Medicare Advantage

Medical Policy

Title:

Hematopoietic Stem Cell Transplantation

Policy #:

MA11.002q

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals, and other applicable Medicare coverage documents.

Coverage for hematopoietic stem cell transplantation (also referred to as bone marrow, peripheral blood, or cord blood stem cell transplantation) is provided when both the type of transplant and the individual's condition meet the medical necessity criteria outlined below.

When hematopoietic stem cell transplantation is considered medically necessary, all required procedures for the transplantation (e.g. mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells; administration of high-dose chemotherapy or radiotherapy prior to transplant) are also considered medically necessary and, therefore, covered, subject to the member's benefit.

Collection and storage of stem cells (apheresis therapy) for future stem cell transplantation is considered medically necessary and, therefore, covered for individuals with an existing condition that meets the medical necessity criteria outlined below.

ALLOGENIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT)

Allogeneic stem cell transplantation (HSCT) is considered medically necessary and, therefore, covered for any of the following indications:

Treatment of leukemia, leukemia in remission, or aplastic anemia
Treatment of severe combined immunodeficiency disease (SCID) and the treatment of Wiskott-Aldrich syndrome
Treatment of myelodysplastic syndromes (MDS) with intermediate-2 or high MDS using the International Prognostic Scoring System (IPSS), or high or very high MDS using the IPSS-Revised, or high or very high using the Molecular IPSS [CMS]
Treatment of individuals with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved prospective clinical study
Treatment of individuals with Dynamic International Prognostic Scoring System (DIPSS Plus) intermediate-2 or high primary or secondary myelofibrosis (MF) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved prospective clinical study
Treatment of individuals with severe, symptomatic sickle cell disease (SCD) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved prospective clinical study

AUTOLOGOUS STEM CELL TRANSPLANTATION

Autologous stem cell transplantation (AuSCT) is considered medically necessary and, therefore, covered for any of the following indications:

Treatment of individuals with acute leukemia in remission who have a high probability of relapse and who have no human leukocyte antigens (HLA)--matched donor
Treatment of individuals with resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following an initial response
Treatment of individuals with recurrent or refractory neuroblastoma
Treatment of individuals with advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched donor

Single autologous stem cell transplantation is considered medically necessary and, therefore, covered for Durie-Salmon Stage II or III individuals when ALL of the following criteria are met:

Newly diagnosed or responsive multiple myeloma. This includes individuals 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.

High-dose melphalan (HDM) and autologous stem cell transplantation are considered medically necessary and, therefore, covered when used together for the treatment of primary amyloid light chain (AL) amyloidosis when both of the following criteria are met:

Amyloid deposition in 2 or fewer organs; and
Cardiac left ventricular ejection fraction (EF) greater than 45%.

EXPERIMENTAL/INVESTIGATIONAL

Autologous stem cell transplantation is considered experimental/investigational and, therefore, not covered for the following conditions because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:

Acute leukemia not in remission
Chronic granulocytic leukemia
Solid tumors (other than neuroblastoma)
Tandem transplantation (multiple rounds of autologous stem cell transplantation) for individuals with multiple myeloma
Non-primary amyloid light chain (AL) amyloidosis

BONE MARROW DONOR SEARCH

Bone marrow donor searches are eligible for reimbursement in increments of five potential donors, in order to avoid screening more potential donors than necessary.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Subject to the terms and conditions of the applicable Evidence of Coverage, stem cell transplantation is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

HEMATOPOIETIC STEM CELL MOBILIZERS

US Food and Drug Administration (FDA)-approved granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) are used to mobilize hematopoietic stem cells into the peripheral blood for collection and subsequent transplantation.

