# Medicare Program; Limitations on Medicare Coverage of Intermittent Positive Pressure Breathing Machine Therapy

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## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** June 29, 1994

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[BPD-781-PN]
RIN 0938-AG44

Medicare Program; Limitations on Medicare Coverage of
Intermittent Positive Pressure Breathing Machine Therapy

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

ACTION: Proposed notice.

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SUMMARY: Intermittent positive pressure breathing (IPPB) machine
therapy is currently covered under Medicare as durable medical
equipment for patients whose ability to breathe is severely impaired.
Based on a Public Health Service recommendation, we propose to limit
Medicare coverage of IPPB machine therapy to: (1) Patients at risk of
respiratory failure because of decreased respiratory function secondary
to kyphoscoliosis or neuromuscular disorders; (2) patients with acute
severe bronchospasm or exacerbated chronic obstructive pulmonary
disease who fail to respond to other standard therapy; and (3) the
management of atelectasis that has not improved with simple therapy
(that is, incentive spirometry, postural drainage, or aerosol therapy).

DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on August
29, 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-781-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-781-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).
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
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
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-
2250. The cost for each copy is $4.50. As an alternative, you can view
and photocopy the Federal Register document at most libraries
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: Francina Spencer, (410) 966-4614

SUPPLEMENTARY INFORMATION:

I. Background

A. Program Description

Section 1862(a)(1)(A) of the Social Security Act (the Act)
generally prohibits payment for any expenses incurred for items or
services ``which, * * * 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 medical and
health care services and items that are not demonstrated to be safe and
effective by acceptable clinical evidence. This prohibition applies to
items for which claims are submitted under Medicare's durable medical
equipment (DME) benefit.
Currently, intermittent positive pressure breathing (IPPB) machine
therapy is covered under Medicare's DME benefit when ordered by a
physician for a patient whose ability to breathe is severely impaired.
IPPB machine therapy is also covered in the hospital setting, in
accordance with the program's respiratory therapy guidelines.
IPPB machine therapy uses a pressure-limited respirator to deliver
a gas, with or without humidity or an aerosol solution (a product that
is packaged under pressure and contains therapeutically or chemically
active ingredients for topical application, inhalation, or introduction
into body orifices), at various preset intervals, to mechanically aid
lung expansion, to deliver drugs, or assist respiration. It is commonly
administered through a mouthpiece for short periods of time in
spontaneous breathing and cooperative patients. Alternatively, this
technique has been used in patients with reversible acute respiratory
failure to forestall or prevent intubation. IPPB machine therapy has
been used in the treatment of acute bronchospasm (the contraction of
smooth muscle in the walls of the bronchi and broncheolus, causing
narrowing of the lumen), croup, chronic obstructive pulmonary disease
(COPD), cystic fibrosis, and neurological disorders affecting
spontaneous breathing, as well as a prophylaxis (the prevention of a
disease or of a process that can lead to disease) against the pulmonary
complications commonly seen after various surgeries.
During IPPB machine therapy, the lungs are actively inflated by
means of device-regulated positive pressure during inspiration; passive
deflation occurs during expiration as a consequence of the elasticity
of the lungs and chest wall. The IPPB machine therapy apparatus
involves a precision flow-sensitive valve that opens to a low set level
of inspiratory negative pressure (in patients with spontaneous
respiration). This is immediately followed by a gradual increase of
airway pressure to a preset level. At onset of expiration, the valve
closes and the airway pressure drops to the ambient atmospheric level,
permitting expiration without external resistance. The expired air is
released through a second valve, providing a minimal dead space.
While compressed or room air is commonly used to deliver
aerosolized medications, mixtures of helium and oxygen have also been
used in IPPB machine therapy. Although home use by patients is not
common, IPPB machine therapy has often been administered by hospital
respiratory therapists three or four times a day for 15- to 20-minute
sessions commonly using pressure and rate levels for adults of 15 to 20
cm water and 8 to 10 respirations per minute.

