On September 24, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) to advance its guidance modernization initiative. The RFI seeks industry perspective to assist HHS-OIG with updating its publicly available resources, including program integrity tools, guidance and datasets, to make largescale improvements to compliance efforts. While the RFI primarily expresses HHS-OIG’s intention to update and expand on existing resources, certain suggested policy changes, such as imposing expiration dates on HHS-OIG’s advisory opinions, may present additional hurdles and uncertainty for industry when developing compliance programs or planning business arrangements.

The RFI presents an opportunity to influence HHS-OIG’s compliance resources and priorities for the coming years. Comments to the RFI should be submitted electronically no later than January 31, 2022, for consideration.

IN DEPTH

The RFI, issued by Acting Inspector General Christi Grimm on September 22, 2021, and published in the Federal Register on September 24, 2021, announced a new “modernization initiative” that involves HHS-OIG examining its historical sub-regulatory guidance practices and eliciting feedback from the healthcare community to help inform that examination. The purpose of this initiative is to modernize the accessibility and usability of HHS-OIG’s publicly available resources, including guidance, program integrity resources, publicly available data and advisory opinions. HHS-OIG’s stated goal is to continue producing useful and timely resources that, among other things, advance the healthcare industry’s voluntary compliance and help prevent fraud, waste and abuse. To that end, HHS-OIG requests that stakeholders suggest ways to improve the usefulness, timeliness, accessibility and usability of HHS-OIG’s resources by:

• Providing insights into how stakeholders use HHS-OIG resources

• Identifying the successes and challenges organizations have had using HHS-OIG resources

• Identifying other potential opportunities for HHS-OIG to provide information to the public and other stakeholders.

In addition to expanding resources, HHS-OIG is considering new mediums through which it will provide guidance, including podcasts and video trainings. Acknowledging that data analytics and automated compliance functions are increasingly valuable to stakeholders, the RFI also requests feedback on the accessibility of HHS-OIG datasets and insight into how industry utilizes the available data to develop automated compliance program features, including application programming interfaces.

HHS-OIG states that feedback received will inform its consideration and prioritization of potential updates to existing resources, modifications of processes for developing resources, changes in how data and information are provided to the public, and development of new materials or datasets, as appropriate. While the RFI indicates that HHS-OIG’s modernization initiative will consist of a multi-step, multi-year process, comments on the RFI will likely impact the trajectory of the initiative and HHS-OIG’s reform priorities.

HHS-OIG Resource Overhaul

The RFI presents both general questions and resource-specific questions for consideration. In its “general questions” to industry, HHS-OIG requests feedback across resource categories to determine which are most useful to particular organizations and which areas would benefit from reform. HHS-OIG asks for comments on the types of arrangements, topical areas and industry sectors that could benefit from improved compliance guidance. HHS-OIG seeks suggestions on both formal and informal mechanisms that could be implemented to solicit regular comments from stakeholders in the future. Suggestions on ways to improve resource accessibility for individuals with disabilities and alternate content formats are welcomed. HHS-OIG also seeks to better understand how the healthcare community uses software, technology systems and OIG data for internal compliance programs.

In addition to seeking general feedback, the RFI targets specific resources, 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. HHS-OIG presents the following questions and suggestions for public comment:

• Advisory Opinions

HHS-OIG implemented its advisory opinion process in 1997, and since then the process has resulted in the submission of more than 1,200 requests and the issuance of almost 400 advisory opinions regarding compliance with the Anti-Kickback Statute and its safe harbors, the prohibition on beneficiary inducement, and the Civil Monetary Penalties Law and exclusion statute.

In the RFI, HHS-OIG recognizes and seeks commentary on the balance between providing thorough and detailed analyses and engaging in a more expeditious process. HHS-OIG also invites industry stakeholders to provide feedback on potential reforms to the advisory opinion process related to the complexity of the requests. For example, HHS-OIG suggests introducing a “short-form” opinion that would have less analysis but could potentially be produced faster, or creating a “frequently asked questions” process. Perhaps most importantly, HHS-OIG is considering whether to set “expiration dates” for advisory opinions or require periodic factual recertifications from the requestor. If adopted, this change could redefine the methods by which industry stakeholders rely on advisory opinions as a resource to structure arrangements and analyze risk.

• Fraud Alerts

HHS-OIG invites industry stakeholders to comment on its special fraud alert process. Currently, any person may request at any time that HHS-OIG issue a special fraud alert to inform the public of practices that are of particular concern under Medicare or a state healthcare program. HHS-OIG’s special fraud alerts have focused on national fraud and abuse trends that may violate the Anti-Kickback Statute and the prohibition against beneficiary inducements. HHS-OIG relies on its Office of Evaluation and Inspections, as well as other experts at HHS-OIG, other HHS agencies, other federal and state agencies, and others in the healthcare industry, to generate fraud alerts.

