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Operational challenges of complying with the Sunshine Act

The Physician Payment Sunshine Provision of the PPACA1 – more commonly known as the ‘Sunshine Act’ – will soon require manufacturers to record all ‘transfers of value’ to health care professionals (HCPs). The act’s unprecedented transparency requirements present some very challenging and complex operational requirements. But are the challenges insurmountable?

Here’s the debate:

Current data on aggregate spend is not accurate or precise enough.
Collection and input of data from events and other interactions with HCPs is not always accurate. Also, current and planned Master Data Management (MDM) systems may not be capable of identifying and verifying HCPs with sufficient precision.
Start at the beginning.
Establish standardized processes and strict controls for collecting and inputting data at HCP events. Improvements at the front end can have a positive ripple effect all the way to the back end.
There are too many parties involved.
Collecting and managing data from third parties is tough because there are so many parties involved in events such as speaker programs and advisory boards.
Consolidate vendors and payments.
Establish a short, pre-approved list of contractors who can collect data and facilitate events. Consolidate payments to third parties through one or two preferred vendors.
R&D payments involve complex relationships that are difficult to track.
Clinical trials and other research programs are often conducted through complex consulting relationships between advisory boards and primary investigators.
Disclose by payee, not primary investigator.
Instead of trying to identify all primary investigators, simply disclose the institution that directly received the payment – along with links that allow interested parties to trace the relationship in greater detail.
Emerging transparency requirements around the world create a moving target.
No company wants to make a substantial compliance investment if it will only satisfy the U.S. requirements.
Global transparency requirements are a consideration, not a roadblock.
Keep global requirements in mind when developing your U.S. compliance strategy, but don’t use them as an excuse for inaction.

Our Take

Kurt Conger, Senior Manager, Deloitte Consulting LLP
Gaurica Chacko, Senior Manager, Deloitte and Touche LLP
Scott Graham, Senior Manager, Deloitte Financial Advisory Services LLP

For most life sciences companies, achieving full compliance with the Sunshine Act will be a long and arduous journey. However, every successful journey starts with a first step. In this case, the first step is to gather accurate data.

The process starts with the organization of the event itself. Data collection and verification can be facilitated by having a standard process in place for registering people at the meeting. This can be further streamlined by giving the event management company the ability to manage invitations, verify participants and handle walk-ins by having them sign appropriate documents at the door. It would also help to give event staff access to NPI2 numbers via a web-enabled mobile device. If the attendee doesn’t have an NPI number, the odds are good that he or she should not be there.

Companies also need processes to help ensure that reps input data into the systems correctly. Items such as the purpose or nature of the HCP interaction, the needs assessment (which has recently been coming under greater scrutiny from the OIG3) and even the basics such as the name and address of the practitioner must all be input correctly and thoroughly documented. Simply referring to a meeting at ‘Dr. Smith’s office' is no longer sufficient.

Improving data quality at the front end can dramatically reduce the burden and expense of data clean up on the back end.

Complying with the Sunshine Act is the beginning — and certainly not the end — of a long journey toward full disclosure in the U.S. and abroad. This journey will likely be fraught with twists and turns but it is also capable of delivering substantial benefits that accompany knowing where every dollar is going. Many companies will for the first time have insight into the effectiveness of their aggregate spend versus their competitors’ (as well as the means to identify risks and opportunities that were previously invisible). The companies that come out ahead will be those who use the Sunshine Act to improve not only their reporting capabilities but also their businesses.

1 Patient Protection and Affordable Care Act
2 National Provider Indentifier
3 Office of Inspector General (for U.S. Department of Health and Human Services)

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