Jamie L. McConaha, PharmD, CGP, BCACP

(MTM) has been used to de&shy;scribe the crucial suite of services pharmacists can provide that make them indispensable in the healthcare field. Before the advent and recognition of MTM, pharmacists ten&shy;ded to be seen as mere medication dispensers and as sources for quick healthcare consultations or advice. As MTM oppor&shy;tunities increased, however, pharmacists moved closer to be&shy;ing accepted as sophisticated healthcare practitioners and to being recognized for their unmatched ability to provide cru&shy;cial, individualized medication recommendations that help to optimize patient care.

	With MTM, a pharmacist can counsel a patient on prescrip&shy;tion and lifestyle therapies as well as their medical/disease conditions, while working with the patient’s physician to cre&shy;ate a medication plan to decrease the likelihood of adverse drug events and increase the chance of an optimal patient outcome.

 In addition, MTM appointments create an oppor&shy;tunity for pharmacists to recognize and address medication nonadherence, which when present is an extremely impor&shy;tant element in a patient’s healthcare outlook. In patients with poor medication adherence, the risks of adverse effects and mortality rise; these not only negatively impact the patient’s well&shy;being, but also result in increased medical spending for both the patient and the healthcare system.

	Given the potential benefits of pharmacist&shy;led MTM, evaluating its feasibility and sustainability is important. In a retrospective, cross-&shy;sectional study, Look and colleagues ex&shy;amined the fiscal aspects of MTM services, finding that the return on investment of an MTM session was $20.31 per pa&shy;tient for a new prescription and $14.76 for a refill, with the overall mean return on investment to the pharmacy benefit manager (PBM) being $3.55.

 This demonstrates that while the priority of MTM programs remains providing health ben&shy;efits to patients, MTM is also fiscally beneficial a notable achievement in the current healthcare climate, influenced by the Affordable Care Act, which has sharpened the focus on outpatient programs that can prevent negative patient outcomes and hospitalizations. As such, CMS has supported MTM services to help pro&shy;vide optimal outcomes for patients. CMS created the Star program to evaluate performance measures in relation to Medicare Part D programs.

	Increased revenue and cost savings tend to drive the implementation of clinical programs in health&shy;care, and each pharmacy that provides MTM servic&shy;es can have a new revenue stream. In fact, MTM has been shown to be beneficial to both patients and health plans in terms of patient care and associated costs,

 and best practices would advocate implementing MTM services into pharmacy work flow as face&shy;to&shy;face in&shy;teractions with patients. However, MTM’s financial incen&shy;tives and associated improved patient outcomes aside, a large barrier to its widespread use remains: how to imple&shy;ment MTM into community pharmacy work flow without disrupting dispensing services.

	The most successful programs implement MTM at a patient’s “home” pharmacy, defined as the location where they fill the majority of their prescriptions.

 Performing MTM for a patient from a remote location could poten&shy;tially result in a less effective session, a higher rate of adverse events, or medication errors, due to the fact that there will be less communication between the pharmacist providing the MTM and the patient’s dispensing pharma&shy;cist at their home pharmacy. There remains a risk that the MTM pharmacist does not communicate with the patient’s home pharmacist, and secondly, the patient may only feel comfortable speaking with their home pharmacist. Implementing MTM into work flow at the home pharmacy allows the dispensing pharmacist to have a clinical role in the patient’s healthcare management, as well as to en&shy;hance the patient&shy;pharmacist relationship.

	Because of the national trend in healthcare to provide more comprehensive outpatient clinical services, CMS designed Star ratings as an evaluative system to assess patient outcomes

 more specifically, to assess Medicare Part D plan sponsors on their quality of patient care. At this time, Medicare Part D plans can improve their Star rating through an in&shy;house MTM service, or utilize a com&shy;munity pharmacy to help improve patient care. While an individual pharmacy does not get a specific Star rating, the health plan or health plan’s PBM that contracts with the pharmacy may create financial incentives as a return on investment based upon the Star rating achieved for advancing the quality of pharmacy care. The outcomes assessed through Star ratings include such parameters as bridging the gaps in therapy for certain disease states (ie, diabetes), avoiding drug&shy;drug interactions, careful consid&shy;eration of the use of high&shy;risk medications in the elderly, and appropriateness of medications in patients with the disease states of diabetes or hypercholesterolemia. Lastly, Star ratings also evaluate the need for appropriate therapy (eg, angiotensin&shy;converting enzyme [ACE] inhibitors and angiotensin receptor blockers [ARBs] in patients with diabetes). The overall goal of the Star rating system is to benefit the patient through appropriate medication man&shy;agement while also reducing healthcare costs.

