DAR File No. 43402

Health, Family Health and Preparedness, Maternal and Child Health

Rule R433-200

Family Planning Access Act

Notice of Proposed Rule

(New Rule)

DAR File No.: 43402
Filed: 11/16/2018 12:20:25 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

S.B. 184 passed during the 2018 General Session enacted the Family Planning Access Act (Act) to permit a pharmacist to dispense a self-administered hormonal contraceptive under a standing prescription order. As required by Section 26-64-105 of the Act, this rule filing provides necessary definitions and establishes the protocol for issuing a valid standing order. This rule also describes information required, created, collected, and maintained by pharmacists under the Act and this rule.

Summary of the rule or change:

Section R443-200-1 states the authority and purpose of this rule in implementing the Act. Section R443-200-2 provides definitions of terms used in this rule. Section R443-200-3 describes relevant information that pharmacists must record under the Act. The information requirements were developed by the Department of Health (Department), as authorized by the Act, in consultation with pharmacists, pharmacist interns, and employers who intend to participate. Section R443-200-4 classifies the information collected by pharmacists and information collected by the Department under the Act, and cites Utah statutory authority governing such information. Section R443-200-5 provides notice of the Department's authority to monitor and ensure compliance with the Act and this rule.

Statutory or constitutional authorization for this rule:

• Title 26, Chapter 3
• Section 26-23-6
• Title 26, Chapter 25
• Title 26, Chapter 64
• Title 58, Chapter 17b

Anticipated cost or savings to:

the state budget:

This proposed rule is not expected to have any fiscal impact on the state budget because this rule neither addresses state government, imposes any new state duty, nor allocates money for the operation of state government.

local governments:

This proposed rule is not expected to have any fiscal impact on local governments because it does not apply to local governments.

small businesses:

The extent of fiscal benefits and costs cannot be estimated because data required to estimate participation by Utah women, participation by pharmacists, the amount of reimbursements and payments shifting from physician practices to pharmacies, and the availability and amount of third party payments for pharmacist consultations (compared to third party payments for physician visits) is not available. Physician's offices and group practices: direct fiscal cost. Pharmacies: direct fiscal benefit.

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

The extent of fiscal benefits and costs cannot be estimated because data required to estimate participation by Utah women, participation by pharmacists, the amount of reimbursements and payments shifting from physician practices to pharmacies, and the availability and amount of third party payments for pharmacist consultations (compared to third party payments for physician visits) is not available. Physician's offices and group practices: direct fiscal cost. Pharmacies: direct fiscal benefit.

Compliance costs for affected persons:

The full fiscal and non-fiscal impact on women receiving contraceptives under the Act and this rule cannot be estimated because the data necessary to determine the number of women likely to participate, the amount of consultation fees charged by pharmacies under this proposed rule, the availability and amount of third party payments in support of such fees, the reduced time and expense incurred by women in initially obtaining contraceptives directly from pharmacists and on an ongoing basis are not available.

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

After conducting a thorough analysis, it was determined that the fiscal impact of this new rule cannot be determined at this time because sufficient data is not available.

Joseph K. Miner, MD, Executive Director

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

Health
Family Health and Preparedness, Maternal and Child Health
,

Direct questions regarding this rule to:

• Laurie Baksh at the above address, by phone at 801-273-2857, by FAX at , 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:

01/16/2019

This rule may become effective on:

01/23/2019

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

Based on figures provided by DOPL, there are approximately 10 non-small business Class A retail pharmacies in Utah that may be impacted by these amendments (NAICS 446110). This proposed rule may impact non-small pharmacy businesses that employ pharmacists or pharmacy interns who opt to dispense self-administered hormonal contraceptives under the proposed rule. The pharmacists and interns would evaluate womens' self-assessments and dispense contraceptives in specific circumstances. This may result in a direct fiscal benefit to non-small pharmacy businesses resulting from consultation fees and contraceptives dispensed. However, the fiscal benefits to these small pharmacy businesses cannot be estimated, because the data necessary to determine how many pharmacists might participate and the number of encounters and the amount of associated payments from multiple potential sources that might shift from prescribers to pharmacists is not available.

 

In addition, there are non-small business employers of prescribing physicians that may be impacted by the proposed rule. The number of such prescribing persons cannot be estimated from NAICS data (which does not disaggregate prescribing businesses from non-prescribing businesses) or other data available to the Department. This proposed rule may result in a direct fiscal cost to these non-small prescribing businesses, because encounters may drop as women become able to obtain self-administered hormonal contraceptives directly from pharmacists without visiting a prescriber, causing payments to prescribers to fall. However, the direct fiscal costs to these non-small prescriber businesses cannot be estimated, because the data necessary to determine the reduced number of encounters and the reduced amount of associated payments is not available.

 

 

R433. Health, Family Health and Preparedness, Maternal and Child Health.

R433-200. Family Planning Access Act.

R433-200-1. Authority and Purpose.

This rule establishes the protocol required by the Family Planning Access Act (Title 26, Chapter 64) for issuance of a valid standing prescription drug order that authorizes pharmacists and pharmacist interns licensed under the Pharmacy Practice Act (Title 58, Chapter 17b) to dispense self-administered hormonal contraception according to the requirements of the standing order. The rule also describes information created and collected under the Family Planning Access Act and this rule.

The requirements of this rule apply to each standing order issued under the Family Planning Access Act.

 

R433-200-2. Definitions.

The terms used in this rule are defined in Section 26-64-102. In addition, the following definitions apply to this rule:

(1) "Department" means the Utah Department of Health.

(2) "Initiate dispensing":

(a) Means to fill or partially fill a self-administered hormonal contraceptive prescription:

(i) at the time a pharmacist or pharmacist intern evaluates a patient's self-assessment form and determines that it is safe to dispense contraceptives to the patient; or

(ii) at any subsequent date requiring review or evaluation by a pharmacist or pharmacist intern.

(b) Does not mean any prescription refill (as defined by R156-17b-102(51)) that may be provided under the applicable standing order without an evaluation or review by a pharmacist or pharmacist intern.

(3) "NDC" means the National Drug Code assigned by the U.S. Food and Drug Administration.

(4) "The Act" means the Family Planning Access Act.

 

R433-200-3. Protocol For Issuance of a Standing Prescription Drug Order.

Each standing prescription drug order for self-administered hormonal contraceptives issued under the Act shall adhere to the requirements of Section 26-64-105. In addition, each order shall also require the following:

(1) Persons authorized to initiate dispensing a self-administered hormonal contraceptive shall make and retain a record that includes the following information:

(a) The age and zip code of each patient receiving a self-administered hormonal contraceptive;

(b) The NDC of each self-administered hormonal contraceptive dispensed;

(c) An annual count of the number of patients who provide their self-screening risk assessment for evaluation by the pharmacist or pharmacist intern; and

(d) Any other relevant information required by the physician's standing order.

 

R433-200-4. Confidentiality.

Information produced or collected by a pharmacist or pharmacist intern under the Act, this rule, or a standing order is "health data" subject to Title 26, Chapter 3 and is confidential and privileged information subject to requirements of Title 26, Chapter 25.

 

R433-200-5. Compliance.

Upon Department request, pharmacists, pharmacist interns, and their employing pharmacies shall provide copies of records required by the Act, this rule, and standing orders to the Department. The Department may also obtain and review records and information.

 

KEY: family planning, contraception, hormonal contraception, birth control

Date of Enactment or Last Substantive Amendment: 2019

Authorizing, and Implemented or Interpreted Law: 26-3; 26-23-6; 26-25; 26-64; 58-17b