Chapter 26. Implementing Value-Added Pharmacy Services

Dr. McDonough is co-owner and Director of Clinical Services at Towncrest and Medical Plaza Pharmacies in Iowa City. He is also an Adjunct Professor (Clinical) at the University of Iowa College of Pharmacy. Dr. McDonough received a B.S. in pharmacy, an M.S. in pharmacy administration, and a Pharm.D. from the University of Iowa College of Pharmacy. At his community practice in Iowa City he has developed and implemented several pharmacy services, including pharmaceutical case management (PCM), medication therapy management (MTM), immunization services, and health screenings. He is board certified in geriatrics and pharmacotherapy. He is invited frequently to speak about practice development and implementation and has published numerous articles and book chapters on these topics.

After completing this chapter, readers should be able to

1. Describe the types of value-added services that pharmacists have implemented in their practices.

2. Discuss the components of a value-added service to consider before implementation.

3. Recognize the key components of a policies and procedures manual.

4. Discuss management of the marketing mix during service implementation.

5. Describe the role that collaborative practice agreements have in developing value-added pharmacy services.

6. Describe strategies for pricing and obtaining compensation for value-added pharmacy services.

Carol Smith, the pharmacist-owner of Care-Rite Pharmacy, is interested in expanding her clinical services. Her pharmacy is located in a city with a population of approximately 100,000 people. Although she has not implemented any specific value-added services in the past, patients and other health care providers recognize her practice as customer friendly and service oriented. She has two full-time pharmacists and two part-time pharmacists who have been working at the pharmacy for a number of years (range 5 to 15 years). Recently, they have completed a strategic plan, a strengths, weaknesses, opportunities, and threats (SWOT) analysis, and a survey of their patients. The results of the patient survey identified their key target market as women 50 years of age and older. Initially, they had wanted to implement a diabetes educational program, but their market research determined that a local hospital sponsored an American Diabetes Association (ADA)-recognized program. The hospital is a strong presence in their community, and the hospital's diabetes educators were not interested in collaborating with local pharmacies. Also, they looked into developing a community-based anticoagulation service, but after some checking into the reimbursement for this type of service, they realized that this service would not be feasible financially. Their market research did show that there was a need in their community for a MTM program. They already had a large percentage of high-risk patients who were taking four or more chronic oral medications and had several chronic medical conditions. Many of these patients expressed a need for assistance with medication management issues. They also serve a large percentage of patients eligible for Medicaid and/or Medicare and they saw an opportunity to provide MTM services for those patients who may be eligible according to their drug plan. Also, they noted that there was not a similar program elsewhere in the community.

1. What are the different types of value-added services that pharmacists have implemented in their practices? Describe the medication management process for each.

2. What are the components of a value-added service that pharmacists should consider and plan before implementation?

3. Why is a policies and procedures manual important to successful service implementation?

4. How should pharmacists manage the marketing mix during the implementation of value-added services?

5. How can a collaborative practice agreement help pharmacists implement value-added services?

6. How much do pharmacists typically charge for their value-added services? What strategies have been successful in obtaining reimbursement from patients? From third-party payers?

As discussed in previous chapters, implementing value-added pharmacy services requires a comprehensive strategic plan that includes a mission statement, SWOT analysis, goals and objectives that the practice hopes to achieve, and strategies to achieve the objectives. This plan provides direction for the practice and guides the allocation of resources and efforts. As the scenario demonstrates, the planning process helped Carol, the pharmacist owner, identify a service that fits with the pharmacy's strategic plan, yet has a niche in the marketplace. Pharmacists can implement many types of services in their practices, but it is essential that they do some market research to determine the opportunities and threats in the marketplace to ensure the success of the new service. Also, it is important to assess the pharmacists' motivations and abilities to provide a service. Ultimately, the success of any service depends both on market opportunities and the pharmacists' ability to provide the service.

Value-added pharmacy services can be thought to exist along a continuum (see Fig. 26-1). On one end of the continuum, pharmacists are more narrowly focused on drug therapy issues that occur during the dispensing functions (i.e., point of care). On the other end of the continuum, pharmacists provide ongoing drug therapy management services for select individuals who have multiple comorbidities requiring complex therapies (i.e., case management). Other types of services fall between these two ends of the continuum. For example, disease-state management programs, clinical services such as anticoagulation or lipid clinics, and health screening services fall somewhere in the middle of the value-added service continuum. Some services such as MTM can be focused or comprehensive and therefore can fall anywhere within the continuum. Focused MTM services can occur during the dispensing when a drug therapy problem is identified and the pharmacist performs a targeted intervention. Comprehensive MTM service is at the other end of the continuum and the pharmacist provides a comprehensive medication review (CMR), identifies problems with the patient's drug therapy, develops a medication action plan (MAP) and a personalized medication record (PMR) in which they share with the patients, and finally the pharmacist sends her patient workup to the physician or other health care provider.

Regardless of the service being provided, the clinical activities and process of medication management provided by pharmacists implementing value-added services are similar along the continuum. These clinical activities or patient workups have been described elsewhere (McDonough, 1996; Strand et al., 1988, 1992). The medication management process includes collection of pertinent patient data regarding the patient's medical and medication histories, evaluation or assessment of this information, identification of a problem occurring with the patient's medication, development of a plan of action to resolve the problem, and implementation of the plan, including follow-up as needed. Implementing a plan to manage drug therapy typically involves communication with the patient (i.e., patient education), as well as with practitioners (e.g., physicians). Appropriate documentation of patient care activities is an integral component of value-added services.

