4.0 POLICY
4.1 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.
4.1.1 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.
4.1.2 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.
4.2 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).
4.2.1 Non-Hodgkin’s
lymphoma, follicular, intermediate, or high-grade; when:
4.2.1.1 Conventional
dose chemotherapy has failed; or
4.2.1.2 The patient has relapsed following a course
of radiation therapy; or
4.2.1.3 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.
4.2.2 Hodgkin’s disease when:
4.2.2.1 Conventional dose chemotherapy has failed;
or
4.2.2.2 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
4.2.2.3 The patient is in second or third complete
remission.
4.2.3 Neuroblastoma.
4.2.3.1 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.
4.2.3.2 Tandem autologous PSCT for high-risk neuroblastoma
(INSS Stage III with either N-MYC gene amplification or unfavorable
Shimada histology or INSS Stage IV).
4.2.4 Acute lymphocytic or nonlymphocytic leukemias
(e.g., myelocytic, myelogenous, myeloblastic, or myelomonoblastic).
4.2.5 Primitive Neuroectodermal Tumors (PNET)/Ewing’s
Sarcoma.
4.2.6 Gliofibromas
(also known as desmoplastic astrocytoma; desmoplastic glioblastoma).
4.2.7 Glioblastoma multiforme.
4.2.8 Posterior fossa teratoid brain tumors.
4.2.9 Rhabdomyosarcoma and undifferentiated sarcomas.
4.2.10 Multiple myeloma. Tandem autologous stem cell
transplantation is covered for the treatment of multiple myeloma.
4.2.11 Chronic myelogenous leukemia.
4.2.12 Waldenstrom’s macroglobulinemia.
4.2.13 AL (Amyloid Light-Chain) Amyloidosis.
4.2.14 Wilms’ tumor.
4.2.15 Trilateral retinoblastoma/pineoblastoma.
4.2.16 Osteosarcoma (osteogenic sarcoma).
4.2.17 Germ cell tumors in a second or subsequent
relapse.
4.2.18 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.
4.2.19 Immunoablative therapy with ABMT or autologous
PSCT for the treatment of severe systemic lupus erythematosus refractory
to conventional treatment.
4.3 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).
4.3.1 Aplastic anemia.
4.3.2 Acute lymphocytic or nonlymphocytic leukemias
(e.g., myelocytic, myelogenous, myeloblastic, myelomonoblastic);
Chronic Myelogenous Leukemia (CML); or preleukemic syndromes.
4.3.3 Severe combined immunodeficiency; e.g., adenosine
deaminase deficiency and idiopathic deficiencies.
4.3.3.1 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.
4.3.3.2 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).
4.3.3.3 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).
4.3.4 Wiskott-Aldrich
Syndrome.
4.3.5 Infantile
malignant osteopetrosis (Albers-Schonberg syndrome or marble bone
disease).
4.3.6 Thalassemia
major.
4.3.7 Intermediate
and high grade non-Hodgkin’s lymphoma.
4.3.8 Myeloproliferative/dysplastic syndromes.
4.3.9 Congenital mucopolysaccharidoses.
4.3.10 Congenital amegakaryocytic thrombocytopenia.
4.3.11 Metachromatic leukodystrophy.
4.3.12 Sickle cell disease.
4.3.13 Chronic Lymphocytic Leukemia (CLL) when previous
therapy has failed or when the CLL is refractory to conventional
therapy.
4.3.14 Hyperesinophilic
Syndrome.
4.3.15 Multiple
myeloma when HCD with ABMT or PSCT has failed.
4.3.16 X-linked hyper-IgM Syndrome.
4.3.17 Chediak-Higashi Syndrome.
4.3.18 Langerhans Cell Histiocytosis, refractory to
conventional treatment.
4.3.19 Hodgkin’s disease.
4.3.20 Primary Plasma Cell Leukemia.
4.4 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:
4.4.1 Is in relapse
following an adequate trial of HDC with allogeneic stem cell transplantation
of CML or AML; and
4.4.2 Qualified (or would have qualified) for authorization
for HDC with allogeneic stem cell transplantation according to the
provisions set forth in this policy.
4.5 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).
4.5.1 Aplastic
anemia.
4.5.2 Acute lymphocytic
or non-lymphocytic leukemias.
4.5.3 Chronic myelogenous leukemia.
4.5.4 Severe combined immunodeficiency.
4.5.5 Wiskott-Aldrich syndrome.
4.5.6 Infantile malignant osteopetrosis.
4.5.7 Blackfan-Diamond anemia.
4.5.8 Fanconi anemia.
4.5.9 Neuroblastoma.
4.5.10 X-linked lymphoproliferative syndrome.
4.5.11 Hunter syndrome.
4.5.12 Hurler syndrome.
4.5.13 Congenital amegakaryocytic thrombocytopenia.
4.5.14 Sickle cell anemia.
4.5.15 Globoid cell leukodystrophy.
4.5.16 Adrenoleukodystrophy.
4.5.17 Kostmann’s Syndrome.
4.5.18 Lesch-Nyhan disease.
4.5.19 Intermediate and high grade non-Hodgkin’s lymphoma.
4.5.20 Thalassemia major.
4.5.21 Myelodysplastic Syndrome.
4.5.22 X-linked hyper-IgM Syndrome.
4.5.23 Langerhans Cell Histiocytosis, refractory to
conventional treatment.
4.6 Syngeneic (identical twin donor) stem cell
transplantation is covered for the treatment of Hodgkin’s disease.
4.7 TRICARE will reimburse costs for donor searches.
4.7.1 Charges for donor searches must be fully itemized
and billed by the transplant center.
4.7.2 Costs for donor searches will be cost-shared
in accordance with established reimbursement guidelines for outpatient
diagnostic testing.
4.7.3 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.
4.8 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:
4.8.1 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.
4.8.2 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.
4.9 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.
4.10 Benefits are allowed for Hepatitis B and pneumococcal
vaccines for patients undergoing transplantation.
4.11 Benefits may be allowed for Deoxyribonucleic
Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing in determining
histocompatibility.
4.12 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.
4.13 Charges for the umbilical cord blood bank may
be allowed only for patients who have undergone a covered transplant.
4.14 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.
4.15 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.
4.16 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.
5.0 EXCLUSIONS
Benefits will not be paid for:
5.1 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.
5.2 Expenses
waived by the transplant center (i.e., beneficiary/sponsor not financially
liable).
5.3 Services
and supplies not provided in accordance with applicable program
criteria (i.e., part of a grant, or research program; unproven procedure).
5.4 Administration of an unproven immunosuppressant
drug that is not FDA approved.
5.5 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).
5.6 Transportation of a donor.
5.7 Allogeneic BMT for treatment of low grade non-Hodgkin’s
lymphoma is not a benefit.
5.8 Autologous UCBT therapy as this procedure is
considered unproven.
5.9 Allogeneic BMT for neuroblastoma as this procedure
is considered unproven.
5.10 Allogeneic donor BMT (infusion) performed with
or after organ transplants for the purpose of increasing tolerance
of the organ transplant is considered unproven.
5.11 HDC with ABMT or PSCT is not covered for treatment
of breast cancer.
5.12 HDC with allogeneic BMT is not a benefit for
treatment of Waldenstrom’s macroglobulinemia.
5.13 HDC with Stem Cell Rescue (SCR) is not a benefit
for the treatment of epithelial ovarian cancer.
5.14 HDC with allogeneic stem cell transplantation
is not covered for the treatment of cold agglutinin disease.
5.15 Donor lymphocyte infusion if not specifically
listed as covered in
paragraph 4.4.
5.16 Myeloablative and non-myeloablative therapy
with BMT or PSCT for the treatment
of multiple sclerosis is unproven.
5.17 Immunoablative therapy with BMT or PSCT is
unproven and not covered for the treatment of rheumatoid arthritis
and juvenile idiopathic arthritis.
5.18 Immunoablative therapy with allogeneic BMT
or allogeneic PSCT is not covered for the treatment of systemic
lupus erythematosus.
5.19 Allogeneic non-myeloablative hematopoietic
stem cell transplantation for Crohn’s disease.
6.0 EFFECTIVE
DATES
6.1 May 1,
1987, for HDC with ABMT or PSCT for Hodgkin’s disease, non-Hodgkin’s
lymphoma and neuroblastoma.
6.2 November 1, 1987, for HDC with ABMT or PSCT
for acute lymphocytic and nonlymphocytic leukemias.
6.3 November 1, 1983, for HDC with allogeneic BMTs
using related donors.
6.4 July 1, 1989, for HDC with allogeneic BMTs
using unrelated donors.
6.5 July 11, 1996, for HDC with ABMT or PSCT for
multiple myeloma.
6.6 January 1, 1994, for HDC with ABMT and PSCT
for Wilms’ tumor.
6.7 January 1, 1995, for allogeneic UCBTs.
6.8 January 1, 1994, for HDC with ABMT or PSCT
for chronic myelogenous leukemia.
6.9 January 1, 1996, for HDC with ABMT or PSCT
for Waldenstrom’s macroglobulinemia.
6.10 January 1, 1996, for allogeneic BMTs using
related three antigen mismatch donors for patients with undifferentiated
leukemia, CML, aplastic anemia, ALL or AML.
6.11 October 1, 1996, for HDC with ABMT or PSCT
for AL Amyloidosis.
6.12 January 1, 1995, for allogeneic BMT for hypereosinophilic
syndrome.
6.13 May 1,
1997, for HDC with ABMT or PSCT for trilateral retinoblastoma/pineoblastoma.
6.14 January 1, 1997, for HDC with ABMT or PSCT
for follicular lymphoma.
6.15 January 1, 1997, for HDC with ABMT or PSCT
for non-Hodgkin’s lymphoma in first complete remission.
6.16 November 28, 1997, for HDC with ABMT or PSCT
for Hodgkin’s disease in second or third remission.
6.17 January 1, 1996, for HDC with allogeneic BMT
for multiple myeloma.
6.18 July 1, 1999, for HDC with ABMT or PSCT for
germ cell tumors in a second or subsequent relapse.
6.19 January 1, 1998, for HDC with ABMT or PSCT
for osteosarcoma (osteogenic sarcoma).
6.20 June 1, 1995, for allogeneic BMT for Chediak-Higashi
syndrome.
6.21 January
1, 1998, for allogeneic PSCT.
6.22 June 1, 2003, for Langerhans Cell Histiocytosis,
refractory to conventional treatment.
6.23 January 24, 2002, for allogeneic stem cell
transplant for Hodgkin’s disease.
6.24 May 19, 2005, for tandem autologous PSCT for
high-risk neuroblastoma.
6.25 January 1, 2006, for HDC with ABMT or PSCT
for desmoplastic small round cell tumor.
6.26 April 2, 2009, for immunoablative therapy with
ABMT or autologous PSCT for severe systemic lupus erythematosus,
refractory to conventional treatment.
6.27 November 1, 2007, for Donor Lymphocyte Infusion
(DLI) for AML.