DAR File No. 42788

Health, Health Care Financing, Coverage and Reimbursement Policy

Rule R414-60B

Preferred Drug List

Notice of Proposed Rule

(Amendment)

DAR File No.: 42788
Filed: 04/11/2018 09:42:12 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this change is to clarify the criteria upon which the Pharmacy and Therapeutics (P&T) Committee makes its recommendations to cover therapeutic drugs.

Summary of the rule or change:

This amendment clarifies clinical and cost-related factors for the P&T Committee to recommend which therapeutic drugs to cover in the Preferred Drug List (PDL). It also makes other technical changes.

Statutory or constitutional authorization for this rule:

• Section 26-1-5
• Section 26-18-3
• Section 26-18-2.4

Anticipated cost or savings to:

the state budget:

There is no impact to the state budget because this change only clarifies criteria upon which to base recommendations. It neither affects member services nor provider reimbursement.

local governments:

There is no impact to local governments because they neither fund the P&T Committee nor determine the criteria used to make recommendations.

small businesses:

There is no impact to small businesses because this change only clarifies criteria upon which to base recommendations. It neither affects member services nor provider reimbursement.

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

There is no impact to Medicaid providers or to Medicaid members because this change only clarifies criteria upon which to base recommendations. It neither affects member services nor provider reimbursement.

Compliance costs for affected persons:

There is no impact to a single Medicaid provider or to a Medicaid member because this change only clarifies criteria upon which to base recommendations. It neither affects member services nor provider reimbursement.

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

After conducting a thorough analysis, it was determined that this proposed rule change will not result in a fiscal impact to businesses.

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
Health Care Financing, Coverage and Reimbursement Policy
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Craig Devashrayee at the above address, by phone at 801-538-6641, by FAX at 801-538-6099, or by Internet E-mail at cdevashrayee@utah.gov

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:

05/31/2018

This rule may become effective on:

06/07/2018

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2018	FY 2019	FY 2020
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 above. Inestimable impacts for Non - Small Businesses are described below.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

None of the 735 providers of pharmacy services will see a fiscal impact because this rule only clarifies criteria upon which to base drug recommendations, and does not affect provider reimbursement.

 

 

R414. Health, Health Care Financing, Coverage and Reimbursement Policy.

R414-60B. Preferred Drug List.

R414-60B-1. Introduction and Authority.

(1) The Division of [Health]Medicaid and [Care]Health Financing ([DHCF]DMHF) has established a Preferred Drug List (PDL) to operate within the pharmacy program and at the Division's discretion.

(2) The Preferred Drug List is authorized under Section 26-18-2.4.

 

R414-60B-2. Client Eligibility Requirements.

A PDL is available to categorically and medically needy individuals.

 

R414-60B-3. Program Access Requirements.

A PDL is established for certain therapeutic classes of drugs and is available through the point of sale system of any Medicaid provider. At its discretion, [DHCF]DMHF establishes and implements the scope and therapeutic classes of drugs.

 

R414-60B-4. Service Coverage.

(1) Upon the recommendation of the Pharmacy and Therapeutics (P&T) Committee, [DHCF]DMHF pharmacy staff select the therapeutic classes and select the most clinically effective and cost effective drug or drugs within each class.

(2) The prescriber must obtain prior authorization from the Department to dispense drugs designated as "non-preferred" in each class, through the Department's current prior authorization system. Criteria for a Non-preferred Prior Authorization (NPA) is established by the Department in consultation with the [Pharmacy and Therapeutics]P&T Committee.

(3) A prior authorization is not placed on any preferred drugs under Section R414-60B-4. Nevertheless, a prior authorization may apply if set by the Drug Utilization Review Board (DURB).

(4) For NPA requests submitted during normal business hours, Monday through Friday, 8 a.m. to 5 p.m., the prior authorization system shall provide either telephone or fax approval or denial within 24 hours of the receipt of the request.

(5) In an emergency situation for a prior authorization needed outside of normal business hours, a 72-hour supply of a non-preferred drug may be dispensed and the Department shall issue an NPA for the 72-hour supply on the next business day. Further quantity requests shall be subject to all NPA requirements.

