[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Notices]
[Page 32528-32529]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2177-FN]
Medicare and Medicaid Programs; Approval of the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO) for Deeming
Authority for Hospices
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to re-approve the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) for
continued recognition as a national accreditation program for hospice
facilities seeking to participate in the Medicare or Medicaid programs.
EFFECTIVE DATE: This final notice is effective June 19, 2003 through
June 19, 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)(1) of the Social Security Act (the Act) establishes
distinct criteria for facilities seeking designation as a hospice
program. 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. The regulations at 42 CFR
part 418 specify the conditions that a hospice facility 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, 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 these
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 assurances 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 reapply for continued approval of
deeming authority every 6 years or sooner as determined by us. The
JCAHO's term of approval as a recognized accreditation program for
hospice facilities expires June 18, 2003.
II. Deeming Applications Approval Process
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 January 24, 2003, we published a proposed notice in the Federal
Register (68 FR 3532) announcing the JCAHO's request for reapproval as
a deeming organization for hospices. In this notice, we specified in
detail our evaluation criteria. Pursuant to section 1865(b)(2) of the
Act and our regulations at Sec. 488.4, we conducted a review of the
JCAHO 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 JCAHO'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 JCAHO's hospice accreditation standards to
our current Medicare hospice conditions for participation.
[sbull] A documentation review of JCAHO's survey processes to:
+ Determine the composition of the survey team, surveyor
qualifications, and the ability of JCAHO to provide continuing surveyor
training.
+ Compare JCAHO's processes to those of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
+ Evaluate JCAHO's procedures for monitoring providers or suppliers
found to be out of compliance with JCAHO program requirements. The
monitoring procedures are used only when JCAHO identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
+ Assess JCAHO's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ Establish JCAHO's ability to provide us with electronic data in
ASCII-comparable code and reports necessary for effective validation
and assessment of JCAHO's survey process.
+ Determine the adequacy of staff and other resources.
+ Review JCAHO's ability to provide adequate funding for performing
required surveys.
+ Confirm JCAHO's policies for whether surveys are announced or
unannounced.
+ Obtain JCAHO'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 JCAHO's
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requirements met or exceeded the Medicare conditions of participation
for hospices. We received no public comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between JCAHO and Medicare's Conditions and Survey
Requirements
We compared the standards contained in JCAHO's ``Comprehensive
Accreditation Manual for Home Care'' (CAMHC) and its survey process in
the ``Request for Continued Deeming for Hospice Handbook'' with the
Medicare hospice conditions for participation and our State and
Regional Operations Manual. Our review and evaluation of JCAHO's
deeming application, which were conducted as described in section III
of this notice yielded the following:
[sbull] In order to meet the requirements of Sec. 488.4(a)(4)(v),
JCAHO provided a copy of their Conflict of Interest and Financial
Integrity policy that is required to be signed by all JCAHO surveyors.
[sbull] JCAHO provided a list of all full and partial hospice
accreditation surveys scheduled to be performed by the organization in
2002 and 2003 to satisfy our requirements at Sec. 488.4(a)(10).
[sbull] To satisfy the requirements of Sec. 488.4(b)(3)(v), JCAHO
provided documentation that allows its surveyors to serve as witnesses
if we take an adverse action based on accreditation findings.
[sbull] In order to comply with Sec. 418.100(k)(2)(i), JCAHO
agreed to add to its ``intent'' statement that Medicare certified
hospice, facilities require that a physician must order all medications
for the patient.
[sbull] To comply with Sec. 418.22(b), JCAHO agreed to add to
their ``intent'' statement that in a Medicare certified hospice
``terminally ill'' means that the individual has a medical prognosis
that his or her life expectancy is 6 months or less if the terminal
illness runs its normal course.
B. Term of Approval
Based on the review and observations described in section IV of
this final notice, we have determined that JCAHO's requirements for
hospices meet or exceed our requirements. Therefore, we recognize the
JCAHO as a national accreditation organization for hospices that
request participation in the Medicare program, effective June 19, 2003
through June 19, 2009.
V. 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, specified in 42 CFR
part 488, ``Survey, Certification, and Enforcement Procedures,'' are
currently approved by OMB under OMB approval number 0938-0690.
VI. Regulatory Impact Statement
We have examined the impact of this notice as required by Executive
Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 98-354).
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 100 beds.
This final notice recognizes JCAHO 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. 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 hospices already certified as well as provide relief
to State budgets in this time of tight fiscal restraints, we deem
hospices accredited by JCAHO 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 the Office of Management and Budget. In
accordance with Executive Order 13132, we have determined that this
notice will not significantly affect 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: April 18, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 03-13471 Filed 5-29-03; 8:45 am]
BILLING CODE 4163-18-P