Car T-cell Therapy: Coverage and Billing-Inpatient 9/13/21

Visante/Car T-cell Therapy: Coverage and Billing-Inpatient 9/13/21
Car T-cell Therapy: Coverage and Billing-Inpatient 9/13/21
Published date: September 13, 2021

Chimeric Antigen Receptor (CAR) T-cell therapy is an example of a rapidly emerging immunotherapy approach called adoptive cell transfer (ACT) where patients’ own immune cells are collected and used to treat their cancer. Accurate billing for these products and the associated services is extremely important due to the cost and clinical resource intensity of administering the products.

We previously provided instructions for the billing of CAR T-cell therapies when provided to an outpatient. This newsletter provides billing and reimbursement information when these products are administered to hospital inpatients.

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. The FDA provides a list of approved cellular and gene therapies including five that are Car T-cell therapies (current as of 09/09/2021):

KYMRIAH (tisagenlecleucel)

YESCARTA (axicabtagene ciloleucel)

BREYANZI (lisocabtagene maraleucel)

ABECMA (idecabtagene vicleucel)

TECARTUS (brexucabtagene autoleucel)

Coverage

CMS finalized a National Coverage Determination (NCD 110.24) on CAR T-cell therapies on 8/7/2019 and has published a revision scheduled to be implemented on 09/20/2021. The revisions include additional general information about the use of CAR T-cell therapies in cancer, and to add HCPCS code C9076 for Breyanzi to the list of covered products. This information is in CMS Transmittal 10891 issued on July 20, 2021. 

The NCD details that for Medicare Fee-For-Service and Medicare Advantage, Medicare covers the autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when:

  • Administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and, 

  • Used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) – i.e. is used for either an FDA-approved indication (according to the FDA-approved label for the product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia

The use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements noted above are not met.

In addition, the routine costs in clinical trials that use CAR T-cell therapy as an investigational agent are covered when they meet the requirements listed in NCD 310.1.

NOTE: The use of allogenic T-cells from healthy donors are not autologous CAR T treatments and should not be billed as autologous CAR-T treatments.

NOTE: As specific codes are created for current and future FDA-approved CAR T-cell therapies, the MACs will update their local systems and websites accordingly.

Billing and Reimbursement

General Billing

All CAR T-cell products should be billed using revenue code 891- – Special Processed Drugs – FDA (U.S. Food and Drug Administration) Approved Cell Therapy – Charges for Modified cell therapy.

CMS provides instructions that providers may include all costs and charges and report them under revenue code 891, or they may separately report cell collection, storage and other preparatory activities. However, CMS does not reimburse these codes separately and they are reported for information only. Detailed examples on these two options for CAR T-cell billing for outpatients is available at CMS Transmittal #10454– (November 13, 2020) and MLN Matters Article SE19009 (May 28, 2019).

Some payers also require that the claim include a new value code 86 with the invoice/acquisition cost when revenue code 891 is present on an outpatient claim.

Product Reimbursement

Kymriah and Yescarta

From October 1, 2018 until September 30, 2020, Kymriah and Yescarta received New Technology Add-on Payment (NTAP) when administered to Medicare inpatients. The NTAP payment expired on September 30, 2020, but a new MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy) was created to incorporate the higher costs for the CAR T-cell therapies. New ICD-10-PCS codes XW033J7/XW043J7 (tisagenlecleucel) and XW033H7/XW043H7 (axicabtagene ciloleucel) are used to identify claims on or after October 1, 2021 for inclusion in MS-DRG 018. Previously, both Kymriah and Yescarta were reported with the same ICD-10-PCS codes. (Note: claims continue to be eligible for outlier payments when appropriate).

Breyanzi (lisocabtagene maraleucel)

Breyanzi received FDA approval on 2/5/2021, and is assigned new ICD-10-PCS codes effective 10/1/2021: XW033N7– Introduction of Lisocabtagene Maraleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 and XW043N7– Introduction of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7. CMS considers Breyanzi to be substantially similar to Kymriah and Yescarta in treatment of DLBCL and therefore would be included in the payment for MS-DRG-18 for that indication. However, CMS recognizes that Breyanzi is not substantially similar in the specific subpopulation of cases without DLBCL, but with follicular lymphoma grade 3b. In evaluating the data provided by the manufacturer, CMS was unable to determine whether Breyanzi represented a substantial clinical improvement due to a sample size of two or three patients. Therefore they are not approving NTAP payments for FY 2022.

Abecma (idecabtagene vicleucel)

Abecma received FDA approval on 3/26/2021 for the treatment of adult patients with relapsed or refractory (RR) multiple myeloma (MM) (RRMM) who have received at least four prior therapies including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody (for example, triple-class-exposed). ICD-10-PCS codes were created for use on or after October 1, 2021: XW033K7-Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7, and XW043K7– Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7. Abecma was granted NTAP status with a FY 2022 maximum payment of $272,675.

Tecartus (brexucabtagene autoleucel)

Tecartus received FDA approval on 10/24/2020 for the treatment of adult patients with relapsed and refractory (r/r) mantel cell lymphoma (MCL), and received new ICD-10-PCS codes effective 10/1/2021: XW033M7– Introduction of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 and XW043K7– Introduction of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7. CMS approved NTAP payments for Tecartus for FY 2022 with a maximum of $259,350.

Cost Report- New Worksheet D-6

For cost reports on or after October 1, 2020, a new worksheet D-6, Computation of Acquisition Costs, is intended to calculate costs associated with hematopoietic stem cells for transplant, as well as T-cells for CAR T-cell immunotherapy infusion. It is predicted that only 116 providers will be impacted by this new worksheet, it may potentially have a material effect on future reimbursement. CMS published a notice of collection of information in the Federal Register on November 10, 2020.

SHOUT-OUTS!

  1. Pharmacy and Revenue Integrity should determine if CAR T-cell therapy will be provided and ensure that appropriate chargemaster entries for the products are established with product specific HCPCS codes and the unique revenue code, 891.

  2. Pharmacy, Managed Care and Revenue Integrity should determine if any payers require the invoice cost to be added to claim with value code 86 and establish a process to ensure that the invoice cost is correctly added to the claim.

  3. Revenue Integrity and HIM Coders should receive instructions as to which products will be utilized and the medical record location where the administration will be recorded. 

  4. Pharmacy should ensure that if the product is administered under a clinical trial, or received at no cost from the manufacturer, that it is clearly indicated in the medical record to ensure proper billing and coding.

  5. Coders should be made aware that new ICD-10-PCS codes have been assigned for CAR T-cell therapy products and replace codes assigned prior to October 1, 2021.

  6. Finance should develop auditing mechanisms to predict which CAR T-cell therapies will receive NTAP reimbursement and that all CAR T-cell patient claims are identified in MS-DRG 18.

  7. Reimbursement should review the new Cost Report Worksheet D-6 for reporting acquisition costs for CAR T-cell therapies for cost reports beginning with October 1, 2020.

***If you would like assistance in establishing a Car T-cell therapy program at your health-system, Contact Us at Visante to discuss your needs: https://www.visanteinc.com/contact-us/

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