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AB68-SSA1,1324,1313(b) An authorized generic drug, as defined in 42 CFR 447.502.
AB68-SSA1,1324,1514 (c) A drug that entered the market prior to 1962 and was not originally
15marketed under a new drug application.
AB68-SSA1,1324,16 16(8) “Manufacturer” means an entity that does all of the following:
AB68-SSA1,1324,1917 (a) Engages in the manufacture of a drug product or enters into a lease with
18another manufacturer to market and distribute a prescription drug product under
19the entity's own name.
AB68-SSA1,1324,2120 (b) Sets or changes the wholesale acquisition cost of the drug product or
21prescription drug product described in par. (a).
AB68-SSA1,1324,23 22(9) “Over-the-counter drug” means a drug intended for human use that does
23not require a prescription and meets the requirements of 21CFR parts 328 to 364.
AB68-SSA1,1324,24 24(10) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
AB68-SSA1,1325,2
1(11) “Prescription drug product” means a brand name drug, a generic drug, a
2biologic, or a biosimilar.
AB68-SSA1,2959 3Section 2959. 601.785 of the statutes is created to read:
AB68-SSA1,1325,8 4601.785 Prescription drug affordability review board. (1) Mission. The
5purpose of the board is to protect state residents, the state, local governments, health
6plans, healthcare providers, pharmacies licensed in this state, and other
7stakeholders of the healthcare system in this state from the high costs of prescription
8drug products.
AB68-SSA1,1325,9 9(2) Powers and duties. (a) The board shall do all of the following:
AB68-SSA1,1325,1210 1. Meet in open session at least 4 times per year to review prescription drug
11product pricing information, except that the chair may cancel or postpone a meeting
12if there is no business to transact.
AB68-SSA1,1325,1413 2. To the extent practicable, access and assess pricing information for
14prescription drug products by doing all of the following:
AB68-SSA1,1325,1715 a. Accessing and assessing information from other states by entering into
16memoranda of understanding with other states to which manufacturers report
17pricing information.
AB68-SSA1,1325,1818 b. Assessing spending for specific prescription drug products in this state.
AB68-SSA1,1325,1919 c. Accessing other available pricing information.
AB68-SSA1,1325,2020 (b) The board may:
AB68-SSA1,1325,2121 1. Promulgate rules for the administration of this subchapter.
AB68-SSA1,1326,222 2. Enter into a contract with an independent 3rd party for any service
23necessary to carry out the powers and duties of the board. Unless written permission
24is granted by the board, any person with whom the board contracts may not release,

1publish, or otherwise use any information to which the person has access under the
2contract.
AB68-SSA1,1326,6 3(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide
4public notice of each board meeting at least 2 weeks prior to the meeting and shall
5make the materials for each meeting publicly available at least one week prior to the
6meeting.
AB68-SSA1,1326,97 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for
8public comment at each open meeting and shall provide the public with the
9opportunity to provide written comments on pending decisions of the board.
AB68-SSA1,1326,1210 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board
11concerning proprietary data and information shall be conducted in closed session
12and shall in all respects remain confidential.
AB68-SSA1,1326,1413 (d) The board may allow expert testimony at any meeting, including when the
14board meets in closed session.
AB68-SSA1,1326,18 15(4) Conflicts of interest. (a) A member of the board shall recuse himself or
16herself from a decision by the board relating to a prescription drug product if the
17member or an immediate family member, as defined in s. 97.605 (4) (a) 2., has
18received or could receive any of the following:
AB68-SSA1,1326,2019 1. A direct financial benefit deriving from a determination, or a finding of a
20study or review, by the board relating to the prescription drug product.
AB68-SSA1,1326,2321 2. A financial benefit in excess of $5,000 in a calendar year from any person who
22owns, manufactures, or provides a prescription drug product to be studied or
23reviewed by the board.
AB68-SSA1,1327,224 (b) A conflict of interest shall be disclosed by the board when hiring board staff,
25by the appointing authority when appointing members to the board, and by the board

1when a member of the board is recused from any final decision resulting from a
2review of a prescription drug product.
AB68-SSA1,1327,53 (c) A conflict of interest shall be disclosed no later than 5 days after the conflict
4is identified, except that, if the conflict is identified within 5 days of an open meeting
5of the board, the conflict shall be disclosed prior to the meeting.
AB68-SSA1,1327,106 (d) The board shall disclose a conflict of interest under this subsection on the
7board's Internet site unless the chair of the board recuses the member from a final
8decision resulting from a review of the prescription drug product. The disclosure
9shall include the type, nature, and magnitude of the interests of the member
10involved.
