No. 30281 (Amendment): R414-60B. Preferred Drug List

DAR File No.: 30281
Filed: 08/01/2007, 11:44
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This amendment is necessary to clarify service coverage for the preferred drug list (PDL), to clarify the establishment of a Pharmacy and Therapeutics (P&T) Committee within the Division of Health Care Financing, to clarify the independence of the P&T Committee, to clarify public notice requirements for P&T Committee meetings, and to clarify clinical and cost-related factors for the PDL.

Summary of the rule or change:

This amendment clarifies coverage policy for preferred drugs and medical necessity requirements for nonpreferred drugs. It also adds and removes language to clarify the legal authority under which public notice is given for P&T Committee meetings, adds language to affirm the establishment of the P&T Committee, and includes language to clarify that the P&T Committee bases its determinations on clinical and cost-related factors. These factors include cost, clinical and therapeutic effects, and medical necessity requirements. This amendment also removes language to clarify that the P&T Committee operates independently.

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 no budget impact because this change only clarifies service coverage and specifies criteria that the P&T Committee uses to make PDL recommendations.

local governments:

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

small businesses and persons other than businesses:

There is no budget impact to other persons and small businesses because this change only clarifies service coverage and specifies criteria that the P&T Committee uses to make PDL recommendations.

Compliance costs for affected persons:

There is no budget impact because this change only clarifies service coverage and specifies criteria that the P&T Committee uses to make PDL recommendations.

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

In response to public comments, this rule will clarify the criteria to be used by the P&T committee as it makes recommendations to the Division of Health Care Financing. No fiscal impact on business is anticipated as a result of these amendments. 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:

09/14/2007

Interested persons may attend a public hearing regarding this rule:

8/28/2007 at 3:00 PM, Cannon Health Building, 288 N 1460 W, Room 125, Salt Lake City, UT

This rule may become effective on:

09/21/2007

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-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.](2) The prescriber must write "medically necessary -- dispense as written" on the prescription and have justification in the patient's medical record substantiating the medical necessity of a non-preferred drug in order for this to be reimbursed.

(3) The preferred drug or drugs are covered without the notation required in (2).

 

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

(1) There is created a Pharmacy and Therapeutics Committee within DHCF. 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, t]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 52-4-202]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 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]Clinical and Cost-Related Factors.

[Pharmaceuticals are reimbursed using the established fee schedule in the Utah Medicaid State Plan, which is incorporated by reference in Section R414-1-5.]The P&T Committee shall base its determinations on the following clinical and cost-related factors as established by the Drug Utilization Review Board:

(1) If clinical and therapeutic considerations are substantially equal, then the P&T Committee shall recommend to DHCF 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) In making its recommendations to DHCF, 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: 2007

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