The Vermont Statutes Online
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Title 18: Health
Chapter 091: Prescription Drug Cost Containment
- Subchapter 001: Generic Drugs
§ 4601. Definitions
As used in this chapter:
(1) “Biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition in human beings.
(2) “Brand name” means the registered trademark name given to a drug product by its manufacturer or distributor.
(3) “Generic drug” means a drug listed by generic name and considered to be chemically and therapeutically equivalent to a drug listed by brand name, as both names are identified in the most recent edition of or supplement to the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
(4) “Generic name” means the official name of a drug product as established by the U. S. Adopted Names Council (USAN) or its successor, if applicable.
(5) “Interchangeable biological product” means a biological product that the U.S. Food and Drug Administration has:
(A) licensed and determined, pursuant to 42 U.S.C. § 262(k)(4), to be interchangeable with the reference product against which it was evaluated as may be reflected in the U.S. Food and Drug Administration’s Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (the Purple Book); or
(B) determined to be therapeutically equivalent as set forth in the latest edition of or supplement to the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
(6) “Pharmacist” means a natural person licensed by the State Board of Pharmacy to prepare, compound, dispense, and sell drugs, medicines, chemicals, and poisons.
(7) “Prescriber” means any duly licensed physician, dentist, veterinarian, or other practitioner licensed to write prescriptions for the treatment or prevention of disease in man or animal.
(8) “Proper name” means the nonproprietary name of a biological product.
(9) “Reference product” means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which the interchangeable biological product was evaluated by the U.S. Food and Drug Administration pursuant to 42 U.S.C. § 262(k). (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2017, No. 193 (Adj. Sess.), § 1.)
§§ 4602-4604. Repealed. 2001, No. 63, § 124.
§ 4605. Alternative drug or biological product selection
(a)(1) When a pharmacist receives a prescription for a drug that is listed either by generic name or brand name in the most recent edition of or supplement to the U.S. Department of Health and Human Services’ publication Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) of approved drug products, the pharmacist shall select the lowest priced drug from the list that is equivalent as defined by the Orange Book, unless otherwise instructed by the prescriber, or by the purchaser if the purchaser agrees to pay any additional cost in excess of the benefits provided by the purchaser’s health benefit plan if allowed under the legal requirements applicable to the plan, or otherwise to pay the full cost for the higher-priced drug.
(2) When a pharmacist receives a prescription for a biological product, the pharmacist shall select the lowest-priced interchangeable biological product unless otherwise instructed by the prescriber, or by the purchaser if the purchaser agrees to pay any additional cost in excess of the benefits provided by the purchaser’s health benefit plan if allowed under the legal requirements applicable to the plan, or otherwise to pay the full cost for the higher priced biological product.
(3) Notwithstanding subdivisions (1) and (2) of this subsection, when a pharmacist receives a prescription from a Medicaid beneficiary, the pharmacist shall select the preferred brand-name or generic drug or biological product from the Department of Vermont Health Access’s preferred drug list.
(b) The purchaser shall be informed by the pharmacist or his or her representative that an alternative selection as provided under subsection (a) of this section will be made unless the purchaser agrees to pay any additional cost in excess of the benefits provided by the purchaser’s health benefit plan if allowed under the legal requirements applicable to the plan, or otherwise to pay the full cost for the higher-priced drug or biological product.
(c) When refilling a prescription, pharmacists shall receive the consent of the prescriber to dispense a drug or biological product different from that originally dispensed and shall inform the purchaser that a substitution shall be made pursuant to this section unless the purchaser agrees to pay any additional cost in excess of the benefits provided by the purchaser’s health benefit plan if allowed under the legal requirements applicable to the plan, or otherwise to pay the full cost for the higher-priced drug or biological product.
(d) Any pharmacist substituting a generically equivalent drug or interchangeable biological product shall charge no more than the usual and customary retail price for that selected drug or biological product. This charge shall not exceed the usual and customary retail price for the prescribed brand.
(e)(1) Except as described in subdivision (4) of this subsection, within five business days following the dispensing of a biological product, the dispensing pharmacist or designee shall communicate the specific biological product provided to the patient, including the biological product’s name and manufacturer, by submitting the information in a format that is accessible to the prescriber electronically through one of the following:
(A) an interoperable electronic medical records system;
(B) an electronic prescribing technology;
(C) a pharmacy benefit management system; or
(D) a pharmacy record.
(2) Entry into an electronic records system as described in subdivision (1) of this subsection shall be presumed to provide notice to the prescriber.
(3)(A) If a pharmacy does not have access to one or more of the electronic systems described in subdivision (1) of this subsection (e), the pharmacist or designee shall communicate to the prescriber the information regarding the biological product dispensed using telephone, facsimile, electronic transmission, or other prevailing means.
(B) If a prescription is communicated to the pharmacy by means other than electronic prescribing technology, the pharmacist or designee shall communicate to the prescriber the information regarding the biological product dispensed using the electronic process described in subdivision (1) of this subsection (e) unless the prescriber requests a different means of communication on the prescription.
(4) Notwithstanding any provision of this subsection to the contrary, a pharmacist shall not be required to communicate information regarding the biological product dispensed in the following circumstances:
(A) the U.S. Food and Drug Administration has not approved any interchangeable biological products for the product prescribed; or
(B) the pharmacist dispensed a refill prescription in which the product dispensed was unchanged from the product dispensed at the prior filling of the prescription.
