[Federal Register Volume 67, Number 56 (Friday, March 22, 2002)]
[Notices]
[Pages 13344-13345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-2140-PN]


Medicare and Medicaid Programs; Application by the Joint 
Commission on Accreditation of Healthcare Organizations (JCAHO) for 
Approval of Deeming Authority for Critical Access Hospitals

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of an initial application by the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) for consideration as 
a national accreditation program for critical access hospitals that 
wish to participate in the Medicare or Medicaid programs. Section 
1865(b)(3)(A) of the Social Security Act (the Act) requires that within 
60 days of receipt of an organization's complete application, we 
publish a notice that identifies the national accrediting body making 
the request, describes the nature of the request, and provides at least 
a 30-day public comment period.

DATES: Written comments will be considered if received at the 
appropriate address, as provided in ADDRESSES, no later than 5 p.m. on 
April 22, 2002.

ADDRESSES: Mail written comments (an original and three copies) to the 
following address only: Centers for Medicare and Medicaid Services, 
Department of Health and Human Services, Attention: CMS-2140-PN, PO Box 
8010, Baltimore, MD 21244-1850.
    If you prefer, you may deliver by courier your written comments (an 
original and three copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or,
Room C5-14-03, Central Building, 7500 Security Boulevard, Baltimore, MD 
21244-1850.

    Comments mailed to the indicated addresses may be delayed and could 
be considered late.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code CMS-2140-PN.
    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, at the following address: 7500 Security 
Blvd., Baltimore, Maryland 21244, Monday through Friday of each week 
from 8:30 a.m. to 5:00 p.m. (phone: (410) 786-7197) to schedule an 
appointment.

FOR FURTHER INFORMATION CONTACT: Irene H. Dustin, (410) 786-0495.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a critical access hospital (CAH) provided the 
hospital meets certain requirements. Sections 1820(c)(2)(B) and 
1861(mm) of the Social Security Act (the Act) establish distinct 
criteria for facilities seeking designation as a CAH. Under this 
authority, the Secretary has set forth in regulations minimum 
requirements that a CAH must meet to participate in Medicare. The 
regulations at 42 CFR part 485, subpart F (Conditions of Participation: 
Critical Access Hospitals (CAHs)) determine the basis and scope of 
covered services provided by a CAH, set out rural health network 
specifications and establish staff qualifications. Conditions for 
Medicare payment for critical access services can be found at 
Sec. 413.70. Applicable regulations concerning provider agreements are 
at 42 CFR part 489 (Provider Agreements and Supplier Approval) and 
those pertaining to the survey and certification of facilities are at 
42 CFR part 488, (Survey, Certification and Enforcement Procedures), 
subparts A (General Provisions) and B (Special Requirements).
    In order for a CAH to be approved for participation in or coverage 
under the Medicare program, the hospital must have a current provider 
agreement to participate in the Medicare program as a hospital. The 
provider agreement must be in place at the time the hospital applies 
for CAH designation and be in compliance with part 482 (Conditions of 
Participation for Hospitals), as well as part 485, subpart F 
(Conditions of Participation: Critical Access Hospitals (CAHs)). 
Generally, in order to enter into a provider agreement, a hospital must 
first be certified by a State survey agency as complying with the 
conditions or standards set forth in the statute and part 482 of our 
regulations. Then, the hospital is subject to regular surveys by a 
State survey agency to determine whether it continues to meet Medicare 
requirements. There is an alternative, however, to surveys by State 
agencies.
    Exceptions are provided in the Balanced Budget Refinement Act of 
1999 (Pub. L. 106-113) for rural health clinics that were previously 
downsized from an acute care hospital, or for a closed hospital that is 
requesting to reopen as a CAH. In these instances, only the provisions 
of 42 CFR part 485, subpart F apply.
    Section 1865(b)(1) of the Act permits ``accredited'' hospitals to 
be exempt from routine surveys by State survey agencies to determine 
compliance with Medicare conditions of participation. Accreditation by 
an accreditation organization is voluntary and is not required for 
Medicare participation. Section 1865(b)(1) of the Act provides that, if 
a provider demonstrates through accreditation that all applicable 
Medicare conditions are met or exceeded, CMS shall ``deem'' the 
hospital as having met the requirements.
    If an accrediting organization is recognized in this manner, any 
provider accredited by a national accrediting body approved program 
would be deemed to meet the Medicare conditions of participation. The 
American Osteopathic Association (AOA) is currently the only 
organization recognized with deeming authority for critical access 
hospitals. The final notice approving the AOA for deeming authority for 
CAHs was published in the Federal Register on September 28, 2001 (66 FR 
49677).
    A national accreditation organization applying for approval of 
deeming authority under section 488, subpart A must provide us with 
reasonable assurance that the accreditation organization requires the 
accredited providers to meet requirements that are at least as 
stringent as the Medicare conditions of participation.

II. Approval of Deeming Organizations

    Section 1865(b)(2) of the Act requires that our findings concerning 
review of national accrediting organizations consider, among other 
factors, an accreditation organization's requirements for the 
following: accreditation, survey procedures, resources for conducting 
required surveys, capacity to furnish information for use in 
enforcement activities, and monitoring procedures for provider entities 
found not in compliance with the conditions or requirements, and 
ability to provide us with necessary data for validation.

[[Page 13345]]

    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 the request 
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 to become a national accreditation 
program for CAHs. This notice also solicits public comment on the 
ability of JCAHO requirements to meet or exceed the Medicare conditions 
of participation for CAHs.

III. Evaluation of Deeming Authority Request

    On February 1, 2002, JCAHO submitted all the necessary materials 
concerning its request for approval as a deeming organization for CAHs 
to enable us to make a determination. 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 a critical access 
hospital as compared with our comparable critical access hospital 
conditions of participation.
     JCAHO's survey process to determine the following:

--Survey team composition, surveyor qualifications, and the capacity of 
the organization to provide continuing surveyor training.
--The comparability of JCAHO's processes to that 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 to be 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(b)(3).
--JCAHO's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
--JCAHO's capacity to provide us with electronic data in an ASCII 
comparable format as well as the reports necessary for 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 and Notice Upon Completion of Evaluation

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all public comments we receive by the date and time specified in the 
DATES section of this preamble, and, when we proceed with a final 
notice, we will respond to the public 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.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this proposed notice.
    In accordance with Executive Order 13132, we have determined that 
this proposed notice would not have a significant affect on the right 
of States, local or tribal governments.

    Authority: Sec. 1865(b)(3)(A) of the Social Security Act (42 
U.S.C. 1395bb(b)(3)(A)).

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance Program; Program No. 93.774, Medicare--
Supplemental Medical Insurance Program; and Program No. 93.778, 
Medical Assistance Program)

    Dated: March 18, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-6954 Filed 3-21-02; 8:45 am]
BILLING CODE 4120-01-P