Health Care

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 The final guidance comes more than two years after the FDA published its draft guidance in July 2011.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

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?

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office ancillary services exception (IOASE).

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.

Today pharmaceutical and medical device manufacturers and group purchasing organizations (“GPOs”)  start to collect data on their financial arrangements with physicians and teaching hospitals to comply with the Physician Payments Sunshine Act (‘‘Sunshine Act’’). 

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program.