New Indication FDA Approved for BAVENCIO

We are pleased to announce that on June 30, 2020 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication.  BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc.


BAVENCIO was originally approved by the FDA on March 23, 2017 under Accelerated Approval, and EMD Serono has executed a signed Medicaid National Drug Rebate Agreement.


Please  refer to the revised  Full Prescribing Information for BAVENCIO.


We are respectfully requesting that you update your claims processing system(s), and any applicable coverage policies to reflect this new indication.  NOTE:  The national Level II Healthcare Common Procedure Coding System (HCPCS) J-code for BAVENCIO is J9023 (injection, avelumab, 10mg), and the 11-digit NDC is 44087-3535-01.


Karyopharm Therapeutics Inc

Discover a new option for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)


FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer

FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer

Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable or metastatic hepatocellular carcinoma

Tecentriq combination improved overall survival and progression-free survival compared to the previous standard of care

Application approved under FDA’s Project Orbis initiative and Real-Time Oncology Review pilot program

South San Francisco, CA -- May 29, 2020 --

Genentech Press Release Imbrave

Register for Xofigo Coding & Billing Webinar

Bayer HealthCare Pharmaceuticals is presenting a series of Xofigo coding and billing webinars. Click Here for more information on registering for the webinar. 

FDA approves KADCYLA™ for HER2+ metastatic breast cancer

Genentech is excited to share the news of a new FDA approval for HER2+ metastatic breast cancer: KADCYLA™ (ado-trastuzumab emtansine).

KADCYLA™ (ado-trastuzumab emtansine) injection, for intravenous use, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.

Genomic Health – Oncotype DX Colon - 2nd confirmatory Validation Study for Stage II Colon

Results determine 3 year recurrence for stage II colon cancer.   The assay reveals the biology of the tumor (T3) indicates which are more similar to T4 Disease. The Oncotype DX colon cancer test was made available in 2010 based on results from the QUASAR study, allowing physicians to go beyond the limited set of clinical and pathologic markers to make more informed decisions about the adjuvant use of chemotherapy for stage II colon cancer based on the quantitative individualized assessment of recurrence risk," said Steven Shak, M.D., chief medical officer at Genomic Health. "These results, together with the positive confirmatory clinical study presented by the CALGB at ASCO in June and Medicare's recent coverage announcement pave the way for expanded reimbursement and increased patient access to the Oncotype DX colon cancer test."

The QUASAR clinical validation study analyzed 1,436 patients with stage II colon cancer.


Genomic Health launched an Oncotype DX DCIS Test in January 2012.

This is a multigene assay that can accurately quantify a woman’s risk of recurrence prior to radiation therapy. The assay was validated on patients from ECOG 5194 Study.

The study, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

Understanding the biological risk will better determine the risk and help patients and clinician’s weight the treatment options.

Effective for dates of service on or after January 1, 2012, the new J-code for both Prolia® and XGEVA® is J0897

Amgen is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) have established a product-specific Healthcare Common Procedures Coding System (HCPCS) J-code, or permanent code, for Prolia® (denosumab) and XGEVA® (denosumab).  Effective for dates of service on or after January 1, 2012, the new J-code for both Prolia® and XGEVA® is J0897

The new J-code, J0897 for Prolia® and for XGEVA®, should be used instead of the current miscellaneous J-code (J3590) as well as the current C-code (C9272) when processing claims forms with dates of service on or after January 1, 2012.

The new J0897 code is included in the 2012 version of coding manuals that providers rely on for coding information. We encourage that this new code be implemented within the first 90 days of the calendar year, to allow for a smooth transition in processing physician claims.

Important Update: New HCPCS J-Code Effective January 1, 2012

Effective January 1, 2012 JEVTANA® has been assigned a HCPCS J-Code:
J9043 Injection, cabazitaxel, 1 mg
by CMS (Centers for Medicare and Medicaid Services).
Click here information for JEVTANA® using the CMS 1500.