OBRA 690 and Your Pharmacy Computer System To keep patient profiles and handle other functions mandated by the new Medicaid law) your computer system may need some changes. by Renato Cataldo, Jr., PharrnD
Introduction Reports on the Omnibus Budget Reconciliation Act of 1990 COBRA '90) have generally focused on such issues as the impact on pharmaceutical companies, pharmacist reimbursement, and patient counseling. 1 But what about the influences OBRA '90 will have on your pharmacy computer system? The portion of OBRA '90 that directly affects pharmacy-the Medicaid Drug Utilization Review provision-goes into effect January 1, 1993 , and could significantly reduce the amount that state Medicaid programs pay for prescription dnlgs. To comply with the law, your computer system will need to handle increased telecommunications, expanded patient profiles, drug utilization review CDUR) processing, and greater clinical information. In addition to making changes in your computer system's capabilities, you also may fmd yourself paying higher maintenance fees to your vendor, since the cost of developing new software and providing increased maintenance will result in an increased cost of operations.
Drug Utilization Review Under OBRA '90, states are required to establish prospective and retrospective DUR programs to ensure that prescriptions are appropriate, medically necessary, and are not likely to result in adverse medical effects. 2 Each state must establish a DUR board to defme retrospecVol. NS32, No. 11 Nove mber 1992/ 895
tive DUR criteria, assess data on dnlg use against predetermined standards, and develop programs to teach physicians and pharmacists how to identify and avoid inappropriate medication use and unnecessary care. Regarding the prospective-screening system states must provide for covered outpatient dnlgs, the law says: The state DUR plan shall provide a review of drug therapy before each prescription is filled or delivered to an individual receiving benefits, typically at the point of sale or point of distribution. The review shall include screening for potential dnIg therapy problems due to therapeutic duplication, drug disease contraindications, dnIg-drug interactions (including serious interactions with nonprescription or over-the-counter [OTe] dnIgs), incorrect MIg dosage or duration of dnIg treatment, dnIg-allergy interactions, and clinical abuse/misuse.
The law requires pharmacists to "make a reasonable effort to obtain, record, and maintain information" on Medicaid recipients receiving prescriptions. However, the law instructs states to defme what "reasonable effort" means. Thus, to carry out prospective DUR before a prescription is filled, your computer system will likely have to maintain and process a detailed patient profile. The medical history of the patient must include disease or diagnosis and clinical monitoring data, as well as a "comprehensive list" of medications and devices they use. Patients can fill out a questionnaire, or you can interview them. The law does not specifically address when the medical history is to be taken, but to fill the flfst prescription, some basic information-such as diagnosis and allergies-will be needed. The law does not say that you must maintain a record of OTe medications the patient uses, but to check thoroughly for potential drug interactions, this will be necessary. This information can be stored in a "nondispensing" profile. AMERICAN PHARMACY
A potential pitfall is that some Medicaid patients, particularly those who see multiple providers and use several pharmacies, may not know enough about their medical history to provide specific information, and inadequate or incorrect data may be entered into the computer system. In addition, many of the people who present prescription orders are not the patients and cannot be relied on for accurate histories. Either case presents an opportunity for the pharmacist to discuss diagnosis and medical history with the patient. You can also verify information by asking the patient to bring all currently used medications to the pharmacy, which allows you to check drug names and identify the prescribing physicians.
Electronic Transfer of Information To meet the federal DUR requirements, each state must determine how it is going to collect and evaluate information in a timely manner. OBRA '90 encourages each state to incorporate electronic claims management (ECM) into its program at the point of sale (POS) for instant determination of eligibility, recording of claims, adjudication of claims, and electronic payments. States that choose to make ECM available will need to standardize the processed information so that any pharmacy system vendor in that state can transmit data to the ECM system. Each pharmacy that participates in ECM would need a dedicated telephone line and a high-speed modem. To encourage states to develop an ECM system, the federal government is providing 90% of the funding. Despite this, however, many states may fmd it difficult to come up with the additional staff and funds necessary to implement ECM.
