Implementation of a comprehensive pharmaceutical care program for an underserved population LISA A. MASCARDO, KIMBERLY A. SPADING, AND PAUL W. ABRAMOWITZ LISA A. MASCARDO, PHARM.D., is Assistant Director; and KIMBERLY A. SPADING, B.S.PHARM., is Manager, Ambulatory Care Pharmacy, University of Iowa Hospitals and Clinics (UIHC), Iowa City. PAUL W. ABRAMOWITZ, PHARM.D., FASHP, is Chief Executive Ofcer and Executive Vice President, American Society of Health-System Pharmacists, Bethesda, MD; at the time of writing, he was Chief Pharmacy Ofcer, UIHC. Address correspondence to Dr. Mascardo at the Department of Pharmaceutical Care, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52241 (lisa-mascardo@uiowa.edu). The authors have declared no potential conicts of interest. Copyright 2012, American Society of Health-System Pharma- cists, Inc. All rights reserved. 1079-2082/12/0702-1225$06.00. DOI 10.2146/ajhp110490 An audio interview that supplements the information in this article is available on AJHPs website at www.ajhp.org/site/misc/ podcasts.xhtml. A ccess to and affordability of medications have a direct im- pact on the success of phar- maceutical care. According to a report by the Robert Wood Johnson Foundation in 2009, an estimated 49 million Americans are uninsured or underinsured. 1 Between 2003 and 2007, the proportion of nonelderly adult Americans who went without prescribed medications due to the inability to afford them increased to 17.8% from 13.8%. 2 Iowa has had an indigent care program for almost 100 years, but as the number of uninsured or underinsured patients has grown in the past decade to sur- pass the states ability to meet their needs, the program has changed dramatically. University of Iowa Hospitals and Clinics (UIHC) is a 734-bed compre- hensive academic medical center and regional referral center. Indigent care laws passed in Iowa, beginning as early as 1915 and continuing through the present day, have had a constant Purpose. The implementation of a pre- scription benet program for low-income patients emphasizing clinical pharmacist services and strict formulary control is described, with a review of program expen- ditures and cost avoidance. Summary. In 2006, University of Iowa Hospitals and Clinics (UIHC) launched a program to provide a limited prescription benefit to indigent patients under the IowaCare Medicaid demonstration waiver. Sudden dramatic growth in IowaCare enrollment, combined with sharp budget cuts, forced UIHC pharmacy leaders to implement creative cost-control strategies: (1) the establishment of an ambulatory care clinic staed by a clinical pharmacy specialist, (2) increased reliance on an al- most exclusively generic formulary, (3) col- laboration with social services sta to help secure medication assistance for patients requiring brand-name drugs, (4) optimized purchasing through the federal 340B Drug Pricing Program, and (5) the imposition of medication copayments and mailing fees for prescription rells. Now in its seventh year, the UIHC pharmacy program has expanded indigent patients access to phar- maceutical care services while reducing their use of hospital and emergency room services and lowering program medica- tion costs by an estimated 50% (from $2.6 million in scal year 2009 to $1.3 million in scal year 2010). Conclusion. The UIHC ambulatory care pharmacy implemented a prescription pro- gram in collaboration with social service workers to address the medication needs of the states low-income and uninsured patients in a scally responsible manner by managing purchasing contracts, revising a generic formulary, implementing copay- ments and mailing fees, and reviewing medication proles. Am J Health-Syst Pharm. 2012; 69:1225- 30 inuence on patient access and care at UIHC. Background The Iowa Indigent Patient Care Program (previously known as the State Papers program), originally established under legislation en- acted in 1915, enabled every Iowa county to refer a specied number of patients for care at UIHC at no cost to the patient or the county. 3
Patients eligible for State Papers ben- ets received comprehensive care at UIHC, including a 90-day supply of medications for chronic disorders PRACTICE REPORTS Pharmaceutical care program 1226 Am J Health-Syst PharmVol 69 Jul 15, 2012 at each visit. Recognizing that travel to UIHC to get medication rells could be a hardship for many pa- tients, the medical centers pharmacy implemented a mail-out program to ensure continuous medication provi- sion throughout the year. Program costs were controlled through the progressive design and adaption of a medication formulary. Approximately 3600 patients were served by the State Papers program at the point of peak enrollment in 2005. This program was in place until June 30, 2005, when it was replaced by the IowaCare Program. IowaCare program Created by the IowaCare Act passed by the state legislature in s- cal year 2005, IowaCare was designed as a Medicaid demonstration waiver program to provide patients with a limited health benefits package and a limited provider network. 