Pediatric Advisory Committee Meeting Announcement - 09/16/2026

FDA posted a Pediatric Advisory Committee meeting announcement that engages ethical questions around protections for children in regulated therapies. The topic is relevant to consent and permission, safety oversight, and how institutions evaluate risks for pediatric populations. As an ethics post, it fits ongoing public-interest concerns about safeguards for vulnerable groups in medical regulation.

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Regulatory Science Innovations Catalyzing Medical Device Development

FDA published a meeting notice seeking public input on future medical device regulatory science. While the notice is broad, it is relevant to privacy because connected, software-driven, and sensor-based devices depend on governance for data handling within digital health systems. The agenda-setting process may influence how privacy and cybersecurity questions are addressed in device development and oversight.

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Third meeting of the Global Initiative on AI for Health

WHO’s event page for the third meeting of the Global Initiative on AI for Health highlights privacy-preserving evaluation approaches that keep clinical data under institutional control while models are assessed securely. This is relevant to privacy because it points to governance and technical methods that reduce the need to centralize sensitive health data. The meeting suggests continued international interest in evaluating health AI without broad data sharing.

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Trump Administration Announces Nearly $17 Million to Adopt Emerging Healthcare Technologies and Improve Patient Transportation Between Facilities Across Rural Kansas

CMS announced nearly $17 million for Kansas through the Rural Health Transformation Program to support adoption of emerging health care technologies and improve patient transportation between facilities. The funding represents a distinct federal rural-health policy action with a state-specific focus. It differs from the already published titles, which centered on KFF polling about health care costs and the midterms.

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2026 Transmittals

CMS's 2026 transmittals page includes R13930CP, dated September 11, 2026, implementing FY 2027 Inpatient Prospective Payment System and Long-Term Care Hospital changes for Medicare administration. The posting points to routine program instructions used to operationalize payment and hospital policy updates. This is a Medicare administration item distinct from previously covered drug pricing and ACO announcements.

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Eye Practice and Physician Owner Agree to Pay $350,000 to Resolve Allegations of False Claims to Medicare

The Justice Department announced that an eye practice and its physician owner agreed to pay $350,000 to resolve allegations that they submitted false claims to Medicare. According to the announcement, the matter involves healthcare billing enforcement under the False Claims Act. The case is a smaller but distinct Medicare fraud settlement compared with previously covered large-scale healthcare fraud and kickback matters.

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2026-09

CMS published a September 2026 marketplace update page that includes a Medicaid and CHIP Coverage Data Matching Issue checklist. The page is relevant to eligibility and administrative coordination across public coverage programs, especially where data matching affects enrollment or case handling. It serves as an operational resource rather than a policy announcement.

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Hims & Hers

The FTC updated its case page for an enforcement action alleging that a telehealth company shared sensitive health information with advertising platforms. The matter is notable for privacy because it centers on handling of health-related data in a consumer-facing digital care setting. It also signals continued regulator focus on how telehealth firms disclose, use, and share sensitive information for marketing and advertising purposes.

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Trump Administration Announces $11.7 Million to Expand Access, Improve Patient Care Facilities, and Strengthen Workforce Capacity in Nursing Homes and Long-Term Care System Across Rural Vermont

CMS announced $11.7 million in rural-health funding for Vermont aimed at expanding access, improving patient care facilities, and strengthening workforce capacity in nursing homes and the long-term care system. The announcement is a separate administration policy item focused on rural care infrastructure and staffing. It is materially different from previously published election-related polling coverage.

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Addressing the Public Health Effects of Opioid Medications - 09/09/2026

FDA announced a public meeting focused on the public health effects of opioid medications. The notice raises ethics questions about how agencies and manufacturers balance therapeutic benefits against widespread risks and downstream harms. It also points to broader issues of public duty, transparency, and accountability in medication oversight.

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New NIH Authorities to Strengthen Accountability in Hostile Work Environment Investigations

NIH announced policy changes aimed at strengthening accountability in hostile work environment investigations across NIH-funded research. The update is designed to prevent investigators from avoiding scrutiny by moving between institutions, while emphasizing due process and safer research settings. The ethics relevance centers on institutional responsibility, researcher conduct, and protections for people working in biomedical research environments.

