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Oar rulebook - pharmacuetical services

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. (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.pdf (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. [ED. NOTE: Tables referenced are not included in rule text. Click here for PDF copy of table(s).] Stat. Auth.: ORS 409.010, 409.025, 409.040, 409.050, 409.110, 414.065, 414.325 Stats. Implemented: ORS 414.065 Table 121-0030-1 Oregon FFS Enforcable Physical Health
Preferred Drug List - effective 1/1/11
Preferred
HYDROCODONE-ACETAMINOPHEN TABLETHYDROMORPHONE HCL CARISOPRODOLBACLOFENCARISOPRODOL COMPOUNDCYCLOBENZAPRINE HCL METHOCARBAMOLORPHENADRINE CITRATEORPHENADRINE COMPOUND FORTETIZANIDINE HCL Preferred
AMOX TR-POTASSIUM CLAVULANATSUSP RECONCEPHALEXIN ERYTHROMYCIN ETHYLSUCCINATE TABLETDOXYCYCLINE HYCLATE Preferred
AVAPROBENAZEPRILBENICARCAPTOPRILDIOVANENALAPRILFOSINOPRIL LISINOPRILLOSARTANMICARDISMOEXIPRILQUINAPRILRAMIPRILTRANDOLAPRIL Preferred
AVALIDEBENAZEPRIL-HYDROCHLOROTHIAZIDEBENICAR HCTCAPTOPRIL/HYDROCHLOROTHIAZIDEDIOVAN HCTENALAPRIL-HYDROCHLOROTHIAZIDE FOSINOPRIL-HYDROCHLOROTHIAZIDELISINOPRIL-HYDROCHLOROTHIAZIDELOSARTAN-HYDROCHLOROTHIAZIDEMICARDIS HCTMOEXIPRIL-HYDROCHLOROTHIAZIDEQUINAPRIL-HYDROCHLOROTHIAZIDELIPITOR PIPERONYL BUTOXIDE/PYRETHRINSGEL (GM)PIPERONYL BUTOXIDE/PYRETHRINSKITPIPERONYL BUTOXIDE/PYRETHRINSLIQUIDPIPERONYL BUTOXIDE/PYRETHRINSSHAMPOOBACITRACIN Preferred
ALCLOMETASONE DIPROPIONATE CREAM(GM)ALCLOMETASONE DIPROPIONATE OINT.(GM)BETAMETHASONE DIPROPIONATE CREAM(GM)BETAMETHASONE DIPROPIONATE LOTIONBETAMETHASONE DIPROPIONATE OINT.(GM)BETAMETHASONE VALERATE Preferred
Preferred
Preferred
NEOMYCIN-POLYMYXIN-DEXAMETHDROPS SUSPTOBRADEX Preferred
NEOMYCIN-POLYMYXIN-GRAMICIDINDROPSOFLOXACIN DEXAMETHASONE SODIUM PHOSPHDROPSDICLOFENAC SODIUM BRIMONIDINE TARTRATE (0.15, 0.2%DROPSCOMBIGAN Preferred
Table 121-0030-1 Oregon Fee-for-Service Voluntary Mental Health
Preferred Drug List - effective 1/1/11
Preferred
410-121-0032 Supplemental Rebate Agreements
(1) The Division of Medical Assistance Programs (Division) has a
CMS approved Supplemental Rebate Agreement. This template and instructions are available on the Department website at; http://www.oregon.gov/DHS/healthplan/supp-rebate/main.shtml (2) The Division negotiates Supplemental Rebate Agreements for specific drug products through the Sovereign States Drug Consortium (SSDC) multi-state pool and pharmaceutical manufacturers. Negotiations are confidential, and shall not be disclosed, except in connection with an agreement/contract or as may be required by law. Confidentiality is required of any third party involved in administration (3) Manufacturers may submit supplemental rebate offers for consideration to include their drug(s) on the Practitioner’s-Managed Prescription Drug Plan (PMPDP) Preferred Drug List (PDL), OAR 410-121-0030 after gaining access to the SSDC secure web-based (4) Manufacturers must abide by requirements of the SSDC. (5) The Practitioner-Managed Prescription Drug List (PMPDP) also called the Preferred Drug List (PDL) consist of drugs after the Food and Drug Administration (FDA) has determined to be safe and effective and reimbursable as determined by the Centers for Medicaid and Medicare Services (CMS), and evaluated using an evidence- based review process by the Oregon Health Resources Commission (HRC). If pharmaceutical manufacturers enter into supplemental rebate agreements with the SSDC that reduced the cost of a drug below the Average Net Price (ANP) for the PDL class, the Department may include that drug on the PDL. (a) The Division may accept an offer through the SSDC process as long as the offer meets the cost reduction requirements of ANP (b) The SSDC will notify manufacturers of the status of their offer(s). (c) Supplemental Agreements will be executed after signed by all parties, approved by CMS if required, and added to the PMPDP Preferred Drug List by the Administrative rule process. (d) The Division may contract for the functions of tracking utilization, invoicing, and dispute resolution for supplemental rebate products. Stat. Auth.: ORS 409.010, 409.025, 409.040, 409.050, 409.110 &

Source: http://www.artiasolutions.com/Portals/34/Oregon%20supp-rebate-rules%202011.pdf

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Journal of Biopharmaceutical Statistics , 18: 468–482, 2008Copyright © Taylor & Francis Group, LLCISSN: 1054-3406 print/1520-5711 onlineDOI: 10.1080/10543400801993002SAMPLE SIZE CALCULATIONS IN THOROUGHQT STUDIES Lu Zhang1, Alex Dmitrienko1, and George Luta2 1 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, USA 2 Georgetown University, Washington, DC, USA An ana

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