FDA-approved colony-stimulating factors (G-CSF or GM-CSF) used to mobilize peripheral blood progenitor cells for hematopoietic stem cell transplantation include:

tbo-filgrastim (Granix)
sargramostim (Leukine)
plerixafor (Mozobil)
pegfilgrastim (Neulasta)
filgrastim (Neupogen)
filgrastim-aafi (Nivestym)
filgrastim-sndz (Zarxio)
filgrastim-txid (Nypozi)

FDA-approved CXCR4 inhibitors/antagonists (i.e., motixafortide) may be used in conjunction with G-CSF to mobilize hematopoietic stem cells in individuals with multiple myeloma scheduled for an autologous hematopoietic stem cell transplantation.

MYELODYSPLASTIC SYNDROMES (MDS): IPSS, IPSS-R, IPSS-M SCORING SYSTEM

INTERNATIONAL PROGNOSTIC SCORING SYSTEM (IPSS)

Intermediate-2 and high overall score: ≥1.5

	Score Value
Prognostic variable	0	0.5	1.0	1.5	2.0
Marrow blasts (%)	<5	5–10	—	11–20	21–30
Karyotype	Good	Intermediate	Poor	—	—
Cytopenia	0/1	2/3	—	—	—

REVISED INTERNATIONAL PROGNOSTIC SCORING SYSTEM

High and very high overall score: >4.5

	Score Value
Prognostic variable	0	0.5	1	1.5	2	3	4
Cytogenetic	Very good	—	Good	—	Intermediate	Poor	Very Poor
Marrow blasts (%)	≤2	—	>2–<5	—	5–10	>10	—
Hemoglobin	>10	—	8–<10	<8	—	—	—
Platelets	≥100	50–<100	<50	—	—	—	—
ANC	≥0.8	<0.8	—	—	—	—	—

MOLECULAR INTERNATIONAL PROGNOSTIC SCORING SYSTEM*

High and very high overall score: >0.5

*Refer to the IPSS-M web calculator.

MYELOMA: DURIE-SALMON STAGING SYSTEM

STAGE I

All of the following:

Hemoglobin value > 10 g/dL
Serum calcium value normal or ≤ 12 mg/dL
On bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only
Low M-component production rate (IgG value < 5 g/dL; IgA value < 3 g/dL)
Urine light chain M-component on electrophoresis < 4 g/24 h

STAGE II

Neither stage I nor stage III

STAGE III

One or more of the following:

Hemoglobin value < 8.5 g/dL
Serum calcium value > 12 mg/dL
Advanced lytic bone lesions (scale 3)
High M-component production rate (IgG value > 7 g/dL; IgA value > 5 g/dL)
Urine light chain M-component on electrophoresis > 12 g/24 h

SUBCLASSIFICATION

Either A or B:

A = Relatively normal renal function (serum creatinine < 2.0 mg/dL)

B = Abnormal renal function (serum creatinine ≥ 2.0 mg/dL)

MYELOMA: INTERNATIONAL STAGING SYSTEM

STAGE I

Serum beta-2 microglobulin is less than 3.5 mg/L, and
Albumin level is 3.5 g/dL or greater

STAGE II

Neither Stage I nor Stage III, meaning that either:

Beta-2 microglobulin level is between 3.5 mg/L and 5.5 mg/L (with any albumin level), OR
Albumin is below 3.5 g/dL while the beta-2 microglobulin is less than 3.5 mg/L

STAGE III

Serum beta-2 microglobulin is 5.5 mg/L or greater

MYELOFIBROSIS: DYNAMIC INTERNATIONAL PROGNOSTIC SCORING SYSTEM (DIPSS)

The DIPSS plus prognostic score is based on eight risk factors (need for red blood cell transfusion, hemoglobin level, platelet count, leukocyte count, circulating blasts in the blood, constitutional symptoms, unfavorable cytogenetic profile, and age). There are four risk categories based on the DIPSS plus score as shown in the following table:

Risk Category	Number of Risk Factors
Low	None
Intermediate - 1	1
Intermediate - 2	2 or 3
High	4 or more

Description

Traditionally, high-dose chemotherapy, also known as myeloablative therapy, and extensive radiation therapy have been used to treat certain drug-resistant cancers or relapsed diseases. High-dose chemotherapy and radiation generally affect cells that divide rapidly, and cancer cells divide more often than most healthy cells. High-dose chemotherapy involves the administration of cytotoxic agents at doses several times greater than the standard therapeutic dose.

