Manager Management

Thomas G. Irvin

*** ********* ***** ***** **. Charles, MO 63303 719-***-**** **********@*****.***

**NOTE: I am relocating to Colorado as this opportunity becomes available**

Professional Profile

Over 6 years experience in various roles within the healthcare/pharmaceutical industry in positions as

Director of Retail Network Audit & Compliance, Manager of Prescription Drug Sample & Compliance, and

Pharmaceutical Compliance/Diversion Investigator with expertise in pharmaceutical compliance, vendor

relations, and claims operations management.

Presently, as Director of Retail Network Audit & Compliance for Express Scripts, Inc., specializing

in complete solutions in pharmacy benefit claims audit, statistical analysis of claims data, operations

management, client management, and strategic alignment.

Rich mix of pharmaceutical compliance techniques to include brand and generic sample distribution

guidance, vendor relationship management, implementation of compliance training programs, on-

site, drug sample accountability audits and FDA/DEA reporting.

Expertise in controlled substances identification, Code of Federal Regulation

interpretation/application, and methods of abuse/misuse of prescription drugs, and thorough

knowledge of ARCOS and Suspicious Order Monitoring & Identification.

SUMMARY OF QUALIFICATIONS

• Operations Management • Process Improvement • SOP Design & Mgt.

• Policy Development • Performance Management • Strategic Thinker

• Client Presentations • Risk Assessment • Project Management

CAREER PERFORMANCE OVERVIEW

Selected to direct diverse book of business to include auditing of over 2,000 commercial health plans,

Medicare Part D, Medicaid, and Worker’s Compensation pharmacy claims.

Restructured Drug Sample Accountability operations to align department vision with corporate

compliance initiatives.

Subject Matter Expert in the fields of pharmaceutical drug compliance with state and federal regulations

while providing focused assistance to registrants to achieve regulatory compliance.

CAREER CHRONOLOGY

Express Scripts, Inc., St. Louis, MO 04/2009 – Present

Director, Retail Network Audit & Compliance

Ther-Rx Corporation, St. Louis, MO 03/2008 – 04/2009

Manager, Prescription Drug Sample Accountability & Compliance

Drug Enforcement Administration, Salt Lake City, UT 06/2005 – 03/2008

Pharmaceutical Compliance (Diversion) Investigator

Federal Bureau of Prisons, Florence, CO 07/1997 – 06/2005

Correctional Investigations Case Manager

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EXPERIENCE AND ACCOMPLISHMENTS

As Director of Retail the Network Audit & Compliance team for Express Scripts, Inc., I was selected to

oversee a diverse book of business for the commercial audit team. Effectively manage 3 direct reports and 23

indirect reports. Responsible for network pharmacy audit and compliance to ensure all internal and external

audits are within compliance of all applicable state/federal regulations and provider contracts. Possess in-

depth, working knowledge and understanding of HIPAA regulations, CMS Regulations, Med D compliance,

and Worker’s Compensation regulations. Directly responsible for identifying areas of compliance

vulnerability and risk to negate corporate liability. I possess a proven track record for driving results while

exceeding organizational recovery and revenue goals. I develop highly detailed metrics depicting overall

department revenue and recovery goals and other key audit metrics to include sophisticated compliance

components, ROI, negative margin analysis, and manage a yearly budget up to $1.2M.

Key Achievements:

Recovered $36.8M in 2009 for Commercial clients from pharmacy network audits

Successfully presented over 30 client facing audits for Commercial/Managed Care BOB

Actively partnered with Account Management, Operations, Finance, and Government/Client Audit

on numerous escalated issues to effectively resolve client concerns

As Manager, Prescription Drug Sample Accountability and Compliance for Ther-Rx Corporation (KV

Pharmaceuticals), managed and directed the day-to-day operations of the Drug Sample Accountability and

Regulatory Compliance Departments for Ther-Rx Corporation/KV Pharmaceuticals. In this capacity, I was

chiefly responsible for maintaining PDMA Compliance, PhRMA Code Compliance, and OIG Regulatory

Compliance. Presented business operations plans to Marketing and Sales management on a regular basis to

provide trend analysis, forecasting, and process improvement initiatives where warranted. Directly managed

vendor relations with Supply Chain Management outsourced vendor to achieve optimal drug sample

accountability results and expectations.

Key Achievements:

Led department wide revision of sample accountability policies and procedures and implemented a

tracking metric to ensure yearly reporting and compliance

Successfully managed all prescription drug sample shipments and accountability for over 350

external sales representatives

Reduced the number of reportable cases to the FDA by 60% from the previous year

As a Pharmaceutical Compliance (Diversion) Investigator for the Drug Enforcement Administration, I

was responsible for conducting regulatory and administrative investigations to enforce the Controlled

Substances Act (CSA). I was chiefly responsible for addressing the problem of diversion of controlled

pharmaceuticals and regulated chemicals from the legitimate channels in which they were manufactured,

distributed and dispensed. I conducted on-site investigations/audits of numerous manufacturers, distributors,

pharmacies, narcotic treatments centers, researcher applicants and other registrants.

Key Achievements:

Applied technical expertise in numerous situations to assist registrants in developing P&P’s/SOP’s

and associated internal regulations to reflect the guidance of 21 CFR Part 1300

Reviewed ARCOS reports, approval of registrations, registrant record-keeping requirements and

enforced all controlled substance security requirements

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As a Correctional Investigations Case Manager for the Federal Bureau of Prisons, I was directly

responsible for conducting institutional level investigations involving inmates who were found to have

committed a prohibited act in a penal institution. My primary focus was on the safety and security of all

inmates and staff members. I conducted in-depth interviews of inmates who requested protective custody and

validated the nature of the cause. Served as the lead on all internal tours of the Administrative Maximum

facility to include tours for former Attorney General John Ashcroft, Federal and State prosecutors, and

attorneys from the United Sates Attorney’s Office.

Key Achievements:

Successfully referred numerous investigations for prosecution of inmate misconduct to include:

Inciting a Riot, Assault on a Staff Member, Possession of a Narcotic in a Penal Institution, Rape and

Attempted Escape from a Federal Institution

Performed numerous interviews with inmates and concluded their involvement with violations of

institution rules and regulations (Unit Disciplinary Committee)

Assisted in the classification and de-briefing of high profile inmates who required a monthly FBI

status report per the United States District Court

EDUCATION

LINDENWOOD UNIVERSITY – ST. CHARLES, MISSOURI

Masters of Science in Healthcare Administration

(Graduation date: 12/2010)

COLORADO STATE UNIVERSITY – PUEBLO, COLORADO

Bachelors of Science

MILITARY EXPERIENCE

U.S. Army – 4-years active duty – Honorable Discharge 1996

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