B. Recommendation to Limit Coverage of IPPB Machine Therapy

The medical efficacy of IPPB machine therapy had been seriously
questioned by well-known and respected authorities in the field of
pulmonary medicine. Consequently, the National Heart, Lung and Blood
Institute sponsored a 5-year clinical trial study from 1978 through
1982 on IPPB machine therapy for COPD. The study concluded that IPPB
machine therapy appeared to be no more effective in treating patients
than the use of a simple hand-held nebulizer. As a result of this
study, a compilation of the latest medical and scientific literature on
the subject of IPPB machine therapy was presented to the HCFA
Physicians Panel on May 7, 1986.
In 1986, the HCFA Physicians Panel, which met approximately once
every 6 to 8 weeks, was comprised of physicians and other health
professionals in HCFA's Central Office and their counterparts from the
Public Health Service (PHS). HCFA's chief source of medical assessments
on issues of medical safety and efficacy of services and items is PHS.
The Panel recommended that PHS's Office of Health Technology Assessment
(OHTA) conduct an assessment of the safety and effectiveness of IPPB
machine therapy. The use of OHTA to conduct this assessment is
consistent with HCFA's long-standing procedures for making coverage
decisions, as discussed in the proposed rule entitled ``Medicare
Program; Criteria and Procedures for Making Medical Services Coverage
Decisions that Relate to Health Care Technology'' published on January
30, 1989, in the Federal Register (54 FR 4302).
OHTA announced in the Federal Register on June 17, 1986 (51 FR
21984), on August 29, 1988 (53 FR 32941), and on April 10, 1990 (55 FR
13325), that it was coordinating an assessment of the safety and
effectiveness of IPPB machine therapy. The notices requested
information as to the risks and benefits associated with the use of
this mode of treatment. OHTA also requested information pertaining to
the advantages and disadvantages of IPPB machine therapy in the
treatment of acute bronchospasm, COPD, or other forms of lung diseases.
In addition, it requested information on other uses of IPPB machine
therapy either as a therapeutic modality or as a preventive measure
against pulmonary complications following abdominal surgery. OHTA
sought the information to determine if this treatment method offers any
advantages over using a compression nebulizer or a meter-dose inhaler
with or without the drug B-agonists. OHTA also requested information
about the clinical results of IPPB machine therapy as compared to deep
breathing exercises (DBE) or incentive spirometry (IS) (pulmonary
measurement with a spirometer) as well as comparison of complications
with the use of a hand-held nebulizer. Finally, the notices requested
whether there were conditions or circumstances under which IPPB machine
therapy is not only a reasonable and necessary therapy but is the
preferred therapy.
The notices invited relevant information from any person or group
wishing to respond. In response to the three OHTA Federal Register
notices and the solicitation of information and opinions from
physicians and institutions involved with IPPB machine therapy, OHTA
received 12 comments. They included information and advice from PHS
components, including the Food and Drug Administration (FDA) and the
National Institutes of Health (NIH), and from medical specialty groups
and other respondents to the notices. OHTA evaluated this information.
On March 12, 1991, OHTA provided us with recommendations concerning
Medicare coverage for IPPB machine therapy, based substantially on the
information and advice it received in response to its solicitation.
(The assessment, by the U.S. Department of Health and Human Services,
Public Health Service, Agency for Health Care Policy Research (AHCPR),
was entitled ``Intermittent Positive Pressure Breathing Therapy
(IPPB).'' The AHCPR Health Technology Assessment Report, Number 1, was
published in December 1991. Copies of the assessment may be obtained
from the Publications and Information Branch, National Center for
Health Services Research, 5600 Fishers Lane, Parklawn Building, Room
18-12, Rockville, Maryland 20857.) OHTA finds that the only categories
for which the technology is useful are: (1) Patients at risk of
respiratory failure because of decreased respiratory function secondary
to kyphoscoliosis (the convex backward and lateral curvature of the
spine: Severe, congestive heart failure is not infrequently a
complication) or neuromuscular disorders (referring to the relationship
between nerve and muscle, in particular to the motor innervation of
skeletal muscles and its pathology); (2) patients with acute severe
