[Federal Register: September 24, 2004 (Volume 69, Number 185)]
[Notices]
[Page 57305-57306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2204-PN]
RIN 0938-ZA61
Medicare and Medicaid Programs; Application by the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) for
Home Health Agencies
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Proposed notice.
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SUMMARY: This proposed notice with comment period acknowledges the
receipt of an application from the Joint Commission on Accreditation of
Healthcare Organizations for continued recognition as a national
accreditation program for Home Health Agencies that wish to participate
in the Medicare or Medicaid programs. The statute requires that within
60 days of receipt of an organization's complete application, we will
publish a notice that will announce our receipt of the accreditation
organization's application for approval, describe the criteria we will
use in evaluating the application, and provide at least a 30-day public
comment period.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on October 25, 2004.
ADDRESSES: In commenting, please refer to file code CMS-2204-PN.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-2204-
PN, P.O. Box 8017, Baltimore, MD 21244-8017.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.
SUPPLEMENTARY INFORMATION:
I. Background
[If you choose to comment on issues in this section, please include
the caption ``Background'' at the beginning of your comments.]
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. 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. The
regulations at 42 CFR 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.
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
[[Page 57306]]
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 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 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 determined by CMS. The
JCAHO's term of approval as a recognized accreditation program for HHAs
expires March 31, 2005.
II. Approval of Deeming Organizations
[If you choose to comment on issues in this section, please include
the caption ``Approval of Deeming Organizations'' at the beginning of
your comments.]
Section 1865(b)(2) of the Act and our regulations at Sec. 488.8(a)
require that our findings concerning review and reapproval of a
national accrediting organization's requirements consider, among other
factors, the reapplying accreditation organization's: Requirements for
accreditation; survey procedures; resources for conducting required
surveys; capacity to furnish information for use in enforcement
activities; monitoring procedures for provider entities found not in
compliance with the conditions or requirements; and ability to provide
us with the necessary data for validation.
Section 1865(b)(3)(A) of the Act further requires that we publish,
within 60 days of receipt of an organization's complete application, a
notice identifying the national accreditation body making the request,
describing the nature of the request, and providing at least a 30-day
public comment period. We have 210 days from our receipt of a completed
application to publish approval or denial of the application.
The purpose of this proposed notice is to inform the public of our
consideration of JCAHO's request for approval of continued deeming
authority for HHAs. This notice also solicits public comment on the
ability of JCAHO requirements to meet or exceed the Medicare conditions
for participation for HHAs.
III. Evaluation of Deeming Authority Request
[If you choose to comment on issues in this section, please include
the caption ``Evaluation of Deeming Authority Request'' at the
beginning of your comments.]
On June 30, 2004, JCAHO submitted all the necessary materials to
enable us to make a determination concerning its request for reapproval
as a deeming organization for HHAs. Under section 1865(b)(2) of the Act
and our regulations at Sec. 488.8 (Federal review of accreditation
organizations), our review and evaluation of JCAHO will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of JCAHO standards for an HHA as compared
with our comparable HHA conditions of participation.
JCAHO's survey process to determine the following:
+ The composition of the survey team, surveyor qualifications, and
the ability of the organization to provide continuing surveyor
training.
+ The comparability of JCAHO processes to those of State agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
+ JCAHO's processes and procedures for monitoring providers or
suppliers found out of compliance with JCAHO program requirements.
These 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).
+ JCAHO's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
+ JACAHO's capacity to provide us with electronic data in ASCII
comparable code, and reports necessary for effective validation and
assessment of the organization's survey process.
+ The adequacy of JCAHO's staff and other resources, and its
financial viability.
+ JCAHO's capacity to adequately fund required surveys.
+ JCAHO's policies with respect to whether surveys are announced or
unannounced.
+ 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).
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Upon completion of our evaluation, including evaluation of comments
received as a result of this notice, we will publish a final notice in
the Federal Register announcing the result of our evaluation.
V. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, this
proposed 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)
Dated: September 10, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-21193 Filed 9-23-04; 8:45 am]
BILLING CODE 4120-01-P