AB355: Bill Text

AB355,12,12 (2) (a) By January 1, 2004, the committee shall determine the relative clinical efficacy and safety of the prescription drugs within each therapeutic class. The committee shall conduct an evidence-based analysis to determine the relative clinical efficacy and safety, including a review of relevant literature. The committee shall periodically review and amend its determinations of relative clinical efficacy and safety.

AB355,12,16 (b) Notwithstanding par. (a), the committee may adopt determinations of relative clinical efficacy and safety made by a similar governmental entity in another state, if the other entity uses standards for determining clinical efficacy and safety that are similar to the standards adopted by the committee.

AB355,12,21 (c) The committee shall make a determination regarding the relative clinical efficacy and safety of a new single-source prescription drug within 60 days after it is approved by the federal food and drug administration or, if the committee does not receive sufficient information to make a determination within 60 days after approval, within 60 days after receiving such information.

AB355,13,4 (3) (a) The department shall solicit bids or proposals from manufacturers and labelers to provide rebates on prescription drugs that are purchased under state-supported health care assistance programs. Any rebate offered by a manufacturer or labeler in response to a solicitation under this paragraph shall be in addition to any rebate that the manufacturer or labeler provides under 42 USC 1396r-8 and in addition to any rebate required under state law or provided under an agreement between the state and a manufacturer or labeler that is in effect on the effective date of the solicitation.

AB355,13,9 (b) Subject to sub. (8), the department shall solicit bids or proposals from manufacturers and labelers to provide rebates on prescription drugs that are purchased under the Prescription Drug Assistance Program, under health care coverage plans for government employees, or under private health care coverage plans.

AB355,13,11 (c) The department may join with similar governmental entities in other states to solicit rebates under this subsection.

AB355,13,13 (4) (a) Using the method prescribed under par. (b) the department shall create the following 2 preferred drug lists:

AB355,13,14 1. One preferred drug list for state-supported health care assistance programs.

AB355,13,17 2. A 2nd preferred drug list for the Prescription Drug Assistance Program, health care coverage plans for government employees, and private health care coverage plans.

AB355,13,24 (b) The department shall consider the relative clinical efficacy and safety and the cost of each prescription drug in a therapeutic class, and place the most cost-effective prescription drug or drugs in the class on a preferred drug list. In determining cost under this paragraph, the department shall consider any rebate offered under sub. (3) (a) or (b), whichever is applicable, any existing rebate agreement or requirement, dosing practices, and any other relevant cost information.

AB355,14,8 (c) Notwithstanding par. (b), the department shall include all prescription drugs that the committee determines are clinically effective and safe for treating acquired immunodeficiency syndrome or the human immunodeficiency virus on both preferred drug lists created under this subsection. The department shall also include all prescription drugs that bear generic names on the preferred drug lists unless the prescription drugs that bear generic names are unreasonably priced compared to other prescription drugs within a therapeutic class that are selected for a preferred drug list.

AB355,14,13 (5) By July 1, 2004, the department shall enter into agreements with the manufacturers or labelers of the prescription drugs on the preferred drug list under sub. (4) (a) 1. to pay the state the rebates proposed under sub. (3) (a) on prescription drugs that are purchased under state-supported health care assistance programs on or after July 1, 2004.

AB355,14,17 (6) (a) Subject to sub. (8), the department shall enter into agreements with the manufacturers or labelers of prescription drugs on the preferred drug list under sub. (4) (a) 2. to pay the rebates proposed under sub. (3) (b) on prescription drugs that are purchased under the following programs or plans:

AB355,14,18 1. The Prescription Drug Assistance Program.

AB355,14,20 2. Health care coverage plans offered by the state to state employees who are not subject to collective bargaining.

AB355,14,24 3. Health care coverage plans offered by the state to state employees who are subject to collective bargaining, if the employees agree through collective bargaining to subject their health care coverage to policies that encourage use of the preferred drug list under sub. (4) (a) 2.

AB355,15,4 4. Health care coverage plans offered by a local governmental unit to employees of the local governmental unit who are subject to collective bargaining, if the employees agree through collective bargaining to subject their health care coverage to policies that encourage use of the preferred drug list under sub. (4) (a) 2.

AB355,15,8 5. Health care coverage plans offered by a local governmental unit to its employees who are not subject to collective bargaining or private health care coverage plans, if the department approves the plan, or the employment contract that provides for the plan under par. (b).

AB355,15,14 (b) An entity that purchases or negotiates health insurance coverage for employees of a local governmental unit or that purchases or negotiates a private health care coverage plan may apply to the department to approve a health care coverage plan, or an employment contract that provides for health care coverage. The department shall approve the plan or contract if it includes policies to encourage use of the preferred drug list under sub. (4) (a) 2.

