42 CFR § 493.1834 - Civil money penalty.
(a) Statutory basis. Sections 1846 of the Act and 353(h)(2)(B) of the PHS Act authorize the Secretary to impose civil money penalties on laboratories. Section 1846(b)(3) of the Act specifically provides that incrementally more severe fines may be imposed for repeated or uncorrected deficiencies.
(b) Scope. This section sets forth the procedures that CMS follows to impose a civil money penalty in lieu of, or in addition to, suspending, limiting, or revoking the certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures of a laboratory that is found to have condition level deficiencies.
(c) Basis for imposing a civil money penalty. CMS may impose a civil money penalty against any laboratory determined to have condition level deficiencies regardless of whether those deficiencies pose immediate jeopardy.
(d) Amount of penalty -
(1) Factors considered. In determining the amount of the penalty, CMS takes into account the following factors:
(i) The nature, scope, severity, and duration of the noncompliance.
(ii) Whether the same condition level deficiencies have been identified during three consecutive inspections.
(iii) The laboratory's overall compliance history including but not limited to any period of noncompliance that occurred between certifications of compliance.
(iv) The laboratory's intent or reason for noncompliance.
(2) Range of penalty amount.
(4) Increased penalty amounts. CMS may, before the hearing, propose to increase the penalty amount for a laboratory that has deficiencies which, after imposition of a lower level penalty amount, become sufficiently serious to pose immediate jeopardy.
(e) Procedures for imposition of civil money penalty -
(1) Notice of intent.
(ii) The notice includes the following information:
(A) The statutory basis for the penalty.
(B) The proposed daily or per violation amount of the penalty.
(D) The opportunity for responding to the notice in accordance with § 493.1810(c).
(E) A specific statement regarding the laboratory's appeal rights.
(2) Appeal rights.
(f) Accrual and duration of penalty -
(1) Accrual of penalty. The civil money penalty begins accruing as follows:
(i) 5 days after notice of intent if there is immediate jeopardy.
(ii) 15 days after notice of intent if there is not immediate jeopardy.
(2) Duration of penalty. The civil money penalty continues to accrue until the earliest of the following occurs:
(i) The laboratory's compliance with condition level requirements is verified on the basis of the evidence presented by the laboratory in its credible allegation of compliance or at the time or revisit.
(ii) Based on credible evidence presented by the laboratory at the time of revisit, CMS determines that compliance was achieved before the revisit. (In this situation, the money penalty stops accruing as of the date of compliance.)
(g) Computation and notice of total penalty amount -
(i) The 60 day period for requesting a hearing has expired without a request or the laboratory has explicitly waived its right to a hearing; or
(2) Notice of penalty amount and due date of penalty. The notice includes the following information:
(i) Daily or per violation penalty amount.
(ii) Number of days or violations for which the penalty is imposed.
(iii) Total penalty amount.
(iv) Due date for payment of the penalty.
(h) Due date for payment of penalty.
(i) Collection and settlement -
(1) Collection of penalty amounts.
(ii) Interest accrues on the unpaid balance of the penalty, beginning on the due date. Interest is computed at the rate specified in § 405.378(d) of this chapter.