Amendment SA2-AB56

AB56-SA2,45,3 (a) The department shall designate a state agency to become a licensed wholesale distributor or to contract with a licensed wholesale distributor and shall seek federal certification and approval to import prescription drugs.

AB56-SA2,45,6 (b) The prescription drug importation program under this section shall comply with relevant requirements of 21 USC 384, including safety and cost savings requirements.

AB56-SA2,45,9 (c) The prescription drug importation program under this section shall import prescription drugs from Canadian suppliers regulated under any appropriate Canadian or provincial laws.

AB56-SA2,45,12 (d) The prescription drug importation program under this section shall have a process to sample the purity, chemical composition, and potency of imported prescription drugs.

AB56-SA2,45,16 (e) The prescription drug importation program under this section shall import only those prescription drugs for which importation creates substantial savings for residents of the state and only those prescription drugs that are not brand-name drugs and that have fewer than 4 competitor prescription drugs in the United States.

AB56-SA2,45,19 (f) The department shall ensure that prescription drugs imported under the program under this section are not distributed, dispensed, or sold outside of the state.

AB56-SA2,45,21 (g) The prescription drug importation program under this section shall ensure all of the following:

AB56-SA2,45,23 1. Participation by any pharmacy or health care provider in the program is voluntary.

AB56-SA2,45,25 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

AB56-SA2,46,3 3. Any pharmacy or health care provider participating in the program charges a consumer or health plan the actual acquisition cost of the imported prescription drug that is dispensed.

AB56-SA2,46,7 (h) The prescription drug importation program under this section shall ensure that a payment by a health plan or health insurance policy for a prescription drug imported under the program reimburses no more than the actual acquisition cost of the imported prescription drug that is dispensed.

AB56-SA2,46,10 (i) The prescription drug importation program under this section shall ensure that any health plan or health insurance policy participating in the program does all of the following:

AB56-SA2,46,12 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

AB56-SA2,46,15 2. Bases cost-sharing amounts for participants or insureds under the plan or policy on no more than the actual acquisition cost of the prescription drug imported under the program that is dispensed to the participant or insured.

AB56-SA2,46,18 3. Demonstrates to the department or a state agency designated by the department how premiums under the policy or plan are affected by savings on prescription drugs imported under the program.

AB56-SA2,46,21 (j) Any wholesale distributor importing prescription drugs under the program under this section shall limit its profit margin to the amount established by the department or a state agency designated by the department.

AB56-SA2,46,24 (k) The prescription drug importation program under this section may not import any generic prescription drug that would violate federal patent laws on branded products in this country.

AB56-SA2,47,5 (L) The prescription drug importation program under this section shall comply to the extent practical and feasible before the prescription drug to be imported comes into possession of the state's wholesale distributor and fully after the prescription drug to be imported is in possession of the state's wholesale distributor with tracking and tracing requirements of 21 USC 360eee to 360eee-1.

AB56-SA2,47,8 (m) The prescription drug importation program under this section shall establish a fee or other approach to finance the program that does not jeopardize significant savings to residents of the state.

AB56-SA2,47,10 (n) The prescription drug importation program under this section shall have an audit function that ensures all of the following:

AB56-SA2,47,13 1. The department has a sound methodology to determine the most cost-effective prescription drugs to include in the importation program under this section.

AB56-SA2,47,15 2. The department has a process in place to select Canadian suppliers that are high quality, high performing, and in full compliance with Canadian laws.

AB56-SA2,47,17 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

AB56-SA2,47,19 4. The prescription drug importation program is complying with the requirements of this subsection.

AB56-SA2,47,22 5. The prescription drug importation program under this section is adequately financed to support administrative functions of the program while generating significant cost savings to residents of the state.

AB56-SA2,47,24 6. The prescription drug importation program under this section does not put residents of the state at a higher risk than if the program did not exist.

AB56-SA2,48,2 7. The prescription drug importation program under this section provides and is projected to continue to provide substantial cost savings to residents of the state.

AB56-SA2,48,5 (2) Anticompetitive behavior. The department, in consultation with the attorney general, shall identify the potential for and monitor anticompetitive behavior in industries affected by a prescription drug importation program.

AB56-SA2,48,16 (3) Approval of program design; certification. No later than the first day of the 7th month beginning after the effective date of this subsection .... [LRB inserts date], the department shall submit to the joint committee on finance a report that includes the design of the prescription drug importation program in accordance with this section. The department may not submit the proposed prescription drug importation program to the federal department of health and human services unless the joint committee on finance approves the proposed prescription drug implementation program. Within 14 days of the date of approval by the joint committee on finance of the proposed prescription drug importation program, the department shall submit to the federal department of health and human services a request for certification of the approved prescription drug importation program.

