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.

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:

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 41/2-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).