	The objectives of the current study were to design and assess the feasibility of MTM implementation in high-&shy;volume settings, as well as to evaluate the fiscal benefit of providing comprehensive care versus following the traditional dispensary model. The most difficult aspects of providing comprehensive care are identifying patients and having the ability to bill for the services rendered. Patient identification remains a barrier to providing MTM because without full transparency from the health plan or PBM, the eligibility status of a patient to receive MTM services is unknown. Then, even if a patient is identified as eligible to receive MTM services, service billing is often problem&shy;atic because each health plan has an individualized billing protocol, which the pharmacist may not be familiar with.

	The OutcomesMTM platform handles both barri&shy;ers by identifying patients eligible for MTM (ie, patients whose prescription insurance is contracted through Out&shy;comesMTM) and by providing a defined billing structure that, depending on the type of pharmacist intervention, assures a certain profit. OutcomesMTM allows for easy, universal billing to all PBMs and health plans by the phar&shy;macist and can be completed within the platform, which focuses on the 6 criteria most pertinent to the CMS Star ratings. Specifically, these are: 1) treating hypertension in patients with diabetes with ACE inhibitors and ARBs, 2) medication adherence with ACE inhibitors and ARBs, 3) medication adherence with diabetes medications, 4) medication adherence with statins, 5) drug&shy;drug interac&shy;tions that can potentially cause harm to the patient, and 6) high&shy;risk medications in the elderly.

	Adherence to medications is measured through the metric called proportion of days covered (PDC), which the Pharmacy Quality Alliance defines as “the proportion of days in the measurement period ‘covered’ by prescription claims for the same medication or another in its therapeu&shy;tic class.”3 OutcomesMTM has created a Targeted Interven&shy;tion Program (TIP) that provides individualized messages to pharmacists that address a concern about a particular patient. Concerns include a suspected gap in therapy, a prescribed medication that has a potentially less expen&shy;sive but equally therapeutic alternative, the lack of an ACE inhibitor or ARB prescription for a patient with diabetes and hypertension, a medication adherence “red flag,” an elderly patient prescribed a high&shy;risk medication, the need for a medication (eg, the need for a statin in a patient with diabetes), and potential necessary dose adjustments.

	An “invalid” TIP is defined as one that is incorrectly identified for a patient if, for instance, the patient is al&shy;ready compliant with all medications or a medical ratio&shy;nale exists against the proposed intervention. Conversely, an “approved” TIP is one accepted by OutcomesMTM for payment.

 If a patient is eligible for a TIP, they are most likely eligible to receive an annual Comprehensive Medi&shy;cation Review (CMR), an extensive evaluation of their medication regimen. While a TIP targets a specific end point, a CMR can be tailored in a way that is patient&shy;spe&shy;cific and addresses all potential medication issues.

	OutcomesMTM obtains data from prescription claims. If a patient is part of a prescription insurance plan that contracts with the patient’s home community pharmacy, gaps in therapy will be discovered by OutcomesMTM, then relayed to that pharmacy, and a pharmacist there will provide the intervention. When a TIP is identified, it can trigger the pharmacist to perform a CMR for the patient as long as they are eligible.

	While OutcomesMTM identifies patients who need in&shy;terventions, the Electronic Quality Improvement Platform for Plans and Pharmacies (EQuIPP) database measures the success of pharmacies that have implemented MTM services. As of January 2013, EQuIPP defines successful MTM services as those meeting or exceeding the follow&shy;ing criteria: ACE inhibitor/ARB use in patients with dia&shy;betes (83%); ACE inhibitors/ARBs PDC (76%), cholesterol (statin) medication PDC (72%), and diabetes medications PDC (76%). Rates of less than 5.5% and 19% for drug&shy;drug interactions and high&shy;risk medications, respectively, are acceptable. ACE inhibitor and ARB are used to provide re&shy;nal protection in patients with diabetes. Adherence mea&shy;sures are important, as they help to prevent complications of the patient’s diagnosis such as hypertensive emergency, hypertensive urgency, stroke, diabetic ketoacidosis, renal dysfunction, and myocardial infarction. Drug&shy;drug inter&shy;actions help to prevent the interaction of 2 medications interacting that may be potentially harmful to patients. Lastly, high&shy;risk medications in the elderly help to prevent elderly patients from receiving medications that may pro&shy;mote cognitive decline and/or cause harm to the patient.

