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How is it possible that plan sponsors are charged for non-FDA-approved medications?
FDA approval is not required to obtain a National Drug Code (NDC) for the medication to be added to national drug databases, and PBMs ingest this database information into their formularies without regard to the legal status of the medications.
What laws and regulations govern the required FDA approval for a medication to be introduced into the marketplace?
The Food, Drug, and Cosmetic Act mandates that all prescription drugs be approved by FDA for safety and effectiveness before they can be marketed in the United States. FDA approval is necessary to ensure that drug products are safe and effective for use under the conditions prescribed or recommended on the product label. A new drug may not be introduced or delivered for introduction into interstate commerce unless a new drug application approved by the FDA is in effect for the drug. Additionally, the False Claims Act, ERISA governance, the plan sponsor/PBM contract, and/or Fraud, Waste, and Abuse statutes may also be pertinent depending upon the type of plan sponsor.
What specific services are provided?
Vickers Consulting offers a multi-year retrospective historical review and a monthly ongoing prospective pharmacy compliance review.
What are the fees?
There is no upfront cost for the historical compliance assessment, as our revenue earned is a shared arrangement based on the amount recovered after the plan sponsor has realized and received the reimbursement or credit. The monthly ongoing compliance service has a nominal per member per month (PMPM) fee.
What firms offer this same level of intellectual capital and technology to identify all non-FDA-approved medications?
There are no other firms in the country that offer what Vickers Consulting provides, as our list of non-FDA-approved medications contains more than 7,000 NDCs cultivated and continuously maintained for ten years.
In addition to recouping misspent dollars for non-FDA-approved medications, are there other benefits to ensuring that a plan sponsor does not cover nor pay for unapproved medications?
There are significant health risks for patients consuming medications that have never been reviewed for safety, which includes the manufacturing location and conditions, sterility, ingredient composition, clinical results for effectiveness, and clinical results for side effects and potential hazards.
