False Claims Act (FCA)

Under the False Claims Act, those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds are liable for three times the government’s damages plus civil penalties of $10,781 to $21,563 per false claim.

Health Science Center researchers must follow billing compliance policies, standards, and processes so no participant or third party payer is billed for any services that a Sponsor has provided or offered funds for. Even if the services are considered standard of care or medically necessary and even if it is the hospital receiving the insurance reimbursement and the University is receiving the Sponsor’s funds, this is a form of a False Claim.

Other Regulations Pertinent to False Claims

There are many statutes that deal with false claims and/or research issues. Note that these regulations can be appended to one another, so they are not mutually exclusive. A violation of one may also be a violation of another. These statues include, but are not limited to, the following:

• Anti-kickback – Anti-kickback Statute – 42 USCA § 1320a-7b (a) and Anti-kickback regulations – 42 CFR Part 1001
• The Common Rule – http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
• Conflict of Interest – UF College of Medicine Conflict of Interest Program
• False or Fraudulent Claims – False, Fictitious, or Fraudulent Claims – U.S. Code 18 USCA § 287.
• Financial Disclosure By Clinical Investigators – FDA Regulation -21 CFR Parts 54
• Health Insurance Portability and Accountability Act – http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.html
• Institutional Review Boards – FDA Regulation – 21 CFR Parts 56
• Mail Fraud – Mail fraud statute – 18 USCA §1341
• Patient Privacy – University of Florida Privacy Office.
• Patient Protection and Affordable Care Act 2010 –http://www.healthcare.gov/law/full/
• Protection of Human Subjects – FDA Regulation -21 CFR Parts 50
• Qui-tam – The statute providing private qui tam actions – 31 USCA § 3730(b).
• Wire fraud – 18 USCA § 1343.