[Federal Register Volume 65, Number 85 (Tuesday, May 2, 2000)]
[Notices]
[Pages 25492-25493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-2117-N]


Medicare, Medicaid, and CLIA Programs; Clinical Laboratory 
Improvement Amendments of 1988 Removal of Exemption of Laboratories in 
the State of Oregon

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

ACTION: Notice.

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SUMMARY: This notice removes the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) exemption previously granted to laboratories 
within the State of Oregon. Section 353(p) of the Public Health Service 
Act grants us the authority to exempt from CLIA clinical laboratories 
located in a State that enacts and implements laws with requirements 
equal to or more stringent than the CLIA requirements.

EFFECTIVE DATE: The provisions of this notice are effective on May 2, 
2000.

FOR FURTHER INFORMATION CALL: Judith Yost, (410) 786-3531.

SUPPLEMENTARY INFORMATION:

[[Page 25493]]

I. Background

    Section 353 of the Public Health Service Act (PHSA), as amended by 
the Clinical Laboratory Improvement Act of 1988 (CLIA), requires 
laboratories that perform tests on human specimens to meet the 
requirements we establish. Laboratories that also request to be paid 
for services furnished to Medicare beneficiaries must meet the 
requirements of section 353 of the PHSA, as stipulated in section 6141 
of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239. 
Subject to specific exceptions, laboratories must have a current and 
valid CLIA certificate to test human specimens to receive payment from 
the Medicare or Medicaid programs. Regulations implementing section 353 
of the PHSA are contained in 42 CFR part 493 (Laboratory Requirements).
    Section 353(p) of the PHSA authorizes us to exempt from the CLIA 
requirements laboratories located in a State that applies laboratory 
licensure requirements equal to or more stringent than those of CLIA. 
Part 493, subpart E (Accreditation by a Private, Nonprofit 
Accreditation Organization or Exemption Under an Approved State 
Laboratory Program) implements section 353(p) of the PHSA.
    Section 493.553 sets forth the information that must be submitted 
with a State licensure program's application for CLIA approved status. 
Sections 493.551 and 493.553 provide that we may exempt from CLIA 
requirements, for a period not to exceed 6 years, State licensed or 
approved laboratories in a State if the State licensure program meets 
specific conditions. After that time, the State must re-apply to us for 
continued exemption. Section 493.575(f) provides that we will publish a 
notice in the Federal Register containing justification for removing 
the CLIA approved status of a State licensure program.

II. CLIA Exemption of Licensed Oregon State Laboratories

    The State of Oregon's period of exemption began on June 13, 1996, 
with the publication of our notice entitled, ``Medicare, Medicaid, and 
CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 
Exemption of Laboratories in the State of Oregon,'' in the Federal 
Register (61 FR 30072). That exemption period expired December 31, 
1999. The State of Oregon has formally notified us that it will not be 
re-applying for exemption of its licensed laboratories located within 
the State. Without an application for continued approval of Oregon's 
licensure program, we cannot continue to exempt Oregon laboratories 
from the CLIA requirement.

III. Removal of CLIA Approval of the State of Oregon's Laboratory 
Licensure Program

    The nearly 4\1/2\-year exemption period that we granted to 
laboratories in the State of Oregon expired on December 31, 1999. 
Therefore, we are removing the CLIA approved status of Oregon's 
licensure program effective May 2, 2000.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: March 3, 2000.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 00-10882 Filed 5-1-00; 8:45 am]
BILLING CODE 4120-01-P