Health Care

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 The final guidance comes more than two years after the FDA published its draft guidance in July 2011.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.

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.

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. 

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.

Last week, the Massachusetts’ Secretary of Health and Human Services, John Polanowicz, announced the launch of a new $5 million program designed to detect and prevent provider fraud, waste, and abuse in MassHealth, the Commonwealth’s Medicaid program.

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services (“HHS”) has committed to issuing guidance by September 23rd (the compliance date for the Rule) on the drug refill provisions in the HIPAA Omnibus Rule (the “Rule”).

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug refill reminders.

This past Friday, hospital company HCA Holdings, Inc. asked a federal court judge to dismiss a False Claims Act (FCA) suit filed by whistleblower and former employee, Stephen McMullen.

Add the Fifth Circuit to the list of jurisdictions questioning the use of the federal False Claims Act (FCA) in instances where - using the theory of implied certification - the alleged falsity is not apparent on the face of the claim. 

Qui tam actions filed against health care organizations unsealed in 2013 reveal that, although the government intervenes in less than 40% of qui tam actions, the government continues to aggressively prosecute multiple aspects of pharmaceutical companies’ sales and marketing activities.

The Office for Civil Rights’ (OCR) latest seven-figure fine for HIPAA violations resulted from a failure to remove protected health information or “PHI” from the hard drive of a leased photocopier.

Bravo Health Pennsylvania, Inc. (Bravo), a Medicare Advantage Plan Sponsor and subsidiary of Cigna Corporation, agreed to pay $225,000 to the Government for allegedly misrepresenting or falsifying information furnished to the OIG during an audit.  Bravo and the OIG entered into the settlement on July 26, 2013.

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA).  Could the underlying opinion pose a threat to future DOJ health care enforcement efforts?