CIS Compliance Blog

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...
Thou Shalt Conduct Inventory and Reconciliations The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…conducting the annual physical inventory and preparation of the reconciliation report…” While inventory and reconciliation requirements...
Thou Shalt Take Corrective and Disciplinary Actions The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative system for identifying any significant loss of drug samples and notifying FDA of the loss…” In...
By: | On: September 10, 2014 | In: CIS Compliance Blog | Government Programs
We look forward to seeing you next week at MDRP in Chicago! I wanted to give you a heads up on our main conference general session on Tuesday. We will be talking about the complexities of recalculations across Government Programs. The guidance and protocols vary across the programs, Medicaid,...
The OIG released Report OEI-05-11-00580 on August 19, 2014 on how Medicaid Drug Rebate Dispute resolution can be improved. I can say that I was one of the fortunate ones to be interviewed for this report and I do see some of my recommendations clearly mentioned here. As a reminder...
By: | On: September 4, 2014 | In: CIS Compliance Blog | Government Programs
This Wednesday, August 27th, the U.S. District Court, for the District of Columbia finally issued a ruling addressing all of the motions and affidavits filed this summer in the orphan drug exclusion rule litigation. The ruling was very brief – it outlined both parties’ positions (PhRMA argued that HRSA...