Health Law Advisor - Laws and Regulations Affecting Health Care and Life Sciences - Featuring HEAL® | Epstein Becker Green https://www.healthlawadvisor.com/category/agency-information Mon, 13 Jul 2026 00:10:24 -0700 "Enough is Enough": HHS-OIG Freezes Funds for New York Medicaid Fraud Control Unit, Effective July 1 https://www.healthlawadvisor.com/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 enough-is-enough-hhs-oig-freezes-funds-for-new-york-medicaid-fraud-control-unit-effective-july-1 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 https://www.healthlawadvisor.com/straight-from-the-source-ahla-annual-meeting-highlights-fraud-and-abuse-enforcement-efforts-in-2026-and-beyond George B. Breen, Caitlin Carlton, Hailey Genaw straight-from-the-source-ahla-annual-meeting-highlights-fraud-and-abuse-enforcement-efforts-in-2026-and-beyond 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.

]]> At the Half: No Free Kicks in FDA’s 2026 Enforcement https://www.healthlawadvisor.com/at-the-half-no-free-kicks-in-fdas-2026-enforcement Megan Robertson at-the-half-no-free-kicks-in-fdas-2026-enforcement Tue, 30 Jun 2026 09:00:03 -0700 As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated companies around the globe. We are at the midpoint of 2026, and several patterns are emerging based on FDA’s activity so far. Based on our own weekly tracking and analysis, we are sharing some of the key themes that have bubbled up as priorities for regulated industries and their stakeholders to watch as 2026 progresses.

]]> CMS Codifies Drug Price Negotiation Program—With Modifications for 2029 https://www.healthlawadvisor.com/cms-codifies-drug-price-negotiation-program-with-modifications-for-2029 Constance A. Wilkinson cms-codifies-drug-price-negotiation-program-with-modifications-for-2029 Tue, 30 Jun 2026 09:00:04 -0700 On June 16, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule, “Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program” (“Proposed Rule”), to codify the Medicare Drug Price Negotiation Program (“Negotiation Program” or “MDPNP”) and to establish new policies with respect to the MDPNP, for initial price applicability year 2029 and subsequent years.

]]> Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers https://www.healthlawadvisor.com/vermonts-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 vermonts-h-583-restricts-private-equity-and-hedge-funds-with-ownership-and-controlling-interests-from-interfering-with-clinical-judgment-of-health-care-providers Thu, 25 Jun 2026 09:00:05 -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.

]]> FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements https://www.healthlawadvisor.com/fda-regulations-to-establish-minimum-cgmp-requirements-for-manufacturing-packaging-labeling-and-holding-of-dietary-supplements Elena M. Quattrone, Jack Wenik fda-regulations-to-establish-minimum-cgmp-requirements-for-manufacturing-packaging-labeling-and-holding-of-dietary-supplements Wed, 24 Jun 2026 09:00:06 -0700 On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality (“FDA Notice”). Written comments (including recommendations) are due to OMB by July 20, 2026.

]]> OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing https://www.healthlawadvisor.com/oig-advisory-opinion-26-14-offers-another-favorable-path-for-patient-access-through-sponsored-testing Shannon K. DeBra, Robert (Bob) R. Hearn, Alison Fethke, Andrew (Andy) P. Rusczek 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.

]]> FDA Warns Against “Over-Reliance” on AI Pharmaceutical Manufacturing . . . But How Much Reliance Is Too Much? https://www.healthlawadvisor.com/fda-warns-against-over-reliance-on-ai-pharmaceutical-manufacturing-but-how-much-reliance-is-too-much James A. Boiani fda-warns-against-over-reliance-on-ai-pharmaceutical-manufacturing-but-how-much-reliance-is-too-much Thu, 28 May 2026 09:00:08 -0700 Pharmaceutical and biotech manufacturers using artificial intelligence (AI) to support compliance with Food and Drug Administration (FDA) regulations should take note: the lack of human oversight of AI quality tools can constitute a current good manufacturing practice (CGMP) violation.

]]> Five Federal Cases Health Care and Life Sciences GCs Should Continue to Watch in 2026 https://www.healthlawadvisor.com/five-federal-cases-health-care-and-life-sciences-gcs-should-continue-to-watch-in-2026 James (Jim) P. Flynn five-federal-cases-health-care-and-life-sciences-gcs-should-continue-to-watch-in-2026 Tue, 26 May 2026 09:00:09 -0700 [This material was presented as part of Epstein Becker Green’s Counsel to Counsel Roundtable on Monday, May 4, 2026. Co-presenters were Professor Kathleen M. Boozang and Professor David W. Opderbeck of Seton Hall School of Law.]

In 2026, several federal cases are poised to shape regulatory risk, reimbursement, and False Claims Act exposure, as well as innovation pathways across the health care and life sciences sectors. These include cases decided in 2024 and 2025 that continue to have ongoing impacts, as well as more recent cases involving cutting-edge technology. This article highlights five cases to monitor (or their progeny), why these cases matter to in-house legal teams, and practical steps for health care and life sciences general counsel (GC) to consider.

