Amendment AA16-ASA2-AB50

AB50-ASA2-AA16,65,8 2. Assisting with audits.

AB50-ASA2-AA16,65,9 3. Providing centralized payment.

AB50-ASA2-AA16,65,10 4. Performing certification in a specialized care program.

AB50-ASA2-AA16,65,11 5. Providing compliance support.

AB50-ASA2-AA16,65,12 6. Setting flat fees for generic drugs.

AB50-ASA2-AA16,65,13 7. Assisting with store layout.

AB50-ASA2-AA16,65,14 8. Managing inventory.

AB50-ASA2-AA16,65,15 9. Providing marketing support.

AB50-ASA2-AA16,65,17 10. Providing management and analysis of payment and drug dispensing data.

AB50-ASA2-AA16,65,18 11. Providing resources for retail cash cards.

AB50-ASA2-AA16,65,21 (b) “Independent pharmacy” means a pharmacy operating in this state that is licensed under s. 450.06 or 450.065 and is under common ownership with no more than 2 other pharmacies.

AB50-ASA2-AA16,65,22 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA16,66,2 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

AB50-ASA2-AA16,66,4 1. Contracts with an independent pharmacy to conduct business with a 3rd- party payer on the independent pharmacy’s behalf.

AB50-ASA2-AA16,66,7 2. Provides at least one administrative service to an independent pharmacy and negotiates and enters into a contract with a 3rd-party payer or pharmacy benefit manager on behalf of the independent pharmacy.

AB50-ASA2-AA16,66,10 (e) “Third-party payer” means an entity, including a plan sponsor, health maintenance organization, or insurer, operating in this state that pays or insures health, medical, or prescription drug expenses on behalf of beneficiaries.

AB50-ASA2-AA16,66,17 (2) Licensure. (a) Beginning on the first day of the 12th month beginning after the effective date of this paragraph .... [LRB inserts date], no person may operate as a pharmacy services administrative organization without being licensed by the commissioner as a pharmacy services administrative organization under this subsection. In order to obtain a license under this paragraph, the person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application for licensure under this paragraph shall include all of the following:

AB50-ASA2-AA16,66,19 1. The name, address, telephone number, and federal employer identification number of the applicant.

AB50-ASA2-AA16,66,21 2. The name, business address, and telephone number of a contact person for the applicant.

AB50-ASA2-AA16,66,22 3. The fee under s. 601.31 (1) (nw).

AB50-ASA2-AA16,66,23 4. Evidence of financial responsibility of at least $1,000,000.

AB50-ASA2-AA16,67,1 5. Any other information required by the commissioner.

AB50-ASA2-AA16,67,3 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

AB50-ASA2-AA16,67,8 (c) A license issued under par. (a) may be renewed. Renewal applications shall be submitted to the commissioner on a form provided by the commissioner and shall include all the items described in par. (a) 1. to 5. A renewal application under this paragraph may not be submitted more than 90 days prior to the end of the term of the license being renewed.

AB50-ASA2-AA16,67,12 (3) Disclosure to the commissioner. (a) A pharmacy services administrative organization licensed under sub. (2) shall disclose to the commissioner the extent of any ownership or control of the pharmacy services administrative organization by an entity that does any of the following:

AB50-ASA2-AA16,67,13 1. Provides pharmacy services.

AB50-ASA2-AA16,67,14 2. Provides prescription drug or device services.

AB50-ASA2-AA16,67,16 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

AB50-ASA2-AA16,67,19 (b) A pharmacy services administrative organization licensed under sub. (2) shall notify the commissioner in writing within 5 days of any material change in its ownership or control relating to an entity described in par. (a).

AB50-ASA2-AA16,67,21 (4) Rules. The commissioner may promulgate rules to implement this section.”.

AB50-ASA2-AA16,67,22 24. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,67,23 “Section 74. 601.31 (1) (nv) of the statutes is created to read:

AB50-ASA2-AA16,68,2 601.31 (1) (nv) For issuing or renewing a license as a pharmaceutical representative under s. 632.863, an amount to be set by the commissioner by rule.

AB50-ASA2-AA16,75 Section 75. 632.863 of the statutes is created to read:

AB50-ASA2-AA16,68,5 632.863 Pharmaceutical representatives. (1) Definitions. In this section:

AB50-ASA2-AA16,68,8 (a) “Health care professional” means a physician or other health care practitioner who is licensed to provide health care services or to prescribe pharmaceutical or biologic products.

AB50-ASA2-AA16,68,10 (b) “Pharmaceutical” means a medication that may legally be dispensed only with a valid prescription from a health care professional.

AB50-ASA2-AA16,68,13 (c) “Pharmaceutical representative” means an individual who markets or promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical manufacturer for compensation.

AB50-ASA2-AA16,68,21 (2) Licensure. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmaceutical representative in this state without being licensed by the commissioner as a pharmaceutical representative under this subsection. In order to obtain a license under this subsection, the individual shall apply to the commissioner in the form and manner prescribed by the commissioner and shall pay the fee under s. 601.31 (1) (nv). The term of a license issued under this subsection is one year, and the license is renewable.

AB50-ASA2-AA16,69,2 (3) Display of license. A pharmaceutical representative licensed under sub. (2) shall display the pharmaceutical representative’s license during each visit with a health care professional.

AB50-ASA2-AA16,69,6 (4) Enforcement. (a) Any individual who violates this section or any rules promulgated under this section shall be fined not less than $1,000 nor more than $3,000 for each offense. Each day of continued violation constitutes a separate offense.

AB50-ASA2-AA16,69,11 (b) The commissioner may suspend or revoke the license of a pharmaceutical representative who violates this section or any rules promulgated under this section. A suspended or revoked license under this paragraph may not be reinstated until the pharmaceutical representative remedies all violations related to the suspension or revocation and pays all assessed penalties and fees.

