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 Immunoblative therapy with
BMT or PSCT is not covered for the treatment of multiple sclerosis.
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.