DDR Changes Approved by OMB, Changes will be implemented on the 19th and due...
Blog Alert – DDR Changes Approved by OMB, Changes will be implemented on the 19th and due by July 30th! At 11:45 today, a notice went out to all Medicaid Technical Contact by CMS alerting manufacturers...
View ArticleDéjà vu at VA FSS?
On June 11, 2014, Ms. Jane Stroder, new Director of VA’s Federal Supply Schedule Service (FSS), made a presentation to the Sustaining Members of AMSUS (Association of Military Surgeons of the U.S) at...
View ArticleA Complication for an “Inverted Domestic Corporation” Seeking a Government...
Corporate decision-making about whether a company should become an “inverted domestic corporation” to avoid some US taxes has recently become national news and a hot topic of political discussion. A...
View ArticleThe Ins and Outs of Government Program Recalculations – Main session at MDRP
We look forward to seeing you next week at MDRP in Chicago! I wanted to give you a heads up on our main conference general session on Tuesday. We will be talking about the complexities of...
View ArticleManufacturer Release 91
CMS posted Manufacturer Release 91 on September 12, 2014 and here are the highlights: Timely Reporting of AMP and BP – a reminder to all manufacturers that they are responsible for reporting monthly...
View ArticleMedicaid/CHIP Enrollment Grows by 8.7 Million (and more Expansion News)
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...
View ArticleManufacturer’s Perspective: What to do when a 340B Covered Entity provides a...
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...
View ArticleOIG Publishes its 2015 Work Plan
Each year, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) publishes a work plan that lays out priorities and areas for review in the upcoming year. It’s important...
View ArticleCMS Posts a New Date for the AMP Final Rule
We have a new mystery date for the CMS AMP Final Rule. According to RegInfo.gov, the AMP Final Rule is scheduled for April of 2015. I don’t know, it could be a set up for an interesting April Fool’s...
View ArticleManufacturer Release 92
CMS posted Manufacturer Release 92 on March 30, 2015 and here are the highlights: BIOSIMILARS AND THE MEDICAID DRUG REBATE PROGRAM – The Affordable Care Act (ACA) amended the PHS Act to create an...
View ArticleThe Patient Protection and Affordable Care Act (PPACA) AMP Final Rule at the...
On August 4, 2015, the long-awaited Average Manufacturer Price (AMP) Final Rule was sent to the Office of Information and Regulatory Affairs (OIRA) (a division of the Office of Management and Budget)...
View ArticleOMB concludes review of AMP final rule: Federal Register may publish public...
On Friday, December 11, 2015, the Office of Management and Budget (OMB) concluded its Executive Order 12866 Regulatory Review of the AMP final rule.1 The final rule is not yet public, but we expect...
View ArticleOMB concludes second review of AMP final rule: publication expected soon
On Tuesday, January 19, 2016, the Office of Management and Budget (OMB) concluded its second Executive Order 12866 Regulatory Review of the AMP final rule.1 The final rule is not yet public, but we...
View ArticleAMP final rule published
On Thursday, January 21, 2016, the Centers for Medicare and Medicaid Services (CMS) released the long-awaited final rule that implements new statutory provisions for the calculation of Average...
View ArticleInitial takeaways on the AMP final rule
Since yesterday’s release by the Centers for Medicare and Medicaid Services (CMS) of the long-awaited final rule that implements new statutory provisions for the calculation of Average Manufacturer...
View ArticleThe impact of AMP – operational and legal considerations
Marcy Imada (Principal, Deloitte & Touche LLP) and John Shakow (Partner, King & Spalding) will provide a general overview of the AMP final rule, its implications from both operational and...
View ArticleA closer look at AMP and other regulations – the impact on generics
We will break down the provisions of the AMP final rule and other regulatory guidance with a special focus on the needs and considerations of generic manufacturers. The post A closer look at AMP and...
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