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Learning Objectives 1. Analyze the evolution of medication therapy man- agement (MTM) in pharmacy practice. 2. Demonstrate an understanding of the American Pharmacists Association’s Core Elements in MTM encounters. 3. Assess the current marketplace for MTM services. 4. Devise a plan to incorporate MTM services into a pharmacist’s practice. 5. Apply reimbursement strategies to MTM services. 6. Evaluate the future of MTM on the basis of health care reform legislation. Introduction e practice of pharmacy has evolved from the traditional role of compounding and dispensing drugs. Historically, except in some specialized areas, pharmacy practice did not include patient monitoring or ensuring that patients achieved optimal therapeutic outcomes from their drugs. e typical pharmacist’s role began to change in 1990 when Hepler and Strand published their paper describing pharmaceutical care. is chapter reviews the development of pharmacy practice, starting with the concept of pharmaceutical care and progressing through disease state management and medication therapy management (MTM) to the potential impact of health care reform on pharmacists as managers of pharmaceutical care. To continue this evolution to active participants in the management of drug therapy, the pharmacist must understand these concepts and capitalize on the potential opportunities they present in today’s practice seings. Pharmaceutical Care In 1990, the term pharmaceutical care was coined; since then, the pharmacist’s role has continued to expand in a variety of practice seings. Hepler and Strand defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life.” Not only should the pharmacist dispense drugs, but he/she should also assume responsibility for Medication Therapy Management By Schwanda Flowers, Pharm.D.; and Anne Pace, Pharm.D. Reviewed by Elaine Lau, Pharm.D.; Katherine H. Chessman, Pharm.D., FCCP, BCPS, BCNSP; and Amy C. Dill, Pharm.D., BCPS Baseline Review Resources e goal of PSAP is to provide only the most recent (past 3–5 years) information or topics. Chapters do not provide an overall review. Suggested resources for background information on this topic include: Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990;47:533–43. Cranor CW, Christensen DB. e Asheville Project: short-term outcomes of a community pharmacy diabe- tes care program. J Am Pharm Assoc 2003;43:149–59. Cranor CW, Bunting BA, Christensen DB. e Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc 2003;43:173–84. Bunting BA, Cranor CW. e Asheville Project: long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management program for asthma. J Am Pharm Assoc 2006;46:133–47. Cipolle RJ, Strand LM, Morley PC, eds. Pharmaceutical Care Practice, 2nd ed. e Clinician’s Guide. New York: McGraw-Hill, 2004. Pellegrino AN, Martin MT, Tilton JJ, Touchee DR. Medication therapy management services: definitions and outcomes. Drugs 2009;69:393–406. 2-495

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Page 1: Medication Therapy Management - ACCP

Learning Objectives 1. Analyze the evolution of medication therapy man-

agement (MTM) in pharmacy practice.2. Demonstrate an understanding of the American

Pharmacists Association’s Core Elements in MTM encounters.

3. Assess the current marketplace for MTM services.4. Devise a plan to incorporate MTM services into a

pharmacist’s practice.5. Apply reimbursement strategies to MTM services.6. Evaluate the future of MTM on the basis of health

care reform legislation.

Introduction The practice of pharmacy has evolved from the traditional role of compounding and dispensing drugs. Historically, except in some specialized areas, pharmacy practice did not include patient monitoring or ensuring that patients achieved optimal therapeutic outcomes from their drugs. The typical pharmacist’s

role began to change in 1990 when Hepler and Strand published their paper describing pharmaceutical care. This chapter reviews the development of pharmacy practice, starting with the concept of pharmaceutical care and progressing through disease state management and medication therapy management (MTM) to the potential impact of health care reform on pharmacists as managers of pharmaceutical care. To continue this evolution to active participants in the management of drug therapy, the pharmacist must understand these concepts and capitalize on the potential opportunities they present in today’s practice settings.

Pharmaceutical Care In 1990, the term pharmaceutical care was coined; since then, the pharmacist’s role has continued to expand in a variety of practice settings. Hepler and Strand defined pharmaceutical care as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life.” Not only should the pharmacist dispense drugs, but he/she should also assume responsibility for

Medication Therapy Management

By Schwanda Flowers, Pharm.D.; and Anne Pace, Pharm.D.Reviewed by Elaine Lau, Pharm.D.; Katherine H. Chessman, Pharm.D., FCCP, BCPS, BCNSP; and Amy C. Dill, Pharm.D., BCPS

Baseline Review Resources The goal of PSAP is to provide only the most recent (past 3–5 years) information or topics. Chapters do not provide an overall review. Suggested resources for background information on this topic include:• Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm

1990;47:533–43.• Cranor CW, Christensen DB. The Asheville Project: short-term outcomes of a community pharmacy diabe-

tes care program. J Am Pharm Assoc 2003;43:149–59.• Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes

of a community pharmacy diabetes care program. J Am Pharm Assoc 2003;43:173–84.• Bunting BA, Cranor CW. The Asheville Project: long-term clinical, humanistic, and economic outcomes of a

community-based medication therapy management program for asthma. J Am Pharm Assoc 2006;46:133–47.• Cipolle RJ, Strand LM, Morley PC, eds. Pharmaceutical Care Practice, 2nd ed. The Clinician’s Guide. New

York: McGraw-Hill, 2004.• Pellegrino AN, Martin MT, Tilton JJ, Touchette DR. Medication therapy management services: definitions

and outcomes. Drugs 2009;69:393–406.