AB355,15,16 (c) For purposes of this section, all of the following constitute policies to encourage use of the preferred drug list under sub. (4) (a) 2.:

AB355,15,17 1. Prior authorization for off-list prescription drugs.

AB355,15,19 2. Higher copayments for off-list prescription drugs than for drugs that are on the preferred drug list.

AB355,15,21 3. Education for practitioners who prescribe off-list prescription drugs without medical justification.

AB355,16,2 (d) The department shall charge entities that receive rebates under par. (a) 4. or 5. a fee to support the administrative costs of creating and maintaining the preferred drug lists under sub. (4). The department shall promulgate rules establishing the method for determining the amount of the fee. All fees collected under this paragraph shall be credited to the appropriation account under s. 20.435 (4) (jt).

AB355,16,5 (e) Manufacturers and labelers shall pay rebates under par. (a) 1., 2., and 3., to the state, and shall pay rebates under par. (a) 4. and 5. to the entity designated by the department.

AB355,16,12 (7) All rebates paid to the state under subs. (5) and (6) (a) 1., 2., and 3. shall be credited to the appropriation account under s. 20.435 (4) (jx). The department shall calculate the amount of rebates earned on prescription drugs purchased under each of the state-supported health care assistance programs, under the Prescription Drug Assistance Program, and under health care coverage plans for state employees, and shall allocate the amount earned under each program or plan for that program or plan.

AB355,16,15 (8) The department shall determine when to cover each of the programs or plans under sub. (6) (a) 1., 2., 3., 4., and 5. in solicitations under sub. (3) (b) and in agreements under sub. (6) (a).

AB355,16,18 (9) (a) By July 1, 2004, the department shall implement at least one of the following prescription drug cost containment measures using the preferred drug list created under sub. (4) (a) 1.:

AB355,17,5 1. The department may require practitioners to obtain prior authorization from the department or its fiscal agent for any off-list prescription drug purchased under a state-supported health care assistance program and may prohibit reimbursement of pharmacists, pharmacies, or any other provider for any off-list prescription drug purchased under a state-supported health care assistance program for which prior authorization is not obtained. If the department requires prior authorization under this subdivision, and a practitioner requests prior authorization for an off-list prescription drug, the department or its fiscal agent shall respond to the request by telephone or other telecommunication means within 24 hours after the request is received. In an emergency situation, the department shall reimburse a pharmacy or pharmacist for at least a 7-day supply of a prescription without prior authorization.

AB355,17,11 2. The department may monitor the purchase of prescription drugs under state-supported health care assistance programs to identify practitioners who routinely prescribe off-list prescription drugs without medical justification and request that the medical examining board, board of nursing, or dentistry examining board, whichever is applicable, investigate and, if appropriate, require education for such practitioners under s. 441.16 (7), 447.08, or 448.075, whichever is applicable.

AB355,17,17 (b) The department may monitor the purchase of prescription drugs under the Prescription Drug Assistance Program to identify practitioners who routinely prescribe off-list prescription drugs without medical justification and request that the medical examining board, board of nursing, or dentistry examining board, whichever is applicable, investigate and, if appropriate, require education for such practitioners under s. 441.16 (7), 447.08, or 448.075, whichever is applicable.

AB355,17,20 (10) (a) The department may enter into a contract with an entity to perform the duties and exercise the powers of the department, other than promulgation of rules, under subs. (3), (4), (5), and (6).

AB355,17,25 (b) The department may not contract under this subsection with an entity if the entity, its parent company, or its subsidiary has any direct or indirect financial interest in sales of a particular prescription drug. The department shall require an entity to disclose all such financial interests before the department contracts with the entity under this subsection.

AB355,18,3 (c) An entity that enters into a contract with the department under this subsection, or a parent company or subsidiary of that entity, may not incur a financial interest in sales of a particular prescription drug during the term of the contract.

AB355,18,6 (d) The department shall periodically audit any entity with which it contracts under this subsection to determine whether the entity, its parent company, or a subsidiary has any financial interests that are prohibited under this subsection.

AB355, s. 14 Section 14. 49.692 of the statutes is created to read:

AB355,18,8 49.692 Prescription drug assistance. (1) In this section:

AB355,18,9 (a) "Labeler" has the meaning given in s. 49.69 (1) (d).

AB355,18,10 (b) "Manufacturer" has the meaning given in s. 49.69 (1) (f).

AB355,18,14 (c) "Participating pharmacy or pharmacist" means a person who is licensed as a pharmacy or pharmacist in any state and who agrees to sell prescription drugs to a person who has a prescription drug card issued under sub. (3) for the amount provided under sub. (5).

AB355,18,15 (d) "Prescription drug" has the meaning given in s. 450.01 (20).

AB355,18,16 (e) "Prescription order" has the meaning given in s. 450.01 (21).

