Health Care Week in Review | Democrats Secure Both House and Senate Majorities; CMS Issues Annual Medicare Payment Rules

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 November 2, 2026, the Food and Drug Administration (FDA) released final guidance entitled, Potency Assurance for Cellular and Gene Therapy Products. This final guidance provides recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, FDA describes how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, FDA describes requirements for potency assurance, including testing required for lot release assays. The final guidance announced in this notice finalizes the draft guidance of the same title issued on December 28, 2023.
• On November 2, 2026, FDA released final guidance entitled, Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus. This final guidance provides blood establishments that collect blood and blood components, including Source Plasma, with FDA’s recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The final guidance announced in this notice finalizes the July 2025 draft guidance entitled, Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen. The final guidance also supersedes the documents entitled, Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) (December 1987 Memorandum), FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) (September 1991 Memorandum), Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes (November 2007 Final Guidance), Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) (May 2010 Final Guidance), Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection (November 2011 Final Guidance), and Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus (October 2012 Final Guidance). The final guidance supersedes the recommendations specific to HBV in Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T- Lymphotropic Virus Type I (HTLV-I) (July 1996 Memorandum).
• On November 4, 2026, FDA released a final order entitled, Medical Devices: Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System with Artificial Intelligence Algorithm. FDA is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm 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 digital cervical cytology slide imaging system with artificial intelligence algorithm. 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. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On November 4, 2026, FDA released a final order entitled, Medical Devices: Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment. FDA is classifying the prognostic assessment software of mild cognitive impairment 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 prognostic assessment software of mild cognitive impairment. 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. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On November 4, 2026, FDA released a final order entitled, Medical Devices: Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use. FDA is classifying the wearable vibration device for orthopedic 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 wearable vibration device for orthopedic use. 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 wearable vibration device for orthopedic use.
• On November 4, 2026, the Centers for Medicare & Medicaid Services (CMS) released a final rule entitled, Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies. This final rule sets forth routine updates to the Medicare home health (HH) payment rates in accordance with existing statutory and regulatory requirements. The final rule also makes changes to Medicare provider and supplier enrollment requirements and Durable Medical Equipment (DME), Prosthetics, Orthotics, and Supplies (DMEPOS) policies, including clarifying face-to-face encounter requirements for replacement DMEPOS items and implementing a DME benefit expansion for certain infusion pumps and drugs.
• On November 4, 2026, CMS released a final rule entitled, Medicare and Medicaid Programs: Calendar Year 2027 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc. This final rule updates the Medicare Physician Fee Schedule (PFS) and other Medicare Part B payment and coverage policies for calendar year (CY) 2027.
• On November 4, 2026, CMS released a final rule with comment period entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems, and Quality Reporting Programs, etc. This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for CY 2027.
• On November 5, 2026, FDA released a final order entitled, Medical Devices: Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion. FDA is classifying the external mechanical stimulator for the relief of congestion 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 external mechanical stimulator for the relief of congestion. 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. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On November 5, 2026, CMS released a final rule entitled, Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program. This final rule codifies the Medicare Drug Price Negotiation Program (“Negotiation Program”) and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program (“Part D Program”) as required by the IRA. This final rule also finalizes a proposed policy for specific fixed combination drugs that are new formulations.
• On November 5, 2026, CMS released a proposed rule entitled, Medicare and Medicaid Programs: Cutting Administrative Requirements for Excellence in Patient Care. This proposed rule would reform Medicare and Medicaid regulations deemed obsolete or excessively burdensome on healthcare providers and suppliers, with the objective of reducing costs, enhancing flexibility in delivering innovative care, and streamlining existing regulations. This proposed rule seeks to enable healthcare professionals to devote more resources to improving patient care by eliminating or minimizing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.

Event Notices

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

• November 9, 2026: The National Institutes of Health (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: The Centers for Disease Control and Prevention (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 2, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting 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: The Department of Health and Human Services (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 fiscal year (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, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. 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

