AB355: Bill Text

AB355,7,11 49.45 (49) Prescription drug prior authorization committee. (a) The secretary shall exercise his or her authority under s. 15.04 (1) (c) to create a prescription drug prior authorization committee to do all of the following:

AB355,7,13 1. Advise the department on issues related to prior authorization decisions made concerning prescription drugs on behalf of Medical Assistance recipients.

AB355,7,15 2. Determine the relative clinical efficacy and safety of prescription drugs for the purpose of creating preferred drug lists as required under s. 49.69 (2).

AB355,7,17 (b) The secretary shall appoint as members of the prescription drug prior authorization committee at least the following:

AB355,7,18 1. Two physicians, as defined in s. 448.01 (5), who are currently in practice.

AB355,7,19 2. Two pharmacists, as defined in s. 450.01 (15).

AB355,7,22 3. One advocate for recipients of Medical Assistance who has sufficient medical background, as determined by the department, to evaluate the relative and clinical efficacy and safety of a prescription drug.

AB355,8,2 4. For the purpose of making determinations under s. 49.69 (2) regarding the relative clinical efficacy and safety of prescription drugs within a particular therapeutic class, persons who have medical expertise with respect to the disease or medical condition that the prescription drugs are intended to treat.

AB355,8,12 (c) A member of the prescription drug prior authorization committee may not be employed by or be a party to a contract with a manufacturer, as defined in s. 450.01 (12), a distributor, as defined in s. 450.01 (9), or a labeler, as defined in s. 49.69 (1) (d). Each committee member shall disclose any potential conflicts of interest related to an issue on which the committee acts and shall disclose the receipt of grant funding within the previous 36 months from a manufacturer, distributor, or labeler or ownership of stock in a manufacturer, distributor, or labeler. A member may not vote on an item if the member or the member's employer has a conflict of interest in the outcome of the vote. A member who may not vote on an item due to conflict of interest may participate in discussions related to the item.

AB355,8,17 (d) Notwithstanding the requirement under s. 15.04 (1) (c) that members of committees serve without compensation, members of the prescription drug prior authorization committee who are not officers or employees of this state shall be paid $100 for each day on which they are actually and necessarily engaged in performance of their duties.

AB355,8,22 (e) The prescription drug prior authorization committee shall accept information or commentary from representatives of the pharmaceutical manufacturing industry and from consumer advocates in the committee's review of prior authorization policies and in its determinations regarding the relative clinical efficacy and safety of prescription drugs.

AB355, s. 9 Section 9. 49.68 (3) (b) of the statutes is amended to read:

AB355,9,15 49.68 (3) (b) From the appropriation accounts under ss. 20.435 (4) (e) and, (je), and (jx) the state shall pay the cost of medical treatment required as a direct result of chronic renal disease of certified patients from the date of certification, including the cost of administering recombinant human erythropoietin to appropriate patients, whether the treatment is rendered in an approved facility in the state or in a dialysis or transplantation center which is approved as such by a contiguous state, subject to the conditions specified under par. (d). Approved facilities may include a hospital in-center dialysis unit or a nonhospital dialysis center which is closely affiliated with a home dialysis program supervised by an approved facility. Aid shall also be provided for all reasonable expenses incurred by a potential living-related donor, including evaluation, hospitalization, surgical costs and postoperative follow-up to the extent that these costs are not reimbursable under the federal medicare program or other insurance. In addition, all expenses incurred in the procurement, transportation, and preservation of cadaveric donor kidneys shall be covered to the extent that these costs are not otherwise reimbursable. All donor-related costs are chargeable to the recipient and reimbursable under this subsection.

AB355, s. 10 Section 10. 49.683 (2) of the statutes is amended to read:

AB355,9,18 49.683 (2) Approved costs for medical care under sub. (1) shall be paid from the appropriation accounts under s. 20.435 (4) (e) and, (je), and (jx).

AB355, s. 11 Section 11. 49.685 (2) of the statutes is amended to read:

AB355,9,25 49.685 (2) Assistance program. From the appropriation accounts under s. 20.435 (4) (e) and, (je), and (jx) the department shall establish a program of financial assistance to persons suffering from hemophilia and other related congenital bleeding disorders. The program shall assist such persons to purchase the blood derivatives and supplies necessary for home care. The program shall be administered through the comprehensive hemophilia treatment centers.

AB355, s. 12 Section 12. 49.688 (7) (a) of the statutes is amended to read:

AB355,10,18 49.688 (7) (a) Except as provided in par. (b), from the appropriation accounts under s. 20.435 (4) (bv) and, (j), beginning on September 1, 2002, and (jx) the department shall, under a schedule that is identical to that used by the department for payment of pharmacy provider claims under medical assistance, provide to pharmacies and pharmacists payments for prescription drugs sold by the pharmacies or pharmacists to persons eligible under sub. (2) who have paid the deductible specified under sub. (3) (b) 1. or 2. or who, under sub. (3) (b) 1., are not required to pay a deductible. The payment for each prescription drug under this paragraph shall be at the program payment rate, minus any copayment paid by the person under sub. (5) (a) 2. or 4., and plus, if applicable, incentive payments that are similar to those provided under s. 49.45 (8v). The department shall devise and distribute a claim form for use by pharmacies and pharmacists under this paragraph and may limit payment under this paragraph to those prescription drugs for which payment claims are submitted by pharmacists or pharmacies directly to the department. The department may apply to the program under this section the same utilization and cost control procedures that apply under rules promulgated by the department to medical assistance under subch. IV of ch. 49.

AB355, s. 13 Section 13. 49.69 of the statutes is created to read:

AB355,10,21 49.69 Preferred drug lists; prescription drug cost containment. (1) In this section:

AB355,10,23 (a) "Committee" means the prescription drug prior authorization committee created under s. 49.45 (49).

AB355,10,24 (b) "Generic name" has the meaning given in s. 450.12 (1) (b).

AB355,11,2 (c) "Health care coverage plan for government employees" means a health care coverage plan offered by the state or by a local governmental unit to its employees.

AB355,11,6 (d) "Labeler" means a person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale, and has a labeler code issued by the federal food and drug administration under 21 CFR 207.20 (b).

AB355,11,10 (e) "Local governmental unit" means a political subdivision of this state, a special purpose district in this state, an instrumentality or corporation of the political subdivision or special purpose district or a combination or subunit of any of the foregoing.

AB355,11,12 (f) "Manufacturer" means a person engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drugs.

AB355,11,14 (g) "Off-list prescription drug" means a prescription drug that is not included on the applicable preferred drug list created under sub. (4).

AB355,11,15 (h) "Practitioner" has the meaning given in s. 450.01 (17).

AB355,11,16 (i) "Prescription drug" has the meaning given in s. 450.01 (20).

AB355,11,18 (j) "Prescription Drug Assistance Program" means the program under s. 49.692.

AB355,11,22 (k) "Private health care coverage plan" means a health care coverage plan offered by a private employer to its employees or a health care coverage plan, other than a health care coverage plan for government employees, that is negotiated on behalf of a group of individuals who individually purchase coverage under the plan.

AB355,11,25 (L) "Single-source prescription drug" means a prescription drug that is produced or distributed under an original new drug application approved by the federal food and drug administration under 21 USC 355.

AB355,12,3 (m) "State-supported health care assistance program" means the Medical Assistance Program or the program under s. 49.665, 49.68, 49.683, 49.685, 49.688, or 146.93 or ch. 149.

AB355,12,6 (n) "Therapeutic class" means a class of prescription drugs that are intended to treat the same disease or medical condition by substantially similar biochemical and physiological mechanisms.

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.