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Oregon Bulletin

April 1, 2011

 

Oregon Health Authority,
Division of Medical Assistance Programs
Chapter 410

Rule Caption: Updates and changes to the Preferred Drug List (PDL).

Adm. Order No.: DMAP 2-2011(Temp)

Filed with Sec. of State: 3-1-2011

Certified to be Effective: 3-1-11 thru 8-20-11

Notice Publication Date:

Rules Amended: 410-121-0030

Subject: The Pharmaceutical Services Program administrative rules govern Division of Medical Assistance Programs’ (Division) payments for services provided to certain clients. The Division will amend 410-121-0030 to remove ineligible products from the PDL (Table 121-0030-1). The failure of certain manufacturers to execute Supplemental Rebate Agreements with the State resulted in the Net Price of their drug products being above the ANP for their drug class. Consequently, the Division must immediately amend OAR 410-121-0030 to remove those drugs from the PDL that are no longer eligible for placement on the PDL under the Division’s rules.

Rules Coordinator: Darlene Nelson—(503) 945-6927

410-121-0030

Practitioner-Managed Prescription Drug Plan (PMPDP)

(1) The Practitioner-Managed Prescription Drug Plan (PMPDP) is a plan that ensures that fee for service clients of the Oregon Health Plan shall have access to the most effective prescription drugs appropriate for their clinical conditions at the best possible price:

(a) Licensed health care practitioners (informed by the latest peer reviewed research), make decisions concerning the clinical effectiveness of the prescription drugs;

(b) The licensed health care practitioners also consider the health condition of a client or characteristics of a client, including the client’s gender, race or ethnicity.

(2) PMPDP Preferred Drug List (PDL):

(a) The PDL is the primary tool that the Department has developed to inform licensed health care practitioners about the results of the latest peer-reviewed research and cost effectiveness of prescription drugs;

(b) The PDL consists of prescription drugs in selected classes that the Department, in consultation with the Health Resources Commission (HRC), has determined represent the most effective drug(s) available at the best possible price;

(c) For each selected drug class, the PDL shall identify the drug(s) in the class that the Department determines to be the most effective drug(s) and determine the Net Price for each drug and Average Net Price of the class;

(d) The PDL shall include drugs in the class that are Medicaid reimbursable and the Food and Drug Administration (FDA) has determined to be safe and effective if the relative cost is less than the Average Net Price. If pharmaceutical manufacturers enter into supplemental rebate agreements with the Department that reduce the cost of their drug below that of the Average Net Price for the class, the Department, in consultation with the HRC recommendations, may include their drug on the PDL;

(e) A copy of the current PDL is available on the web at: www.dhs.state.or.us/policy/healthplan/guides/pharmacy/rulebooks/CRB121rb101810p.pdfin table 121.0030-1

(3) PMPDP PDL Selection Process:

(a) The Department shall utilize the recommendations made by the HRC, that result from an evidence-based evaluation process, as the basis for identifying the most effective drug(s) within a selected drug class;

(b) The Department shall determine the drugs identified in (3)(a) that are available for the best possible price and shall consider any input from the HRC about other FDA-approved drug(s) in the same class that are available for a lesser relative price. The Department will determine relative price using the methodology described in subsection (4);

(c) The Department shall evaluate drug classes and selected drugs for the drug classes periodically:

(A) Evaluation shall occur more frequently at the discretion of the Department if new safety information or the release of new drugs in a class or other information makes an evaluation advisable;

(B) New drugs in classes already evaluated for the PDL shall be non-preferred until the new drug has been reviewed by the HRC;

(C) The Department shall make all changes or revisions to the PDL, using the rulemaking process and shall publish the changes on the Department’s Pharmaceutical Services provider rules Web page.

