Julie A. Schmittdiel, PhD

To examine the impact of enrolling in a healthcare plan through the Affordable Care Act (ACA) healthcare exchanges on self-reported access to care. 

Cohort study using self-reported data of patients newly enrolled in Kaiser Permanente California and Kaiser Permanente Colorado through the ACA healthcare exchanges for coverage beginning January 1, 2014. 

 Baseline and follow-up surveys conducted via mail and telephone, with response rates of 45% and 51%, respectively. 

 We found significant increases in the percentage of people who reported having a personal healthcare provider (59% vs 73%; 

 <.01) and significant decreases in those who reported delaying needed medical care due to costs (37% vs 25%; 

 <.01) before and after ACA enrollment. There was also a significant increase in the percentage of patients who reported receiving a flu shot during the prior year (41% vs 52%; 

 <.01). Among the people who reported having less than 4 months of healthcare coverage in 2013, these improvements were even more pronounced. This group also showed significant increases in the percentages who felt they had a place to go when they needed medical care (43% vs 56%; 

 <.01) and who reported they received advice to quit smoking or using tobacco (46% vs 72%; 

These findings are an important addition to the evidence base that the ACA is improving the healthcare experience and reducing barriers due to costs for individuals obtaining insurance coverage through the healthcare exchanges.

Among patients newly enrolling in Kaiser Permanente California and Colorado through the Affordable Care Act (ACA) healthcare exchanges, we found: 

		Significant increases in the percentage of people who reported having a personal healthcare provider. 

		Significant decreases in the percentage of people who reported delaying needed medical care due to costs.

		Significant increases in the percentage who felt they had a place to go when they needed medical care and who received advice to quit smoking.

These findings are an important addition to the evidence base that the ACA may be improving access to care for people obtaining insurance coverage through the healthcare exchanges.

A major goal of the Affordable Care Act (ACA) is to increase access to healthcare, particularly for those who are uninsured, underinsured, or without stable healthcare insurance.

 The ACA has reduced the size of the uninsured population, and in 2016, close to 13 million Americans enrolled in a health plan through the federal or state-operated healthcare exchanges.

 However, there has been significant debate as to whether the ACA has achieved its goals of improving access and decreasing costs and whether it should continue in its current form.

 Most empirical studies since implementation of the ACA’s healthcare exchanges in 2014 have focused on the number of uninsured Americans within the United States and by state

 or examined care trends at the population level.

 The impact of insurance obtained through healthcare exchanges on access and costs of care at the individual level is largely unknown. The purpose of our study was to measure changes in self-reported healthcare access and cost-related barriers to healthcare among patients obtaining insurance through the ACA’s healthcare exchanges.

We surveyed 2145 adults aged 18 to 64 years who obtained insurance coverage through Kaiser Permanente (KP) by enrolling via the California or Colorado state healthcare exchanges starting on January 1, 2014. The survey was restricted to individuals who had not had KP healthcare coverage in the 5 years prior to initial exchange enrollment. Survey questions asked about healthcare experiences in the prior year and individuals' perceptions of whether they had a usual source of care and a regular healthcare provider or had delayed healthcare due to cost. Questions also assessed patient self-reported preventive behaviors and health behavior counseling. New KP members eligible for the survey were initially contacted by mail and asked to return a paper version of the survey; nonrespondents were called and offered the survey by phone. Responders to the initial baseline survey were re-contacted in 1 year and asked the same set of questions in order to assess if access, preventive behaviors, or cost barriers had changed since healthcare exchange enrollment. The response rate for the baseline survey was 45%, and the response rate for the follow-up survey was 51%. We compared differences in individual baseline survey responses regarding experiences in the year prior to ACA enrollment (2013) with follow-up survey responses regarding experiences in the year post-ACA enrollment (2014) at the individual level using χ

 tests for significance. Analyses were performed using SAS version 9.2 (SAS Institute, Cary, North Carolina). This study was approved by the KP Northern California and KP Colorado institutional review boards. 

A total of 528 patients completed both the baseline and follow-up surveys; these responders were 55% female and 71% non-Hispanic white, with 62% reporting a household income of less than $50,000 per year (data not shown). We found significant increases in the percentage of people who reported having a personal healthcare provider (59% vs 73%; 

 <.01) and significant decreases in the percentage of people who reported delaying needed medical care due to costs (37% vs 25%; 

 <.01) before and after ACA enrollment. There was a significant increase in the percentage of patients who reported receiving a flu shot as well (41% vs 52%; 

). Among the individuals who reported having fewer than 4 months of healthcare coverage in 2013, these improvements were even more pronounced (

). In addition, healthcare exchange enrollment was associated with significant increases in the percentage who felt they had a place to go when they needed medical care (43% vs 56%; 

 <.01) and who reported receiving advice to quit smoking or using tobacco (46% vs 72%; 

We found that adults obtaining insurance through the healthcare exchanges reported increased access to care, increased use of preventive care, and fewer barriers to medical care due to cost. These positive changes were even greater among patients with fewer than 4 months of healthcare coverage during the year prior to enrollment. One prior study found improved trends in access and affordability after the ACA’s enactment by examining population-level trends

; our analysis adds significant strength to the argument that the ACA has had a positive impact on care access, receipt of preventive services, and costs by examining changes in patient experiences at the individual level. Although our study was conducted among ACA enrollees in systems whose cost-sharing structures might not represent all exchange plans, our finding that delays in receiving needed medical care were reduced after enrolling through the ACA exchanges is particularly important in light of the fact that many exchange insurance products offered are high-deductible health plans

 that involve significant cost sharing for patients until the deductible is met. 

