Code of Maine Rules
90 - INDEPENDENT AGENCIES
590 - MAINE HEALTH DATA ORGANIZATION (MHDO)
Chapter 570 - UNIFORM REPORTING SYSTEM FOR PRESCRIPTION DRUG PRICE DATA SETS
Section 590-570-4 - Compliance

Current through 2024-13, March 27, 2024

A. Certification of accuracy. A notification or report to the MHDO by a reporting entity shall include a signed, written certification of the notification or report's accuracy. Reporting entities will be allowed to attest to the accuracy of their notification or report through the MHDO Prescription Drug Price Data Portal web interface. Confirmation will be documented electronically and will count as the written certification.

B. Audit. With a 30-day notice, the MHDO may audit the finalized data submitted by a reporting entity, and that entity shall pay for the costs of the audit. The MHDO will consider recommendations from the reporting entity as to the scope of the audit and the selection of the independent auditor.

C. Corrective action plan. The MHDO may require a reporting entity to develop a corrective action plan to correct any deficiencies in compliance discovered during an audit. The corrective action plan shall include, in writing: the specific requirement to be extended; an explanation of the cause; the methodology proposed to eliminate the necessity of the extension; and the time frame required to come into compliance.

D. Enforcement. The failure to file, report, or correct prescription drug price data sets when required in accordance with the provisions of this chapter may be considered a civil violation under 22 M.R.S. §8705-A and Code of Maine Rules 90-590, Chapter 100: Enforcement Procedures.

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