Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 57305

special interest in ensuring that women, 

minority groups, and physically 

challenged individuals are adequately 

represented on the MCAC. Therefore, 

we encourage nominations of qualified 

candidates from these groups. 

All nominations must be 

accompanied by curricula vitae. 

Nomination packages must be sent to 

Michelle Atkinson at the address listed 

in the ADDRESSES section. 

Criteria for Members 

Nominees for voting membership 

must have expertise and experience in 

one or more of the following fields: 

clinical medicine of all specialties, 

administrative medicine, public health, 

patient advocacy, epidemiology and 

biostatistics, methodology of trial 

design, biologic and physical sciences, 

health care data and information 

management and analysis, the 

economics of health care, medical 

ethics, and other related professions. 

We are also seeking nominations for 

nonvoting consumer and industry 

representatives. Nominees for these 

positions must possess appropriate 

qualifications to understand and 

contribute to the MCAC’s work. 

The nomination letter must include a 

statement that the nominee is willing to 

serve as a member of the MCAC and 

appears to have no conflict of interest 

that would preclude membership. We 

are requesting that all curricula vitae 

include the following: Date of birth, 

place of birth, social security number, 

title and current position, professional 

affiliation, home and business address, 

telephone and fax numbers, e-mail 

address, and list of areas of expertise. In 

the nominations letter, we are 

requesting that the nominee specify 

whether applying for voting member, 

Industry Representative, or Consumer 

Representative. Potential candidates 

will be asked to provide detailed 

information concerning such matters as 

financial holdings, consultancies, and 

research grants or contracts in order to 

permit evaluation of possible sources of 

conflict of interest. 

Members are invited to serve for 

overlapping 4-year terms. A member 

may serve after the expiration of the 

member’s term until a successor takes 

office. Any interested person may 

nominate one or more qualified persons. 

Self-nominations are also accepted.

Authority: 5 U.S.C. App. 2, section 10(a)(1) 

and (a)(2).

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: September 14, 2004. 

Sean R. Tunis, 

Director, Office of Clinical Standards and 

Quality, Centers for Medicare & Medicaid 

Services.

[FR Doc. 04–21200 Filed 9–23–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2204–PN] 

RIN 0938–ZA61 

Medicare and Medicaid Programs; 

Application by the Joint Commission 

on Accreditation of Healthcare 

Organizations (JCAHO) for Home 

Health Agencies

AGENCY: Centers for Medicare & 

Medicaid Services, HHS.

ACTION: Proposed notice.

SUMMARY: This proposed notice with 

comment period acknowledges the 

receipt of an application from the Joint 

Commission on Accreditation of 

Healthcare Organizations for continued 

recognition as a national accreditation 

program for Home Health Agencies that 

wish to participate in the Medicare or 

Medicaid programs. The statute requires 

that within 60 days of receipt of an 

organization’s complete application, we 

will publish a notice that will announce 

our receipt of the accreditation 

organization’s application for approval, 

describe the criteria we will use in 

evaluating the application, and provide 

at least a 30-day public comment 

period.

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on October 25, 2004.

ADDRESSES: In commenting, please refer 

to file code CMS–2204–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may 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–2204–PN, 

P.O. Box 8017, Baltimore, MD 21244–

8017. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

7195 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 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 

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 

received after the comment period.

FOR FURTHER INFORMATION CONTACT:

Cindy Melanson, (410) 786–0310.

SUPPLEMENTARY INFORMATION:

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Background’’ at the beginning 

of your comments.]

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a Home Health Agency 

(HHA) provided certain requirements 

are met. Sections 1861(o) and 1891 of 

the Social Security Act (the Act) 

establish distinct criteria for facilities 

seeking designation as an HHA. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. The regulations 

at 42 CFR 484 specify the conditions 

that an HHA must meet in order to 

participate in the Medicare program, the 

scope of covered services, and the 

conditions for Medicare payment for 

Home Health care. 

Generally, to enter into an agreement, 

an HHA must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

57306 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

part 484 of our regulations. Then, the 

HHA is subject to regular surveys by a 

State survey agency to determine 

whether it continues to meet these 

requirements. There is an alternative, 

however, to surveys by State agencies. 

Section 1865(b)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization that 

all applicable Medicare conditions are 

met or exceeded, we would ‘‘deem’’

those provider entities as having met the 

requirements. Accreditation by an 

accreditation organization is voluntary 

and is not required for Medicare 

participation. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accreditation organization applying for 

approval of deeming authority under 

part 488, subpart A must provide us 

with reasonable assurance that the 

accreditation organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning reapproval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require 

accreditation organizations to reapply 

for continued approval of deeming 

authority every 6 years or sooner as 

determined by CMS. The JCAHO’s term 

of approval as a recognized 

accreditation program for HHAs expires 

March 31, 2005. 

II. Approval of Deeming Organizations 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Approval of Deeming 

Organizations’’ at the beginning of your 

comments.] 

Section 1865(b)(2) of the Act and our 

regulations at § 488.8(a) require that our 

findings concerning review and 

reapproval of a national accrediting 

organization’s requirements consider, 

among other factors, the reapplying 

accreditation organization’s: 

Requirements for accreditation; survey 

procedures; resources for conducting 

required surveys; capacity to furnish 

information for use in enforcement 

activities; monitoring procedures for 

provider entities found not in 

compliance with the conditions or 

requirements; and ability to provide us 

with the necessary data for validation. 

Section 1865(b)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accreditation 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from our receipt of 

a completed application to publish 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of our 

consideration of JCAHO’s request for 

approval of continued deeming 

authority for HHAs. This notice also 

solicits public comment on the ability of 

JCAHO requirements to meet or exceed 

the Medicare conditions for 

participation for HHAs. 

III. Evaluation of Deeming Authority 

Request 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Evaluation of Deeming 

Authority Request’’ at the beginning of 

your comments.]

On June 30, 2004, JCAHO submitted 

all the necessary materials to enable us 

to make a determination concerning its 

request for reapproval as a deeming 

organization for HHAs. Under section 

1865(b)(2) of the Act and our regulations 

at § 488.8 (Federal review of 

accreditation organizations), our review 

and evaluation of JCAHO will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of JCAHO 

standards for an HHA as compared with 

our comparable HHA conditions of 

participation. 

• JCAHO’s survey process to 

determine the following: 

+ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

+ The comparability of JCAHO 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

+ JCAHO’s processes and procedures 

for monitoring providers or suppliers 

found out of compliance with JCAHO 

program requirements. These 

monitoring procedures are used only 

when JCAHO identifies noncompliance. 

If noncompliance is identified through 

validation reviews, the survey agency 

monitors corrections as specified at 

§ 488.7(d). 

+ JCAHO’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

+ JACAHO’s capacity to provide us 

with electronic data in ASCII 

comparable code, and reports necessary 

for effective validation and assessment 

of the organization’s survey process. 

+ The adequacy of JCAHO’s staff and 

other resources, and its financial 

viability. 

+ JCAHO’s capacity to adequately 

fund required surveys. 

+ JCAHO’s policies with respect to 

whether surveys are announced or 

unannounced. 

+ JCAHO’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, 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, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

V. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this proposed 

notice was not reviewed by the Office of 

Management and Budget.

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb)

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773)

Dated: September 10, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–21193 Filed 9–23–04; 8:45 am] 

BILLING CODE 4120–01–P