Budget Amendment ID: FY2017-S4-494

EHS 494

First Dose Monitoring

Ms. Chandler moved that the proposed new text be amended by inserting the following section: -

“SECTION ___. Chapter 175H of the General Laws is hereby amended by inserting after subsection (b)2 the following new subsection:- (3) This section shall not apply to a discount, rebate or other payment by a pharmaceutical manufacturing company to a patient or other person on the patient’s behalf (other than the prescriber of the drug or biologic), for health care items or services related to the patient’s use of a drug or biologic of the manufacturer, where such items or services are required under a Food and Drug Administration Risk Evaluation and Mitigation Strategy or are for the purpose of monitoring or facilitating the use of the drug or biologic in a manner consistent with the provisions set forth in the drug or biologic’s approved labeling.”