Inspired BlogPerspectives from Inspired Health Strategies and occassional industry experts
According to the FDA: The Life Sciences Industry Relationship with Patients is About to Change – Yea!
The FDA Patient Focused Drug Development meeting held Monday, March 19, 2018 was a game changer for me – and the life sciences industry. The FDA, specifically, the Center for Drug Evaluation and Research (CDER) Office of Strategic Initiatives is responsible for the implementation of the 21st Century Cures Act. This meeting was the second in a series of workshops to implement a four-stage plan to support the Cures Act. At this workshop, the lead, Theresa Mullins, PhD, Associate Director for Strategic Initiatives, made it clear that the goal of the plan is to ensure the patient has input to the full breadth of drug development – from pre-IND through commercial. This is music to my ears! It stunned me that the FDA has evolved to this degree – and it is going to push the industry.
Pfizer has partnered with rareLife solutions to harness the power of the rareLife solutions data management system to provide credible and reliable information to the sickle cell community. Sickle cell is unlike most other rare diseases in that the community is made up of multitudes of advocacy organizations, not just one or two. These organizations each have their own missions, as would be expected. However, it is always a challenge to get all organizations in any community to work together. This partnership between Pfizer and rareLife solutions provides an opportunity for collaboration through www.oneSCDvoice.com.
At Inspired Health Strategies, as we prepare to rollout our updates therapeutic area agnostic app/platform we are excited at this news from CMS. Providers will now be reimbursed for the time it takes to review data provided digitally. The Center for Medicare and Medicaid Services (CMS) “unbundled” a code that will allow physicians to be paid $56.80 for a cumulative of 30 minutes of reviewing biometric data digitally transmitted by the patient starting in 2018. This means our app can be used much more easily used and made more accessible to help people better manage their health. Providers will be reimbursed for the time it takes to review data provided digitally. We thought the best way to share the details of this major change is to share a detailed explanation of this change that was originally published by Cromwell & Morning Health Law and can be viewed here – http://bit.ly/2ze3cBF