DAR File No. 40928

Commerce, Occupational and Professional Licensing

Rule R156-37f

Controlled Substance Database Act Rule

Notice of Proposed Rule

(Amendment)

DAR File No.: 40928
Filed: 11/01/2016 02:39:12 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 239, Access to Opioid Prescription Information via Practitioner Data Management Systems, passed during the 2016 General Session, required the division to make rules to limit access to and use of opioid prescription information in the Controlled Substance Database (database) by an electronic data system, and by any prescriber, pharmacist, or other individual granted access to the database via an electronic data system (EDS user). These new sections accomplish that mandate.

Summary of the rule or change:

New Section R156-37f-302 clarifies that deposition testimony is included in the restrictions of Subsection 58-37f-302(2), prohibiting any individual or organization with lawful access to data from being compelled to testify regarding that data. New Section R156-37f-303 limits and protects access and use of opioid prescription information in the database by: 1) requiring an electronic data system accessing opioid prescription information to interface with the database through the Appriss Prescription Monitoring Program (PMP) Gateway system, and to comply with all other database access and use restrictions of the Controlled Substance Database Act and Controlled Substance Database Act Rule; 2) requiring an EDS user who is accessing opioid prescription information via an electronic data system to register with the database, to use the same personal identification number (PIN) for all access, and to comply with all of the other access and use restrictions of the Controlled Substances Database Act and Controlled Substance Database Act Rule; and 3) establishing a proactive administrative action for the Division where the Division may immediately suspend an electronic data system's or EDS user's access to the database without notice or opportunity to be heard if the Division determines such access may lead to an unlawful release or use of database information under Section 58-37f- 601, or may otherwise compromise the integrity, privacy, or security of the database's opioid prescription information.

Statutory or constitutional authorization for this rule:

• Subsection 58-37f-301(1)
• Subsection 58-1-106(1)(a)

Anticipated cost or savings to:

the state budget:

The Division will incur minimal costs of approximately $75 to print and distribute the rule once the proposed sections are made effective. The cost to the state to implement the standards imposed by the proposed new sections are addressed in the fiscal note attached to H.B. 239 (2016). Any additional costs to the Department of Commerce and to the Division should be absorbed in their current budgets because implementation will be handled within regular working hours and through existing vendors providing ongoing maintenance and support.

local governments:

The proposed new sections may impact local governments if they need to upgrade their software to meet the new standards. Such costs, if any, should be minimal since any required changes should be absorbed through the support costs paid to the local government's computer software vendor for ongoing maintenance and support. The amount of any cost cannot be estimated as it will vary depending on circumstances.

small businesses:

The proposed new sections will impact small-business pharmacies and prescribers who will be accessing the opioid prescription information in the database via electronic data systems. As addressed in the fiscal note attached to H.B. 239 (2016), the vendors for small business electronic data systems will need to work with Appriss on establishing connectivity to the PMP Gateway and Appriss estimated that there will be a startup fee of $7,500 and then a $50 per year cost per prescriber. There may also be costs incurred by small-business users to access this data via the Appriss PMP Gateway, once the system is up and running. However, access to the system by this method is voluntary. Additional costs will be incurred by small businesses that will need to further upgrade their software to meet the new standards, though such costs may be minimal since most of those changes should be absorbed through the support costs these pharmacies and prescribers already pay to their computer software vendors for ongoing maintenance and support. The proposed amendments may provide some cost savings for small-business pharmacies and prescribers if the new systems upgrade and streamline their work process. The exact amount of the costs or of any savings cannot be estimated as it will vary depending on circumstances. H.B. 239 (2016) required the Division to prepare the improved system, but does not require health systems to use the improved system.

persons other than small businesses, businesses, or local governmental entities:

