Sources for HHS OIG Fraud, Waste, and Abuse Guidelines
The HHS OIG fraud, waste, and abuse guidelines are intended to support healthcare organizations in their efforts to self-monitor compliance with all applicable laws and program requirements. The guidelines can be found in many different sources, including guidance documents, advisory opinions, online training programs, and the HHS OIG YouTube channel.
The healthcare industry is one of the most highly regulated industries in the U.S. Federal rules and regulations exist that govern patient safety (i.e., PSQIA), data security (i.e., HIPAA), and the physical environment (i.e., OSHA). In addition, each state has its own requirements for licensing healthcare organizations and healthcare practitioners. Failure to comply with these rules, regulations, and requirements can result in fines, facility closures, and/or loss of license.
However, the most substantial penalties for non-compliance are often reserved for offenses against the federal government – particularly offenses that relate to fraud, waste, and abuse against a healthcare program operated by the Department of Health and Human Services (HHS). If an individual or organization is found guilty of misconduct against an HHS program, they could face a multi-million dollar fine, a jail sentence, and/or exclusion from HHS programs.
How Guidelines Help Reduce Fraud, Waste, and Abuse
Investigations into misconduct against HHS programs are carried out by the HHS Office of Inspector General (OIG). Despite employing more than 1,650 auditors, evaluators, and investigators, HHS OIG cannot be in all places at all times. Therefore, it asks healthcare organizations to self-monitor compliance with all applicable laws and program requirements, self-disclose violations, and take corrective actions to prevent violations from re-occurring.
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To support healthcare organizations in their efforts to self-monitor compliance, the Office of Inspector General publishes HHS fraud, waste, and abuse guidelines. The guidelines can be applied by healthcare organizations to help prioritize compliance efforts, integrate policies that reduce fraud, waste, and abuse with other operational policies, and train members of the workforce on recognizing fraud, waste, and abuse – and reporting it when they see it.
Sources of HHS OIG Fraud, Waste, and Abuse Guidelines
HHS OIG fraud, waste, and abuse guidelines can be found in multiple sources. One of the best sources is the HHS OIG website which includes a section dedicated to compliance. Within this section, there are links to the General Compliance Program Guidance, a comprehensive database of Frequently Asked Questions, multiple HHS OIG’s Advisory Opinions, links to download the RAT-STATS analytical software and instructions on how to use it.
General Compliance Program Guidance
The General Compliance Program Guidance contains an overview of the most important regulations published by HHS to combat fraud, waste, and abuse in healthcare. These include the Anti-Kickback Regulations, Stark Law, and the False Claims Act. HIPAA also gets a mention because of the Security and Breach Notification Rules – but there is no guidance on Part 162 compliance for organizations involved in billing and electronic fund transfers.
Most of the remainder of the document covers the seven elements of a compliance program and how small or large healthcare organizations can right-size compliance programs to meet organizational requirements. There are also additional sections linking to compliance toolkits and providing further information on subjects such as HHS OIG bulletins and fraud alerts, Corporate Integrity Agreements, and how to self-disclose fraud, waste, and abuse.
The Frequently Asked Questions Database
Although the link to the Frequently Asked Questions database appears at the bottom of the list of compliance subjects, it can be a mine of useful information for healthcare organizations in situations not covered by the general HHS OIG fraud, waste, and abuse guidelines. A recent example is hospitals that provide free naloxone rescue kits to Medicare beneficiaries in potential violation of the Anti-Kickback regulations when HHS OIG Safe Harbor regulations do not apply.
However, it is important to be aware that the answers to the FAQs are informal and non-binding – and can be changed at a later date (without notice) due to a change in regulations. Indeed, HHS OIG notes in the preamble to the FAQ database “the answers published on this page do not confer prospective immunity from OIG administrative sanctions on any party.” Organizations searching the FAQs for binding answers are advised to review the HHS OIG’s advisory opinions.
