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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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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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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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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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Massachusetts Softens the Gift Ban Law

July 10, 2012 | Blog | By Brian Dunphy

On July 8, 2012, Massachusetts Governor Deval Patrick signed into law amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, frequently referred to as the “gift ban law.”  The amendments softened the strict gift ban law in several ways.
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Legal Challenges, Risks Of Rx Drug Adherence Programs

July 9, 2012 | Blog | By Karen Lovitch

A Law360 article written by my colleague, Theresa Carnegie, provides an overview of the key health regulatory issues that manufacturers, plans, pharmacy benefit managers (PBMs), pharmacies and related providers may face when structuring drug adherence programs and suggests approaches for minimizing legal risks.
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My colleagues from ML Strategies, George Atanasov and Julie Cox, published a client alert discussing changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct. 
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OMB Extends Review Period for HIPAA/HITECH Omnibus Rule

June 26, 2012 | Blog | By Dianne Bourque

The Office of Management and Budget (OMB) announced on Friday, June 22, 2012, that it has extended the review period for the highly-anticipated omnibus rule intended to update key definitions and enforcement provisions relating to the implementation of  the Health Insurance Portability and Accountability Act (HIPAA).
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On Monday, June 18th, the Office of Inspector General (OIG) published a notice that it intends to update its Provider Self-Disclosure Protocol (Protocol), through which health care providers can disclose potential fraud and resolve liability under the OIG’s civil monetary penalty authority. 
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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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OCR Shares Preliminary HITECH Audit Results; What Regulated Entities Can Expect Next

June 11, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

Last week at the OCR/NIST conference, Building Assurance through HIPAA Security, Linda Sanches of the Office for Civil Rights provided an extensive update on the pilot HITECH audit program, including preliminary findings,  what regulated entities can expect next and suggestions for covered entities concerned about being audited. 
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In OIG Advisory Opinion 12-06, the OIG determined that two proposed arrangements between an anesthesia services provider (the "Requestor") and professional corporations ("PCs") or limited liability companies ("LLCs") that own ambulatory surgical centers ("ASCs") would potentially violate the federal Anti-Kickback Statute ("AKS") and thus would be subject to enforcement and administrative sanctions.
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One month from today, the law that permits independent laboratories to bill and receive payment from Medicare Part B for the technical component of certain anatomic pathology, cytopathology, and surgical pathology services ("TC Services") provided to patients of "covered hospitals" will expire.
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Keeping the Whistle Away from the Whistleblower

May 24, 2012 | Blog | By Karen Lovitch

The G2 Compliance Report recently published a very informative article written by Hope Foster, Leader of Mintz Levin's Health Care Enforcement Defense Practice, on the whistleblower's role in health care fraud enforcement and strategies for avoiding qui tam suits. 
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Sellers Prepare: Health Care Due Diligence

May 23, 2012 | Blog | By Karen Lovitch

Health care transactions present unique due diligence challenges. The buyer must evaluate the seller's compliance policies and procedures, arrangements with referral sources, patient and payor data, clinical data and compliance with federal and state licensure, certification and reimbursement regulations. 
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