decisionhealth Newsletters, Answer Books - 2009 Issue 3 (March)
Anti-Kickback Advisory Opinion Summaries / 2006 OIG Advisory Opinions / Opinion 06-10 - Charity May Expand Scope of Drug Therapy Assistance Program
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Article Overview
This premium advisory-opinion summary explains how the OIG evaluated a nonprofit charity’s assistance program for patients receiving costly drug therapy and why the arrangement was viewed as permissible under the Anti-Kickback Statute. It is relevant to compliance, reimbursement, pharmacy, and health care legal audiences that need to understand the general structure of the program, the role of donors, and the types of safeguards discussed in the opinion. The article focuses on broad fraud-and-abuse considerations and program design features rather than coding guidance.
Why This Topic Matters
Organizations that support patients with medication costs or therapy management need to understand how OIG assesses charity-based assistance arrangements, especially when donor funding comes from entities connected to the products involved. The summary helps readers gauge compliance risk and the policy considerations involved in expanding assistance programs to Medicare beneficiaries.
What You Will Learn
- How OIG analyzed a charity-based drug assistance program under the Anti-Kickback Statute
- What broad safeguards were considered important in the advisory opinion
- Why donor relationships, patient eligibility standards, and data controls matter in these arrangements
- How therapy management support was described in the context of the program
Who Should Read This
- Healthcare compliance professionals
- Health care attorneys
- Pharmacy administrators
- Revenue cycle and reimbursement professionals
- Nonprofit charity administrators
- Medical billing and coding professionals interested in fraud and abuse policy
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