[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49817-49819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23449]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3336-FN]


Medicare and Medicaid Programs: Approval of an Application From 
the Joint Commission (TJC) for Continued CMS Approval of Its Critical 
Access Hospital (CAH) 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 Joint 
Commission (TJC) for continued recognition as a national accrediting 
organization for critical access hospitals (CAHs) that wish to 
participate in the Medicare or Medicaid programs.

DATES: This final notice is effective November 21, 2017 through 
November 21, 2023.

FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-3410, Karena 
Meushaw, (410) 786-6609 or Patricia Chmielewski, (410) 786-6899.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program eligible beneficiaries may receive 
covered services in a critical access hospital (CAH), provided certain 
requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social 
Security Act (the Act) establish distinct criteria for facilities 
seeking designation as a CAH. The minimum requirements that a CAH must 
meet to participate in the Medicare Program are at 42 CFR part 485, 
subpart F. Conditions for Medicare payment for CAHs are at 42 CFR 
413.70. Applicable regulations concerning provider agreements are at 42 
CFR part 489 and those pertaining to facility survey and certification 
are at 42 CFR part 488, subparts A and B.
    For a CAH to enter into a provider agreement with the Medicare 
program, a CAH must first be certified by a State survey agency as 
complying with the conditions or requirements set forth in section 1820 
of the Act and our regulations at part 485. Subsequently, the CAH is 
subject to ongoing review by a State survey agency to determine whether 
it continues to meet the Medicare requirements. However, there is an 
alternative to State compliance surveys. Certification by a nationally 
recognized accreditation program can substitute for ongoing State 
review.
    Section 1865(a)(1) of the Act provides that if the Secretary of the 
Department

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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 the 
Centers for Medicare & Medicaid Services (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 Joint Commission's (TJC's) 
term of approval as a recognized Medicare accreditation program for 
CAHs expires November 21, 2017.

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 May 19, 2017, we published a proposed notice in the Federal 
Register (82 FR 23004) announcing TJC's request for continued approval 
of its Medicare 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 Sec.  488.5, we conducted a review of TJC's 
Medicare CAH accreditation application in accordance with the criteria 
specified by our regulations, which include, but are not limited to the 
following:
    <bullet> An onsite administrative review of TJC'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.
    <bullet> A comparison of TJC's Medicare accreditation program 
standards to our current Medicare CAH Conditions of Participation 
(CoPs).
    <bullet> A documentation review of TJC's survey process to do the 
following:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TJC's ability to provide continuing surveyor 
training.
    ++ Compare TJC'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 CAHs.
    ++ Evaluate TJC's procedures for monitoring CAHs found to be out of 
compliance with TJC's program requirements. (This pertains only to 
monitoring procedures when TJC 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 TJC's ability to report deficiencies to the surveyed 
hospitals and respond to the hospital's plan of correction in a timely 
manner.
    ++ Establish TJC'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 TJC's staff and other resources.
    ++ Confirm TJC's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TJC's policies with respect to surveys being 
unannounced.
    ++ Obtain TJC'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 May 19, 
2017 proposed notice also solicited public comments regarding whether 
TJC's requirements met or exceeded the Medicare CoP for CAHs. There 
were two comments submitted, neither of which related to the content of 
the proposed notice.

IV. Provisions of the Final Notice

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

    We compared TJC's CAH accreditation requirements and survey process 
with the Medicare CoPs at part 485, and the survey and certification 
process requirements of parts 488 and 489. TJC's standards and 
crosswalk were also examined to ensure that the appropriate CMS 
regulations would be included in citations as appropriate. We reviewed 
and evaluated TJC's CAH application, which was conducted as described 
in section III of this final notice. As a result TJC has revised the 
following standards and certification processes:
    <bullet> Section 482.21(d)(2): Updated its standards and crosswalk 
to include a comparable standard to allow facilities to develop and 
implement an information technology system explicitly designed to 
improve patient safety and quality of care as part of its quality 
improvement program.
    <bullet> Section 482.21(d)(4): Updated its standards and crosswalk 
to include a comparable standard that requires facilities that do not 
participate in a cooperative project to implement projects that are of 
comparable effort.
    <bullet> Sections 482. 22(b)(4)(iii) through (b)(4)(iv): Updated 
its standards and crosswalk to ensure that CAHs are not permitted to 
have a ``unified and integrated medical staff.''
    <bullet> Section 482.28(b)(2): Updated its standards and crosswalk 
to include a comparable standard to require that all patient diets, 
including therapeutic diets, must be ordered by a practitioner 
responsible for the care of the patient, or by a qualified dietitian or 
qualified nutrition professional as authorized by the medical staff and 
in accordance with State law governing dietitians and nutritional 
professionals.
    <bullet> Section 482.53(b): Updated its standards and crosswalk to 
include the ``preparation'' of radioactive materials.
    <bullet> Section 485.618(d)(4): Updated its standards and crosswalk 
to address the withdrawal of a request for using Registered Nurses on a 
temporary basis as part of their State Rural Healthcare Plan with the 
State Boards of Medicine and Nursing.
    <bullet> Sections 485.627(b)(1) through (b)(3): Updated its 
standards and

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crosswalk to include comparable standards to require disclosure of the 
names and addresses of the facility's owners, or those with a 
controlling interest in the CAH or in any subcontractor in which the 
CAH directly or indirectly has a 5 percent or more ownership interest.
    <bullet> Section 485.645(a)(2): Updated its crosswalk to include 
the correct regulatory language to require that the facility limits 
inpatient beds to no more than 25 and is verified on all surveys.
    <bullet> Section 488.5(a)(4)(vii): Updated its policies and review 
process to ensure that approved plans of correction fully address all 
non-compliant practices identified during the survey; that appropriate 
policy changes have been made to ensure compliance; and that plans of 
correction identify the responsible party for ensuring corrective 
actions are implemented within the CAH and contain a description of how 
the CAH will monitor and evaluate the effectiveness of the corrective 
actions, analyze the data, and report findings to the senior leadership 
and governing body to ensure continued regulatory compliance.
    <bullet> Section 488.5(a)(12): Provided CMS with assurance that its 
procedures for responding to, and investigating complaints against 
accredited facilities are fully implemented and followed.
    <bullet> Section 488.26(b): Revised surveyor documentation to 
include appropriately detailed deficiency statements that clearly 
support the determination of noncompliance and appropriate level of 
deficiency.
    TJC revised its survey policy and procedure to clearly delineate 
that a survey will not occur until after the applicable Regional Office 
has made a determination of the CAH's compliance with location and 
distance requirements.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that TJC's CAH program 
requirements meet or exceed our requirements, and its survey processes 
are comparable to ours. Therefore, we approve TJC as a national 
accreditation organization for critical access hospitals that request 
participation in the Medicare program, effective November 21, 2017 
through November 21, 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: October 16, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-23449 Filed 10-26-17; 8:45 am]
 BILLING CODE 4120-01-P