Exclusion Screening

Summary of HHS OIG Modernization Initiative RFI


Emptech's founder, Jeff Aleixo


Jeffrey Aleixo

OIG Modernization Initiative RFI, Healthcare Compliance

In September 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a formal request for information (RFI) regarding its modernization initiative to improve publicly available resources. Given that one of OIG’s key compliance priorities is modernizing the agency’s program integrity and compliance information, the RFI aims to obtain the healthcare industry’s perspective on this topic and assist in the process of updating OIG’s resources. The deadline for submitting comments to the OIG modernization initiative RFI was January 31, 2022.

Value of OIG Resources

OIG’s resources, including advisory opinions, Special Fraud Alerts (SFAs), Special Advisory Bulletins (SABs), and Compliance Program Guidance documents, provide essential guidance when it comes to promoting compliance with the federal fraud and abuse laws, structuring effective compliance programs, and similar topics. However, many of the resources have not been updated in decades, and advancements in technology now allow stakeholders to manage data and information in ways that were previously unavailable.

Through the modernization initiative RFI, OIG sought 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 their value and timeliness. 

In order to improve the usefulness, accessibility, and usability of resources, by means of modernization initiative RFI, OIG requested:

  • Insights into how stakeholders use OIG resources,
  • Identification of the successes and challenges organizations have had using OIG resources, and
  • Identification of other potential opportunities for OIG to provide information to the public and other stakeholders.

Also, in addition to expanding resources, OIG aims to use new mediums for providing guidance, such as podcasts and video training.

Key Areas of Focus Within Modernization Initiative RFI

In the modernization initiative RFI, OIG provided a brief description of and sought feedback on the following resources:

Advisory Opinions

HHS-OIG implemented its advisory opinion process in 1997. Since then it has resulted in the submission of more than 1,200 requests and the issuance of almost 400 advisory opinions.

In the modernization initiative RFI, OIG sought comment on the balance between providing thorough and detailed analyses and engaging in a more expeditious process.

Fraud Alerts

OIG also invited industry stakeholders to comment on its special fraud alerts in order to make them more meaningful. Any person may request the issuance of a special fraud alert to inform the public of practices that are of particular concern under Medicare or a state healthcare program. OIG’s special fraud alerts mainly focus on national fraud and abuse trends that may violate the Anti-Kickback Statute and the prohibition against beneficiary inducements, and the Office of Evaluation and Inspections generates them.

Special Advisory Bulletins

If OIG lacks the enforcement experience necessary to issue a special fraud alert, it may choose to publish a special advisory bulletin covering potentially abusive healthcare practices. In order to make them more useful or timely, OIG requested comments from stakeholders about their experiences regarding special advisory bulletins. 

Compliance Program Guidance

OIG’s compliance program guidance (CPG) documents outline the fundamental principles of healthcare compliance programs in order to encourage their voluntary development. Therefore, OIG requested information on CPGs benefits, the necessity for publishing additional CPGs, and potential improvements to their existing format.

Frequently Asked Questions

The modernization initiative RFI also requested feedback on the value of published FAQs, using the FAQs process implemented throughout the COVID-19 pandemic as a model. Thus, OIG aimed to find out how to improve this process for future health emergencies and how to implement a similar FAQs process that would continue beyond the context of the pandemic.

Use this detailed guide on exclusion screening to ensure creating an effective healthcare compliance program and resolving any potential risks on time.

Other Compliance Guidance and Resources

One of OIG’s goals was to collect information on using targeted resources developed to aid specific segments of the healthcare industry. Based on results, OIG is ready to consider alternative delivery models that would be more valuable, such as podcasts and videos.

Corporate Integrity Agreements

While Corporate Integrity Agreements are only binding for the individuals or entities that are parties to such agreements, the modernization initiative RFI highlighted several CIA resources available on OIG’s website. To refine internal compliance programs, OIG sought opinions on using publicly available information relating to CIAs.

List of Excluded Individuals and Entities

OIG publishes a list of individuals and entities currently excluded from participation in federally funded healthcare programs, Medicare, or state healthcare programs. The LEIE provides an important safeguard to liability, because an individual who hires a listed person or entity may be subject to civil monetary penalties. However, OIG acknowledged that the presentation and accessibility of these data may be improved and, therefore, sought feedback regarding software applications and how the LEIE may be integrated into onboarding processes for new hires.

Audits and Evaluations

Audits and evaluations are a significant part of OIG’s work in assessing HHS programs and the performance of contractors and grantees. OIG generates and publishes reports of its audits and evaluations, and also summarizes forthcoming and completed evaluations. HHS-OIG’s Work Plan priorities and ongoing audits are available within the Active Work Plan Items, but also within publicly available Semiannual Report to Congress.

The modernization initiative RFI noted that OIG is in the process of upgrading its audit and evaluation resources to include a repository of recommendations. While building this database, OIG requested comments on functionalities that would be most useful to the industry and stakeholders. 

OIG’s Modernization Efforts

Given that OIG has used the RFI mechanism in the past before major changes, it is expected that the agency intends to undertake a significant, multi-year effort to change its guidance practices. Therefore, OIG’s modernization initiative RFI presented healthcare organizations and others operating in the healthcare industry with an opportunity to influence its compliance resources and priorities for the coming years. To create an effective culture of compliance within their organizations, healthcare providers have to be prepared for continuously evolving activities aimed at preventing fraud and ensuring patient safety in the healthcare industry. To achieve this successfully, they can outsource healthcare compliance activities and rely on technology to reduce costs while gaining efficiency. As a result, healthcare organizations can not only increase compliance but also protect themselves from both financial and reputational risk.

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