Medicare: Limited Information Exists on the Effects of Synchronizing Medication Refills

Medication adherence—that is, taking medications as prescribed—is important because not doing so increases the risk of hospitalization and can result in avoidable medical costs. According to some pharmacy industry groups, medication synchronization may help improve medication adherence, particularly for patients with multiple chronic conditions. More than 40 percent of Medicare beneficiaries had two or more chronic conditions in 2015.

Congress included a provision in the Bipartisan Budget Act of 2018 for GAO to review and report on the use of medication synchronization. In this report, GAO examines (1) what is known about the use and potential effects of medication synchronization and (2) steps CMS and selected states have taken to support its use.

GAO identified and reviewed 22 peer-reviewed studies on medication synchronization. In addition, GAO interviewed CMS officials and 30 stakeholders to gather a wide range of perspectives on medication synchronization. Among others, GAO interviewed six selected pharmacies and two selected Medicare health plans. GAO also reviewed CMS regulations as well as medication synchronization laws from five selected states that vary by geographic region.

GAO provided a draft of this report to the Department of Health and Human Services, which provided technical comments. GAO incorporated these comments, as appropriate.

Medication synchronization is a process whereby a pharmacist aligns the refill dates of two or more of a patient's medications to a single day (see figure below). GAO found that no comprehensive national data exist on the extent to which medication synchronization has been used or its potential effects. However, limited information suggests that the use of medication synchronization has increased in recent years and that it may have benefits. According to a study published in the American Journal of Managed Care that examined survey data on retail pharmacies, the number of pharmacies using medication synchronization increased from 3,324 in 2013 to 5,534 in 2014. Most of the studies that GAO identified found positive effects from medication synchronization, primarily on patients. For example, a 2018 study reported a 3 percent improvement in medication adherence among patients using medication synchronization than those who were not. Several stakeholders also identified potential limitations of using medication synchronization. For example, some patients may not be able to afford paying all the copayments for their medications at one time each month, and some patients prefer the social interaction of multiple trips to the pharmacy each month.

The Centers for Medicare & Medicaid Services (CMS) issued a regulation and some states enacted laws that may help support the use of medication synchronization. While CMS does not have a formal medication synchronization policy for Medicare, a CMS regulation allows for reduced beneficiary cost sharing (for example, a lower copayment) when the beneficiary receives less than a month's supply of a medication. Similar laws pertain to private health plans that provide prescription drug coverage for patients in the five states GAO selected—Georgia, Illinois, Maine, Texas, and Washington. Such measures support medication synchronization because initially aligning the refill dates of multiple medications may require one or more of these medications to be refilled with a quantity that is less than a month's supply. Officials from CMS and four of the selected pharmacies said that lowering the copayments for these refills reduces the financial burden on patients when they first have their medications synchronized. They noted that requiring full copayments for a shorter supply may have discouraged or prevented patients from using medication synchronization.

Patients who do not take—that is, adhere to—their medications as  prescribed are at increased risk for hospitalization. Medication adherence  is particularly important for patients with one or more chronic conditions,  such as diabetes, high cholesterol, or hypertension. In 2015, about 24  million of the 55 million Medicare beneficiaries had two or more chronic  conditions, and Medicare spent over $307 billion for these beneficiaries,  according to data from the Centers for Medicare & Medicaid Services  (CMS). Almost 4 million Medicare beneficiaries had a prescription that  they did not fill that year—one potential sign that beneficiaries are not  taking their medications as prescribed. Studies have shown that in the  United States, the failure to adhere to medications results in avoidable  medical costs annually, such as costs associated with hospitalizations  and emergency department visits.

To improve medication adherence, some pharmacy industry groups have  advocated for the use of medication synchronization, a process whereby  a pharmacist aligns the refill dates of all of a patient’s medications so that  they can be dispensed on a single day. These industry groups have  reported that medication synchronization may improve adherence,  particularly for patients with multiple chronic conditions or those who have  difficulty managing their medications, by preventing missed refills and  disruptions in their medication regimen. As of 2019, 27 states had  enacted laws related to medication synchronization, according to the  National Community Pharmacists Association.

The Bipartisan Budget Act of 2018 includes a provision for us to review  and report on the use of medication synchronization. This report  describes  1.  what is known about the use and potential effects of medication  2.  steps CMS and selected states have taken to support the use of  medication synchronization.

To determine what is known about the use and potential effects of  medication synchronization, we reviewed 22 peer-reviewed studies on  medication synchronization published between October 2013 and  October 2018. We identified these studies by searching several  bibliographic databases, including Google Scholar, PubMed, ProQuest,  and Scopus. We also searched for additional studies from other sources,  including citations in the studies we reviewed. Seventeen of the 22  studies evaluated the effects of medication synchronization for patients,  pharmacies, or health plans. The results of these evaluative studies are  not generalizable. The remaining five studies were systematic literature  reviews that provided an overview of research on medication  synchronization. For a complete list of the 22 studies we reviewed, see  the Bibliography page at the end of this report.

