[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[email protected]. 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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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:
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.
An individual with vertebral abnormalities as demonstrated
by X-ray to be indicative of osteoporosis, low bone mass (osteopenia),
or vertebral fracture.
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.)
An individual with primary hyperparathyroidism.
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:
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.
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:
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, or vertebral
fracture.
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.
An individual with primary hyperparthyroidism.
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