CIS Compliance Blog

By: | On: July 17, 2014 | In: CIS Compliance Blog | Commercial Compliance
Establish Compliance Components and Documentation Once an Implementation Plan is developed for the Program, an assessment of the current compliance program and supporting documentation (i.e., Code of Conduct, policies and procedures, and governance documents) is needed. The assessment identifies risks, identifies alignment with the current regulations and identifies the...
By: | On: July 17, 2014 | In: CIS Compliance Blog | Commercial Compliance
With the first Open Payments reporting deadline behind us, we thought it would be timely to take a step back and evaluate how the industry is meeting the demands of implementing the new federal reporting requirements on top of the complex state reporting requirements. In doing so, we are...
By: | On: July 14, 2014 | In: CIS Compliance Blog | Commercial Compliance
No rest for the weary it seems…just as we were all breathing a sigh of relief in meeting the Federal and state deadlines for transparency reporting, the FDA was very timely in challenging the industry in our drug sample transparency reporting responsibilities under the Affordable Care Act. On Friday,...
A lot has been happening since last month’s court order when the 340B Orphan Drug Rule litigation was issued. As we previously reported, on May 23, 2014, the U.S. District Court for the District of Columbia vacated the Orphan Drug Rule that went into effect on October 1, 2013...
By: | On: June 19, 2014 | In: CIS Compliance Blog | Government Programs
Blog Alert – DDR Changes Approved by OMB, Changes will be implemented on the 19th and due by July 30th! At 11:45 today, a notice went out to all Medicaid Technical Contact by CMS alerting manufacturers that the DDR changes that were communicated to manufacturers on April 18th have been approved...
On June 11, 2014, Ms. Jane Stroder, new Director of VA’s Federal Supply Schedule Service (FSS), made a presentation to the Sustaining Members of AMSUS (Association of Military Surgeons of the U.S) at their meeting outside of Chicago.  The presentation dealt with activities, initiatives, and goals of VA FSS...
By: | On: June 18, 2014 | In: CIS Compliance Blog | Government Programs
I am proud to announce that Mike Hepburn with Janssen Pharmaceuticals accepted CIS’ 2014 GP Geek of the Year Award at the recent CBI Medicaid and Government Pricing Congress in Orlando.  This is the third time the GP Geek of the Year Award has been sponsored by CIS (year...
As you may be aware, the Affordable Care Act (ACA) amended several portions of Section 1927 of the Social Security Act (the Act).  In accordance with those changes, CMS will be implementing several new fields and features in the Drug Data Reporting for Medicaid (DDR) system in the upcoming...
The HHS OIG published an AMP report on Friday, June 6th. I think you would have to be somewhat of a GP Geek to understand the details of the OIG report, as it delves pretty deeply into AMP methodology.  I found that the report reaffirms much of what we have...
By: | On: June 5, 2014 | In: CIS Compliance Blog | General
My Dear Beloved Luke, It’s Monday morning June 2, 2014 and I’m sitting in an airport.  I miss you.  I always do when you’re not with me. Last night, just before you were falling asleep, I had my typical ‘man of the house’ and ‘protect your mother’ speech with...