Pharmacy and Therapeutics - January 2008 - (Page 10) PRESCRIPTION: WASHINGTON FDA Considers New Avenue For Pharmacist Reimbursement Customers Must Consult with Pharmacists To Buy Behind-the-Counter Drugs Stephen Barlas Stephen Barlas is a freelance writer based in Washington, DC, who covers issues inside the Beltway. Send ideas for topics and your comments to sbarlas@verizon.net. ical Pharmacy, says there is no “maybe” about that. It is a proven fact, based on pilot studies such as the Asheville Project. In that study, the clinical services and interventions of pharmacists, in collaboration with other health care providers, substantially improved the clinical, economic, and humanistic outcomes for patients with diabetes, asthma, and lipid disorders. Every organization representing pharmacists thinks that a BTC class is a wonder ful idea—subject, of course, to suitable reimbursements. Such a method shouldn’t be all that difficult to implement. The recent approval of the American Medical Association’s (AMA’s) categor y 1 Current Procedural Terminology (CPT) codes for pharmacists’ faceto-face medication therapy services for patients provides a standardized and Health Insurance Portability and Accountability Act (HIPAA)–compliant framework for building and documenting these services. Coming up with the drugs to be included in a BTC category might be a more imposing problem, and deciding which qualifications pharmacists must have in order to work with this class of drugs will be another challenge. Ed Webb, for example, says that pharmacists who earned a Doctor of Pharmacy degree in the past decade are supremely prepared for this new responsibility. But he acknowledges: There are pharmacists in practice now who have graduated 15, 20, 25 years ago for whom this set of activities and skills will not necessarily be second nature, but that doesn’t mean that they can’t be prepared and educated to assist in this process. A s many readers are aware, the U.S. Food and Drug Administration (FDA) is seriously exploring establishing the idea of a new “behind-thecounter (BTC)” class of drugs. Pharmacy customers would have access to these products only if they receive counseling from a pharmacist. In turn, the pharmacist would receive additional reimbursement from health plans, Medicare, and Medicaid. The FDA discussed the concept on November 14 in a meeting likely to be the opening bell in a political slugfest between pharmacists and physicians. There is some question as to whether the FDA has the authority to establish a new BTC class, but former FDA Commissioner Mark McClellan, MD, PhD, has publicly said that the major FDA reform bill that Congress passed last fall included language authorizing the new class. Be that as it may, a BTC class is not exactly a radical notion. The United Kingdom already has a “pharmacy-only” class of drugs, and all sorts of variations on that system exist in Australia, Canada, France, Germany, and Italy. The goal in creating this new class in the U.S. is essentially two-fold. First, in the words of Randall Lutter, PhD, Acting Deputy Commissioner for Policy and Planning at the FDA, the idea is to allow people who might not be able to see a physician, for whatever reason, to obtain needed medication from a pharmacist. Second, pharmacists might be able to improve clinical outcomes. C. Edwin Webb, PharmD, MPH, Director of Government and Professional Affairs for the American College of Clin- Expect the AMA to jump up and down in opposition to a BTC class; if that doesn’t work, expect the group to try to keep the category as narrow as possible and the reimbursement as low as possible. Joseph Cranston, PhD, AMA Director of Science, Research, and Technology, explains that the AMA has a number of reasons for opposing a BTC class of drugs. The AMA doesn’t think the FDA has the statutory authority to create a BTC class. He claims that there is no evidence that the U.K.’s pharmacy-only class or any other similar system in any other country has provided much in the way of consumer benefits. Dr. Cranston cited a Government Accountability Office (GAO) report from 1995 to support his contention. Sidney Wolfe, M., Director of the Health Research Group at Public Citizen, the public interest group, also cites the GAO survey when voicing his opposition to a BTC class. He argues that pharmacists, although qualified to counsel, simply do not have the time. Given the many dramatic changes in pharmacy practice, drug pricing, and pharmacist education since the mid1990s, Dr. Wolfe and the AMA will probably need to come up with more ammunition than a 12-year-old GAO report. In addition, even though Dr. Wolfe has prominent influence as a consumer advocate, other consumer groups (e.g., the National Women’s Health Network) like the BTC idea. Bill Vaughn, Senior Policy Analyst for Health, Consumers Union, thinks that a BTC class is a good concept, but “this has to be done right and it has to be done carefully.” In particular, the insurance companies must agree, obviously. Allowing patients to buy certain lowrisk drugs from pharmacists seems like a win–win situation. The sick can get the drugs they need more quickly, and thirdparty payers probably save money, which might lead to savings for consumers— that is, if health plans pass along their savings, which would happen in a perfect world. I 10 P&T® • January 2008 • Vol. 33 No. 1
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