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Trump Administration Announces $4.8 Million to Strengthen West Virginia’s Rural Healthcare Workforce and Expand Preventive Care

CMS announced $4.8 million for West Virginia to strengthen the rural health care workforce and expand preventive care, including support tied to home dialysis access and transportation. The release presents a distinct federal health policy and funding development with implications for rural service delivery. It is separate from previously covered KFF polling on health care costs and midterm politics.

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CMS Cracks Down on Massive $3.4 Billion Medical Equipment Supplier Fraud Scheme

CMS announced enforcement actions against 11 medical equipment suppliers over suspected fraudulent Medicare Advantage and Part D billing totaling about $3.4 billion. The action highlights a major federal anti-fraud initiative in health care administration rather than a campaign or polling story. It is materially different from previously covered KFF election-focused health cost polling items.

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Indian Health Service leaders follow gains from Indiana Federal EHR go-live

A VA article says Indian Health Service leaders visited Indiana to review lessons from the Federal EHR deployment there before IHS begins its own rollout in late September. The piece highlights operational and clinical workflow observations from the Indiana go-live and frames them as preparation for IHS implementation. This is a public-program technology and care delivery update with implications for federal health system readiness.

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Precertification requirements

VA Community Care states that, effective September 8, 2026, VA no longer requires precertification before providing authorized care for veterans. The update affects care coordination and administrative steps tied to authorized community care. For public-program participants and providers, the change signals a simplification of an access-related requirement.

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Trump Administration Announces $120 Million to Expand Maternal and Infant Health Services, Increase Primary Care Access and Grow the Healthcare Workforce Across Indiana

CMS announced a $120 million award in Indiana aimed at expanding maternal and infant health services, increasing primary care access, and growing the health care workforce. The press release says the funding is also intended to reduce rural barriers to care, tying workforce and service expansion to access goals. The award stands out as a concrete state investment tied to multiple access-related needs at once.

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The Villages Health System LLC Agrees to $541.5M Settlement to Resolve False Claims Act Allegations

DOJ announced a $541.5 million settlement with The Villages Health System LLC to resolve False Claims Act allegations related to diagnosis coding. The government alleged unsupported diagnoses inflated Medicare Advantage payments, raising compliance and documentation concerns. The settlement is notable for its size and for its implications for coding accuracy, reimbursement oversight, and standards affecting patient care records.

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Governor Sherrill Signs Legislation Strengthening Protections for Reproductive Healthcare and Gender Affirming Care

New Jersey Governor Sherrill announced the signing of state legislation strengthening protections for reproductive healthcare and gender-affirming care. The enacted law is presented as a state-level effort to protect access to these services and reinforce legal safeguards for patients and providers. As signed legislation rather than a proposal, it marks an immediate policy development in New Jersey.

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Federal Register / Vol. 91, No. 156 / Friday, August 14, 2026 / Regulatory Plan

This HHS-OCR regulatory plan outlines a forthcoming HIPAA Privacy Rule stage focused on individual access, care coordination, emergency disclosures, and related privacy-accountability tradeoffs. Ethically, it raises questions about how to balance patient privacy with timely information-sharing for treatment and emergencies. The plan is useful for tracking how federal policymakers frame competing obligations to autonomy, safety, and system responsibility in health information governance.

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Veloxis Pharmaceuticals Agrees to Pay Over $46M to Resolve Criminal and Civil Liability for Kickback Schemes

DOJ announced that Veloxis Pharmaceuticals agreed to pay more than $46 million to resolve criminal and civil allegations tied to kickback schemes involving prescriptions for a transplant drug. The resolution centers on alleged unlawful payments and federal healthcare program implications, with DOJ framing the case around program integrity and patient safety. The case underscores continued enforcement against pharmaceutical marketing practices that may influence prescribing.

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Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes Proposed Rule (CMS-2452-P)

CMS published a proposed Medicaid financing rule addressing the indirect hold harmless threshold for health care-related taxes under federal law. The fact sheet indicates the proposal would change how this threshold is applied in evaluating state tax arrangements tied to Medicaid financing. Because these rules can affect state funding structures, the proposal may have significant implications for state Medicaid policy and budgeting.

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CMS Proposes Transformational Medicare Reforms to Expand Accountable Care, Modernize Physician Payment, and Shift from Sick Care to Healthcare

CMS released a proposed physician payment rule for 2026 that ties cost policy to broader payment reform, including accountable care incentives and updates to physician reimbursement. The agency says the proposal would help modernize payment while avoiding an estimated $2.38 billion in improper advanced alternative payment model incentive payments over 10 years. For cost watchers, the proposal is notable because it frames physician payment changes as both a budget issue and a lever for moving Medicare away from volume-driven care.

