(Medicare Claims Processing Manual)

a. 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 (ICD -10-CM diagnosis codes C91.01, C92.01, C92,41, C92.51, C92.61, C92.A1, C93.01, C94.01, C94.21, C94.41, C95.01);   Resistant non- Hodgkin's lymphomas or those presenting with poor prognostic  features following  an initial response  (ICD - 10-CM diagnosis codes C82.01- C85.29, C85.81- C86.6, C96.4, and C96.Z -C96.9);   Recurrent  or refractory  neuroblastoma  (see ICD -10-CM codes  Neoplasm by site, malignant for the appropriate diagnosis  code) following ranges are reported: C00 -  C96, and D00 -  D09 Resistant non-  Hodgkins lymphomas); or, Advanced Hodgkin's disease who have failed conventional therapy and  have no HLA -matched donor (ICD -10-CM codes C81.01 -  C81.99).   a. Effective  for services  performed on  or after October 1, 2000:   Single  AuSCT  is only covered  for Durie -Salmon  Stage II  or III multiple myeloma patients (ICD -10-CM codes C90.00, C90.01, C90.02 and D47.Z9) 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.    b. 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  (ICD -10-CM codes  E85.4, E85.81, E85.89 and  E85.9)  who meet  the following criteria:    Amyloid  deposition  in 2 or fewer  organs;  and,   Cardiac left ventricular ejection  fraction  (EF)  greater  than 45%.   E85.4 Organ- limited amyloidosis   E85.81 Light  chain  (AL) amyloidosis  E85.89 Other  amyloidosis   E85.9 Amyloidosis, unspecified   As the applicable ICD -10 CM codes E85.4, E85.81, E85.9, and E85.89 for amyloidosis do not differentiate between primary and non- primary, A/B MACs (B) should perform prepay reviews on all claims with a diagnosis of ICD - 10-CM code  E85.4, E85.81, E85.9, and E85.89 to determine  whether  payment  is appropriate.  C. Nationally Non-Covered Indications   I. Allogeneic  Hematopoietic  Stem  Cell Transplantation  (HSCT)   Effective for claims  with dates  of service on or after May 24, 1996, through January 27, 2016, allogeneic HSCT is not covered as  treatment for multiple  myeloma  (if ICD-10-CM is applicable,  ICD- 10-CM codes C90.00, C90.01, C90.02 and D47.Z9).   II. Autologous  Stem  Cell Transplantation  (AuSCT)   AuSCT  is not considered reasonable and  necessary  within  the meaning  of l862(a)(1)(A)  of the Act and is not covered  under Medicare for the following conditions:     Acute leukemia not in remission prior to October 1, 2000 ( if  ICD-10-CM is applicable, ICD -10-CM codes C91.00, C92.00, C93.00, C94.00, and C95.00)    Chronic  granulocytic  leukemia  prior  to October  1, 2000 (if ICD-10-CM is applicable,  ICD -10-CM code C92.10);   1.Solid  tumors  prior  to October  1, 2000 (other  than  neuroblastoma) (if ICD -10-CM is applicable, ICD -10- CM codes  C00.0  C80.2 and D00.0  D09.9);   2. Multiple myeloma prior to October 1, 2000 (if ICD -10-CM is applicable, ICD -10-CM codes C90.00, C90.01, C90.02 and D47.Z9);   3. Tandem transplantation, on or after October 1, 2000 (if ICD-10-CM is applicable, ICD -10-CM codes C90.00, C90.01, C90.02, and D47.Z9)  ; 4. Non- primary amyloidosis on or after 10/01/00, for all Medicare  beneficiaries   5. Primary AL amyloidosis effective October 1, 2000, through March  14, 2005 for Medicare beneficiaries  age                                 64. (if ICD -10-CM is applicable,  ICD -10-CM codes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        E85.4, E85.81, E85.9, and E85.89);                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               As the ICD -10-CM is applicable, as the applicable ICD -10 CM codes E85.4, E85.81, E85.9, and E85.89 for amyloidosis do not differentiate between primary and non- primary, A/B MACs (B) should perform prepay reviews on all claims with a diagnosis of ICD -10-CM code E85.4, E85.81, E85.9, and E85.89 to determine  whether  payment is appropriate.   2. Other   All other indications for stem cell transplantation not otherwise noted above as covered or non- covered remain at local Medicare Administrative  Contractor  discretion.   3. Suggested MSN  and RA Messages   The contractor shall use an appropriate MSN and CARC message  such as the following:   MSN  - 15.4, The  information provided does  not support  the need for  this service or  item;  CARC -  150, Payment adjusted because the payer deems the  information  submitted  does  not support  this level  of service.   4. Clinical Trials for Allogeneic Hematopoietic Stem Cell  Transplantation (HSCT) for Myelodysplastic Syndrome  (MDS), Multiple Myeloma, Myelofibrosis (MF), and for  Sickle  Cell Disease  (SCD)    Background   Effective for services performed on or after August 4, 2010, contractors shall pay for claims for allogeneic HSCT for the treatment  of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence  Development  (CED) in the context  of a Medicare- approved,  prospective  clinical study.   Effective for services performed on or after January 27, 2016, contractors  shall  pay for claims  for allogeneic HSCT  for the treatment  of multiple myeloma, myelofibrosis (MF), and for sickle cell disease  (SCD) pursuant to CED, in the context of a Medicare -approved, prospective  clinical study.   Refer to Pub.100- 03, National Coverage Determinations Manual, Chapter 1, section 110.23, for more information about this policy, and Pub. 100 -04, Medicare Claims Processing Manual, Chapter 3,  section  90.3, for  information on inpatient billing  of this CED.    Adjudication Requirements   Payable Conditions. For claims with dates of service on and after August 4, 2010, contractors  shall  pay for claims  for allogeneic  HSCT for MDS when the service was provided pursuant to a  Medicare- approved clinical study under CED; these services are paid  only in the inpatient setting (Type of Bill (TOB) 11X), as outpatient  Part B (TOB 13X), and in Method II critical access hospitals (TOB  85X).   Contractors  shall require  the following coding in order  to pay for these claims:    Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims  Processing Manual, Chapter 32, section 69, and inpatient  billing requirements regarding acquisition of stem cells in  Pub. 100-  04, Medicare Claims Processing Manual,  Chapter 3, section 90.3.1.     If ICD -10-CM is applicable, ICD -10-PCS, procedure  codes 30230G2, 30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3.    If Outpatient Hospital or Professional Claims: HCPCS  procedure  code 38240  If ICD -10-CM is applicable, ICD -10-CM codes D46.A, D46.B, D46.C, D46.Z, D46.0, D46.1, D46.4, D46.9, D46.20, D46.21, D46.22, and Z00.6.   Professional  claims  only:  place  of service codes  19, 21, or  22.  Payable Conditions. For claims with dates of service on and  after January 27, 2016, contractors shall pay for claims for  allogeneic HSCT for multiple myeloma, myelofibrosis (MF), and for sickle cell disease (SCD) when the service was provided  pursuant to a Medicare -approved clinical study under CED; these  services  are paid only in the inpatient  setting  (Type  of Bill (TOB) 11X), as outpatient Part B (TOB 13X), and in Method II critical  access  hospitals (TOB  85X).   Contractors  shall require  the following coding in order  to pay for these claims:    Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims  Processing Manual, Chapter 32, section 69, and inpatient  billing requirements regarding acquisition of stem cells in  Pub. 100-  04, Medicare Claims Processing Manual,  Chapter 3, section 90.3.1.    ICD-10-PCS codes 30230G2, 30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and  30243Y3.