Title of Regulation: 18VAC76-20. Regulations Governing the Prescription Monitoring Program (amending 18VAC76-20-40).

Statutory Authority: §§ 54.1-2505 and 54.1-2520 of the Code of Virginia.

Effective Date: October 1, 2011.

Agency Contact: Ralph Orr, Program Manager, Department of Health Professions, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4523, FAX (804) 527-4470, or email ralph.orr@dhp.virginia.gov.

Summary:

The amendments to the standards for the manner and format of reports to the Prescription Monitoring Program are adopted pursuant to §§ 54.1-2520 and 54.1-2521 of the Code of Virginia, which grant authority to the Director of the Department of Health Professions to promulgate regulations necessary to implement the Prescription Monitoring Program and require information necessary for the Prescription Monitoring Program to be eligible to receive federal funds.

The National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER) created a formula grant program under the authority of the U.S. Secretary for Health and Human Services (Secretary). To qualify for federal funding available since 2010, Virginia’s Prescription Monitoring Program is required to include certain information. States receiving NASPER grants must adopt the 4.1 or higher version of the American Society of Automation in Pharmacy (ASAP) reporting standard to ensure that gross formatting errors are minimized. In 42 USC 280g-3, the Secretary is required to "specify a uniform electronic format for the reporting, sharing and disclosure of information under this section." To that end, the Secretary has identified the ASAP 4.1 reporting standard; therefore, subsection A of 18VAC76-20-40 is amended to identify that standard as the format pharmacies must use for reporting data.

Data elements of the required report, set out in 42 USC 280g-3, are already listed in § 54.1-2521 of the Code of Virginia or are added in new subsection E of 18VAC76-20-40, several of which are already included on the current reporting format.

The standards for federal funding in 42 USC 280g-3 further require that the dispenser report to the state after each dispensing of a covered controlled substance not later than one week after the date of dispensing. The timetable for reporting simply will require a pharmacy to program reporting weekly instead of semi-monthly.

18VAC76-20-40. Standards for the manner and format of reports and a schedule for reporting.

A. Data shall be transmitted to the department or its agent on a semi-monthly basis within seven days of dispensing as provided in the Telecommunication Format for Controlled Substances (, May 1995,) Electronic Reporting Standard for Prescription Monitoring Programs, Version 4.1 (November 2009) of the American Society of Automation in Pharmacy (ASAP), which are hereby incorporated by reference into this chapter.

B. Data shall be transmitted in a file layout provided by the department and shall be transmitted by a media acceptable to the vendor contracted by the director for the program. Such transmission shall begin on a date specified by the director, no less than 30 days from notification by the director to dispensers required to report.

C. Under extraordinary circumstances, an alternative means of reporting may be approved by the director.

D. Data not accepted by the vendor due to a substantial number of errors or omissions shall be corrected and resubmitted to the vendor within five business days of receiving notification that the submitted data had an unacceptable number of errors or problems.

E. Required data elements shall include those listed in subsection B of § 54.1-2521 of the Code of Virginia and the following:

1. The Drug Enforcement Administration (DEA) registration number of the dispenser;

2. The total number of refills ordered;

3. Whether the prescription is a new prescription or a refill; and

4. The date the prescription was written by the prescriber.

DOCUMENTS INCORPORATED BY REFERENCE (18VAC76-20)

Telecommunication Format for Controlled Substances, May 1995, American Society for Automation in Pharmacy (ASAP).

Implementation Guide ASAP Standard (Electronic Reporting Standard) for Prescription Monitoring Programs, Version 4, Release 1, November 2009, American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, PA 19422 (http://www.asapnet.org).