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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.
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.
On October 31, 2011, the City of New York agreed to pay $70 million to settle False Claims Act allegations that the City violated New York state Medicaid regulations governing the Medicaid personal care services program.

CMS Publishes Final Medicare Physician Fee Schedule for CY 2012

November 2, 2011 | Blog | By Karen Lovitch

Yesterday CMS released the Medicare Physician Fee Schedule Final Rule for CY 2012, along with a press release and fact sheet summarizing key issues.
On October 31, 2011,  President Obama signed and released an Executive Order directing the FDA and the Department of Justice to take actions  designed to reduce prescription drug shortages, protect consumers, and prevent price gouging regarding certain prescription drugs.
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.
Today, CMS released the final rule that will implement the Medicare Shared Savings Program (MSSP) mandated by section 3022 of the Affordable Care Act.
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.
Can a factually accurate claim submitted to the government for payment be “false or fraudulent" under the False Claims Act (FCA)? For many years, federal courts have grappled with the issue, as discussed in a Mintz Levin client advisory 

HHS OIG Reviews FY 2010 Recoveries by State MFCUs

October 17, 2011 | Blog | By Brian Dunphy

Last week, the OIG released an interesting interactive chart listing, by state, key statistics of state Medicaid Fraud Control Units (MFCU) for FY 2010. The statistics, while perhaps an imperfect comparison among the MFCUs, provide insight into the level of activity in each state, the total amount recovered by each MFCU, and the resources allocated to combat Medicaid fraud, waste, and abuse in each state.
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.” 

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.
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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