Earlier today H.R. 6, “21st Century Cures” passed the House  of Representatives by an overwhelming vote of 344-77.  Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent grants and contracting with? the Department of Health of Human Services (HHS). According to a summary of the bill provided by the House Energy and Commerce, section 4006, “would clarify and expand the HHS Office of the Inspector General’s authority to use civil monetary penalties in cases of proven HHS grant or contract fraud.” The text of section 4006 can be found here (starting on page 336). Specifically, section 4006 allows the Secretary of HHS to seek:

  • A maximum of $10,000 per claim for knowingly presenting or causing to be presented a false or fraudulent specified claim under an HHS contract or grant;
  • A maximum of $50,000 for each instance of knowingly making, using, or causing to be made or used a false statement, omission, or misrepresentation of material fact in a document required to be submitted to receive or retain funds under an HHS contract or grant;
  • A maximum of $50,000 per claim or record for knowingly making, using, or causing to be made or used a false record or statement that is material to a false or fraudulent “specified claim”;
  • A maximum of $50,000 per record or statement for knowingly making, using, or causing to be made or used a false record or statement material to an obligation to pay or transmit funds or property owed to HHS with respect to an HHS grant or contract;
  • A maximum $10,000 per day for knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation owed to HHS with respect to an HHS grant or contract;
  • A maximum of $15,000 per day for failing to grant timely access to the HHS Office of Inspector General (OIG) upon reasonable request for audits or to carry out other statutory functions in matters involving an HHS grant or contract.

In addition to these CMPs, HHS can make “assessments” in lieu of damages. These assessments are up to three times the amount claimed under the violations above. Finally, on top of the CMP or the assessment, the provision allows HHS to make a determination “to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program.”

The sizable margin by which Cures passed the House could put pressure to act.  Indications are the Senate would start the process in earnest later this year and seek to complete it in 2016 – which may coincide with the start of the Prescription Drug User Fee Act (PUDFA) legislative process.  We will continue to monitor the path of 21st Century Cures and regardless of the outcome, companies contracting with or receiving grants from HHS should carefully consider provisions such as section 4006.