• The OIG Issues Advisory Opinion on the Waiver of Cost-Sharing Obligations for Blood Glucose Equipment During Clinical Trial
  • April 27, 2004 | Authors: David E. Matyas; Leah B. Guidry
  • Law Firm: Epstein Becker & Green, P.C. - Washington Office
  • In its first advisory opinion in 2004 (Advisory Opinion No. 04-01), the OIG determined that it would not impose penalties on a medical supplier that waived cost-sharing obligations for self-monitored blood glucose equipment and supplies used by Medicare beneficiaries who are participating in a government sponsored clinical trial.

    The opinion was requested by a supplier of the blood glucose monitors for the clinical trial that proposed providing such supplies free of charge to the participants in the clinical trial while seeking reimbursement from Medicare, Medicaid and other private or public health insurance programs.

    On September 19, 2000, the Center for Medicare & Medicaid Services issued a National Coverage Determination ("NCD") which extended Medicare coverage to the routine costs of qualifying clinical trials and, accordingly extended all program fraud and abuse authorities. Notwithstanding this NCD, the OIG determined that the proposed arrangement would not constitute grounds for the imposition of civil monetary sanctions and, although the arrangement could potentially generate prohibited remuneration under the anti-kickback statute, it would not impose administrative sanctions.

    In reaching its conclusion, the OIG noted that the arrangement "reasonably accommodates the needs of an important, government-sponsored scientific study without posing a significant risk of fraud and abuse." Furthermore, the OIG's decision seems to have been informed by the fact that the clinical trial is "not intended to develop, study, or benefit and specific commercial product" and the resolution of the issues posed by the clinical trial are likely to have a significant impact on the professional medical treatment of the patients targeted by the study, including Medicare beneficiaries.

    Advisory Opinion No. 04-01 can be found on the OIG website at http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2004/ao0401G.pdf.


    For more information about this advisory opinion or the advisory opinion process, please contact David E. Matyas at 202/861-1833, Mr. Matyas' e-mail address is [email protected], or Leah B. Guidry at 202/861-1896, Ms. Guidry's e-mail address is [email protected]

    This publication is provided by Epstein Becker & Green, P.C. for general information purposes; it is not and should not be used as a substitute for legal advice.