For additional information on the use and effects of medication  synchronization, we interviewed 30 stakeholders that we identified  through background research. The 30 stakeholders, among others,  included organizations representing patients, pharmacies or pharmacists,  and health plans, experts who worked on issues related to medication  synchronization, and selected pharmacies and health plans. We  interviewed officials from six selected pharmacies—including four retail  pharmacy chains, one independent retail pharmacy, and one mail order  pharmacy. We selected these pharmacies to represent different sizes  and types of pharmacies and experience with medication synchronization.  We also interviewed officials from two selected Medicare health plans.  We selected these plans because they were among the top five Medicare  plans in terms of the number of Medicare beneficiaries that had  prescription drug coverage as of August 2018. Together, the two health  plans offered prescription drug coverage to about 14 million Medicare  beneficiaries. While we selected stakeholders to include a broad range of  perspectives, their views are not generalizable beyond the 30  stakeholders interviewed. Additional information about the 30  stakeholders is presented in appendix I. We also interviewed CMS  officials.

To describe efforts by CMS and selected states to support the use of  medication synchronization, we reviewed CMS regulations and laws in  five selected states. The five states—Georgia, Illinois, Maine, Texas, and  Washington—were selected because they varied in geographic region  and had laws related to medication synchronization as of 2018. In  addition, we interviewed CMS officials regarding agency regulations that  may support the use of medication synchronization. We also asked the 30  stakeholders we interviewed about their views on how CMS regulations  and state laws have supported medication synchronization.

We conducted this performance audit from June 2018 to July 2019 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings based on audit objectives. We believe that the evidence obtained  provides a reasonable basis for our findings based on our audit  objectives.

Medication synchronization is a process whereby a pharmacist aligns the  refill dates of two or more of a patient’s medications to a single day each  month—referred to as the synchronization date. Patients who are  interested in medication synchronization must enroll or opt into the  service, if offered at their pharmacy. To initiate medication  synchronization, the pharmacist selects an anchor medication to which  the other medications are synchronized, and dispenses short fills—that is,  a quantity of less than a month’s supply—so that the patient has enough  medication until the next synchronization date. Figure 1 illustrates the  process by which a pharmacist may synchronize three medications for a  patient.

Before each synchronization date, the pharmacist generally contacts the  patient to determine if the patient has had any changes in his or her  medications or medical history. The pharmacist then makes any needed  adjustments so that the patient can continue to pick up his or her  medications on the synchronization date and avoid disruptions in their  medication regimen.

Prescription Drug Expenditure and Coverage

In 2017, national spending on prescription drugs dispensed by  pharmacies totaled over $330 billion. Medicare accounted for over $100  billion and private health plans accounted for over $140 billion of total  spending on prescription drugs that year.

Medicare provides prescription drug coverage under Part D, a voluntary  program in which beneficiaries can elect to enroll. In February 2019,  about 45 million or three-fourths of Medicare beneficiaries were enrolled  in Part D plans—including stand-alone prescription drug plans and  Medicare Advantage prescription drug plans, which combine medical and  prescription drug benefits. In comparison, in 2017, about 200 million  patients were enrolled in a private health plan that provides prescription  drug coverage, among other benefits, according to CMS.

Health plans that provide prescription drug coverage interact with both  patients and pharmacies. For patients, health plans may vary their  benefits with regards to cost-sharing arrangements—such as copayments  for medications—and quantity limits for medications covered—such as  restricting the dosage or number of refills of a medication provided within  a given period of time. For pharmacies, health plans pay pharmacies a  share of the medication costs and a dispensing fee for the pharmacies’  administrative costs in preparing and dispensing the medication.

Limited Information Suggests the Use of Medication Synchronization Has Increased; Some Studies and Stakeholders Reported Several Potential Benefits and Limitations

One Study and Several Stakeholders Suggest the Use of Medication Synchronization Has Increased in Recent Years

Limited information available indicates that the use of medication  synchronization has increased, but comprehensive data on its use by  pharmacies and patients do not exist. Among the 22 peer-reviewed  studies we identified, one study reported that the use of medication  synchronization increased among pharmacies and patients. Specifically,  the study examined survey data on the use of medication synchronization  in retail pharmacies and reported that the number of retail pharmacies  using medication synchronization increased from 3,324 in 2013 to 5,534  in 2014, a 66 percent increase. In addition, the study found that the  number of patients using medication synchronization at these retail  pharmacies increased from 124,608 in 2013 to 438,100 patients in 2014.  We did not identify other studies that examined the use of medication  synchronization.

