Other Payments to Health Care Practitioners

(1) No pharmaceutical or medical device manufacturing company that employs or contracts with a pharmaceutical or medical device manufacturer agent may provide: (a) entertainment or recreational items of any value, including, but not limited to, tickets to the theater or sporting events, concerts, sporting equipment, or leisure or vacation trips, to any health care practitioner who is not a salaried employee of the pharmaceutical or medical device manufacturing company; (b) payments of any kind including cash or cash equivalents, equity, "in kind" or tangible items including any "complimentary" items such as pens, coffee mugs, gift cards, etc. to health care practitioners either directly or indirectly, except as compensation for bona fide services; (c) any grants, scholarships, subsidies, supports, consulting contracts, or educational or practice related items in exchange for prescribing, disbursing, or using prescription drugs, biologics or medical devices or for a commitment to continue prescribing, disbursing, or using prescription drugs, biologics or medical devices; (d) any other payment or remuneration, in cash or in kind, directly or indirectly, including any rebate or "kickback" that is prohibited under applicable federal or state "fraud and abuse" laws or regulations including the federal "Anti-Kickback Statute" (42 U.S.C. 1320a-7b) and equivalent Massachusetts laws such as M.G.L. c. 118E, § 41 and M.G.L. c. 175H, § 3. (2) Nothing in 105 CMR 970.000 shall prohibit the following: (a) Reasonable compensation for bona fide services, or the reimbursement of other reasonable out-of-pocket costs incurred by the health care practitioner directly as a result of the performance of such services, where the compensation and reimbursement is specified in, and paid for under, a written agreement; (b) Payment or reimbursement for the reasonable expenses, including travel and lodging related expenses necessary for technical training of health care practitioners on the use of a medical device; (c) The provision, distribution, dissemination or receipt of peer reviewed academic, scientific or clinical information; (d) The purchase of advertising in peer reviewed academic, scientific or clinical journals; (e) The provision of prescription drugs to a health care practitioner solely and exclusively for use by the health care practitioner's patients; (f) The provision of reasonable quantities of medical device demonstration and evaluation units provided to a health care practitioner to assess the appropriate use and functionality of the product and determine whether or not and when to use or recommend the product in the future; (g) The provision of price concessions, such as rebates or discounts, in the normal course of business; (h) Provision of reimbursement information regarding products, including identifying appropriate coverage, coding, or billing of products, or of procedures using those products and information, in support of accurate and responsible billing to Medicare and other payers and provision of information designed to offer technical or other support intended to aid in the appropriate and efficient use or installation of products, provided, however, that this technical or other support shall not be offered or provided for the purpose of inducing health care practitioners to purchase, lease, recommend, use, or arrange for the purchase, lease or prescription of products; or (i) The provision of payments, or the provision of free outpatient prescription drugs, to health care practitioners for the benefit of low income individuals, through established "patient assistance programs" (PAPs), provided the program meets the criterion for a permissible program in accordance with the relevant published guidance available from the U.S. Department of Health and Human Services Office of the Inspector General, or is otherwise permitted under applicable federal laws and regulations including the "Anti-Kickback Statute" (42 USC 1320a-7b). (j) The provision of charitable donations provided that the donation: 1. is not provided in exchange for prescribing, disbursing or using prescription drugs, biologics or medical devices or for a commitment to continue prescribing, disbursing or using prescription drugs, biologics or medical devices, and 2. does not otherwise violate the provisions of 105 CMR 970.000.