Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 71163 

Dated: November 17, 2005. 

Betsey Dunaway, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E5–6506 Filed 11–23–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Institute for Occupational 

Safety and Health Advisory Board on 

Radiation and Worker Health 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following committee 

meeting: 

Name: Working Group of the Advisory 

Board on Radiation and Worker Health 

(ABRWH), National Institute for 

Occupational Safety and Health (NIOSH). 

Audio Conference Call Time and Date: 

10 a.m.–4 p.m., EST, Monday, November 28, 

2005. 

Place: Audio Conference Call via FTS 

Conferencing. The USA toll free dial in 

number is 1–888–810–8159 with a pass code 

of 69883. 

Status: Open to the public, but without a 

public comment period. 

Background: The ABRWH was established 

under the Energy Employees Occupational 

Illness Compensation Program Act 

(EEOICPA) of 2000 to advise the President, 

delegated to the Secretary, Department of 

Health and Human Services (HHS), on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Board include providing 

advice on the development of probability of 

causation guidelines which have been 

promulgated by HHS as a final rule, advice 

on methods of dose reconstruction which 

have also been promulgated by HHS as a 

final rule, advice on the scientific validity 

and quality of dose estimation and 

reconstruction efforts being performed for 

purposes of the compensation program, and 

advice on petitions to add classes of workers 

to the Special Exposure Cohort (SEC). In 

December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Board to HHS, which 

subsequently delegated this authority to CDC. 

NIOSH implements this responsibility for 

CDC. 

Purpose: This board is charged with (a) 

providing advice to the Secretary, HHS on 

the development of guidelines under 

Executive Order 13179; (b) providing advice 

to the Secretary, HHS on the scientific 

validity and quality of dose reconstruction 

efforts performed for this Program; and (c) 

upon request by the Secretary, HHS, advise 

the Secretary on whether there is a class of 

employees at any Department of Energy 

facility who were exposed to radiation but for 

whom it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such radiation 

doses may have endangered the health of 

members of this class. 

Matters To Be Discussed: Agenda for the 

conference call includes reports from the 

Working Groups on the Bethlehem Steel Site 

Profile, Y–12 Site Profile, and a discussion 

concerning the Board’s approach to making 

an SEC Petition. 

The agenda is subject to change as 

priorities dictate. 

In the event a member of the working 

group cannot attend, written comments may 

be submitted. Any written comments 

received will be provided at the meeting and 

should be submitted to the contact person 

below well in advance of the meeting. 

For Further Information Contact: Dr. Lewis 

V. Wade, Executive Secretary, NIOSH, CDC, 

4676 Columbia Parkway, Cincinnati, Ohio 

45226, telephone 513/533–6825, fax 513/ 

533–6826. 

Due to administrative issues concerning 

the topics for discussion, which were not 

confirmed until this week, the Federal 

Register notice is being published less than 

fifteen days before the date of the meeting. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC). 

[FR Doc. E5–6508 Filed 11–23–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1294–N] 

RIN 0938–AN99 

Medicare Program; Coverage and 

Payment of Ambulance Services; 

Inflation Update for CY 2006 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces an 

updated Ambulance Inflation Factor 

(AIF) for payment of ambulance services 

during calendar year (CY) 2006. The 

statute requires that this inflation factor 

be applied in determining the fee 

schedule amounts and payment limits 

for ambulance services. The updated 

AIF for 2006 applies to ambulance 

services furnished during the period 

January 1, 2006, through December 31, 

2006. 

DATES: Effective date: The AIF for 2006 

is effective for ambulance services 

furnished during the period January 1, 

2006, through December 31, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Anne E. Tayloe, (410) 786–4546. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Legislative and Regulatory History 

Under section 1861(s)(7) of the Social 

Security Act (the Act), Medicare Part B 

(Supplementary Medical Insurance) 

covers and pays for ambulance services, 

to the extent prescribed in regulations at 

42 CFR Part 410 and Part 414, when the 

use of other methods of transportation 

would be contraindicated. The House 

Ways and Means Committee and Senate 

Finance Committee Reports that 

accompanied the 1965 legislation 

creating the Act suggest that the 

Congress intended that: the ambulance 

benefit cover transportation services 

only if other means of transportation are 

contraindicated by the beneficiary’s 

medical condition; and only ambulance 

service to local facilities be covered 

unless necessary services are not 

available locally, in which case, 

transportation to the nearest facility 

furnishing those services is covered 

(H.R. Rep. No. 213, 89th Cong., 1st Sess. 

37 and S. Rep. No. 404, 89th Cong., 1st 

Sess., Pt I, 43 (1965)). The reports 

indicate that transportation may also be 

provided from one hospital to another, 

to the beneficiary’s home, or to an 

extended care facility. 

Our regulations relating to ambulance 

services are located at 42 CFR Part 410, 

subpart B and Part 414, subpart H. 

