[Federal Register Volume 63, Number 121 (Wednesday, June 24, 1998)]
[Rules and Regulations]
[Pages 34320-34328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 410

[HCFA-3004-IFC]
RIN 0938-AI89


Medicare Program; Medicare Coverage of and Payment for Bone Mass 
Measurements

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period provides for 
uniform coverage of, and payment for, bone mass measurements for 
certain Medicare beneficiaries for services furnished on or after July 
1, 1998. It implements provisions in section 4106(a) of the Balanced 
Budget Act of 1997.

DATES: Effective date: These regulations are effective on July 1, 1998.
    Comment date: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on August 
24, 1998.

ADDRESSES: Mail an original and 3 copies of written comments to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-3004-IFC, P.O. Box 26585, 
Baltimore, MD 21207-0385.
    If you prefer, you may deliver an original and 3 copies of your 
written comments to one of the following addresses: Room 309-G, Hubert 
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 
20201, or Room C5-09-26, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850.
    Comments may also be submitted electronically to the following e-
mail address: HCFA<a href="/cdn-cgi/l/email-protection#8fbcbfbfbbe6e9eccfe7ece9eea1e8e0f9"><span class="__cf_email__" data-cfemail="390a09090d505f5a79515a5f58175e564f">[email protected]</span></a>. For e-mail and comment procedures, 
see the beginning of SUPPLEMENTARY INFORMATION. For information on 
ordering copies of the Federal Register containing this document and on 
electronic access, see the beginning of SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: William Larson, (410) 786-4639. 
(Conditions for Coverage, and Frequency Standards) William Morse, (410) 
786-4520. (Physician Fee Schedule Payments)

SUPPLEMENTARY INFORMATION: E-mail comments must include the full name 
and address of the sender, and must be submitted to the referenced 
address in

[[Page 34321]]

order to be considered. All comments must be incorporated in the e-mail 
message because we may not be able to access attachments. 
Electronically submitted comments will be available for public 
inspection at the Independence Avenue address, below. Because of 
staffing and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission. In commenting, please refer to file code 
HCFA-3004-IFC. Comments received timely will be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, in Room 309-G of the 
Department's offices at 200 Independence Avenue, SW., Washington, D.C., 
on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: 
(202) 690-7890).
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password required). Dial-in users should use communications software 
and modem to call (202) 512-1661; type swais, then login as guest (no 
password required). For general information about GPO Access, contact 
the GPO Access User Support Team by sending Internet e-mail to 
<a href="/cdn-cgi/l/email-protection#b6ded3dac6f6d3dfd2c5868398d3dfd2c5d1c6d998d1d9c0"><span class="__cf_email__" data-cfemail="acc4c9c0dcecc9c5c8df9c9982c9c5c8dfcbdcc382cbc3da">[email protected]</span></a>; by faxing to (202) 512-1262; or by calling 
(202) 512-1530 between 7 a.m. and 5 p.m. Eastern time, Monday through 
Friday, except for Federal holidays.

I. Background

A. Current Medicare Coverage

    In general, bone mass measurements, using bone mineral 
densitometers and bone sonometers, are considered to be the most 
valuable objective indicator of the risk of fracture and/or 
osteoporosis. The clinical use of these devices is based on the 
assumption that bone mass is an important determinant of osteoporotic 
fractures, and that bone mass measurements may help reduce the number 
of fractures by identifying high-risk individuals, who can then receive 
appropriate preventive measures. Because osteoporosis is generally 
considered preventable, but not reversible, we believe that early 
detection of at-risk individuals is a desirable health outcome.
    Before the enactment of the Balanced Budget Act of 1997 (BBA), 
Medicare coverage of bone mass measurements and the related physician 
interpretation of those procedures were available for some 
beneficiaries under sections 1861(s)(1) and (s)(3) of the Social 
Security Act (the Act). Section 1861(s)(1) of the Act provides for 
general Medicare coverage of physician services, including a 
physician's interpretation of the results of tests performed. Section 
1861(s)(3) of the Act provides for general Medicare coverage of 
diagnostic x-ray, clinical laboratory and other diagnostic tests. 
Furthermore, section 1862(a)(1)(A) of the Act provides that Medicare 
cover only services that are reasonable and necessary for the diagnosis 
or treatment of illness or injury. In developing the current Medicare 
policy on bone mass measurements, we determined, based on the advice of 
our medical consultants, that certain measurements were consistent with 
the provisions of section 1862(a)(1)(A) of the Act.
    Medicare coverage policy on bone mass measurements is described in 
section 50-44 of the Medicare Coverage Issues Manual (CIM). 
Specifically, the CIM provides for coverage of single-photon 
absorptiometry (SPA) if it is used in assessing changes in bone density 
of beneficiaries with osteodystrophy or osteoporosis. In addition, a 
bone biopsy, a physiological test that is a surgically, invasive 
procedure, is covered if used for the qualitative evaluation of bone. 
Finally, the CIM provides for coverage of photodensitometry, a 
noninvasive radiological procedure that attempts to assess bone mass. 
The CIM also states that dual-photon absorptiometry (DPA), is a 
noncovered service.
    In recent years, various new bone mass measurements have been 
developed and gained acceptance in the medical community. Since they 
have not been excluded from coverage under section 50-44 of the CIM, 
most Medicare contractors have begun to pay for the medically necessary 
use of these measurements, but some Medicare contractors have not. As a 
result, Medicare coverage of bone mass measurements has been 
inconsistent in its application with regard to the types of (1) 
beneficiaries eligible, (many Medicare contractors have considered bone 
mass measurements of estrogen-deficient women to be screening services 
and not covered under Medicare) and (2) bone mass measurements 
considered to be clinically effective.

B. Recent Legislation

    Section 4106(a)(1) of the BBA adds section 1861(s)(15) to provide 
for uniform coverage of bone mass measurements under the Part B program 
for services furnished on or after July 1, 1998. The law defines a 
``bone mass measurement'' to mean (1) a radiologic, radioisotopic, or 
other procedure approved by the Food and Drug Administration (FDA) for 
the purpose of identifying bone mass, detecting bone loss, or 
interpreting bone quality, and (2) it includes a physician's 
interpretation of the results of those bone mass measurement 
procedures. The law also authorizes Medicare coverage of those 
medically necessary approved measurements that are performed for a 
``qualified individual'' that fall into at least one of five diagnostic 
categories. These include (1) an estrogen-deficient woman at clinical 
risk for osteoporosis, (2) an individual with vertebral abnormalities, 
(3) an individual receiving long-term glucocorticoid (steroid) therapy, 
(4) an individual with primary hyperparathyroidism, and (5) an 
individual being monitored to assess the response to, or efficacy of, 
an approved osteoporosis drug therapy.
    Section 4106(a)(2) of the BBA also requires the Secretary to 
establish frequency standards governing the time period when qualified 
individuals will be eligible to receive covered bone mass measurements.
    Section 4106(b)(2) of the BBA amended section 1848(j)(3) of the 
Act, which defines ``physicians' services'' to include a bone mass 
measurement as a physician service. Physicians' services as defined in 
section 1848(j)(3) are paid for under the physician fee schedule (42 
CFR part 414).

[[Page 34322]]

II. Rationale for Coverage of Bone Mass Measurements

    We have consulted with appropriate Federal government organizations 
and reviewed medical literature regarding (1) the clinical efficacy of 
the various available bone mass measurement procedures that the FDA has 
approved or cleared for marketing for assessing bone density, (2) the 
medical indications for the five categories of Medicare beneficiary 
eligible to receive coverage under Medicare for the procedures, and (3) 
the frequency standards that the Secretary is required by law to 
establish under the new benefit. Based on review of the law and our 
research, we have reached the following conclusions on the various 
major issues raised by the coverage of bone mass measurements.

