At the March 29, 2022 Health Care Compliance Association (HCCA) conference, Christi A. Grimm, HHS-OIG Inspector General, presented an update on key agency initiatives and priorities that directly impact health care and compliance communities. In April of 2021, Ms. Grimm initially addressed the importance of modernizing program integrity and compliance information with the HCCA community, stating, ““We have been thinking about what OIG can do to make program integrity and compliance easier across the health care industry. We all know that when we make something easier to accomplish, we often get more of that thing. Modernizing program integrity and compliance information means making it easier for you to access and use information that supports your work. Through doing so, we hope to spur innovation and improve compliance programs.” Ms. Grimm specifically noted the importance of improved LEIE data access as an OIG priority for improvement.
As a pioneer in the field of automated screening services, Streamline Verify has created technology solutions to bridge the data challenges posed by the LEIE database limitations. Streamline Verify has closely following the modernization work of the OIG over the last year. While the work being undertaken is much needed, from an industry perspective, there remain challenges that may exceed to the scope of the OIG’s initiative. As noted in an article in 2021, Streamline Verify identified the most significant challenges that with LEIE data: first, the currency of the data which is highly dependent on timely state submissions of exclusion actions; second, the complexity of data cross-verification among the multiple databases; and third, the limited LEIE search function, which is unwieldy and does not include any historical exclusion data.
Modernization Initiative Overview
In September of 2021, the OIG launched its Modernization Initiative with its purpose to enhance the accessibility and usability of OIG’s publicly available data and information, including the List of Excluded Individuals and Entities (LEIE). The OIG published a Request for Information (RFI) for users to provide their assessment on how to improve OIG could both improve its guidance and modernize the accessibility and usability of the OIG’s publicly available resources. The RFI provided compliance professionals in particular with an opportunity to influence the OIG’s future priorities about use of OIG resources and data to support the needs of the compliance community. In her remarks in March 2022, Ms. Grimm highlighted the following feedback received as a result of the RFI:
“Three big takeaways from your feedback are:
First, you value OIG’s publicly available resources. And you are interested in more ways to use them to educate stakeholders. We received feedback about making it easier for you to use OIG’s information for a variety of auiences and purposes. You would like more videos, podcasts, infographics, data toolkits, and Frequently Asked Questions.
Second, you would like more ways to connect the dots. It’s not enough to have the most recent audit or corporate integrity agreement (CIA). You want more information about how it fits with our other related work.
Third, you would benefit from better, more searchable data and interactive tools that help put more of our information at your fingertips, faster. For example, you said OIG’s work plan is valuable information used regularly, but we could make it even better and more useable for you.
As health care grows more complex, organizational priorities are in constant competition. You said that more, better, and up-to-date information from OIG can help keep compliance a top priority at your organizations.”
Noted in articles about OIG’s outreach to the industry, the RFI targeted specific areas, such as advisory opinions, fraud alerts, special advisory bulletins, compliance program guidance, frequently asked questions, other compliance guidance and resources, corporate integrity agreements, searchable databases such as the list of excluded individuals and entities, and audits and evaluations. Due to the scope and complexity of the potential changes, this is a multi-year project for the OIG.
As recently explained by attorney Jennifer Michael of Bass, Berry and Sims (former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS)) on a recent American Health Lawyers Association (AHLA) podcast, “There’s been a very big push towards using data and I think the OIG’s done a great job on the enforcement side and using data to, for example, target outliers. But now they want to try to use that data on the compliance side and make it available for people to use in their compliance programs. Advancements in technology – data at your fingertips is a term they say a lot – I think that is what is driving this push.”
The compliance community has been receptive to the proposed changes to the LEIE, as well as updates to the FAQs, fraud alerts, bulletins and other written guidance. Some of these can be completed fairly quickly while changes to the LEIE may require more time. In addition, certain suggested policy changes, such as imposing expiration dates on the OIG’s advisory opinions, may take longer and will create some uncertainties and increased complexities for compliance programs as they advise on proposed business arrangements. While advisory opinions are not binding precedent that can be used to defend decisions if challenged by the OIG, these opinions do offer guidance to industry stakeholders who rely on advisory opinions to structure arrangements and analyze risk.
As acknowledged by the OIG, the data and policy modernization work is a complex multi-year project. It may take years to implement the updates needed, including those to address the LEIE limitations that require manual workarounds for many of its users. While very supportive of the OIG innovations ahead, Streamline Verify offers its clients an alternative to these challenges, having invested resources over many years to develop and refine a system solution for the complex screening requirements to which the healthcare industry is subject.