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If your health care organization swipes credit cards, such as for the collection of copayments, parking fees, or even gifts in a gift shop, you should read this important update regarding “Backoff” Malware, which includes practical steps for protecting your credit card data. 
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A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery (“Hospital”), its former CEO, and an outside billing company alleging that they violated the federal False Claims Act (FCA) and the New York FCA resulting from alleged violations of the Anti-Kickback Statute (AKS) and the Stark Law. 
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ML Strategies Posts Weekly Health Care Update on August 25, 2014

August 27, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments. 
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Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations.  While manufacturers are likely not out from underneath the microscope, it seems as though the lens may have shifted slightly to focus on the rest of the prescription drug transaction. 
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In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal anti-kickback statute and would pose a risk of fraud and abuse. 
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As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the Sunshine Act report payments and transfers of value made to physicians and teaching hospitals.
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Acute Care Hospitals Settle FCA Lawsuits for $98 Million

August 18, 2014 | Blog | By Brian Dunphy

Community Health Systems, Inc. (CHS) and Community Health Systems Professional Services Corporation, together a national owner and operator of acute care hospitals, and 119 of their hospitals, agreed to pay $98 million to settle seven False Claims Act (FCA) lawsuits filed by qui tam relators around the country. 
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Federal Court Rejects Relator's Swapping Allegations in False Claims Act Case

August 15, 2014 | Blog | By Samantha Kingsbury, Karen Lovitch

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country's largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former employee, Kevin P. McDonough. 
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The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program.
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ML Strategies Posts Weekly Health Care Update on August 11, 2014

August 13, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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CMS Temporarily Closes the Open Payments System

August 12, 2014 | Blog | By Brian Dunphy

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act.
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On August 5, 2014, the Tenth Circuit Court of Appeals reinstated claims of monopolization and attempted monopolization under Section 2 of the Sherman Act brought by a manufacturer of surgical bone mills against a competitor.
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ML Strategies Posts Weekly Health Care Update on July 28, 2014

August 1, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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Continued Delays for Visa Issuance Around the World

August 1, 2014 | Alert | By Susan Cohen

As we reported on Monday, due to a massive software failure of the Department of State’s Consular Consolidated Database (CCD), there continue to be delays in the issuance of visas at consular posts around the globe.
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Delays at U.S. Consular Posts Around the World

July 28, 2014 | Alert | By Danielle Lifrieri

Multiple reports have confirmed that the U.S. Department of State’s global database for issuing travel documents recently crashed. While the system has been restored, it is operating at reduced capacity and significant backlogs have developed.
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In recent healthcare mergers and acquisitions, we have seen the parties increasingly focus on the survival length of the representations and warranties in the purchase agreements. 
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On July 22nd, 2014, two federal appellate courts issued conflicting decisions, within hours of each other, regarding the IRS final rule published on May 23, 2012 (the “IRS Rule”), intended to implement the exchange-related tax credit provisions of the Affordable Care Act (“ACA” or the “Act”). 
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ML Strategies Posts Weekly Health Care Update on July 21, 2014

July 22, 2014 | Blog | By Theresa Carnegie

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

July 18, 2014 | Blog | By Karen Lovitch, Samantha Kingsbury

The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals.
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Many states prohibit or limit the corporate practice of medicine (CPOM), either through statute or common law. These states generally bar a business corporation from practicing medicine or employing a physician to provide professional medical services. 
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