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.
AB68-SSA1,1336,18
13(5) Charging for services by nonparticipating provider; notice and consent. 14(a) Except as provided in par. (c), a provider of an item or service that is entitled to
15payment under sub. (4) may not bill or hold liable an enrollee for any amount for the
16item or service that is more than the cost-sharing amount determined under sub. (4)
17(b) for the item or service unless the nonparticipating provider provides notice and
18obtains consent in accordance with all of the following:
AB68-SSA1,1336,2119
1. The notice states that the provider is not a participating provider in the
20enrollee's defined network plan, preferred provider plan, or self-insured
21governmental plan.
AB68-SSA1,1336,2522
2. The notice provides a good faith estimate of the amount that the provider
23may charge the enrollee for the item or service involved, including notification that
24the estimate does not constitute a contract with respect to the charges estimated for
25the item or service.
AB68-SSA1,1337,3
13. The notice includes a list of the participating providers at the facility that
2would be able to provide the item or service and notification that the enrollee may
3be referred to one of those participating providers.
AB68-SSA1,1337,64
4. The notice includes information about whether or not prior authorization or
5other care management limitations may be required before receiving an item or
6service at the participating facility.
AB68-SSA1,1337,117
5. The enrollee provides consent to the provider to be treated by the
8nonparticipating provider, and the consent acknowledges that the enrollee has been
9informed that the charge paid by the enrollee may not meet a limitation that the
10enrollee's defined network plan, preferred provider plan, or self-insured
11governmental plan places on cost sharing, such as an in-network deductible.
AB68-SSA1,1337,1312
6. A signed copy of the consent described under subd. 5. is provided to the
13enrollee.
AB68-SSA1,1337,1514
(b) To be considered adequate, the notice and consent under par. (a) shall meet
15one of the following requirements, as applicable:
AB68-SSA1,1337,1916
1. If the enrollee makes an appointment for the item or service at least 72 hours
17before the day on which the item or service is to be provided, any notice under par.
18(a) shall be provided to the enrollee at least 72 hours before the day of the
19appointment at which the item or service is to be provided.
AB68-SSA1,1337,2220
2. If the enrollee makes an appointment for the item or service less than 72
21hours before the day on which the item or service is to be provided, any notice under
22par. (a) shall be provided to the enrollee on the day that the appointment is made.
AB68-SSA1,1338,323
(c) A provider of an item or service that is entitled to payment under sub. (4)
24may not bill or hold liable an enrollee for any amount for the ancillary item or service
25that is more than the cost-sharing amount determined under sub. (4) (b) for the item
1or service, unless the commissioner specifies by rule that the provider may balance
2bill for the specified item or service, if the ancillary item or service is any of the
3following:
AB68-SSA1,1338,44
1. Related to an emergency medical service.
AB68-SSA1,1338,55
2. Anesthesiology.
AB68-SSA1,1338,88
5. Neonatology.
AB68-SSA1,1338,99
6. A item or service provided by an assistant surgeon, hospitalist, or intensivist.
AB68-SSA1,1338,1010
7. Diagnostic service, including a radiology or laboratory service.
AB68-SSA1,1338,1211
8. An item or service provided by a specialty practitioner that the commissioner
12specifies by rule.
AB68-SSA1,1338,1513
9. An item or service provided by a nonparticipating provider when there is no
14participating provider who can furnish the item or service at the participating
15facility.
AB68-SSA1,1338,25
16(6) Notice by provider or facility. Beginning no later than January 1, 2022,
17a health care provider or health care facility shall make available, including posting
18on an Internet site, to enrollees in defined network plans, preferred provider plans,
19and self-insured governmental plans notice of the requirements on a provider or
20facility under subs. (3) and (5), of any other applicable state law requirements on the
21provider or facility with respect to charging an enrollee for an item or service if the
22provider or facility does not have a contractual relationship with the plan, and of
23information on contacting appropriate state or federal agencies in the event the
24enrollee believes the provider or facility violates any of the requirements under this
25section or other applicable law.
