[Federal Register Volume 68, Number 163 (Friday, August 22, 2003)]
[Proposed Rules]
[Pages 50735-50739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21443]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-1167-P]
RIN 0938-AL27


Medicare Program; Payment for Respiratory Assist Devices With Bi-
level Capability and a Back-up Rate

AGENCY: Center for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would clarify that respiratory assist 
devices with bi-level capability and a back-up rate must be paid as 
capped rental items and not paid as items requiring frequent and 
substantial servicing (FSS), as defined in section 1834(a)(3) of the 
Social Security Act. This action would correct coding and payment 
errors, which began in 1994, when some Medicare contractors 
misinterpreted our statutorily prescribed policy and allowed these 
devices to be paid under the category for items requiring FSS.

DATES: Comment Date: Comments will be considered if we receive them at 
the appropriate address, as provided below, no later than 5 p.m. on 
October 21, 2003.

ADDRESSES: In commenting, please refer to file code CMS-1167-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission or e-mail.
    Mail written comments (one original and two copies) to the 
following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-1167-P, P.O. Box 8017, Baltimore, MD 
21244-1850.

    Please allow sufficient time for mailed comments to be timely 
received in the event of delivery delays.
    If you prefer, you may deliver (by hand or courier) your written 
comments (one original and two copies) to one of the following 
addresses:

Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.

(Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are

[[Page 50736]]

encouraged to leave their comments in the CMS drop slots located in the 
main lobby of the building. A stamp-in clock is available for persons 
wishing to retain a proof of filing by stamping in and retaining an 
extra copy of the comments being filed.)

    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joel Kaiser, (410) 786-4499.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, phone (410) 786-7195.
    Copies: This Federal Register document is available from the 
Federal Register online database through GPO Access, a service of the 
U.S. Government Printing Office. The web site address is: http://www.access.gpo.gov/nara/index.html.

I. Background

A. DME Fee Schedule Payment Methodology

    The Medicare Part B (Supplementary Medical Insurance) payment rules 
for durable medical equipment (DME) are located in section 1834(a) of 
the Social Security Act (the Act). In accordance with section 1834(a) 
of the Act, payment for DME is made on a fee schedule basis with items 
falling into several different payment categories, each with its own 
unique payment rules. The respiratory assist devices with bi-level 
capability would be placed in the category for other items of durable 
medical equipment, or capped rental items, as defined in section 
1834(a)(7) of the Act.
    Section 1834(a) of the Act provides that Medicare payment for DME 
is equal to 80 percent of the lesser of the actual charge for the item 
or the fee schedule amount for the item. It classifies DME into the 
following payment categories:
    [sbull] Inexpensive or other routinely purchased DME.
    [sbull] Items requiring frequent and substantial servicing (FSS).
    [sbull] Customized items.
    [sbull] Oxygen and oxygen equipment.
    [sbull] Other covered items (other than DME).
    [sbull] Other items of DME (capped rental items).
    There are different payment rules for each category of DME. With 
the exception of customized items, fee schedule amounts are calculated 
for each item of DME, identified by codes in the Healthcare Common 
Procedure Coding System (HCPCS). The Medicare payment amount for a 
customized item of DME is based on the Medicare carrier's individual 
consideration of that item.
    In general, the fee schedule amounts for DME are calculated on a 
statewide basis using average Medicare payments made in each State from 
1986 and 1987 under the former reasonable charge payment methodology. 
The fee schedule amounts are generally adjusted annually by the change 
in the Consumer Price Index for all Urban Consumers (CPI-U) for the 12-
month period ending June 30 of the preceding year. The fee schedule 
amounts are limited by a ceiling (upper limit) and floor (lower limit) 
equal to 100 percent and 85 percent, respectively, of the median of the 
statewide fee schedule amounts.
    Section 13543 of the Omnibus Budget Reconciliation Act of 1993 
(OBRA of 1993) (Pub. L. 103-66) amended section 1834(a)(3)(A) of the 
Act to remove certain ventilators, namely ``intermittent assist devices 
with continuous airway pressure devices,'' from the DME payment 
category for items requiring FSS. Payment for an item in the FSS 
category is made on a monthly rental basis, with rental payments 
continuing as long as the item remains medically necessary. The 
conference report for OBRA of 1993 states that ``this category is 
intended to include items which require frequent servicing in order to 
avoid imminent danger to a beneficiary's health.'' Those ventilators 
which were excluded from the FSS category by OBRA of 1993 fall into the 
payment category for capped rental (CR) items. Payment for items in the 
CR category is made on a monthly rental basis, with rental payments 
being capped at 15 months or 13 months, depending on whether the 
beneficiary, based upon an option that must be offered by the supplier 
in the 10th rental month, chooses to continue renting the item or take 
over ownership of the item via the ``purchase option'' provided by the 
statute. If the beneficiary chooses the ``purchase option,'' then 
rental payments continue through the 13th month of use and the title 
for the equipment transfers from the supplier to the beneficiary. 
Medicare would then make payments for any necessary maintenance and 
servicing of the patient-owned equipment. If the beneficiary chooses to 
continue renting the equipment, then rental payments continue through 
the 15th month of use, and the supplier continues to own the equipment. 
The supplier must continue to supply the rented item to the beneficiary 
as long as medically necessary. The supplier is entitled to receive a 
semi-annual maintenance and servicing payment in an amount not to 
exceed 10 percent of the purchase price for the equipment as determined 
by the statute. Total Medicare payments made through the 13th and 15th 
months of rental equal 105 and 120 percent, respectively, of the 
statutory purchase price for the equipment.
    Suppliers of DME must meet the standards specified in 42 CFR 
414.57. These standards specify that the supplier ``must maintain and 
replace at no charge or repair directly, or through a service contract 
with another company, Medicare-covered items it has rented to 
beneficiaries.'' This requirement applies to items in both the FSS and 
CR payment categories. Therefore, for rental items in either category, 
the supplier is responsible for ensuring that the equipment is in good 
working order. In the case of items for which the patient has selected 
the purchase option, the patient arranges for the servicing and repair 
of the patient-owned equipment. Medicare payments are made as needed 
for maintenance and servicing of patient-owned equipment in the CR 
category.
    It is not necessary for a respiratory therapist to perform the 
maintenance and servicing of respiratory assist devices. If DME 
suppliers perform maintenance and servicing of equipment, they are paid 
by Medicare for this service, regardless of whether the item is in the 
FSS or CR category. We are confident that this change in payment 
category will not result in a decrease in the current level of service 
being provided to the beneficiaries.

