In Japan, nicotine dependence treatment service for outpatients at registered medical institutions has been started under health insurance coverage since 2006. The reimbursed treatment program consists of five treatment sessions over 12 week duration. Nicotine patch or varenicline can be prescribed under health insurance coverage during the treatment period. The surveys conducted in 2007 and 2009 have proved the effectiveness of the service. However, the accessibility and utilization of smoking cessation treatment are not sufficient, considering the fact that the percentage of smokers who underwent smoking cessation treatment in Japan remained low compared with other countries. Future challenges call for implementing effective measures to improve the accessibility and utilization of the service, while maintaining a satisfactory level of treatment quality.