3.0 POLICY
3.1 Benefits
are allowed for HDC with ABMT or autologous PSCT, allogeneic BMT
or allogeneic PSCT, with or without HDC, and allogeneic UCBT, with
or without HDC.
3.1.1 TRICARE Prime enrollee must
have a referral from his/her Primary Care Manager (PCM) and an authorization
from the contractor before obtaining transplant-related services.
If network providers furnish transplant-related services without
prior PCM referral and contractor authorization, penalties will
be administered according TRICARE network provider agreements. If
Prime enrollees receive transplant-related services from non-network
civilian reporters without the required PCM referral and contractor
authorization, contractors shall reimburse charges for the services
on a Point of Services (POS) basis. Special cost-sharing requirements
apply to POS claims.
3.1.2 For Standard and Extra (through
December 31, 2017) and TRICARE Select enrollees (starting January
1, 2018) patients residing in a Managed Care Support (MCS) region,
preauthorization authority is the responsibility of the MCS Medical
Director or other designated utilization staff.
3.2 HDC
with ABMT or autologous PSCT is covered in the treatment of the
following malignancies. The list of indications is not all inclusive.
Other indications are covered when documented by reliable evidence
as safe, effective and comparable or superior to standard care (proven).
3.2.1 Non-Hodgkin’s
lymphoma, follicular, intermediate, or high-grade; when:
3.2.1.1 Conventional dose chemotherapy
has failed; or
3.2.1.2 The patient has relapsed following
a course of radiation therapy; or
3.2.1.3 The
patient is in first complete remission with risk factors for relapse.
Note: For purposes of coverage, mantle
cell lymphomas will be considered as intermediate grade, non-Hodgkin’s
lymphomas.
3.2.2 Hodgkin’s disease when:
3.2.2.1 Conventional dose chemotherapy
has failed; or
3.2.2.2 The patient has relapsed following
a course of radiation therapy, and has also failed at least one
course of conventional dose chemotherapy subsequent to the failed
radiation therapy; and
3.2.2.3 The patient is in second or
third complete remission.
3.2.3 Neuroblastoma.
3.2.3.1 Stage III or IV, when the patient
is one for whom further treatment with a conventional dose therapy
is not likely to achieve a durable remission.
3.2.3.2 Tandem autologous PSCT for
high-risk neuroblastoma (INSS Stage III with either N-MYC gene amplification
or unfavorable Shimada histology or INSS Stage IV).
3.2.4 Acute lymphocytic or nonlymphocytic
leukemias (e.g., myelocytic, myelogenous, myeloblastic, or myelomonoblastic).
3.2.5 Primitive Neuroectodermal Tumors
(PNET)/Ewing’s Sarcoma.
3.2.6 Gliofibromas (also known as
desmoplastic astrocytoma; desmoplastic glioblastoma).
3.2.7 Glioblastoma multiforme.
3.2.8 Posterior fossa teratoid brain
tumors.
3.2.9 Rhabdomyosarcoma and undifferentiated
sarcomas.
3.2.10 Multiple myeloma. Tandem autologous
stem cell transplantation is covered for the treatment of multiple
myeloma.
3.2.11 Chronic myelogenous leukemia.
3.2.12 Waldenstrom’s macroglobulinemia.
3.2.13 AL (Amyloid Light-Chain) Amyloidosis.
3.2.14 Wilms’ tumor.
3.2.15 Trilateral retinoblastoma/pineoblastoma.
3.2.16 Osteosarcoma (osteogenic sarcoma).
3.2.17 Germ cell tumors in a second
or subsequent relapse.
3.2.18 HDC with ABMT or PSCT for the
treatment of desmoplastic small round cell tumor may be considered
on a case-by-case basis under the TRICARE provisions for treatment
of rare diseases.
3.2.19 Immunoablative therapy with
ABMT or autologous PSCT for the treatment of severe systemic lupus
erythematosus refractory to conventional treatment.
3.3 Allogeneic BMT or allogeneic
PSCT, with or without HDC, is covered in the treatment of the following
disease processes when either a related or unrelated donor is used.
The list of indications is not all inclusive. Other indications
are covered when documented by reliable evidence as safe, effective and
comparable or superior to standard care (proven).
3.3.1 Aplastic anemia.
3.3.2 Acute lymphocytic or nonlymphocytic
leukemias (e.g., myelocytic, myelogenous, myeloblastic, myelomonoblastic);
Chronic Myelogenous Leukemia (CML); or preleukemic syndromes.