AB355,18,17 (f) "State" has the meaning given in s. 441.50 (2) (m).

AB355,18,20 (2) (a) A person to whom all of the following applies is eligible to purchase prescription drugs from a participating pharmacy or pharmacist for the amount provided under sub. (5):

AB355,18,21 1. The person is a resident, as defined in s. 27.01 (10) (a), of this state.

AB355,19,2 2. The person is not a recipient of Medical Assistance, does not have health care coverage under s. 49.665, does not have a policy issued under ch. 149, is not enrolled in the program under s. 49.688, and does not have insurance coverage for prescription drugs for outpatient care, except that a person who receives benefits under 42 USC 1395 to 1395ccc may have supplemental health insurance that covers prescription drugs for outpatient care.

AB355,19,5 (b) A person may apply to the department, on a form provided by the department, for a determination of eligibility and issuance of a prescription drug card for purchase of prescription drugs under this section.

AB355,19,10 (3) The department shall devise and distribute a form for applying for the program under sub. (2), shall determine eligibility for each 12-month benefit period of applicants, and, after payment by the applicant of a program enrollment fee for each 12-month benefit period, shall issue to eligible persons a prescription drug card for use in purchasing prescription drugs, as provided under this section.

AB355,19,12 (4) The department shall set maximum prices and a maximum dispensing fee for prescription drugs purchased under this section.

AB355,19,18 (5) Beginning September 1, 2004, a participating pharmacy or pharmacist may not charge a person who presents a valid prescription order and a prescription drug card issued under sub. (3) more than the maximum price established by the department under sub. (4) for a prescription drug, less any rebate amount agreed to under s. 49.69 (6) (a) 1., plus the maximum dispensing fee established by the department under sub. (4).

AB355,19,23 (6) From the appropriation account under s. 20.435 (4) (jx) and (8) (mb), the department shall reimburse participating pharmacies and pharmacists the applicable rebate amounts specified in agreements under s. 49.69 (6) (a) 1., if any, for each prescription drug that the pharmacy or pharmacist sells to a person who has a prescription drug card issued under sub. (3).

AB355,19,24 (7) The department shall promulgate rules establishing the following:

AB355,20,2 (a) The method for determining the maximum retail price for a prescription drug.

AB355,20,3 (b) The method for determining the maximum dispensing fee.

AB355,20,5 (c) The method for informing participating pharmacies and pharmacists of the maximum prices, dispensing fees, and rebate amounts for prescription drugs.

AB355,20,7 (d) The process by which a participating pharmacy or pharmacist may claim reimbursement for rebates.

AB355,20,10 (e) The process for resolving discrepancies between the rebate amount claimed by a participating pharmacy or pharmacist and the amount paid by a manufacturer or labeler.

AB355, s. 15 Section 15 . 49.692 (6) of the statutes, as created by 2003 Wisconsin Act .... (this act), is amended to read:

AB355,20,17 49.692 (6) From the appropriation account under s. 20.435 (4) (jx) and (8) (mb), the department shall reimburse participating pharmacies and pharmacists the applicable rebate amounts specified in agreements under s. 49.69 (6) (a) 1., if any, for each prescription drug that the pharmacy or pharmacist sells to a person who has a prescription drug card issued under sub. (3).

AB355, s. 16 Section 16. 146.93 (1) (a) of the statutes is amended to read:

AB355,20,23 146.93 (1) (a) From the appropriation appropriation accounts under s. 20.435 (4) (gp) and (jx), the department shall maintain a program for the provision of primary health care services based on the primary health care program in existence on June 30, 1987. The department may promulgate rules necessary to implement the program.

AB355, s. 17 Section 17. 149.14 (4c) (c) of the statutes is created to read:

AB355,21,7 149.14 (4c) (c) The department or an entity with which the department contracts shall provide to a drug manufacturer that sells drugs for prescribed use in this state documents designed for use by the manufacturer in entering into a rebate agreement with the department or entity that is modeled on the rebate agreement specified under 42 USC 1396r-8. The department or entity may enter into a rebate agreement under this paragraph that shall include all of the following as requirements:

AB355,21,14 1. That, as a condition of coverage for prescription drugs of a manufacturer under this section other than prescription drugs that are prescribed for the treatment of acquired immunodeficiency syndrome or human immunodeficiency virus, the manufacturer shall make rebate payments for each prescription drug of the manufacturer, that is prescribed for and purchased by an eligible person, to the state treasurer to be credited to the appropriation account under s. 20.435 (4) (jh), each calendar quarter or according to a schedule established by the department.

AB355,21,16 2. That the amount of the rebate payment shall be determined by a method specified in 42 USC 1396r-8 (c).