A. Clinically Effective Bone Mass Measurements

    Section 1861(rr)(1) of the Act, as added by section 4106(a) of the 
BBA, defines the term ``bone mass measurement'' to mean, in part, ``a 
radiological, radioisotopic, or other procedure approved by the Food 
and Drug Administration'' that is ``performed on a qualified person . . 
. for the purpose of identifying bone mass or detecting bone loss or 
determining bone quality. * * *'' In addition, section 4106(b) of the 
BBA amended the law to provide that payment for bone mass measurements 
that are covered under this new benefit must be made under the Medicare 
physician fee schedule, as provided in section 1848(j)(3) of the Act. 
We have interpreted these provisions to mean that the scope of the bone 
mass measurement benefit includes bone densitometry or bone sonometry 
procedures that are performed with devices that have been approved or 
cleared for marketing by the FDA. We are not including payment for 
biochemical markers within this benefit at the present time. Even 
though biochemical markers have been approved for marketing by the FDA, 
they are, in fact, clinical laboratory tests that may be paid for under 
the Medicare clinical laboratory fee schedule (sections 1833(a)(1)(D) 
and 1833(h) of the Act), rather than under the Medicare physician fee 
schedule (many Medicare contractors currently pay for biochemical 
markers under the Medicare clinical laboratory fee schedule). We plan 
to raise the issue of coverage for biochemical markers used in 
measuring bone mass when we implement section 4554 of the BBA 
concerning national coverage and administrative policies for clinical 
laboratory tests. That section of the statute requires the use of a 
negotiated rulemaking process and was announced on June 3, 1998 (63 FR 
30166).
    The expansion of Medicare coverage to include additional preventive 
benefits for bone mass measurement reflects a Congressional intent to 
improve the overall health of qualified individuals that is consistent 
with medical science. There is a well-established causal relationship 
between reduced bone mass and the risk of fracture, particularly in the 
hip and spine. Although numerous risk factors exist for the development 
of fractures (Heaney, Robert P., M.D., ``Bone Mass, Bone Loss, and 
Osteoporosis Prophylaxis,'' Annals of Internal Medicine, Volume 128, 
Number 4, pages 313-314 (February 15, 1998)), bone mass is the most 
extensively-studied fragility factor, in tandem with considerable 
therapeutic options for restoration of bone mass. From a public health 
perspective, it has been noted in the medical literature that bone loss 
is highly prevalent among elders (Genant, H.K., Guglielmi, G., Jergas, 
M., (Eds) ``Bone Densitometry and Osteoporosis'' (Epidemiology of 
Osteoporosis) Ross, P.D., pgs 23-25 (1998)), and that only about ten 
percent of women in the United States over age 65 have ``normal'' bone 
mass.
    At present, the FDA has approved or cleared for marketing a number 
of different types of bone densitometry or bone sonometry devices (or 
techniques) that can be used to perform bone mass measurements on the 
human skeleton. According to the information we have reviewed, the 
older densitometry x-ray techniques of single photon absorptiometry 
(SPA) and dual photon absorptiometry (DPA), which use isotope sources, 
have largely been replaced by the newer x-ray techniques of single X-
ray absorptiometry (SEXA) and dual-X-ray absorptiometry (DEXA), which 
are superior in terms of accuracy, precision, and shorter exam time. We 
understand that the current FDA-recognized, and generally available, 
bone densitometry techniques for measuring the peripheral skeleton 
include SEXA, peripheral dual-X-ray absorptiometry (pDEXA), 
radiographic absorptiometry (RA), and peripheral quantitative computed 
tomography (pQCT), all of which are limited to measurement of the 
peripheral skeleton, principally the forearm, heel, or fingers. 
Recently, the FDA has approved for marketing a bone sonometry device 
that estimates bone mass or strength of the heel using ultrasound 
measurements. For measurement of the central skeleton, the currently 
FDA-approved or cleared, and available techniques are DEXA and 
quantitative computed tomography (QCT), both of which can measure the 
spine or hip, and the DEXA can measure the peripheral skeleton or whole 
body as well.
    Based on the medical information we have reviewed, all of the FDA-
approved or cleared bone densitometry and sonometry devices are 
currently being used actively in clinical practice, except for the SPA 
and the DPA devices. With respect to the last two devices, we 
considered not covering bone mass measurements performed on either one 
of these devices because they are generally considered to be obsolete 
and no longer of any clinical value.
    Generally, coverage of medical items or services performed with 
FDA-approved or cleared devices is available to Medicare beneficiaries 
unless the item or service is precluded from payment by the reasonable 
and necessary exclusion in section 1862(a)(1)(A) of the Act, or is 
otherwise precluded from payment by one of the other Medicare statutory 
exclusions.
    Based on our review of the medical information, we have decided to 
continue with our present policy of coverage of bone mass measurements 
performed on SPA devices and our noncoverage of measurements performed 
on DPA devices. Our noncoverage of the DPA procedure was established in 
1983, and was based on medical advice received from the Public Health 
Service, indicating that it was not demonstrated to be medically 
effective, and, thus, should be excluded from coverage by the statutory 
``reasonable and necessary'' exclusion of section 1862(a)(1)(A) of the 
Act.
    Our review of available Medicare claims data for 1995 and 1996 
shows that the use of the SPA procedure under the Medicare program has 
declined significantly in recent years. However, the claims data 
appears to indicate that Medicare beneficiaries may still benefit from 
the use of this procedure in some parts of the country. In view of this 
evidence, however, we have decided to request comments on the 
possibility of withdrawing coverage of the SPA. We expect that certain 
remote rural areas may not have bone densitometry or bone sonometry 
devices available at present for use in testing Medicare beneficiaries. 
Therefore, we are soliciting comments on whether this is, in fact, a 
problem that merits the continued coverage of SPA. In assessing this 
issue, we request specific examples of problems, within particular 
localities, such as remote and rural areas, and details regarding how 
such a regulation

[[Page 34323]]

may adversely affect bone mass measurement services.
    In regard to the clinical utility of peripheral versus central bone 
density devices, there is a consensus that measurements of the central 
skeletal sites is the preferred method of assessment. The American 
College of Radiology reports that central techniques are associated 
with relatively higher predictive relative risk ratios for hip 
fractures than peripheral techniques, and allow for more frequent 
evaluations because of their intrinsic ability to better assess bone 
metabolic activity. Although either central or peripheral techniques 
may be used for most bone mass measurement indications, experts 
representing the National Osteoporosis Foundation have suggested 
clinical situations in which only central studies should be performed 
(that is, vertebral abnormalities, glucocorticoid maintenance, and 
monitoring the response to osteoporosis drug treatment).
    Ultimately, however, it is essential that the physician treating 
the beneficiary be afforded flexibility in ordering those diagnostic 
measurements that are best suited to the beneficiaries in their special 
circumstances. For example, our consultation with the FDA indicated 
that peripheral bone mass measurements may be used for monitoring 
osteoporosis drug treatment in some cases. Our interim final policy 
allows physicians discretion to use peripheral bone mass measurements 
in this manner. Given the differential access and convenience of 
various bone mass measurement techniques available to Medicare 
beneficiaries, the attending physician must be given the option to 
order the most appropriate bone mass measurement for a beneficiary in a 
particular set of circumstances. Emerging literature on both existing 
and new technologies shows that bone mass measurement exists within a 
highly dynamic clinical setting, which can only be successfully 
approached with flexibility. In other words, there will be a continual 
need to reexamine which are the most pertinent bone mass measurement 
techniques for generating useful diagnostic information.
    In view of these uncertainties about the clinical role of the 
peripheral measurement, we plan to monitor the Medicare use of these 
measurements. Based on data on the effectiveness of these measurements, 
we will reconsider our coverage policy in this regard if warranted. 
Although peripheral bone mass measurements have some apparent 
advantages in terms of access and convenience, if, over time, these 
parameters become more relatively favorable for central bone mass 
measurement, then our policies will be correspondingly updated.

B. Medical Indications for Medicare Beneficiaries

    As previously mentioned, section 1861(rr)(2) of the Act identifies 
five categories of ``qualified individuals'' who may receive Medicare 
coverage under the new bone mass measurement benefit. These include the 
following: (1) An estrogen-deficient woman at clinical risk for 
osteoporosis; (2) an individual with vertebral abnormalities; (3) an 
individual receiving long-term glucocorticoid (steroid) therapy; (4) an 
individual with primary hyperparathyroidism; or (5) an individual being 
monitored to assess the response to or efficacy of an approved 
osteoporosis drug therapy. (For purposes of this interim final rule, we 
refer to these ``qualified individuals'' as those categories of 
Medicare beneficiaries who may receive covered bone mass measurements.) 
In addition, section 1861(rr)(2) of the Act provides authority for 
further clarification of these categories to help ensure uniform 
national standards ``in accordance with regulations prescribed by the 
Secretary.''
    We have interpreted this section of the statute, and are clarifying 
the five categories of Medicare beneficiaries who may receive these 
covered services as follows:
    <bullet> An estrogen-deficient woman at clinical risk for 
osteoporosis means 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 or other findings.
    <bullet> An individual with vertebral abnormalities as demonstrated 
by X-ray to be indicative of osteoporosis, low bone mass (osteopenia), 
or vertebral fracture.
    <bullet> An individual receiving glucocorticoid (steroid) therapy 
equivalent to 7.5 mg of prednisone, or greater, per day for more than 3 
months, or if the expected duration of such therapy is more than 3 
months. (Review of medical literature has indicated that doses of 
steroid therapy lower than 7.5 mg of prednisone per day for periods 
shorter than 3 months usually do not result in significant bone loss.)
    <bullet> An individual with primary hyperparathyroidism.
    <bullet> An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.
    In regard to the definition of estrogen-deficient women at clinical 
risk for osteoporosis, there is agreement among medical experts in the 
United States regarding the efficacy of the use of estrogen-replacement 
therapy (ERT) in preventing and treating post-menopausal bone loss and 
osteoporosis. According to the American Association of Clinical 
Endocrinologists ``Clinical Practice Guidelines for the Prevention and 
Treatment of Post-Menopausal Osteoporosis'' (March 1996), ERT ``is the 
standard of care for preventing and treating post-menopausal bone loss 
and should be considered for all estrogen-deficient women without 
contradictions.'' In addition, the guidelines provide that ``for 
maximal skeletal protection, therapy should begin at the time of 
menopause or oophorectomy, although therapy can be initiated at any 
time after menopause. Studies indicate that correction of estrogen 
deficiency at any age prevents or slows bone loss in post-menopausal 
women with osteoporosis.''
    However, based on our review of the medical literature and other 
information, it appears that not every woman who has been prescribed 
ERT may be receiving an ``adequate'' dose of the therapy and, thus, may 
not be sufficiently protected against further bone loss. In view of the 
difficulty of trying to define the estrogen-deficient statutory 
category precisely, we have decided in this interim final rule to allow 
a woman's treating physician or other treating practitioner to 
determine whether she is estrogen-deficient and at clinical risk of 
osteoporosis, based on her medical history or other findings.

C. Frequency Standards

    Section 1861(rr)(3) of the Act provides that ``the Secretary shall 
establish such standards regarding frequency with which a qualified 
individual shall be eligible to be provided benefits'' under the bone 
mass measurement provision. The American Association of Clinical 
Endocrinologists (AACE), the American College of Radiology, and 
National Osteoporosis Foundation appear to be generally in agreement 
with respect to the need to follow certain clinical guidelines for 
performing follow-up bone mass measurements to the initial bone mass 
measurement that is performed. In their 1996 clinical practice 
guidelines, the AACE indicated that with the use of the dual-x-ray 
absorptiometry, a change in bone mass ``of 5 percent is considered 
clinically significant and is usually not observed in less than 2 
years.'' For patients taking long-term steroids, or other drug 
therapies that have been demonstrated

