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.
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 sodium (Actonel/Atelvia)
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
Vertebral fracture assessment (Procedure code 77086) is not within the scope of this LCD and is, therefore, subject to individual consideration.