Health Care Week in Review | CMS Announces Conclusion of Medicare Part D Premium Subsidies and Releases Medicare Part A Final Rules for FY 2027, Including IPPS

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 July 27, 2026, the Food and Drug Administration (FDA) released final guidance entitled, Cancer Clinical Trial Eligibility Criteria: Laboratory Values. The guidance is part of a broader FDA effort to modernize eligibility criteria in cancer clinical trials and recommends the use of laboratory value requirements that are appropriately tailored to the specific trial rather than relying on unnecessarily restrictive or routinely adopted thresholds. FDA stated that overly restrictive laboratory criteria can limit patient participation, slow trial enrollment, and reduce the applicability of trial results to the broader patient population expected to use the therapy after approval.
• On July 27, 2026, FDA released final guidance entitled, Cancer Clinical Trial Eligibility Criteria: Performance Status. The guidance is part of FDA’s broader effort to modernize eligibility criteria in cancer clinical trials and recommends expanding enrollment criteria to include patients with a wider range of performance status when scientifically appropriate. FDA noted that overly restrictive eligibility requirements can limit patient access to clinical trials, slow enrollment, and produce study populations that do not fully reflect the patients who will ultimately receive the treatment in clinical practice. The final guidance applies to clinical trials of investigational cancer therapies regulated by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). It encourages sponsors to carefully evaluate whether performance status restrictions are necessary based on the specific trial and available safety data, rather than relying on routinely used criteria.
• On July 27, 2026, FDA released final guidance entitled, Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications. The final guidance applies to clinical trials of investigational cancer therapies regulated by CDER and CBER. It encourages sponsors to carefully evaluate whether washout periods or restrictions on concomitant medications are scientifically justified and necessary to protect participant safety or ensure reliable trial results. FDA stated that routinely applied exclusions should be reconsidered when they are not supported by the specific risks or objectives of a study. The guidance finalizes a draft issued in April 2024, incorporates public comments, and includes minor clarifying revisions.
• On July 28, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Award of a Sole Source Cooperative Agreement: Public Health Foundation. CDC announced an award of approximately $1.5 million for year one funding to the Public Health Foundation. The award will support the modernization and enhancement of the CDC Training Finder Real-time Affiliate Integrated Network (TRAIN) and the TRAIN Learning Network overall; capacity building and training to improve the skills and competence of the public health workforce; performance management, quality improvement, and innovation in governmental public health; and expanded collaborations between health departments and academic institutions. Funding amounts for years two to five will be set at continuation.
• On July 28, 2026, FDA released a notice entitled, Medical Devices: Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy. FDA is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phase-changing fiducial marker for radiation therapy. FDA is taking this action because the agency has determined that classifying the device into special controls will provide a reasonable assurance of 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 July 29, 2026, the Centers for Medicare & Medicaid Services (CMS) released a rule entitled, Medicare Program: Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; etc. This rule updates Medicare's durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) program integrity requirements by adding items to three existing lists used to identify products at risk for fraud, waste, abuse, or improper payments. Specifically, CMS adds 20 Healthcare Common Procedure Coding System (HCPCS) codes to the Master List of items potentially subject to oversight requirements, 22 HCPCS codes to the Required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) List, and 8 HCPCS codes to the Required Prior Authorization List. The newly added items include certain orthoses, wheelchairs, ventilators, oxygen equipment, and air-fluidized beds. CMS states that the changes are intended to reduce improper payments and strengthen oversight of high-risk DMEPOS items while maintaining beneficiary access to care, with prior authorization requirements for newly added upper-limb orthoses being phased in nationally over time.
• On July 29, 2026, FDA released a notice entitled, Biosimilar User Fee Rates for Fiscal Year 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.
• On July 29, 2026, FDA released a notice entitled, Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027. FDA is announcing the FY 2027 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the FD&C Act as amended by the FDA Food Safety Modernization Act (FSMA).
• On July 29, 2026, FDA released a notice entitled, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027. FDA is announcing the FY 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the FD&C Act, as amended by the FDA FSMA. FDA also announced the fee rate for certification bodies applying for direct FDA accreditation.
• On July 29, 2026, FDA released a notice entitled, Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027. FDA is announcing the FY 2027 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the FD&C Act, as amended by the FDA FSMA. This fee is effective on August 1, 2026, and will remain in effect through September 30, 2027.
• On July 29, 2026, FDA released a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2027. FDA is announcing the FY 2027 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the FD&C Act, as amended by the FDA FSMA.
• On July 29, 2026, FDA released a notice entitled, Medical Device User Fee Rates for Fiscal Year 2027. FDA is announcing the fee rates and payment procedures for medical device user fees for FY 2027. The FD&C Act, as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures applicants should follow, and how applicants may qualify for reduced small business fees.
