A Welcome Letter From a 340B Compliance Manager

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Dear Fellow 340B Community Members,

Please allow me a moment to introduce myself. My name is Edward Vargas. I live in Rochester, N.Y., with my lovely wife and a new addition to the family on the way! Ever since I was introduced to the world of 340B at the University of Rochester Medical Center (URMC) and the amazing impact that the program had on my community, I was hooked. The intellectual challenge, the rigor required to ensure program compliance, and the mission-based orientation appealed to me like nothing else I have encountered professionally.

The initial exposure and experience I gained from my 340B position at URMC directly contributed to a more impactful role at Rochester Regional Health. At RRH, I was responsible for independently evaluating and monitoring system-wide 340B program compliance. My exposure to the 340B world expanded beyond my immediate community when I spent several years in a role as a 340B consultant at StoneBridge Business Partners where I advised covered entities on preparation for HRSA audits, including performing mocks audits at dozens of covered entities across the country.

I am writing to share my perspective on the 340B world as it stands today from the vantage point as the 340B Compliance Manager for tangoRx Solutions, a Brooklyn N.Y.-based TPA. First, a short plug for my current employer. I have always chosen my professional trajectory very carefully and made sure that the organizations I aligned my career with had an impeccable track record. It’s of key importance to me that the organization I represent is fully dedicated to the mission of improving care for the most vulnerable and the underserved. TangoRx is just such an organization. They specifically recruited me to leverage my experience helping the covered entities we serve stay compliant and educated on what is required to achieve audit readiness on a continuous basis. It is my role to ensure that our partners avoid disruptions in their ability to administer the program and to provide the guidance needed to navigate the compliance and operational challenges placed on their 340B programs.

  1. Trial balance crosswalk data – yes/no designation added for use of 340B drugs at each site during patients encounters.
  2. Provider list documentation – added start and termination dates of employment/contract for each provider
  3. Contract pharmacy documentation – added a designation of whether the hospital is using the contract pharmacy
  4. Purchasing documentation – added a detailed list of required data elements for six months of 340B drug purchases that includes:
    1. Ordering location (parent, offsite facility, contract pharmacy)
    2. Wholesaler name
    3. Account number
    4. Invoice number and date
    5. Drug description and NDC
    6. Quantity ordered and price paid

Updated HRSA Audit Requirements for FY 2022:  I now turn to a short update on the state of the HRSA audit process as we are quickly approaching 2022. As I suspect most of you know by now, in September, HRSA began sending notices announcing the return of onsite audits to those 340B providers who have been selected for an audit in FY 2022. Part of that announcement were several key updates to the requested data elements that providers will be required to pull. I will summarize some of these changes for you here:

It is my personal mission to remain on top of these changes and help spread the word as far and wide as possible so that the entire 340B community can stay ahead of the curve and maintain the ability to fully leverage the benefits of this crucial program. I would like to sincerely thank the 340B Report team for providing a forum where we can come together to stay educated on current events and share knowledge in pursuit of ensuring that the safety-net remains robust in the United States.

In service,

Edward Vargas, MBA, 340B ACE

For more information, Edward can be reached at edward.vargas@tangorxsolutions.com.

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