Abstract:
Stem cell transplantation is a process in which stem cells are harvested from either a patient's (autologous) or donor's allogenic bone marrow or peripheral blood for intravenous infusion. (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 (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplantation (HSCT) is a procedure in which a portion of a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion. Allogeneic HSCT may also be used to restore function in recipients having an inherited or acquired deficiency or defect. Hematopoietic stem cells are multi-potent stem cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental self destruct. (CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2: Section 110.23).
...bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage. When bone marrow or peripheral blood stem cell transplantation is non-covered, none of the steps are covered. (CMS Publication 100-03, Medicare National Coverage Determinations(NCD) Manual, Chapter 1, Part 2: Section 110.23).
The CMS National Coverage Determination (NCD) for Stem Cell Transplantation describes nationally covered indications for stem cell transplant, the details of which will not be repeated here. This Medical policy article describes additional locally covered indications for stem cell transplant.
Indications and Limitations:
Hematopoietic Progenitor Cell (HPC);Autologous Transplantation
(ICD-10-PCS Procedure codes 30233C0, 30233G0, 30243C0, 30243G0, 30233Y0, and 30243Y0)
The NCD lists the following nationally covered indications:
- Acute leukemia in remission in patients who have a high probability of relapse and who have no human leucocyte antigens (HLA)-matched donor;
- Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following an initial response;
- Recurrent or refractory neuroblastoma;
- Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched donor;
- Single HPC, autologous 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.
- HPC, autologous in combination with high dose melphalan for patients with primary amyloid light chain amyloidosis, with amyloid deposition in two or fewer organs and a cardiac left ventricular ejection fraction greater than 45%.
In addition to the nationally covered indications for HPC, autologous, the following indication will be covered locally, for those jurisdictions or providers for whom this Medical Policy article applies, when medically necessary:
- Anaplastic large cell lymphoma
- Large cell lymphoma/B-cell lymphoma
- Peripheral T-cell lymphoma
- Primary central nervous system lymphoma
- Testicular cancer
- Waldenström macroglobulinemia
The NCD lists the following nationally non-covered indications:
- Acute leukemia not in remission;
- Chronic granulocytic leukemia;
- Solid tumors (other than neuroblastoma); and
- Tandem transplantation (multiple rounds of HPC, autologous) for patients with multiple myeloma
Coding Information
Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare
For services requiring a referring/ordering physician, the name and NPI of the referring/ordering physician must be reported on the claim
A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act
The diagnosis code(s) must best describe the patient's condition for which the service was performed.
Advance Beneficiary Notice of Noncoverage (ABN) Modifier Guideline
An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.
For claims submitted to the Part B MAC:
All services/procedures performed on the same day for the same beneficiary by the physician/provider should be billed on the same claim.
For claims submitted to the Part A MAC:
Hospital Inpatient Claims:
- The hospital should report the patient's principal diagnosis in Form Locator (FL) 67 of the UB-04. The principal diagnosis is the condition established after study to be chiefly responsible for this admission.
- The hospital enters ICD-10-CM codes for up to eight additional conditions in FLs 67A-67Q if they co-existed at the time of admission or developed subsequently, and which had an effect upon the treatment or the length of stay. It may not duplicate the principal diagnosis listed in FL 67.
- For inpatient hospital claims, the admitting diagnosis is required and should be recorded in FL 69. (See CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 25, Section 75 for additional instructions.)
Hospital Outpatient Claims:
- The hospital should report the full ICD-10-CM code for the diagnosis shown to be chiefly responsible for the outpatient services in FL 67. If no definitive diagnosis is made during the outpatient evaluation, the patient's symptom is reported. If the patient arrives without a referring diagnosis, symptom or complaint, the provider should report an ICD-10-CM code for Persons Without Reported Diagnosis Encountered During Examination and Investigation of Individuals and Populations (Z00.00-Z13.9).
- The hospital enters the full ICD-10-CM codes in FLs 67A-67Q for up to eight other diagnoses that co-existed in addition to the diagnosis reported in FL 67.
Sources of Information:
CMS National Coverage Policy
CMS Publications:
CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2:110.23 Stem Cell Transplantation
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 3, Section 90.3.1 Stem Cell Transplantation.
Anagnostopoulos A, Hari PN, Pèrez WS, et al. Autologous or allogeneic stem cell transplantation in patients with Waldenstrom’s macroglobulinemia. Biology of Blood and Marrow Transplantation. 2004;12:845-854.
Ballantyne JC. Mao J. Opioid Therapy for Chronic Pain. N Engl J Med. 2003;349:1943-1953.
