[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8725-8727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-2059-FN]
RIN 0938-AJ69


Medicare and Medicaid Programs; Reapproval of the Deeming 
Authority of the Community Health Accreditation Program, Incorporated 
(CHAP) for Home Health Agencies (HHAs)

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final notice.

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SUMMARY: This notice announces the reapproval of the Community Health 
Accreditation Program, Incorporated (CHAP) as a national accreditation 
organization for home health agencies (HHAs) that request participation 
in the Medicare program. We have found that CHAP's standards for HHAs 
meet or exceed those established by the Medicare program. Therefore, 
HHAs accredited by CHAP will be granted deemed status under the 
Medicare program.

[[Page 8726]]


EFFECTIVE DATE: This final notice is effective February 22, 2000, 
through March 31, 2005.

FOR FURTHER INFORMATION CONTACT: Joan C. Berry, (410) 786-7233.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 1861(o) and 1891 of the Social Security Act (the Act) and 
part 484 of the Medicare regulations specify the conditions that a home 
health agency (HHA) must meet in order to participate in the Medicare 
program. Generally, in order to enter into an agreement with Medicare, 
an HHA must first be certified by a State survey agency as complying 
with the conditions or standards set forth in part 484 of the 
regulations. Then, the HHA is subject to routine surveys by a State 
survey agency to determine whether it continues to meet Medicare 
requirements.
    There is an alternative, however, to surveys by State agencies. 
Section 1865(b)(1) of the Act permits ``accredited'' HHAs to be exempt 
from routine surveys by State survey agencies to determine compliance 
with Medicare conditions of participation. Accreditation by an 
accreditation organization is voluntary and is not required for 
Medicare certification. Section 1865(b)(1) of the Act provides that, if 
a provider is accredited by a national accreditation body under a set 
of standards that meet or exceed the Medicare conditions, the Secretary 
can ``deem'' that HHA as having met the Medicare requirements for those 
conditions.
    Our regulations concerning reapproval of accrediting organizations 
are set forth at 42 CFR 488.4 and 488.8(d)(3). Section 488.8(d)(3) 
requires reapplication at least every 6 years and permits the Secretary 
to determine the required materials from those enumerated in 
Sec. 488.4, as well as the deadline to reapply for continued approval 
of deeming authority. We have determined that the procedures set out in 
section 1865(b)(3)(A) of the Act for initial applications for deeming 
authority should apply to renewals as well. These procedures require us 
to--(1) publish a notice in the Federal Register within 60 days after 
receiving an accreditation organization's written request that we make 
a determination regarding whether its accreditation requirements 
continue to meet or exceed Medicare requirements; (2) identify in the 
notice the organization and the nature of the request and allow a 30-
day public comment period; and (3) publish a notice of our approval or 
disapproval within 210 days after we receive the organization's 
application and complete package of information.

II. Provisions of the Proposed Notice

    On September 10, 1999, we published a proposed notice in the 
Federal Register (64 FR 49198) announcing the receipt of an application 
from CHAP for renewal of its privileges as a national accreditation 
organization for HHAs. In the proposed notice, we detailed the factors 
on which we would base our evaluation. Under section 1865(b)(2) of the 
Act and our regulations at Sec. 488.8(d)(3)(i), our review and 
evaluation of the CHAP application were conducted in accordance with 
the following procedures:
     An on-site administrative review of the following: (1) The 
accrediting organization's corporate policies; (2) its financial and 
human resources available to accomplish the proposed surveys; (3) the 
training, monitoring, and evaluation of its surveyors, (4) its ability 
to investigate and respond appropriately to complaints against 
accredited facilities; and (5) its survey review and decision-making 
process for accreditation.
     A determination of the equivalency of CHAP's standards for 
an HHA to our comparable HHA conditions of participation.
     A review, both through documentation and on-site 
observation, of CHAP's survey processes to determine--

--The comparability of CHAP's processes to those of State agencies, 
including survey frequency and whether surveys are announced or 
unannounced;
--The adequacy of the guidance, instructions, and survey forms CHAP 
provides to surveyors; and
--CHAP's procedures for monitoring providers or suppliers found to be 
out of compliance with our requirements (these procedures are used when 
CHAP identifies noncompliance).

     CHAP's procedures for responding to complaints and for 
coordinating these activities with appropriate Federal, State, and 
local licensing bodies and ombudsmen programs.
     CHAP's policies and procedures for identifying potential 
fraud and abuse, and its coordination with or reporting to us.
     CHAP's survey team, the content and frequency of the in-
service training provided, the evaluation systems used to assess the 
performance of surveyors, and potential conflict-of-interest policies 
and procedures.
     CHAP's data management system and reports used to--

--Assess its surveys and accreditation decisions; and
--Provide us with electronic data and new statistical validation 
information including--
    + The number, accreditation status, and resurvey cycle for 
facilities;
    + The number, types, and resolution times for follow-up when 
deficiencies are detected during surveys;
    + The 10 most common deficiencies found in surveyed HHAs; and
    + The number of actionable cases of noncompliance and an indication 
of the method and timeframe for resolution including plans of 
correction, if any.
     A review of all types of accreditation status CHAP offers 
and the extent to which each type corresponds with HCFA's standards of 
compliance.
     The adequacy of CHAP's staff and other resources to 
perform the surveys, and its financial viability.
     CHAP's written agreement to--
--Meet our requirements to provide to all relevant parties timely 
notifications of changes to accreditation status or ownership, to 
report to all relevant parties remedial actions or situations of 
immediate jeopardy, and to conform its requirements to changes in 
Medicare requirements; and
--Permit its surveyors to serve as witnesses for us in adverse actions 
against its accredited facilities.
    In accordance with section 1865(b)(3)(A) of the Act the proposed 
notice also solicited public comment on whether CHAP's requirements 
meet or exceed the Medicare conditions of participation for HHAs. We 
received no public comments in response to our proposed notice.