(4) Relative cost and best possible price determination:

(a) The Department shall determine the relative cost of all drugs in each selected class that are Medicaid reimbursable and that the FDA has determined to be safe and effective;

(b) The Department may also consider dosing issues, patterns of use and compliance issues. The Department shall weigh these factors with any advice provided by the HRC in reaching a final decision;

(c) The Department shall determine the Average Net Price for each PDL drug class;

(d) The Department shall include drugs on the PDL based on all of the above and with a Net Price under the Average Net Price.

(5) Regardless of the PDL, pharmacy providers shall dispense prescriptions in the generic form, unless the practitioner requests otherwise, subject to the regulations outlined in OAR 410-121-0155.

(6) The exception process for obtaining non-preferred physical health drugs that are not on the PDL drugs shall be as follows:

(a) If the prescribing practitioner, in their professional judgment, wishes to prescribe a physical health drug not on the PDL, they may request an exception, subject to the requirements of OAR 410-121-0040;

(b) The prescribing practitioner must request an exception for physical health drugs not listed in the PDL subject to the requirements of OAR 410-121-0060;

(c) Exceptions shall be granted in instances:

(A) Where the prescriber in their professional judgment determines the non-preferred drug is medically appropriate after consulting with the Division or the Oregon Pharmacy Help Desk; or

(B) Where the prescriber requests an exception subject to the requirement of (6)(b) and fails to receive a report of PA status within 24 hours, subject to OAR 410-121-0060.

(7) Table 121-0030-1, PMPDP PDL (Revised, effective 3/1/11).

[ED. NOTE: Tables referenced are available from the agency.]

Stat. Auth.: ORS 409.010, 409.025, 409.040, 409.050, 409.110, 414.065, 414.325

Stats. Implemented: ORS 414.065

Hist.: OMAP 25-2002, f. 6-14-02 cert. ef. 7-1-02; OMAP 31-2002, f. & cert. ef. 8-1-02; OMAP 36-2002, f. 8-30-02, cert. ef. 9-1-02; OMAP 29-2003, f. 3-31-03 cert. ef. 4-1-03; OMAP 35-2003, f. & cert. ef. 5-1-03; OMAP 47-2003, f. & cert. ef. 7-1-03; OMAP 57-2003, f. 9-5-03, cert. ef. 10-1-03; OMAP 70-2003(Temp), f. 9-15-03, cert. ef. 10-1-03 thru 3-15-04; OMAP 82-2003, f. 10-31-03, cert. ef. 11-1-03; OMAP 9-2004, f. 2-27-04, cert. ef. 3-1-04; OMAP 29-2004, f. 4-23-04 cert. ef. 5-1-04; OMAP 34-2004, f. 5-26-04 cert. ef. 6-1-04; OMAP 45-2004, f. 7-22-04 cert. ef. 8-1-04; OMAP 81-2004, f. 10-29-04 cert. ef. 11-1-04; OMAP 89-2004, f. 11-24-04 cert. ef. 12-1-04; OMAP 19-2005, f. 3-21-05, cert. ef. 4-1-05; OMAP 32-2005, f. 6-21-05, cert. ef. 7-1-05; OMAP 58-2005, f. 10-27-05, cert. ef. 11-1-05; OMAP 16-2006, f. 6-12-06, cert. ef. 7-1-06; OMAP 32-2006, f. 8-31-06, cert. ef. 9-1-06; OMAP 48-2006, f. 12-28-06, cert. ef. 1-1-07; DMAP 4-2007, f. 6-14-07, cert. ef. 7-1-07; DMAP 16-2008, f. 6-13-08, cert. ef. 7-1-08; DMAP 36-2008, f. 12-11-08, cert. ef. 1-1-09; DMAP 39-2009, f. 12-15-09, cert. ef. 1-1-10; DMAP 17-2010, f. 6-15-10, cert. ef. 7-1-10; DMAP 40-2010, f. 12-28-10, cert. ef. 1-1-10; DMAP 2-2011(Temp), f. & cert. ef. 3-1-11 thru 8-20-11

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.

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