CIS Compliance Blog

By: | On: March 26, 2015 | In: CIS Compliance Blog | Government Programs
On Tuesday, March 24th, the House of Representatives Committee on Energy and Commerce held a hearing on the PHS/340B program. The hearing focused on current areas where there has been significant scrutiny by both Congress and the press (for a summary of 340B related activity, see my related blog article,...
In February 2015, FDA released the Revised Draft Guidance for Industry: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.  The 90-day comment period has begun and interested parties can submit comments to the Division of Dockets...
By: | On: March 19, 2015 | In: CIS Compliance Blog | Government Programs
On March 6, 2015, DHA sent notification to manufacturers of upcoming “cut-off” dates for submitting disputes for numerous processing quarters.  For processing quarters 3Q2010 through 4Q2011, DHA will accept disputes until MARCH 31, 2015; and for processing quarters 1Q2012 through 4Q2012, DHA will accept disputes until APRIL 30, 2015. ...
By: | On: March 10, 2015 | In: CIS Compliance Blog | Government Programs
The Centers for Medicare and Medicaid Services (CMS) Medicaid Branded Prescription Drug (BPD) team sent out an email on the morning of March 9th to manufacturers regarding the annual Branded Prescription Drug Fee (BPDF) and encouraged manufacturers to monitor data in the Drug Data Reporting (DDR) system to ensure...
By: | On: March 5, 2015 | In: CIS Compliance Blog | Government Programs
On February 23, 2015, U.S. Chief District Judge Nancy Torresen overturned Maine’s drug importation law.  The Court ruled in favor of the plaintiffs, Maine Pharmacy Association, Maine Society of Health System Pharmacists and the Retail Association of Maine (PhRMA, which was one of the original parties, was dismissed as...
By: | On: March 4, 2015 | In: CIS Compliance Blog
The laws and regulations of the healthcare industry grow more numerous and nuanced each year. Individual states have their own laws and requirements separate from federal mandates, and the flood of regulator updates, clarifications, drafts, and final rules shows no sign of letting up. With so many documents released...
By: | On: February 23, 2015 | In: CIS Compliance Blog | Government Programs
The TRICARE Retail Refund Team distributed a draft TRICARE Retail Refund Program Manufacturer Policy and Procedures Guide and corresponding Feedback Form on Friday, February 6, 2015. Manufacturers were asked to submit feedback no later than close of business today, Friday, February 20, 2015. Click here to view the comments...
If you are a manufacturer, you may have seen a recent letter or email from the state of Maine regarding the annual $500 fee. This program was put in place in 2011 due to the reduced funding in the drug trial and drug marketing programs, which was partially offset...
By: | On: February 18, 2015 | In: CIS Compliance Blog | Government Programs
The Defense Health Agency hosted a TRICARE Webinar on Thursday, January 29, 2015. The webinar focused on high level components of the TRICARE Retail Refund program.  The highlight of the call was DHA’s announcement of a new, formal Manufacturer Policy and Procedures Guide and the agency’s request for comments...
By: | On: February 12, 2015 | In: CIS Compliance Blog | Government Programs
CMS recently announced updates associated with the Medicare Part D Coverage Gap Discount Program Dispute and Appeal Process.   This update comes on the heels of another recent announcement of significant changes to the direct payment process (brief summary below). The dispute updates remove certain dispute codes rarely applied...