Officials from all five selected pharmacies that reported using medication  synchronization told us that their pharmacies have increased their use of  medication synchronization, but they generally could not provide us with  data on their patients’ use of medication synchronization over time. The  pharmacies included three retail pharmacy chains—two large national  chains and one mid-size regional chain—one independent pharmacy, and  one mail order pharmacy. Officials from four of these pharmacies told us  that they started using medication synchronization within the last 5 years;  officials from the fifth pharmacy told us that they started using medication  synchronization in 2011. For example, officials from the two large retail  pharmacy chains, each with about 10,000 pharmacies nationwide, told us  that they first piloted medication synchronization to a small number of  pharmacies in either 2015 or 2016. One of these chains now uses  medication synchronization at all of its pharmacies, and the other is in the  process of doing so. Officials from the mid-size retail pharmacy chain  stated that they piloted medication synchronization in 2011 with about  2,500 patients enrolled across 50 pharmacies. They have since expanded  it to about 83,000 patients across all their more than 90 pharmacies.

Seven other stakeholders, including those representing patients and  pharmacies, also told us that the use of medication synchronization has  increased in recent years, but generally did not provide data on the  increase. In addition, officials from an organization representing  pharmacies told us that as of 2018, approximately 80 percent of  independent pharmacies offered medication synchronization; however,  they could not provide data from prior years.

Studies and Stakeholders Suggest that Medication Synchronization Can Be Beneficial to Patients, Pharmacies, and Health Plans

Limited information exists on the effects of medication synchronization,  but available studies and stakeholders indicate several potential benefits,  primarily for patients. According to CMS officials, CMS does not have  data on the effects of medication synchronization, such as patient  medication adherence; other stakeholders we interviewed indicated that  such national data do not exist. Seventeen of the 22 peer-reviewed  studies we identified evaluated the effects of medication  synchronization—14 of these studies evaluated effects for patients and  the rest for pharmacies and health plans. However, the data reported by  these studies are limited in scope and are not generalizable to broader  populations.

Twelve of 14 peer-reviewed studies evaluating the potential effects of  medication synchronization for patients reported two potential benefits— improved medication adherence or improved medical outcomes.

Improved medication adherence. Twelve peer-reviewed studies that  evaluated the potential effects of medication synchronization on  patients’ adherence reported that medication synchronization  improved adherence. For example, nine of the 12 studies compared  medication adherence among patients using and not using medication  synchronization and found that medication adherence was greater  among patients using medication synchronization—one of the most  recent studies showed adherence was 3 percent higher for those  using medication synchronization. Two studies compared  medication adherence among patients before and after using  medication synchronization and found that adherence improved after  synchronization was started—the most recent of these studies  showed an improvement of 2 percent in average adherence after a  year of enrollment. The last study reported that 56 percent of  patients surveyed stated that they would be more adherent to their  medications if their refills were synchronized. In addition, eight of  these studies evaluated the effects of medication synchronization for  patients with different chronic conditions and found differences by  type of chronic condition. According to the studies, medication  adherence improves as a result of medication synchronization  because it simplifies the refilling process.

Improved medical outcomes. One peer-reviewed study reported  that medication synchronization may also lead to improved medical  outcomes for patients. The study found that rates of hospitalization  and emergency department visits and rates of outpatient visits were 9  percent and 3 percent lower, respectively, among patients using  medication synchronization compared with those who were not.

Stakeholders also cited improved medication adherence and medical  outcomes as potential benefits for patients, and also identified additional  benefits that may result from medication synchronization. Specifically, 14  of the 15 stakeholders representing patient and pharmacy organizations  and selected pharmacies we interviewed said that medication  synchronization may help improve patients’ medication adherence, and  12 of these stakeholders said that it may improve patients’ medical  outcomes. These stakeholders also indicated other potential benefits for  patients:  Improved convenience. Medication synchronization improves  convenience for patients—for example, by reducing the number of  trips patients need to make to the pharmacy or making it easier to  manage their medications, according to 10 of the 15 stakeholders  representing patient and pharmacy organizations and selected  pharmacies. Fewer trips to the pharmacy help to minimize the need  for transportation arrangements, which is particularly important for  older patients, patients who live in rural areas, and patients who lack  reliable transportation. Five of the 10 stakeholders added that  medication synchronization simplifies patients’ experience with  managing their medications—patients no longer need to keep track of  multiple refill dates for all their medications. Under medication  synchronization, the pharmacists proactively perform this work and  send reminders to the patients.

Increased interaction between pharmacists and patients. Seven  of 15 stakeholders representing patient and pharmacy organizations  and selected pharmacies told us that medication synchronization  increases the interaction patients have with their pharmacists, which  may help patients better manage their medication regimens and  improve their overall health. For example, a stakeholder representing  pharmacies said that prior to the medication synchronization date,  pharmacies generally contact patients to confirm that their  medications should be filled; as part of this outreach, they also inquire  about any changes in the patients’ medical history or therapy. If such  changes are identified, pharmacists follow up with patients, and their  physicians if necessary, to ensure that patients receive refills  reflecting any necessary medication changes. In addition, according  to some stakeholders, if a consultation is also provided on the  medication synchronization date, pharmacists have more  opportunities to answer patients’ questions about medication use,  provide counseling, and offer patients other auxiliary services. For  example, some stakeholders told us that pharmacists may provide  screenings for blood pressure and diabetes, or recommend  immunizations to patients when they pick up their medications.  Because pharmacists regularly assess patients’ medical history in  preparing for medication synchronization, they can target patients who  may be at high risk for medical problems or immunization-preventable  diseases.

