The Omnibus Budget Reconciliation Act (OBRA) of 1990 requires that each State establish a Medicaid Drug Utilization Review (DUR) Program that consists of Prospective Drug Review (ProDUR), Retrospective Drug Review (RetroDUR), Application of Standards and an Educational Program. The program should ensure that prescriptions issued to Medicaid members are medically appropriate, necessary, and not likely to result in adverse events. To accomplish these goals, the DUR program uses criteria to screen for therapeutic problems, attempts to change prescribing practices through provider intervention, and then assess the impact of these activities. In addition, States are required to establish a DUR Board. In the state of Iowa, the DUR Board is referred to as the Iowa Medicaid DUR Commission. The state of Iowa established the DUR Commission in 1984 prior to the enactment of OBRA '90. Complete OBRA ’90 language regarding DUR programs is found in the tab labeled OBRA ’90 DUR Language.
OBRA ‘90 language requires each state to have an operational DUR program consisting of prospective DUR (proDUR), retrospective DUR (retroDUR), and an educational program. The goal of the DUR program is to ensure appropriate medication therapy, while permitting appropriate professional judgment to individualize medication therapy.
OBRA ’90 requires that DUR Boards utilize clinically based and scientifically valid predetermined standards to assess medication therapy. The state, a DUR contractor, a commercial vendor, or an independent organization may develop these predetermined standards. The sources used in developing these standards must be consistent with peer-reviewed medical literature and the official compendia consisting of AHFS Drug Information, USP Drug Information (or its successor publications), and DRUGDEX Information System. The DUR board through a consensus process should resolve inconsistency among source materials. The language also directs that predetermined standards be compatible between proDUR and retroDUR systems.
These predetermined standards shall be used to determine if there is a population at risk for clinically significant adverse medical outcomes. Failure to meet these standards signals that in-depth review or intervention may be warranted.
RetroDUR programs consist of an ongoing periodic examination of claims data to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care. Claims reviews may be based on physician, pharmacist, or individuals receiving benefits, drug, or groups of drugs. Predetermined standards for retroDUR shall be used to monitor therapeutic appropriateness, overutilization, underutilization, appropriate use of generic medication, therapeutic duplication, drug-disease contraindications, incorrect dosage, incorrect duration, and clinical abuse or misuse.
ProDUR programs require point-of-sale or point-of-distribution review of drug therapy using predetermined standards. These standards must be provided to pharmacists either through on-line messaging or educational training. Predetermined standards for proDUR shall monitor therapeutic duplication, drug-disease contraindications, adverse drug-drug interactions, incorrect dosage, incorrect duration, drug-allergy interactions, and clinical abuse or misuse. This portion of the OBRA ’90 language also includes mandates regarding member counseling by pharmacists and maintenance of pharmacy member profiles.
OBRA ’90 language also requires DUR Boards to conduct an ongoing educational program to educate practitioners about medication therapy problems, with the goal of improving prescribing and dispensing practices. DUR Boards are directed to utilize claims data identifying medication therapy problems and to design educational interventions in an effort to resolve these problems. DUR Boards may partner with accredited health care educational institutions, state medical societies, and state pharmacy associations to meet these educational objectives. This educational program shall include dissemination of information regarding the DUR Board's responsibilities and the Board's predetermined standards. Based on these findings, DUR Boards suggest changes in prescribing or dispensing practices, which may be conveyed by written, oral, electronic, or face-to-face communication. These suggestions may be member-specific, or drug-specific, or both.
The OBRA ’90 language requires the establishment of a DUR Board. The Board must have between 33% and 51% physician membership as well as at least 33% pharmacist membership. These members must be actively practicing and licensed practitioners, who have recognized knowledge and expertise in at least one of the following areas:
Each DUR Board serves an advisory role for their state’s Department of Human Services (DHS). However, the DHS has the authority to accept or reject any recommendations or decisions of the DUR Board. According to the OBRA ’90 language, the DUR Board's actions shall include, but not be limited to, the following activities:
The DUR program for Iowa Medicaid is performed by the Iowa Medicaid Enterprise (IME) through contractual relations between Goold Health Systems (GHS), a Change Healthcare Company, and the DHS. GHS coordinates and supports the DUR Commission. GHS is responsible for providing the retroDUR and educational components of the program, as well as administrative and clinical support. The Point of Sale (POS) contractor, GHS, administers the proDUR component of the program. The DUR Board reviews and makes recommendations regarding the criteria used by the POS contractor for the proDUR program.
The Iowa Medicaid DUR Commission is composed of four Iowa licensed physicians, four Iowa licensed pharmacists, and one member from the DHS. Other participants in Commission meetings may include DHS contractors and subcontractors who are responsible for components of the DUR program. Students on an experiential rotation with Commission members may participate in the open session portion of the meeting under the direction of that member.
