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. |
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The Tenth Circuit Court of Appeals delivered an unfavorable outcome for independent pharmacies and state initiatives addressing abusive practices by Pharmacy Benefit Managers (PBMs), including patient "steering." |
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The court’s 53-page opinion held that the Employee Retirement Income Security Act (ERISA) and Medicare
Part D preempted certain provisions in Oklahoma’s Patient’s Right to Pharmacy Choice Act. If upheld, this decision could adversely impact independent
pharmacies and hinder states’ ability to regulate PBMs.
To learn more, read article by Frier Levitt attorneys
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An Iowa pharmacy recently received a refund of $137,000 from a pharmacy benefit manager (PBM) following a complaint about the PBM's practice of retroactively recouping funds.
The recouped amount pertained to "effective rate reconciliation" for the 2022 period. However, Iowa has recently implemented laws prohibiting PBMs from retroactively reducing reimbursement. Other states taking such action include North Dakota and Tennessee.
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The FDA has issued a Guidance that provides a one-year enforcement discretion period for the Drug Supply Chain Security Act (DSCSA) requirement of electronic interoperability for tracking transactions. This delay was requested by pharmacy groups, wholesalers, and members of Congress due to concerns about readiness, potential
drug shortages, and disruptions in the supply chain.
to be in full compliance of DSCSA requirements.
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Numerous states have enacted laws that regulate the reimbursement rates PBMs offer to contracted providers and seek to ensure that providers are adequately compensated for the services they provide.
In a new article, Frier Levitt attorneys A.J. Barbarito and Conor McCabe discuss some of these laws, as well as strategies providers may take to curb abusive and unsustainable PBM reimbursement practices.
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The House Committee on Oversight and Accountability conducted a hearing titled, "The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered." This hearing featured industry witnesses who highlighted the impact of abusive practices by Pharmacy Benefit Managers (PBMs) on the pharmaceutical supply industry.
Both the bipartisan committee and the Federal Trade Commission (FTC) seem to be in consensus regarding the urgency of addressing PBM misconduct, recognizing it as a significant public concern.
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Congress has moved closer to regulating prescription drug prices and enhancing affordability for Medicare Beneficiaries with a significant development. Senators introduced bipartisan legislation aimed at untethering the compensation of Pharmacy Benefit Managers (PBMs) from the expenses associated with prescription drugs and their utilization in Medicare Part D.
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Governor DeSantis of Florida has taken steps to enhance Pharmacy Benefit Manager (PBM) accountability and transparency in the state by approving rules related to Florida’s Prescription Drug Reform Act, Senate Bill 1550 (SB 1550).
Specifically, the new rules require PBMs to submit an application to operate in Florida from January 1, 2024, onwards. Failure to apply could result in fines of $10,000 per violation per day. Additionally, pharmaceutical companies are mandated to disclose price increases leading to a 15 percent rise within a year or a 30 percent rise within three years.
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Pharmaceutical company Eli Lilly has initiated legal action against some medical spas, wellness centers, and compounding pharmacies aiming to prevent them from selling compounded products containing tirzepatide, an active ingredient in Eli Lilly's medication Mounjaro.
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Pharmacies are facing increasing risks when it comes to Pharmacy Benefit Manager (PBM) audits. From recoupments and network terminations to governmental investigations, the stakes are higher than ever. Properly addressing audit issues and implementing preventative measures are crucial to ensuring a positive audit result.
This informative webinar led by Frier Levitt attorneys Dae Lee and Harini Bupathi will discuss the key challenges, potential risks, and best practices to navigate PBM audits successfully.
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"Navigating PBM Audits: Ensuring Pharmacy Compliance and Mitigating Risks"
Wednesday October 11, 2023, 1:00-1:30 PM ET
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Webinar Agenda:
- Understand PBM audits and implications on network participation
- Learn about proactive efforts to self-audit pharmacy operations in advance of PBM audit
- Develop best practices for pharmacy operations
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Bonus: Download the PBM Audit Checklist to kickstart your audit preparedness journey! |
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To address the rising costs of prescription drugs, plan sponsors—including self-funded plans (employers, labor funds, public sector, and federal), health plans (commercial, Medicare, Medicaid, and exchange plans), and regulated markets (Medicare, Medicaid, and public health exchanges)—have turned to the services of Pharmacy Benefit Managers (“PBMs”) for processing prescription medication claims. However, PBMs have taken advantage of their positions as “middlemen”, adding fees and charges to the process, usually for their own financial benefit, resulting in higher prescription costs for both health plans and patients.
Frier Levitt has extensive experience representing plans and plan sponsors in negotiations and disputes with PBMs. We have observed the unethical practices of PBMs and the negative impact they have on healthcare and life sciences industry stakeholders, including plan sponsors. If you are a plan sponsor dealing with PBM contract issues or are experiencing other issues with a PBM, contact Frier Levitt to speak with an experienced attorney on our team.
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Frier Levitt is excited to share our latest
Plan Sponsor Newsletter, helping large employers, union groups and self-insured companies understand their drug benefit design.
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For any questions or assistance, please contact:
Jonathan E. Levitt, Esq.
Co-Founding Partner
Frier Levitt
973.618.1660
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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 $80M in damages on behalf of its pharmacy clients arising from trials and settlements. For more information, please visit www.frierlevitt.com.
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© 2023 Frier Levitt. All rights reserved. ATTORNEY ADVERTISING.
The contents of this newsletter and all related communications do not constitute legal advice or an attorney-client relationship. Publication contents are for general information purposes and are not intended to be a substitute for legal advice. You should seek legal advice or other professional advice in relation to any particular questions that you or your organization may have.
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