[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Notices]
[Pages 55616-55618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2182-FN]


Medicare and Medicaid Programs; Reapproval of the Community 
Health Accreditation Program (CHAP) for Deeming Authority for Hospices

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This notice announces the reapproval of the Community Health 
Accreditation Program (CHAP) as a national accreditation program for 
hospices that request participation in the Medicare or Medicaid 
programs.

EFFECTIVE DATE: This final notice is effective November 21, 2003 
through November 21, 2009.

FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.

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 
provider. 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. Regulations concerning provider agreements 
are located in 42 CFR part 489, and regulations pertaining to 
activities relating to the survey and certification of facilities are 
located in 42 CFR part 488. Section 1905(o)(i)(A) of the Act generally 
extends the hospice Medicare requirements to payments for

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hospice services under the Medicare program.
    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 facility is subject to regular surveys by a State 
survey agency to determine whether it continues to meet those 
requirements. There is an alternative, however, to surveys by State 
agencies.
    Section 1865(b)(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. 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 
accreditation organizations to apply for continued approval of deeming 
authority every 6 years or sooner as determined by us. The Community 
Health Accreditation Program's (CHAP's) term of approval as a 
recognized accreditation program for hospice facilities expires 
November 20, 2003.

II. Approval Process for Deeming Applications

    Section 1865(b)(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 April 25, 2003, we published a proposed notice in the Federal 
Register (68 FR 20391) announcing the CHAP's request for reapproval as 
a deeming organization for hospice facilities. In this notice, we 
specified in detail our evaluation criteria. Under section 1865(b)(2) 
of the Act and our regulations at Sec.  488.4, we conducted a review of 
the CHAP application in accordance with the criteria specified in our 
regulation, which include, but are not limited to the following:
    [sbull] 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.
    [sbull] A comparison of CHAP's hospice accreditation standards to 
our current Medicare hospice conditions of participation.
    [sbull] A documentation review of CHAP s survey processes to:
    [sbull] Determine the composition of the survey team, surveyor 
qualifications, and the ability of CHAP to provide continuing surveyor 
training.
    [sbull] Compare CHAP s processes to those of State survey agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    [sbull] 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 CHAP identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at Sec.  
488.7(d).
    [sbull] Assess CHAP's ability to report deficiencies to the 
surveyed facilities and respond to the facility's plan of correction in 
a timely manner.
    [sbull] Establish CHAP's ability to provide us with electronic data 
in ASCII-comparable code and reports necessary for effective validation 
and assessment of CHAP's survey process.
    [sbull] Determine the adequacy of staff and other resources.
    [sbull] Review CHAP's ability to provide adequate funding for 
performing required surveys.
    [sbull] Confirm CHAP's policies concerning whether surveys are 
announced or unannounced.
    [sbull] Obtain CHAP'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(b)(3)(A) of the Act, the proposed 
notice also solicited public comments regarding whether CHAP's 
requirements met or exceeded the Medicare conditions of participation 
for hospice facilities. We received no public comments in response to 
our proposed notice.

IV. Provisions of the Final Notice

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

    We compared the standards contained in CHAP's ``Standard of 
Excellence for Hospice'' and ``The Core Standards of Excellence'' and 
its survey process in the ``Reapplication for Deeming Authority For 
Hospice Programs'' with the Medicare hospice conditions for 
participation and our State and Regional Operations Manual. Our review 
and evaluation of CHAP's deeming application, which were conducted as 
described in section III of this notice yielded the following:
    [sbull] CHAP agreed to add the language ``for pain control and 
respite purposes'' to its standard that deals with inpatient care. CHAP 
s standard now states: ``The general inpatient level of care is 
arranged when the patient requires palliation treatment for acute 
medical and/or psychological symptoms and/or for pain control that 
cannot be managed in the patient's home. Inpatient care is also 
available for respite purposes,'' which meets the requirements of Sec.  
418.98.
    [sbull] In order to meet the requirements of the conditions of 
participation at Sec.  418.94, CHAP agreed to change the term ``Home 
Care Aide'' to ``Home Health Aide.''
    [sbull] In order to meet the requirements of Sec.  418.204, CHAP 
agreed to remove the terms ``social worker'' and ``personal care'' and 
add the word ``homemaker'' to its standards that dealt with special 
coverage requirements.
    [sbull] In order to meet the regulations at Sec.  418.84, CHAP 
replaced the term ``professional social worker'' with ``qualified 
social worker.''
    [sbull] In order to comply with Sec.  418.58(b) and to clarify who 
is responsible for

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reviewing the plan, CHAP added to its standard the wording, ``by the 
attending physician, the medical director or physician designee and the 
IDT/IDG.''
    [sbull] In order to meet the requirements of Sec.  418.22(d)(2), 
CHAP added certification and recertification of the terminal illness 
with a six-month prognosis, signed by a physician, as necessary 
elements that needed to be maintained in the medical record.
    [sbull] The word ``paraprofessional'' was removed and replaced with 
the term ``Home Health Aide'' in the CHAP standard.
    [sbull] CHAP agreed to change homemaker supervision from every 6 
months to 1 month.
    [sbull] To meet the requirements of the 2000 edition of the Life 
Safety Code and to comply with Sec.  418.100, CHAP has agreed to add an 
additional standard that states that roller latches are not used on 
corridor doors.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that CHAP's requirements for 
hospices meet or exceed our requirements. Therefore, we recognize CHAP 
as a national accreditation organization for hospices that request 
participation in the Medicare program, effective November 21, 2003 
through November 21, 2009.

IV. Collection of Information Requirements

    This final notice does not impose any information collection and 
record keeping 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 organizations, codified in 42 CFR 
part 488, ``Survey, Certification, and Enforcement Procedures,'' are 
currently approved by OMB under OMB approval number 0938-0690.

V. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any one year). This final 
notice recognizes CHAP as a national accreditation organization for 
hospices that request participation in the Medicare and Medicaid 
programs. There are neither significant costs nor savings for the 
program and administrative budgets of Medicare. Therefore, 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.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and government agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $6 
million to $29 million in any one year. Individuals and States are not 
included in the definition of a small entity. We are not preparing an 
analysis for the RFA because we have determined that this notice will 
not have a significant economic impact on a substantial number of small 
entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 100 beds. We are not preparing an 
analysis for section 1102(b) of the Act because we have determined that 
this notice will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    In an effort to better ensure the health, safety, and services of 
beneficiaries in hospices already certified as well as provide relief 
to State budgets in this time of tight fiscal restraints, we deem 
hospices accredited by CHAP as meeting our Medicare requirements. Thus, 
we continue our focus on ensuring the health and safety of services by 
providers and suppliers already certified for participation in a cost-
effective manner.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million. This notice will have no consequential 
effect on the governments mentioned or on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since this notice does not impose any costs on State or 
local governments, the requirements of E.O. 13132 are not applicable.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    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: August 7, 2003.
Thomas Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 03-24547 Filed 9-25-03; 8:45 am]
BILLING CODE 4120-01-P