CIS Compliance Blog

Based on the Kaiser Health Report’s synopsis of the recently released report by the Department of Health and Human Services, the number of low–income people enrolled in Medicaid rose 3 million to a total of 62.3 million from October through February.    For the states that expanded Medicaid under the...
By: | On: April 22, 2014 | In: CIS Compliance Blog | General | Government Programs
CMS Medicaid Drug Rebate Program Notice, Manufacturer Release #90, dated April 18, 2014 was distributed on Monday April 21st. The letter reiterates guidance and protocols related to drugs that are sold to another manufacturer.  In general, I would say that the main emphasis of the letter is the notion...
By: | On: April 21, 2014 | In: CIS Compliance Blog | General
CMS issued a communication to Technical Contacts on Friday, April 18, 2014 outlining upcoming changes to the Drug Data Reporting for Medicaid (DDR) system. In this communication, CMS stated, “To facilitate the collection of the new fields, we are revising the CMS Forms 367b (monthly pricing file format), c...
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...