A major goal of the ACA is to help American healthcare achieve the “Triple Aim” of simultaneously optimizing healthcare access and quality while reducing costs.

 These findings are an important addition to the evidence base that the ACA may be improving the healthcare experience, reducing barriers due to costs, and contributing to a greater sense of engagement with the healthcare system

 in people obtaining insurance coverage through the healthcare exchanges.

 Division of Research, Kaiser Permanente Northern California (JAS, DW, LM), Oakland, CA; Institute for Health Research, Kaiser Permanente Colorado (JCB, SMS), Denver, CO; Kaiser Permanente (DS), Santa Clara, CA; School of Public Health, University of California at Berkeley (CVC), Berkeley, CA

 This study was funded by the Kaiser Permanente Center for Effectiveness and Safety Research, Contract no. KR021125. Dr Schmittdiel also received support from the Health Delivery Systems Center for Diabetes Translational Research (CDTR) [NIDDK grant 1P30-DK092924].

 Drs Schmittdiel and Sam, and Ms Barrow and Ms Shetterly are employed by Kaiser Permanente. Ms Barrow and Ms Shetterly received grant funding for this project from the Kaiser Permanente national office. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. 

 Concept and design (JAS, JCB, DS); acquisition of data (JAS, JCB, CVC, SMS); analysis and interpretation of data (JAS, LM, DS, SMS); drafting of the manuscript (JAS, JCB, DW, LM); critical revision of the manuscript for important intellectual content (JCB, DS, CVC, SMS); statistical analysis (JAS, LM); provision of patients or study materials (DW); obtaining funding (JAS, JCB); administrative, technical, or logistic support (JCB, DW, CVC); and supervision (JAS). 

 Julie A. Schmittdiel, PhD, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612. E-mail: Julie.A.Schmittdiel@kp.org. 

1. Blumenthal D, Abrams M, Nuzum R. The Affordable Care Act at 5 years. 

 2015;372(25):2451-2458. doi: 10.1056/NEJMhpr1503614.

2. Jost T. The 2016 open enrollment tally: 12.7 million selected plans, 1 million more than 2015.  

 Blog website. http://healthaffairs.org/blog/2016/02/04/the-2016-open-enrollment-tally-12-7-million-selected-plans-1-million-more-than-2015/. Published February 4, 2016. Accessed February 11, 2016.

3. Berwick DM, Feeley D, Loehrer S. Change from the inside out: health care leaders taking the helm. 

2015;313(17):1707-1708. doi: 10.1001/jama.2015.2830.

4. Carman KG, Eibner C, Paddock SM. Trends in health insurance enrollment, 2013-15. 

2015;34(6):1044-1048. doi: 10.1377/hlthaff.2015.0266.

5. Sommers BD, Buchmueller T, Decker SL, Carey C, Kronick R. The Affordable Care Act has led to significant gains in health insurance and access to care for young adults. 

2013;32(1):165-174. doi: 10.1377/hlthaff.2012.0552.

6. Sommers BD, Gunja MZ, Finegold K, Musco T. Changes in self-reported insurance coverage, access to care, and health under the Affordable Care Act. 

2015;314(4):366-374. doi: 10.1001/jama.2015.8421.

7. Wharam JF, Ross-Degnan D, Rosenthal MB. The ACA and high-deductible insurance—strategies for sharpening a blunt instrument. 

2013;369(16):1481-1484. doi: 10.1056/NEJMp1309490.

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Articles

Affordable Care Act exchange enrollees in California and Colorado reported significant improvements in access to care and fewer barriers to receiving care due to costs.

Improvements in Access and Care Through the Affordable Care Act

 Although research suggests that mail order pharmacy use is associated with greater medication adherence and cardiovascular disease risk factor control, no research has examined the potential impact of mail order pharmacy use on patient safety and utilization.

To compare safety and utilization outcomes in patients using mail order versus local pharmacies.

 Cross-sectional, observational study of 17,217 Kaiser Permanente Northern California adult diabetes patients prescribed new cardiometabolic medications in 2006.

 Multivariate logistic regressions assessed the association between mail order pharmacy use and all-cause and preventable hospitalizations and emergency department (ED) visits; laboratory tests for monitoring persistent medications; and overlapping days of supply of contraindicated medications. Results were stratified by patient age and converted to adjusted predicted percentages.

 Patients aged less than 65 years using mail order had fewer ED visits (33.8% vs 40.2%; 

<.001); preventable ED visits (7.7% vs 9.6%; 

<.01); and serum creatinine laboratory monitoring tests after angiotensin-converting enzyme inhibitor/angiotensin receptor blocker or diuretic initiation (41.2% vs 47.2%; 

 <.01). Among patients aged 65 or more years, mail order users had fewer preventable ED visits (13.4% vs 16.3%; 

 <.01); but slightly more occurrences of overlapping days of supply of contraindicated medications (1.1% vs 0.7%; 

 Mail order pharmacy use is not associated with adverse outcomes in most diabetes patients, and is associated with lower ED use. Interventions to increase mail order pharmacy use should use a patient-centered approach that is sensitive to primary and preventive care access.

Mail order pharmacy use is associated with better medication adherence and cardiovascular disease risk factor control, but its impact on patient safety and utilization is unknown.Among mail order users, we found:

		Diabetes patients aged less than 65 years had fewer emergency department (ED) visits, but fewer monitoring tests after angiotensin-converting enzyme inhibitor/angiotensin receptor blocker or diuretic initiation.

