L29086-LCD

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Local Coverage Determination (LCD) for Bone Mineral Density Studies (L29086)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29086

LCD Title Bone Mineral Density Studies

Contractor's Determination Number 77078

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 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 13, Section 140

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 150.3

CR 3719, Transmittal 501, dated 03/11/2005

42 CFR 410.31, Bone Mass Measurement: Conditions for Coverage and Frequency Standards CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80.5 Section 1861(s)(15)and(rr)(1) of Social Security Act (the Act)

Section 1862(a)(1)(A) of the Act

CR 5521, Transmittals 69, 70 and 1236, dated 05/11/07

Indications and Limitations of Coverage and/or Medical Necessity

Bone (mineral) density studies are used to evaluate diseases of bone and/or the responses of bone diseases to treatment. The studies access bone mass or density associated with such diseases as osteoporosis, osteomalacia, and renal osteodystrophy. Various single or combined methods of measurement may be required to: (a) diagnose bone disease, (b) monitor the course of bone changes with disease progression, or (c) monitor the course of bone changes with therapy.

Covered methods for measuring bone mineral density include:

• Single energy x-ray absorptiometry (SEXA)

• Dual energy x-ray absorptiometry (DXA)

• Quantitative computed tomography (QCT)

• Bone ultrasound densitometry (BUD)

• Photodensitometry

• Radiographic absorptiometry (RA)

The following bone mass measurements are NOT covered under Medicare because they are not considered reasonable and necessary under section 1862(a)(1)(A) of the Act:

• Single photon absorptiometry (SPA), CPT code 78350 (effective 01/01/2007)

• Dual photon absorptiometry (DPA), CPT code 78351.

Bone density can be measured at the wrist, spine, hip or calcaneus. The medical literature is divided on the accuracy of predicting osteoporosis of the spine or hip by measuring peripheral sites (wrist, calcaneus). It does appear, however, that measurement of bone density of the bone involved gives a better measurement of osteoporosis than does measurement of another bone not known to be involved.

Precise calibration of the equipment is required for accuracy and to reduce variation of test results and risk of misclassification of the degree of bone density. Lack of standardization in bone mineral measurement remains an issue, and tests are best done on the same suitably precise instrument to insure accuracy. It is important to use results obtained with the same scanner when comparing a patient to a control population, as systematic differences among scanners have been found. To ensure reliability of bone mass measurements, the densitometry technologist must have proper training in performing this procedure. Malpositioning of a patient or analyzing a scan incorrectly can lead to great errors in bone mineral density studies.

Indications:

Medicare considers a bone mineral density study to be medically reasonable and necessary for the following indications. In addition, all coverage criteria listed below must be met.

1. A patient with vertebral abnormalities as demonstrated by an x-ray to be indicative of osteoporosis, osteopenia (low bone mass), or vertebral fracture.

2. A patient being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy. This service must be performed using dual energy x-ray absorptiometry system (axial skeleton) – CPT code 77080.

3. A patient with known primary hyperparathyroidism.

4. A patient receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to an average of 5.0 mg of prednisone or greater, per day, for more than 3 months.

5. A woman who has been determined by the physician or a qualified non physician practitioner treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history and other findings.

NOTE: Since not every woman who has been prescribed estrogen replacement therapy (ERT) maybe receiving an “adequate” dose of the therapy, the fact that a woman is receiving ERT should not preclude her treating physician or other qualified treating nonphysician practitioner from ordering a bone mass measurement for her. If a bone mass measurement is ordered for a woman following a careful evaluation of her medical need, however, it is expected that the ordering/treating physician (or other qualified treating nonphysician practitioner) will document in her medical record why he or she believes that the woman is estrogen-deficient and at clinical risk for osteoporosis.

An estrogen-deficient woman qualifies if she is at clinical risk for osteoporosis, based on her medical history and other findings. Unless this applies and is documented in the medical record, the service is not payable.

In addition to gender and estrogen-deficiency, pertinent factors acceptable as documentation for the clinical risk include, but are not limited to: age, family history and personal history of fractures as an adult, race, bone structure and body weight, premature menopause, lifestyle, medications, chronic diseases, and other genetic and environmental factors. Symptoms and findings of osteoporosis include, but are not limited to: back pain, loss of height, curving spine, and chest x-ray showing osteopenia.

Bone density measurement is not a covered Medicare benefit when utilized for osteoporosis screening in an estrogen-deficient woman, who has not been determined by the physician or a qualified nonphysician practitioner treating her to be at clinical risk for osteoporosis, based on her medical history and other findings.

If - in addition to gender and estrogen-deficiency - a woman has been determined to be at clinical risk for osteoporosis, based on her history and other findings, and this has been appropriately documented in the medical record, this Carrier will interpret the menopausal state as symptomatic.

