New Upstate Medicare Division NY Local Medical Review Policies.

 

 

Noninvasive Vascular Diagnostic Studies (VS001E06) Revision #6:

Diagnosis codes are added under the following VS001E06 sections per 2003 ICD-9-CM codes update:

 

1.                         Cerebrovascular Arterial Studies (93875, 93880, 93882, 93886, 93888) - 430,                          443.21, 443.24.

 

2.                         Extremity Arterial Studies (93922, 93923, 93924, 93925, 93926, 93930, 93931) - 443.22, 443.29, 445.01-445.02.

 

3.                         Extremity Venous Studies (93965, 93970, 93971) - 454.8, 459.11-459.13, 459.19, 459.31-459.33, 459.39.

 

4.                         Visceral Vascular Studies (93975, 93976, 93978, 93979) - 443.23, 443.29, 445.81, 445.89.

 

5.                        "Coding Guidelines" #10 is updated to add places of service (31) for the professional component (modifier 26); (32) and (33) for the global service or a component of the global service (modifier TC or 26).


 

 

Diagnostic Cardiac Catheterization CV013E01 Revision #3:

1.                        ICD-9-CM codes 428.20-428.43 have been added as indications supporting medical necessity for CPT codes 93503, 93561, 93562, 93501, 93526, 93527, 93528, and 93529. 
 
2.                        ICD-9-CM codes 414.06 and 428.20-428.43 have been added as indications supporting medical necessity for CPT codes 93555, 93556, 93508, 93539, 93540, 93543, 93544, 93545, 93510, 93511, 93514, and 93524. 
 
3.                        ICD-9-CM code 445.81 has been added as an indication supporting medical necessity for CPT codes 75625-75724 and 36120-36248. 

LMRP Title:  Ibritumomab Tiuxetan Therapy (Zevalin(R))

Contractor's Policy Number
DR018E00

Contractor Name
HealthNow

Contractor Number
00801

Contractor Type
Carrier

 

AMA CPT Copyright Statement
CPT codes, descriptions, and other data only are copyright 2002 American Medical Association (or such other data of publication of CPT). All Rights Reserved. Applicable FARS/DFARS clauses apply.

CMS National Coverage Policy

   -  Title XVIII of the Social Security Act, Section 1862 (a)(7) 
      This section excludes routine physical examinations. 
   -  Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). 
      This section allows coverage and payment for only those services 
      considered medically reasonable and necessary. 
   -  Title XVIII of the Social Security Act, Section 1833 (e) 
      This section prohibits Medicare payment for any claim that lacks the 
      necessary information to process the claim. 
   -  CMS transmittal AB-02-120 
      This program memorandum provides billing instructions for ibritumomab 
      tiuxetan. 

Primary Geographic Jurisdiction
Upstate New York

Secondary Geographic Jurisdiction
N/A

CMS Region
02

CMS Consortium
Northeast

Original Policy Effective Date
06/23/2003

Original Policy Ending Date

Revision Effective Date

Revision Ending Date

LMRP Description
Ibritumomab tiuxetan is an immunoconjugate monoclonal antibody that can be labeled with radioactive isotopes and is indicated for the treatment of relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL), including patients with or without rituximab-refractory follicular NHL. The antibody part of the radiopharmaceutical is specific for the CD20 surface antigen on lymphocytes. The therapy requires prior diagnostic testing to determine the distribution of the pharmaceutical. Both the diagnostic testing and the therapeutic treatment require infusion of rituximab prior to the administration of the ibritumomab tiuxetan. The diagnostic ibritumomab tiuxetan is labeled with indium-111, and the therapeutic ibritumomab tiuxetan is yttrium-90 labeled. The diagnostic test is performed eight (8) days prior to the therapeutic treatment. The diagnostic test is performed with a standard dose of 5mCi of the In-111 ibritumomab tiuxetan. The therapeutic dose is 0.4mCi/kg body weight of yttrium-90 ibritumomab tiuxetan with a maximum dose of 32mCi regardless of weight. The dose is reduced to 0.3mCi/kg for patients with platelet counts less than 140,000 and should not be administered if the platelet count is less than 100,000. The radiopharmaceutical is furnished to the nuclear medicine physician fully prepared ready for administration, by the manufacturer/supplier-laboratory.

