CIS Compliance Blog
By: Karen Brown | On: May 16, 2013 | In: CIS Compliance Blog | Clinical Practice Related Content | Clinical R&D | GxP Related Content
CIS’ Clinical practice group recently participated in a Proactive GCP Compliance conference produced by EXL Pharma. The event presented various views on risk-based approaches to clinical quality and compliance. While the first day of workshops focused on ensuring quality from the onset through programs such as QbD1, QMS2 and...
By: Steve Moore | On: May 9, 2013 | In: CIS Compliance Blog | General | Government Programs | Uncategorized
Last week I had the pleasure of chatting with Steven Moore, Senior Director of Business Development, GP Geek Expert at Compliance Implementation Services (CIS). Not only did he share his insights on the current Medicaid environment but also his journey as a road warrior. Here's what he had to...
Preparing for the CIS Orphan Drug Webinar last week had me reminiscing into my career and remembering the reason why I became involved in the Pharmaceutical Industry and why my passion in this industry continues to remain strong. Many years ago, I will spare you the number; my very...
On February 8, 2013, the Centers for Medicare & Medicaid Services (CMS) published the final rule for OPEN PAYMENTS. OPEN PAYMENTS is CMS’ program, under which applicable manufacturers and group purchasing organizations (GPOs) will begin tracking and reporting payments and other transfers of value to physicians and teaching hospitals....
CMS issued Manufacturer Release #86 today, reiterating its January 2011 guidance that manufacturers must report the total AMP-eligible units, as well as the calculated AMP, for each monthly submission. The Release notes that the units should be reported at the Medicaid unit (NDC-9) level, with the same number reported...
The on-going compliance monitoring of sales and marketing activities is becoming an increasingly important area of interest for pharmaceutical manufacturers. The financial implications and consequences of noncompliance can be extremely severe. The sales and marketing activities of pharmaceutical manufacturers is a difficult area to ensure compliance as the space...
It is time for the second annual GP Geek of the Year award! You probably know CIS for a lot of the GP work we do, the PCX, our thought leadership events, the Blog, monthly Webinar Series and the GP Forum. You probably also know that we like to...
By: Josef Magpantay | On: April 26, 2013 | In: CIS Compliance Blog | General | Government Programs | Uncategorized
On February 7 2013, HRSA released the Policy Release 2013-1. The release clarified the 340B Drug Pricing Program’s policy regarding prohibition of covered entities in obtaining outpatient drugs through a group purchasing organization (GPO) or purchase agreement. Furthermore, it touched on a covered entity’s purchasing options based on its...
The Centers for Medicare and Medicaid Services (CMS) recently published four Fact Sheets on Open Payments for applicable manufacturers, Group Purchasing Organizations (GPOs), physicians, and teaching hospitals to utilize as a resource when preparing for the Final Rule. The industry has dubbed transparency reporting as “sunshine” requirements; however, “Open...
CIS has been working with manufacturers for some years now, helping to develop what we call the Product Master. We feel that there is an increasing need for a Product Master, and that not having one can put your company at risk. A problem though is that what we...