		Diabetes patients aged 65 or more years had fewer preventable ED visits, but slightly more overlapping days of supply of contraindicated medications.

		Interventions to increase mail order pharmacy use may improve outcomes, but should employ patient-centered approaches sesitive to care access.

Mail order pharmacies are widely used to deliver medications in the United States, with up to one-third of chronic illness medications delivered by mail.

 Research suggests a positive association between mail order pharmacy use and greater adherence to diabetes and antihypertensive medications,

 and with better low-density lipoprotein cholesterol control.

 These   favorable outcomes may reflect improved access to medications with mail order pharmacy use,

which may be of particular value to patients with disabilities, time constraints, or limited transportation (

However, there may be unintended consequences to using mail order pharmacies. When medical offices and pharmacies are in the same location, patients who use mail order pharmacies may be less likely to access preventive care services. This may increase the risk of hospitalizations and emergency department (ED) visits that are sensitive to preventive care quality.

Diabetes patients, who often take multiple medications, may be particularly at risk for exposure to contraindicated medications.

Mail order pharmacy users may miss face-to-face consultations with pharmacists and physicians designed to prevent contraindicated medication use. Finally, many medications require laboratory monitoring to reduce the risk of potential adverse drug events,

 and mail order pharmacy use may inadvertently   reduce the likelihood that such tests are ordered by physicians and completed by patients. The purpose of this study was to examine the relationship between mail order pharmacy use and safety and healthcare outcomes in diabetes patients, and whether effects vary by key patient characteristics.

This study was conducted within Kaiser Permanente Northern California (KPNC), an integrated health system providing  comprehensive medical care to more than 3 million members. We selected subjects from the KPNC Diabetes Registry. The registry, established in 1993, is updated annually by adding patients with diabetes identified from automated databases of pharmacy data,laboratory data, hospitalization records, and outpatient diagnoses.

 Study subjects were required to be at least 18 years of age by January 1, 2006, and to have been prescribed a new antiglycemic, antihypertensive, or lipid-lowering medication from January 1 through May 31, 2006. We defined having a new medication as having no history of any medication prescription fill within the same therapeutic drug class within the past 24 months. If patients were prescribed multiple new cardiometabolic medications during this period, the earliest prescription was defined as the index medication. We excluded the small proportion (<5%) of  members who lacked KPNC drug benefits during the study period.

KPNC maintains a mail order pharmacy distribution system in coordination with more than 120 local walk-in KPNC pharmacies located within outpatient clinics and hospitals.

 The first fill of a medication is typically at a local KPNC pharmacy and includes a pharmacist consultation. Patients may then refill existing prescriptions either by mail or at any KPNC local pharmacy. Mail delivery of medications with free shipping can be requested by phone or online. While KPNC members also have the option of filling prescriptions at non-KPNC pharmacies, the cost of these fills is not covered by the patient’s pharmacy benefit. Pharmacists are available via telephone to answer medicationrelated questions regardless of the mode of delivery. There is no proscribed days of supply of pills required for mail delivery; KPNC typically dispenses 100-day supplies through both mail order and local pharmacies. Some patients have a financial incentive to use mail order in the form of a lower copayment for the same number of days of supply.  For this analysis, patients were defined as local KPNC pharmacy users if they never used the mail order pharmacy to fill the new index medication in the 12 months after initiation, and as mail order pharmacy users if they filled the index medication at least once via mail during that time frame.

All-cause hospitalizations, preventable hospitalizations, all-cause ED use, and preventable ED use were defined as no episodes versus 1 or more episodes in the 3 years after the index medication initiation date. Preventable hospitalizations and preventable ED visits were defined using published and validated lists of encounters that are considered sensitive to primary care access and quality (eg, hospitalizations and ED visits for asthma).

Among patients whose index medication was an angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker (ARB), or diuretic, we examined whether there was an appropriate potassium or serum creatinine lab test within 30 days after the index date.

 These tests monitor for the possibility of electrolyte abnormalities or decreased renal function in patients new to these medications.

Potential for serious medication interaction was defined using a published list of contraindicated medications

 and was operationalized as 2 or more occurrences of overlapping days of supply of contraindicated drugs (eg, anticoagulants and thyroid hormones) for 1 or more days in the 15 months after the index date.

We estimated separate logistic regression models to examine the relationship between mail order pharmacy use and each outcome variable. In each analysis we adjusted for age; sex; race/ethnicity; neighborhood deprivation score calculated with geocoded census socioeconomic data

; number of comorbidities; smoking status; use of nonformulary medications, antidepressants, or insulin; whether the index medication was generic or brand name; length of therapy with the index medication; days of supply of the first refill; distance from the patient’s home to their nearest local KPNC pharmacy; and the patient’s KPNC primary outpatient medical facility (operationalized as a series of dichotomous variables). Detailed definitions of these variables have been published previously.

 Patients with missing covariates (n = 85) were excluded from the analysis. Models included interaction terms for mail order use with age, race/ethnicity, and deprivation score to assess whether different groups of patients might be more vulnerable to potential safety concerns when using the mail order pharmacy. Since the age interaction was the only interaction term that was significant, we present the results as adjusted percentages from models stratified by age less than 65 years versus age 65 years or older.

