[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28853-28855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3338-FN]


Medicare and Medicaid Programs: Approval of an Application From 
the Center for Improvement in Healthcare Quality 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 Center 
for Improvement in Healthcare Quality (CIHQ) 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 July 26, 2017 through July 26, 
2023.

FOR FURTHER INFORMATION CONTACT: Lillian Williams (410) 786-8638, Monda 
Shaver, (410) 786-3410, or Patricia Chmielewski, (410) 786-6899.

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.  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. The Center for 
Improvement in Healthcare Quality's (CIHQ's) term of approval as a 
recognized Medicare accreditation program for hospitals expires July 
26, 2017.

[[Page 28854]]

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 February 24, 2017, we published a proposed notice in the Federal 
Register (82 FR 11579) announcing CIHQ'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 
CIHQ'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 CIHQ'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 CIHQ's Medicare accreditation program 
standards to our current Medicare hospital Conditions of Participation 
(CoPs).
     A documentation review of CIHQ's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and CIHQ's ability to provide continuing surveyor 
training.
    ++ Compare CIHQ'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 CIHQ's procedures for monitoring hospitals it has found 
to be out of compliance with CIHQ's program requirements. (This 
pertains only to monitoring procedures when CIHQ 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 CIHQ's ability to report deficiencies to the surveyed 
hospitals and respond to the hospital's plan of correction in a timely 
manner.
    ++ Establish CIHQ'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 CIHQ's staff and other resources.
    ++ Confirm CIHQ's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm CIHQ's policies with respect to surveys being 
unannounced.
    ++ Obtain CIHQ'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 February 
24, 2017 proposed notice also solicited public comments regarding 
whether CIHQ's requirements met or exceeded the Medicare CoP for 
hospitals. There were no comments submitted.

IV. Provisions of the Final Notice

A. Differences Between CIHQ's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared CIHQ's hospital accreditation requirements and survey 
process with the Medicare CoPs at part 482, and the survey and 
certification process requirements of parts 488 and 489. CIHQ's 
standards crosswalk, which maps CIHQ's standards with the corresponding 
requirements under the Medicare CoPs, was also examined to ensure that 
the appropriate CMS regulation was included in citations as 
appropriate. We reviewed and evaluated CIHQ's hospital application, 
conducted as described earlier. As a result, CIHQ has revised its 
materials, standards, and certification processes to reflect the 
following Medicare requirements:
     Sec.  482.12: Updated the summary description of this 
provision in the crosswalk to be consistent with its accreditation 
standards.
     Sec.  482.12(a)(1) through (10): Updated the summary 
description of this provision in the crosswalk to be consistent with 
its accreditation standards.
     Sec.  482.12(a)(10): Revised its standards to address the 
hospital's responsibility to consult directly with the medical staff.
     Sec.  482.12(c): Updated the summary description of this 
provision in the crosswalk to be consistent with its accreditation 
standards.
     Sec.  482.12(c)(1)(ii): Updated the CFR citation to 
properly reference the regulatory requirement on its standards 
crosswalk.
     Sec.  482.12(c)(2): Updated the CFR citation to properly 
reference the regulatory requirement on its standards crosswalk.
     Sec.  482.12(c)(4)(i): Clarified the use of the word 
``develops'' to indicate if the condition was present on admission or 
developed during the hospitalization on its standards crosswalk.
     Sec.  482.12(f)(2): Revised its standards to ensure the 
medical staff have written policies and procedures for appraisals of 
emergencies, initial treatment and referral.
     Sec.  482.13(a)(1) and Sec.  482.13(a)(2): Updated the 
summary description of these provisions in the crosswalk to be 
consistent with its accreditation standards.
     Sec.  482.13(a)(2)(i): Revised its standards to ensure the 
patient's right to submit ``written or verbal'' grievances.
     Sec.  482.13(a)(2)(ii), Sec.  482.13(b)(3), Sec.  
482.13(b)(4) and Sec.  482.13(c)(2): Updated the summary description of 
these provisions in the crosswalk to be consistent with its 
accreditation standards.
     Sec.  482.13(e)(5): Updated the CFR citation to properly 
reference the regulatory requirement.
     Sec.  482.13(e)(6), Sec.  482.13(f)(1)(ii), Sec.  
482.13(g), Sec.  482.13(g)(2), Sec.  482.13(h), Sec.  482.21(b)(1), 
Sec.  482.21(d)(2) and Sec.  482.21(d)(4): Updated the summary 
description of these provisions in the crosswalk to be consistent with 
its accreditation standards.
     Sec.  482.22(a)(2): Updated its standards to reflect that 
temporary practice privileges are granted by the governing body.
     Sec.  482.22(b)(1): Updated the summary description of 
this provision in the crosswalk to be consistent with its accreditation 
standards.
     Sec.  482.22(b)(3): Revised its standards to reflect CMS 
requirements for medical staff organization and accountability.
     Sec.  482. 22(b)(4): Updated the summary description of 
this provision in the crosswalk to be consistent with its accreditation 
standards.
     Sec.  482.23(c)(4): Updated its standards to fully address 
requirements for blood transfusions.