 

R414-60B-5. P&T Committee Composition and Membership Requirements.

(1) There is created a [Pharmacy and Therapeutics]P&T Committee within [DHCF]DMHF. The [DHCF]DMHF Director shall appoint the members of the P&T Committee for a two-year term. [DHCF]DMHF has the option of making the appointments renewable.

(2) [DHCF]DMHF staff request nominations for appointees from professional organizations within the state. These nominations are then given to the Director for selection and appointment.

(a) If there are no recommendations within 30 days of a request, [DHCF]DMHF may submit a list of potential candidates to professional organizations for consideration.

(b) If there are no willing nominees for appointment from professional organizations, the Director may seek recommendations from [DHCF]DMHF staff.

(3) The P&T Committee consists of one physician from each of the following specialty areas:

(a) Internal Medicine;

(b) Family Practice Medicine;

(c) Psychiatry; and

(d) Pediatrics.

(4) The [PadT]P&T Committee consists of one pharmacist from each of the following areas:

(a) Pharmacist in Academia;

(b) Independent Pharmacy;

(c) Chain Pharmacy; and

(d) Hospital Pharmacy.

(5) [DHCF]DMHF shall appoint one voting committee manager.

(6) Up to two non-voting ad hoc specialists participate on the committee at the committee's invitation.

(7) An individual considered for nomination must demonstrate no direct connection to and must be independent of the pharmaceutical manufacturing industry.

(8) The P&T Committee shall elect a chairperson to a one-year term from among its members. The chairperson may serve consecutive terms if reelected by the committee.

(9) When a vacancy occurs on the committee, the Director shall appoint a replacement for the unexpired term of the vacating member.

(10) P&T Committee members serve at the discretion of the DMHF Director.

 

R414-60B-6. P&T Committee Responsibilities and Functions.

(1) The P&T Committee functions as a professional and technical advisory board to [DHCF]DMHF in the formulation of a PDL.

(2) P&T Committee recommendations must:

(a) represent the majority vote at meetings in which a majority of voting members are present; and

(b) include votes by at least one committee member from the group identified in Subsection R414-60B-5(3) and one member from the group identified in Subsection R414-60B-5(4)

(3) The P&T Committee manager shall schedule meetings, set agendas, provide meeting materials, keep minutes, record committee business, notify the Director when vacancies occur, provide meeting notices, and coordinate functions between the committee and [DHCF]DMHF.

(4) Notice for a P&T Committee meeting shall be given in accordance with applicable law.

(5) The P&T Committee chairperson shall conduct all meetings. The P&T Committee manager shall conduct meetings if the chairperson is not present.

(6) P&T Committee meetings shall occur at least quarterly.

(7) P&T Committee meetings shall be open to the public except when meeting in executive session.

(8) The committee shall:

(a) review drug classes and make recommendations to [DHCF]DMHF for PDL implementation;

(b) review new drugs, new drug classes or both, to make recommendations to [DHCF]DMHF for PDL implementation;

(c) review drugs or drug classes as [DHCF]DMHF assigns or requests;

(d) review drugs within a therapeutic class and make a recommendation to [DHCF]DMHF for the preferred drug or drugs within the therapeutic class; and

(e) review evidence based criteria and drug information.

 

R414-60B-7. Clinical and Cost-Related Factors.

The P&T Committee shall base its determinations on the following [clinical and cost-related ]factors as established by the [Drug Utilization Review Board]DURB:

(1) If clinical and therapeutic considerations are substantially equal, then the P&T Committee shall recommend to [DHCF]DMHF that it consider only cost.

[(2) If cost information available to the P&T Committee indicates that costs are substantially the same, then the P&T Committee makes its recommendation to DHCF based on the clinical and therapeutic profiles of the drugs.]

([3]2) In making its recommendations to [DHCF]DMHF, the P&T Committee may also consider whether the clinical, therapeutic effects, and medical necessity requirements justify the cost differential between drugs within a therapeutic class.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [July 22, 2009]2018

Notice of Continuation: June 14, 2017

Authorizing, and Implemented or Interpreted Law: 26-18-2.4; 26-18-3; 26-1-5