(Medicare Claims Processing Manual)

For a complete list of approved transplant centers, visit: https://www.cms.gov/Medicare/Provider-Enrollment- and-Certification/CertificationandComplianc/downloads/ApprovedTransplantPrograms.pdf    A. - Effective Dates   The effective date of coverage for heart transplants performed at facilities applying after July 6, 1987, is the date the facility receives approval as a heart transplant facility.  Coverage is effective for discharges October 17, 1986 for facilities that would have qualified and that applied by July 6, 1987.  All transplant hospitals will be recertified under the final rule, Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007, / Rules and Regulations.  The CMS informs each hospital of its effective date in an approval letter.   B. - Drugs   Medicare Part B covers immunosuppressive drugs following a covered transplant in an approved facility.  C. - Noncovered Transplants  Medicare will not  cover transplants or re-transplants in facilities that have not been approved as meeting the facility criteria.  If a beneficiary is admitted for and receives a heart transplant from a hospital that is not approved, physicians' services, and inpatient ser vices associated with the transplantation procedure are not covered.   If a beneficiary received a heart transplant from a hospital while it was not an approved facility and later requires services as a result of the noncovered transplant, the services are covered when they are reasonable and necessary in all other respects.   D. - Charges for Heart Acquisition Services   The excising hospital bills the OPO, who in turn bills the transplant (implant) hospital for applicable services.  It should not submit a bill to its contractor.  The transplant hospital must keep an itemized statement that identifies the services rendered , the charges, the person receiving the service (donor/recipient), and whether this person is a potential transplant donor or recipient.  These charges are reflected in the transplant hospital's heart acquisition cost center and are used in determining its standard charge for acquiring a donor's heart.  The standard charge is not a charge representing the acquisition cost of a specific heart; rather, it reflects the average cost associated with each type of heart acquisition.  Also, it is an all inclusive c harge for all services required in acquisition of a heart, i.e., tissue typing, post- operative evaluation, etc.   Acquisition charges shall be billed on a 081X revenue code.  Such charges are not considered for the IPPS outlier calculation when billed for a heart transplant.  E. - Bill Review Procedures   The contractor takes the following actions to process heart transplant bills.  It may accomplish them manually or modify its MCE and Grouper interface programs to handle the processing.  1. MCE Interface   The MCE creates a Limited Coverage edit for heart transplant procedure codes.  Where these procedure codes are identified by MCE, the contractor checks the provider number to determine if the provider is an approved transplant center, and checks the effect ive approval date.  The contractor shall also determine if the facility is certified for adults and/or pediatric transplants dependent upon the patients age.  If payment is appropriate (i.e., the center is approved and the service is on or after the approval date) it overrides the limited coverage edit.  2. Handling Heart Transplant Billings From Nonapproved Hospitals   Where a heart transplant and covered services are provided by a nonapproved hospital, the bill data processed through Grouper and Pricer must exclude transplant procedure codes and related charges.   90.3 - Stem Cell Transplantation  (Rev.11348; Issued: 04- 07-22; Effective: 05 -09-22; Implementation: 05 -09-22)  A. General   Stem cell transplantation is a process in which stem cells are harvested from either a patients (autologous) or donors (allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologous stem cell transplantation (AuSCT) is a technique for restoring stem cells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic hematopoietic stem cell transplantation (HSCT) is a procedure in which a portion of a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion. Allogeneic HSCT may be used to restore function in recipients having an inherited or acquired deficiency or defect.  Hematopoietic stem cells are multi- potent stem cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis -  a process by which cells that are unneeded or detrimental will self -destruct.   The Centers for Medicare & Medicaid Services (CMS) is clarifying that bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the admi nistration of high dose chemotherapy or radiotherapy prior to the actual transplant.  