Section 410.10(i) lists ambulance 

services as one of the covered medical 

and other health services under 

Medicare Part B. Ambulance services 

are subject to basic conditions and 

limitations set forth at § 410.12 and to 

specific conditions and limitations 

included at § 410.40. Part 414, subpart 

H describes how payment is made for 

ambulance services covered by 

Medicare. 

Ambulance services are divided into 

different levels of services based on the 

medically necessary treatment provided 

during transport as well as into ground 

(including water) and air ambulance 

services. These services include the 

following levels of service. 

For Ground: 

• Basic Life Support (BLS) 

• Advanced Life Support, Level 1 

(ALS1) 

• Advanced Life Support, Level 2 

(ALS2) 

71164 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 

• Specialty Care Transport (SCT) 

• Paramedic ALS Intercept (PI) 

For Air: 

• Fixed Wing Air Ambulance (FW) 

• Rotary Wing Air Ambulance (RW) 

Historically, payment levels for 

ambulance services depended, in part, 

upon the entity that furnished the 

services. Prior to implementation of the 

ambulance fee schedule on April 1, 

2002, providers (hospitals, including 

critical access hospitals, skilled nursing 

facilities, and home health agencies) 

were paid on a retrospective reasonable 

cost basis. Suppliers, which are entities 

that are independent of any provider, 

were paid on a reasonable charge basis. 

On February 27, 2002, the Fee 

Schedule for Payment of Ambulance 

Services and Revisions to the Physician 

Certification Requirements for Coverage 

of Non-Emergency Ambulance Services 

final rule was published in the Federal 

Register (67 FR 9100). That final rule 

implemented section 1834(l) of the Act 

(which was added by the Balanced 

Budget Act of 1997) and established a 

fee schedule for the payment of 

ambulance services under the Medicare 

program effective for services furnished 

on or after April 1, 2002. The fee 

schedule described in the final rule 

replaced the retrospective reasonable 

cost payment system for providers and 

the reasonable charge system for 

suppliers of ambulance services. In 

addition, that final rule: Implemented 

the requirement in section 1834(l)(6) of 

the Act that ambulance suppliers accept 

Medicare assignment; codified the 

establishment of new Health Care 

Common Procedure Coding System 

(HCPCS) codes to be reported on claims 

for ambulance services; established 

increased payment under the fee 

schedule for ambulance services 

furnished in rural areas based on the 

location of the beneficiary at the time 

the beneficiary is placed on board the 

ambulance; and revised the certification 

requirements for coverage of nonemergency ambulance services. That 

final rule also provided for a 5-year 

transition period during which program 

payment for Medicare covered 

ambulance services would be based 

upon a blended rate comprised of a fee 

schedule portion and a reasonable cost 

(providers) or reasonable charge 

(suppliers) portion. We are now in the 

fourth year of that transition over to full 

payment based solely on the fee 

schedule amount. 

B. Ambulance Inflation Factor (AIF) for 

CY 2006 

Section 1834(l)(3)(B) of the Act 

provides the basis for updating payment 

amounts for ambulance services. Our 

implementing regulations at § 414.610(f) 

provide that the ambulance fee schedule 

must be updated by the AIF annually, 

based on the consumer price index for 

all urban consumers (CPI–U) (U.S. city 

average) for the 12-month period ending 

with June of the previous year. 

Our regulations at § 414.620 provide 

that changes in payment rates resulting 

from incorporation of the AIF will be 

announced by notice in the Federal 

Register without opportunity for prior 

comment. We find it unnecessary to 

undertake notice and comment 

rulemaking because the statute and 

regulations specify the methods of 

computation of annual updates. This 

notice does not change policy, but 

merely applies the update methods 

specified in the statute and regulations. 

II. Provisions of the Notice 

A. Ambulance Inflation Factor (AIF) for 

2006 

Section 1834(l)(3)(B) of the Act, as 

specified in § 414.610(f), provides for an 

update in payments for CY 2006 that is 

equal to the percentage increase in the 

CPI for all urban consumers (CPI–U), for 

the 12-month period ending with June 

of the previous year (that is, June 2005). 

For CY 2006 that percentage is 2.5 

percent. 

The national fee schedule for 

ambulance services has been phased in 

over a five-year transition period 

beginning April 1, 2002. (See § 414.615). 

According to section 414 of the 

Medicare Prescription Drug, 

Improvement and Modernization Act of 

2003 (MMA) (Pub. L. 108–173), CMS 

established new § 414.617 which 

specifies that for ambulance services 

furnished during the period July 1, 2004 

through December 31, 2009, the ground 

ambulance base rate is subject to a floor 

amount, which is determined by 

establishing nine fee schedules based on 

each of the nine census divisions, and 

using the same methodology as was 

used to establish the national fee 

schedule. If the regional fee schedule 

methodology for a given census division 

results in an amount that is lower than 

or equal to the national ground base 

rate, then it is not used, and the national 

fee schedule amount applies for all 

providers and suppliers in the census 

division. If the regional fee schedule 

methodology for a given census division 

results in an amount that is greater than 

the national ground base rate, then the 

fee schedule portion of the base rate for 

that census division is equal to a blend 

of the national rate and the regional rate. 