4 It was intended to expand health care coverage to a larger number of low- income, uninsured adults and pro- vide financial stability for Iowa safety net hospitals providing large amounts of uncompensated care. Since July 1, 2005, IowaCare has covered adults age 1964 years who have incomes of 200% of the ap- plicable federal poverty level, who lack comprehensive private insurance, and who are not otherwise eligible for Medicaid. Initially, IowaCare provider institutions included Broadlawns Medical Center in Des Moines (for Polk County residents) and UIHC (for all other Iowa counties). Services covered include inpatient and out- patient hospital services, physician and midlevel practitioner services, limited dental services, and tobacco cessation services. Unlike the State Papers program, IowaCare imposes no cap on the number of eligible patients, but the IowaCare legislation specied only a limited prescription benet. Per agreement with the Department of Human Services, a 10-day supply of medications is provided at the time of a patients discharge from an inpatient stay. Participants in the program are asked to pay premiums, but they may request that these be waived as a nancial hardship. Pa- tients previously enrolled in the State Papers program continued to receive supplies of medications for chronic conditions. In an attempt to best serve and more easily follow the needs of the IowaCare patient population, UIHC created a new clinic (Primary Care Clinic North) for program enrollees. In the spring of 2006, a full-time equivalent (FTE) clinical pharmacy specialist position was established at the clinic. The position was nan- cially justied by planned pharmacist initiatives such as the development and implementation of a formulary to optimize care and control costs; collaboration with prescribers to recommend cost-effective therapy; review of therapies to optimize out- comes, reduce polypharmacy, pre- vent adverse drug events, and ensure medication compliance; monitoring of hospitalizations; and working with inpatient pharmacists to facilitate ap- propriate discharge prescribing and help track medication use among IowaCare participants. Medication Assistance Center In the summer and early fall of 2005, ambulatory care pharmacy managers, clinical pharmacy special- ists, and clinical pharmacists worked closely with the UIHC social services department to manage the transi- tion from the State Papers program to the IowaCare program. Before the transition, two social workers were responsible for helping patients complete applications for medica- tion assistance programs (MAPs); the transition away from primary reliance on the large State Papers formulary toward reliance on MAPs (when generic medications were not available) meant their work would increase substantially. A decision was made in July 2005 to continue to cover medications for chronic diseases during IowaCares rst year for patients previously covered by the State Papers program. In a shared FTE position, two pharmacist fi- nancial counselors worked with the ambulatory care clinical pharmacy specialists to review the medication proles of the more than 1500 for- mer State Papers patients deemed to have chronic conditions that war- ranted ongoing medication coverage, recommend conversions to lower- cost generic alternatives, and contact prescribers to request changes in therapy. Patients who were identied as needing brand-name medications were referred to MAP social workers for assistance lling out applications. The drastic reduction in medi- cation coverage resulting from the transition from State Papers to IowaCare led to the closure of one of three UIHC ambulatory care outpatient pharmacies in 2005. The clinic space was reopened as the UIHC Medication Assistance Center in July 2006, providing work space for two social workers, two phar- macist financial counselors, and a pharmacy technician to handle MAP applications and medication distribution, as well as a place for meetings with patients. IowaCare Prescription Program By May 2006, approximately 16,000 patients were enrolled in IowaCare, with approximately 10,000 patients designated to receive servic- es at UIHC. The number of patients covered by IowaCare far exceeded the systems ability to provide ap- pointments. The limited medication benet (only a 10-day supply of med- ications at discharge) also proved challenging during the rst year of the IowaCare Prescription Program. A small number of patients previous- ly covered by State Papers continued to receive medications for chronic conditions identied before the tran- sition to IowaCare, but medications PRACTICE REPORTS Pharmaceutical care program 1227 Am J Health-Syst PharmVol 69 Jul 15, 2012 for newly diagnosed conditions were not covered. During this period, approximately 2000 former State Papers patients became eligible for Medicare Part D benets; despite this development, the gap in the provision of pharmacy services for the majority of IowaCare patients quickly became evident. Medical providers and pharmacists alike could not effectively manage patients who could not afford to take their prescribed medications. There were increases in repeat hospitaliza- tions and emergency department visits due to therapeutic failures related to medication nonadher- ence. Registration and billing data for the 12 months ending on April 30, 2006, indicate that a total of 6600 IowaCare patients incurred hospital charges during that periodan an- nual hospital utilization rate of 66%. The costs to UIHC of caring for the patients were more than the state ap- propriation for reimbursement. Cost analysis. In an effort to improve the care of program par- ticipants and decrease overall health care costs, UIHC pharmacy leaders proposed the concept of providing medications to IowaCare patients through a program similar to that cre- ated under the State Papers program (i.e., one