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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that stem cell transplantation is covered for the following indications:
I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
a) 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,
b) 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.
c) 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.
MDS refers to a group of diverse blood disorders in which the bone marrow does not produce enough healthy,
functioning blood cells. These disorders are varied with regard to clinical characteristics, cytologic and
pathologic features, and cytogenetics. The abnormal production of blood cells in the bone marrow leads to low
blood cell counts, referred to as cytopenias, which are a hallmark feature of MDS along with a dysplastic and
hypercellular-appearing bone marrow
Medicare payment for these beneficiaries will be restricted to patients enrolled in an approved clinical study. In
accordance with the Stem Cell Therapeutic and Research Act of 2005 (US Public Law 109-129) a standard
dataset is collected for all allogeneic transplant patients in the United States by the Center for International Blood and Marrow Transplant Research. The elements in this dataset, comprised of two mandatory forms plus
one additional form, encompass the information we require for a study under CED.
II. Autologous Stem Cell Transplantation (AuSCT)
a) Effective for services performed on or after April 28, 1989, AuSCT is considered reasonable and necessary
under l862(a)(1)(A) of the Act for the following conditions and is covered under Medicare for patients with:
1. Acute leukemia in remission who have a high probability of relapse and who have no human
leucocyte antigens (HLA)-matched;
2. Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following
an initial response;
3. Recurrent or refractory neuroblastoma; or,
4. Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched
donor.
b) Effective October 1, 2000, single AuSCT is only covered for Durie-Salmon Stage II or III patients that fit
the following requirements:
1. 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
2. Adequate cardiac, renal, pulmonary, and hepatic function.
c) 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:
Blood and Marrow Transplant Research. The elements in this dataset, comprised of two mandatory forms plus
one additional form, encompass the information we require for a study under CED.
II. Autologous Stem Cell Transplantation (AuSCT)
a) Effective for services performed on or after April 28, 1989, AuSCT is considered reasonable and necessary
under l862(a)(1)(A) of the Act for the following conditions and is covered under Medicare for patients with:
1. Acute leukemia in remission who have a high probability of relapse and who have no human
leucocyte antigens (HLA)-matched;
2. Resistant non-Hodgkin's lymphomas or those presenting with poor prognostic features following
an initial response;
3. Recurrent or refractory neuroblastoma; or,
4. Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched
donor.
b) Effective October 1, 2000, single AuSCT is only covered for Durie-Salmon Stage II or III patients that fit
the following requirements:
1. 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
2. Adequate cardiac, renal, pulmonary, and hepatic function.
c) 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:
1. Amyloid deposition in 2 or fewer organs; and,
2. Cardiac left ventricular ejection fraction (EF) greater than 45%.
You can find these rules in the Medicare National Coverage Determination (NCD) Stem Cell Transplantation
(Formerly 110.8.1), Section 110.23.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.