Bone Mass Measurement

LCD Information Document Information Source LCD ID N/A LCD ID L36460 Original ICD-9 LCD ID Not Applicable LCD Title Bone Mass Measurement Proposed LCD in Comment Period N/A Source Proposed LCD DL36460 Opens in a new window Original Effective Date For services performed on or after 02/01/2016 Revision Effective Date For services performed on or after 01/04/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 12/17/2015 Notice Period End Date 01/31/2016 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. 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. CPT is a registered trademark of the American Medical Association. 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Issue Issue Description No changes, annual review was completed. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations(NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs andcoverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD)Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judgemay 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 CMSsources:Title XVIII of the Social Security Act (SSA):Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessaryfor the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to processthe claim.Section 1861(r) provides the definition of a physician.Section 1861(s)(2)(V)(15) includes bone mass measurement as a physician service.Section 1861(rr) provides the definition of bone mass measurement.Code of Federal Regulations:Title IV of the Balanced Budget Act of 1997, Section 4106 includes language providing for Medicare coverageof bone mass measurement procedures, and coverage of FDA-approved bone mass measurement techniquesand equipment for "qualified" individuals. These procedures are only covered when medically necessary.CMS Publications:CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15:80.5 Bone Mass Measurements (BMMs)CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1:150.3 Bone (Mineral) Density Studies (Effective January 1, 2007)CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 13:140 Bone Mass Measurements (BMMs). Coverage Indications, Limitations, and/or Medical Necessity Bone mass measurement (BMM) studies are radiologic, radioisotopic or other procedures that meet all of thefollowing conditions: quantify bone mineral density, Mdetect bone loss or determine bone quality; are performed with either a bone densitometer (other than single-photon or dual-photonabsorptiometry) or a bone sonometer system that has been cleared for marketing for BMM by the Foodand Drug Administration (FDA) under 21 CFR part 807, or approved for marketing under 21 CFR part814. include a physician's interpretation of the results. The following procedures are used to measure bone mineral density: dual energy x-ray absorptiometry (DXA) radiographic absorptiometry (RA); bone sonometry (ultrasound); single energy x-ray absorptiometry; (SEXA), quantitative computed tomography (QCT). Indications:Medicare will cover a bone mass measurement test when it meets all of the following criteria: 1. It is performed with one of the covered tests listed above.2. It is performed on a qualified individual for the purpose of identifying bone mass, detecting bone loss ordetermining bone quality. The term "qualified individual" means an individual who meets the medicalindications for at least one of the five categories listed below: ° A woman who has been determined by the physician or a qualified nonphysician practitionertreating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medicalhistory and other findings;° An individual with vertebral abnormalities as demonstrated by an x-ray to be indicative ofosteoporosis, osteopenia (low bone mass), or vertebral fracture;° An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to 5mg of prednisone, or greater, per day, for more than three (3) months;° An individual with primary hyperparathyroidism;° An individual being monitored to assess the response to or efficacy of an FDA-approvedosteoporosis drug therapy. 3. It is furnished by a qualified supplier or provider of such services under at least the general level ofsupervision of a physician as defined in 42 CFR 410.32(b).4. The test is ordered by the individual's physician or qualified non-physician practitioner, who is treatingthe beneficiary following an evaluation of the need for the measurement, including a determination asto the medically appropriate measurement to be used for the individual, and who uses the results in themanagement of the patient.5. The test is reasonable and necessary for diagnosing, treating, or monitoring of a "qualified individual"as defined above in #2. Monitoring is defined as subsequent testing in patients on FDA-approved drugtherapy.6. Medicare may cover a bone mass measurement for a beneficiary once every 2 years (if at least 23months have passed since the month the last bone mass measurement was performed).7. For conditions specified, Medicare will cover a bone mass measurement for a qualified beneficiarymore frequently than every two years, if medically necessary for the diagnosis or treatment of thepatient and if related to the condition listed. In these instances payment may be made for testsperformed after eleven months have elapsed since the previous bone mass measurement test.Examples include, but are not limited to, the following medical circumstance: ° Monitoring beneficiaries on long-term glucocorticoid ( 5 mg/day) therapy of more than 3months (patients must be on glucocorticoids for greater than three months duration, but BMMmonitoring is at yearly intervals). ° Confirming baseline BMMs to permit monitoring of beneficiaries in the future.In addition, bone mass measurement for the following may be reimbursed more frequently thanevery two years:° Follow up bone mineral density testing to assess FDA-approved osteoporosis drug therapy untila response to such therapy has been documented over time. 8. A confirmatory baseline BMM is only covered when it is performed with a dual-energy x-rayabsorptiometry system (axial skeleton) and the initial BMM