The EU Commission Approves Italy’s Grant of €23 Million of State Aid to Novartis
May 11, 2012
The EU Commission (the "Commission") has approved the grant of €23 million of state aid by Italy to Novartis Vaccines & Diagnostics S.r.l. ("Novart...
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IPAA Appeal Forces BSEE to Vacate NTL No. 2010-N05
May 8, 2012
On April 27, 2012, Director of the Bureau of Safety and Environmental Enforcement ("BSEE"), James Watson, vacated NTL No. 2010-N05, originally issued on June 8...
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Eight “Misconceptions” in Acquisition Process Discussed by Office of Federal Procurement Policy
May 8, 2012
On May 7, 2012, the Office of Federal Procurement Policy ("OFPP") issued a memorandum describing and correcting what it characterizes as common misconceptions...
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Challenges to Reporting Physician Ownership and Investment Interests
May 7, 2012
The Sunshine Act requires that applicable manufacturers and "group purchasing organizations" (GPOs) report certain ownership and investment interests held by...
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U.S. Senate Finance Committee Members Solicit Ideas from Health Care Community Regarding Combating Fraud and Abuse
May 4, 2012
In a letter dated May 2, 2012, addressed to members of the health care community, six members of the U.S. Senate Finance Committee solicited ideas from the health care...
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CMS Issues Frequently Asked Questions Refining Self-Disclosure Protocol
May 4, 2012
Last month, CMS issued several new frequently asked questions related to physician self-referral issues and the self-disclosure protocol. Notably, CMS acknowledged in...
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Fourth Circuit Affirms Secretary of HHS’s Decision on Medical Device Coverage
May 4, 2012
Last week, the United States Court of Appeal for the Fourth Circuit issued an opinion upholding the Secretary of Health and Human Services' ("HHS")...
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Medicare Fraud Strike Force Charges 107 Individuals, Alleges $450 Million in False Billings
May 4, 2012
On May 2, 2012, the Department of Justice and the Department of Health and Human Services announced that a "nationwide takedown" coordinated by Medicare Fraud...
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GAO Issues Report on EHR Incentive Program Eligibility
May 4, 2012
On April 30, 2012, the Government Accountability Office ("GAO") published a report addressing CMS determinations on provider eligibility for electronic health...
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GAO Issues Report on Oversight of Hospital Group Purchasing Organizations
May 4, 2012
On April 30, 2012, the GAO published a report addressing current federal oversight practices with respect to group purchasing organizations ("GPOs"). The report...
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IOM Reports that FDA Should Perform Ongoing Safety Studies of Risky Drugs
May 4, 2012
On May 1, 2012, the Institute of Medicine ("IOM") released a report evaluating the ethical and scientific aspects of performing safety studies of already...
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CMS Implements Therapy Caps and Exceptions to Therapy Services Furnished in Hospital Outpatient Departments
May 4, 2012
In the Balanced Budget Act of 1997, Congress imposed financial limitations on outpatient physical therapy, occupational therapy, and speech-language pathology services...
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Who Reports Transfers of Value?
April 30, 2012
The Sunshine Act requires that "applicable manufacturers" report payments or transfers of value provided to physicians and teaching hospitals by the applicable...
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CMS Issues FY 2013 Inpatient Prospective Payment System Proposed Rule
April 27, 2012
On April 24, 2012, the Centers for Medicare and Medicaid Services ("CMS") issued the inpatient prospective payment system ("IPPS") proposed rule...
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CMS Issues Final Rule Implementing Provider and Supplier Enrollment Changes
April 27, 2012
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On April 27, 2012, CMS published a final rule addressing a Patient Protection and Affordable Care Act requirement that all providers and suppliers qualifying for a...
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