3.3.3 Severe combined immunodeficiency;
e.g., adenosine deaminase deficiency and idiopathic deficiencies.
3.3.3.1 Partially matched-related donor
stem cell transportation (without regard for the number of mismatched
antigens in determining histocompatibility) in the treatment of
Bare Lymphocyte Syndrome.
3.3.3.2 Unrelated donor and/or related
donor (without regard for mismatched antigens) with or without T
cell lymphocyte depletion in the treatment of Familial Erythrophagocytic Lymphohistiocytosis,
(FEL; generalized lymphohistiocytic infiltration; familial lymphohistiocytosis; familial
reticuloendotheliosis; Familial Hemophagocytic Lymphohistiocytosis;
FHL) for patients whose medical records document failure of conventional
therapy (etoposide; corticosteroids; intrathecal methotrexate; and
cranial irradiation).
3.3.3.3 Partially matched-related donor
stem cell transplantation (without regard for the number of mismatched
antigens) in the treatment of X-linked Severe Combined Immunodeficiency
Syndrome (X-Linked SCID).
3.3.4 Wiskott-Aldrich Syndrome.
3.3.5 Infantile malignant osteopetrosis
(Albers-Schonberg syndrome or marble bone disease).
3.3.6 Thalassemia major.
3.3.7 Intermediate and high grade
non-Hodgkin’s lymphoma.
3.3.8 Myeloproliferative/dysplastic
syndromes.
3.3.9 Congenital mucopolysaccharidoses.
3.3.10 Congenital amegakaryocytic
thrombocytopenia.
3.3.11 Metachromatic leukodystrophy.
3.3.12 Sickle cell disease.
3.3.13 Chronic Lymphocytic Leukemia
(CLL) when previous therapy has failed or when the CLL is refractory
to conventional therapy.
3.3.14 Hyperesinophilic Syndrome.
3.3.15 Multiple myeloma when HCD with
ABMT or PSCT has failed.
3.3.16 X-linked hyper-IgM Syndrome.
3.3.17 Chediak-Higashi Syndrome.
3.3.18 Langerhans Cell Histiocytosis,
refractory to conventional treatment.
3.3.19 Hodgkin’s disease.
3.3.20 Primary Plasma Cell Leukemia.
3.4 Unirradiated
donor lymphocyte infusion (donor buffy coat infusion, donor leukocyte
infusion or donor mononuclear cell infusion) is covered for patients
with CML or Acute Myelogenous/Myeloid Leukemia (AML), who relapse
following their first or subsequent course of HDC with allogeneic
stem cell transplantation. The medical record must document that
the patient:
3.4.1 Is in relapse following an
adequate trial of HDC with allogeneic stem cell transplantation
of CML or AML; and
3.4.2 Qualified (or would have qualified)
for authorization for HDC with allogeneic stem cell transplantation
according to the provisions set forth in this policy.
3.5 Allogeneic UCBT, with or without
HDC, is covered in the treatment of the following disease processes
when either a related or unrelated donor is used. The list of indications
is not all inclusive. Other indications are covered when documented
by reliable evidence as safe, effective and comparable or superior
to standard care (proven).
3.5.1 Aplastic anemia.
3.5.2 Acute lymphocytic or non-lymphocytic
leukemias.
3.5.3 Chronic myelogenous leukemia.
3.5.4 Severe combined immunodeficiency.
3.5.5 Wiskott-Aldrich syndrome.
3.5.6 Infantile malignant osteopetrosis.
3.5.7 Blackfan-Diamond anemia.
3.5.8 Fanconi anemia.
3.5.9 Neuroblastoma.
3.5.10 X-linked lymphoproliferative
syndrome.
3.5.11 Hunter syndrome.
3.5.12 Hurler syndrome.
3.5.13 Congenital amegakaryocytic
thrombocytopenia.
3.5.14 Sickle cell anemia.
3.5.15 Globoid cell leukodystrophy.
3.5.16 Adrenoleukodystrophy.
3.5.17 Kostmann’s Syndrome.
3.5.18 Lesch-Nyhan disease.
3.5.19 Intermediate and high grade
non-Hodgkin’s lymphoma.
3.5.20 Thalassemia major.
3.5.21 Myelodysplastic Syndrome.
3.5.22 X-linked hyper-IgM Syndrome.
3.5.23 Langerhans Cell Histiocytosis,
refractory to conventional treatment.
