Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration

Abstract

The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July 2009 under Chapter 305 of the Acts of 2008, An Act To Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care. The state law requires pharmaceutical and medical device manufacturers to comply with a marketing code of conduct, obey specific compliance activities, and disclose payments to Massachusetts-licensed healthcare providers with a value of $50 or more in connection with sales and marketing activities. This thesis qualitatively assessed the impact of 105 CMR 970.000 on physician-industry collaboration related to technology development and physician education in the Massachusetts medical device industry, as depicted by academic physicians and representatives of medical device companies during the first quarter of calendar year 2010. A pilot study comprising interviews and surveys of stakeholders in the Massachusetts medical device industry was conducted to summarize the initial impressions of the impact of 105 CMR 970.000 on medical device physician-industry collaboration, with the intention of creating a roadmap for future analysis. Informal interviews (36) included individuals at medical device manufacturers, distributors, academic medical centers, venture capital firms, law firms, consulting firms, MassMedic, and the DPH. Formal surveys (40) included academic physicians and medical device company representatives selling to Massachusetts licensed physicians. The hypothesis was confirmed that 105 CMR 970.000 has impaired medical device physician-industry collaboration related to technology development and physician education in Massachusetts. Our results may have state and federal regulatory implications for the medical device industry and can serve as a guide for future analysis.