Bill Text: OR SB777 | 2013 | Regular Session | Engrossed

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Bill Title: Relating to drug reviews by the Oregon Health Authority; declaring an emergency.

Spectrum: Committee Bill

Status: (Failed) 2013-07-08 - In committee upon adjournment. [SB777 Detail]

Download: Oregon-2013-SB777-Engrossed.html

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     77th OREGON LEGISLATIVE ASSEMBLY--2013 Regular Session

NOTE:  Matter within  { +  braces and plus signs + } in an
amended section is new. Matter within  { -  braces and minus
signs - } is existing law to be omitted. New sections are within
 { +  braces and plus signs + } .

LC 3071

                           A-Engrossed

                         Senate Bill 777
                 Ordered by the Senate April 19
           Including Senate Amendments dated April 19

Sponsored by COMMITTEE ON HEALTH CARE AND HUMAN SERVICES

                             SUMMARY

The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure.

  Modifies meeting requirements for Pharmacy and Therapeutics
Committee of Oregon Health Authority.
  Declares emergency, effective on passage.

                        A BILL FOR AN ACT
Relating to drug reviews by the Oregon Health Authority; amending
  ORS 414.354, 414.356 and 414.361; and declaring an emergency.
Be It Enacted by the People of the State of Oregon:
  SECTION 1. ORS 414.354 is amended to read:
  414.354. (1) Except as provided in ORS 414.356, the Pharmacy
and Therapeutics Committee shall operate in accordance with ORS
chapter 192. The committee shall annually elect a chairperson
from the members of the committee.
  (2) A committee member is not entitled to compensation but is
entitled to reimbursement for actual and necessary travel
expenses incurred in connection with the member's duties,
pursuant to ORS 292.495.
  (3) A quorum consists of six members of the committee.
  (4) The committee may establish advisory committees to assist
in carrying out the committee's duties under ORS 414.351 to
414.414, with the approval of the Director of the Oregon Health
Authority.
  (5) The Oregon Health Authority shall provide staff and support
services to the committee.
  (6) The committee shall meet no less than four times each year
at a place, day and hour determined by the director. The
committee also shall meet at other times and places specified by
the call of the director or a majority of the members of the
committee. No less than 30 days prior to a meeting the committee
shall post to the authority website:
  (a) The agenda for the meeting;
  (b) A list of the drug classes to be considered at the meeting;
 { - and - }
   { +  (c) The name of any drug to be discussed by the committee
for the purpose of recommending the drug's inclusion on or
exclusion from the Practitioner-Managed Prescription Drug Plan
adopted by the Oregon Health Authority under ORS 414.334; and + }