A number of studies have examined the impact that pharmacists can have delivering drug therapy management services at the point of care during the dispensing process (Christensen et al., 1999; Dobie and Rascati, 1994; Knapp et al., 1998; Rupp, 1988, 1992; Smith et al., 1999). The information that needs to be collected at the point of care may not be as comprehensive as for other services along the continuum. For example, during the dispensing process, it may be determined that the patient has an allergy to a specific medication. By focusing efforts on resolving this problem, data is collected pertaining to this allergy, an alternative is identified, the physician is called, the pharmacist's recommendation is made, the medication is changed, and the pharmacist documents a quick patient note (in the patient dispensing record) to complete the process. While the clinical process in this scenario is narrowly focused, this is an essential and clinically relevant service commonly performed by pharmacists.

Pharmacists' monitoring/screening services and wellness/health-promotion programs are the next level of value-added services along the continuum. These types of services, although relatively narrowly focused, require more patient data collection and may be delivered over an extended period. Documentation may be more comprehensive, with a patient chart being created in addition to the dispensing record. The clinical process remains the same as the point-of-care service but occurs separate from the dispensing function. Examples of ongoing monitoring services include pharmacist-managed anticoagulation services (Ansall et al., 1997; Davis and Sczupak, 1979; Knowlton et al., 1999; McCurdy, 1993; Norton and Gibson, 1996; Reinders and Steinke, 1979) and lipid management services (Furmaga, 1993; Simpson et al., 2001; Tsukuki et al., 1999). Health-promotion/screening programs also have been developed in community pharmacies in areas of smoking cessation (Kennedy et al., 2002), osteoporosis screening (Elliott et al., 2002), and lipid screenings with cardiovascular assessment (Madejski and Madejski, 1996; Tice and Phillips, 2002).

The next types of clinical services along the continuum are those which pertain to disease-state management. These services occur separately from the dispensing function over an extended period but have an added feature of ongoing patient education and an extensive review of drug therapy as it relates to attainment of the patient's therapeutic goals. A comprehensive patient chart is created, patient sessions may last from 15 to 60 minutes, and pharmacists may review the entire medication profile, although their efforts are focused more on the disease state they are following. Pharmacist-managed hypertension (Hawkins et al., 1979; McKenney et al., 1973, 1978; Reinders et al., 1975), diabetes (Baran et al., 1999; Berringer et al., 1999; Coast-Senior et al., 1998; Jaber et al., 1996; Schilling, 1977; Swain and Macklin, 2001; Tiggelaar, 1987), and asthma (Grainger-Rousseau et al., 1997; Herbog et al., 2001; Kneoll et al., 1998; Pauley et al., 1995; Rupp et al., 1992) disease-state management programs have been cited frequently in the literature.

The most comprehensive of drug therapy management services is that of case management. In this situation, pharmacists are responsible for complete patient workups. A thorough patient history needs to be taken, a comprehensive review of all medications is done, and the patient is followed for an extended period. These services also occur separate from dispensing and can be the most challenging for pharmacists. Patients' medical problems can be complex, and multiple physicians often are involved. Several studies have investigated the impact of pharmacists' reviews in high-risk patients in the community setting. (Cowper et al., 1998; Hanlon et al., 1996; Petty et al., 2002).

Once it is determined which service is to be implemented, it is important to put some thought into what the service will look like and how it will be delivered at the practice. As discussed previously, regardless of the type of service (i.e., diabetes, lipids, asthma, etc.), the medication management processes used by pharmacists remain relatively the same. Some component of the service will require the pharmacist to collect patient clinical information, including laboratory data. The pharmacist also needs to assess the patient information that has been collected and make a clinical decision regarding the appropriateness of the therapy. Patient education is a component of each type of service, but may be emphasized more so with certain services (e.g., wellness programs and services focused on disease-state management). Lastly, some consideration should be given to the clinical outcomes that the pharmacists want to achieve when implementing the service.

Data Collection

Patient data collection is a critical component of any value-added service. The information collected provides pharmacists with important baseline and monitoring parameters for patients. The amount and type of information needed from the patient or other health care providers may differ depending on the service, but nonetheless, this information is the foundation on which the other components of the service are built. Forms can be developed to help pharmacists collect this information (see Figs. 26-2, 26-3, and 26-4). In addition, some consideration should be given to how this information will be stored (e.g., paper charts or electronic patient database). The information that should be collected from the patient includes demographic information, medical history, family history, and medication history. Since some of the information may need to be collected from other providers and health care institutions, an authorization to release medical information should be signed by the patient and kept as part of the chart (see Fig. 26-5). Lastly, pharmacists should ensure that their site is in compliance with the Health Insurance Portability and Accountability Act (HIPAA—See Chapter 28) and reinforce to their patients that the information they provide is confidential and secure at the pharmacy.

Pharmacy-Based Laboratory Monitoring/Screening Services

Although pharmacists can receive objective patient data from local laboratories or from physicians, it may be decided that it is more convenient for the patient and pharmacist if a laboratory monitoring/screening service is performed at the point of care. Several types of monitors and equipment can be purchased by pharmacists and integrated into their practices. For example, pharmacists who implement wellness programs may purchase a body-fat analyzer, a weight scale, or a monitor that measures lipid and blood glucose levels. Alternatively, pharmacists who develop a diabetes program may obtain a device that measures the glycosylated hemoglobin (A1c) of patients. Also, some pharmacists may decide to develop a women's health program and purchase a bone densitometer that measures bone mineral density to determine fracture risk owing to osteoporosis.

Pharmacies implementing monitoring/screening services must become familiar with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA was enacted to ensure that all medical laboratories meet quality standards. These amendments are administered by the Centers for Medicare and Medicaid Services (CMS), which is responsible for laboratory registration, certificate generation, surveys, and surveyor guidelines for development and training. Tests typically performed by pharmacists in pharmacies (e.g., glucose, lipid panels, hemoglobin A1c, and international normalization ratio [INR] tests) are considered CLIA-waived tests. CLIA-waived tests are considered by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to be simple to administer and have little risk of error. Currently, 40 tests have been approved for certificate of waiver (COW) (Centers for Medicare and Medicaid Services, 2003).

