Health Law Advisor - Laws and Regulations Affecting Health Care and Life Sciences - Featuring HEAL® | Epstein Becker Green

"Enough is Enough": HHS-OIG Freezes Funds for New York Medicaid Fraud Control Unit, Effective July 1

Melissa L. Jampol, Sarah M. Hall, Allison R. Ness — Tue, 07 Jul 2026 09:00:01 -0700

One week after the U.S. Department of Justice on June 23, 2026, announced the results of its annual National Health Care Fraud Takedown—taking aim at Medicaid fraud and partnering with all 50 state Medicaid Fraud Control Units (MFCUs)—the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) denied recertification for New York’s MFCU and froze $60 million in annual federal funds for New York’s MFCU, effective July 1.

Straight From the Source: AHLA Annual Meeting Highlights Fraud and Abuse Enforcement Efforts in 2026 and Beyond

George B. Breen, Caitlin Carlton, Hailey Genaw — Thu, 02 Jul 2026 09:00:02 -0700

On the final day of the American Health Law Association’s Annual Meeting in New York, officials from the U.S. Department of Justice (DOJ), the Centers for Medicare & Medicaid Services (CMS), and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) gave their own take on their agencies’ ramped-up enforcement efforts regarding health care fraud in mid-2026.

Federal Embryo Adoption Program Raises Potential Legal Questions for Reproductive Health

Erin Sutton — Thu, 25 Jun 2026 09:00:03 -0700

In June 2026, the Trump administration announced nearly $2 million in federal grant funding for an Embryo Adoption Awareness and Services (EAA) program administered through the Department of Health and Human Services (HHS). While embryo adoption programs have existed at the federal level since 2002, the new grant notice contains language that may have far-reaching implications for reproductive health law, in vitro fertilization (IVF) regulation, and the ongoing legal debate over fetal personhood.

Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers

Daniel L. Fahey, John W. Eriksen, Timothy J. Murphy — Thu, 25 Jun 2026 09:00:04 -0700

On June 15, 2026, Vermont Governor Phil Scott signed H. 583—imposing significant restrictions on private equity groups, hedge funds, and entities they control, including management services organizations (MSOs). The legislation prohibits interference with the clinical judgment of health care providers and establishes reporting requirements to an independent state agency regarding ownership and control.

OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing

Tue, 23 Jun 2026 11:00:00 -0700

On June 10, 2026, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26-14 (AO 26-14), another favorable advisory opinion (its fourth in as many years) involving sponsored tests.

IL HB 5000 Set to Expand Notice Requirements for Health Care Transactions in Illinois

John W. Eriksen, Daniel L. Fahey, Timothy J. Murphy — Wed, 17 Jun 2026 09:00:06 -0700

On May 28, 2026, both houses of the Illinois legislature passed HB 5000, enhancing oversight of health care mergers, acquisitions, and contracting affiliations in the state.

CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices, Home Health Agencies

Mark E. Lutes, David E. Matyas, Timothy J. Murphy, John W. Eriksen — Fri, 15 May 2026 09:00:07 -0700

On May 13, 2026, the Centers for Medicare and Medicaid Services (CMS) announced an aggressive nationwide crackdown on fraud—with the start of six-month moratoria on new Medicare enrollment for hospices and home health agencies (HHAs) and on changes in majority ownership that would require a new enrollment under 42 C.F.R. §450(b).

Medicaid Behavioral Health Investigations and Payment Suspensions in D.C. Are Increasing – How Providers Can Limit Risk

Sarah M. Hall, Chloe T. Hillard, Clifford E. Barnes — Thu, 14 May 2026 09:00:08 -0700

Behavioral health providers in the District of Columbia (“District” or “D.C.”) are operating in an environment of heightened government scrutiny. In recent months, federal and District authorities have signaled an intensified focus on Medicaid fraud in the behavioral health space, combining criminal prosecutions by the U.S. Attorney’s Office with aggressive program integrity actions by the D.C. Department of Health Care Finance (“DHCF”). These efforts have included criminal and civil investigations into alleged billing irregularities and, at an increasing rate, the suspension of Medicaid payments to providers based on suspected fraud. Such suspensions are implemented in almost all cases, as permitted by regulations, before any final determination on the merits. These developments raise significant legal, financial, and operational risks for behavioral health providers in D.C.

‘Emilie’ Is Not a Psychiatrist: Pennsylvania Board of Medicine Alleges Unlawful Practice of Medicine by an AI Chatbot

Frances M. Green, Alaap B. Shah, Eleanor T. Chung — Wed, 13 May 2026 09:00:09 -0700

On May 1, 2026, Pennsylvania’s State Board of Medicine (or “Petitioner”) filed a lawsuit in the Commonwealth Court of Pennsylvania—alleging that an artificial intelligence (“AI”) chatbot developed by Character Technologies, Inc. (or “Respondent”) engaged in the unlawful practice of medicine.

DOJ FOCUS Initiative Prioritizes “High Quality” Data Miner Actions by FCA Whistleblowers

Erica Sibley Bahnsen, George B. Breen — Fri, 08 May 2026 09:00:10 -0700

On April 30, 2026, the Department of Justice (DOJ) announced plans to prioritize “high quality” actions by data miners filing False Claims Act (FCA) qui tam complaints, indicating an ever-growing reliance on FCA whistleblowers as well as technology to uncover fraud, waste, and abuse.