HHS OIG Finds Low Hepatitis C Treatment Rates Among Medicaid Beneficiaries

On November 2, 2026, the HHS Office of Inspector General (OIG) released a data brief entitled, Less Than 25 Percent of Medicaid Beneficiaries With Hepatitis C Received Treatment Within 6 Months. OIG analyzed 2023 and 2024 Medicaid and Medicare claims data to assess the extent to which Medicaid beneficiaries with hepatitis C received treatment within six months of testing. OIG identified approximately 230,000 Medicaid beneficiaries with hepatitis C in 2023 and found that only 23 percent received treatment within six months, despite clinical and public health guidance recommending treatment as soon as the virus is detected. Treatment rates were particularly low among beneficiaries diagnosed only with acute hepatitis C (five percent), dual-eligible beneficiaries (14 percent compared with 28 percent among Medicaid-only beneficiaries), and beneficiaries aged 65 and older (12 percent). Among beneficiaries who received treatment within six months, the median time from testing to treatment was 49 days, and 41 percent received their initial prescription from a primary care provider. OIG also found substantial variation among states, with treatment rates among Medicaid-only beneficiaries ranging from seven percent to 41 percent. OIG recommended that CMS take additional steps to increase hepatitis C treatment rates in Medicaid, including building on the new Medicaid hepatitis C quality measure beginning in 2027, and take targeted steps to increase treatment among dual-eligible beneficiaries. CMS concurred with both recommendations.

Other Health Policy News

On November 3, 2026, the Midterm Elections were held for the 120^th Congress. During this election, 33 Senate seats and 36 governors’ seats were up for re-election.

U.S. House of Representatives

As of Friday, November 6^th, Democrats have been ruled the victors in 253 House races, guaranteeing them the House majority for the 120^th Congress. 25 races have yet to be called, and Democrats currently lead in 11 of these races.

U.S. Senate

As of Friday, November 6^th, Democrats have flipped several Republican-held Senate seats, including wins in North Carolina, Georgia, South Carolina, Ohio, Maine, Iowa, Kansas, and Texas. Democrats also maintain slim leads in races in Alaska and Mississippi, which have yet to be officially called. Democrats now hold the majority in the Senate in the 120^th Congress. This freshman class includes two physicians, Annie Andrews of South Carolina and Abdul El-Sayed of Michigan.

Post-Election Timeline

Republican House and Senate leadership elections are scheduled for November 10, 2026. Democratic House leadership elections are scheduled for November 18, 2026. Current Democratic Minority Leaders Chuck Schumer (D-NY) and Hakeem Jefferies (D-NY-8) have announced their candidacy to retain their positions, as has current Majority Leader John Thune (D-SD), while Speaker Mike Johnson (R-LA-4) has announced that he will not be running for Minority Leader.

The lame duck session is scheduled to begin on November 9, 2026, and the 120^th Congress is scheduled to be sworn in on January 3, 2027. During this time, Congressional activity is expected to focus on nominations, government funding, key non-health legislation, and health extenders. Presently, HHS nominees including Chris Klomp as Deputy Secretary of HHS, Sean Kaufman as Assistant Secretary for Preparedness and Response, Ge Bai as Assistant Secretary for Planning and Evaluation, Timothy Westlake as Assistant Secretary for Mental Health and Substance Use, Mary Lazare as Assistant Secretary for Aging, and Nicole Saphier as Surgeon General are awaiting Senate confirmation.

On December 11, 2026, the continuing resolution (CR) funding the government at FY 2026 levels is set to expire. Presently, the House has passed three FY 2027 appropriations bills and referred the other nine bills out of Committee, while the Senate Appropriations Committee has yet to release FY 2027 appropriations bills. If Congress does not pass all FY 2027 appropriations bills before December 11, 2026, Congress may pass a second CR to extend government funding into the 120th Congress.

Additionally, enacting a new reconciliation resolution to provide increased funding for defense and raise the debt limit has been a priority for President Trump. The House passed a third budget resolution on July 22, 2026, which included $73 billion for defense, $12 billion for agriculture, and $10 billion for election security-related proposals. Senate Budget Committee Chairman Ron Johnson (R-WI) released an expanded Senate counterpart on August 7, 2026, adding instructions worth $55 billion beyond the House resolution, but action has stalled since then. The significant losses for Republicans, particularly among House members, may make another reconciliation package difficult during this Congress due to the already slim majority and expected member attendance issues.

CMS Finalizes CY 2027 Medicare Physician Fee Schedule With Payment and MIPS Changes

On November 4, 2026, CMS released the CY 2027 Medicare PFS final rule. The final rule will decrease payments to physicians. Specifically, the qualifying alternative payment model (APM) participant conversion factor (CF) of $32.95 represents a projected decrease of $0.62 (-1.83%) from the current CF of $33.57. The non-qualifying APM participant CF of $32.63 represents a projected decrease of $0.77 (-2.31%) from the current CF of $33.40.  