If a pharmacy is interested in performing waived tests as part of its services, it must complete a COW. Instructions for how to obtain a COW can be found at www.cms.hhs.gov/CLIA. The COW should be sent to the local CMS office. CMS will assign the pharmacy with a CLIA number and send the pharmacy a CLIA fee-remittance coupon. Pharmacies must pay a nominal fee for the COW ($150 in 2011), and the COW must be renewed every 2 years. After receiving the CLIA number, the pharmacy may start providing the service. Pharmacists providing waived tests agree to follow good laboratory practices that include following the manufacturer's instructions on instrument operation and maintenance, performing quality-control procedures, appropriately documenting test data, and storing the monitoring equipment and its reagents properly (Rosenthal, 2000).

In addition to CLIA, pharmacists should be knowledgeable about the Occupational Safety and Health Act (OSHA) that regulates workplace safety. In particular, pharmacists who perform laboratory tests that require finger sticks are at risk from exposure to blood-borne pathogens. Pharmacies that perform these tests should have a blood-borne pathogen exposure control plan (BPEPC) that describes who should be trained about the hazards of blood-borne exposure, precautions that need to be taken to prevent exposure, and what to do when an exposure incident occurs (Rosenthal, 2000). More information regarding OSHA and an example BPEPC can be found at the OSHA Web site (www.osha.gov).

Medication Management Protocols

The next component of a value-added pharmacy service is the medication management that pharmacists will provide once they have collected the patient's clinical information and laboratory data. During this component of the service, pharmacists will assess patients, determine if they are reaching their goals of therapy, identify and resolve any drug therapy problems, and develop a care plan that helps to guide the pharmacists' follow-up and monitoring of the patients. For some services, protocols may be developed to help guide the pharmacists' therapeutic decisions (e.g., anticoagulation clinic protocols). For others, general decision pathways may be used to guide the pharmacists depending on the clinical situation that may occur during the patient assessment (e.g., lipid management programs). The protocols may be specific (e.g., adjustment of warfarin given a specific target INR) or more general without specific drug therapy recommendations regarding patients' therapy. For example, in comprehensive MTM services, a protocol may be developed to describe what clinical activities the pharmacists will perform at each patient visit, the documents that will be created from the services provided, and the communication/documentation that the pharmacist provides to the physician or prescriber to resolve identified drug therapy problems. The protocols and clinical decision pathways should be evidence based and supported by national guidelines and/or the primary literature. Protocols and clinical decision pathways for many disease states and conditions are gathered by the Agency for Healthcare Research and Quality (AHRQ) and can be obtained from their Web site at www.guidelines.gov.

Patient Education

Patient education is a component of each type of value-added pharmacy service. The comprehensiveness of the education differs though, depending on the service being implemented. For example, pharmacists implementing lipid screenings may see patients for a limited time (during the screening) and provide them with baseline education to help them understand their cardiovascular risk factors, fasting lipid panel results, and lifestyle-modification strategies. On the other hand, pharmacists providing diabetes educational services may provide more comprehensive education by determining the patients' educational needs, providing ongoing educational services to help them achieve their self-management goals, and assessing if the patients are achieving their therapeutic end points. In this situation, there usually will be multiple educational sessions with patients, including comprehensive documentation. In both examples, patient education is a well-defined and integrated component of the service.

Pharmacists can create or identify existing patient educational resources (e.g., patient brochures, educational fliers, and flip charts) to reinforce important educational messages. These resources should be screened for accuracy and completeness. Also, reading difficulty should be assessed to make sure that difficult technical terms are replaced with more patient-friendly language (e.g., instead of blood glucose, use the term blood sugar). Another consideration is that some patients may not be able to read at all, especially if English is not their primary language. Therefore, it is not appropriate to simply hand out educational materials without first assessing the patient's understanding and reading ability. Once the educational resources are selected, it should be determined how they will be used as part of the service. Also, adequate copies should be ordered or created, and these should be inventoried periodically to make sure that there are sufficient supplies to meet patients' demands.

Outcome measurements are covered in more detail in Chapter 9, but pharmacists should determine what outcomes they will be assessing to evaluate the effectiveness of their service. These measures help pharmacists decide if certain aspects of the service need reviewing and altering if outcomes are not being achieved. Clinical outcomes are the most readily apparent and easiest outcomes to assess. These outcomes include objective parameters such as blood pressure, lipid panels, blood glucose, hemoglobin A1c, and weight. Clinical outcomes usually are part of the patient chart and so are easily accessed. Humanistic outcomes (e.g., health-related quality of life and patient satisfaction) can be collected from surveys that become part of the service delivery. If such surveys do become a component of the service, then it should be determined how frequently patients fill out the surveys and how the data will be stored and used. Economic outcomes may require other types of data that pharmacists do not always collect, such as hospitalizations, emergency room visits, or physician visits. If economic outcomes are of interest, then a data-collection tool can be created that routinely requests these types of data. Patient knowledge also may be of interest to pharmacists who are providing comprehensive educational services. For this type of outcome, before and after knowledge-assessment quizzes/tests can be used.

Data Collection

After performing a SWOT analysis and some baseline market research, Carol and the other pharmacists at Care-Rite Pharmacy have decided to develop a MTM service. One of Carol's pharmacists volunteered to put together a prototype patient chart that will be used by the pharmacists to document their activities. The patient chart contains several forms, including a patient history form that requests some basic demographic information (see Fig. 26-2), medical and medication histories forms (see Figs. 26-3 and 26-4), and an authorization to release medical information that is signed and dated by the patient (see Fig. 26-5). Also, a communication form was created to fax clinical information and pharmacists' recommendations to the physician (see Fig. 26-6). Several copies of each individual form will be kept in separate folders in a file cabinet located in a secure area of the pharmacy. One of the pharmacists will be responsible for making sure that enough copies are always on hand. Completed charts will be kept in a filing cabinet that is arranged in alphabetical order by patient last name.

Pharmacy-Based Laboratory/Monitoring Service

The pharmacists at Care-Rite Pharmacy decided to purchase a Cholestech LDX portable analyzer to measure the lipid profiles of their patients. They realized that many of their patients who they were targeting for the MTM service had cardiovascular disease. By purchasing the Cholestech LDX analyzer, they are able to assess lipid profiles and glucose levels for those patients who are willing to pay for this additional service. The system was chosen for its ease of use, quick results, and wide range of tests that it offers (i.e., lipid profile, glucose, and alanine aminotransferase (ALT)). The Cholestech LDX lipid profile is considered a CLIA-waived test. Also, the pharmacists sent in their completed application for a COW, paid the biennial fee, and received their CLIA number. All the pharmacists were trained in use of the Cholestech and how to perform quality-control procedures. The pharmacists were taught how to do finger sticks, appropriate procedures on how to minimize exposure to blood-borne pathogens, and proper disposal of used supplies. Each pharmacist was required to perform a test on another pharmacist to demonstrate his or her competency in using this analyzer. Lastly, a cardiovascular risk assessment form was created. The results from the test are added to the form and reviewed with the patient during the 5-minute test (see Table 26-1).

Medication Management Protocols

Owing to the complexities of the patients that the Care-Rite pharmacists were targeting for their MTM service, they determined that there was not one single type of protocol that they could use to assess and manage a patient. For patients who did have cardiovascular disease requiring lifestyle modifications and/or lipid-lowering therapy, however, a general protocol using data from the ATP III guidelines was developed (see Table 26-2). The protocol provided a clinical decision pathway to determine treatment strategies depending on the patients' low-density lipoprotein (LDL) concentration and risk factors. To help in their assessment of patients, the pharmacists used the cardiovascular risk assessment form. The protocol, although providing direction for pharmacists, did not give specific recommendations regarding which medications to choose if the patients need LDL-lowering medications in addition to therapeutic lifestyle changes (TLCs). By using this protocol, the pharmacists still had some discretion regarding medication options based on patient-specific factors.

Patient Education

The pharmacists of Care-Rite Pharmacy also developed patient educational tools to be used during the patient assessment and patient education components of the MTM service. Because many of the targeted patients have similar medical conditions, education materials were developed for specific disease states, including hypertension, ischemic heart disease, diabetes, asthma, chronic obstructive pulmonary disease (COPD), and so on. Also, educational materials were developed for certain therapeutic classes of medications. The Care-Rite pharmacists also determined that many patients needed individualized education materials, so they implemented a drug information/educational service as part of the MTM service. With this service, patients can ask questions regarding their medical conditions and/or drug therapies. The pharmacists will research and provide an individualized written response for each patient.

Outcome Measures

The main patient outcome measures of interest to the pharmacists at Care-Rite Pharmacy are clinical outcomes, patient knowledge, and patient satisfaction. Also, the pharmacists were interested in monitoring physician response to their clinical recommendations. The information collected would be kept in the patient chart. An electronic database was created to store and collate outcome data. One of the pharmacists is responsible for periodically entering data. The information garnered from these efforts would be used to identify areas needing improvement, to market the program to other providers, and to ensure payment from third-party payers.

To help provide an organized approach to service delivery, a policies and procedures manual should be created to guide pharmacy staff during program implementation. The policies and procedures manual is a comprehensive road map to the service, providing information regarding the purpose of the service, patient eligibility, how patients will be evaluated, what happens during each clinic visit, and the documentation that will be kept. Also, a copy of all forms, patient educational tools, patient assessments, and protocols are included in the manual. The policies and procedures manual is a dynamic document that must be updated and changed as new information becomes known or as the program is modified.

The policies and procedures document should be kept at the pharmacy, used as a training tool for pharmacists and other personnel, and referred to as needed during the patient care process. It should be easy to access information in the manual. A table of contents should be included, sections tabbed, and an appendix created containing the forms that will be part of the program. Also, published medical guidelines and key articles from the primary literature should be included in the manual.

The Care-Rite pharmacists created a comprehensive policies and procedures document for their MTM service. They determined that the purpose of their program is to

• Manage the drug therapy of high-risk patients. The criteria chosen to define the target population for the program were patients who used four or more chronic oral medications and had at least one chronic medical condition.
• Assess patients for drug therapy problems.
• Resolve drug therapy problems by working collaboratively with patients, physicians, and other prescribers.
• Provide comprehensive and ongoing education to patients and/or family members about common drug therapy problems, therapeutic goals, and the importance of becoming informed consumers of their own health care.

Next, they developed their policies for the program. The policies contained information regarding the evaluation of patients. The initial evaluation will occur after the patient is enrolled into the MTM service either by a health plan, other health care provider or self-referral. A patient chart will be created containing the patient's demographic information and medical and medication histories. The patients will sign an authorization to release medical information form and a lipid clinic contract that outlines the patient's responsibilities in the program. To be eligible for the program, patients must meet the eligibility criteria. Patients must be able to attend clinic appointments, must agree to come in for scheduled follow-up visits at the pharmacy, and should have the capacity to understand their health condition and the implications for therapy. Also, patients must be willing to be active participants in their health maintenance.

