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OIG Publishes Wide-Ranging Request for Information

By Jennifer Michael on September 24, 2021
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One of the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) key compliance priorities is modernizing the agency’s program integrity and compliance information.

OIG has explained that its goals for this priority are to continue producing timely and useful resources and to make the resources it provides easier to access and use, to spur innovation and improve compliance programs.  On September 22, in furtherance of these goals, OIG posted a request for information (RFI) on its website.

OIG Seeks to Understand Value of Its Resources

Although all of the guidance available on OIG’s website remains “good guidance,” many of the resources have not been updated in decades.  In addition, advancements in technology now allow stakeholders to manage and operationalize data and information in previously unavailable ways.  Through the RFI, OIG seeks input from the healthcare industry and the public on a wide range of issues, including how stakeholders use OIG’s resources, as well as how to improve the value and timeliness of those resources.

In the RFI, OIG provides a brief description of, and seeks feedback on, the following resources:

  • Advisory Opinions
  • Fraud Alerts
  • Special Advisory Bulletins
  • Compliance Program Guidance (CPG)
  • Frequently Asked Questions (FAQs)
  • Other Compliance Guidance and Resources
  • Corporate Integrity Agreements (CIAs)
  • The List of Excluded Individuals and Entities (LEIE)
  • Audits and Evaluations

Key Areas of Focus

Several areas of OIG’s focus are particularly noteworthy.  Regarding advisory opinions, OIG notes that it has received feedback that the process is too restrictive, slow, and cumbersome, and states that the agency is seeking input on how to balance the value of including a detailed analysis in each opinion with the value of a more expeditious approach, under which opinions would not include detailed legal analyses.  OIG also asked if an FAQ process, similar to the COVID-19 FAQ process, would be a preferable alternative to the advisory opinion process for certain types of arrangements.  Finally, OIG states that it is considering whether advisory opinions should expire, or if the agency should require requesting parties to recertify as to the facts presented in an advisory opinion, and terminate opinions in cases where the parties fail to do so.

OIG also requested information about its other guidance documents – including CPGs, fraud alerts, and special advisory bulletins – asking what the agency can do differently to make these guidance documents more meaningful, useful, or timely.  Turning to CIAs, OIG acknowledges that industry stakeholders often consult CIAs as a resource for compliance best practices and asks what search capabilities would be most useful.

Finally, OIG notes that the LEIE website receives approximately 26 million visits annually and that users must either download a spreadsheet or use web queries for up to five providers at a time.  OIG recognizes that the manual nature of these interactions provides considerable opportunities to reduce the burdens and costs associated with checking employees and other contracted persons against the LEIE and solicits input on how it can improve access to this resource.

Key Takeaways

Although the RFI suggests that OIG may implement meaningful changes to the way it solicits and issues guidance and shares its data, the agency was careful to calibrate expectations, noting that this initiative likely will be a multi-year effort.

The deadline to submit comments is January 31, 2022.

If you have any questions about the information above, please contact the author.

Photo of Jennifer Michael Jennifer Michael

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential…

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA).

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Inside the False Claims Act
  • Organization:
    Bass, Berry & Sims PLC
  • Article: View Original Source

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