FSIS Updates Research Priorities To Address Emerging Food Safety Concerns
December 14, 2012
The U.S. Department of Agriculture ("USDA")'s Food Safety and Inspection Service ("FSIS") has updated its research priorities related to meat,...
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U.S. House Democrats to Introduce New Meningitis Legislation
December 13, 2012
Earlier this week, two representatives, Rosa De Lauro (D-CT) and Nita Lowery Lowey (D-NY) introduced legislation aimed at bolstering federal oversight of compounded drugs...
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OIG Report Addresses Obstacles to Medicare EHR Incentive Program
December 13, 2012
On November 28, 2012, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") issued a report detailing certain vulnerabilities to...
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Safety Net Hospitals Face Significant DSH Cuts in States Not Expanding Medicaid
December 12, 2012
Safety net hospitals that generally treat a higher number of uninsured and poor patients, thus providing millions in uncompensated care every year, face significant...
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President Signs Into Law Bill that Grants CMS Regulatory Flexibility in Sanctioning Labs that Send Test Samples to Other Labs for Analysis
December 12, 2012
On December 4, 2012, President Obama signed into law, H.R. 6118, the Taking Essential Steps for Testing Act of 2012. The legislation amends the Public Health Service Act...
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IRS Releases Final Regulations on Medical Device Tax
December 11, 2012
This week the IRS released final regulations on the 2.3 percent medical device excise tax, enacted as part of the Affordable Care Act, which is scheduled to go into...
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IRS Holds Hearing on New Charity Care Requirements for Non-Profit Hospitals
December 11, 2012
On December 5, 2012, representatives from across the health care sector testified before an IRS committee regarding the proposed rules for non-profit hospital charity...
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Court of Appeals Invokes First Amendment to Reverse Conviction of Sales Rep for Off-Label Promotion
December 10, 2012
On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 decision, reversed the conviction of a pharmaceutical sales representative for...
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Supreme Court Hears Argument on Deadline for Medicare Reimbursement Appeals
December 10, 2012
On Tuesday, the U.S. Supreme Court heard oral arguments about whether the 180-day deadline for bringing Medicare reimbursement appeals is fixed or open to equitable...
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FDA Suspends First Food Facility Registration
December 6, 2012
On November 26, 2012, the U.S. Food and Drug Administration ("FDA") suspended the food facility registration of Sunland Inc., a New Mexico producer of nuts, and...
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FDA Issues Draft Guidance for IRBs, Clinical Investigators, and Sponsors
December 6, 2012
On November 20, 2012, the U.S. Food and Drug Administration ("FDA") released a draft guidance , entitled "Guidance for IRBs, Clinical...
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No Privilege for Compliance Logs and Business Audits in Hospital False Claims Case
December 5, 2012
A hospital's compliance matters and business audits aren't protected by the attorney-client privilege just because they're "funneled through an attorney&q...
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Court Nixes Repeat CID After Dismissal of Whistleblower Complaint
December 5, 2012
A federal court rejected the government's second civil investigative demand ("CID") to a hospital after the court had already dismissed the complaint. The...
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GAO Director of Health Care Kathleen King Testifies Regarding CMS Efforts to Reduce Health Care Fraud
December 4, 2012
Director of the Government Accountability Office ("GAO") Health Care Section, Kathleen King, testified to the House Committee on Energy and...
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Effectiveness of Proposed Medicare “Smart Card” on Preventing Fraud and Abuse Debated at Recent Congressional Hearing
December 4, 2012
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At a November 28th Energy and Commerce Subcommittee on Health Hearing entitled "Examining Options to Combat Health Care Waste, seven witnesses testified regarding...
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