FDA Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List

Daniel L. Fahey, Erin Sutton, James A. Boiani — Wed, 06 May 2026 09:00:11 -0700

On April 30, 2026, the U.S. Food and Drug Administration (FDA) announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List (“503B Bulks List”)—finding no clinical need for outsourcing facilities to compound the three drugs from bulk substances absent a drug shortage.

The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Reporting Requirements”

Elizabeth J. McEvoy, Elena M. Quattrone — Thu, 30 Apr 2026 09:00:12 -0700

Epstein Becker Green (“EBG”) has previously advised U.S. organizations that share data in bulk or otherwise grant access to U.S. sensitive data to countries of concern or covered persons to “Know Their Data” and “Know Their Vendors.” In this post, we discuss why U.S. organizations across all industries with cross-border operations – including health care / life sciences, finance, e-commerce, and research – must “know their reporting requirements,” to fully comply with the BSD Rule and its brand-new reporting obligations.

Is Your Product Ready to Be Listed? What the Dietary Supplement Listing Act of 2026 Means for Your Business

Julianna Dzwierzynski, Zachary S. Taylor, Jack Wenik — Wed, 29 Apr 2026 09:00:13 -0700

The Dietary Supplement Listing Act of 2026 (H.R. 8370, 119th Congress) (the “Act”), introduced in the U.S. House of Representatives on April 20, 2026, has the potential to significantly impact the dietary supplement industry. The Act proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”), via a new Section 403D, and create the first mandatory FDA product-listing regime for dietary supplements.

New York’s Food Safety and Chemical Disclosure Act: A State-Level Overhaul of GRAS Regulation

Julianna Dzwierzynski, Elena M. Quattrone — Wed, 29 Apr 2026 09:00:14 -0700

New York has passed sweeping food additive legislation that, if signed by the Governor, will fundamentally reshape how food manufacturers and suppliers operate in the state. The Food Safety and Chemical Disclosure Act (S1239F) (the “Act”) would establish the first state-level disclosure and database regime for substances that companies have independently determined to be “Generally Recognized as Safe” (“GRAS”). The bill represents a significant escalation in state-level food safety regulation with far-reaching consequences for food manufacturers, ingredient suppliers, and consumer products companies operating in the New York market.

Fighting Fire with Fire: Project Glasswing and AI-Powered Cyber Defense in Health Care, Financial Health and Other Critical Infrastructure

Alaap B. Shah, Brian G. Cesaratto, Eleanor T. Chung — Tue, 28 Apr 2026 09:00:15 -0700

Anthropic’s new initiative—“Project Glasswing,” announced in April 2026—reflects a significant development in the cybersecurity landscape that should command the immediate attention of every C-suite leader, privacy officer, information security professional, and compliance executive in health care and life sciences, financial services and other critical infrastructure industries, and their legal counsel.

Contractor to Pay More Than $17 Million in First DOJ False Claims Act Settlement Alleging Illegal DEI

Erica Sibley Bahnsen, George B. Breen, Daniella R. Lee, Haley Morrison — Mon, 20 Apr 2026 09:00:16 -0700

On April 10, the U.S. Department of Justice (DOJ) announced the first settlement to resolve False Claims Act (FCA) allegations regarding a private employer’s failure to comply with anti-discrimination requirements in contracts with the federal government. The settlement with IBM comes just two weeks after the March 26 signing of a new executive order called “Addressing DEI Discrimination by Federal Contractors” (EO 14398), curbing diversity, equity, and inclusion (DEI) programming (read more here).

FDA Launches Home Innovation Challenge for Medical Device Technologies

James A. Boiani — Tue, 14 Apr 2026 09:00:17 -0700

The Food and Drug Administration (FDA) is urging innovators, providers, and patients to “reimagine the home as an integral part of the health care system.” If you’re skeptical, the “Home as a Health Care Hub” initiative was introduced in 2024 by the FDA’s Center for Devices and Radiological Health (CDRH) in response to changing needs of health care and feedback from the public, accelerated by the COVID-19 pandemic.

FDA Meeting Invites Stakeholders to Weigh in on Dietary Supplement Ingredients

Elena M. Quattrone, Zachary S. Taylor, James A. Boiani — Tue, 14 Apr 2026 09:00:18 -0700

On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.” Sponsored by FDA’s Office of Dietary Supplement Programs (“ODSP”), the meeting was designed for agency officials and stakeholders “to discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.”

California Targeted in House Committee Investigation of Hospice Fraud

Jeremy A. Avila, Sarah M. Hall, John M. Puente, Raja Sékaran — Tue, 31 Mar 2026 09:00:19 -0700

On March 23, 2026, the U.S. House of Representatives’ Committee on Oversight and Government Reform sent a letter to California Governor Gavin Newsom requesting “documents and communications” surrounding the state’s oversight of its federally funded hospice programs.

HHS OIG Issues Favorable Advisory Opinion Regarding Surgical Supply Discounts to Ambulatory Surgery Centers in Exchange for Software Purchases

Ashley A. Creech — Thu, 12 Mar 2026 10:00:00 -0700

On March 4, the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued a favorable result in OIG Advisory Opinion No. 26-03, regarding a Requestor’s proposal to offer discounts to certain ambulatory surgery centers (“ASCs”) on intraocular lenses (“IOLs”) and supplies in cataract surgery. The discounts would be contingent on physician practices—with ophthalmic surgeons performing cataract surgery at the ASCs—purchasing and entering into subscription agreements for the Requestor’s software product (the “Proposed Arrangement”).