bronchospasm or exacerbated COPD who fail to respond to other standard
therapy; and (3) the management of atelectasis (the absence of gas from
a part or the whole of the lungs as a result of the failure of
expansion or resorption of gas from the alveoli) that has not improved
with simple therapy (that is, IS, postural drainage, or aerosol
therapy). While these specified conditions are generally treated in a
hospital, it is conceivable that in certain circumstances, and for
selected patients, the clinical condition could be effectively treated
in an outpatient setting. There are no data that support the conclusion
that IPPB machine therapy must be furnished in the inpatient setting in
order to treat these conditions. We have reviewed the record of current
medical opinion on this therapy since 1991 and believe that the
conclusions reached by PHS in 1991 remain valid.
Although there is currently a lack of scientific data regarding the
efficacy of IPPB machine therapy, there was, however, some rationale
for its wide application. According to the OHTA report, after the 1947
demonstration by H. Motley, L. Werko, A. Cournand, and others,
described in the article entitled ``Observations on the Clinical Use of
Intermittent Positive Pressure'' (J Aviation Med 1947; 18:417-435),
which indicated that the use of IPPB machine therapy can increase lung
volume and improve blood gases, proponents of this technology offered
the rationale that, especially for patients with COPD, IPPB machine
therapy would--
(1) Provide better distribution of inhaled aerosols or gases to
poorly ventilated areas of the lungs;
(2) Augment humidity and decrease airway obstruction to facilitate
removal of excessive pulmonary secretions;
(3) Decrease effort of breathing;
(4) Induce cough; and
(5) Increase inspired volume.
In addition, it was recognized that postoperative pulmonary
complications are the most frequent cause of postoperative morbidity;
these complications occur in 20 to 40 percent of patients, particularly
those subjected to abdominal or thoracic surgery. In an article
entitled ``Role of Intermittent Positive Pressure Breathing
Postoperatively'' (JAMA 1958; 167:1093-1096), N.E. Rudy and J. Crepeau
first proposed the use of IPPB machine therapy as a method of
preventing the common postoperative sequence of progressive alveolar
collapse, atelectasis, and pneumonia. Proponents of IPPB machine
therapy have promoted its widespread use as a routine postoperative
prophylactic technique, especially for patients with COPD, obesity, or
cardiovascular diseases, and for the elderly.
OHTA advises that clinical studies have not adequately addressed
optimal techniques for the delivery of respiratory therapy and patient
selection criteria. The use of IPPB machine therapy, however, has
evolved as a controversial modality in medicine. Despite the immense
popularity of IPPB machine therapy in the 1960's and the early 1970's,
the increasing number of reports questioning its clinical utility and
the conflicting data from controlled trials of its efficacy in the
prevention or treatment of pulmonary conditions have resulted in a
marked reduction of its use. In recent years, IPPB machine therapy has
represented only a very small percentage of the total volume of
respiratory therapy services.
The failure of the medical literature to document the efficacy of
IPPB machine therapy has resulted in physicians and respiratory
therapists often recommending alternative therapies, including postural
change, IS, DBE, cough regimens, chest physiotherapy, and aerosols for
therapy or prophylaxis. Generally agreed upon specifications for the
administration of IPPB machine therapy do not exist. Volumes, flows,
pressures, duration and frequency of therapy, and associated medication
have not been standardized for the treatment of any condition. All the
mechanical effects of IPPB machine therapy are short-lived, lasting
only about 1 hour after treatment, and its long-term effects have not
been adequately evaluated.
Some case studies have suggested that IPPB machine therapy might be
valuable for the treatment of atelectasis in the patients failing DBE
or IS, those with severe bronchospasm, and in patients whose
respiratory muscles are fatigued. However, subsets of patients for whom
beneficial effects of IPPB machine therapy can be derived have not been
conclusively identified. In addition, P.P. Sutton, D. Pavia, and J.R.M.
Bateman have stated in ``Chest Physiotherapy: A Review'' (Eur J Respir
Dis 1982; 63:188-201) that it is excessively optimistic to expect IPPB
machine therapy (provided for only 15 minutes, three or four times
daily) to result in significant clinical benefits.
A beneficial effect of IPPB machine therapy derives from its