[[Page 34324]]

to cause a more rapid rate of bone loss, the AACE and others in the 
medical community have recommended that Medicare patients should have 
more frequent assessment (for example, baseline and after 6 months).
    In determining the appropriate frequency interval for follow-up 
serial bone mass measurements, we also believe it is necessary to 
consider the clinical role that biochemical markers may play in 
monitoring the effectiveness of osteoporosis drug therapy. Bone mass 
measurement imaging provides one type of skeletal assessment, compared 
to assaying biochemical markers that provide a profile of bone 
turnover. With respect to quantifying bone loss, multiple collagen 
crosslink tests for pyridinoline, deoxypyridinoline, and the 
telopeptides can provide adjunct diagnostic information in concert with 
bone mass measurement (Siebel, Markus J. and Gangberg, Caren M., 
``Basic Science and Clinical Utility of Biochemical Markers of Bone 
Turnover--A Congress Report'', Volume 107, pages 125-133, (1997)).
    We have been informed by the FDA that the use of biochemical 
markers may be useful in assessing the effectiveness of osteoporosis 
treatment. Although we believe that bone mass measurement and 
biochemical markers have complementary roles to play in monitoring 
osteoporosis drug therapy, there are not yet specific, evidence-based 
guidelines for performing both in tandem. However, proper management of 
osteoporosis patients, who are on long-term therapeutic regimens, may 
require reliance upon such clinical laboratory testing (for example, at 
intervals of less than 1 year) after therapy is initiated.
    We have decided to establish the following frequency standards for 
coverage of bone mass measurements:
    <bullet> In general, coverage for follow-up bone mass measurements 
will be limited to only one measurement every 2 years for beneficiaries 
who receive coverage of bone mass measurements.
    <bullet> Follow-up bone mass measurements performed more frequently 
than once every 2 years may be covered when medically necessary. 
Examples of situations where more frequent bone mass measurements 
procedures may be medically necessary include, but are not limited to, 
the following medical circumstances: (1) Monitoring beneficiaries on 
long-term glucocorticoid (steroid) therapy of more than 3 months; and 
(2) allowing for a confirmatory baseline bone mass measurement (either 
central or peripheral) to permit monitoring of beneficiaries in the 
future if the initial test was performed with a technique that is 
different from the proposed monitoring method, (for example, if the 
initial test was performed using bone sonometry and monitoring is 
anticipated using bone densitometry, we will allow coverage of baseline 
measurement using bone densitometry).

III. Provisions of the Interim Final Rule

    This interim final rule will implement section 4106 of the BBA by 
establishing conditions for coverage and frequency standards for bone 
mass measurements to ensure that they are paid for uniformly throughout 
the Medicare program and that they are reasonable and necessary for 
Medicare beneficiaries who are eligible to receive these measurements.

A. Coverage Conditions and Frequency Standards

    We are establishing conditions for coverage and frequency standards 
for medically necessary bone mass measurements for five categories of 
Medicare beneficiaries in Sec. 410.31.
    We are defining ``bone mass measurement'' based on the statutory 
definition (Sec. 410.31(a)). We are setting forth conditions for 
coverage of all of the bone mass measurements that we will cover 
effective July 1, 1998. Under the ``reasonable and necessary'' 
provisions of section 1862(a)(1)(A) of the Act, we are establishing 
conditions under which we will cover bone mass measurements 
(Sec. 410.31(b)). Consistent with Sec. 410.32 (Diagnostic x-ray tests, 
diagnostic laboratory tests, and diagnostic tests: Conditions), we are 
providing that coverage be available for the bone mass measurement only 
if it is ordered by the physician or a qualified nonphysician 
practitioner treating the beneficiary following an evaluation of the 
beneficiary's need for the test, including a determination as to the 
medically appropriate procedure to be used for the beneficiary. We 
believe that bone mass measurements are not demonstrably reasonable and 
necessary unless (among other things) they are ordered by the physician 
treating the beneficiary following a careful evaluation of the 
beneficiary's medical need, and they are employed to manage the 
beneficiary's care.
    In addition, certain nonphysician practitioners who furnish 
services that would be physician services if furnished by a physician, 
and who are operating within the scope of the statutory benefit and 
their authority under State law or regulations, may also order bone 
mass measurements for their patients. Nonphysician practitioners who 
meet this definition are physician assistants (section 1861(s)(2)(K)(i) 
of the Act), nurse practitioners (section 1861(s)(2)(K)(ii) of the 
Act), clinical nurse specialists (section 1861(s)(2)(K)(iii) of the 
Act), and nurse-midwives (section 1861(s)(2)(L) and 1861(gg) of the 
Act).
    To ensure that the bone mass measurement is performed as accurately 
and consistently in accordance with appropriate quality assurance 
guidelines as possible, we are requiring that it be performed under the 
appropriate supervision of a physician as defined in Sec. 410.32(b)(3) 
of these regulations. To ensure that the bone mass measurement is 
medically appropriate for the five categories specified in the law, we 
are providing that it be reasonable and necessary for diagnosing, 
treating, or monitoring the condition of the beneficiary who meets the 
coverage requirements specified in Sec. 410.31(d).
    Furthermore, in Sec. 410.31(c), we are setting forth limitations on 
the frequency for covering a bone mass measurement. Generally, we will 
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. However, we will allow for coverage of follow-up bone mass 
measurements performed more frequently than once every 23 months when 
medically necessary. Examples of situations where more frequent bone 
mass measurements procedures may be medically necessary include, but 
are not limited to, the following medical circumstances: (1) Monitoring 
beneficiaries on long-term glucocorticoid (steroid) therapy of more 
than 3 months; and (2) allowing for a confirmatory baseline bone mass 
measurement (either central or peripheral) to permit monitoring of 
beneficiaries in the future if the initial test was performed with a 
technique that is different from the proposed monitoring method.

B. Beneficiaries Who May Be Covered

    In Sec. 410.31(d), we offer coverage for a bone mass measurement to 
the following Medicare beneficiaries:
    <bullet> 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.
    <bullet> An individual with vertebral abnormalities as demonstrated 
by an x-ray to be indicative of osteoporosis, osteopenia, or vertebral 
fracture.
    <bullet> An individual receiving (or expecting to receive) 
glucocorticoid (steroid) therapy equivalent to 7.5 mg of

[[Page 34325]]

prednisone, or greater, per day, for more than 3 months.
    <bullet> An individual with primary hyperparthyroidism.
    <bullet> An individual being monitored to assess the response to or 
efficacy of an FDA-approved osteoporosis drug therapy.

C. Waiver of Liability

    Under Sec. 410.31(e), a beneficiary who did not know and could not 
reasonably have been expected to know that Medicare payment would be 
denied for a bone mass measurement under section 1862(a)(1)(A) of the 
Act receives protection from financial liability in accordance with 
Secs. 411.400 through 411.406 under the limitation on liability 
provision of section 1879 of the Act. Existing regulations concerning 
limitation on liability in Secs. 411.400 through 411.406 would apply to 
denial of bone mass measurements under Secs. 410.31(b) through (d). 
Medicare payment may be made for certain claims for a bone mass 
measurement if the measurement was excluded from coverage in accordance 
with Sec. 411.15(k) as not reasonable and necessary under section 
1862(a)(1)(A) of the Act. Similarly, when the beneficiary is protected 
and the provider or supplier also did not know and could not reasonably 
have been expected to know that payment would be denied, the provider 
or supplier also receives protection from financial liability in 
accordance with the limitation on liability provision. Consequently, 
Medicare payment may be made to the provider or supplier.

D. Payments for Bone Mass Measurements

    Medicare payments for covered bone mass measurements will be paid 
for under the physician fee schedule (42 CFR part 414) as required by 
statute. We are revising the definition of ``physician services'' in 
Sec. 414.2 to include bone mass measurements. When bone mass 
measurement procedures are furnished to hospital inpatients and 
outpatients, the technical components of the procedures are payable 
under existing payment methods for hospital services. These methods 
include payments under the prospective payment system, on a reasonable 
cost basis, or under a special provision for determining pay rates for 
hospital outpatient radiology services.

The codes listed below are payable under this benefit.

76075--Dual energy x-ray absorptiometry (DEXA), bone density study, one 
or more sites; axial skeleton (e.g., hips, pelvis, spine)
76076--Dual energy x-ray absorptiometry (DEXA), bone density study, one 
or more sites; appendicular skeleton (peripheral) (e.g., radius, wrist, 
heel)
76078--Radiographic absorptiometry (photodensitometry), one or more 
sites
78350--Bone density (bone mineral content) study, one or more sites; 
single photon absorptiometry
G0130--Single energy x-ray (SEXA) absorptiometry bone density study, 
one or more sites, appendicular skeleton (peripheral) (e.g., radius, 
wrist, heel)
G0131--Computerized tomography bone mineral density study, one or more 
sites; axial skeleton (e.g., hips, pelvis, spine)
G0132--Computerized tomography bone mineral density study, one or more 
sites; appendicular skeleton (peripheral) (e.g., radius, wrist, heel)
G0133--Ultrasound bone mineral density study, one or more sites, 
appendicular skeleton (peripheral) (e.g., radius, wrist, heel)

    The relative value units and payment amounts for CPT codes 76075, 
76076, 76078, and 78350, including their component parts (professional 
component (PC) identified by a -26 modifier and technical component 
(TC) identified by a -TC modifier), are the same as published in the 
Medicare physician fee schedule final rule of October 31, 1997 (62 FR 
59048). The payment amounts for G0130, G0132, and G0133 and their 
component parts are the same as determined for CPT 78350 and its 
components parts under that final rule. The amounts payable for G0131 
and its component parts is the same as listed for CPT 76070 and its 
component parts under that final rule.
    We are revising Sec. 414.50(a), regarding physician billing for 
purchased diagnostic tests, to clarify that section does not apply to 
payment for bone mass measurements.

E. Conforming Changes

    To allow for appropriate placement in the CFR of the bone mass 
measurement coverage requirements, we are redesignating Sec. 410.31 
(Prescription drugs used in immunosuppressive therapy) as Sec. 410.30.

F. Manual Instructions

    Currently, section 50-44 of the Coverage Issues Manual sets forth 
instructions for Medicare carriers concerning coverage of bone mass 
measurements. The provisions of this interim final rule supersede the 
current manual instructions. We intend to revise the instructions to 
conform them to this final rule.
IV. Response to Comments
    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, when we proceed with a subsequent 
document, we will respond to the major comments in the preamble to that 
document.

V. Waiver of Proposed Rulemaking and Delayed Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed, and the terms of the 
proposed rule or a description of the subjects and issues involved (5 
U.S.C. 555(b)). This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued. In 
addition, we ordinarily publish a rule not less than 30 days before the 
rule's effective date in order to afford persons affected a reasonable 
time to prepare for the effective date of the rule. The 30-day delay in 
the effective date can be waived for good cause found and published 
within the rule.
    We find good cause to waive the notice and comment procedure for 
these rules implementing section 4106 of the BBA. This rule involves 
little exercise of agency discretion, but rather conforms the 
regulations to the revisions contained in section 4106 of the BBA. 
Notice-and-comment rulemaking is generally considered ``unnecessary'' 
so far as the public is concerned for such technical, conforming 
changes. Indeed, under both the Administrative Procedure Act and the 
Social Security Act, interpretative rules are generally exempt from 
notice and comment rulemaking (5 U.S.C. 553(b); 42 U.S.C. 
1395hh(b)(2)(C)). While this rule interprets the statute, publication 
in the Federal Register is necessary to identify the categories of 
Medicare beneficiaries who may receive covered bone mass measurements 
under section 1861(rr)(2) of the Act and to promote uniform Medicare 
coverage of bone mass

[[Page 34326]]

measurements under section 1861(s)(15) of the Act.
    We also find good cause to waive the notice and comment procedures 
and to waive the 30 day-delay in the effective date because those 
procedures would be contrary to the public interest. Section 4106 of 
the BBA of 1997 expands Medicare coverage to a larger group of 
beneficiaries, and it will enable these individuals to obtain timely 
treatment to prevent irreversible bone loss. The explicit provision of 
benefits in section 4106 that are implemented by these rules will 
provide a broader range of bone mass measurement procedures to a 
broader set of beneficiaries. The statute, however, requires the 
Secretary to issue regulations in order to implement this benefit. 
Thus, any delay in this rule's effective date to permit additional 
public participation in the rulemaking process would harm the intended 
beneficiaries of this statute. Moreover, although these rules expand 
Medicare coverage, the rules do not impose additional documentation 
requirements or alter the existing procedures for submitting Medicare 
claims. Because many individuals or entities affected by these rules 
are already familiar with these procedures, it is expected that the 
public would not require 30 days in order to prepare for changes 
necessitated by these rules. We will, of course, consider any public 
comments received on this interim final rule, and to the extent 
necessary, we will issue a final rule with additional clarifications or 
expansions.
    We also note that in this preamble, we identify a number of interim 
1998 codes for bone densitometry and bone sonometry procedures. Since 
technology in the bone mass measurement area is changing rapidly, as 
new techniques are being approved or cleared for marketing by the FDA, 
and as these techniques are being phased into clinical practice in the 
United States, there is a need to adopt new codes (or changes in 
existing codes) so that the new procedures performed with these 
techniques can be billed under Medicare.
    For the above reasons, we find good cause to waive the notice of 
proposed rulemaking and to issue this final rule on an interim basis. 
We are providing a 60-day comment period for public comment. Since we 
have referenced existing physician fee schedule relative value units 
(RVUs) to establish RVUs on bone mass measurement procedures, we are 
inviting comments on these linkages. We will consider comments when we 
establish the final RVUs that will be used to compute Medicare payments 
for the bone mass measurement codes in 1999. These final RVUs will be 
established by the physician fee schedule final rule scheduled for 
publication later this year.

VI. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

VII. Regulatory Impact Statement

    We have examined the impacts of this interim final rule under 
Executive Order (E.O.) 12866, the Unfunded Mandates Act of 1995, and 
the Regulatory Flexibility Act. E.O. 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects; distributive impacts and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more annually). The 
benefit changes in this interim final rule due to section 4106 of BBA 
1997 will result in additional expenditures of $10 million and $100 
million for fiscal years 1998 and 1999, respectively.
    Because the expenditures resulting from this interim final rule are 
expected to reach $100 million in FY 1999, it is considered a major 
rule, and, as required by law, this final rule is subject to 
congressional review. Therefore, this interim final rule is being 
forwarded to the Congress for a 60-day review period.
    The Unfunded Mandates Reform Act of 1995 also requires (in section 
202) that agencies prepare an assessment of anticipated costs and 
benefits for any rule that may result in annual expenditures by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $100 million. The final rule has no consequential effect on 
State, local, or tribal governments. We believe the private sector 
costs of this rule fall below these thresholds, as well.
    Consistent with the provisions of the Regulatory Flexibility Act, 
we analyze options for regulatory relief for small businesses and other 
small entities. We prepare a Regulatory Flexibility Analysis (RFA) 
unless we certify that rule will not have a significant economic impact 
on a substantial number of small entities. The RFA must include a 
justification of why action is being taken, the kinds and number of 
small entities the interim final rule will affect, and an explanation 
of any considered meaningful options that achieve the objectives and 
will lesson any significant adverse economic impact on the small 
entities.
    For purposes of the Act, all physicians are considered to be small 
entities. Thus, we have prepared the following analysis, which, 
together with the rest of this preamble, meets all three assessment 
requirements. It explains the rationale for the purposes of this rule, 
details the costs of the rule, analyzes alternatives, and presents the 
measures to minimize the burden on small entities.
    Section 4106 of the BBA 1997 provides for uniform coverage of 
certain bone mass measurements, effective July 1, 1998, subject to 
certain frequency and payment limits. Specifically, the revised 
coverage will allow periodic coverage of medically necessary bone mass 
measurements performed with (1) all of the FDA approved or cleared 
devices that are currently in clinical use in the United States, and 
for (2) five mandated categories of eligible Medicare beneficiaries, 
who meet certain medical indications, including estrogen-deficient 
women at clinical risk for osteoporosis. Before enactment of the BBA, 
periodic coverage of bone mass measurements was available to certain 
beneficiaries in at least four of the five categories in most parts of 
the country, but not uniformly throughout the Medicare program. In 
addition, coverage of some of the bone mass measurements--particularly 
several of the peripheral techniques--has not been available throughout 
the United States for imaging Medicare beneficiaries, even though these 
techniques have been approved or cleared for marketing by the FDA. In 
the case of the fifth category (estrogen-deficient women at clinical 
risk of osteoporosis), coverage of bone mass measurements has not been 
available in many parts of the country. We estimate that these changes 
in the coverage of bone mass measurements will result in an increase in 
Medicare payments. These payments will be made to a large number of 
physicians, mostly medical specialists such as gynecologists, 
radiologists, rheumatologists, and clinical endocrinologists, but also 
to certain primary care physicians and hospital outpatient departments 
who perform these services.

