44370 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 

Development, Bureau of Primary Health 

Care, HRSA, at 301–594–4300. 

Dated: August 24, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–20818 Filed 8–27–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2299–FN] 

Medicare and Medicaid Programs; 

Application of the American 

Osteopathic Association for Continued 

Deeming Authority for Hospitals 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This notice announces our 

decision to approve the American 

Osteopathic Association (AOA) for 

continued recognition as a national 

accreditation program for hospitals 

seeking to participate in the Medicare or 

Medicaid programs. 

DATES: Effective Date: This final notice 

is effective September 25, 2009 through 

September 25, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Lillian Williams, (410) 786–8636. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospital provided 

certain requirements are met. The 

regulations specifying the Medicare 

conditions of participation (CoPs) for 

hospitals are located at 42 CFR part 482. 

These conditions implement section 

1861(e) of the Social Security Act (the 

Act), which specifies services covered 

as hospital care and the conditions that 

a hospital program must meet in order 

to participate in the Medicare program. 

Regulations concerning provider 

agreements are located at 42 CFR part 

489 and those pertaining to activities 

relating to the survey and certification 

of facilities are located at 42 CFR part 

488. 

Generally, in order to enter into a 

provider agreement, a hospital must first 

be certified by a State survey agency as 

complying with the conditions or 

requirements set forth in the statute and 

part 482 of the regulations. Then, the 

hospital is subject to routine State 

agency surveys to determine whether it 

continues to meet the Medicare 

requirements. There is an alternative, 

however, to State compliance surveys. 

Section 1865(a)(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 may ‘‘deem’’ those 

provider entities as having met the 

requirements. 

If an accreditation organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, a 

provider entity accredited by the 

national accreditation organization 

approved program would be deemed to 

meet the Medicare conditions. 

Accreditation by an accreditation 

organization is voluntary and is not 

required for Medicare participation. 

A national accreditation organization 

applying for 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 the 

reapproval of accreditation 

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 

deeming authority every 6 years or 

sooner as determined by CMS. 

AOA’s term of approval as a 

recognized accreditation program for 

hospitals expires September 25, 2009. 

II. Deeming Applications Approval 

Process 

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

provides a statutory timetable to ensure 

that our review of deeming applications 

is conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of a complete 

application, with any documentation 

necessary to make a determination, to 

complete our survey activities and 

application review. Within 60 days of 

receiving a complete application, we 

must publish a notice in the Federal 

Register that identifies the national 

accreditation organization making the 

request, describes the request, and 

provides no less that a 30-day public 

comment period. At the end of the 210- 

day period, we must publish an 

approval or denial of the application. 

III. Provisions of the Proposed Notice 

and Response to Comments 

On April 24, 2009, we published a 

proposed notice in the Federal Register 

(74 FR 18728) announcing AOA’s 

request for reapproval as a deeming 

organization for hospitals. In this notice, 

we detailed the evaluation criteria. 

Under section 1865(a)(2) of the Act and 

our regulations at § 488.4, we conducted 

a review of the AOA’s application in 

accordance with the criteria specified by 

our regulations, which include, but are 

not limited to the following factors: 

• An onsite administrative review of 

AOA’s (1) corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its surveyors; (4) ability to 

investigate and respond appropriately to 

complaints against accredited facilities; 

and, (5) survey review and decisionmaking process for accreditation. 

• A comparison of AOA’s hospital 

accreditation standards to our current 

Medicare hospital CoPs. 

• A documentation review of AOA’s 

survey processes to: 

+ Determine the composition of the 

survey team, surveyor qualifications, 

and AOA’s ability to provide continuing 

surveyor training. 

+ Compare AOA’s processes to those 

of State survey agencies, including 

survey frequency, and the ability to 

investigate and respond appropriately to 

complaints against accredited facilities. 

+ Evaluate AOA’s procedures for 

monitoring providers or suppliers found 

to be out of compliance with AOA 

program requirements. The monitoring 

procedures are used only when AOA 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as specified 

at § 488.7(d). 

+ Assess AOA’s ability to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

+ Establish AOA’s ability to provide 

us with electronic data and reports 

necessary for effective validation and 

assessment of AOA’s survey process. 

+ Determine the adequacy of staff and 

other resources. 

+ Review AOA’s ability to provide 

adequate funding for performing 

required surveys. 

+ Confirm AOA’s policies with 

respect to whether surveys are 

announced or unannounced. 

+ Obtain AOA’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. 

In accordance with section 

1865(a)(3)(A) of the Act, the April 24, 

2009 proposed notice also solicited 

public comments regarding whether 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices 44371 

AOA’s requirements met or exceeded 

the Medicare CoPs for hospitals. We 

received 28 comments in response to 

our proposed notice. 

