This is the preview version of the Wisconsin State Legislature site.
Please see http://docs.legis.wisconsin.gov for the production version.
AB50-ASA2-AA16,59,97(e) Other prescription drug products, including drugs to address public health
8emergencies, that may create affordability challenges for the health care system
9and patients in this state.
AB50-ASA2-AA16,59,1410(2) Affordability review. (a) After identifying prescription drug products
11under sub. (1), the board shall determine whether to conduct an affordability
12review for each identified prescription drug product by seeking stakeholder input
13about the prescription drug product and considering the average patient cost share
14of the prescription drug product.
AB50-ASA2-AA16,59,2015(b) The information used to conduct an affordability review under par. (a) may
16include any document and research related to the manufacturers selection of the
17introductory price or price increase of the prescription drug product, including life
18cycle management, net average price in this state, market competition and context,
19projected revenue, and the estimated value or cost-effectiveness of the prescription
20drug product.
AB50-ASA2-AA16,59,2321(c) The failure of a manufacturer to provide the board with information for an
22affordability review under par. (b) does not affect the authority of the board to
23conduct the review.
AB50-ASA2-AA16,60,8
1(3) Affordability challenge. When conducting an affordability review of a
2prescription drug product under sub. (2), the board shall determine whether use of
3the prescription drug product that is fully consistent with the labeling approved by
4the federal food and drug administration or standard medical practice has led or
5will lead to an affordability challenge for the health care system in this state,
6including high out-of-pocket costs for patients. To the extent practicable, in
7determining whether a prescription drug product has led or will lead to an
8affordability challenge, the board shall consider all of the following factors:
AB50-ASA2-AA16,60,109(a) The wholesale acquisition cost for the prescription drug product sold in
10this state.
AB50-ASA2-AA16,60,1411(b) The average monetary price concession, discount, or rebate the
12manufacturer provides, or is expected to provide, to health plans in this state as
13reported by manufacturers and health plans, expressed as a percentage of the
14wholesale acquisition cost for the prescription drug product under review.
AB50-ASA2-AA16,60,1815(c) The total amount of the price concessions, discounts, and rebates the
16manufacturer provides to each pharmacy benefit manager for the prescription drug
17product under review, as reported by the manufacturer and pharmacy benefit
18manager and expressed as a percentage of the wholesale acquisition cost.
AB50-ASA2-AA16,60,2019(d) The price at which therapeutic alternatives to the prescription drug
20product have been sold in this state.
AB50-ASA2-AA16,60,2321(e) The average monetary concession, discount, or rebate the manufacturer
22provides or is expected to provide to health plan payors and pharmacy benefit
23managers in this state for therapeutic alternatives to the prescription drug product.
AB50-ASA2-AA16,61,3
1(f) The costs to health plans based on patient access consistent with labeled
2indications by the federal food and drug administration and recognized standard
3medical practice.
AB50-ASA2-AA16,61,54(g) The impact on patient access resulting from the cost of the prescription
5drug product relative to insurance benefit design.
AB50-ASA2-AA16,61,76(h) The current or expected dollar value of drug-specific patient access
7programs that are supported by the manufacturer.
AB50-ASA2-AA16,61,108(i) The relative financial impacts to health, medical, or social services costs
9that can be quantified and compared to baseline effects of existing therapeutic
10alternatives to the prescription drug product.
AB50-ASA2-AA16,61,1211(j) The average patient copay or other cost sharing for the prescription drug
12product in this state.
AB50-ASA2-AA16,61,1313(k) Any information a manufacturer chooses to provide.
AB50-ASA2-AA16,61,1414(L) Any other factors as determined by the board by rule.
AB50-ASA2-AA16,61,1815(4) Upper payment limit. (a) If the board determines under sub. (3) that use
16of a prescription drug product has led or will lead to an affordability challenge, the
17board shall establish an upper payment limit for the prescription drug product after
18considering all of the following:
AB50-ASA2-AA16,61,19191. The cost of administering the drug.
AB50-ASA2-AA16,61,20202. The cost of delivering the drug to consumers.
AB50-ASA2-AA16,61,21213. Other relevant administrative costs related to the drug.
AB50-ASA2-AA16,62,422(b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board
23shall solicit information from the manufacturer regarding the price increase. To

1the extent that the price increase is not a result of the need for increased
2manufacturing capacity or other effort to improve patient access during a public
3health emergency, the board shall establish an upper payment limit under par. (a)
4that is equal to the cost to consumers prior to the price increase.
AB50-ASA2-AA16,62,85(c) 1. The upper payment limit established under this subsection shall apply
6to all purchases and payor reimbursements of the prescription drug product
7dispensed or administered to individuals in this state in person, by mail, or by other
8means.
AB50-ASA2-AA16,62,1992. Notwithstanding subd. 1., while state-sponsored and state-regulated
10health plans and health programs shall limit drug reimbursements and drug
11payment to no more than the upper payment limit established under this
12subsection, a plan subject to the Employee Retirement Income Security Act of 1974
13or Part D of Medicare under 42 USC 1395w-101 et seq. may choose to reimburse
14more than the upper payment limit. A provider who dispenses and administers a
15prescription drug product in this state to an individual in this state may not bill a
16payor more than the upper payment limit to the patient regardless of whether a
17plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
18Medicare under 42 USC 1395w-101 et seq. chooses to reimburse the provider above
19the upper payment limit.
AB50-ASA2-AA16,62,2120(5) Public inspection. Information submitted to the board under this
21section shall be open to public inspection only as provided under ss. 19.31 to 19.39.
AB50-ASA2-AA16,63,222(6) No prohibition on marketing. Nothing in this section may be construed
23to prevent a manufacturer from marketing a prescription drug product approved by

1the federal food and drug administration while the prescription drug product is
2under review by the board.
AB50-ASA2-AA16,63,73(7) Appeals. A person aggrieved by a decision of the board may request an
4appeal of the decision no later than 30 days after the board makes the
5determination. The board shall hear the appeal and make a final decision no later
6than 60 days after the appeal is requested. A person aggrieved by a final decision of
7the board may petition for judicial review in a court of competent jurisdiction.
AB50-ASA2-AA16,91238Section 9123. Nonstatutory provisions; Insurance.
AB50-ASA2-AA16,63,159(1) Staggered terms for prescription drug affordability review board.
10Notwithstanding the length of terms specified for the members of the prescription
11drug affordability review board under s. 15.735 (1) (b) to (e), 2 of the initial
12members shall be appointed for terms expiring on May 1, 2027; 2 of the initial
13members shall be appointed for terms expiring on May 1, 2028; 2 of the initial
14members shall be appointed for terms expiring on May 1, 2029; and 2 of the initial
15members shall be appointed for terms expiring on May 1, 2030.
AB50-ASA2-AA16,942316Section 9423. Effective dates; Insurance.
AB50-ASA2-AA16,63,2017(1) Prescription drug affordability review board. The treatment of ss.
1815.07 (3) (bm) 7., 15.735, 601.78, 601.785, and 601.79 and subch. VI (title) of ch. 601
19and Section 9123 (1) of this act take effect on the first day of the 7th month
20beginning after publication..
AB50-ASA2-AA16,63,212122. At the appropriate places, insert all of the following:
AB50-ASA2-AA16,63,2222Section 71. 632.869 of the statutes is created to read:
AB50-ASA2-AA16,64,2
1632.869 Reimbursement to federal drug pricing program
2participants. (1) In this section:
AB50-ASA2-AA16,64,73(a) Covered entity means an entity described in 42 USC 256b (a) (4) (A), (D),
4(E), (J), or (N) that participates in the federal drug pricing program under 42 USC
5256b, a pharmacy of the entity, or a pharmacy contracted with the entity to
6dispense drugs purchased through the federal drug pricing program under 42 USC
7256b.
AB50-ASA2-AA16,64,88(b) Pharmacy benefit manager has the meaning given in s. 632.865 (1) (c).
