Title 18: Health
Chapter 91: PRESCRIPTION DRUG COST CONTAINMENT
Sub-Chapter 03: Information Requirements
18 V.S.A. § 4631a. Expenditures by manufacturers of prescribed products
§ 4631a. Expenditures by manufacturers of prescribed products
(a) As used in this section:
(1) "Allowable expenditures" means:
(A) Payment to the sponsor of a significant educational, medical, scientific, or policy-making conference or seminar, provided:
(i) the payment is not made directly to a health care professional or pharmacist;
(ii) funding is used solely for bona fide educational purposes, except that the sponsor may, in the sponsor's discretion, apply some or all of the funding to provide meals and other food for all conference participants; and
(iii) all program content is objective, free from industry control, and does not promote specific products.
(B) Honoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide significant educational, medical, scientific, or policy-making conference or seminar, provided:
(i) there is an explicit contract with specific deliverables which are restricted to medical issues, not marketing activities; and
(ii) consistent with federal law, the content of the presentation, including slides and written materials, is determined by the health care professional.
(C) For a bona fide clinical trial:
(i) gross compensation for the Vermont location or locations involved;
(ii) direct salary support per principal investigator and other health care professionals per year; and
(iii) expenses paid on behalf of investigators or other health care professionals paid to review the clinical trial.
(D) For a research project that constitutes a systematic investigation, is designed to develop or contribute to general knowledge, and reasonably can be considered to be of significant interest or value to scientists or health care professionals working in the particular field of inquiry:
(i) gross compensation;
(ii) direct salary support per health care professional; and
(iii) expenses paid on behalf of each health care professional.
(E) Payment or reimbursement for the reasonable expenses, including travel and lodging-related expenses, necessary for technical training of individual health care professionals on the use of a medical device if the commitment to provide such expenses and the amounts or categories of reasonable expenses to be paid are described in a written agreement between the health care provider and the manufacturer.
(F) Royalties and licensing fees paid to health care providers in return for contractual rights to use or purchase a patented or otherwise legally recognized discovery for which the health care provider holds an ownership right.
(G) The payment of the reasonable expenses of an individual related to the interview of the individual by a manufacturer of prescribed products in connection with a bona fide employment opportunity or for health care services on behalf of an employee of the manufacturer.
(H) Sponsorship of an educational program offered by a medical device manufacturer at a national or regional professional society meeting at which programs accredited by the Accreditation Council for Continuing Medical Education, or a comparable professional accrediting entity, are also offered, provided:
(i) no payment is made directly to a health care professional or pharmacist; and
(ii) the funding is used solely for bona fide educational purposes, except that the manufacturer may provide meals and other food for program participants.
(I) Other reasonable fees, payments, subsidies, or other economic benefits provided by a manufacturer of prescribed products at fair market value.
(2) "Bona fide clinical trial" means an FDA-reviewed clinical trial that constitutes "research" as that term is defined in 45 C.F.R. § 46.102 and reasonably can be considered to be of interest to scientists or health care professionals working in the particular field of inquiry.
(3) "Clinical trial" means any study assessing the safety or efficacy of prescribed products administered alone or in combination with other prescribed products or other therapies, or assessing the relative safety or efficacy of prescribed products in comparison with other prescribed products or other therapies.
(4) "Free clinic" means a health care facility operated by a nonprofit private entity that:
(A) in providing health care, does not accept reimbursement from any third-party payor, including reimbursement from any insurance policy, health plan, or federal or state health benefits program that is individually determined;
(B) in providing health care, either:
(i) does not impose charges on patients to whom service is provided; or
(ii) imposes charges on patients according to their ability to pay;
(C) may accept patients' voluntary donations for health care service provision; and
(D) is licensed or certified to provide health services in accordance with Vermont law.
(5) "Gift" means:
(A) anything of value provided for free to a health care provider or to a member of the Green Mountain Care Board established in chapter 220 of this title; or
(B) except as otherwise provided in subdivision (a)(1)(A)(ii) of this section, any payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided to a health care provider or to a member of the Green Mountain Care Board established in chapter 220 of this title, unless:
(i) it is an allowable expenditure as defined in subdivision (a)(1) of this section; or
(ii) the health care provider or Board member reimburses the cost at fair market value.
(6) "Health benefit plan administrator" means the person or entity who sets formularies on behalf of an employer or health insurer.
(7)(A) "Health care professional" means:
(i) a person who is authorized by law to prescribe or to recommend prescribed products, who regularly practices in this state, and who either is licensed by this State to provide or is otherwise lawfully providing health care in this State; or
(ii) a partnership or corporation made up of the persons described in subdivision (i) of this subdivision (7)(A); or
(iii) an officer, employee, agent, or contractor of a person described in subdivision (i) of this subdivision (7)(A) who is acting in the course and scope of employment, of an agency, or of a contract related to or supportive of the provision of health care to individuals.
(B) The term shall not include a person described in subdivision (A) of this subdivision (7) who is employed solely by a manufacturer.
(C) "Regularly practices" means to practice at least periodically under contract with, as an employee of, or as the owner of, a medical practice, health care facility, nursing home, hospital, or university located in Vermont.