The anticipated costs and savings that apply to small businesses will also impact larger businesses accessing the database; they also will need to work with Appriss on establishing connectivity to the PMP Gateway, pay the startup fee and per-prescriber fee, and any Gateway data access fees. These larger businesses also may need to upgrade their software to meet the new standards, although such costs may be minimal since most changes should be absorbed through support costs they already pay to their computer software vendors for ongoing maintenance and support. The proposed amendments may provide some cost savings for larger pharmacies and prescribers if the new systems they implement upgrade and streamline their work process. The exact amount of the costs or of any savings to larger businesses cannot be estimated as it will vary from business to business depending on circumstances. Again, H.B. 239 (2016) required the Division to prepare the improved system, but does not require health systems to use the improved system. There are no anticipated costs or savings to persons other than businesses, small businesses, and local government entities, as the new sections only implement procedures regarding database access for businesses and government entities.

Compliance costs for affected persons:

There are no anticipated compliance costs for affected persons, as the new sections only implement procedures regarding database access for businesses and government entities.

Comments by the department head on the fiscal impact the rule may have on businesses:

These new sections implement the mandate of the Legislature related to limiting access to and use of opioid prescription information in the Controlled Substance Database (CSD) when accessed by electronic data system users (EDS users). The new sections are required by H.B. 239, passed in the 2016 General Session. The use of an EDS to access the database is wholly voluntary, but requires the user to interface with the database through the Appriss Prescription Monitoring Program Gateway system. The current Appriss startup fee is $7,500 with a $50 per year cost per prescriber. This startup cost may be burdensome to certain small businesses and they may choose to access the database other than through an EDS.

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• Marvin Sims at the above address, by phone at 801-530-6232, by FAX at 801-530-6511, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/15/2016

Interested persons may attend a public hearing regarding this rule:

• 11/17/2016 11:00 AM, Heber Wells Bldg, 160 E 300 S, Hearing Room 403 (fourth floor), Salt Lake City, UT

This rule may become effective on:

12/22/2016

Authorized by:

Mark Steinagel, Director

R156. Commerce, Occupational and Professional Licensing.

R156-37f. Controlled Substance Database Act Rule.

R156-37f-302. Other Restrictions on Access to Database.

Subsection 58-37f-302(2), which prohibits any individual or organization with lawful access to the data from being compelled to testify with regard to the data, includes deposition testimony.

 

R156-37f-303. Access to Opioid Prescription Information Via an Electronic Data System.

In accordance with Subsection 58-37f-301(1) and Section 58-37f-303:

(1) Pursuant to Subsection 58-37f-303(4)(a)(i), to access opioid prescription information in the database, an electronic data system just:

(a) interface with the database through the Appriss Prescription Monitoring Program (PMP) Gateway system; and

(b) comply with all restrictions on database access and use of database information, as established by the Utah Controlled Substances Database Act and the Controlled Substance Database Act Rule.

(2) Pursuant to Subsection 58-37f-303(4)(a)(ii), to access opioid prescription information in the database via an electronic data system, an EDS user must:

(a) register to use the database;

(b) use a unique personal identification number (PIN) that is identical to the PIN the EDS user was issued to access database information through the original internet access system;

(c) comply with all restrictions on database access established by the Utah Controlled Substance Database Act and the Controlled Substance Database Act Rule; and

(d) use opioid prescription information in the database only for the purposes and uses designated in Section 58-37f-201, and as more particularly described in the Utah Controlled Substances Database Act and the Controlled Substances Database Act Rule.

(3) The division may immediately suspend, without notice or opportunity to be heard, an electronic data system's or an EDS user's access to the database, if the division determines by audit or other means that such access may lead to a violation of Section 58-37f-601 or may otherwise compromise the integrity, privacy, or security of the database's opioid prescription information. This remedy shall be in addition to the criminal and civil penalties imposed by Section 58-37f-601 for unlawful release or use of database information, and the division's obligation under Subsections 58-37f-303(5) and (6) to immediately suspend or revoke database access and pursue appropriate corrective or disciplinary action against a non-compliant electronic data system or EDS user.

 

KEY: controlled substance database, licensing

Date of Enactment or Last Substantive Amendment: [ January 7, ]2016

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37f-301(1)