• On July 29, 2026, FDA released a notice entitled, Outsourcing Facility Fee Rates for Fiscal Year 2027. FDA is announcing the FY 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the FD&C Act. The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2027 rates for the small business establishment fee ($7,142), the non-small business establishment fee ($22,074), and the reinspection fee ($21,427) for outsourcing facilities; provides information on how the fees for FY 2027 were determined; and describes the payment procedures outsourcing facilities should follow.
• On July 29, 2026, FDA released a notice entitled, Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027. The FD&C Act, as amended by the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II), authorizes FDA to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for FYs 2026 through 2030. This notice publishes the OMUFA fee rates for FY 2027.
• On July 29, 2026, FDA released a notice entitled, Prescription Drug User Fee Rates for Fiscal Year 2027. FDA is announcing the rates for prescription drug user fees for FY 2027. The FD&C Act, as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2027.
• On July 30, 2026, CMS released a final rule entitled, Fiscal Year 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements. This final rule increases Medicare hospice payments by 2.3 percent and is expected to raise overall hospice payments by approximately $755 million in FY 2027. The final rule also introduces several policy and quality reporting changes, including requiring hospices to provide a hospice election statement addendum to all beneficiaries at the time of enrollment beginning October 1, 2026, expanding transparency around services that the hospice will not cover, and implementing a new Service and Spending Variation Index (SSVI) to publicly report hospice utilization and non-hospice spending patterns. CMS also highlighted significant growth in Medicare spending on non-hospice services furnished during hospice elections and finalized updates to hospice quality reporting, provider oversight, and telehealth recertification policies.
• On July 30, 2026, CMS released a final rule entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program. This final rule increases Inpatient Rehabilitation Facility (IRF) payments by 2.3 percent, which is expected to raise Medicare payments to rehabilitation facilities by approximately $340 million in FY 2027. The final rule finalizes several coverage and operational policies, including requiring all ordered therapy treatments and evaluations to begin within 36 hours of admission and requiring an initial interdisciplinary team meeting within four days of admission. CMS also finalized updates to the IRF Quality Reporting Program, including accelerated data submission deadlines beginning in FY 2029, completed the final phase-out of the rural adjustment for facilities transitioning from rural to urban status, and solicited feedback on potential future payment reforms that could modernize patient classification and comorbidity adjustment methodologies. Additionally, the final rule increases bid surety bond requirements for suppliers participating in Remote Item Delivery competitive bidding programs under the DMEPOS Competitive Bidding Program.
• On July 31, 2026, FDA released final guidance entitled, Assessing Adhesion with Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications. This guidance provides recommendations for how generic drug manufacturers should design and conduct studies evaluating the adhesion performance of transdermal and topical delivery systems, such as patches. The guidance outlines approaches for assessing adhesion either as a standalone study or alongside bioequivalence testing and is intended to support abbreviated new drug applications (ANDAs) for generic products. FDA noted that the guidance replaces a 2023 draft version and reflects the agency’s current recommendations for demonstrating that generic transdermal and topical delivery systems perform comparably to their reference products.
• On July 31, 2026, FDA released draft guidance entitled, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications. This revised draft guidance provides updated recommendations for evaluating the potential of generic transdermal and topical delivery systems to cause skin irritation or sensitization. The draft guidance is intended to support ANDAs and clarifies FDA’s expectations for designing and conducting human studies that compare the irritation and sensitization profiles of proposed generic products with their reference products. The agency noted that the revision clarifies when sensitization studies may not be necessary and is seeking public comment on the guidance, including alternative approaches for assessing irritation and sensitization in generic transdermal and topical delivery systems.
• On July 31, 2026, FDA released draft guidance entitled, Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts. This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies FDA’s recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the guidance for industry entitled, Questions and Answers on Biosimilar Development and the BPCI Act and the guidance for industry entitled, Considerations in Demonstrating Interchangeability With a Reference Product for biosimilar and interchangeable biosimilar products, respectively.
• On July 31, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, 340B Rebate Model Pilot Program.  The HRSA Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), issued this notice to announce the availability of a revised 340B Rebate Model Pilot Program. The pilot provides a rebate mechanism through which qualifying drug manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities. Consistent with HRSA’s longstanding statutory authority, rebates will be used instead of upfront discounts.
• On July 31, 2026, CMS released a final rule entitled, Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2027 Rates; etc. This final rule will revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes. The Office of the National Coordinator for Health Information Technology (ONC) also adopts certain health information technology (IT) standards and specifications on behalf of the Department of Health and Human Services (HHS).

