[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36524-36527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3290-FN]


Medicare and Medicaid Programs; Continued Approval of The Joint 
Commission's (TJC's) 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 Joint 
Commission (TJC) for continued recognition as a national accrediting 
organization for hospitals that wish to participate in the Medicare or 
Medicaid programs. A hospital that participates in Medicaid must also 
meet the Medicare conditions of participation (CoPs) as required under 
section 1905(a) of the Social Security Act (``Act'') and 42 CFR 
482.1(a)(5). This approval is effective July 15, 2014 through July 15, 
2020.

DATES: This final notice is effective July 15, 2014 through July 15, 
2020.

FOR FURTHER INFORMATION CONTACT: Monda Shaver (410) 786-3410, Cindy 
Melanson, (410) 786-0310, 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 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 part 488. The regulations at part 482 specify the specific 
conditions that a provider must meet to participate in the Medicare 
program as a hospital.
    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 us 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 us may substitute for both 
initial and ongoing state review.
    Section 1865(a)(1) of the Act provides that, if 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 and 
requires that a national accrediting organization applying for approval 
of its Medicare accreditation program must provide us 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.  488.4 and Sec.  
488.8(d)(3). The regulations at Sec.  488.8(d)(3) require an 
accrediting organization to reapply for continued approval of its 
Medicare accreditation program every 6 years or sooner as determined by 
us. TJC's current term of approval as a recognized

[[Page 36525]]

Medicare accreditation program for hospitals expires July 15, 2014.

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

    In the January 29, 2014 Federal Register (79 FR 4727), we published 
a proposed notice announcing TJC's request for continued approval of 
its Medicare hospital accreditation program. In the January 29, 2014 
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 TJC'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 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.
     The comparison of TJC's Medicare accreditation program 
standards to our current Medicare hospital CoPs.
     A documentation review of TJC's survey process to 
determine 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 hospitals.
    ++ Evaluate TJC's procedures for monitoring hospitals it has found 
to be out of compliance with TJC's program requirements. (This pertains 
only to monitoring procedures when TJC identifies non-compliance. If 
noncompliance is identified by a state survey agency through a 
validation survey, the state survey agency monitors corrections as 
specified at Sec.  488.7(d).)
    ++ 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 us 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 us 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 January 
29, 2014 proposed notice also solicited public comments regarding 
whether TJC's requirements met or exceeded the Medicare CoPs for 
hospitals. We received two unrelated comments in response to our 
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 hospital accreditation requirements and survey 
process with the Medicare CoPs of 42 CFR Part 482, and the survey and 
certification process requirements of Parts 488 and 489. Our review and 
evaluation of TJC's hospital application, which were conducted as 
described in section III of this final notice, yielded the following 
areas where, as of the date of this notice, TJC is in the process of or 
has completed revising its standards and certification processes in 
order to meet the requirements at:
     Sec.  482.12(a)(1), to address the hospital's 
responsibility to determine which categories of practitioners are 
eligible candidates for appointment to the medical staff.
     Sec.  482.12(a)(2), to ensure recommendations of the 
existing members of the medical staff are considered by the governing 
body during the medical staff appointment process.
     Sec.  482.12(c)(2), to include the requirement that 
patients are admitted to the hospital only on the recommendation of a 
licensed practitioner.
     Sec.  482.13(a)(1), to ensure hospitals inform each 
patient or patient's representative of the patient's rights, in advance 
of furnishing or discontinuing patient care whenever possible.
     Sec.  482.13(b)(4), to address the patient's right to have 
a family member or representative of his or her choice notified 
promptly of the patient's admission to the hospital.
     Sec.  482.13(h) and Sec.  482.13(h)(1), to include the 
provisions that require hospitals inform each patient of his or her 
visitation rights and address the requirement for hospitals to have 
written policies and procedures regarding the visitation rights of 
patients, including those setting forth any clinical restriction or 
limitation that the hospital may need to place on such rights and the 
reasons for the clinical restriction or limitation.
     To meet the requirements at Sec.  482.13(h)(2), TJC 
revised its standards to include the requirement that the hospital must 
inform each patient of their right to receive designated visitors.
     Sec.  482.13(h)(4), to ensure all visitors enjoy full and 
equal visitation privileges consistent with patient preferences.
     Sec.  482.21, to address the hospital governing body's 
responsibility for maintaining an ongoing quality assessment and 
performance improvement (QAPI) program that includes services provided 
under arrangement; maintenance and demonstration of evidence of its 
QAPI program for review by us; and that the QAPI program is developed 
and executed in a manner that reflects the complexity of the hospital 
scope and focus.
     Sec.  482.22(a), to indicate that the medical staff may 
also include other categories of non-physician practitioners as 
eligible for appointment by the governing body.
     Sec.  482.23(b)(3), to require that a registered nurse 
must supervise the nursing care of each patient.
     Sec.  482.23(b)(5), to ensure a registered nurse assigns 
the nursing care of each patient to other nursing personnel.
     Sec.  482.23(c)(6)(i)(A) and Sec.  482.23(c)(6)(ii)(A), to 
require a written order permitting patient self-administration of 
hospital issued medications and the patient's own medications brought 
to the hospital.

[[Page 36526]]

     Sec.  482.23(c)(6)(ii)(B), to include a provision for 
assessing the patient's capacity to self-administer medications and 
determining if the patient needs instruction in the safe and accurate 
administration of medications.
     Sec.  482.24(a), to ensure the organization of the medical 
record service is appropriate to the scope and complexity of the 
services performed.
     Sec.  482.24(b), related to the form and retention of the 
medical record.
     Sec.  482.24(b)(2), to include a provision that hospitals 
have a system that allows for timely retrieval by diagnosis and 
procedure, in order to support medical care evaluation and studies.
     Sec.  482.24(c)(2), to require all orders, including 
verbal orders, be dated, timed, and authenticated promptly by the 
ordering practitioner or another practitioner who is responsible for 
the care of the patient.
     Sec.  482.24(c)(4)(iv), to require documentation of 
complications, hospital-acquired infections, and unfavorable reactions 
to drugs and anesthesia.
     Sec.  482.25(a), to include the requirement that the 
pharmacy or drug storage area must be administered in accordance with 
accepted professional principles.
     Sec.  482.26, to include therapeutic radiologic services 
and the requirement that radiologic services must meet professionally 
approved standards for safety and personnel qualifications.
     Sec.  482.26(b)(3), to require radiation workers be 
checked periodically for amounts of radiation exposure.
     Sec.  482.27, to require that the hospital maintain, or 
have available, adequate laboratory services to meet the needs of its 
patients and that such services are performed in a facility certified 
in accordance with part 493 of this chapter.
     Sec.  482.28, to address the hospital's responsibility to 
have a dietitian who serves the hospital on a full-time, part-time, or 
consultant basis either directly or through a contractual arrangement.
     Sec.  482.28(a)(1), to require that hospitals have a full-
time employee responsible for the food and dietetic service.
     Sec.  482.41, to address the hospital's responsibility to 
provide facilities for special services appropriate to the needs of the 
community.
     Sec.  482.41(a)(1), to address the requirement for 
emergency power and lighting in intensive care and emergency rooms.
     Sec.  482.41(b)(1)(i) and chapters 18/19.7.1.2 and 18/
19.7.1.3 of the Life Safety Code (LSC), to address various fire drill 
requirements that include transmission of a fire alarm signal, 
simulation of emergency fire conditions, varying conditions, and 
employees being instructed in life safety procedures and devices.
     Sec.  482.41(b)(2), to require submission of an 
equivalency or waiver request, including the supporting documentation 
along with TJC's recommendation for approval, to the applicable CMS 
Regional Office for processing.
     Sec.  482.41(b)(6), to address the proper routine storage 
and prompt disposal of trash.
     Sec.  482.41(b)(7), to include the requirement that the 
fire control plan must contain provisions for the prompt reporting of 
fires.
     Sec.  482.43(c)(4), to address the hospital's 
responsibility to reassess the patient's discharge plan if there are 
factors that may affect continuing care needs or the appropriateness of 
the discharge plan.
     Sec.  482.43(c)(6), to include the requirement that a home 
health agency (HHA) must request to be included on the list of HHAs a 
hospital provides to patients as part of their discharge plan.
     Sec.  482.51(a)(4), to include a requirement for surgical 
services to maintain a roster of practitioners, specifying the surgical 
privileges of each practitioner.
     Sec.  482.51(b)(2), to include a requirement that a 
properly executed informed consent for an operation must be in the 
patient's chart before surgery, except in emergencies.
     Sec.  482.52(a)(5), to include a requirement that the 
supervising anesthesiologist for an anesthesiologist's assistant be 
immediately available if needed.
     Sec.  482.53(b)(3), to ensure laboratory tests performed 
in the nuclear medicine service meet the applicable requirement for 
laboratory services specified in Sec.  482.27.
     Sec.  482.53(d)(3), to require the hospital maintain 
records of the disposition of radiopharmaceuticals.
     Sec.  482.55, to require the hospital to meet the 
emergency needs of patients in accordance with acceptable standards of 
practice.
     Sec.  482.56(a)(2), to ensure physical therapy, 
occupational therapy, speech-language pathology, and audiology services 
are provided by qualified therapists, as defined in 42 CFR part 484.
     Sec.  482.56(b)(2), to require the personnel 
qualifications of those providing care must be in accordance with 
nationally accepted standards of practice and meet the requirements at 
Sec.  409.17.
     Sec.  482.57(b)(2), to require blood gases or other 
laboratory tests performed in the respiratory care unit to meet the 
applicable requirements for laboratory services specified in Sec.  
482.27.
     Sec.  488.3(a), to ensure that all services, including 
physician and ambulatory care services, which are furnished under the 
hospital's Medicare provider agreement are surveyed for compliance with 
TJC's CMS-approved Medicare hospital accreditation program.
     Sec.  488.4(a)(4), to clarify the minimum composition of 
its survey team for its Medicare hospital accreditation program.
     Sec.  488.4(a)(4)(ii) through (v), to ensure compliance 
with its own policies that require evidence that its surveyors are 
appropriately qualified, trained, and evaluated.
     Sec.  488.4(a)(6), to ensure compliance with its own 
policies that require plan of correction requests to be timely, follow-
up surveys for ITL situations to be conducted timely, and that findings 
are accurately reported to us via the ASSURE database system.
     Sec.  488.4(b)(3)(iii) and Sec.  488.8(d), to ensure we 
are notified of any proposed changes in its CMS-approved Medicare 
hospital accreditation program prior to implementation of such changes 
within 30 days, and to confirm that it will not implement changes we 
have disapproved or required to be modified.
     Sec.  488.8, to provide us with data that ensures the 
following information is accurately reported: The date of a complaint 
receipt; determination of complaints as substantiated or 
unsubstantiated; determinations of ITL situations; final accreditation 
decisions for surveys where no deficiencies are found; and surveyor 
documentation that includes a detailed deficiency statement that 
clearly supports the determination of manner and degree of non-
compliance and the appropriate level of citation.
     To ensure comparability with the survey process 
requirements at Sec.  488.26(d), TJC:
    ++ Updated its accreditation process policies to clarify that all 
surveys for TJC's Medicare hospital accreditation program are conducted 
unannounced.
    ++ Updated its accreditation process policies to ensure all 
required follow-up surveys for its Medicare hospital accreditation 
program meet the Medicare requirements.
    ++ Revised its accreditation process policies to clarify that the 
appropriate level of citation be made when an

