CIS Compliance Blog

It’s been almost two months since the 340B Orphan Drug Rule was vacated by the U.S. District Court for the District of Columbia, and manufacturers are still uncertain as to how to handle sales of orphan drugs to newly covered entities. Since our last blog post, there have been...
Implement the Program With an Implementation Plan in hand, the right vendor partner(s) selected and legal interpretations documented, the program’s success relies on incorporating it all into processes that align with daily business activities. Implementing the program appropriately is critical to its success. Data needs to be captured accurately...
Select the Right Vendor Partners Without the right support, companies may miss the opportunity to address internal business and compliance needs. The right vendor partners can provide a company with the ability to understand the interrelationships between large groups of users and departments, obtain strategic insight on spend and...
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...
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...