(f) The Board of Pharmacy shall maintain a link on its website to the current lists of all biological products that the U.S. Food and Drug Administration has determined to be interchangeable biological products. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2005, No. 71, § 306, eff. June 21, 2005; 2009, No. 35, § 3; 2017, No. 193 (Adj. Sess.), § 2.)
§ 4606. Brand certification
If the prescriber has determined that the generic equivalent of a drug or the interchangeable biological product for the biological product being prescribed has not been effective or with reasonable certainty is not expected to be effective in treating the patient’s medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient, the prescriber shall indicate “brand necessary,” “no substitution,” “dispense as written,” or “DAW” in the prescriber’s own handwriting on the prescription blank or shall indicate the same using electronic prescribing technology and the pharmacist shall not substitute the generic equivalent or interchangeable biological product. If a prescription is unwritten and the prescriber has determined that the generic equivalent of the drug or the interchangeable biological product for the biological product being prescribed has not been effective or with reasonable certainty is not expected to be effective in treating the patient’s medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient, the prescriber shall expressly indicate to the pharmacist that the brand-name drug or biological product is necessary and substitution is not allowed and the pharmacist shall not substitute the generic equivalent drug or interchangeable biological product. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2009, No. 103 (Adj. Sess.), § 4; 2017, No. 193 (Adj. Sess.), § 3.)
§ 4607. Information; labeling
(a) Every pharmacy in the State shall have posted a sign in a prominent place that is in clear unobstructed view that shall read: “Vermont law requires pharmacists in some cases to select a less expensive generic equivalent drug or interchangeable biological product for the drug or biological product prescribed unless you or your physician direct otherwise. Ask your pharmacist.”
(b) The label of the container of all drugs and biological products dispensed by a pharmacist under this chapter shall indicate the generic or proper name using an abbreviation if necessary, the strength of the drug or biological product, if applicable, and the name or number of the manufacturer or distributor. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2001, No. 63, § 124; 2009, No. 103 (Adj. Sess.), § 5; 2017, No. 193 (Adj. Sess.), § 4.)
§ 4608. Liability
(a) Nothing in this chapter shall affect a licensed hospital with the development and maintenance of a hospital formulary system in accordance with that institution’s policies and procedures that pertain to its drug distribution system developed by the medical staff in cooperation with the hospital’s pharmacist and administration.
(b) The substitution of a generic drug or interchangeable biological product by a pharmacist under the provisions of this chapter does not constitute the practice of medicine. (Added 1977, No. 127 (Adj. Sess.), § 1; amended 2017, No. 193 (Adj. Sess.), § 5.)
- Subchapter 002: Evidence-Based Education Program
§ 4621. Definitions
Except as otherwise specified, for the purposes of this subchapter:
(1) “Department” means the Department of Health.
(2) “Evidence-based” means based on criteria and guidelines that reflect high-quality, cost-effective care. The methodology used to determine such guidelines shall meet recognized standards for systematic evaluation of all available research and shall be free from conflicts of interest. Consideration of the best available scientific evidence does not preclude consideration of experimental or investigational treatment or services under a clinical investigation approved by an institutional review board. (Added 2007, No. 80, § 14; amended 2009, No. 156 (Adj. Sess.), § I.21.)
§ 4622. Evidence-based education program
(a)(1) The Department of Health, in collaboration with the Attorney General, the University of Vermont area health education centers program, and the Department of Vermont Health Access, shall establish an evidence-based prescription drug education program for health care professionals designed to provide information and education on the therapeutic and cost-effective utilization of prescription drugs to physicians, pharmacists, and other health care professionals authorized to prescribe and dispense prescription drugs. To the extent practicable, the program shall use the evidence-based standards developed by the Blueprint for Health. The Department of Health may collaborate with other states in establishing this program.
(2) The program shall notify prescribers about commonly used brand-name drugs for which the patent has expired within the last 12 months or will expire within the next 12 months. The Departments of Health and of Vermont Health Access shall collaborate in issuing the notices.
(3) To the extent permitted by funding, the program may include population-based medication management.
(b) The Department of Health shall request information and collaboration from physicians, pharmacists, private insurers, hospitals, pharmacy benefit managers, the Drug Utilization Review Board, medical schools, the Attorney General, and any other programs providing an evidence-based education to prescribers on prescription drugs in developing and maintaining the program.
(c) The Department of Health may contract for technical and clinical support in the development and the administration of the program from entities conducting independent research into the effectiveness of prescription drugs.
(d) The Department of Health and the Attorney General shall collaborate in reviewing the marketing activities of pharmaceutical manufacturing companies in Vermont and determining appropriate funding sources for the program, including awards from suits brought by the Attorney General against pharmaceutical manufacturers. (Added 2007, No. 80, § 14; amended 2009, No. 156 (Adj. Sess.), § I.22; 2011, No. 63, § E.311.)
- Subchapter 003: Information Requirements
§ 4631. Confidentiality of prescription information
(a) It is the intent of the General Assembly to advance the State’s interest in protecting the public health of Vermonters, protecting the privacy of prescribers and prescribing information, and to ensure costs are contained in the private health care sector, as well as for State purchasers of prescription drugs, through the promotion of less costly drugs and ensuring prescribers receive unbiased information.