AB355, s. 18 Section 18. 149.143 (1) (a) of the statutes is amended to read:

AB355,21,20 149.143 (1) (a) First from the moneys transferred to the fund from the appropriation account under s. 20.435 (4) (af) and from the moneys appropriated for the health insurance risk-sharing plan under s. 20.435 (4) (jh) and (jx).

AB355, s. 19 Section 19. 441.16 (7) of the statutes is created to read:

AB355,22,7 441.16 (7) Upon the request of the department of health and family services, the board shall investigate an advanced practice nurse to determine whether the advanced practice nurse routinely prescribes prescription drugs that are not on the applicable preferred drug list established under s. 49.69 to beneficiaries of state-supported health care assistance programs, as defined in s. 49.69 (1) (m), or to persons enrolled in the prescription drug assistance program under s. 49.692, without medical justification. If the board determines that an advanced practice nurse routinely prescribes drugs that are not on the applicable preferred drug list without medical justification, the board shall require the advanced practice nurse to complete the preferred drug list education program under s. 448.075 (2) at the earliest possible opportunity.

AB355, s. 20 Section 20. 447.08 of the statutes is created to read:

AB355,22,18 447.08 Preferred drug list compliance. Upon the request of the department of health and family services, the board shall investigate a dentist to determine whether the dentist routinely prescribes prescription drugs that are not on the applicable preferred drug list established under s. 49.69 to beneficiaries of state-supported health care assistance programs, as defined in s. 49.69 (1) (m), or to persons enrolled in the Prescription Drug Assistance Program under s. 49.692, without medical justification. If the board determines that a dentist routinely prescribes drugs that are not on the applicable preferred drug list without medical justification, the board shall require the dentist to complete the preferred drug list education program under s. 448.075 (2) at the earliest possible opportunity.

AB355, s. 21 Section 21. 448.075 of the statutes is created to read:

AB355,23,6 448.075 Preferred drug list compliance. (1) Upon the request of the department of health and family services, the board shall investigate a physician or physician assistant to determine whether the physician or physician assistant routinely prescribes prescription drugs that are not on the applicable preferred drug list established under s. 49.69 to beneficiaries of state-supported health care assistance programs, as defined in s. 49.69 (1) (m), or to persons enrolled in the Prescription Drug Assistance Program under s. 49.692, without medical justification. If the board determines that a physician or physician assistant routinely prescribes drugs that are not on the applicable preferred drug list without medical justification, the board shall require the physician or physician assistant to complete the preferred drug list education program under sub. (2) at the earliest possible opportunity.

AB355,23,16 (2) The department of regulation and licensing shall develop an education program on the preferred drug lists created under s. 49.69 for practitioners, as defined in s. 450.01 (17). The department of regulation and licensing shall consult with the department of health and family services in developing the education program and shall present the education program both as a class and in visits to practitioners' offices. The department of regulation and licensing shall charge practitioners who are required under sub. (1) or s. 441.16 (7) or 447.08 to participate in the education program to pay a fee to cover the cost of the class or office visit. All fees collected under this subsection shall be credited to the appropriation account under s. 20.435 (4) (jt).

AB355, s. 22 Section 22. 450.02 (2) of the statutes is renumbered 450.02 (2) (intro.) and amended to read:

AB355,23,20 450.02 (2) (intro.) The board shall adopt rules defining promulgate all of the following rules, which apply to all applicants for licensure under s. 450.05:

AB355,23,22 (a) Defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05.

AB355, s. 23 Section 23. 450.02 (2) (b) of the statutes is created to read:

AB355,24,2 450.02 (2) (b) Requiring disclosure by a pharmacist to a prescription drug purchaser who has a card issued under s. 49.692 (3) of the amount of the discount on the retail price of the prescription drug that is provided to the purchaser as a result of the program under s. 49.692.

AB355, s. 24 Section 24. 450.075 of the statutes is created to read:

AB355,24,4 450.075 Manufacturer gift reporting. (1) In this section:

AB355,24,5 (a) "Health benefit plan" has the meaning given in s. 632.745 (11).

AB355,24,6 (b) "Hospital" means a facility approved as a hospital under s. 50.35.

AB355,24,7 (c) "Nursing home" has the meaning given in s. 50.01 (3).

AB355,24,12 (2) (a) Except as provided in par. (c), each person who engages in manufacturing shall annually report to the board the value, nature, and purpose of any gift, payment, subsidy, or other economic benefit valued at $25 or more that the person directly or indirectly provides to any of the following in connection with the person's promotional or marketing activities:

AB355,24,13 1. A practitioner.

AB355,24,14 2. A pharmacist or an owner or operator of a pharmacy.

AB355,24,17 3. A hospital, nursing home, or organization that offers a health benefit plan, or an employee of a hospital, nursing home, or organization that offers a health benefit plan.

AB355,24,19 4. Any other person authorized to purchase prescription drugs for retail or wholesale resale.