CMS Pub. 100-04, ch. 3, § 90.3

A. General

Stem cell transplantation is a process in which stem cells are harvested from either a

patient’s (autologous) or donor’s (allogeneic) bone marrow or peripheral blood for

intravenous infusion. 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 (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic

hematopoietic 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 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 will self-destruct.

The Centers for Medicare & Medicaid Services (CMS) is clarifying that 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.

Allogeneic and autologous stem cell transplants are covered under Medicare for

specific diagnoses. Effective October 1, 1990, these cases were assigned to MS -DRG

009, Bone Marrow Transplant.

The A/B MAC (A)'s Medicare Code Editor (MCE) will edit stem cell transplant

procedure codes against diagnosis codes to determine which cases meet specified

coverage criteria. Cases with a diagnosis code for a covered condition will pass (as

covered) the MCE noncovered procedure edit. When a stem cell transplant case is

selected for review based on the random selection of beneficiaries, the QIO will review

the case on a post-payment basis to assure proper coverage decisions.

Bone marrow transplant codes that are reported with an ICD-9-CM that is “not

otherwise specified” are returned to the hospital for a more specific procedure code.

ICD-10-PCS codes are more precise and clearly identify autologous and

nonautologous stem cells.

The A/B MAC (A) may choose to review if data analysis deems it a priority.

B. Nationally Covered Indications

I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

a. General

• Allogeneic stem cell transplantation ( ICD-10-PCS codes 30230G2,30230G3,

30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2,

30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3) is

a procedure in which a portion of a healthy donor's stem cells are obtained and

prepared for intravenous infusion to restore normal hematopoietic function in

recipients having an inherited or acquired hematopoietic deficiency or defect.

See Pub. 100-03, National Coverage Determinations (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.

Expenses incurred by a donor are a covered benefit to the recipient/beneficiary

but, except for physician services, are not paid separately. Services to the

donor include physician services, hospital care in connection with screening

the stem cell, and ordinary follow-up care.

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

i. Effective for services performed on or after August 1, 1978:

For the treatment of leukemia, leukemia in remission, or aplastic anemia

when it is reasonable and necessary;

ii. Effective for services performed on or after June 3, 1985:

For the treatment of severe combined immunodeficiency disease (SCID),

and for the treatment of Wiskott-Aldrich syndrome;

iii. 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.

iv. Effective for claims with dates of service on or after January 27, 2016:

1. Allogeneic HSCT for multiple myeloma 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.

2. Allogeneic HSCT for myelofibrosis (MF) 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.

3. Allogeneic HSCT for sickle cell disease (SCD) is covered by Medicare

only for beneficiaries with severe, symptomatic SCD who participate in

an approved prospective clinical study.

II.

III. Autologous Stem Cell Transplantation (AuSCT)

a. General

• Autologous stem cell transplantation (ICD-10-PCS codes 30230C0, 30230G0,

30230Y0, 30233G0, 30233C0, 30233Y0, 30240C0, 30240G0, 30240Y0, 30243C0,

30243G0, and 30243Y0) 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 used to treat various malignancies.

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.

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:

Acute leukemia in remission who have a high probability of relapse and who

have no human leucocyte antigens (HLA)-matched;

Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic

features following an initial response;

Recurrent or refractory neuroblastoma; or,

Advanced Hodgkin's disease who have failed conventional therapy and have no

HLA-matched donor.

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) amyloidosis 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.