    { - (c) - }  { +  (d)  + }Background materials and supporting
documentation provided to committee members with respect to drugs
and drug classes that are before the committee for review { +
and any other documents to be considered by the committee, except
for confidential documents that will be considered exclusively in
an executive session under ORS 414.356 + }.
  (7)  { + The agenda for each meeting of the committee must be
divided into two separate sessions, with one session for drug use
review and the other session for the consideration of whether to
recommend a drug for inclusion on or exclusion from the
Practitioner-Managed Prescription Drug Plan. + } The committee
shall provide appropriate opportunity for public testimony
 { - at each regularly scheduled committee meeting - }  { +  in
each session + }.  Immediately prior to deliberating on any
 { - recommendations - }  { +  committee action + } regarding a
drug or a class of drugs, the committee shall accept testimony,
in writing or in person, that is offered by a manufacturer of
those drugs or another interested party.
  (8) The committee may consider more than 20 classes of drugs at
a meeting only if:
  (a) There is no new clinical evidence for the additional class
of drugs; and
  (b) The committee is considering only substantial cost
differences between drugs within the same therapeutic class.
   { +  (9) If the committee will be discussing an agenda item
during an executive session, the agenda must specify the basis
under ORS 414.356 (1) for meeting in executive session. + }
  SECTION 2. ORS 414.356 is amended to read:
  414.356. (1) Notwithstanding ORS 192.610 to 192.690, the
Pharmacy and Therapeutics Committee shall meet in an executive
session for purposes of:
  (a) Reviewing the prescribing or dispensing practices of
individual physicians or pharmacists;
  (b) Discussing drug use review data pertaining to individual
physicians or pharmacists;
  (c) Reviewing profiles of individual patients; or
  (d)  { + Subject to subsection (3) of this section, + }
reviewing confidential drug pricing information, including
substantial cost differences between drugs within the same
therapeutic class, that is necessary for the committee to make
final recommendations under ORS 414.361 or to comply with ORS
414.414.
  (2) A meeting held in executive session is subject to the
requirements of ORS 192.650 (2).
   { +  (3) The committee may meet in executive session for
purposes of subsection (1)(d) of this section only after the
committee, by a majority vote, finds that the uses, safety and
efficacy of the drugs under consideration within the same
therapeutic class are comparable enough that a substantial
difference in the net cost, after deducting rebates and other
applicable cost reductions, would be the determining factor in
the committee's recommendation to include a drug on the
Practitioner-Managed Prescription Drug Plan. + }
  SECTION 3. ORS 414.361 is amended to read:
  414.361. (1) The Pharmacy and Therapeutics Committee shall
advise the Oregon Health Authority on:
  (a) Adoption of rules to implement ORS 414.351 to 414.414 in
accordance with ORS chapter 183.
  (b) Implementation of the medical assistance program
retrospective and prospective programs as described in ORS
414.351 to 414.414, including the type of software programs to be
used by the pharmacist for prospective drug use review and the
provisions of the contractual agreement between the state and any
entity involved in the retrospective program.
  (c) Development of and application of the criteria and
standards to be used in retrospective and prospective drug use
review in a manner that ensures that such criteria and standards
are based on compendia, relevant guidelines obtained from
professional groups through consensus-driven processes, the
experience of practitioners with expertise in drug therapy, data
and experience obtained from drug utilization review program
operations. The committee shall have an open professional
consensus process for establishing and revising criteria and
standards. Criteria and standards shall be available to the
public. In developing recommendations for criteria and standards,
the committee shall establish an explicit ongoing process for
soliciting and considering input from interested parties. The
committee shall make timely revisions to the criteria and
standards based upon this input in addition to revisions based
upon scheduled review of the criteria and standards. Further, the
drug utilization review standards shall reflect the local
practices of prescribers in order to monitor:
  (A) Therapeutic appropriateness.
  (B) Overutilization or underutilization.
  (C) Therapeutic duplication.
  (D) Drug-disease contraindications.
  (E) Drug-drug interactions.
  (F) Incorrect drug dosage or drug treatment duration.
  (G) Clinical abuse or misuse.
  (H) Drug allergies.
  (d) Development, selection and application of and assessment
for interventions that are educational and not punitive in nature
for medical assistance program prescribers, dispensers and
patients.
  (2) In reviewing retrospective and prospective drug use, the
committee may consider only drugs that have received final
approval from the federal Food and Drug Administration.
  (3) The committee shall make recommendations to the authority,
subject to approval by the Director of the Oregon Health
Authority or the director's designee, for drugs to be included on
any preferred drug list adopted by the authority and on the
Practitioner-Managed Prescription Drug Plan. The committee shall
also recommend all utilization controls, prior authorization
requirements or other conditions for the inclusion of a drug on a
preferred drug list.
  (4) In making recommendations under subsection (3) of this
section, the committee may use any information the committee
deems appropriate. The recommendations must be based upon
 { + and include committee findings on + } the following factors
in order of priority:
   { +  (a) The use or uses for the drug that have been approved
by the federal Food and Drug Administration. + }
    { - (a) - }  { +  (b) The + } safety and efficacy of the
drug.
    { - (b) - }  { +  (c) + } The  { + impact of prior
authorization requirements or other restrictions on access to
drugs on the + } ability of Oregonians to   { - access - }  { +
obtain + } effective prescription drugs that are appropriate for
their clinical conditions.
    { - (c) - }  { +  (d) + } Substantial differences in the
 { + net + } costs of drugs within the same therapeutic
class { + , after deducting all rebates and other applicable cost
reductions that reduce the net cost to the authority + }.
  (5) The committee shall post a recommendation to the website of
the authority no later than 30 days after the date the committee
approves the recommendation. The director shall approve,
disapprove or modify any recommendation of the committee as soon
as practicable, shall publish the decision on the website and
shall notify persons who have requested notification of the
decision. A recommendation adopted by the director, in whole or
in part, with respect to the inclusion of a drug on a preferred
drug list or the Practitioner-Managed Prescription Drug Plan may
not become effective less than 60 days after the date that the
director's decision is published.
  (6) The director shall reconsider any decision to adopt or
modify a recommendation of the committee with respect to the
inclusion of a particular drug on a preferred drug list or the
Practitioner-Managed Prescription Drug Plan, upon the request of
any interested person filed no later than 30 days after the
director's decision is published on the website. The decision on
reconsideration shall be sent to the requester and posted to the
website without undue delay.
  SECTION 4.  { + This 2013 Act being necessary for the immediate
preservation of the public peace, health and safety, an emergency
is declared to exist, and this 2013 Act takes effect on its
passage. + }
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