Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it...

Good News for Clinical Pathology Laboratories: Medicare Officials Intend to Rescind Rule Requiring Physician Signatures on Paper Lab Reqs

CMS says it will take steps to rescind the final rule before its scheduled implementation on April 1, 2011 Clinical laboratories and pathology groups will welcome the news that the federal Centers for Medicare & Medicaid Services (CMS) will take steps to rescind the final rule that requires the physician’s signature be on all paper requisitions for medical laboratory tests ordered on behalf of Medicare patients. It means that implementation of the rule—now scheduled to become effective on...

CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs

Pathologists and medical laboratory managers should be alert to compliance changes CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories. Laboratory management consultants tell Dark Daily...

HITECH ACT Mandates New Patient Privacy Requirements on Labs and Pathology Groups

Labs Must Report Privacy Breaches of 500 or More to the Media Call it HITECH collides with HIPAA! Most pathologists and lab executives know that passage of the HITECH Act was the part of 2009’s American Recovery and Reinvestment Act (also referred to as “ARRA” or the “stimulus bill”). HITECH provides incentives for the expanded use of electronic health records by physicians and other providers. But what is lesser known is how the HITECH Act creates new legal obligations of covered entities and...
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