Outcomes of a Medicare Part D telephone medication therapy management program Leticia R. Moczygemba, Jamie C. Barner, and Evelyn R.

Transcription

1 RESEARCH Outcomes of a Medicare Part D telephone medication therapy management program Leticia R. Moczygemba, Jamie C. Barner, and Evelyn R. Gabrillo Abstract Objective: To determine the impact of telephone medication therapy management (MTM) on medication- and health-related problems (MHRPs), medication adherence, and total drug costs for Medicare Part D participants. Design: Quasiexperimental. Setting: Regional Medicare Part D plan in Texas in Participants: Medicare Part D beneficiaries who were MTM eligible. Intervention: Pharmacist-provided telephone MTM consultation. Main outcome measures: Change in MHRPs, medication adherence, and total drug costs from baseline to 12-month follow-up. Results: The intervention (n = 60) and control (n = 60) groups were similar in age (71.2 ± 7.5 years and 73.9 ± 8.0 years [mean ± SD], respectively), number of medications (13.0 ± 3.2 and 13.2 ± 3.4), chronic diseases (6.5 ± 2.3 and 7.0 ± 2.1), and medication regimen complexity index (21.5 ± 7.8 and 22.8 ± 6.9). Men made up 51% of the intervention group and 28% of the control group (P = 0.009). MHRPs at baseline were 4.8 ± 2.7 in the intervention group and 9.2 ± 2.9 in the control group, with 2.2 ± 2.0 and 7.3 ± 3.0 at the 12-month follow-up. MHRPs decreased (P = 0.01) in the intervention group. We found no predictors of change in medication adherence. Drug costs decreased by $682 ± 2,141 in the intervention group and increased by $119 ± 1,763 in the control group. A t test indicated that the cost difference was significant (P = 0.03), but the adjusted regression analysis did not identify any significant predictors. Conclusion: A telephone MTM program reduced MHRPs. Unadjusted cost comparisons showed cost savings in the intervention group. Future research should focus on understanding how telephone MTM affects medication adherence. Keywords: Medication therapy management, Medicare Part D, telephone, pharmacists, medication-related problems. J Am Pharm Assoc. 2012;52:e144 e152. doi: /JAPhA Received December 14, 2011, and in revised form June 29, Accepted for publication July 21, Leticia R. Moczygemba, PharmD, PhD, is Assistant Professor, School of Pharmacy, Virginia Commonwealth University, Richmond. Jamie C. Barner, PhD, is Professor, University of Texas, Austin. Evelyn R. Gabrillo, PharmD, is Clinical Pharmacist Specialist, Scott & White Health Plan Prescription Services, Temple, TX. Correspondence: Leticia R. Moczygemba, PharmD, PhD, School of Pharmacy, Virginia Commonwealth University, PO Box , Richmond, VA Fax: lrmoczygemba@vcu.edu Disclosure: The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: By the American Society of Health- System Pharmacists Foundation. Also supported in part by award no. KL2TR from the National Center for Advancing Translational Sciences. The contents of this article are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Acknowledgments: To Nishi Sarda Goel, PharmD, for assistance with data collection and to Paul Godley, PharmD; John Chaddick, BS, BSPharm; and the Scott & White Health Plan medication therapy management providers and staff for their support of this study. Previous presentation: International Society of Pharmacoeconomics and Outcomes Research Annual Meeting, May 21-25, 2011, Baltimore, MD. e144 JAPhA 52:6 Nov/Dec 2012

2 PART D TELEPHONE MTM RESEARCH The Medicare Modernization Act of 2003 mandated the provision of medication therapy management (MTM) for Medicare Part D beneficiaries with multiple chronic diseases, multiple Part D drugs, and high prescription drug costs. 1 When Medicare Part D was implemented in 2006, MTM was a new service for Medicare beneficiaries. However, MTM was not a new concept for pharmacists, who have been managing medications for diseases such as diabetes, hypertension, dyslipidemia, and asthma and identifying and resolving medication-related problems for more than 20 years Moreover, the explicit recognition of pharmacists as MTM providers by the Centers for Medicare & Medicaid Services (CMS) highlighted the pharmacist's role in medication management and served as a catalyst for advancing pharmacist services. 1 Since 2003, the pharmacy profession has made considerable progress in advancing MTM. In addition to defining MTM and creating an MTM framework, 18,19 pharmacists have been proactive in the development of MTM programs. Program delivery has varied from face-to-face to telephone to a combination of the two. 20 MTM has been provided in a variety of settings, including ambulatory care, community pharmacy, and safety net, and to both Medicare and non-medicare populations. 