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NEW YORK STATE MEDICARE LOCAL MEDICAL REVIEW POLICY

Contractor Policy Number:
RD009E00

Contractor Name:
Empire Medicare Services

Contractor Number:
00803

Contractor Type:
Carrier

LMRP Title:
INTRAVASCULAR BRACHYTHERAPY

AMA CPT / ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2004 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS clauses apply. Current Dental Terminology (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

• Title XVIII of the Social Security Act, section 1862(a)(7)
  This section excludes routine physical checkups.
• Title XVIII of the Social Security Act, section 1862(a)(1)(A)
  This section allows coverage and payment for only those services that are considered to be 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 for processing.
• Medicare Carrier’ s Manual, section 15022 (B) (1 and 2)
  This section prohibits payment of the technical component of radiological procedures by Medicare Part B to hospital inpatients.
• Medicare Carrier’ s Manual, section 15022 (D) (2 and 4)
  This section describes the services that are bundled with brachytherapy procedures.

Primary Geographic Jurisdiction:
Downstate NY (excluding Queens)

CMS Region:
02

CMS Consortium:
Northeast

Original Policy Effective Date:
03/17/2002

LMRP Description:

Intra-vascular brachytherapy is the application of radiation therapy in the management of in-stent restenosis of the coronary artery. The rationale for the use of ionizing radiation is the demonstrated inhibition of neointimal formation following balloon/ stent injury to the coronary vessel. The resultant interruption of scar tissue growth reduces the occurrence of in-stent restenosis. Radiation can be delivered by catheters containing radioactive wires, radioactive seeds, a beta-emitted liquid filled balloon or balloon coated with beta emitting radioisotopes.

Intra-vascular brachytherapy requires the expertise of a multidisciplinary team that includes an interventional cardiologist, a radiation oncologist, and a radiation physicist.

Indications

The Food and Drug Administration (FDA) approved two devices for the delivery of therapeutic doses of radiation to treat in-stent restenosis. These devices are Cordis™ Checkmate and Novoste Beta-Cath™ .

Empire Medicare Services will consider appropriate services rendered on or after September 1, 2001 [the date corresponding to the release of the draft (CAC) version of this policy] through the effective date of this policy, for payment on an individual basis ("individual consideration").

The only covered indication for the application of this modality is the management of the status post coronary stent placement patient who presents with symptoms of chest pains attributable to in-stent restenosis.

• At this time, the benefit is not available to coronary artery disease patient without the above stated conditions. Specifically, it is not covered for symptomatic patients where this option is added as part of a therapeutic revascularization procedure.
• Services performed prior to the effective date of this policy (March 17, 2002) are noncovered, although those performed on and after September 1, 2001, may be individually reviewed and considered for payment.

CPT/HCPCS Section & Benefit Category:
Radiation Oncology/Cardiovascular

CPT/HCPCS Codes:

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 code book appropriate to the year in which the claim is submitted.

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

ICD-9-CM Codes That DO NOT Support Medical Necessity:

Any ICD-9-CM code not included in the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy.

• A claim submitted without a valid ICD-9-CM diagnosis code will be returned as an incomplete claim under 1833(e).
• A claim submitted without one of the ICD-9-CM diagnoses codes listed in the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy will be denied under 1862(a)(1)(A).
• 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.
• Section 1821(a)(7) of the Social Security Act does not extend Medicare coverage for screening procedures.
• Claims submitted for dates of service prior to September 1, 2001, will be denied as investigational.
• The following CPT codes are add-on codes and must be reported in conjunction with the appropriate primary codes and on the same claim. When the add-on codes are reported without the primary codes or on different claims, they will be denied:

• CPT code 92974 is an add-on code and should be reported with 92980 or 92982 or 93508.
• CPT code 92978 is an add-on code and should be reported with 92980 or 92982 or 93508.
• CPT code 92979 is an add-on code and should be reported with 92978 plus codes 92980 or 92982 or 93508.
• CPT code 92981 is an add-on code and should be reported with 92980.
• CPT code 92984 is an add-on code and should be reported with 92982.

Noncovered ICD-9-CM Code(s):
Use of any ICD-9-CM diagnosis code not listed in the "ICD-9-CM Diagnosis Codes That Support Medical Necessity" section of this policy will be denied.

