decisionhealth Newsletters, Coder Pink Sheets - 2003 Issue 12 (December)
Purchasing Hyalgon or Synvisc from Canada ? Buyer Beware!
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Article Overview
This article explains why buying certain office-administered drugs from Canada can raise U.S. regulatory and billing concerns even when reimbursement is occurring from private payers or Medicare. It is aimed at practices, billers, and coders who need to understand the distinction between payment acceptance and legal compliance, along with the roles of the FDA, CMS, and the False Claims Act in this context. The discussion covers drug importation, re-importation, and a related federal enforcement action involving Canadian drug sellers.
Why This Topic Matters
The topic matters because a practice may appear to be properly reimbursed while still facing legal or compliance exposure related to drug sourcing and claims submission. Understanding the regulatory landscape helps offices evaluate risk before billing for medications obtained outside the U.S. supply chain.
What You Will Learn
- Why drug sourcing can matter for office billing and compliance
- How FDA jurisdiction differs from Medicare payment considerations
- What general risks are associated with Canadian drug purchase and re-importation
- Why federal enforcement actions can affect office drug procurement choices
Who Should Read This
- Medical practice administrators
- Medical coders
- Billers
- Compliance staff
- Physician office managers
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