Oregon Health Authority, Division of Medical Assistance Programs, Chapter 410
Rule Caption: Amending Preferred Drug List and Prior Authorization Guide — May 31, 2012 DUR/P&T Action.
Adm. Order No.: DMAP 40-2012(Temp)
Filed with Sec. of State: 8-20-2012
Certified to be Effective: 8-20-12 thru 1-18-13
Notice Publication Date:
Rules Amended: 410-121-0030, 410-121-0040
Rules Suspended: 410-121-0030(T), 410-121-0040(T)
Subject: 410-121-0030: Remove Aerobid and Pulmicort from the Pulmonary Asthma Controllers class.
Add clobazam to the Neurologic Oral Anticonvulsant class.
Add Other Lipid Lowering Agents drug class, making cholestyramine, gemfibrozil tabs, fenofibrate tabs, fenofibric acid tabs, Niaspan and Niacor preferred.
410-121-0040: Asthma Controller — update criteria.
Clobazam — new criteria.
LABA/ICS Inhalers — update criteria.
Leukotriene Inhibitors — update criteria.
Synagis — new criteria.
Rules Coordinator: Cheryl Peters—(503) 945-6527
Practitioner-Managed Prescription Drug Plan
(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 Division 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 (as defined in 410-121-0000 (cc) consists of prescription drugs that the Division, in consultation with the Drug Use Review (DUR)/Pharmacy & Therapeutics Committee (P&T), has determined represent the most effective drug(s) available at the best possible price;
(c) The PDL shall include drugs that are Medicaid reimbursable and the Food and Drug Administration (FDA) has determined to be safe and effective.
(3) PMPDP PDL Selection Process:
(a) The Division shall utilize the recommendations made by the P&T, that result from an evidence-based evaluation process, as the basis for selecting the most effective drug(s);
(b) The Division shall determine the drugs selected in (3)(a) that are available for the best possible price and shall consider any input from the P&T about other FDA-approved drug(s) in the same class that are available for a lesser relative price. The Division shall determine relative price using the methodology described in subsection (4);
(c) The Division shall evaluate selected drug(s) for the drug classes periodically:
(A) Evaluation shall occur more frequently at the discretion of the Division if new safety information or the release of new drugs in a class or other information which 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 P&T;
(C) The Division shall make all changes or revisions to the PDL, using the rulemaking process and shall publish the changes on the Division’s Pharmaceutical Services provider rules Web page.
(4) Relative cost and best possible price determination:
(a) The Division 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 Division may also consider dosing issues, patterns of use and compliance issues. The Division shall weigh these factors with any advice provided by the P&T in reaching a final decision;
(5) Pharmacy providers shall dispense prescriptions in the generic form, unless:
(a) The practitioner requests otherwise, subject to the regulations outlined in OAR 410-121-0155;
(b) The brand name medication is listed as preferred on the PDL.
(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
[ED. NOTE: Tables referenced are available from the agency.]
Stat. Auth.: ORS
409.025, 409.040, 409.110, 414.065, 413.042 & 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. 1-1-11; DMAP 2-2011(Temp), f. & cert. ef. 3-1-11 thru 8-20-11; DMAP 19-2011, f. 7-15-11, cert. ef. 7-17-11; DMAP 44-2011, f. 12-21-11, cert. ef. 1-1-12; DMAP 12-2012(Temp), f. & cert. ef. 3-16-12 thru 9-11-12; DMAP 18-2012, f. 3-30-12, cert. ef. 4-9-12; DMAP 26-2012, f. & cert. ef. 5-14-12; DMAP 29-2012, f. & cert. ef. 6-21-12; DMAP 33-2012(Temp), f. 7-18-12, cert. ef. 7-23-12 thru 1-18-13; DMAP 40-2012(Temp), f. & cert.ef. 8-20-12 thru 1-18-13
Prior Authorization Required for Drugs and Products
(1) Prescribing practitioners are responsible for obtaining prior authorization (PA) for the drugs and categories of drugs requiring PA in this rule, using the procedures required in OAR 410-121-0060.
