R-Squared's Blog

Written By: Marc Adler, Esq.

Written by: Marc Adler, Esq.

A Systemized Approach to Aggregate Spend and the Sunshine Act

Part 2: Harmonizing Data to Enable Efficiency in Reporting 

A Complimentary Webinar from R-Squared

Date: Thursday, April 25, 2013
Time: 1:00pm (Eastern) (60 minutes)

Background:
The breadth and depth of federal reporting required by the new “Sunshine Act” affects manufacturers, distributors and wholesalers of drugs and devices alike.  Meals, consulting fees, gifts, certain educational materials, and more are covered.  And regardless of how much time and thought you’ve given to compliance, the time is now to kick your planning into high gear and initiate a program for aggregate spend that can be supported internally and executed flawlessly.

Aggregate Spend and the Sunshine Act for Distributors and Wholesalers

A Complimentary Webinar from R-Squared 

Date: Thursday, April 18, 2013

Time: 1:00pm (Eastern) (60 minutes)

Background: 

To the surprise of many, the breadth and depth of federal reporting required by the new Sunshine Act now applies to distributors and wholesalers of drugs and devices.  Certain educational materials, meals, consulting fees, gifts, and more are must be captured, processed, and reported accurately and timely.  With a very short window to come into compliance, the time is now to kick your actions into high gear and initiate a program for agg spend compliance that can be supported internally and executed flawlessly. 

Written by: Michael Spaltro, Esq., Compliance Consultant

The Office of Inspector General has issued a Special Fraud Alert that focuses on the practices of physician-owned distributorships or “PODs.” The OIG reiterated its long-standing position that PODs are inherently suspect under the anti-kickback statute and is especially concerned with the proliferation of PODs and physician-owners who earn a disproportionate return on investment.

Written by: Marc Adler, Esq., Principal & Director of Compliance Consulting

Here is the second part of our ongoing Q&A on the Sunshine regulations.  Keep the great questions coming and stay tuned for Part III!

QUESTION 4: CONSIGNMENT

What is the responsibility of a manufacturer that uses independent 3rd party distributors where the sales model is consignment (charges for products do not occur until used by the hospital)? Is consignment considered to be transfer of title?

ANSWER 4:

Typically, in a consignment transaction, title to products on consignment remains with the consignor (here, the manufacturer) until the sale takes place.  A consignment sale is not a true sale until the consignee (i.e., the distributor) actually sells the goods; until then title remains with the owner/consignor/manufacturer.   The agreement between the parties would address these specifics, particularly if the manufacturer is seeking to establish and perfect its security interest in its inventory under the Uniform Commercial Code. Consequently, in such consignment arrangements the distributor likely is considered the agent of the manufacturer, and if so, the manufacturer would be responsible for collecting and submitting the distributor’s spend items. 

A Systemized Approach to Aggregate Spend and the Sunshine Act

Part 1: Finding & Categorizing Spend

A Complimentary Webinar from R-Squared 

Date: Thursday, April 4, 2013

Time: 1:00pm (Eastern) (60 minutes)

Background: 

The breadth and depth of federal reporting required by the new Sunshine Act affects manufacturers, distributors and wholesalers of drugs and devices alike.  Meals, consulting fees, gifts, certain educational materials, and more are covered.  And regardless of how much time and thought you’ve given to compliance, the time is now to kick your planning into high gear and initiate a program for agg spend that can be supported internally and executed flawlessly.

R-Squared’s 3-part series on Aggregate Spend will cover the core topics of (1) Finding & Categorizing Spend, (2) Harmonizing Data to Enable Efficiency in Reporting, and (3) Reporting & Leveraging Data.  By attending all three webinars, participants will have a roadmap on how best to proceed for full compliance.

Written by: Marc Adler, Esq., Director of Compliance Consulting

While I am sure your organization has been primarily focused on efforts to comply with the federal "Sunshine" law as well as filing the Vermont and/or West Virginia disclosure reports, our Compliance Services team wanted to share with you some of the noteworthy aggregate spend bills proposed in 2013 (so far).

Massachusetts

The Massachusetts legislature has proposed amendments that focus on the new quarterly, "non-CME educational presentation" reports enacted into law last year.  Unfortunately for the life sciences industry, however, just as companies were starting to think that the Massachusetts requirements would become less strict, the proposed changes would impose additional burden.  Specifically, bills in the Massachusetts House and Senate, which are now under consideration by the Joint Committee on Public Health, contain the following proposed changes:  

Written by: Marc Adler, Esq., and Allison Whitehead, Esq.

In Compliance Week's recent article "Final Version Provides Little Relief for Complex Sunshine Act," several compliance experts were interviewed, including R-Squared CEO, Mike Bell, to discuss their thoughts on the final regulations. Below is an excerpt from the article. The full article can be found here.