(b) As used in this section:
(1) “Electronic transmission intermediary” means an entity that provides the infrastructure that connects the computer systems or other electronic devices used by health care professionals, prescribers, pharmacies, health care facilities and pharmacy benefit managers, health insurers, third-party administrators, and agents and contractors of those persons in order to facilitate the secure transmission of an individual’s prescription drug order, refill, authorization request, claim, payment, or other prescription drug information.
(2) “Health care facility” shall have the same meaning as in section 9402 of this title.
(3) “Health care professional” shall have the same meaning as health care provider in section 9402 of this title.
(4) “Health insurer” shall have the same meaning as in section 9410 of this title.
(5) “Marketing” shall include advertising, promotion, or any activity that is intended to be used or is used to influence sales or the market share of a prescription drug, influence or evaluate the prescribing behavior of an individual health care professional to promote a prescription drug, market prescription drugs to patients, or evaluate the effectiveness of a professional pharmaceutical detailing sales force.
(6) “Pharmacy” means any individual or entity licensed or registered under 26 V.S.A. chapter 36.
(7) “Prescriber” means an individual allowed by law to prescribe and administer prescription drugs in the course of professional practice.
(8) “Promotion” or “promote” means any activity or product the intention of which is to advertise or publicize a prescription drug, including a brochure, media advertisement or announcement, poster, free sample, detailing visit, or personal appearance.
(9) “Regulated records” means information or documentation from a prescription dispensed in Vermont and written by a prescriber doing business in Vermont.
(c)(1) The Department of Health and the Office of Professional Regulation, in consultation with the appropriate licensing boards, shall establish a prescriber data-sharing program to allow a prescriber to give consent for his or her identifying information to be used for the purposes described under subsection (d) of this section. The Department and Office shall solicit the prescriber’s consent on licensing applications or renewal forms and shall provide a prescriber a method for revoking his or her consent. The Department and Office may establish rules for this program.
(2) The Department or Office shall make available the list of prescribers who have consented to sharing their information. Entities who wish to use the information as provided for in this section shall review the list at minimum every six months.
(d) A health insurer, a self-insured employer, an electronic transmission intermediary, a pharmacy, or other similar entity shall not sell, license, or exchange for value regulated records containing prescriber-identifiable information, nor permit the use of regulated records containing prescriber-identifiable information for marketing or promoting a prescription drug, unless the prescriber consents as provided in subsection (c) of this section. Pharmaceutical manufacturers and pharmaceutical marketers shall not use prescriber-identifiable information for marketing or promoting a prescription drug unless the prescriber consents as provided in subsection (c) of this section.
(e) The prohibitions set forth in subsection (d) of this section shall not apply to the following:
(1) the sale, license, exchange for value, or use of regulated records for the limited purposes of pharmacy reimbursement; prescription drug formulary compliance; patient care management; utilization review by a health care professional, the patient’s health insurer, or the agent of either; or health care research;
(2) the dispensing of prescription medications to a patient or to the patient’s authorized representative;
(3) the transmission of prescription information between an authorized prescriber and a licensed pharmacy, between licensed pharmacies, or that may occur in the event a pharmacy’s ownership is changed or transferred;
(4) care management educational communications provided to a patient about the patient’s health condition, adherence to a prescribed course of therapy, and other information relating to the drug being dispensed, treatment options, recall or patient safety notices, or clinical trials;
(5) the collection, use, or disclosure of prescription information or other regulatory activity as authorized by chapter 84, chapter 84A, or section 9410 of this title, or as otherwise provided by law;
(6) the collection and transmission of prescription information to a Vermont or federal law enforcement officer engaged in his or her official duties as otherwise provided by law; and
(7) the sale, license, exchange for value, or use of patient and prescriber data for marketing or promoting if the data do not identify a prescriber, and there is no reasonable basis to believe that the data provided could be used to identify a prescriber.
(f) In addition to any other remedy provided by law, the Attorney General may file an action in Superior Court for a violation of this section or of any rules adopted under this section by the Attorney General. The Attorney General shall have the same authority to investigate and to obtain remedies as if the action were brought under the Vermont Consumer Protection Act, 9 V.S.A. chapter 63. Each violation of this section or of any rules adopted under this section by the Attorney General constitutes a separate civil violation for which the Attorney General may obtain relief. (Added 2007, No. 80, § 17; amended 2007, No. 89 (Adj. Sess.), § 3, eff. March 5, 2008; 2009, No. 59, § 1; 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)
§ 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 that 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 subdivisions (1)(A)(ii) and (1)(H)(ii) of this subsection (a), 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 that 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 U.S. 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 that does not achieve its primary intended purposes through chemical action within or on such body and that 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 not 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, 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; 2015, No. 97 (Adj. Sess.), § 50a.)
§ 4632. Disclosure of allowable expenditures and gifts by manufacturers of prescribed products
(a)(1)(A) Annually on or before April 1 of each year, every manufacturer of prescribed products shall disclose to the Office of the Attorney General for the preceding calendar year the value, nature, purpose, and recipient information of any allowable expenditure or gift permitted under subdivision 4631a(b)(2) of this title to any health care provider or to a member of the Green Mountain Care Board established in chapter 220 of this title, except:
(i) Royalties and licensing fees as described in subdivision 4631a(a)(1)(F) of this title.
(ii) Rebates and discounts for prescribed products provided to health care providers in the normal course of business as described in subdivision 4631a(b)(2)(F) of this title.
