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);Allogeneic Transplantation
The ICD-10-PCS Procedure codes are: 30233G2, 30233G3, 30233Y2, 30233Y3, 30243G2, 30243G3, 30243Y2 and 30243Y3.
The NCD lists the following nationally covered indications:
- Leukemia;
- Leukemia in remission;
- Aplastic anemia;
- Severe combined immunodeficiency disease (SCID); and
- Wiskott-Aldrich syndrome.
- Effective for services performed on or after August 4, 2010, for the treatment of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study. (Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2: Section 110.23).
Allogeneic HSCT is covered only for Medicare beneficiaries with the following indications when participating in an approved prospective clinical study meeting specific criteria under the CED paradigm:
- Multiple myeloma only for beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma;
- Myelofibrosis (MF) only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary MF or
- Sickle cell disease (SCD) only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study meeting specific criteria under the CED paradigm. (Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2: Section 110.23).
In addition to the nationally covered indications for HPC, allogenic, the following indications will be covered locally, for those jurisdictions or providers for whom this Medical Policy article applies, when medically necessary:
- Primary refractory Hodgkin's and non-Hodgkin's lymphoma; and
- Thalassemia major for patients with minimal or no portal fibrosis, hepatomegaly, or active hepatitis.
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.
Specific coding guidelines for this Medical Policy article
Per CMS Transmittal No. 193, Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, and Transmittal No. 3556, Publication 100-4, Medicare Claims Processing Manual, Change Request #9620, July 1, 2016 the following coding guidelines are specified for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS), multiple myeloma, myelofibrosis (MF) and sickle cell disease (SCD):
For the treatment of Myelodysplastic Syndromes (MDS) ICD-10-CM codes D46.A, D46.B, D46.C, D46.0, D46.1, D46.20, D46.21,D46.22, D46.4, D46.9, D46.Z) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.23, for further information about this policy.
Effective for services performed on or after January 27, 2016:
- Allogeneic HSCT for multiple myeloma (ICD-10-CM codes C90.00, C90.01, and C90.02) is covered by Medicare only for beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and participating in an approved prospective clinical study. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.23, for further information about this policy.
- Allogeneic HSCT for myelofibrosis (MF) (ICD-10-CM codes C94.40, C94.41, C94.42, D47.4, and D75.81) is covered by Medicare only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary MF and participating in an approved prospective clinical study. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.23, for further information about this policy.
- Allogeneic HSCT for sickle cell disease (SCD) (ICD-10-CM codes D57.00, D57.01, D57.02, D57.03, D57.09, D57.1, D57.20, D57.211, D57.212, D57.213, D57.218, D57.219, D57.40, D57.411, D57.412, D57.413, D57.418, D57.419, D57.42, D57.431, D57.432, D57.433, D57.438, D57.439, D57.44, D57.451, D57.452, D57.453, D57.458, D57.459, D57.80, D57.811, D57.812, D57.813, D57.818, and D57.819) is covered by Medicare only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.23, for further information about this policy.
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.
CMS Transmittal No. 127, Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Change Request #7137, October 8, 2010 updates Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS) to allow Medicare coverage for treatment of MDS only if provided in the context of a Medicare-approved clinical study meeting specific criteria under the CED paradigm.
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