Of note, the PFS rule finalized a proposal to limit reimbursement for remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services solely for when the services are provided by a clinician employed by the billing provider. However, it delayed implementation of this restriction until January 1, 2029, meaning contracted clinical staff may continue to be used through December 31, 2028. CMS additionally finalized a 20 percent payment reduction, rather than the proposed 50 percent, when an office/outpatient evaluation and management (O/O E/M) visit billed with modifier 25 is furnished on the same day as a 0-day global procedure. Under the finalized policy, CMS will pay the most expensive service at 100 percent and the lower-cost O/O E/M visit or surgical procedure(s) furnished that day at 80 percent. CMS did not finalize its proposal to apply this policy to 10- or 90-day global procedures.

CMS will sunset the traditional Merit-based Incentive Payment System (MIPS) reporting option beginning with the CY 2031 performance period. Clinicians will have through CY 2030 to transition to the MIPS Value Pathways (MVPs), which reflects two additional years of transition time compared to the proposed rule. CMS also finalized a proposal to phase-out of the indirect practice cost index (IPCI) over two years and implement a practice expense (PE) stabilization adjustment. Further, CMS will allocate indirect PE using both the work relative value unit (RVU) and clinical labor PE RVU and will adjust the indirect PE allocation for visits furnished to beneficiaries in a Part A stay in a skilled nursing facility. Finally, CMS finalized proposed updates to the mandatory Ambulatory Specialty Model.

The PFS final rule may be found here. The HHS press release may be found here, and the CMS press release may be found here. The CMS fact sheet may be found here, and the CMS Medicare Shared Savings Program fact sheet may be found here.

The PFS final rule goes into effect on January 1, 2027.

CMS Finalizes CY 2027 OPPS and ASC Payment Rule With 340B Reimbursement Changes

On November 4, 2026, CMS released the CY 2027 OPPS and ASC Payment System final rule. CMS finalized a 2.3 percent update for hospital outpatient departments (HOPDs) and ASCs, based on a 3.2 percent market basket increase, reduced by a 0.9 percentage point productivity adjustment. For CY 2027, CMS projects total OPPS payments of $114.4 billion, about $10.7 billion above CY 2026. Additionally, CMS finalized its proposal to expand its site-neutral payment policy to imaging without contrast services at excepted off-campus departments, setting the reimbursement rate at 40 percent of the OPPS rate. CMS is exempting rural sole community hospitals from this policy and expects a reduction in Medicare Part B expenditures by approximately $260 million in the first year.

The rule finalized a proposal to reduce Medicare reimbursement for 340B drugs from the current rate of the average sales price (ASP) plus six percent to ASP minus 28 percent, with a 7.5 percent budget neutral increase for non-drug items and services, marking a lower cut than the proposed rate of ASP minus 33.4 percent. CMS will exempt rural sole community hospitals as well as PPS-exempt cancer hospitals and children’s hospitals. Drugs acquired outside of the 340B Program will continue to be paid for separately payable drugs at ASP plus six percent. Additionally, CMS finalized a 2.0 percent conversion factor reduction for payments for non-drug items and services beginning in CY 2027, compared to the proposed 3.0 percent reduction. This two percent reduction will remain in effect until the estimated payment reduction reaches $7.8 billion (a clawback CMS contends is necessary due to the Supreme Court’s ruling that CMS’s payment policy for 340B drugs from 2018 to 2022 was unlawful), which CMS estimates will occur in CY 2031.

CMS is continuing to phase out the inpatient only (IPO) list over a three-year period and, in the second year of three-year phase out, finalized the removal of 637 services from this list. In addition, CMS is finalizing updates to the validation of Hospital Outpatient Quality Reporting Program data, including the validation of electronic clinical quality measure (eCQM) measures.

The rule goes into effect on January 1, 2027.

The OPPS final rule may be found here. The CMS press release may be found here, and the CMS fact sheet may be found here.

CMS Finalizes CY 2027 Home Health Payments and Medicare Provider Enrollment Changes

On November 4, 2026, CMS released the CY 2027 HH PPS final rule, inclusive of provisions impacting Medicare provider enrollment. The final rule increases home health payments by 2.4 percent in CY 2027 compared to CY 2026. This update includes a 2.1 percent home health payment update  and a 0.3 percent increase to reflect the updated fixed dollar loss (FDL) amount. CMS also is implementing a three percent temporary reduction to the base payment rate to maintain budget neutrality due to continued implementation of the 30-day unit of payment and Patient-Driven Groupings Model (PDGM) case-mix adjustment methodology per the Bipartisan Budget Act of 2018.

