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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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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 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 | By Ellyn Sternfield

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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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 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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In the kickoff to this year’s fall conference season, Mintz Levin’s own Thomas S. Crane will be speaking about the Anti-Kickback Statute (AKS) and current developments on Monday, September 26th at the American Health Lawyers Association (AHLA) Fraud and Compliance Forum.
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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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Medicaid RACs: Coming Soon to a State Near You

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

Eliminating fraud, waste, and abuse in health care has long been a top government priority, but — as demonstrated by a series of events this week — it likely will garner even more attention as the government seeks to reduce the federal deficit by $1.5 trillion over the next ten years. Providers should closely monitor the developments.
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CMS has announced the publication of a proposed rule that will require HIPAA-covered laboratories to make test results available to patients no later than 180 days after the rule's effective date, which will be 60 days after publication in tomorrow's Federal Register. 
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OIG Advisory Opinion Permits Donation of Telemedicine Items and Services

September 12, 2011 | Blog | By Brian Dunphy, Karen Lovitch

In a recent advisory opinion, the OIG allowed a hospital to share telemedicine resources with another hospital, in the interest of promoting new models of consultation and improving patient care by reducing unnecessary patient transfers.

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Qui Tam "Seal” Windows Shrinking?

August 22, 2011 | Blog | By Daria Niewenhous, Ellyn Sternfield

When qui tam relators/whistleblowers file suit under the civil False Claims Act (FCA), they are “standing in the shoes” of the government to allege that the government has suffered damages due to fraud. 
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