Health Care Financing Administration [BPDÄ780ÄPN]

RIN 0938ÄAG43

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

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed notice.

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: BPDÄ780ÄPN, 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 309ÄG, 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
BPDÄ780ÄPN. 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 309ÄG 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) 690Ä7890).

FOR FURTHER INFORMATION CONTACT: Anne Marie Hummel, (410) 966Ä4637.

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. 13Ä3) and section 2055 of the Medicare Carriers
Manual (HCFA Pub. 14Ä3), under limited circumstances, for example, to confirm
appropriate treatment and for a maximum of 2 nights of testing. Section 35Ä24,
"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: 1Ä800Ä358Ä9295.) 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. 14Ä3).

 Section 3112.5 of the Medicare Intermediary Manual (HCFA Pub. 13Ä3).

 Section 35Ä24 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. 94Ä41 Filed 1Ä3Ä94; 8:45 am]

BILLING CODE 4120Ä01ÄP