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Most CMS Audits of Medicare Part D Prescription Drug Plans Revealed Deficiencies, Many Plans Yet to Be Audited
December 27, 2011 | Blog | By Karen Lovitch
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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New HHS Essential Health Benefits Bulletin Emphasizes State Flexibility
December 21, 2011 | Blog
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 Posts Weekly Health Care Reform Update, December 5, 2011
December 6, 2011 | Blog | By Daria Niewenhous
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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OIG Questions Laboratory Management Arrangement in Advisory Opinion 11-17
November 29, 2011 | Blog | By Karen Lovitch
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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OIG Approves Arrangement Based on New Exception to Beneficiary Inducement Prohibition
November 16, 2011 | Blog | By Karen Lovitch
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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Delay in Publication of Sunshine Act Regulations Persists Despite Bipartisan Pressure
November 8, 2011 | Blog | By Karen Lovitch
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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Guidance for Biotech/Life Sciences Companies on Avoiding Litigation with Contract Partners
November 1, 2011 | Blog | By Brian Dunphy
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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OIG Advisory Opinion 11-15 Nixes Laboratory Management Services Joint Venture
October 12, 2011 | Blog | By Karen Lovitch
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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OIG Is Watching: FY12 Work Plan Focuses on Data Mining
October 10, 2011 | Blog | By Brian Dunphy
The Office of Inspector General released its Work Plan for Fiscal Year 2012 describing the focus of its activity for the next fiscal year.
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ML Strategies Weekly Health Care Reform Update Posted on October 3rd
October 5, 2011 | Blog | By Karen Lovitch
ML Strategies has posted its weekly Health Care Reform Update providing timely 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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Wisconsin Medicare Part C FCA Settlement for Business Misconduct
October 4, 2011 | Blog
In a Medicare Part C (or “Medicare Advantage”) False Claims Act settlement announced by the Milwaukee-Wisconsin Journal-Sentinel on September 25th, an operator of a Germantown Wisconsin Medicare Advantage plan and its parent agreed to pay $4.8 million to settle allegations that the company improperly paid eligible individuals to enroll in the Medicare Advantage plans, then misled them about the scope of coverage.
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Petitions for Cert Seek Review of the Implied Certification Theory of Liability Under the FCA
October 3, 2011 | Blog | By Kevin McGinty
The split among the federal circuit courts over the “implied certification” of liability under the federal False Claims Act (FCA) is figuratively banging at the Supreme Court’s door.
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ML Strategies Weekly Health Care Reform Update Posted on September 26th
September 27, 2011 | Blog | By Karen Lovitch
ML Strategies has posted its weekly Health Care Reform Update providing timely 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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OIG "tweets" fraud and abuse educational materials for physicians
September 21, 2011 | Blog | By Brian Dunphy
On September 18, the Office of Inspector General (OIG) for the Department of Health & Human Services “tweeted” about its Physician Education Training Materials, which are designed to teach physicians how to comply with the Federal fraud and abuse laws. OIG has increasingly used Twitter to publish information that may be of interest to providers.
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Texas Health Care Privacy Law
September 20, 2011 | Blog | By Daria Niewenhous
In this article "Texas Law Gives Privacy More Muscle than HIPAA", published by Law360 on September 16, 2011, Mintz Levin attorney Dianne Bourque is quoted regarding the aggressive new Texas health care privacy law.
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