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. | |
SPOTLIGHT: Tirzepatide Compounding - Navigating Legal and Regulatory Shifts
As the landscape surrounding Tirzepatide evolves, Frier Levitt attorneys will continue to monitor the changing developments impacting compounding pharmacies and the broader industry. We have covered these critical updates, and below are the articles that detail them.
Our commitment is to keep you informed about the latest regulatory and legal issues to ensure you are well-prepared for any changes that may arise.
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The Federal Trade Commission (FTC) filed an administrative complaint on September 20, 2024, against the three largest Pharmacy Benefit Managers (PBMs) and their affiliated Group Purchasing Organizations for engaging in anticompetitive and unfair rebating practices.
For a deeper dive into the case, read the article by Lucas Morgan and Caitlin Collins here.
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A new law effective January 1, 2025, will significantly impact how PBMs calculate rebates, offering a competitive edge to savvy value-based providers with shared savings arrangements.
Read the article by Jason Silberberg and Michael Sheflin to learn more here.
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Pharmaceutical manufacturers have introduced copay coupon programs to reduce patients' copay costs and promote adherence to branded drugs. Recently, pharmacies have experienced a string of new audits from the third-party companies managing these programs.
Jesse Dresser discusses this growing trend in audits of copay coupon claims in an insightful article here.
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The FDA extended the enforcement deadline for the DSCSA provisions to November 27, 2024, but many manufacturers and distributors still lack interoperable electronic systems for tracking transactions. .
To learn more about the end of the FDA enforcement discretion period and what this means for pharmacies, read the article by Martha Rumore and Dae Y. Lee here.
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Arkansas’ Governor and Insurance Commissioner announced penalties totaling nearly $1.5 million against major PBMs Caremark, Express Scripts, MedImpact, and Magellan. This follows the Supreme Court's decision in Rutledge v. PCMA, which upheld Arkansas laws requiring PBMs to reimburse pharmacies at or above acquisition costs.
To learn more, read the article by Lucas Morgan and Christopher Caltavuturo here.
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Recently, Frier Levitt attorneys Matthew Modafferi and Martha Rumore held a webinar addressing key issues surrounding the compounding of GLP-1 agonists, like tirzepatide and semaglutide. The concepts and topics covered in that webinar remain at the forefront of compounding, and we have summarized them for you in an insightful article.
Read here.
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Medication nonadherence, where patients fail to take medication as prescribed, is a significant issue affecting health outcomes and increasing healthcare costs.
Matthew Kupferberg elaborates on the scope of this problem in more detail, discussing contributing factors to poor medication adherence and their impact here.
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A recent Settlement Agreement serves as a warning for healthcare providers involved in capitated payment models. Oak Street Health, a large provider with mostly Medicare and Medicaid patients, allegedly paid insurance agents and brokers to refer patients to its practice in order to increase its patient membership size, violating the AKS and FCA.
For a deeper dive into the case and key takeaways for capitated providers, read the article by Jason Silberberg and Diana Ryzhova here.
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In a groundbreaking decision, a federal court has struck down the whistleblower provisions of the FCA as unconstitutional, raising new questions about the future of qui tam cases.
Jason Silberberg analyzes the implications of this ruling in a new article. Read here.
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If you’re a provider in a value-based care (VBC) contract, it's crucial to check whether you're being properly credited for drug manufacturer rebates that payors and plans receive. These rebates can reduce the actual cost of drugs, and if they go undisclosed, you may be overpaying or missing out on savings without ever knowing it.
Read the article by Jason Silberberg and Michael Sheflin to learn more here.
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In September, a federal District Court ruled against pharmaceutical manufacturers in Pharmaceutical Research and Mfrs of America v. Murrill, upholding Act 358, a state law which prohibits drug manufacturers and distributors from interfering with a 340B Covered Entity’s contract pharmacy arrangements.
To learn more, read the article by Maria Stahl and Matthew Kupferberg here.
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BOPs and PBMs in Focus: Navigating Industry Changes for 2024-2025
Frier Levitt attorneys Dae Y. Lee, Lucas Morgan and Nicole DeWitt will present a webinar, “BOPs and PBMs in Focus: Navigating Industry Changes for 2024-2025” on November 19, 2024, from 12:30 to 1:30 p.m. ET. This insightful webinar will focus specifically on changes and updates regarding Boards of Pharmacy (BOPs) and Pharmacy Benefit Managers (PBMs). Dae, Lucas and Nicole will delve into industry developments and considerations for 2024/2025, BOP & PBM changes as well as new areas of focus, and highlight reasons for industry optimism.
Click the image below to register:
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Who should attend?
We encourage pharmacists, pharmacy owners, pharmacy technicians, those who have or want to acquire a pharmacy, and wholesalers to attend this webinar.
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Frier Levitt’s Government Investigations, Litigation & White-Collar Defense Group is comprised of seasoned professionals, including a former Assistant United States Attorney, Deputy Attorneys General, and healthcare litigators who have decades of experience defending corporate entities, executives, and healthcare and life sciences professionals for alleged healthcare violations.
Our attorneys bring a wealth of firsthand knowledge of how government agencies conduct investigations and prosecute cases. This litigation-centric experience and skillset, combined with the firm’s extensive regulatory, transactional, and clinical knowledge, work to resolve such cases successfully, often doing so before public charges are filed.
Contact Frier Levitt to speak to an attorney about regulatory concerns, government inquiries, subpoena and CID defense, as well as litigation defense.
Learn more about Frier Levitt's Government Investigations, Litigation & White-Collar Defense here.
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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 $100M 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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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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