LCD L36460

Coverage Guidance

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 and

coverage 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 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:

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 necessary

for 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 process

the 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 coverage

of bone mass measurement procedures, and coverage of FDA-approved bone mass measurement techniques

and 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).

Indications and Limitations of Coverage

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.

Summary of Evidence

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Analysis of Evidence

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Bibliography

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