Compliance and Legal professionals need a strong partner from the Commercial organization to help coordinate the patient assistance OIG response. The role of the Commercial representative is to provide the organizational context within which decisions can be made. Working together, compliance, legal, and commercial can create programs that match revenue optimization with the current risk tolerance within the organization. We can create long-term value that’s resistant to future regulatory clawbacks and fines. But how is it done?

The commercial team is important because it can balance the sales and marketing objectives of the organization with the need for OIG compliance. Starting in the pharmacy, at the patient, and working backward, the commercial team can map out the key financial decision points and optimize the programs to match each product in the portfolio.

In this role, the commercial professional should:

  • Work with the legal team to identify innovative strategies that could meet the needs of State’s Attorneys General while still providing profitable incremental access to patients
  • Challenge the Compliance team to envision and communicate clear patient program guidelines for field sales to appropriately limit the company’s risk
  • Enable a dialog between Legal and Compliance teams – both inside the company and with outside counsel and consultants – to meet the needs of the organization while balancing profits
  • Translate these company policies, procedures, and business rules to patient program vendors/partners to ensure diligent implementation
  • Monitor and provide feedback to all stakeholders, including senior management, to ensure adequate adherence to company policies (make sure the programs run as they were envisioned to run and make course corrections if either profitability or compliances expectations aren’t being met)

To do this, the commercial lead must know the legal frameworks and compliance concerns stemming from the OIG guidelines while also understanding pharmacy transactions at the switch level. Expecting junior level marketers to perform this task, AND having multiple brand teams interacting with Legal and Compliance on a one-off basis is suboptimal. Creating centralized procedures and frameworks reduces Legal and Compliance workflow and reduces operational risk. Furthermore, ‘pushing’ the response to Compliance or Legal to dictate the terms of engagement to Brand teams, may result in an overly restrictive approach. Often neither Legal nor Compliance has the operational scope, expertise, nor manpower to perform program analytics, reporting, or monitoring.

There are subtle program tweaks that may be permissible in some brand or population specific circumstances that are only possible once the rest of the programs at an organization are cleaned up. An organized system enables the potential for calculated risk. A disorganized system creates the likelihood that things will be missed.

  • Who in your organization is empowered to streamline and coordinate your OIG response? Are they too timid? Are they too aggressive?
  • Have you seen the risk mitigation documentation?
  • How, without outside perspective, can you be sure that your response meets the midpoint of the industry? Are you in the top 10%?
  • How’s your coupon and copay data? What’s the cross-over with commercial managed care discounts?
  • How many pharmacies have been eliminated from your coupon network this year for erroneous or malicious or highly dubious claims?

Unless you’re able to answer every one of these questions with specifics, you’re not in the top echelons of the industry. And too many companies are counting on their copay card vendors for these answers. Who do you have looking over their shoulders? The ‘errors’ that you find may not even be a mistake; the cards and programs may be designed that way.

We’ve been there. We’ve seen it all. We can assess your programs and provide a detailed plan for incrementally improving your coupon and copay programs and data reporting. We can introduce you to the best and brightest in the industry, companies who ‘get it’ and we can help you get the most from your program. We can work based on a fee-for-service model or a model where we only get paid if your program proves to be more profitable.

It IS possible to clean up these programs AND become more aligned to your Physician and Patient’s needs. And that will be the subject of another blog post.

Please contact us via our info page for more information regarding how we can help coordinate your OIG response AND provide more net revenues to your organization.


Please note that ChiralLogic cannot and will not provide Legal or Compliance advice or recommendations. We work with your Legal and Compliance team to create a response that matches your organizational risk tolerance and shareholder expectations.

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