L28764-LCD

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Local Coverage Determination (LCD) for Bone and/or Joint Imaging (L28764)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28764

LCD Title Bone and/or Joint Imaging

Contractor's Determination Number A78300

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. 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

Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Bone and/or joint imaging, also known as a bone scan, skeletal scintigraphy, or a radionuclide bone scan is a nuclear medicine study utilizing an intravenous injection of a technetium-99m phosphonate radiopharmaceutical which localizes in bone with intensity proportional to the degree of metabolic activity present. This diagnostic study records the distribution of this radioactive tracer in the skeletal system in planar (two-dimensional) and/or tomographic (three-dimensional) images normally 2-4 hours after the injection of the radiopharmaceutical agent.

A whole body bone scan produces planar images of the skeleton including anterior and posterior views of the axial skeleton. Anterior and/or posterior views of the appendicular skeleton are also obtained. Additional views may be obtained as needed. The limited bone scan records images of only a portion of the skeleton.

Bone single photon emission computed tomography (SPECT) produces a tomographic image of a portion of the skeleton. This technique increases diagnostic accuracy by improving sensitivity, providing more precise localization of the radiopharmaceutical, and allowing improved visualization of subtle abnormalities.

Three-phase imaging, also known as multiphase bone scintigraphy consists of blood flow images, immediate images and delayed images and is utilized to distinguish skeletal from soft-tissue infection. The blood flow images consist of a dynamic sequence of planar images of the area of greatest interest obtained as the tracer is injected. The immediate (blood pool) images consist of one or more static planar images of the areas of interest, obtained within 10 minutes after injection of the tracer. Delayed images may be limited to the areas of interest or may include the whole body, may be planar or tomographic, and are usually acquired 2 to 5 hours after injection. Further additional images obtained up to 24 hours following the tracer injection may be obtained if necessary.

Florida Medicare will consider bone and/or joint imaging medically reasonable and necessary for the following indications:

• Extraskeletal primary malignancies for the presence of metastatic disease. The application of imaging in these patients include initial staging, protocol monitoring in response to chemotherapy and decision to change therapy, radiation therapy for treatment field planning and response to radiation therapy, and detection of areas at risk for pathological fracture.

• Primary malignant bone tumors when metastasis is suspected. Normally, plain radiographs, CT and MRI are a better diagnostic test to portray the tumor margins in bone and allow assessment of soft tissue extent. However, a whole body scan is appropriate to assess osseous metastasis.

• Benign bone tumors including osteoid osteomas, osteochondromas, chondroblastomas and enchondromas.

• Skeletal trauma to evaluate the presence of occult fractures when the initial standard radiographic procedure is normal and the clinical presentation is highly suspicious of fracture.

• Assessing the full extent of injury in patients with multiple injuries.

• Athletic injuries to evaluate for stress fractures and shin splints.

• Determine bone viability in infarction, osteonecrosis, and grafts.

• Osteomyelitis. The evaluation of osteomyelitis is performed utilizing the triple-phase bone scan. This technique is used to differentiate osteomyelitis from cellulitis.

• Diagnosis and evaluation of musculoskeletal infections to rule out bone involvement. A triple-phase bone scan is utilized for this indication.

• Metabolic bone disease such as osteoporosis and Paget’s Disease when the results of the bone scan will be used to guide treatment.

• Diagnosis and evaluation of reflex sympathetic dystrophy. The evaluation of reflex sympathetic dystrophy is performed utilizing the triple-phase bone scan.

• Evaluate a prosthetic joint for loosening or infection.

• Unexplained musculoskeletal pain when the initial standard radiographic procedure fails to determine the etiology and a musculoskeletal etiology is suspected.

• Evaluation of abnormal radiographic findings or abnormal laboratory findings demonstrating skeletal involvement.

• Determine the distribution of osteoblastic activity prior to therapy with strontium-89.

Note: as indicated above, the triple-phase bone scan is normally utilized to evaluate, but not limited to: osteomyelitis; diagnose and evaluate musculoskeletal infections to rule out bone involvement; and to diagnose and evaluate reflex sympathetic dystrophy. Therefore, it is expected that this technique is utilized to evaluate these conditions.

Skeletal scintigraphy is a sensitive marker of both osteoarthritis and rheumatoid arthritis. Numerous attempts have been made over the last two decades to develop scintigraphic techniques for staging the severity of arthritis and assessing response to therapy. These have been largely unsuccessful, and skeletal scintigraphy, although not common, may be used to evaluate arthritis in current clinical practice.

It is expected that a whole body scan (procedure code 78306) is performed only when an evaluation of the entire skeletal system is necessary, such as the evaluation for metastatic disease, or for the evaluation of localized pain of unknown etiology. A limited or muliple area body scan is medically necessary when the patient’s signs, symptoms, or condition is limited to a certain body area. For example, it is expected that a limited bone scan be performed on patients with a stress fracture of the foot. A multiple area body scan is necessary in conditions in which more than one body area is affected, however, a total assessment of the skeletal system is not needed. A triple-phase body scan is medically necessary for the assessment of the skeletal system to differentiate a skeletal infection versus a soft tissue infection.

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

014x Hospital - Laboratory Services Provided to Non-patients

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.

0341 Nuclear Medicine - Diagnostic

CPT/HCPCS Codes

78300 BONE AND/OR JOINT IMAGING; LIMITED AREA

78305 BONE AND/OR JOINT IMAGING; MULTIPLE AREAS

78306 BONE AND/OR JOINT IMAGING; WHOLE BODY

78315 BONE AND/OR JOINT IMAGING; 3 PHASE STUDY

78320 BONE AND/OR JOINT IMAGING; TOMOGRAPHIC (SPECT)

ICD-9 Codes that Support Medical Necessity N/A

XX000 Not Applicable

Diagnoses that Support Medical Necessity N/A

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

XX000 Not Applicable

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation must clearly indicate the medical necessity of the service being billed. In addition, the documentation must support that the service was performed. This information is normally found in the office/progress notes, hospital records, and test results.

If the provider of the service is other than the ordering/referring provider, the provider of the service must maintain documentation of the test results and interpretation, along with copies of the ordering/referring provider’s order for the studies. The ordering/referring provider must state the reason for the study in the order for the test.

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

Greenspan, A., & Tehranzadeh, J. (2001). Imaging of musculoskeletal and spinal infections: Imaging of infectious arthritis. Radiologic Clinics of North America, 39(2). Retrieved October 14, 2002 from MD Consult database on

the World Wide Web: http://home.mdconsult.com. Used to support the use of bone scans for musculoskeletal infections.

Michota, F. A. (2001). Diagnostic Procedures Handbook (2nd ed.). Cleveland, OH: Lexi-Comp Inc. Used to support the indications for coverage.

Noble, J. (2001). Textbook of primary care medicine (3rd ed.). St Louis: Mosby, Inc. Supported the use of a triple

-phase bone scan for reflex sympathetic dystrophy.

Thrall, J. H., & Ziessman, H. A. (2001). Nuclear medicine: The requisites (2nd ed.). St Louis: Mosby. Supported the indications identified in the policy.

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 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 Original

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

Start Date of Notice Period: 12/04/2008 Original 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 (L28764) replaces LCD L13768 as the policy in notice. This document (L28764) 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 14 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 0341 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: 78300 descriptor was changed in Group 1 78305 descriptor was changed in Group 1 78306 descriptor was changed in Group 1 78315 descriptor was changed in Group 1

Reason for Change