It s Spring! Are You Ready for the Sunshine (Act)?

After extensive review and revision, the Centers for Medicaid and Medicare has at long last published the Physician Payment Sunshine Act final rule. This is the legislation that will require manufacturers of pharmaceuticals, biologic medical products, medical devices and medical supplies to track and report payments, gifts or other transfers of value to physicians or teaching hospitals (also known as covered recipients).

Data collection begins August 1, and data for August through December must be reported by March 31, 2014. Unwittingly failing to report a transfer of value can result in penalties of between $1,000 and $10,000 per transaction, up to $150,000 per year. Knowingly failing to report a payment can incur penalties ranging from $10,000 to $100,000 per transaction, with a combined maximum total penalty of $1.15 million.

While most product samples intended for patient use are excluded by the act, there is consensus among life sciences companies that marketing and point-of-sale materials are subject to reporting. Given the proximity of the data collection start date, now would be a good time to look at your internal systems and processes, if you handle fulfillment in-house. If you outsource production and fulfillment, you should check in with your vendors and bring them up to speed on what you need to be compliant with the new regulations.

One basic tool that will help you enormously in meeting the new requirements is an online ordering system. Most basic online systems allow you to set user access and ordering privileges, as well as to track and report on who places orders and where they're sent information that can help you control inventory levels and usage to stay within budget parameters.

Better online systems can offer capabilities that help you with actual compliance issues for example, automatic pop-up messaging that requires users to acknowledge applicable terms or conditions before a document can be ordered. This helps your users stay within compliance parameters and provides an audit trail to protect your company against claims of misuse.

Iron Mountain Fulfillment Services' online ordering system goes a step further by incorporating a Sunshine Act tool to track the value of materials ordered through the system. We'll be demonstrating this, along with other compliance and marketing fulfillment solutions, at INTERPHEX 2013, April 23-25, in New York City. Register as our guest and receive free exhibit hall admission and 50% off conference passes. Hope to see you at Booth 1672!

LINK:	http://blog.ironmountain.com/2013/healthcare-information-management/it...
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