(Medicare Claims Processing Manual)

Autologous  stem  cell transplantation  is not covered  for the following conditions:    a) 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)   b) Chronic  granulocytic  leukemia  prior  to October  1, 2000 (if ICD-10-CM is applicable,  ICD-10-CM code  C92.10);   c) 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);   d) 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);   e) 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)  ;  f) Non- primary amyloidosis on or after 10/01/00, for all Medicare  beneficiaries   g) 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);    NOTE: Coverage for conditions other than those specifically designated as  covered in  90.2 or 90.2.1 or specifically designated as non -covered in this  section will be at the discretion of the individual A/B MAC  (B).  90.4 - Edits  (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation:  11-17-21)  NOTE: Coverage for conditions other than those specifically designated as  covered  in 80.2 or  specifically  designated as  non- covered  in this section  will be  at the discretion of  the individual A/B  MAC (B).    Appropriate diagnosis to procedure code edits should be  implemented  for the non-covered conditions  and services  in 90.2 90.2.1, and 90.3 as applicable   As the ICD-10-CM codes  E85.4, E85.81, E85.89, and E85.9  amyloidosis  does 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 codes E85.4, E85.81, E85.89, and E85.9 and a HCPCS procedure code of 38241 to determine whether  payment  is appropriate.   90.5 - Suggested MSN and RA Messages  (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation:  11-17-21)   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.   90.6 - Clinical Trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS)  (Rev. 11035, Issued:10 -13-21, Effective: 11-17-21; Implementation:  11-21)  Myelodysplastic Syndrome (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.   On August 4, 2010, the Centers for Medicare & Medicaid Services  (CMS)  issued  a national  coverage  determination  (NCD)  stating  that CMS believes that the evidence does not demonstrate that the use of  allogeneic hematopoietic stem cell transplantation (HSCT) improves  health outcomes in Medicare beneficiaries with MDS. Therefore,  allogeneic  HSCT  for MDS  is not  reasonable  and necessary  under  1862(a)(1)(A) of the Social Security Act (the Act). However,  allogeneic  HSCT  for MDS  is reasonable  and necessary  under  1862(a)(1)(E)  of the Act and therefore covered  by Medicare ONLY if provided pursuant to a Medicare -approved clinical study under  Coverage with Evidence Development (CED). Refer to Pub.100- 03, National Coverage Determinations Manual, Chapter 1, section  110.8.1, for more information about this policy, and Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.1, for  information  on CED.   B Adjudication Requirements   Payable Conditions. For claims with dates of service on and after  August  4, 2010, contractors  shall  pay for claims  for 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 90.3.3.    If ICD -10-CM is applicable, ICD -10-PCS, procedure codes  30230C0, 30230G0, 30230Y0, 30233G0, 30233C0, 30233Y0, 30240C0, 30240G0, 30240Y0, 30243C0, 30243G0, and30243Y0    If Outpatient  Hospital  or Professional  Claims: HCPCS  procedure  code 38240   If ICD -10-CM is applicable, ICD -10-CM diagnosis codes, D46.A, D46.B, D46.C, D46.Z, D46.0, D46.1, D46.20, D46.21, D46.22, D46.4, D46.9, and Z00.6  Professional  claims  only:  place  of service codes  21 or  22.  Denials. Contractors shall deny claims failing to meet any of the above criteria. In addition, contractors shall apply the following  requirements:    Providers  shall  issue  a hospital  issued  notice  of non-coverage (HINN) or advance beneficiary notice (ABN) to the beneficiary if the services performed are not provided in accordance with CED.    Contractors  shall  deny claims  that do not  meet  the criteria  for coverage with the  following messages:   CARC 50 -  These are non -covered services because this is not  deemed  a 'medical necessity'  by the payer.   NOTE:  Refer to the 835 Healthcare Policy Identification  Segment  (loop 2110 Service Payment  Information  REF),  if present.   RARC N386 -  This decision was based on a National Coverage  Determination  (NCD). An  NCD provides  a coverage determination  as to whether a particular item or service is covered. A copy of this  policy is available a t http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a  copy of the NCD.   Group Code   Patient  Responsibility  (PR) if HINN/ABN issued, otherwise  Contractual  Obligation (CO)   MSN  16.77  This  service/item  was not covered  because  it was  not provided as part of a qualifying trial/study. (Este  servicio/artculo no fue cubierto porque no estaba incluido como  parte de  un ensayo  clnico/estudio calificado.)   100  Billing Requirements for Expanded Coverage of Cochlear Implantation  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  Effective for dates of services on and after September 26, 2022, the Centers for Medicare & Medicaid Services (CMS) has expanded the coverage for cochlear implantation to cover bilateral pre-  or post - linguistic, sensorineural, moderate -to-profound hearing loss in individuals with hearing test scores equal to or less than 60% correct in the best aided listening condition on recorded tests of  open -set sentence recognition and who demonstrate limited benefit from amplification.  (See Publication 100 -03, Chapter 1, Section 50.3, for complete coverage criteria).   In addition, CMS is covering cochlear implants for beneficiaries not meeting the coverage criteria listed  under Publication 100- 03, Chapter 1, Section 50.3 when performed in context with:    A Food and Drug Administration (FDA) -approved category B investigational device exemption (IDE) clinical trial as defined at 42 CFR 405.201; or    As a routine cost in a clinical trial under the CMS clinical trial policy (see Pub. 100 -03, section 310.1).     100.1  A/B MACs (Part A) Billing Procedures  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  There are no special payment methods.  Existing payment methods shall apply.  100.1.1  Applicable Bill Types  (Rev. 601, Issued: 07- 01-05; Effective:  04 -04-05; Implementation: 07 -25-05)  11X, 12X (see note below), 13X, 83X, 85X   NOTE :  Surgical procedures are not acceptable on 12x bill types.   100.1.2  Special Billing Requirements for A/B MACs (A) for Inpatient Billing  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)   The second or subsequent diagnosis code must be ICD -10-CM Z00.6 (Encounter for exam for normal comparison and control in clinical research program).  These diagnoses alert the claims processing system that this is a clinical trial.    For patients in an FDA -approved category B IDE clinical trial  the - Q0 modifier must be reported with the cochlear implantation device and all other related costs or; (see note below)    For patients in an approved clinical trial under the clinical trial policy the - Q1 modifier must be billed for routine costs and not for the device itself   NOTE:  The - Q0/-Q1 modifiers do not need to be applied to these services (92601- 92604, 92507 & 92521-92524).   100.2  Intermediary Payment Requirements (Rev. 601, Issued: 07- 01-05; Effective:  04 -04-05; Implementation: 07 -25-05)  There are no special payment methods.  Existing payment methods shall apply.  100.3  A/B MACs (Part B) Billing Procedures  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  Effective for dates of service performed on and after September 26, 2022, the following applies:   A/B MACs (Part B) shall accept claims for cochlear implantation devices and services for beneficiaries meeting the coverage criteria listed under Publication 100- 03, Chapter 1, section 50.3.