ability to deliver aerosolized medications. However, most reported
studies have failed to separate the pharmacological effects of the
bronchodilator from the mechanical effects of the IPPB machine therapy.
If IPPB machine therapy is effective in the treatment of severe COPD or
bronchospasm, these positive effects appear to be readily duplicated by
more physiologic and simpler techniques than IPPB machine therapy.
Explanations for the lack of efficacy of IPPB machine therapy, when
using the commonly applied pressure cycled devices to prevent or treat
postoperative pulmonary complications, relate to the fact that the
machines used to deliver IPPB therapy allow only for a pressure
adjustment, without measurement or control of maximum lung volume.
Therefore, a reduction in functional residual capacity combined with
the typical postoperative decrease in pulmonary compliance results in a
smaller volume of gas delivered for the same pressure, which can lead
to more shallow ventilation. In the presence of atelectasis, increased
inflation pressures could overextend normal alveoli and lead to a
ventilation-perfusion mismatch and exacerbation of hypoxemia.
Additional risks of IPPB machine therapy include infection,
excessive ventilation and excessive oxygenation (when using oxygen as
the gas source), decreased partial pressure of carbon dioxide during
treatment, the induction or exacerbation of pneumothorax (the presence
of air or gas in the pleural cavity), and the exacerbation of
hemoptysis (the expectoration of blood or of blood-stained sputum).
The following is a summary of the 12 comments OHTA received in
response to its Federal Register notices of its assessment and the
solicitation of information and opinions from physicians and
institutions involved with IPPB machine therapy:
One professional society and one university medical center believed
that there is no evidence that IPPB machine therapy is useful or
desirable for home use. Two other professional organizations believed
there is little evidence to support the concept that IPPB machine
therapy is of value as a preventive measure against the pulmonary
complications following any type of major surgery. They further stated
that for the prevention or treatment of postoperative atelectasis, IS
and DBE are more effective than routine IPPB machine therapy. One
clinic stated there is no evidence to show that IPPB machine therapy
has any advantage in bronchitis and emphysema COPD. The clinic stated,
however, that IPPB machine therapy might be beneficial in individuals
whose respiratory muscles fail because of paralysis or chest wall
deformity (for example, kyphoscoliosis) resulting in respiratory
``pump'' failure. In addition, the clinic commented that there is no
clear-cut evidence that IPPB machine therapy used routinely after
abdominal surgery prevents pulmonary complications.
Three other professional associations and a university medical
department believed that IPPB machine therapy is of value in specific
limited circumstances and should not be regarded as a routine
therapeutic modality. One professional association believed that, in
patients unable to coordinate their breathing pattern to obtain maximal
benefit from aerosols delivered by simple devices, the use of IPPB
machine therapy may allow more effective aerosol therapy. This
professional association recommended IPPB machine therapy, coupled with
DBE and chest physiotherapy, to help decrease or control unstable
carbon dioxide tension in patients with exacerbated COPD and severe
ventilatory impairment. In addition, the association stated that the
use of IPPB machine therapy in the prophylaxis of atelectasis remains
controversial. However, the association believed that IPPB machine
therapy can be beneficial in treating acute lobar atelectasis. It also
supported the use of IPPB machine therapy as the preferred mode of
therapy for hospitalized kyphoscoliosis patients who may be at risk of
developing respiratory failure.
The position of another professional association concerning IPPB
machine therapy is that it offers no advantage over alternative modes
of routine treatment for most patients with stable asthma, chronic
bronchitis, and emphysema, and there is no evidence that IPPB machine
therapy offers any advantage over standard bronchial hygiene therapy.
In addition, the association stated that IPPB machine therapy is of
value for the following circumstances and should not be regarded as a
routine therapeutic modality: For therapeutic purposes, IPPB machine
therapy (with or without aerosol) may be appropriate for the following
purposes: (1) For pulmonary atelectasis (segmental or greater) when
alternative modes of therapy have been unsuccessful; (2) for patients
