[Federal Register Volume 59, Number 189 (Friday, September 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24335]
[[Page Unknown]]
[Federal Register: September 30, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 405, 410, 411, 413, and 494
[BPD-724-F]
RIN 0938-AF26
Medicare Program; Medicare Coverage of Screening Mammography
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule revises interim final regulations on Medicare
coverage of screening mammography that were published in the Federal
Register on December 31, 1990 (55 FR 53510). Those regulations
implemented section 4163 of the Omnibus Budget Reconciliation Act of
1990, setting forth payment limitations and conditions for coverage of
screening mammography. The conditions consist of quality standards to
ensure the safety and accuracy of screening mammography services
performed by qualified physicians and other suppliers of these
services.
As a result of the implementation of the Mammography Quality
Standards Act of 1992 (MQSA) by the Food and Drug Administration (FDA),
we are conforming the conditions for coverage to the applicable FDA
certification requirements that all Medicare suppliers of services must
meet effective October 1, 1994. The revisions in this final rule also
respond to certain comments we received on the interim final rule
published on December 31, 1990; they provide clarification of certain
of its provisions; and they establish conditions for coverage of
diagnostic mammography that are similar to those we have established
for screening mammography. In addition, this final rule reflects
changes resulting from the final rule on the fee schedule for
physicians' services, which was published in the Federal Register on
December 2, 1993 (58 FR 63626).
DATES: These regulations are effective October 1, 1994.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) 783-3238 or by faxing to (202) 512-
2250. The cost for each copy is $6.00. As an alternative, you can view
and photocopy the Federal Register document at most libraries
designated as Federal Depository Libraries and at many other public and
academic libraries throughout the country that receive the Federal
Register.
FOR FURTHER INFORMATION CONTACT: William Larson (Conditions for
Coverage), (410) 966-4639. William Morse (Payment Limits), (410) 966-
4520.
SUPPLEMENTARY INFORMATION:
I. Background
On December 31, 1990, we published interim final regulations
concerning Medicare coverage of screening mammography in the Federal
Register (55 FR 53510). These regulations implemented section 4163 of
the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Public Law
101-508), which was enacted on November 5, 1990. Section 4163 amended
sections 1833, 1834, 1861, 1862, 1863, 1864, 1865, 1902, and 1915 of
the Social Security Act (the Act) to provide coverage of screening
mammography (including a physician's interpretation of the images or
films produced by the radiologic procedure) effective January 1, 1991,
subject to frequency limitations, quality standards, and special
payment rules.
Before we could follow up on the interim final rule and publish a
final rule on Medicare coverage of screening mammography, the
Mammography Quality Standards Act of 1992 (MQSA) (Public Law 101-539)
was enacted on October 27, 1992, establishing new national quality
standards for all mammography services. The MQSA amended part F of
title III of the Public Health Service Act (the PHS Act) (42 U.S.C.
263b) to establish a comprehensive statutory mechanism for
certification and inspection of all mammography facilities in the
United States, except facilities of the Department of Veterans Affairs
(VA). The authority to implement the provisions of the MQSA was
delegated by the Secretary to the Food and Drug Administration (FDA),
which published interim final regulations in this regard in the Federal
Register (58 FR 67558 and 58 FR 67565) on December 21, 1993, with an
effective date of February 22, 1994.
The MQSA did not explicitly repeal section 1834(c) of the Act,
which contains the provisions governing Medicare standards for
screening mammography. Furthermore, conforming provisions that would
tie Medicare coverage for both screening and diagnostic mammography to
MQSA standards were initially included in the Omnibus Budget
Reconciliation Act of 1993 by the House of Representatives, but
subsequently had to be dropped along with other nonbudget provisions in
response to Senate procedural rules. These provisions were included
again in a technical corrections bill that the Congress attempted to
pass late in 1993, but did not pass for reasons unrelated to the
substance of the bill.
The MQSA, however, as it was enacted, specifically provides that
the standards under the PHS Act apply to all facilities in the country
furnishing mammography, except VA facilities. Thus section 354(b) of
the PHS Act, added by the MQSA, states that ``No facility may conduct
an examination or procedure * * * involving mammography * * * unless
the facility obtains * * * a certificate issued * * * by the
Secretary.'' Similarly, the MQSA defines a facility in the broadest
terms: It includes ``a hospital, outpatient department, clinic,
radiology practice, or mobile unit, an office of a physician, or other
facility * * * that conducts breast cancer screening or diagnosis
through mammography activities.''
The plain language of the PHS Act requires that facilities
furnishing mammography to Medicare beneficiaries meet the standards
promulgated under the MQSA. Moreover, we believe that the language of
the law indicates that the Congress intended that all facilities
furnishing mammography meet a consistent set of national standards.
When the Congress wished to exclude facilities from these standards, it
did so explicitly; thus, VA facilities are specifically not subject to
the Federal standards under the MQSA. Finally, we have compared the
requirements contained in the MQSA and quality standards in section
1834(c) of the Act and believe that the Medicare requirements are
substantially subsumed in the PHS Act. For the reasons stated above, we
believe that it was the Congress' intent that facilities have to meet
only one set of Federal mammography standards and that the MQSA
standards supersede the previous Medicare standards.
II. Provisions of the Interim Final Rule
The interim final rule, published in the Federal Register on
December 31, 1990 (55 FR 53510), implemented section 4163 of OBRA '90
by setting forth Medicare payment limitations and establishing
conditions for coverage of screening mammography to ensure the safety
and accuracy of the screening process.
