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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Many have asked whether various drugs can still be compounded once they are removed from the FDA 506e shortage list and marked as 'resolved'. As of August 5, 2024, tirzepatide and semaglutide remain on the shortage list, but new compounding restrictions will apply once they are removed.
Learn more in our latest article by Martha Rumore, PharmD, Esq, MS, LLM, FAPhA here.
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Beneficiaries of Wells Fargo’s prescription drug benefit plan have filed an ERISA class action lawsuit against the bank, following a similar case against Johnson & Johnson. This indicates a rising trend of litigation against Plan Sponsors for not properly monitoring PBMs.
Terence Park, Matt Modafferi and Dae Y. Lee discuss this case here.
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On July 17, 2024, the Vermont Attorney General filed a lawsuit against Express Scripts, Caremark, and their subsidiaries, alleging that these PBMs falsely claim to help lower drug costs, when in reality, they do the opposite.
Learn more in a new article by Jonathan Levitt, Matt Modafferi and Terence Park here.
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The FTC’s recent interim report exposes concerning PBM practices including patient steering, where PBMs direct patients to their own affiliated pharmacies, and vertical integration, where increased concentration has led to a market dominated by a few large PBMs.
Nicholas Batlle, Steven Bennet and A.J. Barbarito break down what this means for you and your pharmacy. Read here.
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On August 1, 2024, the FTC held an Open Commission Meeting to discuss its interim "Pharmacy Benefit Managers Report." The FTC highlighted concerns over how PBMs, through vertical integration and market concentration, may inflate drug costs and squeeze independent pharmacies.
Jesse Dresser delves into Frier Levitt’s statement to the FTC in a new article here.
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Underwater reimbursement, where pharmacies are paid less than the cost to acquire a drug, has become a major issue for pharmacies in PBM networks. To mitigate these losses, some pharmacies consider not filling specific prescriptions or turning away patients, however, PBM agreements may prohibit this.
Read the article by Jesse Dresser to learn more here.
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Frier Levitt has noted an uptick in PBMs citing discrepancies related to pharmacies obtaining prior authorizations, a relatively clear procedure. However, through deceptive tactics, PBMs exploit the process in order to terminate pharmacies and collect exorbitant fees.
Read the article by Kelly Reynolds and Payal Amin to learn more here.
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The DOJ announced a $101 million settlement with Rite Aid Corporation and its subsidiaries for False Claims Act violations involving fraudulent rebate retention.
Terence Park, Matt Modafferi and Dae Y. Lee provide key insights here.
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CVS Caremark has agreed to repay Illinois $45 million for pharmaceutical manufacturer rebates that it or its affiliate failed to pass through.
For a deeper dive, read the article by Jonathan Levitt, Adam Farkas and Dae Y. Lee here.
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In early 2024, CVS Caremark announced it would replace Humira® with Hyrimoz®, a biosimilar from its subsidiary Cordavis, starting April 1, 2024. This move, raising concerns among patients and pharmacies, marks a significant step in vertical integration within the pharmacy benefits space.
Read the article by Martha Rumore, Jesse Dresser and Andrea Hageman here.
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The West Virginia Office of the Insurance Commissioner entered into a series of Consent Orders with four PBMs for operating without appropriate state licenses. This situation highlights the complexity of state regulatory requirements, which often contain nuances that can lead to disciplinary action if not thoroughly reviewed.
Adam Farkas sheds light on this matter here.
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PBMs are becoming stricter about documentation and records demonstrating the remittance of copayments, therefore, comprehensive copayment policies are critical for pharmacies when facing PBM audits.
Read the article by Andrea Hageman and Harini Bupathi here.
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The New York Assembly recently introduced Assembly Bill 10107, aimed at improving reimbursement rates for independent pharmacies in the state.
Read the article by Lucas Morgan and Eric Knowles to learn more here.
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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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