[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: 42CFR493.639]



[Page 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.  493.639  Fee for revised certificate.



    (a) If, after a laboratory is issued a registration certificate, it 

changes its name or location, the laboratory must pay a fee to cover the 

cost of issuing a revised registration certificate. The fee for the 

revised registration certificate is based on the cost to issue the 

revised certificate to the laboratory.

    (b) A laboratory must pay a fee to cover the cost of issuing a 

revised certificate in any of the following circumstances:

    (1) The fee for issuing an appropriate revised certificate is based 

on the cost to issue the revised certificate to the laboratory as 

follows:

    (i) If a laboratory with a certificate of waiver wishes to perform 

tests in addition to those listed in Sec.  493.15(c) as waived tests, it 

must, as set forth in Sec.  493.638, pay an additional fee for the 

appropriate certificate to cover the additional testing.

    (ii) If a laboratory with a certificate for PPM procedures wishes to 

perform tests in addition to those specified as PPM procedures or listed 

in Sec.  493.15(c) as waived tests, it must, as set forth in Sec.  

493.638, pay an additional fee for the appropriate certificate to cover 

the additional testing.

    (2) A laboratory must pay a fee to cover the cost of issuing a 

revised certificate when--

    (i) A laboratory changes its name, location, or its director; or

    (ii) A laboratory deletes services or wishes to add services and 

requests that its certificate be changed. (An additional fee is also 

required under Sec.  493.643(d) if it is necessary to determine 

compliance with additional requirements.)



[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr, 24, 1995]