III. Discussion of Public Comments
We received 42 timely items of correspondence in response to the
December 31, 1990 interim final rule. The comments were from
professional organizations, State governments, hospitals, consumer
organizations, suppliers of mammography equipment, and individual
practitioners.
Of these 42 items, 30 of them dealt exclusively with the quality
standards described in 42 CFR part 494, subpart B, and only 12 of them
offered any comments on the other provisions of the interim regulations
relating to the payment, coverage frequency, and other provisions.
Since we are deleting the quality standards in subpart B and are
replacing them with a cross-reference to the applicable FDA
requirements, as discussed in section IV. of this preamble, it is no
longer necessary to respond in this rule to the comments that were
received on those standards. The other comments and our responses to
those comments, however, are discussed below.
A. Payment Limitations
Comment: One commenter suggested that the allocation between the
professional and technical components for the screening mammogram
should be the same as for a diagnostic mammogram.
Response: In the interim final rule (55 FR 53512), we used the same
allocation between the two components of a screening mammogram that we
had in place under the Medicare radiologist fee schedule for diagnostic
mammograms because it was the best information we had available at the
time and because of the lack of a persuasive argument that there should
be different allocations for the two types of mammograms. In this final
rule, we are changing the apportionment between the professional
component and the technical component, effective for services furnished
beginning January 1, 1995, to reflect the relationship between the
relative value units established for a diagnostic bilateral mammogram
under the fee schedule for physicians' services for the year in
question. We will not include the percentages for the professional
component and the technical component in this final rule because the
specificity requires a time-consuming rulemaking process when we modify
the apportionment. We will announce the apportionment of the payment
limits between the two components for 1995, and each year thereafter,
at the same time as we announce the statutory payment limit in effect
for that year. At this time, we anticipate that the apportionment of
the payment limit in 1995 will be 32 percent professional component and
68 percent technical component.
Comment: One commenter objected to the discussion in the preamble
of the interim final rule (55 FR 53513) of the difficulty rural
hospitals have in furnishing the technical component of a screening
mammogram within the payment limit because the rural hospitals may have
a low volume of services. The commenter believed that, if a hospital
and a radiologist entered into an agreement stating that the
radiologist would accept a lower amount for the interpretation than
Medicare would pay the radiologist directly for the interpretation, the
agreement would constitute a ``kickback'' of a portion of the
radiologist's fee to the hospital.
Response: We acknowledge that this agreement could constitute a
kickback under the Medicare and Medicaid anti-kickback statute (42
U.S.C. 1320a-7b(b)). That statute makes it a felony to offer, pay,
solicit, or receive remuneration with the intention of inducing the
referral of Medicare, Medicaid, Maternal and Child Health Services
Block Grant, or Social Services Block Grant program business.
Activities that come within the purview of the statute are not subject
to prosecution if they fit within specified safe harbors, as set forth
in the regulation published in the Federal Register July 29, 1991 (56
FR 35952). Consequently, an organization or individual should enter
into an agreement such as that referenced in the December 1990 interim
final rule only if the agreement does not violate the anti-kickback
statute.
Comment: Several commenters suggested that the rule should be
modified so that a portion of the professional component of a screening
mammogram be determined to represent the contribution of the primary
care physician if the screening mammogram is taken in the primary care
physician's office but interpreted by another physician. The commenters
believed that the allocation of 37 percent of the payment limit to the
interpreting physician's role overcompensates that physician and
ignores the primary care physician's role in furnishing the mammogram.
One commenter stated that the Physician Payment Reform Commission
report entitled ``The Costs of Providing Screening Mammography''
allocates a flat $12 for the interpretation. As an alternative, the
commenter suggested that the primary care physician be permitted to
contract with the interpreting physician for payment at a rate less
than 37 percent of the payment limit. Another commenter recommended
that the interpretation represent 20 percent of the total fee.
Response: Medicare does not pay for referrals, and exacting a fee
for referrals is against the law. A qualified physician who furnishes
the interpretation of the screening mammogram receives payment for the
professional component of the screening mammogram. If the primary care
physician furnishes neither the professional component nor the
technical component of the screening mammogram, he or she is entitled
to no payment for the screening mammogram.
The apportionment of the screening mammography payment limit
between the professional component and the technical component will
reflect the payment split for the corresponding components for
diagnostic mammography under the fee schedule for physicians' services.
The weights of the factors reflect historical payment data, and we have
no reason to believe that the apportionment is not appropriate for a
screening mammography procedure.
Comment: One commenter stated that the purchased service limitation
set forth in section 1842(n) of the Act should not apply to the
technical component of a screening mammography procedure furnished in a
primary care physician's office that customarily uses a temporary or
leased technologist because--
The technologist is under the direct control and
supervision of the primary care physician and, as such, meets the
common law rules for an employer/employee relationship applied under
the Internal Revenue Code; and
The screening mammography procedure is performed under the
supervision of the primary care physician in conformance with the
definition of ``direct supervision'' set forth in Sec. 410.32(a).
Response: The purchased service limitation does not apply to
screening mammography services because the procedures are not included
in the definition of diagnostic tests under section 1861(s)(3) of the
Act, as required by section 1842(n) of the Act, the statutory basis of
the purchased service limitation. Section 1861(s)(13) of the Act
provides for Part B coverage of screening mammography services, which
are not subject to the requirements of section 1842(n) of the Act.
Comment: Two commenters stated that a ``screening mammogram'' is no
different from a ``diagnostic mammogram'' and therefore should be paid
at the same level.
Response: A screening mammogram and a diagnostic mammogram are
similar in many respects, but the purposes of the two tests are
distinctly different. A screening mammogram is a routine medical check;
a diagnostic mammogram is made to diagnose a specific complaint or
medical problem already identified by the patient or her attending
physician. Section 1834(c)(4)(A) of the Act clearly establishes a $55
overall limit applicable to a screening mammography procedure in 1991
with increases in subsequent years limited to the percentage increase
in the Medicare Economic Index for the subsequent year. Section
1834(b)(4)(B) of the Act authorizes the Secretary of the Department of
Health and Human Services (the Secretary) to reduce this limit, after
appropriate review, but does not authorize the Secretary to raise the
limit. If we decide to establish the same payment for the two
procedures, we might have to lower the payments for most diagnostic
mammograms.
Comment: Two commenters recommended that the interim final rule be
amended to waive the beneficiary's copayment liabilities so that older
women will not have to bear out-of-pocket costs for the screening
mammography procedure.
Response: A waiver of copayment liabilities would have to be
authorized by the Congress. Section 1834(c)(1)(C) of the Act
specifically limits Medicare payments to 80 percent of the least of the
actual charge, the radiologist fee schedule or the physicians' fee
schedule established under section 1848 of the Act as applicable, or
the statutory limit for the service.
Comment: One commenter stated that insufficient payment levels
should not be a deterrent to women having access to screening
mammography services and that the relationship between current charges,
payment levels, and access to the service should be taken into
consideration in determining payment levels.
Response: We have to apply the overall payment limit established in
section 1834(c)(4) of the Act. There is no provision for exceptions to
ensure access to these services in special circumstances.
Comment: One commenter believed that it is critical that any
changes to the Medicare Part B payment system not be counter to
physician payment reform. The existence of an overall national payment
limit concerned another commenter who believed that the limit is
inconsistent with the premise of a resource-based relative value scale
payment schedule adjusted for geographic cost variations.
Response: Section 1834(c)(1)(C) of the Act requires that the amount
of payment for screening mammography services be equal to 80 percent of
the least of the actual charge, the radiologist fee schedule, or the
physicians' fee schedule established under section 1848 of the Act, as
applicable, or the statutory limit for the service.
Comment: One commenter, while conceding that we had no choice under
the statute in imposing an overall $55 limit, stated that a single
national rate without any recognition of geographic variations is
inappropriate. The commenter believed that we should establish a price
for screening mammograms within the context of other radiology services
and ask the Congress to repeal the separate limit for these procedures.
Response: If it becomes apparent that the statutory limit is
inadequate, we may make the proposal.
Comment: One commenter stated that radiologists would charge $32
for their interpretation, leaving only about $23 for the hospital, an
amount which would cover only the cost of the film.
Response: Under the statutory allocation methodology implemented in
the interim final rule (55 FR 53512), the professional component of the
procedure in 1991 was limited to $20.35 (37 percent of $55), while the
technical component was limited to $34.63 (63 percent of $55). The 1991
limiting charges for nonparticipating physicians and suppliers were:
$68.75 (global), $25.44 (professional component), and $43.31 (technical
component). Therefore, payment to hospitals for the technical component
of screening mammography services is not determined by subtracting the
amount billed for the professional component charge from the overall
limit, but rather on the basis of the allocation methodology described
in the interim final rule (55 FR 53512).
Comment: One commenter stated that the payment limit in section
1834(c)(4) of the Act is lower than the costs for screening mammography
services furnished by a mobile unit in rural areas. The commenter
believed that the operating costs of a mobile unit are higher than
those of a stationary unit. Another commenter expressed concern that
the processing of Medicare claims will increase the costs of mobile
facilities and other screening centers that previously have not handled
Medicare claims.
Response: Section 1834(c)(4) of the Act does not provide for any
exception to the overall limit. Nonparticipating physicians and
suppliers may bill beneficiaries higher amounts for the procedure up to
the limiting charge set forth in Sec. 405.535.
B. Limitations on Screening Mammography Services
Comment: One commenter believed that the screening mammography
radiologic procedure covered under the Medicare program should not be
limited to the four-view procedure specified in Sec. 410.34(b)(1) of
the interim final rule, but that additional views should be allowed as
necessary in the case of particular patients.
Response: As we indicated in the preamble to the interim final rule
(55 FR 53513), the basis for specifying that the screening mammography
service must be a bilateral four-view procedure (that is, cranio-caudal
and a medial lateral oblique view of each breast) is congressional
intent as expressed in the Report of the Committee of Conference that
accompanied Public Law No. 100-360 (H.R. Rep. No. 100-661, 100th
Congress, 2nd Sess. 171 (1988)). In that report, the conferees stated
that they ``understood that a bilateral four-view procedure is
currently considered to be the standard of care in the United States
for screening mammography * * * [and] therefore anticipate that this
would be initially included in the quality standards to be developed by
the Secretary as a requirement for coverage.''
We recognize that it may be necessary in the case of some patients
to perform more than a bilateral four-view procedure. In view of the
possibility that more than four images will need to be taken in the
case of a particular patient, we have revised Sec. 410.34(b)(1)
(redesignated in this final rule as Sec. 410.34(d)(1)) to state that
generally ``the service must, at a minimum, be a four-view exposure * *
*.'' The need to do additional images will not have any effect on the
payment amount that will be allowed for the Medicare screening
mammography services because the payment amount is prescribed by
statute.
To accommodate postmastectomy screening of certain women, however,
we will allow, at a minimum, a two-view exposure (that is, a cranio-
caudal and a medial lateral oblique view) of the remaining breast for
those individuals, and still permit the facility to meet the standard.
We are setting that standard as a two-view exposure.
Comment: Several commenters expressed concern about the limitations
on the frequency of coverage of mammography screenings.
Response: As explained in the interim final rule (55 FR 53513), the
frequency limitations specified in Sec. 410.34 reflect the provisions
imposed by section 1834(c)(2) of the Act, except for the high risk
factors that were identified in Sec. 410.34(b)(4)(i) (redesignated in
this final rule as Sec. 410.34(d)(4)(i)). As provided in section
1834(c)(2)(B) of the Act, the frequency limitations may be revised by
the Secretary in consultation with the National Cancer Institute (NCI).
This matter is under consideration, and will be addressed in a later
notice, as appropriate.
Comment: One commenter suggested that this final rule discuss the
importance of women having a clinical breast examination performed by a
physician that would supplement the preventive value of using the
Medicare screening mammography benefit. The commenter acknowledged that
Medicare law authorizing screening mammography coverage does not
provide for coverage and payment for a clinical breast examination as
part of the screening mammography benefit. However, the commenter
suggested that this final rule, at a minimum, indicate that a
supplementary clinical breast examination performed by a physician be
recommended in conjunction with a screening mammography examination and
related physician's interpretation of the results of that radiologic
examination.
Response: The commenter is correct. We do not have the legal
authority under the screening mammography benefit to provide for
coverage and payment for a clinical breast examination performed by a
physician in conjunction with the use of screening mammography
services. We understand, however, that NCI, ACS, the American Medical
Association (AMA), the American Society of Internal Medicine, the
National Medical Association, the American Academy of Family
Physicians, the American College of Radiology, and other specialty
groups recommend that a combination of screening mammography and a
clinical breast examination is necessary for a complete early breast
cancer detection program. In this regard, NCI publishes public
information brochures that explain screening mammography and strongly
advise that a doctor also perform a clinical breast examination to
supplement the value of the screening service. Information about breast
cancer screening, including information regarding the importance of
clinical breast examinations, can be obtained, free of charge, by
calling the NCI-funded Cancer Information Service at 1-800-4-CANCER.
Comment: One commenter questioned the inclusion of ``not given
birth prior to age 30'' as a factor indicating a high risk of
developing breast cancer.
Response: We included ``not given birth prior to age 30'' as a
factor indicating a high risk of developing breast cancer in the
interim final rule based upon advice we received from NCI, and, in
response to the comment, we have consulted further with NCI. NCI staff
have advised us that the relative risk of women who have ``not given
birth prior to age 30'' developing breast cancer is 1.4; that is, a
woman who has not given birth prior to age 30 has a 40 percent higher
chance of developing breast cancer over her lifetime than would
otherwise be the case. This elevated risk applies over the age range of
40 to 49 that is subject to the high risk factor provision specified in
the Medicare statute. Based on the advice of NCI, we have decided to
retain in this final rule ``not given birth prior to age 30'' as a
factor indicating a high risk of developing breast cancer.
Comment: One commenter believed that there is a need to clarify the
meaning of the term ``personal history of breast cancer'' that is cited
in Sec. 410.34(b)(4) as one of the factors indicating a high risk of
developing breast cancer. The commenter also requested clarification as
to whether a biopsy that reveals a lump to be benign is reasonable
evidence of ``a history of breast cancer.''
Response: The use of the term ``a personal history of breast
cancer'' in Sec. 410.34(b)(4) of the interim final rule was intended to
mean that there is documented evidence in the woman's medical record
that she has tested positive for breast cancer. Thus, a woman who has a
biopsy of a lump in her breast that is determined to be benign would
not be considered to have ``a history of breast cancer.''
Comment: One commenter expressed concern that the interim final
rule made no reference to the possibility that the Medicare program may
pay for certain medically necessary mammograms that are performed more
often than the frequencies stated in the statute and the interim final
rule for screening mammograms. The commenter suggested that we clarify
this.
Response: The commenter is correct that the Medicare program may
pay for certain medically necessary mammograms (also referred to as
diagnostic mammograms as distinguished from screening mammograms) that
are performed more frequently than the frequencies stated in the law
and the interim final rule for screening mammograms. We stated this
fact in the interim final rule (55 FR 53511). Under this policy,
mammograms are covered if medically necessary to diagnose a specific
complaint or medical problem that has been identified by the patient or
her attending physician, including medical problems that may have been
identified on the basis of a previous screening mammogram. This
coverage is based on sections 1861(s)(1) and (s)(3) of the Act, which
provide for Medicare coverage of interpretation of diagnostic X-ray
tests by a physician.
Comment: Three commenters observed that a diagnostic mammogram
requires essentially the same level of professional attention and
professional expertise as does a screening mammogram, and one of these
commenters suggested that similar quality standards be applied to both
types of mammography services under the Medicare program.
Response: We agree. As we noted in response to a previous comment,
a diagnostic mammogram and a screening mammogram are similar in many
respects, and the Congress recognized this fact when it enacted the
MQSA, which authorized the application of quality standards to both
types of mammograms, effective October 1, 1994. Accordingly, we are
including a condition for coverage in this rule at Sec. 410.34(b)(2)
that, in order to qualify for payment for diagnostic mammograms under
the Medicare program, suppliers of these services must meet the same
FDA certification requirements that we are adopting in this final rule
for screening mammograms. (These certification requirements are set
forth in section 354 of the PHS Act, implemented by 21 CFR part 900,
subpart B.)