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managing drug-related effectiveness, resolving drug-related adverse events, and preventing potential drug-related problems. This expanded role for pharmacists was favorably received by pharmacy organizations and colleges/schools of pharmacy, resulting in expanded curricula and conversion to the doctor of pharmacy as the entry-level degree into the pharmacy profession. Many worked to implement the pharmaceutical care philosophy into practice, but there have been barriers. Reimbursement was one of the main barriers: the pharmacist is traditionally reimbursed on the basis of dispensing a drug product, not for the cognitive services provided during the encounter. In addition to reimbursement, pharmacists faced resistance from other health care providers as their professional role changed. One of the first reported projects to evaluate pharmaceutical care was conducted in Asheville, North Carolina, starting in 1997. Pharmacy leaders formed the North Carolina Center for Pharmaceutical Care and collaborated with the city of Asheville to offer pharmaceutical care services to city employees with diabetes. In 1999, a second employer, Mission St. Joseph’s Health System, joined the project. Participating pharmacists were trained in diabetes management, and they then provided education, training, assessment, monitoring, and follow-up for patients enrolled in the program. These patients met with a pharmacist regularly (usually monthly) and received incentives through waived diabetic drug copayments; they also were assessed for clinical, economic, and humanistic outcomes, including hemoglobin A1C and serum cholesterol concentrations.

In the combined groups (city of Asheville and Mission St. Joseph’s Health System), significantly more patients reached the hemoglobin A1C goal of less than 7% at follow-up compared with baseline (57% vs. 42%). The number of patients reaching low-density lipoprotein and high-density lipoprotein cholesterol goals also increased, although not significantly. In the first year of the program, the city of Asheville saved almost $20,000 on overall health care expenses for the city’s enrolled employees compared with the previous year. Employees who participated in the program also had an increase in the total days worked. In 1999, the North Carolina Center for Pharmaceutical Care and the City expanded the program to asthma services. Since the beginning of the Asheville Project, many cities have replicated the Asheville model with diverse employers.

Disease State Management Disease state management began in the 1990s as a coordinated effort among health care providers to help patients achieve goals for improved health outcomes by following recommendations in clinical practice guidelines. Programs focused on specific diseases, and their goals were designed to empower patients to take an active role in their disease state management through education. The pharmacist was responsible for monitoring and recommending optimal drug therapy to achieve disease-specific, evidence-based goals. Among the disease state management programs developed by pharmacists were anticoagulation, hypertension, dyslipidemia, asthma, and diabetes. Typically, pharmacists providing these programs reviewed the drugs specifically related to the condition addressed by the program, not the patient’s complete drug profile. The many examples of pharmacists implementing disease-state management programs include Project ImPACT: Hyperlipidemia, a 2-year demonstration project that evaluated a dyslipidemia management program. Pharmacists at 26 different community-pharmacy practice sites in 12 states were selected to meet with patients who were newly diagnosed with hyperlipidemia or who were already receiving lipid-lowering drugs but with poorly controlled disease. The study protocol directed pharmacists to identify patient drug-therapy problems and work collaboratively with physicians to resolve them. Pharmacists tested patients’ lipid concentrations at the initial visit, meeting with patients monthly for the first 3 months and then quarterly. The pharmacist contacted the physician when drug therapy problems were identified. Adherence to the lipid-lowering drug regimen in the study population increased from 40% to 90%. In addition, 63% of participants who completed the study achieved National Cholesterol Education Program goals. The Diabetes Ten City Challenge is another example of a disease-state management project that showed

Abbreviations in This ChapterACA Affordable Care ActAPhA American Pharmacists

AssociationCMR Comprehensive medication

reviewCMS Centers for Medicare &

Medicaid ServicesCPT Current Procedural

TerminologyMAP Medication-related action planMMA Medicare Modernization Act of

2003MTM Medication therapy

managementMTR Medication therapy reviewNACDS National Association of Chain

Drug StoresPMR Personal medication record

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improvement in clinical and economic outcomes. Employers in 10 distinct geographic locations contracted with community pharmacies to provide self-management care services for those with diabetes. Employers waived copayments for diabetic drugs and supplies for employees and their family members if they met regularly with a pharmacist specially trained to manage their diabetes. Patients learned how to self-manage their diabetes and to track key indicators of disease control through medical tests and foot and eye examinations. The 573 patients studied experienced significant improvements in hemoglobin A1C, mean low-density lipoprotein cholesterol concentrations, and systolic blood pressure.

Medication Therapy Management According to the Centers for Medicare & Medicaid Services (CMS) National Health Expenditure Accounts, U.S. health care spending continues to rise. In 2009, the total health-related expenditures were $2.54 trillion, or 17.6% of the gross domestic product, compared with 16.6% of the gross domestic product in 2008. This 4.0% rate of growth in expenditures was the slowest growth rate in almost 50 years. In addition, more patients are taking drugs, and many take several drugs, possibly because of the increasing age of the population, which adds to the risk of adverse effects and drug interactions. According to the Kaiser Family Foundation, 12 prescriptions, on average, were filled per person at U.S. pharmacies in 2009. Medication therapy management is an ideal way for pharmacists to become active participants in health care teams, thereby improving health outcomes and lowering health care costs. Finally, with the current shortage of primary care physicians, pharmacists can alleviate some of the access barriers in underserved communities. In 2003, Congress passed the Medicare Modernization Act (MMA), which established Medicare Part D. The MMA included a provision for MTM services to be included in Medicare Part D plans, and it required reimbursement for MTM services. Goals set forth by CMS for MTM programs were to improve outcomes and decrease adverse events through appropriate drug use. Although CMS outlined goals for MTM programs, it did not provide a clear definition of MTM or describe how MTM programs should be developed. As a result, 11 national pharmacy organizations joined to define MTM as “a distinct service or group of services that optimize therapeutic outcomes for individual patients. Medication therapy management services are independent of, but can occur in conjunction with, the provision of a medication product.”

