We are pleased to present "Life Sciences Legal Insights" as a valuable resource to help life sciences and pharmacy industry stakeholders in overcoming the intricate regulatory and transactional obstacles.

Client Triumphs

Frier Levitt Successfully Settles Arbitration for COVID-19 Testing Company

Frier Levitt represented a testing company in arbitration proceedings against its billing company, asserting claims of breach of contract and negligence. The billing company had failed to properly submit claims for COVID-19 testing and secure reimbursement from payors. The case was successfully resolved with a settlement of nearly $400,000 in favor of our client.

Frier Levitt successfully defended a national PBM’s attempt to categorize a pharmacy into specialty pharmacy requirements. 

Frier Levitt successfully defended significant audit findings and pushed a PBM to accept Corrective Action Plan.

Federal Court Victory Against Caremark: Preserving Arbitration Rights for Clients

Frier Levitt’s Life Sciences team recently achieved a significant legal victory on behalf of 19 clients in a high-stakes dispute against Caremark. The Arizona federal court denied Caremark’s motion to dismiss 19 arbitrations that are pending before the American Arbitration Association (AAA) and to require our clients to refile and restart the arbitration process in JAMS, an alternate arbitration forum. In a decisive win, the court also granted Frier Levitt’s motion to allow the arbitrations to proceed with the AAA, safeguarding our clients’ chosen dispute resolution forum and ensuring their cases proceed without any unnecessary costs or delays.

This outcome underscores our firm’s commitment to aggressively protecting our clients' interests in complex disputes with PBMs and other industry players.

Recent Publications

Pennsylvania Provider Alert: New Law to Take Effect

Pennsylvania has enacted a Pharmacy Benefit Reform Act (“Law”) to help regulate PBMs in the state. Codified under 40 P.S. 4501-4562, the Law took effect November 14, 2024.

Caitlin Collins and Lucas Morgan provide an overview of the new Law in a recent article. Read here.

New Year, New State Board of Pharmacy Rules

As the new year approaches, pharmacies and pharmacists should prepare for regulatory changes, including updates from their state Boards of Pharmacy. One example is Ohio's updated "Duty to Report" rule, which will take effect on March 1, 2025. 

Lucas Morgan and Caitlin Collins discuss what licensees should know about duties to report in a new article. Read here.

FDA Still Undecided if Tirzepatide is in Shortage

Our latest article unpacks the ongoing legal and regulatory complexities surrounding Tirzepatide's shortage status. 

Read the full piece by Martha Rumore to stay informed about this critical development here.

The Expansion of Anti-Obesity Drug Coverage: Opportunities and Risks for Pharmacies

In a new article, Dae Lee explores the groundbreaking Biden administration policy expanding Medicare and Medicaid coverage for anti-obesity medications like Wegovy

and Ozempic.

Read more here.

Update on FTC’s Lawsuit Against Three Largest PBMs and their GPOs

As Frier Levitt has recently covered, the FTC filed an administrative complaint against the three largest PBMs—Caremark, Express Scripts, and Optum Rx—and their affiliated Group Purchasing Organizations.

Lucas Morgan and Caitlin Collins provide updates on recent developments following the FTC’s filing in a new article. Read here.

New PBM Regulations Take Effect in New York

The New York State Department of Financial Services’ new PBM Regulations took effect on November 27, 2024, marking the third set of rules designed to regulate PBMs in the state.

Lucas Morgan and Caitlin Collins provide a summary of some of the key components of the new regulations in an insightful article. Read here.

Federal Court Blocks Corporate Transparency Act Nationwide

On December 3, 2024, a United States District Court for the Eastern District of Texas ruling blocked the Corporate Transparency Act (“CTA”) nationwide.

In the opinion, the CTA was found to be “likely unconstitutional” and that its looming December 31, 2024, deadline would cause irreparable harm to companies that were required to comply.

Learn more here.

Clinicians Corner

Healthcare Policy Shifts on the Horizon – What to Expect and How to Prepare

With a new administration upon us, the healthcare landscape is poised for policy shifts that could affect patient care, compliance, and operations. 

In a new article, Haroon Mian sheds light on what providers should expect and how to prepare for these anticipated changes at both the federal and state levels, as new strategies will likely emerge to improve affordability, access, and healthcare delivery. 

Read here.

Newsworthy

Dae Lee Featured in USA Today “FDA: Weight Loss Drug Zepbound, Diabetes Drug Mounjaro No Longer in Shortage”

Dae Lee and Martha Rumore Featured in Pharmacy Practice News Discussing GLP-1 Compounding

• Lucas Morgan Featured in New York Law Journal “Pharmacy Lawyers See Promise in NY Regulator’s Curbs on PBM Industry”

• Lucas Morgan Featured in MedCity News “The Big 3 PBMs are Countersuing the FTC. Does Their Argument Have Any Teeth?”

Jesse Dresser Featured in Modern Healthcare “Supreme Court’s Silence Fortifies 340B Contract Pharmacy Laws”

For any questions or assistance, please contact:

Jonathan E. Levitt, Esq.

Co-Founding Partner

Frier Levitt

jlevitt@frierlevitt.com

973.618.1660

Bio | LinkedIn

Frier Levitt, established in 2000, is a premier law firm with offices in New York and New Jersey. Firm attorneys are leaders in providing services to healthcare and life sciences clients nationally. Frier Levitt serves the provider community, wholesalers, manufacturers and plan sponsors, large physician group practices, hospitals, hospital medical staff, ambulatory surgery centers, and laboratory companies. The firm is a renowned leader in PBM contracts and applicable law. Firm attorneys are at the forefront of disputing PBM-imposed DIR fees and have successfully challenged DIR fees against major PBMs, obtaining more than $100M in damages on behalf of its pharmacy clients arising from trials and settlements. For more information, please visit www.frierlevitt.com.