R-Squared Compliance Quick Reference Guides Available

For members of this website, R-Squared has made available its Compliance Quick Reference (CQR) guides for notable aggregate spend disclosure and gift ban laws, including Massachusetts, Vermont and the federal “Sunshine” law.   These resources serve as an easy-to-read-and-navigate guide to the new requirements.  In each guide, the relevant statute and regulation is explained in a simple Question and Answer format, highlighting the challenges, nuances and potential opportunities embedded in the law’s requirements.

Please click on the following links in order to access the CQRs for Massachusetts, Vermont and the federal “Sunshine” law.

The May 17th, 2011, version of the Vermont CQR is only available to clients and paid subscription members.

If you have any trouble opening or downloading the files, please call or email us at info@r2ss.com.

R-Squared Conducting Agg Spend Mini Summit for Medical Device Manufacturers

Fourth Annual Summit On Disclosure, Transparency and Aggregate Spend For Drug, Device & Biotech Companies

March 26 – 28, 2012; Renaissance Hotel, Washington, DC

The interactions between covered recipients and medical device manufacturers can vary significantly from those common to pharmaceutical manufacturers.  From plant tours to evaluation units, the disclosure laws, including the Sunshine Act, present unique compliance challenges to device manufacturers.  In this session, Michael Bell and Marc Adler (R-Squared), Jean Bicknell (Baxter), and Amy Papranec (Styker) will explore such topics as:

• Demo, eval, and loaner units
• Instrumentation, product parts and other “costs”
• Multi-component products & Multi-product distributors
• Allocating for training and other group spend events
• Significance of data on medical device enforcement

Clients and friends of R-Squared are entitled to a discount on the registration fee–email us at info@r2ss.com for more information.  Click here for details about the Disclosure Summit.

Hope to see you there!

R-Squared and Concur Partner to Create Integrated Aggregate Spend Solution

The integration between R-Squared’s SpendTracker aggregate spend reporting solution and Concur’s expense reporting tools will provide Life Sciences companies with an easy and cost effective means to aggregate and report on physician spend. 

Princeton, NJ (February 7, 2012) – R-Squared Services & Solutions, an industry leader in evidence-based compliance solutions, is pleased to announce its partnership with Concur®, the leading provider of integrated travel and expense management solutions.  This strategic alliance merges R-Squared’s SpendTracker® module with Concur’s expense reporting solution via the Concur Connect Platform, resulting in the optimal solution to streamline and facilitate compliance with the federal Physician Payment Sunshine Act requirements, and the growing body of transparency disclosure laws, which are known as “aggregate spend” reporting laws.

The seamless and real-time integration of SpendTracker and Concur will reduce the amount of time spent by sales representatives and others entering the needed data for compliance.  Users will have the ability to search their master data of physicians and other health care professionals (HCPs) stored in SpendTracker directly through the Concur interface, minimizing hassle and the risk of incorrect HCP selection.  Similarly, sales reps will be able to initiate a review and approval process for the addition of HCPs and other third parties through Concur, saving time and minimizing effort.

“Aggregate spend compliance is about to get a whole lot easier for Concur customers”

“Aggregate spend compliance is about to get a whole lot easier for Concur customers,” said Barry Padgett, EVP, Concur Connect Platform.  “Concur’s integration with SpendTracker will allow our customers to exchange important data in real time through Concur, offering simplicity and efficiency, which is exactly what our customers want.”

“An effective solution is one that enhances compliance and minimizes administrative burden, and this does just that,” said Michael Bell, CEO of R-Squared.  “The connected solution reduces the burden on sales reps while increasing data accuracy, making it a true win-win for both compliance and the business.”

About R-Squared

R-Squared Services & Solutions, Inc. (R-Squared) is software group that helps companies develop more efficient and effective ways to assure compliance with the web of regulations and laws affecting the organization. We are especially good at translating regulatory requirements into workable tools and practices that simplify the task of abiding by regulations — while generating solid evidence of compliance at the same time. We’re about tighter compliance, with fewer burdens.  R-Squared is uniquely qualified to provide these services because of the vast depth of internal subject matter expertise starting with its CEO, Mike Bell, Esq. and it’s team of health care attorney’s and former compliance officers actively involved in the functional development of the entire suite of compliance solutions. 

About Concur 

Concur is a leading provider of integrated travel and expense management solutions.  Concur Connect is the platform that enables the entire travel and expense ecosystem of customers, suppliers, and developers to access and extend Concur’s T&E cloud.  Concur’s easy-to-use Web-based and mobile solutions help companies and their employees control costs and save time. Concur’s systems adapt to individual employee preferences and scale to meet the needs of companies from small to large. Visit www.concur.com to learn more.

Michael Bell to lead Aggregate Spend Compliance Webinar for PAMS

April 25, 2012, 1PM ET

The Pennsylvania Association of Medical Suppliers (PAMS) hosts regular Webinars on a variety of topics that impact their members.  On April 25, 2012, 1PM ET, Michael Bell, Esq. and CEO of R-Squared will lead a Manufacturers Compliance Webinar entitled: “Understanding Sunshine Act Compliance.”

With all the uncertainty of how this law applies to medical device / medical equipment manufacturers, this 90 minute session is a must for anyone struggling with how to manage to these regulations.

Click here for a program brochure or visit the PAMS website at www.pamsonline.org.

Michael Bell quoted in Device Industry Outlook

The Bloomberg/Bureau of National Affairs (BNA) released a report on 1/11/2012 highlighting some of the regulatory challenges and issues for the Medical Device Industry for 2012.  This article covers issues including: Tax Law, Changes at FDA, Changes to 510(k) process, Physician Payments Sunshine Act, Off Label Promotion and the government’s enforcement.   A must read for anyone working in the Medical Device Industry.

Click here to read the article.  For more information about Bloomberg/BNA, please visit www.bna.com.

R-Squared publishes latest Vermont CQR Guide

Registered users can access the revised Vermont Compliance Quick Reference (CQR) guide here.