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.

Newsworthy

Frier Levitt Secures Landmark $22M+ Trial Victory Against Caremark, Recovering 100% of DIR Fees, Interest, and Attorney Fees

Frier Levitt secured a landmark federal court judgment on behalf of New York Cancer & Blood Specialists (NYCBS), confirming an arbitration award against Caremark, sharply criticizing one of CVS Health's most secretive programs.

Judge Buchwald of the United States District Court for the Southern District of New York issued an order, requiring Caremark to pay NYCBS over $22 million. This amount covers the full return of all DIR fees, interest, expenses, and attorney’s fees.

Additionally, during the associated House Oversight and Accountability hearing, Chairman James Comer and Congressman Nick Langworthy referenced our arbitration award. The case was discussed while questioning CVS Health’s David Joyner regarding Caremark’s unlawful DIR practices.

Click the image below to listen:

FTC's Landmark PBM Report Cites Frier Levitt Research Three Times to Highlight Complex PBM Practices

In mid-July, the FTC issued an Interim Staff Report entitled “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies,” in which the Agency reported on the dangers to consumers and competition that has arisen in the prescription drug access marketplace

due to vertical integration between PBMs and their affiliates.

The FTC cites to Frier Levitt three times in the report, specifically to our 2022

COA White Paper, “Pharmacy Benefit Manager Exposé: How PBMs Adversely Impact Cancer Care While Profiting at the Expense of Patients, Providers, Employers, and Taxpayers” in addition to our research on PBM “effective rates” and our analysis of PBM post-sale adjustments. These cited reports have become “go to” references for various governmental agencies and represent many hours of Frier Levitt work product. 

We’re honored that our work on effective rate guarantees, novel fee structures, and opaque PBM contracting practices helped inform this important investigation. Access the FTC report here.

Frier Levitt Cited Three Times in House Committee Report on PBMs “The Role of Pharmacy Benefit Managers in Prescription Drug Markets”

Frier Levitt is honored to be cited three times in the House Committee on Oversight and Accountability Staff's latest report, "The Role of Pharmacy Benefit Managers in Prescription Drug Markets" which highlights critical issues in the PBM industry.

This recognition underscores our commitment to advocating for transparency and fairness in the healthcare and life sciences industries. We are proud to contribute to impactful policy changes in the U.S. healthcare system.

Recent Publications

Supreme Court Overturns the Chevron Doctrine – Potential Impacts on Healthcare Providers and Pharmacies – Part 2

On June 28, 2024, the US Supreme Court overturned the Chevron Doctrine in the landmark decision Loper Bright Enterprises et al. v. Raimondo.

In a new article, Frier Levitt attorneys Todd Mizeski, A.J. Barbarito and Nicholas Batlle examine the Court’s decision, their reasoning, and implications for entities in the healthcare and life sciences space. Read here.

Additionally, read Part 1, "Supreme Court Revisits the Chevron Doctrine – Potential Impacts on Healthcare Providers and Pharmacies" here.

Pharmacy Benefit Managers Must Now Be Licensed to Operate in Oregon

In Oregon, Governor Tina Kotek recently signed House Bill 4149 into law, enhancing the state's PBM regulations to increase transparency and oversight.



Frier Levitt attorneys Eric Knowles and Lucas Morgan discuss key provisions and their implications in a new article. Read here.

Importance of Inventory Management in the Face of Increasing Pharmacy Invoice Reconciliation Audits by PBMs

PBMs frequently audit pharmacies on invoice reconciliation, where purchasing records are compared with billed claims over a set period of time. As invoice reconciliation audits increase, it is important for pharmacies to properly manage their inventory and take proactive steps to mitigate risks.

To learn more, read the article by Frier Levitt attorneys Payal Amin and Jesse Dresser here.

Federal Trade Commission Investigating Rebate Aggregators’ Retention of Money from Drug Manufacturers

The Federal Trade Commission (FTC) continues to investigate PBMs and their impact on prescription drug costs and availability. Recently, the FTC issued an interim report addressing drug manufacturer rebates.

To learn more, read the article by Frier Levitt partners Matt Modafferi and Dae Y. Lee where they discuss findings from the FTC’s report.

Read here.

State Prescription Drug Affordability Boards – All Eyes On Colorado

State legislatures in the U.S. are aggressively tackling high drug costs by establishing prescription drug affordability boards (PDABs). These boards aim to align drug prices with clinical value by evaluating drug affordability and potentially setting upper payment limits. Currently, Colorado’s PDAB is notably active.

To learn more, read the article by Frier Levitt partner Matthew Kupferberg, where he sheds light on Colorado’s state efforts, the response from drug manufacturers, and the industry wide impact of upper payment limits. Read here.

D.C. Circuit Opines On Pharmaceutical Manufacturers’ Contract Pharmacy Restrictions

In May, the U.S. Court of Appeals for the D.C. Circuit upheld the district court’s ruling, that the Federal 340B program does not prevent manufacturers from imposing certain limitations on the use of contract pharmacies.

For a deeper dive into this decision and its implications, read the article by Frier Levitt attorneys Maria Stahl and Jesse Dresser here.

Copay Coupons – Latest Updates Amidst Continuing Uncertainty

Frier Levitt partner Matthew Kupferberg explores the latest developments regarding copay coupons and copay accumulators in the ever-evolving pharmacy landscape. Matthew provides insights into state legislative actions and their impact on manufacturers, with a focus on the HIV and Hepatitis Policy Institute et al v. HHS case.

Read the article here.

On-Demand Webinar Series

Mastering GLP-1 Compounding: Regulatory Insights, Business Strategies, Reimbursement, Telehealth, and Legal Considerations

This 3-part series offers an in-depth exploration of the regulatory landscape for compounding pharmacies.

Click the images below to view each webinar:

Part 1, “Understanding FDA Regulations: Key Insights for 503A and 503B Compounding.” 

Part 2, "Innovative Business Models and Reimbursement Strategies: Navigating Telehealth, Kickback Regulations, and Payment Challenges."

Part 3, "Navigating Litigation and Intellectual Property in 503A Compounding: Challenges and Risk Mitigation Strategies."

Industry Insights

Jonathan Levitt Quoted in Bloomberg Law “Health Plan Cost Control Suits Ramp Up as Pricing Data Revealed”

Jesse Dresser Featured in Specialty Pharmacy Continuum “The Challenges of PBMs”

Martha Rumore Published in Pharmacy Times “Regulatory Considerations Regarding the 503B to 503A Compounding Model For Community Pharmacies”

Jesse Dresser Featured in AIS Health – Radar on Specialty Pharmacy “Home Infusion Providers Can Navigate Contracting Process with Various Strategies”

Client Triumphs

Frier Levitt Successfully Overturns More Than 90% of Major PBM Audit Findings for Arizona Pharmacy – Key Takeaways 

Frier Levitt Successfully Reverses 100% of Two Major PBM Audit Findings for Dispensing Physician Practice

Frier Levitt Helps New Jersey Pharmacy Overturn 91% of Major PBM Audit Findings

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.