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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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The recent decision by a federal court judge in Mississippi to deny defendants’ motion for summary judgment in United States ex rel. Jamison v. McKesson rejected a well-established defense to claims that competitively procured arrangements for goods and services constituted “remuneration” for purposes of the Anti-Kickback Statute ("AKS").
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Health care providers and suppliers concerned about how the Centers for Medicare & Medicaid Services (CMS) plans to implement the 60-day deadline for returning Medicare and Medicaid overpayments enacted as part of the Affordable Care Act (ACA) now have a proposed rule that provides some insight.
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Massachusetts Corporate Practice of Medicine Regulations Finalized

February 15, 2012 | Blog | By Daria Niewenhous, Ellen Janos, Rachel Irving Pitts

The Massachusetts Board of Registration in Medicine recently released final revised physician licensing and discipline regulations, effective February 1, 2012.  The final regulations mark the end of a six-year process to overhaul these regulations.
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Case Study: Messner v. Northshore University HealthSystem

February 13, 2012 | Blog | By Karen Lovitch

Law360 recently published an interesting article examining the Seventh Circuit's recent opinion in Messner v. Northshore University HealthSystem.
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CMS posted additional sub-regulatory guidance regarding the Medicare Loss Ratio (MLR) under Section 2718 of the Public Health Service Act, as added by the Affordable Care Act (ACA). 
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An OIG Alert issued today reminds physicians who reassign their right to submit claims to and receive payment from Medicare may be liable for any false claims submitted to the government. The OIG linked this alert to recent settlements under the Civil Monetary Penalty Law with physicians whose Medicare payment reassignments resulted in false claims. 
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HITECH Data Breach Reporting Deadline Approaches

February 7, 2012 | Blog | By Daria Niewenhous, Dianne Bourque

It’s time for mandatory data breach reporting to the Office of Civil Rights (“OCR”) under The Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the interim/final breach notification rules.
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ML Strategies has posted their 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.
Read more

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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D.C. Circuit Finds Physicians Can Pursue Challenge to Stark Law Regulation

December 27, 2011 | Blog | By Karen Lovitch, Thomas Crane

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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