[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55616-55618]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-73]
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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
[[Page 55618]]
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