MTM Core Elements After the consensus definition of MTM, the American Pharmacists Association (APhA) and the National Association of Chain Drug Stores (NACDS)

Foundation jointly developed a model framework for MTM implementation. This framework is designed to aid in implementing MTM services in the community setting and to maximize the efficiency and effectiveness of these services. The framework, which outlines the core elements of MTM, is meant for use with all patients who need MTM services regardless of their health care coverage. The five core elements are medication therapy review (MTR), personal medication record (PMR), medication-related action plan (MAP), intervention and/or referral, and documentation and follow-up. The model suggests that patients be offered these services from a pharmacist with whom they have an existing relationship and in a private or semiprivate environment where they can focus on identifying and resolving drug-related problems.

Medication Therapy Review The MTR is a comprehensive or targeted review with the patient, preferably conducted face-to-face. The review should include an evaluation of available objective data to assess the patient’s overall health, including current and past prescription and nonprescription drugs, herbal products and other supplements; laboratory values; current and past vital signs; medical conditions; and adverse reactions or undesirable signs and symptoms related to drug therapy. In addition, the MTR should include a discussion of patient preferences regarding therapy based on cultural issues, patient education or literacy level, financial barriers, and other potential patient-specific factors. The MTR also allows the pharmacist to assess patients’ understanding regarding indications for and expectations of their drug therapy. The pharmacist should assess the appropriateness of each drug and dosage as well as patient adherence. The pharmacist should also identify any potential duplicate therapy or unnecessary drugs in the patient’s profile. Monitoring current disease states and specific patient outcomes can be included in the MTR, as can communications with the patient’s physician or other health care provider regarding therapy. The MTR provides the pharmacist an opportunity to work with the patient and physician to optimize drug therapy and provide education or other information to improve patient outcomes. The targeted MTR can be used to examine specific problems identified by the pharmacist, to evaluate new drugs, or to use for monitoring. The APhA/NACDS Foundation framework suggests that each patient receive an MTR at least annually, with follow-up targeted MTRs throughout the year, if warranted on the basis of changes in the patient’s therapy or health status.

Personal Medication Record The second core component outlined in the APhA/NACDS Foundation model framework is the PMR. The

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PMR should include all pertinent patient demographics, a prescription and nonprescription drug profile, allergies, contact information for the patient’s physicians and pharmacists, and the date of the last PMR. For each drug, the profile should include start and stop dates, indication, dosing regimen, and prescriber information. The PMR must be updated regularly to reflect changes in the patient’s information. This document should be made available to the patient for personal use, and it should be portable so that it can be shared with all the patient’s health care providers. Figure 4-1 provides an example of a PMR adapted from a PMR published in the APhA/NACDS Foundation model framework.

Medication-Related Action Plan The MAP is the third core element of MTM. A critical part of MTM documentation, MAP should include

specific actions for the patient. This document should not include interventions that are awaiting physician approval or items that are outside the scope of the pharmacist’s practice. This document, when used in conjunction with patient education, will encourage the patient to actively participate in the health care plan. In addition to specific action items for the patient, contact information for the patient’s pharmacists and physicians, the date the MAP was prepared and/or updated, and any necessary follow-up information should be included. An example of a MAP adapted from the APhA/NACDS Foundation model framework is shown in Figure 4-2.

Intervention and/or Referral Intervention and/or referral, the fourth core element of MTM, is also crucial in showing the impact of

My Medication RecordName:_____________________________________________________ Birth date:____________________________Primary Care Physician:_______________________________________ Phone:_______________________________Pharmacist/Pharmacy:________________________________________ Phone:_______________________________AllergiesWhat allergies do I have? (medicines, food, other) What happened?

When do I take it?Drug Name Dose Take for… Morning Noon Evening Bedtime Start Date Stop Date Doctor Special Instructions

Over the Counter Medications

Special Notes

Patients Signature:Date:

Figure 4-1. One example of a personal medical record (PMR).

This form is based on forms developed by the American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Reproduced with permission from APhA and NACDS Foundation.

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the pharmacist on patient outcomes. Any drug-related problems identified should be documented and communicated to the patient’s physician. Communicating these interventions with the patient is critical for resolving existing or potential problems. Referral to a physician or other health care provider may be required, such as when patients need further diagnostic testing or evaluation, extensive disease state education for other chronic conditions, or additional monitoring that cannot be provided by the pharmacist.

Documentation and Follow-up Documentation and follow-up is the final MTM core element. Pharmacists must follow-up with patients after making an intervention to evaluate patient outcomes. They must document their services and interventions to show their value, evaluate patient outcomes, and bill payers for services.

MTM Marketplace According to the 2009 National Pharmacist Workforce Survey, pharmacists across the country are spending less time performing distributive and management functions and more time providing direct patient care and education and engaging in research. Because of the MMA, Medicare beneficiaries were provided opportunities to receive MTM. Today, the scope of patients eligible for MTM services includes more patients than just those with Medicare Part D. As reported in the APhA Medication Therapy Management Digest: Tracking the Expansion of MTM in 2010, MTM services are provided to patients with a variety of insurance. State Medicaid programs, employer benefit groups, health maintenance organizations, other managed care organizations, preferred provider organizations, and others are now providing MTM services to eligible patients.

