Health Care

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.

In the weeks since our first post on the Chinese investigation of GlaxoSmithKline (GSK) for alleged “widespread bribery of doctors” to induce the prescription of GSK’s drugs, more details have emerged about the bribery scheme.

On July 16, 2013, the U.S. Department of Justice  (DOJ) indicted Michael Baker and Michael Gluk, the former CEO and CFO, respectively, of ArthroCare Corp. – a Texas-based publicly traded surgical device company. 

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers of value. 

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for calendar year 2014. The rule proposes several changes that, if finalized, would have grave consequences for independent laboratories. 

This week, CMS announced the shared savings results and the clinical achievements from the first year of the Pioneer ACO Program.

The LA Times recently reported the firing of six workers at Cedars-Sinai Medical Center in connection with the unauthorized access to patient medical records. 

Individuals or entities who voluntarily disclose potential fraud to the Office of Inspector General for the Department of Health and Human Services (the OIG) under the Provider Self-Disclosure Protocol (SDP) may now submit their disclosure online using the OIG’s newly released Self-Disclosure Online Form. 

Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting to defend its members’ 340B Program operations. 

This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential "economic crimes."

Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the "Requestor") tiered rebate program (the "Proposed Arrangement").

CMS hosted a webinar yesterday focusing on best practices for Medicare Advantage and Prescription Drug Plan Sponsors looking to enhance their Star Ratings.

The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation. 

The Stark Law regulations are not without controversy, as an unsuccessful appeal by a group of urologists brought against the Centers for Medicare & Medicaid Services (CMS) illustrates.The Council for Urological Interests, a nonprofit association of physician-owned lithotripsy joint ventures, sought to overturn a 2008 CMS regulatory change to the Stark Law that made the urologists’ joint ventures illegal.