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Reports on Non-Device Software Functions

FDA requested input for its 2026 report on non-device software functions, covering areas such as electronic patient records and software that transfers or displays data. The request is privacy-relevant because these functions often involve the handling, movement, and presentation of sensitive patient information, even when they are not regulated as medical devices. It also highlights patient-safety implications tied to data management tools that sit outside traditional device oversight.

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CMS Acts to Strengthen Care Quality, Cut Drug Costs, and Slash Out-of-Pocket Expenses for Medicare Beneficiaries

CMS proposed OPPS and ASC payment changes aimed at affordability for Medicare beneficiaries, with a focus on drug payment policy, site-of-care incentives, and lower out-of-pocket costs. The agency highlights 340B drug payment changes and projected savings for Medicare and taxpayers, alongside reforms intended to reduce incentives that can make hospital outpatient care more expensive. The proposal is significant on cost because it combines beneficiary affordability with federal savings and provider payment redesign.

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Marketplace 2026 Eligibility Determination Notice (July 2026)

CMS published the July 2026 Marketplace eligibility determination notice materials used in coverage, eligibility, and enrollment communications. The page provides access to template notices that explain decisions and next steps to applicants and enrollees. It is an operational communications resource rather than a policy announcement or enrollment report.

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National Health Care Fraud Takedown Results in 455 Defendants Charged in Connection with Over $6.5 Billion in Alleged Fraud

DOJ announced a nationwide healthcare fraud enforcement action charging 455 defendants in connection with more than $6.5 billion in alleged fraud. The announcement spans schemes involving healthcare fraud, opioid-related conduct, provider exclusions, and allegations of patient harm. It reflects the scale of federal enforcement and the legal risks facing providers, executives, and intermediaries across multiple parts of the healthcare system.

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Justice Department Requires OhioHealth to Stop Using Anticompetitive Healthcare Contract Terms That Raise Costs for Ohio Patients

The Justice Department announced a proposed settlement requiring OhioHealth to stop using contract terms alleged to restrict competition. According to DOJ, the challenged terms raised healthcare costs for Ohio patients and employers by limiting insurers' ability to steer patients to lower-cost providers. The matter highlights antitrust scrutiny of healthcare contracting practices with downstream effects on prices and patient choice.

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CMS Takes Bold New Approach to Stewarding Medicaid Demonstration Project Spending

CMS issued guidance signaling tighter oversight of budget neutrality for Medicaid section 1115 demonstrations. The move centers on constraining how demonstration spending is measured and justified, with direct consequences for both federal and state Medicaid costs. This is a meaningful cost development because it could limit financing flexibility that states have used to support higher spending under waiver authority.

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Medicaid Community Engagement Requirement for Certain Individuals Interim Final Rule with Comment Period (CMS-2454-IFC)

CMS issued an interim final rule with comment period to implement Medicaid community engagement requirements for certain adults. The fact sheet frames the policy as applying to specified individuals and outlines the federal rulemaking step taken in June 2026. Because eligibility and coverage conditions can affect access to care, the rule is a consequential change for Medicaid administration and beneficiaries.

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Federal Rule Takes Aim at Health Care Bureaucracy, Reducing Dispute Fees, and Boosting Transparency

CMS finalized changes to the No Surprises Act independent dispute resolution process that lower administrative fees and revise batching and transparency rules. While the rule mainly addresses insurer-provider payment disputes, its cost relevance lies in reducing administrative friction and fees tied to resolving out-of-network payment disagreements. The changes could affect system costs indirectly by altering how often disputes are filed and what they cost to pursue.

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CMS Moves to Rein In Misused Medicaid Dollars and Reward Quality Care

CMS proposed Medicaid managed-care financing and payment changes aimed at state directed payments, provider taxes, and spending growth. The agency says the proposal would curb financing practices it views as inflating federal Medicaid costs while tying payments more closely to quality. Cost implications are potentially large because the rule targets mechanisms many states use to raise provider payments and draw down federal funds.

