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»  Posts By   December 2014 

Specialty Drug and PBM Formulary Wars

Express Scripts (ESI) announced December 22, 2014 that it would offer exclusive coverage for AbbVie's Viekira Pak for the treatment of genotype I hepatitis C, excluding other popular therapies such as Harvoni, Sovaldi, and Olysio from its 2015 formulary. Although Viekira has proven effective in clinical trials, some have argued that it is not the preferred treatment for all prescribers. Viekira must be taken with adjunct therapies whose known side...

Should Veterinary Compounders Care About Anti-Kickback Statute Compliance?

Veterinary compounders should be concerned with and pay particular attention to compliance with state and federal laws that control the relationship between pharmacies and referral sources. The Federal Anti-Kickback Statute (Federal AKS) imposes criminal penalties against individuals and entities that pay or receive remuneration in return for referring an individual for services paid under a Federal health care program. Veterinary compounders have historically avoided scrutiny under the Federal AKS, as...

Catamaran Auditing and Reviewing Compound Pharmacy Contracts for Fee-Splitting and Price-Rolling

It's that time of year again… As the PBMs gear up for 2015, Frier Levitt is noticing a very recent trend with Catamaran auditing and reviewing compound pharmacy contracts for “Price-Rolling” and “Fee-Splitting”. Generally, “Price Rolling” and “Fee-Splitting” refer to compound pharmacy practices designed to avoid the prior authorization process after a compound claim rejects at the POS due to the reimbursement exceeding a given plan’s monetary threshold limit. Instead of...

Alert Regarding Automatic Refill and Restocking

On December 15, 2014, a federal jury convicted the owner of a Maryland-based pharmacy chain of health care fraud for automatically submitting refills for prescription drugs to health care benefit programs such as Medicare and Medicaid without patients’ knowledge and consent. The automatically refilled medications were typically expensive HIV and cancer medications. In addition, claims for payment were not reversed when customers did not receive the medications. Some medications which...

FDA Announces Pharmacy Compounding Advisory Committee Members

The FDA took another step forward in the implementation of the compounding provisions of the Drug Quality and Security Act (DQSA) today by announcing the membership of the Pharmacy Compounding Advisory Committee which will play a central role in shaping the regulation of compounding pharmacies. The 14 members of the Committee (12 voting, 2 non-voting) are experts in pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulations and include representation...