A deceptively simple NCD & the confusion that it threw down
Medicare coverage of services and therapies is limited to those that are reasonable and necessary and within the scope of a Medicare benefit category. National coverage determinations (NCDs) are developed by the Centers for Medicare and Medicaid Services (CMS) to describe the circumstances for Medicare coverage nationwide for a specific medical service procedure, therapy, or device. NCDs generally outline the conditions for which a service is considered to be covered (or not covered). In the absence of an NCD, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination (LCD). In the rare instance of contradicting information in the NCD and LCD, the NCD overrides the LCD.
The first CAR-T approval was in mid 2017 (here). In 2019, CMS issued an NCD (110.24), in which about 150 words declare that CAR-T therapies would be covered on FDA indications and compendium (e.g. NCCN) endorsed indications in facilities enrolled in the FDA REMS:
"Medicare covers 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 that 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 NCD is the formal policy. For Medicare beneficiaries enrolled in Medicare Advantage plans, coverage determinations are be made by the Medicare Advantage plan (R10891CP). Effective for services performed on or after August 7, 2019, routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1 will be covered by the Medicare Administrative Contractors (MCD search 12-03-2021)."
In the claims processing change request (CR) transmittal (10454) issued on November 13, 2020, CMS stated that certain things are NOT covered under the NCD:
Common Procedural Terminology (CPT) codes for cell collection, transport, and prep (0537T, 0538T, and 0539T) are not separately payable services under NCD 110.24 (they are tracking codes only). But HCPCS code 0540T is a covered service. The costs of these steps and the reimbursement of them are not relatively large; they amount to a few thousand dollars, based on our Medicare claims analysis, compared to the total cost of a CAR T case of about $425k+. However, if CMS changes to paying ASP + a flat amount, omitting payment for these services would become more important.
MA patients were paid for under Medicare FFS for the first two years under the NCD: ". . . for CYs 2019 (beginning August 7, 2019) and 2020 only, original fee-for-service Medicare will pay for CAR T-cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage (MA) plans when the coverage criteria outlined in the NCD are met. Plans should account for CAR T-cell therapy for cancer items and services in their contract year 2021 bids."
The weird part: "Contractors shall deny claims for CAR T-cell therapy when the service is not rendered to an inpatient or outpatient of a hospital, including critical access hospitals or hospital-based outpatient clinics . . . Medicare coverage for CAR T-cell therapy is restricted to the hospital inpatient or HOPD settings."
So it seemed CAR Ts weren't covered in freestanding physician's offices.
MACs, Medicaid programs, and providers took that last weird part and ran. First Coast - the MAC for Florida - issued this puzzling guidance. In it, they introduce "Part A outpatient." Part A in Medicare is typically for inpatient services, and Part B is for outpatient services. "Part A outpatient" is for services provided at outpatient hospital facilities. The next perplexing verbiage is associated with all of the CAR Ts on the market. Each CAR T HCPCS (listed in rows in a table) is shown as "Not payable in Part B. Payable in Part A outpatient," which seems to come from the CMS transmittal regarding outpatient administration only in HOPDs (we were referred to the transmittal when we asked the MAC asked why the table says the CAR Ts are not covered). First Coast has said they are trying to fix the verbiage to be more clear.
Medi-Cal, California's Medicaid program, also issued this CAR T policy update, which clearly states, "Outpatient administration is restricted to Hospital Outpatient Services only." They, too, refer to that pesky CMS transmittal 10454.
CMS released another transmittal (11179, January 2022) that re-instructed MACs that Medicare only covers CAR T therapy when administered in a REMS-certified healthcare facility. When a facility submits a claim, in order to acknowledge that they are REMS-certified, the claim must have the KX modifier appended to the CAR T administration code 0540T. In the transmittal, CMS clarified that the KX modifier is only required for CAR T claims submitted by outpatient hospital facilities and physician practices.
More importantly, CMS notes:
"NOTE: Specific to NCD 110.24, CAR-T, CMS is providing further clarifying information regarding coverage/claims processing: CMS does not prohibit Part B payment for reasonable and necessary CAR-T services, so long as the therapies are furnished in Risk Evaluation and Mitigation Strategies (REMS) - approved facilities and the claims include the appropriate coding."
THANK YOU FOR THE CLARIFICATION, CMS!
But wait, there's more... "For instance, the physician/NPP would provide the CAR-T service at a Part A facility, Inpatient (IP) or Outpatient (OP) setting, and would bill Part B for the administration only (0540T)." What the what does that mean? If the provider of a CAR T therapy is a hospital, they would bill Part A (inpatient or outpatient) for everything related to the CAR T (they won't get reimbursed separately for the cell prep, as previously stated), and they would bill Part B for the administration. This clarification should not be interpreted as the provider can only bill Medicare for the administration, or that Part B only covers 0540T. As of today, we haven't seen local MACs or Medicaid programs pick up on the change request transmittals. We'll keep you posted if we see anything, though.