```

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29714-29715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12524]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3307-FN]

Medicare and Medicaid Programs; Continued Approval of The Joint 
Commission's Hospice Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: This final notice announces our decision to approve The Joint 
Commission (TJC) for continued recognition as a national accrediting 
organization for hospices that wish to participate in the Medicare or 
Medicaid programs. A hospice that participates in Medicaid must also 
meet the Medicare Conditions of Participation (CoPs).

DATES: This final notice is effective June 18, 2015 through June 18, 
2021.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, 
Cindy Melanson, (410) 786-0310, or Patricia Chmielewski, (410) 786-
6899.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospice provided certain requirements are met by 
the hospice. Section 1861(dd) of the Social Security Act (the Act) 
establishes distinct criteria for facilities seeking designation as a 
hospice. 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 418 specify the conditions that a hospice must meet in 
order to participate in the Medicare program, the scope of covered 
services and the conditions for Medicare payment for hospices.
    Generally, to enter into an agreement, a hospice must first be 
certified as complying with the conditions set forth in part 418 and 
recommended to the Center for Medicare & Medicaid (CMS) for 
participation by a state survey agency. Thereafter, the hospice 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, CMS 
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.  488.4 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 
CMS. The Joint Commission's (TJC's) current term of approval for its 
hospice accreditation program expires June 18, 2015.

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 December 19, 2014 Federal Register (79 FR 75817), we 
published a proposed notice announcing TJC's request for continued 
approval of its Medicare hospice accreditation program. In the December 
19, 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 hospice 
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 hospice surveyors; (4) ability to investigate and 
respond appropriately to complaints against accredited hospices; and 
(5) survey review and decision-making process for accreditation.
     The comparison of TJC's Medicare hospice accreditation 
program standards to our current Medicare hospice CoPs.
     A documentation review of TJC's survey process to--
    ++ 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 hospices.
    ++ Evaluate TJC's procedures for monitoring hospices 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)).

[[Page 29715]]

    ++ Assess TJC's ability to report deficiencies to the surveyed 
hospice and respond to the hospice'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 December 
19, 2014 proposed notice also solicited public comments regarding 
whether TJC's requirements met or exceeded the Medicare CoPs for 
hospices. No comments were received in response to 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 hospice accreditation requirements and survey 
process with the Medicare CoPs of part 418, and the survey and 
certification process requirements of parts 488 and 489. Our review and 
evaluation of TJC's hospice 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 to 
meet the requirements at:
     Sec.  418.52(a)(1), to ensure hospices' provide verbal 
notification of the patient's rights and responsibilities.
     Sec.  418.52(b)(4)(i), to ensure all alleged violations of 
mistreatment are immediately reported to the hospice administrator.
     Sec.  418.54(c)(6) and Sec.  418.54(c)(6)(v), to ensure 
the patient's prescriptions, over the counter drugs, including herbal 
remedies and other alternative treatments, and drug therapy associated 
with laboratory monitoring are reviewed when completing the 
comprehensive assessment.
     Sec.  418.58(d)(1), to ensure that the number and scope of 
distinct performance improvement projects conducted annually, based on 
the needs of the hospice's population and internal organizational 
needs, reflect the scope, complexity, and past performance of the 
hospice's operations.
     Sec.  418.58(e)(1), to ensure the ongoing quality 
improvement and patient safety program is evaluated annually.
     Sec.  418.64(d)(3)(iv), to ensure the family is advised of 
the availability of spiritual counseling services.
     Sec.  418.76(c)(4), to ensure the direct supervision of 
the hospice aide training is completed by a registered nurse.
     Sec.  418.76(g)(1), to ensure written patient care 
instructions for the hospice aide are prepared by a registered nurse 
who is responsible for the supervision of the hospice aide.
     Sec.  418.76(h)(1)(i), to ensure the registered nurse's 
supervision of the hospice aide includes an assessment of the quality 
of care and services provided by the hospice aide and to ensure that 
services ordered by the hospice interdisciplinary group meet the 
patient's needs.
     Sec.  418.78(a), to ensure the hospice maintains, 
documents, and provides volunteer orientation and training that is 
consistent with hospice industry standards.
     Sec.  418.104(a)(2), to address the requirement that 
hospices include a signed copy of the election statement in the 
patient's clinical record.
     Sec.  418.106(a)(1), to ensure the interdisciplinary group 
``confers'' with an individual with education and training in drug 
management to make sure drugs and biologicals meet the patient's needs.
     Sec.  418.106(e)(2)(i)(B), to address the requirement for 
the hospice to educate the patient, or representative and the family on 
the safe use and disposal of controlled drugs ``in a language and 
manner that they understand.''
     Sec.  418.106(e)(3)(i), to address the requirement that 
only personnel authorized to administer controlled drugs have access to 
the locked compartments.
     Sec.  418.108(c)(5), to address when inpatient care is 
provided under arrangement, that the hospice retains a description of 
the training provided and documents the names of those giving the 
training.
     Sec.  418.110(d), to ensure the Life Safety Code (LSC) 
requirements apply to all certified in-patient hospice facilities 
regardless of the number of certified beds.
     Sec.  418.110(f)(3)(vi), to ensure patient rooms are 
equipped with an easily-activated, functioning and accessible device 
that is used for calling for assistance.
     Sec.  418.110(m), to ensure all patients have the right to 
be free from physical or mental abuse and corporal punishment.
     Sec.  418.110(m)(7)(ii), to address that each order for 
restraint used ensures the physical safety of the non-violent or non-
self-destructive patients.
     Sec.  418.114(d)(1), to address the requirement that all 
contracted entities obtain criminal background checks on contracted 
employees who have direct patient contact or access to patient records.
     Sec.  488.4(a)(3)(ii), to ensure compliance with its own 
policies related to the minimum number of medical records reviewed 
while conducting an onsite hospice survey.
     Sec.  488.4(a)(4)(i), to clarify the minimum size and 
composition of its survey team for its Medicare hospice accreditation 
program.
     Sec.  488.4(a)(4)(ii) through (v), to ensure its surveyors 
are appropriately qualified, trained, and evaluated.
     Sec.  488.4(a)(6), to ensure the minimum number of medical 
records are reviewed for complaint surveys.
     Sec.  488.8(a)(2)(v), to ensure data reported to CMS is 
accurate and complete.
     Sec.  488.26(b), to improve surveyors' abilities to--
    ++ Accurately and completely document instances of non-compliance 
at the appropriate level of citation (condition versus standard level 
citations).
    ++ Ensure that all instances of observed non-compliance are 
documented in the survey report.

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 hospices that request participation in the Medicare 
program, effective June 18, 2015 through June 18, 2021.

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. 35).

    Dated: May 5, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-12524 Filed 5-21-15; 8:45 am]
BILLING CODE 4120-01-P
```