13,15,17,21 Overall, the impact of MTM programs has been positive, with At a Glance Synopsis: This study looked at the delivery of medication therapy management (MTM) services by telephone in a Medicare Part D plan in Texas, comparing intervention participants with a control group that chose not to have MTM. Effectiveness of MTM was measured by looking at changes in medication- and health-related problems, medication adherence, and total drug costs from baseline to a 12-month followup. Intervention participants were significantly more likely than the control group to have a resolution of medication therapy problems, indicating that telephone MTM can be an effective way to deliver the service. In addition, participants in the intervention group saw an overall decline in drug costs. Analysis: Part of this study was focused on outcomes central to patient health, such as medication problems or adherence. Validation of the effectiveness of telephone MTM is clearly important for several reasons, including patient convenience, patient access, use of pharmacist resources, and the fact that Medicare Part D, in requiring MTM, permits the telephone as one method of delivery. Insurance companies, the government, and the health care field in general are looking for ways to reduce costs, and as telephone MTM showed a capacity in this study to contain drug costs, it is worth further investigation. Any method that can simultaneously benefit patients and reduce costs should be explored. multiple studies reporting improvements in clinical and economic outcomes. 3,4,11,15,22,23 MTM was also included in the health care reform legislation and has been recognized as an integral component of the medical home model by the Patient-Centered Primary Care Collaborative. 24 Further, a recent report highlighted the positive impact of MTM in a call for recognition of pharmacists as health care providers. 25 All of the 2011 Medicare Part D MTM programs used the telephone as one way to deliver MTM 20 ; therefore, understanding the impact of telephone MTM is important. Telephone MTM programs for Medicare Part D patients have been reported to improve efficacy and safety of medication regimens 26 and reduce drug costs Providing MTM via the telephone may be an effective alternative to face-to-face MTM services, particularly if pharmacy/pharmacist resources are limited or if patient conditions such as poor physical functioning or transportation barriers prevent provision of face-to-face MTM. This study reports 12-month outcomes, with an emphasis on resolution of medication- and health-related problems (MHRPs), medication adherence, and total Part D drug costs from the Scott & White Health Plan (SWHP) telephone MTM program for Medicare Part D patients. Objectives The objectives of this study were to (1) describe the type and number of MHRPs identified and resolved by pharmacists during a telephone MTM consultation, (2) determine whether patients receiving MTM services (intervention group) had improved resolution of MHRPs compared with patients who did not receive MTM services (control group), (3) determine whether the intervention group had improved medication adherence compared with the control group, and (4) determine whether the intervention group had decreased total Part D drug costs compared with the control group. Methods MTM intervention In 2007, SWHP provided a telephone MTM program that was developed by the SWHP MTM coordinator in collaboration with physicians and other health professionals. 29 The opt-in MTM program was provided internally to eligible beneficiaries by SWHP pharmacists according to an established program protocol based on the MTM framework created by the American Pharmacists Association and National Association of Chain Drug Stores Foundation. 19 Because the pharmacists were already employees of SWHP, they were not reimbursed separately, as the payment for MTM was included as an administrative fee in the plan bid. The foundation of the MTM consultation was a comprehensive medication therapy review conducted via telephone by the SWHP pharmacist. The review was individualized based on the patient's needs. The medication review included assessing, identifying, and resolving medication therapy problems related to appropriateness, effectiveness, adherence, cost, and safety. The categories for medication-related problems were cost-related/formulary interchange, potential or actual drug interaction, drug needed but not prescribed, N ov/dec :6 JAPhA e145