AB68-SSA1,1327,1311 (e) A member of the board or a 3rd party contractor may not accept any gift or
12donation of services or property that indicates a potential conflict of interest or has
13the appearance of biasing the work of the board.
AB68-SSA1,2960 14Section 2960. 601.79 of the statutes is created to read:
AB68-SSA1,1327,16 15601.79 Drug cost affordability review. (1) Identification of drugs. The
16board shall identify prescription drug products that are any of the following:
AB68-SSA1,1327,2117 (a) A brand name drug or biologic that, as adjusted annually to reflect
18adjustments to the U.S. consumer price index for all urban consumers, U.S. city
19average, as determined by the U.S. department of labor, has a launch wholesale
20acquisition cost of at least $30,000 per year or course of treatment or whose wholesale
21acquisition cost increased at least $3,000 during a 12–month period.
AB68-SSA1,1327,2422 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not
23at least 15 percent lower than the referenced brand biologic at the time the biosimilar
24is launched.
AB68-SSA1,1328,4
1(c) A generic drug that has a wholesale acquisition cost, as adjusted annually
2to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
3city average, as determined by the U.S. department of labor, that meets all of the
4following conditions:
AB68-SSA1,1328,105 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
6days based on the recommended dosage approved for labeling by the U.S. food and
7drug administration, a supply lasting a patient for fewer than 30 days based on the
8recommended dosage approved for labeling by the federal food and drug
9administration, or one unit of the drug if the labeling approved by the federal food
10and drug administration does not recommend a finite dosage.
AB68-SSA1,1328,1311 2. Increased by at least 200 percent during the preceding 12–month period, as
12determined by the difference between the resulting wholesale acquisition cost and
13the average of the wholesale acquisition cost reported over the preceding 12 months.
AB68-SSA1,1328,1614 (d) Other prescription drug products, including drugs to address public health
15emergencies, that may create affordability challenges for the healthcare system and
16patients in this state.
AB68-SSA1,1328,21 17(2) Affordability review. (a) After identifying prescription drug products
18under sub. (1), the board shall determine whether to conduct an affordability review
19for each identified prescription drug product by seeking stakeholder input about the
20prescription drug product and considering the average patient cost share of the
21prescription drug product.
AB68-SSA1,1329,222 (b) The information to conduct an affordability review under par. (a) may
23include any document and research related to the manufacturer's selection of the
24introductory price or price increase of the prescription drug product, including life
25cycle management, net average price in this state, market competition and context,

1projected revenue, and the estimated value or cost–effectiveness of the prescription
2drug product.
AB68-SSA1,1329,43 (c) The failure of a manufacturer to provide the board with information for an
4affordability review does not affect the authority of the board to conduct the review.
AB68-SSA1,1329,12 5(3) Affordability challenge. When conducting an affordability review of a
6prescription drug product, the board shall determine whether use of the prescription
7drug product that is fully consistent with the labeling approved by the federal food
8and drug administration or standard medical practice has led or will lead to an
9affordability challenge for the healthcare system in this state, including high
10out–of–pocket costs for patients. To the extent practicable, in determining whether
11a prescription drug product has led or will lead to an affordability challenge, the
12board shall consider all of the following factors:
AB68-SSA1,1329,1413 (a) The wholesale acquisition cost for the prescription drug product sold in this
14state.
AB68-SSA1,1329,1815 (b) The average monetary price concession, discount, or rebate the
16manufacturer provides, or is expected to provide, to health plans in this state as
17reported by manufacturers and health plans, expressed as a percent of the wholesale
18acquisition cost for the prescription drug product under review.
AB68-SSA1,1329,2219 (c) The total amount of the price concessions, discounts, and rebates the
20manufacturer provides to each pharmacy benefit manager for the prescription drug
21product under review, as reported by the manufacturer and pharmacy benefit
22manager and expressed as a percent of the wholesale acquisition costs.
AB68-SSA1,1329,2323 (d) The price at which therapeutic alternatives have been sold in this state.
AB68-SSA1,1330,3
1(e) The average monetary concession, discount, or rebate the manufacturer
2provides or is expected to provide to health plan payors and pharmacy benefit
3managers in this state for therapeutic alternatives.
AB68-SSA1,1330,64 (f) The costs to health plans based on patient access consistent with labeled
5indications by the federal food and drug administration and recognized standard
6medical practice.
AB68-SSA1,1330,87 (g) The impact on patient access resulting from the cost of the prescription drug
8product relative to insurance benefit design.
AB68-SSA1,1330,109 (h) The current or expected dollar value of drug–specific patient access
10programs that are supported by the manufacturer.
AB68-SSA1,1330,1311 (i) The relative financial impacts to health, medical, or social services costs that
12can be quantified and compared to baseline effects of existing therapeutic
13alternatives.
