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After years of debate and compromise, President George W. Bush signed the Medicare Prescription Drug, Improvement and Modernization Act of 2003 into law in December 2003.1 (A complete discussion of Medicare reform is beyond the scope of this article.) In addition, however, to providing a prescription drug benefit, this legislation requires plans offering Medicare Part D to develop medication therapy management services and to compensate pharmacists for providing those services. Patients eligible to receive those services include patients taking multiple medications or suffering from selected chronic disease states (diabetes, asthma, hypertension, hyperlipidemia, congestive heart failure). Congress has finally recognized the valuable contributions pharmacists can make to patient care.
The medication therapy management program introduced in Medicare Part D is not a new concept. It is typically referred to as collaborative drug therapy management (CDTM). The American College of Clinical Pharmacy defines CDTM by pharmacists as follows: a collaborative practice agreement between physicians and qualified pharmacists whereby pharmacists work within the context of a defined protocol, permitting them to assume professional responsibility for performing patient assessments; ordering drug therapy-related laboratory tests; administering drugs; and selecting, initiating, monitoring, continuing, and adjusting drug regimens.2 In this role, pharmacists are acting as physician enhancers, applying their specific drug therapy knowledge to accompany that of the collaborating professionals.
History of CDTM
Less than 100 years ago, pharmacists were able to prescribe drugs legally. The passage of the Federal Food, Drug and Cosmetic Act of 1938 and the Durham-Humphrey Amendment of 1951 resulted in the legal separation of prescribing and dispensing. Over the years, the 2 activities have been merging together again in the form of CDTM. In the 1960s, pharmacists in the Indian Health Service began assuming an active role in drug therapy management. In 1973, the Pharmacist Practitioner Program was developed, and it remains in existence today.3 In 1974, the Department of Health, Education and Welfare enacted a drug regimen review regulation for nursing homes. In 1995, the Veterans Health Administration began allowing pharmacists with advanced training to participate in CDTM. These programs?as well as the success of early CDTM programs in California, Washington, and Florida?have all contributed to the expansion of CDTM.
Federal legislation defers authority for determining pharmacist scope of practice to the individual state pharmacy practice acts. Therefore, collaborative agreements vary significantly, based on state legislation, practice environment, and pharmacist training and education requirements. At the end of 2002, 39 states allowed various types of CDTM within their pharmacist scope of practice.
Obstacles and Requirements for Establishing CDTM
Many pharmacists, even those in states that have legislative approval, do not currently engage in CDTM because of various obstacles. These obstacles include the following:
The American College of Clinical Pharmacy has identified some key elements for pharmacists to successfully participate in CDTM (Table). These elements are discussed below.2
One of the most important elements for a successful CDTM service is a collaborative relationship with physicians. Physicians are responsible for referring patients to the service, assisting with protocol development and review, drafting the CDTM agreement, and providing patient data, if not readily available, as well as promoting the service to other physicians.
Physicians may not be aware of the role pharmacists can play in drug therapy management. Educating physicians about the pharmacist's role, in addition to acting as a resource and being willing to assist when called on, can help change this view of what is expected from a pharmacist. Several national pharmacy organizations such as the American Society of Health-System Pharmacists and the American Pharmacists Association (APhA), along with national primary care physician groups, support cognitive services being provided by pharmacists.
Access to Medical Records
Access to patient medical records is probably one of the most challenging steps for pharmacists located in the community pharmacy setting. With good knowledge of basic physical assessment skills and with the availability of many point-of care devices, however, much of the physical assessment and laboratory data can be gathered within the pharmacy. Maintaining a good working relationship with the referring provider and office staff will be helpful in obtaining missing patient information.
A pharmacist's educational requirements and training to participate in CDTM may vary with state legislation requirements or with the requirements of the collaborating practitioners. Some may require a Doctor of Pharmacy degree, residency training, or, at a minimum, credentialing in the disease state being managed. National and state pharmacy associations may offer these specialized credentialing programs. For example, the APhA has established an Advanced Practice Institute to train pharmacists to participate in collaborative practices.5
Appropriate documentation of the patient visit is crucial. A clinic encounter form can be created to provide direct documentation of the patient visit that can be easily communicated to the provider, have all the appropriate elements for billing, and adhere to legal requirements. Policies and procedures should be in place defining the pharmacist and physician roles within the CDTM service, how information will be shared, ensuring patient privacy and confidentiality, and how patient outcomes will be measured.
Passage of the new Medicare legislation is not insignificant when it comes to reimbursement for pharmacists' services. Third-party payers and others usually follow the lead of Medicare when determining reimbursement rates. Until these parameters are more clearly defined, however, pharmacists must educate themselves regarding billing for services in order to ensure appropriate reimbursement rates. Consulting with institutional billing departments or with the collaborating physician's billing department may be a good place to start.
Establishing CDTM services provides many obstacles and challenges. On the other hand, the rewards of improving patient health outcomes, building a close working relationship with physicians in the community, and the satisfaction of providing pharmaceutical care services are well worth the effort. The need for pharmacist involvement in such services will only continue to grow as the number of patients taking multiple medications for chronic disease states continues to increase. Medicare reform has opened the door for increased reimbursement for these services, and national and state pharmacy organizations are working hard to ensure appropriate reimbursement.
Dr. Singla is an assistant professor of pharmacy practice at Midwestern University College of Pharmacy?Glendale, Glendale, Ariz.
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