Omitted (unmeasured) variable bias may be of particular concern when studying the impact of mail order pharmacy use on patient safety outcomes. It is possible that patients who used the mail order pharmacy were different from those who did not in ways we were unable to measure (eg, patient motivation). As a sensitivity analysis, we examined the potential impact of unmeasured variables on the relationship between mail order pharmacy use and our outcomes using methods that test the robustness of effect sizes in the presence of confounding.

All analyses were performed using Stata release 10.1 (StataCorp, College Station, Texas). The study protocol was approved by the KPNC Institutional Review Board.

A total of 17,217 diabetes patients met study eligibility criteria. Of these, 5890 (34.2%) used the mail order pharmacy at least once to refill their new cardiometabolic medication during the study period (

). Mail order pharmacy users were more likely to be white (56.7% vs 37.1%; 

<.001) and to live in census tracts with higher socioeconomic status (

 shows the adjusted predicted percentages of patients experiencing each outcome, stratified by age. After adjustment for demographic, clinical, and census-block characteristics, patients aged less than 65 years using the mail order pharmacy were less likely to have an all-cause ED visit (33.8% vs 40.2%; 

 <.001); less likely to have a preventable ED visit (7.7% vs 9.6%; 

 <.01); and less likely to receive a recommended serum creatinine lab test within 30 days if their index medication was an ACE, ARB, or diuretic (41.2% vs 47.2%; 

 <.01). Among patients aged 65 or more years, those using mail order were less likely to experience a preventable ED visit (13.4% vs 16.3%; 

<.05) and slightly more likely to experience 2 or more occurrences of overlap in days of supply of contraindicated medications (1.1% vs 0.7%; 

Our sensitivity analysis found that our observed effects of mail order use on ED visits, hospitalizations, and overlapping days of supply of contraindicated medications were very robust to the presence of a hypothetical unmeasured confounder; for example, even an unmeasured confounder strongly related to an outcome such as ED use (assuming a relative risk of 2.0) and prevalent in more than 50% of the mail order pharmacy—using population would not change the relationship seen in our findings.

This is the first study to examine the relationship between mail order pharmacy use and patient safety and utilization outcomes. We found that mail order use was not negatively associated with patient safety outcomes overall, suggesting that mail order use does not serve as a barrier to receiving primary and preventive care services for most patients. Patients aged less than 65 years who used the mail order pharmacy did have slightly lower rates of serum creatinine testing with ACE, ARB, or diuretic use (41.4% vs 47.2%; 

 <.01). While there was no statistically significant difference in potassium laboratory testing in this group, or for any lab testing in patients aged 65 or more years, our findings suggest that inperson pharmacy refills may increase opportunities for monitoring of persistent medications in settings where laboratories and pharmacies are co-located.

Our study also found that patients aged 65 or more years had slightly higher rates of 2 or more occurrences of overlapping days of supply of contraindicated medications. While these rates were extremely low for both mail order and local pharmacy users (1.1% and 0.7%, respectively), our analysis adds to the evidence suggesting that older patients using multiple medications may require additional monitoring for adverse events.

 It is important that pharmacies provide increased access to chronic illness medications while also maintaining appropriate systems for preventing contraindicated medication use.

We found mail order pharmacy use was associated with lower overall ED use in patients aged less than 65 years, as well as lower preventable ED use in patients in all age groups. Previous studies have shown mail order use is associated with greater medication adherence

 and low-density lipoprotein cholesterol control.

 Since good medication adherence and cardiovascular disease risk factor control are associated with reduced hospitalizations and better outcomes,

mail order use may lead to lower preventable utilization over time.

Mail order pharmacy services, which are provided at the healthcare delivery system level rather than the physician or practice level, can be considered a structural or system-level intervention for improving access to chronic illness medications.

suggest that using mail order pharmacy services may improve outcomes, our study also suggests that certain patients may be more sensitive to any potential negative impact of mail order pharmacy use on healthcare access. System-level efforts to promote mail order use should preserve patient choice in pharmacy services and maintain a patient-centered approach to meeting an individual’s overall healthcare needs. Future research should continue to address the important issue of how to appropriately target and promote mail order pharmacy services while preserving the benefits of in-person interaction with pharmacists and other care providers.

This study has several limitations. Observational studies cannot entirely control for differences between patients who use mail order pharmacy services and those who do not. While our sensitivity analysis demonstrated that the relationship between mail order pharmacy use and our outcomes would still be observed even in the presence of a powerful, prevalent confounder, future research should leverage randomized controlled trial designs to examine the impact of mail order pharmacy use on intermediate outcomes, healthcare utilization, and patient safety.

We were unable to ascertain pharmacy utilization at non-KPNC pharmacies. However, we limited our analyses to members with a drug benefit, which is only recognized at KPNC pharmacies. This under-ascertainment should be minimal, as previous research suggests that diabetes patients with drug benefits report extremely low use of non-KPNC pharmacies.

This study was conducted in an integrated delivery system where patients access prescription medications differently than in many other settings. Use of “brick and mortar” pharmacies to fill prescriptions is primarily limited to KPNC local pharmacies; KPNC’s mail order and local pharmacies do not differ in the standard days of supply of pills issued; and mail order pharmacy does not require physician enrollment of the prescription. In addition, KPNC local pharmacies are primarily co-located with medical offices and laboratories, which is often not the case in other settings. This co-location may make any relationship between in-person pharmacy use and preventive care services stronger than in cases where patients obtain in-person refills from brick-and-mortar pharmacies that are not integrated with outpatient care. It is therefore possible that the use of mail order pharmacy services in KPNC has a different impact on outcomes than it would have in other settings.

