decisionhealth Newsletters, Answer Books - 2009 Issue 3 (March)
Drugs / Compliance Tips and Tools / As inquiries expand, you should beware drug-maker pitches
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Article Overview
This article explains general compliance concerns that arise when physicians and other providers interact with drug companies. It covers broad risk areas such as inducements, sample-related issues, Internet pharmacy relationships, clinical trials, off-label use, and post-marketing studies, along with the role of government oversight and compliance guidance. The piece is useful for providers, compliance staff, and billing professionals who need a high-level understanding of pharmaceutical-industry interaction risks and related regulatory context.
Why This Topic Matters
Relationships with drug manufacturers can create fraud-and-abuse exposure, billing concerns, and regulatory scrutiny. Understanding the article’s scope helps readers identify whether they need the full compliance guidance before engaging in or reviewing pharmaceutical arrangements.
Article Sections
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Pharmaceutical company interactions and fraud risks
Introduces general compliance concerns in provider relationships with drug companies. Covers broad categories of conduct that may raise fraud, abuse, or ethics issues.
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Internet pharmacy issues
Discusses risks associated with prescribing through online pharmacy arrangements and the need to evaluate legitimacy and oversight of outside companies.
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Clinical drug trials
Summarizes compliance concerns tied to physician participation in research studies. Addresses the general oversight issues that can arise in subject recruitment, payments, and reporting.
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Off-label uses
Covers billing and regulatory concerns related to uses of medications outside program-specific coverage parameters. References federal policy context for off-label drug use.
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Post-marketing studies
Describes compliance concerns in research-like arrangements after a product reaches the market. Focuses on distinguishing bona fide research from marketing-related activity.
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Additional steps to avoid running afoul of OIG requirements
Reviews broader guidance on staying aligned with government compliance expectations. Includes references to model compliance planning and safe-harbor concepts.
What You Will Learn
- Common compliance risks in physician relationships with pharmaceutical companies
- General oversight issues in Internet pharmacy, research, and post-marketing arrangements
- How off-label use and coverage concerns fit into a compliance framework
- The role of government guidance and safe-harbor concepts in provider-drug company interactions
Who Should Read This
- Physicians
- Healthcare providers
- Compliance officers
- Medical billing and coding professionals
- Practice managers
Codes Discussed
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