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David R. Gilboa

Associate

[email protected]

+1.212.692.6736

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David’s practice encompasses transactional, compliance, privacy, and regulatory matters for a broad spectrum of health care clients, including hospitals, clinical laboratories, nursing homes, home care agencies, physician practices, and health plans, as well as clients in the pharmaceutical supply chain, such as pharmacy benefit managers, rebate aggregators and pharmacies. Drawing on his experience as in-house counsel and as a health law attorney, he provides business-focused advice to clients on strategic transactions, US and international privacy laws and regulations, contract negotiation, and a variety of health law matters.

Prior to joining Mintz, David was an associate general counsel at a health intelligence company that provides diagnostic laboratory testing and applies artificial intelligence (AI) and machine learning to clinical and genomic data. In that role, he provided strategic counsel on a wide range of matters, including the adoption of new business lines, multiple financings, a SPAC merger, the going public process, and an acquisition of a genomic testing company. He also drafted and negotiated complex agreements, such as for joint ventures as well as software and data license, laboratory services, consulting, and partnership agreements. In addition, he negotiated contracts with pharmaceutical companies and advised on health system partnerships and collaborations for research, data sharing, and other services. His role also included advising on legal issues associated with health care fraud and abuse compliance, and US and global privacy laws and regulations, including HIPAA, HITECH, and GDPR, as well as state privacy laws. He also drafted the company’s privacy policies, notices of privacy practices, terms of service, and other company policies and procedures. Lastly, he helped set up and oversee the company’s compliance program.

Earlier, while working as an associate at a national full-service law firm and a firm focused on health care matters, David represented health care providers in transactional, compliance, and general corporate matters; negotiated various contracts and agreements; and advised on IP issues related to licensing, joint venture, and other agreements. His work at the national firm also included providing guidance on FDA regulations relating to medical device classification, good clinical practice and clinical trials, and compliance with federal and state fraud and abuse laws, such as the Stark Law and the Anti-Kickback Statute, and state privacy and security laws. At the health law firm, David served a variety of health care clients in many transactional and corporate matters, including supporting the Office of Clinical Trials for a major hospital in New York City and working on mergers and acquisitions of health care facilities. He began his legal career at a firm based in Long Island, New York, where he advised health care providers on regulatory, privacy, and Medicare and Medicaid issues and assisted with transactional, employment, and consulting matters.

In law school, David served on the Fordham International Law Journal. He also participated in the Fordham Law Dispute Resolution Society and the Brendan Moore Trial Advocacy team and in competitions for both teams. In addition, he received the Philip R. Rusco Memorial Award.

viewpoints

The PBM Policy and Legislative Update — Spring 2025 edition builds upon prior issues and summarizes activity from January through March (2025) that affects the PBM industry. It highlights federal activities, state activities, and other noteworthy events and trends affecting the PBM industry.

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The PBM Policy and Legislative Update — Winter 2025 edition builds upon prior PBM Policy and Legislative Updates and summarizes activity from October through December (2024) that affects the PBM industry. It highlights (i) federal activities, (ii) state activities, and (iii) other noteworthy events and trends affecting the PBM industry.

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On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically targeting PBMs. Signed into law by Governor Healey on January 9, 2025, the comprehensive bill, titled “An Act Relative to Pharmaceutical Access, Costs and Transparency” (the Act), introduces a multifaceted approach that aims to reduce prescription drug costs, enhance data transparency, and impose stronger oversight of PBMs and pharmaceutical manufacturers.

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Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.

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In ‘Third Edition: Q2 2024’ of the Mintz IRA Update, we cover updates to the Medicare Drug Price Negotiation Program being considered by CMS, developments in litigation challenging the program, the consequences and costs of redesigning the Part D program, opposition to the use of march-in rights to lower drug prices, and the growing use of state prescription drug affordability boards.

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Read about the 2025 redesign of the Medicare Part D program pursuant to the Inflation Reduction Act of 2022 and how those changes impact Medicare Part D plan sponsors, beneficiaries, and manufacturers.

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On May 8, 2024, the U.S. House of Representatives Ways & Means Committee passed a bipartisan bill entitled the “Preserving Telehealth, Hospital and Ambulance Access Act” by a vote of 41-0, which will potentially have far-reaching consequences for Medicare beneficiaries, health care providers, and the telehealth and PBM industries.

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Mintz is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from October through December 2023 that affects the PBM industry and will specifically highlight (i) federal legislative and enforcement updates, (ii) state legislative updates and litigation, (iii) other industry news, and (iv) Inflation Reduction Act (IRA) updates.

 

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As we wrote about in our prior blog post, on September 29, 2023, John D. Bates of the U.S. District Court for the District of Columbia struck down a federal rule that permitted health plans and pharmacy benefit managers (PBMs) to exclude drug manufacturer copayment (copay) assistance from a patient’s cost sharing limits. In two separate filings this week, HHS signaled that it intends to support the continued use of copay accumulator programs as the industry has been using them since 2021.

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News & Press

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MMIT quoted a recent article written by Mintz attorneys Theresa Carnegie, Xavier Hardy, and David Gilboa in a story discussing the US district court ruling that overturned a federal rule allowing health plans to exclude copayment assistance from members’ out-of-pocket costs. The article notes the Department of Health and Human Services’ current stance of refraining from immediate action.

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podcasts

Host, Bridgette Keller is joined by Associate, David Gilboa to break down the highlights from our Spring 2025 PBM Policy and Legislative Update. In just five minutes, we cover the most impactful federal and state developments shaping the PBM landscape this season.

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Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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