Mail order pharmacy use is not associated with adverse events in most diabetes patients and may be associated with improved health outcomes. System-level interventions to increase mail order pharmacy use may be an important strategy for improving processes and outcomes of care for patients with chronic illness; however, these interventions should use a patient-centered approach that does not increase risk in older patients and others who may be sensitive to primary and preventive care access.

 From Division of Research (JAS, AJK, WTD), Pharmacy Outcomes Research Group (JC), Kaiser Permanente Northern California, Oakland, CA; David Geffen School of Medicine (KD), University of California, Los Angeles; Los Angeles, CA.

This study was funded by the Division of Diabetes Translation, Centers for Disease Control and Prevention, contract CDC U58 DP002641. This activity was also supported by the Health Delivery Systems Center for Diabetes Translational Research (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK] grant 1P30-DK092924), the Diabetes Study of Northern California (NIDDK grant R01 DK080726), and the Diabetes and Aging Study (NIDDK grant R01 DK0817960); the Harold Amos Medical Faculty Development Program from the Robert Wood Johnson Foundation; and the National Institute on Aging (grant K08 AG033630). The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the funding organizations.

 The authors (JAS, AJK, WTD, JC, OKD) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design (JAS, AJK, OKD); acquisition of data (JAS, AJK, WTD); analysis and interpretation of data (JAS, WTD, JC, OKD); drafting of the manuscript (JAS); critical revision of the manuscript for important intellectual content (AJK, JC, OKD); statistical analysis (WTD); obtaining funding (JAS, AJK); administrative, technical, or logistic support (JC); and supervision (JAS).

Julie A. Schmittdiel, PhD, Division of Research, Kaiser Permanente, 2000 Broadway, Oakland, CA 94612. E-mail: Julie.A.Schmittdiel@kp.org1. Medel M; for the Pharmaceutical Strategies Group. PBM 101. http:// www.psgconsults.com/resources/pbm_101.pdf. Published 2011. Accessed June 24, 2011.

2. Federal Trade Commission. Pharmacy Benefit Managers: Ownership of Mail-Order Pharmacies. Washington, DC: Federal Trade Commission; 2005.

3. Duru OK, Schmittdiel J, Dyer W, et al. Mail-order pharmacy use and adherence to diabetes-related medications. Am J Manag Care. 2010;16(1):33-40.

4. Pittman DG, Tao Z, Chen W, Stettin GD. Antihypertensive medication adherence and subsequent health care utilization and cost. Am J Manag Care. 2010;16(8):568-576.

5. Devine S, Vlahiotis A, Sundar H. A comparison of diabetes medication adherence and healthcare costs in patients using mail order pharmacy and retail pharmacy. J Med Econ. 2010;13(2):203-211.

6. Zhang L, Zakharyan A, Stockl KM, Harada AS, Curtis BS, Solow BK. Mail-order pharmacy use and medication adherence among Medicare Part D beneficiaries with diabetes. J Med Econ. 2011;14(5):562-567.

Patients using mail order pharmacies have lower healthcare utilization, but somewhat less laboratory monitoring of persistent medications and slightly higher contraindicated medication use.

Safety and Effectiveness of Mail Order Pharmacy Use in Diabetes

 used prescription claims from mail-order pharmacies and local pharmacies to compare medication possession rates across both sites. Based on this analysis, they concluded that patients using mail-order pharmacies had higher adherence to antiglycemic, antihypertensive, and lipid-lowering medications than patients using local pharmacies.

The authors neglect the fact that mail-order pharmacies typically enroll patients in automatic refill programs in order to compensate for the 10- to 14-day advance notice needed to fill prescriptions. With these programs, the mail-order pharmacy sends prescriptions automatically to patients on a regular basis at a predetermined time interval to ensure the patient receives the medication prior to consuming previous supplies. There is no mention of whether the community pharmacies also provided this service. We are assuming that the majority of them did not because this is not a standard of practice.

Given this difference, it is not surprising that an analysis of mail-order pharmacy claims would provide higher medication possession rates. The authors should have considered comparing mail-order pharmacies with community pharmacies that provide automatic refills. That would have been a more appropriate and fair comparison.

Dr Duru and his team also attempted to associate the possession of medication with adherence by providing 3 citations of previous research that found a correlation between the 2 measures. Two of these citations are 22 and 13 years old, respectively, and the third citation represents research that was completed outside of the United States. All 3 citations were based on local pharmacy claims or were conducted prior to the use of automatic refill programs in mail-order pharmacies. In local pharmacies, patients typically request refills when they have consumed most of their medication. This is why medication possession is highly correlated with adherence. We challenge the use of the medication possession concept as a proxy for medication adherence with mail-order pharmacies, which send the medication regardless of how much medication the patient may have remaining.

The authors’ analysis was based on claims for patients who were in a diabetes registry. Despite the limited study population, the conclusion of the research was applied to all patients without discussion of the generalizability of the study population to a larger group.

In their discussion, Dr Duru and colleagues acknowledge that interventions by pharmacists to address adherence have been proven effective. However, they contend that the expansion of responsibilities and the cost of such programs will be barriers to implementation. This has not been the case. In the Medicare Part D program, pharmacists have been providing medication therapy management services since 2006. A recent study estimates that the provision of these services has produced a drug cost savings of $15 to $40 per month.