AB56-SA2,48,24 (4) Implementation of certified program. After the federal department of health and human services certifies the prescription drug importation program submitted under sub. (3), the department shall begin implementation of the program and the program shall be fully operational by 180 days after the date of certification by the federal department of health and human services. The department shall do all of the following to implement the prescription drug importation program to the extent the action is in accordance with other state laws and the certification by the federal department of health and human services:

AB56-SA2,49,3 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

AB56-SA2,49,5 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c).

AB56-SA2,49,9 (c) Create an outreach and marketing plan to communicate with and provide information to health plans and health insurance policies, employers, pharmacies, health care providers, and residents of the state on participating in the prescription drug importation program.

AB56-SA2,49,12 (d) Develop and implement a registration process for health plans and health insurance policies, pharmacies, and health care providers interested in participating in the prescription drug importation program.

AB56-SA2,49,14 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

AB56-SA2,49,17 (f) Create, publicize, and implement a method of communication to promptly answer questions from and address the needs of persons affected by the implementation of the program before the program is fully operational.

AB56-SA2,49,19 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

AB56-SA2,49,22 (h) Conduct any other activities determined by the department to be important to successful implementation of the prescription drug importation program under this section.

AB56-SA2,49,24 (5) Report. By January 1 and July 1 of each year, the department shall submit to the joint committee on finance a report including all of the following:

AB56-SA2,50,2 (a) A list of prescription drugs included in the importation program under this section.

AB56-SA2,50,5 (b) The number of pharmacies, health care providers, and health plans and health insurance policies participating in the prescription drug importation program under this section.

AB56-SA2,50,10 (c) The estimated amount of savings to residents of the state, health plans and health insurance policies, and employers resulting from the implementation of the prescription drug importation program under this section reported from the date of the previous report under this subsection and from the date the program was fully operational.

AB56-SA2,50,12 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.”.

AB56-SA2,50,13 97. Page 433, line 5: delete lines 5 to 11 and substitute:

AB56-SA2,50,14 “ Section 1892b. 250.10 (1m) (b) of the statutes is amended to read:

AB56-SA2,50,20 250.10 (1m) (b) Award in each fiscal year to qualified applicants grants totaling $25,000 no less than $50,000 for fluoride supplements, $25,000 for a fluoride mouth-rinse program varnish and other evidence-based oral health activities, $700,000 for school-based preventive dental services, and $120,000 for a school-based dental sealant program $100,000 for school-based restorative dental services.”.

AB56-SA2,50,22 98. Page 433, line 12: delete the material beginning with that line and ending with page 434, line 2, and substitute:

AB56-SA2,50,23 “ Section 1893b. 250.20 (3) of the statutes is amended to read:

AB56-SA2,51,10 250.20 (3) From the appropriation account under s. 20.435 (1) (kb) (cr), the department shall annually award grants for activities to improve the health status of economically disadvantaged minority group members. A person may apply, in the manner specified by the department, for a grant of up to $50,000 in each fiscal year to conduct these activities. An awardee of a grant under this subsection shall provide, for at least 50 percent of the grant amount, matching funds that may consist of funding or an in-kind contribution. An applicant that is not a federally qualified health center, as defined under 42 CFR 405.2401 (b) shall receive priority for grants awarded under this subsection. An applicant that provides maternal and child health services shall receive priority for grants awarded under this subsection.

AB56-SA2,1894b Section 1894b. 250.20 (4) of the statutes is amended to read:

AB56-SA2,51,15 250.20 (4) From the appropriation account under s. 20.435 (1) (kb) (cr), the department shall award a grant of up to $50,000 in each fiscal year to a private nonprofit corporation that applies, in the manner specified by the department, to conduct a public information campaign on minority health.”.

AB56-SA2,51,17 99. Page 434, line 3: delete the material beginning with that line and ending with page 445, line 17, and substitute:

AB56-SA2,51,19 “ Section 1896b. 253.06 (1) (a) of the statutes is renumbered 253.06 (1) (am) and amended to read:

AB56-SA2,51,23 253.06 (1) (am) “Authorized Approved food" means food identified by the department as an authorized food in accordance with 7 CFR 246.10 as acceptable for use under the federal special supplemental food nutrition program for women, infants and children under 42 USC 1786.

AB56-SA2,1897b Section 1897b. 253.06 (1) (ag) of the statutes is created to read:

AB56-SA2,52,4 253.06 (1) (ag) “Alternate participant” means a person who has been authorized by a participant to request benefits, participate in nutrition education, bring an infant or child to a Women, Infants, and Children program appointment, and have access to information in the participant's file.

AB56-SA2,1898b Section 1898b. 253.06 (1) (b) of the statutes is repealed.

AB56-SA2,1899b Section 1899b. 253.06 (1) (br) of the statutes is created to read:

AB56-SA2,52,10 253.06 (1) (br) “Cardholder” means a participant; alternate participant; parent, legal guardian, or caretaker of a participant; or another person in possession of a Women, Infants, and Children program electronic benefit transfer card and the personal identification number for the card.