Patient Counseling Although OBRA '90 mandates patient counseling as part of a state's prospective DUR program for Medicaid patients, state law will establish standards for pharmacists to counsel individuals. OBRA '90 states that counseling should include at least the following: 2 The pharmacist must offer to discuss with each individual receiving benefits or caregiver of such individual (in person, whenever practicable, or through access to a telephone service which is toll free for long distance calls) who presents a prescription, matters which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant including the following: • The name and description of the medication. • The route, dosage form, dosage, route of administration, and duration of drug therapy. • Special directions and precautions for preparation, administration, and use by the patient. • Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur. AMERICAN PHARMACY
• • • •
Techniques for self-monitoring drug therapy. Proper storage. Prescription refill information. Action taken in the event of a missed dose. Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual receiving benefits refuses consultation.
Although OBRA '90 leaves the quantity or quality of information presented up to the professional judgment of the pharmacist, every Medicaid patient must be offered consultation. When counseling patients, many pharmacists like to supplement their discussion with printed sheets that detail important drug-related information. If your pharmacy system does not already include the ability to print drug-education leaflets, you can either get preprinted forms or buy another software program. Most patient-education software can operate on an IBM-compatible microcomputer and is relatively inexpensive. Patient-education software can be purchased from such organizations as the American Society of Hospital Pharmacists (ASHP), the United States Pharmacopeia CUSP), MediSpan, and First Databank.3 These products are based on references that are approved by OBRA '90 to be valid sources of drug information. MediSpan licenses the patient education data from USP and modifies the monographs so they include only significant interactions, have a lower reading level than the original material, and print on one page. The First Databank information is licensed from ASHP and is integrated with drug interaction software. When using any of these stand-alone software products, you need to enter the name and drug prescribed for each patient to whom you want to give printed information. An advantage is that this operation can be performed by a technician, because this is not part of the dispensing process or consultation.3 A disadvantage is that because the software is not integrated into the pharmacy system, it creates an additional step-which can be time-consuming when you are trying to keep up with a large volume of patients. MediSpan, USP, ASHP, and First Databank also license their data to pharmacy systems vendors. This allows participating systems to print patient-education leaflets based on the information in the patient's profile-a feature that will be very useful to pharmacists as the OBRA '90 DUR system takes effect. There are many other sources of patient drug information. Check with your pharmacy system developer to inquire about what they plan to provide. Keep in mind, however, that providing leaflets is not a substitute for the patient counseling required under OBRA '90.
Cognitive Services OBRA '90 states that pharmacists must make a "reasonable effort" to carry out the following activities for Medicaid November 1992/896
Vol. NS32, No. 11
patients-activities that fall in the realm of "cognitive services":2 • Record patient's name, address, telephone nun1ber, date of bitth or age, and sex. • Record and maintain a medical history "where significant," including the patient's disease states; known allergies and drug reactions; and a con1prehensive list of medications and medical devices the patient uses. • Make comments in the patient's record relevant to his or her dnlg therapy. OBRA '90 includes a provision for developing a demonstration project on the cost-effectiveness of reitubursement for phalmacists' cognitive services, to be conducted at five sites. The report for the project is due January 1, 1995. Although not required by OBRA '90, it would be wise for all pharmacists to track the time they spend on interventions. Having quantifiable data available before any reimbursement policy goes into effect regarding cognitive services will make it easier to address questions about how much time was spent, how luuch pharmacists should be paid, and how payment can be justified. Software programs for productivity and intervention monitoring used in hospital pharmacy practice can serve as models for developing software to monitor pharmacists' activities. Most pharmacy software systems, however, do not include the ability to quantify or qualify time spent.
