decisionhealth Newsletters, Answer Books - 2009 Issue 4 (April)
Anti-Kickback Advisory Opinion Summaries / 2002 OIG Advisory Opinions / Opinion 02-13 - Pharmaceutical Company's Financial Assistance Program Banned
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Article Overview
This summary reviews a 2002 Office of Inspector General advisory opinion involving a pharmaceutical manufacturer, a nonprofit foundation, and patient financial assistance for copayments. It explains the general compliance concerns discussed by OIG, including anti-kickback risk, Medicare cost shifting, competitive concerns, and the availability of alternative foundation-based assistance structures. The piece is relevant to compliance professionals, pharmacy benefit stakeholders, and healthcare organizations that monitor manufacturer support programs.
Why This Topic Matters
It helps readers understand why certain manufacturer-funded assistance arrangements may raise federal fraud-and-abuse concerns and how OIG distinguishes them from other foundation-based aid models.
What You Will Learn
- What the 2002 OIG advisory opinion addressed
- Why patient copayment assistance arrangements can raise compliance concerns
- What general fraud-and-abuse issues OIG considered
- How alternative charitable assistance structures are discussed in the advisory opinion context
Who Should Read This
- Healthcare compliance officers
- Pharmaceutical manufacturers
- Pharmacy benefit stakeholders
- Healthcare legal counsel
- Revenue cycle and patient assistance program staff
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