AB68-SSA1,1339,17
1(7) Negotiation; dispute resolution. A provider or facility that is entitled to
2receive an initial payment or notice of denial under sub. (2) (c) 4. a. or (4) (c) may
3initiate, within 30 days of receiving the initial payment or notice of denial, open
4negotiations with the defined network plan, preferred provider plan, or self-insured
5governmental plan to determine a payment amount for the emergency medical
6service or other item or service for a period that terminates 30 days after initiating
7open negotiations. If the open negotiation period under this subsection terminates
8without determination of a payment amount, the provider, facility, defined network
9plan, preferred provider plan, or self-insured governmental plan may initiate,
10within the 4 days beginning on the day after the open negotiation period ends, the
11independent dispute resolution process as specified by the commissioner. If the
12independent dispute resolution decision maker determines the payment amount,
13the party to the independent dispute resolution process whose amount was not
14selected shall pay the fees for the independent dispute resolution. If the parties to
15the independent dispute resolution reach a settlement on the payment amount, the
16parties to the independent dispute resolution shall equally divide the payment for
17the fees for the independent dispute resolution.
AB68-SSA1,1339,18
18(8) Continuity of care. (a) In this subsection:
AB68-SSA1,1339,1919
1. “Continuing care patient” means an individual who is any of the following:
AB68-SSA1,1339,2120
a. Undergoing a course of treatment for a serious and complex condition from
21a provider or facility.
AB68-SSA1,1339,2322
b. Undergoing a course of institutional or inpatient care from a provider or
23facility.
AB68-SSA1,1339,2524
c. Scheduled to undergo nonelective surgery, including receipt of postoperative
25care, from a provider or facility.
AB68-SSA1,1340,2
1d. Pregnant and undergoing a course of treatment for the pregnancy from a
2provider or facility.
AB68-SSA1,1340,43
e. Terminally ill and receiving treatment for the illness from a provider or
4facility.
AB68-SSA1,1340,55
2. “Serious and complex condition” means any of the following:
AB68-SSA1,1340,86
a. In the case of an acute illness, a condition that is serious enough to require
7specialized medical treatment to avoid the reasonable possibility of death or
8permanent harm.
AB68-SSA1,1340,119
b. In the case of a chronic illness or condition, a condition that is
10life-threatening, degenerative, potentially disabling, or congenital and requires
11specialized medical care over a prolonged period of time.
AB68-SSA1,1340,1712
(b) If an enrollee is a continuing care patient and is obtaining items or services
13from a participating provider or facility and the contract between the defined
14network plan, preferred provider plan, or self-insured governmental plan and the
15participating provider or facility is terminated or the coverage of benefits that
16include the items or services provided by the participating provider or facility are
17terminated by the plan, the plan shall do all of the following:
AB68-SSA1,1340,2018
1. Notify each enrollee of the termination of the contract or benefits and of the
19right for the enrollee to elect to continue transitional care from the provider or facility
20under this subsection.
AB68-SSA1,1340,2221
2. Provide the enrollee an opportunity to notify the plan of the need for
22transitional care.
AB68-SSA1,1341,423
3. Allow the enrollee to elect to continue to have the benefits provided under
24the plan under the same terms and conditions as would have applied to the item or
25service if the termination had not occurred for the course of treatment related to the
1enrollee's status as a continuing care patient beginning on the date on which the
2notice under subd. 1. is provided and ending 90 days after the date on which the
3notice under subd. 1. is provided or the date on which the enrollee is no longer a
4continuing care patient, whichever is earlier.
AB68-SSA1,1341,8
5(9) Rule making. The commissioner may promulgate any rules necessary to
6implement this section, including specifying the independent dispute resolution
7process. The commissioner may promulgate rules to modify the list of those items
8and services for which a provider may not balance bill under sub. (5) (c).
AB68-SSA1,2963
9Section
2963. 609.713 of the statutes is created to read:
AB68-SSA1,1341,11
10609.713 Essential health benefits; preventive services. Defined network
11plans and preferred provider plans are subject to s. 632.895 (13m) and (14m).