CIS Compliance Blog

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...
Thou Shalt Monitor Compliance 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… auditing and detecting falsified or incomplete drug sample records… storing drug samples by representatives.” When it comes...
Thou Shalt Have Vendor Contacts The PDMA states, “Any manufacturer or authorized distributor of record that uses a fulfillment house, shipping or mailing service or other third party… to meet any of the requirements of the PDMA… remains responsible for creating and maintaining all requests, receipts, forms, reports, and records...