(2) All drugs and categories of drugs, including but not limited to those drugs and categories of drugs that require PA as described in this rule, are subject to the following requirements for coverage:
(a) Each drug must be prescribed for conditions funded by Oregon Health Plan (OHP) in a manner consistent with the Oregon Health Services Commission’s Prioritized List of Health Services (OAR 410-141-0480 through 410-141-0520). If the medication is for a non-covered diagnosis, the medication shall not be covered unless there is a co-morbid condition for which coverage would be extended. The use of the medication must meet corresponding treatment guidelines, be included within the client’s benefit package of covered services, and not otherwise excluded or limited;
(b) Each drug must also meet other criteria applicable to the drug or category of drug in these pharmacy provider rules, including PA requirements imposed in this rule.
(3) The Oregon Health Authority (Authority) may require PA for individual drugs and categories of drugs to ensure that the drugs prescribed are indicated for conditions funded by OHP and consistent with the Prioritized List of Health Services and its corresponding treatment guidelines (see OAR 410-141-0480). The drugs and categories of drugs that the Authority requires PA for this purpose are found in the OHP Fee-For-Service Pharmacy PA Criteria Guide (PA Criteria Guide) dated August 20, 2012, incorporated in rule by reference and found on our Web page at: http://www.dhs.state.or.us/policy/healthplan/guides/pharmacy/clinical.html
(4) The Authority may require PA for individual drugs and categories of drugs to ensure medically appropriate use or to address potential client safety risk associated with the particular drug or category of drug, as recommended by the Pharmacy & Therapeutics Committee (P&T) and adopted by the Authority in this rule (see OAR 410-121-0100 for a description of the DUR program). The drugs and categories of drugs for which the Authority requires PA for this purpose are found in the Pharmacy PA Criteria Guide.
(5) New drugs shall be evaluated when added to the weekly upload of the First DataBank drug file:
(a) If the new drug is in a class where current PA criteria apply, all associated PA criteria shall be required at the time of the drug file load;
(b) If the new drug is indicated for a condition below the funding line on the Prioritized List of Health Services, PA shall be required to ensure that the drug is prescribed for a condition funded by OHP;
(c) PA criteria for all new drugs shall be reviewed by the DUR/P&T Committee.
(6) PA is required for brand name drugs that have two or more generically equivalent products available and that are NOT determined Narrow Therapeutic Index drugs by the Oregon DUR/P&T Committee:
(a) Immunosuppressant drugs used in connection with an organ transplant must be evaluated for narrow therapeutic index within 180 days after United States patent expiration;
(b) Manufacturers of immunosuppressant drugs used in connection with an organ transplant must notify the department of patent expiration within 30 days of patent expiration for (5)(a) to apply;
(c) Criteria for approval are:
(A) If criteria established in subsection (3) or (4) of this rule applies, follow that criteria;
(B) If (6)(A) does not apply, the prescribing practitioner must document that the use of the generically equivalent drug is medically contraindicated, and provide evidence that either the drug has been used and has failed or that its use is contraindicated based on evidence-based peer reviewed literature that is appropriate to the client’s medical condition.
(7) PA is required for non-preferred Preferred Drug List (PDL) products in a class evaluated for the PDL except in the following cases:
(a) The drug is a mental health drug as defined in OAR 410-121-0000;
(b) The original prescription is written prior to 1/1/10;
(c) The prescription is a refill for the treatment of seizures, cancer, HIV or AIDS; or
(d) The prescription is a refill of an immunosuppressant.
(8) PA may not be required:
(a) When the prescription ingredient cost plus the dispensing fee is less than the PA processing fees as determined by the Authority;
(b) For over-the-counter (OTC) covered drugs when prescribed for conditions covered under OHP or;
(c) If a drug is in a class not evaluated from the Practitioner-Managed Prescription Drug Plan under ORS 414.334.
