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Budget Summary FY2015

Outside Section 146
Data Current as of:  10/17/2014




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Prohibition on clinical laboratory self-referrals III

SECTION 146.   Said chapter 111D is hereby further amended by striking out section 13, as appearing in the 2012 Official Edition, and inserting in place thereof the following 2 sections:-

Section 13. (a) No individual shall: (i) maintain a clinical laboratory in the commonwealth without a license in violation of section 4; (ii) maintain a clinical laboratory in violation of the terms of a license issued under section 5; (iii) engage in, aid, abet, cause or permit any act prohibited under section 8; or (iv) refer, request, order or send any specimen derived from the human body in violation of section 8A. A violation of this subsection, shall be punished by imprisonment for not more than 5 years in state prison, or by imprisonment in a jail or house of correction for not more than 2 1/2 years, or by a fine of not more than $10,000 or by both such fine and imprisonment. The commissioner shall transmit to the attorney general evidence of an offense, which is in the department's possession.

(b) If a person or company violates clause (17) of section 8 or section 8A, the attorney general may bring a civil action, either in lieu of or in addition to a criminal prosecution, and may recover a civil penalty of not less than $5,000 and not more than $10,000 per violation, plus 3 times the amount of damages sustained, including consequential damages. A person violating clause (17) of section 8 or section 8A shall be liable to the commonwealth for the expenses of the civil action brought to recover any such penalty or damages, including, but not limited to, reasonable attorney's fees, reasonable expert's fees and the costs of investigation. No action shall be brought under this section more than 6 years after it accrues. The commissioner shall transmit to the attorney general such evidence of an offense as the department may have in its possession.

(c) A person or company that solicits, offers or enters into a referral arrangement or scheme with a clinical laboratory which the person or company knows or should know has a principal purpose of assuring referrals by the person or company to a particular clinical laboratory which, if the person or company directly made referrals to such clinical laboratory, would be in violation of clause (17) of section 8 or section 8A, shall be liable to the commonwealth for a civil penalty of not more than $100,000 for each referral arrangement or scheme plus 3 times the amount of damages sustained, including consequential damages. No action shall be brought under this section more than 6 years after it accrues. The commissioner shall transmit to the attorney general such evidence of an offense as the department may have in its possession.

Section 14. The department shall require all clinical laboratories to disclose any ownership interests in writing to the department every 2 years. The disclosure shall contain the name and ownership interest of the disclosing person or company, as well as the names and all ownership interests of all other parties with an ownership interest in the clinical laboratory. A copy of the disclosure shall be provided by the clinical laboratory to the attorney general. Any person who fails to provide such disclosure shall be subject to a fine not exceeding $5,000 by the department.