CMS finalized several proposed changes to Medicare provider enrollment, including provisions such as expanding CMS’s retroactive revocation authority from retroactive revocations only for certain revocation grounds, such as fraud and intentional misconduct, to all revocation grounds, coupled with the addition of new grounds for revocation and denial of enrollment and revisions to expand existing grounds. CMS now may make Medicare enrollment revocations effective as of the date noncompliance began, allowing the agency to recover payments dating back to that point. These provisions apply across Medicare provider and supplier types.

CMS also finalized broader enrollment disclosure obligations, including changes to reporting requirements for certain qualifying affiliations. Additionally, hospices, home health agencies (HHAs), and DMEPOS suppliers must reenroll in Medicare as a new provider and undergo a survey/accreditation if they experience certain changes in majority ownership. CMS finalized its authority to deny or revoke enrollment if the provider does not comply with this requirement. CMS also finalized an expansion of existing authorities for revocation or denial of enrollment due to suspensions or revocations of a provider’s license and or participation in a federal health care program to include suspensions or revocations involving the provider’s owners and managing employees or organizations.

The rule goes into effect on January 1, 2027.

The HH PPS final rule may be found here. The CMS press release may be found here, and the CMS fact sheet may be found here.

CMS Finalizes Medicare Drug Price Negotiation Rules for 2029 and Beyond

On November 5, 2026, CMS released the Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program final rule, codifying key policies for the Medicare Drug Price Negotiation Program and Medicare Part D Program, building on the agency’s previous implementation guidance under the IRA. The final rule codifies the Negotiation Program for 2029 and beyond, establishes new policies to continue implementation of statutory provisions under the Negotiation Program, and finalizes revisions to certain policies. Specifically, the final rule establishes a regulatory framework for identifying drugs eligible for negotiation and determining when previously negotiated prices may be renegotiated. The final rule also establishes requirements for drug manufacturers that choose to participate in the Negotiation Program regarding entering into agreements with CMS and submitting information about each selected drug. The final rule codifies the negotiation process for calculating and applying maximum fair prices (MFPs) for certain drugs and biological products. It also clarifies how CMS will treat certain fixed-combination drugs and former orphan drugs, assess whether an approved generic or biosimilar is being marketed in compliance with statutory requirements, and calculate a 30-day equivalent supply for certain one-time Part B treatments, including some vaccines, gene therapies, and cancer therapies. Additional provisions address transfers of manufacturer responsibilities following acquisitions, off-label uses that may warrant renegotiation, and a temporary price floor for qualifying small biotech drugs in 2029 and 2030.

The regulations take effect December 5, 2026, and generally apply to the Negotiation Program beginning with drugs selected for the 2029 price applicability year, while existing CMS guidance will continue to govern the 2026 through 2028 program years. CMS will select up to 20 drugs covered under Part D and/or payable under Part B for initial price applicability year 2029 and for each subsequent initial price applicability year. In addition to the drugs selected for negotiation, CMS may also select drugs for renegotiation if selected drugs with an agreed-upon MFP meet certain eligibility and selection criteria.

The full text of the final rule may be found here. A fact sheet may be found here.

CMS Proposes CARE Rule to Reduce Medicare and Medicaid Administrative Requirements

On November 5, 2026, CMS released a proposed rule entitled, Cutting Administrative Requirements for Excellence in Patient Care (CARE). CMS is proposing revisions to the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation for Medicare- and Medicaid-participating providers and suppliers. Within hospitals, CMS is proposing to remove staff training requirements for transfer protocols, emergency services readiness, both of which are currently effective, as well as obstetric (OB) care and the OB-care specific Quality Assessment and Performance Improvement (QAPI) requirements, both of which would be otherwise effective on January 1, 2027. CMS additionally proposes to establish new requirements regarding patients’ rights related to birth tissue collection by critical access hospitals (CAHs) that provide OB care services, including standards for informed consent and policies and procedures to support families requesting their birth tissues for cultural, religious, or personal reasons.

The rule also rescinds some Medicaid payment transparency reporting requirements for Nursing Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IIDs); revises regulations to clarify CAH distance eligibility determinations; and removes COVID-19 vaccine requirements for long-term care (LTC) facilities, ICFs/IIDs, and rural emergency hospitals (REHs). The proposed rule additionally solicits comments on strategies to minimize burden for hospitals to comply with ongoing infectious illness data reporting requirements, and transplant program initial certification, among others. CMS estimates the proposals would save $320 million, returning more than 3.26 million hours of staff time to providers.

Comments must be received by January 9, 2026.

The proposed rule may be found here. The CMS fact sheet may be found here.

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