3.6 Syngeneic (identical twin donor)
stem cell transplantation is covered for the treatment of Hodgkin’s
disease.
3.7 TRICARE will reimburse costs
for donor searches.
3.7.1 Charges for donor searches
must be fully itemized and billed by the transplant center.
3.7.2 Costs
for donor searches will be cost-shared in accordance with established
reimbursement guidelines for outpatient diagnostic testing.
3.7.3 Donor search costs may be billed
at any time. There is no limit on how many searches a transplant
center may request from the search printout.
3.8 For the purposes of TRICARE
coverage, the greatest degree of incompatibility allowed between donor
or recipient (for either related or unrelated donors) is a single
antigen mismatch at the A, B, or Dr. locus except for:
3.8.1 Patients with undifferentiated
leukemia, CML, aplastic anemia, Acute Lymphocytic Leukemia (ALL)
or Acute Myelogenous Leukemia (AML), when histocompatible related
or unrelated donors are not available, a three antigen mismatch
is allowed for related donors.
3.8.2 For patients under 18 years
of age with a relapsed leukemia, when histocompatible related or
unrelated donors are not available, parental CD34++ stem cell transplantation
with two-three antigen mismatch is allowed.
3.9 BMT, PSCT, and UCBT is a process
which includes mobilization, harvesting, and transplant of bone
marrow, peripheral blood stem cell, or umbilical cord blood stem
cells and the administration of HDC or radiotherapy prior to the
actual transplant. When BMT, PSCT, or UCBT is covered, all necessary steps
are included in coverage. When BMT, PSCT, or UCBT is noncovered,
none of the steps are covered. The prophylactic harvesting, cryopreservation
and storage of bone marrow, peripheral blood stem cells, or umbilical
cord blood stem cells when proposed for possible future use is not
covered. In the event that the patient expires prior to the stem
cell reinfusion being completed, benefits for the harvesting may
be allowed.
3.10 Benefits are allowed for Hepatitis
B and pneumococcal vaccines for patients undergoing transplantation.
3.11 Benefits may be allowed for
Deoxyribonucleic Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing
in determining histocompatibility.
3.12 Charges
for stem cell and umbilical cord blood preparation and storage shall
be billed through the transplantation facility in the name of the
TRICARE patient.
3.13 Charges for the umbilical cord
blood bank may be allowed only for patients who have undergone a
covered transplant.
3.14 Claims
for services and supplies related to the HDC and transplant for
beneficiaries under the age of 18 will be reimbursed based on billed
charges. Claims for HDC and transplant for adult patients, 18 years
and older, will be reimbursed under the Diagnosis Related Group
(DRG) payment system. Outpatient institutional facility charges
will be paid as billed. Professional services are reimbursed under
the CHAMPUS Maximum Allowable Charge (CMAC) Methodology.
3.15 Transportation of the patient
by air ambulance may be cost-shared when determined to be medically
necessary. Benefits for advanced life support air ambulance (to
include attendant) may be preauthorized by the appropriate preauthorizing
authority on an individual case basis in conjunction with the preauthorization
for the services themselves.
3.16 In
those cases where the beneficiary fails to obtain preauthorization,
benefits may be extended if the services or supplies otherwise would
qualify for benefits but for the failure to obtain preauthorization.
If preauthorization is not received, the appropriate preauthorizing
authority is responsible for determining if the patient meets the
coverage criteria. Charges for transplant and transplant-related
services provided to TRICARE Prime enrollees who failed to obtain
PCM referral and contractor authorization for HDC with ABMT or PSCT
will be reimbursed only under POS rules.
4.0 EXCLUSIONS
Benefits will not be paid for:
4.1 HDC with ABMT or autologous
PSCT, allogeneic BMT or allogeneic PSCT, with or without HDC, or
allogeneic UCBT, with or without HDC, if the patient has a concurrent
condition (other existing illness) that would jeopardize the achievement
of successful transplantation.
4.2 Expenses waived by the transplant
center (i.e., beneficiary/sponsor not financially liable).
4.3 Services and supplies not provided
in accordance with applicable program criteria (i.e., part of a grant,
or research program; unproven procedure).
4.4 Administration of an unproven
immunosuppressant drug that is not FDA approved.
4.5 Pre- or post-transplant nonmedical
expenses (i.e., out-of-hospital living expenses, to include, hotel,
meals, privately owned vehicle for the beneficiary or family members).
