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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.”)...
| 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...
Q: How can analytical tools lead to improved pricing capabilities?

Mel Walker: Having an integrated analytics interface that sits on top of the data layer allows people in the contract management, government pricing, sales and marketing and finance functions to extract the data in their systems and use it to...
Q: Why might CFOs want to consider outsourcing commercial operations?

Mel Walker: Many life sciences companies could be leaving significant financial value on the table due to limitations in their current contract management systems’ ability to collect and analyze transaction and pricing data. As stewards of company financial value across...
and | March 14, 2016
If you are working in medical affairs, as a Medical Science Liaison (MSL), or conducting an investigator-initiated study, staying up-to-date on efficient communication techniques and maintaining clinical compliance is essential to your daily operations. One area of importance is assessing Fair Market Value (FMV) of investigator-initiated trials (IIT) prior...
| March 10, 2016
In the Deloitte Center for Health Solutions report, Unlocking the potential of value-based care in Medicare Advantage, we surveyed how health plans and providers approach Medicare Advantage (MA) using VBC payment models. Not surprisingly, each has their own perspective about the value these new payment models can achieve and...