CAR-T Coding Hits Community Oncology

I have seen awfully hard coding in my time (looking at you, Interventional Radiology), but we are seeing CAR-Ts migrating from the hospital to the office setting and the coding/billing is totally weird. That's the bad news. The good news is that we are seeing Community claims being paid, so somebody out there actually knows what they are doing--Congrats!

We suspect some of the rest of you will want to bill these innovative drugs when they come your way, so here is the scoop...remember this is Part B only; all others can be found in this comprehensive guide.

Cell Harvesting and Delivery Activities

Until January 1, 2025, these were Level III HCPCS and were paid by a number of payers. The new 2025 codes are:

• 38225 – Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day

• 38226 – …preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)

• 38227 – …receipt and preparation of CAR-T cells for administration

These codes have a "B" status for Medicare, so they are bundled and not paid. Check with your private payers regarding reimbursement. As we said, some were paying the old codes.

Place of Service

For Part B (outpatient claims), HCPCS codes (always Q-codes) for CAR T-cell products will only be paid in POS 11 (office) or 49 (independent clinic). Any other place of service will be denied if they are billed as we describe in the next sections. Again, hospital claims are different.

To give CAR-Ts your office needs to be FDA REMS approved. To denote this you must use a -KX Modifier. When a provider submits a KX HCPCS modifier on CAR T-cell therapy services, they are acknowledging the service is being submitted by or performed in an FDA REMS approved facility. Claims billed without the KX HCPCS modifier will be denied.

Number of Units

Here comes the trickiest part.

Effective for DOS on and after January 1, 2022, when entering the dollar amount for the charge of a service, providers are limited to a maximum of $99,999.99 per claim because $100,000.00 would exceed the CMS-1500 field size.

In most cases, the total payment for the CAR T-cell products will be divided by 10 and the provider will need to bill in 0.1-unit fractions. The provider will need to bill a total of 10 fractional units to reach the total Medicare allowed payment amount or one (1) complete unit, except as follows:

• Providers billing $499,999.99 or less would submit five claims for 0.2 fractional units per claim, for one (1) complete unit.
• For claims priced over $500,000.00, providers would bill 10 claims for 0.1 fractional units per claim.
• The total units for fractions billed shall not exceed one (1) unit.
• All claims for fractional units shall be billed with HCPCS modifier LU (fractionated payment CAR T-cell therapy).
• CPT® modifier 76 (repeat service) should also be used to bill for all subsequent fractional unit claims, but not the first one.
• Claims for fractional units billed without HCPCS modifier LU will be denied.

Let's take an example:

CAR T-cell product allowed payment per a total of one unit (1.0) is $445,000:

Claim 1 — 0.2 units = $89,000.06

Claim 2 — 0.2 units = $89,000.00

Claim 3 — 0.2 units = $88,999.99

Claim 4 — 0.2 units = $88,999.98

Claim 5 — 0.2 units = $88,999.97

Note: Each fractional unit would be billed on a separate claim--same thing when billing. Contractors shall only pay up to one (1.0) unit per HCPCS code. Anything above one (1.0) unit will be denied. Don't forget that on Claims 2-5 would necessitate Modifiers KX, LU, and 76, while the first one will only require KX and LU.

When Dosage Exceeds Code Descriptor

When the dose exceeds the code descriptor for CAR T-cell products, use HCPCS code J3490, J3590 or J9999 for the exceeded dosage. The provider would bill a total of one (1.0) unit of the Q code plus a total of one (1.0) unit of the J code and include the CAR T-cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent.

Example: Q2041 (Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T-cells.)

If the provider gives 300 million cells, they will bill:

• Q2041 for 0.1 fraction $42,294.00 x10 for 200 million cells (total $422,940.00)
• J9999 for 0.2 fractions $42,294.00 x5 for 100 million cells (total $211,470.00)
• Note: The FDA labels for CAR T-cell products state the maximum number of cells to be infused. The HCPCS code descriptors for Q2041, Q2042, Q2053, Q2054, Q2055 and Q2056 all align with the FDA label maximum number of cells to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare, which may be a good thing since these will most probably be reviewed and then denied, unless there is something extraordinary.

CAR-T Admin

Probably the easiest part of all of this:

38228 Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous (CMS National Non-Facility Allowable $280.12), effective January 1, 2025.

Notice this is not a time based code.

Summary

Here are the important concepts described herein:

• Fractional Billing--Due to the high cost of CAR-T billing, providers must divide the total cost by 5 or 10 and bill in 0.2 or 0.1- claim fractions to equal 1.0
• Modifier LU-- When billing with fractional amounts, use LU to signify fractionalized billing for CAR-T billing
• Modifier KX--This modifier signifies that the billing practice is a REMS-approved facility
• Modifier 76--This modifier, usually used for surgery, is used on subsequent claims (to the first one) for fractionalized billing
• 38228--New(ish) code for CAR-T administration.

 

For more information, see this Medlearn Matters or, for a more comprehensive view, see the Palmetto web site.