Allogeneic for Stem Cell Transplantation

90.3.1 - Allogeneic for Stem Cell Transplantation (Rev. 12948; Issued: 11-06-24; Effective:03-06-24; Implementation:10-07-24) A. Definition of Acquisition Charges for Allogeneic Stem Cell Transplants 1. Effective for Cost Reporting Periods Beginning Prior to October 1, 2020 Acquisition charges for allogeneic stem cell transplants include, but are not limited to, charges for the costs of the following services: • National Marrow Donor Program fees, if applicable, for stem cells from an unrelated donor; • Tissue typing of donor and recipient; • Donor evaluation; • Physician pre-admission/pre-procedure donor evaluation services; • Costs associated with harvesting procedure (e.g., general routine and special care services, procedure/operating room and other ancillary services, apheresis services, etc.); • Post-operative/post-procedure evaluation of donor; and • Preparation and processing of stem cells. Payment for these acquisition services is included in the MS-DRG payment for the allogeneic stem cell transplant when the transplant occurs in the inpatient setting, and in the OPPS APC payment for the allogeneic stem cell transplant when the transplant occurs in the outpatient setting. The Medicare contractor does not make separate payment for these acquisition services, because hospitals may bill and receive payment only for services provided to the Medicare beneficiary who is the recipient of the stem cell transplant and whose illness is being treated with the stem cell transplant. Unlike the acquisition costs of solid organs for transplant (e.g., hearts and kidneys), which are paid on a reasonable cost basis, acquisition costs for allogeneic stem cells are included in prospective payment. Acquisition charges for stem cell transplants apply only to allogeneic transplants, for which stem cells are obtained from a donor (other than the recipient himself or herself). Acquisition charges do not apply to autologous transplants (transplanted stem cells are obtained from the recipient himself or herself), because autologous transplants involve services provided to the beneficiary only (and not to a donor), for which the hospital may bill and receive payment (see Pub. 100-04, chapter 4, §231.10 and paragraph B of this section for information regarding billing for autologous stem cell transplants). 2. Effective for Cost Reporting Periods Beginning on or After October 1, 2020 Allogeneic hematopoietic stem cell acquisition costs are as follows: • Registry fees from a national donor registry described in 42 U.S.C. 274k, if applicable, for stem cells from an unrelated donor. • Tissue typing of donor and recipient. • Donor evaluation. • Physician pre-admission/pre-procedure donor evaluation services. • Costs associated with the collection procedure (for example, general routine and special care services, procedure/operating room and other ancillary services, apheresis services), and transportation costs of stem cells if the recipient hospital incurred or paid such costs. • Post-operative/post-procedure evaluation of donor. • Preparation and processing of stem cells derived from bone marrow, peripheral blood stem cells, or cord blood (but not including embryonic stem cells). Effective for cost reporting periods beginning on or after October 1, 2020, a subsection (d) hospital that furnishes an allogeneic hematopoietic stem cell transplant to an individual during such a period, payment to such hospital for hematopoietic stem cell acquisition shall be made on a reasonable cost basis. Payment for allogeneic hematopoietic stem cell acquisition services continues to be included in the OPPS APC payment when the transplant occurs in the outpatient setting. Acquisition charges for stem cell transplants apply only to allogeneic transplants, for which stem cells are obtained from a donor (other than the recipient himself or herself). Acquisition charges do not apply to autologous transplants (transplanted stem cells are obtained from the recipient himself or herself), because autologous transplants involve services provided to the beneficiary only (and not to a donor), for which the hospital may bill and receive payment (see Pub. 100-04, chapter 4, §231.10 and paragraph B of this section for information regarding billing for autologous stem cell transplants). B. Billing for Acquisition Services The hospital bills and shows acquisition charges for allogeneic stem cell transplants based on the status of the patient (i.e., inpatient or outpatient) when the transplant is furnished. See Pub. 100-04, chapter 4, §231.11 for instructions regarding billing for acquisition services for allogeneic stem cell transplants that are performed in the outpatient setting. When the allogeneic stem cell transplant occurs in the inpatient setting, allogeneic bone marrow/stem cell acquisition charges shall be billed using revenue code 0815. Revenue code 0815 (Allogeneic Stem Cell Acquisition/Donor Services) charges should include all services required to acquire stem cells from a donor, as defined above. Effective for discharges occurring on or after October 1, 2021, such charges are not considered for the IPPS outlier calculation when billed for an allogeneic stem cell transplant. On the recipient’s transplant bill, the hospital reports the acquisition charges, cost report days, and utilization days for the donor’s hospital stay (if applicable) and/or charges for other encounters in which the stem cells were