[[Page 36527]]

Immediate Threat to Health or Safety (ITL) is identified.
    ++ Clarified its survey policies in the surveyor activity guide 
(SAG) to address how ``Special Issue Resolution'' is handled during 
surveys lasting only one day.
    ++ Updated its accreditation process policies to ensure its 
definition of a small hospital is consistent across its policies.
     Sec.  488.28(a), to include all documented observations of 
non-compliance and all internal, uncompleted Plans for Improvement 
(PFI) listed in the accredited hospital's ``Statement of Condition 
(SOC) to correct Life Safety Code Deficiencies'' into the survey 
report.
     Sec.  489.13, related to the effective date of 
accreditation for facilities undergoing a survey for purposes of its 
initial participation in Medicare to ensure the survey process and 
effective date of accreditation when deficiencies have been identified 
are consistent with the regulatory requirements.
     Complied with section 1861(e)(9)(C) of the Act, to require 
that waiver and equivalency requests submitted by accredited 
organizations for Life Safety Code deficiencies that would result in 
unreasonable hardship for such a facility to resolve and would not 
jeopardize patient health or safety, be reviewed by TJC, and forwarded 
to us for approval, as appropriate.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve TJC as a national accreditation 
organization for hospitals that request participation in the Medicare 
program, effective July 15, 2014 through July 15, 2020.
    To verify TJC's continued compliance with the provisions of this 
final notice, we will conduct a follow-up corporate on-site visit and 
survey observation within 18 months of the date of publication of this 
notice.

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).

    Dated: June 16, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-15103 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P