L28933-LCD

Automated World Health

Local Coverage Determination (LCD) for Myocardial Imaging, Positron Emission

Tomography (PET) Scan (L28933)

Contractor Information

Contractor Name

First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28933

LCD Title

Myocardial Imaging, Positron Emission Tomography (PET) Scan

Contractor's Determination Number A78459

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2011 Revision Ending Date

CMS National Coverage Policy

CMS Transmittal AB-03-092, Change Request 2687 CMS Transmittal AB-03-119, Change Request 2853 CMS Transmittal 428, Change Request 3640

Medicare National Coverage Determinations Manual, Pub. 100-03, Chap. 1, Part 4, Sections 220.68

Indications and Limitations of Coverage and/or Medical Necessity

PET is a noninvasive diagnostic imaging procedure that assesses the level of metabolic activity and perfusion in various organ systems of the human body. A positron camera (tomograph) is used to produce cross-sectional tomographic images, which are obtained from positron emitting radioactive tracer substances (radiopharmaceutical) such as FDG (2-{flourine-18}-fluoro-2-dexoy-D-glucose) that are usually administered intravenously to the patient.

The following indications may be covered for PET under certain circumstances. Details of Medicare PET coverage are discussed later in this policy. Unless otherwise indicated, the clinical conditions below are covered when PET utilizes FDG as the tracer.

Clinical Condition (Effective Date)Coverage

Myocardial Viability (July 1, 2001 to September 30, 2002)Covered only following an inconclusive SPECT

Myocardial Viability (October 1, 2002)Primary or initial diagnosis prior to revascularization, or following an inconclusive SPECT.

Perfusion of the heart using ammonia N-13* tracer (October 1, 2003)Covered for noninvasive imaging of the perfusion of the heart

*Not FDG PET.

General Conditions of Coverage for FDG PET

A. Allowable FDG PET Systems

1. Definitions: For purposes of this section,

a. “Any FDA approved” means all systems approved or cleared for marketing by the FDA to image radionuclides in the body.

b. “FDA approved” means that the system indicated has been approved or cleared for marketing by the FDA to image radionuclides in the body.

c. “Certain coincidence systems” refers to the systems that have all the following features:

• Crystal at least 5/8-inch thick

• Techniques to minimize or correct for scatter and/or randoms, and

• Digital detectors and iterative reconstruction.

Scans performed with gamma camera PET systems with crystals thinner than 5/8-inch will not be covered by Medicare. In addition, scans performed with systems with crystals greater than or equal to 5/8-inch in thickness, but that do not meet the other listed design characteristics are not covered by Medicare.

2. Allowable PET systems by covered clinical indication:

Allowable Type of FDG PET System

Covered Clinical Condition (Prior to July 1, 2001)July 1, 2001 through December 31, 2001 (On or after January 1, 2002)

Determination of myocardial viability only following an inconclusive SPECT (Not covered by Medicare)Full ring

(FDA approved:Full ring Partial ring)

Myocardial Viability Primary or initial diagnosis prior to revascularization (Continued coverage following an inconclusive SPECT is

also allowed) (Not covered by Medicare)Not covered (Effective October 1, 2002, Full and partial ring)

NOTE: PET is not covered for other diagnostic uses, and is not covered for screening (testing of patients without specific symptoms).

Monitoring - Use of PET to monitor tumor response during the planned course of therapy (i.e. when no change in therapy is being contemplated) is NOT covered. Restaging only occurs after a course of treatment is completed, and this is covered, subject to the conditions above.

Coverage of PET Scans for Noninvasive Imaging of the Perfusion of the Heart

1. Rubidium 82 (Effective March 14, 1995)

Effective for services performed on or after March 14, 1995, PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical Rubidium 82 (Rb

82) are covered, provided the requirements below are met:

• The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or

• The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test(s) whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.)

• For any PET scan for which Medicare payment is claimed for dates of services prior to July 1, 2001, the claimant must submit additional specified information on the claim form (including proper codes and/or modifiers), to indicate the results of the PET scan. The claimant must also include information on whether the PET scan was performed after an inconclusive noninvasive cardiac test. The information submitted with respect to the previous noninvasive cardiac test must specify the type of test performed prior to the PET scan and whether it was inconclusive or unsatisfactory. These explanations are in the form of special G codes used for billing PET scans using Rb 82. Beginning July 1, 2001, claims should be submitted with the appropriate codes.

2. Ammonia N-13 (Effective October 1, 2003)

Effective for services performed on or after October 1, 2003, PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical ammonia N-13 are covered, provided the requirements below are met:

• The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or

• The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.)

Coverage of FDG PET for Myocardial Viability

Beginning July 1, 2001 through September 30, 2002, Medicare covers FDG PET for the determination of myocardial viability, following an inconclusive SPECT.

