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Disease management clinics targeting diabetes, hypertension, hyperlipidemia, and other chronic conditions have expanded patient care opportunities for many community pharmacists. Although each condition or patient population has unique requirements for patient care, a generalized approach for initiating a disease management clinic is outlined in the Table. The remainder of this article will address common challenges faced during clinic development, including choosing the target population, working within budget constraints, meeting regulatory requirements, seeking compensation, and gaining support from other health care providers.
Choosing the Most Appropriate Target Population
Identifying the target disease and/or patient population is the first step in any clinic development. Basing this decision solely on the clinical interests of the providers of the service can fail to match the needs of the patients and the available resources. Whereas expertise in the targeted therapeutic area is imperative, a needs assessment should be performed to verify disease prevalence and demographics. For example, an asthma management clinic is well suited for pediatric patients in areas of high asthma prevalence, which can be measured through the pharmacy database and local reports from health departments or American Lung Association affiliates. An additional benefit of a needs assessment is avoidance of duplicate services. Identifying existing services allows for the development of a clinic directed at unmet patient care needs and may result in collaborative relationships with other health care providers.
Working Within Budget Constraints
Developing a clinic with limited funds is a commonly faced dilemma. A conservative approach to resource utilization in the areas of work flow, equipment, and marketing can help relieve budget pressures and promote efficient service delivery. Choosing blocked hours of operation based on prescription volume and staffing characteristics can facilitate initial work flow. Expanded hours can then be offered as the clinic becomes established. The use of support personnel for administrative tasks?such as patient data intake, filing, and billing? can focus pharmacist time on patient care duties and provide further efficiency.
Equipment and supply costs can often dominate a disease management clinic budget. When considering a target disease state, associated equipment, supplies, storage, maintenance, and training costs must be identified. For example, equipment for a hypertension management clinic is typically limited to blood pressure measurement devices, which require little maintenance and no special storage. In contrast, the cholesterol-testing devices utilized in a lipid-management clinic require supplies, maintenance, and specialized storage. Consideration should be given to the use of alternate sources of laboratory data, which can reduce operating costs. Point-of-care testing can then be pursued as the clinic services expand over time.
Supply costs can be further minimized through the use of paper documentation and filing systems and the use of free patient education materials published by national health organizations and government agencies. Again, clinic growth can allow for expansion to computerized documentation and the publication and printing of personalized patient education materials.
Marketing strategies, such as television and newspaper advertisements and direct mailings, can add considerable costs to clinic operations. Because clinic enrollment is dependent on referral from other providers and from direct pharmacist-patient communications, verbal marketing should be the initial focus, with other strategies added as funds allow.
Meeting Regulatory Requirements
Regulation of patient confidentiality and prescription processing is familiar to any pharmacy provider of disease management services. As laboratory testing is integrated into the clinic, however, additional regulations must be considered. The Clinical Laboratory Improvement Amendments (CLIA) guide the regulation of all laboratory testing, including the use of point-of-care testing devices common to pharmacy-based clinics for diabetes, lipids, and anticoagulation. For information, visit www.cms.hhs.gov/clia, which provides links to the local agencies that further facilitate the process. Performance of finger-stick testing also requires consideration of the Occupational Safety and Health Administration (OSHA) blood-borne pathogen standards. These standards can be accessed at www.osha.gov.
Compensation strategies in pharmacy-based disease management clinics often are limited by the physical separation of the pharmacy from other health care providers. This situation can restrict the ability to bill third-party payers "incident to" or in association with the services of an established provider. Although the most direct method of compensation is out-of-pocket payment by the patient, all potential payers must be considered when developing a clinic, including employers and insurance providers. Pursuit of small contracts with local, self-insured employers or insurance providers can build a foundation for pursuit of larger arrangements in the future. Success in these negotiations requires a sound documentation strategy that shows consistent service delivery and patient outcomes.
Projecting the financial outcomes of pharmacy-based clinics can be a difficult task as successful compensation models continue to be tested and pharmacists pursue provider status. The clinic plan always should consider potential indirect sources of income, including prescription and nonprescription drug and merchandise sales that result from patient loyalty. Additionally, the financial impact of the recruitment and retention of satisfied employees interested in the delivery of expanded patient care services should not be minimized.
Gaining Support from Other Health Care Providers
The success of a pharmacy-based disease management clinic relies heavily on support from other health care providers, both as a referral base and as partners in patient care. Clear communication of program outcomes?such as improved use of medications, detection of adverse effects, and adherence to lifestyle modifications?can emphasize the noncompetitive nature of the service. The use of nationally recognized treatment standards in the development of clinic policies and procedures further emphasizes their collaborative nature and provides a common ground for communication across disciplines. The National Guideline Clearinghouse is a useful resource for locating updated treatment guidelines. It can be accessed at www.guideline.gov.
Many of the obstacles faced during the development of a pharmacy-based disease management clinic are common to all targeted disease states. Anticipating and planning for the obstacles can facilitate a smooth transition to patient care and a successful clinic.