[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Pages 9799-9801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3370-FN]


Medicare and Medicaid Programs: Approval of an Application From 
the Accreditation Association for Hospitals and Health Systems/
Healthcare Facilities Accreditation Program for Continued CMS Approval 
of Its Hospital Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
Accreditation Association for Hospitals and Health Systems/Healthcare 
Facilities Accreditation Program (AAHHS/HFAP) (formerly known as the 
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, 2019 through 
September 25, 2023.

FOR FURTHER INFORMATION CONTACT: Tara Lemons (410) 786-3030, Mary Ellen 
Palowitch (410) 786-4496, or Monda Shaver, (410) 786-3410.

SUPPLEMENTARY INFORMATION:

I. Background

    A healthcare provider may enter into an agreement with Medicare to 
participate in the program as a hospital provided certain requirements 
are met. Section 1861(e) of the Social Security Act (the Act) 
establishes criteria for providers seeking participation in Medicare as 
a hospital. Regulations concerning Medicare provider agreements in 
general are at 42 CFR part 489 and those pertaining to the survey and 
certification for Medicare participation of providers and certain types 
of suppliers are at 42 CFR part 488. The regulations at 42 CFR part 482 
specify the specific conditions that a provider must meet to 
participate in the Medicare program as a hospital. Hospitals that wish 
to be paid under the Medicaid program must be approved to participate 
in Medicare, in accordance with 42 CFR 440.10(a)(3)(iii).
    Generally, to enter into a Medicare hospital provider agreement, a 
facility must first be certified as complying with the conditions set 
forth in part 482 and recommended to the Centers for Medicare & 
Medicaid Services (CMS) for participation by a State survey agency. 
Thereafter, the hospital is subject to periodic surveys by a State 
survey agency to determine whether it continues to meet these 
conditions. However, there is an alternative to certification surveys 
by State agencies. Accreditation by a nationally recognized Medicare 
accreditation program approved by CMS may substitute for both initial 
and ongoing state review.
    Section 1865(a)(1) of the Act provides that, if the Secretary of 
the Department of Health and Human Services (the Secretary) finds that 
accreditation of a provider entity by an approved national accrediting 
organization meets or exceeds all applicable Medicare conditions, we 
may treat the provider entity as having met those conditions, that is, 
we may ``deem'' the provider entity to be in compliance. Accreditation 
by an accrediting organization is voluntary and is not required for 
Medicare participation.
    Part 488, subpart A, implements the provisions of section 1865 of 
the Act and requires that a national accrediting organization applying 
for approval of its Medicare accreditation program must provide CMS 
with reasonable assurance that the accrediting organization requires 
its 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.  488.5. The 
regulations at Sec. 

[[Page 9800]]

488.5(e)(2)(i) require an accrediting organization to reapply for 
continued approval of its Medicare accreditation program every 6 years 
or sooner as determined by CMS. On January 14, 2019, CMS recognized the 
change in ownership from American Osteopathic Association/Healthcare 
Facilities Accreditation Program (AOA/HFAP) to the new owner, 
Accreditation Association for Hospitals and Health Systems/Healthcare 
Facilities Accreditation Program (AAHHS/HFAP). This recognition 
included a transfer and continuation of CMS-approval for AAHHS/HFAP's 
hospital accreditation program, as was published under the AOA/HFAP 
approval on August 28, 2013. AAHHS/HFAP's term of approval as a 
recognized Medicare accreditation program for hospitals expires 
September 25, 2019.

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 provide 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 October 17, 2018, we published a proposed notice in the Federal 
Register (83 FR 52458) announcing AAHHS/HFAP's request for continued 
approval of its Medicare 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.  488.5, we 
conducted a review of AAHHS/HFAP's Medicare hospital accreditation 
application in accordance with the criteria specified by our 
regulations, which include, but are not limited to the following:
     An onsite administrative review of AAHHS/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 hospital surveyors; (4) ability to 
investigate and respond appropriately to complaints against accredited 
hospitals; and, (5) survey review and decision-making process for 
accreditation.
     A comparison of AAHHS/HFAP's Medicare accreditation 
program standards to our current Medicare hospital Conditions of 
Participation (CoP).
     A documentation review of AAHHS/HFAP's survey process to 
do the following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and AAHHS/HFAP's ability to provide continuing surveyor 
training.
    ++ Compare AAHHS/HFAP's processes to those we require of State 
survey agencies, including periodic resurvey and the ability to 
investigate and respond appropriately to complaints against accredited 
hospitals.
    ++ Evaluate AAHHS/HFAP's procedures for monitoring hospitals it has 
found to be out of compliance with AAHHS/HFAP's program requirements. 
(This pertains only to monitoring procedures when AAHHS/HFAP identifies 
non-compliance. If non-compliance is identified by a State survey 
agency through a validation survey, the State survey agency monitors 
corrections as specified at Sec.  488.9(c)).
    ++ Assess AAHHS/HFAP's ability to report deficiencies to the 
surveyed hospitals and respond to the hospital's plan of correction in 
a timely manner.
    ++ Establish AAHHS/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 AAHHS/HFAP's staff and other 
resources.
    ++ Confirm AAHHS/HFAP's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm AAHHS/HFAP's policies with respect to surveys being 
unannounced.
    ++ Obtain AAHHS/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 October 
17, 2018 proposed notice also solicited public comments regarding 
whether AAHHS/HFAP's requirements met or exceeded the Medicare CoP for 
hospitals. There were no comments submitted.