1. The interventional cardiologist is a member of the team that provides intracoronary brachytherapy. The cardiologist should code the service using CPT 93508 and 92974 to describe his/her role in the invasive placement of the radioactive element.
2. When appropriate, CPT codes 92980 [transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel] or 92982 [percutaneous transluminal coronary balloon angioplasty single vessel] and 92978 [intravascular ultrasound (coronary vessel or graft) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report initial vessel] may be reported by the interventionalist.
3. An intravascular ultrasound, CPT code 92978 may be billed with the radiation with GAMMA procedure.
4. Diagnostic Cardiac Catheterization codes may also be reported on the same day as the intravascular brachytherapy.
5. The following CPT codes are add-on codes and must be reported in conjunction with the appropriate primary codes and on the same claim:

• CPT code 92974 is an add-on code and should be reported with 92980 or 92982 or 93508.
• CPT code 92978 is an add-on code and should be reported with 92980 or 92982 or 93508.
• CPT code 92979 is an add-on code and should be reported with 92978 plus codes 92980 or 92982 or 93508.
• CPT code 92981 is an add-on code and should be reported with 92980.
• CPT code 92984 is an add-on code and should be reported with 92982.

6. Appropriate consultation services by various specialties may be reported.
7. The vessel modifier must be used to identify which artery is treated. The modifiers are:

• RC for right coronary artery.
• LC for left coronary artery.
• LD for left anterior descending coronary artery.

8. The radiation oncologist may use the appropriate codes for the services described by the following CPT codes:

• 77262, 77280, 77285, 77326, 77327, 77781, 77782, and 77783

9. The codes 77336 and 77370 (radiation physics), 77790 (loading of radioelement) and 77431 (radiation management with complete course of therapy consisting of one or two fractions only) must not be reported.
10. Services described in this policy as Intra-vascular Brachytherapy may be reimbursed under Medicare Part B in an inpatient hospital (21) only.

• Documentation supporting the medical necessity, such as ICD-9-CM diagnosis codes, must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary.
• A written, signed, and dated prescription or treatment plan designed by the radiation oncologist must be on file. The prescription must include all of the following information: designation of the treatment site, designation of the isotope, designation of the number of source positions, and the planned dose to each point.
• Given the multiplicity of services that are inherent in brachytherapy, it is essential that the medical records reflect each service in a clear linear and temporally logical form. Flow charts, where helpful, are recommended. All procedures should be documented with a procedural note.
• Documentation must be available to Medicare upon request.

Utilization Guidelines:
Frequency of services will be reviewed on an individual consideration basis.

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. A waiver of liability should be signed when a provider/supplier does not want to accept financial responsibility for the service.

• Endoluminal Beta-Radiation Therapy for the Prevention of Coronary Restenosis after Balloon Angioplasty, by V. Verin M.D., Y. Popowski M.D., B. DeBruyne M.D., D. Baumgart M.D., W. Sauerwein M.D., G. Kovacs M.D., M. Thomas M.D. F. Calman M.D., C. Disco M.Sc., P. Serruys M.D. W. Wijns M.D. for the Dose-Finding Group, reprinted from The New England Journal of Medicine, Vol. 344:243-249 (January 25, 2001)
• Three-Year Clinical and Angiographic Follow-up after Intracoronary Radiation: Results of a Randomized Clinical Trial, by Teirstein, PS, Massullo, V. Jani, S. Circulation 2000; 101:360.
• Use of Intracoronary Radiation to Prevent Restenosis, by Bruce D. Klugherz and Daniel M. Kolansky from UpToDate, Vol. 9, No. 2

• This policy was presented at the October 17, 2001, Carrier Advisory Committee meeting by Empire Medicare Services.
• This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with the contractor’s Advisory Committee, which includes representatives from the New York Society of Therapeutic Radiology and Oncology (downstate), the Medical Society of the state of New York and New York State Chapter of the American College of Cardiology.

Start Date of Comment Period:
10/17/2001

End Date of Comment Period:
12/01/2001

Start Date of Notice Period:
01/31/2002

Revision History:

Norbert W. Rainford, M.D.
Carrier Medical Director