CIS Compliance Blog

By: | On: April 15, 2014 | In: CIS Compliance Blog | General | Government Programs
In an April 9th letter to CMS, multiple stakeholders sent a joint letter to Kathleen Sebelius, Secretary of the Department of Health and Human Services. In this letter, the stakeholders express their concerns about CMS’ plans to implement AMP-based FULs in July 2014 and ask for a one-year transition...
By: | On: April 10, 2014 | In: CIS Compliance Blog | General | Government Programs
Please note that the pending 340B Drug Pricing Program Regulations, aka “The Mega Rule” is now with the Office of Management and Budget (OMB: http://www.whitehouse.gov/omb). As you will see from the screen shot below taken from the OMB’s website, the status of the rule is “Pending Review.” This is...
CMS recently issued Manufacturer Release #89 in which it first reminds drug manufacturers to review the accuracy of utilization data for all quarters in 2013 for the upcoming Branded Prescription Drug fee.  A copy of CMS’ guidance to manufactures is available at: http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Branded-Prescription-Drug.html, look under the BPD Disputes heading,...
Happy Spring everyone.  It certainly has been some kind of winter… As I mentioned in my previous blog, CIS is working on its new State Medicaid Initiative, which will assist manufacturers in staying abreast of all of the constant changes going on at the state level.   In this week’s...
By: | On: March 19, 2014 | In: CIS Compliance Blog | Government Programs
Setting the Bar of Compliance The bar is set high for manufacturers to be in compliance with Medicaid and other government programs, yet there is not really a specific definition for what it means to be in compliance. Add to this the fact that there is insufficient guidance across...
By: | On: March 18, 2014 | In: CIS Compliance Blog | General | Government Programs
We all know how much activity in mergers and acquisitions is driving the pharmaceutical industry.  Many of you have been on the front lines, providing key support to management to evaluate the impact of the transactions, and to help operationalize the transition. Mergers and Acquisitions have a significant impact...
By: | On: March 10, 2014 | In: CIS Compliance Blog | General | Government Programs
If I were to ask a Government Programs (GP) Professional “what’s on your mind?”  I am pretty sure I would get an earful! We are all pretty busy, facing significant challenges now while also trying to be prepared for the changes that will come with the CMS AMP Final...
By: | On: March 3, 2014 | In: CIS Compliance Blog | General | Government Programs
On the eve of the 340B Winter Coalition Conference’s main session, the Office of Inspector General (OIG) released a report discussing 340B contract pharmacies.  To many of us in the Pharmaceutical Manufacturer “corner,” this report was met with some relief knowing that assumptions, especially in the area of the...
By: | On: February 21, 2014 | In: CIS Compliance Blog | Commercial Compliance | Uncategorized
The Vermont Office of the Attorney General today issued a memorandum that provides amnesty for manufacturers of medical devices and biologics who failed to make reports as required by Vermont’s Prescribed Products Gift Ban and Disclosure Law. Manufacturers who did not report in FY10, FY11, FY12 and who anticipate...
By: | On: February 21, 2014 | In: CIS Compliance Blog | General | Government Programs
If you are a manufacturer, you may have seen a recent letter from the state of Maine regarding the annual $500 fee. Our view at CIS is that this letter is consistent with the program put in place by Maine in 2011, requiring manufacturers to pay an annual $500 fee....