Indications and Limitations of Coverage and/or Medical Necessity
Indications
The yttrium-90 ibritumomab tiuxetan is indicated for the treatment of relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL), including patients with or without rituximab-refractory follicular NHL, as a single course of treatment. Patients must be CD20 surface antigen positive. The yttrium-90 ibritumomab tiuxetan must be administered personally by the physician or under his/her direct personal supervision ("incident to"). The physician must be present for the entire infusion of the radiopharmaceutical.

Limitations

   1) The dose of the yttrium-90 ibritumomab tiuxetan should be reduced from 
      0.4mCi/kg to 0.3mCi/kg in patients with platelet counts less than 
      140,000, and should not be administered to patients with platelet 
      counts less than 100,000. 
   2) The ibritumomab tiuxetan therapeutic regimen is contraindicated and 
      should not be given to patients with > 25% lymphoma marrow involvement 
      and/or impaired bone marrow reserve, (e.g., prior myeloablative 
      therapies; platelet count <100,000; neutrophil count <1,500; 
      hypocellular bone marrow as denoted by <15% cellularity or marked 
      reduction in bone marrow precursors), or a history of failed stem cell 
      collection. 
   3) The ibritumomab tiuxetan therapeutic regimen is intended and considered 
      to be a single course treatment regimen.  The efficacy, safety, and 
      toxicity of multiple courses of the therapeutic regimen have not been 
      established and more than one course of treatment is considered not 
      reasonable and necessary. 
   4) Yttrium-90 ibritumomab tiuxetan is not indicated for primary therapy 
      for non-Hodgkin's lymphoma. 
   5) Yttrium-90 ibritumomab tiuxetan is not indicated for treatment of 
      conditions other than non-Hodgkin's lymphoma. 

CPT/HCPCS Section & Benefit Category
Diagnostic tests/ Nuclear Medicine/Medicine
Administrative, Miscellaneous and Investigational
Procedures and Professional Services

CPT/HCPCS Codes

For dates of service prior to January 1, 2003
Diagnostic test

    ________________ ______________________________________________________  
   |A4641           |Supply of radiopharmaceutical diagnostic imaging      | 
   |                |agent, not otherwise classified                       | 
   |________________|______________________________________________________| 
   |78800           |Radiopharmaceutical localization of tumor;  limited   | 
   |                |area                                                  | 
   |________________|______________________________________________________| 
   |78801           |multiple areas                                        | 
   |________________|______________________________________________________| 
   |78802           |whole body                                            | 
   |________________|______________________________________________________| 

Therapeutic Service

    ________________ ______________________________________________________  
   |79400           |Radiopharmaceutical therapy, nonthyroid,              | 
   |                |nonhematologic                                        | 
   |________________|______________________________________________________| 
   |79900           |Provision of therapeutic radiopharmaceutical(s)       | 
   |________________|______________________________________________________| 

For dates of service on or after January 1, 2003
Diagnostic Test

    ________________ ______________________________________________________  
   |A9522           |Supply of radiopharmaceutical diagnostic imaging      | 
   |                |agent, indium-111 ibritumomab tiuxetan, per MCI       | 
   |________________|______________________________________________________| 
   |                |Radiopharmaceutical biodistribution, single or        | 
   |G0273           |multiple scans on one or more days, , pre-treatment   | 
   |                |planning for radiopharmaceutical therapy of           | 
   |                |non-Hodgkin's lymphoma, includes administration of    | 
   |                |radiopharmaceutical (e.g., radiolabeled antibodies)   | 
   |________________|______________________________________________________| 

