CIS Compliance Blog

This is a follow-up to my report back in April of this year. The numbers continue to grow…. Based on the report released October 17, 2014 by the Centers for Medicare & Medicaid Services, there are approximately 8.7 million additional Americans with coverage through Medicaid and CHIP. Medicaid enrollment...
By: and | On: October 28, 2014 | In: CIS Compliance Blog | Commercial Compliance
The Art of Educating Recipients about Open Payments It has been just under a month since CMS has published its first wave of Open Payments data, and there have been many interesting effects across industry.  As with anything that’s new, there are understandably some misunderstandings about what all of...
By: | On: October 16, 2014 | In: CIS Compliance Blog | Government Programs
As previously reported, there was a final ruling in the 340B orphan drug rule litigation at the end of August. The ruling essentially held that while the HRSA’s final orphan drug exclusion rule was invalidated, HRSA’s interpretive rule issued on July 21st remained in effect. The Court stated that...
I just came across the letter the Republican leaders of the House and Senate Committees of jurisdiction sent to Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner on September 18, 2014 regarding the ongoing challenges states are facing while implementing the health law’s changes to Medicaid. I...
By: | On: October 2, 2014 | In: CIS Compliance Blog | Government Programs
In order to participate in the various Government Programs, drug manufacturers are required to calculate and report an array of price points on a monthly, quarterly, and annual basis. Though the operational burden on manufacturers can vary based on a manufacturer’s size, type, and product portfolio, all manufacturers are...
By: | On: October 1, 2014 | In: CIS Compliance Blog | Commercial Compliance
Yesterday afternoon, September 30, 2014, the Centers for Medicare & Medicaid Services (CMS) released the first round of Open Payments data to the public.  The data collection period for 2013 started on August 1 and lasted until December 31.  During that time, CMS reported that the data contained 4.4...
By: | On: September 24, 2014 | In: CIS Compliance Blog | Government Programs
At the 2014 Medicaid Drug Rebate Program conference (managed by IIR) held in Chicago this past week, Andy Vasquez, Deputy Director of Texas Medicaid/CHIP Vendor Drug Program indicated that Texas Medicaid will be changing to a NADAC-based reimbursement model. For products that don’t have a published NADAC the state...
CMS posted Manufacturer Release 91 on September 12, 2014 and here are the highlights: Timely Reporting of AMP and BP – a reminder to all manufacturers that they are responsible for reporting monthly pricing data in the Drug Data Reporting for Medicaid (DDR) system no later than 30 days...
By: | On: September 15, 2014 | In: CIS Compliance Blog | Commercial Compliance
2014 has been quite a busy year for the pharmaceutical and medical device industries: February 18, 2014 saw the Phase 1 of registration and data submission of industry applicable manufacturers for the CMS Open Payments Portal begin March 31, 2014 was the deadline for completing registration and data submission...
By: | On: September 11, 2014 | In: CIS Compliance Blog | Government Programs
CMS sent out an update yesterday to Technical Contacts which provided some important clarification.  It dealt specifically with terminated products that were not listed in the FDA database.  We at CIS were working with several clients on this specific question, as it was not clear the specific impact if...