4.6 Transportation of a donor.
4.7 Allogeneic BMT for treatment
of low grade non-Hodgkin’s lymphoma is not a benefit.
4.8 Autologous UCBT therapy as
this procedure is considered unproven.
4.9 Allogeneic BMT for neuroblastoma
as this procedure is considered unproven.
4.10 Allogeneic donor BMT (infusion)
performed with or after organ transplants for the purpose of increasing
tolerance of the organ transplant is considered unproven.
4.11 HDC with ABMT or PSCT is not
covered for treatment of breast cancer.
4.12 HDC with allogeneic BMT is
not a benefit for treatment of Waldenstrom’s macroglobulinemia.
4.13 HDC with Stem Cell Rescue (SCR)
is not a benefit for the treatment of epithelial ovarian cancer.
4.14 HDC with allogeneic stem cell
transplantation is not covered for the treatment of cold agglutinin
disease.
4.15 Donor lymphocyte infusion if
not specifically listed as covered in
paragraph 3.4.
4.16 Myeloablative and non-myeloablative
therapy with BMT or PSCT for the treatment of multiple sclerosis
is unproven.
4.17 Immunoablative therapy with
BMT or PSCT is unproven and not covered for the treatment of rheumatoid
arthritis and juvenile idiopathic arthritis.
4.18 Immunoablative therapy with
allogeneic BMT or allogeneic PSCT is not covered for the treatment
of systemic lupus erythematosus.
4.19 Allogeneic non-myeloablative
hematopoietic stem cell transplantation for Crohn’s disease.
5.0 EFFECTIVE DATES
5.1 May 1, 1987, for HDC with ABMT
or PSCT for Hodgkin’s disease, non-Hodgkin’s lymphoma and neuroblastoma.
5.2 November 1, 1987, for HDC with
ABMT or PSCT for acute lymphocytic and nonlymphocytic leukemias.
5.3 November 1, 1983, for HDC with
allogeneic BMTs using related donors.
5.4 July 1, 1989, for HDC with
allogeneic BMTs using unrelated donors.
5.5 July 11, 1996, for HDC with
ABMT or PSCT for multiple myeloma.
5.6 January 1, 1994, for HDC with
ABMT and PSCT for Wilms’ tumor.
5.7 January 1, 1995, for allogeneic
UCBTs.
5.8 January 1, 1994, for HDC with
ABMT or PSCT for chronic myelogenous leukemia.
5.9 January 1, 1996, for HDC with
ABMT or PSCT for Waldenstrom’s macroglobulinemia.
5.10 January 1, 1996, for allogeneic
BMTs using related three antigen mismatch donors for patients with
undifferentiated leukemia, CML, aplastic anemia, ALL or AML.
5.11 October 1, 1996, for HDC with
ABMT or PSCT for AL Amyloidosis.
5.12 January 1, 1995, for allogeneic
BMT for hypereosinophilic syndrome.
5.13 May 1, 1997, for HDC with ABMT
or PSCT for trilateral retinoblastoma/pineoblastoma.
5.14 January 1, 1997, for HDC with
ABMT or PSCT for follicular lymphoma.
5.15 January 1, 1997, for HDC with
ABMT or PSCT for non-Hodgkin’s lymphoma in first complete remission.
5.16 November 28, 1997, for HDC
with ABMT or PSCT for Hodgkin’s disease in second or third remission.
5.17 January 1, 1996, for HDC with
allogeneic BMT for multiple myeloma.
5.18 July 1, 1999, for HDC with
ABMT or PSCT for germ cell tumors in a second or subsequent relapse.
5.19 January 1, 1998, for HDC with
ABMT or PSCT for osteosarcoma (osteogenic sarcoma).
5.20 June 1, 1995, for allogeneic
BMT for Chediak-Higashi syndrome.
5.21 January 1, 1998, for allogeneic
PSCT.
5.22 June 1, 2003, for Langerhans
Cell Histiocytosis, refractory to conventional treatment.
5.23 January 24, 2002, for allogeneic
stem cell transplant for Hodgkin’s disease.
5.24 May 19, 2005, for tandem autologous
PSCT for high-risk neuroblastoma.
5.25 January 1, 2006, for HDC with
ABMT or PSCT for desmoplastic small round cell tumor.
5.26 April 2, 2009, for immunoablative
therapy with ABMT or autologous PSCT for severe systemic lupus erythematosus,
refractory to conventional treatment.
5.27 November 1, 2007, for Donor
Lymphocyte Infusion (DLI) for AML.