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»  Posts By   January 2014 

New Letters by FDA Commissioner Hint at Push to Make Purchasing Sterile Compounds from Registered Outsourcing Facilities a State Requirement or Part of the Medical Standard of Care

Section 503B of the FDCA (Drug Quality and Security Act of 2013) provides that a facility that compounds sterile drugs can elect to register with the FDA as an Outsourcing Facility (OF). Upon registering as an OF, the facility would be required to meet certain regulatory requirements including: providing FDA with information about the products they compound, complying with cGMPs, reporting adverse events and providing appropriate labeling for their products....

Final Rule Excludes Laboratories from EHR Donation Exception to Stark and Extends Exception Expiration Date

The 2006 Stark exception for Certain Electronic Prescribing and Electronic Health Records Arrangements (EHR Donation Exception), and a 2006 Safe Harbor to the Federal Anti-Kickback Statute allow physicians to receive non-monetary remuneration in the form of electronic health records software (EHR) or information technology and associated training services. CMS and the OIG (the Agencies) issued a Final Rule on December 27, 2013 amending the EHR Donation Exception and extending the sunset date...

Abbott Laboratories Pays $5.5 Million to Settle Anti-Kickback Violations for Paying Doctors for Speaking Engagements and Lecturing

Last month, the U.S. Department of Justice settled False Claims Act claims against Abbott Laboratories over allegations that Abbott Laboratories had been engaging in a practice of paying prominent physicians for speaking engagements and other learning assignments with the expectation that, in return, the physicians would arrange for their affiliated hospitals to purchase Abbott Laboratories’ carotid, biliary and peripheral vascular products. The federal government viewed this relationship and payment structure...

Physician Pleads Guilty to Accepting Bribes in Biodiagnostic Laboratory Services Case

A New Jersey doctor recently admitted to accepting bribes in exchange for diagnostic test referrals. The doctor pleaded guilty in Federal Court in New Jersey in the latest development in the investigation and prosecution of the long-running scheme operated by Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, NJ. BLS allegedly bribed numerous physicians through leasing, service, and consulting agreements. As stated by the U.S. Attorney for the District of New...

Express Scripts Implements New Credentialing Processes for Compounding Pharmacies Requiring Detailed Information and Documentation

Express Scripts, Inc. has recently adopted new credentialing processes for compounding pharmacies that differ markedly from pharmacies’ previous recredentialing format. Citing increased risk of fraud related to the dispensing of compounding prescriptions, Express Scripts has adopted new terms and conditions for compounders, and has implemented a new enhanced online credentialing process for all compounding pharmacies. If a pharmacy meets the new enhanced terms and conditions, the pharmacy will receive a...
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