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Blog
Exclusion List Exposure: The Case for Proactive, Data-driven Monitoring and Prevention – Part 3 of 3 in a Series
Jeff Duffy, PhD, Sr. Director, Advanced Methods & Strategy, Gross-to-Net Solutions, IQVIA
Shiraz Hasan, General Manager, Gross-to-Net Solutions, IQVIA
Nov 06, 2023

From delivering dangerous treatments to billing for services not rendered, there are a host of reasons why a healthcare provider or entity could end up on federal and/or state Exclusion Lists. As we explained in our first and second posts, despite the existence of these lists, “bad actors” continue to deliver care and submit claims. In fact, an IQVIA analysis revealed a jaw-dropping $893 million in estimated drug expenditures in 2021 and 2022 from members on “bad actor” lists.

For pharmaceutical companies, this finding points to significant compliance risk. It suggests opportunities to tighten up commercial practices. And it opens the door to a much larger financial exposure: rebates paid to and through individuals and entities on Exclusion Lists.

Within many companies, there hasn't been a high level of awareness about Exclusion List exposure. As market conditions become more challenging, it’s critical that leaders from the C-suite to Market Access and Compliance teams become more aware of these risks.

Can you quantify your organization’s current exposure to Exclusion Lists? What steps are you taking to reduce that exposure? What are the benefits of adopting a more proactive, preventive approach over the long term?


Understand your current state

If you don’t already have a clear understanding of your current exposure, consider performing a data-driven audit of your individual company. IQVIA’s Gross-to-Net team has experience with such audits. The process requires your company to provide IQVIA with rebate claims for the drugs to be analyzed. Our team then flags rebate claims where the fill date falls within an exclusion period and creates a summary of results by list category.

At the same time, consider incorporating an additional review of claims from deactivated NPIs, as well as those from Medicare opt-out HCPs, as measures to improve program integrity and reduce potential exposure to fraudulent activity.


Conduct ongoing monitoring

A one-time audit is an excellent starting point, but not sufficient to reduce risk exposure over time. To that end, organizations need to invest in proactive monitoring of Exclusion Lists. This requires  connecting data to help eliminate gaps where bad actors can create compliance risks and unintended consequences in contracting and rebating processes.


Realize the benefits of a proactive approach

IQVIA experience points to three key advantages of a more proactive approach:

  • Stay abreast of exposure risk. Having a data-driven audit strategy creates a foundation for tracking rebates being paid and developing key performance indicators as part of your compliance program. Only through regular monitoring can you promptly identify (and address) Exclusion List exposure. How do you know your exposure unless there is regular monitoring?
  • Stop paying rebates based on excluded claims. Once you have a handle on exposure risk, you can create policies around these complex risk areas and include terms in contracts with payers. You can then develop business rules based on those policies and terms — helping prevent payment of rebates based on excluded claims.
  • Strengthen your gross-to-net and market access brand strategies. Ongoing monitoring, internal policies, contract terms, and business rules should be integrated into the design of patient assistance programs and incorporated into your healthcare provider targeting strategy.

Connect the dots, reduce the risk

With a proactive, data-driven approach, your organization can avoid the risk of doing business with excluded healthcare providers and entities. IQVIA has a unique combination of data sources and expertise to help you connect all the dots — and support your compliance, program integrity, and contracting effectiveness goals.

IQVIA’S Market Access Center of Excellence

In a time when better access has never mattered more, IQVIA has built the largest and most experienced market access team in the industry. That team of experts drives IQVIA’s Market Access Center of Excellence, powered by intelligent connections between data, analytics, technology, and strategy to help clients navigate today’s challenging access environment.
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