B. HCPCS Coding for Respiratory Assist Devices

    On January 1, 1992, code E0452 with the description of 
``intermittent assist device with continuous positive airway pressure 
device (CPAP)'' was added and became effective in the HCPCS. This code 
was added to describe respiratory assist devices with bi-level air 
pressure capability, with or without a back-up rate, and with the 
ability to switch to CPAP mode. Bi-level pressure capability means that 
the device can deliver a lower level of pressure when the patient 
exhales than when the patient inhales, as opposed to CPAP, which is the

[[Page 50737]]

continuous delivery of a single level of positive air pressure. A back-
up rate feature enables the device to automatically switch between the 
two levels of pressure at pre-determined intervals. The original 
manufacturer of bi-level respiratory assist devices submitted 
documentation to us as part of its HCPCS coding recommendation. The 
manufacturer stated the following in the documentation:
    [sbull] The word ``intermittent'' refers to devices that are 
designed to be used by the patient for only part of the day, usually 
during the hours of sleep.
    [sbull] The bi-level equipment requires very little maintenance and 
servicing.
    [sbull] Other than monthly replacement of the air inlet filter on 
the front of the system, there is no routine maintenance required.
    [sbull] Recommends that a performance verification be performed 
after each year of operation to ensure that the device is functioning 
properly.
    In accordance with OBRA of 1993, intermittent assist devices are 
excluded from the FSS payment category and, therefore, fall into the CR 
payment category.
    On January 1, 1992, code E0453 with the description of 
``therapeutic ventilator; suitable for use 12 hours or less per day'' 
was added and became effective in the HCPCS. This code was added to 
describe ventilators that are used on a part time basis by patients who 
are dependent on volume ventilators (HCPCS code E0450) for more than 12 
hours a day. The premise behind the therapeutic ventilator (code E0453) 
is similar to the portable oxygen equipment. The stationary volume 
ventilator (E0450), like stationary oxygen equipment, would be the 
primary equipment used by the patient. The portable therapeutic 
ventilator, like portable oxygen equipment, would be used part of the 
day by the patient to move about in order to exercise muscles, prevent 
decubitus ulcers, and achieve other therapeutic goals. Therapeutic 
ventilators were properly classified in the FSS payment category.
    Beginning as early as May 25, 1992, some Medicare carriers issued 
erroneous guidance to suppliers that intermittent assist devices with a 
back-up rate should be billed for using the HCPCS code E0453 for 
therapeutic ventilators (FSS payment category) instead of the HCPCS 
code E0452 for intermittent assist devices (CR payment category). We 
are not certain to what degree carriers and suppliers were using code 
E0453 as opposed to code E0452 to bill for intermittent assist devices 
with a back-up rate. However, this practice continued to some extent 
through 1993 and 1994, the respective years in which the OBRA of 1993 
change in payment categories for intermittent assist devices was 
enacted and implemented. Responsibility for processing DME claims was 
transferred during this time from 34 local carriers to 4 regional 
carriers known as Durable Medical Equipment Regional Carriers (DMERCs). 
The DMERCs also issued erroneous guidance to suppliers that the 
intermittent assist devices with a back-up rate should be billed for 
using code E0453 instead of code E0452.
    The classification of intermittent assist devices with a back-up 
rate under the FSS payment category versus the CR payment category 
results in a substantial increase in Medicare payments. For example, 
