[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Pages 64344-64346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3266-FN]


Medicare and Medicaid Programs; Approval of the Community Health 
Accreditation Program for Continued Deeming Authority for Hospices

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

ACTION: Final notice.

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SUMMARY: This notice announces our decision to approve the Community 
Health Accreditation Program (CHAP) 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) 
as referenced in our regulations.

DATES: Effective Date: This final notice is effective November 20, 2012 
through November 20, 2018.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636.
    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)(1) of the Social Security Act (the Act) establishes 
distinct criteria for entities seeking designation as a hospice 
program. 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 hospice care.
    Generally, to enter into an agreement, a hospice must first be 
certified by a State survey agency as complying with 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.
    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, we 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 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 meet the

[[Page 64345]]

Medicare conditions. A national accrediting organization applying for 
approval of its accreditation program under part 488, subpart A, must 
provide us 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 reapproval 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 
deeming authority every 6 years, or sooner as determined by CMS. CHAP's 
current term of approval for their hospice accreditation program 
expires November 20, 2012.

II. Deeming 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 with 210 calendar days after the date of receipt of an application 
to complete our survey activities and decision-making process. Within 
60 days of 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 of approving or denying the 
application.

III. Provisions of the Proposed Notice

    On May 25, 2012, we published a proposed notice (77 FR 31362) 
announcing CHAP'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 (Application and reapplication procedures for accrediting 
organizations), we conducted a review of CHAP'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 CHAP'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 CHAP's hospice accreditation standards 
to our current Medicare conditions of participation.
     A documentation review of CHAP's survey processes to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and the ability of CHAP to provide continuing surveyor 
training.
    ++ Compare CHAP's processes to that of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ Evaluate CHAP's procedures for monitoring providers or suppliers 
found to be out of compliance with CHAP program requirements. The 
monitoring procedures are used only when the CHAP identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    ++ Assess CHAP's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ Establish CHAP's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of CHAP's 
survey process.
    ++ Determine the adequacy of staff and other resources.
    ++ Review CHAP's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm CHAP's policies with respect to whether surveys are 
announced or unannounced.
    ++ Obtain CHAP'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 25, 
2012 proposed notice (77 FR 31362) also solicited public comments 
regarding whether CHAP's requirements meet or exceed the Medicare CoPs 
for hospices. We received no public comments in response to our 
proposed notice.

IV. Provisions of the Final Notice

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

    We compared the standards contained in CHAP's accreditation 
requirements and survey process with the Medicare hospice CoPs and 
survey process as outlined in the State Operations Manual (SOM). Our 
review and evaluation of CHAP's deeming application, which were 
conducted as described in section III of this final notice, yielded the 
following:
     To meet the requirements at Sec.  488.4(a)(4), CHAP 
implemented a monitoring plan to ensure all personnel files include a 
current license.
     To meet the requirements at Sec.  488.4(a)(5), CHAP 
modified its policies and procedures related to the establishment of an 
accreditation effective date for participation in Medicare.
     To meet the requirements in Appendix M of the SOM, CHAP 
developed a monitoring plan to ensure the minimum number of medical 
record reviews with home visits is completed during a survey.
     To meet the requirements at section 2728B of the SOM, CHAP 
revised its policies to ensure accepted plans of correction include a 
monitoring plan to ensure deficiencies stay corrected.
     To meet the requirements at section 5075.9 of the SOM, 
CHAP revised its policies to ensure complaint investigations triaged as 
non-immediate jeopardy medium are conducted within 45 calendar days 
following receipt of a complaint.
     To meet the requirements at Sec.  418.54(c)(7), CHAP 
revised its standards to address the needs of ``other individuals'' in 
the bereavement assessment. In addition, CHAP included language to 
ensure ``information gathered from the initial bereavement assessment 
must be incorporated into the plan of care and considered in the 
bereavement plan of care.''
     To meet the requirements at Sec.  418.64(b)(3), CHAP 
revised its standards to include language that addresses the provision 
of highly specialized nursing services provided so infrequently by 
direct hospice employees would be impracticable and prohibitively 
expensive.
     To meet the requirements at Sec.  418.100, CHAP revised 
its standards to address the hospice's responsibility to ``organize, 
manage, and administer its resources to provide hospice care and 
services.''
     To meet the requirements at Sec.  418.100(c), CHAP revised 
its standards to specify that a hospice must be primarily engaged in 
providing care and services consistent with accepted standards of 
practice.
     To meet the requirements at Sec.  418.110(d), CHAP revised 
its standards to include language that addresses the waiver of space 
and occupancy and alcohol-based hand rub requirements.
     CHAP revised its crosswalk to ensure that all current CHAP 
standards

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clearly address the following sections of the CFRs: Sec.  418.52, Sec.  
418.54(e)(2), Sec.  418.56(a), Sec.  418.56(d), Sec.  418.56(e), Sec.  
418.58, Sec.  418.58(a)(2), Sec.  418.58(c)(2), Sec.  418.58(d)(1), 
Sec.  418.60(b)(2)(ii), Sec.  418.62(b), Sec.  418.62(c), Sec.  
418.64(a)(1-3), Sec.  418.64(b)(1), Sec.  418.64(d)(3)(iv), Sec.  
418.72, Sec.  418.76(a)(1), Sec.  418.76(b)(3)(i), Sec.  418.76(c), 
Sec.  418.76(e), Sec.  418.76(h)(1), Sec.  418.76(j)(2), Sec.  
418.76(k), Sec.  418.76(k)(2), Sec.  418.100(b), Sec.  418.100(c)(2), 
Sec.  418.100(f)(1)(i), Sec.  418.100(g)(3), Sec.  418.104(d), Sec.  
418.104(f), Sec.  418.106(b)(1), Sec.  418.106(c)(1), Sec.  
418.106(e)(1), Sec.  418.108(c)(3), Sec.  418.110(a), Sec.  
418.110(c)(1)(i), Sec.  418.110(c)(1)(ii), Sec.  418.110(e), Sec.  
418.110(e)(2), Sec.  418.110(f)(1), Sec.  418.110(f)(3)(iv), Sec.  
418.110(f)(3)(vi), Sec.  418.112(f), and Sec.  418.116(b)(2).

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that CHAP's accreditation program 
for hospices meet or exceed our requirements. Therefore, we approve 
CHAP as a national accreditation organization for hospices that request 
participation in the Medicare program, effective November 20, 2012 
through November 20, 2018.

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).

VI. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, this 
proposed notice was not reviewed by the Office of Management and 
Budget.

(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: September 10, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-25467 Filed 10-18-12; 8:45 am]
BILLING CODE 4120-01-P