponsors, pharmacy benefit managers (PBMs), and pharmacies affects prescription drug utilization and payments. Focusing on four large vertically integrated Part D plan sponsors, the report found that their owned pharmacies accounted for about one-quarter of prescription drug utilization and pharmacy payments in 2023, with most dispensing occurring through mail-order pharmacies. GAO also found that payments and beneficiary cost-sharing were generally lower at owned pharmacies for the most commonly used and highest-spending Part D drugs, although some higher-cost medications had higher cost-sharing at owned pharmacies. A review of pharmacy contracts found that payment rates for owned pharmacies were not consistently higher or lower than rates for non-owned pharmacies, suggesting that differences in payment arrangements varied across sponsors and contracts.

Health Affairs Highlights Opportunities to Improve LTSS Coordination for Dual-Eligible Beneficiaries

On October 9, 2026, Health Affairs released a report entitled Unlocking the Promise of Integrated Care Through LTSS Coordination. The report examines challenges and opportunities for improving coordination of long-term services and supports (LTSS) for individuals dually eligible for Medicare and Medicaid. The report found that while integrated care models, particularly Dual Eligible Special Needs Plans (D-SNPs), can help reduce nursing home use and increase access to home- and community-based services, coordination is often hindered by fragmented benefit structures, limited data sharing, and administrative barriers. The authors recommend expanding fully integrated dual-eligible plans, strengthening information sharing among Medicare and Medicaid partners, improving coordination of supplemental and Medicaid-covered LTSS benefits, and increasing access to home- and community-based services to better support dual-eligible beneficiaries. 

Other Health Policy News

CMS Announces Medicare Improvement Fund Rebates for Beneficiaries

On October 3, 2026, CMS announced that it would provide $90 rebates to 20.8 million eligible fee-for-service (FFS) Medicare beneficiaries to help offset their October health insurance premiums. The payments total approximately $1.87 billion and will be drawn from the Medicare Improvement Fund (MIF), which previously held approximately $2 billion. Congress created the MIF as a reserve fund to finance improvements to FFS Medicare. Historically, lawmakers have often used the fund to offset the cost of other legislative priorities, such as physician payment updates or extensions of temporary add-on payments for providers. In a press release announcing the rebates, the Administration argues that returning MIF savings directly to beneficiaries is one of the best ways to improve Medicare. However, nearly exhausting the fund means that any imminent Medicare policy changes with additional costs may require other offsets.

The White House press release is available here. A CMS fact sheet is available here.

CMS Seeks Input on New Medicare and Medicaid Fraud Prevention Strategy

On October 5, 2026, CMS released a request for information (RFI) seeking industry feedback on a proposed new operating model for combating fraud, waste, and abuse in Medicare and Medicaid. According to the notice, CMS is considering a shift in how future fraud defense contracts will be structured. While contractors would continue to play a significant role in investigations and enforcement support, CMS proposes taking a more direct role in directing investigations. CMS is asking stakeholders to provide innovative ideas for how contractors could operate within that framework and to identify any risks or challenges the proposed approach may create. CMS notes that responses should not be constrained by traditional policies and processes, such as those in the current Unified Program Integrity Contractor (UPIC) Statements of Work or the Medicare Program Integrity Manual.

CMS emphasized that the RFI is intended solely for market research and planning purposes and will not result in a contract award. Interested vendors must submit responses using CMS's designated questionnaire by November 4, 2026.

Text of the CMS RFI may be found here.

Federal Agencies Finalize Transparency in Coverage Updates

On October 5, 2026, HHS, DOL, and the Treasury (hereinafter “Departments”) finalized updates to the Transparency in Coverage regulations that aim to make payer pricing data more accessible, standardized, and useful for consumers, researchers, and market stakeholders. The final rules reduce reporting burden by shifting machine-readable file updates from monthly to quarterly, consolidate in-network rate reporting at the provider-network level, require new taxonomy and utilization files to add context around negotiated rates, lower the threshold for reporting out-of-network payment data, and establish standardized file-location requirements to improve public access. The Departments also require executive-level attestations to improve data accuracy and accountability and align certain Transparency in Coverage requirements with the No Surprises Act by requiring plans and issuers to provide cost-sharing information by phone upon request. Officials estimate the changes will generate approximately $174.5 million in annual savings after implementation while expanding the availability and usability of payer pricing data for consumers and market analysts.

The final rules are available here. An HHS press release on the final rules is available here. A CMS fact sheet on the final rules is available here.

Pallone Introduces No Surprises Act Reform Legislation

On October 8, 2026, Representative Frank Pallone (D-NJ), Ranking Member of the House Energy and Commerce Committee, released the Lower Premiums, Faster Payments Act, legislation that would reform dispute resolution within provisions of the No Surprises Act.

Specifically, the Lower Premiums, Faster Payments Act would replace the independent dispute resolution (IDR) process for determining payment amounts with the Qualifying Payment Amount (QPA) for all items and services furnished on or after January 1, 2028. The bill calculates the QPA as the median of the contracted rates that the plan or issuer recognized on January 31, 2019, for the same or a similar item or service furnished by providers in the same specialty and in the same geographic area and paid under the same plan or coverage. The calculation would include patient cost-sharing, the plan-paid amount, and the average expected amount of incentive-based or retroactive payments or payment adjustments, including risk-sharing payments, bonuses, and penalties. This calculated median amount would also be adjusted for inflation using the change in CPI-U from January 31, 2019, and then adjusted in 2029 and beyond by the change in CPI-U from the prior year.

The legislation requires the plan or issuer to pay within 30 days after the provider or facility sends the bill when the QPA is the out-of-network rate. It also requires annual audits of claims data from at least 25 group health plans and health insurance issuers beginning in 2028.

A press release on the bill can be found here. The text of the bill can be found here.

CMS Releases 2027 Medicare Advantage and Part D Star Ratings

On October 8, 2026, CMS released the 2027 Medicare Advantage (MA) and Part D Star Ratings, which will be used during the upcoming Medicare Open Enrollment period (October 15, 2026 – December 7, 2026) and will impact 2028 MA quality bonus payments (QBPs). Approximately 37 percent of MA prescription drug (MA-PD) contracts earned four stars or higher, representing about 71 percent of MA-PD enrollees, while the average enrollment-weighted MA-PD rating was 3.99 stars. Stand-alone Part D plans saw a modest increase in their average rating from 3.01 stars in 2026 to 3.22 stars in 2027.

A CMS fact sheet on the updated Star Ratings is available here.

HHS Launches New Initiatives on Vaccine Injury Research and Reporting

On October 8, 2026, HHS announced a series of actions intended to strengthen how the federal government identifies, documents, investigates, and responds to health problems reported following vaccination, with a focus on improving patient care and collecting evidence on potential vaccine-related injuries. These actions include opening a new NIH clinic dedicated to research and caring for patients that experience health problems following vaccination; a proposal to reimburse physicians for reporting suspected vaccine-related injuries; a requirement for electronic health records (EHRs) to capture vaccine-related adverse events; and modernizing the CDC Vaccine Adverse Event Reporting System (VAERS) to simplify reporting and improve the tools available to researchers investigating potential adverse effects.

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