[Federal Register Volume 59, Number 124 (Wednesday, June 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15773]


[[Page Unknown]]

[Federal Register: June 29, 1994]


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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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