My Medication‐Related Action PlanName:_____________________________________________________ Birth date:____________________________Primary Care Physician:_______________________________________ Phone:_______________________________Pharmacist/Pharmacy:________________________________________ Phone:_______________________________Date Prepared:______________________________________________The list below has important Action Steps to help you get the most from your medications. Follow the check‐list to help you work with your pharmacist and doctor to manage your medications ANDmake notes of your actions next to each item on your list. Action Steps ‐what I need to do… Notes‐ What I did and when I did it…

My next appointment with My Pharmacist is on:_____________________(date) at _________________Special Notes

Patients Signature:Date:

Figure 4-2. One example of a medication-related action plan (MAP).

This form is based on forms developed by the American Pharmacists Association and the National Association of Chain Drug Stores Foundation. Reproduced with permission from APhA and NACDS Foundation.

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Many strategies are being employed to identify patients eligible for MTM services. To identify which patients could benefit from MTM services, providers are using criteria such as specific disease states or drugs, high annual drug expenditures, history of nonadherence to drug therapy regimens, or more than average hospitalizations or emergency department visits. The two most common methods of determining MTM eligibility are identifying patients with specific disease states (e.g., diabetes, hypertension, asthma) and identifying patients receiving a certain number of chronic drugs. In 2009, almost 50% of providers identified eligible patients on the basis of chronic disease states. In 2010, according to the APhA MTM Digest: Tracking the Expansion of MTM, the majority of patients were identified by MTM payers. However, the majority of payers report that less than 25% of eligible patients actually participate in the services available to them. Payers provide MTM services to patients in several ways. Most payers use in-house or contract pharmacists to provide MTM services, but some use in-house contract nurses or physicians to provide these services. Although the APhA/NACDS Foundation core MTM elements encourage providers to deliver services face-to-face, a 2009 survey found that less than 50% of payers reported face-to-face encounters with eligible patients. However, in 2010, 57% of payers reported using face-to-face encounters to deliver MTM. In the APhA Medication Therapy Management Digest: Tracking the Expansion of MTM in 2010, about 83% of payers reported using the telephone to deliver MTM services, a 9% increase from 2009. Many payers reported using a tiered algorithm to determine which method of MTM delivery a patient is qualified to receive. Eligibility for method of delivery is determined in ways similar to those for MTM eligibility. The patients who are most at risk according to their payer may receive face-to-face MTM services; those determined by the payer to be at lower risk will qualify for MTM by telephone or other services, such as educational mailings or disease state management, that do not fit the accepted definition for MTM services. Since MMA was enacted, providers have faced many challenges in implementing MTM services for patients. Key issues facing providers are compensation and billing. Billing can be tedious and difficult, and the amount of compensation for providing MTM services is often deemed inadequate to compensate for these difficulties. Often, pharmacists try to continue their drug distribution responsibilities while adding MTM services, leaving them feeling understaffed with inadequate time to devote to patients. When providers working in various settings (e.g., chain, independent, hospital, mail service pharmacies) were asked how many patients could be provided MTM services daily, the response was 20 patients, with a range of 0–1000

patients. Twenty patients per day would translate to 10–20 hours/day if MTM were provided according to the consensus definition. This level of service cannot be accomplished by a single provider or by providers with other management or distribution responsibilities. Depending on the practice setting, MTM can be more difficult to incorporate into daily workflow if pharmacists have other responsibilities or if the MTM is provided face-to-face. Another barrier in the community setting is the lack of access to complete patient information. Pharmacists typically have access to prescription data, but they rarely have access to the patient’s complete medical record. In other instances, providers in a clinic setting may have access to the medical record but not to the patient’s current drugs or a complete prescription record. One barrier experienced across the health care system is that patients often miss their appointments or follow-up visits for MTM. Convincing patients that MTM and follow-up visits are worth their time is critical to affecting patient outcomes through drug therapy management. The APhA Medication Therapy Management Digest: Perspectives on 2009 noted that providers and others reported three barriers to patients keeping their appointments. Both providers and patients identify as barriers a lack of patient interest, physician resistance, and concerns about whether identified patients really need MTM. The only significant barrier reported by MTM providers was difficulty with billing for MTM services; however, the providers who did not provide MTM also noted barriers to implementation (e.g., inadequate time, difficult documentation, inadequate reimbursement). Of interest, it does not appear that providers perceive lack of support from upper management a barrier. Many practitioners were providing MTM services without compensation; only about 68% of MTM providers reported that they were billing for their services in 2010.

2010 Medicare Part D MTM Programs After examining the MTM services offered to Medicare beneficiaries, CMS revised the requirements for MTM in 2010 to provide more consistent services to these patients. Chapter 7 of the Prescription Drug Benefit Manual describes these changes. As a result, all Part D sponsors are required to provide MTM services to their beneficiaries; every spring, they must submit a description of their program to CMS for approval. Medicare beneficiaries are eligible for MTM services if they have multiple disease states, take several chronic drugs, or spend a specific amount annually for drugs. These changes are considered positive for the Part D sponsor’s beneficiaries.