[[Page 28855]]

     Sec.  482.24(b): Updated its standards to fully address 
requirements for the form and retention of medical records.
     Sec.  482.24(c)(2) through (c)(4)(viii): Updated the 
Medicare regulatory language on its standards crosswalk to ensure that 
its accreditation standards are consistent with Medicare standards.
     Sec.  482.25(b)(2)(ii): Updated the crosswalk and standard 
to add references to the Comprehensive Drug Abuse Prevention and 
Control Act of 1970.
     Sec.  482.26: Updated the summary description of this 
provision in the crosswalk to be consistent with its accreditation 
standards.
     Sec.  482.41: Revised its standards to reflect the 
requirements of the ``Physical Environment''.
     Sec.  482.43: Revised its standards to ensure that the 
hospital discharge planning process applies to all patients.
     Sec.  482.51(b)(6) and Sec.  482.56(a)(2): Updated the 
summary description of these provisions in the crosswalk to be 
consistent with its accreditation standards.
     Sec.  482.56(b)(2): Revised its standards to address the 
requirements at Sec.  409.17 related to physical therapy, occupational 
therapy, and speech language pathology services.
     Sec.  482.57(b)(3): Updated the CFR citation to properly 
reference the regulatory requirement on its crosswalk.
     Sec.  482.57(b)(4): Updated the CFR citation to properly 
reference the regulatory requirement on its crosswalk and in its 
accreditation standards.
     Sec.  488.4(a)(6): Revised its standards to include a 
process to track and trend complaints received.
     Sec.  488.5(a)(4)(ii): Revised its standards to ensure 
that an appropriate number of open, inpatient medical records are fully 
reviewed during the survey process.
     Sec.  488.5(a)(4)(iv): Revised its standards to assure 
that findings of non-compliance are documented under all appropriate 
CMS standards where non-compliance is found; and that adverse findings 
for each CoP are reviewed for manner and degree of non-compliance and 
subsequently cited at the appropriate level (that is, condition versus 
standard level).
     Sec.  488.5(a)(7) through (9): Revised its standards to 
ensure that newly hired surveyors receive orientation so as to ensure 
AO compliance with these provisions.
     Sec.  488.26(b): Revised its standards to improve surveyor 
documentation to include the appropriately detailed deficiency 
statements that clearly support the determination of noncompliance and 
level of deficiency.
     Sec.  489.13: Revised its standards to reflect CMS policy 
regarding effective dates of participation in the Medicare program and 
develop a plan for monitoring for sustained compliance.
     CIHQ revised its complaint policy and procedure to clearly 
identify the individual(s) that are responsible for triaging complaints 
submitted to the accrediting organization.
     CIHQ revised its policy to clarify that an ``Immediate 
Jeopardy'' finding remains cited at the Conditional level, even if 
abated while onsite.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that CIHQ's hospital program 
requirements meet or exceed our requirements. Therefore, we approve 
CIHQ as a national accreditation organization for hospitals that 
request participation in the Medicare program, effective July 26, 2017 
through July 26, 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: June 20, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-13207 Filed 6-23-17; 8:45 am]
 BILLING CODE 4120-01-P