Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new advisory committee, convened by the Public Health and Health Planning Council (PHHPC), has been charged with evaluating the state’s current CON framework and recommending changes to improve transparency in ownership, strengthen financial accountability, and streamline decision-making.
Continue Reading Policy Brief: Aligning Nursing Home Bed Planning with New York’s Certificate of Need Reform Goals

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act (FCA) – described in the announcement as “one of the government’s most effective and successful tools” for fighting fraud. In Fiscal Year 2024, the Department of Justice recovered more than $2.9 billion through settlements and judgments under the FCA, with $1.6 billion (57%) coming from healthcare-related matters.
Continue Reading DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider Centered AI Landscape.” The session addressed the growing legal, operational, and ethical risks of AI adoption in healthcare, emphasizing the importance of thoughtful governance and risk mitigation. Key discussion points included regulatory compliance, implementation strategies, liability trends, Marsh’s generative AI risk framework, and insurance considerations.
Continue Reading Key Insights from Sheppard Mullin and Marsh McLennan’s Webinar on Navigating Healthcare Risks in a Rapidly Evolving AI Landscape

On June 30, 2025, New York State released its long-anticipated Master Plan for Aging (MPA), a 10-year strategic framework designed to improve the way the state supports older adults, individuals with disabilities, and family caregivers. With more than 25% of New Yorkers expected to be over the age of 60 by 2030, the MPA arrives at a critical demographic inflection point. It is not merely a set of recommendations; it signals a broad realignment of healthcare, housing, and social infrastructure policy across the state.
Continue Reading New York’s Master Plan for Aging: What Legal, Health, and Policy Leaders Need to Know

Since the Dobbs v. Jackson Women’s Health Organization decision (which overturned the landmark Roe v. Wade decision), the healthcare industry has continued to grapple with renewed concerns over patient privacy and reproductive healthcare. Legislators and regulators have not been idle, establishing a patchwork of authorities which require careful navigation and consideration. It is worth noting that reproductive healthcare privacy is not a concern exclusive to women. Rather, such privacy concerns also apply to services traditionally received by men, such as testosterone replacement and male fertility treatments.
Continue Reading The State of Reproductive Healthcare Privacy

On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA encouraged health centers to “begin implementing these updated award terms immediately to ensure full compliance and maximize patient benefit.” The announcement comes in response to the Trump Administration’s April 14, 2025 Executive Order on “Lowering Drug Prices by Once Again Putting Americans First” (the “Executive Order”).[1] The Executive Order had instructed the Secretary of the Department of Health and Human…
Continue Reading HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

In June 2025, the U.S. House of Representatives introduced a budget reconciliation bill titled the One Big Beautiful Bill Act (OBBBA). The legislation proposes a number of administrative changes to existing federal health programs, including modifications to automatic enrollment procedures affecting individuals who qualify for both Medicare and Medicaid. The bill does not repeal current benefit programs but includes provisions that would revise the process through which certain low-income individuals access premium and cost-sharing assistance programs.
Continue Reading Congressional Budget Proposal Includes Adjustments to Dual-Eligible Enrollment Pathways and Medicare Savings Program Rules

New York’s Medicaid financing strategy—particularly its use of a managed care organization (MCO) tax—has come under renewed federal scrutiny amid recent legislative proposals and regulatory developments. The federal reconciliation bill, known as the One Big Beautiful Bill Act (OBBBA), alongside newly proposed guidance from the Centers for Medicare & Medicaid Services (CMS), could significantly influence how New York and other states structure healthcare-related tax mechanisms used to draw down federal Medicaid matching funds.
Continue Reading Understanding the Federal Reconciliation Bill’s Implications for MCO Tax Structure

Overview of SB 951

Oregon Governor Tina Kotek on Monday, June 9, 2025, signed a first-of-its-kind law that significantly reshapes the state’s regulatory landscape for non-physician investment in medical practices. Senate Bill 951 (“SB 951” or the “Law”) imposes broad restrictions on how non-professional parties, such as private equity firms and other non-physician investors, participate in the ownership, management, and operation of medical practices in Oregon. The Law strengthens and expands Oregon’s existing corporate practice of medicine (“CPOM”) prohibition, directly impacting the way investors, management services organizations (“MSOs”), and professional medical entities structure their relationships. The Law has garnered national…
Continue Reading Oregon Targets Corporate Practice of Medicine with Enacted Bill: What SB 951 Means for MSOs, PE-Backed Physician Groups, and Physicians

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

At the end of May, the Department of Justice (DOJ) announced the formation of a Civil Rights Fraud Initiative to “utilize the False Claims Act to investigate and, as appropriate, pursue claims against any recipient of federal funds that knowingly violates federal civil rights laws.” In connection with the Initiative, we will see DOJ’s False Claims Act practitioners in the Civil Division and the U.S. Attorneys’ Offices pairing with DOJ’s Civil Rights Division to “identify and root out instances in which recipients of federal funds fail to uphold their basic obligations under federal civil rights laws.”…
Continue Reading DOJ Civil Rights Fraud Initiative Will Use the False Claims Act to Target Antisemitism and DEI Programs

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote of 215-214, the One Big Beautiful Bill Act (OBBBA), a budget reconciliation bill with a provision imposing a 10-year moratorium on the enforcement of most state and local laws that target AI systems. If enacted, OBBBA would pause the enforcement of existing state AI laws and regulations and take precedence over emerging AI legislation in state legislatures across the country.
Continue Reading The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug manufacturers must obtain pre-approval from HRSA before implementing rebate models under the 340B Program. Specifically, U.S. District Judge Friedrich (“Friedrich”) found that HHS and HRSA did not exceed their authority when they required Eli Lilly & Co., Bristol Myers Squibb Co., Sanofi-Aventis U.S. LLC, Novartis Pharmaceuticals Corp. (“Novartis”) and Kalderos Inc., a health care tech company (together, the “Companies”) to seek pre-approval of the rebate…
Continue Reading Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance