4518 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitledConsultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

XII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 13, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.1262 is added to 

subpart D to read as follows: 

§ 180.1262 Sorbitol octanoate; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sorbitol octanoate in or on all food 

commodities when used in accordance 

with label directions. 

[FR Doc. 06–756 Filed 1–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–1167–F] 

RIN 0938–AN02 

Medicare Program; Payment for 

Respiratory Assist Devices With BiLevel Capability and a Backup Rate 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule clarifies that 

respiratory assist devices with bi-level 

capability and a backup rate must be 

paid as capped rental items of durable 

medical equipment (DME) under the 

Medicare program and not paid as items 

requiring frequent and substantial 

servicing (FSS), as defined in section 

1834(a)(3) of the Social Security Act. 

Before 1999, respiratory assist devices 

with bi-level capability (with or without 

a backup rate feature) were referred to 

as ‘‘intermittent assist devices with 

continuous positive airway pressure 

devices’’ under the Medicare program 

and in the Healthcare Common 

Procedure Coding System (HCPCS). 

This final rule responds to public 

comments received on a proposed rule 

published in the Federal Register on 

August 22, 2003, and finalizes the 

policy in that proposed rule. The rule 

will ensure that respiratory assist 

devices are consistently and properly 

paid under Medicare as capped rental 

items. 

DATES: The provisions of this final rule 

are effective on April 1, 2006. 

FOR FURTHER INFORMATION CONTACT: Joel 

Kaiser, (410) 786–4499. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Legislative Authority for Payment for 

Durable Medical Equipment (DME) 

Section 1834(a) of the Social Security 

Act (the Act) sets forth the payment 

methodology and requirements for 

payment for the purchase or rental of 

new and used durable medical 

equipment (DME) for Medicare 

beneficiaries under Medicare Part B 

(Supplementary Medical Insurance). In 

accordance with section 1834(a) of the 

Act, payment for DME is made on a fee 

schedule basis. Each item of DME that 

is paid under Medicare Part B is 

classified into one of the following 

payment categories: 

• Inexpensive or other routinely 

purchased DME. 

• Items requiring frequent and 

substantial servicing (FSS). 

• Customized items. 

• Oxygen and oxygen equipment. 

• Other covered items (other than 

DME). 

• Other items of DME (capped rental 

(CR) items). 

Each category has its own unique 

payment rules. With the exception of 

customized items, for each item of DME 

that is identified by a code in the 

Healthcare Common Procedure Coding 

System (HCPCS), a fee schedule amount 

is calculated. The Medicare payment 

amount for a customized item of DME 

is based on the Medicare carrier’s 

individual consideration of that item. 

Section 1834(a) of the Act provides 

that Medicare payment for DME is equal 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4519 

to 80 percent of the lesser of the actual 

charge for the item or the fee schedule 

amount for the 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. 

Implementing regulations for these 

statutory provisions are located in 42 

CFR part 414, subpart D. 

B. Issuance of Proposed Rulemaking 

On August 22, 2003, we published in 

the Federal Register (68 FR 50735) a 

proposed rule to clarify that one of the 

items of DME, a respiratory assist device 

with bi-level capability and a backup 

rate, must be paid as a CR category item 

under the Medicare program and not 

paid as an item that requires FSS. As 

explained below, we issued this 

proposal to correct coding and payment 

errors that have been made by some 

Medicare contractors that 

misinterpreted our statutorily 

prescribed policy and allowed 

respiratory assist devices to be paid 

under the category for items requiring 

FSS. In the August 22, 2003 proposed 

rule, we proposed 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. 

We proposed that rental claims received 

on or after the effective date of the final 

regulation would be considered claims 

for the initial month of rental for capped 

rental payment purposes. 

A summary of the public comments 

we received on the proposed rule and 

our responses to those comments appear 

under section III of this preamble. 

II. Payment for Ventilators as DME 

Under Medicare 

A. Payment Methodology 

Under section 1834(a) of the Act, 

payment may be made under Medicare 

Part B for various types of ventilators as 

items of DME. Section 1834(a)(3) of the 

Act, as amended, provides for payment 

for covered items of DME requiring 

frequent and substantial servicing such 

as intermittent positive pressure 

breathing (IPPB) machines and 

ventilators, excluding ventilators that 

are either continuous positive airway 

pressure (CPAP) devices or intermittent 

assist devices with CPAP devices (now 

referred to as respiratory assist devices), 

to avoid risk to the patient’s health. 

Payment for an item in the FSS category 

is made on a monthly rental basis, and 

rental payments continue as long as the 

item remains medically necessary for 

the beneficiary. Section 414.222 of our 

regulations implements the payment 

provisions for the types of items of DME 

that are paid under the FSS category. 

Ventilators that are excluded from the 

FSS payment category are paid in 

accordance with section 1834(a)(7) of 

the Act under the CR category on a 

rental basis. Section 414.229 of the 

regulations implements the payment 

provisions relating to items of DME that 

are paid under the CR category. 

Payment for an item in the CR category 

is made on a monthly rental basis. 

During the 10th rental month, the 

supplier is required to offer the 

beneficiary the option to take over 

ownership of the item. If the beneficiary 

chooses this option, Medicare rental 

payments end after the 13th month of 

use and the title for the equipment 

transfers from the supplier to the 

beneficiary. After the title for the 

equipment has transferred to the 

beneficiary, Medicare will make 

payments for any necessary 

maintenance and servicing of the 

patient-owned equipment. If the 

beneficiary chooses to continue renting 

the equipment, Medicare rental 

payments end after the 15th month of 

use, the supplier continues to own the 

equipment, and the supplier must 

continue to supply the item to the 

beneficiary until the medical necessity 

ends or Medicare coverage ceases. 

Beginning 6 months after the 15th 

month of use, the supplier may bill and 

receive a semiannual maintenance and 

servicing payment in an amount not to 

exceed 10 percent of the purchase price 

for the equipment as determined in 

accordance with the statute and 

§ 414.229(c). These maintenance and 

servicing payments are made regardless 

of whether maintenance and servicing 

were actually performed on the 

equipment during the 6-month period. 

Total Medicare payments made through 

the 13th and 15th months of rental 

equal 105 and 120 percent, respectively, 

of the statutory purchase price of the 

equipment. 

Suppliers of DME must meet the 

standards specified in regulations at 

§ 424.57. 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 an item for 

which the beneficiary has selected the 

purchase option, the patient arranges for 

the servicing and repair of the patientowned equipment. Medicare payments 

are made as needed for maintenance 

and servicing of patient-owned 

equipment in the CR category. 

B. Legislative Change Relating to Types 

of Ventilators Payable Under the FSS 

Category 

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 by establishing 

two exceptions to the previously 

existing statutory authority that all 

ventilators were classified as items 

requiring FSS for Medicare DME 

payment purposes. One category of 

ventilators that are excluded from the 

FSS payment category is ‘‘intermittent 

assist devices with continuous positive 

airway pressure devices,’’ now referred 

to under the Medicare program as 

respiratory assist devices. The 

legislative history of the House Report 

accompanying H.R. 3545 (H.R. Conf. 

Rep. 103–213, 1993 U.S.C.C.A.N. 1088 

at 703 (1987)) states that the FSS 

‘‘category is intended to include items 

which require frequent servicing in 

order to avoid imminent danger to a 

beneficiary’s health.’’ As a result of this 

legislative amendment, ventilators that 

are excluded from the Medicare DME 

FSS payment category fall into the DME 

payment category of CR items. 

C. HCPCS Coding for Intermittent Assist 

Devices 

Effective January 1, 1992, code E0452 

with the description of ‘‘intermittent 

assist device with continuous positive 

airway pressure device (CPAP)’’ was 

added to the HCPCS. This code was 

added to describe respiratory assist 

devices with bi-level air pressure 

capability, with or without a backup 

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 

continuous delivery of a single level of 

positive air pressure. A backup rate 

feature enables the device to 

automatically switch between the two 


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4520 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

1The CR payment includes 15 monthly rental 

payments plus 7 payments for maintenance and 

servicing that can be billed every 6 months 

beginning 6 months after the 15th rental payment 

has been made. 

levels of pressure at predetermined 

intervals. The original manufacturer of 

bi-level respiratory assist devices 

submitted documentation to us as part 

of our HCPCS coding recommendation. 

The manufacturer stated the following 

in the documentation: 

• 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. 

• The bi-level equipment requires 

very little maintenance and servicing. 

• Other than monthly replacement of 

the air inlet filter on the front of the 

system, there is no routine maintenance 

required. 

The manufacturer recommended that 

a performance verification be performed 

after each year of operation to ensure 

that the device is functioning properly. 

The nomenclature for code E0452, 

intermittent assist device with 

continuous positive airway pressure 

(CPAP) device, was established to 

describe positive airway pressure 

devices with bi-level capability, with or 

without a backup rate feature. The term 

‘‘respiratory assist device’’ is used today 

to refer to this exact same group of 

items. As indicated earlier, in 

accordance with OBRA of 1993, 

intermittent assist devices or respiratory 

assist devices are excluded from the FSS 

payment category for DME and are 

classified under the CR payment 

category under Medicare. 

Effective January 1, 1992, code E0453 

with the description of ‘‘therapeutic 

ventilator; suitable for use 12 hours or 

less per day’’ was added to the HCPCS. 

This code was added to describe 

ventilators that are used on a part-time 

basis by patients who are dependent on 

stationary ventilators (HCPCS code 

E0450) for more than 12 hours a day. 

The premise behind the therapeutic 

ventilator (code E0453) is similar to 

portable oxygen equipment. The 

stationary ventilator (code 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 because they 

were not one of the types of ventilators 

(CPAPs or intermittent assist devices) 

excluded from this category by OBRA of 

1993. 

D. Billing for Intermittent Assist Devices 

With a Backup Rate 

Beginning as early as May 25, 1992, 

some Medicare carriers issued 

erroneous guidance to suppliers that 

intermittent assist devices with a 

backup rate should be billed to 

Medicare using HCPCS code E0453 for 

therapeutic ventilators (in the FSS 

payment category) instead of HCPCS 

code E0452, the code category 

established for intermittent assist 

devices (in the CR payment category). 

We are not certain to what extent 

carriers and suppliers were using code 

E0453 as opposed to code E0452 to bill 

for intermittent assist devices with a 

backup rate. However, this practice 

continued to some extent through 1993 

and 1994, the years in which the OBRA 

of 1993 change in payment categories 

for intermittent assist devices was, 

respectively, 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 intermittent 

assist devices with a backup rate should 

be billed using code E0453 instead of 

code E0452. 

The classification of intermittent 

assist devices or respiratory assist 

devices with a backup rate under the 

FSS payment category versus the CR 

payment category results in a 

substantial increase in Medicare 

payments. Total Medicare payments for 

one device furnished to one patient 

under the FSS payment category would 

be as much as $38,530 after 5 years as 

opposed to $12,201 if the device were 

classified under the CR payment 

category.1 This difference in costs 

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. 

In 1998, for the first time, the 

DMERCs conducted an in-depth review 

of the use of intermittent assist devices 

and issued proposed medical review 

policies that included a 

recommendation to revise the 

nomenclature for the HCPCS codes for 

these devices. The term ‘‘respiratory 

assist device, bi-level pressure 

capability’’ was proposed to replace the 

HCPCS wording of ‘‘intermittent assist 

device with continuous positive airway 

pressure (CPAP),’’ and separate HCPCS 

codes were proposed to differentiate 

between devices with a backup rate and 

devices without a backup rate. 

E. Public Meeting on Payment for 

Respiratory Assist Devices 

During the course of reviewing the 

DMERC medical review policies on 

intermittent assist devices (now referred 

to as 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 

respiratory assist 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 (64 FR 30042) the 

convening of a public meeting on June 

25, 1999, to obtain input from the 

supplier community regarding the 

appropriate DME payment category for 

respiratory assist devices with a backup 

rate. We made presentations at the June 

25, 1999 public meeting. 

Representatives of the Food and Drug 

Administration (FDA) and the National 

Institutes of Health, respiratory assist 

device manufacturers, suppliers, 

clinicians, beneficiaries, and others also 

made presentations at the meeting. 

Testimony was given at the public 

meeting to support the claim that there 

is a need for FSS of respiratory assist 

devices with bi-level capability and a 

backup rate. Speakers 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 

regimen. The testimony pointed out that 

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 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4521 

With Continuous Positive Airway 

Pressure Device) 

• K0533 Respiratory Assist Device, 

Bi-Level Pressure Capability, With BackUp Rate Feature, Used With 

Noninvasive Interface, E.G., Nasal Or 

Facial Mask (Intermittent Assist Device 

With Continuous Positive Airway 

Pressure Device) 

• K0534 Respiratory Assist Device, 

Bi-Level Pressure Capability, With BackUp 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, that had 

been coded under codes E0452 and 

E0453 of the HCPCS since 1992. Code 

K0532 describes those intermittent 

assist devices that did not have a 

backup rate and were previously coded 

under code E0452 (the CR payment 

category). Codes K0533 and K0534 

describe those intermittent assist 

devices that did have a backup rate, but 

had been coded under code E0453 (the 

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, we delayed our 

decision regarding the appropriate DME 

payment category for devices with the 

backup rate (codes K0533 and K0534) to 

allow more time for consideration of 

comments made at the June 25, 1999 

public meeting. Since that time, code 

numbers K0532, K0533, and K0534 have 

been replaced in the HCPCS by code 

numbers E0470, E0471, and E0472, 

respectively. 

After reviewing all of the information 

presented at the June 25, 1999 public 

meeting, we concluded that respiratory 

assist devices with bi-level pressure 

capability and a backup rate do not 

require FSS payment. We also 

concluded that these devices are a type 

of intermittent assist device with CPAP 

and, therefore, are excluded from the 

FSS payment category by section 

1834(a)(3)(A) of the Act. We concluded 

that all payments made for these devices 

in the past under the FSS payment 

category were erroneous. 

As a result of these conclusions (and 

in conjunction with the findings of the 

1999 OIG report discussed in section 

II.F of this preamble), we issued the 

August 22, 2003 proposed rule. As 

noted above, the only regular servicing 

necessary for these devices is changing 

the filter once a year; thus, we believe 

that 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, Medicare pays for this 

service, regardless of whether the item 

is in the FSS or the CR category. At the 

time that we issued the proposed rule, 

we were confident that this change in 

payment category would not result in a 

decrease in the current level of service 

being provided to Medicare 

beneficiaries. After consideration of all 

comments, we have maintained the 

proposed provisions in this final rule. 

F. Office of Inspector General (OIG) 

Report on Respiratory Assist Devices 

As we explained in the August 2003 

proposed rule, in 1999, the OIG began 

an inspection to determine if respiratory 

assist devices with a backup rate receive 

frequent and substantial servicing. To 

assess whether devices received 

frequent and substantial servicing, the 

OIG reviewed a stratified random 

sample of Medicare claims and 

associated supplier records. The OIG 

also conducted surveys of beneficiaries, 

suppliers, manufacturers, and 

accreditation agencies. In June 2001, the 

OIG issued its report on respiratory 

assist devices with a backup rate (OEI–

07–99–00440) and recommended that 

these devices be moved from the FSS 

payment category to the CR payment 

category. The OIG made its 

recommendation based on information 

gathered from the surveys it conducted. 

The OIG included the following 

findings in its report: 

• Supplier services consist primarily 

of routine maintenance and patient 

monitoring. 

• For most beneficiaries, actual 

supplier visits do not meet the 

suppliers’ own protocols or 

recommendations for frequency of visits 

that are developed in the absence of 

official guidelines regarding the number 

of visits that are necessary for the 

device. 

• Contrary to supplier protocols, the 

number of beneficiaries receiving visits 

declines over time. 

• Covering the respiratory assist 

device with backup rate in the capped 

rental category would have saved 

Medicare $11.5 million annually. 

Therefore, the OIG, after conducting a 

detailed inspection, determined that 

respiratory assist devices with a backup 

rate do not receive FSS. 

III. Public Comments Received on the 

Proposed Rule and Departmental 

Responses 

We received 15 timely pieces of 

correspondence containing multiple 

comments on the August 22, 2003 

proposed rule. A summary of these 

public comments and the Department’s 

responses to those comments follow: 

Comment: All of the commenters 

opposed the proposed change in the 

Medicare payment category for 

respiratory assist devices with backup 

rate capability (HCPCS code K0533 or 

E0471) from the FSS category to the CR 

category. Some commenters viewed the 

proposed change as a reduction in 

payment rather than a correction of a 

coding error and requested withdrawal 

of the proposal because the rationale 

was unsupportable. The commenters 

stated that the alleged payment error 

originally occurred when, they believe, 

CMS incorrectly relabeled what the 

industry now refers to as bi-level 

ventilators or noninvasive positive 

pressure ventilators (NPPVs) as 

respiratory assist devices. The 

commenters indicated that the term 

‘‘respiratory assist device’’ is ambiguous 

and its use is inconsistent with current 

practice, with medical literature, and 

with the FDA classification of these 

devices. The commenters pointed out 

that the FDA classifies NPPVs as 

ventilators and, as such, their purpose 

and function require monitoring and 

servicing to avoid risk to the patient’s 

health, and, thus, classification under 

the Medicare FSS payment category. 

The commenters added that Medicare 

payment policy is the only area where 

these ventilators are referred to as 

‘‘respiratory assist devices.’’

Response: Respiratory assist devices 

with bi-level capability and a backup 

rate, or NPPVs as they are referred to by 

suppliers and manufacturers of these 

devices, are a type of intermittent assist 

device with CPAP and, therefore, are 

excluded from the FSS payment 

category by law. CPAP devices and 

intermittent assist devices with CPAP 

are indeed referred to as ventilators in 

the statute, but are nonetheless 

excluded from the FSS category under 

section 1834(a)(3) of the Act. This 

statutory provision does not allow us to 

exempt certain types of intermittent 

assist devices (that is, those with backup 

rate features). The terms ‘‘intermittent 

assist device’’ and ‘‘respiratory assist 

device’’ describe the same general 

category of bi-level positive airway 

pressure device technology that was 

brought onto the market under the trade 

name of BiPAP and that still exists 

today. While some bi-level devices 

include a backup rate feature and some 

do not, the term ‘‘intermittent assist 

devices’’ was developed for HCPCS 

code E0452 to describe all bi-level 

devices, and this is the statutory 

language that was used to exclude 


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4522 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

certain ventilators from the FSS 

payment category. Therefore, the law 

requires this change. 

We note that FDA classification of 

devices for the purpose of clearing 

products for market distribution does 

not determine Medicare coverage and 

payment rules or our policy 

development. Likewise, our definitions 

and classification of devices under the 

Medicare program have no direct effect 

on FDA classification of drugs and 

devices. The process of clearing devices 

for marketing and determining coverage 

and payment of devices under Medicare 

are two different programs with 

different parameters. 

Comment: A number of commenters 

stated that CMS does not have the legal 

authority under the plain meaning of 

the language in the statute to change the 

payment category for NPPVs or 

respiratory assist devices with bi-level 

capability and backup rate. In addition, 

they believed CMS is taking too narrow 

a view of the term ‘‘servicing’’ in the 

language of the 1993 statutory 

amendments to the Act and the 

legislative history. The commenters 

stated that the House Report language 

clarifies that ‘‘frequent and substantial 

servicing’’ refers more broadly to the 

servicing, monitoring, and adjustments 

needed to make certain that these 

ventilators are both functioning 

properly and being used properly by the 

patient, not just to the equipment itself. 

Further, one commenter indicated that 

the House Report further states that 

these items are typically quite expensive 

and often subject to relatively rapid 

technological changes. Therefore, the 

commenters pointed out, NPPV 

ventilators fit the statutory definition for 

the FSS payment category. 

Response: As indicated above, 

respiratory assist devices with bi-level 

capability and a backup rate, or NPPVs 

as they are referred to by suppliers and 

manufacturers of these devices, are a 

type of intermittent assist device with 

CPAP and, therefore, are excluded from 

the FSS payment category by section 

1834(a)(3) of the Act. This statutory 

provision does not allow us to exempt 

certain types of intermittent assist 

devices (that is, those with backup rate 

features). Therefore, we do not have the 

discretion to place these items in the 

FSS category. Even assuming arguendo 

that the items did require frequent and 

substantial servicing, which we believe 

they do not, based on information we 

have received, including the OIG report 

on this subject, the law excludes them 

from this category of items. 

Comment: A number of commenters 

suggested that if CMS wanted to take 

corrective action against suppliers who 

are noncompliant with established 

protocols pertaining to the FSS category, 

the better approach would be to 

sanction those providers for 

inappropriate or fraudulent billing 

practices, not to reduce payments for 

the devices. Another commenter who 

agreed with the OIG report believed that 

CMS must protect beneficiaries and take 

action when suppliers of DME fail to 

properly set up, adjust incrementally, 

and provide careful followup on the use 

of the equipment. The commenter 

believed that corrective action would be 

proper, but disagreed with the lowering 

of the payment for the services needed. 

Response: Section 1834(a)(20) of the 

Act, as added by section 302(a) of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Pub. L. 108–173), requires us to 

establish quality standards for suppliers 

of DME, including respiratory assist 

devices, to be applied by recognized 

independent accreditation 

organizations. We expect to implement 

this statutory provision in the near 

future, at which point suppliers of 

respiratory assist devices will not be 

allowed to bill Medicare for furnishing 

these devices if they do not meet the 

established quality standards. In 

addition, we will continue to implement 

and refine our procedures for 

identifying and sanctioning fraudulent 

and abusive suppliers under Medicare. 

With regard to the lowering of overall 

Medicare payments for the device that 

would result from implementation of 

this rule, it is not the intent of this rule 

to lower payments in order to take 

corrective action against suppliers who 

fail to provide necessary services. This 

rule would place respiratory assist 

devices with bi-level capability and a 

backup rate feature in the CR category 

in order to comply with section 

1834(a)(3) of the Act. 

Comment: Several commenters 

believed that the OIG study 

investigating the impact of the proposed 

policy was flawed in design, 

interpretation of results and 

conclusions, and they challenged the 

four major findings cited in the 

proposed rule (see also section II.D of 

this final rule). The commenters 

believed that there were (1) Inconsistent 

interpretation of the statute and intent 

of the Congress; (2) disregard for FDA’s 

regulatory classification of NPPVs as 

ventilators; (3) conclusions regarding 

the nature and frequency of services to 

patients using NPPVs that are 

inconsistent with the underlying data 

(data that they believed were incorrect 

and misleading); and (4) 

recommendations that were in conflict 

with published medical views of NPPVs 

that pose health risks and prevent 

access to devices by beneficiaries. 

Response: The overriding issue 

addressed by the proposed rule and this 

final rule is the fact that the statute 

excludes intermittent assist devices or 

respiratory assist devices from the FSS 

category. Although the OIG report 

indicates that suppliers of respiratory 

assist devices are not performing 

frequent and substantial servicing of the 

devices, the report itself cannot affect 

the legal mandate to exclude these items 

from the FSS payment category. 

Comment: A number of commenters 

recommended that CMS establish a 

standard for payment of respiratory care 

services for patients who require the use 

of NPPV, as well as guidelines specific 

to ventilator treatment of patients with 

amyotrophic lateral sclerosis (ALS). The 

commenters believed that switching 

NPPV to the category of capped rental 

items without simultaneously covering 

the cost of respiratory care services that 

the comments state that ventilator 

dependent patients need would 

eliminate followup care by clinical 

personnel for these patients and would 

endanger the lives of many patients who 

suffer from respiratory insufficiency due 

to such diseases as ALS and post-polio 

syndrome. 

Response: As mentioned in an earlier 

response, section 1834(a)(20) of the Act, 

as added by section 302(a) of Public 

Law 108–173, requires us to establish 

quality standards for suppliers of DME, 

including respiratory assist devices, to 

be applied by recognized independent 

accreditation organizations. We expect 

to implement this provision in the near 

future. 

With regard to the services of a 

respiratory therapist and other clinical 

services related to the care of a patient 

using a respiratory assist device, these 

services do not fall within the scope of 

the DME benefit. The overall clinical 

care of a beneficiary who receives DME 

is the responsibility of the beneficiary’s 

treating physician. Therefore, payment 

under the DME benefit does not include 

payment for the clinical services of a 

respiratory therapist or other clinicians 

that relate to the care of the patient. 

Further clarification of this issue will be 

provided through the DME supplier 

quality standards. 

Comment: A number of commenters 

believed that the proposed change (1) 

would have a significant adverse impact 

on beneficiaries’ access to ventilator 

therapy (for people with neuromuscular 

diseases such as ALS, post-polio 

syndrome, and multiple sclerosis); (2) 

would jeopardize the health and safety 

of disabled beneficiaries with 

neuromuscular diseases; and (3) would 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4523 

create additional costs to the Medicare 

program through an increase in the 

number of hospitalizations and urgent 

care visits. Some of the commenters 

believed that these issues were not 

adequately addressed in the proposed 

rule, despite their presentation at the 

1999 public meeting. 

Commenters acknowledged that there 

is no provision in the Medicare statute 

that authorizes coverage and payment 

for services of a health care professional 

who provides ‘‘hands-on’’ care for a 

home ventilator patient. However, the 

commenters pointed out that, in the real 

world, a professional who is attempting 

to provide FSS to the equipment 

invariably also interacts with and may 

provide care to the patient, a service 

that would be eliminated if the category 

payment change is made. One 

commenter indicated that loss of 

payment resulting from the change in 

payment category means loss of service 

to needy individuals. 

Response: The proposed rule and this 

final rule pertain only to respiratory 

assist devices, not to ventilator therapy. 

They do not affect coverage of 

ventilators, which continue to be 

covered under the DME benefit. We 

disagree that the proposed rule and this 

final rule will significantly affect 

beneficiary access to respiratory assist 

devices. The law requires that 

intermittent assist devices or respiratory 

assist devices be excluded from the 

DME FSS payment category under 

Medicare. We believe the payments for 

these respiratory assist devices as 

capped rental items will cover the costs 

of medically necessary equipment and 

services. 

Comment: One commenter pointed 

out that a DME company has no 

obligation to provide any services for a 

beneficiary who selects the purchase 

option and that this creates a hazard to 

some beneficiaries. The commenter 

added that it will not be cost-effective 

to provide necessary services to 

beneficiaries with severe respiratory 

problems if the device is moved to the 

CR payment category. 

Response: We do not believe that the 

provisions of the proposed rule and this 

final rule will create a hazard for 

beneficiaries. Medicare will make rental 

payments for respiratory assist devices 

as DME under the provisions of the 

statute and will make payments for any 

necessary maintenance and servicing of 

patient-owned equipment if the 

beneficiary selects the purchase option 

during the 10th rental month of the 15- 

month rental. In addition, as we have 

indicated earlier, we are in the process 

of developing rules that will establish 

quality standards for suppliers of DME, 

including respiratory assist devices, to 

be applied by recognized independent 

accreditation organizations. These 

standards will implement provisions of 

section 1834(a)(20) of the Act as added 

by section 302(a) of Pub. L. 108–173. 

Comment: A number of commenters 

believed that the proposed rule would 

have a disproportionate adverse 

economic effect on small businesses, 

given the estimated significant 

reductions in payments that would 

occur if the proposed rule were 

finalized, that is, a 78-percent reduction 

in payments over a 5-year period. The 

commenters pointed out the limited 

number of suppliers of NPPV ventilators 

nationally and that, of the top 30 

suppliers cited by CMS in the proposed 

rule, 83 percent are probably small 

businesses. The commenters agreed 

with CMS’ assessment in the proposed 

rule that the top 30 suppliers account 

for 50 percent of the use of code K0533 

and that 5 of these suppliers account for 

40 percent of expenditures for the code. 

One commenter indicated that as a 

result of the revised DMERC policy, 

many companies have already stopped 

offering respiratory assist services. This 

commenter believed that most 

companies would not offer to provide 

NPPV at all under the proposed change 

in the payment category. 

Response: We agree that some small 

suppliers may be adversely affected by 

this rule. However, given that the 

current monthly fee schedule ceiling for 

this device is $642.17 and is very 

generous compared to the monthly fee 

schedule ceiling of $256.60 for the 

device without the back-up rate feature, 

we do not believe that many of the 

current suppliers of respiratory assist 

devices will be significantly affected. In 

addition, we do not anticipate problems 

with beneficiary access to respiratory 

assist devices as a result of this rule 

given this generous payment schedule. 

We refer readers to a further discussion 

of the impact of this final rule on small 

suppliers in section VI of this final rule. 

Comment: One commenter believed 

that the rapid rise in Medicare 

expenditures for use of ventilators was 

due to the fact that the benefits of NPPV 

were relatively unknown until 1995, not 

to the misuse of the device and coding. 

The commenter indicated that CMS also 

failed to consider the cost savings from 

decreased hospitalizations among the 

groups of patients receiving NPPVs. 

Response: The reasons for the growth 

in expenditures for respiratory assist 

devices are not relevant to this final 

rule. The law requires that these devices 

be excluded from the DME FSS payment 

category under Medicare. 

Comment: One commenter believed 

that CMS failed to meet the statutory 

requirement to analyze options for 

regulatory relief under the Regulatory 

Flexibility Act when over half of the 

small businesses would be seriously 

impacted by the proposed rule (16 of 

25). The commenter wanted to know 

where and how it could seek relief. This 

commenter also disagreed with CMS’

determination that the costs and 

benefits of the proposed rule would be 

economically insignificant, that is, less 

than $100 million. 

Response: The statute specifically 

excludes intermittent assist devices 

(now referred to as respiratory assist 

devices) from the DME FSS payment 

category under Medicare. The only 

relief from this statutory exclusion 

would be a legislative change. As we 

discuss in detail under section VI of this 

preamble, we estimate that this final 

rule will result in total expenditures of 

less than the $100 million threshold per 

year defined in the Executive Order as 

economically significant. 

IV. Provisions of the Final Rule 

After consideration of the public 

comments received, we are adopting as 

final the proposed clarification of the 

payment category policy for respiratory 

assist devices under Medicare Part B. In 

this final rule, we are specifying that 

respiratory assist devices with bi-level 

capability and a backup rate must be 

paid as capped rental items under the 

Medicare program and not paid as items 

requiring frequent and substantial 

servicing. In cases where beneficiaries 

are currently receiving these items, the 

capped rental period will begin for 

claims with dates of service on or after 

April 1, 2006. 

V. Collection of Information 

Requirements 

This final rule does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget under the authority of the 

Paperwork Reduction Act of 1995. 

VI. 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 19, 

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. 


rmajette on PROD1PC67 with RULES
4524 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

A. Executive Order 12866 

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). 

Based on the OIG study (OEI–07–99–

00440), moving these devices to the CR 

payment category will result in annual 

savings of approximately 27 percent. 

Based on 2004 expenditures of 

approximately $70 million for this 

device, below are the estimated 5-year 

savings for this regulation. 

Fiscal year Savings * 

(million) 

2006 ...................................... $0 

2007 ...................................... 20 

2008 ...................................... 20 

2009 ...................................... 20 

2010 ...................................... 20 

* Rounded to the nearer $10 million. 

Since we estimate that this final rule 

will result in reductions in total 

expenditures of less than $100 million 

per year, this final 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. 

B. Regulatory Flexibility Analysis 

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 because of their 

nonprofit status or because they have 

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 will be 

minimal because most companies 

supply more than this one type of 

equipment. We estimate that total 

Medicare expenditures for DME are 

approximately $7 billion per year. 

As indicated above, we estimate that 

the overall impact on Medicare revenue 

associated with moving respiratory 

assist devices with a backup rate to the 

CR payment category will be payment 

reductions that range from 

approximately $15 million in FY 2005 

to $45 million in FY 2009. Therefore, 

the overall impact on the total industry 

annual receipts will be small, that is, 

less than a 1-percent reduction in 

Medicare revenue. However, while the 

overall impact is small, some suppliers 

will 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 will be 

seriously affected by this final rule. We 

have reviewed data from the statistical 

analysis conducted by DMERCs for the 

top 30 suppliers of respiratory assist 

devices with backup rate that were 

furnished during the period of October 

through December 2003 and billed using 

HCPCS code K0533. These suppliers 

accounted for over 66 percent of the 

total allowed charges in that quarter for 

code K0533. For these suppliers, the 

percentage of total DME allowed charges 

that were made up by allowed charges 

for code K0533 was 22.5 percent on 

average. The top 3 DME suppliers of 

code K0533 accounted for over 50 

percent of the total allowed charges for 

code K0533 and are not small suppliers 

based on Medicare allowed charges 

attributed to these suppliers. For these 

3 suppliers, the percentage of total DME 

allowed charges that were made up by 

allowed charges for code K0533 ranged 

from 1.4 percent to 2.9 percent. All but 

one of the other 30 suppliers would be 

considered small suppliers based on 

Medicare allowed charge data alone (we 

are not certain what revenue sources 

these entities may have other than 

Medicare). The percentage of total DME 

allowed charges that were made up by 

allowed charges for code K0533 was 

over 50 percent for only 6 of the top 30 

suppliers, and the total allowed charges 

for code K0533 that were associated 

with these 6 suppliers accounted for 

only 4.4 percent of total allowed charges 

for code K0533 during that quarter. 

Based on these data, we conclude that 

most small suppliers of respiratory 

assist devices with backup rate will not 

be significantly affected by this final 

rule. 

C. Impact on Rural Areas 

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 604 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 because we have 

determined that this final rule will not 

have a significant economic impact on 

the operation of a substantial number of 

small rural hospitals. 

D. Unfunded Mandates 

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 final 

rule will not have an effect on the 

governments mentioned, and private 

sector costs will be less than the $110 

million threshold. 

E. Executive Order 13132 

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. 

F. Executive Order 12866 

In accordance with the provisions of 

Executive Order 12866, this final 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 is amending 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: 


rmajette on PROD1PC67 with RULES
Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4525 

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 § 414.222 paragraph (a)(1) is 

revised to read as follows: 

§ 414.222 Items requiring frequent and 

substantial servicing. 

(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 backup 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 7, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: August 10, 2005. 

Michael O. Leavitt, 

Secretary. 

Editorial Note: This document was 

received at the Office of the Federal Register 

January 24, 2006. 

[FR Doc. 06–798 Filed 1–26–06; 8:45 am] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 06–21; MB Docket No. 05–16; RM–

11143, RM–11295] 

Radio Broadcasting Services; La 

Grange, Shallotte, Swansboro, Topsail 

Beach, and Wrightsville Beach, NC 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In response to a Notice of 

Proposed Rule Making, 70 FR 7220 

(February 11, 2005), this Report and 

Order upgrades Channel 279C3, Station 

WBNU(FM), Shallotte, North Carolina, 

to Channel 279C2, reallots Channel 

279C2 to Wrightsville Beach, North 

Carolina, and modifies the license of 

Station WBNU(FM) accordingly. The 

coordinates for Channel 279C2 at 

Wrightsville Beach are 33–59–56 NL 

and 77–54–35 WL, with a site restriction 

of 25.4 kilometers (15.8 miles) 

southwest of Wrightsville Beach. The 

Report and Order also upgrades 

Channel 229A, Station WBNE(FM, 

Wrightsville Beach, to Channel 229C3, 

reallots Channel 229C3 to Topsail Beach 

and modifies the license of Station 

WBNE(FM) accordingly. The 

coordinates for Channel 229C3 at 

Topsail Beach are 34–25–37 NL and 77–

38–33 WL, with a site restriction of 7.0 

kilometers (4.3 miles) north of Topsail 

Beach. In addition, the Report and 

Order downgrades Channel 280C3, 

Station WWTB(FM), Topsail Beach, 

North Carolina, to Channel 281A, 

reallots Channel 281A to Swansboro, 

North Carolina, and modifies the license 

of Station WWTB(FM) accordingly. The 

coordinates for Channel 281A at 

Swansboro are 34–42–41 NL and 77–

16–07 WL, with a site restriction of 13.9 

kilometers (8.7 miles) west of 

Swansboro. Lastly, the Report and Order 

upgrades Channel 284C3, Station 

WZUP(FM), La Grange, North Carolina, 

to Channel 284C2. The coordinates for 

Channel 284C2 at LaGrange are 35–07–

39 NL and 77–42–59 WL, with a site 

restriction of 20.9 kilometers (13.0 

miles) south of La Grange. 

DATES: Effective February 21, 2006. 

FOR FURTHER INFORMATION CONTACT: R. 

Barthen Gorman, Media Bureau, (202) 

418–2180. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order, MB Docket No. 05–16, 

adopted January 4, 2006, and released 

January 6, 2006. The full text of this 

Commission decision is available for 

inspection and copying during normal 

business hours in the FCC’s Reference 

Information Center at Portals II, 445 

12th Street, SW., Room CY–A257, 

Washington, DC 20554. The document 

may also be purchased from the 

Commission’s duplicating contractor, 

Best Copy and Printing, Inc., Portals II, 

445 12th Street, SW., Room CY–B402, 

Washington, DC 20554, telephone 1–

800–378–3160 or http:// 

www.BCPIWEB.com. The Commission 

will send a copy of this Report and 

Order in a report to be sent to Congress 

and the Government Accountability 

Office pursuant to the Congressional 

Review Act, see 5 U.S.C. 801(a)(1)(A). 

List of Subjects in 47 CFR Part 73 

Radio, Radio broadcasting. 

■ Part 73 of Title 47 of the Code of 

Federal Regulations is amended as 

follows: 

Part 73—RADIO BROADCAST 

SERVICES 

■ 1. The authority citation for Part 73 

reads as follows: 

Authority: 47 U.S.C. 154, 303, 334, 336. 

§ 73.202 [Amended] 

■ 2. Section 73.202(b), the Table of FM 

Allotments under North Carolina, is 

amended by removing Channel 284C3 

and adding Channel 284C2 at La 

Grange; by removing Channel 279C3 at 

Shallotte, by adding Swansboro, 

Channel 281A, by removing Channel 

280C3 and adding Channel 229C3 at 

Topsail Beach and by removing Channel 

229A and by adding Channel 279C2 at 

Wrightsville Beach. 

Federal Communications Commission. 

John A. Karousos, 

Assistant Chief, Audio Division, Media 

Bureau. 

[FR Doc. 06–800 Filed 1–26–06; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[DA 06–13; MB Docket No. 03–147, RM–

10722; MB Docket No. 03–148, RM–10724; 

MB Docket No. 03–177, RM–10749; MB 

Docket No. 03–178; RM–10750; and MB 

Docket No. 03–180, RM 10753] 

Radio Broadcasting Services; 

Anacoco, LA; Barstow, CA; Erie, PA, 

Greenfield, CA; and Newcastle, TX 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: The Audio Division, at the 

request of Linda A. Davidson, allots 

Channel 267A at Barstow, California, as 

the community’s third local FM 

transmission service. See 68 FR 42664, 

July 18, 2003. Channel 267A can be 

allotted to Barstow in compliance with 

the Commission’s minimum distance 

separation requirements at city 

reference coordinates. The coordinates 

for Channel 267A at Barstow are 34–53–

55 North Latitude and 117–01–19 West 

Longitude. Because Barstow is located 

within 320 kilometers (199 miles) of the 

U.S.-Mexican border, Mexican 

concurrence has been requested. 

However, concurrence of the Mexican 

government has not yet been received. 

If a construction permit for Channel 

267A at Barstow is granted prior to the 

Commission’s receipt of formal 

concurrence in the allotment by the 

Mexican Government, the construction 

permit will include the following 

condition: ‘‘Use of this allotment is 

subject to suspension, modification, or 

termination without right to hearing, if 

found by the Commission to be 

necessary in order to conform to the 

1992 USA-Mexico FM Broadcast 

Agreement or if specifically objected to 


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