Statement of the National Association of Chain Drug Stores For the Joint Hearing on “H1N1 Preparedness: An Overview Of Vaccine Production And Distribution" House Energy and Commerce Committee Subcommittee on Health and Subcommittee on Oversight and Investigations November 18, 2009 Chairmen Pallone and Stupak, the National Association of Chain Drug Stores appreciates the opportunity to submit this statement for today’s hearing. Addressing the serious public health threat posed by the H1N1 virus should be a top concern to our nation’s political leaders and its health providers, so we commend you for holding this important hearing to raise public awareness about the problem and to explore ways to address production and distribution issues. NACDS, its member companies and the 120,000 dedicated pharmacists who work in chain community pharmacies stand ready to assist policymakers and public health officials at all levels of government in preventing the spread, and alleviating the symptoms, of this dangerous disease. The National Association of Chain Drug Stores (NACDS) represents 154 traditional drug stores, supermarkets, and mass merchants with pharmacies – from regional chains with four stores to national companies. NACDS members also include more than 900 pharmacy and front-end suppliers, and over 70 international members from 24 countries. Chains operate 37,000 pharmacies, and employ more than 2.5 million employees, including 118,000 full- time pharmacists. They fill more than 2.5 billion prescriptions annually, which is more than 72 percent of annual prescriptions in the United States. The total economic impact of all retail stores with pharmacies transcends their $815 billion in annual sales. Every $1 spent in these stores creates a ripple effect of $3.82 in other industries, for a total economic impact of $3.11 trillion, equal to 26 percent of GDP. The first wave of the H1N1 pandemic began in the spring of this year, originating in Mexico and spreading quickly into the United States and other countries, forcing public health officials to dramatically revise their pandemic plans. Although the severity of the illness was mild -- comparable to seasonal flu -- it was possible that subsequent waves of the pandemic would be more virulent beginning in the fall. Another grave concern was the fact that H1N1 influenza seemed to occur more frequently and with greater morbidity in children and young adults than seasonal influenza. The resulting mass H1N1 vaccination campaign is the largest such undertaking in history, requiring broad coordination across the entire healthcare continuum and an increase in the number of vaccination providers. Community pharmacies are uniquely capable of immunizing large numbers of people, thanks to their convenient locations, easy access during evenings and weekends and specially trained pharmacists. The laws in all fifty states authorize pharmacists to administer vaccinations. There are more than 56,000 community pharmacies in every community in the country, with nearly 80,000 pharmacists qualified to administer vaccinations. During the current influenza season, pharmacists are expected to administer more than 5 million seasonal influenza vaccinations. Pharmacies also provide oral anti-viral medications and ancillary health care supplies, such as hand sanitizers, as well as retail health clinics offering additional healthcare services in many locations. Pharmacies are also technologically proficient, using real-time electronic claims processing systems to access patient eligibility, coverage limitations, and copayments for pharmacy benefits. During the summer, chain pharmacies began making plans to support public health H1N1 pandemic initiatives, specifically for administration of H1N1 vaccine and distribution of oral anti-viral agents. Due to the large number of unknown variables in state and federal planning, collaboration with other provider groups, public health agencies, and government officials was necessary to promote consistency and operational effectiveness. To address these issues, NACDS convened a stakeholder workgroup meeting with pharmacy representatives and other key organizations1, and after several meetings, produced the Operational Framework for Partnering with Pharmacies for Administration of 2009 H1N1 Vaccine, a document published by the Association of State and Territorial Health Officials (ASTHO) to serve as a guide to state and territorial health officials. This Framework describes the unique capabilities of community pharmacies to administer H1N1 vaccine, a template provider agreement between public health and community pharmacies, and a template executive order proposing emergency amendments to expand state-level use of community pharmacists in H1N1 vaccination programs. In addition, NACDS continued to work with the American Pharmacists Association and America’s Health Insurance Plans (AHIP) to develop a mechanism for pharmacies to submit medical claims to health plans for reimbursement of H1N1 vaccine administration, culminating in a recommended roster billing form that can be used if this service is not covered through the health plan’s pharmacy benefit. We are pleased to report that the potential contribution of community pharmacies has been well recognized in public health pandemic plans. Community pharmacies have enrolled broadly as H1N1 vaccine providers in state provider networks. Several states have issued Emergency Orders to expand the ability of pharmacists to administer H1N1 vaccine, such as by lowering the age limits and streamlining H1N1 vaccination protocols. Many state Medicaid programs issued rules to reimburse pharmacies for administering H1N1 vaccine to 1 The American Pharmacists Association, the National Alliance of State Pharmacy Associations, the National Community Pharmacists Association, the Food Marketing Institute, the Convenient Care Association, the Healthcare Distribution Management Association, Rx Response, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials, the Centers for Disease Control and Prevention, the Department of Homeland Security, the Department of Health and Human Services, and the Federal Emergency Management Agency. beneficiaries. Community pharmacies prepared their pharmacists and contract vendors to receive and administer H1N1 vaccine, and now await delivery of the vaccine for administration to priority patient groups. In addition to community pharmacy’s engagement in H1N1 prevention, it also is engaged in treatment. In response to the ongoing shortage of commercially manufactured Tamiflu for Oral Suspension, an important anti-viral medication for high-priority pediatric patients, pharmacists continue to compound the liquid product in cooperation with guidance from the Food and Drug Administration and the Centers for Disease Control and Prevention. Community pharmacy’s support of H1N1 vaccination involves ongoing challenges. The wide variety of state and local H1N1 vaccination processes and restrictions have added complexity to community pharmacy support and we would recommend a more uniform process in the future. The uncertainty of product delivery, including the lack in advance identification of which product type and quantities will be delivered, and the undefined delivery schedule make it difficult to schedule vaccination services. There has been an unwillingness of some state officials to ship vaccine to non-resident locations, failing to take advantage of the efficiency of chain pharmacy distribution centers. There continues to be lack of clarity concerning some health plan’s coverage, billing procedures, and patient copayments for H1N1 vaccinations. In conclusion, we appreciate federal and state efforts to provide vaccine to protect the public from H1N1 influenza, and their recognition of the contributions of community pharmacies. The experience from this relatively mild pandemic and the difficulties implementing a nationwide solution should improve future efforts. Community pharmacies, the face of neighborhood health care, remain committed to assist public health efforts to protect our citizens through convenient vaccination services and distribution of influenza countermeasures. We look forward to working with your committees and Congress as a whole to ensure that the nation’s community pharmacies are utilized to the greatest extent possible in helping combat this serious health threat. Thank you for the opportunity to submit this statement. If you have any questions, please contact Paul T. Kelly, Vice President, Federal Government Affairs.