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State and Federal Pharmaceutical Enforcement Litigation: What’s Next?

October 8, 2012 | Blog | By Karen Lovitch, Ellyn Sternfield

I recently co-chaired an American Conference Institute (ACI) forum on Pharmaceutical Pricing Litigation, which featured a number of key players who provided their unique perspectives on state and federal litigation involving pharmaceutical manufacturers and their products.
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Earlier this week, New York State Governor Andrew Cuomo vetoed legislation that would have brought the State’s restrictions on physician self-referrals (the State Law) in line with the federal ban on self-referrals, which is commonly known as the Stark Law.  
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As reported in an earlier post, the U.S. Department of Health and Human Services Office of Inspector General (OIG) has released its Work Plan for Fiscal Year 2013 (Work Plan). 
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ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise 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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The use of employee-owned devices in the business setting - often referred to as "bring-your-own-device" or "BYOD" - presents data security challenges for all businesses. 
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HHS OIG Releases Work Plan for FY 2013

October 2, 2012 | Blog | By Karen Lovitch

HHS OIG posted its Work Plan for FY 2013 earlier today. The Work Plan is always of interest to the health care industry because it provides a roadmap of the HHS OIG's priorities for the coming fiscal year. 
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Secretary Sebelius and Attorney General Holder issued a joint letter to the American Hospital Association and four other associations representing hospitals and medical centers, warning of indications that some providers are using electronic health records (EHRs) to upcode the intensity of patient care.
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Massachusetts DPH Proposes Amendments to Regulations to Implement Gift Ban Law Changes

September 24, 2012 | Blog | By Brian Dunphy, Thomas Crane

On September 19th, the Massachusetts Department of Public Health (“DPH”) published emergency amendments to its regulations, 105 CMR 970.000 et seq. (“Proposed Regulations”), designed to implement recent changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, M.G.L. c. 111N (the “Gift Ban Law”). 
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MEEI Breach Notification Prompts OCR Investigation and Settlement

September 18, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

The most recent, published Office for Civil Rights (OCR) HIPAA enforcement action serves as an important reminder that self-reported breaches can and do lead to investigations and enforcement.
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The Antitrust Agencies' Latest Target: MFN Clauses

September 14, 2012 | Blog | By Karen Lovitch

On September 10, 2012, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) hosted a public workshop exploring the uses of most-favored-nation (MFN) clauses and their implications for antitrust enforcement policy. 
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ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise 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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California Assembly Votes to Amend State False Claims Act

August 24, 2012 | Blog | By Brian Dunphy, Carrie Roll

On August 16, 2012, the California Assembly passed a bill (AB 2492) amending California’s False Claims Act, Cal. Gov’t Code §§ 12650-12656 (“CA FCA”), which must be signed into law by Governor Jerry Brown. 
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The owner of a Long Island medical supply company was convicted last week on charges of a $10.7 million Medicare fraud and wrongful disclosure of private medical information under the Health Insurance Portability and Accountability Act (HIPAA). (United States v. Michel, E.D.N.Y., No. 07-cr-889-JFB, jury verdict 8/15/12).   
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Qui Tam Relator Not Original Source; U.S. ex rel. Repko v. Guthrie Clinic

August 17, 2012 | Blog | By Daria Niewenhous, Ellyn Sternfield

In U.S. ex rel. Repko v. Guthrie Clinic et al., the Third Circuit recently ended an attempt by Rodney Repko, former general counsel and executive vice president for Guthrie Healthcare System and its related entities, to bring a qui tam case against his former employer. 
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Earlier this week, a New Mexico district court issued an order unsealing the complaint in a case (U.S. v. Deming Hospital Corporation, et al.) alleging that Mimbres Memorial Hospital (Mimbres) violated the federal False Claims Act and two New Mexico laws by billing Medicare and Medicaid for substandard laboratory services. 
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FTC Uses Creative Remedy to Halt Cardiology Practice Merger

August 9, 2012 | Blog | By Karen Lovitch

The Federal Trade Commission (FTC) is leaving no stone unturned in its scrutiny of physician acquisitions, as indicated by its recent enforcement action related to the acquisition of a small cardiology group in Reno, Nevada. The FTC's order in that case required suspension of employed physicians' non-compete contracts.
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ML Strategies has posted its weekly Health Care Reform Update.  This publication provides timely and concise 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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On July 27th, the U.S. Court of Appeals for the D.C. Circuit purportedly handed the Office of Inspector General for the Department of Health and Human Services (OIG) a loss in its bid to exclude Purdue Frederick Company (Purdue) executives from the federal health care programs for twelve years, based on their misdemeanor convictions for misbranding the painkiller OxyContin. 
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Public-Private Partnership to Fight Fraud Formed

July 27, 2012 | Blog | By Brian Dunphy

Private insurance companies, among others, are teaming up with the Government to prevent health care fraud.
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The Massachusetts Legislature has carved out the first exception to the Massachusetts private payer anti-kickback statute since its enactment in 1988. 
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