COVERAGE CRITERIA FOR BONE MASS MEASUREMENTS:

1. There must be an order by the individual’s physician or qualified nonphysician practitioner treating the patient following an evaluation of the need for a measurement, including a determination as to the medically appropriate measurement to be used for the individual. A physician or qualified nonphysician practitioner treating the beneficiary for purposes of this provision is one who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the patient. For the purpose of the bone mass measurement benefit, qualified nonphysician practioners include physician assistants, nurse practioners, clinical nurse specialists and certified nurse midwives.

2. This service must be furnished by a qualified supplier or provider of such services under the appropriate level of physician supervision as defined in CFR 410.32(b);

3. This service must be reasonable and necessary for diagnosing, treating, or monitoring a qualified individual as defined above; and

4. This service is a radiologic or radioisotopic procedure which must be performed with a bone densitometer or a bone sonometer system cleared for marketing by the FDA, under 21 CFR part 807 or approved for marketing under 21 CFR part 814 for identifying bone mass or detecting bone loss or determining bone quality, with the exception of dual photon absorptiometry devices.

FREQUENCY STANDARDS

Medicare may cover a bone mass measurement for a patient once every 2 years. However, if medically necessary, Medicare may cover a bone mass measurement for a patient more frequently than every 2 years. Examples of situations where more frequent bone mass measurements procedures may be medically necessary include, but are not limited to, the following medical circumstances:

• Monitoring patients on long-term glucocorticoid (steroid) therapy of more than 3 months; and

• In the case of any individual who meets the conditions as defined above, and who has a confirmatory BMM, is performed by a dual-energy x-ray absorptiometry system (axial skeleton) if the initial BMM was not performed by a dual-energy x-ray absorptiometry system (axial skeleton). A confirmatory baseline BMM is not covered if the initial BMM was performed by a dual-energy x-ray absorptiometry system (axial skeleton).

• Monitoring a patient to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy if the result is being used to determine the need for continued treatment of osteoporosis. Agents approved by the FDA for osteoporosis prevention and/or treatment include:

o estrogen therapy (for purposes of this policy, the estrogen must be specifically used for treatment of osteoporosis)

o alendronate (Fosamax)

o calcitonin-salmon (Miacalcin-nasal spray or injection) o raloxifene (Evista)

o risedronate (Actonel)

o teriparatide (Forteo) injection o ibandronate (Boniva)

o zoledronic acid (Reclast) injection o denosumab (Prolia)

• To determine a patient’s response to pharmacologic therapy when the therapy has been changed to another family of therapeutic agents

Limitations

Vertebral fracture assessment (CPT code 77082) is not within the scope of this LCD and is, therefore, subject to individual consideration.

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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

* Effective for dates of service on or after 01/01/2007, dual-energy x-ray absorptiometry (CPT code 77080) must be performed when monitoring osteoporosis drug therapy.

76977 ULTRASOUND BONE DENSITY MEASUREMENT AND INTERPRETATION, PERIPHERAL SITE(S), ANY METHOD

77078 COMPUTED TOMOGRAPHY, BONE MINERAL DENSITY STUDY, 1 OR MORE SITES; AXIAL SKELETON (EG, HIPS, PELVIS, SPINE)

77080 DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA), BONE DENSITY STUDY, 1 OR MORE SITES; AXIAL SKELETON (EG, HIPS, PELVIS, SPINE)

77081 DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA), BONE DENSITY STUDY, 1 OR MORE SITES; APPENDICULAR SKELETON (PERIPHERAL) (EG, RADIUS, WRIST, HEEL)

G0130 SINGLE ENERGY X-RAY ABSORPTIOMETRY (SEXA) BONE DENSITY STUDY, ONE OR MORE SITES; APPENDICULAR SKELETON (PERIPHERAL) (EG, RADIUS, WRIST, HEEL)

ICD-9 Codes that Support Medical Necessity

252.00 - 252.08 HYPERPARATHYROIDISM, UNSPECIFIED - OTHER HYPERPARATHYROIDISM

255.0* CUSHING'S SYNDROME

256.2 POSTABLATIVE OVARIAN FAILURE

256.31 - 256.39 PREMATURE MENOPAUSE - OTHER OVARIAN FAILURE

627.2 SYMPTOMATIC MENOPAUSAL OR FEMALE CLIMACTERIC STATES

627.4 SYMPTOMATIC STATES ASSOCIATED WITH ARTIFICIAL MENOPAUSE

733.1 * OSTEOPOROSIS UNSPECIFIED

733.2 * SENILE OSTEOPOROSIS

733.3 * IDIOPATHIC OSTEOPOROSIS

733.4 * DISUSE OSTEOPOROSIS

733.09* OTHER OSTEOPOROSIS

733.90* DISORDER OF BONE AND CARTILAGE UNSPECIFIED

805.00 - 805.9 CLOSED FRACTURE OF CERVICAL VERTEBRA UNSPECIFIED LEVEL - OPEN FRACTURE OF UNSPECIFIED PART OF VERTEBRAL

806.00 - 806.9 COLUMN WITHOUT SPINAL CORD INJURY CLOSED FRACTURE OF C1-C4 LEVEL WITH UNSPECIFIED SPINAL CORD INJURY - OPEN FRACTURE OF UNSPECIFIED VERTEBRA WITH SPINAL CORD INJURY

* Effective for dates of service on or after 01/01/07, procedure codes G0130, 77078,77081, and 76977 will be denied when billed with these ICD-9-CM codes.