providing full prescription benefits). Prescription volume and cost estimates were performed using IowaCare enrollment numbers, pa- tient visits to date, and historical pre- scription data from the State Papers program. The calculations projected a volume increase of approximately 101,000 prescriptions per year, with just over 52,000 prescriptions to re- quire mailing, at an estimated cost of $2.2 million (excluding personnel, packaging, and mailing expenses of $800,000). Adding to that gure the projected $3 million cost of provid- ing maintenance medications to patients grandfathered in from the State Papers program resulted in a total annual program cost estimate of $4.9 million. Formulary management. Claims for the 10-day discharge supplies initially covered by the IowaCare program were submitted electroni- cally to the Iowa Medicaid program for reimbursement and followed the Medicaid preferred drug list, which included many brand-name medications. While the State Papers prescription benet had also cov- ered both brand-name and generic medications on formulary, it would not have been feasible to implement the same formulary under IowaCare given the much higher number of patients enrolled. With the entry of generic versions of many drugs into the market at that timeincluding key classes such as angiotensin- converting enzyme inhibitors, statins, and selective serotonin-reuptake inhibitorsit was determined that the pharmaceutical needs of the IowaCare population could be met by using a generic-only medication formulary. This decision was nal- ized after a determination that pre- scription program expenses would not be covered by the Medicaid waiver program but would instead be borne solely by UIHC. It was therefore decided before the start of IowaCares second year of operation that UIHC would move forward with the creation of a prescription program to address the issues stemming from constricted medication coverage. The goal set for the planned UIHC-managed prescription pro- gram was to control overall health care costs and utilization by main- taining patients health through the use of cost-effective and clinically appropriate medication regimens. The IowaCare pharmacy benefit would provide up to 30-day supplies of generic medications and a mail- out service to help facilitate rells. While prescription program costs would not be reimbursable through the IowaCare appropriations process, UIHC leaders felt that the program would result in overall cost savings for the institution by preventing hospitalizations and emergency and clinic visits. The prescription pro- gram was initiated in August 2006. Cost-management strategies In the six years since the incep- tion of the IowaCare Prescription Program, judicious management of medications provided to patients with IowaCare coverage has proved crucial to the programs financial viability. As the number of patients has increased far beyond the original projections, the number of pre- scriptions provided has grown pro- portionally. As UIHC continues to provide pharmaceutical care services without reimbursement, a number of tactics have been employed to en- sure that drug costs are kept in check without compromising patient care. Extensive pharmacist involvement with the UIHC medical team has also been a key to the success of the generic-only formulary. Optimized drug purchasing. As a disproportionate-share hospital eligible to participate in the federal 340B Drug Pricing Program, UIHC has been able to implement changes in purchasing practices to capitalize on 340B contracts. This has been key in ensuring the provision of the lowest-cost medication services. During the initial years of the pro- gram, staff education regarding con- tract and inventory issues helped to promote a general awareness of the importance of cost control among all pharmacy staff. Pharmacists and technicians who previously had little involvement in medication order- ing or inventory are now asked to inform UIHC management of cases in which they nd more-affordable options available. Largely as a result of the programs ongoing emphasis on cost control, the average drug cost per prescription lled dropped from $16.06 in 2007 to $8.64 in 2011 (Fig- ure 1); by comparison, in 2008 the national average retail prescription cost was $71.69, with an average drug cost of $59.50. 5 PRACTICE REPORTS Pharmaceutical care program 1228 Am J Health-Syst PharmVol 69 Jul 15, 2012 Formulary management. As at other large hospitals, UIHC formu- lary maintenance is primarily driven by inpatient needs. The IowaCare outpatient formulary was origi- nally intended to include all generic medications on the UIHC formulary and a 30-day supply of brand-name medications (as a bridge to MAP approval or other payment arrange- ments). Applying this inpatient-style formulary to an outpatient popula- tion has not consistently t with the goals of preventing rehospitalization, meeting patient needs, and manag- ing IowaCare Prescription Program costs. A number of exceptions in coverage have been made to close coverage gaps. For example, the large number of patients with diabetes and associated long-term complications has neces- sitated the coverage of brand-name insulins, syringes, blood glucose meters, and testing supplies. Specic brands of insulin and supplies were added to the formulary. The very selective use of a few brand-name medications has been considered im- portant enough in preventing rehos- pitalization that they are