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As discussed previously, CMS established broad criteria for MTM eligibility to increase the number of beneficiaries receiving MTM services. For the multiple disease state criteria, the plan can determine whether eligible patients must have a minimum of two or three chronic diseases. In 2010, the majority of plans required patients to have at least three chronic diseases to be eligible for MTM services; only about 28% of plans required a minimum of two chronic diseases. In addition, plans can designate specific chronic diseases to identify eligible patients. Seven core chronic disease states have been identified by CMS: hypertension, heart failure, diabetes, dyslipidemia, respiratory disease, bone disease–arthritis, and mental health diseases. If a plan targets any specific disease states, CMS requires that they target a minimum of four of these core disease states. Each payer must set a minimum number of drugs a patient must be taking to meet eligibility criteria. Depending on the plan, the number could be two to five drugs. A plan may choose to include all Part D drugs or only chronic drugs or drugs indicated for specific disease states. Important changes implemented in 2010 included the following. (1) Annual costs for Part D drugs decreased from $4000 to $3000. (2) Plans were required to use quarterly claims data and an opt-out method to enroll eligible patients. (3) All plans were required to provide an annual comprehensive medication review (CMR) and a targeted medication review each quarter, with documentation regarding the MTM encounter provided to the patient. These requirements increase the opportunity for pharmacists to provide MTM services.

Reimbursement, Billing, and Documentation MTM Services Codes Two of the biggest obstacles for the widespread provision of MTM services by pharmacists are the difficulty in billing for these services and the lack of insurance reimbursement. Billing for health care services (e.g., physician services) is done through Current Procedural Terminology (CPT) coding. The CPT codes, which are developed and maintained by the American Medical Association, describe the services performed and the complexity of the visit. In 2002, a group of pharmacy organizations petitioned to develop CPT codes for pharmacist services. In 2006, three temporary CPT codes were developed, and in 2008, these codes were made permanent. These CPT codes are as follows: 99605, initial face-to-face visit with a new patient (15 minutes); 99606, follow-up visit with an established patient (15 minutes); and 99607, each additional 15 minutes. These CPT codes can be used by pharmacists to bill third parties (e.g., Medicare Part D) for MTM services. Unlike physician CPT codes, which incorporate

many aspects of the visit, these codes do not allow documentation of the complexity of the patient visit, but only the time spent with the patient. Each insurance provider determines the CPT codes for which it will pay and how much it will pay. Currently, the average rate for MTM services is $1–3 per minute. There are two ways to charge for MTM services: (1) receiving a cash payment from the patient or (2) billing the patient’s insurance provider. Cash is the most enticing option for providers because of ease of billing, real-time payment, and lack of administrative work. However, cash is not an appealing option to most patients because they are not accustomed to paying up front for medical services. Therefore, many pharmacists offering MTM services must try to bill the patient’s insurance provider.

Third-party Reimbursement Third-party payers fall into two general groups: government payers (Medicare and Medicaid) or the private sector. Since 2003, MTM services have been a required component of each Medicare Part D plan. However, from the start, CMS provided little guidance about what an MTM program should look like, and not all Part D plans developed their MTM plan to be consistent with the APhA/NACDS Foundation core MTM elements. Many Part D plans provide MTM services to their eligible beneficiaries through in-house call centers. In this situation, an outside pharmacist conducting an MTM encounter with one of the plan’s patients is providing a duplication of service and is not allowed to bill for MTM services. Two national Medicare Part D plans and some regional plans allow pharmacists to bill for MTM services; to do so, the pharmacist must follow the guidelines developed by each prescription drug plan. Some plans route the MTM cases to the pharmacy and reimburse on the basis of the pharmacy’s NPI (National Provider Identifier) number, limiting the provision of MTM services by individual pharmacists not associated with a dispensing pharmacy. Other third-party plans contract with pharmacies and individual pharmacists who agree to the terms of their contract. Several state Medicaid programs (e.g., those in Iowa, North Carolina) allow pharmacists to bill for MTM services. Reimbursement and required documentation vary for MTM services. For patients who are not receiving Medicare or Medicaid benefits but who have private insurance, the pharmacist can bill the insurance company using the CPT codes. Despite the availability of CPT codes to bill for MTM services, many third-party payers either do not pay for MTM services or require a prior authorization before payment. The pharmacist can contact each payer to determine whether reimbursement is based on pharmacist services CPT codes or whether another mechanism allows billing for MTM services.

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A pharmacist’s practice setting may also determine success in billing for MTM services. Ambulatory care pharmacists in a physician’s office have an option to bill MTM services using the Incident to Physician Services Regulations for patients with Medicare Part B. This regulation allows physicians to bill for services performed in the office by another provider as long as the physician is in the building and the services are an integral part of care. This billing method does not use the CPT codes, and the reimbursement from Medicare goes to the physician, not directly to the pharmacist. Another option for ambulatory care pharmacists who work in a hospital-based outpatient clinic is to bill through the Outpatient Prospective Payment System. Pharmacist-provided services can be billed using Ambulatory Payment Classification codes, and the payment is sent to the facility, not to the individual provider.

Documentation Platforms Another challenge to successfully implementing MTM services is the lack of standardized documentation and billing methods. In 2008, CMS released Exploratory Research on Medication Therapy Management, which showed variability among the plans, the documentation systems they require, and the levels of information captured regarding each MTM encounter. Many Internet-based proprietary documentation/billing platforms exist for MTM services (e.g., Mirixa, Outcomes). However, each platform is quite different, and some employers do not allow pharmacists to access the platforms because of concerns about the security of patient data. This variation presents an additional barrier to pharmacists providing MTM services. Some pharmacists may not want to learn several documentation platforms. The APhA has adopted a policy on technology barriers to MTM and has promoted more standardized documentation platforms. In addition to making it easier for the pharmacist, standardized documentation will enhance continuity of care.

