Health Care Counsel Blog
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Health care providers using skin substitutes now face a two-front enforcement campaign. On August 5, the US Attorney’s Office for the District of Nevada indicted physician Dr. Stephen Dubin on health care fraud charges, alleging a $95 million illegal kickback scheme to bill Medicare for medically unnecessary amniotic wound allografts.
Headlines that Matter for Companies and Executives in Regulated Industries
The Texas Attorney General’s office recently announced a settlement of nearly $34 million with AstraZeneca Pharmaceuticals LP. The settlement resolves allegations that AstraZeneca violated the Texas Health Care Program Fraud Prevention Act (THFPA) — the state-law analog to the federal False Claims Act and Anti-Kickback Statute (AKS) — in connection with the sale of 17 of the company’s drugs.
In Sala v. Premier Imaging Holdings, LLC, 240 Conn. App. 793, 2026 WL 2220267 (Conn. App. Aug. 4, 2026), the Connecticut Appellate Court affirmed the trial court’s decision to overturn an arbitration award that had declared a physician noncompete “valid and binding,” because the arbitration award enforced a restrictive covenant that exceeded the one-year and 15-mile limits for physician noncompetes allowed under CT Gen Stat § 20-14p.
On August 11, out-of-network health care providers scored an important, although not complete, victory under the federal No Surprises Act (NSA) when the US Court of Appeals for the Fifth Circuit, sitting en banc, issued its decision in Texas Medical Association v. United States Department of Health and Human Services, No. 23-40605.
On July 14, the US Food and Drug Administration (FDA) announced final guidance regarding clinical investigations of psychedelic drugs.
Headlines that Matter for Companies and Executives in Regulated Industries
On June 26, Illinois Governor JB Pritzker signed House Bill 4517 into law, amending the Illinois Authorized Electronic Monitoring in Long-Term Care Facilities Act.
On July 2, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (CMS-1850-P).
On July 16, the Centers for Medicare & Medicaid Services (CMS) published the 2027 Physician Fee Schedule (PFS) proposed rule. Among other provisions, CMS has now proposed to convert a previously voluntary filing to a mandatory submission: requiring 340B Covered Entities to submit Part D claims data to the Medicare Part D Claims Data 340B Repository beginning in 2027.
A newly filed California suit, Winters v. OpenAI, Inc. et al., may become the first case to test whether product liability and negligence per se theories can reach a generative artificial intelligence (AI) chatbot’s design and deployment decisions, after ChatGPT-4o’s health-related guidance allegedly contributed to a plaintiff’s near-fatal medical emergency.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules, the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year.
In the last year, the Massachusetts Attorney General (AG) adopted two sets of sweeping consumer protection regulations directly impacting assisted living residence (ALR) operators. These regulations significantly expand ALR obligations regarding disclosures, billing, tenancy protections, resident rights, and pricing transparency.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Beginning July 1, the State of Washington will require all assisted living facilities that operate memory care units — or market themselves as providing specialized dementia care — to obtain a new state certification or face state Consumer Protection Act liability. Here is what current operators and prospective applicants need to know.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On May 13, the Centers for Medicare & Medicaid Services (CMS) implemented two separate nationwide moratoria that halt the Medicare enrollment of new home health agencies (HHAs) and hospice providers. The moratoria took effect immediately.
Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.
Headlines that Matter for Companies and Executives in Regulated Industries
Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.
The Federal Trade Commission (FTC) is signaling that health care and life sciences companies should expect heightened regulatory scrutiny related to consumer protection and competition.