IV. Provisions of the Final Notice

A. Differences Between AAHHS/HFAP's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared AAHHS/HFAP's hospital accreditation requirements and 
survey process with the Medicare CoP at part 482, and the survey and 
certification process requirements of parts 488 and 489. AAHHS/HFAP's 
standards crosswalk, which maps AAHHS/HFAP's standards with the 
corresponding requirements under the Medicare CoP, was also examined to 
ensure that the appropriate CMS regulation was included in citations as 
appropriate. We reviewed and evaluated AAHHS/HFAP's hospital 
application, as described in section III of this final notice. This 
review yielded the following areas where, as of the date of this 
notice, AAHHS/HFAP has revised its standards and certification 
processes:
     Sec.  482.13(e), to ensure that AAHHS/HFAP's crosswalk 
reflects the comparable restraint and seclusion requirements.
     Sec.  482.13(h)(1) through Sec.  482.13(h)(4) regarding 
patient visitation rights, to ensure that redundant language in its 
standards is removed.
     Sec.  482.15(d)(1)(i) regarding emergency preparedness 
training, to ensure AAHHS/HFAP's standards require a comparable 
standard to this CMS requirement.
     Sec.  482.15(d)(1)(iii) regarding documentation of 
emergency preparedness training, to ensure AAHHS/HFAP's standards 
require compliance with this CMS requirement.
     Sec.  482.15(d)(1)(iv) regarding demonstration of staff 
knowledge of emergency preparedness procedures, to ensure AAHHS/HFAP's 
standards require compliance with this CMS requirement.
     Sec.  482.15(d)(2)(i) through Sec.  482.15(d)(2)(ii)(B), 
to ensure AAHHS/HFAP's standards require compliance with these CMS 
requirements regarding staff emergency preparedness testing.
     Sec.  482.15(e)(3), to clarify its requirement related to 
maintaining an emergency onsite fuel source.

[[Page 9801]]

     Sec.  482.15(f)(4) through Sec.  482.15(f)(5), to address 
these CMS requirements regarding emergency plans, policies and 
procedures for integrated health care systems.
     Sec.  482.21, to ensure that redundant language regarding 
the Quality Assessment and Performance Improvement Condition of 
participation is removed.
     Sec.  482.23(b)(1) regarding nursing services, to ensure 
that CMS references are accurately referenced.
     Sec.  482.27(b)(11) regarding hepatitis C virus 
notifications, to ensure that redundant language in its standard is 
removed.
     Sec.  482.41(a)(2), to ensure that the requirement for 
emergency water supply for structures is adequately addressed.
     Sec.  482.41(b)(1)(i) and Sec.  482.41(b)(2), to ensure 
that the 2012 edition of the Life Safety Code is accurately referenced.
     Sec.  482.41(b)(7), to clarify that Alcohol-Based Hand Rub 
dispensers are permitted to be installed in areas other than exit 
access corridors.
     Sec.  482.41(b)(8)(ii), to ensure that fire watches are to 
be maintained until the system is back in service.
     Sec.  488.5(a)(4)(ii), to ensure that survey activities, 
including the review of all records, are administered in a 
comprehensive method comparable to CMS processes.
     Sec.  488.5(a)(4)(iii), to ensure that patient sample 
sizes are based on the hospital's average daily census and meets 
minimum sample requirements; and to ensure compliance with AAHHS/HFAP's 
policies related to documentation related to medical record review.
     Sec.  488.5(a)(4)(iv), to ensure findings of non-
compliance are documented under all appropriate CMS standards where 
non-compliance is found; and to ensure that all citations of 
noncompliance accurately identify the appropriate CMS requirement.
     Sec.  488.5(a)(12), to ensure that its complaint 
investigations address the minimum patient sample size for review, as 
applicable.
     Sec.  488.26(b), to ensure that surveyor documentation is 
reviewed for manner and degree of non-compliance and subsequently cited 
at the appropriate level (that is, condition versus standard level).
     Sec.  488.28(a), to ensure that facility plans of 
correction contain all required elements to be considered comparable to 
CMS.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that AAHHS/HFAP's hospital 
program requirements meet or exceed our requirements. Therefore, we 
approve AAHHS/HFAP as a national accreditation organization for 
hospitals that request participation in the Medicare program, effective 
September 25, 2019 through September 25, 2023.

V. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

    Dated: March 12, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-05037 Filed 3-15-19; 8:45 am]
 BILLING CODE 4120-01-P