[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Pages 66364-66365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3110-FN]


Medicare & Medicaid Programs: Application From the Accreditation 
Commission for Health Care for Continued CMS-Approval of Its Hospice 
Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
Accreditation Commission for Health Care (ACHC) for continued 
recognition as a national accrediting organization for hospices that 
wish to participate in the Medicare or Medicaid programs.

DATES: Effective: This final notice is effective November 27, 2013 
through November 27, 2019.

FOR FURTHER INFORMATION CONTACT: Valarie Lazerowich, (410) 786-4750. 
Cindy Melanson, (410) 786-0310. 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. 
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 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 by a state survey agency as complying with the conditions or 
requirements set forth in part 418. Thereafter, the hospice is subject 
to regular surveys by a state survey agency to determine whether it 
continues to meet these requirements. However, there is an alternative 
to surveys by state agencies. Certification by a nationally recognized 
accreditation program can substitute for ongoing state review.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, CMS will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
would be deemed to have met the Medicare conditions. A national 
accrediting organization applying for approval of its accreditation 
program under part 488, subpart A, must provide CMS with reasonable 
assurance that the accrediting organization requires the 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 accrediting organizations to 
reapply for continued approval of its accreditation program every 6 
years or sooner as determined by CMS.
    The ACHC's current term of approval for their hospice accreditation 
program expires November 27, 2013.

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 3, 2013, we published a proposed notice in the Federal 
Register (78 FR 26036) announcing Accreditation Commission for Health 
Care's request for approval of its hospice 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.  488.4 and Sec.  
488.8, we conducted a review of ACHC's application in accordance with 
the criteria specified by our regulations, which include, but are not 
limited to the following:
     An onsite administrative review of ACHC's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against accredited facilities; and (5) 
survey review and decision-making process for accreditation.
     The comparison of ACHC's accreditation requirements to our 
current Medicare hospice conditions of participation.
     A documentation review of ACHC's survey process to 
determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
ACHC's ability to provide continuing survey or training.
    ++ Comparability of ACHC's processes to those of state survey 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ ACHC's procedures for monitoring hospices out of compliance with 
ACHC's program requirements. The monitoring procedures are used only 
when ACHC identifies noncompliance. If noncompliance is identified 
through validation reviews, the State survey agency monitors 
corrections as specified at Sec.  488.7(d).
    ++ ACHC's ability to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    ++ ACHC's ability to provide CMS with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    ++ The adequacy of staff and other resources.
    ++ ACHC's ability to provide adequate funding for performing 
required surveys.
    ++ ACHC's policies with respect to whether surveys are announced or 
unannounced.

[[Page 66365]]

    ++ ACHC'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 3, 
2013 proposed notice also solicited public comments regarding whether 
ACHC's requirements met or exceeded the Medicare conditions of 
participation for hospices. We received no comments in response to our 
proposed notice.

IV. Provisions of the Final Notice

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

    We compared ACHC's hospice requirements and survey process with the 
Medicare conditions of participation and survey process as outlined in 
the State Operations Manual (SOM). Our review and evaluation of ACHC's 
hospice application, which were conducted as described in section III 
of this final notice, yielded the following:
     To meet the requirement at Sec.  418.3(2), ACHC amended 
its crosswalk and standards to accurately reflect the current 
regulatory language that the attending physician is identified by the 
individual, at the time he or she elects to receive hospice care, as 
having the most significant role in the determination and delivery of 
the individual's medical care.
     To meet the requirement at Sec.  418.24(c)(3), ACHC 
amended its preamble to accurately reflect the current regulatory 
language that an election to receive hospice care will be considered to 
continue through the initial election period and through the subsequent 
election periods without a break in care as long as the individual is 
not discharged from the hospice under the provisions in Sec.  418.26.
     To meet the requirement at Sec.  418.70, ACHC revised its 
standard to accurately address the care/services provided directly and 
those provided under arrangement.
     To meet the requirement at Sec.  418.76(c), ACHC revised 
its standards to address the requirement that hospice aide services can 
be provided by an individual only after the successful completion of a 
competency evaluation program.
     To meet the requirement at Sec.  418.78, ACHC revised its 
standard to reflect that the hospice must use volunteers in defined 
roles.
     To meet the requirement at Sec.  418.104(d), ACHC revised 
its standard to reflect that if the hospice discontinues operation, 
hospice policies must provide for retention and storage of clinical 
records.
     To meet the requirement at Sec.  418.106(e)(2)(i)(A), ACHC 
revised its standard to reflect that the hospice will provide a copy of 
the hospice's written policies and procedures on the management and 
disposal of controlled drugs to the patient representative.
     To meet the requirement at Sec.  418.106(e)(2)(i)(B), ACHC 
revised its standard to reflect the discussion of the hospice's 
policies and procedures managing the safe use and disposal of 
controlled drugs to the patient representative.
     To meet the requirement at Sec.  418.108(b)(1)(ii), ACHC 
revised its standard to allow for pain control, symptom management, and 
respite purposes in a Medicare or Medicaid-certified nursing facility, 
in addition to a Medicare or Medicaid-certified hospice or hospital 
that also meets the standards specified in Sec.  418.110(e).
     To meet the requirement at Sec.  418.110(n)(2)(i), ACHC 
revised its standard to address techniques to identify staff behaviors, 
events, and environmental factors that may trigger circumstances that 
require the use of a restraint or seclusion.
     To meet the requirement at Sec.  418.112(c), ACHC provided 
a clear definition of the management of crisis situations and temporary 
emergencies.
     To meet the requirement at Sec.  418.202(g), ACHC amended 
its preamble to accurately reflect the requirement that homemaker 
services may include assistance in maintenance of a safe and healthy 
environment and services to enable the individual to carry out the 
treatment plan.
     To meet the requirements of Appendix M of the SOM, ACHC 
instituted processes and audits to ensure that the Medicare Enrollment 
Application Form CMS-855A is verified by the assigned Medicare 
Administrative Contractor (MAC) prior to conducting an initial survey.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we have determined that ACHC's hospice accreditation 
program requirements meet or exceed our requirements. Therefore, we 
approve ACHC as a national accreditation organization for hospices that 
request participation in the Medicare program, effective November 27, 
2013 through November 27, 2019.

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.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program).

    Dated: October 29, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-26374 Filed 11-4-13; 8:45 am]
BILLING CODE 4120-01-P