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 maintained by the ordering/referring physician/qualified nonphysician practitioner must indicate the medical necessity for performing the test and interpretation of the test results. In addition, if the service exceeds the frequency parameter listed in this policy, documentation of medical necessity must be submitted. This information is usually found in the history and physical, office/progress notes, or test results.

If the provider of the service is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain a copy of test results and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the studies. The clinical indication/medical necessity for the study must be indicated in the order for the test.

Documentation should support the criteria for coverage as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy and should reflect how the results of this test will be used in the patient’s plan of care.

Appendices

Utilization Guidelines

Medicare may cover a bone mass measurement for a patient once every 2 years (after 23 months have elapsed since the last test). However, if medically necessary, Medicare may cover a bone mass measurement for a patient more frequently than every 2 years.

Examples of situations where more frequent (once a year/after 11 months have elapsed since the last test) bone mass measurements procedures may be medically necessary include, but are not limited to, the following medical circumstances:

• Monitoring patients receiving glucocorticoid (steroid) therapy equivalent to an average of 5.0 mg of prednisone or greater, per day, for more than 3 months

• Monitoring a patient to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy if the result is being used to determine the need for continued treatment of osteoporosis. This service must be performed using dual-energy x-ray absorptiometry. Agents approved by the FDA for osteoporosis prevention and/or treatment include:

o estrogen therapy (for purposes of this policy, the estrogen must be specifically used for treatment of osteoporosis)

o alendronate (Fosamax)

o calcitonin-salmon (Miacalcin-nasal spray or injection) o raloxifene (Evista)

o risedronate (Actonel)

o teriparatide (Forteo) injection o ibandronate (Boniva)

o zoledronic acid (Reclast) injection o denosumab (Prolia)

• To determine a patient’s response to pharmacologic therapy when the therapy has been changed to another family of therapeutic agents.

Note: A bone mineral density study code should be billed only once regardless of the number of sites being tested or included in the study ( i.e., if the spine and hip are performed as part of the same study only one can be billed).

Sources of Information and Basis for Decision

Banks, Linda M. (2001) Dual Energy X-ray absorptiometry (DXA). R. G. Grainger, D. Allison, A. Adams and A. Dixon (Eds.), Diagnostic Radiology: A Textbook of Medical Imaging, 4th ed (pp. 185-186). Churchill Livingstone, Inc, London.

Harris, Edward D., Budd, Ralph C., Genovese, Mark C., Firestein, Gary S. Sargent, John S., Clement, Seldge B. Kelly’s Textbook of Rheumatology, 7th ed (pp1458-59 & 1474-85). Elseiver Science, 2005 Philadelphia.

Lewiecki, E. Michael, Watts, Nelson B., McClung, Michael R., et al (2004). Journal of Clinical Endocrinology and Metabolism, 89(8), 3651-55

Plotnikoff, Gregory A. and Norling, Sharon (2003). Osteoporosis. Rakel (Ed), Integrative Medicine, 1st ed. (pp 247-254). W.B. Saunders, Philadelphia

U.S. Preventative Services Task Force. (2002). Screening for osteoporosis in postmenopausal women: recommendations and rationale. American Family Physician, 66(8), 1430-1432.

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 LC 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 08/01/2010

Revision History Number 3

Revision History Explanation Revision Number:3 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012

LCR B2012-011

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. CPT codes 77079 and 77083 were deleted. The effective date of this revision is based on date of service.

Revision Number 2

Start Date of Comment Period:N/A Start Date of Notice Period:08/01/2010 Revised Effective Date: 07/13/2010

LCR B2010-055

July 2010 Update

Explanation of Revision: The ‘Frequency Standards’ and ‘Utilization Guidelines’ sections of the LCD have been revised to add denosumab (Prolia) to the list of agents approved by the FDA for osteoporosis prevention and/or treatment. The effective date of this revision is for claims processed on or after 07/13/2010 for dates of service on or after 06/01/2010.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:03/01/2009 Revised Effective Date: 03/19/2009

LCR B2009-051

March 2009 Update

Explanation of Revision: The ‘Frequency Standards’ and ‘Utilization Guidelines’ sections of LCD have been revised to add zoledronic acid (Reclast) injection to the list of agents approved by the FDA for osteoporosis prevention and/or treatment. 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:02/02/2009

LCR B2009-044FL LCR B2009-045PR/VI

December 2008 Bulletin

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

For Florida (00590) this LCD (L29086) replaces LCD L5829 as the policy in notice. This document (L29086) is effective on 02/02/2009.

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:

77078 descriptor was changed in Group 1 77079 descriptor was changed in Group 1 77080 descriptor was changed in Group 1

11/21/2011 - The following CPT/HCPCS codes were deleted: 77079 was deleted from Group 1

77083 was deleted from Group 1

Reason for Change