[[Page 34327]]



                 Projected Budget Impact of New Benefit                 
                              [In millions]                             
------------------------------------------------------------------------
   FY 1998        FY 1999        FY 2000        FY 2001        FY 2002  
------------------------------------------------------------------------
$10..........          $100           $140           $180          $190 
------------------------------------------------------------------------

    We believe that the effect of this rule on beneficiaries will be a 
very positive one. Medical experts agree that early detection and 
management of disease can lead to substantial reductions in life-
threatening and serious illness. The National Osteoporosis Foundation 
estimates that there are over 10 million people in the United States 
who have osteoporosis and that another 18 million are at risk for the 
disease. Through earlier detection of low bone mass made possible under 
the new benefit and the use of appropriate prevention and treatment 
measures, our expectation is that the ravaging effects of this disease 
among the Medicare population will be reduced in the future.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

VIII. Effect of the Contract With America Advancement Act of 1996 
(Pub. L. 104-121)

    This rule has been determined to be a major rule as defined in 
Title 5, United States Code, section 804(2). Ordinarily under 5 U.S.C. 
801, as added by section 251 of Pub. L. 104-121, a major rule shall 
take effect 60 days after the later of (1) the date a report on the 
rule is submitted to the Congress, or (2) the date the rule is 
published in the Federal Register. However, section 808(2) of Title 5, 
United States Code, provides that, notwithstanding 5 U.S.C. 801, a 
major rule shall take effect at such time as the Federal agency 
determines if for good cause the agency finds that notice and comment 
procedures are impracticable, unnecessary, or contrary to the public 
interest. As explained above, for good cause we find that it was 
impracticable, unnecessary, or contrary to the public interest to 
complete notice and comment procedures before publication of this rule. 
Accordingly, pursuant to 5 U.S.C. 808(2), these regulations are 
effective on July 1, 1998.

List of Subjects

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Rural areas, X-rays.

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.
    For the reasons set out in the preamble, 42 CFR Chapter IV is 
amended as follows:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

    A. Part 410 is amended to read as follows:
    1. The authority citation for part 410 continues to read as 
follows:

    Authority: Sections 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), unless otherwise indicated.

    2. Section 410.31 is redesignated as Sec. 410.30.
    3. New Sec. 410.31 is added to read as follows:


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 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. Medicare covers a medically necessary 
bone mass measurement if the following conditions are met:
    (1) 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.
    (2) It is performed under the appropriate level of supervision of a 
physician (as set forth in Sec. 410.32(b)).
    (3) It is reasonable and necessary for diagnosing, treating, or 
monitoring the condition of a beneficiary who meets the conditions 
described in paragraph (d) of this section.
    (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.
    (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 bone mass measurement 
(either central or peripheral) to permit monitoring of beneficiaries in 
the future if the initial test was performed with a technique that is 
different from the proposed monitoring method.
    (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 7.5 mg of prednisone, or 
greater, per day for more than 3 months.
    (4) An individual with primary hyperparathyroidism.

[[Page 34328]]

    (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 HCFA 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.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

    B. Part 414 is amended to read as follows:
    1. The authority citation for part 414 continues to read as 
follows:

    Authority: Sections 1102, 1871, and 1881(b)(1) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).

    2. In Sec. 414.2, in the definition of ``Physician services'', a 
new paragraph (7) is added to read as follows:


Sec. 414.2  Definitions.

* * * * *
    Physician services * * *
    (7) Bone mass measurement.
* * * * *


Sec. 414.50  [Amended]

    3. In Sec. 414.50(a), in the first sentence, revise ``If a'' to 
read ``For services covered under section 1861(s)(3) of the Act and 
paid for under this part 414 subpart A, if a''.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: June 3, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.

    Dated: June 9, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-16783 Filed 6-19-98; 3:00 pm]
BILLING CODE 4120-01-P


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