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: September 14, 2016 - 9:50 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 300, Board Room 3, Richmond, VA 23233-1463.

Public Comment Deadline: September 23, 2016.

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.

Basis: The statutory authority for the Director of the Department of Health Professions to promulgate regulations is found in § 54.1-2520 of the Code of Virginia, which authorizes the director to promulgate such regulations necessary to implement the prescription monitoring program. The statutory authority for specifying data elements contained in and the format for the Prescription Monitoring Program (PMP) report is found in § 54.1-2521 of the Code of Virginia.

Purpose: Prescription drug abuse is one of the leading causes of death in the Commonwealth. The Governor's Task Force on Prescription Drug and Heroin Abuse has been studying ways to combat the problem from several perspectives, including data collection and monitoring. It is the task force's recommendation that updating the reporting format and including additional data elements will assist prescribers and other providers in a better understanding of the standard of care for prescribing opioids and other drugs with potential for abuse. To the extent that collection of more precise data on prescribing and dispensing can address the issue of prescription drug abuse, this regulatory action is necessary to protect the health and safety of the citizens of the Commonwealth.

Substance: The format for reporting data to the PMP is amended to Version 4.2 (2011) of the Electronic Reporting Standard for Prescription Monitoring Programs of the American Society of Automation in Pharmacy. The requirement for notifying dispensers and software providers when a new file layout with new data elements is prescribed in regulation is amended from 30 days to 90 days to give them longer to conform.

To facilitate collection of meaningful data that is more useful in developing reports on prescribing of controlled substances, 18VAC76-20-40 is amended to include the following data elements: (i) the National Provider Identifier, which identifies the specialty area of practice; (ii) the species code, which identifies whether the prescription is written for a human or animal; (iii) the gender code; (iv) the Electronic Prescription Reference Number if it is an electronic prescription; and (v) an indicator if the prescription is a partial fill.

Issues: The primary advantage to the public would be more complete information in the PMP and timelier reporting so that prescribers and dispensers have sufficient data to make appropriate decisions for patients. There are no disadvantages to the public. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Upon recommendation from the Governor's Task Force on Prescription Drug and Heroin Abuse and the Prescription Monitoring Program (PMP) Advisory Committee, the Department of Health Professions (DHP) proposes to add several new pieces of information that doctors who dispense medications and pharmacists will be required to report to the PMP. DHP also proposes to allow affected entities 90 days to start reporting the newly required data.

Result of Analysis. Benefits likely outweigh costs for these proposed regulatory changes.

Estimated Economic Impact. Current regulation requires reporting of certain information on prescriptions dispensed in the Commonwealth to the PMP. Currently, health care providers that dispense medications as well as pharmacists are required to report 1) the Drug Enforcement Administration registration number of the dispenser, 2) the total number of refills ordered, 3) whether the prescription is new or a refill and 4) the date that the prescription was written by the prescriber. This information is filled out and submitted electronically and is pulled from payment system software that collects much more data than is required by the PMP. Currently, effected entities have 30 days to start reporting required data after they are notified that such reports are required.

As a consequence of recommendations from the Governor's Task Force on Prescription Drug and Heroin Abuse and the Prescription Monitoring Program (PMP) Advisory Committee, DHP now proposes to add requirements that these entities also report: 1) the National Provider Identifier of the prescriber, 2) whether the prescription is a partial refill, 3) the gender code of the patient, 4) a species code for the patient (so that the system can differentiate medicines prescribed for humans versus medicines prescribed for animals) and 5) the Electronic Prescription Reference Number and the Electronic Prescription Order Number, if it is an electronic prescription. Most of the newly required data elements will make patients easier to identify and differentiate. The requirement to report partial fills for prescriptions will allow the system to refrain from flagging an individual for filling two prescriptions for the same drug in a short amount of time when in actuality one prescription was filled in two partial orders (likely because the pharmacist did not have enough of the medication to fill it all at once but the patient could not wait for a new order of the medication to come in). DHP also proposes to allow providers 90 days, rather than the 30 days they are currently allowed, to adjust to reporting these new data points.

DHP reports that affected entities will not incur any costs on account of these proposed changes. Providers will only need to check additional elements in their already existing software interface in order for those elements to be reported to the PMP. These changes will likely benefit both consumers and health care providers as they will reduce the chances of either a patient or a provider being unfairly flagged either because of ambiguous identity or because partial fills of prescriptions are being viewed as multiple complete fills.

Businesses and Entities Affected. These proposed regulatory changes will affect all pharmacists as well as doctors and dentists who dispense drugs. DHP reports that there are 2,183 dispensers who currently report to the PMP.

Localities Particularly Affected. No locality will be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. These proposed regulatory changes are unlikely to have any effect on employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

Small Businesses:

Definition. Pursuant 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."

Costs and Other Effects. Small businesses are unlikely to incur any costs on account of these proposed regulatory changes.

Alternative Method that Minimizes Adverse Impact. Small businesses are unlikely to incur any costs on account of these proposed regulatory changes.

Adverse Impacts:

Businesses. Businesses are unlikely to incur any costs on account of these proposed regulatory changes.

Localities. Localities in the Commonwealth are unlikely to see any adverse impacts on account of these proposed regulatory changes.

Other Entities. No other entities are likely to be adversely affected by these proposed changes.

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

Summary:

The proposed amendments update the required version for reporting data electronically to the Prescription Monitoring Program, require several new data elements in the report, and allow dispensers at least 90 days from notification by the director to comply when a new file layout with new data elements is prescribed.

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 seven days of dispensing as provided in the Electronic Reporting Standard for Prescription Monitoring Programs, Version 4.1 (November 2009) 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 30 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;

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

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

4. 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 1 2, November 2009 September 2011, American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160, Blue Bell, PA 19422 (http://www.asapnet.org).