Therapeutic Services

    ________________ ______________________________________________________  
   |A9523           |Supply of radiopharmaceutical therapeutic imaging     | 
   |                |agent, yttrium 90 ibritumomab tiuxetan, per MCI       | 
   |________________|______________________________________________________| 
   |G0274           |Radiopharmaceutical therapy, non-Hodgkin's lymphoma,  | 
   |                |includes administration of radiopharmaceutical (e.g., | 
   |                |radiolabeled antibodies)                              | 
   |________________|______________________________________________________| 

ICD-9-CM Codes that Support Medical Necessity
TRUNCATED DIAGNOSIS CODES ARE NOT ACCEPTABLE.

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider's responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the service is provided.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

 

    ________________ ______________________________________________________ 

   |202.00-202.08   |Nodular lymphoma                                      |

   |________________|______________________________________________________|

   |202.80-202.88   |Other malignant neoplasms of lymphoid and  histiocytic|

   |                |tissue, other lymphomas                               |

   |________________|______________________________________________________|

ICD-9-CM Codes that DO NOT Support Medical Necessity
Use of any ICD-9-CM code not listed in the "ICD-9-CM Codes that Support Medical Necessity" section of this policy will be denied.

Reasons for Denial

   1) A claim submitted without a valid ICD-9-CM code will be returned as an 
      incomplete claim under 1833(e). 
   2) A claim submitted without one of the ICD-9-CM codes listed in the 
      "ICD-9-CM Codes that Support Medical Necessity" section of this policy 
      will be denied under 1862 (a)(1)(A). 
   3) A claim for services rendered in any place of service other than those 
      indicated as payable in the "Coding Guidelines" section of this policy 
      will be denied. 
   4) Section 1862 (a)(7) of the Social Security Act does not extend Medicare 
      coverage for screening procedures. 
   5) A claim for (these services), submitted without the UPIN number of the 
      referring/ordering physician or qualified non-physician practitioner, 
      will be returned as an incomplete claim under 1833 (e). 
   6) A claim failing to meet the both the indications and limitations listed 
      in this policy will be denied for medical necessity. 
   7) A claim without adequate documentation in the patient's medical records 
      of the patient's medical condition, prior treatment, weight and 
      platelet count may be denied on post-pay review.  The physician 
      administering the ytttrium-90 ibritumomab tiuxetan treatment, as well 
      as the primary provider treating the patient for the non-Hodgkin's 
      lymphoma must maintain the records. 
   8) A follow-up imaging scan after the administration of the yttrium-90 
      ibritumomab tiuxetan is not indicated and will be denied as not 
      medically necessary. 
   9) Claims for initiation of intravenous access and administration of 
      either the diagnostic or therapeutic radiopharmaceutical are included 
      in the imaging and therapeutic services, respectively, and are not 
      separately reimbursable.  If billed they will be denied as being 
      included in another service. 
   10)Only one E&M service (total) is appropriate for the patient encounter 
      by the nuclear medicine provider prior to the diagnostic and 
      therapeutic procedures. 
   11)Claims for services not indicated as separately payable in the coding 
      guidelines section will be denied as being included as part of the 
      appropriate coded services. 
   12)Claims for the yttrium-90 ibritumomab tiuxetan for which the performing 
      physician did not personally administer the drug, or was not personally 
      present throughout the entire infusion will be denied as non-covered. 