Stat. Auth.: ORS
409.110, 413.042, 414.065 & 414.334
Stats. Implemented: ORS 414.065
Hist.: AFS 56-1989, f. 9-28-89, cert. ef. 10-1-89; AFS 2-1990, f. & cert. ef. 1-16-90; HR 29-1990, f. 8-31-90, cert. ef. 9-1-90, Renumbered from 461-016-0170; HR 10-1991, f. & cert. ef. 2-19-91; HR 14-1993, f. & cert. ef. 7-2-93; HR 25-1994, f. & cert. ef. 7-1-94; HR 6-1995, f. 3-31-95, cert. ef. 4-1-95; HR 18-1996(Temp), f. & cert. ef. 10-1-96; HR 8-1997, f. 3-13-97, cert. ef. 3-15-97; OMAP 1-1999, f. & cert. ef. 2-1-99; OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00; OMAP 31-2001, f. 9-24-01, cert. ef. 10-1-01; OMAP 44-2002, f. & cert. ef. 10-1-02; OMAP 66-2002, f. 10-31-02, cert. ef. 11-1-02; OMAP 29-2003, f. 3-31-03 cert. ef. 4-1-03; OMAP 40-2003, f. 5-27-03, cert. ef. 6-1-03; OMAP 43-2003(Temp), f. 6-10-03, cert. ef. 7-1-03 thru 12-15-03; OMAP 49-2003, f. 7-31-03 cert. ef. 8-1-03; OMAP 84-2003, f. 11-25-03 cert. ef. 12-1-03; OMAP 87-2003(Temp), f. & cert. ef. 12-15-03 thru 5-15-04; OMAP 9-2004, f. 2-27-04, cert. ef. 3-1-04; OMAP 71-2004, f. 9-15-04, cert. ef. 10-1-04; OMAP 74-2004, f. 9-23-04, cert. ef. 10-1-04; OMAP 89-2004, f. 11-24-04 cert. ef. 12-1-04; OMAP 4-2006(Temp), f. & cert. ef. 3-15-06 thru 9-7-06; OMAP 32-2006, f. 8-31-06, cert. ef. 9-1-06; OMAP 41-2006, f. 12-15-06, cert. ef. 1-1-07; DMAP 4-2007, f. 6-14-07, cert. ef. 7-1-07; DMAP 26-2007, f. 12-11-07, cert. ef. 1-1-08; DMAP 9-2008, f. 3-31-08, cert. ef. 4-1-08; DMAP 16-2008, f. 6-13-08, cert. ef. 7-1-08; DMAP 34-2008, f. 11-26-08, cert. ef. 12-1-08; DMAP 14-2009 f. 6-12-09, cert. ef. 7-1-09; 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. 1-1-11; DMAP 27-2011(Temp), f. & cert. ef. 9-30-11 thru 3-15-12; DMAP 44-2011, f. 12-21-11, cert. ef. 1-1-12; DMAP 12-2012(Temp), f. & cert. ef. 3-16-12 thru 9-11-12; DMAP 18-2012, f. 3-30-12, cert. ef. 4-9-12; DMAP 23-2012(Temp), f. & cert. ef. 4-20-12 thru 10-15-12; DMAP 27-2012(Temp), f. & cert. ef. 5-14-12 thru 10-15-12; DMAP 29-2012, f. & cert. ef. 6-21-12; DMAP 33-2012(Temp), f. 7-18-12, cert. ef. 7-23-12 thru 1-18-13; DMAP 40-2012(Temp), f. & cert.ef. 8-20-12 thru 1-18-13
Rule Caption: 2% rate reduction for OB, Anesthesia and non primary care services.
Adm. Order No.: DMAP 41-2012(Temp)
Filed with Sec. of State: 8-22-2012
Certified to be Effective: 9-1-12 thru 2-28-13
Notice Publication Date:
Rules Amended: 410-120-1340
Subject: The Division of Medical Assistance Programs’ General Rules, administrative rules govern payments for services provided to certain eligible clients. The Division temporarily amended OAR 410-120-1340 to implement rate changes to specified fee-for-service providers to comply with budget limitations. Implementation of these amendments is subject to approval by the Centers for Medicare and Medicaid Services (CMS). The Division amended 410-120-1340- Relative Value Units (RVU) for OB, non primary care services and anesthesia conversion factor.
Rules Coordinator: Cheryl Peters—(503) 945-6527
(1) The Division of Medical Assistance Programs (Division) shall make payment only to the enrolled provider (see OAR 410-120-1260) who actually performs the service or to the provider’s enrolled billing provider for covered services rendered to eligible clients. Any contracted billing agent or billing service submitting claims on behalf of a provider but not receiving payment in the name of or on behalf of the provider does not meet the requirements for billing provider enrollment. If billing agents and billing services intend to submit electronic transactions they must register and comply with the Oregon Health Authority (Authority) Electronic Data Interchange (EDI) rules, OAR 407-120-0100 through 407-120-0200. Division reimbursement for services may be subject to review prior to reimbursement.
