Blog

and | September 20, 2016
Gross-to-net (GTN) calculations are a growing challenge for life sciences manufacturers navigating increasingly complex supply chains, a changing regulatory environment, and the enhanced negotiating power of consolidated distributor networks. Manufacturers are required to report not only their gross sales, but also their net sales, which are calculated after taking...
| July 15, 2016
On July 6, 2016, the Centers for Medicare and Medicaid Services (CMS) published “Covered Outpatient Drug Final Rule with Comment (CMS-2345-FC) Frequently Asked Questions.”  This document is intended to respond to questions raised by various stakeholders regarding the AMP Final Rule that was published in the Federal Register on...
| May 27, 2016
Arguably one of the most prevalent story lines in the life sciences industry, and perhaps international business as well, is the unprecedented amount of mergers and acquisitions (“M&A”) occurring over the past few years. The life sciences industry has seen billions of dollars exchange hands, with some companies basing...
| May 23, 2016
Anne Phelps | Principal, US Health Care Regulatory Leader, Deloitte & Touche LLP A year and 11 days after President Obama signed the Medicare Access and CHIP Reauthorization Act (MACRA) into law, the US Centers for Medicare and Medicaid Services (CMS) released the first major regulation, setting forth the...
Texas’ monthly Texas Drug Code Index (TDCI) reporting requirements are coming to an end in the next few weeks. On May 6, 2016, the Texas Federal Register published Amendments to the Texas Administrative Code Chapters 354 and 355, including § 354.1921 (“Addition of Drugs to the Texas Code Index.”)...
and | April 29, 2016
As a prelude to their discussion on “The Evolution of Industry-Standard FMV Rates” at the 2016 FMV of HCP and Investigator Payments Conference, Ashley Riley, manager, Deloitte & Touche LLP, and Kirsten Midtbo, consultant, Deloitte & Touche LLP, review changes in industry-standard FMV rates for Healthcare Provider (HCP) payments...
| April 14, 2016
Our highly requested AMP final rule reference guide takes a deeper dive to help executives and operational personnel understand the final rule provisions expected to have a significant impact on revenue and operations. Key questions explore challenges and implementation considerations from a strategic, methodological, operational, and financial perspective. We...
| April 4, 2016
On March 31, 2016, The Centers for Medicare & Medicaid Services (CMS) published Manufacturer Release No. 96, which delays implementation of the 5i AMP calculation provisions from April 1, 2016 to July 1, 2016. The release states: It has come to our attention that drug manufacturers may need additional...
Q: What are some issues to consider when evaluating whether outsourcing maintenance of systems could be beneficial?

Mel Walker: First, it’s important to consider how and whether outsourcing contract management activities could impact an organization’s ability to identify, contain and address compliance risk.
Q: What are some other challenges that outsourcing commercial operations could help address?

Mel Walker: While the in-house and third-party systems that some large pharmas use to manage revenue activities might be sufficient for managing transactional compliance, such systems may not be equipped to incorporate new or changed compliance requirements...