(8) "Health care provider" means a health care professional, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase for distribution prescribed products in this state. The term does not include a hospital foundation that is organized as a nonprofit entity separate from a hospital.
(9) "Manufacturer" means a pharmaceutical, biological product, or medical device manufacturer or any other person who is engaged in the production, preparation, propagation, compounding, processing, marketing, packaging, repacking, distributing, or labeling of prescribed products. The term does not include a wholesale distributor of biological products, a retailer, or a pharmacist licensed under 26 V.S.A. chapter 36. The term also does not include a manufacturer whose only prescribed products are classified as Class I by the U.S. Food and Drug Administration, are exempt from pre-market notification under Section 510(k) of the federal Food, Drug and Cosmetic Act, and are sold over-the-counter without a prescription.
(10) "Marketing" shall include promotion, detailing, or any activity that is intended to be used or is used to influence sales or market share or to evaluate the effectiveness of a professional sales force.
(11) "Pharmaceutical manufacturer" means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs, whether directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling, or distribution of prescription drugs. The term does not include a wholesale distributor of prescription drugs, a retailer, or a pharmacist licensed under 26 V.S.A. chapter 36.
(12) "Prescribed product" means a drug as defined in section 201 of the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321, a compound drug or drugs, a medical device as defined in this subsection, a biological product as defined in section 351 of the Public Health Service Act, 42 U.S.C. § 262, for human use, or a combination product as defined in 21 C.F.R. § 3.2(e), but shall not include prescription eyeglasses, prescription sunglasses, or other prescription eyewear.
(13) "Sample" means a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device. The term includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price. The term does not include prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded patient assistance program.
(14) "Significant educational, scientific, or policy-making conference or seminar" means an educational, scientific, or policy-making conference or seminar that:
(A) is accredited by the Accreditation Council for Continuing Medical Education or a comparable organization or is presented by an approved sponsor of continuing education, provided that the sponsor is not a manufacturer of prescribed products; and
(B) offers continuing education credit, features multiple presenters on scientific research, or is authorized by the sponsor to recommend or make policy.
(15) "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is:
(A) recognized in the official National Formulary or the United States Pharmacopeia, or any supplement to them;
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals; or
(C) intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on such body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
(b)(1) It is unlawful for any manufacturer of a prescribed product or any wholesale distributor of medical devices, or any agent thereof, to offer or give any gift to a health care provider or to a member of the Green Mountain Care Board established in chapter 220 of this title.
(2) The prohibition set forth in subdivision (1) of this subsection shall not apply to any of the following:
(A) Samples of a prescribed product or reasonable quantities of an over-the-counter drug, a nonprescription medical device, an item of nonprescription durable medical equipment, an item of medical food as defined in the federal Orphan Drug Act, as amended, 21 U.S.C. § 360ee(b)(3), or infant formula as defined in Section 201(z) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321, provided to a health care provider for free distribution to patients.
(B) The loan of a medical device for a short-term trial period, not to exceed 120 days, to permit evaluation of a medical device by a health care provider or patient.
(C) The provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.
(D) The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.
(E) Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.
(F) Rebates and discounts for prescribed products provided in the normal course of business.
(G) Labels approved by the federal Food and Drug Administration for prescribed products.
(H) The provision to a free clinic of financial donations or of free:
(i) prescription drugs;
(ii) over-the-counter drugs;
(iii) medical devices;
(iv) biological products;
(v) combination products;
(vi) medical food;
(vii) infant formula; or
(viii) medical equipment or supplies.
(I) Prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded Patient Assistance Program.
(J) Fellowship salary support provided to fellows through grants from manufacturers of prescribed products, provided:
(i) such grants are applied for by an academic institution or hospital;
(ii) the institution or hospital selects the recipient fellows;
(iii) the manufacturer imposes no further demands or limits on the institution's, hospital's, or fellow's use of the funds; and
(iv) fellowships are not named for a manufacturer and no individual recipient's fellowship is attributed to a particular manufacturer of prescribed products.
(K) The provision of coffee or other snacks or refreshments at a booth at a conference or seminar.
(c) Except as described in subdivisions (a)(1)(C) and (D) of this section, no manufacturer or other entity on behalf of a manufacturer shall provide any fee, payment, subsidy, or other economic benefit to a health care provider in connection with the provider's participation in research.
(d) The Attorney General may bring an action in the Civil Division of the Washington Unit of the Superior Court for injunctive relief, costs, and attorney's fees and may impose on a manufacturer that violates this section a civil penalty of no more than $10,000.00 per violation. Each unlawful gift shall constitute a separate violation. In any action brought pursuant to this section, the Attorney General shall have the same authority to investigate and to obtain remedies as if the action were brought under the Consumer Protection Act, 9 V.S.A. chapter 63. (Added 2009, No. 59, § 3; amended 2009, No. 128 (Adj. Sess.), § 32, eff. May 27, 2010; 2011, No. 48, § 3d; 2011, No. 51, § 1; 2011, 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012; 2011, No. 171 (Adj. Sess.), § 32a; 2013, No. 130 (Adj. Sess.), § 5a.)