provided indenitely until a MAP supply is received. To ensure the optimization of 340B contract pricing, a brand preferred over generic list was estab- lished and is continuously updated. This list allows the dispensing of brand-name drugs if they are avail- able through the 340B program at prices lower than those of equivalent generics. Medication prole reviews. With increasing numbers of patients seen in UIHC primary care clinics, thor- ough medication reviews are difcult but crucial. Many patients new to the program are using a long list of medi- cations reecting local provider pref- erences or whatever samples could be provided. Before forwarding requests for MAP applications to the social work staff, a pharmacist or pharmacy student completes a prole review, looking for opportunities to switch patients from brand-name products to lower-cost therapeutically equiva- lent alternatives and working with providers to implement changes; this provides for consistency of treatment and avoids time spent on unneces- sary MAP applications. Refill mail-out program. Iowa- Care patients travel to UIHC from as far as six hours away by car, so the need to mail rells was immediately apparent to prescription program leaders. The initial estimate of mail- ing costs was based on a projected average mailing fee of $8 per pack- age and an anticipated volume of approximately 52,500 packages per year. That estimate proved to be high, with the maximum number of packages mailed and shipped reach- ing about 25,000 during scal year 2007 at an average cost of $4.21 per package. Copayments and mailing fees. By the end of the programs 2008 scal year, the number of IowaCare pre- scriptions lled annually exceeded the predicted number of 150,000 by almost 50,000. Filling almost 200,000 IowaCare prescriptions and mailing over 25,000 packages that year posed a number of challenges. UIHC phar- macy leaders decided that a greater patient accountability was needed, as concerns regarding hoarding and inappropriate use had surfaced. In early 2009, IowaCare ofcials began planning for the implemen- tation of a new requirement that patients make copayments and pay mailing and shipping fees. As the program receives no state funding, decisions regarding specic copay- ment amounts and mailing charges were determined by pharmacy and hospital leadership. It was decided that patients would be charged $4 per prescription up to a limit of $20 per calendar month. Shipping fees of $5 for regular mail and $10 for overnight or special shipping were applied. The logistics of billing and collection, as well as ways of handling cases of inability to pay, had to be determined. Effective on March 1, 2009, the copayment plan was put into place. In addition to increasing patient accountability and helping Figure 1. IowaCare Prescription Program cost per prescription in scal years 200711 (the scal period is July 1June 30 for all years except 2006; that year, the program reporting period began on August 14). Fiscal Year C o s t
( $ ) 2007 2008 2009 2010 2011 Drug cost per prescription Average cost per prescription minus average copayment paid 0 16 12 10 8 6 18 14 2 4 PRACTICE REPORTS Pharmaceutical care program 1229 Am J Health-Syst PharmVol 69 Jul 15, 2012 to address real or perceived system abuses, the copayments and mail-out fees helped reduce program costs by approximately $600,000 in the most recent scal year (2011). Implementation of the copayment requirement brought challenges as well as benets. Initially, the number of billing statements sent to patients increased dramatically, and some patients were unable to afford the modest copayments. The pharmacy departments existing collections policy was reviewed and adjusted to ensure that it did not adversely affect the hospitals bad debt. Under the re- vised policy, patients with any history of bad debt are placed on cash-only status and must prepay before medi- cations are mailed or shipped. Co- ordination with the hospitals social services department has helped pre- vent any delays in patient discharges due to inability to pay. The education of all staff regarding pharmacy busi- ness ofce policies, coupled with the consistent application of the collec- tions policy, has helped stabilize the number of statements and accounts payable. Current challenges The number of IowaCare enrollees has far exceeded the number predict- ed in 2005. It was originally predicted that IowaCare would cover 14,000 individuals; to date, over 72,600 indi- viduals have been covered. A number of factors have contributed to this increase, including the economic recession and the historic Iowa City ooding that resulted in job losses in 2008. Moreover, during the depths of the recession in 2008, UIHC experi- enced a budget crisis. Already strug- gling with increases in the number of IowaCare patients and the prescrip- tion volume, the pharmacy was forced to deal with a reduced person- nel budget and resulting decreases in staff. Those pressures forced a review of the pharmacys workload, and it was decided that medications for chronic illnesses would be pro- vided in 60-day rather than 30-day supplies; the increased supply quan- tity decreased the total number of prescriptions (temporarily) and the number of mail-outs. Even with the increase in patient numbers, the management of the UIHC prescription benet has en- sured the continued provision of care. Based on the original projec- tions (a program cost of $5.18 mil- lion per year initially, with