was not performed by a dual-energy x-rayabsorptiometry system (axial skeleton).A confirmatory baseline BMM is not covered if the initial BMM was performed by a dual-energy x-rayabsorptiometry system (axial skeleton).9. For an individual being monitored to assess the response to, or efficacy of, an FDA-approvedosteoporosis drug therapy, the test is only covered if it is performed with a dual-energy x-rayabsorptiometry system (axial skeleton).10. The test must include a physician's interpretation of the results.11. Since not every woman who has been prescribed estrogen replacement therapy (ERT) may be receivingan "adequate" dose of the therapy, the fact that a woman is receiving ERT should not preclude hertreating physician/other qualified nonphysician practitioner from ordering a bone mass measurementtest for her. If a bone mass measurement test is ordered for a woman following a careful evaluation ofher medical need, it is expected that the ordering/treating physician/qualified non-physician practitionerwill document, why he or she believes that the woman is estrogen deficient and at clinical risk forosteoporosis. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A

Bone mass measurement (BMM) studies are radiologic, radioisotopic or other procedures that meet all of the following conditions: quantify bone mineral density, M detect bone loss or determine bone quality ; are performed with either a bone densitometer (other than single-photon or dual-photon absorptiometry) or a bone sonometer system that has been cleared for marketing for BMM by the Food and Drug Administration (FDA) under 21 CFR part 807, or approved for marketing under 21 CFR part 814. include a physician's interpretation of the results. The following procedures are used to measure bone mineral density: dual energy x-ray absorptiometry (DXA) radiographic absorptiometry (RA); bone sonometry (ultrasound); single energy x-ray absorptiometry; (SEXA), quantitative computed tomography (QCT). Indications: Medicare will cover a bone mass measurement test when it meets all of the following criteria: 1. It is performed with one of the covered tests listed above. 2. It is performed on a qualified individual for the purpose of identifying bone mass, detecting bone loss or determining bone quality. The term "qualified individual" means an individual who meets the medical indications for at least one of the five categories listed below: ° A woman who has been determined by the physician or a qualified nonphysician practitioner treating her to be estrogen-deficient and at clinical risk for osteoporosis, based on her medical history and other findings; ° An individual with vertebral abnormalities as demonstrated by an x-ray to be indicative of osteoporosis, osteopenia (low bone mass), or vertebral fracture; ° An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to 5 mg of prednisone, or greater, per day, for more than three (3) months; ° An individual with primary hyperparathyroidism; ° An individual being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy. 3. It is furnished by a qualified supplier or provider of such services under at least the general level of supervision of a physician as defined in 42 CFR 410.32(b). 4. The test is ordered by the individual's physician or qualified non-physician practitioner, who is treating the beneficiary following an evaluation of the need for the measurement, including a determination as to the medically appropriate measurement to be used for the individual, and who uses the results in the management of the patient. 5. The test is reasonable and necessary for diagnosing, treating, or monitoring of a "qualified individual" as defined above in #2. Monitoring is defined as subsequent testing in patients on FDA-approved drug therapy. 6. Medicare may cover a bone mass measurement for a beneficiary once every 2 years (if at least 23 months have passed since the month the last bone mass measurement was performed). 7. For conditions specified, Medicare will cover a bone mass measurement for a qualified beneficiary more frequently than every two years, if medically necessary for the diagnosis or treatment of the patient and if related to the condition listed. In these instances payment may be made for tests performed after eleven months have elapsed since the previous bone mass measurement test. Examples include, but are not limited to, the following medical circumstance: ° Monitoring beneficiaries on long-term glucocorticoid ( 5 mg/day) therapy of more than 3 months (patients must be on glucocorticoids for greater than three months duration, but BMM monitoring is at yearly intervals). ° Confirming baseline BMMs to permit monitoring of beneficiaries in the future. In addition, bone mass measurement for the following may be reimbursed more frequently than every two years: ° Follow up bone mineral density testing to assess FDA-approved osteoporosis drug therapy until a response to such therapy has been documented over time. 8. A confirmatory baseline BMM is only covered when it is performed with a dual-energy x-ray absorptiometry system (axial skeleton) and 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). 9. For an individual being monitored to assess the response to, or efficacy of, an FDA-approved osteoporosis drug therapy, the test is only covered if it is performed with a dual-energy x-ray absorptiometry system (axial skeleton). 10. The test must include a physician's interpretation of the results. 11. Since not every woman who has been prescribed estrogen replacement therapy (ERT) may be receiving an "adequate" dose of the therapy, the fact that a woman is receiving ERT should not preclude her treating physician/other qualified nonphysician practitioner from ordering a bone mass measurement test for her. If a bone mass measurement test is ordered for a woman following a careful evaluation of her medical need, it is expected that the ordering/treating physician/qualified non-physician practitioner will document, why he or she believes that the woman is estrogen deficient and at clinical risk for osteoporosis.