(2) The Division (Division of Medical Assistance Programs or another Division within the Authority) that is administering the program under which the billed services or items are provided sets fee-for-service (FFS) payment rates.
(3) The Division uses FFS payment rates in effect on the date of service that are the lesser of:
(a) The amount billed;
(b) The Division maximum allowable amount or;
(c) Reimbursement specified in the individual program provider rules:
(4) Amount billed may not exceed the provider’s “usual charge” (see definitions);
(5) The Division’s maximum allowable rate setting process uses the following methodology. The rates are updated periodically and posted on the Authority web site at http://www.oregon.gov/OHA/healthplan/data_pubs/feeschedule/main.shtml:
(a) Relative Value Unit (RVU) weight-based rates: For all CPT/HCPCS codes assigned an RVU weight, the Division shall use the 2010 Transitional Total RVU weights published in the Federal Register, Vol. 74, November 25, 2009 with technical corrections published Dec. 10, 2009, to be effective for dates of services on or after January 1, 2011.
(A) For professional services not typically performed in a facility, the Non-Facility Total RVU weight shall be adopted;
(B) For professional services typically performed in a facility the Transitional Facility Total RVU weight shall be adopted;
(b) The Division applies the following conversion factors:
(A) $40.79 for labor and delivery codes (59400-59622);
(B) $27.82 for primary care providers and services. A current list of primary care CPT, HCPCs and provider specialty codes is available at http://www.oregon.gov/OHA/healthplan/data_pubs/feeschedule/main.shtml
(C) $25.48 for all remaining RVU weight based CPT/HCPCS codes;
(D) $26.81 for vision codes (92340-92342 and 92352-92353) regardless of the RVU.
(6) Other non RVU based rates:
(a) Surgical assist reimburses at 20% of the surgical rate;
(b) $20.78 is the base rate for anesthesia service codes 00100-01996. The rate is based on per unit of service;
(c) Clinical lab codes are priced at 70% of the Medicare clinical lab fee schedule;
(d) All approved Ambulatory Surgical Center (ASC) procedures are reimbursed at 80% of the Medicare fee schedule;
(e) Physician administered drugs, billed under a HCPCS code, are based on Medicare’s Average Sale Price (ASP). When no ASP rate is listed the rate shall be based upon the Wholesale Acquisition Price (WAC) plus 6.25%. If no WAC is available, then the rate shall be reimbursed at Acquisition Cost. Pricing information for WAC is provided by First Data Bank. These rates may change periodically based on drug costs;
(f) All procedures used for vision materials and supplies are based on contracted rates that include acquisition cost plus shipping and handling.
(g) Individual provider rules may specify reimbursement rates for particular services or items.
(7) The Division reimburses inpatient hospital service under the DRG methodology, unless specified otherwise in the Division’s Hospital Services Program administrative rules (chapter 410, division 125). Reimbursement for services, including claims paid at DRG rates, shall not exceed any upper limits established by federal regulation.
(8) The Division reimburses all out-of-state hospital services at Oregon DRG or FFS rates as published in the Hospital Services Program rules (OAR chapter 410, division 125) unless the hospital has a contract or service agreement with the Division to provide highly specialized services.
(9) Payment rates for in-home services provided through Department of Human Services (Department) Aged and Physically Disabled Division (APD) will not be greater than the current Division rate for nursing facility payment.
(10) The Division sets payment rates for out-of-state institutions and similar facilities, such as skilled nursing care facilities, psychiatric and rehabilitative care facilities at a rate that is:
(a) Consistent with similar services provided in the State of Oregon; and
(b) The lesser of the rate paid to the most similar facility licensed in the State of Oregon or the rate paid by the Medical Assistance Programs in that state for that service; or
(c) The rate established by APD for out-of-state nursing facilities.
(11) The Division shall not make payment on claims that have been assigned, sold, or otherwise transferred or when the billing provider, billing agent or billing service receives a percentage of the amount billed or collected or payment authorized. This includes, but is not limited to, transfer to a collection agency or individual who advances money to a provider for accounts receivable.
(12) The Division shall not make a separate payment or copayment to a nursing facility or other provider for services included in the nursing facility’s all-inclusive rate. The following services are not included in the all-inclusive rate (OAR 411-070-0085) and may be separately reimbursed:
(a) Legend drugs, biologicals and hyperalimentation drugs and supplies, and enteral nutritional formula as addressed in the Pharmaceutical Services Program administrative rules (chapter 410, division 121) and Home Enteral/Parenteral Nutrition and IV Services Program administrative rules, (chapter 410, division 148);
(b) Physical therapy, speech therapy, and occupational therapy provided by a non-employee of the nursing facility within the appropriate program administrative rules, (chapter 410, division 129 and 131);
(c) Continuous oxygen which exceeds 1,000 liters per day by lease of a concentrator or concentrators as addressed in the Durable Medical Equipment, Prosthetics, Orthotics and Supplies Program administrative rules, (chapter 410, division 122);
(d) Influenza immunization serum as described in the Pharmaceutical Services Program administrative rules, (chapter 410, division 121);
(e) Podiatry services provided under the rules in the Medical-Surgical Services Program administrative rules, (chapter 410, division 130);
(f) Medical services provided by a physician or other provider of medical services, such as radiology and laboratory, as outlined in the Medical-Surgical Services Program rules, (chapter 410, division 130);
(g) Certain custom fitted or specialized equipment as specified in the Durable Medical Equipment, Prosthetics, Orthotics and Supplies Program administrative rules, (chapter 410, division 122).
(13) The Division reimburses hospice services based on CMS Core-Based Statistical Areas (CBSA’s). A separate payment will not be made for services included in the core package of services as outlined in OAR chapter 410, division 142.
(14) Payment for Division clients with Medicare and full Medicaid:
(a) The Division limits payment to the Medicaid allowed amount, less the Medicare payment, up to the Medicare co-insurance and deductible, whichever is less. The Division’s payment cannot exceed the co-insurance and deductible amounts due;
(b) The Division pays the Division allowable rate for Division covered services that are not covered by Medicare.
(15) For clients with third-party resources (TPR), the Division pays the Division allowed rate less the TPR payment but not to exceed the billed amount.
(16) The Division payments, including contracted PHP or CCO payments, unless in error, constitute payment in full, except in limited instances involving allowable spend-down or copayments. For the Division, such payment in full includes:
(a) Zero payments for claims where a third party or other resource has paid an amount equivalent to or exceeding Division allowable payment; and
(b) Denials of payment for failure to submit a claim in a timely manner, failure to obtain payment authorization in a timely and appropriate manner, or failure to follow other required procedures identified in the individual provider rules.
(17) Payment by the Division does not restrict or limit the Authority or any state or federal oversight entity’s right to review or audit a claim before or after the payment. Claim payment may be denied or subject to recovery if medical review, audit or other post-payment review determines the service was not provided in accordance with applicable rules or does not meet the criteria for quality of care, or medical appropriateness of the care or payment.