Pharmacy System Developers Given the requirements of state DUR, patient monitoring, counseling, and other provisions of OBRA '90, what are the pharmacy system vendors doing and how far along are they? Many companies are still working on redesigning their current pharmacy system. Bill Jordan, director of marketing at QS/1 , one of the largest national vendors, provided the following details about what his corporation is doing. • Therapeutic duplication. In the patient profiles, the QS/1 system visually screens for two prescriptions for the same dnlg with the same National Dnlg Code number; two prescriptions for the same drug, one brand and one generic; and two prescriptions for different dnlgs in the same therapeutic class. The screening process was designed to be a manual function for pharmacists to accept or override as part of their professional performance. • Drug-disease contraindication. These are screened through the use of medical condition codes. • Drug-drug interaction. These codes screen for drugdrug interactions using information supplied by the University of South Carolina College of Pharmacy. Only interactions with Significance levels 1 and 2 are displayed. The pharmacist must override this information to fill the prescription order. • Drug-OTC interaction. OTC drugs the patient uses are entered into the patient profile through anon - prescriptionVol. NS32, No. 11 November 1992/ 897
ftlling function. When the pharmacist fills a prescription, the system checks the OTC record for drug-dnlg interactions. The pharmacist must override any interactions found to fill the prescription order. • Incorrect drug dosage. The system monitors drug dosage by establishit1g a "units-per-day" field, then by comparing actual usage to that field. If inconsistencies are found, the appropriate message is displayed. • Duration of treatment. Through a "days supplied" field, the system monitors for early refill and duration of treatment. • Drug-allergy interactions. The allergy codes and tables are "hard coded" (not changeable by the pharmacist) in the software program. When a dnlg-allergy interaction is found, the pharmacist is alerted. • Clinical abuse or ~suse. Through the use of warnings regarding duration of treatment, overdose, early refills, etc. , pharmacists can monitor for clinical abuse or misuse. • Underutilization. The system can automatically notify patients for underutilization and print refill-reminder reports. The reports are printed in batches and pharmacists determine if they wish to mail them to patients.
Conclusion OBRA '90 has made the following clear: • Therapy outcomes have become a prominent issue in the health care system. Just getting the correct drug and dosage to the patient is not enough. • The professional judgment and interventions of pharmacists are important and should be documented. • Through the use of electronics, a closer working relationship will develop among medical practitioners to communicate patient status and provide optimal pharmacotherapy. Because the pharmacy computer system will play such a vital role in the OBRA '90 DUR process, you should try to participate in your pharmacy system users ' group to see what they plan to develop and discuss your needs. If you are unable to attend a users' group meeting, write or call your system vendor about your concerns so they can better prepare for the future. Renato Cataldo, jr., PharmD, is director of microcomputer applications and assistant professor ofpharmacy administration at St. Louis College of Pharmacy, St. Louis, Mo.
References 1. Martin S. Medicaid drug rebate law is working to change reimbursement. Am Pharm. 1991;NS31:476--8. 2. Omnibus Budget Reconciliation Act of 1990, Washington, DC: U.S. Government Printing Office, 1990:152-71. 3. Cataldo R. Computers: Drug Information Software. Am Pharm. 1991;NS31:710.
AMERICANPHARMACY
Introduction Reports on the Omnibus Budget Reconciliation Act of 1990 COBRA '90) have generally focused on such issues as the impact on pharmaceutical companies, pharmacist reimbursement, and patient counseling. 1 But what about the influences OBRA '90 will have on your pharmacy computer system? The portion of OBRA '90 that directly affects pharmacy-the Medicaid Drug Utilization Review provision-goes into effect January 1, 1993 , and could significantly reduce the amount that state Medicaid programs pay for prescription dnlgs. To comply with the law, your computer system will need to handle increased telecommunications, expanded patient profiles, drug utilization review CDUR) processing, and greater clinical information. In addition to making changes in your computer system's capabilities, you also may fmd yourself paying higher maintenance fees to your vendor, since the cost of developing new software and providing increased maintenance will result in an increased cost of operations.
Drug Utilization Review Under OBRA '90, states are required to establish prospective and retrospective DUR programs to ensure that prescriptions are appropriate, medically necessary, and are not likely to result in adverse medical effects. 2 Each state must establish a DUR board to defme retrospecVol. NS32, No. 11 Nove mber 1992/ 895
tive DUR criteria, assess data on dnlg use against predetermined standards, and develop programs to teach physicians and pharmacists how to identify and avoid inappropriate medication use and unnecessary care. Regarding the prospective-screening system states must provide for covered outpatient dnlgs, the law says: The state DUR plan shall provide a review of drug therapy before each prescription is filled or delivered to an individual receiving benefits, typically at the point of sale or point of distribution. The review shall include screening for potential dnIg therapy problems due to therapeutic duplication, drug disease contraindications, dnIg-drug interactions (including serious interactions with nonprescription or over-the-counter [OTe] dnIgs), incorrect MIg dosage or duration of dnIg treatment, dnIg-allergy interactions, and clinical abuse/misuse.
The law requires pharmacists to "make a reasonable effort to obtain, record, and maintain information" on Medicaid recipients receiving prescriptions. However, the law instructs states to defme what "reasonable effort" means. Thus, to carry out prospective DUR before a prescription is filled, your computer system will likely have to maintain and process a detailed patient profile. The medical history of the patient must include disease or diagnosis and clinical monitoring data, as well as a "comprehensive list" of medications and devices they use. Patients can fill out a questionnaire, or you can interview them. The law does not specifically address when the medical history is to be taken, but to fill the flfst prescription, some basic information-such as diagnosis and allergies-will be needed. The law does not say that you must maintain a record of OTe medications the patient uses, but to check thoroughly for potential drug interactions, this will be necessary. This information can be stored in a "nondispensing" profile. AMERICAN PHARMACY
A potential pitfall is that some Medicaid patients, particularly those who see multiple providers and use several pharmacies, may not know enough about their medical history to provide specific information, and inadequate or incorrect data may be entered into the computer system. In addition, many of the people who present prescription orders are not the patients and cannot be relied on for accurate histories. Either case presents an opportunity for the pharmacist to discuss diagnosis and medical history with the patient. You can also verify information by asking the patient to bring all currently used medications to the pharmacy, which allows you to check drug names and identify the prescribing physicians.
Electronic Transfer of Information To meet the federal DUR requirements, each state must determine how it is going to collect and evaluate information in a timely manner. OBRA '90 encourages each state to incorporate electronic claims management (ECM) into its program at the point of sale (POS) for instant determination of eligibility, recording of claims, adjudication of claims, and electronic payments. States that choose to make ECM available will need to standardize the processed information so that any pharmacy system vendor in that state can transmit data to the ECM system. Each pharmacy that participates in ECM would need a dedicated telephone line and a high-speed modem. To encourage states to develop an ECM system, the federal government is providing 90% of the funding. Despite this, however, many states may fmd it difficult to come up with the additional staff and funds necessary to implement ECM.
Patient Counseling Although OBRA '90 mandates patient counseling as part of a state's prospective DUR program for Medicaid patients, state law will establish standards for pharmacists to counsel individuals. OBRA '90 states that counseling should include at least the following: 2 The pharmacist must offer to discuss with each individual receiving benefits or caregiver of such individual (in person, whenever practicable, or through access to a telephone service which is toll free for long distance calls) who presents a prescription, matters which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant including the following: • The name and description of the medication. • The route, dosage form, dosage, route of administration, and duration of drug therapy. • Special directions and precautions for preparation, administration, and use by the patient. • Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur. AMERICAN PHARMACY
• • • •
Techniques for self-monitoring drug therapy. Proper storage. Prescription refill information. Action taken in the event of a missed dose. Nothing in this clause shall be construed as requiring a pharmacist to provide consultation when an individual receiving benefits refuses consultation.
Although OBRA '90 leaves the quantity or quality of information presented up to the professional judgment of the pharmacist, every Medicaid patient must be offered consultation. When counseling patients, many pharmacists like to supplement their discussion with printed sheets that detail important drug-related information. If your pharmacy system does not already include the ability to print drug-education leaflets, you can either get preprinted forms or buy another software program. Most patient-education software can operate on an IBM-compatible microcomputer and is relatively inexpensive. Patient-education software can be purchased from such organizations as the American Society of Hospital Pharmacists (ASHP), the United States Pharmacopeia CUSP), MediSpan, and First Databank.3 These products are based on references that are approved by OBRA '90 to be valid sources of drug information. MediSpan licenses the patient education data from USP and modifies the monographs so they include only significant interactions, have a lower reading level than the original material, and print on one page. The First Databank information is licensed from ASHP and is integrated with drug interaction software. When using any of these stand-alone software products, you need to enter the name and drug prescribed for each patient to whom you want to give printed information. An advantage is that this operation can be performed by a technician, because this is not part of the dispensing process or consultation.3 A disadvantage is that because the software is not integrated into the pharmacy system, it creates an additional step-which can be time-consuming when you are trying to keep up with a large volume of patients. MediSpan, USP, ASHP, and First Databank also license their data to pharmacy systems vendors. This allows participating systems to print patient-education leaflets based on the information in the patient's profile-a feature that will be very useful to pharmacists as the OBRA '90 DUR system takes effect. There are many other sources of patient drug information. Check with your pharmacy system developer to inquire about what they plan to provide. Keep in mind, however, that providing leaflets is not a substitute for the patient counseling required under OBRA '90.
Cognitive Services OBRA '90 states that pharmacists must make a "reasonable effort" to carry out the following activities for Medicaid November 1992/896
Vol. NS32, No. 11
patients-activities that fall in the realm of "cognitive services":2 • Record patient's name, address, telephone nun1ber, date of bitth or age, and sex. • Record and maintain a medical history "where significant," including the patient's disease states; known allergies and drug reactions; and a con1prehensive list of medications and medical devices the patient uses. • Make comments in the patient's record relevant to his or her dnlg therapy. OBRA '90 includes a provision for developing a demonstration project on the cost-effectiveness of reitubursement for phalmacists' cognitive services, to be conducted at five sites. The report for the project is due January 1, 1995. Although not required by OBRA '90, it would be wise for all pharmacists to track the time they spend on interventions. Having quantifiable data available before any reimbursement policy goes into effect regarding cognitive services will make it easier to address questions about how much time was spent, how luuch pharmacists should be paid, and how payment can be justified. Software programs for productivity and intervention monitoring used in hospital pharmacy practice can serve as models for developing software to monitor pharmacists' activities. Most pharmacy software systems, however, do not include the ability to quantify or qualify time spent.
Pharmacy System Developers Given the requirements of state DUR, patient monitoring, counseling, and other provisions of OBRA '90, what are the pharmacy system vendors doing and how far along are they? Many companies are still working on redesigning their current pharmacy system. Bill Jordan, director of marketing at QS/1 , one of the largest national vendors, provided the following details about what his corporation is doing. • Therapeutic duplication. In the patient profiles, the QS/1 system visually screens for two prescriptions for the same dnlg with the same National Dnlg Code number; two prescriptions for the same drug, one brand and one generic; and two prescriptions for different dnlgs in the same therapeutic class. The screening process was designed to be a manual function for pharmacists to accept or override as part of their professional performance. • Drug-disease contraindication. These are screened through the use of medical condition codes. • Drug-drug interaction. These codes screen for drugdrug interactions using information supplied by the University of South Carolina College of Pharmacy. Only interactions with Significance levels 1 and 2 are displayed. The pharmacist must override this information to fill the prescription order. • Drug-OTC interaction. OTC drugs the patient uses are entered into the patient profile through anon - prescriptionVol. NS32, No. 11 November 1992/ 897
ftlling function. When the pharmacist fills a prescription, the system checks the OTC record for drug-dnlg interactions. The pharmacist must override any interactions found to fill the prescription order. • Incorrect drug dosage. The system monitors drug dosage by establishit1g a "units-per-day" field, then by comparing actual usage to that field. If inconsistencies are found, the appropriate message is displayed. • Duration of treatment. Through a "days supplied" field, the system monitors for early refill and duration of treatment. • Drug-allergy interactions. The allergy codes and tables are "hard coded" (not changeable by the pharmacist) in the software program. When a dnlg-allergy interaction is found, the pharmacist is alerted. • Clinical abuse or ~suse. Through the use of warnings regarding duration of treatment, overdose, early refills, etc. , pharmacists can monitor for clinical abuse or misuse. • Underutilization. The system can automatically notify patients for underutilization and print refill-reminder reports. The reports are printed in batches and pharmacists determine if they wish to mail them to patients.
Conclusion OBRA '90 has made the following clear: • Therapy outcomes have become a prominent issue in the health care system. Just getting the correct drug and dosage to the patient is not enough. • The professional judgment and interventions of pharmacists are important and should be documented. • Through the use of electronics, a closer working relationship will develop among medical practitioners to communicate patient status and provide optimal pharmacotherapy. Because the pharmacy computer system will play such a vital role in the OBRA '90 DUR process, you should try to participate in your pharmacy system users ' group to see what they plan to develop and discuss your needs. If you are unable to attend a users' group meeting, write or call your system vendor about your concerns so they can better prepare for the future. Renato Cataldo, jr., PharmD, is director of microcomputer applications and assistant professor ofpharmacy administration at St. Louis College of Pharmacy, St. Louis, Mo.
References 1. Martin S. Medicaid drug rebate law is working to change reimbursement. Am Pharm. 1991;NS31:476--8. 2. Omnibus Budget Reconciliation Act of 1990, Washington, DC: U.S. Government Printing Office, 1990:152-71. 3. Cataldo R. Computers: Drug Information Software. Am Pharm. 1991;NS31:710.
AMERICANPHARMACY