Regarding pharmacies, some studies and stakeholders identified the  following potential benefits of medication synchronization.

Operational efficiencies. Three peer-reviewed studies reported that  medication synchronization can lead to operational efficiencies. For  example, one study reported that medication synchronization can help  pharmacists better manage inventory and personnel costs and  improve workflow. Nine out of 12 stakeholders representing  pharmacy organizations and selected pharmacies also said that  medication synchronization can lead to improvements in operational  efficiencies. For example, officials from one organization representing  pharmacies said that pharmacists save time when they can dispense  all of a patient’s medications at one time instead of several times  throughout the month.

Increased marketability of pharmacies to health plans. According  to one peer-reviewed study and five of the 12 stakeholders  representing pharmacy organizations and selected pharmacies, the  extent to which a pharmacy’s medication synchronization program  improves patient care, such as by improving medication adherence,  may make the pharmacy more desirable to health plans. For example,  according to the study and officials from one organization  representing pharmacies, health plans may include pharmacies with  highly adherent patients in the plans’ preferred pharmacy networks.  Pharmacies in preferred pharmacy networks can offer lower  medication prices, attracting more customers.

Increased revenue. Three peer-reviewed studies and five of the 12  stakeholders representing pharmacy organizations and selected  pharmacies reported that, to the extent that medication  synchronization can improve patients’ medication adherence, it can  also lead to increased pharmacy revenues generally because of an  increase in filled prescriptions. For example, one of the three peer- reviewed studies reported that medication synchronization resulted in  an average increase in medication adherence of almost 5 percent  over the first 6 months of its use. Similarly, an industry study found  that medication synchronization leads to an additional 20 fills per  patient per year, and may lead to an average of $1,120 of additional  revenue per enrolled patient annually. The three peer-reviewed  studies and the industry study did not examine the causes of the  increase in prescription fills, but their authors generally attributed the  increase to the improved adherence of patients using medication  synchronization. Two of the three studies reported that medication  synchronization can increase pharmacy revenues generally because  of an increase in filled prescriptions. In addition, officials from four  stakeholders representing pharmacy organizations and selected  pharmacies told us that pharmacies that use medication  synchronization can leverage these opportunities to speak with  patients and offer additional services, such as immunizations; these  services can further help increase pharmacy revenue.

Regarding health plans, some studies and stakeholders identified the  following potential benefits of medication synchronization.

Higher Medicare quality performance scores. Three peer-reviewed  studies reported that medication synchronization can potentially  improve health plans’ Medicare quality performance scores. CMS  assesses the quality performance of Part D plans using information on  various measures, such as adherence to medications for diabetes,  high cholesterol, or hypertension. Specifically, CMS rates the plans’  performance using a star rating system, which gives each plan a  score of between one and five stars, with five stars being the highest  rating. Medication adherence measures are triple weighted in the  calculation of a plan’s overall rating. Plans with the highest star  ratings are rewarded with member enrollment incentives, while plans  with lower star ratings are penalized. In addition, Medicare Advantage  plans with high ratings may also receive financial bonuses from  Medicare. To the extent that there are improvements in  beneficiaries’ medication adherence as a result of medication  synchronization, health plans may experience improved performance  ratings and the commensurate financial benefits. However, only one  of the four stakeholders representing health plan organizations and  selected health plans indicated improved Medicare quality  performance scores as a potential benefit of medication  synchronization.

Reduced medical costs. Medication synchronization may also  benefit health plans by reducing their overall medical costs, according  to one peer-reviewed study. The study found that medication  synchronization can result in significant savings in medical costs for  health plans, despite the increase in medication costs to the health  plan. Specifically, the study reported that medical savings per  additional dollar spent on medications under medication  synchronization ranged from approximately $1 to $37, depending on  the medication. According to the study, health plans could potentially  experience such reduced medical costs as a result of medication  synchronization because when patients are adherent to their  medications, they may decrease their utilization of healthcare  services. However, only one of the four stakeholders representing  health plan organizations and selected health plans cited this as a  potential benefit.

Studies and Stakeholders also Identified Potential Limitations of Medication Synchronization for Patients, Pharmacies, and Health Plans

A small number of studies and several stakeholders indicated that there  are some potential limitations associated with medication synchronization.  For example,

Patients. One peer-reviewed study indicated that medication  synchronization may not be beneficial for all patients. Similarly, 14 of  the 15 stakeholders representing patient and pharmacy organizations  and selected pharmacies said that not every patient may want to use  medication synchronization. For example, 12 of the 14 stakeholders  said that some patients may not be able to afford paying all  copayments for their medications at one time each month, which  deters them from using medication synchronization. In addition, one  stakeholder said that some patients prefer going to the pharmacy  regularly or consider trips to the pharmacy as opportunities for social  interaction and may not be interested in medication synchronization.