	EQuIPP with its goals created in collaboration with CMS for pharmacies to gauge their success participates with both community pharmacies and health plans to evaluate a community pharmacy. EQuIPP obtains data from pharmacy claims from participating prescription in&shy;surance plans, then calculates PDC and medication usage for identified patients; these usages are then shared with the community pharmacy to assess areas in which the pharmacy is not meeting goals. The results from EQuIPP are calculated as percentages, and they are compared with the standards set forth by EQuIPP for obtaining 5&shy;Star CMS ratings. The Star ratings are evaluated annually while EQuIPP scores provide a monthly (ie, starting off as ev&shy;ery 3 months and then becoming monthly) evaluation of the pharmacy’s progress.

 The patients recognized by the EQuIPP platform are those whose health plan has con&shy;tracted with EQuIPP in most cases, a health plan con&shy;tracted with EQuIPP is contracted with an MTM platform as well. EQuIPP acts as a barometer for how successfully the pharmacy is providing patient care services. 

Three locations of Giant Eagle a regional grocery store chain pharmacy, each with high-&shy;volume work flow were selected to pilot a program to design and ob&shy;serve the success of MTM services in the form of TIPs and CMRs. The 3 stores were selected based upon high vol&shy;ume of prescriptions, structure of current work flow, and geographic location.

	High&shy;-volume stores were defined as those processing more than 500 prescriptions per day. Pharmacies that had already implemented the EQuIPP and OutcomesMTM platforms in their work flow were chosen to participate in this pilot. Finally, the geographic locations were iden&shy;tified as areas in which the patient population was of lower socioeconomic standing as defined by the 2012 HHS Poverty Guidelines,5 meaning an income less than $11,170 in a household of 1, or less than $38,890 for a household of 8 (with gradations in between). Historically, such locations include patients with a higher&shy;than&shy;average utilization of Medicaid&shy;based prescription insurance, and may offer healthcare not as qualitatively distinguished as that in more affluent geographic locations. Because of this diminished quality, there may be a greater need for MTM services, to help ensure better patient outcomes.

	The EQuIPP and OutcomesMTM databases were used to extract data for the study. The EQuIPP database as&shy;sessed each pharmacy from June 2012 to January 2013 in terms of the 6 criteria in which gaps of therapy are com&shy;mon and problematic: ACE inhibitor/ARB use in patients with diabetes; PDC with ACE inhibitors/ARBs, diabetes medications, and cholesterol medications; drug&shy;drug in&shy;teractions; and high&shy;risk medications.

	The observational phase of the study to assess work flow design occurred between November 1 and November 30, 2012; the implementation of the principal investigator (PI) into work flow conducting MTM services occurred be&shy;tween December 1 and December 31, 2012. The EQuIPP rating for each piloted store was noted on June 1, Septem&shy;ber 1, and December 1, 2012, and January 1, 2013, while overall claims for payment were extracted at the conclu&shy;sion of the study period from the OutcomesMTM database to measure efficacy and profitability. Results for EQuIPP were initially reported quarterly, and then monthly begin&shy;ning in December 2012. Data were collected from EQuIPP and OutcomesMTM from the database to assess the vol&shy;ume of TIPs and CMRs completed, revenue obtained, and changes in hypothesized Star ratings. Results from Out&shy;comesMTM show revenue from services as well as the number of TIPs and CMRs completed.

	To develop the standardized protocol for implementing TIPs into the pharmacy work flow, the PI spent the month of November 2012 (minimum 40 hours per week) in the pilot locations evaluating the work flow. After evaluation, the PI was then incorporated into the work flow during the month of December 2012, completing TIPs and CMRs in an effort to mimic a traditional staffing pharmacist and the challenges they face. With the experiences gleaned from 2 months of observation, the standardized protocol was created. A standardized protocol for all stores was then created, one that allowed flexibility where needed be&shy;cause each store has a different work flow. The standard&shy;ized protocol can be found in the 

). The protocol provides a guideline on how to conduct MTM services in a work flow that utilizes qualified pharmacy technicians and pharmacy interns. It can be individualized and adapted to fit any store. The protocol was created so that implementation of MTM ser&shy;vices can be successful without the addition of extra staff, in an effort to continue providing high&shy;quality dispensing services along with patient&shy;centric, individualized care. Successful completion of the TIPs entailed identifying the nature of the TIP, researching its validity, providing the intervention, and then billing the TIP appropriately. A TIP was considered invalid if the clinical situation was no longer pertinent to the patient. A TIP will remain in the OutcomesMTM system until it is addressed; in these stores, MTM utilization was not present (although avail&shy;able), so TIPs that were almost a year old remained pres&shy;ent until they were deemed invalid. A successful CMR was defined as evaluating a patient’s medication regimen and then having a consultation with the patient to verify that the medications were safe and efficacious.

