No. 36559 (5-year Review): Rule R414-60B. Preferred Drug List

DAR File No.: 36559
Filed: 07/30/2012 03:32:23 PM

NOTICE OF REVIEW AND STATEMENT OF CONTINUATION

Concise explanation of the particular statutory provisions under which the rule is enacted and how these provisions authorize or require the rule:

This rule is authorized under Section 26-18-2.4, which sets forth the policies of the Preferred Drug List (PDL) and the procedures and organization of the Pharmacy and Therapeutics (P&T) Committee. In addition, Section 26-18-3 requires the Department to implement Medicaid policy through administrative rules, which allow the Department to administer the Medicaid drug program.

Summary of written comments received during and since the last five-year review of the rule from interested persons supporting or opposing the rule:

The comments received are: 1) the comment advocated a provision for how the Department would apply the psychotropic and anti-psychotic drug exclusion as found in Section 26-18-2.4; 2) another comment expressed concern that pharmacies would bear the burden of documenting a physician's override of a script that purports to override the preferred drug list; 3) another comment suggested that language in the rule should direct the Department to carry out its duties of selecting therapeutic classes of drugs and selecting members to the P&T Committee; 4) another comment suggested the conflict of interest provision in the rule should extend to members on the committee who may have a direct or indirect conflict of interest, or appearance of the same; 5) another comment suggested the rule include a provision for a "vice chair" for those circumstances when the "chairperson" is not present; 6) another comment suggested the Department appoint a replacement from the same specialty area as the person who vacated the position on the committee; 7) another comment suggested the committee not make a decision based on a simple majority but rather having at least five members of the committee agreeing to the proposed action; 8) another comment suggested the chair of the committee should have more authority by setting agendas and meeting dates. The comment also suggested the vice chair, as designated by the chair, should chair all meetings instead of the staff manager; 9) another comment suggested there be greater notice than required by the Utah Open and Public Meetings Act to allow persons from out-of-state to travel and for those affected by the committee's actions to prepare for the meeting; 10) another comment suggested the rule not allow the committee manager to run meetings in the absence of the chairperson; 11) another comment suggested the rule declare when an executive session may be called, for what purpose, and how the committee shall conduct this session; 12) another comment stated the rule is redundant in its criteria (Subsections R414-60B-6(8)(a) through(d)) for reviewing drug classes and making recommendations; 13) another comment stated that the "substantially equal" standard as applied in the rule may not be proper where drug regimens need to be strictly regulated. For example, the federal equivalency standard may be as much as 80% but not more than 120% effective as the named drug; 14) another comment suggested that if therapeutic considerations cost are substantially the same under Subsections R414-60B-7(1) and (2), then all drugs should be authorized; 15) another comment stated that Subsection R414-60B-7(3) is confusing and contradictory to Subsections R414-60B-7(1) and (2) and should be removed; and 16) another comment suggested the committee consider the cost and clinical and therapeutic impact of requiring a patient to change to a preferred drug.

Reasoned justification for continuation of the rule, including reasons why the agency disagrees with comments in opposition to the rule, if any:

This rule is necessary because it implements the composition and membership requirements of the P&T Committee to provide medically necessary and cost effective services for Medicaid recipients. This rule should also be continued because it spells out the functions of committee members to carry out their responsibilities for the Medicaid drug program. The Department response to the written comments it received is as follows: 1) the Department will seek additional guidance from the Legislature concerning psychotropic and anti-psychotic drugs before they come before the P&T Committee for consideration; and the burden of the requirement to document medical necessity is on the prescribing physician; 2) the Department does not expect the pharmacy to verify the physician's documentation. Enforcement of this provision will likely be undertaken by audits of prescribers who appear to have a pattern of excessively overriding the prescription drug list; the intent of Subsections R414-60B-4(1) and R414-60B-5(2) and (6) is clear; 3) the Department will consider adding directive language in the future and the rule should not be delayed to add this clarification; 4) conflict of interest provisions are intended to prevent persons from sitting on the committee who, by being a member of the committee, gain opportunity to influence the outcome of a decision by which they, their fellow associates, or their employers may personally profit. It is not intended to prohibit "intellectual bias" such as may occur by seating on the committee, either from within the Division or from within a specialty, a subject matter expert having no income interest in the outcome of the decision;. 5) the rule requires that the committee elect a chairperson. It neither requires nor prohibits the election of a vice-chairperson. The committee will likely elect a vice-chair as the need becomes apparent. The rule does not need to require a vice-chair. The rule dictates the makeup of the committee;. 6) if the pediatrician member resigns, only a pediatrician can possibly be appointed; 7) the simple majority decision is a fact on all committees whose members are selected on the basis of the interests they represent. The Department will study the suggestion that at least five members of the committee agree to a proposed action before making a decision. The committee is an advisory body; 8) the chairman organizes the committee and conducts the meetings utilizing the help of the committee manager. A vice chair will likely be elected by the committee; 9) the intent of the rule is to include the Utah Open and Public Meetings Act as well as other laws that apply, whether federal or state. It does not remove any requirement to comply with the Utah Open and Public Meetings Act. The Department and the committee have taken great efforts to inform all interested parties well in advance of the meetings. The committee had published a schedule detailing when it expects to deal with each class of drugs. This schedule is sufficient to allow interested parties to effectively participate in the process; 10) the committee will likely select a vice-chairperson to sit in the stead of the chair when the chair is absent instead of a committee manager; 11) the instances when any public body may go into executive session are established in the Utah Open and Public Meetings Act, which will be followed by the committee; 12) the Department does not view Subsection R414-60B-6(8)(a) through(d) as redundant. It is a statement of the activities that the Department has directed the committee may undertake in providing advice to the Department; 13) the comment on the "substantially equal" standard confuses the federal FDA New Drug Application (NDA) standard for approving generic drugs with the standard established in this rule. The standard established in this rule is not the federal NDA standard. The 80 to 120% NDA standard applies to drug content for a specific generic drug. This rule looks to clinical and therapeutic considerations among a class of drugs, not drug content for a specific generic drug; 14) it is correct that if all drugs in a class were substantially the same in cost and clinical and therapeutic consideration, they would all be equally available on the preferred drug list or would simply not be restricted; 15) Subsection R414-60B-7(3) guides the committee on how to select among drugs within a class where the clinic and therapeutic considerations are not equal such that medical necessity may justify a more costly drug. Eliminating this subsection would deprive patients from receiving medically necessary drugs because they are more expensive; and 16) before requiring a patient to change to a preferred drug, the Department uses a grandfathering tool that considers both the drug and the disease state as reason dictates. Additionally, the physician has the ability to override the preferred drug if there is medical necessity.

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]

Authorized by:

David Patton, Executive Director

Effective:

07/30/2012

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