3 RESEARCH PART D TELEPHONE MTM dose, efficacy, schedule/duration, prescribed drug not needed, adverse effects, medication adherence, therapeutic duplication, and safety. Education needs regarding medications and/or disease management were also assessed. A unique component of the program was its emphasis on conducting a comprehensive review of preventive care needs as well as medicationrelated problems. The U.S. Preventive Task Force Recommendations were used to guide the preventive care assessment, which included a review of whether patients were up to date with immunizations (tetanus, influenza, and pneumococcal), comprehensive metabolic profile, sigmoidoscopy/colonoscopy, mammography/breast exam, depression screening, cholesterol screening, liver function tests, thyroid-stimulating hormone test, and dual x-ray absorptiometry scan. Diabetes preventive care needs, which included making sure eye and foot exams and urine creatinine labs were up to date, were also assessed. Follow-up was determined on a case-by-case basis and individualized based on a patient's needs. The MTM consultation was documented in a customized SWHP database created by the MTM coordinator and an information systems programmer. 29 Following the MTM consultation, patients were mailed a personal and portable medication record for self-management. Patients were also mailed a medication action plan that contained patient-tailored information for the patient to use in optimizing medication and health self-management. The action plan also reinforced education provided during the MTM consultation by including educational materials when applicable. Patients were encouraged to voluntarily share the medication record and action plan with health care providers to enhance continuity of care and help ensure that the provider was aware of the patient's most current MHRPs. The interventions included working with the patient and/or caregiver on patient-specific problems or communicating with physicians or other health care providers about the opportunities to resolve existing or potential MHRPs. Beneficiaries who had two or more chronic diseases, were taking two or more Part D medications, and incurred at least $1,000 in Part D costs per quarter were eligible for SWHP's MTM program. Approximately 18,000 beneficiaries were enrolled in SWHP's Medicare Part D Plan in 2007 and, of these, 1,999 were eligible for MTM and 123 beneficiaries received MTM services. Study design and sample This study used a quasiexperimental design for comparing the change in the number of MHRPs, change in medication adherence, and change in total Part D drug costs between the intervention and control groups from baseline to a 12-month followup. All SWHP Medicare Part D beneficiaries who received an MTM consultation from a SWHP pharmacist in 2007 (n = 123) were targeted and invited to participate in the study at the end of the MTM consultation. In addition to meeting SWHP's MTM eligibility criteria, beneficiaries in the intervention group had to verbally consent to participate in the study and consent to the use and disclosure of protected health information. Beneficiaries 90 years or older were excluded from the study due to patient privacy concerns. MTM was conducted over the telephone one time during the study period. Recruitment for the study began in May 2007 and lasted until January The intervention group consisted of patients who voluntarily enrolled in the SWHP MTM program and received at least one MTM consultation during the period from May 2007 to January The control group consisted of patients who were eligible to receive MTM but did not enroll in the program. To control for selection bias and baseline differences, intervention and control groups were matched by the number of chronic diseases and Part D drugs. Data collection in the intervention and control groups occurred via retrospective review of the electronic medical record (number of MHRPs) and secondary database analysis of prescription claims (medication adherence and total Part D drug costs). The study was approved by the University of Texas, Virginia Commonwealth University, and SWHP institutional review boards. MHRPs: Intervention group The pharmacist reviewed the patient's electronic medical record, which consisted of medical history, medications, physician notes, laboratory reports and prescription claim records, to identify potential MHRPs to discuss with the patient (i.e., preassessment). MHRPs were further assessed in the intervention group during the MTM telephone consultation (i.e., assessment). During the telephone consultation, problems identified in the chart review were confirmed and additional MHRPs were assessed. The pharmacist then made recommendations to the patient for resolution of MHRPs. The personal medication record and medication action plan were mailed to each patient after the MTM consultation. When necessary, the patient followed up with his/her physician for recommendations such as a medication change. The duration of the MTM consultation was an estimated 45 to 140 minutes for MTM preassessment, assessment, and documentation, with an average of 75 minutes spent per patient. The number of problems was assessed at baseline and at the 12-month follow-up. The change in MHRPs was defined as the difference in the number of MHRPs from baseline to follow-up. The electronic medical record and prescription claims were used to determine resolution of MHRPs. Only medication therapy related problems identified at baseline were evaluated at the follow-up. Recommendations that were not accepted were considered as a failure to resolve the MHRP. A detailed description of the MHRPs has previously been reported. 