Md. Code Regs. 10.25.18.13 - Noncontrolled Prescription Drugs Dispenser Reporting

A. For each noncontrolled prescription drug dispensed, the dispenser shall report drug information to the State-designated HIE in accordance with this regulation.

B. MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.

(1) The Commission shall develop a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.

(2) The Commission shall approve a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual by June 1 of each year to be used for reporting by the last business day of September of the same calendar year.

(3) The MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual shall minimally:

(a) Specify the data and prescription drug information that must be submitted by dispensers to the State-designated HIE in accordance with this regulation, including specifying the American Society for Automation in Pharmacy (ASAP) standard;

(b) Specify the timeframe and frequency of data submissions to the State-designated HIE;

(c) Require a dispenser to report data elements consistent with the ASAP standard identified in MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual;

(d) Include electronic reporting specifications, encryption algorithms, file layout, and the process for dispensers who are unable to submit data due to mechanical, electrical, or other technical failure; and

(e) Align, to the extent possible, with the Maryland Prescription Drug Monitoring Program Data Submitter User Guide.

(4) The Commission shall publish a draft Noncontrolled Prescription Drugs Dispenser Data Submission Manual on the Commission's website and in the Maryland Register at least 30 days before the public meeting at which the Commission shall consider the manual for final approval and provide at least 20 days for the submission of public comment.

(5) The Commission shall consider all comments received before final approval of the Noncontrolled Prescription Drugs Dispenser Data Submission Manual.

(6) The Commission shall publish the final MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual on its website within 5 days of its approval.

(7) The State-designated HIE shall post a link to MHCC's Noncontrolled Prescription Drugs Dispenser Data Submission Manual prominently on its website.

(8) The Commission may correct incomplete or erroneous information in the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual as necessary and shall provide notice of each correction:

(a) On its website; and

(b) By email to the designated dispenser contact person.

C. Means of Data Submission and Data Format. A dispenser shall transmit noncontrolled prescription drug information to the State-designated HIE:

(1) Consistent with the requirements detailed in the most recent version of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual;

(2) By use of an encrypted electronic transmission method or a secure electronic reporting form; and

(3) In a format or utilizing data standards approved by the Commission.

D. Reporting Deadline.

(1) Unless granted a waiver under §F of this regulation, a dispenser shall report to the State-designated HIE:

(a) The noncontrolled prescription drug information required by the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual no later than the end of the next day of operation after the prescription is dispensed; or

(b) A zero report no later than the end of the next day of operation after a day without dispenses of noncontrolled prescription drugs.

(2) A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser's ability to report noncontrolled prescription data electronically shall:

(a) Notify the State-designated HIE by a communication method approved by the State-designated HIE within 24 hours of discovery of the technical failure; and

(b) Submit a report for each noncontrolled prescription drug dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting.

E. Acceptance and Disclosure of Noncontrolled Prescription Drug Information by the State-designated HIE.

(1) The State-designated HIE shall:

(a) Electronically collect noncontrolled prescription drug information from dispensers;

(b) Not impose any fees or other assessments on dispensers to support its operation;

(c) Make information technology available for dispensers to report noncontrolled prescription drug information to the State-designated HIE; and

(d) Retain noncontrolled prescription drug information collected pursuant to this section for at least 5 years from the date of receipt, except for the PHI of patients who opt-out of an HIE consistent with Regulation .03 of this chapter.

(2) The State-designated HIE may reject data submitted by dispensers that does not comply with the requirements of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual.

(3) If the State-designated HIE rejects the data submitted by a dispenser, the dispenser shall correct and resubmit the data no later than 7 business days after receiving notification from the State-designated HIE of receipt of incomplete or inaccurate data.

(4) Beginning January 1, 2026, the State-designated HIE shall make patient-specific prescription information submitted by dispensers under this section available for purposes allowed under applicable law.

(5) Upon written request for public health purposes and as allowed by applicable law, the State-designated HIE shall provide data collected under this regulation within 5 days to the Maryland Department of Health, local health departments, the Commission, or the Health Services Cost Review Commission.

F. Dispenser waiver request process.

(1) Prior to September 1, 2025, dispensers of noncontrolled prescription drug information are exempt from reporting dispensed information to the State-designated HIE.

(2) A dispenser that dispenses noncontrolled prescription drugs may seek a waiver from the Commission of the requirements in this regulation based on:

(a) Economic hardship;

(b) Technology limitations that are not reasonably within the dispenser's control;

(c) Dispensing less than 100 noncontrolled prescription drugs annually; or

(d) Other circumstances determined by the Commission to be extenuating.

(3) A request for a waiver shall be in writing and shall include:

(a) A detailed explanation of the need for the waiver;

(b) An attestation as to the accuracy of the information in the waiver request; and

(c) An attestation that the dispenser shall immediately inform the Commission if the circumstances necessitating a waiver no longer exist.

(4) Within 45 days after receipt of complete information from a dispenser requesting a waiver, the Commission shall:

(a) Grant a time-limited waiver request; or

(b) Deny the waiver request, with an explanation that enumerates the reasons for the denial.

(5) A dispenser shall inform the Commission and immediately begin reporting in compliance with this regulation if the dispenser no longer meets the conditions of a waiver request.

Notes

Md. Code Regs. 10.25.18.13

Regulation .13 adopted effective 52:7 Md. R. 322, eff. 4/14/2025.