Stat. Auth.: ORS
Stats. Implemented: ORS 414.025, 414.033, 414.065, 414.095, 414.705, 414.727, 414.728, 414.742 & 414.743
Hist.: PWC 683, f. 7-19-74, ef. 8-11-784; PWC 803(Temp), f. & ef. 7-1-76; PWC 812, f. & ef. 10-1-76; Renumbered from 461-013-0061; PWC 833, f. 3-18-77, ef. 4-1-77; Renumbered from 461-013-0061; AFS 5-1981, f. 1-23-81, ef. 3-1-81; Renumbered from 461-013-0060, AFS 47-1982, f. 4-30-82 & AFS 52-1982, f. 5-28-82, ef. 5-1-82 for providers located in the geographical areas covered by the branch offices of North Salem, South Salem, Dallas, Woodburn, McMinnville, Lebanon, Albany and Corvallis, ef. 6-30-82 for remaining AFS branch offices; AFS 117-1982, f. 12-30-82, ef. 1-1-83; AFS 24-1985, f. 4-24-85, ef. 6-1-85; AFS 50-1985, f. 8-16-85, ef. 9-1-85; HR 2-1990, f. 2-12-90, cert. ef. 3-1-90, Renumbered from 461-013-0081, 461-013-0085, 461-013-0175 & 461-013-0180; HR 41-1991, f. & cert. ef. 10-1-91; HR 32-1993, f. & cert. ef. 11-1-93, Renumbered from 410-120-0040, 410-120-0220, 410-120-0200, 410-120-0240 & 410-120-0320; HR 2-1994, f. & cert. ef. 2-1-94; HR 5-1997, f. 1-31-97, cert. ef. 2-1-97; OMAP 10-1999, f. & cert. ef. 4-1-99; OMAP 3-2003, f. 1-31-03, cert. ef. 2-1-03; OMAP 62-2003, f. 9-8-03, cert. ef.10-1-03; OMAP 10-2004, f. 3-11-04, cert. ef. 4-1-04; OMAP 39-2005, f. 9-2-05, cert. ef. 10-1-05; OMAP 15-2006, f. 6-12-06, cert. ef. 7-1-06; OMAP 45-2006, f. 12-15-06, cert. ef. 1-1-07; DMAP 24-2007, f. 12-11-07 cert. ef. 1-1-08; DMAP 34-2008, f. 11-26-08, cert. ef. 12-1-08; DMAP 35-2008, f. 12-11-08, cert. ef. 1-1-09; DMAP 38-2009, f. 12-15-09, cert. ef. 1-1-10; DMAP 39-2010, f. 12-28-10, cert. ef. 1-1-11; DMAP 22-2011(Temp), f. 7-29-11, cert. ef. 8-1-11 thru 1-25-12; DMAP 36-2011, f. 12-13-11, cert. ef. 1-1-12; DMAP 28-2012, f. 6-21-12, cert. ef. 7-1-12; DMAP 41-2012(Temp), f. 8-22-12, cert. ef. 9-1-12 thru 2-28-13
Rule Caption: Legislatively mandated implementation of Drug Use Review/Pharmacy & Therapeutics Committee.
Adm. Order No.: DMAP 42-2012(Temp)
Filed with Sec. of State: 9-12-2012
Certified to be Effective: 9-12-12 thru 3-10-13
Notice Publication Date:
Rules Adopted: 410-121-0111
Rules Amended: 410-121-0033, 410-121-0100
Rules Suspended: 410-121-0033(T), 410-121-0100(T)
Subject: 410-121-0033: Change Pharmacy & Therapeutics (P&T) Committee to Drug Use Review (DUR) / Pharmacy & Therapeutics (P&T) Committee.
410-121-0100: Remove information relating to the abolished DUR Board and replace with information about the new DUR/P&T Committee.
410-121-0110: Rule adopted to transfer and define duties from the abolished DUR Board to the DUR/P&T Committee.
Rules Coordinator: Cheryl Peters—(503) 945-6527
(1) The Division may impose prescription drug payment limitations on clients with more than 15 unique fee-for-service drugs in a six-month period.
(2) The Division will review the client's drug therapy in coordination with the client's prescribing practitioner to evaluate for appropriate drug therapy.
(3) Appropriate drug therapy criteria will include, but is not limited to, the following:
(a) Overuse of selected drug classes;
(b) Under-use of generic drugs;
(c) Therapeutic drug duplication;
(d) Drug to disease interactions;
(e) Drug to drug interactions;
(f) Inappropriate drug dosage;
(g) Drug selection for age;
(h) Duration of treatment;
(i) Clinical abuse or misuse.
(4) The Division Medical Director in conjunction with the Drug Use Review/Pharmacy & Therapeutics Committee will make final determinations on imposed drug prescription payment limitations relating to this policy.