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Federal Register / Vol. 91, No. 97 / Wednesday, May 20, 2026 / Rules and Regulations

This final federal rule addresses documentation standards for consumer consent in the Marketplace, making it relevant to ethical questions about informed consent, enrollment integrity, and administrative accountability. By clarifying what must be documented, the rule aims to reduce unauthorized or improper enrollments and strengthen oversight of entities handling consumer decisions. The ethics angle centers on whether healthcare administration practices adequately respect individual choice while maintaining trustworthy records and compliance.

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CMS Final Rule Lowers Costs, Cracks Down on Fraud, and Expands State Control

CMS finalized its 2027 Payment Notice with lower Exchange user fees and other policy changes affecting individual-market affordability and oversight. The agency presents the rule as a cost-lowering measure that also addresses fraud and gives states more flexibility, with implications for premiums, administrative expenses, and coverage dynamics. For a cost-focused audience, the key issue is how marketplace fee and affordability policy can shape what enrollees and taxpayers pay.

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HHS Notice of Benefit and Payment Parameters for 2027 Final Rule

This CMS fact sheet summarizes the final 2027 Marketplace payment notice and the standards it sets for Exchanges, insurers, brokers, and related coverage rules. It also covers final policies on hardship exemptions and other operational requirements affecting Marketplace coverage. The document reflects finalized federal policy rather than proposed changes.

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Operators of Day Treatment Program for Children Agree to $15.2 Million Civil Judgment to Resolve Medicaid Fraud Allegations

A U.S. Attorney's Office announced a $15.2 million civil judgment resolving Medicaid fraud allegations involving operators of a children's day treatment program. The matter involves behavioral health services for children and includes a corporate integrity agreement and compliance obligations. The resolution highlights legal and oversight risks in pediatric Medicaid-funded care and the importance of program compliance.

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KFF Health Tracking Poll: Health Care Costs and the Midterms

This KFF poll focuses on how health care affordability is influencing voter preferences in the 2026 midterm cycle. It adds updated public opinion data on the political weight of health costs and the role the issue may play in electoral choices. The findings help explain why health care remains central in campaign strategy and policy messaging.

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National Partnership of Insurance Brokers and its Former Subsidiary Agree to Pay Over $135 Million For Affordable Care Act Enrollment Fraud Scheme

DOJ announced that the National Partnership of Insurance Brokers and its former subsidiary agreed to pay more than $135 million to resolve allegations involving an Affordable Care Act enrollment fraud scheme. The case concerns alleged misconduct affecting consumers and federal enrollment processes, with particular relevance to protections for vulnerable enrollees. It illustrates legal exposure for entities involved in insurance marketing and enrollment assistance.

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HTI-3 Final Rule

ASTP/ONC’s HTI-3 Final Rule updates federal health IT policy on information blocking, including privacy-related changes. The rule adds a new Protecting Care Access Exception and revises provisions connected to reproductive health information, which is significant for how providers, developers, and health information networks handle sensitive data requests and disclosures. For privacy watchers, this is a notable regulatory development affecting access, permitted restrictions, and compliance expectations in electronic health information exchange.

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2026 Marketplace Open Enrollment Period Public Use Files

CMS released public-use files for the 2026 Marketplace open enrollment period to support deeper analysis beyond national topline figures. The datasets can be used to examine state-level enrollment patterns, Medicaid and CHIP assessment activity, and Basic Health Program participation. This source is primarily a data release intended for public analysis and transparency.

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Exchange Coverage Remains Near Record High as 23.1 Million Enroll in 2026, Reflecting Continued Strength and Stability

CMS reported that 23.1 million people selected or were automatically re-enrolled in Marketplace coverage for 2026, describing exchange participation as near a record high. The release highlights continued use of financial assistance, relatively low out-of-pocket premium costs for many enrollees, and ongoing trends in plan affordability and cost-sharing support. It presents the 2026 results as evidence of continued Marketplace stability and strong consumer demand.

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Readout: CMS Convenes First Rural Health Transformation Summit to Advance State-Led Innovation

CMS said it held its first Rural Health Transformation Summit to support state-led work to strengthen rural health systems and expand access to care. The readout describes the summit as part of the agency’s rural transformation program and highlights collaboration with states on implementation and innovation. The announcement points to a federal effort focused on practical system changes in rural areas rather than only broad policy goals.

