Health Care

/Health Care

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Client Alert – FDA Issues Draft Guidance on Bulk Compound Drug Substances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

Client Alert – Department of Justice Launches the “PIL” Opioid Task Force

Earlier this week, U.S. Attorney General Jeff Sessions announced the creation of a new task force designed to fight the prescription opioid crisis. The task force is called the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force and will focus particularly on opioid manufacturers and distributors. The task force represents yet another step [...]

Client Alert – New York Man Admits to $45 Million Health Care Fraud

Steven M. Butcher pleaded guilty last week in a New Jersey federal court to conspiracy to commit health care fraud and violate the Anti-Kickback Statute. Butcher, a former pharmaceutical sales rep, formed MedMax, LLC, a marketing company for compounded medications, and used the company as a vehicle to perpetrate a fraudulent scheme to bilk private [...]

Client Alert – Judge Rules that $1 Billion False Claims Act Suit against UnitedHealth can Proceed

Earlier this week, a federal court judge in California shot down UnitedHealth Group Inc.’s (UnitedHealth) attempt to dismiss a whistleblower’s suit claiming that UnitedHealth had wrongly retained more than $1 billion from the Medicare program after submitting invalid diagnostic data for patients enrolled in Medicare Advantage Plans from 2011 through 2014. The Department of Justice [...]