AB68-SSA1,1330,1514 (j) The average patient copay or other cost sharing for the prescription drug
15product in the state.
AB68-SSA1,1330,1616 (k) Any information a manufacturer chooses to provide.
AB68-SSA1,1330,1717 (L) Any other factors as determined by the board by rule.
AB68-SSA1,1330,21 18(4) Upper payment limit. (a) If the board determines under sub. (3) that use
19of a prescription drug product has led or will lead to an affordability challenge, the
20board shall establish an upper payment limit for the prescription drug product after
21considering all of the following:
AB68-SSA1,1330,2222 1. The cost of administering the drug.
AB68-SSA1,1330,2323 2. The cost of delivering the drug to consumers.
AB68-SSA1,1330,2424 3. Other relevant administrative costs related to the drug.
AB68-SSA1,1331,6
1(b) For a prescription drug product identified in sub. (1) (d), the board shall
2solicit information from the manufacturer regarding the price increase. To the
3extent that the price increase is not a result of the need for increased manufacturing
4capacity or other effort to improve patient access during a public health emergency,
5the board shall establish an upper payment limit under par. (a) that is equal to the
6cost to consumers prior to the price increase.
AB68-SSA1,1331,107 (c) 1. The upper payment limit established under this subsection shall apply
8to all purchases and payor reimbursements of the prescription drug product
9dispensed or administered to individuals in this state in person, by mail, or by other
10means.
AB68-SSA1,1331,2111 2. Notwithstanding subd. 1., while state-sponsored and state-regulated
12health plans and health programs shall limit drug reimbursements and drug
13payment to no more than the upper payment limit established under this subsection,
14a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
15Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the
16upper payment limit. A provider who dispenses and administers a prescription drug
17product in this state to an individual in this state may not bill a payor more than the
18upper payment limit to the patient regardless of whether a plan subject to the
19Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42
20USC 1395w-101
et seq. chooses to reimburse the provider above the upper payment
21limit.
AB68-SSA1,1331,23 22(5) Public inspection. Information submitted to the board under this section
23shall be open to public inspection only as provided under ss. 19.31 to 19.39.
AB68-SSA1,1332,2 24(6) No prohibition on marketing. Nothing in this section may be construed to
25prevent a manufacturer from marketing a prescription drug product approved by the

1federal food and drug administration while the prescription drug product is under
2review by the board.
AB68-SSA1,1332,7 3(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 determination.
5The board shall hear the appeal and make a final decision no later than 60 days after
6the appeal is requested. A person aggrieved by a final decision of the board may
7petition for judicial review in a court of competent jurisdiction.
AB68-SSA1,2961 8Section 2961 . 601.83 (1) (a) of the statutes is amended to read:
AB68-SSA1,1332,219 601.83 (1) (a) The commissioner shall administer a state-based reinsurance
10program known as the healthcare stability plan in accordance with the specific terms
11and conditions approved by the federal department of health and human services
12dated July 29, 2018. Before December 31, 2023, the commissioner may not request
13from the federal department of health and human services a modification,
14suspension, withdrawal, or termination of the waiver under 42 USC 18052 under
15which the healthcare stability plan under this subchapter operates unless
16legislation has been enacted specifically directing the modification, suspension,
17withdrawal, or termination. Before December 31, 2023, the commissioner may
18request renewal, without substantive change, of the waiver under 42 USC 18052
19under which the health care stability plan operates in accordance with s. 20.940 (4)
20unless legislation has been enacted that is contrary to such a renewal request. The
21commissioner shall comply with applicable timing in and requirements of s. 20.940.
AB68-SSA1,2962 22Section 2962. 609.045 of the statutes is created to read:
AB68-SSA1,1332,24 23609.045 Balance billing; emergency medical services. (1) Definitions.
24In this section:
AB68-SSA1,1333,4
1(a) “Emergency medical services” means emergency medical services for which
2coverage is required under s. 632.85 (2) and includes emergency medical services
3described under s. 632.85 (2) as if section 1867 of the federal Social Security Act
4applied to an independent freestanding emergency department.
AB68-SSA1,1333,85 (b) “Preferred provider plan,” notwithstanding s. 609.01 (4), includes only any
6preferred provider plan, as defined under s. 609.01 (4), that has a network of
7participating providers and imposes on enrollees different requirements for using
8providers that are not participating providers.
AB68-SSA1,1333,129 (c) “Self-insured governmental plan” means a self-insured health plan of the
10state or a county, city, village, town, or school district that has a network of
11participating providers and imposes on enrollees in the self-insured health plan
12different requirements for using providers that are not participating providers.
