(Medicare Claims Processing Manual)

2. Effective for services performed on or after October 1,  2000:   Single AuSCT  is only covered for Durie -Salmon Stage II or III patients that fit the following requirements:   Newly diagnosed or responsive multiple myeloma. This includes those patients with previously untreated disease, those with at least a partial response to prior chemotherapy (defined as a 50% decrease either in measurable paraprotein [serum and/or urine] or  in bone marrow infiltration, sustained for at least 1 month), and those in responsive relapse;  and   Adequate cardiac, renal, pulmonary, and hepatic  function.  3. Effective for services performed on or after March 15,  2005:   When recognized clinical risk factors are employed to select patients for transplantation, high dose melphalan (HDM) together with AuSCT is reasonable and necessary for Medicare beneficiaries of any age group with primary amyloid light chain (AL) amyloidos is who meet the following criteria:    Amyloid deposition in 2 or fewer organs;  and,  Cardiac left ventricular ejection fraction (EF) greater than 45%.   C. Nationally Non -Covered Indications   I. Allogeneic Hematopoietic Stem Cell Transplantation  (HSCT)  Effective for claims with dates of service on or after May 24, 1996, through January 26, 2016, allogeneic HSCT is not covered as treatment for multiple myeloma. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this  policy, and Pub. 100- 04, chapter 32, section 90, for information on coding.  II. Autologous Stem Cell Transplantation  (AuSCT)   Insufficient data exist to establish definite conclusions regarding the efficacy of AuSCT for the following conditions:   a) Acute leukemia not in  remission;  b) Chronic granulocytic  leukemia;  c) Solid tumors (other than neuroblastoma);  d) Up to October 1, 2000, multiple myeloma;  e) Tandem transplantation (multiple rounds of AuSCT) for patients with multiple  myeloma; f) Effective October 1, 2000, non primary AL amyloidosis;  and, g) Effective October 1, 2000, through March 14, 2005, primary AL amyloidosis for Medicare beneficiaries age 64 or  older.   In these cases, AuSCT is not considered reasonable and necessary within the meaning of  l862(a)(1)(A) of the Act and is not covered under Medicare. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy, and Pub. 100- 04, chapter 32, section 90, for information on coding.  D. Other  All other indications for stem cell transplantation not otherwise noted above as covered or non- covered remain at local Medicare Administrative Contractor discretion.    90.3.1 -  Allogeneic  for Stem Cell Transplantation  (Rev. 11113; Issued: 11- 16-21; Effective: 12 -17-21; Implementation: 12 -17-21)   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 paym ent.  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 recipients transplant bill, the hospital reports the acquisition charges, cost report days, and utilization days for the donors 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 recipients Medicare beneficiary identification number. These charges wil l 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 t he 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.   90.3.2 - Autologous Stem Cell Transplantation (AuSCT)  (Rev.11348; Issued: 04- 07-22; Effective: 05 -09-22; Implementation: 05 -09-22)  A. - General   Autologous stem cell transplantation (AuSCT ) is a technique for restoring stem cells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (high dose chemotherapy (HDCT)) and/or radiotherapy use d to treat various malignancies.   If ICD -10-PCS is applicable, use the following Procedure Codes and Descriptions -    30230C0  Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Peripheral Vein, Open Approach  30230G0  Transfusion of Autologous Bone Marrow into Peripheral Vein, Open Approach  30230Y0  Transfusion of Autologous Hematopoietic Stem Cells into Peripheral Vein, Open Approach  30233G0  Transfusion of Autologous Bone Marrow into Peripheral Vein, Percutaneous Approach  30233C0  Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Peripheral Vein, Percutaneous Approach  30233Y0  Transfusion of Autologous Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach  30240C0  Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Central Vein, Open Approach  30240G0  Transfusion of Autologous Bone Marrow into Central Vein, Open Approach  30240Y0  Transfusion of Autologous Hematopoietic Stem Cells into Central Vein, Open Approach  30243C0  Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Central Vein, Percutaneous Approach  30243G0  Transfusion of Autologous Bone Marrow into Central Vein, Percutaneous Approach  30243Y0  Transfusion of Autologous Hematopoietic Stem Cells into Central Vein, Percutaneous Approach    NOTE: Please note that effective September 30, 2021 PCS codes for Allogeneic SCT 30230G2,  30230G3, 30230Y2, 30230Y3, 30240G2, 30240G3, 30240Y2, 30240Y3 and PCS codes for Autologous SCT 30230C0, 30230G0, 30230Y0, 30240C0, 30240G0, 30240Y0 are end -dated.    B. - Covered Conditions   1. Effective for services performed on or after April 28,  1989:   For acute leukemia in remission for patients who have a high probability of relapse and who have no human leucocyte antigens (HLA) -matched, the following diagnosis codes are reported:    If ICD -10-CM is applicable, use the following Diagnosis Codes and Descriptions -