Bjartmar C, Trapp BD. Axonal injury and disease progression in multiple sclerosis: stem cell therapy for autoimmune disease. Landes Bioscience. 2004;34.
Burt RK, Georganas C, Schroeder J, et al. Autologous hematopoietic stem cell transplantation in refractory rheumatoid arthritis: sustained response in two of four patients. Arthritis Rheum. 1999;42(11):2281-2285.
Burt RK, Kozak T. Hematopoetic stem cell transplantation for multiple sclerosis: finding equipoise. Bone Marrow Transplantation. 2003;32:545-548.
Burt RK, Loh Y, Cohen B et al. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009;8(3):244-253.
Burt RK, Loh Y, Pearce W, et al. Clinical applications of blood-derived and marrow-derived stem cells for nonmalignant diseases. JAMA. 2008;299(8):925-936.
Burt RK, Marmont A, Oyama Y, et al. Randomized controlled trials of autologous hematopoietic stem cell transplantation for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum. 2006;54(12):3750 3760.
Burt RK, Patel D, Thomas J, et al. The rationale behind autologous autoimmune hematopoietic stem cell transplant conditioning regimens: concerns over the use of total body irradiation in systemic sclerosis. Bone Marrow Transplant. 2004;34(9):745-751.
Burt RK, Traynor A, Statkute L, et al. Nonmyeloablative hematopoietic stem cell transplantation for systemic lupus erythematosis. JAMA. 2006;295(5):527-535.
d’Amore F, Relander T, Lauritzsen GF, et al. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. Journal of Clinical Oncology. 2012 Sep;30(25):3093-3099.
Daikeler T, Kötter I, Bocelli Tyndall C, et al. EBMT Autoimmune Diseases Working Party. Haematopoietic stem cell transplantation for vasculitis including Behcet's disease and polychondritis: a retrospective analysis of patients recorded in the European Bone Marrow Transplantation and European League Against Rheumatism databases and a review of the literature. Ann Rheum Dis. 2007;66(2):202-207.
Dietrich PY, Duchosal MA. Bevacizumab therapy before autologous stem-cell transplantation for POEMS syndrome. Ann Oncol. 2008;19(3):595.
Dimopoulos MA, Gertz MA, Kastritis E, et al. Update on treatment recommentations from the fourth international workshop on Waldenström’s macroglobulinemia. Journal of Clinical Oncology. 2009;27(1):120-126.
Duarte RF, Schmitz N, Servitje O, Sureda A. Haematopoietic stem cell transplantation for patients with primary cutaneous T-cell lymphoma. Bone Marrow Transplant. 2008;41(7):597-604.
Farge D, Passweg J, van Laar JM, et al. Autologous stem cell transplantation in the treatment of systemic sclerosis: report from the EBMT/ EULAR registry. Ann Rheum Dis. 2004;63(8):974-981.
Foundation for the Accreditation of Cellular Therapy (FACT). Joint Accreditation Committee – ISCT and EBMT. Guidance to Accompany the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration. Fourth Edition. October 2008. Copyright © 2008 Foundation for the Accreditation of Cellular Therapy (FACT). Copyright © 2008 Joint Accreditation Committee ISCT and EBMT (JACIE).
Ganti AK, Bierman PJ, Lynch JC, Bociek RG, Vose JM, Armitage JO. Hematopoietic stem cell transplantation in mantle cell lymphoma: Ann Oncol. 2005;16(4):618-624.
Gertz MA, Reeder CB, Kyle RA, Ansell SM. Stem cell transplant for Waldenström macroglobulinemia: an underutilized technique. Bone Marrow Transplantation. 2012;47:1147-1153.
Greenberg P, Cox C, LeBeau MM, et al. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997;15;89(6):2079-2088. Erratum in: Blood.1998;91(3):1100.
Jayne D, Passweg J, Marmont A, et al. European Group for Blood and Marrow Transplantation, European League Against Rheumatism Registry. Autologous stem cell transplantation for systemic lupu erythematous. Lupus. 2004;13(3):168-176.
Khouri IF, Saliba RM, Admirand J, et al. Graft-versus-leukaemia effect after non-myeloablative haematopoietic transplantation can overcome the unfavourable expression of ZAP-70 in refractory chronic lymphocytic leukaemia. Br J Haematol. 2007;137(4):355-363.
Kim MK, Kim S. Lee SS, et al. High-dose chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: complete response at transplant predicts survival. Ann Hematol. 2007 Jun;86(6):435-442.
Kiss TL, Mollee P, Lazarus HM, Lipton JH. Stem cell transplantation for mantle cell lymphoma: if, when and how? Bone Marrow Transplant. 2005;36(8):655-661.
