Any person who solicits or receives any remuneration, directly or indirectly, overtly or covertly, in cash or in kind in return for purchasing, leasing, ordering or arranging for or recommending purchasing, leasing, or ordering of any good, facility, service, or item for which payment is or may be made in whole or in part by a health care insurer, or any person who offers or pays any remuneration, including any bribe or rebate, except as provided in subsection (b), directly or indirectly, overtly or covertly, in cash or in kind to induce any person to purchase, lease, order or arrange for or recommend purchasing, leasing or ordering of any good, facility, service, or item for which payment is or may be made in whole or in part by a health care insurer, shall be punished by a fine of not more than ten thousand dollars, or by imprisonment in a jail or house of correction for not more than two and one-half years or in the state prison for not more than five years, or by both such fine and imprisonment, and may be held liable in a civil action under section seven.
(b) Effective until January 1, 2023
(1) This section shall not apply to any discount or free product vouchers that a retail pharmacy provides to a consumer in connection with a pharmacy service, item or prescription transfer offer or to any discount, rebate, product voucher or other reduction in an individual's out-of-pocket expenses, including co-payments and deductibles, on: (i) any biological product as defined in section 351 of the Public Health Service Act, 42 USC 262, or (ii) any prescription drug provided by a pharmaceutical manufacturing company, as defined in section 1 of chapter 111N, that is made available to an individual if the discount, rebate, product voucher or other reduction is provided directly or electronically to the individual or through a point of sale or mail-in rebate, or through similar means; provided, however, that a pharmaceutical manufacturing company shall not exclude or favor any pharmacy in the redemption of such discount, rebate, product voucher or other expense reduction offer to a consumer.
(2) Pharmaceutical manufacturing companies shall be prohibited from offering any discount, rebate, product voucher or other reduction in an individual's out-of-pocket expenses, including co-payments and deductibles, for any prescription drug that has an AB rated generic equivalent as determined by the United States Food and Drug Administration or for any prescription drug that is an opioid placed by the commissioner of public health on schedule II pursuant to subsection (a) of section 2 of said chapter 94C.
(3) This section shall not apply to a discount, rebate or other payment by a pharmaceutical manufacturing company to a patient or another 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 drug or biologic’s approved labeling.
(c) Effective until January 1, 2023
Subsection (b) shall not: (i) restrict a pharmaceutical manufacturing company with regard to how it distributes a prescription drug, biologic or vaccine; (ii) restrict a carrier or a health maintenance organization, as defined in section 1 of chapter 118G, with regard to how its plan design will treat such discounts, rebates, product voucher or other reduction in out-of-pocket expenses; or (iii) affect the obligations of practitioners and pharmacists pursuant to the generic substitution statute as defined in section 12D of chapter 112.
(d) Effective until January 1, 2023
For purposes of the federal Health Insurance Portability and Accountability Act of 1996, hereinafter referred to as HIPAA, and regulations promulgated under HIPAA, nothing in this section shall be deemed to require or allow the use or disclosure of health information in any manner that does not otherwise comply with HIPAA or regulations promulgated under HIPAA.
|Last updated:||December 11, 2020|