Billing and Coding: Stem Cell Transplantation

**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
  * Waldenstrom 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, Perez 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, Kotter 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 Waldenstrom'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 (C) 2008
Foundation for the Accreditation of Cellular Therapy (FACT). Copyright (C)
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 Waldenstrom
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.  
  
Rodriquez J, Conde E, Gutierrez 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.