[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Notices]
[Pages 308-311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-41]
[[Page Unknown]]
[Federal Register: January 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-780-PN]
RIN 0938-AG43
Medicare Program; Withdrawal of Coverage of Diagnostic Nocturnal
Penile Tumescence Testing (Impotence Testing)
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed notice.
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SUMMARY: This notice announces the Medicare program's proposal to
revise its national policy by withdrawing coverage for diagnostic
nocturnal penile tumescence (NPT) testing in the sleep disorder clinic.
For all other settings, we are proposing to exclude rather than
withdraw coverage because the Medicare program does not have a national
policy that provides for coverage of NPT testing by plethysmography and
other monitoring devices in settings other than sleep disorder clinics.
Public Health Service studies show that NPT testing is not a reliable
index for evaluating impotence. Therefore, it does not meet HCFA's
criteria for effectiveness.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on March
7, 1994.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address:
Health Care Financing Administration, Department of Health and Human
Services, Attention: BPD-780-PN, P.O. Box 26688, Baltimore, MD 21207.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore,
MD 21207.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code BPD-780-PN. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in room 309-G of
the Department's offices at 200 Independence Avenue, SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Anne Marie Hummel, (410) 966-4637.
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
Administration of the Medicare program is governed by the Medicare
statute, title XVIII of the Social Security Act (the Act). The Congress
intended, at the time Medicare was enacted in 1965, that Medicare
provide health insurance to protect the elderly (and later, the
disabled) from the substantial costs of health care services. The
Medicare law provides coverage for broad categories of benefits,
including inpatient and outpatient hospital care, skilled nursing
facility (SNF) care, home health care, and physicians' services.
The Medicare program consists of two separate but complementary
health insurance programs, a Hospital Insurance (HI) program (known as
Part A) and a Supplementary Medical Insurance (SMI) program (known as
Part B). Although Part A is called Hospital Insurance, covered benefits
also include medical services furnished in SNFs or by home health
agencies (HHAs) and hospices. For purposes of the Medicare program, we
refer to these entities as ``providers.'' These providers must be
certified as qualified providers of services and must sign an agreement
to participate in the program. Part B covers a wide range of medical
services and supplies such as those furnished by physicians, providers,
or others in connection with physicians' services, outpatient hospital
services, outpatient physical therapy and occupational therapy
services, and home health services. Physicians' services covered under
Part B include visits to patients in the home, office, hospital, and
other institutions. Part B also covers certain drugs and biologicals,
diagnostic x-ray and laboratory tests, purchase or rental of durable
medical equipment (DME), ambulance services, prosthetic devices, and
certain medical supplies.
While the Medicare law provides coverage for the broad categories
of benefits described above, it also places categorical limitations on
the coverage of the services furnished by certain health care
practitioners, such as dentists, chiropractors, and podiatrists, and it
specifically excludes some categories of services from coverage, such
as cosmetic surgery, personal comfort items, custodial care, and
routine physical checkups. The statute also provides direction as to
the manner in which payment is made for Medicare services, the rules
governing eligibility for services, and the health, safety, and quality
standards to be met by providers and some types of suppliers that
furnish services to Medicare beneficiaries.
The Medicare law does not, however, provide an all-inclusive list
of specific items, services, treatments, procedures, or technologies
covered by Medicare. Thus, except for the examples of DME in section
1861(n) of the Act, some of the medical and other health services
listed in section 1861(s) of the Act, and exclusions from coverage
listed in section 1862(a) of the Act, the statute does not specify
medical devices, surgical procedures, or diagnostic and therapeutic
services that should be covered or excluded from coverage.
The Congress understood that questions about coverage for specific
services would arise and would require us to make specific decisions
about coverage. Thus, it gave the Secretary the authority to make those
decisions. Section 1862(a)(1)(A) of the Act prohibits payment for items
or services that ``are not reasonable and necessary for the diagnosis
or treatment of illness or injury or to improve the functioning of a
malformed body member.''