Stat. Auth.: ORS
409.120, 413.042 & 414.380
Stats. Implemented: ORS 414.065
Hist.: OMAP 1-2004, f. 1-23-04, cert. ef. 2-1-04; DMAP 27-2011(Temp), f. & cert. ef. 9-30-11 thru 3-15-12; DMAP 12-2012(Temp), f. & cert. ef. 3-16-12 thru 9-11-12; DMAP 42-2012(Temp), f. & cert. ef. 9-12-12 thru 3-10-13
Drug Use Review
(1) Drug Use Review (DUR) in Division of Medical Assistance Programs (Division) is a program designed to measure and assess the proper utilization, quality, therapy, medical appropriateness, appropriate selection and cost of prescribed medication through evaluation of claims data. This is done on both a retrospective and prospective basis. This program shall include, but is not limited to, education in relation to over-utilization, under-utilization, therapeutic duplication, drug-to-disease and drug-to-drug interactions, incorrect drug dosage, duration of treatment and clinical abuse or misuse:
(a) Information collected in a DUR program that identifies an individual is confidential;
(b) Staff of the Drug Use Review (DUR)/Pharmacy & Therapeutics (P&T) Committee and contractors may have access to identifying information to carry out intervention activities approved by the Division. The Division, DUR/P&T Committee or contractors shall adhere to all requirements of the Health Insurance Portability and Accountability Act (HIPAA) and all Division policies relating to confidential client information.
(2) Prospective DUR is the screening for potential drug therapy problems before each prescription is dispensed. It is performed at the point of sale by the dispensing pharmacist:
(a) Dispensing pharmacists must offer to counsel each Division client receiving benefits who presents a new prescription, unless the client refuses such counsel. Pharmacists must document these refusals;
(A) Dispensing pharmacists may offer to counsel the client’s caregiver rather than the client presenting the new prescription if the dispensing pharmacist determines that it is appropriate in the particular instance;
(B) Counseling must be done in person whenever practicable;
(C) If it is not practicable to counsel in person, providers whose primary patient population does not have access to a local measured telephone service must provide access to toll-free services (for example, some mail order pharmacy services) and must provide access to toll-free service for long-distance client calls in relation to prescription counseling;
(b) Prospective DUR is not required for drugs dispensed by Fully Capitated Health Plans (FCHPs);
(c) Oregon Board of Pharmacy rules defining specific requirements relating to patient counseling, record keeping and screening must be followed.
(3) Retrospective DUR is the screening for potential drug therapy problems based on paid claims data. The Division provides a professional drug therapy review for Medicaid clients through this program:
(a)The criteria used in retrospective DUR are compatible with those used in prospective DUR. Retrospective DUR criteria may include Pharmacy Management (Lock-In), Polypharmacy, and Psychotropic Use in Children. Drug therapy review is carried out by pharmacists with the Oregon State University College of Pharmacy, Drug Use Research and Management Program.
(b) If therapy problems are identified, an educational letter is sent to the prescribing provider, the dispensing provider, or both. Other forms of education are carried out under this program with Division approval.
(4) The DUR/P&T Committee is designed to develop policy recommendations in the following areas in relation to Drug Use Review:
(a) Appropriateness of criteria and standards for prospective DUR and needs for modification of these areas. DUR criteria are predetermined elements of health care based upon professional expertise, prior experience, and the professional literature with which the quality, medical appropriateness, and appropriateness of health care service may be compared.
(b) The use of different types of education and interventions to be carried out or delegated by the DUR/P&T Committee and the evaluation of the results of this portion of the program; and
(c) The preparation of an annual report on Oregon Medicaid DUR Program which describes:
(A) DUR/P&T Committee Activities;
(i) A description of how pharmacies comply with prospective DUR;
(ii) Detailed information on new criteria and standards in use; and
(iii) Changes in state policy in relation to DUR requirements for residents in nursing homes;
(B) A summary of the education/intervention strategies developed; and
(C) An estimate of the cost savings in the pharmacy budget and indirect savings due to changes in levels of medical visits and hospitalizations.
