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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.
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Seven-Figure HIPAA Settlement Prompted by Photocopier Breach

August 15, 2013 | Blog | By Theresa Carnegie, Dianne Bourque

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.
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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.
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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?
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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).
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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.
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Ready or Not - Sunshine Act Data Collection Starts Today

August 1, 2013 | Blog | By Karen Lovitch

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’’). 
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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.
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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.
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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. 
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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. 
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This week, CMS announced the shared savings results and the clinical achievements from the first year of the Pioneer ACO Program.
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Keeping Up With the Kardashians Is NOT a Defense Under HIPAA

July 18, 2013 | Blog | By Karen Lovitch, Dianne Bourque

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. 
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OIG Releases Online Self-Disclosure Form

July 16, 2013 | Blog | By Brian Dunphy

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. 
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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."
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Yesterday, the OIG issued a favorable advisory opinion regarding an ophthalmologic manufacturer’s (the "Requestor") tiered rebate program (the "Proposed Arrangement").
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CMS Conducts Star Ratings Best Practices Webinar

June 26, 2013 | Blog | By Roy Albert

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