comparing cost of E0453 over 5 years using the 2000 fee schedule 
ceiling of $612.52, total Medicare payments under the FSS payment 
category would be $36,751.20 after 5 years as opposed to $7,778.99 if 
the device was classified under the CR payment category.\1\ Based on 
retail prices we obtained, we determined for the year 2000, that the 
purchase prices for intermittent assist devices with a back-up rate 
range from approximately $3,000 to $6,000. This highlights the fact 
that the correct classification of these devices for Medicare payment 
purposes is a significant issue in terms of safeguarding the Medicare 
trust fund. That is, placing these devices in the FSS payment category 
instead of the CR category results in Medicare paying every 5 years 
approximately $36,700 rather than $7,700 for an item that can be 
purchased for $6,000 or less.
---------------------------------------------------------------------------

    \1\ The CR payment of $7,778.99 includes the 15 monthly rental 
payments plus 7 payments of $61.25 for maintenance and servicing 
that can be billed every 6 months beginning 6 months after the 15th 
rental payment has been made.
---------------------------------------------------------------------------

    In 1998, for the first time, the DMERCs conducted an in-depth 
review of the use of intermittent assist devices with CPAP. As a 
result, in July 1998, the DMERCs issued proposed medical review 
policies on intermittent assist devices with CPAP, which called for a 
revision to the HCPCS codes for these devices and the adoption of more 
specific nomenclature to describe respiratory assistance technology. 
The term ``respiratory assist device, bi-level pressure capability'' 
was proposed to replace the HCPCS wording of ``intermittent assist 
device with CPAP,'' and separate HCPCS codes were proposed to 
differentiate between devices with a back-up rate and devices without a 
back-up rate.

C. Public Meeting on Payment for Respiratory Assist Devices

    During the course of reviewing the DMERC medical review policies on 
respiratory assist devices, we became aware that the carriers and 
DMERCs had been allowing HCPCS code E0453 to be used primarily for the 
billing of respiratory assist devices with a back-up rate. As a result, 
we intended to take action to clarify that these devices belonged in 
the CR payment category. Because of concerns raised by the industry on 
the appropriate coding and payment classification for these devices, we 
announced in the Federal Register on June 4, 1999 that a public meeting 
would be held on June 25, 1999 to get input from the supplier community 
regarding the appropriate DME payment category for respiratory assist 
devices with a back-up rate. We made presentations at the June 25, 1999 
public meeting, in addition to the Food and Drug Administration, the 
National Institutes of Health, respiratory assist device manufacturers, 
suppliers, clinicians, beneficiaries, and others.
    The testimony at the public meeting that was given to support the 
claim that there is a need for FSS of respiratory devices with bi-level 
capability and a back-up rate described the need to have a respiratory 
therapist visit the beneficiary to make sure that the device is being 
used appropriately by the beneficiary and that the beneficiary is 
complying with the treatment. After the respiratory therapist performs 
an assessment of the beneficiary and has consulted with the 
beneficiary's physician, it may be determined that the pressure setting 
on the equipment needs to be adjusted. However, no information was 
presented at the public meeting that would indicate that the equipment 
itself requires FSS as required by section 1834(a)(3)(A) of the Act.
    The DMERC medical review policies on respiratory assist devices 
were implemented on October 1, 1999. The following HCPCS codes were 
added as part of these new policies:

K0532 Respiratory Assist Device, Bi-Level Pressure Capability, Without 
Back-up Rate Feature, Used With Noninvasive Interface, E.G., Nasal Or 
Facial Mask (Intermittent Assist Device With Continuous Positive Airway 
Pressure Device)
K0533 Respiratory Assist Device, Bi-Level Pressure Capability, With 
Back-up Rate Feature, Used With Noninvasive Interface, E.G., Nasal Or 
Facial Mask (Intermittent Assist Device With Continuous Positive Airway 
Pressure Device)

[[Page 50738]]

K0534 Respiratory Assist Device, Bi-Level Pressure Capability, With 
Back-up Rate Feature, Used With Invasive Interface, E.G., Tracheostomy 
Tube (Intermittent Assist Device With Continuous Positive Airway 
Pressure Device)

    These codes were added to better describe those respiratory assist 
devices, or intermittent assist devices with CPAP, that had been coded 
under codes E0452 and E0453 of the HCPCS since 1992. Code K0532 
describes those intermittent assist devices with CPAP that did not have 
a back-up rate and were previously coded under code E0452 (CR payment 
category). Codes K0533 and K0534 describe those intermittent assist 
devices with CPAP that did have a back-up rate but had been coded under 
code E0453 (FSS payment category). It was also decided that no code was 
needed for therapeutic ventilators, the devices originally intended to 
fall under code E0453. Although the DMERC medical review policies were 
implemented on October 1, 1999, the decision regarding the appropriate 
DME payment category for devices with the back-up rate (codes K0533 and 
K0534) was delayed until now to allow more time for consideration of 
comments made at the June 25, 1999 public meeting.
    After reviewing all of the information presented at the June 25, 
1999 public meeting, we conclude that respiratory assist devices with 
bi-level pressure capability and a back-up rate do not require FSS 
payment. We also conclude that these devices are a type of intermittent 
assist device with CPAP and are therefore excluded from the FSS payment 
category by section 1834(a)(3)(A) of the Act. We conclude that all 
payments made for these devices in the past under the FSS payment 
category were erroneous.

D. Office of Inspector General (OIG) Report on Respiratory Assist 
Devices

    In 1999, the OIG began an inspection to determine if respiratory 
assist devices with a back-up rate receive FSS. During the course of 
their inspection, the OIG conducted surveys of beneficiaries, 
suppliers, manufacturers, and accreditation agencies. In June 2001 
(OEI-07-99-00440), the OIG issued their report on respiratory assist 
devices with a back-up rate, recommending that these devices be moved 
from the FSS payment category to the CR payment category. This 
recommendation is based on information gathered from the surveys 
conducted by the OIG that resulted in the following findings listed in 
the report:
    [sbull] Supplier services consist primarily of routine maintenance 
and patient monitoring.
    [sbull] For most beneficiaries, visits (from suppliers) do not meet 
supplier protocols for frequency.
    [sbull] Contrary to supplier protocols, the number of beneficiaries 
receiving visits declines over time.
    [sbull] Covering the respiratory assist device with back-up rate 
under capped rental would have saved Medicare $11.5 million annually.
    Therefore, the OIG, after conducting a detailed inspection, has 
determined that respiratory assist devices with a back-up rate do not 
receive FSS.

II. Provisions of the Proposed Regulations

    For the reasons stated above, we propose to include respiratory 
assist devices billed using HCPCS codes K0533 and K0534 in the DME fee 
schedule payment category for other items of DME, or capped rental 
items, as defined in section 1834(a)(7) of the Act. Rental claims 
received on or after the effective date of this provision would be 
claims considered for the initial month of rental for capped rental 
payment purposes.