a conser- vative estimate of 7% annual growth in prescription volume), current pro- gram costs were expected to be about $6.8 million annually; instead, more patients are being served at a cost of $3.4 million per year. As the result of vigilance in formulary and contract management, program medication costs have decreased by nearly 50% (from $2.6 million in fiscal year 2009 to $1.3 million in scal year 2011; Figure 2). Active medication management by clinical pharmacists at the patient level, collaboration among care providers (physicians, pharmacists, and social workers), and prudent business practices have all contributed to the continued suc- cess of the program. The impact of the prescription benet program in terms of patient outcomes and cost avoidance is more difcult to quantify. Relative to a hypothetical scenario in which IowaCare (or other uninsured) patients had continued to access UIHC emergency room and other hospital care at the rate seen in 2006 (66% utilization), it could be reason- ably inferred that many millions of dollars in cost savings have resulted from implementation of the pro- gram. More important, patients with chronic medical conditions such as diabetes and hypertension are receiv- ing more consistent treatment, which should ultimately help reduce associ- ated morbidity and mortality. Current and future challenges The IowaCare Medicaid dem- onstration waiver was renewed for the period October 2010December 2013 and updated to include chang- es designed to facilitate compli- ance with new federal health re- Figure 2. IowaCare Prescription Program costs and revenues in scal years 200711 (the scal period is July 1June 30 for all years except 2006; that year, the program reporting period began on August 14). UIHC = University of Iowa Hospitals and Clinics. Fiscal Year C o s t
( $
M i l l i o n s ) 0 4.5 3.5 3.0 2.5 2.0 1.5 5.0 4.0 0.5 1.0 2007 2008 2009 2010 2011 Drug cost Shipping cost Personnel cost Total cost to UIHC Copayment and mailing fee revenues PRACTICE REPORTS Pharmaceutical care program 1230 Am J Health-Syst PharmVol 69 Jul 15, 2012 form requirements. Implemented or planned changes include expanding the program to medical homes based at 8 of the states 13 Federally Qualied Health Centers, including UIHC and Broadlawns Medical Cen- ter. Two new medical homes were created in 2010. While many patients reassigned to the new medical homes have beneted from reduced travel times to IowaCare facilities, some have experienced difculties secur- ing appointments, while changes in medication formularies and program guidelines have posed challenges for other patients. To ease the transi- tion, it was decided that the program would honor all valid medication rells until transferred patients es- tablish relationships with their new care providers. UIHC is officially designated to serve as a medical home for the county in which it resides, as well as the nine surrounding counties. However, until the Iowa Medicaid program opens the additional medi- cal homes that are planned, UIHC continues to provide coverage to all IowaCare patients in the state not otherwise assigned to a medical home. More than six years after imple- mentation of the prescription pro- gram, a number of challenges and opportunities are evident. The billing of assigned copayments and mailing charges has been a manual process; as this program is unique to UIHC and not funded from outside sources, available solutions have so far been limited. We believe that the provision of pharmaceutical care to this patient population has improved outcomes in a number of ways, but mecha- nisms for tracking and measuring outcomes are needed. Continuity of care continues to be an issue, as some patients continue to seek a portion of their care from outside providers and others are being sent to medi- cal homes other than the one on the UIHC campus. However, we see all of these challenges as opportunities for improvement. With time and ef- fort, billing can be streamlined, out- comes can be measured, and better continuity of carean elusive goal at all points across the health care continuumcan be achieved. Conclusion The UIHC ambul atory care pharmacy implemented a prescrip- tion program in collaboration with social service workers to address the medication needs of the states low-income and uninsured patients in a fiscally responsible manner by managing purchasing contracts, revising a generic formulary, imple- menting copayments and mailing fees, and reviewing medication profiles. References 1. Dubay L, Cook A. How will the uninsured be affected by health reform? Non-elderly uninsured. Timely Analysis of Immediate Health Policy Issues. 2009; Aug:1-8. 2. Felland L, Reschovsky JD. More non- elderly Americans face problems affording prescription drugs. Center for Studying Health System Change Tracking Report. 2009; Jan(no. 22). 3. University of Iowa Hospitals and Clin- ics. Overview of the Indigent Patient Care Program: presented to the Board of Regents, State of Iowa (December 16, 2004). www.regents.iowa.gov/Meetings/ DocketMemos/04Memos/dec04/Indigent PatientCare.pdf (accessed 2012 Apr 4). 4. IowaCareIowas 1115 demonstration waiver: presentation to Health and Human Services Appropriations Subcommittee (February 10, 2011). www.legis.iowa.gov/ DOCS/LSA/SC_Material sDist/2011/ SDJRB027.pdf (accessed 2012 Apr 4). 5. Lundy J. Prescription drug trends. Kaiser Family Foundation. 2010; May:1-10. Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.