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The Physician Payment Sunshine Act, passed in March, 2010, requires manufacturers of drugs, medical devices, medical supply and biologicals to capture and report certain payments and items of value given to physicians and teaching hospitals.  In addition, manufacturers and group purchasing (GPOs) must report certain ownership interests held by physicians and their immediate family members. 

 

After several extensions by the Department of Health and Human Services (HHS), these companies are now faced with a compressed time schedule to comply with aggregate spend regulations and avoid penalties for non-compliance.

 

These companies must begin recording aggregate spend information by August 1, 2013 and the first is due March 31, 2014 to the Department of Health and Human Services (HHS) and must in an electronic, easily downloadable, and searchable format.  Payments under $10 are excluded, but only if the total spent on the Health Care Provider (HCP) is less than $100 annually.  

 

Monetary penalties can be incurred from $1000 to $10,000 for each payment not reported (not to exceed $150,000 annually) and intentionally failing to report can result in a penalty of $10,000 to $100,000 for each payment (not to exceed $1,000,000 annually).  

 

Adherence to the Sunshine Act can present formidable challenges  

 

The following is a list of considerations that can increase the complexity of Sunshine Act compliance and drive home the importance of a disciplined approach to developing the needed policies, procedures, data capture, certification, and reporting:  

  • Most companies use multiple systems for different HCP payments that can vary from sales force systems, expense reporting, education and event management, research grants, and trade show materials to name a few. This also means that various departmental personnel may contribute to the data capture and aggregation requiring consistent policies and procedures.
  • Since many of the affected companies have world-wide organizations, the impact on global legislation and the Foreign Corrupt Practices Act (FCPA) policies and processes needs to be considered.  
  • Adding to the complexity, several states have additional laws that need to be integrated to assure compliance.  
  • Systems, policies and procedures may need to be modified to ensure accurate data capture and proper categorization of payment type categories consistently by both employees and across systems.  
  • In order to minimize errors, audit failures and potential fines, the processes and systems need to be able to monitor transactions, generate alerts, resolve issues, and produce a scalable, audit-able and repeatable set of processes.  

Compliancy’s FastTrack Solution  

 

Compliancy’s FastTrack solution for the Sunshine Act can quickly make sure that your company is correctly capturing the correct data for the initial compliance deadline.   From there, Compliancy can help you take the necessary steps to address any of the above complexities and ensure compliance.  

 

The Compliancy FastTrack solution is staged to improve efficiencies and cost effectiveness:  

 

First Stage: Assessment  

The first stage is an assessment of the current status of data capture to meet the regulatory guidelines.  

 

Second Stage:  Adjustment  

The second stage is aimed at addressing any deficiencies to ensure data is being captured, attributed to the correct HCP, can be aggregated and reports can be derived from the data that are electronic, easily downloadable and searchable.  

 

Third Stage: Automation  

The third stage introduces automation and business intelligence to ensure the compliance regulations are met on an ongoing, cost effective basis.  

 

Compliancy’s FastTrack provides a fast and easier way to make sure you can be compliant with the Sunshine Act for both the near term deadlines and the future ongoing reporting.  More importantly, your company can be assured of reliable, audit-able, scalable, and repeatable processes complete with monitoring, alerts and automated issue management to ensure compliance by your employees on a local and global basis.  

 

Capabilities that make a difference in reducing risk

The following are just a few of the benefits and capabilities gained with Compliancy.

  • Comprehensive data capture, strong enforcement and proof of compliance. Comprehensive automated alerts, notifications and follow-up along with complete documentation, record keeping, and audit automation.
  • Easier implementation, utilization and management.   Web based with re-utilization of current forms and processes, visual mapping, templates, Individualized Task Routing for reduced training and support and management Dashboard tools with drill down for faster and more effective risk management.  
  • Mobile access from smart phones and tablets.  Forms are optimized for each device; automatically detected by the system and users can switch between mobile and desktops/laptops on the same form.  
  • Granular access security and electronic sign-off.  Access control for any level of detail to ensure that the right individuals have access to only authorized processes, documentation, and systems.  Complete routing for approval at any and all levels for electronic signature. 
  • World-wide integration.  Consistent forms, documents, and processes across divisions, third-parties, and geographies to reduce cost and simplify utilization.
  • World-wide view of third parties and all compliance activities.  Customer Partner Portal for ensuring third party compliance and GlobalTrak for Dashboard level management and drill down of all company and third party activities.  

Contact Compliancy today to learn more about Compliancy's FastTrack solution for Sunshine Act compliance.  

 

For more information contact us at info@compliancy.com or call +1-919-806-4343.

 

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