It is unfortunate that the above issues limit the usefulness of this research. Instead, it comes off as a thinly veiled attempt to support mail-order pharmacy.

 Mr Brown reports serving as a paid consultant to community pharmacy associations. Dr Rickles reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Todd A. Brown, MHP, Department of Pharmacy Practice, Northeastern University, 360 Huntington Ave, 206 Mugar Bldg, Boston, MA 02115. E-mail: 

1. Duru OK, Schmittdiel JA, Dyer WT, et al. 

Mail-order pharmacy use and adherence to diabetes-related medications. 

Impact on drug cost and use of Medicare part D of medication therapy management services delivered in 2007. 

We appreciate the opportunity to confirm the validity of our methods by clarifying 2 incorrect assumptions made by Mr Brown and Dr Rickles. First, the Kaiser Permanente Northern California (KPNC) mail-order pharmacy did not have an automatic refill program in 2006 and 2007 when our data were collected. Although a few KPNC pharmacies have recently launched pilot auto-refill programs, those programs did not overlap with our study window. In our study, mailed medication refills were delivered only after patients initiated refill requests and provided payment. This is no different than the standard of care at community pharmacies, which therefore allows for a fair comparison of adherence between the 2 pharmacy types.

Second, the KPNC diabetes registry has been in existence since 1994 and is designed to be comprehensive rather than to represent a limited subset of patients. Annual, planwide screening protocols examine pharmacy data, laboratory data, hospitalization records, and recorded outpatient diagnoses to add every new case of diabetes to the registry. Comparisons between the registry and self-reported diabetes on member surveys indicate that registry capture is 99% complete. Therefore, our results reflect the broad membership of a health plan rather than a select subgroup.

We stand behind our published findings—specifically, that the likelihood of good adherence to a new diabetes-related medication is greater when refills are obtained through the mail. Although patients can contact the pharmacy call center with questions, better adherence may very well come with a price if inappropriate medication usage is increased for patients who do not interact with community pharmacists. Patients who do not frequent a local pharmacy may be less likely to receive on-site preventive care such as influenza vaccinations. We are initiating analyses to examine these important issues. Still, we believe that the use of mail-order pharmacies may represent a feasible, economical, and sustainable approach to improve adherence to chronic medications for many patients.

Although outcome evaluation studies are ongoing, we agree with Mr Brown and Dr Rickles that interventions in local pharmacies such as medication therapy management programs may be very effective for select populations. These programs target Medicare Part D beneficiaries with multiple chronic health conditions and high pharmacy utilization. The funding and inclusion criteria for these programs were linked to passage of the Medicare drug benefit.

 Unfortunately, the expense and logistics of developing such programs for the millions of other Americans taking chronic medications will be prohibitive in an era of rapidly escalating healthcare costs and deepening budget deficits.

In general, the research on mail-order pharmacies is funded by organizations with presumed agendas of promoting the career interests of community pharmacists or of increasing business opportunities for pharmacy benefit managers. Our work was funded by the Centers for Disease Control and Prevention and the National Institutes of Health, with the sole agenda of improving medication adherence and health outcomes. We believe that there is an urgent need for additional work examining the use of mail-order versus local pharmacies, but this work must be unbiased and focus primarily on the potential benefits and/or harms to patients.

This study was jointly funded by program announcement 04005 from the Centers for Disease Control and Prevention (CDC) (Division of Diabetes Translation) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the CDC or the NIDDK.

See page 39 of AJMC's January 2010 issue to read the complete disclosure statement.

The authors (OKD, JAS, WTD, MMP, CSU, JC, AJK) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

O. Kenrik Duru, MD, MSHS, Division of General Internal Medicine, Department of Medicine, The David Geffen School of Medicine at UCLA, University of California, Los Angeles, 911 Broxton Plaza, Los Angeles, CA 90024. E-mail: 

1. Barnett MJ, Frank J, Wehring H, et al. 

Analysis of pharmacist-provided medication therapy management (MTM) services in community pharmacies over 7 years. 

Mail-Order Versus Local Pharmacies on Adherence: Study Methods Make for Unfair Comparison

To investigate whether patients who use mail-order  pharmacies were more likely to have good medication adherence than patients who use local pharmacies.

 We conducted cross-sectional analyses of patients from the Kaiser Permanente Northern California (KPNC) diabetes registry who received a new antiglycemic, antihypertensive, or lipid-lowering index medication between January 1, 2006, and May 31, 2006. We defined good adherence as medication availability at least 80% of the time (ie, a continuous measure of medication gaps value of ≤20%) and compared adherence between mail-order users (≥66% of refills by mail) and KPNC local pharmacy users (all refills in person). Adherence was calculated from the initial dispensing through 15 months of follow-up, medication discontinuation, or May 31, 2007, whichever came first. We analyzed the data using multivariate logistic regression models, after determining that unmeasured patient-level factors and self-selection did not significantly bias our analyses.

 A total of 13,922 eligible patients refilled an index medication. Compared with those who used only local KPNC pharmacies, patients who received medications by mail were more likely to have good adherence (84.7% vs 76.9%, 

 <.001). After adjusting for potential confounders, including days’ supply and out-of-pocket costs, mailorder users had better adherence to antiglycemic, antihypertensive, and lipid-lowering medications (

 Compared with patients who obtained medication refills at local pharmacies, patients who received them by mail were more likely to have good adherence. The association between mail-order use and medication adherence should be evaluated in a randomized clinical trial.