(iii) Payments for clinical trials as described in subdivision 4631a(a)(1)(C) of this title, which shall be disclosed after the earlier of the date of the approval or clearance of the prescribed product by the Food and Drug Administration for the use for which the clinical trial is being conducted or four calendar years after the date the payment was made. For a clinical trial for which disclosure is delayed under this subdivision (iii), the manufacturer shall identify to the Attorney General the clinical trial, the start date, and the web link to the clinical trial registration on the national clinical trials registry.
(iv) Interview or health care expenses as described in subdivision 4631a(a)(1)(G) of this title.
(v) Coffee or other snacks or refreshments at a booth at a conference or seminar.
(vi) Loans of medical devices for short-term trial periods pursuant to subdivision 4631a(b)(2)(B) of this title, provided the loan results in the purchase, lease, or other comparable arrangement of the medical device after issuance of a certificate of need pursuant to chapter 221, subchapter 5 of this title.
(vii) Prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded patient assistance program.
(B) Annually on or before April 1 of each year, every manufacturer of prescribed products shall disclose to the Office of the Attorney General for the preceding calendar year, if the manufacturer is reporting other allowable expenditures or permitted gifts pursuant to subdivision (A) of this subdivision (a)(1), the product, dosage, number of units, and recipient information of over-the-counter drugs, nonprescription medical devices, items of nonprescription durable medical equipment, medical food, and infant formula provided to a health care provider for free distribution to patients pursuant to subdivision 4631a(b)(2)(A) of this title, provided that any public reporting of such information shall not include information that allows for the identification of individual recipients of such products or connects individual recipients with the monetary value of the products provided.
(C) Annually on or before April 1 of each year, every manufacturer of prescribed products shall disclose to the Office of the Attorney General for the preceding calendar year the value, nature, purpose, and recipient information of any allowable expenditure or gift to an academic institution; to a nonprofit hospital foundation; or to a professional, educational, or patient organization representing or serving health care providers or consumers located in or providing services in Vermont, except:
(i) Royalties and licensing fees as described in subdivision 4631a(a)(1)(F) of this title.
(ii) Rebates and discounts for prescribed products provided in the normal course of business as described in subdivision 4631a(b)(2)(F) of this title.
(iii) Payments for clinical trials as described in subdivision 4631a(a)(1)(C) of this title, which shall be disclosed after the earlier of the date of the approval or clearance of the prescribed product by the Food and Drug Administration for the use for which the clinical trial is being conducted or four calendar years after the date the payment was made. For a clinical trial for which disclosure is delayed under this subdivision (iii), the manufacturer shall identify to the Attorney General the clinical trial, the start date, and the web link to the clinical trial registration on the national clinical trials registry.
(D) Any public reporting of the provision of free prescription or over-the-counter drugs, medical devices, biological products, medical equipment, combination products, medical food, infant formula, or supplies to a free clinic shall not include information that allows for the identification of individual recipients of such products or that connects individual recipients with the monetary value of the products provided.
(2)(A)(i) Subject to the provisions of subdivision (B) of this subdivision (a)(2) and to the extent allowed under federal law, annually on or before April 1 of each year beginning in 2012, each manufacturer of prescribed products shall disclose to the Office of the Attorney General all samples provided to health care providers during the preceding calendar year, identifying for each sample the product, recipient, number of units, and dosage.
(ii) The Office of the Attorney General may contract with academic researchers to release to such researchers data relating to manufacturer distribution of samples, subject to confidentiality provisions and without including the names or license numbers of individual recipients, for analysis and aggregated public reporting.
(iii) Any public reporting of manufacturer distribution of samples shall not include information that allows for the identification of individual recipients of samples or connects individual recipients with the monetary value of the samples provided.
(B) Subdivision (A) of this subdivision (a)(2) shall not apply to samples of prescription drugs required to be reported under Sec. 6004 of the Patient Protection and Affordable Care Act of 2010, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, if the Office of the Attorney General determines that the U.S. Department of Health and Human Services will collect and report state- and recipient-specific information regarding manufacturer distribution of samples of such prescription drugs.
(3) Annually on or before April 1, each manufacturer of prescribed products also shall disclose to the Office of the Attorney General the name and address of the individual responsible for the manufacturer’s compliance with the provisions of this section.
(4) Disclosure shall be made on a form and in a manner prescribed by the Office of the Attorney General and shall require manufacturers of prescribed products to report each allowable expenditure or gift permitted under subdivision 4631a(b)(2) of this title, including:
(A) except as otherwise provided in subdivisions (1)(B) and (2) of this subsection (a), the value, nature, and purpose of each allowable expenditure and gift permitted under subdivision 4631a(b)(2) of this title according to specific categories identified by the Office of the Attorney General;
(B) the name of the recipient;
(C) the recipient’s address;
(D) the recipient’s institutional affiliation;
(E) prescribed product or products being marketed, if any; and
(F) the recipient’s State board number or, in the case of an institution, foundation, or organization, the federal tax identification number or the identification number assigned by the Attorney General.
(5) [Repealed.]
(6) Except as otherwise provided in subdivisions (1)(B) and (2)(A) of this subsection, the Office of the Attorney General shall make all disclosed data publicly available and searchable through an Internet website.
(7) [Repealed.]
(b)(1) Annually on or before April 1, the Office of the Attorney General shall collect a $500.00 fee from each manufacturer of prescribed products filing annual disclosures of expenditures greater than zero described in subsection (a) of this section.
(2) Fees collected under this section shall fund collection and analysis of information on activities related to the marketing of prescribed products under section 4631a of this title and under this section. The fees shall be collected in a special fund assigned to the Office.
(c) 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 to impose on a manufacturer of prescribed products that fails to disclose as required by subsection (a) of this section a civil penalty of no more than $10,000.00 per violation. Each unlawful failure to disclose 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.
(d) The terms used in this section shall have the same meanings as in section 4631a of this title. (Added 2001, No. 127 (Adj. Sess.), § 1, eff. June 13, 2002; amended 2003, No. 122 (Adj. Sess.), § 128b; 2005, No. 71, § 54a; 2005, No. 191 (Adj. Sess.), § 45; 2007, No. 80, §§ 3, 4; 2009, No. 59, § 4; 2009, No. 128 (Adj. Sess.), § 33; 2009, No. 156 (Adj. Sess.), § I.23; 2011, No. 48, § 3e; 2011, No. 51, § 2, eff. Jan. 1, 2012; 2011, No. 171 (Adj. Sess.), § 32b; 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.), § 41(f), eff. May 16, 2012; 2015, No. 131 (Adj. Sess.), § 12; 2021, No. 73, § 15.)
§ 4633. Pharmaceutical marketer price disclosure
(a) When a pharmaceutical marketer engages in any form of prescription drug marketing directly to a physician or other person authorized to prescribe prescription drugs, the marketer shall disclose to the physician or other prescriber the average wholesale price (AWP) of the drugs being marketed. Disclosure shall include the AWP per pill and the price relationship between the drug being marketed and other drugs within the same therapeutic class.
(b) The disclosures required under this section shall be on a form and in a manner prescribed by the Office of the Attorney General. The Attorney General may adopt rules to implement the provisions of this section.
(c) In addition to any other remedy provided by law, the Attorney General after consultation with the Commissioner of Financial Regulation may file an action in Superior Court for a violation of this section or of rules adopted under this section. In any such action, 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. Each violation of this section or of rules adopted under this section constitutes a separate civil violation for which the Attorney General may obtain relief.
(d) As used in this section:
(1) “Average wholesale price” or “AWP” means the wholesale price charged on a specific commodity that is assigned by the pharmaceutical manufacturing company and listed in a nationally recognized drug pricing file.
(2) “Pharmaceutical manufacturing company” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(3) “Pharmaceutical marketer” means a person who, while employed by or under contract to represent a pharmaceutical manufacturing company, engages in marketing as that term is defined in section 4631a of this title. (Added 2003, No. 122 (Adj. Sess.), § 128c; amended 2007, No. 80, § 5; 2009, No. 59, § 6; 2011, No. 78 (Adj. Sess.), § 2, eff. April 2, 2012; 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)
§ 4634. Prescription drug price disclosure
(a) Upon request, a pharmacy shall disclose to any consumer or health care provider the usual and customary retail price of a prescription drug.
(b) With each prescription dispensed, a pharmacy shall disclose to the consumer, in writing, the price of the prescription and any payment toward the price required of the consumer.
(c) For purposes of this section:
(1) “Price of the prescription” means the amount charged by the pharmacy to the consumer or, if applicable, to the consumer’s health benefit plan.
(2) “Usual and customary retail price” means the total price charged to a consumer who does not have prescription drug coverage under a health benefit plan.
(d) In addition to any other remedy provided by law, the Attorney General may file an action in Superior Court for a violation of this section. In any such action, 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. Each violation of this section constitutes a separate civil violation for which the Attorney General may obtain relief. (Added 2003, No. 122 (Adj. Sess.), § 128a; amended 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)
§ 4635. Prescription drug cost transparency
(a) As used in this section:
(1) “Manufacturer” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(2) “Prescription drug” means a drug as defined in 21 U.S.C. § 321.
(b)(1)(A) The Department of Vermont Health Access shall create annually a list of 10 prescription drugs on which the State spends significant health care dollars and for which the wholesale acquisition cost has increased by 50 percent or more over the past five years or by 15 percent or more during the previous calendar year, creating a substantial public interest in understanding the development of the drugs’ pricing. The list shall include at least one generic and one brand-name drug and shall indicate each of the drugs on the list that the Department considers to be specialty drugs. The Department shall include the percentage of the wholesale acquisition cost increase for each drug on the list; rank the drugs on the list from those with the largest increase in wholesale acquisition cost to those with the smallest increase; indicate whether each drug was included on the list based on its cost increase over the past five years or during the previous calendar year, or both; and provide the Department’s total expenditure for each drug on the list during the most recent calendar year.
(B) The Department of Vermont Health Access shall create annually a list of 10 prescription drugs on which the State spends significant health care dollars and for which the cost to the Department of Vermont Health Access, net of rebates and other price concessions, has increased by 50 percent or more over the past five years or by 15 percent or more during the previous calendar year, creating a substantial public interest in understanding the development of the drugs’ pricing. The list shall include at least one generic and one brand-name drug and shall indicate each of the drugs on the list that the Department considers to be specialty drugs. The Department shall rank the drugs on the list from those with the greatest increase in net cost to those with the smallest increase and indicate whether each drug was included on the list based on its cost increase over the past five years or during the previous calendar year, or both.