We have interpreted this statutory provision to exclude from
Medicare coverage those medical and other health care services that are
not demonstrated to be safe or effective. Effectiveness in this context
is the probability of benefit to individuals from a medical item,
service, or procedure for a given medical problem under average
conditions of use; that is, day-to-day medical practice. In day-to-day
medical practice, physicians diagnose and treat clinical conditions
following inquiry into an individual's medical history, performance of
a physical examination, and interpretations of a variety of diagnostic
tests and procedures. To be of value to the physician, the information
obtained from any diagnostic test or procedure must be sufficiently
accurate to provide a reasonably reliable measure for establishing or
ruling out the presence of a given disease. Payment may not be made
under Medicare for any diagnostic test or procedure that does not
produce accurate results when properly performed, since that test
cannot be considered ``reasonable and necessary for the diagnosis or
treatment of illness or injury.''
B. Medicare Coverage of Diagnostic Nocturnal Penile Tumescence Testing
(Testing for Impotence)
Impotence is the inability to attain and maintain an erection
sufficient to permit satisfactory intercourse and is considered by
Medicare to be the failure of a body part when the diagnosis, and
frequently the treatment, require medical expertise. Impotence can be
organic or psychogenic in origin. The focus of diagnostic tests is to
determine the origin of impotence to establish the appropriate
treatment.
Currently, Medicare covers diagnostic NPT testing by
plethysmography (for example, mercury strain gauges) and other
monitoring devices in a sleep disorder clinic to determine whether
erectile impotence is organic or psychogenic. Although impotence is not
a sleep disorder, the nature of the testing requires that it be
performed while the patient sleeps. In the past, it was believed that
patients with predominantly psychogenic impotence would regularly
attain normal erections during rapid-eye-movement (REM) sleep, while
patients with organic impotence would not demonstrate significant
sleep-associated normal erections.
During NPT testing, mercury strain gauges placed on the shaft of
the penis can detect and measure changes in penile circumference during
sleep. A normal result of NPT, measured with strain gauges, is two or
more periods of sustained erections lasting more than 20 minutes and
associated with at least a 25-mm increase in penile circumference.
Normal NPT in a person with sexual dysfunction implies intact
neurovascular structures and suggests psychogenic impotence. An
abnormal recording, however, is not definitive and only suggests
organic impotence and will require further testing for a more definite
diagnosis. In addition, NPT testing has a high incidence (15 to 20
percent) of false-positive and, although not as common, false-negative
findings.
Currently, diagnostic NPT testing in a sleep disorder clinic is
listed as covered under ``Sleep Disorder Clinics'' in section 3112.5 of
the Medicare Intermediary Manual (HCFA Pub. 13-3) and section 2055 of
the Medicare Carriers Manual (HCFA Pub. 14-3), under limited
circumstances, for example, to confirm appropriate treatment and for a
maximum of 2 nights of testing. Section 35-24, ``Diagnosis and
Treatment of Impotence,'' of the Medicare Coverage Issues Manual (HCFA
Pub. 6), does not address the use of plethysmography, a non-specific
test for vascular competence, which may include monitoring devices,
rigidometers, strain gauges, and stamp tests. However, we are revising
this manual section to state that plethysmography is noncovered for use
in the diagnosis of impotence because it does not indicate the rigidity
and the duration of tumescence, both of which are necessary components
in the evaluation of impotence. (Before publication, RS will confirm
the status of this manual instruction.)
C. Recommendations to Withdraw Coverage for Diagnostic Nocturnal
Penile Tumescence Testing in a Sleep Disorder Clinic
In 1986, a Medicare contractor requested advice about paying for
items and services related to impotence testing. Medicare coverage
instructions on the diagnosis and treatment of impotence did not
specifically address the issues of plethysmography and in-home
impotence testing devices. At that time, two monitoring devices had
been developed for in-home testing under a physician's direction: the
Snap-gauge, which measures the tumescence of the penis during sleep,
and Rigiscan, which measures the duration and frequency of erections as
well as the degree of rigidity and tumescence during sleep.
