Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices 71619 

accompanying requirements are used by 

Federal or State surveyors as a basis for 

determining whether a hospice qualifies 

for approval or re-approval under 

Medicare. We believe that the 

availability to the hospice of the type of 

records and general content of records, 

which the final rule (72 FR 32088) 

specifies, is standard medical practice, 

and is necessary in order to ensure the 

well-being and safety of patients and 

professional treatment accountability. 

There are no program changes to this 

information collection request, meaning 

there are no new requirements; 

however, we are currently adjusting the 

numbers of respondents and responses. 

The final numbers will be present in the 

30-day notice. Form Number: CMS– 

10277 (OCN: 0938–1067); Frequency: 

Yearly; Affected Public: Private sector— 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 2,872; Total Annual 

Responses: 1,808,345; Total Annual 

Hours: 2,152,396. (For policy questions 

regarding this collection contact 

Danielle Shearer at 410–786–6617.) 

Dated: November 22, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–28537 Filed 11–27–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3285–FN] 

Medicare and Medicaid Programs; 

Continued Approval of American 

Osteopathic Association/Healthcare 

Facilities Accreditation Program’s 

Critical Access Hospital Accreditation 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the American 

Osteopathic Association/Healthcare 

Facilities Accreditation Program (AOA/ 

HFAP) for continued recognition as a 

national accrediting organization (AO) 

for critical access hospitals (CAH) that 

wish to participate in the Medicare or 

Medicaid programs. 

DATES: This final notice is effective 

December 27, 2013 through December 

27, 2019. 

FOR FURTHER INFORMATION CONTACT: 

James Cowher, (410) 786–41948, 

Cindy Melanson, (410) 786–0310, or 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a CAH provided certain 

requirements are met. Sections 

1820(c)(2)(B), 1820(e), and 1861(mm)(1) 

of the Social Security Act (the Act) 

establish distinct criteria for facilities 

seeking designation as 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 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, subpart F. Thereafter, the CAH 

is subject to regular surveys by a state 

survey agency to determine whether it 

continues to meet these requirements. 

However, there is an alternative to 

surveys by state agencies. Certification 

by a nationally recognized accreditation 

program can substitute for ongoing state 

review. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national AO that all applicable 

Medicare conditions are met or 

exceeded, we will deem those provider 

entities as having met the requirements. 

Accreditation by an AO is voluntary and 

is not required for Medicare 

participation. A national AO applying 

for approval of its accreditation program 

under part 488, subpart A, must provide 

CMS with reasonable assurance that the 

AO requires the accredited provider 

entities to meet requirements that are at 

least as stringent as the Medicare 

conditions. 

Our regulations concerning the 

approval of AOs are set forth at § 488.4 

and § 488.8(d)(3). The regulations at 

§ 488.8(d)(3) require AOs to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by CMS. The AOA/HFAP’s 

current term of approval for their CAH 

accreditation program expires December 

27, 2013. 

II. Application Approval Process 

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

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On June 25, 2013, we published a 

proposed notice in the Federal Register 

(78 FR 38043) announcing AOA/HFAP’s 

request for approval of its CAH 

accreditation program. In the proposed 

notice, we detailed our evaluation 

criteria. Under section 1865(a)(2) of the 

Act and in our regulations at § 488.4 and 

§ 488.8, we conducted a review of AOA/ 

HFAP’s application in accordance with 

the criteria specified by our regulations, 

which include, but are not limited to the 

following: 

• An onsite administrative review of 

AOA/HFAP’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. 

• The comparison of AOA/HFAP’s 

accreditation to our current Medicare 

CAH conditions of participation (CoPs). 

• A documentation review of AOA/

HFAP’s survey process to: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and AOA/HFAP’s ability to provide 

continuing surveyor training. 

++ Compare AOA/HFAP’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/HFAP’s procedures 

for monitoring CAHs out of compliance 

with AOA/HFAP’s program 

requirements. The monitoring 

procedures are used only when AOA/

HFAP identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the state survey 

agency monitors corrections as specified 

at § 488.7(d). 


sroberts on DSK5SPTVN1PROD with NOTICES
71620 Federal Register / Vol. 78, No. 230 / Friday, November 29, 2013 / Notices 

++ Assess AOA/HFAP’s ability to 

report deficiencies to the surveyed 

facilities and respond to the facility’s 

plan of correction in a timely manner. 

++ Establish AOA/HFAP’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ Determine the adequacy of staff 

and other resources. 

++ Confirm AOA/HFAP’s ability to 

provide adequate funding for 

performing required surveys. 

++ Confirm AOA/HFAP’s policies 

with respect to whether surveys are 

announced or unannounced. 

++ Obtain AOA/HFAP’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 June 25, 

2013 proposed notice also solicited 

public comments regarding whether 

AOA/HFAP’s requirements met or 

exceeded the Medicare conditions of 

participation for CAHs. We received no 

comments in response to our proposed 

notice. 

IV. Provisions of the Final Notice 

A. Differences Between AOA/HFAP’s 

Standards and Requirements for 

Accreditation and Medicare’s 

Conditions and Survey requirements 

We compared AOA/HFAP’s CAH 

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/HFAP’s CAH 

application, which were conducted as 

described in section III of this final 

notice, yielded the following: 

• To meet the requirements at 

§ 485.623(b)(5), AOA/HFAP revised its 

standards to require all ventilation 

systems, both new and existing, 

supplying operating rooms to meet the 

humidity control requirements.. 

• To meet the requirements at 

§ 485.623(c)(1), AOA/HFAP revised its 

standards to incorporate specific staff 

training requirements for protection in 

place or methods for the evacuation of 

patients, when necessary. 

• To meet the requirements at 

§ 485.635(e), AOA/HFAP revised its 

standards to include staff qualification 

requirements for rehabilitation therapy 

services. 

• To meet the requirements at 

§ 488.4(a)(6), AOA/HFAP revised its 

‘‘Complaint/Incident Management 

Policy,’’ to ensure all onsite complaint 

surveys are documented on a survey 

report. 

• To meet the requirements of section 

2728 of the SOM, AOA/HFAP will 

continue to use its internal monitoring 

plan to ensure timeframes for sending or 

receiving a plan of correction (PoC) are 

met. 

• To meet the requirements of section 

2728B of the SOM, AOA/HFAP will 

continue to conduct monthly internal 

audits to ensure accepted PoC’s contain 

all of the required elements. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that AOA/ 

HFAP’s CAH accreditation program 

requirements meet or exceed our 

requirements. Therefore, we approve 

AOA/HFAP as a national AO for CAHs 

that request participation in the 

Medicare program, effective December 

27, 2013 through December 27, 2019. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection, recordkeeping or 

third party disclosure 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. Chapter 35). 

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: November 12, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–28521 Filed 11–27–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1439] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Adverse Event 

Program for Medical Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information regarding 

the Adverse Event Program for medical 

devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 28, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 


sroberts on DSK5SPTVN1PROD with NOTICES