It was decided that there will be an initial visit and one to three follow-up visits within a 12-month period. All sessions will include a comprehensive review of medications, vital signs and laboratory values (as needed), patient education (as needed), and physician communication.

The initial session will last approximately 30 to 45 minutes, and the follow-up visits will last approximately 15 to 20 minutes. The follow-up visits will occur at 3 to 6 month intervals depending on the clinical situation. Pharmacists will assess the following information at each visit:

• Patient vital signs
• Dietary considerations
• Patient laboratory values
• Family history
• Medication history
• General activity
• Social history, including alcohol use and smoking
• Health problems
• Compliance with therapy
• Signs and symptoms of intolerance to a drug

Medication and/or dosage changes will be made, if necessary, based on the pharmacists' assessment, and patients will be counseled on these changes. The physician communication form will be used to communicate clinical recommendations regarding drug therapy. Also, patient education will be reinforced and documented. Patients will be instructed on when to return to the clinic, and referrals to physicians will occur as needed. The referrals are based on patient complications of therapy or condition and patient resistance to therapy.

The documentation will occur via a patient chart. Subjective patient information and objective laboratory data will be stored in the chart. Assessments of patients during the clinic visit will be documented in pharmacy progress notes contained in the chart. Acceptance of pharmacy recommendations by physicians will constitute an order change, and this will be documented in the patient record as well. Lastly, patient outcomes (i.e., clinical, knowledge, and satisfaction) will be documented in the patient record.

The other components of the policies and procedures manual include the medication management protocol and detailed instructions on use of the Cholestech LDX analyzer. The appendix of the policies and procedure manual contains copies of the forms and patient educational tools used in the program.

As with any successful implementation of a pharmacy service, education and training of pharmacy staff prior to the implementation of the service are essential for success. Pharmacists should achieve proficiency in providing the service before the start date of the service. The time needed to train pharmacy staff depends on the complexity of the service and the experience of the staff. Not only do the pharmacists need to be knowledgeable about the service, but they also may need to practice some of the skills required for some services (e.g., giving a flu shot or completing a lipid panel). Therefore, there should be sufficient practice and a demonstration of competence before they work with actual patients. To help illustrate how the education and training can occur, the preparation of pharmacists at Care-Rite Pharmacy for their MTM service will be discussed.

Care-Rite Pharmacy developed a comprehensive pharmacist educational/training program for its MTM service. This educational program had multiple components and activities that the pharmacists needed to demonstrate knowledge of or proficiency in before they were ready for service implementation. Initially, it was determined that a general knowledge of patient care, types and categories of drug therapy problems, and how to perform a patient assessment should be the foundation for the rest of the education. To help improve pharmacists' knowledge of this topic, the pharmacists were responsible for reading several articles on patient care delivery from the primary literature, a general overview of patient medication assessment from a therapeutics textbook, and articles on how to communicate to physicians and other prescribers. The readings were standardized so that the pharmacists were all learning from the same materials. They were given 4 weeks to read all the material and also given 10 standardized patient cases to work up to demonstrate their knowledge. At the end of the 4 weeks, a 3-hour review of the material and cases was scheduled so that the pharmacists could discuss their cases and ask any questions regarding the material.

Carol had hired a local clinical pharmacist who had expertise in ambulatory care as a consultant to assist with the pharmacists' education and skills development. The clinical consultant facilitated the case discussions. The cases that were developed for this program required pharmacists to assess and modify patients' dietary habits and activity levels. Also, they needed to identify and develop plans for resolving drug therapy problems. They practiced writing recommendations to physicians on the physician communication form.

The next component of the pharmacists' education was demonstrating their abilities to perform a finger stick and a lipid panel. The pharmacists first watched a video provided by Cholestech that demonstrated these two activities. Also, a component of the training included information regarding CLIA, the importance of good technique when performing a test, OSHA requirements, and discussions about the reduction of exposure to blood-borne pathogens. The pharmacists were given adequate time to practice using the Cholestech LDX analyzer. Once the practice was over, pharmacists were assessed on their competency to perform the test. A checklist with required activities that needed to be completed during a lipid panel was used as the grading criterion. Once the pharmacists were capable of providing the test, their proficiency with the Cholestech LDX analyzer was documented and stored in their personnel files.

Once the service is ready for implementation, recruiting patients into the program becomes the next activity. This requires a basic knowledge of marketing principles that were covered in Chapters 21 and 22. Successful implementation of value-added pharmacy services requires that pharmacists manage each of the variables of the marketing mix. An illustration of how Care-Rite Pharmacy managed its marketing mix is provided below.

The product that Care-Rite Pharmacy is marketing is its MTM service. As discussed throughout this chapter, much attention has been given to developing each component of the service and planning for its implementation so that it is perceived as a quality service by patients and other providers. Also, pharmacists updated their knowledge regarding patient care and medication assessments and developed proficiency for testing patients' lipid panels. They hope to be perceived as knowledgeable and competent when providing the service. Lastly, protocols, policies and procedures, and standardized forms were all created to ensure consistency in service delivery among the providers.

The next marketing-mix variables that need careful consideration are the place and physical facility. Care-Rite Pharmacy will be providing the MTM service on site at the pharmacy. Therefore, pharmacy staff need to consider the characteristics of their space to provide the service. In preparation for this service, Carol did some remodeling of her pharmacy. She created two semiprivate patient areas using office partitions. One area was designated as the area where lipid testing would be performed. The Cholestech LDX analyzer and its supplies were stored in this area. Also, CLIA and OSHA guidelines were kept there as well. The second patient care area was created in case there were multiple appointments at the same time. Both areas had a small table, three chairs, and a computer terminal as standard equipment.