AB68-SSA1,1333,17 13(2) Emergency medical services. A defined network plan, preferred provider
14plan, or self-insured governmental plan that covers any benefits or services provided
15in an emergency department of a hospital or emergency medical services provided
16in an independent freestanding emergency department shall cover emergency
17medical services in accordance with all of the following:
AB68-SSA1,1333,1818 (a) The plan may not require a prior authorization determination.
AB68-SSA1,1333,2119 (b) The plan may not deny coverage based on whether or not the health care
20provider providing the services is a participating provider or participating
21emergency facility.
AB68-SSA1,1333,2422 (c) If the emergency medical services are provided to an enrollee by a provider
23or in a facility that is not a participating provider or facility, the plan complies with
24all of the following:
AB68-SSA1,1334,4
11. The emergency medical services are covered without imposing on an enrollee
2a requirement for prior authorization or any coverage limitation that is more
3restrictive than requirements or limitations that apply to emergency medical
4services provided by participating providers or in participating facilities.
AB68-SSA1,1334,85 2. Any cost-sharing requirement imposed on an enrollee for the emergency
6medical service is no greater than the requirements that would apply if the
7emergency medical service were provided by a participating provider or in a
8participating facility.
AB68-SSA1,1334,139 3. Any cost-sharing amount imposed on an enrollee for the emergency medical
10service is calculated as if the total amount that would have been charged for the
11emergency medical service if provided by a participating provider or in a
12participating facility is equal to the amount paid to the provider or facility that is not
13a participating provider or facility as determined by the commissioner.
AB68-SSA1,1334,1414 4. The plan does all of the following:
AB68-SSA1,1334,1715 a. No later than 30 days after the provider or facility transmits to the plan the
16bill for emergency medical services, sends to the provider or facility an initial
17payment or a notice of denial of payment.
AB68-SSA1,1334,2118 b. Pays to the provider or facility a total amount that, incorporating any initial
19payment under subd. 4. a., is equal to the amount by which the rate for a provider
20or facility that is not a participating provider or facility exceeds the cost-sharing
21amount or an amount determined under sub. (7).
AB68-SSA1,1335,222 5. The plan counts any cost-sharing payment made by the enrollee for the
23emergency medical services toward any in-network deductible or out-of-pocket
24maximum applied by the plan in the same manner as if the cost-sharing payment

1was made for an emergency medical service provided by a participating provider or
2in a participating facility.
AB68-SSA1,1335,13 3(3) Provider billing limitation for emergency medical services; ambulance
4services.
A provider of emergency medical services or a facility in which emergency
5medical services are provided that is entitled to payment under sub. (2) may not bill
6or hold liable an enrollee for any amount for the emergency medical service that is
7more than the cost-sharing amount determined under sub. (2) (c) 3. for the
8emergency service. A provider of ambulance services that is not a participating
9provider under an enrollee's defined network plan, preferred provider plan, or
10self-insured governmental plan may not bill or hold liable an enrollee for any
11amount of the ambulance service that is more than the cost-sharing amount that the
12enrollee would be charged if the provider of ambulance services was a participating
13provider under the enrollee's plan.
AB68-SSA1,1335,19 14(4) Nonparticipating provider in participating facility. For items or services
15other than emergency medical services that are provided to an enrollee of a defined
16network plan, preferred provider plan, or self-insured governmental plan by a
17provider who is not a participating provider but who is providing services at a
18participating facility, the plan shall provide coverage for the item or service in
19accordance with all of the following:
AB68-SSA1,1335,2220 (a) The plan may not impose on an enrollee a cost-sharing requirement for the
21item or service that is greater than the cost-sharing requirement that would have
22been imposed if the item or service was provided by a participating provider.
AB68-SSA1,1336,223 (b) Any cost-sharing amount imposed on an enrollee for the item or service is
24calculated as if the total amount that would have been charged for the item or service

1if provided by a participating provider is equal to the amount paid to the provider
2that is not a participating provider as determined by the commissioner.
AB68-SSA1,1336,43 (c) No later than 30 days after the provider transmits the bill for services, the
4plan shall send to the provider an initial payment or a notice of denial of payment.
AB68-SSA1,1336,85 (d) The plan shall make a total payment directly to the provider that provided
6the item or service to the enrollee that, added to any initial payment described under
7par. (c), is equal to the amount by which the out-of-network rate for the item or
8service exceeds the cost-sharing amount or the amount determined under sub. (7).
AB68-SSA1,1336,129 (e) The plan counts any cost-sharing payment made by the enrollee for the item
10or service toward any in-network deductible or out-of-pocket maximum applied by
11the plan in the same manner as if the cost-sharing payment was made for the item
12or service when provided by a participating provider.
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