Blog

| February 8, 2016
The Centers for Medicare & Medicaid Services (CMS) is holding three Q&A sessions to address questions related to the 2015 Open Payments program year. The Open Payments team will respond to questions submitted in advance through an online registration process. Session schedule: Tuesday, February 16, 2016: Data submission Tuesday,...
| January 28, 2016
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 regulatory requirement considerations, and what CMS has stated they expect manufacturers to implement by April 1. Date: Friday, February...
| January 22, 2016
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 Price (AMP) and Best Price (BP), we have been busy reading and digesting the AMP final rule, and we have our...
| January 21, 2016
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 Manufacturer Price (AMP) and Best Price (BP). AMP and BP are used as the basis for pharmaceutical manufacturer rebates to state...
| January 20, 2016
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 expect that it will be published in the Federal Register soon. We will send a...
| January 6, 2016
On Tuesday, January 5, 2016, the Office of Management and Budget (OMB) received the AMP final rule and is conducting a second Executive Order 12866 Regulatory Review.1 The rule was previously released by OMB in December 2015, so it is assumed that OMB asked the Centers for Medicare &...
| December 14, 2015
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 that it will be published in the Federal Register soon. We are monitoring the Federal...
| November 30, 2015
The Centre for Health Solutions launched its report "The challenge of compliance in life sciences: moving from cost to value" at the Financial Times Global Pharmaceutical and Biotechnology Conference in association with Deloitte. The report, which is based on interviews conducted with senior compliance leaders in 11 major life...
| November 6, 2015
On October 30, 2015, the Senate passed and the President signed H.R. 1314, the Bipartisan Budget Act of 2015.  Section 602 of the bill amends the Medicaid Drug Rebate Program (MDRP) to impose a price increase penalty on generic drugs. Until now, the price increase penalty only applied to...
| November 9, 2015
The objective of the International Committee for Harmonization (ICH)’s Guideline for Good Clinical Practice (GCP) “is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions should be...