The Commission elects a Chairperson and Vice Chairperson annually from the Commission membership. The Chairperson and Vice Chairperson will be elected by a simple majority and serve for a period of one year. The Chairperson will facilitate the meeting and discussion of agenda items. In the event the Chairperson is unable to attend a meeting the Vice Chairperson will facilitate the meeting. The Project Coordinator and the IME staff will continue to provide the administrative support currently provided to the Commission. The annual election will occur in August of each year.
The office of the DUR Commission is located at the Iowa Medicaid Enterprise (IME), 100 Army Post Road, in Des Moines. Staff at this location includes at least one Iowa licensed pharmacist who is available to the DHS during regular business hours. The staff shall also provide support for inquiries from Medicaid providers regarding the DUR program.
The Commission shall meet on the first Wednesday six months of the year (August, October, December, February, April, and June) in Des Moines, Iowa. The location for these meetings varies upon meeting site availability. Meeting times shall be 9:30 a.m. to 1:30 p.m. Changes in the meeting date, time, or location will be announced at least two months prior to the scheduled meeting. A simple majority of the voting members of the DUR Commission is required to conduct business. No business can be transacted without a simple majority, except to adjourn the meeting; if no question is raised, debate is allowed but no vote can be taken.
Commission members will receive packets containing pertinent information relating to the activities of DUR meetings as well as member profiles for their review before each DUR meeting. Packets with confidential information will be mailed three weeks prior to the meeting. Additional information may be available at the DUR meeting. Packets without the confidential information will also be made available on the DUR website; www.iadur.org, for any interested parties to view.
All meetings of the DUR Commission are conducted in accordance with Chapter 21 of the Code of Iowa. Therefore, any person may attend the open sessions of the Commission meetings. Public notice of the meetings will be physically posted on the bulletin board in the lobby of the Iowa Medicaid Enterprise (IME) building, 100 Army Post Road, Des Moines and posted on the DUR Commission website at www.iadur.org. Upon request, meeting notice shall be e-mailed to organizations with an interest in DUR activities.
Individuals attending meetings of the DUR Commission shall have an opportunity to address the Commission. This opportunity will be granted twice during the open portion of the meeting. In order to accommodate all interested parties, all speakers are requested to limit their comments to 5 minutes or less. If the speaker represents a drug manufacturer as an employee, as a contractor, as a member of the manufacturer's Speaker Bureau, or by any other means, it is the expectation that the speaker will cover the individual product or entire product line in that five-minute time frame. Speakers who represent multiple manufacturers will share their 5 minutes with the other manufacturer representative(s) whose product they are speaking on.
Closed sessions will occur to discuss confidential information as allowed by the Iowa Code. See the tab labeled Iowa Code Chapter 21 for complete information.
In accordance with HF 760 passed in the 1999 Legislative Session, the DHS shall ensure that the DUR Commission incorporates term limits for physician and pharmacist members in its membership policy. Each member of the Commission will serve one four-year term. Terms will begin on July 1, of each year. Each year, the term of one physician member and either one pharmacist member or one college of pharmacy member will expire on June 30. Commission members may apply to be considered for reappointment for up to two additional four-year terms for a lifetime limit of three terms of four years each. These terms may be served consecutively or separately.
New members for the Commission will be recruited by placing a notice in the DUR Digest. A letter will be sent regarding recruitment for vacancies to the Iowa Medical Society, Iowa Pharmacy Association, Iowa Osteopathic Medical Association, and the Iowa Academy of Family Physicians for dissemination to their membership. If there are no applications from current Commission members, a letter will be sent to Medicaid physicians and pharmacist providers having a suitable level of Medicaid activity in order to solicit individuals’ interest in the program.
All interested individuals may submit a letter of application to the DUR Project Coordinator, along with documentation of qualifications. Applicants should have expertise in at least one of the practice areas described in the CMS language and serve Medicaid members in his or her practice.
The DUR Project Coordinator will review the applications received and select a slate of potential members based on the applicants' qualifications. As the Commission must maintain a diverse membership, other factors will also be considered to ensure an appropriate mix of members. These factors shall include, but are not limited to, practice specialty, professional designations, practice setting, geographic location, and gender. Commission members are not appointed to serve a professional association, so membership in a particular association is not required. The DUR Project Coordinator will select qualified applicants who are most likely to complement the current mix of Commission members and recommend these individuals to the DHS for their approval. If the DHS concurs with the recommendation, the recommendation is approved. The member representing the DHS is not subject to term limits. This appointment is at the discretion of the DHS.
In the course of service on the DUR Commission, Commission members, staff, and students may review information that is considered confidential. This information may include, but is not limited to, oral, written, or recorded information that indicates the identity of a provider's professional practice patterns or the eligibility status of a member. Confidential information shall be utilized only as necessary to conduct utilization review or quality control review, or as otherwise authorized by law. All persons viewing confidential information shall sign documents acknowledging this responsibility. Commission members will complete a confidentiality form every four years. When it is necessary to discuss confidential information, the Commission will hold a closed session meeting.
The Confidentiality form, in the format of a Memorandum of Understanding and Business Associate Agreement,must be completed by each member.
Commission members will sign the Conflict of Interest form on an annual and as needed basis. Any Conflict of Interest on the part of the Commission member, their practice setting, or immediate family member will be disclosed and be made a matter of public record. The Commission member will not participate in any vote or take affirmative action to influence any vote on any matter before the Commission where there is a Conflict of Interest.
Persons speaking or presenting to the DUR are asked to disclose any financial or other affiliation with organizations that may have a direct or indirect interest in the business in front of the Commission. All participants speaking or presenting at a DUR meeting will disclose this information by signing the Conflict of Interest disclosure form.
The Conflict of Interest formmust be completed by each member.
Meeting attendance by Commission members is critical to the success of the DUR program. Members are expected to attend all regular meetings of the Commission. If a Commission member is unable to attend regular meetings at the expected level, that member may be replaced for the remainder of his or her term.
Members are to arrive at the meeting prepared to discuss the agenda items. Members are also to return all profiles to the Project Coordinator with comments regarding potential therapeutic or cost saving interventions. During the closed session, each member will present several patient profiles to the Commission for discussion.
Members shall arrive in a timely fashion, attend through the completion of the meeting, and avoid meeting disruptions from cell phones and other electronic devices.
Commission members shall be compensated per meeting attended. This compensation is offered for professional opinions shared during Commission discussions as well as the review of member profiles as assigned. In addition, reasonable expenses and mileage will be reimbursed. Compensation may be reduced if meeting attendance falls below expected levels.
The DUR contractor shall coordinate all activities related to the DUR Commission. The DUR contractor shall appoint a pharmacist as the Project Coordinator to serve as the primary communication link between the DHS and the Commission. Any Commission member experiencing problems or difficulties concerning their service on the DUR Commission shall discuss these issues with the Project Coordinator. If resolution is not found, the Commission member shall consult the DHS representative on the Commission.
Commission members shall not represent the DHS in any capacity unless specifically requested to do so by the DHS. Commission members shall not represent themselves as possessing any authority to affect Medicaid policy, as the Commission only serves in an advisory capacity for the DHS.
Commission members are under no obligation to meet with manufacturer representatives at their place of business. Should a manufacturer contact you for a meeting, you have the right to refuse to meet with them and inform them they have the opportunity to present information to the entire DUR Commission during the public comment section of the meeting.
Established in 1984, the DUR Commission is charged with promoting the appropriate and cost-effective use of medications within the Iowa Medicaid member population. Acting as a professional advisory group, the Commission analyzes medication utilization by the members of Iowa Medicaid and performs educational initiatives to optimize member outcomes. The Commission performs retroDUR and educational outreach through patient-focused reviews and problem-focused reviews. The Commission supports the proDUR program through criteria review and acts as a resource to the DHS on other issues concerning appropriate medication use.
Patient-focused reviews are completed with the review of 300 member profiles at each meeting (six times annually). The DUR contractor generates these profiles through a complex screening process. The first step of the screening process subjects member profiles to a therapeutic criteria screen. If a profile is found to have failed one or more therapeutic criteria, the member profiles are then assigned a level of risk based on their medication history and potential for adverse events regarding medication. The profiles with the highest level of risk are then selected for the Commission to review. Six months of prescription claims data and medical claims data, if available, are assessed to determine this risk factor.
The member profiles selected from this process are manually reviewed by the Commission to minimize false positives generated by the computer selection process. The Commission identifies situations where educational intervention might be appropriate. Through these interventions, suggestions regarding medication therapy are communicated to the care providers. Templates are developed for suggestions that are frequently communicated to providers. The reviewer may also author an individualized suggestion if a template suggestion is not applicable. These template suggestions are located in the tab labeled Therapeutic Recommendations.
Educational interventions are generally done by letters to prescribers and pharmacists, but may also be done by telephone or in person. The suggestions made by the Commission are educational and informative in nature. Suggestions may be classified as either therapeutic or cost saving in nature. In addition, these suggestions are classified by problem identified for reporting purposes. The classifications are as follows:
Suggestions are intended to promote appropriate and cost-effective use of medications. When suggestions result in cost savings, these savings are calculated based on decreased cost of medications. However, several of these classes of interventions are intended to increase the use of medications. Examples are member underuse and missing drug therapy. In these cases, the addition of medication therapy will increase medication expenditures, but will be beneficial to the member and should result in cost savings in medical services or improved quality of life. Cost savings in these situations cannot be calculated due to data limitations. Therefore, these suggestions are considered to have a positive impact on the program with no medication cost savings. Cost savings on medical services are assumed however not calculated.