AB56-SA2,1900b Section 1900b. 253.06 (1) (c) of the statutes is repealed.

AB56-SA2,1901b Section 1901b. 253.06 (1) (cm) of the statutes is amended to read:

AB56-SA2,52,15 253.06 (1) (cm) “Food Direct distribution center" means an entity, other than a vendor, that is under contract with the department under sub. (3m) to distribute authorized approved food to participants.

AB56-SA2,1902b Section 1902b. 253.06 (1) (cp), (cr), (ct) and (cv) of the statutes are created to read:

AB56-SA2,52,20 253.06 (1) (cp) “Electronic benefit transfer” means a method that permits electronic access to Women, Infants, and Children program benefits using a device, approved by the department, with payments made in accordance with ch. 410.

AB56-SA2,52,24 (cr) “Food instrument” means a voucher, check, electronic benefit transfer card, electronic benefit transfer card number and personal identification number, coupon, or other method used by a participant to obtain Women, Infants, and Children program approved foods.

AB56-SA2,53,2 (ct) “Infant formula supplier” means a wholesaler, distributor, retailer, or manufacturer of infant formula.

AB56-SA2,53,6 (cv) “Local agency” means an entity that has a contract with the department to provide services under the Women, Infants, and Children program such as eligibility determination, benefit issuance, and nutritional counseling for participants.

AB56-SA2,1903b Section 1903b. 253.06 (1) (dm) of the statutes is repealed.

AB56-SA2,1904b Section 1904b. 253.06 (1) (dr) and (dv) of the statutes are created to read:

AB56-SA2,53,11 253.06 (1) (dr) “Summary suspension” means an emergency action taken by the department to suspend an authorization under the Women, Infants, and Children program.

AB56-SA2,53,12 (dv) “Trafficking” means doing any of the following:

AB56-SA2,53,15 1. Buying, selling, stealing, or otherwise exchanging for cash or consideration other than approved food Women, Infants, and Children program food instruments or benefits that are issued and accessed via a food instrument.

AB56-SA2,53,17 2. Exchanging firearms, ammunition, explosives, or controlled substances, as defined in 21 USC 802, for a food instrument.

AB56-SA2,53,19 3. Intentionally purchasing and reselling for cash or consideration other than approved food a product that is purchased with a food instrument.

AB56-SA2,53,21 4. Intentionally purchasing with cash or consideration other than approved food a product that was originally purchased with a food instrument.

AB56-SA2,1905b Section 1905b. 253.06 (1) (e) of the statutes is amended to read:

AB56-SA2,53,25 253.06 (1) (e) “Vendor" means a grocery store or pharmacy that sells authorized person that operates one or more stores or pharmacies authorized by the department under sub. (3) to provide approved foods under a retail food delivery system.

AB56-SA2,1906b Section 1906b. 253.06 (1) (f) of the statutes is repealed.

AB56-SA2,1907b Section 1907b. 253.06 (1) (g) of the statutes is created to read:

AB56-SA2,54,5 253.06 (1) (g) “Women, Infants, and Children program” means the federal special supplemental nutrition program for women, infants and children under 42 USC 1786 and this section.

AB56-SA2,1908b Section 1908b. 253.06 (1m) of the statutes is created to read:

AB56-SA2,54,9 253.06 (1m) Program administration. (a) The department may identify an alternate participant as the Women, Infants, and Children program cardholder for purposes of electronic administration of the Women, Infants, and Children program.

AB56-SA2,1909b Section 1909b. 253.06 (3) (a) (intro.) of the statutes is amended to read:

AB56-SA2,54,12 253.06 (3) (a) (intro.) The department may authorize a vendor to accept drafts only if the vendor meets all of the following conditions:

AB56-SA2,1910b Section 1910b. 253.06 (3) (a) 5. of the statutes is created to read:

AB56-SA2,54,20 253.06 (3) (a) 5. The vendor has an electronic benefit transfer-capable cash register system or payment device, approved by the department, that is able to accurately and securely obtain Women, Infants, and Children program food balances associated with the electronic benefit transfer card, maintain the necessary electronic files such as the approved food list, successfully complete Women, Infants, and Children program electronic benefit transfer purchases, and process Women, Infants, and Children program electronic benefit transfer payments.

AB56-SA2,1911b Section 1911b. 253.06 (3) (bg) of the statutes is amended to read:

AB56-SA2,54,25 253.06 (3) (bg) The department may limit the number of vendors that it authorizes under this subsection if the department determines that the number of vendors already authorized under this subsection is sufficient to permit participants to obtain authorized approved food conveniently.

AB56-SA2,1912b Section 1912b. 253.06 (3) (c) of the statutes is amended to read: