73086 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

The panel is governed by the Federal 

Advisory Committee Act, as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory committees. 

Dated: November 18, 2010. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2010–29945 Filed 11–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4154–PN] 

Medicare and Medicaid Programs; 

Renewal of Deeming Authority of the 

National Committee for Quality 

Assurance for Medicare Advantage 

Health Maintenance Organizations and 

Local Preferred Provider Organizations 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces the receipt of an application 

to renew the Medicare Advantage 

Deeming Authority of the National 

Committee for Quality Assurance 

(NCQA) for Health Maintenance 

Organizations and Preferred Provider 

Organizations for a term of 4 years. The 

new term of approval would begin 

October 19, 2010, and would end 

October 18, 2014. In addition, this 

proposed notice announces a 30-day 

public comment period on the renewal 

of the application. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on January 28, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–4154–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–4154–PN, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

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 to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–4154–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 before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey 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.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

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. 

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: 

Caroline L. Baker (410) 786–0116. 

SUPPLEMENTARY INFORMATION: 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. Follow the search 

instructions 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 covered 

services through a Medicare Advantage 

(MA) organization that contracts with 

the Centers for Medicare & Medicaid 

Services (CMS). The regulations 

specifying the Medicare requirements 

that must be met in order for an 

Medicare Advantage Organization 

(MAO) to enter into a contract with 

CMS are located at 42 CFR part 422. 

These regulations implement Part C of 

Title XVIII of the Social Security Act 

(the Act), which specifies the services 

that an MAO must provide and the 

requirements that the organization must 

meet to be an MA contractor. Other 

relevant sections of the Act are Parts A 

and B of Title XVIII and Part A of Title 

XI of the Act pertaining to the provision 

of services by Medicare certified 

providers and suppliers. 

Generally, for an entity to be an MA 

organization, the organization must be 

licensed by the State as a risk bearing 

organization as set forth in Part 422 of 

our regulations. 

To assure compliance with certain 

Medicare requirements, an MA 

organization may chose to become 

accredited by a CMS approved 

accrediting organization (AO). By doing 

so, the MA organization may be 

‘‘deemed’’ compliant in one or more of 

6 requirements set forth in section 

1852(e)(4)(B) of the Act. In order for an 

AO to be able to ‘‘deem’’ an MA plan as 

compliant with these MA requirements, 

the AO must prove to CMS that its 

standards are at least as stringent as 

Medicare requirements. MA 

organizations that are licensed as health 

maintenance organizations (HMOs) or 

preferred provider organizations (PPOs) 

and are accredited by an approved 

accrediting organization may receive, at 

their request, deemed status for CMS 

requirements in the following six MA 

survey areas: (1) Quality Improvement, 

(2) Antidiscrimination, Access to 

Services, (3) Confidentiality and 

Accuracy of Enrollee Records, (4) 

Information on Advanced Directives, 

and Provider Participation Rules. (See 

42 CFR 422.156(b).) We note that at this 

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Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73087 

time, deeming does not include the Part 

D areas of review listed in § 422.156(b). 

Organizations that apply for MA 

deeming authority are generally 

recognized by the health care industry 

as entities that accredit HMOs and 

PPOs. As we specified in 

§ 422.157(b)(2), the term for which an 

AO may be approved by CMS may not 

exceed 6 years. For continuing approval, 

the AO must renew their application 

with CMS. 

The National Committee for Quality 

Assurance (NCQA) was approved as an 

accrediting organization for MA 

deeming of HMOs from January 19, 

2002 through January 18, 2008. The 

NCQA was reapproved as an accrediting 

organization for MA deeming of HMOs 

on January 18, 2008, for a term of 6 

years, which was set to expire on 

January 17, 2014. 

The NCQA was approved for MA 

deeming of PPOs from October 20, 2004 

through October 19, 2010. On July 20, 

2010, the NCQA submitted an 

application to renew their deeming 

authority which, at the request of CMS 

for administrative simplification 

purposes, combined their HMO and 

PPO deeming authority. On July 20, 

2010, the NCQA also submitted all of 

the prerequisite materials as specified in 

§ 422.158(a) for receiving CMS deeming 

program approval. This information was 

previously submitted to CMS by NCQA 

as a part of their initial HMO and PPO 

applications. 

