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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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ML Strategies Publishes Weekly Health Care Reform Update on October 1, 2012
October 2, 2012 | Blog | By Daria Niewenhous
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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Bring-Your-Own Device Policies Present Special Challenges for the Health Care Sector
October 2, 2012 | Blog | By Karen Lovitch
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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Joint CMS, DOJ Letter on EHR’s Potential for Billing Fraud; AHA, AAHC Respond
September 25, 2012 | Blog | By Daria Niewenhous
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
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 Publishes Weekly Health Care Reform Update on September 10, 2012
September 11, 2012 | Blog | By Daria Niewenhous
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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Multi-Million Medicare Fraud and HIPAA Conviction: A Cautionary Tale
August 21, 2012 | Blog | By Karen Lovitch
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
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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False Claims Act Case Questioning Quality of Laboratory Services Unsealed in New Mexico
August 9, 2012 | Blog | By Karen Lovitch
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 Posts Weekly Health Care Reform Update on August 6, 2012
August 7, 2012 | Blog | By Daria Niewenhous
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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D.C. Circuit Rejects Length of Purdue Executives' Exclusion but Remands for Reconsideration
July 29, 2012 | Blog | By Karen Lovitch
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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Exception for Coupons on Branded Pharmaceuticals Added to Massachusetts Anti-Kickback Statute
July 11, 2012 | Blog | By Karen Lovitch , Ellen Janos
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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Massachusetts Legislature Makes Major Changes to the Gift Ban Law
June 29, 2012 | Blog | By Brian Dunphy
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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