Practical Applications of MTM Developing an MTM practice in a pharmacy can be a challenge, and without proper planning, it will not be successful. As previously stated, barriers limiting the ability of pharmacists to develop MTM programs have been identified. Because barriers vary with the different practice settings, the pharmacist must identify potential barriers and possible solutions in their setting before establishing MTM services.

Ambulatory Care Clinic Most ambulatory care pharmacists practice in a multi-physician or multidisciplinary clinic. Many pharmacists practicing in this setting already offer services similar to MTM, such as counseling on new prescriptions and monitoring drug adherence and outcomes. The

expansion of pharmacy practice into MTM services offers an avenue for pharmacist services to more directly align with the core MTM elements. With their increased access to patient information and proximity to patients’ physicians, ambulatory care pharmacists are well positioned to provide MTM services. In addition, these clinics often have an administrative support structure, including staff dedicated to billing, which allows the pharmacist to focus on providing MTM services rather than administrative issues. When planning an MTM service in an ambulatory care clinic, the pharmacist should complete five tasks: (1) perform a needs assessment, (2) develop provider and staff relationships, (3) develop a business and marketing plan, (4) establish clinic procedures, and (5) identify methods to assess outcomes. The needs assessment determines provider and patient interest in MTM services, as well as anticipated demand for MTM services based on the patients currently seen in the clinic. Key to the program’s success is the support it receives from physicians and staff, which makes developing and nurturing relationships an important step for any pharmacist planning MTM services. The pharmacist should develop a business plan for the MTM service to summarize background information, including results from the needs assessment, as well as the purpose of the service. The plan should include financial projections, including costs and projected revenue and revenue sources associated with MTM services. Marketing is important for any new service; therefore, a plan should be developed before the service is started. The potential markets for MTM services will mainly be the physicians in the clinic or outside clinics and patients. Procedures should be outlined for all aspects of the patient visit, including clinic referrals, registration, documentation, patient education, referral for other services, and follow-up. Outcome assessment (e.g., achievement of national clinical outcomes, drug regimen adherence) should also be planned. Additional aspects of MTM services that require planning include space, scheduling, and documentation. The pharmacist should identify space within the clinic to provide MTM services. In clinics with minimal free space, creative solutions may be needed. In the beginning, scheduling may also be an issue. It is difficult to determine how much time is required for each visit. In general, initial visits will take longer than follow-up visits, so visits should be scheduled accordingly. Finally, the pharmacist should identify how to document services and outcomes for the physicians and other clinical staff and for reimbursement.

Community Pharmacy The community pharmacy is where many envision MTM services will be provided because of the ready and frequent access to patients. Implementing MTM

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services in a community pharmacy requires many of the same tasks as in the ambulatory clinic setting. Particular attention to planning for the space to perform MTM services is required. Finding a suitable space in a community pharmacy may be difficult because there generally are no private offices or consultation rooms. It may also be more difficult to incorporate MTM services into the pharmacy workflow. When evaluating the site, the pharmacist should determine how to enhance or adjust the workflow to make it more conducive to providing MTM services. An additional goal is to make the workflow more efficient to allow the pharmacist time to provide MTM services. The pharmacist should identify in advance how MTM services will be provided. It often works best to offer MTM services by appointment only, allowing the pharmacist to adjust staffing accordingly. In addition to the needs assessment previously described, the pharmacist must develop a fee structure for the service, establish a documentation system, develop policies and procedures for the MTM service, and formulate a marketing plan. In addition to marketing to patients and physicians, the community pharmacist may need to market to local or regional corporate management to be allowed to provide the services.

Health Care Reform On March 23, 2010, the U.S. health care system changed significantly when President Obama signed into law the Patient Protection and Affordable Care Act. A week later, he signed the Health Care and Education Reconciliation Act of 2010, which amended the initial bill. These two bills, collectively referred to as the Affordable Care Act (ACA), include many provisions that affect pharmacy. The ACA is focused on improving the quality, safety, and cost-effectiveness of health care. This act includes provisions that address MTM and the expansion of MTM services within and beyond Medicare Part D. Starting in 2013, all plan sponsors must offer MTM services to targeted beneficiaries, with the goal of increased adherence to prescription drugs and other objectives as determined by the Secretary of the Department of Health and Human Services. The legislation does not describe these additional goals. The MTM programs must include an annual CMR, either face-to-face or using telehealth technologies by a licensed pharmacist or other qualified provider. The annual CMR must include a review of the individual’s drug therapy and may result in the development of a MAP. The CMR should also include a written or printed summary of the review, as well as follow-up interventions warranted by findings in the CMR. The plan sponsors must also have a process in place to assess, at least quarterly, the drug use of other at-risk individuals enrolled in the plan but

not eligible for MTM services. Finally, the plans must have a process in place to automatically enroll patients in the program but permit the beneficiaries to opt out if they choose. The ACA also addresses expanding MTM services to patients beyond Medicare Part D. The law establishes the Patient Safety Research Center within the Agency for Healthcare Research and Quality, which is part of the Department of Health and Human Services. The Medication Management Services in Treatment of Chronic Disease program, which will provide grants for MTM programs, will be administered through the Patient Safety Research Center. The ACA directed the Secretary of the Department of Health and Human Services to begin the grant program on May 1, 2010; however, the law did not initially fund the program, and implementation has been delayed. The program will provide grants or contracts to eligible entities to implement MTM services provided by pharmacists as part of a collaborative multidisciplinary team. According to the law, the grant programs should target patients who (1) take four or more prescribed drugs, including nonprescription drugs and dietary supplements; (2) take any high-risk drugs; (3) have two or more chronic diseases; or (4) have undergone a transition of care or other factor likely to create a high risk of drug-related problems. The MTM provisions included in the ACA provide an opportunity for pharmacists to expand MTM services.

