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2011-The Year In Review: Trends in Health Care Enforcement

February 1, 2012 | Blog | By Brian Dunphy, Samantha Kingsbury

Mintz Levin’s Health Care Enforcement Defense Group reviewed health care fraud enforcement activities in 2011 to offer a general snapshot of the environment in which health care providers and pharmaceutical and medical device manufacturers operate. 
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The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule giving pharmaceutical and medical device manufacturers as well as group purchasing organizations some insight into how CMS intends to implement the Physician Payment Sunshine Act, which was enacted as part of health care reform.
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Relators and their counsel are increasingly being held accountable for the misuse of qui tam defendants’ confidential and privileged documents in connection with lawsuits alleging violations of the False Claims Act (“FCA”). 
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As discussed in a previous post, CMS recently issued a proposed rule implementing the Sunshine Act, but many pharmaceutical and medical device manufacturers are still trying to determine the scope of their continuing obligations under related state laws, such as the Massachusetts “gift ban” law. 
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HHS Issues Bulletin Outlining Essential Health Benefits

December 29, 2011 | Blog | By Karen Lovitch

As discussed in a previous post published on December 21st, HHS recently released its Essential Health Benefits Bulletin, which outlines the intended regulatory approach to defining the essential health benefits required by section 1302 of the Affordable Care Act. 
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CMS Requests Comments on Changes to Star Rating Methodology

December 28, 2011 | Blog | By Karen Lovitch, Susan Berson

CMS is soliciting comments from Medicare Advantage Organizations, Prescription Drug Plan Sponsors, and other interested parties on its Proposed Methodology for 2013 Plan Ratings (the “Proposed Methodology”).
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The HHS OIG recently issued a Report concluding that the vast majority of audited Medicare Part D Prescription Drug Plans (PDP) in existence between 2006 and 2009 had problems, many of which resulted from beneficiaries’ coverage status or payment issues.
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The D.C. Court of Appeals gave Medicare providers and suppliers a holiday gift last week with the issuance of a rare jurisdictional ruling involving a challenge to the Stark Law regulations.
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On Friday, December 16th, the Department of Health and Human Services (“HHS”)released its Essential Health Benefits Bulletin (the “Bulletin”) that outlines the HHS’s intended regulatory approach to defining the essential health benefits (“EHBs”) required by section 1302 of the Affordable Care Act (the “Act”). 
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Sunshine Act: Proposed Regulations Shed Some Light on Implementation

December 15, 2011 | Blog | By Brian Dunphy, Karen Lovitch

Pharmaceutical and medical device manufacturers, along with physicians and teaching hospitals, who have been grappling with how to implement the requirements of the federal Physician Payment Sunshine Act have finally received long-awaited guidance.
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Attention HIPAA Covered Entities: Keep an Eye on Your Mailbox....

December 14, 2011 | Blog | By Karen Lovitch, Dianne Bourque

The HHS Office of Civil Rights has begun notifying the 150 covered entities chosen for its first round of audits under HITECH, and it has posted a sample audit notification letter.   
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ML Strategies has posted its weekly Health Care Reform Update. The Health Care Reform Update 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 OIG addressed yet another proposed laboratory management arrangement in OIG Advisory Opinion 11-17, which concerns a proposal by a laboratory management services company (“Requestor”) to enter into exclusive contracts with various primary care physicians and physician practices (collectively, “Physicians”) to operate allergy testing laboratories in the Physicians’ medical offices (the “Arrangement”).
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Rockford Rerun: FTC Sues to Stop Hospital Merger

November 28, 2011 | Blog | By Karen Lovitch

My colleagues Christi Braun, Rob Kidwell, and Bruce Sokler have authored a health care antitrust advisory detailing an administrative complaint and a district court complaint recently filed by the FTC to block OSF Healthcare System’s proposed acquisition of Rockford Health System.
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In OIG Advisory Opinion 11-16, the OIG found that a Domiciliary Services Program (the “Program”) offered by a non-profit research hospital (the “Requestor”) is protected from enforcement under the Anti-Kickback Statute and the prohibition on beneficiary inducement found in the civil monetary penalties law (the "CMP law").
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HHS OCR Begins HIPAA Audits

November 9, 2011 | Blog | By Dianne Bourque

The HHS Office of Civil Rights (OCR) begins its pilot HIPAA compliance audit program this month. Section 13411 of the Health Information Technology for Economic and Clinical Health Act, or (HITECH) Act, requires HHS to perform these periodic audits of covered entities and business associates to evaluate compliance with the HIPAA Privacy and Security.
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CMS has yet to issue regulations required under the federal Physician Payment Sunshine Act even though they were due on October 1, 2011. 
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BioWorld Perspectives recently published an article by Mintz Levin attorneys Sam Davenport and Matt Hurley entitled “Avoiding Litigation While Protecting Your Interests,” which discusses the essential steps for companies to take after entering into a collaboration, license, or supply agreement to avoid ending up in litigation down the road.
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In an Advisory Opinion long awaited by many in laboratory industry, the OIG concluded that a proposed arrangement that would have allowed physicians to profit from their own referrals for anatomic pathology services would “pose more than a minimal risk of fraud and abuse.” 
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Manufacturers Still in the Dark About the Sunshine Act

October 11, 2011 | Blog | By Brian Dunphy

Manufacturers of pharmaceuticals, devices, and biological or medical supplies are well aware of an impending January 1, 2012 deadline to start collecting information for reports mandated by the federal “Physician Payments Sunshine Act,” which was part of health care reform legislation.
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