Short Course:

Coming in April

Field Compliance Monitoring

Our third Alliance “short course” will focus on how to establish an effective compliance program specific to your employee and contractor interactions with healthcare practitioners (HCPs). Why is this compliance effort so critical to your company?  Simply stated: Risk. Risk to corporate integrity and good name. Risk around effective healthcare practices. Risk of criminal and civil penalties.

The HHS Office of Inspector General (OIG) stated this very succinctly when they issued industry guidance 15 years ago. “The OIG believes a comprehensive compliance program provides a mechanism that addresses the public and private sectors’ mutual goals of reducing fraud and abuse; enhancing healthcare provider operational functions; improving the quality of healthcare services; and reducing the cost of healthcare.” It is the responsibility of the pharmaceutical industry to implement compliance strategies to reduce the potential for off-label promotion and violations of the Anti-Kickback statute. This one-day, intensive, short course will (1) help define what your Field Compliance Monitoring program should look like, and (2) educate “monitors” on how to properly respond to real or perceived violations identified during their critical compliance role.

Laws, Regulations & Guidance - At the outset, we need to understand corporate best practices and the legal do’s & don’ts around pharma sales promotions and other HCP interactions. This session will provide that framework, from which our compliance efforts flow.

Identifying Specific Risks - What are the internal and external process related risks? Are there risks unique to specific products? Understanding the corporate and individual risks, specific to program or issue type, is a critical step in ensuring compliance.

Monitoring - This session will focus on the substance of our efforts around Speaker Programs, Ride-Alongs, Record Reviews, Consultants, Publications, Grants, and Researchers; including a discussion of objectives, scope, team, templates, coverage, reporting, and corrective action. Also: Are existing policies, SOPs, and Training consistent with our efforts and identified risks?

Corporate Integrity Agreements - This is the “What have we learned?” segment of the day. There is an abundance of federal guidance to be found by studying past violations and the resulting CIAs. We will walk through a sampling of past and not so past CIA history, highlighting well-defined government expectations.

Open Forum - In group discussion, we will open the floor to your questions and concerns, providing you with the added opportunity to learn from the experiences of your peers.

 

Questions? You can reach us at mail@sharingalliance.org or call 914-747-1400.

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