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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On August 19, 2024, Douglas County, Colorado, filed a federal lawsuit against Aetna Life Insurance Company, alleging that Aetna owes the County $1.12 million in drug manufacturer rebates. We envision that this will be a trend followed by other public and private actors.
Dae Y. Lee and Terence Park shed light on this matter in a new article, read here.
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Many pharmacies use electronic prior authorization (ePA) platforms, like CoverMyMeds, to help facilitate prior authorizations. PBMs have increased audits related to pharmacies’ alleged participation in the prior authorization process, with particular attention paid to pharmacies’ use of CoverMyMeds.
In a recent article, Jesse Dresser discusses the intricacies of CoverMyMeds accounts and how pharmacies can defend against prior authorization audits. Read here.
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In October of 2023, the DOJ introduced a voluntary disclosure policy with respect to corporate mergers and acquisitions, which impacts providers, pharmacies, and MCOs. In effect, companies that discover criminal misconduct and disclose it within six months post-closing, while paying required penalties, can avoid a criminal guilty plea.
Learn more in an article by Michael Sheflin here.
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AmeriHealth Caritas, a managed care organization providing Medicaid services, which processes pharmacy claims through PerformRx's PBM, has dramatically increased audits and investigations of pharmacies. These AmeriHealth investigations are primarily focused on allegations of fraud, waste, and abuse, and have often led to referrals to regulatory agencies.
Read the article by Payal Amin and Jesse Dresser to learn more here.
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The Massachusetts Board of Registration in Pharmacy has announced plans to enforce a requirement for non-resident pharmacies to obtain a non-resident license in the coming months. Nonresident pharmacies must have at least one Massachusetts licensed pharmacist, and the process for obtaining such a license can take up to 60 days.
Arielle Miliambro and Lucas Morgan provide more detail on this topic in an insightful article. Read here.
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New York has enhanced its existing efforts to monitor prescription drug prices by implementing New York Insurance Law Section 111-A, which requires prescription drug manufacturers to report to the state Superintendent of Insurance certain qualifying price increases before they occur.
Matthew Kupferberg delves into the new law, who it applies to, reporting requirements, penalties for non-compliance, legal challenges, and more. Read the article here.
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Pharmacists face various professional and personal challenges throughout their careers, including the requirement to demonstrate "good moral character" for licensure, as mandated by many State Boards of Pharmacy.
Eric Knowles and Lucas Morgan delve into moral character hearings in a new article here. They discuss the application process for pharmacists, how to prepare for these hearings and legal representation, and important factors considered by State Boards of Pharmacy when evaluating moral character.
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Specialty medications offer lifesaving treatments for complex diseases, but come with high costs, leading self-funded employer plans to turn to alternative funding programs (AFPs) to manage expenses.
In a new article, Matthew Kupferberg sheds light on how AFPs work and their negative impact on plans, beneficiaries, and providers. Read here.
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Mastering GLP-1 Compounding Series Q&A Roundup
Frier Levitt’s healthcare and pharmacy law attorneys, Dae Y. Lee, Arielle Miliambro and Dr. Martha Rumore present a follow-up webinar “Mastering GLP-1 Compounding Series Q&A Roundup,” where they tackle key issues based on the most pressing questions from our recent GLP-1 Compounding Series.
Listen in to learn more about GLP-1 compounding, legal updates, critical topics ranging from due diligence in pharmacy operations, to compounding regulations.
Click the image below to view the webinar:
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340B & Telehealth: Regulatory Considerations
In this webinar, Frier Levitt attorneys Jesse Dresser, Arielle Miliambro, and Maria Stahl provide an in-depth overview of the 340B Drug Pricing Program and its intersection with innovative telehealth arrangements. This presentation highlights the complex regulatory landscape and underscores the importance for stakeholders to stay informed about legal developments and proposed changes.
Click the image below to view the 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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© 2024 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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