As a result, we consulted the HCFA Physicians Panel, a group of
staff physicians and other health professionals in HCFA's central
office and their counterparts in the Public Health Service (PHS). They
advised us to ask PHS, through the Office of Health Technology
Assessment (OHTA), to assess the safety and effectiveness of the
principal diagnostic tests for impotence currently in use. (Our current
process for making coverage decisions is discussed in the January 30,
1989, proposed rule entitled ``Medicare Program Criteria and Procedures
for Making Medical Services Coverage Decisions that Relate to Health
Care Technology'' (54 FR 4305)).
In September 1986, we asked OHTA to conduct a full assessment of
the safety and effectiveness of diagnostic tests for impotence and the
methods for treating impotence. To conduct this assessment, OHTA
solicited information from manufacturers, researchers, other government
agencies, other components of PHS, and the National Institutes of
Health (NIH). OHTA also evaluated the latest scientific studies,
medical literature, information from medical specialty groups, and
respondents to the March 19, 1987, notice entitled ``National Center
for Health Services Research and Health Care Technology Assessment;
Assessment of Medical Technology'' (54 FR 8648). In that notice, OHTA
announced that it was assessing the safety and effectiveness of
diagnostic tests and treatment methods for impotence. OHTA researched
and analyzed published medical and scientific literature and relevant
studies and reports.
At the time we received the OHTA assessment on the diagnosis and
treatment for impotence dated October 31, 1989, we asked for an
assessment on sleep disorders. (Since December 1989, OHTA has been a
part of PHS' Agency for Health Care Policy and Research.) The OHTA
assessment, ``Sleep Disorders,'' dated February 3, 1992, did not raise
issues that would result in further coverage changes. Although OHTA's
assessment on the diagnosis and treatment of impotence was issued 3
years ago, we have determined that the medical evidence and conclusions
of the assessment are still accurate based on our own medical expertise
and a thorough review of all the medical literature on the subject
since 1989.
The OHTA assessment, ``Public Health Service Assessment--The
Diagnosis and Treatment of Impotence'' includes a bibliography of
studies evaluating the effectiveness of various types of impotence
testing and treatment. (Copies of this assessment may be obtained from
the Agency for Health Care Policy and Research Publications
Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907; Toll Free: 1-
800-358-9295.) In the assessment, OHTA concluded that reliable tests
for evaluating impotence include Doppler ultrasound, arteriography,
cavernosography, cavernosometry, hormonal assays, and
electrophysiological testing. NPT testing by plethysmography and other
monitoring devices in the clinical setting or in the home is determined
to be unreliable.
According to OHTA, there are no accepted standards for NPT test
results. Results cannot be compared among laboratories because each
laboratory has its own set of standards by which to evaluate NPT.
False-positive and false-negative results occur frequently indicating
that NPT testing is not a reliable index for differentiating organic
from psychogenic impotence, thereby making it impossible to choose the
appropriate treatment. Also, OHTA does not consider other in-home
monitoring devices to be reliable for diagnosing impotence.
II. Provisions of This Proposed Notice
Based on the conclusion of the OHTA technology assessment that
scientific evidence indicates that NPT testing is not a reliable index
for evaluating impotence, we have concluded that NPT testing does not
meet our criteria for effectiveness. Therefore, we propose to revise
our national policy by withdrawing coverage for NPT testing in the
sleep disorder clinic. We do not have a national policy regarding NPT
testing in other settings. Therefore, we propose to exclude coverage
for NPT testing, rather than withdraw coverage, in all other settings.
Because NPT test results are not standardized and are frequently
inaccurate and have a high rate of false-positive and false-negative
results, the appropriate treatment cannot be determined.
The provisions of this notice would not affect existing Medicare
regulations. However, they would affect the following manual
instructions:
Section 2055 of the Medicare Carriers Manual (HCFA Pub.
