OIG Issues Advisory Opinion
Related to a Clinical Trial
February 13, 2004 - The Office of the Inspector General
(OIG) of the Department of Health and Human Services (HHS)
Feb. 9 posted Advisory
Opinion 04-01, concerning the waiver of Part B cost-sharing
obligations for equipment and supplies used by Medicare beneficiaries
to monitor blood glucose levels in a clinical trial sponsored
by the National Institutes of Health (NIH). The Advisory Opinion
analyzes a clinical trial that is intended to investigate
the best medical approaches for addressing coronary artery
disease in people with Type II diabetes. It will compare the
effectiveness of two different drug therapies, and also compare
the effectiveness of drug therapy combined with early surgery
to drug therapy alone. All patients in the trial will be required
to self-monitor their blood glucose levels. All supplies for
the blood glucose monitoring will be provided to enrolled
patients without charge through an agreement between the National
Heart, Blood, and Lung Institute (NHLBI) and a specified manufacturer.
While the OIG analysis indicates that the arrangement may
implicate section 1128A(a)(5) of the Social Security Act and
the anti-kickback statute, the agency concludes that penalties
would not be imposed "since the Proposed Arrangement
reasonably accommodates the needs of an important, government-sponsored
scientific study without posing a significant risk of fraud
and abuse."
The OIG distinguishes this clinical trial from commercial
or private studies by commenting "since commercial or
private studies pose significantly different risks under the
NCD and the Medicare fraud and abuse authorities, routine
waivers of cost-sharing obligations to enrollees in such studies
would not necessarily be sheltered from civil monetary penalties…or
sanction under the anti-kickback statute, absent an applicable
exception."
Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490
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