Event Notices

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

• August 2-4, 2026: The National Institutes of Health (NIH) announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences. This is a virtual meeting with some sessions open to the public.
• August 3, 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.
• August 5, 2026: FDA announced a meeting entitled, Medical Device User Fee Amendments. This is a hybrid meeting open to the public.
• August 6, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is a hybrid meeting open to the public.
• August 10, 2026: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting with some sessions open to the public.
• August 24, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a virtual meeting open to the public.
• August 24, 2026: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
• August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
• August 26, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
• **August 26, 2026: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). this is a virtual meeting open to the public.
• August 31, 2026: NIH announced a meeting of the National Institute on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• September 2, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
• September 9-10, 2026: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a hybrid meeting open to the public.
• **September 10, 2026: NIH announced a meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). This is a virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a virtual meeting with some sessions open to the public.
• **September 10-11, 2026: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health (NCCIH). This is a hybrid meeting with some sessions open to the public.
• September 14, 2026: FDA announced a meeting on the potential future therapeutic use of psychedelic drugs. This is a hybrid hearing open to the public.
• September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• **September 15, 2026: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• **September 15, 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.
• **September 15, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). This is a virtual meeting open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
• **September 18, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a hybrid meeting open to the public.
• **September 18, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• **September 23, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• **September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting open to the public.
• September 24, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
• October 8, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 14, 2026: 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 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. 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 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: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions 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 PTAC. This is a hybrid meeting open to the public.
• January 16, 2027: HHS announced a meeting of PACCARB. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On July 29, 2026, the Congressional Budget Office (CBO) released a report entitled, Developments in CBO's Projections for Medicare Part D. In the report, CBO explains that it has substantially revised its projections for the Medicare Part D provisions enacted in the Inflation Reduction Act (IRA) after new implementation data showed outcomes differing from its original estimates. CBO initially projected that Medicare drug price negotiation and inflation rebate policies would generate enough savings to more than offset the costs of redesigning the Medicare Part D benefit, resulting in net deficit reduction. However, CBO now finds that negotiated drug prices have produced smaller savings than expected, inflation rebate collections have been reduced by higher-than-anticipated inflation, and the Medicare Part D redesign has driven significantly higher costs due to increased prescription drug utilization and larger-than-expected plan bids. As a result, CBO now projects that the combined Medicare Part D provisions will increase, rather than reduce, federal deficits over the budget window. The agency noted that Medicare Part D spending projections have risen sharply in recent years, with updated evidence suggesting beneficiaries have responded more strongly to reduced out-of-pocket costs than originally anticipated, particularly for high-cost specialty drugs, and stated that it will continue refining its models as additional data become available.
• On July 31, 2026, the Congressional Research Service (CRS) released a report entitled, The Uniform Grants Regulation: OMB’s Relation to Federal Grantmaking Agencies. The report analyzes a May 2026 proposal by the Office of Management and Budget (OMB) and 41 federal agencies to replace the Uniform Guidance with a new Uniform Grants Regulation (UGR) governing federal financial assistance awards. The report explains that while the current Uniform Guidance establishes government-wide requirements for grant administration, cost principles, and audits, its provisions generally become binding on nonfederal entities only after grantmaking agencies implement them through their own regulations. The proposed UGR would retain, modify, or eliminate existing Uniform Guidance provisions and, most notably, would allow future OMB amendments to take effect government-wide without requiring separate agency rulemakings, potentially centralizing greater authority within OMB. The report reviews OMB’s statutory justification for this approach, discusses legal questions regarding the extent of OMB’s authority to impose requirements that affect nonfederal entities, examines how agencies have historically implemented Uniform Guidance amendments, and notes that Congress retains broad authority to affirm, modify, or restrict the proposed framework and other aspects of federal grants management policy.

