CIS Compliance Blog

By: | On: November 17, 2014 | In: CIS Compliance Blog | Commercial Compliance
On September 30, 2014, CMS publically published Open Payments data and needless to say, it has been a bumpy road.  With about 40 percent of records de-identified due to what CMS stated was a result of “inconsistent physician information, such as National Provider Identifier (NPI) for one doctor and...
By: | On: November 14, 2014 | In: CIS Compliance Blog | Government Programs
For your information, as posted on Reginfo.gov, the HRSA 340B “Mega Rule” (RIN: 0906-AB04) has been withdrawn. The Mega Rule, as it had come to be known, was in a proposed status, and was expected to provide some significant and much needed guidance for the PHS/340B Program, such as...
By: | On: November 13, 2014 | In: CIS Compliance Blog | Government Programs
If you are a representative of a pharmaceutical manufacturer or biotech company working in the area of Government Programs (GP), you may have received letters from Covered Entities (CE’s) regarding a refund owed to your organization. These refunds relate to historical purchases made at the Public Health Service (PHS)...
This is a follow-up to my report back in April of this year. The numbers continue to grow…. Based on the report released October 17, 2014 by the Centers for Medicare & Medicaid Services, there are approximately 8.7 million additional Americans with coverage through Medicaid and CHIP. Medicaid enrollment...
By: and | On: October 28, 2014 | In: CIS Compliance Blog | Commercial Compliance
The Art of Educating Recipients about Open Payments It has been just under a month since CMS has published its first wave of Open Payments data, and there have been many interesting effects across industry.  As with anything that’s new, there are understandably some misunderstandings about what all of...
By: | On: October 16, 2014 | In: CIS Compliance Blog | Government Programs
As previously reported, there was a final ruling in the 340B orphan drug rule litigation at the end of August. The ruling essentially held that while the HRSA’s final orphan drug exclusion rule was invalidated, HRSA’s interpretive rule issued on July 21st remained in effect. The Court stated that...
I just came across the letter the Republican leaders of the House and Senate Committees of jurisdiction sent to Centers for Medicare and Medicaid Services (CMS) Administrator Marilyn Tavenner on September 18, 2014 regarding the ongoing challenges states are facing while implementing the health law’s changes to Medicaid. I...
By: | On: October 2, 2014 | In: CIS Compliance Blog | Government Programs
In order to participate in the various Government Programs, drug manufacturers are required to calculate and report an array of price points on a monthly, quarterly, and annual basis. Though the operational burden on manufacturers can vary based on a manufacturer’s size, type, and product portfolio, all manufacturers are...
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...