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

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: February 2, 2022.

Effective Date: February 17, 2022.

Agency Contact: Ralph Orr, Program Manager, Prescription Monitoring Program, 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.

Basis: Regulations governing the Prescription Monitoring Program (PMP) are promulgated under the statutory mandate in § 54.1-2520 of the Code of Virginia. Section 54.1-2521 of the Code of Virginia provides reporting requirements for the program. Authority for the Director of the Department of Health Professions to establish the PMP is found in § 54.1-2505 of the Code of Virginia.

Purpose: The purpose of the regulatory change is to update the regulation to allow for newer standards for reporting for the Prescription Monitoring Program (PMP) without placing additional burdens on dispensers by specifying the most current version that is the 2019 Version 4b of the American Society of Automation in Pharmacy (ASAP) Standard. The goal of this regulatory action is to simplify and facilitate reliable reporting by allowing dispensers more than one standard to use for reporting to the PMP and simplify the reporting process for dispensers located in Virginia or dispensing to Virginia residents by allowing each dispenser to choose either the older Version 4.2 or a different version. Reporting of certain data by dispensers to PMP is not only required by the Code of Virginia but essential to ensure the protection of the health, safety, and welfare of the citizens because the PMP is used to track excessive prescribing and dispensing of covered drugs and to alert for possible diversion of such drugs into communities.

Rationale for Using Fast-Track Rulemaking Process: This regulatory action is expected to be noncontroversial because the director is deleting an outdated standard and allowing more than one standard to be acceptable to dispensers. Provided the data elements specified in § 54.1-2521 of the Code of Virginia and the vendor utilized by the Department of Health Professions (DHP) recognizes the standard, then DHP will recognize it as an acceptable version.

Substance: Amendments delete language that requires that dispensers report according to a specific version of the ASAP standard.

Issues: The primary advantage to the public of the PMP is that prescribers and dispensers have access to information on a patient's prescription history, which ensures that prescribers and dispensers can provide safe courses of treatment that are individualized to a patient's particular needs. The regulatory action facilitates the ability of dispensers to share this information through their choice of reporting standard, thus facilitating receipt of this information prior to patients receiving prescriptions in the future. The regulatory change will primarily benefit dispensers that currently report under multiple standards. There are no disadvantages to the public. There are no advantages or disadvantages to this agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Department of Health Professions (DHP) seeks to repeal discretionary language that requires dispensers of certain covered substances to use a specific version of a reporting standard when submitting data to the Prescription Monitoring Program (PMP).¹ DHP seeks to repeal this language because that specific version has since been superseded by newer versions of the standard. Further, DHP does not seek to add a reference to the newer version since the existing regulatory text already directs dispensers to use a specific file layout, which implicitly reflects the reporting standard. Dispensers using the older file layout will be able to continue to do so, thus, the regulatory change is intended to provide dispensers with greater flexibility.

Background. The PMP is a database containing information on dispensed controlled substances in Schedules II, III and IV; those in Schedule V for which a prescription is required; naloxone, all drugs of concern, and cannabidiol oil or THC-A oil dispensed by a pharmaceutical processor in Virginia.² As per 18VAC76-20-40 Standards for the manner and format of reports and a schedule for reporting, "Data shall be transmitted to the department or its agent within 24 hours of dispensing or the dispenser's next business day, whichever comes later, as provided in the Electronic Reporting Standard for Prescription Monitoring Programs, Version 4.2 (September 2011) of the American Society of Automation in Pharmacy (ASAP), which are hereby incorporated by reference into this chapter." DHP seeks to repeal the text citing the standard and incorporating the document by reference.

ASAP has released newer versions of the electronic reporting standard since 2011. Some dispensers report data to DHP under Version 4.2 and to other states" monitoring programs using these newer versions. The Virginia PMP vendor can currently accommodate reporting of data in ASAP reporting standard versions 4.2 and 4.2a.³ Subsection B of the section requires dispensers to transmit the data using a file layout provided by the director of the PMP, beginning no fewer than 90 days from notification by the director to dispensers required to report. The latest version of the Dispenser Guide, effective June 2020, contains the file layout for ASAP version 4.2a.⁴ However, dispensers would not be required to switch to the newer file layout. Thus, repealing the reference to version 4.2 and the document incorporated by reference would provide dispensers with the option of using either version of the reporting standard.

Estimated Benefits and Costs. DHP anticipates that dispensers who already use the file layout for ASAP 4.2a to report prescription data to other states monitoring programs will start using it for reports to the Virginia PMP as well. These dispensers would likely benefit from having consistent reporting requirements across different states to the extent that it reduces their overall cost of meeting reporting requirements. Pharmaceutical processors and dispensaries are the current most probable users of ASAP 4.2a because of their unique regulatory status. However, dispensers currently using the file layout corresponding to the ASAP 4.2 standards may continue to do so without facing any additional costs.

Businesses and Other Entities Affected. The proposed amendments primarily affect any individuals or entities that dispense a "covered substance" as defined in § 54.1-2519 of the Code of Virginia. DHP reports that there are 2,117 entities currently reporting prescription data to DHP.

Small Businesses⁵ Affected. The proposed amendments do not create any new costs and therefore would not adversely affect any small businesses. Pharmacies or dispensaries that are small businesses could benefit to the extent that the proposed amendment would allow them to standardize their prescription reporting across multiple states including Virginia.

Localities⁶ Affected.⁷ The proposed amendments do not introduce new costs for local governments and are unlikely to affect any locality in particular.

Projected Impact on Employment. The proposed amendments are unlikely to impact employment by dispensers of covered substances.

Effects on the Use and Value of Private Property. To the extent that the option to use ASAP 4.2a reporting standards allows some dispensers to reduce their overall reporting costs by streamlining their reporting process, the value of those entities may see a modest increase. Real estate development costs are not affected.

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¹See § 54.1-2519 of the Code of Virginia for the definition of covered substances with respect to the PMP: https://law.lis.virginia.gov/vacode/title54.1/chapter25.2/section54.1-2519/.

²See https://www.dhp.virginia.gov/PractitionerResources/PrescriptionMonitoringProgram/.

³See Agency Background Document https://townhall.virginia.gov/l/GetFile.cfm?File=59\5733\9276\AgencyStatement_DHP_9276_v2.pdf.

⁴See Appendix A of the Virginia PMP Dispenser's Guide: https://www.dhp.virginia.gov/media/dhpweb/docs/pmp/VA Data Submission Dispenser Guide_v 2.4.pdf

⁵Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁶"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁷§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The Department of Health Professions concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendments delete a requirement that dispensers report according to a specific version of the American Society of Automation in Pharmacy standard and remove the standard as incorporated by reference into the regulation.

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 within 24 hours of dispensing or the dispenser's next business day, whichever comes later, as provided in the Electronic Reporting Standard for Prescription Monitoring Programs, Version 4.2 (September 2011) 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 90 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 National Provider Identifier of the prescriber;

3. The total number of refills ordered;

4. Whether the prescription is a new prescription or a refill;

5. Whether the prescription is a partial fill;

6. The gender code;

7. The species code;

8. The Electronic Prescription Reference Number, and the Electronic Prescription Order Number if it is an electronic prescription; and

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

DOCUMENTS INCORPORATED BY REFERENCE (18VAC76-20)

Implementation Guide ASAP Standard (Electronic Reporting Standard) for Prescription Monitoring Programs, Version 4, Release 2, September 2011, American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, PA 19422 (http://www.asapnet.org)