Limitations:

In the event that a patient has received a single photon computed tomography test (SPECT) with inconclusive results, a PET scan may be covered.

Beginning October 1, 2002, Medicare will cover FDG PET for the determination for myocardial viability as a primary or initial diagnostic study prior to revascularization, and will continue to cover FDG PET when used as a follow-up to an inconclusive SPECT. However, if a patient received a FDG PET study with inconclusive results, a follow-up SPECT is not covered.

Limitations:

In the event that a patient receives a SPECT with inconclusive results, a PET scan may be performed and covered by Medicare. However, a SPECT is not covered following a FDG PET with inconclusive results.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0404 Other Imaging Services - Positron Emission Tomography

CPT/HCPCS Codes

78459 MYOCARDIAL IMAGING, POSITRON EMISSION TOMOGRAPHY (PET), METABOLIC EVALUATION

78491 MYOCARDIAL IMAGING, POSITRON EMISSION TOMOGRAPHY (PET), PERFUSION; SINGLE STUDY AT REST OR STRESS

78492 MYOCARDIAL IMAGING, POSITRON EMISSION TOMOGRAPHY (PET), PERFUSION; MULTIPLE STUDIES AT REST AND/OR STRESS

A9526 NITROGEN N-13 AMMONIA, DIAGNOSTIC, PER STUDY DOSE, UP TO 40 MILLICURIES A9555 RUBIDIUM RB-82, DIAGNOSTIC, PER STUDY DOSE, UP TO 60 MILLICURIES

ICD-9 Codes that Support Medical Necessity

The following ICD-9 codes are applicable to Procedure codes 78459, 78491 and 78492 only:

411.0 POSTMYOCARDIAL INFARCTION SYNDROME

411.81 ACUTE CORONARY OCCLUSION WITHOUT MYOCARDIAL INFARCTION

412 OLD MYOCARDIAL INFARCTION

413.1 PRINZMETAL ANGINA

414.1 CORONARY ATHEROSCLEROSIS OF UNSPECIFIED TYPE OF VESSEL NATIVE OR GRAFT

414.2 CORONARY ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY

414.3 CORONARY ATHEROSCLEROSIS OF AUTOLOGOUS VEIN BYPASS GRAFT

414.4 CORONARY ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL BYPASS GRAFT

414.6 CORONARY ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY OF TRANSPLANTED HEART

414.7 CORONARY ATHEROSCLEROSIS OF BYPASS GRAFT (ARTERY) (VEIN) OF TRANSPLANTED HEART

414.10 ANEURYSM OF HEART (WALL)

414.11 ANEURYSM OF CORONARY VESSELS

414.12 DISSECTION OF CORONARY ARTERY

414.19 OTHER ANEURYSM OF HEART

414.3 CORONARY ATHEROSCLEROSIS DUE TO LIPID RICH PLAQUE

414.4 CORONARY ATHEROSCLEROSIS DUE TO CALCIFIED CORONARY LESION

414.8 OTHER SPECIFIED FORMS OF CHRONIC ISCHEMIC HEART DISEASE

426.2 LEFT BUNDLE BRANCH HEMIBLOCK

426.3 OTHER LEFT BUNDLE BRANCH BLOCK

426.4 RIGHT BUNDLE BRANCH BLOCK 426.50 - 426.54 opens in

new window BUNDLE BRANCH BLOCK UNSPECIFIED - TRIFASCICULAR BLOCK

426.6 OTHER HEART BLOCK

427.31 ATRIAL FIBRILLATION

428.1 CONGESTIVE HEART FAILURE UNSPECIFIED

428.2 LEFT HEART FAILURE

428.20 - 428.23 UNSPECIFIED SYSTOLIC HEART FAILURE - ACUTE ON CHRONIC SYSTOLIC HEART FAILURE

428.30 - 428.33 UNSPECIFIED DIASTOLIC HEART FAILURE - ACUTE ON CHRONIC DIASTOLIC HEART FAILURE

428.40 - 428.43 UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE - ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE

428.9 HEART FAILURE UNSPECIFIED

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Documentation that the required conditions (as indicated in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy) for each of the FDG PET scans performed has been met must be maintained by the referring physician in the beneficiary’s medical record. PET scan facilities must keep patient record information on file for each Medicare patient for whom such a PET scan claim is made. The medical record must include standard information (e.g., age, sex, and height) along with any annotations regarding body size or type which indicate a need for a PET scan to determine the patient’s condition. Documentation containing medical necessity of procedures in addition to testing results such as images and reports must be maintained.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

N/A Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number: 1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011

LCR A2011-078

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Added new diagnosis code 414.4 for CPT codes 78459, 78491 and 78492. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28933) replaces LCD L1144 as the policy in notice. This document (L28933) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0404 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

78491 descriptor was changed in Group 1 78492 descriptor was changed in Group 1

Reason for Change