Pharmacies. One peer-reviewed study reported that using medication  synchronization is time- and labor-intensive for pharmacies.  Specifically, the study reported that almost 60 percent of pharmacists  surveyed indicated that implementing medication synchronization  involves a significant change in a pharmacy’s workflow. Seven of 12  stakeholders representing pharmacy organizations and selected  pharmacies said this was because of several challenges. For  example, it may be complicated to set up the initial synchronization,  determine the best anchor medication and synchronization date, or  adjust patients’ medication synchronization because of changes in  their medical needs or therapy. In addition, pharmacists may have to  conduct extensive follow-up with health plans because health plans  may not be consistent in how they process pharmacies’ claims that  involve short fills. For example, private health plans may initially deny  coverage of short fills; such denials may require the pharmacist to  expend additional resources to follow-up with the health plan to obtain  approval for the short fill.

Health plans. Officials from the two selected health plans told us that  they do not require their Part D network pharmacies to use medication  synchronization, nor do they compensate pharmacies for providing  these services. While all stakeholders representing health plan  organizations and selected health plans said that they view  medication synchronization as having the potential to improve  patients’ medication adherence and health outcomes, two of these  stakeholders noted the lack of data explicitly tying medication  synchronization to improved patient medication adherence, medical  outcomes, and overall medical costs.

A CMS Regulation and Laws in Selected States May Support the Use of Medication Synchronization, Such as By Reducing Patient Cost Sharing

Our review shows that a CMS regulation and laws related to prescription  drug coverage in five selected states may support the use of medication  synchronization. For example, CMS and the five selected states allow for  reduced patient cost sharing for short fills needed to synchronize their  medications.

CMS does not have a formal medication synchronization program or  policy for Medicare; however, a CMS regulation related to prescription  drug benefits may support medication synchronization by reducing  beneficiary cost sharing for certain amounts dispensed, according to  officials. Specifically, CMS issued a regulation that, starting in 2014,  required Medicare Part D plans to establish a daily cost-sharing rate (for  example, a prorated copayment) when a beneficiary receives less than a  month’s supply of a prescription medication—generally referred to as a  short fill. According to CMS, the primary goal of the regulation was to  reduce medication cost and waste—such as by allowing beneficiaries to  initially receive a short fill of a new medication so that they can assess, in  consultation with their providers, the efficacy of the medication and any  associated adverse side effects.

Because short fills may be needed to initially synchronize multiple  medications to the same refill date, the prorated copayment may reduce  the financial burden on beneficiaries who require these fills, according to  CMS officials. In addition, officials from a selected pharmacy and officials  from a technology vendor added that from a value perspective,  beneficiaries may be reluctant to enroll in medication synchronization if  they had to pay a full copayment for less than a month’s supply of  medication. For example, as illustrated in figure 2, to initiate medication  synchronization for a beneficiary taking three medications, each with a  different refill date, the pharmacist may dispense short fills for two of the  three medications. In this case, the pharmacist may dispense 8 days’  supply of one medication and 3 days’ supply of another medication. Prior  to the regulation, the beneficiary would have paid $45 in copayments for  these two short fills, as compared to $7 with prorated copayments—a  difference of $38.

The five selected states—Georgia, Illinois, Maine, Texas, and  Washington—enacted laws within the last 4 years that may support  medication synchronization. Specifically, these laws:

Require insurance coverage of short fills. Laws in all five selected  states require health plans in their state to provide coverage for  medication short fills. These laws may also support medication  synchronization by allowing health plans and pharmacies to work  around certain plan policies that may impose limits on medication  refills. Specifically, officials from a technology vendor told us that  some health plans may impose limits on the number of refills that can  be dispensed in a month. For example, if a patient is taking five  medications and is limited to five refills a month, a short fill would  count towards that limit and the patient may not then be able to get all  of his or her medications covered by the health plan that month. Such  laws allow the health plan and pharmacy to work around these  quantity limits so that the patient can receive the needed short fills to  synchronize all of his or her medications. Additionally, two states— Maine and Texas—specifically require their health plans to allow  pharmacies to override denials related to refilling a prescription too  soon. A pharmacy may receive such denials when refilling a  prescription after having just filled it—for example, dispensing a short  and full refill of a medication too close together. Officials from two  selected pharmacies and an organization representing pharmacies  told us that such laws also help to reduce the time and resources that  pharmacies otherwise would have expended on addressing issues  with these drug claims.

Require prorated cost sharing for short fills. Like CMS’s  regulation, laws in all five selected states require health plans in their  state to prorate a patient’s cost sharing, such as a copayment, when  the patient receives a short fill of a medication. Officials from four  selected pharmacies told us such laws help reduce the financial  burden on patients when they first have their medications  synchronized. Without such a law, patients would have paid a full  copayment for these medications, which may have discouraged or  prevented some patients from enrolling in medication synchronization.

