Hodgkin Disease

Medically Necessary:

1. An allogeneic (ablative and non-myeloablative) or autologous hematopoietic stem cell transplantation is considered medically necessary for individuals with primary refractory Hodgkin disease or Hodgkin disease that has relapsed after an initial first remission (regardless of remission status at the time of transplant).
2. An allogeneic hematopoietic stem cell transplantation after a prior autologous hematopoietic stem cell transplantation is considered medically necessary for individuals with Hodgkin disease who meet the above criteria.
3. A repeat autologous or allogeneic (ablative or non-myeloablative) hematopoietic stem cell transplantation due to primary graft failure or failure to engraft is considered medically necessary.
4. A planned tandem* autologous (autologous/autologous) hematopoietic stem cell transplantation is considered medically necessary for risk-adapted salvage treatment for either primary refractive Hodgkin disease or individuals who have relapsed after standard therapy.

*Tandem transplantation refers to a planned infusion (transplant) of previously harvested hematopoietic stem cells with a repeat hematopoietic stem cell infusion (transplant) that is performed within 6 months of the initial transplant. This is distinguished from a repeat transplantation requested or performed more than 6 months after the first transplant, and is used as salvage therapy after failure of initial transplantation or relapsed disease.

Investigational and Not Medically Necessary:

1. Allogeneic (ablative and non-myeloablative) hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation is considered investigational and not medically necessary for all other uses in Hodgkin disease including, but not limited to, initial therapy for newly diagnosed disease to consolidate a first complete remission (i.e., in individuals with a complete response to standard-dose induction therapy for newly diagnosed disease).
2. A planned tandem* allogeneic (allogeneic/allogeneic) hematopoietic stem cell transplantation is considered investigational and not medically necessary.
3. A planned tandem autologous (autologous/autologous) hematopoietic stem cell transplantation is considered investigational and not medically necessary, except when criteria above are met.
4. A repeat autologous or allogeneic (ablative or non-myeloablative) hematopoietic stem cell transplantation due to persistent, progressive or relapsed Hodgkin disease is considered investigational and not medically necessary.
5. Hematopoietic stem cell harvesting for a future but unscheduled transplant is considered investigational and not medically necessary.

non-Hodgkin Lymphoma (NHL)

Medically Necessary:

1. Allogeneic (ablative and non-myeloablative) hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation is considered medically necessary to treat individuals with NHL subtypes classified by the National Cancer Institute (NCI) modified REAL classification system as “Indolent” in either of the following situations: (see Rationale section for NCI classification)
   1. as salvage therapy for those who do not achieve a complete remission (CR) after first-line treatment (induction) with a full course of standard-dose chemotherapy; or
   2. to achieve or consolidate a CR for those in a documented chemosensitive first or subsequent relapse, whether or not their lymphoma has undergone transformation to a higher grade.
2. Allogeneic (ablative and non-myeloablative) hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation is considered medically necessary to treat individuals with NHL subtypes classified by the National Cancer Institute (NCI) modified REAL system as “Aggressive” in any of the following situations: (see Rationale section for NCI classification)
   1. as salvage therapy for those who do not achieve a complete remission (CR) after first-line treatment (induction) with a full course of standard-dose chemotherapy; or
   2. to consolidate a first CR for those with an International Prognostic Index (IPI) or age-adjusted IPI score that predicts a high- or high-intermediate risk of relapse (see Rationale section for IPI score description); or
   3. to achieve or consolidate a CR for those in a chemosensitive first or subsequent relapse.
3. An autologous hematopoietic stem cell transplantation is considered medically necessary to consolidate a first CR for individuals with mantle cell lymphoma. Note: criteria above or below may also apply to individuals with mantle cell lymphoma.
4. An allogeneic (ablative or non-myeloablative) hematopoietic stem cell transplantation after a prior autologous hematopoietic stem cell transplantation is considered medically necessary to treat individuals with NHL who meet the above criteria.
5. A repeat autologous or allogeneic (ablative or non-myeloablative) hematopoietic stem cell transplantation due to primary graft failure or failure to engraft is considered medically necessary.
6. Hematopoietic stem cell harvesting* for an anticipated but unscheduled transplant is considered medically necessary in individuals who meet all of the following:
   1. follicular and low-grade non-Hodgkin lymphoma presenting with bone marrow involvement as documented by bone marrow biopsy/flow cytometry studies; and
   2. who meet the criteria above for transplant; and
   3. the treating physician documents that a future transplant is likely; and
   4. harvesting is performed following chemotherapeutic treatment when the individual is in remission.
      *NOTE: Hematopoietic stem cell harvesting does not include the transplant procedure.

Investigational and Not Medically Necessary:

1. Allogeneic (ablative and non-myeloablative) hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation is considered investigational and not medically necessary in the following situations:
   1. as initial therapy (i.e., without a full course of standard-dose induction chemotherapy) for all NHL;
   2. to consolidate a first CR for individuals with NHL subtypes classified by the National Cancer Institute (NCI) modified REAL system as “Aggressive” that does not meet the Medically Necessary criteria above.
2. A planned tandem* allogeneic (allogeneic/allogeneic) hematopoietic stem cell transplantation is considered investigational and not medically necessary as a treatment for individuals with NHL.
3. A planned tandem* autologous (autologous/autologous) hematopoietic stem cell transplantation is considered investigational and not medically necessary as a treatment for individuals with NHL.
4. A repeat autologous or allogeneic (ablative or non-myeloablative) hematopoietic stem cell transplant due to persistent, progressive or relapsed NHL is considered investigational and not medically necessary.
5. Hematopoietic stem cell harvesting for a future but unscheduled transplant is considered investigational and not medically necessary when the criteria above are not met.

*Tandem transplantation refers to a planned infusion (transplant) of previously harvested hematopoietic stem cells with a repeat hematopoietic stem cell infusion (transplant) that is performed within 6 months of the initial transplant. This is distinguished from a repeat transplantation requested or performed more than 6 months after the first transplant, and is used as salvage therapy after failure of initial transplantation or relapsed disease.