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Rural Health

CMS’s rural health framework outlines how the agency plans to improve care in rural, Tribal, and geographically isolated communities. The page emphasizes health equity, identifies persistent access barriers, and describes CMS priorities for strengthening coverage, services, and care delivery in underserved areas. It serves as a policy overview for how the agency is approaching rural access challenges at a national level.

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March 2026 Report to Congress: Medicare Payment Policy

MedPAC’s March 2026 report to Congress reviews Medicare payment adequacy, beneficiary cost burdens, spending trends, and reform options across major payment systems. It provides a cross-cutting baseline for understanding where Medicare costs are rising, how payment rates compare with provider costs, and what policy changes lawmakers could consider. The report is especially useful for comparing cost pressures across hospital, physician, post-acute, and other sectors rather than focusing on a single CMS rule.

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CMS Strengthens Patient Protections and Accountability in Organ Donation System

CMS announced stronger safeguards and oversight measures for the organ donation and procurement system, with a stated focus on patient protections and accountability. The guidance-centered action indicates closer scrutiny of how organ procurement organizations operate and are monitored. The changes are intended to reinforce standards in a system with significant consequences for patients awaiting transplants and donor families.

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March 2026 Report to Congress on Medicaid and CHIP

MACPAC’s March 2026 report includes analysis of Medicaid payment policy for the home- and community-based services workforce, linking payment rates to access and long-term spending pressures. Although narrower than a full program financing review, it addresses how states can use payment policy to stabilize care delivery and affordability in long-term services and supports. The report is relevant to cost because workforce payment decisions can influence both near-term Medicaid spending and the availability of less institutional care settings.

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KFF Health Tracking Poll: Health Care Costs, Expiring ACA Tax Credits, and the 2026 Midterms

KFF reports that health care costs remain a salient political issue heading into the 2026 midterms, with the poll also testing reactions to expiring ACA tax credits. The findings highlight how voters view affordability pressures and which party they trust more on health issues. As a public opinion snapshot, the poll is relevant to campaign messaging and congressional debate over health policy.

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CMS Proposes Regulations to Lower Health Care Costs, Expand Consumer Choice, and Protect Taxpayers

CMS announced the proposed 2027 Notice of Benefit and Payment Parameters, outlining potential policy changes for ACA Marketplaces. The proposal addresses eligibility verification, subsidy administration, agent and broker conduct, and standardized plan options, with the stated goals of reducing costs and strengthening program integrity. Because it is a proposal, the release describes possible future rules rather than final requirements.

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2026 Medicare Accountable Care Organization Initiatives Participation Highlights

CMS reported growth in 2026 participation across Medicare Accountable Care Organization initiatives, including the Shared Savings Program and Innovation Center models. The fact sheet highlights participating organizations and the number of beneficiaries aligned to these initiatives. It provides a snapshot of the scale of Medicare’s value-based care programs heading into 2026.

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Marketplace 2026 Open Enrollment Period Report: National Snapshot

This CMS fact sheet provides a national overview of 2026 open enrollment activity across HealthCare.gov and state-based exchanges. It summarizes plan selection totals and other high-level participation measures for the coverage year. The snapshot serves as a baseline federal summary of how the 2026 enrollment season unfolded nationwide.

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Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff January 2026

FDA’s January 2026 final guidance clarifies which clinical decision support software functions are excluded from device regulation. While focused on regulatory scope, the guidance matters for privacy because it helps define oversight boundaries for software that uses, analyzes, or presents patient data in clinical settings. The document is relevant to ongoing questions about digital health data use, accountability, and when federal requirements attach to software functions handling sensitive health information.

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CMS Proposes Rule to Strengthen Oversight of Organ Procurement Organizations and Protect Patients

CMS announced a proposed federal rule to tighten oversight of organ procurement organizations, including stronger recertification standards and performance accountability. The proposal is aimed at improving patient protections and the quality of organ recovery and transplantation services. If finalized, the rule would update how CMS evaluates OPOs and could affect certification status for organizations that fail to meet federal benchmarks.

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CMS Announces Selection of Drugs for Third Cycle of Medicare Drug Price Negotiation Program, Including First-Ever Part B Drugs

CMS announced the 15 drugs selected for the third cycle of Medicare drug price negotiations for 2026, marking the first time the program includes Part B drugs. The selection expands the scope of Medicare price negotiation beyond earlier rounds that focused on Part D products. The announcement signals continued implementation of the negotiation program and identifies the products that will move into the next phase of the pricing process.

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