For CY 2006, this blend would be 40 

percent regional ground base rate and 60 

percent national ground base rate. Prior 

to January 1, 2006, during the transition 

period, the AIF was applied to both the 

fee schedule portion of the blended 

payment amount (both national and 

regional (if it applied)) and to the 

reasonable cost or charge portion of the 

blended payment amount separately, 

respectively, for each ambulance 

provider or supplier. Then, these two 

amounts were added together to 

determine the total payment amount for 

each provider or supplier. As of January 

1, 2006, the total payment amount for 

air ambulance providers and suppliers 

will be based on 100 percent of the 

national ambulance fee schedule, while 

the total payment amount for ground 

ambulance providers and suppliers will 

be based on either 100 percent of the 

national ambulance fee schedule or 60 

percent of the national ambulance fee 

schedule and 40 percent of the regional 

ambulance fee schedule. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

when a collection of information 

requirement is submitted to the OMB for 

review and approval. In order to fairly 

evaluate whether OMB should approve 

an information collection, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

examine the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

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 (44 

U.S.C. 35). 

IV. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register to provide a period of public 

comment before the provisions of a 

notice such as this take effect. We can 

waive this procedure, however, if we 

find good cause that a notice and 

comment procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporate a statement of 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Notices 71165 

finding and its reasons in the notice 

issued. 

We find it unnecessary to undertake 

notice and comment rulemaking 

because the statute and regulation 

specify the methods of computation of 

annual updates, and we have no 

discretion in this matter. Further, this 

notice does not change substantive 

policy, but merely applies the update 

methods specified in statute and 

regulation. Therefore, for good cause, 

we waive notice and comment 

procedures. 

Under the Congressional Review Act, 

major rules generally cannot take effect 

until 60 days after the rule is published 

in the Federal Register. However, 

section 808(2) of the Congressional 

Review Act states that agencies may 

waive this 60-day requirement for ‘‘good 

cause’’ and establish an earlier effective 

date. As explained above, we believe 

that there is ‘‘good cause’’ for waiver of 

the APA requirement for notice and 

comment rulemaking because it would 

be unnecessary for us to fulfill that 

requirement. For the same reason, we 

believe that the ‘‘good cause’’ exception 

applies to the 60-day effective date 

requirement for major rules in the 

Congressional Review Act. 

V. Regulatory Impact Statement 

We have examined the impacts of this 

notice 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 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). As stated above, the AIF 

(equal to the percentage increase in the 

CPI–U of June 30, 2005 as compared to 

June 30, 2004) for 2006 is 2.5 percent. 

We estimate that the application of the 

AIF will result in this notice being 

considered a major rule because it will 

result in an additional total program 

expenditure of approximately $112 

million in CY 2006. 

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 small 

governmental jurisdictions. 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 in any 1 

year. For purposes of the RFA, all 

ambulance providers or suppliers are 

considered to be small entities. 

Individuals and States are not included 

in the definition of a small entity. 

The Department of Health and Human 

Services (HHS) considers that a 

substantial number of entities are 

affected if the rule impacts more than 5 

percent of the total number of small 

entities as it does in this notice. This 

notice will impact every ambulance 

provider and supplier in the same way 

because all ambulance payment rates for 

all ambulance services furnished by all 

types of ambulance providers and 

suppliers are increased by the same 

ambulance inflation factor. While all 

ambulance payment rates are increased 

by the 2.5 percent AIF, the impact of 

this increase does not meet the 

threshold established by HHS to be 

considered a significant impact. 

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. 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 have no data to indicate that 

a substantial number of small rural 

hospitals will be impacted by this 

notice. 

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 

governments, in the aggregate, or by the 

private sector, of $110 million. This 

notice does not result in expenditures in 

any 1 year by State, local, or tribal 

governments of $110 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it publishes a notice 

that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This notice will not have a substantial 

effect on State or local governments. 

We estimate that the total program 

expenditure for CY 2006 for ambulance 

services covered by the Medicare 

program is approximately $4.5 billion. 

Application of an AIF of 2.5 percent 

will result in an additional total 

program expenditure of approximately 

$112 million over CY 2005. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

Authority: Section 1834(l) of the Social 

Security Act (42 U.S.C. 1395m(l)). 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: August 9, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 7, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–23163 Filed 11–23–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0443] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

focus groups as used by FDA to gauge 

public opinion. Policymakers can use 

focus group results to test and refine 

their ideas so they can conduct further 

research, as well as, adopt new policies 

and to allocate or redirect significant 

resources to support these policies. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 24, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets