SB70,3035 11Section 3035 . 480.08 (5) of the statutes is amended to read:
SB70,1555,2012 480.08 (5) Expiration and renewal. The renewal date for certificates granted
13under this chapter, other than temporary certificates granted under sub. (7), is
14specified
shall be as determined by the department under s. 440.08 (2) (a), and the
15renewal fee for certificates granted under this chapter, other than temporary
16certificates granted under sub. (7), is determined by the department under s. 440.03
17(9) (a). Renewal applications shall include evidence satisfactory to the department
18that the applicant holds a current permit issued under s. 77.52 (9). A renewal
19application for an auctioneer certificate shall be accompanied by proof of completion
20of continuing education requirements under sub. (6).
SB70,3036 21Section 3036. 601.31 (1) (mv) of the statutes is created to read:
SB70,1555,2422 601.31 (1) (mv) For initial issuance or renewal of a license as a pharmacy
23benefit management broker or consultant under s. 628.495, amounts to be set by the
24commissioner by rule.
SB70,3037 25Section 3037. 601.31 (1) (nv) of the statutes is created to read:
SB70,1556,2
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.
SB70,3038 3Section 3038 . 601.31 (1) (nw) of the statutes is created to read:
SB70,1556,64 601.31 (1) (nw) For issuing or renewing a license as a pharmacy services
5administrative organization under s. 632.864, an amount to be set by the
6commissioner by rule.
SB70,3039 7Section 3039 . 601.41 (13) of the statutes is created to read:
SB70,1556,138 601.41 (13) Value-based diabetes medication pilot project. The
9commissioner shall develop a pilot project to direct a pharmacy benefit manager, as
10defined in s. 632.865 (1) (c), and a pharmaceutical manufacturer to create a
11value-based, sole-source arrangement to reduce the costs of prescription medication
12used to treat diabetes. The commissioner may promulgate rules to implement this
13subsection.
SB70,3040 14Section 3040. 601.575 of the statutes is created to read:
SB70,1556,20 15601.575 Prescription drug importation program. (1) Importation
16program requirements.
The commissioner, in consultation with persons interested
17in the sale and pricing of prescription drugs and appropriate officials and agencies
18of the federal government, shall design and implement a prescription drug
19importation program for the benefit of residents of this state, that generates savings
20for residents, and that satisfies all of the following:
SB70,1556,2321 (a) The commissioner shall designate a state agency to become a licensed
22wholesale distributor or to contract with a licensed wholesale distributor and shall
23seek federal certification and approval to import prescription drugs.
SB70,1556,2524(b) The program shall comply with relevant requirements of 21 USC 384,
25including safety and cost savings requirements.
SB70,1557,2
1(c) The program shall import prescription drugs from Canadian suppliers
2regulated under any appropriate Canadian or provincial laws.
SB70,1557,43 (d) The program shall have a process to sample the purity, chemical
4composition, and potency of imported prescription drugs.
SB70,1557,85 (e) The program shall import only those prescription drugs for which
6importation creates substantial savings for residents of this state and only those
7prescription drugs that are not brand-name drugs and that have fewer than 4
8competitor prescription drugs in the United States.
SB70,1557,109 (f) The commissioner shall ensure that prescription drugs imported under the
10program are not distributed, dispensed, or sold outside of this state.
SB70,1557,1111 (g) The program shall ensure all of the following:
SB70,1557,1312 1. Participation by any pharmacy or health care provider in the program is
13voluntary.
SB70,1557,1514 2. Any pharmacy or health care provider participating in the program has the
15appropriate license or other credential in this state.
SB70,1557,1816 3. Any pharmacy or health care provider participating in the program charges
17a consumer or health plan the actual acquisition cost of the imported prescription
18drug that is dispensed.
SB70,1557,2219 (h) The program shall ensure that a payment by a health plan or health
20insurance policy for a prescription drug imported under the program reimburses no
21more than the actual acquisition cost of the imported prescription drug that is
22dispensed.
SB70,1557,2423 (i) The program shall ensure that any health plan or health insurance policy
24participating in the program does all of the following:
SB70,1558,2
11. Maintains a formulary and claims payment system with current information
2on prescription drugs imported under the program.
SB70,1558,53 2. Bases cost-sharing amounts for participants or insureds under the plan or
4policy on no more than the actual acquisition cost of the prescription drug imported
5under the program that is dispensed to the participant or insured.
SB70,1558,86 3. Demonstrates to the commissioner or a state agency designated by the
7commissioner how premiums under the plan or policy are affected by savings on
8prescription drugs imported under the program.
SB70,1558,119 (j) Any wholesale distributor importing prescription drugs under the program
10shall limit its profit margin to the amount established by the commissioner or a state
11agency designated by the commissioner.
SB70,1558,1312 (k) The program may not import any generic prescription drug that would
13violate federal patent laws on branded products in the United States.
SB70,1558,1814(L) The program shall comply with tracking and tracing requirements of 21
15USC 360eee
and 360eee-1, to the extent practical and feasible, before the
16prescription drug to be imported comes into the possession of this state's wholesale
17distributor and fully after the prescription drug to be imported is in the possession
18of this state's wholesale distributor.
SB70,1558,2019 (m) The program shall establish a fee or other mechanism to finance the
20program that does not jeopardize significant savings to residents of this state.
SB70,1558,2121 (n) The program shall have an audit function that ensures all of the following:
SB70,1558,2322 1. The commissioner has a sound methodology to determine the most
23cost-effective prescription drugs to include in the program.
SB70,1558,2524 2. The commissioner has a process in place to select Canadian suppliers that
25are high quality, high performing, and in full compliance with Canadian laws.
SB70,1559,2
13. Prescription drugs imported under the program are pure, unadulterated,
2potent, and safe.
SB70,1559,33 4. The program is complying with the requirements of this subsection.
SB70,1559,54 5. The program is adequately financed to support administrative functions of
5the program while generating significant cost savings to residents of this state.
SB70,1559,76 6. The program does not put residents of this state at a higher risk than if the
7program did not exist.
SB70,1559,98 7. The program provides and is projected to continue to provide substantial cost
9savings to residents of this state.
SB70,1559,12 10(2) Anticompetitive behavior. The commissioner, in consultation with the
11attorney general, shall identify the potential for and monitor anticompetitive
12behavior in industries affected by a prescription drug importation program.
SB70,1559,22 13(3) Approval of program design; certification. No later than the first day of
14the 7th month beginning after the effective date of this subsection .... [LRB inserts
15date], the commissioner shall submit to the joint committee on finance a report that
16includes the design of the prescription drug importation program in accordance with
17this section. The commissioner may not submit the proposed program to the federal
18department of health and human services unless the joint committee on finance
19approves the proposed program. Within 14 days of the date of approval by the joint
20committee on finance of the proposed program, the commissioner shall submit to the
21federal department of health and human services a request for certification of the
22approved program.
SB70,1560,5 23(4) Implementation of certified program. After the federal department of
24health and human services certifies the prescription drug importation program
25submitted under sub. (3), the commissioner shall begin implementation of the

1program, and the program shall be fully operational by 180 days after the date of
2certification by the federal department of health and human services. The
3commissioner shall do all of the following to implement the program to the extent the
4action is in accordance with other state laws and the certification by the federal
5department of health and human services:
SB70,1560,86 (a) Become a licensed wholesale distributor, designate another state agency to
7become a licensed wholesale distributor, or contract with a licensed wholesale
8distributor.
SB70,1560,109 (b) Contract with one or more Canadian suppliers that meet the criteria in sub.
10(1) (c) and (n).
SB70,1560,1311 (c) Create an outreach and marketing plan to communicate with and provide
12information to health plans and health insurance policies, employers, pharmacies,
13health care providers, and residents of this state on participating in the program.
SB70,1560,1614 (d) Develop and implement a registration process for health plans and health
15insurance policies, pharmacies, and health care providers interested in participating
16in the program.
SB70,1560,1817 (e) Create a publicly accessible source for listing prices of prescription drugs
18imported under the program.
SB70,1560,2119 (f) Create, publicize, and implement a method of communication to promptly
20answer questions from and address the needs of persons affected by the
21implementation of the program before the program is fully operational.
SB70,1560,2322 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete
23each audit function every 2 years.
SB70,1560,2524 (h) Conduct any other activities determined by the commissioner to be
25important to successful implementation of the program.
SB70,1561,2
1(5) Report. By January 1 and July 1 of each year, the commissioner shall
2submit to the joint committee on finance a report including all of the following:
SB70,1561,43 (a) A list of prescription drugs included in the prescription drug importation
4program under this section.
SB70,1561,75 (b) The number of pharmacies, health care providers, and health plans and
6health insurance policies participating in the prescription drug importation program
7under this section.
SB70,1561,128 (c) The estimated amount of savings to residents of this state, health plans and
9health insurance policies, and employers resulting from the implementation of the
10prescription drug importation program under this section reported from the date of
11the previous report under this subsection and from the date the program was fully
12operational.
SB70,1561,1413 (d) Findings of any audit functions under sub. (1) (n) completed since the date
14of the previous report under this subsection.
SB70,1561,16 15(6) Rulemaking. The commissioner may promulgate any rules necessary to
16implement this section.
SB70,3041 17Section 3041. 601.59 of the statutes is created to read:
SB70,1561,18 18601.59 State-based exchange. (1) Definitions. In this section:
SB70,1561,1919 (a) “Exchange” has the meaning given in 45 CFR 155.20.
SB70,1561,2220 (b) “State-based exchange on the federal platform” means an exchange that is
21described in and meets the requirements of 45 CFR 155.200 (f) and is approved by
22the federal secretary of health and human services under 45 CFR 155.106.
SB70,1562,223 (c) “State-based exchange without the federal platform” means an exchange,
24other than one described in 45 CFR 155.200 (f), that performs all the functions

1described in 45 CFR 155.200 (a) and is approved by the federal secretary of health
2and human services under 45 CFR 155.106.
SB70,1562,9 3(2) Establishment and operation of state-based exchange. The commissioner
4shall establish and operate an exchange that at first is a state-based exchange on
5the federal platform and then subsequently transitions to a state-based exchange
6without the federal platform. The commissioner shall develop procedures to address
7the transition from the state-based exchange on the federal platform to the
8state-based exchange without the federal platform, including the circumstances
9that shall be met in order for the transition to occur.
SB70,1562,12 10(3) Agreement with federal government. The commissioner may enter into
11any agreement with the federal government necessary to facilitate the
12implementation of this section.
SB70,1562,18 13(4) User fees. The commissioner shall impose a user fee, as authorized under
1445 CFR 155.160 (b) (1), on each insurer that offers a health plan through the
15state-based exchange on the federal platform or the state-based exchange without
16the federal platform. The user fee shall be applied at one of the following rates on
17the total monthly premiums charged by an insurer for each policy under the plan for
18which enrollment is through the exchange:
SB70,1562,2019 (a) For any plan year for which the commissioner operates a state-based
20exchange on the federal platform, the rate is 0.5 percent.
SB70,1562,2421 (b) For the first 2 plan years for which the commissioner operates a state-based
22exchange without the federal platform, the rate is equal to the user fee rate the
23federal department of health and human services specifies under 45 CFR 156.50 (c)
24(1) for the federally facilitated exchanges for the applicable plan year.
SB70,1563,3
1(c) Beginning with the 3rd plan year for which the commissioner operates a
2state-based exchange without the federal platform and for each plan year thereafter,
3the rate shall be set by the commissioner by rule.
SB70,1563,5 4(5) Rules. The commissioner may promulgate rules necessary to implement
5this section.
SB70,3042 6Section 3042 . Subchapter VI (title) of chapter 601 [precedes 601.78] of the
7statutes is created to read:
SB70,1563,88 CHAPTER 601
SB70,1563,109 SUBCHAPTER VI
10 Prescription drug
SB70,1563,1111 affordability review board
SB70,3043 12Section 3043. 601.78 of the statutes is created to read:
SB70,1563,13 13601.78 Definitions. In this subchapter:
SB70,1563,15 14(1) “Biologic” means a drug that is produced or distributed in accordance with
15a biologics license application approved under 21 CFR 601.20.
SB70,1563,17 16(2) “Biosimilar” means a drug that is produced or distributed in accordance
17with a biologics license application approved under 42 USC 262 (k) (3).
SB70,1563,19 18(3) “Board” means the prescription drug affordability review board established
19under s. 15.735 (1).
SB70,1563,22 20(4) “Brand name drug” means a drug that is produced or distributed in
21accordance with an original new drug application approved under 21 USC 355 (c),
22other than an authorized generic drug, as defined in 42 CFR 447.502.
SB70,1563,25 23(5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock
24holdings of a member of the board or any immediate family member, and any direct
25financial benefit deriving from the finding of a review conducted under s. 601.79.
SB70,1564,1
1(6) “Generic drug” means any of the following:
SB70,1564,32 (a) A retail drug that is marketed or distributed in accordance with an
3abbreviated new drug application approved under 21 USC 355 (j).
SB70,1564,44(b) An authorized generic drug, as defined in 42 CFR 447.502.
SB70,1564,65 (c) A drug that entered the market prior to 1962 and was not originally
6marketed under a new drug application.
SB70,1564,9 7(7) “Immediate family member” means a spouse, grandparent, parent, sibling,
8child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child,
9stepchild, or grandchild.
SB70,1564,10 10(8) “Manufacturer” means an entity that does all of the following:
SB70,1564,1311 (a) Engages in the manufacture of a prescription drug product or enters into
12a lease with another manufacturer to market and distribute a prescription drug
13product under the entity's own name.
SB70,1564,1514 (b) Sets or changes the wholesale acquisition cost of the prescription drug
15product described in par. (a).
SB70,1564,16 16(9) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).
SB70,1564,18 17(10) “Prescription drug product” means a brand name drug, a generic drug, a
18biologic, or a biosimilar.
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