Price is the third marketing-mix variable. Carol and the pharmacy staff spent considerable time discussing the price of their service. They estimated the length of the time for each session, estimated the costs to provide the service, researched the price of office visits for other providers, and determined the profit level they needed to help them develop a pricing structure for their service. While no local pharmacies provided a MTM service, Carol decided to price the service to be competitive with similar services offered by physicians. The pricing structure for the service is as follows:

• Initial visit: $75
• Follow-up visits: $40 each
• Fasting lipid panel: $50

The pharmacists will monitor patient responses to these prices and their profitability before making any adjustments.

The next marketing-mix component is promotion. Care-Rite has selected several promotional strategies to market their services. Also, Carol has created a marketing budget for the practice. The pharmacists will use press releases in local newspaper to announce the new service. Next, they decided to run an advertisement in the local newspaper twice per month promoting this service. They chose Sundays and Mondays as the days they would place the ads in the newspaper. Sunday was chosen because of the large readership of the newspaper, and Monday was chosen because the newspaper had a special health section on that day. Also, they purchased airtime on their local cable TV and radio to promote the service. They selected channels that attracted viewers and listeners whose demographics matched their target markets (e.g., women over age 50). They placed an ad for the program in a local magazine that was directed toward women, and they created a new ad for their pharmacy in the local telephone directory.

One of the pharmacists began to call on physicians so that he could promote the services face to face. The pharmacist met with some of the local pharmaceutical company representatives to find out which physicians should be identified as key targets for the promotional efforts. Also, the pharmacy created a physician newsletter entitled, “Progress Notes,” that would be sent every other month to key physicians. The format of the newsletter includes sections on new drug updates, clinical pearls, and message updates about Care-Rite Pharmacy. The first newsletter was dedicated to the MTM service.

In-store signage and patient brochures were created to help market the program to current pharmacy patients. Pharmacists were instructed to market the program to patients they encountered who were receiving four or more chronic oral medications. A mailing list was created from the pharmacy's computer system from patients taking four or more chronic oral medications. A brochure describing the program was sent to each of those patients. Lastly, bag stuffers and monthly patient billing statements included information about the new program.

Process management, the next marketing-mix variable, refers to how Care-Rite Pharmacy incorporated the new MTM service into its existing practice. Workflow decisions were made regarding patient flow during the service. It was decided that the service would be by appointment only to minimize disruption of the other aspects of the practice. Schedules for pharmacists were created so that one pharmacist was responsible for clinic services while another covered the dispensing area.

The last marketing-mix variable that needs addressing is personnel. Care-Rite's pharmacists and staff were trained and assessed to ensure that they had adequate knowledge and skills regarding all aspects of pharmacotherapy management. Also, pharmacists need to take responsibility for the success or failure for the program. This means that they should continue to identify patient candidates for the lipid management program, use various promotional strategies to increase the community's awareness of the program, and ensure that they have the knowledge and skills to provide quality care to patients. Carol changed the format of her annual evaluations of pharmacists to include reviewing their impact on the MTM service. As a reward for their efforts, she has agreed to cover the costs of their continuing education each year and attendance at one national pharmacy meeting of their choice.

Once the service is implemented, several strategies should be in place to provide ongoing monitoring to ensure program quality and success. Scheduled staff meetings should be considered regularly, especially early during the implementation phase. These meetings should be used to discuss the number of patients who have enrolled, patient and physician acceptance of the service, feedback that has been received, and areas that need improvement. Staff can provide their own feedback on how they perceive the program's effectiveness and how it can be improved. These meetings can be used as educational offerings for the pharmacists to keep their therapeutic knowledge up to date. It is important to keep a time limit on these meetings to minimize disruption of the practice.

Another strategy to ensure program quality is to monitor the outcomes of the service of interest to the practice itself. One of the goals for service implementation is to create new business and generate additional revenues and profits for the pharmacy. The goals should be realistic and challenging to ensure economic viability for the practice. Pharmacists need to be held accountable for their efforts to help the practice reach its goals. Service outcomes that may be of interest to pharmacy staff are number of patients enrolled, revenue generated from the service, number of physician referrals, and profitability of the service (revenues minus expenses). If the service is not profitable, then it needs to be either eliminated or altered (price increases or improved service delivery efficiencies).

An additional continuous quality improvement strategy is to request feedback from patients who have completed the program and physicians who have referred patients to the pharmacy. The feedback could be as simple as a one-page questionnaire asking open-ended questions to provide more qualitative comments about the service. The information that is gathered from these surveys and/or questionnaires can be used to improve patient and physician perception of the service. Furthermore, the request for feedback gives the impression that the practice is proactive toward meeting the needs of patients and other providers.

Carol decided to schedule pharmacy staff meetings twice monthly on the second Tuesday and fourth Thursday of each month. Those days were selected to ensure that all staff members had the opportunity to attend at least one meeting monthly. The meetings were scheduled at 11:00 a.m. because this usually is the least busy time for the pharmacy. The time limit for the meetings was 1 hour. The format of the meetings were as follows:

• Review of service outcomes (i.e., patient enrollment, revenue generation, and physician referrals): 5 minutes
• Pharmacists' discussion of program improvements: 15 to 20 minutes
• Review of feedback from patients and/or physicians: 5 to 10 minutes
• Miscellaneous issues: 5 to 10 minutes
• Therapeutic updates for pharmacists: 20 to 25 minutes

Carol is tracking the service outcomes over time and documenting pharmacists' activities to ensure successful program implementation. She informed the staff about the change in their annual evaluations to include reviews of their impact on the program. Also, she developed a patient satisfaction survey that patients are given after completing the program. A one-page physician questionnaire has been developed and is sent to physicians who have had patients enrolled in the service.

