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!

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.

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.

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

Consequently, and in light of evolving global transparency efforts, anti-bribery compliance is one of the hottest compliance topics of 2012, which is why R-Squared is proud to be a Bronze Sponsor of CBI’s 9th Annual Pharmaceutical Compliance Congress on January 24-25, 2012, at the Ritz-Carlton in Washington, DC.

At the conference, Michael Bell, Esq, and CEO of R-Squared and Carolyn Bruguera, Esq. (GC, Hansen Medical and former GC of Micrus) are presenting, Implementing Effective “Internal Controls” and “Adequate Procedures” Under the FCPA and UK Bribery Act, which will explore these legal requirements and their application to manufacturer operations, and provide guidance on effective global anti-bribery compliance.

In addition to anti-bribery compliance coverage, sessions will explore Sunshine updates and aggregate spend (another of our favorite topics), the latest updates on monitoring and investigations, employee training, CIA lessons learned, government pricing, fraud and abuse risks in medical and R&D, social media regulation and compliance, and more.  This Congress presents one of the best opportunities to learn from an expert faculty of 16 CCOs and their team members representing 24 biopharmaceutical and medical device companies, as well as network with hundreds of our compliance, legal and regulatory peers.

As a sponsor, we have a limited number of $500 coupons for the Congress on a “first come, first serve” basis, so please let me know as soon as possible if you would want one.  For more information or to register for the Congress, please visit www.cbinet.com/pcc.

We’ll also have an exhibit booth and booth prizes, so please if you go, please pay us a visit!  Hope to see you at the conference!

To read the article, please click here.

Why is CMS late issuing regulations for a law that was enacted in March 2010–over a year and half ago?  According to Administrator Berwick, it is because of President Obama’s Executive Order issued in January 2011, which generally directs federal agencies to take steps to reduce regulatory burdens.   This rationale is both interesting and ironic:  it is “interesting” because the statute is quite specific, leaving CMS with 1.5 years to address a relatively short list of issues that require clarification.  Further, according to the Senators’ request letter, CMS represented–presumably incorrectly–that the draft regulations were delivered to the Office of Management and Budget for review and promulgation.  (???)

CMS’ rationale is ironic because the lack of definitive guidance on these issues creates a far greater burden on the industry, which is working diligently today to implement solutions to comply with this new mandate.   We suspect that the industry would cry out in unison:  JUST GIVE US THE DRAFT REGS ALREADY SO WE CAN PROVIDE COMMENTS!!!

Indeed, the good Senators had the following reaction to Administrator Berwick’s letter:

Sen. Grassley’s comment:

“The administrator’s response doesn’t tell us anything new.  There’s no explanation for the delay and no indication of when to expect completion.   It’s an inadequate response any way you look at it.  Meanwhile, the U.S. government just settled with a medical device maker for $2.4 million over allegations of kickbacks to doctors to use the company’s products.  The payments to doctors are the kind that might be prevented through disclosure as soon as the Sunshine Act is in place.  The longer we wait, the more taxpayers miss out on the benefits.   I’ll continue to press for answers from CMS.”

Sen. Kohl’s comment:

“Given how straightforward and detailed the Sunshine Act provisions were, it’s troubling that the response to our letter would come a month late without any indication on progress, a timeline or what caused the delay.  With medical device and pharmaceutical companies facing the January 1, 2012 deadline to begin collecting information about all payments to physicians, the lack of guidance leaves a great deal of uncertainty and I’m sure that’s why many of the affected companies have joined us in calling for swift implementation.”

If there were a silver lining to this CMS announcement it would be that the Executive Order requires a 60 day comment period, so the industry will be heard.  This also affords affected companies additional time to prepare.  The flipside, however, is that definitive guidance is not likely until sometime in early to mid 2012—several months after the statutory effective date–which prompts a number of questions.  Will CMS persuade Congress to amend the law?  Will CMS simply afford a “grace period” while they get their act together?

And so, the saga continues….

Check in here periodically, as R-Squared will continue follow closely any and all Sunshine developments.

Princeton, NJ (October 31, 2011) — R-Squared Services & Solutions, Inc. (R-Squared), a leading provider of compliance software to the life sciences industries, is pleased to announce Rob Zelinsky has joined the company as the new Vice President of Sales and Marketing. Primarily focusing on expanding the growing momentum for its RADS® Compliance Platform, Rob brings over 20 years of sales and marketing experience to drive R-Squared’s technology business.

Mr. Zelinsky joins R-Squared with a strong track record in the technology, consulting, and data analytics sectors. “Rob brings extensive sales and marketing experience along with knowledge of the healthcare and life sciences industries. Combine that with his passion and energy and we are very excited to have him on our team,” said Michael Bell, CEO of R-Squared.

Rob joins R-Squared after helping to launch Aileron Solutions, a privately held data and technology firm. While at Aileron, he quickly helped to establish their brand and name recognition despite the presence of well-established players, and was instrumental in developing sales processes and key strategies, including leveraging social media.

Prior to that, Zelinsky worked for Health Market Science as the Manager of Business Development focused on launching their aggregate spend compliance solution. In that role, he quickly learned that space and lead the most successful launch in the company history.

“I’m more than excited to be part of the R-Squared team and helping them to grow and improve their sales and marketing efforts,” said Zelinsky. “R-Squared has the unique combination of a rich product set, very deep subject matter expertise, and a management team with a level of honesty, integrity and passion that I have never experienced before in my career.  Considering we are helping companies with their transparency and compliance efforts, that culture of integrity within will be paramount to R-Squared’s continued success.”