All commenters expressed support for 

AOA’s continued deeming authority for 

hospitals. Commenters stated that 

AOA’s standards are clearly written and 

closely aligned with the Medicare CoPs, 

and that AOA’s accreditation program 

provides hospitals with a viable 

alternative to other healthcare 

accreditation organizations. 

IV. Provision of the Final Notice 

A. Differences Between AOA’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey Requirements 

We compared AOA’s hospital 

accreditation requirements and survey 

process with the Medicare CoPs and 

survey process as outlined in the State 

Operations Manual (SOM). Our review 

and evaluation of AOA’s deeming 

application, which were conducted as 

described in section III of this final 

notice, yielded the following: 

• AOA revised its standards to ensure 

that a medical history and physical is 

completed and documented in 

accordance with the requirements at 

§ 482.51(b)(1). 

• To meet the requirements in the 

SOM Appendix A, AOA amended its 

surveyor team handbook to ensure all 

hospital survey teams include a 

Registered Nurse. 

• AOA modified its policies related to 

the accreditation effective date in 

accordance with the requirements at 

§ 489.13. 

• AOA modified its policies regarding 

timeframes for sending and receiving a 

plan of correction (PoC) in accordance 

with section 2728 of the SOM. 

• AOA revised its policies to include 

timeframes for investigation of 

complaints in accordance with the 

requirements at section 5075.9 of the 

SOM. 

• AOA developed and implemented 

internal monitoring procedures to 

ensure its surveyors are trained and 

qualified to meet the requirements at 

§ 488.4(a)(4). 

• AOA developed an action plan to 

ensure that deemed status survey files 

are complete, accurate, and consistent 

with the requirements at § 488.6(a). 

• AOA developed and conducted 

surveyor training on the documentation 

of deficiencies to ensure that all cited 

deficiencies contain a regulatory 

reference, a clear and detailed 

description of the deficient practice, and 

relevant finding. 

• To meet the requirements at 

§ 488.20(a) and § 488.28(a), AOA 

developed a policy to ensure that 

facilities with condition level noncompliance on a recertification survey 

submit an acceptable PoC, and receive 

a follow up onsite focused survey. 

• To meet the requirements at section 

2005A2 of the SOM, AOA revised its 

policies and developed an internal 

tracking tool to ensure that facilities 

with condition level non-compliance on 

an initial survey receive an onsite 

follow-up full survey. 

• To meet the requirements at 

§ 488.4(b), AOA developed and 

incorporated measures to improve the 

accuracy and consistency of data 

submissions to CMS. 

• To meet the requirements at 2700A 

of the SOM, AOA revised its policies on 

blackout dates. 

• AOA revised its accreditation 

decision letters to ensure that they are 

accurate and contain all the required 

elements for the CMS Regional Office to 

render a decision regarding the deemed 

status of an accredited hospital. 

• To meet the survey process 

requirements in Appendix A of the 

SOM, AOA developed a policy 

outlining the minimum number of 

inpatient records required for review 

during a certification survey. 

• AOA removed all references to 

mandatory consultative services from its 

policies to avoid potential conflict of 

interest issues. 

• To verify AOA’s continued 

compliance with the provisions of this 

final notice, CMS will conduct a followup corporate onsite visit within one year 

of the date of publication of this notice. 

B. Term of Approval 

Based on the review and observations 

described in section III of this final 

notice, we have determined that AOA’s 

requirements for hospitals meet or 

exceed our requirements. Therefore, we 

approve AOA as a national accreditation 

organization for hospitals that request 

participation in the Medicare program, 

effective September 25, 2009 through 

September 25, 2013. 

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, 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) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: July 30, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–20203 Filed 8–27–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7016–N] 

Medicare Program; Request for 

Nominations for the Advisory Panel on 

Medicare Education 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice requests 

nominations for individuals to serve on 

the Advisory Panel on Medicare 

Education (the Panel) to fill current 

vacancies and vacancies that will 

become available in 2009. The Panel 

advises and makes recommendations to 

the Secretary of Health and Human 

Services and the Administrator of the 

Centers for Medicare & Medicaid 

Services on the effectiveness of 

consumer education strategies 

concerning the Medicare program. 

DATES: Deadline for Nominations by 

Regular Mail: Monday, September 14, 

2009 at 5 p.m., eastern daylight time 

(e.d.t.). 

Deadline for Nominations by 

Electronic Mail: Monday, September 14, 

2009 at 5 p.m., e.d.t. 

ADDRESSES: Regular Mail: Dwayne E. 

Campbell, Office of External Affairs, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, S1– 

05–14, Baltimore, MD 21244–1850. 

Electronic Mail: 

Dwayne.Campbell@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Dwayne E. Campbell, Health Insurance 

Specialist, Division of Forum and 

Conference Development, (410) 786– 

0291. Please refer to the CMS Advisory 

Committees Information Line (1–877– 


hsrobinson on DSK69SOYB1PROD with NOTICES