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ACT OF THE GENERAL ASSEMBLY 2007-2008

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NO. 89.  AN ACT RELATING TO PRESCRIPTION DRUG PRICING AND INFORMATION.

(H.750)

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1.  Sec. 15 of No. 80 of the Acts of 2007 is amended to read:

Sec. 15.  GENERIC DRUG VOUCHER PILOT PROJECT

(a)  As part of the evidence-based education program established in subchapter 2 of chapter 91 of Title 18, the department of health, in collaboration with the office of Vermont health access and the University of Vermont area health education centers program, shall establish a pilot project to distribute vouchers for a sample of generic drugs equivalent to frequently prescribed prescription drugs that are used to treat common health conditions. 

(b)  The office of Vermont health access shall fund the vouchers from the fee established in section 1998b 2004 of Title 33 and shall provide payment to the pharmacy dispensing the prescription drugs in exchange for the voucher.  The office shall establish a payment rate, including a dispensing fee, using the rules and procedures for the Medicaid program.

Sec. 2.  Sec. 15a of No. 80 of the Acts of 2007 is amended to read:

Sec. 15a.  GENERIC DRUG VOUCHER PILOT; REPORT

(a)  By January 15, 2009 2010, the office of Vermont health access, the department of banking, insurance, securities, and health care administration, the area health education centers, and the joint fiscal office shall provide a report to the house committee on health care and the senate committee on health and welfare describing and evaluating the effects of the generic drug voucher pilot program.

(b)  The report shall describe how the pilot project is implemented, including which health conditions were targeted, the generic drugs provided with the vouchers, and the geographic regions participating.  The report shall compare the distribution of prescribing among generic drugs provided through the vouchers and brand-name drugs before and after the first year of the generic drug sample pilot project and will review a year of prescribing data prior to the implementation of the pilot project to a year of prescribing data during the first year of the pilot project’s implementation.  The data shall be adjusted to reflect how and where the pilot was implemented.

Sec. 3.   18 V.S.A. § 4631 is amended to read:

§ 4631.  CONFIDENTIALITY OF PRESCRIPTION INFORMATION

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(b)  As used in this section:

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(9)  “Regulated records” means information or documentation from a prescription dispensed in Vermont and written by a prescriber doing business in Vermont or a prescription dispensed in Vermont.

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(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 may use regulated records which include prescription information shall not sell, license, or exchange for value regulated records containing prescriber‑identifiable data information, nor permit the use of regulated records containing prescriber-identifiable information for marketing or promoting a prescription drug only if:

(1)(A)  a prescriber has provided consent for the use of that data as provided in subsection (c) of this section; and

(B)  the entity using the regulated records complies with the disclosure requirements in subsection (f) of this section; or

(2)  the entity meets one of the exceptions provided in subsection (e) of this section, 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)  This The prohibitions set forth in subsection (d) of this section shall not apply to the following:

(1)  the sale, license, transfer, exchange for value, or use, or sale 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;

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(7)  the collection, use, transfer, or 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)  When a pharmaceutical marketer engages in any form of prescription drug marketing directly to a physician or other person authorized to prescribe prescription drugs as provided for under this section, the marketer shall disclose to the prescriber evidence-based information as provided for by rule describing the specific health benefits or risks of using other pharmaceutical drugs, including drugs available over the counter; which patients would gain from the health benefits or be susceptible to the risks described; the range of prescription drug treatment options; and the cost of the treatment options. As necessary, the office of Vermont health access, in consultation with the department of health, the area centers on health education, the office of professional regulation, and the office of the attorney general, shall develop rules for compliance with this subsection, including the certification of materials which are evidence-based as defined in section 4621 of this title and which conditions have evidence-based treatment guidelines.  The rules shall be consistent with the federal Food and Drug Administration's regulations regarding false and misleading advertising.  To the extent practicable, the rules shall use the evidence-based standards developed by the blueprint for health.

(g)  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 fraud act, chapter 63 of Title 9.  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.

Sec. 4.   33 V.S.A. § 2004 is amended to read:

§ 2004.  MANUFACTURER FEE

(a)  Annually, each pharmaceutical manufacturer or labeler of prescription drugs that are paid for by the office of Vermont health access for individuals participating in Medicaid, the Vermont Health Access Program, Dr.  Dynasaur, VPharm, or Vermont Rx shall pay a fee to the agency of human services.  The fee shall be 0.5 percent of the previous calendar year’s prescription drug spending by the office and shall be assessed based on manufacturer labeler codes as used in the Medicaid rebate program. 

(b)  Fees collected under this section shall fund collection and analysis of information on pharmaceutical marketing activities under sections 4632 and 4633 of Title 18, analysis of prescription drug data needed by the attorney general’s office for enforcement activities, and the evidence‑based education program established in subchapter 2 of chapter 91 of Title 18.  The fees shall be collected in the evidence‑based education and advertising fund established in section 2004a of this title.

(c)  The secretary of human services or designee shall make rules for the implementation of this section.

Sec. 5.  9 V.S.A. § 2466a is amended to read:

§ 2466a.  Consumer Protections; Prescription Drugs

(a)  A violation of section 4631 of Title 18 shall be considered a violation under this chapter prohibited practice under section 2453 of this title.

(b)  As provided in section 9473 of Title 18, a violation of section 9472 shall be considered a violation under this chapter prohibited practice under

section 2453 of this title.

(c)(1)  It shall be a violation under this chapter prohibited practice under

section 2453 of this title for a manufacturer of prescription drugs to present or cause to be presented in the state a regulated advertisement if that advertisement does not comply with the requirements concerning drugs and devices and prescription drug advertising in federal law and regulations under 21 United States Code, Sections 331 and 352(n) and 21 Code of Federal Regulations, Part 202 and state rules.  A warning or untitled letter issued by the U.S. Food and Drug Administration shall be prima facie evidence of a violation of federal law and regulations.

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Sec. 6.  18 V.S.A. § 9473(a) is amended to read:

(a)  Except as provided in subsection (d) of this section, in addition to any remedy available to the commissioner under this title and any other remedy provided by law, a violation of this subchapter shall be considered a violation of the Vermont consumer fraud act in subchapter 1 of chapter 63 of Title 1 9. Except as provided in subsection (d) of this section, all rights, authority, and remedies available to the attorney general and private parties to enforce the Vermont consumer fraud act shall be available to enforce the provisions of this subchapter.

Sec. 7.  EFFECTIVE DATES; PRESCRIPTION DRUG PRICING AND

             INFORMATION

(a)  This act shall take effect upon passage.

(b)  Notwithstanding the effective dates of this section and of No. 80 of the Acts of 2007, the provisions of Sec. 17 of No. 80 of the Acts of 2007 (adding 18 V.S.A. chapter 91, subchapter 3; prescription drug data confidentiality) and Sec. 21 of No. 80 of the Acts of 2007 (adding 9 V.S.A. § 2466a; consumer protection; prescription drugs) shall not be effective until July 1, 2009; except that the department of health and the office of professional regulation may, immediately upon passage, begin any necessary rulemaking, revision of forms, or other administrative actions necessary to implement the program established in 18 V.S.A. chapter 91, subchapter 3 on July 1, 2009.

Approved:  March 5, 2008



Published by:

The Vermont General Assembly
115 State Street
Montpelier, Vermont


www.leg.state.vt.us