Stat. Auth.: ORS
413.042, 414.355, 414.360, 414.365, 414.370 & 414.380
Stats. Implemented: ORS 414.065
Hist.: HR 29-1990, f. 8-31-90, cert. ef. 9-1-90; HR 38-1992, f. 12-31-92, cert. ef. 1-1-93; HR 20-1994, f. 4-29-94, cert. ef. 5-1-94; OMAP 1-1999, f. & cert. ef. 2-1-99; OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00; OMAP 18-2004, f. 3-15-04 cert. ef. 4-1-04; OMAP 16-2006, f. 6-12-06, cert. ef. 7-1-06; 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 27-2011(Temp), f. & cert. ef. 9-30-11 thru 3-15-12; DMAP 12-2012(Temp), f. & cert. ef. 3-16-12 thru 9-11-12; DMAP 42-2012(Temp), f. & cert. ef. 9-12-12 thru 3-10-13
Drug Use Review/Pharmacy and Therapeutics Committee
(1) Pursuant to Oregon Laws 2011, chapter 720 (HB 2100), the Drug Use Review Board (DUR Board) is abolished and the tenure of office for the members of the DUR Board expires. The legislature transferred the duties, functions and powers previously vested in the DUR Board to the Drug Use Review (DUR)/Pharmacy and Therapeutics (P&T) Committee. This rule is retroactively effective on September 5, 2011, the date the DUR/P&T Committee was created and the DUR Board was abolished by HB 2100, and expires on March 10, 2013 or whenever the Oregon Health Authority (Authority) suspends the rule, whichever comes first.
(2) Unless otherwise inconsistent with these administrative rules or other laws, any administrative rule or agency policy with reference to the DUR Board or a DUR Board volunteer, staff or contractor shall be considered to be a reference to the DUR/P&T Committee or a DUR/P&T Committee volunteer, staff or contractor. The current preferred drug list (PDL), prior authorization process and utilization review process developed by the DUR Board remains in effect until such time as the Authority, after recommendations and advice from the DUR/P&T Committee, modifies them through the adoption of new administrative rules or policies and procedures.
(3) The DUR/P&T Committee shall advise the Oregon Health Authority (Authority) on the:
(a) Implementation of the medical assistance program retrospective and prospective programs, 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;
(b) Implementation of the Practitioner Managed Prescription Drug Plan (PMPDP);
(c) Adoption of administrative rules pertaining to the DUR/P&T Committee;
(d) Development of and application of the criteria and standards to be used in retrospective and prospective drug use review programs 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 DUR/P&T Committee must have an open professional consensus process, establish an explicit ongoing process for soliciting and considering input from interested parties, and make timely revisions to the criteria and standards based on this input and scheduled reviews;
(e) Development, selection and application of and assessment for interventions being educational and not punitive in nature for medical assistance program prescribers, dispensers and patients.
(4) The DUR/P&T Committee shall make recommendations to the Authority, subject to approval by the Director or the Director's designee, for drugs to be included on any PDL adopted by the Authority and on the PMPDP. The DUR/P&T Committee shall also recommend all utilization controls, prior authorization requirements or other conditions for the inclusion of a drug on the PDL.
(5) The DUR/P&T Committee shall, with the approval of the Director or designee, do the following:
(a) Publish an annual report;
(b) Publish and disseminate educational information to prescribers and pharmacists regarding the DUR/P&T Committee and the drug use review programs, including information on the following:
(A) Identifying and reducing the frequency of patterns of fraud, abuse or inappropriate or medically unnecessary care among prescribers, pharmacists and recipients;
(B) Potential or actual severe or adverse reactions to drugs;
(C) Therapeutic appropriateness;
(D) Overutilization or underutilization;
(E) Appropriate use of generic products;
(F) Therapeutic duplication;
(G) Drug-disease contraindications;
(H) Drug-drug interactions;
(I) Drug allergy interactions;
(J) Clinical abuse and misuse.
(6) Adopt and implement procedures designed to ensure the confidentiality of any information that identifies individual prescribers, pharmacists or recipients and that is collected, stored, retrieved, assessed or analyzed by the DUR/P&T Committee, staff of the DUR/P&T Committee, contractors to the DUR/P&T Committee or the Authority.
Stat. Auth.: ORS
413.042, 414.065, 414.355, 414.360, 414.365, 414.370, 414.380, Or Law 2011, chap.
720 (HB 2100)
Stats. Implemented: ORS 414.065, Or Law 2011, chap. 720 (HB 2100)
Hist.: DMAP 12-2012(Temp), f. & cert. ef. 3-16-12 thru 9-11-12; DMAP 42-2012(Temp), f. & cert. ef. 9-12-12 thru 3-10-13