HIPAA; Safe Harbors and Fraud Alerts; Corporate Integrity Agreements

HIPAA: Safe Harbors and Fraud Alerts: Corporate Integrity Agreements
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HIPAA: Safe Harbors and Fraud Alerts: Corporate Integrity Agreements
Health Insurance Portability and Accountability Act (HIPAA) provides a critical blueprint upon which parties operate. HIPAA directions are reinforced by other legal provisions, including Safe Harbors and Fraud Alerts. There is already a mechanism in place geared towards monitoring compliance with HIPAA. For instance, the Special Fraud Alert system is designed to detect and report incidences associated with a lack of accountability or transparency (Stark, 2020). The Special Fraud Alert is a systematic approach to identifying “red flags” from cases that the U.S. Department of Justice has already prosecuted. Such cases include corporates that organize and pay for speaker programs with the intent to influence health care professionals to prescribe, order, or recommend the prescription or order of specific medical products or drugs. The Office of Inspector General is not against genuine and meaningful healthcare provider training and education being facilitated or sponsored by medical and drug-based corporates. The Special Fraud Alert is to enforce compliance with Anti-Kickback Statute. Alerts are issued against different stakeholders, such as healthcare providers, entities, and corporates that violate Anti-Kickback Statute, by favoring particular drugs or medical devices for financial interests (Stark, 2020).
 Medical device corporates sometimes provide remuneration for speaker programs they sponsor during healthcare providers training to influence prescribing, ordering unduly, and recommendations of particular drugs or medical devices, which goes against the principles encapsulated in the Anti-Kickback Statute. Thus, the Special Fraud Alert exists to detect and report corporates who have a history of violating the principles of the Anti-Kickback Statute. The Special Fraud Alert highlights cases of “bad or selfish intention” through various pieces of evidence. These can include abnormally high remunerations or payme...