Medicare Program; Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence Testing)

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