[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: 42CFR493.37]



[Page 989-990]

 

                         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 B_Certificate of Waiver

 

Sec.  493.37  Requirements for a certificate of waiver.



    (a) HHS will issue a certificate of waiver to a laboratory only if 

the laboratory meets the requirements of Sec.  493.35.

    (b) Laboratories issued a certificate of waiver--

    (1) Are subject to the requirements of this subpart and Sec.  

493.15(e) of subpart A of this part; and

    (2) Must permit announced or unannounced inspections by HHS in 

accordance with subpart Q of this part.

    (c) Laboratories must remit the certificate of waiver fee specified 

in subpart F of this part.

    (d) In accordance with subpart R of this part, HHS will suspend or 

revoke or limit a laboratory's certificate of waiver for failure to 

comply with the requirements of this subpart. In addition, failure to 

meet the requirements of this subpart will result in suspension or 

denial of payments under Medicare and Medicaid in accordance with 

subpart R of this part.

    (e)(1) A certificate of waiver issued under this subpart is valid 

for no more than 2 years. In the event of a non-compliance determination 

resulting in HHS action to revoke, suspend, or limit the laboratory's 

certificate of waiver, HHS will provide the laboratory with a statement 

of grounds on which the determination of non-compliance is based and 

offer an opportunity for appeal as provided in subpart R of this part.

    (2) If the laboratory requests a hearing within the time specified 

by HHS,



[[Page 990]]



it retains its certificate of waiver or reissued certificate of waiver 

until a decision is made by an administrative law judge, as specified in 

subpart R of this part, except when HHS finds that conditions at the 

laboratory pose an imminent and serious risk to human health.

    (3) For laboratories receiving payment from the Medicare or Medicaid 

program, such payments will be suspended on the effective date specified 

in the notice to the laboratory of a non-compliance determination even 

if there has been no appeals decision issued.

    (f) A laboratory seeking to renew its certificate of waiver must--

    (1) Complete the renewal application prescribed by HHS and return it 

to HHS not less than 9 months nor more than 1 year before the expiration 

of the certificate; and

    (2) Meet the requirements of Sec. Sec.  493.35 and 493.37.

    (g) A laboratory with a certificate of waiver that wishes to perform 

examinations or tests not listed in the waiver test category must meet 

the requirements set forth in subpart C or subpart D of this part, as 

applicable.



[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60 

FR 20045, Apr. 24, 1995]