[Federal Register Volume 69, Number 185 (Friday, September 24, 2004)]
[Notices]
[Pages 57305-57306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21193]


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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