Collaborative practice agreements (CPAs) (also referred to as Collaborative Drug Therapy Management—CDTM) are a strategy that pharmacists can use to integrate their value-added services with prescribers such as physicians (Ferro et al., 1998). CPAs are used to formalize relationships between providers. They spell out the responsibilities of each provider and the acceptance of mutually agreed-on drug therapy management protocols. Although CPAs are an important aspect of service implementation, they require that pharmacists develop working relationships with prescribers. The development of collaborative working relationships (CWRs) between providers is a four-stage process, with the final stage usually representing the time when prescribers are most comfortable signing off on a CPA (McDonough and Doucette, 2001).

Although physicians and pharmacists may be aware of one another in a certain community, they may not be collaborating, and they may communicate only during discrete episodes of care (Stage 0: professional awareness). Pharmacists who are interested in developing services that require the sharing of patient information and regular communication with physicians and other providers will need to increase their interaction with these other providers. For example, the owner of Care-Rite Pharmacy could meet with physicians in her community and discuss her desire to start an MTM service. During these meetings, she could provide the physicians with preliminary protocols and communication forms and request their feedback. By increasing her communication and face-to-face interactions, she moves into the next stage of the CWR (Stage 1: professional recognition).

In the professional recognition stage, physicians not only are aware that a pharmacy exists, but they also recognize that the pharmacy can offer services that go beyond dispensing medications. Since not all pharmacies are providing MTM services, Carol has set herself and her practice apart from other pharmacies in her community. Although attainment of Stage 1 is important early in the working relationship, there is still not much information being shared between providers. Therefore, pharmacists need to develop closer and stronger professional relationships with other providers. In Carol's situation, she requested and received feedback from one physician group regarding her protocol. The physicians in this practice, although initially skeptical of this new service, believed that some of their patients might benefit from the pharmacy's education regarding risk factors, medications, and lifestyle modifications. Therefore, it was agreed that they would refer one or two patients to Care-Rite's Pharmacy's MTM service (Stage 2: exploration and trial).

The exploration and trial stage is one in which physicians are ready to try the service. It is important that pharmacy staff are ready and able to perform at a high level because the physicians will be monitoring their patients' progress closely. Following along with the chapter's scenario, Carol's staff was fully prepared to provide high-quality services for the two patients that were referred to the program. They worked up the patients, performed the medication management services, provided the patient education, and communicated back to the physicians after each patient appointment. After the patients completed several appointments with the pharmacists, Carol met with the physicians to seek their input regarding the program. The feedback was positive, and the physicians' recommendations to improve the program and communication flow were integrated into the program. The physicians agreed to refer more patients to the MTM service (Stage 3: professional relationship expansion).

If physicians and other provides are satisfied with the quality and efficiency of a pharmacy service, they may be willing to increase their referrals. It is during this stage that communication between providers becomes more bilateral, and physicians and pharmacists are exchanging information more equally. Also, physicians begin to develop expectations about the pharmacists and the service. It is important during this stage that pharmacists maintain or increase the quality of the service so that physicians see a benefit to referring patients. If pharmacists perform consistently and at a high level, they may earn the right to develop a CPA with the physicians (Stage 4: full collaborative working relationships (CWR)).

In the final stage, the CWR, pharmacists have proven their clinical abilities, performed reliably and consistently, and gained the trust of physicians. Because of this trust, physicians are now willing to sign a CPA. This is the case with Care-Rite Pharmacy. Carol and her pharmacists consistently helped the physicians' patients reach their goals of therapy. The patients became more compliant with lifestyle changes, and they spoke positively of their experience working with the pharmacists. At Carol's next meeting with the physicians, she discussed developing a CPA, and the physicians agreed to sign it and refer patients regularly to her practice.

The requirements for participation in a CPA are often spelled out in a state's Pharmacy Practice Act, resulting in variations in requirements to participate and the types of activities on which prescribers and pharmacists may collaborate. The components of a CPA typically include the information contained in the policies and procedures manual, drug therapy management protocols, and pharmacist/physician responsibilities. Pharmacists should seek input from physicians regarding patient eligibility criteria and drug therapy management protocols. Once this information is agreed to, then physicians and pharmacists should sign an agreement form. A copy of the CPA should be kept at the pharmacy and at the physician practice. An example of a CPA for Care-Rite Pharmacy is shown in Fig. 26-7.

Developing and implementing value-added pharmacy services can be challenging and time consuming. An equally challenging task is determining an adequate compensation schedule to ensure that the service is economically viable and sustainable. Factors which must be considered when determining a compensation schedule are the pharmacy's costs to provide the service, what competitors may charge for similar services (both other pharmacies and other health care professionals, and what third-party payers may be willing to pay pharmacies for the service.

The first component to pricing value-added services is to determine all the costs associated with providing the service. This can be especially challenging because all costs—fixed and variable need to be considered. These costs include staff time, rent, overhead costs, equipment and technology, paperwork, and the costs associated with the process of care (e.g., chart generation, faxing, photocopying, etc). It is important to closely review all aspects of the service to ensure that all costs have been included. The principles used to calculate the cost of dispensing a prescription (see Chapter 19) can also be applied to estimate the costs of providing a value-added pharmacy service.

Once the costs are determined, then prices that will be charged for the services should be set. There are different pricing methodologies that have been used. Fee-for-service pricing is the traditional method of billing for health care. This is when a specific rate is charged for a service based on time or a specific intervention. This method has been criticized because of its inherent incentive to providers to provide more care, even when it may not be warranted. Fee-for-service is focused on payment for actions of the provider, and not on fulfilling patient needs for optimal health and quality of life outcomes. Another pricing method is the Resource-based relative-value scale (RBRVS) in which payment is directly related to the level of service provided to the patient. This method uses ICD-9 codes that identify the diagnosis of the patient, and CPT codes that describe specific types of patient visits. Although CPT codes unique to pharmacists have not been traditionally recognized by Medicare and other payers, this has changed with the advent of medication therapy management services (MTMS) as a component covered by Medicare Part D. Pharmacy-specific CPT codes that are used by some payers for MTMS include

99605—An initial encounter service performed face to face with a patient in a time increment of up to 15 minutes.

