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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;
(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; 2023, No. 85 (Adj. Sess.), § 50, eff. July 1, 2024.)
§ 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
$765.00 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; 2025, No. 27, § E.200.2, eff. July 1, 2025.)
§ 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.)