29,30 MHRPs: Control group The assessment of MHRPs in the control group was conducted retrospectively via review of the electronic medical record. The identification of MHRPs was the same procedure used in identifying initial problems (i.e., preassessment) in the intervention group. To ensure consistency in evaluating MHRPs in the intervention and control groups via chart review, the researcher (also a pharmacist) was trained by the SWHP MTM coordinator who conducted MTM consultations in the intervention group. Because the control group did not receive a telephone intervention with the SWHP pharmacist, only the following MHRP e146 JAPhA 52:6 Nov/Dec 2012

4 PART D TELEPHONE MTM RESEARCH subsets were evaluated in the intervention and control groups: therapeutic duplication, cost/formulary interchange, dose, drug interactions, and preventive care needs. The number of MHRPs was recorded and measured at baseline and at the 12-month follow-up. Medication adherence Medication adherence was assessed in the intervention and control groups by examining refill history using SWHP's prescription claims database. The medication possession ratio (MPR) was used to measure adherence at baseline (12 months preintervention) and at the 12-month follow-up (12 months postintervention). An average MPR was calculated. The following formula was used to calculate the MPR for each medication at baseline and 12-month follow-up: sum of each day's supply of prescription medications during the 12-month preintervention period divided by that during the 12-month postintervention period The MPRs then were summed, and finally, the MPR sum was divided by the number of medications to calculate the average MPR for each study participant. The change in medication adherence was measured as the difference in MPR from baseline to 12-month follow-up. Total Part D drug costs Prescription claim records were used to obtain the total cost of all Part D drugs, which included the amount paid by the SWHP Part D program and the patient copay, filled during the study period. The sum of the total Part D drug costs at baseline (12 months preintervention) and follow-up (12 months postintervention) was calculated. The change in total Part D drug costs from baseline to follow-up was calculated from baseline to the 12-month follow-up. All costs were adjusted for inflation to U.S. January 2009 dollars. Independent variable and covariates The primary independent variable in this study was MTM use (yes/no), and it distinguished the intervention and control groups. Sociodemographic covariates included age, gender, and race. Health-related covariates were number of medications, number of chronic diseases, and medication regimen complexity. The medication regimen complexity index (MRCI) 34 was used to determine medication regimen complexity in the intervention and control groups. The MRCI was calculated only for prescription medications in both groups. All sociodemographic and health-related variables were continuous, with the exception of gender and race. Data analysis Descriptive statistics were calculated for all study variables. Bivariate analyses (t tests for continuous variables and chisquare tests for categorical variables) were performed to assess baseline differences between the intervention and control groups. Because some categories of race had less than five observations, race was collapsed into two categories: white and nonwhite, to avoid violating a chi-square assumption. Three separate multiple regression models were used to identify predictors of change in MHRPs, medication adherence, and total Medicare Part D drug costs from baseline to 12-month followup. The data for the variable change in Part D drug costs were normally distributed; therefore, transformation of the data was not necessary. The a priori significance level was Results Of the 123 beneficiaries who met the Medicare Part D criteria, 95 also met the study inclusion criteria. Of those eligible for the study, 60 were enrolled, resulting in a 63% enrollment rate. Reasons for declining to participate included preference and breach of confidentiality. Sociodemographic and health-related variables Table 1 displays the sociodemographic and health-related characteristics of the intervention and control groups. The mean (±SD) age of participants in the intervention group was 71.2 ± 7.5 