III. Provisions of the Final Notice

A. Differences between CHAP and Medicare's Conditions and Survey 
Requirements

    Our review and evaluation of the CHAP application, which were 
conducted as detailed in section II of this notice, yielded the 
following information.
    We compared the standards contained in CHAP's ``1999 Standards of 
Excellence for HHA Organizations,'' in both the ``Core'' (section 
regarding administrative standards applicable to all facilities deemed 
by CHAP) and ``Home Health Organizations Standards'' sections and 
CHAP's survey process as outlined in its ``Site Visitor Training 
Manual,'' supplemented by flow charts comparing the survey process, 
deficiency resolution, complaint monitoring, and accreditation decision 
making with the Medicare

[[Page 8727]]

conditions of participation and our ``State and Regional Operations 
Manual.'' In six areas CHAP has made the following revisions or 
clarifications:
     CHAP incorporated language to address the provisions of 
Sec. 484.10(d) (Privacy Act provisions that apply when gathering OASIS 
data on patients).
     CHAP added specificity to its crosswalk covering 
provisions of Sec. 484.14(f) and (h), to indicate that during each 
survey they assess contracts for services or personnel provided under 
arrangement. Where clinical services are supplied, CHAP clarified that 
it reviews an HHA's certifications and competencies as well as its 
backup procedures.
     CHAP provided us with revised pages to its ``Core'' 
standards reflecting the requirements at Sec. 484.55, setting out the 
way in which the collection, use, and reporting of OASIS data in home 
health agencies will be assessed by surveyors for compliance with the 
regulation.
     CHAP provided us with additional information from its 
revised policy and procedure manual specifying its procedures and 
timeframes for withdrawals and involuntary termination of deemed 
accreditation, its requirements for reporting such withdrawals to HCFA, 
and when an HHA may reapply for deemed status accreditation.
     CHAP provided evidence that its fraud and abuse policy and 
training programs, both through teleconference updates and annual 
training, provide opportunities for surveyors to discuss how to 
identify and appropriately report instances of potential Medicare fraud 
and abuse.
     CHAP provided us with additional materials with respect to 
its appraisal of surveyor or visitor performance including the 
information covered, who conducts the appraisals and when, and how site 
visitor weaknesses are identified and corrected to assure consistency 
and quality in the survey process.
    In addition to these changes, CHAP provided a revised crosswalk 
incorporating all the changes necessitated by our requests.

B. Term of Approval

    Based on the review and observations described in section III. A of 
this notice we have determined that CHAP's requirements for HHAs meet 
or exceed our requirements. Therefore, we recognize CHAP as a national 
accreditation organization for HHAs that request participation in the 
Medicare program, effective February 22, 2000, through March 31, 2005.

IV. Paperwork Reduction Act

    This document does not impose any information collection and 
recordkeeping requirements subject to the Paperwork Reduction Act 
(PRA). Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with granting and withdrawal of deeming 
authority to national accreditation, codified in 42 CFR part 488, 
``Survey, Certification, and Enforcement Procedures,'' are currently 
approved by OMB under OMB approval number 0938-0690, with an expiration 
date of June 30, 2002.

V. Regulatory Impact Statement

    We have examined the impacts of this notice as required by 
Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Public 
Law 96-354). Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety effects; distributive impacts; and equity). The RFA requires 
agencies to analyze options for regulatory relief for small businesses. 
For purposes of the RFA, States and individuals are not considered 
small entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any notice that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such an analysis must conform to the provisions of section 
604 of the RFA. For purposes of section 1102(b) of the Act, we consider 
a small rural hospital as a hospital that is located outside of a 
Metropolitan Statistical Area and has fewer than 50 beds.
    This notice recognizes CHAP as a national accreditation 
organization for HHAs that request participation in the Medicare 
program. There are neither significant costs nor savings for the 
program and administrative budgets of the Medicare program. This notice 
is not a major rule as defined in Title 5, United States Code, section 
804(2) and is not an economically significant rule under Executive 
Order 12866.
    Therefore, we have determined, and the Secretary certifies, that 
this notice will not result in a significant impact on a substantial 
number of small entities and will not have a significant effect on the 
operations of a substantial number of small rural hospitals. Therefore, 
we are not preparing analyses for either the RFA or section 1102(b) of 
the Act.
    In an effort to better assure the health, safety, and services of 
beneficiaries in HHAs already certified, as well as to provide relief 
to State budgets in this time of tight fiscal constraints, we deem HHAs 
accredited by CHAP as meeting our Medicare requirements. Thus, we 
continue our focus on assuring the health and safety of services by 
providers and suppliers already certified for participation in a cost 
effective manner.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by OMB.
    In accordance with Executive Order 13132, Federalism, we have 
determined that this notice will not significantly affect the State, 
local or tribal governments.

(Authority: Sec. 1865(b)(3)(A) of the Social Security Act (42 U.S.C. 
1395bb(b)(3)(A)) (Catalog of Federal Domestic Assistance Program No. 
93.773, Medicare--Hospital Insurance)
(Catalog of Federal Domestic Assistance Program No. 93.778--Medical 
Assistance Programs)

    Dated: February 7, 2000.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 00-4156 Filed 2-18-00; 8:45 am]
BILLING CODE 4120-01-P