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Contractor's Policy Number

99-07-R3

Contractor's Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Transurethral Needle Ablation of the Prostate (TUNA)

AMA CPT Copyright Statement

CPT codes, descriptions, and other data only are copyright 1999 American Medical Association (or such publication of CPT). All rights reserved. Applicable FARS/DFARS clauses apply.

CMS National Coverage Policy

• Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines
• 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 that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
• 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.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

CMS Region

Region III

CMS Consortium

Northeast

Original Policy Effective Date

08/27/1999

Original Policy Ending Date

Revision Effective Date

10/01/2004

10/01/2003

11/17/2000

Revision Ending Date

LMRP Description

Transurethral Needle Ablation of the Prostate (TUNA) is a method of treating symptomatic Benign Prostatic Hypertrophy (BPH), using selective thermal energy to the prostate while preserving the urethra and adjacent structures from harm. This procedure uses the TUNA System Catheter that was approved by the Food and Drug Administration (FDA) on October 8, 1996.

Indications and Limitations of Coverage and/or Medical Necessity

• Symptomatic benign prostatic hypertrophy is the appropriate indication for the use of TUNA.
• Contraindications for TUNA:
• Prostate or bladder cancer,
• Prostate gland with an obstructive median lobe,
• Neurogenic bladder,
• Active cystolithiasis, gross hematuria, urethral stricture, bladder neck contracture, acute prostatitis, or diabetes mellitus affecting bladder function, or;
• Active urinary tract infection.

CPT/HCPCS Section & Benefit Category

Surgery/Urinary System

Type of Bill Code

11X, 13X, 18X, 21X, 83X, 85X

Revenue Codes

360, 361, 369, 49X

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following codes:

53852

©

Prostatic rf thermotx

© CPT American Medical Association

Not Otherwise Classified (NOC)

ICD-9 Codes that Support Medical Necessity

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 claim is submitted.

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.

Medicare is establishing the following limited coverage:

Covered for:

600.00	Hypertrophy (benign) of prostate without urinary obstruction
600.01	Hypertrophy (benign) of prostate with urinary obstruction
600.10	Nodular prostate without urinary obstruction
600.11	Nodular prostate with urinary obstruction
600.20	Benign localized hyperplasia of prostate without urinary obstruction
600.21	Benign localized hyperplasia of prostate with urinary obstruction
600.3	Cyst of prostate
600.90	Hyperplasia of prostate, unspecified, without urinary obstruction
600.91	Hyperplasia of prostate, unspecified, with urinary obstruction

Diagnoses that Support Medical Necessity

As listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Diagnoses that DO NOT Support Medical Necessity

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Reasons for Denial

• The presence of any of the previously delineated contraindications, and;
• The safety and efficacy of TUNA for other prostatic conditions have not been established at this time, and are therefore, not covered by Medicare.

Non-covered ICD-9 Codes

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Non-covered Diagnoses

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Coding Guidelines

• To report this service, use the appropriate HCPCS code,
• All of the coverage criteria must be met before this service can be reimbursed by Medicare,
• Diagnosis (es) must be present on any claim submitted, and be coded to the highest level of specificity, and;
• The diagnosis codes(s) must be representative of the patient's condition.

Documentation Requirements

• Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.

Utilization Guidelines

Medicare will monitor the utilization of this procedure through the Medical Review process.

Other Comments

Financial Responsibility:

Provider Liable

The provider of the service or the ordering physician must have notified the patient in writing, prior to the service, and obtained a signature verifying Advance Beneficiary Notice. Without prior notice, services denied as not medically necessary cannot be billed to the beneficiary. The provider is liable.

Beneficiary Liable

If there is clear evidence that the beneficiary was issued and signed an Advanced Beneficiary Notice (ABN) prior to the service, the liability rests with the beneficiary. Claims for dates of service prior to January 1, 2003 should contain the condition code 20 and occurrence code 32, with date to signify that an ABN was issued to the beneficiary. Absence of these codes will result in a provider liable determination

Claims for dates of service beginning January 1, 2003 should contain the occurrence code 32 with date to signify that an ABN was issued to the beneficiary. Absence of this code will result in a provider liable determination.

Reference: PM AB-02-168, CR 2415

Sources of Information and Basis for Decision

• TrailBlazer Carrier Advisory Committee
• TrailBlazer Medicare Part B Newsletter, No. 030, February 10, 1999
• Program Memorandum, Transmittal AB-00-57, Change Request 1204, June 2000. Updating of ICD-9-CM codes.
• Annual ICD-9-CM updates for FY 2004, PM AB 03-091, CR 2763.

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 contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the appropriate specialty (ies).

Advisory Committee Meeting Date:

Start Date of Comment Period

03/26/1999

End Date of Comment Period

05/10/1999

Start Date of Notice Period

07/28/1999

Revision History

Number	Date	Change
99-07-R3	10/01/2004	Expanded revenue code 36X to 360, 361, 369. Removed revenue code 45X
		as it is not an appropriate location for the service. Removed
		indications under the first “bullet,” making it less restrictive.
99-07-R2	10/01/2003	Annual update of ICD-9 codes. Deleted 600.0, 600.1, 600.2, 600.9,
		added new codes 600.00,600.01, 600.10, 600.11, 600.20, 600.21,
		600.90, and 600.91. (PM 03-091, CR 2763).
		HCPCS descriptor changed to short descriptor.
99-07-R1	11/17/2000	Policy modified to accommodate ICD-9-CM changes. (See 11/17/2000 Provider Bulletin)

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.