Hearings & Markups

• On July 29, 2026, the Senate Committee on Homeland Security and Governmental Affairs held a hearing entitled, Testimony of Anthony Fauci. Dr. Anthony Fauci, former NIH Director, served as the sole witness.
• On July 29, 2026, the Senate Committee on Health, Education, Labor, and Pensions (HELP) Subcommittee on Employment and Workplace Safety held a hearing entitled, The Impact of AI on the Workforce. Witnesses present included: Mr. Ken Clark, President and Chief Executive Officer (CEO), EmployIndy; Ms. Carol Rogers, Director, Indiana Business Research Center; Dr. Liya Palagashvili, Director of the Labor Policy Project, Mercatus Center at George Mason University; Mr. Jonathan Liebert, CEO, BBB of Southern Colorado; and Dr. Justin Heck, Senior Director of Research and Data Production, Opportunity@Work.
• On July 29, 2026, the Senate Special Committee on Aging held a hearing entitled, The AI Deception Machine: Deepfakes, Chatbots, and the New Frontier of Senior Fraud. Witnesses present included: Dr. David Amron, Founder and Medical Director, The Roxbury Institute; Ms. Deborah Del Mastro, Victim of AI-Enabled Scam; Mr. Paul Benda, Executive VP of for Risk, Fraud and Cybersecurity, American Bankers Association; Mr. Matthew Ferraro, Partner, Crowell & Moring LLP; and Mr. Ben Winters, Director of AI and Privacy, Consumer Federation of America.
• On July 30, 2026, the Senate HELP Committee met to discuss the nominations of Dr. Erica Schwartz to be Director of the CDC; Mr. Sean Kaufman to be Assistant Secretary for Preparedness and Response for HHS; and Mr. Keith Sonderling to be Secretary of Labor. The committee also discussed the following legislation:
  • S. 5038, Special Education Administration Protection Act
  • S. 5046, To prohibit the transfer of certain offices and functions of the Department of Education to other Federal agencies, and for other purposes.
  • S. 2511, College Transparency Act
  • S. 3010, 21st Century Dyslexia Act
  • S. 3589, RISE Act
  • S. 4097, State-Based Loan Awareness Act
  • S. 4689, READ Act
  • S. 3333, Emergency Savings Enhancement Act
  • S. 4965, Railroad Retirement Board Stability Act
  • S. 3097, Health Information Privacy Reform Act

Other Health Policy News

HHS Unveils Policy to Restrict High-Risk Life Sciences Research

On July 28, 2026, HHS announced the release of the United States Government Policy for Stopping High-Risk Life Sciences Research, which would prohibit federally supported dangerous gain-of-function (dGOF) research conducted in the United States and abroad and establish stronger oversight for life sciences research that may pose a significant risk to public health, biosecurity, or national security. Specifically, this policy would establish a process of rigorous independent review for identified high-risk life sciences research and restrict federal funding for research conducted in nations or institutions without appropriate biosafety, biosecurity, and oversight standards. Researchers and research institutions are expected to identify, assess, and manage the highest-risk life sciences research before taxpayer dollars are awarded.  The Administration also is urging international partners to strengthen biosafety and biosecurity standards to promote a coordinated global approach to end dGOF research that could pose threats to global health and security.

The HHS press release is available here. The United States Government Policy for Stopping High-Risk Life Sciences Research is available here.

CMS to End Medicare Part D Premium Stabilization Demonstration in 2026

On July 28, 2026, CMS announced the conclusion of the Medicare Part D Premium Stabilization Demonstration at the end of calendar year (CY) 2026. The program, which went into effect in 2025, aimed to stabilize monthly premiums for Medicare Part D enrollees following prescription coverage changes enacted in the IRA. The IRA, passed in 2022, included a multitude of changes to prescription prices and coverage, including caps on out-of-pocket drug spending for Medicare Part D enrollees, which shifted costs onto Part D insurers. The Medicare Part D Stabilization Demonstration was designed to maintain steady premium prices and enrollment through the inclusion of a $15 uniform cut to the base beneficiary premium, a year-over-year increase limit of $35 on a plan’s total Part D premium, and narrowed risk corridors.

In its announcement, CMS notes that for CY 2027, its analysis of the bids submitted indicates that Part D plan sponsors had “sufficient experience” under the redesigned Part D benefit to support their assumptions in developing prescription drug plan (PDP) bids. Therefore, CMS is discontinuing the Medicare Part D Stabilization Demonstration at the end of CY 2026 to return the program to operating under traditional market conditions in CY 2027.

Alongside the termination announcement, CMS reported that insurers submitted an average national monthly bid of $296.05 for 2027 prescription drug plans, marking a 24 percent year-over-year increase from 2026. That bid information is used to calculate the base beneficiary premium, which has been set at $41.33 for 2027, reflecting a six percent increase year over year and the maximum increase permitted by law.

The CMS announcement ending the Medicare Part D Premium Stabilization Demonstration may be found here. The CMS fact sheet reporting the base beneficiary premium may be found here.