The analyzed results compare the health plan’s project&shy;ed Star ratings both pre&shy; and post intervention. Pre&shy;inter&shy;vention, the pharmacies’ projected Star ratings reflect the time period of June 1 to December 1, 2012. The EQuIPP results from January 1, 2013, show the impact of 1 month of TIPs and CMRs being completed at the store level.

 show the pharmacy EQuIPP ratings for each store pre&shy;intervention (months of June, Sep&shy;tember, and December 2012) as well as the rating after 1 month of MTM implementation into work flow (January 2013). In each table, the EQuIPP rating post intervention that meets or exceeds expectations is highlighted.

	Table 1 shows the results from Store 1. Drug&shy;drug in&shy;teractions and high&shy;risk medications did meet the goal (as defined by EQuIPP post implementation), whereas the criteria that did not, included ACE inhibitor/ARB usage in patients with diabetes, and each category of PDC (ACE inhibitor/ARB, cholesterol medications, diabetes medica&shy;tions). While the goal was not reached in some criteria, an upward trend did occur in the categories of ACE inhibitor/ ARB usage in diabetes and cholesterol medication PDC from pre&shy;intervention to post intervention.

	Table 2 shows the results from Store 2. Criteria that did not meet the goal in this store included ACE inhibitor/ARB usage in patients with diabetes, but the goal was met in all other criteria.

	Table 3 shows the results for Store 3. The criteria that met the stated goal included ACE inhibitor/ARB PDC, dia&shy;betes medication PDC, drug&shy;drug interactions, and high&shy;risk medications. The categories of ACE inhibitor/ARB use in diabetes and cholesterol medication PDC did not meet the EQuIPP goal. However, it should be noted that there was an improved trend post intervention in both of these categories.

	An OutcomesMTM analysis summarized the number of completed TIPs, invalid TIPs, and approved TIPs; the number of CMRs completed; and the total compensation for each service received from OutcomesMTM for the pharmacy. This report included data from December 1 to December 31, 2012. A total of 86 TIPs were completed, with 36 TIPs approved for payment. Total compensation for the TIPs provided was $374. A total of 13 CMRs were completed during the study period, providing revenue of $975 (see 

	The metrics involved with completing MTM services are important to note. Throughout this study, the PI docu&shy;mented the amount of time involved in completing the TIPs. On average, these times were: contacting a physician with a voicemail message, 4 minutes; speaking directly with a physician or nurse, 5 minutes; contacting a patient via answering&shy;machine message, 3 minutes; speaking to a patient regarding adherence, 4 to 5 minutes; billing by fax, 1 to 2 minutes, depending on if an explanation was necessary for OutcomesMTM. Since CMRs were not going to be instituted into work flow, an analysis of metrics was not performed.

The results from EQuIPP and OutcomesMTM illustrate that medication therapy management services are both beneficial for the patient and fiscally sound, promoting the clinical and financial aspect of community pharmacy. Results show that after intervention, goals were achieved in some ratings, but most notably, an overall trend toward the goal was established compared with baseline. While the goals may not have been reached in all categories for all stores, the results showed improvement in performance measures in 11 categories for the possible 18 measures among the stores. ACE inhibitor and ARB usage in patients with diabetes did not reach goal as identified in all pilot locations, but improvement occurred in each store. As&shy;sessment in PDC was found to meet the goal in most cat&shy;egories. The percentage of drug&shy;drug interactions in each store fell post intervention, and the percentage of high&shy;risk medication usage in each store increased; still, despite this increase, it remained within goal at each location.

	As for the EQuIPP ratings, an area that clearly needs further attention is the timely initiation of an ACE inhibi&shy;tor or ARB in patients with diabetes, as every store was below the goal level, possibly because of the extra re&shy;quired step of consulting a physician. Proactive screen&shy;ing could improve this metric: when processing and filling a diabetes medication, if a prospective look at the patient’s profile reveals that they are taking a medication for hypertension but are not taking an ACE inhibitor or ARB, a counseling sticker could be applied to the pa&shy;tient’s bag to explain why an ACE inhibitor or ARB might be most appropriate for the patient. If the patient is not taking a hypertension medication, the counseling sticker could instead discuss the risks associated with diabetes and advocate for the patient by suggesting blood pres&shy;sure measurement.

