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Client Alerts 626 results

Client Alert | 2 min read | 10.03.25

FDA Seeks Input on Real-World Performance of AI-Enabled Medical Devices: What Biotech and MedTech Innovators Need to Know

On September 30, 2025, the Food and Drug Administration (FDA) issued a Request for Public Comment (“Request”) inviting stakeholders to share practical experience and recommendations for measuring and evaluating the real-world performance of AI-enabled medical devices, including those powered by GenAI. According to FDA, the Request is not intended to communicate new guidance or regulatory expectations but aims to advance the conversation on how best to assure the safety, effectiveness, and reliability of AI-driven technologies in clinical practice.
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Client Alert | 4 min read | 09.26.25

Court Vacates CMS’s 2023 Final Rule on RADV Audits

On September 25, 2025, the Northern District of Texas granted plaintiffs’ motion for summary judgment in Humana v. Becerra, vacating CMS’s 2023 Final Rule regarding risk adjustment data validation (RADV) audits. In the litigation, Humana challenged CMS’s decision in the Final Rule to not continue applying a Fee-for-Service (FFS) adjuster to its RADV audit methodology.
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Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising.  This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”
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Client Alert | 3 min read | 09.08.25

RADV Audits: Implications and Recommendations for Medicare Advantage Organizations

CMS is well underway in initiating and conducting its Risk Adjustment Data Validation (RADV) audits of Medicare Advantage (MA) organizations for PY 2019, and PY 2020 audit notices are likely to arrive by the end of September. The timing for subsequent PY audits is less clear, but notices will likely be coming soon given CMS’s announced plans to complete all remaining audits by early 2026, including all contracts for PY 2020 and beyond. This approach marks a significant deviation from the agency’s prior policy of reviewing only a fraction of contracts and at a much slower pace.
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Client Alert | 4 min read | 08.29.25

Gender-Affirming Care Targeted for Potential False Claims Act Enforcement

On August 19, 2025, the Office of Personnel Management (OPM) informed insurers participating in the Federal Employees Health Benefits or Postal Service Health Benefits programs that gender-affirming care would no longer be covered for federal workers starting in 2026. This coverage decision is the Trump Administration’s latest action stemming from Executive Order 14187 which aims to prevent certain treatments, such as gender-affirming hormone therapy, surgeries, and puberty blockers for those under the age of 19. As previously discussed, the Administration has also signaled its intent to use various law enforcement tools against gender-affirming care, including  Section 5 of the Federal Trade Commission Act to police false or unsupported claims by medical professionals about gender-affirming treatments.
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Client Alert | 2 min read | 08.04.25

FDA Announces Availability of ICH Draft Guidance on Inclusion of Pregnant and Breastfeeding Women in Clinical Trials

On Monday, July 21, 2025, the Food and Drug Administration (FDA) issued draft guidance entitled “E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials” from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance is currently in Step 2 of the ICH process and open for public comment until September 19, 2025.
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Client Alert | 7 min read | 07.29.25

White House AI Action Plan: Potential Implications for Health Care

On July 23, 2025, the Trump Administration issued an artificial intelligence (AI) action plan titled “Winning the Race: America’s AI Action Plan” (the Plan) to guide AI innovation in the U.S. The Plan includes 90 policy recommendations that will shape future AI guidance and policies impacting a range of entities and industry sectors, including health care/life sciences and entities involved in clinical research.
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Client Alert | 4 min read | 07.21.25

Not So Surprising: The Fifth Circuit Finds No Private Right of Action in the No Surprises Act

On June 12, 2025, the Fifth Circuit ruled in Guardian Flight I[i] and Guardian Flight II[ii] that the No Surprises Act (“NSA”) does not confer a private right of action on parties to confirm an Independent Dispute Resolution (“IDR”) award in court. The Fifth Circuit is the first United States Court of Appeals to weigh in on the issue, which has divided some district courts. On July 11, 2025 the Fifth Circuit denied Appellant’s request for en banc review of the Court’s finding that the NSA lacks a private right of action.[iii] The panel’s ruling is now final and controlling precedent for the Fifth Circuit unless overturned by the Supreme Court.
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Client Alert | 7 min read | 07.11.25

President Trump’s “One Big Beautiful Bill” Makes Changes to Medicaid

On July 4, President Trump signed into law the “One Big Beautiful Bill Act” (“the Act”), or H.R. 1, which makes significant changes to federal healthcare programs, including Medicaid, Medicare, and Health Insurance Marketplaces. As proposed in previous versions of the Act, the Act includes cuts to the Medicaid program and imposes new requirements on beneficiaries, states, and healthcare providers.
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Client Alert | 3 min read | 07.08.25

DOJ and HHS Launch FCA Working Group: Heightened Enforcement Risk for Health Care Entities

On July 2, 2025, the U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) jointly announced the formation of a False Claims Act (FCA) Working Group. This new initiative underscores a coordinated federal enforcement strategy focused on identifying and addressing fraud in federally funded health care programs, particularly Medicare Advantage and Medicaid managed care. The announcement comes days after Matthew R. Galeotti, Head of DOJ’s Criminal Division, announced the results of the “largest coordinated health care fraud takedown in the history of the Department of Justice”  and the creation of a “Health Care Fraud Data Fusion Center” comprised of data specialists that will “break down information silos, using coordinated data analysis to enable our investigative teams to quickly identify and dismantle emerging fraud schemes.” Taken together, these announcements demonstrate the DOJ’s effort—in both civil and criminal divisions—to strengthen its collaboration with HHS to investigate and prosecute health care fraud.
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Client Alert | 4 min read | 07.02.25

Supreme Court Upholds the Constitutionality of the U.S. Preventive Services Task Force and the Affordable Care Act’s Preventive Service Coverage Scheme

On June 27, 2025, the Supreme Court upheld the constitutionality of the USPSTF and its role in identifying preventive services for coverage under the ACA in Kennedy v. Braidwood Management.[1]In the case, the Supreme Court considered whether the Secretary of HHS’s appointment of USPSTF members without the advice and consent of the Senate complied with the Appointments Clause in Article II of the United States Constitution. The Supreme Court found that USPSTF members were “inferior Officers” under the Appointments Clause who did not require Senate confirmation because the Secretary of HHS had the authority to remove USPSTF members at will and “to directly review and block Task Force recommendations before they take effect.” The Supreme Court therefore affirmed that the USPSTF as currently structured may legally recommend preventive services for coverage without cost-sharing requirements under the ACA.
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Client Alert | 3 min read | 06.30.25

The New EU “Pharma Package”: Preparing for the Trilogues

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.
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Client Alert | 3 min read | 06.04.25

CMS Issues Letters to Hospitals on Gender-Affirming Care Practices

On May 28, 2025, Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz sent a letter to select hospitals requesting information about the hospitals’ practices related to treatment for gender dysphoria in children. The letter also requests financial information related to pediatric gender-affirming care paid for “in whole or in part” by the federal government.
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Client Alert | 3 min read | 05.23.25

Executive Order Seeks Most-Favored-Nation Drug Pricing and HHS Announces Price Targets

On May 12, 2025, President Trump issued an Executive Order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," which aims to reduce the costs of prescription drugs and biologics for American consumers and other payers. This Order revives a plan from President Trump’s first term and follows his April Executive Order, “Lowering Drug Prices by Once Again Putting Americans First,” which also sought to reduce drug prices. With drug prices in the United States nearly three times higher than many other countries, this second Order asks drug manufacturers to adopt Most-Favored-Nation (MFN) pricing for drugs sold in the United States or face potential regulation. MFN pricing would tether drug prices offered in the United States to the lower-cost prices offered in other comparably developed nations, such as Canada, Germany, or the United Kingdom.
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Client Alert | 3 min read | 05.16.25

Trump Administration Pauses Enforcement of the MHPAEA Final Rule

The Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (the “Tri-Agencies”) have signaled that changes may be coming to the Mental Health Parity and Addiction Equity Act (“MHPAEA”) Final Rule issued on September 8, 2024. On May 9, 2025, the Tri-Agencies filed a Motion for Abeyance in a lawsuit brought by the ERISA Industry Committee (“ERIC”) challenging the 2024 final MHPAEA regulations in the United States District Court for the District of Columbia.[1] The Motion, which was granted by the Court, indicated that the Tri-Agencies intend to “reconsider” the Final Rule, including “whether to issue a notice of proposed rulemaking rescinding or modifying the Final Rule.” Yesterday, on May 15, 2025, the Tri-Agencies issued a notice of non-enforcement stating that they “will not enforce the 2024 Final Rule or otherwise pursue enforcement actions, based on a failure to comply that occurs prior to a final decision in the litigation, plus an additional 18 months.”
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Client Alert | 3 min read | 05.07.25

NIH Continues Grant Awards Overhaul With New Limitations on Foreign Subawards

On May 1, the NIH issued an update on its grants policy, establishing a “new award structure” that would prohibit foreign subawards from being nested under the parent grant, replacing them with direct awards linked to a prime award. Effective immediately, NIH will no longer issue awards that include a subaward to a foreign entity until the new structure is implemented. The notice did not limit this new structure for foreign recipients to any particular jurisdiction, potentially impacting a wide range of grants and limiting international collaboration with U.S. researchers through the subaward model.
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Client Alert | 3 min read | 04.25.25

Arkansas Takes Aim at PBM Ownership of Retail Pharmacies

On April 17, 2025, Arkansas recently became the first state to enact broad restrictions on pharmacy benefit managers (“PBMs”) owning retail pharmacies within the state.
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Client Alert | 5 min read | 04.21.25

DOJ Secures First Criminal Wage-Fixing Conviction in Home Health Care Staffing Case

In a landmark verdict on April 14, 2025, the U.S. Department of Justice Antitrust Division notched its first-ever jury trial conviction for criminal wage-fixing under the Sherman Act in United States v. Eduardo Lopez in the District of Nevada. A home health care staffing executive, Eduardo (“Eddie”) Lopez, was found guilty of (1) conspiring with several competing home healthcare staffing agencies to fix the wages of home health nurses in the Las Vegas area, and (2) defrauding the unwitting buyer of his agency by concealing the then-ongoing antitrust investigation into nurse wage and hiring practices. It is worth noting, however, that while the Lopez conviction is a significant milestone for the DOJ’s campaign into labor antitrust violations, wage-fixing cases may be more straightforward to prosecute than no-poach agreements, where the DOJ still has not prevailed before a jury. This victory nonetheless affirms the DOJ’s ability to criminally prosecute labor market collusion as a criminal offense after numerous failed attempts, signaling the prudence of further caution for companies and individuals to mitigate risk in labor antitrust markets.
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Client Alert | 6 min read | 04.18.25

Ready To Know Your Data? DOJ Issues Implementation and Enforcement Guidance for Data Security Program Protecting Bulk Sensitive Data

On April 11, 2025, the U.S. Department of Justice (DOJ) issued guidance regarding the implementation and enforcement of the newly enacted final rule, “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” now referred to as the Data Security Program (DSP). The release included an Implementation and Enforcement Policy, a Compliance Guide, and Frequently Asked Questions (FAQs). Collectively, these documents are designed to help entities subject to the DSP understand and comply with the obligations set out under the Final Rule.
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Client Alert | 12 min read | 04.03.25

CMS Issues Marketplace Integrity and Affordability Proposed Rule

In its first healthcare proposed regulation, the Trump Administration, through the Centers for Medicare & Medicaid Services (CMS), displayed on March 10, 2025, a proposed rule titled, “2025 Marketplace Integrity and Affordability Proposed Rule” (the Proposed Rule), which proposes policy changes for the Health Insurance Marketplaces that impact health plans and insurers offering Affordable Care Act (ACA) coverage to consumers. Specifically, the Proposed Rule shortens the Annual Open Enrollment Period (OEP) for all individual market coverage; proposes standards related to income verification for Health Insurance Marketplaces (Marketplaces); modifies eligibility redetermination procedures; and eliminates eligibility for “Deferred Action for Childhood Arrivals” (DACA) recipients, among other provisions.  
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