Bill Summary – FastDemocracy

WEST VIRGINIA LEGISLATURE
REGULAR SESSION
                 Introduced House Bill 5682
                By Delegate Young [Introduced February 13, 2024; Referred to the Committee on Health and Human Resources then Government Organization]
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  A BILL to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section,
            designated §16-8C-1, §16-8C-2, §16-8C-3, §16-8C-4, §16-8C-5, §16-8C-6, §16-8C-7,
            §16-8C-8, §16-8C-9, §16-8C-10, §16-8C-11, §16-8C-12, §16-8C-13, §16-8C-14, §16-8C-
            15, and §16-8C-16 relating to establishing the West Virginia Prescription Drug Affordability
            Board, providing definitions, listing membership requirements for the board, creating the
            Prescription Drug Affordability Stakeholder Council and establishing requirements for
            membership on that council, establishing meeting requirements, prohibiting the
            acceptance of gratuities for the board and council members, requiring a study and report
            from the board and the council, outlining how data is to be collected, requiring a cost review
           of prescription drug products with affordability challenges, listing confidentiality
           requirements, providing for enforcement, establishing a fund, listing the process for setting
           upper payment limits for prescription drug products, listing eligible drug products, providing
           remedies, and listing all report requirements Be it enacted by the Legislature of West Virginia:
     ARTICLE 8C. WEST VIRGINIA PRESCRIPTION DRUG AFFORDABILITY BOARD.
     §16-8C-1.      West Virginia Prescription Drug Affordability Board established.
            The purpose of the board is to protect West Virginia residents, state and local
  governments, commercial health plans, health care providers, pharmacies licensed in the state,
  and other stakeholders within the health care system from the high costs of prescription drug
  products.
     §16-8C-2.                                                                                 Definitions.
            (a) In this subtitle the following words have the meanings indicated.
            (b) "Biologic" means a drug that is produced or distributed in accordance with a biologics
  license application approved under 42 C.F.R. § 447.502.
            (c) "Biosimilar" means a drug that is produced or distributed in accordance with a biologics
  license application approved under 42 U.S.C. § 262(k)(3).
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            (d) "Board" means the West Virginia Prescription Drug Affordability Board.
            (e)(1) "Brand name drug" means a drug that is produced or distributed in accordance with
  an original new drug application approved under 21 U.S.C. § 355(c).
            (2) "Brand name drug" does not include an authorized generic as defined by 42 C.F.R. §
 447.502.
           (f) "Generic drug" means:
           (1) A retail drug that is marketed or distributed in accordance with an abbreviated new drug
 application, approved under 21 U.S.C. § 355(j);
           (2) An authorized generic as defined by 42 C.F.R. § 447.502; or
           (3) A drug that entered the market before 1962 that was not originally marketed under a
 new drug application.
           (g) "Manufacturer" means an entity that:
           (1)(A) Engages in the manufacture of a prescription drug product; or
           (B) Enters into a lease with another manufacturer to market and distribute a prescription
 drug product under the entity's own name; and
           (2) Sets or changes the wholesale acquisition cost of the prescription drug product it
 manufactures or markets.
           (h) "Prescription drug product" means a brand name drug, a generic drug, a biologic, or a
 biosimilar.
           (i) "Stakeholder Council" means the Prescription Drug Affordability Stakeholder Council.
     §16-8C-3.                                       Board members.
            (a)(1) The board consists of the following members, who must have expertise in health
  care economics or clinical medicine:
            (A) One member appointed by the Governor;
            (B) One member appointed by the President of the Senate;
            (C) One member appointed by the Speaker of the House of Delegates;
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            (D) One member appointed by the Attorney General; and
            (E) One member appointed by the Insurance Commissioner.
            (2) The board shall have the following alternate members, who must have expertise in
  health care economics or clinical medicine and who shall be designated by the board chair to
 participate in deliberations of the board when a member is recused:
           (A) One alternate member appointed by the Governor;
           (B) One alternate member appointed by the President of the Senate; and
           (C) One alternate member appointed by the Speaker of the House of Delegates.
           (3) At least one member of the board shall have expertise in:
           (i) The 340B Program under the federal Public Health Service Act;
           (ii) The state's All-Payer Claims Database;
           (iii) How the program and contract interact; and
           (iv) How decisions made by the board will affect the model and contract.
