Oncology Alert: Imfinzi Billing Update — Review Formulary Compliance
New FDA approval for Imfinzi impacts billing practices; update required.
Action required by
May 1, 2017
Review the Action Required section below and ensure your team has completed all compliance steps before this date.
The FDA approved Imfinzi (Durvalumab) as a new molecular entity in oncology, effective May 1, 2017. ## What Changed Imfinzi (Durvalumab) is now FDA-approved for use, which may affect billing practices under Medicare Part B due to its classification as a new injectable. Providers must be aware of potential pricing changes, as reimbursement could align with ASP+6% standards. ## Action Required - Monitor for J-code assignment and incorporate it into billing systems. - Update the formulary to reflect Imfinzi's availability and pricing structure. - Ensure billing processes adhere to new ASP+6% reimbursement standards. ## Upcoming Dates - Effective date: May 1, 2017. Source: FDA-BLA761069. Full document at [http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf]. Content summarized from publicly available federal publications including CMS, MAC contractors, and the Federal Register. CLV Intelligence is not affiliated with or endorsed by any government agency. This is not legal or medical advice.
Quick answers
What is the new pricing structure for Imfinzi?
Imfinzi's reimbursement will likely follow the ASP+6% standard for Medicare Part B.
How should we update our billing systems?
Incorporate the J-code for Imfinzi as soon as it is assigned and ensure compliance with ASP+6% pricing.
Content summarized from publicly available federal publications including CMS, MAC contractors, and the Federal Register. CLV Intelligence is not affiliated with or endorsed by any government agency. This is not legal or medical advice.