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Gaining Control Over HCP Spend

A medical device manufacturer meets compliance obligations with a custom application


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Abstract

A U.S. based medical device manufacturer with global operations and multiple divisions needed to meet newly enacted, more stringent Healthcare Provider (HCP.) Spend reporting and compliance requirements for both Massachusetts and Vermont. Its solutions not only manages HCP Spend transactions, but also helps the company comply with several important components of its Corporate Integrity Agreement (CIA).

The Challenge

The U.S. federal government and various states have passed legislation that requires medical device manufacturers to report certain gifts and payments made to healthcare providers. Failing to comply can lead to fines for each unreported payment as well as potential reputational damage (since any unreported payments, no matter how inadvertent, can give the appearance of trying to "hide something".) With new laws taking effect in both Massachusetts and Vermont, the company needed to develop an efficient compliance process. It was also bound by a Corporate Integrity Agreement (CIA) to implement certain controls and collect data related to HCP Spend.

How We Helped

Deloitte practitioners worked with the company to develop what was essentially a new capability to better manage data and implement controls governing HCP Spend. The project defined corporate policies regarding the "when, why, how and how much" aspects of payments to healthcare providers and established processes that take advantage of business process management (BPM) software and other new technology capabilities to automate workflow and improve controls, data quality and usability.

The solution includes three major components:

  • A spend transaction repository used to manage requests for contracted HCP Spend transactions (e.g. speaker contracts, consulting arrangements, grants, charitable donations) and non-contracted transactions (e.g. plant visits, meals)
  • Integration components to collect data from the company's legacy systems
  • A reporting and analytics repository to generate state-specific reports and proactively manage HCP Spend

A custom application houses and manages all providers involved in HCP Spend transactions, drawing from a database of some 4 million potential providers. the system allows the company to search for and add new HCPs, as well as exchange HCP data with a third-party HCP data provider.

Solution

The company has transformed the way it manages HCP Spend. What used to be a collection of largely ad hoc, manual processes in now a fully integrated and automated system that allows the company to collect high-quality data and enforce compliance controls. The company is able to meet the reporting requirements of Massachusetts, Vermont and the upcoming Sunshine Act, as well as fulfill its CIA obligations. Even more, its new technology and well thought-out controls procedures make it better prepared to meet reporting and compliance needs that may arise in the future.

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