years, and the majority were white (78.3%) and male (51.7%). Members of the intervention group were taking 13.0 ± 3.2 medications, had 6.5 ± 2.3 chronic diseases, and had an MRCI of 21.5 (range 8 43). The three most common diseases were hypertension (95.0%), dyslipidemia (77.0%), and diabetes (55.0%). Control group participants were aged 73.9 ± 8.0 years, and the majority were also white (91.7%). Only 28.3% were male in the control group. Members of this group were taking 13.2 ± 3.4 medications, had 7.0 ± 2.1 chronic diseases, and had an MRCI of 22.8 (range ). The three most common diseases in the control group also were hypertension (95.0%), dyslipidemia (86.7%), and diabetes (60.0%). With the exception of gender (P = 0.009), no significant baseline differences between the two groups were found. MHRPs A total of 357 MHRPs were identified at baseline in the intervention group, and 62% (220 of 357) were considered resolved (i.e., recommendations accepted) at the 12-month follow-up. Pharmacists identified 6.0 ± 2.9 MHRPs per patient at baseline, and this number decreased to 2.3 ± 2.0 MHRPs at the 12-month follow-up, corresponding with an average of 3.7 problems resolved per patient. The most common problem was cost related, with 85% of patients having at least one costrelated problem and 42% having three or more cost-related problems. At least one (range 0 7) preventive care need was identified in 78% of participants, and a need for disease management education was identified in 52% of the study participants in the intervention group. A potential drug interaction was identified in 27% of participants. The most common type of pharmacist recommendation was medication related (51%), followed by preventive care (28%), and education (21%). For the subset of problems that was assessed in both groups, the intervention group had 4.8 ± 2.7 MHRPs at baseline and 2.2 ± 2.0 problems remained at the 12-month follow-up. In contrast, the control group had 9.2 ± 2.9 MHRPs identified at baseline and 7.3 ± 3.0 problems remained at the 12-month follow-up. All of the participants in the control group had at least one preventive care need identified, and approxi- N ov/dec :6 JAPhA e147

5 RESEARCH PART D TELEPHONE MTM Table 1. Sociodemographic and health-related characteristics of Medicare Part D beneficiaries in the intervention and control groups Characteristic Intervention Mean ± SD Control Mean ± SD n Age (years) 71.2 ± ± 8.0 No. of chronic conditions at baseline 6.5 ± ± 2.1 No. of medications at baseline 13.0 ± ± 3.4 Medication regimen complexity a 21.5 ± ± 6.9 Gender, no. (%) Men 31 (51.7) 17 (28.3) Women 29 (48.3) 43 (71.7) Race, no. (%) b White 47 (85.5) 55 (91.7) Nonwhite 8 (14.6) 5 (8.3) a Medication regimen complexity was measured using the medication regimen complexity index. 34 b Race was missing for five participants in the intervention group. mately 70% had five or more preventive care needs. At least one cost-related problem was identified in 92% of participants, and 55% had three or more cost-related problems. One-third of participants in the control group had a potential drug interaction identified during the review. The multiple regression indicated that the difference in MHRPs measured from baseline to 12-month follow-up was statistically significantly larger in the intervention group (P = 0.01) compared with the control group after adjusting for the other variables in the model. No other significant predictors of problems were found. Table 2 summarizes the type and number of problems identified in the intervention and control groups, Table 3 describes the type and number of pharmacist recommendations for the intervention group, and Table 4 reports the multiple regression results. Medication adherence and total Part D drug costs MPR was similar in the intervention and control groups at baseline (0.53 ± 0.15 and 0.55 ± 0.18, respectively) and was relatively unchanged (0.51 ± 0.18 and 0.57 ± 0.17) at the 12-month follow-up. The multiple regression analysis did not identify any significant predictors of change in medication adherence. The Part D drug costs in the intervention group were $4,619 ± 1,746 at baseline and decreased to $3,938 ± 1,022 at 12-month follow-up, resulting in a cost savings of $681 per patient annually. In the control group, Part D drug costs were $4,723 ± 2,520 at baseline and increased by $119 (to $4,842 ± 3,405) at 12-month follow-up. A t test indicated a significant difference in the change in drug costs between the intervention and control groups (P = 0.03), but when sociodemographic, health-related, and use variables were controlled for in the multiple regression analysis, no significant predictors of the change in drug costs were seen. Table 2. Type and number of MHRPs for Medicare Part D beneficiaries in the intervention (n = 60) and control (n = 60) groups at baseline Intervention No. (%) Control a No. (%) Medication-related problems Cost-related/formulary interchange 133 (66.8) 178 (83.6) Potential or actual drug interaction 25 (12.6) 21 (9.9) Drug needed but not prescribed 11 (5.5) Dose 7 (3.5) Efficacy 6 (3.0) 7 (3.3) Schedule/duration 4 (2.0) Prescribed drug not needed 3 (1.5) Adverse effects 3 (1.5) Medication adherence 3 (1.5) Therapeutic duplication 2 (1.0) 2 (0.9) Safety 2 (1.0) 5 (2.3) Total 199 (99.9) b 213 (100.0) Preventive care problems Tetanus immunization 21 (18.3) 40 (12.0) Thyroid-stimulating hormone laboratory 14 (12.2) 13 (3.9) Urine albumin to creatinine ratio (patients with diabetes) 13 (11.3) 27 (8.1) Sigmoidoscopy/colonoscopy 12 (10.4) 32 (9.6) Diabetic eye exam 11 (9.6) 32 (9.6) Pneumococcal immunization 10 (8.7) 27 (8.1) Diabetic foot exam 8 (7.0) 20 (6.0) Influenza immunization 6 (5.2) 54(16.3) Cholesterol panel 4 (3.5) 10 (3.0) Mammography/breast exam 4 (3.5) 23 (6.9) Depression screening 4 (3.5) 23 (6.9) Dual-energy X-ray absorptiometry scan 3 (2.6) 22 (6.6) Comprehensive metabolic profile 3 (2.6) 3 (0.9) Liver function test 2 (1.7) 6 (1.8) Total 115 (100.1) b 332 (99.7) b Education needs Diabetes management 21 (48.8) Medication related 8 (18.6) Over-the-counter medications 5 (11.6) Other disease management c 9 (20.9) Total 43 (99.9) b Total no. of MHRPs All problems 357 Subset of problems Abbreviation used: MHRP, medication- and health-related problem. a Because the pharmacist did not have direct interaction with the control group, only a subset of problems were evaluated in the control group. b Percentages do not add up to 100% because of rounding. c Other disease management included education related to coronary obstructive pulmonary disease, epilepsy, osteoporosis, restless leg syndrome, hypertension, Sjogren s syndrome, constipation, urinary frequency, and smoking cessation. e148 JAPhA 52:6 Nov/Dec 2012

6 PART D TELEPHONE MTM RESEARCH Table 3. Type and number of pharmacist recommendations for 60 Medicare Part D beneficiaries in the intervention group a No. (%) Medication-related recommendations Patient assistance program or coupon 76 (41.3) Change drug 58 (31.5) Laboratory monitoring for efficacy or safety 31 (16.8) Change dose 6 (3.3) Discontinue drug 5 (2.7) Change schedule/duration 5 (2.7) Add drug 3 (1.6) Total 184 (99.9) b Preventive care recommendations Tetanus immunization 21 (18.1) Thyroid-stimulating hormone laboratory 14 (12.1) Urine albumin to creatinine ratio 14 (12.1) Sigmoidoscopy/colonoscopy 12 (10.3) Diabetic eye exam 11 (9.4) Pneumococcal immunization 10 (8.6) Diabetic foot exam 8 (6.9) Influenza immunization 6 (5.2) Cholesterol panel 4 (3.4) Mammography/breast exam 4 (3.4) Depression screening 4 (3.4) Dual-energy X-ray absorptiometry scan 3 (2.6) Comprehensive metabolic profile 3 (2.6) Liver function test 2 (1.7) Total 116 (99.8) b Education recommendations Total 75 (100.0) Total no. of recommendations 375 a Some problems had more than one recommendation. b Percentages do not add up to 100% because of rounding. Discussion This study demonstrated a significant difference in the number of problems resolved and, in the unadjusted analysis, an annual drug cost savings for beneficiaries who participated in a telephone MTM consultation. Given that all Part D plans are using the telephone as one method of MTM delivery, 20 telephone services will likely continue to have a role in MTM. Benefits of telephone services include increased efficiency of use of pharmacy personnel 35 and increased access for participants with transportation barriers or who live in rural areas. 36 In fact, one pharmacist-managed dementia telephone clinic that initially began as face-to-face changed the delivery method to meet the needs of rural participants and those with transportation burdens. 36 SWHP MTM participants are reported to like the convenience of the telephone, 37 and this preference has been noted by others who have participated in services provided by a pharmacist via the telephone. 35,36 Further, one study compared participants in a face-to-face (n = 78) and telephone (n = 79) pharmacist-provided lipid clinic and found that the percentage of participants who met their low-density lipoprotein goals was similar in both groups (74% and 78%, respectively). 35 Despite the benefits of telephone delivery, clinically complex participants with many medications may receive the most benefit from face-to-face services. An initial face-to-face visit with telephone follow-up visits could be an effective delivery model. As MTM evolves, studying and developing criteria that MTM programs can use to determine participants who should receive telephone services, face-to-face services, or a combination of the two will be important. This distinction would help maximize MTM resources and meet patient needs. Only 6% of eligible beneficiaries were enrolled in the SWHP Part D MTM program, which is lower than previous reports of participation rates in Part D opt-in programs that reported average participation ranging from 14% to 18%. 