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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.

Nonprofits: The Art of Negotiating a Sale

December 14, 2011 | Blog | By Daria Niewenhous

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.

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.   
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?

Study Finds Health Care Data Privacy Breaches Are Rising

December 5, 2011 | Blog | By Dianne Bourque

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. 

Berwick Leaves CMS; Tavenner Nominated

December 2, 2011 | Blog | By Daria Niewenhous

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”).

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.
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.

Blood Samples Protected by State Genetic Privacy Law

November 21, 2011 | Blog | By Daria Niewenhous

On November 16th, the Minnesota State Supreme Court held that a blood sample itself is protected information under the  Minnesota Genetic Privacy Act  (the“GPA”). The decision arose out of a suit brought by nine families of newborns’ whose blood had been collected, tested, and retained by the state under its newborn screening statutes.
Stakeholders across the health care spectrum will soon compete for $1 billion in grants offered by the Health Care Innovation Challenge.

ML Strategies Posts Weekly Health Care Reform Update

November 17, 2011 | Blog | By Karen Lovitch

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.
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").

OIG Study Finds Vulnerabilities in ZPIC Data

November 15, 2011 | Blog | By Daria Niewenhous

The OIG has released a Report that shows inaccuracies and a lack of uniformity in data used by the ZPICs (Zone Program Integrity Contractors) resulting from system issues in CMS ARTS, ZPIC reporting errors, ZPICs' interpretations of workload definitions, and inconsistencies in requests for information reports.

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.
CMS has yet to issue regulations required under the federal Physician Payment Sunshine Act even though they were due on October 1, 2011. 

ML Strategies Posts Weekly Health Care Reform Update

November 8, 2011 | Blog | By Daria Niewenhous

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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