Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 970.000 - Pharmaceutical And Medical Device Manufacturer Conduct
Section 970.009 - Reporting to the Department
Current through Register 1531, September 27, 2024
(1) Beginning July 1, 2010, and annually on or before July 1st of each year thereafter, every pharmaceutical or medical device manufacturing company that employs or contracts with a pharmaceutical or medical device manufacturer agent shall disclose to the Department the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents, to any covered recipient in connection with the company's sales and marketing activities.
(2) Each annual disclosure report shall be accompanied by a fee of $2,000. The first annual payment of $2,000 shall be due to the Department on July 1, 2009. No payment pursuant to 105 CMR 970.009(2) shall be required after July 1, 2012.
(3) Disclosures shall be made for the previous calendar year using a standardized reporting format developed by the Department. The first required disclosure report shall cover the period from July 1, 2009 through December 31, 2009. Each annual disclosure report may be submitted to the Department electronically.
(4) Pharmaceutical or medical device manufacturing companies shall certify that to the best of the company's knowledge, information and belief, that any report is true and accurate.
(5) For the purposes of computing the $50 threshold, fees, payments, subsidies and other economic benefits relating to separate events or transactions shall be calculated on an individual transactional basis and shall not be aggregated. Pharmaceutical or medical device manufacturing companies shall not structure fees, payments, subsidies or other economic benefits to health care practitioners to circumvent the reporting requirements of M.G.L. c. 111N, § 6 and 105 CMR 970.009.
(6) Notwithstanding the provisions of 105 CMR 970.009, no pharmaceutical or medical device manufacturing company is required to disclose information to the Department that has been disclosed to a federal agency pursuant to federal law and that is then provided by the Secretary to the Department in annual reports.