II. Approval of Deeming Organizations 

Section 1852(e)(4)(C) of the Act 

provides a statutory timetable to ensure 

that our review of deeming applications 

in conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an application 

to complete our survey activities and 

application review process. At the end 

of the 210 day period, we must publish 

an approval or denial of the application 

in the Federal Register. 

III. Evaluation of Deeming Authority 

Request 

As set forth in § 1852(e)(4) of the Act 

and our regulations at § 422.158, the 

review and evaluation of NCQA’s 

accreditation program (including its 

standards and monitoring protocol) 

were compared to the requirements set 

forth in part 422 for the MA program. 

A. Components of the Review Process 

The review of NCQA’s application for 

approval of MA deeming authority 

included the following components: 

• The types of MA plans that it would 

review as part of its accreditation 

process. 

• A detailed comparison of the 

organization’s accreditation 

requirements and standards with the 

Medicare requirements (for example, a 

crosswalk). 

• Detailed information about the 

organization’s survey process, 

including— 

++ Frequency of surveys and whether 

surveys are announced or unannounced. 

++ Copies of survey forms, and 

guidelines and instructions to 

surveyors. 

++ Description of The survey review 

process and the accreditation status 

decision making process; 

++ The procedures used to notify 

accredited MA organizations of 

deficiencies and to monitor the 

correction of those deficiencies; and 

++ The procedures used to enforce 

compliance with accreditation 

requirements. 

• Detailed information about the 

individuals who perform surveys for the 

accreditation organization, including— 

++ The size and composition of 

accreditation survey teams for each type 

of plan reviewed as part of the 

accreditation process. 

++ The education and experience 

requirements surveyors must meet. 

++ The content and frequency of the 

in-service training provided to survey 

personnel. 

++ The evaluation systems used to 

monitor the performance of individual 

surveyors and survey teams. 

• The organization’s policies and 

practice with respect to the 

participation, in surveys or in the 

accreditation decision process by an 

individual who is professionally or 

financially affiliated with the entity 

being surveyed. 

• A description of the organization’s 

data management and analysis system 

with respect to its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• A description of the organization’s 

procedures for responding to and 

investigating complaints against 

accredited organizations, including 

policies and procedures regarding 

coordination of these activities with 

appropriate licensing bodies and 

ombudsmen programs. 

• A description of the organization’s 

policies and procedures with respect to 

the withholding or removal of 

accreditation for failure to meet the 

accreditation organization’s standards or 

requirements, and other actions the 

organization takes in response to 

noncompliance with its standards and 

requirements. 

• A description of all types (for 

example, full and partial) and categories 

(for example, provisional, conditional, 

and temporary) of accreditation offered 

by the organization, the duration of each 

type and category of accreditation, and 

a statement identifying the types and 

categories that would serve as a basis for 

accreditation if CMS approves the 

accreditation organization. 

• A list of all currently accredited MA 

organizations and the type, category, 

and expiration date of the accreditation 

held by each of them. 

• A list of all full and partial 

accreditation surveys scheduled to be 

performed by the accreditation 

organization as requested by CMS. 

• The name and address of each 

person with an ownership or control 

interest in the accreditation 

organization. 

• The NCQA’s past performance in 

the deeming program and results of 

recent deeming validation reviews, or 

look-behind audits conducted as part of 

continuing Federal oversight of the 

deeming program under § 422.157(d). 

B. Results of the Review Process 

Using the information listed in 

section III.A. of this proposed notice, we 

determined that NCQA’s current 

accreditation program for HMO and 

PPO MA plans continues to be at least 

as stringent as the MA requirements 

contained in the six categories specified 

in section 1852(e)(4)(C) of the Act and 

our methods of evaluation for those 

areas. 

IV. Response to Public Comments and 

Notice Upon Completion of Evaluation 

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 notice, 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). 

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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. 

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