Package/Label & Coding Updates
To submit packaging or coding updates for posting consideration, forward to info@nnecos.org.
Jump to: Package/Label Updates ~ Coding Updates
package/label updates
September 14, 2026 – IMDELLTRA® (tarlatamab-dlle)
IMDELLTRA® (tarlatamab-dlle) prescribing information has been updated to support monitoring in an appropriate healthcare setting from the start of the IMDELLTRA® infusion for 6 to 8 hours on Cycle 1 Days 1 and 8 due to the risk of CRS and neurologic toxicity, including ICANS.
It is recommended that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. A patient assessment including vital signs check should be performed on Cycle 1 Days 2 and 9. Please see below for full details on dosing and administration.
>>Prescribing information
February 5, 2026 – Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency
The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.
>>More information
July 11, 2025 – ELREXFIO® (elranatamab-bcmm)
On July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm). ELREXFIO is approved for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
>>Prescribing information
>>Medication Guide
December 14, 2023 – New Indication for KEYTRUDA® (pembrolizumab)
- Injection 100 mg, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.
- SELECTED SAFETY INFORMATION
>>Prescribing information
>>Medication Guide
December 2023 – KEYTRUDA® (pembrolizumab) Injection 100 mg
- Selected Safety Information
- Severe and Fatal Immune-Mediated Adverse Reactions
August 2023 – New Indication for Reblozyl (luspatercept-aamt)
- anemia without previous erythropoiesis stimulating agent use (ESAnaïve) in adult patients with very low-to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions
coding updates
Product-specific J-code announcement
The CMS announced the assignment of a product-specific J-code in the hospital outpatient setting under Medicare for LYNOZYFIC intravenous infusion.
A J-code has been announced for an FDA-approved treatment option for adult patients with relapsed or refractory multiple myeloma. This J-code is effective as of April 1, 2026, and can be used for all billing and administrative purposes.
Product-specific C-code announcement
The Centers for Medicare & Medicaid Services (CMS) announced the assignment of a product-specific C-code in the hospital outpatient setting under Medicare for LYNOZYFIC.
Effective January 1, 2026, the following C-code can be used for administrative and billing purposes specific to LYNOZYFIC:
C9307 – Injection, linvoseltamab-gcpt, 1 mg LYNOZYFIC is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called LYNOZYFIC REMS. Visit LYNOZYFICREMS.com to learn more.
Please see full Prescribing Information, including Boxed WARNING, for LYNOZYFIC.
Claim Issue Reported 1/8/25
Provider Type(s) Impacted: Part B providers in Jurisdiction JK and Jurisdiction J6
Claim Coding Impact: Claims with healthcare common procedure coding system (HCPCS) G2211 with date of service (DOS) 1/1/2024-9/30/2024
Description of Issue: National correct coding initiative editing for HCPCS G2211 code was updated on 12/5/2024 to require HCPCS G0463 as the primary code for G2211 add-on code. This has resulted in denials of claims for the add-code G2211 when billed with current procedural terminology 99202-99205 and 99211-99215. Impacted claims are for DOS 1/1/2024-9/30/2024 when processed on or after 12/5/2024.
National Government Services Action: National Government Services (NGS) is fully aware of the issue and has reached out to Centers for Medicare & Medicaid Services for instructions. The NGS Provider Call Center has no additional information on these claim denials and calls to the call center on this topic will yield no additional information.
NGS will post additional information on these claims when available.
Healthcare Common Procedure Coding System (HCPCS)* J-Code for ELREXFIO (elranatamab-bccm) injection:
Effective for dates of service on or after April 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding System (HCPCS)* J-Code for ELREXFIO (elranatamab-bccm) injection: J1323- Injection, elranatamab-bcmm, 1 mg
Please see full prescribing information including Boxed Warning, HERE.