[Federal Register Volume 66, Number 73 (Monday, April 16, 2001)]
[Notices]
[Pages 19509-19510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9446]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-2099-PN]


Medicare and Medicaid Programs; Application by the American 
Osteopathic Association (AOA) for Approval of Deeming Authority for 
Critical Access Hospitals

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice with comment period acknowledges the 
receipt of an initial application by the American Osteopathic 
Association (AOA) 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 
May 16, 2001.

ADDRESSES: Mail written comments (an original and three copies) to the 
following address only: Health Care Financing Administration, 
Department of Health and Human Services, Attention: HCFA-2099-PN, P.O. 
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 HCFA-2099-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 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, we can ``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 coverage. To date, no organizations have been recognized 
with deeming authority for critical access hospitals.
    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 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

[[Page 19510]]

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.
    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 notice with comment period is to inform the 
public of our consideration of AOA's request to become a national 
accreditation program for CAHs. This notice also solicits public 
comment on the ability of AOA requirements to meet or exceed the 
Medicare conditions for coverage for CAHs.

III. Evaluation of Deeming Authority Request

    On January 5, 2001, AOA 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 AOA will be conducted in 
accordance with, but not necessarily limited to, the following factors:
     The equivalency of AOA's standards for a critical access 
hospital as compared with our comparable critical access hospital 
conditions of participation.
     AOA'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 AOA's processes to that of State agencies, 
including survey frequency and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    --AOA's processes and procedures for monitoring providers or 
suppliers found to be out of compliance with AOA program requirements. 
These monitoring procedures are used only when AOA identifies 
noncompliance. If noncompliance is identified through validation 
reviews, the survey agency monitors corrections as specified at 
Sec. 488.7(b)(3).
    --AOA's capacity to report deficiencies to the surveyed facilities 
and respond to the facility's plan of correction in a timely manner.
    --AOA'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 AOA's staff and other resources, and its 
financial viability.
    --AOA's capacity to adequately fund required surveys.
    --AOA's policies with respect to whether surveys are announced or 
unannounced.
    --AOA'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, this 
proposed notice was not reviewed by the Office of Management and 
Budget.

    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; and Program No. 93.778, 
Medical Assistance Program)

    Dated: March 22, 2001.
Michael McMullan,
Acting Deputy Administrator, Health Care Financing Administration.
[FR Doc. 01-9446 Filed 4-13-01; 8:45 am]
BILLING CODE 4120-01-P