[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.638]



[Page 1005-1006]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 493_LABORATORY REQUIREMENTS--Table of Contents

 

                    Subpart F_General Administration

 

Sec.  493.638  Certificate fees.



    (a) Basic rule. Laboratories must pay a fee for the issuance of a 

registration certificate, certificate for PPM procedures, certificate of 

waiver, certificate of accreditation, or a certificate of compliance, as 

applicable. Laboratories must also pay a fee to reapply for a 

certificate for PPM procedures, certificate of waiver, certificate of 

accreditation, or a certificate of compliance. The total of fees 

collected by HHS under the laboratory program must be sufficient to 

cover the general costs of administering the laboratory certification 

program under section 353 of the PHS Act.

    (1) For registration certificates and certificates of compliance, 

the costs include issuing the certificates, collecting the fees, 

evaluating and monitoring proficiency testing programs, evaluating which 

procedures, tests or examinations meet the criteria for inclusion in the 

appropriate complexity category, and implementing section 353 of the PHS 

Act.

    (2) For a certificate of waiver, the costs include issuing the 

certificate, collecting the fees, determining if a certificate of waiver 

should be issued,



[[Page 1006]]



evaluating which tests qualify for inclusion in the waived category, and 

other direct administrative costs.

    (3) For a certificate for PPM procedures, the costs include issuing 

the certificate, collecting the fees, determining if a certificate for 

PPM procedures should be issued, evaluating which procedures meet the 

criteria for inclusion in the subcategory of PPM procedures, and other 

direct administrative costs.

    (4) For a certificate of accreditation, the costs include issuing 

the certificate, collecting the fees, evaluating the programs of 

accrediting bodies, and other direct administrative costs.

    (b) Fee amount. The fee amount is set annually by HHS on a calendar 

year basis and is based on the category of test complexity, or on the 

category of test complexity and schedules or ranges of annual laboratory 

test volume (excluding waived tests and tests performed for quality 

control, quality assurance, and proficiency testing purposes) and 

specialties tested, with the amounts of the fees in each schedule being 

a function of the costs for all aspects of general administration of 

CLIA as set forth in Sec.  493.649 (b) and (c). This fee is assessed and 

payable at least biennially. The methodology used to determine the 

amount of the fee is found in Sec.  493.649. The amount of the fee 

applicable to the issuance of the registration certificate or the 

issuance or renewal of the certificate for PPM procedures, certificate 

of waiver, certificate of accreditation, or certificate of compliance is 

the amount in effect at the time the application is received. Upon 

receipt of an application for a certificate, HHS or its designee 

notifies the laboratory of the amount of the required fee for the 

requested certificate.



[60 FR 20047, Apr. 24, 1995]