Kurumagawa T, Seki S, Kobayashi H, et al. Characterization of bronchoalveolar lavage T cell subsets in sarcoidosis on the basis of CD57, CD4 and CD8. Clin Exp Immunol. 2003;133(3):438-447.
Lobeck L. Monitoring disease activity in multiple sclerosis. Landes Bioscience. 2004:35.
Loh Y, Oyama Y, Statkute L, et al. Autologous hematopoietic stem cell transplantation in systemic lupus erythematosus patients with cardiac dysfunction: feasibility and reversibility of ventricular and valvular dysfunction with transplant-induced remission. Bone Marrow Transplant. 2007;40(1):47-53.
Mehta N, Maragulia JC, Moskowitz A, et al. A retrospective analysis of peripheral T-cell lymphoma treated with the intention to transplant in the first remission. Clin Lymphoma Myeloma Leuk. 2013 Dec;13(6):664-670.
Nademanee A, Palmer JM, Popplewell L, et al. High-dose therapy and autologous hematopoietic cell transplantation in the peripheral T cell lymphoma (PTCL): analysis of prognostic factors. Biol Blood Marrow Transplant. 2011 Oct;17(10):1481-1489.
Nash RA, McSweeney PA, Crofford LJ, et al. High dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe system sclerosis: long term follow-up of the US multicenter pilot study. Blood. 2007;110(4):1388-1396.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-Hodgkin’s Lymphomas Version 3.2016. Adult T-Cell leukemia/lymphoma page TCEL-1 (~ p128) and Mycosis Fungoides/Sezary Syndrome page MFSS-1 (~ p105).
Orsini E, Guarini A, Chiaretti S, Mauro FR, Foa R. The circulating dendritic cell compartment in patients with chronic lymphacytic leukemia is severely defective and unable to stimulate an effective T-cell response. Cancer Research. 2003;(63):4497-4506.
Oyama Y, Barr WG, Statkute L, et al. Autologous non-myeloablative hematopoietic stem cell transplantation in patients with systemic sclerosis. Bone Marrow Transplant. 2007;40(6):549-555.
Oyama Y, Sufit R, Loh Y, et al. Autologous non-myeloablative hematopoietic stem cell transplantation for refractory CIDP. Neurology. 2007:69(18):1802-1803.
Ritgen M, Lange A, Stilgenbauer S, et al. Unmutated immunoglobulin variable heavy-chain gene status remains an adverse prognostic factor after autologous stem cell transplantation for chronic lymphocytic leukemia. Blood. 2003;101(5):2049-2053.
Rodríquez J, Conde E, Gutiérrez A, et al. The results of consolidation with autologous stem-cell transplantation in patients with peripheral T-cell lymphoma (PTCL) in first complete remission: the Spanish Lymphoma and Autologous Transplantation Group experience. Annals of Oncology. 2007 Apr;18(4):652-657.
Rosa SB, Voltarelli JC, Chies JA, Pranke P. The use of stem cells for the treatment of autoimmune diseases. Braz J Med Biol Res. 2007;40(12):1579-1597.
Snowden JA, Passweg J, Moore JJ, et al. Autologous hemopoietic stem cell transplantation in severe rheumatoid arthritis: a report from the EBMT and ABMTR. J Rheumatol. 2004;31(3):482-488.
Statkute L, Oyama Y, Barr WG, et al. Autologous non-myeloablative haematopoietic stem cell transplantation for refractory system vascuitis. Ann Rheum Dis. 2008;67:991-997.
Statkute L, Traynor A, Oyama Y, et al. Antiphospholipid syndrome in patients with systemic lupus erythematosus treated by autologous hematopoietic stem cell transplantation. Blood. 2005;106(8):2700-2709.
Teng YK, Verburg RJ, Sont JK, van den hout WB, Breedveld FC, van Laar JM. Long-term followup of health status in patients with severe rheumatoid arthritis after high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. Arthritis Rheum. 2005;52(8):2272-2276.
Traynor AE, Corbridge TC, Eagan AE, et al. Prevalence and reversibility of pulmonary dysfunction in refractory systemic lupus: improvement correlates with disease remission following hematopoietic stem cell transplantation. Chest. 2005;127(5):1680-1689
Voltarelli JC, Couri CE, Stracieri AB, et al. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007;297(14):1568-1576.
Vonk MC, Marjanovic Z, van den Hoogen FH, et al. Long-term follow-up results after haematopoietic stem cell transplantation for severe systemic sclerosis. Ann Rheum Dis. 2008;67(1):98-104.
