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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

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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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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The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.
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In a significant development with far-reaching implications for health plans and pharmacy benefit managers (“PBMs”), Justice John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal rule that allowed health plans to use copay accumulator programs to exclude drug manufacturer copay assistance from a patient’s out-of-pocket costs. This ruling has significant implications for the way health plans and PBMs operate and interact with patients and copay assistance programs.
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The Centers for Medicare & Medicaid Services (CMS) announced a new primary care model—the Making Care Primary (MCP) Model—geared towards smaller, independent primary care practices and organizations that want to participate independently in value-based care initiatives. The MCP Model will be tested in eight states - Colorado, Massachusetts, Minnesota, New Mexico, New Jersey, New York, North Carolina, and Washington.
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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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