In this study of an integrated delivery system, the use of mail-order pharmacies was associated with a higher likelihood of good medication adherence.

Minority patients and patients of low socioeconomic status were less likely to refill their medications by mail. 

Although these findings should be confirmed in other analyses and in a randomized controlled trial, they suggest the intriguing potential of organization-level interventions to improve adherence, particularly among vulnerable populations, by promoting increased mail-order use.

Although recent scientific breakthroughs have produced medications that improve outcomes for chronic conditions, there has not been a corresponding improvement in medication adherence.

 Although better adherence is associated with fewer hospitalizations and lower mortality in patients with diabetes mellitus,

 half of the patients who are prescribed medications for chronic conditions such as diabetes discontinue them after several years. Of patients who continue taking these medications, only 50% to 70% achieve good adherence,

 in part because of various patient-level, providerlevel, and system-level obstacles.

 Patient—system interactions such as medication refills are also important determinants of medication adherence. Successful and timely refills are not a guarantee of medication consumption, but they represent a minimum step necessary to ensure good adherence.

The use of mail-order pharmacies may streamline the refill process because mailed medications eliminate the need for travel to the pharmacy. Home delivery may be particularly beneficial for patients with disabilities, inadequate access to transportation, or time constraints.

 Patients who use mail-order pharmacies purchase more medications than patients using local walk-in pharmacies.

 However, this difference could represent factors other than better adherence such as self-selection into mail order by adherent patients. In addition, most mail-order pharmacies mandate that patients purchase a 90-day medication supply, unlike local pharmacies. Medication purchases by mail-order users may not reflect actual adherence if providers alter the regimen after 30 to 60 days and patients are obligated to waste pills.

 Although one-third of chronic disease prescriptions in the United States are filled by mail,

 there has been little evaluation of patients’ propensity to use mail-order pharmacies or whether the use of mail-order pharmacies is associated with medication adherence.

Among patients with diabetes in an integrated delivery system, we examined (1) the demographic and clinical factors associated with the use of mail-order pharmacies and (2) the likelihood of good adherence to newly prescribed antiglycemic, antihypertensive, and lipid-lowering medications, comparing mail-order pharmacy users with local pharmacy users. We used a data set in which the days’ supply is similar for mail-order and local pharmacies, and we used statistical techniques to assess for selection bias. We hypothesized that patients who used a mail-order pharmacy would be more likely to have good medication adherence over a 12-month period compared with patients who used only local pharmacies.

We conducted this study within Kaiser Permanente Northern California (KPNC), a fully integrated health system that provides comprehensive medical care to more than 3 million members. The KPNC membership includes employed persons and retirees and approximates the general population of northern California racially/ethnically and socioeconomically. The study protocol was approved by the KPNC Institutional Review Board. We selected subjects from the KPNC diabetes registry, established in 1993.

 The registry is updated annually by adding patients with diabetes identified from automated databases of pharmacy data, laboratory data, hospitalization records, and outpatient diagnoses.

Kaiser Permanente Northern California has more than 120 local walk-in pharmacies, located on-site within outpatient clinics and hospital facilities. We identified each patient’s clinic and local pharmacy based on his or her prior utilization or the utilization patterns of other patients in the same zip code.

 Since 1999, KPNC has maintained a mail-order pharmacy distribution system, in coordination with local KPNC pharmacies. After completing a simple enrollment process, patients can obtain medications by mail. Although most new prescriptions are filled in the local pharmacy, KPNC patients also have the option of filling new prescriptions by mail, with telephone access to a pharmacist to answer any medication-related questions. There is no minimum days’ supply required for mail-order delivery at KPNC, which typically dispenses 100-day medication supplies through mail-order and local KPNC pharmacies. Some patients have a financial incentive to use mail order, typically a lower copayment for the same days’ supply obtained by mail versus at a local KPNC pharmacy.

From the diabetes registry, we selected a subset (n = 23,488) of patients who were aged at least 18 years by January 1, 2006; had a pharmacy benefit; and had been prescribed a new diabetes-related medication (no recorded use in the previous 24 months) between January 1, 2006, and May 31, 2006. To most accurately estimate pharmacy utilization, we excluded members who lacked drug benefits during the study period and had little incentive to use KPNC pharmacies (approximately 4% of patients). Diabetes-related medications included antiglycemic, antihypertensive, or lipid-lowering medications. If patients were prescribed multiple new diabetes-related medications during this period, the earliest prescription was defined as the index medication. We estimated adherence for this medication using a cross-sectional study design (described herein). The study window started at the initial dispensing and continued for 15 months, until discontinuation of the medication, or until May 31, 2007, whichever came first. Patients were considered to have discontinued their medication if they did not obtain a refill within 90 days after their existing supply had run out.

To assess adherence to the index medication, we used a pharmacy utilization—based measure of secondary adherence, the continuous measure of medication gaps (CMG).

 The CMG uses refill data to determine the cumulative period for which no medication was available to the patient (gaps), dividing the number of days for which the patient did not have the medication by the number of days in the study window for that participant. The CMG values range from 0% (completely adherent) to 100% (completely nonadherent). We dichotomized CMG values, classifying values of 20% or less as good and greater than 20% as inadequate. This cutoff has been used in previous studies

 that examined the relationship between medication adherence and hospitalizations and mortality rates. Because the CMG cannot be calculated without at least 1 complete refill interval, we excluded 5613 patients who did not fill their prescription at least twice. The CMG cannot be reliably calculated for insulin given the flexible dosing instructions, so we also excluded 658 patients whose index medication was insulin. Patients with oral index medications who were taking insulin concurrently were not excluded.

