Identifying Non-FDA-Approved Medication Utilization

We proudly support patient safety and health, mitigating organizational risk, and eliminating misspent pharmacy benefit dollars.
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The only firm in the country with the intellectual property and technology to provide this specific pharmacy benefit compliance review service.
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Who We Are

Our team specializes in identifying non-FDA-approved medication utilization to achieve organizational compliance, and recouping misspent dollars, when applicable.

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What We Do

Through a decade of pharmaceutical manufacturer and medication research, we utilize a self-created list of more than 7,000 National Drug Codes (NDC) without FDA approval that are found within national drug databases used by PBMs.

Pharmacy utilization that matches NDCs on this list will confirm the total client amount paid for these medications. The remuneration will be provided in the form of a direct client reimbursement or via credits on future invoices, and Vickers Consulting will serve as the internal compliance department to facilitate the refund process.

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Comprehensive Compliance Assessments

Our unique assessment identifies the medications and associated costs for non-FDA-approved medications.
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Risk Mitigation

The results of our assessments provide information to reduce and eliminate health risks to patients, and financial and legal risks to organizations.
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Expertise and Guidance

Through our pharmacy benefit compliance knowledge regarding federal statutes and regulations, the FDA medication approval process, and PBM contracts, we support clients to implement appropriate strategies.
1

Facilitate Documents

Facilitate and execute all required documents between Plan Sponsor and Vickers Consulting.
2

Procure Data

Request 3-5 years of historical pharmacy claims data for pharmacy compliance assessment.
3

Conduct Analysis

Vickers Consulting to provide and review assessment results report.
4

Execute Contract

Commence required contracting process to hire Vickers Consulting to recoup misspent dollars.
5

Provide Refund

Vickers Consulting will pursue and secure the return of misspent dollars.
6

Monthly Service

Discuss the Vickers Consulting ongoing monthly pharmacy compliance review process.

Our Process

There is no upfront cost for our compliance assessment, as our revenue earned is a shared arrangement based on the refund amount realized and received by plan sponsors.

Four non-PHI data fields are needed to complete the compliance assessment, with 3-5 years of historical pharmacy utilization.

This specific work is under the purview of compliance and fraud, waste, and abuse, and is not a PBM audit, so there is no limit to the number of years of pharmacy data that can be provided.

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Frequently Asked Questions

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 Medi-Span, and PBMs often 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.

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Testimonials

"As a health plan, our members expect service that is fair, honest and legal. The Vickers Consulting team was able to identify the number of FDA unapproved drugs filled by our plan and the potential liability to our organization. Vickers Consulting has become a vital risk reduction strategy for Excel Health Plans. We strongly encourage your organization to participate in their simple, seamless process."

Michael Patton
President & Co-Founder

"At ELK Benefit Strategies, we understand the critical significance of pharmacy benefit compliance, risk management, and cost containment for plan sponsors. As part of our extensive suite of pharmacy consulting services, we have established a strategic partnership with Vickers Consulting. This collaboration empowers us to provide retrospective and ongoing pharmacy compliance assessments to our existing clients and potential partners. These assessments play a crucial role in identifying non-FDA-approved medication utilization, ensuring comprehensive compliance and risk mitigation strategies for our clients' long-term success."

Jon Reid
President

"At RxClarity Group, we leave no stone left unturned in our quest to dramatically reduce pharmacy spend and improve lives, one member at a time. Our partnership with Vickers Consulting plays a crucial role in identifying excessive spending and safety issues related to non-FDA approved medications distributed by PBMs. By leveraging this collaboration, we strengthen our platform, refine our processes, and enhance precision in reviewing pharmacy costs while optimizing clinical care."

Nancy Gilbride, MS, RPh
Principal and Chief Commercial Officer

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