AB50-ASA2-AA16,64,109(2) No person, including a pharmacy benefit manager or 3rd-party payer, may
10do any of the following:
AB50-ASA2-AA16,64,1411(a) Reimburse a covered entity for a drug that is subject to an agreement
12under 42 USC 256b at a rate lower than that paid for the same drug to pharmacies
13that are not covered entities and have a similar prescription volume to that of the
14covered entity.
AB50-ASA2-AA16,64,1715(b) Assess a covered entity any fee, charge back, or other adjustment on the
16basis of the covered entitys participation in the federal drug pricing program under
1742 USC 256b.
AB50-ASA2-AA16,64,2018(3) The commissioner may promulgate rules to implement this section and to
19establish minimum reimbursement rates for covered entities and any other entity
20described under 42 USC 256b (a) (4)..
AB50-ASA2-AA16,64,212123. At the appropriate places, insert all of the following:
AB50-ASA2-AA16,64,2222Section 72. 601.31 (1) (nw) of the statutes is created to read:
AB50-ASA2-AA16,65,223601.31 (1) (nw) For issuing or renewing a license as a pharmacy services

1administrative organization under s. 632.864, an amount to be set by the
2commissioner by rule.
AB50-ASA2-AA16,733Section 73. 632.864 of the statutes is created to read:
AB50-ASA2-AA16,65,54632.864 Pharmacy services administrative organizations. (1)
5Definitions. In this section:
AB50-ASA2-AA16,65,66(a) Administrative service means any of the following:
AB50-ASA2-AA16,65,771. Assisting with claims.
AB50-ASA2-AA16,65,882. Assisting with audits.
AB50-ASA2-AA16,65,993. Providing centralized payment.
AB50-ASA2-AA16,65,10104. Performing certification in a specialized care program.
AB50-ASA2-AA16,65,11115. Providing compliance support.
AB50-ASA2-AA16,65,12126. Setting flat fees for generic drugs.
AB50-ASA2-AA16,65,13137. Assisting with store layout.
AB50-ASA2-AA16,65,14148. Managing inventory.
AB50-ASA2-AA16,65,15159. Providing marketing support.
AB50-ASA2-AA16,65,171610. Providing management and analysis of payment and drug dispensing
17data.
AB50-ASA2-AA16,65,181811. Providing resources for retail cash cards.
AB50-ASA2-AA16,65,2119(b) Independent pharmacy means a pharmacy operating in this state that is
20licensed under s. 450.06 or 450.065 and is under common ownership with no more
21than 2 other pharmacies.
AB50-ASA2-AA16,65,2222(c) Pharmacy benefit manager has the meaning given in s. 632.865 (1) (c).
AB50-ASA2-AA16,66,2
1(d) Pharmacy services administrative organization means an entity
2operating in this state that does all of the following:
AB50-ASA2-AA16,66,431. Contracts with an independent pharmacy to conduct business with a 3rd-
4party payer on the independent pharmacys behalf.
AB50-ASA2-AA16,66,752. Provides at least one administrative service to an independent pharmacy
6and negotiates and enters into a contract with a 3rd-party payer or pharmacy
7benefit manager on behalf of the independent pharmacy.
AB50-ASA2-AA16,66,108(e) Third-party payer means an entity, including a plan sponsor, health
9maintenance organization, or insurer, operating in this state that pays or insures
10health, medical, or prescription drug expenses on behalf of beneficiaries.
AB50-ASA2-AA16,66,1711(2) Licensure. (a) Beginning on the first day of the 12th month beginning
12after the effective date of this paragraph .... [LRB inserts date], no person may
13operate as a pharmacy services administrative organization without being licensed
14by the commissioner as a pharmacy services administrative organization under this
15subsection. In order to obtain a license under this paragraph, the person shall
16apply to the commissioner in the form and manner prescribed by the commissioner.
17The application for licensure under this paragraph shall include all of the following:
AB50-ASA2-AA16,66,19181. The name, address, telephone number, and federal employer identification
19number of the applicant.
AB50-ASA2-AA16,66,21202. The name, business address, and telephone number of a contact person for
21the applicant.
