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»  Posts By   February 2015 

New Guidance Issued by the FDA Provides Clarity on Whether Non-Sterile Compounders Can Register as Outsourcing Facilities

February 13, 2015 was certainly “Friday the Thirteenth” type of day within the Food and Drug and Administration (FDA), with the Agencies publishing five draft guidances and policies regarding pharmacy compounding. Among the guidances and documents published included a Draft Guidance intended for entities considering whether to register with the FDA as an Outsourcing Facility under Section 503B of the Food, Drug, and Cosmetic Act. In 2013, Congress passed a...

Data Breach of Health Insurer, Anthem, Compromises Personal Information of 80 Million Customers

Recently, one of the country’s largest health insurers, Anthem, Inc., which includes Anthem Blue Cross and Blue Shield, fell victim to a massive data breach resulting from a sophisticated external cyber-attack. Cyber-attacks on healthcare entities of all sizes is becoming more common. While the investigation is ongoing to determine exactly how much customer data was compromised, the company has confirmed that the effected database housed records for approximately 80 million...

Aetna Found in Violation of the Federal Any Will Provider Laws

With more and more PBMs and insurers owning their own Specialty Pharmacies, independent Specialty Pharmacies are being unfairly excluded from restrictive networks. However, a recent decision helps level the playing field, at least partially. The Centers of Medicare & Medicaid Services (CMS) has found that Aetna violated the Federal Any Willing Provider Law (AWPL) after Aetna denied network admission to qualified pharmacies. CMS entered an “Order” compelling Aetna to modify its behavior....

Pharma Company Pays $39 Million to Settle Kickback Allegations for Physician Speaking Fees

Physician-industry collaborations are customary, and when properly structured, promote medical innovation and improve patient care. Nonetheless, these types of business arrangements may face scrutiny from federal regulators if the compensation structure is not carefully tailored to fit within one of the Anti-Kickback Statute “Safe Harbors” or exceptions. Last month, the United States Department of Justice (DOJ) announced a $39 million settlement agreement with pharmaceutical company, Daiichi Sankyo, Inc., resolving allegations that...