[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.37]

[Page 969]
 
                         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, 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 Secs. 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]

[[Page 970]]