Non-covered ICD-9-CM Codes
N/A

Coding Guidelines

   1. This policy does not take precedence over the Correct Coding Initiative 
      (CCI) and CCI does not interfere with the Indications and Limitations 
      within this policy. 
   2. The diagnostic test and the therapeutic treatment must be submitted on 
      separate claims. 
   3. The administration of the diagnostic and therapeutic 
      radiopharmaceutical, including the initiation of the intravenous 
      access, is included in the imaging and therapeutic procedures and 
      should not be reported separately. 
   4. An E&M service appropriate for the service performed in evaluating the 
      patient for the diagnostic and therapeutic tests, and consistent with 
      the level of care provided, may be billed by the nuclear medicine 
      provider administering these services.  Only one E&M service should be 
      billed for the encounters before the diagnostic test and the 
      therapeutic procedure. 
   5. The UPIN of the physician or qualified non-physician provider ordering 
      the therapy must be included on the claim for both the diagnostic test 
      and the therapeutic treatment. 
   6. Acceptable places of service for billing these services to the Part B 
      Carrier are: 

 

    __________________________________ ___________ ____________ __________ 

   |                                  |   11      |    21      |    22    |

   |Place of Service                  | Office    |Inpatient   |Outpatient|

   |                                  |           | hospital   | hospital |

   |__________________________________|___________|____________|__________|

   |A4641                             |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |A9522, A9523                      |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |78800, 78801, 78802               |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |78800-TC, 78801-TC, 78802-TC      |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |78800-26,  78801-26,  78802-26    |    X      |    X       |    X     |

   |__________________________________|___________|____________|__________|

   |79400                             |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |79400-TC                          |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |79400-26                          |    X      |    X       |    X     |

   |__________________________________|___________|____________|__________|

   |79900                             |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |G0273, G0274                      |    X      |            |          |

   |__________________________________|___________|____________|__________|

   |G0273-26, G0274-26                |    X      |    X       |    X     |

   |__________________________________|___________|____________|__________|

   |G0273-TC, G0274-TC                |    X      |            |          |

   |__________________________________|___________|____________|__________|

For dates of service prior to January 1, 2003
Diagnostic services

   1. For dates of service prior to January 1, 2003, the diagnostic nuclear 
      scans used to assess distribution of the radiopharmaceutical should be 
      coded using only one of the following CPT codes: 78800, 78801 or 78802. 
      The scan should be billed with units of service of one (1).  All scans 
      for this service are considered part of a single tumor scan regardless 
      of the number of scans performed or the number of days on which the 
      scans were obtained. 
   2. For dates of service prior to January 1, 2003, the diagnostic dose of 
      In-111 ibritumomab tiuxetan should be coded using the HCPCS code A4641 
      with unit of services of one (1).  "Indium-111 ibritumomab tiuxetan," 
      along with the invoice cost of the radiopharmaceutical, should be 
      entered into item #19 of the CMS-1500 form, or its electronic 
      equivalent. 

Therapeutic services

   1. For dates of service prior to January 1, 2003 the treatment of the 
      patient with the therapeutic dose of yttrium-90 ibritumomab tiuxetan 
      should be billed using the CPT code 79400. 
   2. For dates of service prior to January 1, 2003, the therapeutic dose of 
      yttrium-90 ibritumomab tiuxetan should be coded using the CPT code 
      79900 with a unit of services equal to the dose of Yttrium-90 
      ibritumomab tiuxetan, in mCi, administered to the patient.  Doses 
      should be rounded up to the next whole mCi.   In addition, the name of 
      the agent, "Yttrium-90 ibritumomab tiuxetan," the dosage used, and the 
      invoice cost of the radiopharmaceutical, should be entered into item 
      #19 of the CMS-1500 form, or its electronic equivalent. 
   3. For dates of service prior to January 1, 2003, the infusion of the 
      radiopharmaceutical; supervision, handling and loading of radiation 
      source; basic radiation dosimetry calculation; and special medical 
      radiation physics consultation are included in the therapeutic 
      treatment code, 79400, and may not be billed separately. 

For dates of service on or after January 1, 2003
Diagnostic Tests

   1. Effective January 1, 2003, code G0273 represents the administration of 
      the radiopharmaceutical and performance and interpretation of all 
      scans.  This code has technical and professional components and can be 
      reported with modifiers TC (technical) or 26 (professional) when 
      appropriate.  It should be reported only once, regardless of the number 
      of scans performed. 
   2. For dates of service on or after January 1, 2003, the charge for the 
      diagnostic radiopharmaceutical should be reported with code A9522.  The 
      invoice cost for the agent and the dosage should be listed in item #19 
      of the CMS 1500 form, or the electronic equivalent. 

