No. 29808 (New Rule): R414-60B. Preferred Drug List

DAR File No.: 29808
Filed: 04/11/2007, 03:11
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule is necessary to implement policies and procedures for the Pharmacy and Therapeutics (P&T) Committee, which reviews and recommends cost effective drugs to establish a preferred drug list (PDL).

Summary of the rule or change:

This new rule outlines client eligibility requirements, program access requirements, service coverage, P&T Committee and membership requirements, P&T Committee responsibilities and functions, and reimbursement methodology for the PDL.

State statutory or constitutional authorization for this rule:

Sections 26-18-3, 26-1-5, and 26-18-2.4

Anticipated cost or savings to:

the state budget:

There is an estimated annual savings of $2,524,930 to the General Fund and $6,375,070 in federal funds.

local governments:

There is no budget impact because local governments do not fund the Medicaid pharmacy program.

other persons:

The majority of pharmaceutical manufacturers lose a portion of $8,900,000 in revenue because of the PDL.

Compliance costs for affected persons:

The estimated cost for a single pharmaceutical manufacturer is less than $1,000,000.

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

Implementation of the preferred drug list will be positive for business. David N. Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division 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 [e-mail]

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:

05/31/2007

This rule may become effective on:

06/08/2007

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

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 Care Financing (DHCF) 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 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 pharmacy staff select the therapeutic classes and select the most clinically effective and cost effective drug or drugs within each class.

(2) The preferred drug or drugs are dispensed without prior authorization requirements.

(3) All other non-preferred drugs within each therapeutic class require prior authorization, unless the prescriber writes "medically necessary - "dispense as written" on the prescription and has justification in the patient's medical record substantiating the medical necessity of the non-preferred drug.

 

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

(1) The DHCF Director shall appoint the members of the P&T Committee for a two-year term. DHCF has the option of making the appointments renewable.

(2) DHCF 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 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 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 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 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.

 

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

(1) Under Section 26-18-106, the P&T Committee functions as a professional and technical advisory board to DHCF 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.

(4) Notice for a P&T Committee meeting shall be given in accordance with Section 26-18-105.

(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 for PDL implementation;

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

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

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

(e) review evidence based criteria and drug information.

 

R414-60B-7. Reimbursement.

Pharmaceuticals are reimbursed using the established fee schedule in the Utah Medicaid State Plan, which is incorporated by reference in Section R414-1-5.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: 2007

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