[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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