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.