38 This lack of participation is concerning because participants were not required to pay an additional fee to participate in Part D MTM. The low uptake of MTM may have been a result of the lack of familiarity with the program or program marketing. CMS now mandates an opt-out enrollment for Part D MTM programs; however, patients must still choose to participate in the program. Therefore, seeking feedback from patients to develop and test marketing tools may help improve patient uptake of services. MHRPs The most common type of problem identified by SWHP pharmacists was related to cost, which differs from other studies that have identified a need for additional drug therapy 13,15,22,23 to be one of the most common medication-related problems. In our study, these findings were not surprising because pharmacists who provided MTM observed that many participants were interested in learning about cost alternatives and how to maximize their Part D benefit during their encounters. The interest in cost savings and the Part D benefit may have been due to the newness of the Medicare Part D program in However, these results coincide with other studies that reported cost-related problems were commonly addressed during Part D pharmacist consultations. In fact, one study found cost-related recommendations to be the second most common pharmacist intervention for a group of Part D beneficiaries who received MTM via the telephone. 39 Another study evaluated the potential impact of pharmacists reviewing Medicare Part D beneficiaries drug regimens for potential therapeutic substitutions and determined that 54% (27 of 50 participants) had possible therapeutic substitutions that could save an estimated $1,300 per year in Part D drug costs. 36 Another telephone MTM program for Part D beneficiaries included a review of medications for cost effectiveness as part of the protocol but did not report how many medication changes resulting from cost were made. 26 Similarly, one Part D plan used their formulary to optimize drug costs by making recommendations such as generic substitutions when appropriate. 28 Because cost appears to be a concern for patients, pharmacists can work with them to identify potential cost savings alternatives and opportunities to avoid the coverage gap or enter the gap later in the year. 40 Al- N ov/dec :6 JAPhA e149

7 RESEARCH PART D TELEPHONE MTM Table 4. Multiple regression of variables predicting change in MHRPs from baseline to 12-month follow-up Variable Parameter estimate (b) t P Intercept Intervention group (MTM use) a Age Female Nonwhite No. of medications No. of chronic diseases Medication regimen complexity Abbreviation used: MTM, medication therapy management. F statistic = 2.11, df = 7, model P value = , R 2 = 0.12, adjusted R 2 = a Statistically significant at P < though the recent health care reform legislation has provisions to close the gap in prescription drug coverage for Part D beneficiaries, it will not be completely closed until During MTM encounters, pharmacists can help patients navigate their Part D plans in order to maximize the benefits. Preventive care needs were commonly identified in both groups, although a low number of preventive care problems were resolved in the intervention group. Given the emphasis on preventive care during the MTM consultation, the low uptake of pharmacist recommendations for preventive care problems was disappointing. A telephone reminder may have improved resolution. In fact, in 2010, CMS expanded MTM program requirements to include ongoing monitoring with reviews at least quarterly, which is likely to improve resolution of problems. Also, participants may not have had previous experience with a pharmacist involved in their preventive care. Nonetheless, preventive care provides an opportunity to expand the pharmacist's roles and responsibilities on health care teams. The Affordable Care Act expanded preventive care coverage for Medicare beneficiaries to include an annual wellness visit that assesses preventive care needs according to the U.S. Preventive Services Task Force guidelines and recommendations. Physicians, physician assistants, nurse practitioners, and clinical nurse specialists and other health professionals such as pharmacists working under direct physician supervision can bill for these services. Medication adherence and total Part D drug costs An MPR of 0.8 or more is commonly accepted as a measure of good adherence. 