We defined 2 patient groups for our analytic comparisons: mail-order users and local pharmacy users. Because the proportion of patients using mail-order exclusively was small (<2% of the sample), we considered patients to be mail-order users (n = 2595) if they used this system predominantly (≥66% of refills by mail). Local pharmacy users (n = 11,327) obtained all their index medication refills in person. Patients who used mail-order intermittently (1%-65% of refills [n = 3295]) were excluded from the analysis.

We included several demographic characteristics in our analyses, including race/ethnicity (non-Latino white, African American, Latino, Asian/Pacific Islander, Native American, mixed race/ethnicity, and missing race/ethnicity). As a contextual measure of socioeconomic status, we used a neighborhood deprivation index20 based on principal components analysis of the following 8 census tract variables from the 2000 US Census: percentage of households in poverty, percentage of households receiving public assistance, percentage of female-headed households with children, percentage of households earning less than $30,000 annually, percentage with less than a high school education, percentage in crowded housing (>1 person per room), percentage unemployed, and percentage of men in management or professional occupations. The socioeconomic deprivation score was standardized to a mean (SD) of 0 (1), with negative scores indicating less deprived neighborhoods.

The number of comorbid conditions for each patient was ascertained from the KPNC outpatient clinical records database for the 18 months before the first refill. Patients were classified by their type of insurance (non-Medicare commercial, Medicare Part D with a group insurer, or Medicare Part D from the individual insurance market) and by whether they had a financial incentive to order by mail. We calculated the linear distance from the patient’s home address to his or her local KPNC pharmacy using MapMarker geocoding software (Pitney Bowes MapInfo, Troy, NY). We categorized the days’ supply of the index medication dispensed at the first refill into 1 to 30, 31 to 60, 61 to 90, or more than 90 days. Finally, we measured the duration of therapy for the index medication, defined as the number of days from the first fill through the last fill before discontinuation or the end of the study window.

We estimated separate logistic regression models using Stata version 9.2 (StataCorp LP, College Station, TX) to examine (1) variables associated with mail-order pharmacy use and (2) differences in the probability of good medication adherence between mail-order and local pharmacy users. In each analysis, we included the following as covariates: age; sex; race/ethnicity; neighborhood socioeconomic deprivation score; number of comorbidities; smoking status; use of nonformulary medications, antidepressants, or insulin; insurance type; financial incentive to order by mail; distance from the patient’s home to the local pharmacy; an indicator for whether the index medication was generic or brand name; length of therapy with the index medication; and medical facility dummy variables. To facilitate interpretability of the results, we estimated predicted percentages (95% confidence intervals) for groups of interest, holding all other covariates at their mean value.

Observational studies are susceptible to more bias than experimental ones when studying causal relationships. Omitted (unmeasured) variable bias, or self-selection (eg, differences in intrinsic patient motivation to use mail order), is of particular concern in this study. We used health econometric techniques, specifically a bivariate probit (BVP) model incorporating an instrumental variable, to assess whether our estimates from the logistic regression predicting medication adherence were subject to omitted variable bias. A nonlinear BVP model is more appropriate than a standard linear instrumental variable model when the outcome (eg, medication adherence) and the treatment variable (eg, mail-order pharmacy use) are binary.

We used distance from the patient’s home to his or her local pharmacy as our instrumental variable in the BVP model based on empirical evidence and theoretical considerations. 

 Greater distance was associated with a greater likelihood of mail-order pharmacy use in unadjusted analyses (

 <.001). In addition, distance was not independently associated with medication adherence or other variables such as age, sex, socioeconomic status, and number of comorbidities. The lack of association between our instrument and these observed variables suggests that it is also independent of other correlated but unobserved variables, although this relationship cannot be directly tested. Finally, multiple health services research studies

 have used distance to healthcare facilities as an instrument.

The likelihood ratio test in the BVP model was nonsignificant (

 = .94), and the observed effect size was similar to the logistic regression model. Because the likelihood ratio test did not provide evidence of omitted variable bias, we elected to report results from the more efficient logistic regression analysis rather than the BVP model.

The final analytic sample included 13,922 patients with diabetes who had been recently prescribed an antiglycemic, antihypertensive, or lipid-lowering medication and filled the prescription at least twice (

). Compared with local KPNC pharmacy users, mail-order pharmacy users were more likely to be non-Latino white (61.0% vs 37.1%) and in the least deprived socioeconomic status quartile (27.5% vs 17.8%) (

 <.001 for both). Compared with local pharmacy users, mail-order pharmacy users were more likely to have a financial incentive to fill their prescriptions by mail (49.6% vs 23.0%) and had a greater mean distance from their home to the local pharmacy (8.0 vs 6.7 miles) (

After multivariate adjustment, characteristics associated with mail-order pharmacy use were largely unchanged. Holding all other covariates constant at their mean, the predicted probabilities of mail-order pharmacy use did not differ by patient sex, age, or number of comorbidities (

). However, non-Latino white patients were predicted to have a higher likelihood of mail-order use (24.1%) than African Americans (4.0%), Latinos (5.2%), Asian/Pacific Islanders (8.4%), and patients of mixed race/ethnicity (8.0%) (

Patients with diabetes were more likely to have good medication adherence if they refilled their medications by mail versus at localpharmacies.

Julie A. Schmittdiel, PhD

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