(C)(i) Each health insurer with more than 5,000 covered lives in this State for major medical health insurance shall create annually a list of 10 prescription drugs on which its health insurance plans spend significant amounts of their premium dollars and for which the cost to the plans, net of rebates and other price concessions, has increased by 50 percent or more over the past five years or by 15 percent or more during the previous calendar year, or both, creating a substantial public interest in understanding the development of the drugs’ pricing. The list shall include at least one generic and one brand-name drug and shall indicate each of the drugs on the list that the health insurer considers to be specialty drugs. The health insurer shall rank the drugs on the list from those with the greatest increase in net cost to those with the smallest increase and indicate whether each drug was included on the list based on its cost increase over the past five years or during the previous calendar year, or both.
(ii) Each health insurer creating a list pursuant to subdivision (i) of this subdivision (b)(1)(C) shall provide to the Office of the Attorney General the percentage by which the net cost to its plans increased over the applicable period or periods for each drug on the list, as well as the insurer’s total expenditure, net of rebates and other price concessions, for each drug on the list during the most recent calendar year. Information provided to the Office of the Attorney General pursuant to this subdivision (b)(1)(C)(ii) is exempt from public inspection and copying under the Public Records Act and shall not be released.
(2) The Department of Vermont Health Access and the health insurers shall provide to the Office of the Attorney General and the Green Mountain Care Board the lists of prescription drugs developed pursuant to subdivisions (1)(A), (B), and (C)(i) of this subsection annually on or before June 1. The Office of the Attorney General and the Green Mountain Care Board shall make all of the information available to the public on their respective websites.
(c)(1)(A) Of the prescription drugs listed by the Department of Vermont Health Access and the health insurers pursuant to subdivisions (b)(1)(B) and (C) of this section, the Office of the Attorney General shall identify 15 drugs as follows:
(i) of the drugs appearing on more than one payer’s list, the Office of the Attorney General shall identify the top 15 drugs on which the greatest amount of money was spent across all payers during the previous calendar year, to the extent information is available; and
(ii) if fewer than 15 drugs appear on more than one payer’s list, the Office of the Attorney General shall rank the remaining drugs based on the amount of money spent by any one payer during the previous calendar year, in descending order, and select as many of the drugs at the top of the list as necessary to reach a total of 15 drugs.
(B) For the 15 drugs identified by the Office of the Attorney General pursuant to subdivision (A) of this subdivision (1), the Office of the Attorney General shall require the manufacturer of each such drug to provide all of the following:
(i) Justification for the increase in the net cost of the drug to the Department of Vermont Health Access, to one or more health insurers, or both, which shall be provided to the Office of the Attorney General in a format that the Office of the Attorney General determines to be understandable and appropriate and shall be provided in accordance with a timeline specified by the Office of the Attorney General. The manufacturer shall submit to the Office of the Attorney General all relevant information and supporting documentation necessary to justify the manufacturer’s net cost increase to the Department of Vermont Health Access, to one or more health insurers, or both during the identified period of time, including:
(I) each factor that specifically caused the net cost increase to the Department of Vermont Health Access, to one or more health insurers, or both during the specified period of time;
(II) the percentage of the total cost increase attributable to each factor; and
(III) an explanation of the role of each factor in contributing to the cost increase.
(ii) A separate version of the information submitted pursuant to subdivision (i) of this subdivision (1)(B), which shall be made available to the public by the Office of the Attorney General and the Green Mountain Care Board pursuant to subsection (d) of this section. In the event that the manufacturer believes it necessary to redact certain information in the public version as proprietary or confidential, the manufacturer shall provide an explanation for each such redaction to the Office of the Attorney General. The information, format, and any redactions shall be subject to approval by the Office of the Attorney General.
(iii) Additional information in response to all requests for such information by the Office of the Attorney General.
(2) Nothing in this section shall be construed to restrict the legal ability of a prescription drug manufacturer to change prices to the extent permitted under federal law.
(d)(1) The Attorney General shall provide a report to the General Assembly on or before December 1 of each year based on the information received from manufacturers pursuant to this section. The Attorney General shall post the report and the public version of each manufacturer’s information submitted pursuant to subdivision (c)(1)(B)(ii) of this section on the Office of the Attorney General’s website.
(2) The Green Mountain Care Board shall post on its website the report prepared by the Attorney General pursuant to subdivision (1) of this subsection and the public version of each manufacturer’s information submitted pursuant to subdivision (c)(1)(B)(ii) of this section, and may inform the public of the availability of the report and the manufacturers’ justification information.
(e) Information provided to the Office of the Attorney General pursuant to subdivision (c)(1)(B) of this section is exempt from public inspection and copying under the Public Records Act and shall not be released in a manner that allows for the identification of an individual drug or manufacturer or that is likely to compromise the financial, competitive, or proprietary nature of the information, except for the information prepared for release to the public pursuant to subdivision (c)(1)(B)(ii) of this section.
(f) The Attorney General may bring an action in the Civil Division of the Superior Court, Washington County for injunctive relief, costs, and attorney’s fees, and to impose on a manufacturer that fails to provide any of the information required by subsection (c) of this section, in the format requested by the Office of the Attorney General and in accordance with the timeline specified by the Office of the Attorney General, a civil penalty of not more than $10,000.00 per violation. Each unlawful failure to provide information 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 2015, No. 165 (Adj. Sess.), § 2, eff. June 2, 2016; amended 2017, No. 193 (Adj. Sess.), § 9, eff. May 30, 2018.)