41,42 In this study, participants in the intervention and control groups had an average MPR of about 0.5 at baseline and this remained stable at the 12-month follow-up. We expected that adherence would increase in the intervention group following the MTM consultation. These results were also surprising considering that medication adherence was not identified as a common problem during the MTM consultation. Participants in both groups may have been using $4 generic programs at local pharmacies when applicable. Also, SWHP pharmacists recommended patient assistance programs during MTM encounters in the intervention group, which may have affected the MPR in the follow-up period. Because patients may obtain medications from sources that are not able to be tracked by administrative claims, it would be useful to document the source of each medication during the consultation. Other studies that have evaluated telephone MTM programs for Part D participants have not included medication adherence as an outcome measure. One of the goals of Part D MTM is to improve medication adherence. Therefore, future research should focus on measuring medication adherence and consider factors such as $4 generic medications when designing the study. Although the adjusted model with the addition of the covariates did not reach statistical significance, the practical importance of saving $682 per patient per year ($57 monthly) should not be overlooked. In our study and others, 26,28,36,39 pharmacists addressed cost-related concerns during MTM consultations, which may suggest that during Part D MTM consultations, emphasis should be given to reviewing medications for cost-saving alternatives. This emphasis on cost is further supported by cost savings in another study that reported a $40 per month cost savings for 12,196 Medicare Part D patients who participated in a telephone MTM service in a community pharmacy setting. 27 In that study, cost savings were higher ($40 vs. $29) in the telephone group than in the face-to-face group (n = 9,140) in the same setting. 27 These studies only considered Part D drug costs. Other costs such as the impact of MTM on overall health care costs and return on investment are important to payer stakeholders and warrant further examination. Limitations This study reports outcomes from a regional Part D telephone MTM program; therefore, these results may not be generalizable to all Part D plans or plans that deliver face-to-face MTM. Despite this limitation, our results support telephone MTM as having a positive impact on medication-related problems, which is important because all Part D plans are using the telephone as one method of MTM delivery. The intervention did not target a specific condition; therefore, evaluating conditionspecific measures was beyond the scope of this study. As all eligible beneficiaries must be offered the opportunity to participate in Medicare Part D MTM programs, randomization was not possible in this study. However, a control group was used e150 JAPhA 52:6 Nov/Dec 2012

8 PART D TELEPHONE MTM RESEARCH to assess the impact of the intervention on study outcomes. Although matching was used to help address selection bias, those who opted into the MTM program may be more proactive about their health and seeking preventive care services compared with those who did not enroll in the program. Maturation bias is also a concern because participants in the intervention group may have been more comfortable managing their problems over time. Further, the retrospective identification of MHRPs in the control group did not allow for confirmation of the problems with participants. To address this limitation, only a subset of problems was evaluated for the comparison between the intervention and control groups. However, the number of problems identified in the control group may be overestimated, as some of the problems might have been potential instead of actual problems. We were not able to capture medical record or prescription claim information for services external to the SWHP system, which is an inherent limitation to using secondary and administrative data. In particular, this lack of information may have affected calculation of the MPR if participants were using $4 generics at local pharmacies. In addition participants may have received vaccinations at influenza clinics or pharmacies in their respective communities. Conclusion A telephone MTM program decreased MHRPs in Medicare Part D beneficiaries. Part D drug cost savings among the intervention group were observed in the unadjusted analysis. Although preventive care recommendations had a low uptake in this study, opportunities to expand the pharmacist's role in preventive care, such as those included in the health care reform legislation, should be explored. Further research is needed to quantify the impact of telephone MTM on medication adherence. References 1. 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