Summary Of Evidence

A 2018 systematic review for the U.S. Preventive Services Task Force (USPSTF) evaluated the evidence on screening for osteoporosis. The review considered centrally measured DXA to be the reference standard against which other screening measures were evaluated. Randomized controlled trials (RCTs) included in the systematic review have shown that osteoporosis medications are effective at reducing fracture risk in postmenopausal women with bone mineral density (BMD) in the osteoporotic range identified by central DXA. A noted limitation of the review was that treatment studies relied on DXA BMD scores to enroll participants into trials and that risk factors beyond bone density, such as bone quality, contribute to osteoporotic fractures. Therefore, “approaches that rely on BMD measurement wholly or in part may not be the most accurate approaches for identifying patients at highest risk for osteoporotic fractures."

For individuals who are eligible for screening of BMD based on risk factor assessment who receive DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of RCTs and cohort studies. Relevant outcomes are morbid events, functional outcomes, quality of life (QOL), hospitalizations, and medication use. Central DXA is the most widely accepted method for measuring BMD and is the reference standard against which other screening tests are evaluated. BMD measurements with central DXA identify individuals at increased risk of fracture, and osteoporosis medications reduce fracture risk in the population identified as osteoporotic by central DXA. Therefore, test results with initial central DXA can be used to guide therapy. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals without osteoporosis on initial screen who receive repeat DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of large cohort and observational studies. Relevant outcomes are morbid events, functional outcomes, QOL, hospitalizations, and medication use. Little research has been done on the frequency of BMD monitoring for osteoporosis. The available research has evaluated repeat measurement with central DXA. Evidence on whether repeat measurements add to risk prediction compared with a single measurement is mixed. Although the optimal interval may differ depending on risk factors, current evidence does not support repeat monitoring in patients with BMD on DXA in the normal range. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Although the evidence is limited, multiple clinical practice guidelines recommend repeat DXA in 3-5 years in patients at low-risk using risk factor assessment. Similarly, multiple guidelines recommend a repeat screening interval of 1-2 years for high-risk individuals and in individuals with a baseline evaluation near a fracture intervention threshold (osteopenia).

For individuals who are receiving pharmacologic treatment for osteoporosis who receive repeat DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of RCTs and observational studies. Relevant outcomes are morbid events, functional outcomes, QOL, hospitalizations, and medication use. There is no high-quality evidence to guide how often to monitor BMD during osteoporosis treatment. Within-person variation in measurement may exceed treatment effects, and fracture risk has been shown to be reduced in some treatment studies in the absence of changes in BMD. Together, these results suggest that frequent (i.e., every 2 years) repeat monitoring has low value. It is unclear whether DXA at the end of the initial 5 years of therapy is sufficiently accurate to guide subsequent therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Although the evidence is limited, multiple clinical practice guidelines recommend repeat DXA at intervals of 1-3 years to monitor treatment response in patients who are receiving pharmacological treatment for osteoporosis, or after a change in, or cessation of treatment.

For individuals who are eligible for screening of BMD based on risk factor assessment who receive ultrasound densitometry, or quantitative computed tomography, or DXA analysis of peripheral sites, the evidence includes observational studies and systematic reviews. Relevant outcomes are morbid events, functional outcomes, QOL, hospitalizations, and medication use. In comparison with central DXA, other measures of bone health showed area under the curves around 0.80 for the identification of osteoporosis. These technologies are not commonly used for BMD measurements in practice, and no studies have shown that they can select patients who benefit from treatment for osteoporosis. There is little to no evidence on the usefulness of repeat measurement of BMD using these techniques. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Analysis of Evidence

Coverage of Bone Mass Measurement is largely outlined in the Medicare Benefits Policy Manual IOM Pub 100-02 Chapter 15, Section 80.5. The information in this LCD further outlines coverage for these services utilizing the latest evidence and guidelines available.

Bone mass measurement (BMM) studies are radiologic, radioisotopic or other procedures that meet all of the following conditions:

• quantify bone mineral density, 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); and
• 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 1 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 1 of the 5 categories listed below:

• 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;
• 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 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 2 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 11 months have elapsed since the previous bone mass measurement test. Examples include, but are not limited to, the following medical circumstance(s):

• Monitoring beneficiaries on long-term glucocorticoid (5 mg/day) therapy of more than 3 months (patients must be on glucocorticoids for greater than 3 months duration, but BMM monitoring is at yearly intervals).
• Confirming baseline BMMs to permit monitoring of beneficiaries in the future.

In addition, BMM for the following may be reimbursed more frequently than every 2 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 non-physician 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.