Senate Finance Democrats Seek Input on Major Health Coverage Reforms

On July 30, 2026, Senate Finance Committee Democrats released a request for information (RFI) seeking stakeholder feedback on a broad set of proposals to reshape the U.S. health coverage system, with a particular focus on the role of private health insurance. The RFI seeks recommendations on reducing premiums, deductibles, and other out-of-pocket costs; strengthening rate review of insurance premiums; expanding enrollment and coverage options; establishing standardized plan designs and benefit structures; improving network adequacy; and exploring Medicare-like coverage options that could compete with or supplement private insurance. The RFI also seeks input on policies to streamline enrollment, improve coverage continuity, and strengthen consumer protections across the individual, employer-sponsored, and other private insurance markets.

The RFI further focuses on insurer practices that Senate Finance Committee Democrats argue contribute to higher costs and barriers to care, including prior authorization requirements, claims denials, narrow networks, vertical integration, medical loss ratio (MLR) reporting, and the use of third-party administrators and other intermediaries. The RFI seeks feedback on potential reforms to increase transparency, oversight, and accountability for health plans, as well as proposals to limit corporate practices that may prioritize profits over patient care. According to a press release, the effort is intended to inform future legislative proposals aimed at improving the affordability, accessibility, and quality of health coverage while addressing insurance practices that can delay or deny care.

Comments are due October 2, 2026. The text of the RFI is available here. A press release is available here.

Senate HELP Committee Advances Health Data Privacy Reform Bill

On July 30, 2026, the Senate HELP Committee advanced three nominations and several bipartisan education and health-related bills to the full Senate for consideration. Of note, the committee favorably reported the nominations of Dr. Erica Schwartz to serve as CDC Director and Mr. Sean Kaufman to serve as HHS Assistant Secretary for Preparedness and Response, despite sharp bipartisan debate over vaccine policy and pandemic preparedness. Dr. Schwartz’s nomination was approved by a bipartisan 13-10 vote, while Mr. Kaufman’s nomination was approved by a party-line 12-11 vote. Both nominations now advance to the Senate floor.

The committee also advanced several pieces of legislation. Of note, the committee considered S. 3097, the Health Information Privacy Reform Act, which would establish privacy protections for health information collected by entities not currently covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). S. 3097 would direct HHS, in consultation with the Federal Trade Commission (FTC), to develop privacy, security, and breach notification standards for health information held by regulated entities such as health apps, wearable technologies, and other non-HIPAA-covered organizations. S. 3097 would also establish individual rights related to access, correction, deletion, and portability of health data; require notification when health information is no longer protected under HIPAA; prohibit the sale of protected health information without patient consent; and direct HHS to develop guidance and standards related to artificial intelligence, de-identified data, and patient data sharing for research purposes. S. 3097 was approved unanimously in a 22-0 vote and reported favorably to the Senate.

More information on this hearing is available here. The full text of S. 3097 is available here.

CMS Finalizes FY 2027 Hospital Payment and Quality Reporting Updates

On July 31, 2026, CMS released the FY 2027 IPPS and LTCH PPS Final Rule, which updates Medicare payment policies and rates for inpatient and long-term care hospitals under the Medicare IPPS and LTCH PPS for FY 2027. The final rule provides a 2.3 percent increase in payment rates for both IPPS hospitals and LTCHs and is expected to increase IPPS payments by approximately $2.1 billion and LTCH PPS payments by $54 million in FY 2027. In addition to the payment updates, CMS finalized changes across several Medicare quality reporting programs, including new quality measures, modifications to readmissions and mortality measures, and removals of existing measures. CMS also finalized changes to the Hospital Readmissions Reduction Program, the Hospital-Acquired Condition Reduction Program, and the Hospital Value-Based Purchasing Program. In addition, the final rule included updates to Medicare Promoting Interoperability Program requirements, including policies to align with proposals made by ONC in the Health Data, Technology, and Interoperability: Assistant Secretary for Technology Policy (ASTP)/ONC Deregulatory Actions to Unleash Prosperity proposed rule, new requirements for graduate medical education programs, and policies relating to organ acquisition. The final rule also establishes the Comprehensive Care for Joint Replacement Expanded (CJR-X) Model, a mandatory nationwide successor to the Comprehensive Care for Joint Replacement Model that will begin on January 1, 2028. The CJR-X Model holds participating hospitals accountable for the cost and quality of joint replacement episodes of care. According to CMS, the original model saved Medicare more than $100 million while maintaining quality of care, and CMS expects CJR-X to further improve care coordination and patient outcomes while reducing unnecessary spending.

The text of the final rule is available here. The press release for the final rule is available here. The fact sheet for the final rule is available here. The ONC fact sheet on Health IT standards finalized in the final rule is available here.

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