unable to raise secretions adequately because of the presence of a
pathological process that severely limits their ability to ventilate
deeply and cough effectively, and who have been unresponsive to, or are
judged to be unsuited for, other modes of treatment; and (3) for the
temporary treatment of hypoventilating patients when it may be
appropriate to use IPPB machine therapy as an alternative to tracheal
intubation and continuous mechanical ventilation. For prophylactic
purposes, IPPB machine therapy may be appropriate to prevent
postoperative complications in patients with limited ability to cough
or breathe deeply.
Another professional organization believed the usefulness of IPPB
machine therapy is limited to patients with obstructive airway disease
with acute carbon dioxide retention, and to facilitate aerosolized
bronchodilator delivery in patients having tachypnea (excessive
rapidity of respiration) and confusion. The organization stated that
IPPB machine therapy has been abandoned for the delivery of aerosol
therapy per se and recommended that its use for otherwise uncomplicated
atelectasis, mucus retention, or postsurgical prophylaxis be
discouraged.
One university medical department stated there is no current
indication for the use of IPPB machine therapy as a treatment for acute
bronchospasm or COPD, since the use of a spontaneous aerosol is as good
as, if not better than, IPPB machine therapy, and DBE or IS have been
shown to be the best ways to treat or prevent pulmonary complications
following surgery. The only indication for IPPB machine therapy,
according to this medical department, is to support an individual who
has stopped breathing until the patient can be placed on an
appropriate, sophisticated volume-cycled ventilator.
In addition, although a university hospital stated that it no
longer uses IPPB machine therapy for the administration of aerosol
solutions, the hospital believed some benefit may be obtained in
administering these solutions by IPPB machine therapy in patients with
severe kyphoscoliosis.
After a 5-year study, the National Heart, Lung and Blood Institute
reached the conclusion that IPPB machine therapy appears to offer no
advantage over simple aerosol nebulizer therapy in the treatment of
patients with stable, chronic asthma. NIH stated that the randomized
trial supported by the National Heart, Lung and Blood Institute
demonstrated no significant difference between IPPB machine therapy and
compressor nebulizer therapy in the long-term management of patients
with COPD. NIH noted that studies of IPPB machine therapy for the
treatment of acute episodes of bronchospasm have produced conflicting
results, and there is increasing evidence that IPPB machine therapy is
not superior, and may be inferior, to other prophylactic treatments
designed to reduce respiratory complications following abdominal
surgery.
In its summary, OHTA indicates that the early widespread
application of IPPB machine therapy has now dramatically diminished in
response to published reports of more recent clinical trials that
either question its utility or document its futility in the prophylaxis
or treatment of the numerous conditions for which it was commonly
prescribed. As indicated by the OHTA assessment, the associated risks
of IPPB machine therapy include more shallow ventilation, ventilation
perfusion mismatch and exacerbation of hypoxemia, infection, decreased
partial pressure of carbon dioxide during treatment, the induction or
exacerbation of pneumothorax, blood-stained sputum, and precipitate
cardiac failure. Moreover, no study has shown IPPB machine therapy to
have unequivocal clinical effectiveness, in terms of morbidity,
mortality, or lung function, when used either alone or in combination
with other modalities. However, IPPB machine therapy may be useful in
the following circumstances: (1) In patients at risk of respiratory
failure because of decreased respiratory function secondary to
kyphoscoliosis or neuromuscular disorders; (2) in patients with acute
severe bronchospasm or exacerbated COPD who failed to respond to other
standard therapy; and (3) in the management of atelectasis that has not
improved with simpler therapy (that is, IS, postural drainage, or
aerosol therapy).
However, the article by Scott F. Davies and Roland H. Ingram
entitled ``Pulmonary Rehabilitation'' (Scientific American Medicine
1992; 14:3, 15) states that the use of IPPB machine therapy and
instruction in special patterns of breathing (also called breathing
retraining) have been abandoned for the most part because beneficial
results, if demonstrated at all, were not sustained beyond the actual
period during which the techniques were practiced.