           (4) A member or an alternate member may not be an employee of, a board member of, or a
 consultant to a manufacturer, pharmacy benefits manager, health insurance carrier, health
 maintenance organization, managed care organization, or wholesale distributor or related trade
 association.
           (5) Any conflict of interest, including whether the individual has an association, including a
 financial or personal association, that has the potential to bias or has the appearance of biasing an
 individual's decision in matters related to the board or the conduct of the board's activities, shall be
 considered and disclosed when appointing members and alternate members to the board.
           (6) To the extent practicable and consistent with federal and state law, the membership of
 the board shall reflect the racial, ethnic, and gender diversity of the state.
           (b)(1) The term of a member or an alternate member is five years.
           (2) The terms of the members and alternate members are staggered and will be
 implemented as follows:
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           (A) The first term of the member appointed by the Governor shall begin in 2024 and end in
 2026, with every other term being five years in length;
           (B) The first terms of the members appointed by the President of the Senate and the
 Speaker of the House shall begin in 2024 and end in 2027, with every subsequent term being five
 years in length;
           (C) The first term of the member appointed by the Attorney General shall begin in 2024 and
 end in 2028, with every other term being five years in length;
           (D) The first term of the member appointed by the Insurance Commissioner shall begin in
 2024 and shall be five years in length, as shall all subsequent terms.
           (E) The first terms of the alternates shall match those of the primary members appointed by
 the same government official.
           (c)(1) The chair shall hire an executive director and staff for the board.
           (2) The chair shall develop a five-year budget and staffing plan and submit it to the board
 for approval.
           (3) Staff of the board shall receive a salary as provided in the budget of the board.
           (d) A member of the board:
           (1) May receive compensation as a member of the board in accordance with the state
 budget; and
           (2) Is entitled to reimbursement for expenses under the reimbursement plans in effect at
 the Department of Health at that time.
           (e)(1) The board shall meet in open session at least four times a year.
           (A) At the chair's discretion, the chair may cancel or postpone a meeting.
           (B) The following actions by the board shall be made in open session:
           (i) The study required under §16-8C-7 of this code;
           (ii) Deliberations on whether to subject a prescription drug product to a cost review under §
 16-8C-8;
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           (iii) Any vote on whether to impose an upper payment limit on purchases and payor
 reimbursements of prescription drug products in the state; and
           (iv) Any decision by the board.
           (2) Notwithstanding the Open Meetings Act, the board may meet in closed session to
 discuss trade secrets or confidential and proprietary data and information. The board shall provide
 public notice of each board meeting in compliance with the Open Meetings Act, including notice of
 whether this is a public meeting.
           (3) Materials for each board meeting shall be made available to the public at least three
 days in advance of the meeting. Materials containing trade secrets or confidential and proprietary
 data or information that is not otherwise available to the public may not be made available to the
 public.
           (4) The board shall provide an opportunity for public comment at each open meeting of the
 board.
           (5) The board shall provide the public with the opportunity to provide written comments on
 pending decisions of the board.
           (6) The board may allow expert testimony at board meetings, including when the board
 meets in closed session.
           (7) To the extent practicable, the board shall access pricing information for prescription
 drug products by:
           (A) Entering into a memorandum of understanding with another state to which
 manufacturers already report pricing information; and
           (B) Accessing other available pricing information.
           (8) A majority of the members of the board constitutes a quorum.
           (9) Members of the board shall recuse themselves from decisions related to a prescription
 drug product if the member, or an immediate family member of the member, has received or could
 receive any of the following:
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            (A) A direct financial benefit of any amount deriving from the result or finding of a study or
  determination by or for the board; or
            (B) A financial benefit from any person that owns, manufactures, or provides prescription
  drug products, services, or items to be studied by the board that in the aggregate exceeds $5,000
  per year.
            (C) For the purposes of this section, a financial benefit includes honoraria, fees, stock, the
  value of the member's or immediate family member's stock holdings, and any direct financial
  benefit deriving from the finding of a review conducted under this subtitle.
            (f) In addition to the powers set forth elsewhere in this subtitle, the board may:
            (1) Adopt regulations to carry out the provisions of this subtitle; and
            (2) Enter into a contract with a qualified, independent third party for any service necessary
  to carry out the powers and duties of the board.
            (g) Unless permission is granted by the board, a third party hired by the board in
  accordance with subsection (f)(2) of this section may not release, publish, or otherwise use any
  information to which the third party has access under its contract.
            (h) The board is subject to the rules and policies of the Purchasing Division.
           (i) The Attorney General is the legal adviser to the board.
           (1) The Attorney General shall designate an assistant attorney general as counsel to the
 board.
           (2) As needed, the Attorney General may assign additional assistant attorneys general to
 the board to give effective legal advice and counsel.
           (3) The counsel to the board may not have a duty other than to:
           (i) Give the legal aid, advice, and counsel required by the board;
           (ii) Supervise the other assistant attorneys general assigned to the board, if any; and
           (iii) Perform for the board the duties that the Attorney General assigns.
           (4) The counsel shall perform these duties subject to the control and supervision of the
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 Attorney General.
           (5) After the Attorney General designates the counsel to the board, the Attorney General
 may not reassign the counsel without consulting the board.
      §16-8C-4.          Prescription Drug Affordability Stakeholder Council.
            (a) There is a Prescription Drug Affordability Stakeholder Council.
            (b) The purpose of the Stakeholder Council is to provide stakeholder input to assist the
  board in making decisions as required under this subtitle.
            (c) The Stakeholder Council consists of 26 members appointed in accordance with this
  subsection.
            (1) The Speaker of the House of Delegates shall appoint:
            (A) One representative of generic drug corporations;
            (B) One representative of nonprofit insurance carriers;
            (C) One representative of a statewide health care advocacy coalition;
            (D) One representative of a statewide advocacy organization for seniors;
           (E) One representative of a statewide organization for diverse communities;
            (F) One representative of a labor union;
            (G) One health services researcher specializing in prescription drugs; and
            (H) One public member at the discretion of the Speaker of the House of Delegates.
            (2) The President of the Senate shall appoint:
            (A) One representative of brand name drug corporations;
            (B) One representative of physicians;
            (C) One representative of nurses;
            (D) One representative of hospitals;
            (E) One representative of dentists;
            (F) One representative of managed care organizations;
            (G) One representative of pharmacists;
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           (H) One clinical researcher; and
           (I) One public member at the discretion of the President of the Senate.
           (3) The Governor shall appoint:
           (A) One representative of brand name drug corporations;
           (B) One representative of generic drug corporations;
           (C) One representative of biotechnology companies;
           (D) One representative of for-profit health insurance carriers;
           (E) One representative of employers;
           (F) One representative of pharmacy benefits managers;
           (G) One representative of the State Budget Office;
           (H) One pharmacologist; and
           (I) One public member at the discretion of the Governor.
           (4) Collectively, the members of the Stakeholder Council shall have knowledge of the
 following:
           (i) The pharmaceutical business model;
           (ii) Supply chain business models;
           (iii) The practice of medicine or clinical training;
           (iv) Consumer or patient perspectives;
           (v) Health care costs trends and drivers;
           (vi) Clinical and health services research; or
           (vii) The state's health care marketplace.
           (5) To the extent practicable and consistent with federal and state law, the membership of
 the Stakeholder Council shall reflect the racial, ethnic, and gender diversity of the state.
           (6) From among the membership of the Stakeholder Council, the board chair shall appoint
 two members to be cochairs of the Stakeholder Council.
           (d)(1) The term of a member is 3 years.
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           (2) The initial members of the Stakeholder Council shall serve staggered terms as follows:
           (A) The first term of the member appointed by the Governor shall begin in 2024 and end in
 2026, with every other term being five years in length;
           (B) The first terms of the members appointed by the President of the Senate shall begin in
 2024 and end in 2026, with every subsequent term being three years in length;
           (C) The first terms of the members appointed by the President of the Senate shall begin in
 2024 and end in 2026, with every subsequent term being three years in length;
           (D) The first terms of the members appointed by the Speaker of the House shall begin in
 2024 and end in 2025, with every subsequent term being three years in length;
           (e) A member of the Stakeholder Council:
           (1) May not receive compensation as a member of the Stakeholder Council; but
           (2) Is entitled to reimbursement travel in accordance with the state budget.
     §16-8C-5.               Disclosure of            conflicts of            interest.
            (a)(1) A conflict of interest shall be disclosed:
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