Prohibit prorated dispensing fees for short fills. Laws in four of the  five selected states prohibit health plans in their state from paying  pharmacies a prorated dispensing fee for medication short fills.  Pharmacies receive a dispensing fee from health plans for each  prescription they fill to cover the pharmacies’ administrative costs of  preparing and dispensing a fill. The dispensing fee is in addition to the  reimbursement pharmacies receive from health plans for the costs of  the medications. In states without this law, health plans may prorate  the dispensing fee for short fills—that is, pay a lower fee because a  smaller quantity of medications (for example, 10 pills rather than 30  pills) is dispensed. Officials from a technology vendor and an  organization representing pharmacies told us that ensuring that a  health plan pays a full dispensing fee provides an incentive for  pharmacies to use medication synchronization. They explained that a  pharmacy’s administrative costs of dispensing a medication remains  the same, regardless of the quantity dispensed.

Require medication synchronization process or policy. Laws in  two of the five selected states—Texas and Washington—require  health plans in their state to establish a process or policy for providing  medication synchronization services. Both states require that, as  part of this process or policy, the pharmacist or prescribing physician  must ensure that medication synchronization is appropriate or in the  best interest of the patient before the process is used. In addition to  approval from both the pharmacist and physician, Texas also requires  that the health plan and patient approve the medication  synchronization plan. Officials from an organization representing  pharmacies said that involving all these entities further helps to  ensure the appropriateness of medication synchronization for a  particular patient.

While stakeholders generally told us that these laws have helped to  support medication synchronization, they also said that the absence of  such laws has not prevented pharmacies from using it in other states. For  example, the five selected pharmacies that reported using medication  synchronization—including three pharmacy chains—offered these  services in at least some states without such laws. Additionally, officials  from a selected pharmacy told us that they continue to offer medication  synchronization despite receiving a prorated dispensing fee for short fills.

We provided a draft of this report to the Department of Health and Human  Services (HHS).  HHS provided technical comments, which we  incorporated as appropriate.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of HHS, and other interested parties. In  addition, the report is available at no charge on the GAO website at  http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or CosgroveJ@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix II.

Appendix I: Information about Stakeholders Interviewed

Appendix I: Information about Stakeholders  Interviewed   We interviewed organizations reflecting a range in interests:  Six organizations representing pharmacies or pharmacists  Three organizations representing patients  Two organizations representing health plans

One organization representing the pharmaceutical industry  1    We interviewed one organization that specializes in Medicare issues and conducts  analysis related to access to and quality of care, among other things.  5    We interviewed selected pharmacies that reported using medication synchronization  Two large national retail chains

One small independent, single-store, retail pharmacy

One mail order pharmacy   1    We interviewed a selected large national retail chain pharmacy that reported not   using medication synchronization.  2    We interviewed two selected Medicare health plans that offer prescription drug  coverage (Part D) that are among the top five Part D plans covering the largest  Medicare populations—the combined Medicare Part D enrollment in these two plans  totaled almost 14 million—or 31 percent of all Part D beneficiaries, as of August 2018.   2    We interviewed two selected medication synchronization vendors that contract with  pharmacies to provide technological support in performing tasks such as identifying  patients who would benefit from medication synchronization; determining the anchor  medication; and setting up automated reminder to patients, in advance of their  prescription refills. We identified these vendors in peer-reviewed studies on  medication synchronization or through interviews with stakeholders.  5    We interviewed experts in medication synchronization, identified in peer-reviewed  studies on medication synchronization or through interviews with stakeholders.

Appendix II: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Tim Bushfield, Assistant Director;  Pauline Adams, Analyst-in-Charge; George Bogart; Nina Daoud; Krister  Friday; Melissa Trinh-Duong Ostergard; and Vikki Porter made key  contributions to this report.

Andrews, S. B., T. R. Marcy, B. Osborn, and L. G. Planas. “The Impact of  an Appointment‐Based Medication Synchronization Programme on  Chronic Medication Adherence in an Adult Community Pharmacy  Population.” Journal of Clinical Pharmacy and Therapeutics, vol. 42, no. 4  (2017): pp. 461-466.

Barnes, Brenda, Ana L. Hincapie, Heidi Luder, James Kirby, Stacey  Frede, and Pamela C. Heaton. “Appointment-Based Models: A  Comparison of Three Model Designs in a Large Chain Community  Pharmacy Setting.” Journal of the American Pharmacists Association, vol.  58, no. 2 (2018): pp. 156-162.

Butler, Kendra T., Janelle F. Ruisinger, Jessica Bates, Emily S. Prohaska,  and Brittany L. Melton. “Participant Satisfaction with a Community-Based  Medication Synchronization Program.” Journal of the American  Pharmacists Association, vol. 55, no. 5 (2015): pp. 534-539.