II. Provisions of the Proposed Notice

Medicare's policy has been to cover the general use of IPPB machine
therapy if the patient's breathing is severely impaired (Medicare
Coverage Issues Manual (HCFA Pub. 6) section 60-9, Durable Medical
Equipment Reference List) and if the therapy is effective for the
breathing impairment. However, after reviewing the medical evidence and
recommendations included in the OHTA assessment, provided to us on
March 12, 1991, we believe the coverage should be limited to three
specific uses of IPPB machine therapy.
OHTA's study does not support the complete withdrawal of coverage
of IPPB machine therapy. The National Heart, Lung and Blood Institute
had suggested the complete withdrawal of IPPB machine therapy because
of its belief that IPPB machine therapy is of minimal therapeutic
benefit and that it exposes the patient to undue risk, for example,
precipitate cardiac failure. The OHTA information, however, does
support limiting IPPB machine therapy use to three specific categories,
namely: (1) Patients at risk of respiratory failure because of
decreased respiratory function secondary to kyphoscoliosis or
neuromuscular disorders; (2) patients with acute severe bronchospasm or
exacerbated COPD who fail to respond to other standard therapy; and (3)
in the management of atelectasis that has not improved with simple
therapy (that is, IS, postural drainage, or aerosol therapy).
Since OHTA's assessment indicates that uses other than those
identified above are not established as effective, we propose, under
the authority of section 1862(a)(1)(A) of the Act, to withdraw from
Medicare coverage any uses except the three conditions identified
above. Issuance of this notice is consistent with the January 30, 1989,
Federal Register proposed rule that describes the process for making
Medicare coverage decisions and states that the process for withdrawal
of coverage of services includes the publication of a proposed notice
of that withdrawal in the Federal Register. We would not exclude
payment for conditions other than the three identified above until 30
days after the date the final notice is published in the Federal
Register. We welcome public comments on this proposal.
The provisions of this notice would not affect any currently
existing Medicare regulations. However, they would affect the Medicare
Coverage Issues Manual (HCFA Pub. 6) section 60-9, Durable Medical
Equipment Reference List.

III. 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.).

IV. Response to Comments

Because of the large number of items of correspondence we normally
receive on Federal Register 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. Regulatory Impact Statement

A. Introduction

Currently, IPPB machine therapy is covered under Medicare's DME
benefit if ordered by a physician for a patient whose ability to
breathe is severely impaired. We propose to limit Part B Medicare
coverage of IPPB machine therapy to the three categories listed in
section I.B. of this preamble for which the technology is considered
useful by OHTA. Despite the immense popularity of IPPB in the 1960's
and the early 1970's, the increasing number of reports questioning its
clinical utility and the conflicting data from controlled trials of its
efficacy in the prevention or treatment of pulmonary conditions have
resulted in a marked reduction of its use. In recent years, IPPB
machine therapy has represented only a very small percentage of the
total volume of respiratory therapy services. Because of the low total
payments currently made by Medicare Part B for this service, less than
$6 million in calendar year 1992, we believe these additional limits
would result in negligible savings during calendar years 1994 through
1998.

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, respiratory
therapists, facilities that are providing this therapy, and suppliers
of IPPB machines 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.
The early widespread application of IPPB machine therapy has now
dramatically diminished in response to published reports of more recent
clinical trials that either question its utility or document its
futility in the prevention or treatment of the numerous conditions for
which it was commonly prescribed. Section 1862(a)(1)(A) of the Act
states in general terms that no payment may be made under Part A or
Part B of Medicare for any expenses incurred 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. Because of the limited use of IPPB machine therapy in recent
years, this proposed notice, imposing limits on coverage, would have
only a minimal effect on small entities. We would not exclude payment
for any therapy until 30 days after the date the final notice is
published, which should allow sufficient time for physicians to
reevaluate a beneficiary's condition and prescribe alternative therapy
if appropriate.
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 proposed 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.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.

(Sections 1861 and 1862 of the Social Security Act (42 U.S.C. 1395x and
1395y))

(Catalog of Federal Domestic Assistance Program No 93.774, Medicare
Supplementary Medical Insurance)

Dated: May 11, 1994
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.

Dated: June 22, 1994
Donna E. Shalala,
Secretary.

Addendum

U.S. Department of Health and Human Services, Public Health
Service, Agency for Health Care Policy Research, ``Intermittent
Positive Pressure Breathing Therapy (IPPB),'' AHCPR Health Technology
Assessment Report, Number 1, December 1991

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[FR Doc. 94-15773 Filed 6-28-94; 8:45 am]
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