The rationale for high-dose chemotherapy is that many chemotherapeutic agents act according to a steep dose-response curve. Small increments in drug dosage result in relatively large increases in tumor cell destruction. The limiting dynamic of high-dose chemotherapy and radiation therapy is the toxic effect that these treatments have on bone marrow cells. Although high-dose chemotherapy kills the tumor cells, it also increases the incidence and severity of adverse effects associated with chemotherapy such as bone marrow destruction (myeloablation), opportunistic infection, hemorrhage, and organ failure.

Bone marrow is a soft, spongelike material found inside bones. Bone marrow contains cells known as hematopoietic, or blood-forming, cells. Hematopoietic stem cells either divide to form additional blood-forming stem cells, or they mature to form one of three types of cells: white blood cells (leukocytes), red blood cells (erythrocytes), or platelets. Most hematopoietic stem cells are found in bone marrow, but some are also found in the bloodstream and are known as peripheral blood stem cells. Blood in the umbilical cord also contains hematopoietic stem cells. In individuals who have undergone high-dose chemotherapy and radiation, hematopoietic stem cell transplantation can be used to regenerate bone marrow and aid in the development of mature blood cell products, thereby decreasing the incidence of life-threatening conditions and aiding in the individual's recovery.

STEM CELL TRANSPLANTATION

Hematopoietic stem cell transplantations—also referred to as bone marrow transplantation, peripheral blood stem cell transplantation, or umbilical cord blood transplantation—are used to restore stem cells destroyed by high-dose chemotherapy and radiation therapy. Transplantation is accomplished in the same manner as a blood transfusion.

The transplantation of hematopoietic stem cells is an adjunctive therapy and follows the administration of high-dose chemotherapy and/or whole-body or localized radiotherapy prior to the transplant. The transplantation of hematopoietic stem cells has been found to increase the efficacy of high-dose chemotherapy and/or radiotherapy in the treatment of certain conditions such as leukemia, lymphomas (e.g., Hodgkin lymphoma), aplastic anemia, and some inherited immune disorders.

TYPES OF STEM CELL TRANSPLANTATION

Transplants are classified as one of three types:

Autologous: an individual receives his or her own stem cells
Allogeneic: an individual receives stem cells from a related or unrelated donor with a human leukocyte antigen (HLA) match
Syngeneic: an individual receives stem cells from his or her identical twin

AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION
In autologous hematopoietic stem cell transplantation, the individual receives his or her own stem cells, which are harvested prior to myeloablative therapy and are relatively cancer-free. Myeloablative chemotherapy is performed to eradicate cancerous cells from the blood and bone marrow, thereby permitting subsequent engraftment and repopulation of bone marrow space with presumably normal hematopoietic progenitor cells or cells that allow themselves to differentiate from other cells. As a result, autologous stem cell transplantation is typically performed as consolidation therapy when the individual's disease is in complete remission. Individuals who receive autologous stem cell transplantation are susceptible to chemotherapy-related toxicities and opportunistic infections prior to engraftment, but not graft-versus-host disease.

High-dose chemotherapy, in conjunction with autologous hematopoietic stem cell transplantation, is the established standard of therapy for various malignancies such as acute myelogenous leukemia, multiple myeloma, and non-Hodgkin lymphoma. Autologous hematopoietic stem cell transplantation is also preferred for the elderly, for individuals who have acute lymphocytic leukemia, or for individuals who lack a donor with suitable HLA typing. HLAs are a set of proteins that are found on the surface of cells and are identifiable by a special blood test. The higher the number of matching HLAs between the individuals, the greater the chance that the recipient will accept the donor’s stem cells.