Conclusion The ACA has significant potential to increase opportunities for pharmacists to provide MTM for eligible patients. The number of eligible patients in 2010 increased and will likely continue to increase. The consensus definition for MTM gives pharmacists a framework to implement MTM in various practice settings; however, significant barriers include billing and reimbursement, documentation, and buy-in from patients and physicians. More data on outcomes and return on investment from payers are required to examine the full impact of pharmacist-provided MTM services on patient outcomes and health care costs.

Annotated Bibliography 1. Thomas J, Zingone MM, Smith J, George CM. Feasibil-

ity of contracting for medication therapy management services in a physician’s office. Am J Health Syst Pharm 2009;66:1390–3.

Reimbursement is a major barrier to providing MTM services. As documented in this article, it is difficult for ambulatory care pharmacists working in a family medi-cine clinic to contract with Medicare Part D providers for reimbursement of these services. Many Part D plans

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used internal staff to provide the MTM services; oth-ers used community pharmacists associated with a pharmacy’s National Council for Prescription Drug Programs number. When this article was published, only one company had contracted with nondispens-ing pharmacists to provide MTM services through referrals. Since then, more Medicare Part D plans are allowing pharmacist reimbursement for MTM services and are contracting with nondispensing pharmacists. However, in most instances, the MTM case would first go to the patient’s primary dispensing pharmacy; this may limit the number of cases that a nondispens-ing pharmacist will receive. If conducted today, this study would likely yield different results because more options exist for nondispensing pharmacists to be reim-bursed for Medicare Part D MTM services.

2. Fera T, Bluml BM, Ellis WM. Diabetes Ten City Chal-lenge: final economic and clinical results. J Am Pharm Assoc 2009;49:383–91.

The Diabetes Ten City Challenge implemented the Patient Self-Management Program for Diabetes with community pharmacists in 10 cities across the country. This study evaluated clinical, economic, and perfor-mance outcomes in participating patients. The Patient Self-Management Credential for Diabetes, a psycho-metrically validated tool developed by the APhA Foundation, was used to assess patient educational needs. The results from the multidimensional ques-tionnaire given by pharmacists through face-to-face interactions guided the development of patient skills. The pharmacist also used a checklist to assess patients on diabetes self-management and prevention measures. Self-insured employers in these cities agreed to partic-ipate in the programs and provide financial incentives to their employees for participating. Improvements were seen in clinical outcomes and some economic outcomes. Statistically significant improvements from baseline occurred in hemoglobin A1C, low-density lipoprotein cholesterol, systolic and diastolic blood pressure, and body mass index. Patient medical costs decreased during the first year compared with baseline expenditures, but drug costs increased compared with baseline and first-year projections. Patients who receive MTM services often have increased drug costs because of increased adherence and the addition of new drugs. This study illustrates the importance of having both the prescription as well as the medical claims data when evaluating an MTM program. The study also points out the need for more standardized medical claims data to collect all necessary information more efficiently. The main weaknesses of this study are the small sample size and possibly the characteristics of the patient popula-tion. Participation in this program was voluntary, and the patients who enrolled may have been inherently more willing to make changes to improve their health than the general population.

3. Ramalho de Oliveira D, Brummel AR, Miller DB. Med-ication therapy management: 10 years of experience

in a large integrated health care system. J Manag Care Pharm 2010;16:185–95.

This study evaluated clinical, humanistic, and eco-nomic outcomes of MTM services provided for 10 years; pharmacists in the primary care clinics of an inte-grated health system mainly provided services. Because there were more than 9000 patients in this retrospective analysis, the authors were able to show cost savings with a return on investment of $1.29 per every $1 spent on MTM services. Cost savings were determined by look-ing at avoidance of medical services and lost workdays. The authors also noted an improvement in previously uncontrolled medical conditions, with most patients reaching their drug therapy goals during the course of their MTM services. The MTM encounters were stan-dardized to the extent possible. Documentation was also standardized, something that has generally not been possible in other studies evaluating MTM services in community pharmacies. Overall, this article is infor-mative because there are few studies of MTM services on a large scale, and this study showed improvements in both clinical and economic outcomes. One of the main limitations of this study was its inability to generalize the data to other populations. It may be difficult to have similar findings in a community or other population outside an integrated health system; in those settings, the pharmacist would not have access to most of the patient’s health-related information.

4. Michaels NM, Jenkins GF, Pruss DL, Heidrick JE, Ferreri SP. Retrospective analysis of community phar-macists’ recommendations in the North Carolina Medicaid medication therapy management program. J Am Pharm Assoc 2010;50:347–53.

During the first year of the North Carolina Medicaid MTM program, physicians accepted 52% of the phar-macists’ recommendations. These results are similar to those of other studies looking at the acceptance rates of recommendations made because of MTM encounters. Another important finding of this study was that MTM services were not always economically advantageous. A cost savings of $2724 occurred in the group of patients whose physicians accepted recommendations for medi-cation changes; however, there was a net loss of $1116 when the group of patients whose physicians did not accept recommendations was included in the analysis. The results and conclusions from this study are limited by the small sample size (only 88 patients). Nonethe-less, because not all recommendations will be accepted, it is important to continue to look at how MTM services can be more efficient to ensure profitability.

5. Millonig MK. Mapping the route to medication therapy management documentation and billing stan-dardization and interoperability within the health care system: meeting proceedings. J Am Pharm Assoc 2009;49:372–82.

The technology available to pharmacists for bill-ing and documenting MTM services is inadequate. In 2008, APhA convened a group of stakeholders to discuss

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improving billing and documentation interoperabil-ity. This review of the meeting provides information from a variety of sources about where health informa-tion technology is moving and how this is important to advancing patient care through MTM services. Future directions identified included pushing for integration of medical and pharmacy claims information, which will be necessary to track the cost savings of MTM and standardizing MTM documentation, including opera-bility within the patient’s electronic health record. This article provides a good overview of the current interop-erability of medical records in the United States and the importance of such interoperability for successful MTM implementation.

6. Matzke GR, Ross LA. Health-care reform 2010: how will it impact you and your practice? Ann Pharmaco-ther 2010;44:1485–91.

This article provides a good review of the ACA’s impact on pharmacy services, including the inclusion of MTM services. New pharmacists’ roles described in the act include responsibilities in “transition-of-care” teams, medical homes, and medication reconciliation. Also described are grant programs that the law estab-lishes to fund the expansion of MTM programs. Finally, the ACA will offer incentives for Medicare Part D plans to offer more extensive MTM programs. This article reviews the provisions of the new law, but the specifics of MTM programs, including their implementation, are not described.

7. McGrath SH, Snyder ME, Dueñas GG, Pringle JL, Smith RB, McGivney MS. Physician perceptions of pharmacist-provided medication therapy management: qualitative analysis. J Am Pharm Assoc 2010;50:67–71.

In this article, the authors examine the results from three focus groups with physicians in Pennsylvania. The 23 participants were primarily private practice pri-mary care physicians. The results suggest that there are significant physician-related barriers associated with pharmacist-provided MTM services. Physicians reported concerns about who should be perform-ing MTM; many believed that physicians were better suited to be providers because of their relationship with patients. Physicians also were unsure whether phar-macists had the clinical training necessary to provide MTM services. Many participants were unaware of what an MTM encounter included and had opinions based on misinformation. The main perceived benefit of MTM was the complete drug list the patient receives after an MTM encounter. The authors noted that increased communication with physicians and educa-tion for physicians and pharmacists regarding MTM was necessary. Although this study had a small sample size, the findings are of concern. Communication with and support from physicians are critical for successfully implementing pharmacist-provided MTM services in the future.

8. Lounsbery JL, Green CG, Bennett MS, Peder-sen CA. Evaluation of pharmacists’ barriers to the

implementation of medication therapy management services. J Am Pharm Assoc 2009;49:51–8.

This cross-sectional study of 970 pharmacists exam-ined barriers to MTM implementation in outpatient practice settings. A survey distributed by e-mail asked pharmacists whether they were providing MTM or were interested in providing MTM. For pharmacists providing MTM, the most common barriers were lack of compensation or ability to obtain compensation and lack of recognition as a provider. The group of pharma-cists not currently providing MTM services reported the most common barriers as lack of staff, poor access to medical data, and issues related to collaborative prac-tice agreements. There were several interesting findings regarding lack of compensation for MTM and direct patient care services. Of note, more than 56% of provid-ers were not being compensated for these services. As in other studies, the authors also cited barriers associated with access to and communication with primary care physicians and access to patient medical records.

9. American Pharmacists Association and National Asso-ciation of Chain Drug Stores Foundation. Medication Therapy Management in Pharmacy Practice: Core Ele-ments of an MTM Service Model, Version 2.0, March 2008. Available at www.pharmacist.com/AM/Template.cfm?Section=Home2&CONTENTID=15496&TEMPLATE=/CM/ContentDisplay.cfm. Accessed August 4, 2011.

This document, a joint effort by APhA and the NACDS Foundation, represents a consensus of 11 national pharmacy organizations; it defines MTM and outlines five core elements for MTM services. This con-sensus statement provides a framework for the delivery of MTM services to improve collaboration with health care providers and patients and to allow patients to achieve optimal outcomes. In addition, the document includes examples of MTM-related documentation. Instructions for writing appropriate notes for documen-tation and sample PMRs and MAPs are also included. This document clearly outlines the MTM service model and framework, which is strengthened because it represents a consensus statement from a variety of pro-fessional pharmacy organizations.

10. Centers for Medicare & Medicaid Services. Fact Sheet: 2011 Medicare Part D Medication Therapy Manage-ment (MTM) Programs. Available at www.cms.gov/PrescriptionDrugCovContra/downloads/MTMFact-Sheet2011063011Final.pdf. Accessed August 22, 2011.

This document outlines programs for 2011 on the basis of several significant changes made in 2010 by CMS in the requirements for MTM programs to improve services and increase the number of Medi-care patients eligible for MTM services. Information regarding Part D sponsors is included to examine dif-ferences in eligibility criteria, processes for enrollment, and documentation for MTM encounters. Data are given regarding which health care providers supply MTM services for Medicare beneficiaries. Pharmacists,

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registered nurses, physicians, and others are considered qualified MTM providers by CMS. Although pharma-cists are still the largest group of providers, more than half of the plans also use other health care providers to supply MTM services.

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