14-3).
Section 3112.5 of the Medicare Intermediary Manual (HCFA
Pub. 13-3).
Section 35-24 of the Medicare Coverage Issues Manual (HCFA
Pub. 6).
III. Regulatory Impact Statement
A. Executive Order 12291
Executive Order 12291 (E.O. 12291) requires us to prepare and
publish a regulatory impact analysis for any notice that meets one of
the E.O. 12291 criteria for a ``major rule''; that is, that would be
likely to result in--
An annual effect on the economy of $100 million or more;
A major increase in costs or prices for consumers,
individual industries, Federal, State, or local government agencies, or
geographic regions; or
Significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based enterprises to compete with foreign-based enterprises in
domestic or export markets.
We propose to revise our national policy and to withdraw Medicare
program coverage for NPT testing in the sleep disorder clinic. Because
we do not have a national policy regarding NPT testing in other
settings, we propose to exclude coverage, rather than withdraw
coverage, for NPT testing by plethysmography and other monitoring
devices in all other settings. In calendar year 1992, Medicare payment
for NPT testing totaled approximately $840,000 for 13,000 allowed
services. This is an increase of approximately 26 percent in
expenditures and a 3 percent increase in the number of services over
the previous year. We anticipate that future costs or savings as a
result of this notice would be negligible. This notice would not meet
the $100 million criterion nor would it meet the other E.O. 12291
criteria. Therefore, this notice is not a major rule under E.O. 12291,
and an initial regulatory impact analysis is not required.
B. Regulatory Flexibility Act
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless the Secretary certifies that a notice would not
have a significant economic impact on a substantial number of small
entities. For purposes of the RFA, all physicians, sleep disorder
clinics, and manufacturers of devices for performing the NPT test are
considered to be small entities.
In addition, section 1102(b) of the Act requires the Secretary to
prepare a regulatory impact analysis if a notice 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 603
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.
Currently, Medicare covers diagnostic NPT testing. Although
impotence is not a sleep disorder, the nature of the testing requires
that it be performed while a patient sleeps. As discussed in detail in
section I.C. of this notice, the OHTA technology assessment has
concluded that NPT testing in the sleep disorder clinic is not a
reliable index for evaluating impotence. False-positive and false-
negative results occur frequently indicating that NPT testing is not a
reliable indicator for choosing the appropriate treatment. Based on
scientific evidence that indicates that NPT testing is not a reliable
index for evaluating impotence, we have concluded that NPT testing does
not meet our criteria for effectiveness, a primary requirement for
Medicare program coverage. We believe the test has not been performed
often by medical practitioners because of the test's limited value.
Therefore, we propose to withdraw Medicare coverage of NPT testing in
the sleep disorder clinic and exclude coverage of NPT testing by
plethysmography and other monitoring devices in all other settings. Our
decision to withdraw coverage should have only a minimal effect on
small entities.
Therefore, we are not preparing analyses for either the RFA or
section 1102(b) of the Act since we have determined, and the Secretary
certifies, that this notice would not result in a significant economic
impact on a substantial number of small entities and would not have a
significant impact on the operations of a substantial number of small
rural hospitals.
IV. Response to Comments
Because of the large number of items of correspondence we normally
receive on FR documents published for comment, we are not able to
acknowledge or respond to them individually. We will consider all
comments we receive by the date and time specified in the DATES section
of this preamble, and, if we proceed with a subsequent document, we
will respond to the comments in the preamble to that document.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
Authority: Secs. 1861 and 1862 of the Social Security Act (42
U.S.C. 1395x and 1395y.
(Catalog of Federal Domestic Assistance Program No. 13.774, Medicare
Supplementary Medical Insurance)
Dated: July 14, 1993.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: November 28, 1993.
Donna E. Shalala,
Secretary.
[FR Doc. 94-41 Filed 1-3-94; 8:45 am]
BILLING CODE 4120-01-P