HHS-OIG invites healthcare stakeholders to comment on their experiences with special fraud alerts and make suggestions on what could be done to make these alerts more meaningful.

• Special Advisory Bulletins

If HHS-OIG lacks the enforcement experience necessary to issue a special fraud alert, it may choose to publish instead a special advisory bulletin covering potentially abusive healthcare practices. Special advisory bulletins may also cover certain compliance measures as applied to specific arrangements, warn against arrangements that may violate the Anti-Kickback Statute, or comment on the scope and effect of certain legal prohibitions.

HHS-OIG seeks comments from stakeholders about their experiences with special advisory bulletins and suggestions on ways to make them more meaningful, useful or timely.

• Compliance Program Guidance

Beginning in 1998, HHS-OIG’s compliance program guidance (CPG) documents have outlined positions on the fundamental principles of healthcare compliance programs. They are intended to encourage the voluntary development of compliance programs.

HHS-OIG asks stakeholders to comment on the benefits of CPGs, considerations for publishing additional CPGs and potential improvements to format, such as a web-based document that could be updated more frequently.

• Frequently Asked Questions (FAQs)

The RFI requests feedback on the value of published FAQs and insight into industry’s implementation of this guidance, using the FAQs process that HHS-OIG has employed to address stakeholder questions throughout the COVID-19 pandemic as a model. While HHS-OIG emphasizes that the published FAQs serve as informal, time-limited guidance for mitigating general compliance risks through the COVID-19 regulatory flexibilities, HHS-OIG acknowledges that FAQs allow for expedited responses to complex industry questions.

HHS-OIG seeks comment on how it could improve this process for future health emergencies and how it could implement a similar FAQs process that would continue beyond the context of the pandemic.

• Other Compliance Guidance and Resources

In general, HHS-OIG seeks to understand how industry uses targeted resources developed to aid specific segments of the healthcare industry, such as resources developed specifically for healthcare boards or resources jointly published by HHS-OIG and other agencies or professional associations. HHS-OIG is open to considering alternate delivery models, such as podcasts and videos, depending on the method that will be most valuable.

• Corporate Integrity Agreements (CIAs)

While CIAs are only binding for the individuals or entities that are parties to such agreements, the RFI highlights several CIA resources available on HHS-OIG’s website, such as postings of open CIAs, listings of closed CIAs and FAQs.

HHS-OIG seeks to understand how stakeholders utilize publicly available information relating to CIAs to refine internal compliance programs.

• List of Excluded Individuals/Entities (LEIE)

HHS-OIG publishes a list of individuals and entities currently excluded from participation in federally funded healthcare programs, Medicare or state healthcare programs. The list is available in spreadsheet format or through a searchable database on the LEIE website. 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.

HHS-OIG acknowledges that the presentation and accessibility of these data may be improved, and seeks 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 HHS-OIG’s work in assessing HHS programs and the performance of contractors and grantees. HHS-OIG generates and publishes reports of its audits and evaluations, which may include datasets and recommendations. Published reports may include toolkits and recommendations to assist other similarly situated entities or providers. In addition to publishing reports, HHS-OIG also summarizes forthcoming and completed evaluations. HHS-OIG’s Work Plan priorities and ongoing audits are available on its Active Work Plan Items webpage, and its Semiannual Report to Congress is also publicly available.

The RFI notes that HHS-OIG is in the process of upgrading its audit and evaluation resources to include a repository of recommendations. As HHS-OIG builds this database, it requests comments on functionalities that would be most useful to industry and stakeholders. In addition to requesting general end-user feedback, HHS-OIG is considering releasing the methodologies it employs for generating data and programing codes in specific audits to grant industry added perspective into HHS-OIG’s assessments.

Industry Impact

HHS-OIG’s modernization initiative RFI presents stakeholders with an opportunity to influence its compliance resources and priorities for the coming years. HHS-OIG has used the RFI mechanism in the past as a precursor to major changes, such as revamping the self-disclosure protocol in 2013 and as the start of the Sprint rulemaking process. Therefore, we can expect that HHS-OIG intends to embark on a significant, multi-year effort to change its guidance practices. This effort could include different vehicles and formats for guidance, but also guidance on new topics and industries. Some of HHS-OIG’s suggestions could impact long-term reliability of current resources, such as advisory opinions. Healthcare organizations and others operating in the healthcare industry should consider submitting comments to address HHS-OIG’s questions and express any concerns with potential changes.

Comments are due by January 31, 2022. As HHS-OIG’s modernization initiative progresses, we will continue to provide updates and inform stakeholders of the latest developments.