AB50-ASA2-AA16,66,22223. The fee under s. 601.31 (1) (nw).
AB50-ASA2-AA16,66,23234. Evidence of financial responsibility of at least $1,000,000.
AB50-ASA2-AA16,67,1
15. Any other information required by the commissioner.
AB50-ASA2-AA16,67,32(b) The term of a license issued under par. (a) shall be 2 years from the date of
3issuance.
AB50-ASA2-AA16,67,84(c) A license issued under par. (a) may be renewed. Renewal applications shall
5be submitted to the commissioner on a form provided by the commissioner and shall
6include all the items described in par. (a) 1. to 5. A renewal application under this
7paragraph may not be submitted more than 90 days prior to the end of the term of
8the license being renewed.
AB50-ASA2-AA16,67,129(3) Disclosure to the commissioner. (a) A pharmacy services
10administrative organization licensed under sub. (2) shall disclose to the
11commissioner the extent of any ownership or control of the pharmacy services
12administrative organization by an entity that does any of the following:
AB50-ASA2-AA16,67,13131. Provides pharmacy services.
AB50-ASA2-AA16,67,14142. Provides prescription drug or device services.
AB50-ASA2-AA16,67,16153. Manufactures, sells, or distributes prescription drugs, biologicals, or
16medical devices.
AB50-ASA2-AA16,67,1917(b) A pharmacy services administrative organization licensed under sub. (2)
18shall notify the commissioner in writing within 5 days of any material change in its
19ownership or control relating to an entity described in par. (a).
AB50-ASA2-AA16,67,2120(4) Rules. The commissioner may promulgate rules to implement this
21section..
AB50-ASA2-AA16,67,222224. At the appropriate places, insert all of the following:
AB50-ASA2-AA16,67,2323Section 74. 601.31 (1) (nv) of the statutes is created to read:
AB50-ASA2-AA16,68,2
1601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical
2representative under s. 632.863, an amount to be set by the commissioner by rule.
AB50-ASA2-AA16,753Section 75. 632.863 of the statutes is created to read:
AB50-ASA2-AA16,68,54632.863 Pharmaceutical representatives. (1) Definitions. In this
5section:
AB50-ASA2-AA16,68,86(a) Health care professional means a physician or other health care
7practitioner who is licensed to provide health care services or to prescribe
8pharmaceutical or biologic products.
AB50-ASA2-AA16,68,109(b) Pharmaceutical means a medication that may legally be dispensed only
10with a valid prescription from a health care professional.
AB50-ASA2-AA16,68,1311(c) Pharmaceutical representative means an individual who markets or
12promotes pharmaceuticals to health care professionals on behalf of a
13pharmaceutical manufacturer for compensation.
AB50-ASA2-AA16,68,2114(2) Licensure. Beginning on the first day of the 12th month beginning after
15the effective date of this subsection .... [LRB inserts date], no individual may act as
16a pharmaceutical representative in this state without being licensed by the
17commissioner as a pharmaceutical representative under this subsection. In order
18to obtain a license under this subsection, the individual shall apply to the
19commissioner in the form and manner prescribed by the commissioner and shall
20pay the fee under s. 601.31 (1) (nv). The term of a license issued under this
21subsection is one year, and the license is renewable.
AB50-ASA2-AA16,69,222(3) Display of license. A pharmaceutical representative licensed under sub.

1(2) shall display the pharmaceutical representatives license during each visit with
2a health care professional.
AB50-ASA2-AA16,69,63(4) Enforcement. (a) Any individual who violates this section or any rules
4promulgated under this section shall be fined not less than $1,000 nor more than
5$3,000 for each offense. Each day of continued violation constitutes a separate
6offense.
AB50-ASA2-AA16,69,117(b) The commissioner may suspend or revoke the license of a pharmaceutical
8representative who violates this section or any rules promulgated under this
9section. A suspended or revoked license under this paragraph may not be
10reinstated until the pharmaceutical representative remedies all violations related
11to the suspension or revocation and pays all assessed penalties and fees.
Loading...
Loading...