obtained from the donor. The donor is covered for medically necessary inpatient hospital days of care or outpatient care provided in connection with the allogeneic stem cell transplant under Part A. Expenses incurred for complications are paid only if they are directly and immediately attributable to the stem cell donation procedure. The hospital reports the acquisition charges on the billing form for the recipient, as described in the first paragraph of this section. It does not charge the donor's days of care against the recipient's utilization record. For cost reporting purposes, it includes the covered donor days and charges as Medicare days and charges. The transplant hospital keeps an itemized statement that identifies the services furnished in collecting allogeneic hematopoietic stem cells including all invoices or statements for purchased services for all donors and their service charges. Records must be for the person receiving the service (donor or recipient). Beginning October 1, 2020, for all donor sources, the hospital must identify the prospective recipient and include the recipient’s Medicare beneficiary identification number. These charges will be reflected in the transplant hospital's stem cell/bone marrow acquisition cost center. For allogeneic stem cell acquisition services in cases that do not result in transplant, due to death of the intended recipient or other causes, hospitals include the costs associated with the acquisition services on the Medicare cost report. The hospital shows charges for the transplant itself in revenue center code 0362 or another appropriate cost center. The hospital shows charges for acquiring allogeneic hematopoietic stem cells for transplant in revenue code 0815. C. Coverage Expansion for Allogeneic Stem Cell Services Effective March 6, 2024 On March 6, 2024, CMS issued a final decision to expand Medicare coverage for allogeneic hematopoietic stem cell transplant (HSCT) using bone marrow, peripheral blood, or umbilical cord blood stem cell products for Medicare patients with myelodysplastic (MDS) syndromes who have prognostic risk scores of: • ≥ 1.5 (Intermediate-2 or high) using the International Prognostic Scoring System (IPSS), or, • ≥ 4.5 (high or very high) using the International Prognostic Scoring System - Revised (IPSS-R), or, • ≥ 0.5 (high or very high) using the Molecular International Prognostic Scoring System (IPSS-M). For these patients, the evidence demonstrates that the treatment is reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act (the Act). In addition, coverage of all other indications for stem cell transplantation not otherwise specified will be made by local Medicare Administrative Contractors under section 1862(a)(1)(A) of the Act. C. Billing for Allogeneic Stem Cell Services on or after March 6, 2024 1. Effective for claims with dates of service on and after March 6, 2024 Effective for claims with dates of service on and after March 6, 2024, contractors shall allow payment for HSCT for MDS under NCD 110.23, when the professional claim for HCPCS code 38240 or institutional claim (TOB 11 X only) for ICD-10-PCS 30233X2, 30233X3, 30243X2 30243X3, XW133C8, or XW143C8 included: • Modifier KX to indicate that they have a qualifying prognostic risk score in their medical record (professional claims only); • For institutional claims, (TOB 11 X only) providers report the CR13604 in Loop 2300 Billing Note NTE02, or in the remark field locator (FL)80 on Line 1, position 1, on DDE or paper claims to indicate that they have qualifying prognostic risk score in their medical record; and • Intermediate-2 or high (IPSS), or, • high or very high (IPSS-R), or, • high or very high (IPSS-M), and, • One of the following ICD-10-CM Diagnosis Codes: D46.A D46.B D46.C D46.Z D46.0 D46.1 D46.4 D46.9 D46.20 D46.21 D46.22 Please note the existing PCS codes related to Allogeneic also apply to claims after March 6, 2024. (30233G2, 30233G3, 30233U2, 30233U3, 30233Y2, 30233Y3, 30243G2, 30243G3, 30243U2, 30243U3, 30243Y2, 30243Y3.) 2. Messaging Effective March 6, 2024 Contractors shall use the following messages, as appropriate, when denying claims without required diagnostic or procedure coding: MSN 9.4 - This item or service was denied because information required to make payment was incorrect. Spanish Version: Este servicio fue denegado debido a que la información requerida para hacer el pago fue incorrecta. CARC 96 – Non-covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC N386 – This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code: CO Contractors shall use the following messages, as appropriate, when denying claims for HSCT for MDS, if submitted with a TOB other than TOB 11X: MSN 21.25 – This service was denied because Medicare only covers this service in certain settings. Spanish Version – El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones. CARC 58 – Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC – Not needed. Group Code - CO NOTE: These messages shall be used for denials under reason code 49141. Contractors shall use the following messages when denying claims with a TOB other than TOB 11X: MSN 21.25 – This service was denied because Medicare only covers this service in certain settings. Spanish Version – El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones. CARC 58 – Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC – Not needed. Group Code - CO NOTE: These messages shall be used for denials under reason code 49142.