Health Care

A government investigation or enforcement action can disrupt a business, delay the launch of a new product, or threaten funding. Life sciences companies that participate in federal grant programs need to be aware of the risks associated with non-compliance with rules and regulations governing those programs.

On November 12, 2013, the Office of Inspector General ("OIG") released Advisory Opinion 13-15 concluding that a proposed arrangement between an anesthesiology group and a hospital-based psychiatry group could potentially generate prohibited remuneration under the federal Anti-Kickback Statute ("Kickback Statute").

Recently, a colleague and I spoke at the NAMSS 37th Educational Conference & Exhibition to nearly 200 medical directors, chief medical officers, and credentialing staff about what constitutes disruptive physician conduct in the hospital setting, and what hospitals can do to manage it.

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements.

On the heels of HHS's recent announcement that qualified health plans (QHPs) purchased through the Affordable Care Act (ACA) insurance exchanges are not "federal health care programs" for purposes of the federal anti-kickback statute.

In a surprising move late last week, HHS Secretary Kathleen Sebelius announced that qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) insurance exchanges are not “federal health care programs” for purposes of the federal anti-kickback statute.

ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely information on implementation of the Affordable Care Act, and other state and federal administrative and legislative activities related to health care reform. 

On October 16, 2013, a New York federal district court granted a partial motion to dismiss a class action suit brought against the New York City Health & Hospitals Corp.

On October 11, 2013, CMS posted the 2014 Medicare Health Plan Quality and Performance Ratings, which are commonly referred to as “Star Ratings.” CMS released the 2014 Star Ratings several days later than originally scheduled, worrying some Plan Sponsors and analysts.

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for several more months but delayed implementation of key portions of the Affordable Care Act (ACA) for one year.

Health care employers concerned that former employees may misappropriate the company’s confidential information to support qui tam lawsuits under the False Claims Act (“FCA”) received guidance from a recent court decision. 

Last week, Democrat and Republican leaders of both houses of Congress agreed to the terms of a bill that would give the U.S. Food and Drug Administration (FDA) greater authority to regulate drug compounding and would revamp the way drugs are tracked from the manufacturer to the pharmacy. 

Plaintiffs’ firms looking to capitalize on the growth in whistleblower litigation are turning to smart phone technology to try to gain a competitive edge. Well known Delaware plaintiffs’ class action law firm Grant & Eisenhofer is attempting to enlarge its footprint in the burgeoning qui tam litigation field with a new smart phone app called, “Whistleblower Laws.

The HHS Office of Civil Rights (OCR) announced that the Health Information Technology (HIT) Policy Committee's Privacy and Security Tiger Team will hold a virtual, public hearing on Monday, September 30 from 11:45 a.m. to 5:00 p.m. EDT to discuss approaches for providing patients with greater transparency about the uses and disclosures of their electronic protected health information (PHI).

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. 

Recently, a federal judge held that a qui tam relator’s allegations that a pharmacy routinely reported falsely inflated “usual and customary” prices for generic medications in claims submitted to federally funded health care programs, was sufficient to state a cause of action under the federal and certain state false claims acts.

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the HIPAA Omnibus Rule. 

In response to recent litigation as well as concerns from the health care industry and privacy advocates, the Office for Civil Rights (OCR) has published guidance regarding the scope of the refill reminder exception under the HIPAA Omnibus Rule.

Yesterday, the Attorney General, the Secretary of the Department of Health and Human Services (HHS), and the Chairwoman of the Federal Trade Commission (FTC) announced an interagency initiative to prevent consumer fraud and privacy violations in connection with the Affordable Care Act’s Health Insurance Marketplace.

With the September 23, 2013 compliance date for the HIPAA Omnibus Rule only one week away, the Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have developed model Notices of Privacy Practices (“NPP”) to help health care providers and health plans ensure compliance.