Regulations targeting health-care fraud are increasing in scope and intensity, causing a stir among both established and emerging players in the sector. Compliance challenges are particularly pronounced for entities harnessing new technologies, as well as data outliers, those considered to be capitalizing on ambiguous requirements, as well as providers failing to ensure patient data security. Moreover, sectors grappling with allegations of kickbacks, unnecessary services, and services not provided also fall within the regulatory radar.
Companies operating in the managed care space, digital health providers, telemedicine-related telemarketers, innovative labs, diagnostics companies, pharmaceuticals, nursing homes, hospice providers, and private equity-owned companies, are particularly susceptible to scrutiny. Amidst the rising regulatory burdens and potential trapping, there are protective measures entities can execute to manage potential exposures.
New Technologies
Technological innovations, including artificial intelligence, digital medicine, or remote patient monitoring, amplify compliance challenges and unwittingly attract regulatory attention. Mounting vigilance from the Biden administration foregrounds the need to devise stringent plans for responsible AI use. The need to evolve compliance programs to match the pace of technology deployment is more critical than ever.
Data Outliers
Data mining has become a potent tool for both federal and state governments to catch outliers. High-risk exposure to data mining affects healthcare service providers, entities in the managed care field, and pharmaceutical companies. Providers may consider proactive data mining to anticipate potential outlier trends and initiate internal investigations where needed. Early detection and swift correction measures are crucial to managing misconduct allegations.
Exploitation Perception
Healthcare industry operators are grappling with a maze of rules, requirements, and directives that often leave room for interpretation. There’s a growing debate on whether fraudulent intent under the False Claims Act can be tied to the defendant’s misinterpretation of an ambiguous directive. The US Supreme Court, in 2023, ruled that an ambiguous requirement does not excuse a provider’s noncompliance. To parry potential allegations of fraudulent intent, entities would do well to create contemporaneous, non-privileged records explaining their interpretations of potentially ambiguous requirements.
Patient Data Safeguards
Given the swift advancement of AI, increasing cybercrime sophistication, telemedicine expansion, and rising patient data marketability, enforcement is likely to tighten around health privacy. The Department of Justice’s Civil Cyber-Fraud Initiative, which seeks to penalize parties providing deficient cybersecurity products or services, exemplifies the need for vigilant patient data safeguarding and responsible reporting of breaches.
Kickbacks, Medical Necessity
The steady persistence of kickback allegations and issues related to needless services and unprovided billed services necessitate a revisited focus on compliance basics.
Covid-19
Reliable detections of Covid-19-related fraud cases and investigations relating to abuse of pandemic relief measures reiterate the importance of internal inspections and appropriate self-disclosure considerations.
The Department of Justice has recently announced plans to recruit additional criminal health-care fraud prosecutors, and health-care enforcers are abundant with resources. The key may be the construction of solid compliance programs, anticipating trouble, and acting promptly.