55862 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–2227–PN] 

Medicare and Medicaid Programs; 

Application by the Accreditation 

Commission for Healthcare for 

Deeming Authority for Home Health 

Agencies 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Accreditation 

Commission for Healthcare for 

recognition as a national accreditation 

program for home health agencies that 

wish to participate in the Medicare or 

Medicaid programs. Section 

1865(b)(3)(A) of the Social Security Act 

requires that within 60 days of receipt 

of an organization’s complete 

application, we publish a notice that 

identifies the national accrediting body 

making the request, describes the nature 

of the request, and provides at least a 

30-day public comment period. 

DATES: To be assured consideration, 

comments must be received at the 

appropriate address, as provided below, 

no later than 5 p.m. on October 24, 

2005. 

ADDRESSES: In commenting, please refer 

to file code CMS–2227–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four 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 regular 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–2227–

PN, P.O. Box 8018, Baltimore, MD 

21244–8018. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send 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–2227–PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. 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 Yolanda Hayes at 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 

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 part 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, in order 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 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 will ‘‘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. 

The Joint Commission on 

Accreditation of Healthcare 

Organizations (JCAHO) and the 

Community Health Accreditation 

Program (CHAP) are currently the only 

approved national accreditation 

organizations for HHAs. 

II. Approval of Deeming Organizations 

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 applying 

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 the Accreditation 

Commission for Healthcare’s (ACHC’s) 

request to become a national 

accreditation organization for HHAs. 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55863 

This notice also solicits public comment 

on the ability of ACHC requirements to 

meet or exceed the Medicare conditions 

for participation for home health 

agencies. 

III. Evaluation of Deeming Authority 

Request 

On August 8, 2005, ACHC submitted 

all the necessary materials to enable us 

to make a determination concerning its 

request for approval 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 ACHC will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of ACHC standards 

for home health care as compared with 

our comparable home health conditions 

of participation. 

• ACHC’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 ACHC processes 

to those of State agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately 

to complaints against accredited 

facilities. 

—ACHC’s processes and procedures for 

monitoring providers or suppliers 

found out of compliance with ACHC 

program requirements. These 

monitoring procedures are used only 

when ACHC identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the survey agency monitors 

corrections as specified at § 488.7(d). 

—ACHC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

—ACHC 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 ACHC’s staff and 

other resources, and its financial 

viability. 

—ACHC’s capacity to adequately fund 

required surveys. 

—ACHC’s policies with respect to 

whether surveys are announced or 

unannounced. 

—ACHC’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 Public Comments and 

Notice Upon Completion of Evaluation 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are not able 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble and will respond to the 

public 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. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this regulation 

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 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 14, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare and 

Medicaid Services. 

[FR Doc. 05–18922 Filed 9–22–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9032–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—April Through June 2005 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice lists CMS manual 

instructions, substantive and 

interpretive regulations, and other 

Federal Register notices that were 

published from April 2005 through June 

2005, relating to the Medicare and 

Medicaid programs. This notice 

provides information on national 

coverage determinations (NCDs) 

affecting specific medical and health 

care services under Medicare. 

Additionally, this notice identifies 

certain devices with investigational 

device exemption (IDE) numbers 

approved by the Food and Drug 

Administration (FDA) that potentially 

may be covered under Medicare. This 

notice also includes listings of all 

approval numbers from the Office of 

Management and Budget for collections 

of information in CMS regulations. 

Finally, this notice includes a list of 

Medicare-approved carotid stent 

facilities. 

Section 1871(c) of the Social Security 

Act requires that we publish a list of 

Medicare issuances in the Federal 

Register at least every 3 months. 

Although we are not mandated to do so 

by statute, for the sake of completeness 

of the listing, and to foster more open 

and transparent collaboration efforts, we 

are also including all Medicaid 

issuances and Medicare and Medicaid 

substantive and interpretive regulations 

(proposed and final) published during 

this 3-month time frame. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

have a specific information need and 

not be able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing 

information contact persons to answer 

general questions concerning these 

items. Copies are not available through 

the contact persons. (See Section III of 

this notice for how to obtain listed 

material.) 

Questions concerning items in 

Addendum III may be addressed to 

Timothy Jennings, Office of Strategic 

Operations and Regulatory Affairs, 

Centers for Medicare & Medicaid 

Services, C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–2134. 

Questions concerning Medicare NCDs 

in Addendum V may be addressed to 

Patricia Brocato-Simons, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1–

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–0261. 

Questions concerning FDA-approved 

Category B IDE numbers listed in 

Addendum VI may be addressed to John 

Manlove, Office of Clinical Standards 

and Quality, Centers for Medicare & 

Medicaid Services, S3–26–10, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786–

6877. 

Questions concerning approval 

numbers for collections of information 

in Addendum VII may be addressed to 

Jim Wickliffe, Office of Strategic 

Operations and Regulatory Affairs,