99606—For use for a subsequent or follow-up encounter with the same patient in a time increment of up to 15 minutes.

99607—An add-on code that may be used to bill for additional increments of 15 minutes of time to either of the above codes.

Other CPT codes that have been used by pharmacists include 99211, which is a code used by pharmacists providing patient care incident to a physician. Pharmacists may bill for lab tests performed in the pharmacy by using CPT codes 82465 for total cholesterol, 80061 for fasting lipid panel, 85610 for INR testing, 76977T for bone mineral density screening, 83036 for A1c, and G001 for a finger stick. Also, pharmacists who are qualified to provide diabetes education may use G108 for individual patient training or G109 for group training. Pharmacists billing utilizing these codes normally use the CMS 1500 claim form. This form is used to bill medical services to an insurance program and is universally recognized and accepted for physician billing.

Lastly, another pricing methodology is a capitation. This is where a service is provided for a fixed fee, usually per patient per month. This payment methodology may be appealing to the payer because their costs are predetermined at a monthly rate. But the provider is at risk because they need to keep their costs below the total monthly capitated amount if the services are to be profitable and sustainable.

Each pricing methodology can be used within a pharmacy practice depending on the service and needs and wants of the customer/payer. Regardless of methodology chosen, there are some basic considerations to setting a reasonable fee for a value-added pharmacy service. As discussed above, it is important to determine the cost of doing business, but it is also important to determine a reasonable profit. One general rule that has been used by some pharmacists is that the individual providing the service should generate two to three times their salary in revenue. Assuming that a pharmacist earns $60/hour, this may mean charging $2.00 to $3.00 per minute for a value-added pharmacy service. But the reality of the marketplace is that pharmacists will not be paid an unlimited amount based on their time spent with the patient, but rather most payers either have a fixed amount or a ceiling on the amount that they will pay. Since this is the most common scenario that most pharmacists will face, it is essential that they become efficient with the service so that their costs (in particular their time) do not become excessive as to make the service unprofitable.

There are strategies that can be used to make value-added pharmacy services more profitable. First and foremost, the pharmacist has to be efficient. Therefore, patient interviews should be methodical and time efficient. Pharmacists should be current with their knowledge, be able to identify drug therapy problems from the information they collected from the patient, develop an action plan to resolve the problems, and communicate/document all this to the prescriber and patient. It is essential that pharmacists have a good working knowledge of therapeutics if they are to be successful.

Pharmacists also need to look to their technicians to help them become more cost effective. Pharmacy technicians can be used to help triage patients, help to collect patient histories, update current medication lists, scheduling patients, and billing patients and payers. Pharmacy technicians can assist pharmacists with health screenings/lab testing. By utilizing technicians in these functions, pharmacists are freed up to spend their time working directly with patients to identify and resolve drug therapy problems.

It is also important to realize that some services are more time intensive than others, making it more difficult to be profitable. For example, immunizations take a relatively short period of time to perform, the paperwork can be filled out by the patient, and pharmacists are usually reimbursed for an administration fee in addition to the vaccine fee. This makes immunizations particularly easy to implement and profitable. But services such as MTM are time intensive and require a lot of time with the initial meeting with a patient. But if the pharmacist does a comprehensive work-up and has a thorough medical and medication history to draw from, follow-ups can be profitable. Unfortunately the way the marketplace is paying for MTM services, it may only be once a year that pharmacist can be reimbursed for a CMR, which makes it more challenging to be profitable. On the other hand, if the patient can be seen 2 to 4 times in a year, and the pharmacist reimbursed for follow-up visits, then there is a possibility of long-term service viability.

To summarize this section on compensation for value-added services, pharmacists need to know all their costs, know how much they can be paid, and understand each payers billing process. Once these factors are known, then pharmacists can determine the amount of time they can spend with a patient to ensure profitability. Costs need to be minimized as much as possible and efficiencies maximized.

Pharmacists are implementing several types of value-added services in their practices. It is important that they follow a systematic process during development and implementation of these services so that the services are of high quality. Regardless of the service being implemented, the process remains the same. First, pharmacists need to determine the essential components of the service (e.g., data collection, medication management, patient education, etc.). Next, they should develop a policies and procedures manual that provides the purpose of the service, patient selection, and a description of each patient visit. Also, it is important that pharmacists are trained to provide quality and efficient care. For a pharmacy to be successful, pharmacists need to manage the marketing mix and develop CWRs with other providers.

Pharmacists can ensure their success with program implementation if they follow these steps. By preplanning and preparing before service initiation, pharmacists can minimize the challenges with any new startup program. As part of their preparation, the development of documentation tools, protocols, and physician communication forms is essential. Lastly, as they develop a trusting relationship with other providers and begin to receive regular referrals, a CPA may need to be created. With this document, pharmacists and physicians will know each other's roles, and an efficient exchange of information begins to occur.

1. This chapter emphasized that the process of implementing value-added pharmacy services remains the same regardless of the service. What may be some differences in the forms used, protocols, and CPAs if the service were a diabetes educational program instead of a medication management service?

2. Discuss how the marketing mix may be similar/different from the scenario used in this chapter and a pharmacist implementing a heart failure clinic.

3. Think about a value-added service that you have an interest in implementing. What are the components of the service?