Advantages of autologous transplants include the reduced toxicity that is associated with treatment and an extended, disease-free survival time, most often without the need for additional treatment.

Tandem transplantation is a type of autologous hematopoietic stem cell transplantation in which the individual receives two sequential courses of high-dose chemotherapy that are typically given several weeks to several months apart.

ALLOGENEIC AND SYNGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Allogeneic hematopoietic stem cell transplantation involves using hematopoietic stem cells harvested from a donor. The success of the transplant depends in part on how well the HLAs of the donor’s stem cells match those of the recipient’s stem cells.

Close relatives, especially siblings, are more likely than unrelated individuals to be HLA-matched; however, only 25 to 35 percent of transplant candidates have a sibling who is an HLA match. Identical twins, having identical genes, also have the same HLAs; an individual's body will, therefore, accept a stem cell transplantation from his or her identical twin. However, identical twins represent a small number of all births, so syngeneic transplantation is rare.

STAGES OF TRANSPLANTATION

Hematopoietic stem cell transplantation involves the mobilization, harvesting, and transplantation of hematopoietic stem cells that have been collected from bone marrow or peripheral blood.

MOBILIZATION
Preparing for a hematopoietic stem cell transplantation first requires stem cell mobilization. Mobilization makes harvesting more efficient and occurs when the accumulation of stem cells has reached its highest level.

Prior to harvesting, autologous blood stem cell donors are occasionally given a course of chemotherapy to destroy some of the malignant tumors in their body. This low-dose chemotherapy reduces the risk for tumor contamination and facilitates the filtering of stem cells for collection. Autologous donors may also receive injections of a colony-stimulating factor (CSF). Colony-stimulating factors are groups of proteins that cause blood cells to grow and mature, which facilitates mobilization. In some cases, a combination of chemotherapy and CSF is used. In autologous stem cell donors with multiple myeloma, mobilization of stem cells in the peripheral blood may be further enhanced with a CXCR4 antagonist in conjunction to G-CSF. CXCR4 is critically involved in the retention of hematopoietic stem and progenitor cells (HSPCs) in the bone marrow. Crees et al. (2023) demonstrated that by blocking the interaction between CXCL12 and its receptor CXCR4, in combination with G-CSF, HSPCs were elevated and sustained over time compared to the placebo plus G-CSF group. The increased HSPC collection may minimize apheresis procedures.

In allogeneic donors, mobilization is accomplished through a series of subcutaneous injections of colony-stimulating factors (i.e., granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF]). Typically, the colony-stimulating factor is administered for 4 to 5 days, followed by apheresis, which generally occurs over the next day or two. Apheresis, also called pheresis, is a procedure in which blood is collected, the stem cells are removed, and the remaining blood is given back to the donor. The stem cells are frozen until they are given to the recipient.

HARVESTING
After mobilization, hematopoietic stem cells can be harvested from bone marrow and/or peripheral blood. Harvesting from bone marrow involves inserting a hollow needle into the pelvic (hip) bone or, in rare cases, the sternum (breastbone), under general or regional anesthesia. The procedure takes about 1 hour. The cells are harvested prior to myeloablative therapy. The harvested cells can sometimes be treated before transplantation in a process known as purging. This process reduces the number of cancer cells, thereby minimizing the likelihood that cancer will recur.

Because purging may damage healthy stem cells, an excess of cells is removed from the individual prior to transplantation so that an adequate supply of healthy stem cells will remain after purging.

In most instances, the harvested marrow is filtered and given to the recipient on the same or next day. If the transplantation cannot occur within that timeframe, the marrow can be combined with a preservative solution and frozen until needed. Known as cryoablation, this technique can preserve the harvested marrow for years. When the recipient is ready to receive the marrow, it is thawed and transfused in a procedure that is similar to a blood transfusion. The hematopoietic stem cells are then drawn to the bone marrow, where they start to grow and produce new blood cells.