§ 4636. Impact of prescription drug costs on health insurance premiums; report
(a)(1) Each health insurer with more than 1,000 covered lives in this State for major medical health insurance shall report to the Green Mountain Care Board for all covered prescription drugs, including generic drugs, brand-name drugs, and specialty drugs provided in an outpatient setting or sold in a retail setting:
(A) the 25 most frequently prescribed drugs and the average wholesale price for each drug;
(B) the 25 most costly drugs by total plan spending and the average wholesale price for each drug; and
(C) the 25 drugs with the highest year-over-year price increases and the average wholesale price for each drug.
(2) A health insurer shall not be required to provide to the Green Mountain Care Board the actual price paid, net of rebates, for any prescription drug.
(b) The Green Mountain Care Board shall compile the information reported pursuant to subsection (a) of this section into a consumer-friendly report that demonstrates the overall impact of drug costs on health insurance premiums. The data in the report shall be aggregated and shall not reveal information as specific to a particular health benefit plan.
(c) The Board shall publish the report required pursuant to subsection (b) of this section on its website on or before January 1 of each year. (Added 2017, No. 193 (Adj. Sess.), § 8, eff. May 30, 2018.)
§ 4637. Notice of introduction of new high-cost prescription drugs
(a) As used in this section:
(1) “Manufacturer” shall have the same meaning as “pharmaceutical manufacturer” in section 4631a of this title.
(2) “Prescription drug” means a drug as defined in 21 U.S.C. § 321.
(b) A prescription drug manufacturer shall notify the Office of the Attorney General in writing if it is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program. The manufacturer shall provide the written notice within three calendar days following the release of the drug in the commercial market. A manufacturer may make the notification pending approval by the U.S. Food and Drug Administration (FDA) if commercial availability is expected within three calendar days following the approval.
(c) Not later than 30 calendar days following notification pursuant to subsection (b) of this section, the manufacturer shall provide all of the following information to the Office of the Attorney General in a format that the Office prescribes:
(1) a description of the marketing and pricing plans used in the launch of the new drug in the United States and internationally;
(2) the estimated volume of patients who may be prescribed the drug;
(3) whether the drug was granted breakthrough therapy designation or priority review by the FDA prior to final approval; and
(4) the date and price of acquisition if the drug was not developed by the manufacturer.
(d) The manufacturer may limit the information reported pursuant to subsection (c) of this section to that which is otherwise in the public domain or publicly available.
(e) The Office of the Attorney General shall publish on its website at least quarterly the information reported to it pursuant to this section. The information shall be published in a manner that identifies the information that is disclosed on a per-drug basis and shall not be aggregated in a manner that would not allow identification of the drug.
(f) The Attorney General may bring an action in the Civil Division of the Superior Court, Washington County for injunctive relief, costs, and attorney’s fees and to impose on a manufacturer that fails to provide the information required by subsection (c) of this section a civil penalty of not more than $1,000.00 per day for every day after the notification period described in subsection (b) of this section that the required information is not reported. 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 2017, No. 193 (Adj. Sess.), § 10, eff. May 30, 2018.)
- Subchapter 004: Wholesale Prescription Drug Importation Program
§ 4651. Wholesale importation program for prescription drugs; design
(a) The Agency of Human Services, in consultation with interested stakeholders and appropriate federal officials, shall design a wholesale prescription drug importation program that complies with the applicable requirements of 21 U.S.C. § 384, including the requirements regarding safety and cost savings. The program design shall:
(1) designate a State agency that shall either become a licensed drug wholesaler or contract with a licensed drug wholesaler in order to seek federal certification and approval to import safe prescription drugs and provide significant prescription drug cost savings to Vermont consumers;
(2) use Canadian prescription drug suppliers regulated under the laws of Canada or of one or more Canadian provinces, or both;
(3) ensure that only prescription drugs meeting the U.S. Food and Drug Administration’s safety, effectiveness, and other standards shall be imported by or on behalf of the State;
(4) import only those prescription drugs expected to generate substantial savings for Vermont consumers;
(5) ensure that the program complies with the tracking and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the extent feasible and practical prior to imported drugs coming into the possession of the State wholesaler and that it complies fully after imported drugs are in the possession of the State wholesaler;
(6) prohibit the distribution, dispensing, or sale of imported products outside Vermont’s borders;
(7) recommend a charge per prescription or another method of support to ensure that the program is funded adequately in a manner that does not jeopardize significant consumer savings; and
(8) include a robust audit function.
(b) On or before January 1, 2019, the Secretary of Human Services shall submit the proposed design for a wholesale prescription drug importation program to the House Committees on Health Care and on Ways and Means and the Senate Committees on Health and Welfare and on Finance. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
§ 4652. Monitoring for anticompetitive behavior
The Agency of Human Services shall consult with the Office of the Attorney General to identify the potential, and to monitor, for anticompetitive behavior in industries that would be affected by a wholesale prescription drug importation program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
§ 4653. Federal compliance
(a) On or before July 1, 2020, the Agency of Human Services shall submit a formal request to the Secretary of the U.S. Department of Health and Human Services for certification of the State’s wholesale prescription drug importation program.
