| October 18, 2016
Some life sciences companies, especially those that have gone through a series of mergers and acquisitions, are often saddled with multiple legacy systems that are unable to communicate with one another. This means data is spread throughout the organization, rarely flowing into a central repository where calculations can be automated and analyzed. The result is... Read More
, and | October 7, 2016
In our previous blog on gross-to-net (GTN) leading practices, we considered the challenges manufacturers face in creating a GTN strategy, which provides predictability through enhanced controls and prioritized risk management, as well as profitability through a better understanding of commercial spend and product investments. Now that we’ve identified these leading practices, how are they typically... Read More
, and | September 29, 2016
Establishing an effective and reliable gross-to-net (GTN) strategy is challenging. There are external factors such as evolving product portfolios and contracting strategies, and internal complications such as siloed business departments and non-integrated data and systems that are slow and cumbersome. To combat these challenges, leading practices for life sciences manufacturers include an integrated, enterprise-wide GTN... Read More
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 into account the discounts and rebates... Read More
| 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 February 1, 2016, as well as... Read More
| 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 entire corporate strategies on it. There... Read More
| 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 new rules under this game-changing law.... Read More
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.”) These amendments were adopted without changes... Read More
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 based on Open Payments reporting and... Read More
| 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 hope you find this guide helpful... Read More