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

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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