Federal Register / Vol. 78, No. 122 / Tuesday, June 25, 2013 / Notices 38043 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3285–PN] 

Medicare and Medicaid Programs; 

Application From the American 

Osteopathic Association/Health 

Facilities Accreditation Program for 

Continued CMS-Approval of Its Critical 

Access Hospital Accreditation 

Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the American 

Osteopathic Association/Health 

Facilities Accreditation Program (AOA/ 

HFAP) for continued recognition as a 

national accrediting organization for 

critical access hospitals (CAHs) that 

wish to participate in the Medicare or 

Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 25, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–3285–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways: 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.regulations.gov. Follow the 

‘‘Submit a comment’’ instructions. 

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–3285– 

PN, P.O. Box 8016, 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 to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3285–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments to 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.) 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

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, call 

telephone number (410) 786–7195 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: 

James Cowher, (410) 786–1948; Cindy 

Melanson, (410) 786–0310; or Patricia 

Chmielewski, (410) 786–6899. 

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 in a critical access hospital 

(CAH) provided certain requirements 

are met by the CAH. Section 1820(e) of 

the Social Security Act (the Act) gives 

the Secretary authority to establish 

distinct criteria for a CAH. 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 

485, subpart F, specify the conditions 

that a CAH must meet to participate in 

the Medicare program, the scope of 

covered services, and the conditions for 

Medicare payment for CAHs. 

Generally, to enter into an agreement, 

a CAH must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 485 of our regulations. Thereafter, 

the CAH 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(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization 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 

approval of its accreditation program 

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. 

Our regulations concerning the approval 

and reapproval of accrediting 

organizations are set forth at § 488.4 and 

§ 488.8(d)(3). The regulations at 

§ 488.8(d)(3) require an accrediting 

organization to reapply for continued 

approval of its accreditation program 

every 6 years or as we determine. The 

AOA/HFAP Accreditation Program’s 

current term of approval for its CAH 

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38044 Federal Register / Vol. 78, No. 122 / Tuesday, June 25, 2013 / Notices 

accreditation program expires December 

27, 2013. 

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 us with the necessary 

data for validation. 

Section 1865(a)(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 accrediting 

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 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 AOA/HFAP’s 

request for continued CMS approval of 

its CAH accreditation program. This 

notice also solicits public comment on 

whether AOA/HFAP’s requirements 

meet or exceed the Medicare conditions 

of participation for CAHs. 

III. Evaluation of Deeming Authority 

Request 

AOA/HFAP submitted all the 

necessary materials to enable us to make 

a determination concerning its request 

for continued approval of its CAH 

accreditation program. This application 

was determined to be complete on May 

31, 2013. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of AOA/HFAP will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of AOA/HFAP’s 

standards for CAHs as compared with 

CMS’ CAH conditions of participation. 

• AOA/HFAP’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 AOA/ 

HFAP’s processes to those of state 

agencies, including survey frequency, 

and the ability to investigate and 

respond appropriately to complaints 

against accredited facilities. 

++ AOA/HFAP’s processes and 

procedures for monitoring a CAH found 

out of compliance with AOA/HFAP’s 

program requirements. These 

monitoring procedures are used only 

when AOA/HFAP identifies 

noncompliance. If noncompliance is 

identified through validation reviews or 

complaint surveys, the state survey 

agency monitors corrections as specified 

at § 488.7(d). 

++ AOA/HFAP’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ AOA/HFAP’s capacity to provide 

us with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of AOA/HFAP’s 

staff and other resources, and its 

financial viability. 

++ AOA/HFAP’s capacity to 

adequately fund required surveys. 

++ AOA/HFAP’s policies with 

respect to whether surveys are 

announced or unannounced, to assure 

that surveys are unannounced. 

++ AOA/HFAP’s agreement to 

provide CMS with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as CMS may require 

(including corrective action plans). 

IV. 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). 

V. Response to Public 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. 

Authority: (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: June 20, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–15175 Filed 6–24–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0651] 

Authorization of Emergency Use of an 

In Vitro Diagnostic for Detection of the 

Novel Avian Influenza A(H7N9) Virus; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

for an in vitro diagnostic device for 

detection of the novel avian influenza 

A(H7N9) virus. FDA is issuing this 

Authorization under the Federal Food, 

Drug, and Cosmetic (FD&C) Act, as 

requested by the Centers for Disease 

Control and Prevention (CDC). The 

Authorization contains, among other 

things, conditions on the emergency use 

of the authorized in vitro diagnostic 

device. The Authorization follows the 

determination by the Secretary of Health 

and Human Services (HHS) that there is 

a significant potential for a public 

health emergency that has a significant 

potential to affect national security or 

the health and security of U.S. citizens 

living abroad that involves the novel 

avian influenza A(H7N9) virus. On the 

basis of such determination, the 

Secretary also declared that 

circumstances exist justifying the 

authorization of emergency use of in 

vitro diagnostics for detection of the 

novel avian influenza A(H7N9) virus 

subject to the terms of any authorization 

issued under the FD&C Act. The 

Authorization, which includes an 

explanation of the reasons for issuance, 

is reprinted in this document. 

DATES: The Authorization is effective as 

of April 22, 2013. 

ADDRESSES: Submit written requests for 

single copies of the EUA to the Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 4121, Silver Spring, MD 20993– 

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