reglab/housing_qa huggingface dataset:
18 V.S.A. § 4601
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4601. Definitions

§ 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.)
18 V.S.A. § 4606
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4606. Brand certification

§ 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.)
18 V.S.A. § 4607
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4607. Information; labeling

§ 4607. Information; labeling|(a) Every pharmacy in the State shall have posted a sign in a prominent place that is in clear unobstructed view which 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.)
18 V.S.A. § 4608
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4608. Liability

§ 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.)
18 V.S.A. § 4621
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4621. Definitions

§ 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.)
18 V.S.A. § 4622
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4622. Evidence-based education program

§ 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.)
18 V.S.A. § 4633
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4633. Pharmaceutical marketer price disclosure

§ 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.)
18 V.S.A. § 4634
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4634. Prescription drug price disclosure

§ 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.)
18 V.S.A. § 4636
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4636. Impact of prescription drug costs on health insurance premiums; report

§ 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.)
18 V.S.A. § 4637
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4637. Notice of introduction of new high-cost prescription drugs

§ 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.)
18 V.S.A. § 4651
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4651. Wholesale importation program for prescription drugs; design

§ 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.)
18 V.S.A. § 4652
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4652. Monitoring for anticompetitive behavior

§ 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.)
18 V.S.A. § 4653
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4653. Federal compliance

§ 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.)
18 V.S.A. § 4654
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4654. Program financing

§ 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.)
18 V.S.A. § 4655
2021 Vermont Statutes|Title 18 - Health|Chapter 91 - Prescription Drug Cost Containment|§ 4655. Implementation provisions

§ 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.)