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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NYSRS Website Host:
Department of Radiology
School of Medicine
State University of New York at Stony Brook
Health Sciences Center