]]> DOJ’s West Coast Strike Force to Target Health Care Fraud in Arizona, Nevada, and Northern California https://www.healthlawadvisor.com/dojs-west-coast-strike-force-to-target-health-care-fraud-in-arizona-nevada-and-northern-california Sarah M. Hall, Jeremy A. Avila, Eric Werner dojs-west-coast-strike-force-to-target-health-care-fraud-in-arizona-nevada-and-northern-california Mon, 11 May 2026 09:00:10 -0700 On April 30, 2026, the newly constituted National Fraud Enforcement Division (NFED) of the U.S. Department of Justice announced the formation of a West Coast Health Care Fraud Strike Force. This new Strike Force combines the resources of DOJ’s Health Care Fraud Unit (which was recently placed under operational control of NFED, as discussed below) and the U.S. Attorney’s Offices (USAOs) for the Districts of Arizona, Nevada, and the Northern District of California.

]]> DOJ FOCUS Initiative Prioritizes “High Quality” Data Miner Actions by FCA Whistleblowers https://www.healthlawadvisor.com/doj-focus-initiative-prioritizes-high-quality-data-miner-actions-by-fca-whistleblowers Erica Sibley Bahnsen, George B. Breen doj-focus-initiative-prioritizes-high-quality-data-miner-actions-by-fca-whistleblowers Fri, 08 May 2026 09:00:11 -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 https://www.healthlawadvisor.com/fda-proposal-would-leave-semaglutide-tirzepatide-and-liraglutide-off-503b-bulks-list Daniel L. Fahey, Erin Sutton, James A. Boiani fda-proposal-would-leave-semaglutide-tirzepatide-and-liraglutide-off-503b-bulks-list Wed, 06 May 2026 09:00:12 -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.

]]> Is Your Product Ready to Be Listed? What the Dietary Supplement Listing Act of 2026 Means for Your Business https://www.healthlawadvisor.com/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 is-your-product-ready-to-be-listed-what-the-dietary-supplement-listing-act-of-2026-means-for-your-business 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 https://www.healthlawadvisor.com/new-yorks-food-safety-and-chemical-disclosure-act-a-state-level-overhaul-of-gras-regulation Julianna Dzwierzynski, Elena M. Quattrone new-yorks-food-safety-and-chemical-disclosure-act-a-state-level-overhaul-of-gras-regulation 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.

]]> The Proposed HHS Budget for 2027: Key Takeaways https://www.healthlawadvisor.com/the-proposed-hhs-budget-for-2027-key-takeaways Jeremy A. Avila, Eleanor T. Chung, John M. Puente, James M. Reilly, Raja Sékaran the-proposed-hhs-budget-for-2027-key-takeaways Tue, 21 Apr 2026 09:00:15 -0700 On April 3, 2026, the director of the Office of Management and Budget submitted to Congress President Donald Trump’s budget for 2027—proposing $111.1 billion in discretionary budget authority for the U.S. Department of Health and Human Services (HHS) for Fiscal Year 2027, beginning October 1, 2026, and ending September 30, 2027. The number represents a $15.8 billion or 12.5 percent decrease from the 2026 enacted level and suggests ongoing emphasis on combatting improper payments and practices in health care. The proposed budget investments also signal potential shifts that will impact service delivery for certain communities and business operations for entities that contract with the federal government or federal government grantees. We’ve noted the following key takeaways from the HHS Budget in Brief on these points, below.

]]> Contractor to Pay More Than $17 Million in First DOJ False Claims Act Settlement Alleging Illegal DEI https://www.healthlawadvisor.com/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 contractor-to-pay-more-than-17-million-in-first-doj-false-claims-act-settlement-alleging-illegal-dei 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 https://www.healthlawadvisor.com/fda-launches-home-innovation-challenge-for-medical-device-technologies James A. Boiani fda-launches-home-innovation-challenge-for-medical-device-technologies 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 https://www.healthlawadvisor.com/fda-meeting-invites-stakeholders-to-weigh-in-on-dietary-supplement-ingredients Elena M. Quattrone, Zachary S. Taylor, James A. Boiani fda-meeting-invites-stakeholders-to-weigh-in-on-dietary-supplement-ingredients 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.”

]]> HHS OIG Issues Favorable Advisory Opinion Regarding Surgical Supply Discounts to Ambulatory Surgery Centers in Exchange for Software Purchases https://www.healthlawadvisor.com/hhs-oig-issues-favorable-advisory-opinion-regarding-surgical-supply-discounts-to-ambulatory-surgery-centers-in-exchange-for-software-purchases Ashley A. Creech hhs-oig-issues-favorable-advisory-opinion-regarding-surgical-supply-discounts-to-ambulatory-surgery-centers-in-exchange-for-software-purchases 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”).

]]> IRS Issues Guidance Regarding Group Exemption Letters https://www.healthlawadvisor.com/irs-issues-guidance-regarding-group-exemption-letters Christine Burke Worthen, Martin L. Monaco, Jr., Jennifer M. Nelson Carney irs-issues-guidance-regarding-group-exemption-letters Tue, 17 Feb 2026 09:00:20 -0800 On January 16, the IRS released two documents – Notice 2026-8 and Rev. Proc. 2026-8 – which provide updated guidance for organizations regarding group tax exemptions.

The guidance also removes the 5+ year moratorium on new exemption rulings. The guidance modifies and supersedes Rev. Proc. 80-27, and incorporates updates from the 2020 notice (Notice 2020-36).

Central organizations and those of their subordinates that are included in the group exemption will generally have one year to come into compliance with the updated guidance. Under IRS Treasury regulations and related guidance, specifically regarding group exemption letters, a central organization is defined as the head or parent organization that holds a group exemption letter and exercises general supervision or control over one or more subordinate organizations. A subordinate organization is defined as a "chapter, local, post, or unit of a central organization".

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