In individuals undergoing peripheral blood stem cell transplantation, stem cells are removed from the bloodstream via apheresis. The purpose of therapeutic apheresis is to remove a component of the blood that contributes to an illness. In apheresis, blood is removed through a large vein in the arm or a central venous catheter (a flexible tube that is placed in a large vein in the neck, chest, or groin area) and sent to sterile equipment, where it is separated into various components, such as red blood cells, white blood cells, and plasma. Healthy parts of the blood are then returned to the individual. Apheresis typically takes 4 to 6 hours. For 4 or 5 days before apheresis, the donor may be given a medication to increase the number of stem cells released into the bloodstream.

TRANSPLANTATION
Upon entering the bloodstream, the stem cells travel to the bone marrow, where they begin to produce new white blood cells, red blood cells, and platelets in a process known as engraftment. Engraftment typically occurs within 2 to 4 weeks after transplantation, and is monitored by blood counts. Following the transplant, full recovery of the immune system may take several months for autologous transplantation recipients and as much as 1 to 2 years for individuals receiving allogeneic or syngeneic transplantations. A bone marrow aspiration may also be performed to determine the progress of the new marrow.

UMBILICAL CORD STEM CELL TRANSPLANTATION

Umbilical cord hematopoietic stem cells are harvested from the placenta via the umbilical cord, post-delivery. The blood in the placenta is rich in hematopoietic stem cells (commonly known as naïve cells), which are easily collected in a process that poses no risk to the donor (the newborn) because the newborn has been separated from the placenta, and the placenta is considered a disposable organ. Cord blood requires no mobilization; once collected, it is mixed in a preservative solution and stored at a very low temperature until needed. Umbilical cord stem cells are immunologically naïve, with a reduced number of mature alloreactive T-cells, allowing for less stringent HLA-matching requirements. They are typically used for children, future offspring, or adults of small stature.

In 2023, the FDA approved an umbilical cord blood-derived cell therapy termed Omisirge (Omidubicel-onlv). Omisirge uses nicotinamide enrichment technology to expand human hematopoietic progenitor cells and nonexpanded myeloid and lymphoid cell products derived from cord blood. In individuals ≥12 years of age with hematologic malignancies, Horwitz et al. (2021) demonstrated a reduced time to neutrophil engraftment following myeloablative procedures favoring the Omisirge cohort compared to standard umbilical cord blood transplantation group. Additional long-term outcomes were measured (e.g., overall survival, graft-versus-host disease, disease-free survival), but clinically meaningful differences between treatments could not be established. Although the evidence is limited, Omisirge may be advantageous when donor selection is sparse.

References

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Stem Cell Transplantation 110.23 (Formerly 110.8.1). [CMS Web site]. 03/06/2024. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=366&ncdver=2&DocID=110.23&bc=gAAAAAgAAAAAAA==&=. Accessed August 12, 2025.

Bernard E, Tuechler H, Greenberg PL, et al. Molecular international prognostic scoring system for myelodysplastic syndromes. NEJM. 2022;1(7). Available at: https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2200008. Web calculator available at: https://mds-risk-model.com/. Accessed August 12, 2025.

Crees ZD, Rettig MP, Jayasinghe RG, et al. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nature Med. 2023;29:869-879.

Horwitz ME, Stiff PJ, Cutler C, et al. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440.

National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Myelodysplastic Syndromes. V.2.2024. 05/22/2024. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf [via free subscription]. Accessed August 12, 2025.

National Cancer Institute (NCI). National Cancer Institute Fact Sheet. Blood-Forming Stem Cell Transplants. [NCI Web site]. 10/05/2023. Available at: http://www.cancer.gov/about-cancer/treatment/types/stem-cell-transplant/stem-cell-fact-sheet. Accessed August 12, 2025.

