Summary Of Evidence

N/A

Analysis of Evidence

N/A

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