• OIG Anti-Kickback Evaluation Criteria
  • May 16, 2008 | Authors: Robert M. Wolin; Donna S. Clark; B. Scott McBride
  • Law Firm: Baker & Hostetler LLP - Houston Office
  • On April 16, 2008, the HHS Office of Inspector General (OIG) published its draft Supplemental Compliance Program Guidance (CPG) for Nursing Facilities. The draft CPG is designed to help nursing facilities develop and implement programs to address areas of risk and governmental focus in their compliance programs. However, the CPG also contains anti-kickback guidance that should be considered by all healthcare providers and suppliers.

    In particular, the CPG provides a useful list of screening criteria suggested by the OIG to evaluate provider relationships with third parties under the federal anti-kickback statute. Violation of the criteria, however, does not mean that a relationship is improper, only that it warrants further analysis. The OIG's criteria are:

    1. Does the provider or supplier (or its affiliates or representatives) provide anything of value to persons or entities in a position to influence or generate federal healthcare program business for the provider or supplier (or its affiliates), directly or indirectly?
    2. Does the provider or supplier (or its affiliates or representatives) receive anything of value from persons or entities for which it generates federal healthcare program business, directly or indirectly?
    3. Could one purpose of the arrangement be to induce or reward the generation of business payable in whole or in part by a federal healthcare program?
    4. Does the arrangement or practice have a potential to interfere with, or skew, clinical decision-making?
    5. Does the arrangement or practice have a potential to increase costs to federal healthcare programs or beneficiaries?
    6. Does the arrangement or practice have a potential to increase the risk of overutilization or inappropriate utilization?
    7. Does the arrangement or practice raise patient safety or quality of care concerns?
    8. What degree of influence do the parties have, directly or indirectly, on the generation of business for each other?
    9. Were parties to a transaction selected to participate in an arrangement in whole or in part because of their past or anticipated referrals?
    10. Does the remuneration take into account, directly or indirectly, the volume or value of business generated? Is the remuneration conditioned in whole or in part on referrals or other business generated between the parties? Is the arrangement itself conditioned, directly or indirectly, on the volume or value of federal healthcare program business? Is there any service provided other than referrals?
    11. Is the remuneration fair market value in an arm's-length transaction for legitimate, reasonable, and necessary services that are actually rendered? Is the provider or supplier paying an inflated rate to a potential referral source? Is the provider or supplier receiving free or below-market rate items or services from the third party vendor? Is compensation tied, directly or indirectly, to federal healthcare program reimbursement? Is the determination of fair market value based upon a reasonable methodology that is uniformly applied and properly documented?
    12. Are items and services actually needed and rendered, commercially reasonable, and necessary to achieve a legitimate business purpose?
    13. Would acceptance of the remuneration diminish, or appear to diminish, the objectivity of professional judgment? If the remuneration relates to the dissemination of information, is the information complete, accurate, and not misleading?
    14. Is the arrangement properly and fully documented in writing? Are the parties documenting the items and services they provide? Is the provider or supplier monitoring items and services provided by outside vendors? Are arrangements actually conducted according to the terms of the written agreements?