Coding

CPT Procedure Code Number(s)

TRANSPLANTATION

38240

38241

ASSOCIATED PROCEDURES (E.G., MOBILIZATION, HARVESTING)

38204

38205

38206

38207

38208

38209

38210

38211

38212

38213

38214

38215

38220

38221

38222

38230

38232

38242

38243

81370

81371

81372

81373

81374

81375

81376

81377

81378

81379

81380

81381

81382

81383

86812

86813

86816

86817

86821

86825

86826

86828

86829

86830

86831

86832

86833

86834

86835

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

ASSOCIATED PROCEDURES (E.G., MOBILIZATION, HARVESTING)

C1830 Powered bone marrow biopsy needle

C9173 Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram

J1442 Injection, filgrastim (G-CSF), excludes biosimilars, 1 mcg

J1447 Injection, tbo-filgrastim, 1 mcg

J2277 Injection, motixafortide, 0.25 mg

J2506 Injection, pegfilgrastim, excludes biosimilar, 0.5 mg

J2562 Injection, plerixafor, 1 mg

J2820 Injection, sargramostim (GM-CSF), 50 mcg

J3406 Injection, omidubicel-onlv, per therapeutic dose

Q5101 Injection, filgrastim-sndz, biosimilar (Zarxio), 1 mcg

Q5110 Injection, filgrastim-aafi, biosimilar (Nivestym), 1 mcg

Q5125 Injection, filgrastim-ayow, biosimilar (Releuko), 1 mcg

Q5148 Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram

S2140 Cord blood harvesting for transplantation, allogeneic

S2142 Cord blood-derived stem-cell transplantation, allogeneic

S2150 Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition

S9537 Home therapy; hematopoietic hormone injection therapy (e.g., erythropoietin, G-CSF, GM-CSF); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

Revenue Code Number(s)

0815 Acquisition of Body Components – Stem Cells - Allogeneic

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.002q:

10/01/2026

Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.

This policy has been identified for the HCPCS code update, effective 10/01/2026.

The following HCPCS code has been added to this policy:

J3406 Injection, omidubicel-onlv, per therapeutic dose

The following HCPCS codes have been removed from this policy:

C9399 Unclassified drugs or biologicals
J3590 Unclassified biologics

Revisions From MA11.002p:

10/20/2025	This version of the policy will become effective 10/20/2025. The following has been revised: Any reference to other Company policies (e.g., Efbemalenograstim alfa-vuxw, filgrastim) were moved from the Policy Section to the Cross Reference Policies section Various hematopoietic stem cell mobilizers were added to the Guidelines section.

Revisions From MA11.002o:

07/01/2025

This policy has been identified for the HCPCS code update, effective 07/01/2025.

The following HCPCS code has been added to this policy:

C9173 Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram

Revisions From MA11.002n:

04/01/2025

This policy has been identified for the HCPCS code update, effective 04/01/2025.

The following HCPCS code has been added to this policy:

Q5148 Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram

Revisions From MA11.002m:

01/01/2025

This policy has been identified for the HCPCS code update, effective 01/01/2025.

The following HCPCS code has been added to this policy:

C9173 Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram

Revisions from MA11.002l:

09/09/2024

The version of this policy will become effective 09/09/2024.

The following policy criteria has been revised:

FROM Treatment of MDS pursuant to Coverage with Evidence Development (CED)

TO Treatment of MDS with intermediate-2 or high MDS using the IPSS, or high or very high MDS using the IPSS-R, or high or very high using the IPSS-M

The following has been added to Guidelines:

IPSS, IPSS-R, IPSS-M Myelodysplastic Syndromes Scoring Systems

The following HCPCS codes have been added as medically necessary to represent umbilical cord blood-derived therapy:

C9399 Unclassified drugs or biologics
J3590 Unclassified biologics

The following HCPCS code has been added as medically necessary:

J2277 Injection, motixafortide, 0.25 mg

Revisions From MA11.002k:

01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
10/01/2022	This policy has been identified for the HCPCS code update, effective 10/01/2022. The following HCPCS code has been deleted from this policy: C9096 The following HCPCS code has been added to this policy: Q5125

Revisions From MA11.002j:

07/01/2022

This policy has been identified for the HCPCS code update, effective 07/01/2022.

