With the Center for Medicare & Medicaid Services (CMS) delaying implementation of a key section of the Affordable Care Act, manufacturers will have more time to ensure customer relationships will not be negatively affected by transparency.

The industry was expecting the final rule sometime in early 2012, which would require the collection of data in 2012, with disclosure to CMS in the spring of 2013. However, in May of this year, CMS announced that it would not require data collection by applicable manufacturers and group purchasing organizations before January 1, 2013, in order to provide time for organizations to prepare for data submission. CMS made this decision in response to the more than 300 comments they received during the comment period of the proposed rule, and to afford more time to prepare for data collection.

It should be a given that manufacturers utilize this delay to ensure that data collected from internal and external sources is aligned with what is required under the current proposed rule and industry best practices; that each customer exists with a unique ID and is maintained to capture changes to important demographic data on an ongoing basis; and that aggregation by each unique customer is technically possible for the purpose of disclosure, alerts/warnings and analysis.

Also during this time, manufacturers should begin, if they haven’t already done so, to prepare for the impact of the “Sunshine Act” on their relationships with customers. The goal should be how to strike a balance between the scrutiny and “perception” of financial interactions with your customers and the advancement of medical science. This can be accomplished by:

  1. Providing a channel for your customers to understand and challenge individual spend transactions
  2. Assisting in managing customers reputations
  3. Enhancing PR and marketing campaigns to include the benefits of relationships between manufacturers and healthcare practitioners.

In order for manufacturers to provide a channel for customers to understand and challenge individual spend transactions, manufacturers should consider a solution that provides customers with the ability to easily log onto a website during a set timeframe to review applicable transactions. This process is not necessarily an approval process, but rather provides the customer with the ability to review and alert the manufacturer of any discrepancies. The solution should also enable the adjudication process to address any discrepancies.

Regarding my second point, manufacturers can help manage customer reputations by proactively scanning social media outlets, efficiently making corrections to inaccurately reported data, and responding to negative messaging regarding customers.

Lastly, manufacturers and/or the professional associations that they belong to should consider enhancing PR and marketing campaigns to include the benefits of relationships between manufacturers and healthcare practitioners. This may include proactively responding to poor public opinions about the industry and starting open communications to the public about how the industry works with healthcare professionals and organizations to develop therapies, which in the end, benefits patient care.

As the overall reputation of a company continues to be as important as a company’s products, manufacturers may need to re-think their approach to transparency and look at it not as an additional administrative layer or as a support function, but rather as a potential long-lasting competitive advantage for the company.

  • Bill Buzzeo

    Bill Buzzeo is an authority on regulatory requirements facing today's pharmaceutical industry, specifically those involving the Prescription Drug Marketing Act (PDMA); international, federal, and state transparency and reporting requirements; and the Controlled Substances Act (CSA).


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