(b) The Agency of Human Services shall seek the appropriate federal approvals, waivers, exemptions, or agreements, or a combination thereof, as needed to enable all covered entities enrolled in or eligible for the federal 340B Drug Pricing Program to participate in the State’s wholesale prescription drug importation program to the fullest extent possible without jeopardizing their eligibility for the 340B Program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018; amended 2019, No. 72, § E.300.5.)
§ 4654. Program financing
The Agency of Human Services shall not implement the wholesale prescription drug importation program until the General Assembly enacts legislation establishing a charge per prescription or another method of financial support for the program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
§ 4655. Implementation provisions
Upon the last to occur of the General Assembly enacting a method of financial support pursuant to section 4654 of this chapter and receipt of certification and approval by the Secretary of the U.S. Department of Health and Human Services, the Agency of Human Services shall begin implementation of the wholesale prescription drug importation program and shall begin operating the program within six months. As part of the implementation process, the Agency of Human Services shall, in accordance with State procurement and contract laws, rules, and procedures as appropriate:
(1) become licensed as a wholesaler or enter into a contract with a Vermont-licensed wholesaler;
(2) contract with one or more Vermont-licensed distributors;
(3) contract with one or more licensed and regulated Canadian suppliers;
(4) engage with health insurance plans, employers, pharmacies, health care providers, and consumers;
(5) develop a registration process for health insurance plans, pharmacies, and prescription drug-administering health care providers who are willing to participate in the program;
(6) create a publicly available source for listing the prices of imported prescription drug products that shall be made available to all participating entities and consumers;
(7) create an outreach and marketing plan to generate program awareness;
(8) starting in the weeks before the program becomes operational, create and staff a hotline to answer questions and address the needs of consumers, employers, health insurance plans, pharmacies, health care providers, and other affected sectors;
(9) establish the audit function and a two-year audit work-plan cycle; and
(10) conduct any other activities that the Agency determines to be important for successful implementation of the program. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
§ 4656. Annual reporting
(a) Annually on or before January 15, the Agency of Human Services shall report to the House Committees on Health Care and on Ways and Means and the Senate Committees on Health and Welfare and on Finance regarding the operation of the wholesale prescription drug importation program during the previous calendar year, including:
(1) which prescription drugs were included in the wholesale importation program;
(2) the number of participating pharmacies, health care providers, and health insurance plans;
(3) the number of prescriptions dispensed through the program;
(4) the estimated savings to consumers, health plans, employers, and the State during the previous calendar year and to date;
(5) information regarding implementation of the audit plan and audit findings; and
(6) any other information the Secretary of Human Services deems relevant.
(b) The provisions of 2 V.S.A. § 20(d) (expiration of required reports) shall not apply to the report to be made under this section. (Added 2017, No. 133 (Adj. Sess.), § 1, eff. May 21, 2018.)
- Subchapter 005: Unused Drug Repository Program
§ 4671. Creation of program
The Agency of Human Services may contract or enter into agreements with qualified entities as needed to create and administer an unused drug repository program for the collection and distribution of unused drugs in Vermont, to the extent that funds are appropriated or otherwise made available for this purpose. (Added 2023, No. 61, § 1, eff. July 1, 2023.)
§ 4672. Agency of Human Services; rulemaking
The Agency of Human Services shall adopt rules for the administration of the program, including rules regarding:
(1) donations to the program, which may include donations from institutional settings in Vermont, such as pharmacies, long-term care facilities, Veterans’ Administration facilities, correctional facilities, hospitals, and other facilities, as well as donations from individuals;
(2) what types of drugs may be donated to the program;
(3) safety criteria for donated drugs, which may include packaging requirements and inspections; and
(4) patient eligibility to receive drugs from the program, which shall be available to any patient, with priority given to patients who meet one or more of the following criteria:
(A) patients whose household income is below 400 percent of the federal poverty level;
(B) patients who are uninsured;
(C) patients who are underinsured;
(D) patients who are Medicare beneficiaries and are experiencing a coverage gap in their Medicare prescription drug coverage; and
(E) patients who are on a high-deductible health plan or on a plan with high co-payment requirements for prescription drugs, or both. (Added 2023, No. 61, § 1, eff. July 1, 2023.)
§ 4673. Limitations on liability
Except in cases of bad faith, gross negligence, intentional misconduct, or noncompliance with the rules adopted pursuant to section 4672 of this chapter, the following persons shall not be subject to civil or criminal liability or professional disciplinary action for participating in or otherwise complying with the program established by this subchapter or rules adopted pursuant to this subchapter:
(1) a person who donates or gives drugs to an eligible recipient, including a drug manufacturer; wholesaler; reverse distributor pharmacy; third-party logistics provider; governmental entity; hospital or other health care facility, as defined in section 9432 of this title; or long-term care facility licensed under 33 V.S.A. chapter 71;
(2) an eligible recipient, as defined by the Agency by rule pursuant to subdivision 4672(4) of this chapter;
(3) a health care provider, as defined in section 9402 of this title, who prescribes or dispenses a donated drug;
(4) an intermediary that helps administer the program by facilitating the donation or transfer of drugs to eligible recipients;
(5) a manufacturer or repackager of a donated drug; and
(6) any employee, volunteer, trainee, or other staff of any person listed in subdivisions (1)–(5) of this section. (Added 2023, No. 61, § 1, eff. July 1, 2023.)
