[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.638]

[Page 997-998]
 
                         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, 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.

[[Page 998]]

    (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]