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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. 
Over the last several years, the federal government has sought to move from a reactive to a proactive approach to Medicare fraud enforcement. In other words, the hope is to stop fraud before it occurs rather than pay claims and then chase payments that are subsequently determined to be improper.
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. 
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”).
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.
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.
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”). 
The U.S. Supreme Court will hear arguments in the cases challenging various aspect of the Affordable Care Act  (“ACA”) that are now before the Court.
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.
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.   
Check out the article, Nonprofits: The Art of Negotiating a Sale.  Written by Daria Niewenhous of Mintz Levin and Mike Ashley of Lancaster Pollard, this article appears in Senior Housing News and offers practical insights on the purchase and sale of nonprofit assets. 
The Federal Trade Commission (FTC) has a long history of challenging state licensing boards’ restrictions on non-professionals whose business poses a competitive threat to that of the boards’ members.
Medical device and pharmaceutical manufacturers and health care providers will have to wait for clarification about the extent to which courts will allow the federal False Claims Act (FCA) to be used to police underlying violations of the many statutory and regulatory requirements that apply to their operations. 
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.
Viewpoint
How will the waiver of certain health care fraud and abuse laws and the implementation of program integrity requirements under the new Medicare Shared Savings Program affect the formation and operation of accountable care organizations?
According to the Ponemon Institute’s Second Annual Benchmark Study on Patient Privacy and Data Security, the number of data breaches involving protected health information has risen by a staggering 32% since 2010. 
The Centers for Medicare & Medicaid Services will be due for new leadership as Don Berwick, its current chief executive, steps down today. If all goes according to the Obama Administration’s plan, Berwick will be replaced by Marilyn Tavenner, the agency’s current principal deputy administrator.
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”).
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.
The OIG’s 2011 Fall Semiannual Report describes the actions the agency undertook between April 1 and September 30, 2011 and summarizes its Medicare and Medicaid claims reviews and its legal, investigative, and monitoring activities.
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