Dao, Nancy, Sun Lee, Micah Hata, and Lord Sarino. “Impact of  Appointment-Based Medication Synchronization on Proportion of Days  Covered for Chronic Medications.” Pharmacy, vol. 6, no. 2 (2018): pp. 1- 9.

DiDonato, Kristen L., Kristin R. Vetter, Yifei Liu, Justin R. May, and D.  Matthew Hartwig. “Examining the Effect of a Medication Synchronization  or an Education Program on Health Outcomes of Hypertensive Patients in  a Community Pharmacy Setting.” INNOVATIONS in Pharmacy, vol. 5, no.  3 (2014): pp. 1-9.

Doshi, Jalpa A., Raymond Lim, Pengxiang Li, Peinie P. Young, Victor F.  Lawnicki, Joseph J. State, Andrea B. Troxel, and Kevin G. Volpp. “A  Synchronized Prescription Refill Program Improved Medication  Adherence.” Health Affairs, vol. 35, no. 8 (2016): pp. 1504-1512.

Doshi, Jalpa A., Raymond Lim, Pengxiang Li, Peinie P. Young, Victor F.  Lawnicki, Andrea B. Troxel, and Kevin G. Volpp. “Synchronized  Prescription Refills and Medication Adherence: A Retrospective Claims  Analysis.” American Journal of Managed Care, vol. 23, no. 2 (2017): pp.  98-104.

Ghassemi, Emily, Jennifer Smith, Laura Owens, Charles Herring, and  Melissa Holland. “Relationship Between Medication Synchronization and  Antiretroviral Adherence.” Journal of the American Pharmacists  Association, vol. 58, no. 4 (2018): pp. S78-S82.

Girdish, Charmaine, William Shrank, Sarah Freytag, David Chen, Doug  Gebhard, Andrew Bunton, Niteesh Choudhry, and Jennifer Polinski. “The  Impact of a Retail Prescription Synchronization Program on Medication  Adherence.” Journal of the American Pharmacists Association, vol. 57,  no. 5 (2017): pp. 579-584.

Hinson, Jessica L., Gretchen K. Garofoli, and Betsy M. Elswick. “The  Impact of Medication Synchronization on Quality Care Criteria in an  Independent Community Pharmacy.” Journal of the American  Pharmacists Association, vol. 57, no. 2 (2017): pp. 236-240.

Holdford, David A., and Timothy J. Inocencio. “Adherence and  Persistence Associated with an Appointment-Based Medication  Synchronization Program.” Journal of the American Pharmacists  Association, vol. 53, no. 6 (2013): pp. 576-583.

Holdford, David, and Kunal Saxena. “Impact of Appointment-Based  Medication Synchronization on Existing Users of Chronic Medications.”  Journal of Managed Care & Specialty Pharmacy, vol. 21, no. 8 (2015):  pp. 662-669.

Krumme, Alexis A., Robert J. Glynn, Sebastian Schneeweiss, Joshua J.  Gagne, J. Samantha Dougherty, Gregory Brill, and Niteesh K. Choudhry.  “Medication Synchronization Programs Improve Adherence to  Cardiovascular Medications and Health Care Use.” Health Affairs, vol. 37,  no. 1 (2018): pp. 125-133.

Krumme, Alexis A., Danielle L. Isaman, Samuel F. Stolpe, J. Samantha  Dougherty, and Niteesh K. Choudhry. “Prevalence, Effectiveness, and  Characteristics of Pharmacy-Based Medication Synchronization  Programs.” American Journal of Managed Care, vol. 22, no. 3 (2016): pp.  179-186.

Luder, Heidi R., Natalie Kunze, Pamela C. Heaton, and Stacey M. Frede.  “An Appointment-Based Model to Systematically Assess and Administer  Vaccinations.” Journal of the American Pharmacists Association, vol. 58,  no. 3 (2018): pp. 290-295.

Nguyen, E., and D. M. Sobieraj. “The Impact of Appointment‐Based  Medication Synchronization on Medication Taking Behaviour and Health  Outcomes: A Systematic Review.” Journal of Clinical Pharmacy and  Therapeutics, vol. 42, no. 4 (2017): pp. 404-413.

Patterson, Julie, and David Holdford. “Understanding the Dissemination  of Appointment-Based Synchronization Models Using the CFIR  Framework.” Research in Social and Administrative Pharmacy, vol. 13,  no. 5 (2017): pp. 914-921.

Patterson, Julie A., David A. Holdford, and Kunal Saxena. “Cost-Benefit  of Appointment-Based Medication Synchronization in Community  Pharmacies.” American Journal of Managed Care, vol. 22, no. 9 (2016):  pp. 587-593.

Renfro, Chelsea P., Michael Patti, Jordan M. Ballou, and Stefanie P.  Ferreri. “Development of a Medication Synchronization Common  Language for Community Pharmacies.” Journal of the American  Pharmacists Association, vol. 58, no. 5 (2018): pp. 515-521.