When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage. When bone marrow or peripheral blood stem cell transplantation is non- covered, none of the steps are covered.   Allogeneic and autologous stem cell transplants are covered under Medicare for specific diagnoses. Effective October 1, 1990, these cases were assigned to MS -DRG 009, Bone Marrow Transplant.   The A/B MAC (A)'s Medicare Code Editor (MCE) will edit stem cell transplant procedure codes against diagnosis codes to determine which cases meet specified coverage criteria. Cases with a diagnosis code for a covered condition will pass (as covered) the MC E noncovered procedure edit. When a stem cell transplant case is selected for review based on the random selection of beneficiaries, the QIO will review the case on a post -payment basis to assure proper coverage decisions.  Bone marrow transplant codes that are reported with an ICD -9-CM that is not otherwise specified are returned to the hospital for a more specific procedure code. ICD -10-PCS codes are more precise and clearly identify autologous and nonautologous stem cell s.  The A/B MAC (A) may choose to review if data analysis deems it a priority.  B. Nationally Covered Indications   I. Allogeneic Hematopoietic Stem Cell Transplantation  (HSCT)  a. General    Allogeneic stem cell transplantation ( ICD -10-PCS codes 30230G2,30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3) is a procedure in which a portion of a healthy donor's stem cells are obtained and prepared for intravenous infusion to restore normal hematopoietic function in recipients having an inherited or acquired hematopoietic deficiency or defect. See Pub. 100- 03, National Coverage Determinations (NCD) Manual, chapt er 1, section 110.23, for further information about this policy, and Pub. 100- 04, chapter 32, section 90, for information on coding.  Expenses incurred by a donor are a covered benefit to the recipient/beneficiary but, except for physician services, are not paid separately. Services to the donor include physician services, hospital care in connection with screening the stem cell, and ordinary follow -up care.   NOTE: Please note that effective September 30, 2021 PCS codes for Allogeneic SCT 30230G2, 30230G3, 30230Y2, 30230Y3, 30240G2, 30240G3, 30240Y2, 30240Y3 and PCS codes for Autologous SCT 30230C0, 30230G0, 30230Y0, 30240C0, 30240G0, 30240Y0 are end- dated.    b. Covered Conditions   i. 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;   ii. 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;   iii. 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.  iv. Effective for claims with dates of service on or after January 27,  2016:   1. Allogeneic HSCT for multiple myeloma is covered by Medicare only for beneficiaries with Durie -Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and participating in an approved prospective clinical  study.  2. Allogeneic HSCT for myelofibrosis (MF) is covered by Medicare only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate -2 or High primary or secondary MF and participating in an approved prospective clinical  study.  3. Allogeneic HSCT for sickle cell disease (SCD) is covered by Medicare only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical  study.  II.  III. Autologous Stem Cell Transplantation  (AuSCT)   a. General   Autologous stem cell transplantation (ICD -10-PCS codes 30230C0, 30230G0, 30230Y0, 30233G0, 30233C0, 30233Y0, 30240C0, 30240G0, 30240Y0, 30243C0, 30243G0, and 30243Y0) is a technique for restoring stem cells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (high dose chemotherapy (HDCT)) and/or radiotherapy used to treat various malignancies. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy, and Pub. 100- 04, chapter 32, section 90, for information on coding.   NOTE: Please note that effective September 30, 2021 PCS codes for Allogeneic SCT 30230G2, 30230G3, 30230Y2, 30230Y3, 30240G2, 30240G3, 30240Y2, 30240Y3 and PCS codes for Autologous SCT 30230C0, 30230G0, 30230Y0, 30240C0, 30240G0, 30240Y0 are end- dated.  b. Covered Conditions   1. Effective for services performed on or after April 28,  1989:   Acute leukemia in remission who have a high probability of relapse and who have no human leucocyte antigens (HLA) -matched;   Resistant non- Hodgkin's lymphomas 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.  2. Effective for services performed on or after October 1,  2000:   Single AuSCT  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% 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.  3. 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) amyloidos is who meet the following criteria:    Amyloid deposition in 2 or fewer organs;  and,  Cardiac left ventricular ejection fraction (EF) greater than 45%.   C. Nationally Non -Covered Indications   I. Allogeneic Hematopoietic Stem Cell Transplantation  (HSCT)