73088 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 18, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–29959 Filed 11–26–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–2332–PN] 

Medicare Program; Application by the 

American Association for 

Accreditation of Ambulatory Surgery 

Facilities, Inc. (AAAASF) for Deeming 

Authority for Providers of Outpatient 

Physical Therapy and SpeechLanguage Pathology Services. 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of a deeming 

application from the American 

Association for Accreditation of 

Ambulatory Surgery Facilities 

(AAAASF) for recognition as a national 

accrediting organization for providers of 

outpatient physical therapy and speechlanguage pathology services that wish to 

participate in the Medicare or Medicaid 

programs. Section 1865(a)(3)(A) of the 

Social Security Act requires that within 

60 days of receipt of an organization’s 

complete application, the Secretary of 

the Department of Health and Human 

Services 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 one of 

the addresses provided below, no later 

than 5 p.m. on December 29, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–2332–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.regulations.gov. Click on the link 

‘‘Submit electronic comments on CMS 

regulations with an open comment 

period.’’ (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–2332– 

PN, P.O. Box 8010, Baltimore, MD 

21244–8010. 

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–2332– 

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 telephone number (410) 786– 

9994 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 information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: L. 

Alexis Prete, (410) 786–0375. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering issues and 

developing policies. You can assist us 

by referencing the file code CMS–2332– 

PN and the specific ‘‘issue identifier’’ 

that precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive outpatient 

physical therapy services (OPT) from a 

provider of services, a clinic, a 

rehabilitation agency, a public health 

agency, or by others under an 

arrangement with and under the 

supervision of such provider, clinic, 

rehabilitation agency, or public health 

agency (collectively, ‘‘organizations’’), 

provided certain requirements are met. 

Section 1861(p)(4) of the Social Security 

Act (the Act) establishes distinct criteria 

for organizations seeking approval to 

provide OPT services. 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. Our regulations at 42 CFR part 

485, subpart H specify the conditions 

that an organization providing OPT 

services must meet in order to 

participate in the Medicare program. 

Generally, in order to enter into a 

provider agreement with the Medicare 

program, an organization offering OPT 

services must first be certified by a State 

survey agency as complying with the 

applicable conditions or requirements 

set forth in part 42 CFR part 485. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73089 

Thereafter, the organization 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 

State certification and surveys by State 

agencies, as a means to enter into a 

Medicare provider agreement. Section 

1865(a)(1) of the Act provides that, if a 

provider entity demonstrates through 

accreditation by a national accrediting 

organization approved by the Secretary, 

that all applicable Medicare conditions 

are met or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting 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 

accrediting organization applying for 

deeming authority under part 488, 

subpart A must provide us with 

reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions of 

participation. The regulations at 

§ 488.8(d)(3) require accrediting 

organizations to reapply for continued 

deeming authority every six years or 

sooner, as determined by the Secretary. 

II. Approval of Deeming Organizations 

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

regulations at § 488.8(a) require that our 

findings concerning review and 

approval of a national accrediting 

organization’s Requirements consider, 

among other factors, the applying 

accrediting 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 the 

Secretary with the necessary data for 

validation. 

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

further requires that the Secretary 

publish, within 60 days of receipt of an 

organization’s complete application, a 

notice identifying the national 

accrediting body making the request, 

describing the nature of the request, and 

providing at least a 30-day public 

comment period. The Secretary has 210 

days from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of AAAASF’s 

request for deeming authority for 

organizations providing OPT services. 

This notice also solicits public comment 

on whether AAAASF’s requirements 

meet or exceed the Medicare conditions 

for participation for such organizations. 

III. Evaluation of Deeming Authority 

Request 

AAAASF submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

approval as a deeming organization for 

organizations providing OPT services. 

This application was determined to be 

complete on October 15, 2010. Under 

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

regulations at § 488.8 (Federal review of 

accrediting organizations), our review 

and evaluation of AAAASF will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of AAAASF’s 

standards for an organization providing 

OPT services, as compared with CMS’ 

OPT organizations’ conditions of 

participation. 

• AAAASF’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 AAAASF’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

—AAAASF’s processes and procedures 

for monitoring OPTs found out of 

compliance with the AAAASF’s 

program requirements. These 

monitoring procedures are used only 

when AAAASF identifies 

noncompliance. If noncompliance is 

identified through validation reviews, 

the State survey agency will monitor 

corrections as specified at § 488.7(d). 

—AAAASF’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

—AAAASF’s capacity to provide the 

Secretary with electronic data and 

reports necessary for effective 

validation and assessment of the 

organization’s survey process. 

—The adequacy of AAAASF’s staff and 

other resources, and its financial 

viability. 

—AAAASF’s capacity to adequately 

fund required surveys. 

—AAAASF’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys 

are unannounced. 

—AAAASF’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. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this proposed notice. 

In accordance with Executive Order 

13132, we have determined that this 

proposed notice would not have a 

significant effect on the rights of States, 

local or tribal governments. 

(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: November 17, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–29966 Filed 11–26–10; 8:45 am] 

BILLING CODE 4120–01–P 

mstockstill on DSKH9S0YB1PROD with NOTICES