Determinations Regarding the Penalty Amounts Sample Clauses

Determinations Regarding the Penalty Amounts. We proposed to add new 42 CFR 1003.1420 that would codify the statutory factors that OIG must consider when imposing CMPs for committing information blocking. Section 3022(b)(2)(A) of the PHSA mandates that in determining the amount of a CMP for information blocking, OIG must consider factors such as the nature and extent of the information blocking and the harm resulting from such information blocking including, where applicable, the number of patients affected, the number of providers affected, and the number of days the information blocking persisted. The proposed regulatory text included these statutory factors. Given the novel nature of information blocking investigations and enforcement, we recognized in the preamble to the proposed rule that we have limited experience to inform the proposal of additional aggravating and mitigating circumstances to adjust the CMP penalties. Thus, we proposed only to implement the statutory factors described above. We also solicited comment on any additional factors that we should consider for the final rule. We received several comments on proposed factors and a number of recommendations to implement other factors. We are finalizing 42 CFR 1003.1420 as proposed with a modification to the regulatory text at 42 CFR 1003.1420(a), which is the factor for “nature and extent of the information blocking.” For this factor, we have added to the regulatory text the specific facts that section 3022(b)(2)(A) of the PHSA directs us to take into account where applicable: the number of patients affected (42 CFR 1003.1420(a)(1)), number of providers affected (42 CFR 1003.1420(a)(2)), and the number of days the information blocking persisted (42 CFR 1003.1420(a)(3)). In the preamble of the proposed rule, we explained our intent was to specifically implement the exact statutory factors in section 3022(b)(2)(A). 85 FR 22987, April 24, 2020.
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