[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53149-53150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3281-FN]


Medicare and Medicaid Programs: Continued Approval of American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP's) Hospital Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve American 
Osteopathic Association/Healthcare Facilities Accreditation Program 
(AOA/HFAP) for continued recognition as a national accrediting 
organization for hospitals that wish to participate in the Medicare or 
Medicaid programs.

DATES: This final notice is effective September 25, 2013 through 
September 25, 2019.

FOR FURTHER INFORMATION CONTACT:  Valarie Lazerowich, (410) 786-4750. 
Cindy Melanson, (410) 786-0310. Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospital provided certain requirements are met. 
Section 1861(e) of the Social Security Act (the Act) establishes 
distinct criteria for facilities seeking designation as a hospital. 
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 
482 specify the conditions that a hospital must meet to participate in 
the Medicare program, the scope of covered services, and the conditions 
for Medicare payment for hospitals.
    Generally, to enter into an agreement, a hospital must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 482. Thereafter, the hospital 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 accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, CMS 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 of 
the Department of Health and Human Services 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 have met the Medicare conditions. A national 
accrediting organization applying for approval of its accreditation 
program under part 488, subpart A, must provide CMS 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 of accrediting 
organizations are set forth at Sec.  488.4 and Sec.  488.8(d)(3). The 
regulations at Sec.  488.8(d)(3) require accrediting organizations to 
reapply for continued approval of its accreditation program every 6 
years or sooner as determined by CMS.
    The American Osteopathic Association/Healthcare Facilities 
Accreditation Program's (AOA/HFAP) current term of approval for their 
hospital accreditation program expires September 25, 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 CMS-approval 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 March 22, 2013, we published a proposed notice in the Federal 
Register (78 FR 17677) announcing AOA/HFAP's request for approval of 
its hospital accreditation program. In the proposed notice, we detailed 
our evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 and Sec.  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 decision-making process for accreditation.
     The comparison of AOA/HFAP's accreditation to our current 
Medicare hospital conditions of participation.
     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

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ability to investigate and respond appropriately to complaints against 
accredited facilities.
    ++ Evaluate AOA/HFAP's procedures for monitoring hospitals 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 Sec.  488.7(d).
    ++ 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 CMS 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 CMS 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 March 22, 
2013 proposed notice also solicited public comments regarding whether 
AOA/HFAP's requirements met or exceeded the Medicare conditions of 
participation for hospitals. 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 hospital requirements and survey process 
with the Medicare conditions of participation and survey process as 
outlined in the State Operations Manual (SOM). Our review and 
evaluation of AOA/HFAP's hospital application, which were conducted as 
described in section III of this final notice, yielded the following:
     To meet the requirements at Sec.  482.41(a)(1), AOA/HFAP 
revised its standards to include the requirement for Type 1 Essential 
Electrical Systems (EES) generators in all hospitals.
     To meet the requirements at Sec.  482.41(b)(1)(ii), AOA/
HFAP revised its standards to ensure roller latches no longer exist on 
hospital corridor doors.
     To meet the requirements at Sec.  482.41(c)(4), AOA/HFAP 
revised its standards to include the National Fire Protection 
Association (NFPA) 99:1999: 5-4.1.1 requirement that addresses the 
capability of controlling the relative humidity at a level of 35 
percent or greater within anesthetizing locations.
     To meet the requirements at Sec.  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 hospital 
accreditation program requirements meet or exceed our requirements. 
Therefore, we approve AOA/HFAP as a national accreditation organization 
for hospitals that request participation in the Medicare program, 
effective September 25, 2013 through September 25, 2019.

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).

(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: July 19, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services, HHS.
[FR Doc. 2013-21008 Filed 8-23-13; 4:15 pm]
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