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Insights on Health Care

1174 total results. Page 1 of 47.

Events
Medicaid Drug Rebate Program (MDRP) Summit 2025 - Master Complex Regulatory Guidelines to Deliver Compliant Government Pricing and Reporting Programs
September 15, 2025
Stephanie Trunk

The Medicaid Drug Rebate Program (MDRP) Summit 2025 will be held in Chicago, IL, from September 15-17, 2025. This hybrid event is hosted by Informa Connect and will feature topics such as 340B, drug pricing policy, and the Inflation Reduction Act (IRA), designed to aid attendees in mastering complex regulatory guidelines.

Investigations Blog
Allied Stone Inc. and Its President Agree to Pay $12.4 Million to Settle FCA Claims Relating to Evaded Customs Duties
August 25, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, John M. Hindley, Roberto Martinez

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
Federal Court Finds Provider/Payer Medicare Advantage Agreements Do Not Implicate Federal Question Jurisdiction
August 22, 2025
Alison Lima Andersen, Mattie Bowden

A North Carolina federal court’s recent order granting remand in the case Nash Hospitals, Inc. v. UnitedHealthcare of North Carolina, Inc., et al., No. 5:25-CV-28-FL underscores the limits of federal question jurisdiction in disputes arising from health care provider-payer agreements, particularly where the claims are grounded in state law and do not necessarily require resolution of a substantial federal issue.

Press Release
Nearly 200 Attorneys Recognized by 2026 The Best Lawyers in America, ‘Ones to Watch’
August 21, 2025

ArentFox Schiff is pleased to announce that 132 attorneys have been recognized by The Best Lawyers in America 2026, with two attorneys highlighted as “Lawyers of the Year” and 66 attorneys listed as “Ones to Watch.”

Health Care Counsel Blog
Understanding OIG Advisory Opinion 25-09: Compliance Guidelines for Physician-Owned Medical Device Companies
August 18, 2025
Douglas A. Grimm

On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs).

Investigations Blog
Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS
August 15, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Shoshana Golden, John M. Hindley

Headlines that Matter for Companies and Executives in Regulated Industries

News
Annie Lee Quoted on Health Care Facilities Seeing Increased ICE Activity
August 14, 2025
Annie Chang Lee

Health Care Industry Group Co-Leader Annie Chang Lee was quoted on how hospitals and health care workers are vulnerable to potential raids by US Immigration and Customs Enforcement (ICE) following changes to federal policy regarding enforcement in sensitive locations.

Investigations Blog
Regeneron Court Permits Government to Pursue False Certification Theory
August 8, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Shoshana Golden

Headlines that Matter for Companies and Executives in Regulated Industries

Events
HDA 2025 Traceability Seminar
August 5, 2025
Abha Kundi*

Food, Drug, Medical Device & Cosmetic Counsel Abha Kundi will deliver the opening presentation of the Healthcare Distribution Alliance’s (HDA) 2025 Traceability Seminar on August 5, 2025.

Investigations Blog
Patio Furniture Firm Pays Millions for Dodging Import Duties
August 1, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Elizabeth Satarov, Meghan F. Hart

Headlines that Matter for Companies and Executives in Regulated Industries

Events
2025 HGPII Annual Best Practices Forum
July 31, 2025
Philip S. English*, Byron Dorgan*, Laura E. Doyle*, Dan Jasnow, Daniel Sjostedt*, Oliver Spurgeon III*, Hillary M. Stemple, Laurel LaMontagne, Mario A. Torrico

On July 31, 2025, ArentFox Schiff hosted the HGPII Annual Best Practices Forum, one of the group purchasing sector’s premier training and leadership development conferences.

Health Care Counsel Blog
Southern California Health Care Providers Confront Immigration Enforcement Officials
July 31, 2025
Annie Chang Lee, Gayland O. Hethcoat II

Immigration enforcement actions are no longer a theoretical concern for health care facilities — they are happening now.

News
Cowley Leongini Quoted on Sarepta’s Halt of Duchenne Gene Therapy Sales Amid FDA Scrutiny
July 25, 2025
Emily Cowley Leongini

Partner Emily Cowley Leongini was quoted on Sarepta Therapeutics’ decision to pause sales of its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) following a request from the US Food and Drug Administration (FDA).

Health Care Counsel Blog
Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know
July 25, 2025
Stephanie Trunk

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These rules are the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule.

Investigations Blog
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict
July 25, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Pascal Naples, Elizabeth Satarov

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
AI Service Agreements in Health Care: Indemnification Clauses, Emerging Trends, and Future Risks
July 23, 2025
Douglas A. Grimm

As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.

News
FCA Working Group Reboot Signals EHR Compliance Risk
July 22, 2025
D. Jacques Smith, Michelle J. Shapiro, Rebekkah R.N. Stoeckler, Stephanie Trunk, Nadia Patel, Pascal Naples

The government has announced a renewed and expanded focus on False Claims Act enforcement, doubling down on traditional healthcare priorities like kickbacks and drug pricing while signaling increased scrutiny of electronic health records manipulation, a shift that could expose data vendors and other nontraditional healthcare entities to scrutiny from the US Department of Justice and the US Department of Health and Human Services.

Health Care Counsel Blog
Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks
July 21, 2025
David S. Greenberg, Molly L. Wiltshire, Nardeen Billan

On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device company would pay licensing fees to a third-party vendor for access to an electronic billing portal used by some of the medical device company’s provider customers.

Investigations Blog
IT Company Resolves FCA Allegations for Nearly $15 Million
July 18, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Apeksha Vora, Nardeen Billan

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS
July 11, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Apeksha Vora, Heather M. Zimmer, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ and HHS Emphasize Continued, Robust, and Coordinated Health Care Enforcement With Revival of False Claims Act Working Group
July 8, 2025
D. Jacques Smith, Nadia Patel, Michelle J. Shapiro, Stephanie Trunk, Pascal Naples, Rebekkah R.N. Stoeckler

The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of Electronic Health Records (EHR) manipulation.

Alerts
FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight
July 1, 2025
Abha Kundi*

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

Press Release
Legal 500 Lists ArentFox Schiff in Top Tier Rankings for 2025
June 30, 2025

ArentFox Schiff is pleased to announce that 21 practices and 84 attorneys have been recognized by The Legal 500 United States 2025 guide, including three Tier 1 rankings for (1) Chicago Elite – Corporate and M&A Leading Law Firms, (2) Intellectual Property – Patents: Prosecution (Including Re–Examination and Post–Grant Proceedings), and (3) Finance – Restructuring (Including Bankruptcy): Municipal.

Alerts
Restructuring DC Health Care Alliance With New Eligibility Rules and Timelines for 2025
June 30, 2025
David P. Grosso, Jon S. Bouker

The District of Columbia is set to implement sweeping changes to its DC Health Care Alliance, a program that has provided vital health coverage to low-income residents who do not qualify for Medicaid or Medicare, including many non-citizens, since its inception in 2001.

Alerts
District of Columbia’s FY 2026 Budget Unveils BHP Initiative
June 27, 2025
David P. Grosso, Jon S. Bouker

District of Columbia Mayor Muriel Bowser’s FY 2026 Budget introduces a new Basic Health Program (BHP) that will fundamentally reshape health coverage options for thousands of District residents beginning next calendar year.

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