Medicare 

Medicare has clearly defined coverage policies for hematopoietic stem cell transplant (HSCT). The Medicare policy, while set nationally, is interpreted locally, which can lead to variation in actual coverage policies. Medicare generally covers indications where HSCT is considered standard of care. The National Coverage Decision is outlined below.

As of July 6, 2004, Medicare removed the coding guidance that was contained in the National Coverage Decision (NCD) for stem cell transplantation at section 110.8.1, under section A of the NCD Manual. Coding guidance remains in the Claims Processing Manual. Based on this decision, Medicare now has the coverage defined below.

Please note that Kepivance™ is not indicated for use in patients with some of the conditions below. Kepivance™ is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. The safety and efficacy of Kepivance™ has not been established in patients with non-hematologic malignancies.

Covered Conditions

Autologous Stem Cell Transplantation

• Acute leukemia in remission who have a high probability of relapse and who have not human leukocyte antigens (HLA)-matched
• Resistant non-Hodgkin's disease or those presenting with poor prognostic features following an initial response
• Recurrent or refractory neuroblastoma; or
• Advanced Hodgkin's disease who have failed conventional therapy and have no HLA-matched donor
• Effective October 1, 2000, single Autologous SCT is only covered for Durie-Salmon Stage II or III patients that fit the following requirements:
  • 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 percent 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
  • Adequate cardiac, renal, pulmonary, and hepatic function.

Allogeneic Stem Cell Transplantation

• For the treatment of leukemia, leukemia in remission, or aplastic anemia when it is reasonable and necessary; and
• For the treatment of sever combined immunodeficiency disease (SCID), and for the treatment of Wiskott-Aldrich syndrome

Non-covered Conditions

Autologous stem cell transplantation for the following conditions:

• Acute leukemia not in remission;
• Chronic granulocytic leukemia;
• Solid tumors (other than neuroblastoma);
• Multiple myeloma;
• Tandem transplantation (multiple rounds of autologous stem cell transplantation) for patients with multiple myeloma;
• Non-primary (AL) amyloidosis; and
• Primary (AL) amyloidosis for Medicare beneficiaries age 64 or older

Allogeneic stem cell transplantation as treatment for multiple myeloma.

• Tandem transplantation for multiple myeloma

Even with these well-defined criteria, coverage policies vary regionally and coverage is not guaranteed even for eligible indications. Most local administrators of Medicare reimbursement policies (carriers and fiscal intermediateness) require pre-authorization for transplant procedures to determine whether they are "reasonable and medically necessary."

Currently Medicare coverage for HSCT, both autologous and allogeneic, is paid under DRG 481: Bone Marrow Transplant. Unlike commercial payors, Medicare does not currently restrict HSCT patients to approved facilities. Transplant coverage includes:

• Necessary tests, labs, and exams before surgery for the patient and the organ donor
• Procurement of stem cells or bone marrow
• Follow-up care for the patient and donor

Kepivance™ (palifermin) generally falls under DRG 481.

Medicare Preadmission Services Rule

The Medicare Preadmission Services Rule states that, if a patient receives outpatient services three days before a hospital admission, the facility typically cannot bill Medicare for the outpatient services. Rather, the services are included in the hospital inpatient DRG payment. The rule applies when the hospital where the patient is admitted-or a facility that the hospital wholly owns or operates-provides the preadmission services.

Under this rule, the following services typically should be included in the DRG:

• Diagnostic services provided within three days of admission, whether or not they are related to the admission; and
• Non-diagnostic services provided within three days of admission, only if they are related to the admission.