Therapeutic services

   1. Effective January 1, 2003, therapeutic treatment using radiolabeled 
      monoclonal antibodies for non-Hodgkin's lymphoma should be reported 
      with code G0274. 
   2. Effective January 1, 2003, the supply of the therapeutic 
      radiopharmaceutical imaging agent should be reported with code A9523. 
      The invoice cost of the agent and the dosage should be listed in item 
      #19 of the CMS 1500 form or the electronic equivalent. 

Documentation Requirements

   -  Each claim must be submitted with ICD-9-CM codes that reflect the 
      condition of the patient, and indicate the reason(s) for which the 
      service was performed.  Claims submitted without ICD-9-CM codes will be 
      returned. 
   -  The medical record must document the need for these services, and 
      include the basis for the diagnosis of non-Hodgkin's lymphoma, a 
      history of prior treatments, and the patient's weight and platelet 
      count (separate records should be maintained by both the nuclear 
      medicine specialist administering these services and by the referring 
      physician). 
   -  The medical record should document that the yttrium-90 ibritumomab 
      tiuxetan was personally administered by the physician or under his/her 
      direct personal supervision. 
   -  A copy of the invoice for both radiopharmaceuticals must be maintained 
      in the patient's medical record. 
   -  Documentation must be available to Medicare upon request. 

Utilization Guidelines

   -  It is expected that this treatment will be performed only once. 
   -  Claims for additional services will be denied as not medically 
      necessary. 

Other Comments

   -  For services that exceed the accepted standard of medical practice and 
      may be deemed not medically necessary, the provider/supplier must 
      provide the patient with an acceptable advance notice of Medicare's 
      possible denial of payment.  An advance beneficiary notice (ABN) should 
      be signed when a provider/supplier does not want to accept financial 
      responsibility for the service. 
   -  Platelet and white blood cell counts may be monitored weekly after the 
      administration of the yttrium-90 ibritumomab tiuxetan, until recovered. 
   -  Rituximab and its administration should be billed separately by the 
      administering provider, in accordance with published guidelines for 
      this drug. 

Sources of Information and Basis for Decision

   1) FDA Product Approval Information at: 
      http://www.fda.gov/cber/approvltr/ibriide021902L.htm 
   2) IDEC Pharmaceuticals Corporation.  Zevalin(TM) Full Prescribing 
      Information at http://www.idecpharm.com/site/science/zevalin_pi.pdf 
      (issue date January 2002). 
   3) Witzig, Thomas et al., "Randomized Controlled Trial of 
      Yttrium-90-Labeled Ibritumomab Tiuxetan Radioimmunotherapy Versus 
      Rituximab Immunotherapy for Patients With Relapsed or Refractory 
      Low-Grade, Follicular, or Transformed B-Cell Non-Hodgkin's Lymphoma", 
      Journal of Clinical Oncology 20(10): 2453-2463 (May 15, 2002). 
   4) Wiseman, Gregory et al., "Ibritumomab tiuxetan radioimmunotherapy for 
      patients with relapsed or refractory non-Hodgkin lymphoma and mild 
      thrombocytopenia: a phase II multicenter trial", Blood 99(12): 
      4336-4342 (June 15, 2002). 

Advisory Committee Notes
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the carrier, this policy was developed in cooperation with advisory groups, which includes representatives from New York and New Jersey societies for Radiology, Nuclear Medicine, Oncology/Hematology, Internal Medicine, and the New York State Medical Society.

Advisory Committee Meeting Date
10/09/2002

Start Date of Comment Period
10/09/2002

End Date of Comment Period
11/23/2002

Start Date of Notice Period
05/09/2003

Revision History


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