Medicare: Limited Information Exists on the Effects of Synchronizing Medication Refills
Released: 2019-07-15T00:00:00

Letter

Background

Medication Synchronization

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.

Selected States

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.

Agency Comments

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 mid-size regional retail chain

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

GAO Contact

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.

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