The following HCPCS code has been added to this policy: C9096

Revisions From MA11.002i:

05/04/2022

This policy has been reissued in accordance with the Company's annual review process.

01/01/2022

This policy has been identified for the HCPCS code update, effective 01/01/2022.

The following HCPCS code has been termed and removed from this policy:

J2505: Injection, pegfilgrastim, 6 mg

The following HCPCS code has been added to this policy:

J2506: Injection, pegfilgrastim, excludes biosimilar, 0.5 mg

Revisions From MA11.002h:

09/23/2019

The following changes were made to this policy:

POLICY SECTION

The reference to Medicare Advantage policy MA08.039 Plerixafor Injection (Mozobil®) was removed because the policy has been archived.

Policy statements regarding Autologous Stem Cell Transplantation were revised for clarity with no impact on intent.

GUIDELINES SECTION

The following guideline was updated:

Myeloma: Durie-Salmon Staging System

Revisions From MA11.002g:

10/01/2018

This policy has been identified for the HCPCS code update, effective 10/01/2018.

The following HCPCS code has been added to this policy: Q5110

Revisions From MA11.002f:

04/01/2018

This policy has been identified for the HCPCS code update, effective 04/01/2018.

The following HCPCS narrative has been revised in this policy: Q5101

Revisions From MA11.002e:

01/01/2018

This policy has been identified for the CPT code update, effective 01/01/2018.

The following CPT code has been added to this policy: 38222

The following CPT code has been termed from this policy: 86822

The following CPT narratives have been revised in this policy: 38220, 38221

Revisions From MA11.002d:

08/25/2017

This version of the policy will become effective 08/25/2017.

Statements were added to the policy section (under Colony-Stimulating Factors) regarding where to find medically necessary criteria for Mozobil® (plerixafor injection) and Neulasta® (pegfilgrastim).

The following HCPCS code was added to the Coding Table: J2562.

The following Revenue Code was added to the Coding Table: 0815.

Revisions From MA11.002c:

09/09/2016

The following indications for allogeneic stem cell transplantation were added as Medically Necessary:

Treatment of individuals with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study.
Treatment of individuals with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary myelofibrosis (MF) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study.
Treatment of individuals with severe, symptomatic sickle cell disease (SCD) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study.

Multiple myeloma using allogeneic stem cell transplantation was removed as Experimental/Investigational.

The following indication for autologous stem cell transplantation was added as Experimental/Investigational:

Tandem transplantation (multiple rounds of autologous stem cell transplantation) for individuals with multiple myeloma

Information regarding the Durie-Salmon Staging System, the International Staging System, and the Dynamic International Prognostic Scoring System were added to the Policy Guidelines.

CODING

AUTOLOGOUS

The following CPT code was removed because it does not apply to Autologous Hematopoietic Stem Cell Transplantation: 38230

The following CPT code was revised: 38241

ALLOGENEIC

The following CPT codes were revised: 38208, 38209, 38240, 38242

Revisions From MA11.002b:

12/30/2015	This policy has been reissued in accordance with the Company's annual review process.
01/01/2016	This policy has been identified for the HCPCS code update, effective 01/01/2016. The following HCPCS code has been added to this policy under both Autologous and Allogeneic: J1447 The following HCPCS code has been removed from this policy under both Autologous and Allogeneic: J1446 The following HCPCS narrative has been revised in this policy: J1442

Revisions From MA11.002a:

07/01/2015

The following HCPCS code has been added to this policy under both Autologous and Allogeneic: Q5101

The following HCPCS codes have been added to this policy under Allogeneic: J1442, J1446

Revisions From MA11.002:

01/01/2015

This is a new policy.

Version Effective Date:

10/1/2026

Version Issued Date: