[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]


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[Federal Register: September 30, 1994]


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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.

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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 
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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-
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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