Healthcare industry investigations are often extremely complex given the intricate set of overlapping healthcare statutes, regulations, and executive orders. However, healthcare enforcement actions aimed at detecting and aggressively investigating healthcare fraud and abuse are among the top priorities.
At the very least, a healthcare investigation can be costly and disrupting for businesses but also lead to civil fines, incarceration, and other criminal and administrative penalties. Therefore, it is critical that healthcare providers and organizations prepare for potential criminal, civil, or administrative risks, and prevent involvement in healthcare enforcement actions.
Healthcare Enforcement Actions against Providers
There are two levels of enforcing laws and rules applicable to the delivery of healthcare in the US – the federal law enforcement system run by the federal government and a state law enforcement system run individually by each state government.
As a federal agency, the HHS Office of Inspector General’s primary responsibility is protecting the federal government from waste, fraud, and abuse within Medicare and Medicaid, and other HHS programs. Most importantly, the OIG has the power to conduct healthcare enforcement actions and investigations, and take civil and criminal legal actions, thus creating significant concerns and potential consequences for healthcare providers.
Given today’s heightened focus on waste, fraud, and abuse, OIG investigations are often conducted as parallel proceedings, meaning that information obtained by investigators can be shared for the purposes of pursuing both civil and criminal action.
Examples of healthcare enforcement actions resulting from the OIG’s work can include:
- Civil monetary penalties (CMPs),
- Individual or entity exclusion,
- Recoupment or restitution,
- Assessment of risks for future fraud, which can result in additional oversite or the obligations to continue participation in federal healthcare programs,
- Corporate Integrity Agreements (CIAs) and Integrity Agreements (IAs) reached through settlements that may lead to exclusion in case of a breach, or
- Criminal prosecution and potential incarceration in federal prison.
OIG Information Requests and Investigations
When initiating more formal steps to investigate healthcare providers for possible violations of the False Claims Act, the Anti-Kickback Statute, or the Stark Law, the OIG generally requests more information from providers. These requests may involve:
- OIG subpoenas as formal legal requests for healthcare providers to provide information to investigators. This usually includes billing records, financial documents, marketing materials, and email communications. Subpoenas are a significant first step in healthcare enforcement actions and they can have potential civil or criminal implications. Therefore, providers who receive them should immediately structure an approach for responding to requests, evaluate the overall direction of investigations, and take necessary steps to seek resolutions.
- In some cases, the OIG may contact healthcare providers and ask to speak with them, even though the providers they wish to speak with are not the target of an investigation. However, providers should exercise caution as these requests can also pose risks.
- In some severe cases, especially when providers ignore initial requests for information or subpoenas, the OIG may come in an unannounced visit to collect files and materials for their investigations.
In any situation involving the OIG information requests, healthcare providers need to understand the seriousness of these initial steps and take necessary measures instead of ignoring them. The same applies to any requests in relation to False Claims violations.
Coronavirus and the Heightened Risk of Healthcare Enforcement Actions
During 2020, the federal government has dedicated a large number of resources to containing and treating the Coronavirus (COVID-19) and stimulating the economy in response to the pandemic. It has also waived many federal health program requirements to allow providers greater flexibility in combatting the virus.
Since the beginning of the COVID-19 nationwide spread, the public was urged to report any COVID-19-related fraud schemes, and a significant number of healthcare enforcement actions have been conducted. This trend includes claims regarding funds allocated as part of the Coronavirus Aid, Relief and Economic Security (CARES) Act, including funds provided to healthcare providers through the Provider Relief Fund. Taking all this into consideration, healthcare providers and all businesses receiving these funds should be prepared for increased scrutiny of how their money is put to use.
Mitigating the Risk of Healthcare Enforcement Actions
The seriousness of OIG information requests, investigations, and healthcare enforcement actions cannot be understated as they can have disastrous results on healthcare providers. Failing to address these issues in the early stages can limit opportunities for pursuing a favorable path for resolution, and potentially lead to devastating final healthcare enforcement actions.
For these reasons, healthcare providers need to limit their exposure to fraud investigations or healthcare enforcement actions. This is even more important in the time of the COVID-19 crisis, when usual and customary ways of providing and billing for healthcare services may not be feasible. Therefore, healthcare organizations need to establish an approach that encourages identification and investigation of potential issues to handle them effectively as well as to stay current on healthcare enforcement trends.
In addition to this, with electronic exclusion software, healthcare providers can ensure effective compliance because the system captures all available data, both externally and internally. As a result, healthcare organizations can stay informed, adapt to changing conditions, and establish healthcare compliance practices.