IV. Provisions of the Final Rule
In this final rule, we are deleting the conditions for coverage
specified in 42 CFR part 494, subpart B, which screening mammography
suppliers must meet to qualify for coverage of the services under the
Medicare program. Instead, we are cross-referencing the applicable FDA
certification requirements, published in the Federal Register on
December 21, 1993 (58 FR 67558 and 58 FR 67565), that suppliers of the
services must meet effective October 1, 1994.
Based on our analysis of section 354 of the PHS Act, as added by
the MQSA, and the related FDA interim regulations, we believe that we
have fulfilled our responsibility to establish quality standards under
section 1834(c)(3) of the Act by adopting the quality standards and
related certification requirements specified in the FDA regulations.
Section 1834(c)(3) of the Act requires the Secretary to establish
standards to ensure the safety and accuracy of screening mammography
services performed under Medicare Part B. The quality standards that
must be established include: (1) Standards that require the use of
equipment specifically designed for mammography and that meet other
radiological standards established by the Secretary for mammography;
(2) standards that require that the mammography be performed by
individuals who are licensed by a State to perform radiological
procedures, or who are certified as qualified to perform radiological
procedures by an appropriate program as the Secretary specifies in
regulations; (3) standards that require that the results of the
mammography be interpreted by a physician who is certified as qualified
to interpret radiological procedures by such an appropriate board (or
program) as the Secretary recognizes in regulations; and (4)
requirements that, with respect to a woman's first screening
mammography performed for which payment is made under the program, the
results of the mammography will be placed in the woman's permanent
medical records.
In the FDA interim final rule, 21 CFR subpart B, Sec. 900.11
(``Requirements for certification''), paragraph (a) provides that after
October 1, 1994, ``a certificate issued by FDA will be required for
lawful operation of all facilities'' and that in order to obtain a
certificate from FDA, facilities ``are required to meet the quality
standards in Sec. 900.12 and to be accredited by an accrediting body
approved by FDA'' as described in 21 CFR part 900, subpart A,
Secs. 900.1 through 900.7. In Sec. 900.12 of the interim final rule,
FDA established standards for mammography equipment, personnel, and
practices. These standards are substantially the same as the Medicare
interim quality standards that were published on December 31, 1990, but
when they do differ from the existing Medicare standards, they still
appear to be consistent with our mandate under section 1834(c)(3) of
the Act. Thus, this final rule will remove the existing Medicare
interim quality standards and, instead, will cross-refer to applicable
interim FDA certification requirements for mammography services.
In addition, we are making several technical and other clarifying
revisions in the remaining provisions of the existing interim
regulations that we published in the Federal Register on December 31,
1990 (55 FR 53510). With the exception of two points of clarification,
a technical change, and certain conforming changes to part 405, subpart
E (``Criteria for Determination of Reasonable Charges; Payment for
Services of Hospital Interns, Residents, and Supervising Physicians''),
the rationale for these revisions is discussed in the ``Discussion of
Public Comments'' in section III. of this rule.
In Sec. 405.534 (``Limitation on payment for screening mammography
services''), we are making technical changes to cross-refer to the fee
schedule for physicians' services. The current Sec. 405.534 refers to
Sec. 405.533. The latter was removed from the CFR on November 25, 1991,
with the publication of the fee schedule for physicians' services in
the Federal Register (56 FR 59622). We are also revising paragraphs (c)
and (d) so that, effective for a screening mammography procedure
furnished beginning January 1, 1995, the payment for the screening
mammography procedure reflects the relationship between the relative
value units for the professional and technical components established
for a diagnostic mammography procedure under the physicians' fee
schedule. Effective January 1, 1995, the apportionment of the payment
limit between the professional and technical components will be changed
to reflect the relationship of the two components for diagnostic
bilateral mammograms under the fee schedule for physicians' services
for 1995.
We are revising the title of Sec. 405.535 to add the words ``and
suppliers.'' It will read, ``Special rules for nonparticipating
physicians and suppliers furnishing screening mammography services.''
We are also making technical changes in this section to cross-refer the
reader to the fee schedule for physicians' services. Additionally, we
are setting forth in Sec. 405.535 requirements for the limiting charge
if the screening mammography services are furnished by a
nonparticipating physician or supplier who does not accept assignment.
Conditions for Coverage
In accordance with section 354 of the PHS Act, regarding coverage
conditions for diagnostic and screening mammography, we are amending 42
CFR by revising Sec. 410.34(a) to specify definitions of the terms (1)
``diagnostic mammography,'' (2) ``screening mammography,'' (3)
``supplier of diagnostic mammography,'' (4) ``supplier of screening
mammography,'' (5) ``certificate,'' (6) ``provisional certificate,''
and (7) ``meets the certification requirements of section 354 of the
Public Health Services (PHS) Act.''
In Sec. 410.34, we are redesignating paragraph (b) as paragraph
(d). We are adding a heading to paragraph (d), ``Limitations on
coverage of screening mammography services.'' In newly redesignated
paragraph (d)(1) of Sec. 410.34, we are clarifying that the current
requirement that a mammogram ``must, at a minimum [emphasis added], be
a four-view exposure (that is, a cranio-caudal and a medial lateral
oblique view of each breast)'' is the minimum requirement that must be
met, except in the case of a woman who is having a postmastectomy
screening, when we will allow a two-view exposure (that is, a cranio-
caudal and a medial lateral oblique view) of the remaining breast.
We are adding a new paragraph (b) to Sec. 410.34 to set forth
conditions for coverage of diagnostic mammography, which essentially
cross-reference the same FDA certification requirements that suppliers
of screening mammography must meet on October 1, 1994. Medicare Part B
pays for diagnostic mammography services if the diagnostic mammography
services are ordered by a doctor of medicine or osteopathy and if they
are furnished by a supplier of diagnostic mammography services that
meets the certification requirements of section 354 of the PHS Act, as
described in 21 CFR part 900 (``Mammography''), subpart B (``Quality
Standards and Certification'').
We are also adding a new paragraph (c) to Sec. 410.34 to set forth
the conditions for payment of screening mammography. Medicare Part B
pays for screening mammography services only if they are furnished by a
supplier of screening mammography services that meets the certification
requirements of section 354 of the PHS Act, as described in 21 CFR part
900, subpart B.
We are revising Sec. 411.15 (``Particular services excluded from
coverage'') to replace the cross reference to subpart B of part 494
(which is being removed and reserved) with a reference to the
certification requirements in section 354 of the PHS Act, as set forth
in 21 CFR part 900, subpart B.
The current Sec. 413.123(b) states that payment to hospitals for
screening mammography services performed on an outpatient basis is
determined in accordance with Sec. 405.534(c). We are changing this to
refer to Sec. 405.534(d) to correct an error.
V. Information Collection Requirements
Due to the enactment of the MQSA and its implementation by FDA, we
are requesting cancellation of the information collection requirements
approved under OMB control number 0938-0608 for Medicare coverage of
screening mammograms, effective October 1, 1994. The latter information
collection document was previously required as a result of the
enactment of section 4163 of OBRA '90.
In implementing section 4163 of OBRA '90, we published interim
final regulations on December 31, 1990 (55 FR 53510), including certain
minimum safety and accuracy standards set forth in 42 CFR subpart B,
which suppliers of screening mammography services had to meet in order
to participate under Medicare, effective January 1, 1991. With the
enactment of the MQSA, however, all mammography facilities in the
United States, except for VA facilities, will be required, effective
October 1, 1994, to have a certificate issued by FDA regardless of
their source of payment. Therefore, under its delegation of authority
from the Secretary of the Department of Health and Human Services, FDA
will replace HCFA on October 1, 1994, as the Federal agency responsible
for surveying and certifying suppliers of screening mammography
services in accordance with the new MQSA standards.
VI. Delay in the Effective Date
As required by the Administrative Procedure Act (APA), we generally
provide for final rules not to be effective until 30 days after the
date of publication unless we find good cause to waive the delay. As a
result of the implementation of the MQSA by FDA, we are conforming the
conditions for Medicare coverage of screening mammography services to
the applicable FDA certification requirements, published in the Federal
Register on December 21, 1993 (58 FR 67558 and 58 FR 67565), that all
Medicare suppliers of services must meet effective October 1, 1994. We
view the changes made by this rule as merely interpretative. The APA
does not require that there be a delayed effective date for an
interpretative rule. Accordingly, this rule will be effective October
1, 1994, the effective date of the FDA requirements on mammography
services.
VII. Regulatory Impact Analysis
A. Introduction
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless the
Secretary certifies that a rule will not have a significant economic
impact on a substantial number of small entities. For purposes of the
RFA, all physicians and suppliers of screening mammography services and
equipment are considered to be small entities.
This final rule revises interim regulations on Medicare coverage of
screening mammography that were published in the Federal Register on
December 31, 1990 (55 FR 53510). Those regulations implemented section
4163 of OBRA '90, setting conditions for coverage for and limitations
on screening mammography.
In the interim final rule, we presented an analysis of the various
effects that the screening mammography benefit would have on
beneficiaries, physicians, and suppliers (55 FR 53518). We received no
comments on the impact analysis. Below, we present revised estimates of
projected Medicare costs and utilization rates and the effects, as far
as they can be foreseen, of the changes we have adopted as a result of
public comment. Our estimates of projected additional costs and
services are lower than those we anticipated when the interim final
rule was published in the Federal Register. One explanation for lower
than anticipated costs and services for this service may be that
physicians have been furnishing screening mammography services but have
been billing for the services using the CPT code for diagnostic
mammography.
We anticipate that Medicare coverage of screening mammography
services will result in the following costs:
Table I.--Projected Budget Impact as a Result of Medicare Coverage of
Screening Mammography
[in millions]
------------------------------------------------------------------------
FY FY FY FY FY
1995 1996 1997 1998 1999
------------------------------------------------------------------------
Benefit costs................... $90 $95 $100 $110 $115
------------------------------------------------------------------------
Table II.--Projected Number of Screening Mammographies Performed as a Result of Medicare Coverage
[in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
CY 1995 CY 1996 CY 1997 CY 1998 CY 1999
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.4.......................... 1.4 1.5 1.6 1.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beginning October 1, 1994, FDA replaces HCFA as the Federal agency
responsible for surveying and certifying suppliers of all mammography
services, both diagnostic and screening. Beginning on that date, all
facilities furnishing mammography services will be expected to meet
only one set of national standards. This provision should benefit
mammography facilities and help ensure the safety and accuracy of
screening mammography services performed under Medicare Part B. The
Medicare program will no longer be responsible for funding this cost.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
B. Rural Hospital Impact Statement
Section 1102(b) of the Act requires the Secretary to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds. We do not believe small
rural hospitals will be required to make any operational changes to
comply with this final rule. Therefore, we are not preparing a rural
impact analysis because we have determined, and the Secretary
certifies, that this final rule will not have a significant impact on
the operations of a substantial number of small rural hospitals.
VII. List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 410
Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Rural areas, X-rays.
42 CFR Part 411
Kidney diseases, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Puerto Rico,
Reporting and recordkeeping requirements.
42 CFR Part 494
Medicare, Reporting and recordkeeping requirements, X-rays.
For the reasons set forth in the preamble and under the authority
of 42 U.S.C. 1302 and 1395hh, 42 CFR chapter IV is amended as follows:
A. Part 405, subpart E is amended as set forth below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart E--Criteria for Determination of Reasonable Charges;
Payment for Services of Hospital Interns, Residents, and
Supervising Physicians
1. The authority citation for subpart E, part 405, is revised to
read as follows:
Authority: Secs. 1102, 1814(b), 1832, 1833(a), 1834(a), (b), and
(c), 1842(b) and (h), 1848, 1861(b), (s), (v), (aa), and (jj),
1862(a)(14), 1866(a), 1871, 1881, 1886, 1887, and 1889 of the Social
Security Act as amended (42 U.S.C. 1302, 1395f(b), 1395k, 1395l(a),
1395m(a), (b), and (c), 1395u(b) and (h), 1395w-4, 1395x(b), (s),
(v), (aa), and (jj), 1395y(a)(14), 1395cc(a), 1395hh, 1395rr,
1395ww, 1395xx, and 1395zz).
2. In Sec. 405.534, the introductory text of paragraphs (b), (c),
and (d), and paragraphs (b)(2), (b)(3), (c)(2), (c)(3), (d)(2), and
(d)(3) are revised to read as follows:
Sec. 405.534 Limitation on payment for screening mammography services.
* * * * *
(b) Global or complete service billing representing both the
professional and technical components of the procedure. If a fee is
billed for a global service, the amount of payment subject to the
deductible is equal to 80 percent of the least of the following:
* * * * *
(2) The amount established for the global procedure for a
diagnostic bilateral mammogram under the fee schedule for physicians'
services set forth at part 414, subpart A.
(3) The payment limit for the procedure. For screening mammography
services furnished in CY 1994, the payment limit is $59.63. On January
1 of each subsequent year, the payment limit is updated by the
percentage increase in the Medicare Economic Index (MEI) and reflects
the relationship between the relative value units for the professional
and technical components of a diagnostic bilateral mammogram under the
fee schedule for physicians' services.
(c) Professional component billing representing only the
physician's interpretation for the procedure. If the professional
component of screening mammography services is billed separately, the
amount of payment for that professional component, subject to the
deductible, is equal to 80 percent of the least of the following:
* * * * *
(2) The amount established for the professional component of a
diagnostic bilateral mammogram under the fee schedule for physicians'
services.
(3) The professional component of the payment limit for screening
mammography services described in paragraph (b)(3) of this section.
(d) Technical component billing representing other resources
involved in furnishing the procedure. If the technical component of
screening mammography services is billed separately, the amount of
payment, subject to the deductible, is equal to 80 percent of the least
of the following:
* * * * *
(2) The amount established for the technical component of a
diagnostic bilateral mammogram under the fee schedule for physicians'
services.
(3) The technical component of the payment limit for screening
mammography services described in paragraph (b)(3) of this section.
3. Section 405.535 is revised to read as follows:
Sec. 405.535 Special rules for nonparticipating physicians and
suppliers furnishing screening mammography services.
If screening mammography services are furnished to a beneficiary by
a nonparticipating physician or supplier that does not accept
assignment, a limiting charge applies to the charges billed to the
beneficiary. The limiting charge is the lesser of the following:
(a) 115 percent of the payment limit set forth in
Sec. 405.534(b)(3), (c)(3), and (d)(3) (limitations on the global
service, professional component, and technical component of screening
mammography services, respectively).
(b) The limiting charge for the global service, professional
component, and technical component of a diagnostic bilateral mammogram
under the fee schedule for physicians' services set forth at
Sec. 414.48(b)(3) of this chapter.
B. Part 410, subpart B is amended as set forth below:
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
Subpart B--Medical and Other Health Services
1. The authority citation for part 410 is revised to read as
follows:
Authority: Secs. 1102, 1832, 1833, 1834, 1835, 1861(r), (s),
(aa), (cc), (ff), and (mm), 1871, and 1881 of the Social Security
Act (42 U.S.C. 1302, 1395k, 1395l, 1395m, 1395n, 1395x(r), (s),
(aa), (cc), (ff), and (mm), 1395hh, and 1395rr).
2. In Sec. 410.10, the introductory text is republished, and
paragraph (e) is revised to read as follows:
Sec. 410.10 Medical and other health services: Included services.
Subject to the conditions and limitations specified in this
subpart, ``medical and other health services'' includes the following
services:
* * * * *
(e) Diagnostic laboratory and X-ray tests (including diagnostic
mammography that meets the conditions for coverage specified in
Sec. 410.34(b) of this subpart) and other diagnostic tests.
* * * * *
3. Section 410.34 is amended by revising the heading, removing the
introductory text, revising paragraph (a), redesignating paragraphs
(b)(1) through (b)(6) as paragraphs (d)(1) through (d)(6), adding a
heading to newly redesignated paragraph (d), revising newly
redesignated paragraph (d)(1), and adding new paragraphs (b) and (c) to
read as follows:
Sec. 410.34 Mammography services: Conditions for and limitations on
coverage.
(a) Definitions. As used in this section, the following definitions
apply:
(1) Diagnostic mammography means a radiologic procedure furnished
to a symptomatic woman for the purpose of detecting breast disease and
includes a physician's interpretation of the results of the procedure.
(2) Screening mammography means a radiologic procedure furnished to
an asymptomatic woman for the purpose of early detection of breast
cancer and includes a physician's interpretation of the results of the
procedure.
(3) Supplier of diagnostic mammography means a facility that is
certified and responsible for ensuring that all diagnostic mammography
services furnished to Medicare beneficiaries meet the conditions for
coverage of diagnostic mammography services as specified in paragraph
(b) of this section.
(4) Supplier of screening mammography means a facility that is
certified and responsible for ensuring that all screening mammography
services furnished to Medicare beneficiaries meet the conditions and
limitations for coverage of screening mammography services as specified
in paragraphs (c) and (d) of this section.
(5) Certificate means the certificate described in 21 CFR 900.2(b)
that may be issued to, or renewed for, a facility that meets the
requirements for conducting an examination or procedure involving
mammography.
(6) Provisional certificate means the provisional certificate
described in 21 CFR 900.2(m) that may be issued to a facility to enable
the facility to qualify to meet the requirements for conducting an
examination or procedure involving mammography.
(7) The term meets the certification requirements of section 354 of
the Public Health Service (PHS) Act means that in order to qualify for
coverage of its services under the Medicare program, a supplier of
diagnostic or screening mammography services must meet the following
requirements:
(i) Must have a valid provisional certificate, or a valid
certificate, that has been issued by FDA indicating that the supplier
meets the certification requirements of section 354 of the PHS Act, as
implemented by 21 CFR part 900, subpart B.
(ii) Has not been issued a written notification by FDA that states
that the supplier must cease conducting mammography examinations
because the supplier is not in compliance with certain critical
certification requirements of section 354 of the PHS Act, implemented
by 21 CFR part 900, subpart B.
(iii) Must not employ for provision of the professional component
of mammography services a physician or physicians for whom the facility
has received written notification by FDA that the physician (or
physicians) is (or are) in violation of the certification requirements
set forth in section 354 of the PHS Act, as implemented by 21 CFR
900.12(a)(1)(i).
(b) Conditions for coverage of diagnostic mammography services.
Medicare Part B pays for diagnostic mammography services if they meet
the following conditions:
(1) They are ordered by a doctor of medicine or osteopathy (as
defined in section 1861(r)(1) of the Act).
(2) They are furnished by a supplier of diagnostic mammography
services that meets the certification requirements of section 354 of
the PHS Act, as implemented by 21 CFR part 900, subpart B.
(c) Conditions for coverage of screening mammography services.
Medicare Part B pays for screening mammography services if they are
furnished by a supplier of screening mammography services that meets
the certification requirements of section 354 of the PHS Act, as
implemented by 21 CFR part 900, subpart B.
(d) Limitations on coverage of screening mammography services. The
following limitations apply to coverage of screening mammography
services:
(1) The service must be, at a minimum--
(i) A four-view exposure (that is, a cranio-caudal and a medial
lateral oblique view of each breast); or
(ii) In the case of a postmastectomy patient, a two-view exposure
(that is, a cranio-caudal and a medial lateral oblique view) of the
remaining breast.
* * * * *
C. Part 411, subpart A is amended as set forth below:
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT
Subpart A--General Exclusions and Exclusion of Particular Services
1. The authority citation for part 411 continues to read as
follows:
Authority: Secs. 1102, 1834, 1842(l), 1861, 1862, 1866, 1871,
1877, and 1879 of the Social Security Act (42 U.S.C. 1302, 1395m,
1395u(l), 1395x, 1395y, 1395cc, 1395hh, 1395nn, and 1395pp).
2. In Sec. 411.15, the introductory text for the section is
republished, and paragraph (a)(1) is revised to read as follows:
Sec. 411.15 Particular services excluded from coverage.
The following services are excluded from coverage.
(a) Routine physical checkups such as--
(1) Examinations performed for a purpose other than treatment or
diagnosis of a specific illness, symptom, complaint, or injury, except
for screening mammography (including a physician's interpretation of
the results) that meets the conditions for coverage and limitations on
coverage of screening mammography specified at Sec. 410.34 of this
chapter and the certification requirements of section 354 of the PHS
Act, as implemented by 21 CFR part 900, subpart B.
* * * * *
D. Part 413, subpart F is amended as set forth below:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES
Subpart F--Specific Categories of Costs
1. The authority citation for part 413 is revised to read as
follows:
Authority: Secs. 1102, 1122, 1814(b), 1815, 1833 (a), (i), and
(n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act
as amended (42 U.S.C. 1302, 1320a-1, 1395f(b), 1395g, 1395l (a),
(i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww).
2. In Sec. 413.123, paragraph (b) is revised to read as follows:
Sec. 413.123 Payment for screening mammography performed by hospitals
on an outpatient basis.
* * * * *
(b) Payment to hospitals for outpatient services. Payment to
hospitals for screening mammography services performed on an outpatient
basis is determined in accordance with the technical component billing
requirements in Sec. 405.534(d) of this chapter.
PART 494--[REMOVED AND RESERVED]
E. Part 494 is removed and reserved.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance.)
Dated: August 3, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: September 8, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-24335 Filed 9-29-94; 8:45 am]
BILLING CODE 4120-01-P