HHS OIG’s Advisory Opinions
Compared to the informality of the FAQs, the HHS OIG’s advisory opinions are legally binding opinions issued by HHS OIG in response to issues raised by healthcare organizations about how the fraud, waste, and abuse regulations apply in specific circumstances. Advisory opinions can be “favorable” or “unfavorable” depending on how HHS OIG has interpreted the issue – favorable opinions protecting a healthcare organization from enforcement action.
This section is an excellent source of HHS OIG fraud, waste, and abuse guidelines for circumstances not covered elsewhere. The section has a database of advisory opinions that can be searched by keyword, but it is important to be aware that protection from enforcement action only applies to the healthcare organization that requested (and paid for) the opinion. It does not protect other organizations, even though the exact same circumstances may exist.
RAT-STATS Analytical Software
The RAT-STATS analytical software is just one of the compliance toolkits mentioned in the General Compliance Program Guidance, but it is worth mentioning in isolation because it is the same software as is used by HHS OIG to sample, identify, and quantify fraudulent claims for reimbursement. In this respect, the OIG compliance software can be used by healthcare organizations to identify claims that may have been submitted incorrectly due to a failure of their billing processes.
RAT-STATS is free to download and use, but it has been criticized for being complicated. The user guide is 394 pages in length, and the companion guide adds a further 245 pages to study. Healthcare organizations looking to take advantage of the software to identify overpayments (and possible underpayments) are advised to review the HHS OIG’s YouTube guides and speak with a compliance professional with experience in using the software before downloading it.
Further Sources to Support HHS OIG Compliance Efforts
It was mentioned above that HHS OIG has YouTube guides on how to use the RAT-STATS software. Thes guides represent a handful of the 200+ videos on the OIGatHHS YouTube channel – including sixteen recorded for the HEAT Provider Compliance Training webcast in 2011. Although more than a decade old and mostly aimed at larger healthcare organizations, the HHS OIG fraud, waste, and abuse guidelines provided in these videos are still relevant.
A possibly more effective source for workforce training on the HHS OIG fraud, waste, and abuse guidelines is the Medicare Learning Network’s web-based training. One module in particular can help reduce fraud, waste, and abuse in a healthcare organization – Combating Medicare Parts C and D Fraud, Waste, & Abuse – as this module ends with an assessment that produces a certificate for workforce members who achieve a 70% or higher pass rate.
Might There Soon be Changes to HHS OIG Compliance?
In September 2021, HHS OIG issued a Request for Information (RFI) about how the usefulness and timeliness of HHS OIG fraud, waste, and abuse guidelines could be enhanced and how their accessibility and usability could be improved. Among the questions asked by the RFI were:
- What type of data or other information could OIG provide to the health care industry to facilitate compliance and program integrity efforts?
- If you have ever considered submitting an advisory opinion request and elected not to do so, why did you not submit a request?
- How, if at all, do you or your organization use General Compliance Program Guidance to understand compliance best practices?
- Which HHS OIG fraud alerts, if any, have you or your organization used as a resource, and how have you used them?
- How, if at all, do you and your organization use HHS OIG’s other compliance resources, like our video training and podcasts?
- What, if anything, could HHS OIG do to make our other compliance resources more useful, relevant, and timely?
- If HHS OIG publishes an API for the HHS OIG Exclusions List, would that be useful to you or your organization?
- What software or app, if any, do you currently use to check the Exclusions List? Is the software or app developed internally or by a third party?
- Does the software or app automate the process of checking the Exclusions List? If so, does it integrate the results with other provider information?
- How could HHS OIG use its toolkits or other resources to help organizations identify compliance risks or improve their compliance programs?
At present, there are multiple changes to HIPAA, the Social Security Act, and the conditions for participation in Medicare and Medicaid being considered. While the 2021 RFI does not imply changes will be made to HHS OIG compliance requirements, the possibility exists that changes may be made to the ways in which compliance with regulations related to fraud and abuse is enforced. Healthcare organizations are advised to keep up to date with potential changes to HHS OIG compliance activities and seek professional compliance advice if required.