Ross, Alexander, Humaira Jami, Heather A. Young, and Richard Katz.  “Sync and Swim: The Impact of Medication Consolidation on Adherence  in Medicaid Patients.” Journal of Primary Care & Community Health, vol.  4, no. 4 (2013): pp. 240-244.

White, Nicole D. “Pharmacy Medication Synchronization Service Works to  Improve Medication Adherence.” American Journal of Lifestyle Medicine,  vol. 10, no. 6 (2016): pp. 385-387.

Witry, Matthew, and Thao Hoang. “Community Pharmacist Attitudes on  Medication Synchronization Programs.” INNOVATIONS in Pharmacy, vol.  8, no. 2 (2017): pp. 1-7.

Not taking medications as prescribed can increase the risk of medical complications and costs. According to pharmacy groups, synchronizing medication refills can make it easier for patients to get their medications and thus promote taking them as prescribed. Pharmacists could realign refill dates for all of a patient's medications so they may be picked up together.

We found no comprehensive information on the effects or extent of this practice. However, most of the 22 studies we reviewed reported positive effects and 1 found the practice increasing.

We also found that Medicare and some states have rules that help facilitate synchronization.

Question: What is medication synchronization?

Answer: Medication synchronization is a process whereby a pharmacist aligns the refill dates of two or more of a patient's medications to a single day (see figure below).

Question: What did GAO discover regarding data on medication synchronization?

Answer: GAO found that no comprehensive national data exist on the extent to which medication synchronization has been used or its potential effects. However, limited information suggests that the use of medication synchronization has increased in recent years and that it may have benefits.

Question: How was this demonstrated by a study published in the American Journal of Managed Care?

Answer: According to a study published in the American Journal of Managed Care that examined survey data on retail pharmacies, the number of pharmacies using medication synchronization increased from 3,324 in 2013 to 5,534 in 2014.

Question: What did GAO find regarding medication synchronization's effect on patients?

Answer: Most of the studies that GAO identified found positive effects from medication synchronization, primarily on patients.

Question: How was this demonstrated by a 2018 study GAO analyzed?

Answer: For example, a 2018 study reported a 3 percent improvement in medication adherence among patients using medication synchronization than those who were not.

Question: What potential limitations to this method did GAO find?

Answer: Several stakeholders also identified potential limitations of using medication synchronization. For example, some patients may not be able to afford paying all the copayments for their medications at one time each month, and some patients prefer the social interaction of multiple trips to the pharmacy each month.

Limited Information Suggests the Use of Medication Synchronization Has Increased; Some Studies and Stakeholders Reported Several Potential Benefits and Limitations

One Study and Several Stakeholders Suggest the Use of Medication Synchronization Has Increased in Recent Years

Studies and Stakeholders Suggest that Medication Synchronization Can Be Beneficial to Patients, Pharmacies, and Health Plans

Studies and Stakeholders also Identified Potential Limitations of Medication Synchronization for Patients, Pharmacies, and Health Plans

Question: What has been done to support the use of medication synchronization?

Answer: The Centers for Medicare & Medicaid Services (CMS) issued a regulation and some states enacted laws that may help support the use of medication synchronization.

Question: What does this CMS regulation allow for?

Answer: While CMS does not have a formal medication synchronization policy for Medicare, a CMS regulation allows for reduced beneficiary cost sharing (for example, a lower copayment) when the beneficiary receives less than a month's supply of a medication.

Question: In what other cases do similar laws apply?

Answer: Similar laws pertain to private health plans that provide prescription drug coverage for patients in the five states GAO selected—Georgia, Illinois, Maine, Texas, and Washington.

Question: How do such measures support medication synchronization?

Answer: Such measures support medication synchronization because initially aligning the refill dates of multiple medications may require one or more of these medications to be refilled with a quantity that is less than a month's supply.

Question: What did officials from CMS note about the financial burden to this method?

Answer: Officials from CMS and four of the selected pharmacies said that lowering the copayments for these refills reduces the financial burden on patients when they first have their medications synchronized. They noted that requiring full copayments for a shorter supply may have discouraged or prevented patients from using medication synchronization.

A CMS Regulation and Laws in Selected States May Support the Use of Medication Synchronization, Such as By Reducing Patient Cost Sharing

Question: What did GAO review to report on medication synchronization?

Answer: GAO identified and reviewed 22 peer-reviewed studies on medication synchronization.

Question: Why did GAO interview CMS officials and stakeholders?

Answer: In addition, GAO interviewed CMS officials and 30 stakeholders to gather a wide range of perspectives on medication synchronization.

Question: What organizations were interviewed?

Answer: Among others, GAO interviewed six selected pharmacies and two selected Medicare health plans.

Question: What regulations did GAO review?

Answer: GAO also reviewed CMS regulations as well as medication synchronization laws from five selected states that vary by geographic region.

Appendix I: Information about Stakeholders Interviewed