[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: 42CFR488.201]



[Page 917]

 

                         TITLE 42--PUBLIC HEALTH

 

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

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 488_SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of 

 

 Subpart D_Reconsideration of Adverse Determinations_Deeming Authority 

for Accreditation Organizations and CLIA Exemption of Laboratories Under 

                             State Programs

 

Sec.  488.201  Reconsideration.



    Source: 57 FR 34012, July 31, 1992, unless otherwise noted.





    (a) Right to reconsideration. (1) A national accreditation 

organization dissatisfied with a determination that its accreditation 

requirements do not provide (or do not continue to provide) reasonable 

assurance that the entities accredited by the accreditation organization 

meet the applicable long-term care requirements, conditions for 

coverage, conditions of certification, conditions of participation, or 

CLIA condition level requirements is entitled to a reconsideration as 

provided in this subpart.

    (2) A State dissatisfied with a determination that the requirements 

it imposes on laboratories in that State and under the laws of that 

State do not provide (or do not continue to provide) reasonable 

assurance that laboratories licensed or approved by the State meet 

applicable CLIA requirements is entitled to a reconsideration as 

provided in this subpart.

    (b) Eligibility for reconsideration. CMS will reconsider any 

determination to deny, remove or not renew the approval of deeming 

authority to private accreditation organizations, or any determination 

to deny, remove or not renew the approval of a State laboratory program 

for the purpose of exempting the State's laboratories from CLIA 

requirements, if the accreditation organization or State files a written 

request for a reconsideration in accordance with paragraphs (c) and (d) 

of this section.

    (c) Manner and timing of request for reconsideration. (1) A national 

accreditation organization or a State laboratory program described in 

paragraph (b), dissatisfied with a determination with respect to its 

deeming authority, or, in the case of a State, a determination with 

respect to the exemption of the laboratories in the State from CLIA 

requirements, may request a reconsideration of the determination by 

filing a request with CMS either directly by its authorized officials or 

through its legal representative. The request must be filed within 60 

days of the receipt of notice of an adverse determination or nonrenewal 

as provided in subpart A of part 488 or subpart E of part 493, as 

applicable.

    (2) Reconsideration procedures are available after the effective 

date of the decision to deny, remove, or not renew the approval of an 

accreditation organization or State laboratory program.

    (d) Content of request. The request for reconsideration must specify 

the findings or issues with which the accreditation organization or 

State disagrees and the reasons for the disagreement.



[57 FR 34012, July 31, 1992, as amended at 58 FR 61843, Nov. 23, 1993]