[Federal Register: March 25, 2005 (Volume 70, Number 57)]
[Notices]
[Page 15331-15333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr05-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2204-FN]
Medicare and Medicaid Programs; Reapproval of the Deeming
Authority of the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) for Home Health Agencies
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Final notice.
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SUMMARY: This notice announces our decision to approve the Joint
Commission on Accreditation of Healthcare Organizations for continued
recognition as a national accreditation program for home health
agencies seeking to participate in the Medicare or Medicaid programs.
EFFECTIVE DATE: This final notice is effective March 31, 2005 through
March 31, 2008.
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 Home Health Agency (HHA) provided certain
requirements are met. Sections 1861(o) and 1891 of the Social Security
Act (the Act) establish distinct criteria for facilities seeking
designation as an HHA program. The regulations at 42 CFR part 484
specify the conditions that an HHA must meet in order to participate in
the Medicare program, the scope of covered services, and the conditions
for Medicare payment for home health care. Regulations concerning
provider agreements are at 42 CFR part 489 and those pertaining to
activities relating to the survey and certification of facilities are
at 42 CFR part 488.
Generally, to enter into an agreement, an HHA must first be
certified by a state survey agency as complying with the conditions or
requirements set forth in part 484 of our regulations. Then, the HHA 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 reapply for continued approval of
deeming authority every 6 years or sooner as we determine. The Joint
Commission on Accreditation of Healthcare Organizations' (JCAHO's) term
of approval as a recognized accreditation program for HHAs expires
March 31, 2005.
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 an
approval or denial of the application.
III. Proposed Notice
On September 24, 2004, we published a proposed notice (69 FR 57305)
announcing the JCAHO's request for reapproval as a deeming organization
for HHAs. In the proposed notice, we detailed our evaluation criteria.
Under section 1865(b)(2) of the Act and our regulations at Sec. 488.4
(Application and reapplication procedures for accreditation
organizations) and Sec. 488.8 (Federal review of accreditation
organization), we conducted a review of the JCAHO application in
accordance with the criteria specified by our regulation, which
include, but are not limited to the following:
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.
A comparison of JCAHO's HHA accreditation standards to our
current Medicare HHA conditions for participation.
[[Page 15332]]
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 the 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 with respect to 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 September
24, 2004 proposed notice (69 FR 57305) also solicited public comments
regarding whether JCAHO's requirements met or exceeded the Medicare
conditions of participation for HHA. We received no public comments in
response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between the Joint Commission on Accreditation of
Healthcare Organizations' and Medicare's Conditions and Survey
Requirements
We compared the standards contained in JCAHO's ``Comprehensive
Accreditation Manual for Home Care'' and its survey process in the
``Request for Continued Deeming Authority for Home Health Agencies
Handbook'' with the Medicare HHA conditions for participation and our
State Operations Manual. Our review and evaluation of JCAHO's deeming
application, which were conducted as described in section III of this
final notice yielded the following:
To comply with the requirements at Sec. 484.20(a), JCAHO
has agreed not to schedule the unannounced home health survey without
written confirmation of a successful Outcomes and Assessment
Information Set (OASIS) transmission.
To meet the requirements at Sec. 488.4(b)(3)(v), JCAHO
amended its policies and procedures to permit its surveyors to serve as
witnesses if we take an adverse action based on accreditation findings.
B. Term of Approval
Based on the review and observations described in sections III and
IV of this final notice, we have determined that JCAHO's requirements
for HHAs meet or exceed our requirements. Therefore, we recognize the
JCAHO as a national accreditation organization for HHAs that request
participation in the Medicare program. Because we are planning to
revise the conditions of participation for HHAs over the next 3 years,
we believe it is most appropriate to renew the current deeming
authority for a similar period. As a result, we are approving JCAHO's
program effective March 31, 2005 through March 31, 2008.
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, codified 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 final 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 HHAs that request participation in the Medicare
program. There are neither significant costs nor savings for the
program and administrative budgets of Medicare. Therefore, this final
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 final 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 provide relief to
State budgets in this time of tight fiscal restraints, we deem HHAs
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
final 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)
[[Page 15333]]
Dated: February 18, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 05-5033 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P