![]() She also regularly leads Sidley teams that mount litigation challenges and pursue advocacy strategies in response to controversial regulatory developments, particularly drug pricing and reimbursement issues, including most recently the challenge to the most favored nations reference pricing regulation: Cal. Meena aggressively defends clients on healthcare regulatory theories of liability – particularly drug pricing and Anti-Kickback Statute theories – in the context of enforcement initiated by the Department of Justice and Office of Inspector General, Department of Health and Human Services. She has earned the reputation of being practical and clients appreciate her cost-effective staffing model depending on the nature and complexity of the market access work. A substantial portion of her work in this area is for novel drug therapy companies focused on rare diseases, gene therapy, cell therapy, and digital therapeutics. Over the years, Meena has served as lead healthcare counsel in 30 new drug and device product launches, where she has effectively partnered with in-house counsel and business teams on a wide variety of critical business issues including clinical trial design distribution and market access models value-based arrangements patient assistance programs early access and post-trial access programs drug pricing and customer interactions in the field. Meena also leads the Firm’s Global Drug Pricing Task Force.Ĭounsels on Market Access and Drug and Device Product Launches. She has cultivated and trained a deep bench of experienced lawyers who support this work and operate efficiently from a time and cost perspective on client projects of all sizes. She has won declinations from DOJ on drug pricing enforcement issues, and has successfully led major disclosures and restatements to the government agencies including CMS, HRSA, and VA. She is frequently sought by clients for review of and updates to internal methodology policies, and she brings a wealth of benchmarking and best practices to her counseling. ![]() She advises dozens of clients on drug price reporting compliance matters including bona fide service fees, wholesaler fees, line extensions, smoothing, transfer price and authorized generics issues, and impact of patient access and assistance programs on government pricing. Her experience spans the Medicaid Drug Rebate Program, Average Sales Price, the 340B Drug Pricing Program, and non-FAMP and the Federal Ceiling Price. Meena is regarded as a leading government price reporting practitioner in the country. Meena helps clients solve critical business problems and formulate litigation strategy involving drug pricing healthcare reform fraud and abuse compliance, particularly in the design and execution of arrangements in compliance with the Federal Anti-Kickback Statute and the Travel Act the Eliminating Kickbacks in Recovery Act (EKRA) state drug price transparency laws federal healthcare program coverage and reimbursement issues healthcare compliance programs market access HIPAA and HITECH implementation and compliance and the Sunshine Act and similar state laws. Meena has also been regularly counseling clients on COVID-19 related matters including crisis management public health reporting service and delivery privacy and risk mitigation. Her client base includes pharmaceutical and medical device manufacturers and their trade associations distributors large healthcare providers telemedicine and telehealth providers genetic and early cancer detection screening companies clinical diagnostic laboratories private equity firms and public companies focused on healthcare and life sciences investments health tech companies and innovators and disruptors. Meena is highly experienced in representing both Fortune 100 healthcare and life sciences companies as well as small biotech, medtech, and telehealth companies, and regularly advises Boards of Directors and c-suite personnel on sensitive regulatory matters. ![]() Meena manages key strategic regulatory, transactional, litigation, and enforcement matters for life sciences, healthcare, and health technology companies throughout the world. Underscoring the depth of Sidley’s talent, Meena’s team was identified in LMG Life Sciences' 2022 edition as first tier for Healthcare: Pricing & Reimbursement, and she was individually ranked as a “Life Sciences Star” in both the FDA: Medical Device and FDA: Pharmaceutical categories (2020–2022). ![]() She was recognized as Regulatory Attorney of the Year: Pricing and Reimbursement in LMG Life Sciences 2021 edition, a marquee award for life sciences lawyers. She also leads the Chicago Healthcare group, and is a member of the firm’s Global Life Sciences Leadership Council and COVID-19 Task Force. MEENA DATTA is a member of the firm’s Executive Committee and global co-leader of Sidley’s Healthcare practice.
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