[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR410.31]

[Page 334-335]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of 
Contents
 
               Subpart B_Medical and Other Health Services
 
Sec.  410.31  Bone mass measurement: Conditions for coverage and 
frequency standards.

    (a) Definition. As used in this section unless specified otherwise, 
the following definition applies:
    Bone mass measurement means a radiologic, radioisotopic, or other 
procedure that meets the following conditions:
    (1) Is performed for the purpose of identifying bone mass, detecting 
bone loss, or determining bone quality.
    (2) Is performed with either a bone densitometer (other than single-
photon or dual-photon absorptiometry) or with a bone sonometer system 
that has been cleared for marketing for this use by the FDA under 21 CFR 
part 807, or approved for marketing by the FDA for this use under 21 CFR 
part 814.
    (3) Includes a physician's interpretation of the results of the 
procedure.
    (b) Conditions for coverage. (1) Medicare covers a medically 
necessary bone mass measurement if the following conditions are met:
    (i) Following an evaluation of the beneficiary's need for the 
measurement, including a determination as to the medically appropriate 
procedure to be used for the beneficiary, it is ordered by the physician 
or a qualified nonphysician practitioner (as these terms are defined in 
Sec.  410.32(a)) treating the beneficiary.
    (ii) It is performed under the appropriate level of supervision of a 
physician (as set forth in Sec.  410.32(b)).
    (iii) It is reasonable and necessary for diagnosing and treating the 
condition of a beneficiary who meets the conditions described in 
paragraph (d) of this section.
    (2) Medicare covers a medically necessary bone mass measurement for 
an individual defined under paragraph (d)(5) of this section if the 
conditions under paragraph (b)(1) of this section are met and the 
monitoring is performed by the use of a dual energy x-ray absorptiometry 
system (axial skeleton).
    (3) Medicare covers a medically necessary confirmatory baseline bone 
mass measurement for an individual defined under paragraph (d) of this 
section, if the conditions under paragraph (b)(1) of this section are 
met and the confirmatory baseline bone mass measurement is performed by 
a dual energy x-ray absorptiometry system (axial skeleton) and the 
initial measurement was not performed by a dual energy x-ray 
absorptiometry system (axial skeleton).
    (c) Standards on frequency of coverage--(1) General rule. Except as 
allowed under paragraph (c)(2) of this section, Medicare may cover a 
bone mass measurement for a beneficiary if at least 23 months have 
passed since the month the last bone mass measurement was performed.

[[Page 335]]

    (2) Exception. If medically necessary, Medicare may cover a bone 
mass measurement for a beneficiary more frequently than allowed under 
paragraph (c)(1) of this section. Examples of situations where more 
frequent bone mass measurement procedures may be medically necessary 
include, but are not limited to the following medical circumstances:
    (i) Monitoring beneficiaries on long-term glucocorticoid (steroid) 
therapy of more than 3 months.
    (ii) Allowing for a confirmatory baseline measurement to permit 
monitoring of beneficiaries in the future if the requirements of 
paragraph (b)(3) of this section are met.
    (d) Beneficiaries who may be covered. The following categories of 
beneficiaries may receive Medicare coverage for a medically necessary 
bone mass measurement:
    (1) 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.
    (2) An individual with vertebral abnormalities as demonstrated by an 
x-ray to be indicative of osteoporosis, osteopenia, or vertebral 
fracture.
    (3) An individual receiving (or expecting to receive) glucocorticoid 
(steroid) therapy equivalent to an average of 5.0 mg of prednisone, or 
greater, per day for more than 3 months.
    (4) An individual with primary hyperparathyroidism.
    (5) An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.
    (e) Denial as not reasonable and necessary. If CMS determines that a 
bone mass measurement does not meet the conditions for coverage in 
paragraphs (b) or (d) of this section, or the standards on frequency of 
coverage in paragraph (c) of this section, it is excluded from Medicare 
coverage as not ``reasonable'' and ``necessary'' under section 
1862(a)(1)(A) of the Act and Sec.  411.15(k) of this chapter.
    (f) Use of the National Coverage Determination Process. For the 
purposes of paragraphs (b)(2) and (b)(3) of this section, CMS may 
determine through the National Coverage Determination process that 
additional bone mass measurement systems are reasonable and necessary 
under section 1862(a)(1) of the Act for monitoring and confirming 
baseline bone mass measurements.

[71 FR 69783, Dec. 1, 2006]