UK MHRA Launches New Procedure for Reclassification of Medicines
December 14, 2012
On December 6, 2012, the UK Medicines and Healthcare products Regulatory Agency ("MHRA" - the government agency responsible for ensuring that medicines and...
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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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Comment Period Opens for EU Proposed Framework on Medical Device Regulation
December 7, 2012
On November 12, 2012, the UK government, through the Medicines and Healthcare products Regulatory Agency ("MHRA"), launched a consultation on the European...
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EU Pharmacovigilance: European Commission Launches Public Consultation on Phasing-in of Symbol Identifying Medicines Under Additional Monitoring
December 7, 2012
The European Commission (the "Commission") has opened a public consultation on phasing-in a black symbol identifying medicines which are subject to additional...
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Blowing the Whistle for Tax Dollars and Early Retirement: Views from the Perspectives of Both Whistleblowers and Taxpayers
December 06, 2012
While businesses have for some time been aware of the possibility of "tax whistleblowers" – employees or outside advisors who anonymously...
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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
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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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