CIS Compliance Blog

By: | On: January 22, 2015 | In: CIS Compliance Blog | Government Programs
If you follow  the CIS blog and GP Forum, you have heard us speak about the Cardinal Reclassification Policy multiple times (beginning in 2010 and as late as January 2014), and you have heard our concerns with having Cardinal automatically reclassify historical customers’ sales on behalf of manufacturers.  This...
By: | On: January 22, 2015 | In: CIS Compliance Blog | Commercial Compliance
Today, compliance departments within bio/pharmaceutical manufacturers have the challenge of ensuring the company maintains its regulatory and ethical obligations, while also empowering the business to achieve its overarching goals. Compliance organizations are not “policing” the company, but instead, assisting critical functions across the company in bringing to fruition and...
By: | On: January 20, 2015 | In: CIS Compliance Blog | Commercial & Federal Contracts
In a September 2, 2014 blog post, I discussed how Congress’ repeated, appropriation-act prohibitions against direct Government contract awards to inverted domestic corporations impacted filling out the “reps & certs” in FAR Clause 52.212-3(a) & (n) (Nov 2013) and in the corresponding portion of SAM. On December 15, 2014,...
By: | On: January 16, 2015 | In: CIS Compliance Blog | Government Programs
On Thursday, January 15th, Cheri Rice, Director of the Medicare Plan Payment Group, released a notice regarding the new Medicare Part D Coverage Gap Discount Program (CGDP) Direct Payment Process.  Beginning in Q1 2015, the new CGDP Portal will include an improved payment process allowing manufacturers to view invoices,...
The Food and Drug Administration has provided trading partners (manufacturers, wholesale distributors, repackagers and dispensers) a 2015 New Year’s gift by postponing the enforcement of the product tracing information requirements set to go into effect January 1, 2015. After many trading partners communicated concerns with the FDA that they...
By: | On: December 22, 2014 | In: CIS Compliance Blog | Government Programs
On December 12, 2014, HRSA put out a release regarding the 340B Medicaid Exclusion File. The release clarifies the use of the file to prevent duplicate discounts (or as we say in the industry “double dipping”), when a drug is discounted under the 340B Drug Program and also subject...
By: | On: December 2, 2014 | In: CIS Compliance Blog | Government Programs
We have a new mystery date for the CMS AMP Final Rule. According to RegInfo.gov, the AMP Final Rule is scheduled for April of 2015. I don’t know, it could be a set up for an interesting April Fool’s day joke!  We shall see. For my recent blog post...
By: | On: November 25, 2014 | In: CIS Compliance Blog | Government Programs
Each year, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) publishes a work plan that lays out priorities and areas for review in the upcoming year. It’s important to recognize what the OIG plans to focus on as its efforts routinely result in billions...
By: | On: November 21, 2014 | In: Government Programs
Sometimes old news is new news and sometimes new news is old news.  In yesterday’s not very informational bulletin CMS announced: “We expect to release the finalized Affordable Care Act FULs at or about the same time that we publish the Medicaid Covered Outpatient Drug final rule (CMS-2345-F),” with...
By: | On: November 17, 2014 | In: CIS Compliance Blog | Commercial Compliance
On September 30, 2014, CMS publically published Open Payments data and needless to say, it has been a bumpy road.  With about 40 percent of records de-identified due to what CMS stated was a result of “inconsistent physician information, such as National Provider Identifier (NPI) for one doctor and...