[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