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Carly Eisenberg Hoinacki

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Carly Eisenberg Hoinacki is a partner in the Corporate Practice Group in the New York office and a member of the Healthcare Team.

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For years, the conversation around health insurer consolidation and vertical integration has simmered through antitrust inquiries, oversight hearings, and policy papers. The Patients Over Profit Act (the “POP Act”)[i], introduced in both chambers of Congress this fall, marks a decisive shift. Rather than regulating insurer-provider integration, the POP Act proposes to ban it outright.Continue Reading Patients Over Profit Act: A Federal Inflection Point on Insurer-Provider Integration and What Comes Next

Leaders from across Sheppard Mullin’s national healthcare team gathered in Dana Point, California, for a day-long strategy session led by Co-Leaders, Eric Klein and Amanda Zablocki, to discuss the most impactful trends shaping the future of healthcare and how to best support our clients.Continue Reading A Look Ahead: Major Industry Trends Our Healthcare Team is Tracking

The Executive Order

Earlier this summer, the White House confirmed that President Trump is actively reviewing policy proposals developed in response to his executive order (“EO”) aimed at expanding access to in vitro fertilization (“IVF”).[1] Signed on February 18, 2025, the EO acknowledges the importance of family formation and the high financial barriers to fertility treatments. Accordingly, the EO solicits policy proposals “protecting IVF access and aggressively reducing out-of-pocket and health plan costs for such treatments.” [2] The initial submission deadline passed in May.Continue Reading Shifting Landscapes: How Federal and State Policies are Expanding Access to IVF

Leonard Lipsky and Carly Eisenberg Hoinacki from Sheppard Mullin’s Healthcare Team recently sat down with Nick Francia[i] and Sarah Bothner[ii] of The Capital ESOP Group at UBS Financial Services Inc.[iii], to explore the ins and outs of employee stock ownership plan (ESOP) transactions as a potential exit strategy for physician practices. Below is the Q&A from their conversation.Continue Reading Selling Your Physician Practice? Don’t Miss Out on ESOPs as an Alternative Exit Strategy

On August 1, 2023, the New York State’s Department of Health (the “DOH”) began implementation of Public Health Law Article 45-A, the State’s new statutory requirement for advance notice and public disclosure of certain material healthcare transactions (the “Material Transactions law”). Now, in response to questions from the healthcare community regarding the reporting requirements and statutory interpretation, the DOH has released a set of Frequently Asked Questions (FAQs) to clarify the scope and application of the Material Transactions law.Continue Reading New York State Releases Much Anticipated Guidance on Reporting Requirements for Material Healthcare Transactions as Budget Negotiations Near Conclusion, Potentially Expanding Law to Include Pre-Closing Review

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

The growth of private equity and other financial sponsor investments in the health care industry has led many states across the country to adopt expansive oversight authority over health care transactions. With the enactment of New York State’s budget for the State Fiscal Year 2023-2024, signed into law on May 3, 2023, the movement for more oversight in New York is coming this summer.Continue Reading New Notice and Public Disclosure Requirements for Material Health Care Transactions in New York