Providers are invited to respond to the Commissions’ suggestions and to request additional information from the Commission. Reponses are voluntary and response rates are calculated for prescribers and pharmacists.
Once a member’s profile is reviewed, it is excluded from the selection process for nine months to eliminate repeat selections. After this waiting period, the current profile for each member is generated and reviewed to determine if the Commission’s suggestion was implemented. If so, fiscal considerations resulting from that change are also calculated. The policy regarding these calculations is included in the tab labeled Evaluation Policy.
Problem-focused reviews narrow the emphasis of review to a specific issue that has been determined to be an area where a targeted educational effort to providers may be valuable. Topics for review are selected from findings of patient-focused reviews or from reviews of medical literature. Criteria are developed to identify the members who may benefit from intervention and educational materials are disseminated to their providers. Providers are encouraged to voluntarily respond. The member profile is generated again in an appropriate amount of time (typically 6 to 9 months) to determine the impact rate of the intervention, along with any fiscal considerations. The policy regarding these calculations is also included in tab labeled Evaluation Policy.
The Commission will review utilization data and medical literature to make recommendations to the DHS regarding policy issues. These recommendations are made to promote the appropriate use of medications and positive member outcomes. Recommendations are made at the request of the DHS or at the Commission's discretion. All authority to accept or reject DUR Commission recommendations lies with the DHS. The Commission may make recommendations but does not make policy. Primary areas for recommendations include proDUR, drug prior authorization (PA), coverage of medications, and administrative and billing procedures.
The Commission reviews the proDUR criteria utilized by the POS contractor and provides input regarding its therapeutic validity for the proDUR program. Special attention is given to eliminating false positive messaging and easing administrative burdens. When available, reports regarding the impact of the proDUR program are reviewed by the Commission. If warranted, suggestions to improve the system are relayed to the DHS.
Upon the request of the DHS, the Commission will recommend medications where the use of prior authorization may decrease inappropriate use and/or result in cost savings to the Medicaid program. Medications appropriate for prior authorization are identified through the Commission's review process. On at least an annual basis, the Commission reviews the current categories of medication requiring prior authorization and renders an opinion if each category should remain on the prior authorization program.
New and revised prior authorization guidelines are based on reviews of medical literature in addition to comparisons with other public and private sector programs. Input from providers outside the Commission, particularly specialists, is often sought when developing these guidelines. Once developed, the guidelines are sent to the Iowa Medical Society, the Iowa Pharmacy Association, the Iowa Osteopathic Medical Association, the Iowa Academy of Family Physicians and the Iowa Psychiatric Society, and other specialty provider groups (as needed) for their comments. After considering any input received, a final recommendation is made to the DHS. The DHS may or may not accept the recommendation or may alter the recommendation.
The DUR Commission makes recommendations to the Iowa Medicaid Pharmacy and Therapeutics (P&T) Committee. In certain instances the DUR Commission may request that the P&T review the status of a particular drug on the Preferred Drug List (PDL) if inappropriate utilization is determined by the DUR. In addition, the Commission receives referrals to review from the P&T Committee.
The Commission also makes recommendations regarding coverage of medication. As most coverage requirements are defined by CMS, these recommendations generally encourage coverage of optional services. An example would be the coverage of select over-the-counter medications. If the DHS accepts the Commission's recommendation, the proposed coverage change would also be subject to the Administrative Rules process and possibly the State Plan Amendment process prior to implementation.
As an educational initiative, the Commission generates a quarterly newsletter, DUR Digest, which is posted on the website www.iadur.org for all prescribers and pharmacies that are Iowa Medicaid providers. This newsletter may include updates on therapeutic alternatives and guidelines, Medicaid policy, and Commission activities. The Commission maintains the website to improve communication and education regarding activities of the Commission. The website includes timely information regarding meeting schedules, location and agendas. Minutes are posted on the website following approval by the Commission. Other pertinent information that is periodically reviewed and updated includes the DUR Digest newsletter, Commission members, meeting attendance and Commission activities.
The Commission supports select research projects that promote the appropriate use of medication in the Medicaid population. These research projects attempt to answer the questions that will lead to improved patient outcomes related to medication use.
The Commission provides the DHS with a state fiscal year annual report of its activities and savings estimates for each contract period. The Commission also provides the DHS with information regarding the DUR Commission's activities as necessary to complete the annual report as required by CMS for the federal fiscal year.