[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62336-62338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2305-FN]


Medicare and Medicaid Programs; Approval of the Accreditation 
Commission for Health Care for Deeming Authority for Hospices

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the

[[Page 62337]]

Accreditation Commission for Health Care (ACHC) for recognition as a 
national accreditation program for hospices seeking to participate in 
the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective November 27, 2009 
through November 27, 2013.

FOR FURTHER INFORMATION CONTACT: 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 facilities seeking designation as a hospice 
program. Under this authority, 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. Provider agreement 
regulations are located in 42 CFR part 489 and regulations pertaining 
to the survey and certification of facilities are located in 42 CFR 
part 488.
    Generally, in order to enter into an agreement, a hospice facility 
must first be certified by a State survey agency as complying with the 
conditions or requirements set forth in part 418 of our regulations. 
Then, the hospice is subject to regular surveys by a State survey 
agency to determine whether it continues to meet these requirements. 
There is an alternative, however, 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 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we would ``deem'' those provider entities as having 
met the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    If an accreditation 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 
Medicare conditions. A national accreditation organization applying for 
approval of deeming authority under part 488, subpart A must provide us 
with reasonable assurance that the accreditation organization requires 
the accredited provider entities to meet requirements that are at least 
as stringent as the Medicare conditions.

II. Deeming Applications Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of deeming applications 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 
application review process. Within 60 days of receiving a completed 
application, we must publish a notice in the Federal Register that 
identifies the national accreditation 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 our approval or denial of the 
application.

III. Provisions of the Proposed Notice

    On July 24, 2009 we published a proposed notice (74 FR 36720) 
announcing ACHC's request for initial approval as a deeming 
organization for hospices. In this notice, we specified in detail our 
evaluation criteria. Under section 1865(a)(2) of the Act and in our 
regulations at Sec.  488.4 (Application and reapplication procedures 
for accreditation organizations), we conducted a review of ACHC's 
application in accordance with the criteria specified in our 
regulation, 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.
     A comparison of ACHC's accreditation standards to our 
current Medicare conditions for participation (CoPs).
     A documentation review of ACHC's survey processes to:
    + Determine the composition of the survey team, surveyor 
qualifications, and the ability of ACHC to provide continuing surveyor 
training.
    + Compare ACHC'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 the ACHC's procedures for monitoring providers or 
suppliers found to be out of compliance with ACHC program requirements. 
The monitoring procedures are used only when ACHC identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    + Assess ACHC's ability to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    + Establish ACHC's ability to provide us with electronic data and 
reports necessary for effective validation and assessment of ACHC's 
survey process.
    + Determine the adequacy of staff and other resources.
    + Review ACHC's ability to provide adequate funding for performing 
required surveys.
    + Confirm ACHC's policies with respect to whether surveys are 
announced or unannounced.
    + Obtain ACHC'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 July 24, 
2009 proposed notice (74 FR 36720) also solicited public comments 
regarding whether ACHC's requirements met or exceeded 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 ACHC's Standards and Requirements and Medicare's 
Conditions and Survey Requirements

    We compared ACHC's accreditation requirements and survey process 
with the Medicare CoPs and survey process as outlined in the State 
Operations Manual (SOM). Our review and evaluation of ACHC deeming 
application, which were conducted as described in section III of this 
notice yielded the following:
     ACHC modified its survey report to clearly identify 
whether an identified deficient practice represented condition level or 
standard level noncompliance.
     ACHC revised it accreditation decision letters to ensure 
that they are accurate and contain all of the required elements for the 
CMS Regional Office to render a decision regarding the deemed status of 
an accredited hospice.
     ACHC modified its policies regarding timeframes for 
sending and receiving a plan of correction (PoC) in accordance with 
section 2728 of the SOM.

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     To meet the CMS requirements related to a PoC, ACHC 
amended its policies to ensure approved PoCs contain all elements 
specified in section 2728 of the SOM.
     To meet the requirements at Sec.  488.28(a) and section 
2726 of the SOM, ACHC developed and implemented new policies that 
require a written PoC for all deficiencies cited.
     ACHC revised its policies to ensure complaints triaged as 
immediate jeopardy are investigated within 2 business days of receipt 
in accordance with the requirements at section 5075.9 of the SOM.
     To meet the requirements at Sec.  418.3, ACHC revised its 
standards to include the definitions used in the Medicare hospice CoPs.
     To meet the requirements at Sec.  418.52(a)(3), ACHC 
revised its standards to require that the hospice obtain the patient's 
or patient's representative signature confirming that he or she 
received a copy of the notice of rights and responsibilities.
     To meet the requirements at Sec.  418.54(c)(8), ACHC 
revised its standards to require that the comprehensive assessment 
consider the patient's need for referrals and further evaluation by 
appropriate health professionals.
     To meet the requirements at Sec.  418.58(d)(1), ACHC 
revised its standards to include the requirement that the hospice 
governing body determine the number and scope of performance 
improvement projects conducted annually.
     To meet the requirements at Sec.  418.110(c), ACHC revised 
its standards to ensure the hospice maintains a safe physical 
environment free of hazards for patients, staff and visitors.
     To meet the requirements at Sec.  418.110(m)(15), ACHC 
revised its standards to require that hospices document in the patient 
clinical record: the one hour face to face medical and behavioral 
evaluation if restraint or seclusion is used to manage violent or self-
destructive behavior; a description of the patient behavior and 
intervention used; alternatives or other less restrictive interventions 
attempted; the patient condition or symptom(s) that warranted the use 
of restraint and seclusion; and the patient response to the 
intervention(s) used, including the rationale for continued use of the 
intervention.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that ACHC's requirements for 
hospices meet or exceed our requirements. Therefore, we recognize ACHC 
as a national accreditation organization for hospices that request 
participation in the Medicare program, effective November 27, 2009 
through November 27, 2013.

V. Collection of Information Requirements

    This final notice does not impose any information collection and 
record keeping requirements. Consequently, it does not need to be 
reviewed by the Office of Management and Budget (OMB) under the 
authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 
35).

VII. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this final notice.
    In accordance with Executive Order 13132, we have determined that 
this final notice will not have a significant effect on the rights of 
States, local or tribal governments.

    Authority:  Section 1865 of the Social Security Act (42 U.S.C. 
1395bb).

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


    Dated: November 5, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-28010 Filed 11-25-09; 8:45 am]
BILLING CODE 4120-01-P