III. 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.

IV. 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 1995.

V. Regulatory Impact Statement

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate that the reductions in annual expenditures that would occur 
as a result of moving respiratory assist devices with a back-up rate to 
the CR payment category will be approximately $10 million, based on the 
payment differential between the CR and FSS payment categories. This 
estimate is based on estimated annual savings of $11.5 million from the 
OIG report, rounded to the nearest $10 million. The OIG found that the 
average number of months a beneficiary used the device between January 
1996 and September 1999 was 16 months. We estimate that Medicare 
beneficiaries utilize 10,000 to 12,000 devices each year. Since this 
rule would result in reductions in total expenditures of less than $100 
million per year, this rule is not a major rule as defined in Title 5, 
United States Code, section 804(2) and is not an economically 
significant rule under Executive Order 12866.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Most hospitals and most other providers and suppliers are small 
entities either by nonprofit status or by having revenues of $6 million 
to $29 million or less in any 1 year. For purposes of the RFA, 
approximately 98 percent of suppliers of DME and prosthetic devices are 
considered small businesses according to the Small Business 
Administration's (SBA) size standards. Individuals and States are not 
included in the definition of a small entity. We estimate that 106,000 
entities bill Medicare for DME, prosthetics, orthotics, surgical 
dressings, and other equipment and supplies each year. We believe the 
impact on the DME industry and small businesses in general would be 
minimal because most companies supply many different types of 
equipment. Total Medicare expenditures for DME are approximately $7 
billion per year.
    The OIG estimates that moving respiratory assist devices with a 
back-up rate to the CR payment category would result in payment 
reductions of

[[Page 50739]]

approximately $11.5 million per year. Therefore, the overall impact on 
the total industry annual receipts would be small, that is, less than 1 
percent reduction in Medicare revenue. However, while the overall 
impact is small, some suppliers would be seriously affected as a result 
of the mix of DME that they furnish to Medicare beneficiaries. Namely, 
suppliers who specialize in furnishing respiratory assist devices would 
be seriously affected by this rule. To estimate how many suppliers 
could be seriously affected by this rule, we analyzed data for the top 
30 suppliers of RADs with a back-up rate, which account for 
approximately 50 percent of Medicare expenditures for code K0533. Total 
allowed charges for code K0533 were $77 million in 2002. Therefore, a 
$10 million reduction in annual expenditures resulting from this 
proposed rule equates to a 13 percent reduction in revenue for 
suppliers for code K0533. These top 30 suppliers were ranked in terms 
of total allowed charges attributed to them for claims received for 
HCPCS code K0533 from October 1, 2002 through December 31, 2002. Five 
of the top 30 suppliers would not be considered small entities by SBA 
standards. These 5 suppliers account for approximately 40 percent of 
total expenditures for K0533. Twenty-five suppliers in the top 30 could 
be considered small entities if such a determination was based solely 
on Medicare expenditures (data on revenue attributed to sources other 
than Medicare has not been obtained for these companies as part of this 
analysis). Therefore, the total reduction in revenue for potential 
small entities as a result of this proposed rule would be approximately 
$6 million. The percentage of Medicare DME business that K0533 devices 
represent for 9 of the 25 potential small entities is 5 percent or 
less. For the remaining 16 potential small entities, the percentage of 
Medicare DME business that K0533 devices represent ranges from 17 to 98 
percent. Therefore, these 16 suppliers would be seriously affected by 
this rule. Other K0533 suppliers not in the list of top 30 suppliers 
could also be small entities and could be seriously affected by this 
rule. The total allowed charges per year for these suppliers for code 
K0533 are less than $250,000.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule 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 100 beds. We are not preparing a 
rural impact analysis since we have determined that this rule would not 
have a significant economic impact on the operation of a substantial 
number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by State, 
local, or tribal government, in the aggregate, or by the private sector 
of $110 million. This rule would not have an effect on the governments 
mentioned, and private sector costs would be less than the $110 million 
threshold.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it publishes a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. We have determined that this rule does not significantly 
affect State or local governments.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.
    For the reasons stated in the preamble, the Centers for Medicare & 
Medicaid Services proposes to amend 42 CFR part 414 as follows:

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

    1. The authority citation for part 414 continues to read as 
follows:

    Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr (b)(1)).

    2. In Sec.  414.222 paragraph (a)(1) is revised to read as follows:


Sec.  414.222  Items requiring FSS.

    (a) Definition. * * *
    (1) Ventilators (except those that are either continuous airway 
pressure devices or respiratory assist devices with bi-level pressure 
capability with or without a back-up rate, previously referred to as 
intermittent assist devices with continuous airway pressure devices).
* * * * *

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

    Dated: April 15, 2003.
Thomas A Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 24, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-21443 Filed 8-21-03; 8:45 am]
BILLING CODE 4120-01-P