	Within the PDC EQuIPP categories, adherence is an&shy;other area requiring further attention and pharmacist intervention. Poor adherence is especially prevalent in as&shy;ymptomatic disease states such as hyperlipidemia. In this study, although it ultimately remained below goal, cho&shy;lesterol medication PDC improved over baseline in all 3 locations due, we believe, to the piloted MTM implemen&shy;tation. Using this protocol with a longer time frame might be more successful in meeting adherence goals.

	The measures of drug&shy;drug interactions fluctuated: in the summer months, they were at a low the June average for the 3 stores was 2.4% but they rose during the fall, reaching a December average of 10.4%. Various factors could account for this increase; possibly, the increased seasonal demands on pharmacists to multitask in verifying prescriptions, administering immunizations, and contend&shy;ing with the higher rate of inappropriate prescribing of antibiotics and other supportive measures during the cold and flu season could contribute to this elevation in interac&shy;tions. Further analysis may justify the placement in stores of more pharmacists who would be devoted to clinical services alone.

	Regarding the management of high&shy;risk medication prescriptions, all pharmacies met their goal. Factors asso&shy;ciated with this success could include increased physician awareness of Beers Criteria for medication usage in the elderly. Studies indicate that extensive physician educa&shy;tion on high&shy;risk medications in the geriatric population has contributed to a decrease in prescribing such medica&shy;tions for them.6&shy;8 Because some high&shy;risk medications are still commonly prescribed to geriatric patients, however, pharmacists must follow up with a prescribing physician regarding the risk&shy;benefit scenario for the medication in question when the situation arises.

	MTM’s fiscal aspect is important. The 36 pertinent TIPs generated revenue of $374, while some TIPs provide rev&shy;enue of $10 to $20. Also, if a physician or patient refuses the intervention, a $2 reimbursement for the pharmacist’s time is given; the average compensation was found to be $10.

	The CMRs completed in this study were done as a secondary aim to assess profitability of providing CMRs for a patient. The 13 CMRs that were billed found no intervention warranted. By billing for the CMR with no in&shy;tervention, nearly $1000 was generated in revenue.

	Besides direct reimbursements and dividends paid by the health plan to the pharmacy, we can address pro&shy;tected profit, which is defined as the amount of profit that a pharmacy should generate from a given patient if that patient remains loyal to the pharmacy and adherent to their medications. For the pharmacies in the study, a protected profit of $3000 per patient per intervention was established (with a total of $108,000). An algorithm cre&shy;ated by the parent company based on Medicare Part D projections for drug costs for 1 patient in 1 year includes an annual drug incursion of $3100.20, multiple diagno&shy;ses for different disease states, and multiple medications taken that are covered under Medicare Part D. The correla&shy;tion between the chosen protected profit and annual drug incursion through Medicare Part D is that, if an interven&shy;tion is performed on the patient, the patient will continue to utilize the pharmacy’s services, ensuring a profit for the pharmacy due to increased adherence, better clinical care, and ensuring that the patient only utilizes 1 pharmacy. For the regional pharmacy chain used in this study, Out&shy;comesMTM contracts with insurance companies, resulting in access to approximately 30,000 patients. A realistic goal would be to interact with 1000 patients per year, accruing revenue of $75,000 (based on receiving $75 from a CMR) with a maximum of $2,250,000 if all patients are evaluated (based on the number of patients in the OutcomesMTM system eligible for interventions for the entire company).

	Clearly, a substantial workforce is necessary to conduct the CMRs. However, the costs of training pharmacists to conduct them using OutcomesMTM are minimal because the platform uses an online repository for this training, which includes mostly videos and documents to be read.

	The time requirements for phone calls that are inte&shy;gral to these services can’t be ignored; such calls would be additional work, outside the scope of normal dis&shy;pensing duties for a pharmacist in the community set&shy;ting. It takes approximately 5 to 8 minutes to complete each TIP and bill appropriately, but pharmacists need not complete all tasks themselves interns, advanced experiential student pharmacists, and trained techni&shy;cians could help with billing, researching the validity of TIPs, and providing necessary background information for the pharmacist.

	The protocol we created is fluid in nature, allowing for its adaptability to any community pharmacy’s needs. The protocol accounts, for instance, for pharmacies that do or do not have interns and trained technicians, or those with a single pharmacist. The strategies employed in the study were found to be successful enough that the community pharmacy in which the study was completed has begun implementing them into work flow. Initial implementation is presumably the biggest hurdle; we anticipate that with familiarity, a more fluid transition from dispensing services to comprehensive care services will occur.

Articles

This study shows how medication therapy management can be integrated into challenging pharmacy work flow, and also assesses the resulting benefits, both clinical and financial.