Health Care

/Health Care

Client Alert: CBD Brands Targeted: FDA Issues a Flurry of Warning Letters and Two More Class Actions are Filed in California

It has been another rough few weeks for CBD companies. Over the last few months we’ve seen a major uptick in class action lawsuit filings and regulatory warnings aimed at CBD brands and the last two weeks have been no different. On November 25, the U.S. Food and Drug Administration (FDA) issued warning letters to [...]

Feds Take Down $1.2 Billion Telemedicine and DME Fraud Scheme

Twenty-four CEOs, COOs, doctors, and others have been charged in a Medicare fraud scheme that cost the federal health care program over $1 billion. Dubbed “Operation Brace Yourself,” the nationwide takedown was led by a task force comprised of members of the FBI, Office of Inspector General – Health and Human Services, (OIG-HHS) along with [...]

FDA Schedules Hearings on Cannabis Regulation

On April 2, 2019, the U.S. Food and Drug Administration issued a public hearing notice and a press release from the Commissioner to announce FDA’s interest in hearing from cannabis-industry stakeholders on the “safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.” The hearing is set for May 31, [...]

FDA Head Gottlieb Spells Out Enforcement Priorities for 2019

In a December 12 speech at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference, Food and Drug Administration (FDA) Commissioner Scott Gottlieb set out a number of oversight and enforcement priorities for 2019 and beyond. While recognizing that many compliance issues with food and drug safety laws and regulations are unintentional and [...]

Client Alert – Compounding Pharmacy Turns the Table on Insurers, Files Proposed Class Action

In a rather novel approach to an ongoing issue with health insurance coverage for compounded pain creams, mail-order pharmacy Excel Pharmacy Services LLC (Excel) has filed a complaint in a Pennsylvania state court alleging that Liberty Mutual Insurance Co., (Liberty) violated the Pennsylvania Workers’ Compensation Act (WCA) and the Unfair Insurance Practices Act (UIPA) by [...]

Client Alert – OIG Issues Advisory Opinion on Provision of Cost-Free Telemedicine Hardware and Services

The Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion No. 18-03 (the “Opinion”) on a question regarding the possible application of the Anti-Kickback Statute in a proposed arrangement between a federally qualified health center look-alike (the “Provider”) and a county clinic (the “Clinic”). In the arrangement, the Provider would give, [...]

New Court Ruling Limits Federal Trade Commission Reach in Data Security Enforcement

Yesterday the 11th U.S. Circuit Court of Appeals in Atlanta vacated a Federal Trade Commission (FTC) cease and desist order directing a medical testing company to overhaul its data security program on the grounds that the order was overbroad and failed to enjoin any specific act or practice. This ruling means that going forward (at [...]

Client Alert – Radiation Therapy Clinic Settles Kickback Allegations for $11.5 Million

In a settlement announced late last week by the U.S. Attorney for the Northern District of Texas, radiation therapy center operator SightLine Health LLC (SightLine), Integrated Oncology Network Holdings LLC (ION), which acquired SightLine in 2011, and a number of leasing and holding companies agreed to pay up to $11.5 million to resolve allegations that [...]

Client Alert – FDA Issues Draft Guidance on Bulk Compound Drug Substances

In January of this year, and in response to concerns over the risks associated with the use of non-FDA approved, compounded drugs (particularly in the wake of the 2012 fungal meningitis outbreak that began with contaminated compounded injectable drugs), the U.S. Department of Health and Human Services Food and Drug Administration (FDA) issued a compounding [...]

Humana Settles Allegations of Pay Discrimination for $2.5 Million

Kentucky-based health insurer Humana has agreed to pay $2.5 million to 753 women employees following allegations of pay discrimination by the U.S. Department of Labor. Following a routine compliance check, the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) determined that Humana had discriminated against 753 women at the company’s headquarters in [...]