Mitigating Risks and Promoting Compliance

FDA approval is not required to obtain an NDC for a medication to be included in national drug databases, and currently there are about 7,000 NDCs without the required FDA approval for safety, effectiveness, and quality.

PBMs and insurance carriers charge plan sponsors for non-FDA-approved medications that do not have a new drug application, which is required by federal law.  The health and safety risk to patients, and the financial and compliance risk to plan sponsors, is significant.

We have provided hundreds of compliance assessments for plan sponsors that utilize many of the PBMs throughout the country, and we have identified non-FDA approved medication utilization 100% of the time in every compliance assessment.  Our specific pharmacy compliance service is the only method available for plan sponsors to recoup these misspent dollars.

We identify the errors or complacency in the management of your pharmacy program related to non-FDA-approved medications, and facilitates the client refund process.

We accomplish this by:

Collecting multiple years of historical pharmacy utilization data

Securely analyzing claims data to identify fraud, waste, and abuse within your pharmacy program

Providing detailed reporting on discrepant prescriptions

Facilitating the recovery and reimbursement process