AB50-ASA2-AA16,69,14 (5) Rules. The commissioner shall promulgate rules to implement this section, including rules that require pharmaceutical representatives to complete continuing educational coursework as a condition of licensure.”.

AB50-ASA2-AA16,69,15 25. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,69,16 “Section 76. 601.31 (1) (mv) of the statutes is created to read:

AB50-ASA2-AA16,69,19 601.31 (1) (mv) For initial issuance or renewal of a license as a pharmacy benefit management broker or consultant under s. 628.495, amounts set by the commissioner by rule.

AB50-ASA2-AA16,77 Section 77. 628.495 of the statutes is created to read:

AB50-ASA2-AA16,69,23 628.495 Pharmacy benefit management broker and consultant licenses. (1) Definition. In this section, “pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB50-ASA2-AA16,70,5 (2) License required. Beginning on the first day of the 12th month beginning after the effective date of this subsection .... [LRB inserts date], no individual may act as a pharmacy benefit management broker or consultant and no individual may act to procure the services of a pharmacy benefit manager on behalf of a client without being licensed by the commissioner under this section.

AB50-ASA2-AA16,70,8 (3) Rules. The commissioner may promulgate rules to establish criteria and procedures for initial licensure and renewal of licensure and to implement licensure under this section.”.

AB50-ASA2-AA16,70,9 26. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,70,10 “Section 78. 632.865 (2m) of the statutes is created to read:

AB50-ASA2-AA16,70,14 632.865 (2m) Fiduciary duty and disclosures to health benefit plan sponsors. (a) A pharmacy benefit manager owes a fiduciary duty to the health benefit plan sponsor to act according to the health benefit plan sponsor’s instructions and in the best interests of the health benefit plan sponsor.

AB50-ASA2-AA16,70,18 (b) A pharmacy benefit manager shall annually provide, no later than the date and using the method prescribed by the commissioner by rule, the health benefit plan sponsor all of the following information from the previous calendar year:

AB50-ASA2-AA16,70,20 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

AB50-ASA2-AA16,70,22 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

AB50-ASA2-AA16,71,3 3. From the amounts received from all drug manufacturers, the amounts retained by the pharmacy benefit manager, and not passed through to the health benefit plan sponsor, that are related to the health benefit plan sponsor’s claims or bona fide service fees.

AB50-ASA2-AA16,71,8 4. The amounts, including pharmacy access and audit recovery fees, received from all pharmacies that are in the pharmacy benefit manager’s network or have a contract to be in the network and, from these amounts, the amount retained by the pharmacy benefit manager and not passed through to the health benefit plan sponsor.”.

AB50-ASA2-AA16,71,9 27. At the appropriate places, insert all of the following:

AB50-ASA2-AA16,71,10 “Section 79. 601.575 of the statutes is created to read:

AB50-ASA2-AA16,71,16 601.575 Prescription drug importation program. (1) Importation program requirements. The commissioner, in consultation with persons interested in the sale and pricing of prescription drugs and appropriate officials and agencies of the federal government, shall design and implement a prescription drug importation program for the benefit of residents of this state, that generates savings for residents, and that satisfies all of the following:

AB50-ASA2-AA16,71,19 (a) The commissioner 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.

AB50-ASA2-AA16,71,21 (b) The program shall comply with relevant requirements of 21 USC 384, including safety and cost savings requirements.

AB50-ASA2-AA16,71,23 (c) The program shall import prescription drugs from Canadian suppliers regulated under any appropriate Canadian or provincial laws.

AB50-ASA2-AA16,72,2 (d) The program shall have a process to sample the purity, chemical composition, and potency of imported prescription drugs.

AB50-ASA2-AA16,72,6 (e) The program shall import only those prescription drugs for which importation creates substantial savings for residents of this 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.

AB50-ASA2-AA16,72,8 (f) The commissioner shall ensure that prescription drugs imported under the program are not distributed, dispensed, or sold outside of this state.

AB50-ASA2-AA16,72,9 (g) The program shall ensure all of the following:

AB50-ASA2-AA16,72,11 1. Participation by any pharmacy or health care provider in the program is voluntary.

AB50-ASA2-AA16,72,13 2. Any pharmacy or health care provider participating in the program has the appropriate license or other credential in this state.

AB50-ASA2-AA16,72,16 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.

AB50-ASA2-AA16,72,20 (h) The program 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.

AB50-ASA2-AA16,72,22 (i) The program shall ensure that any health plan or health insurance policy participating in the program does all of the following:

AB50-ASA2-AA16,73,2 1. Maintains a formulary and claims payment system with current information on prescription drugs imported under the program.

AB50-ASA2-AA16,73,5 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.

AB50-ASA2-AA16,73,8 3. Demonstrates to the commissioner or a state agency designated by the commissioner how premiums under the plan or policy are affected by savings on prescription drugs imported under the program.

AB50-ASA2-AA16,73,11 (j) Any wholesale distributor importing prescription drugs under the program shall limit its profit margin to the amount established by the commissioner or a state agency designated by the commissioner.

AB50-ASA2-AA16,73,13 (k) The program may not import any generic prescription drug that would violate federal patent laws on branded products in the United States.

AB50-ASA2-AA16,73,18 (L) The program shall comply with tracking and tracing requirements of 21 USC 360eee and 360eee-1, to the extent practical and feasible, before the prescription drug to be imported comes into the possession of this state’s wholesale distributor and fully after the prescription drug to be imported is in the possession of this state’s wholesale distributor.

AB50-ASA2-AA16,73,20 (m) The program shall establish a fee or other mechanism to finance the program that does not jeopardize significant savings to residents of this state.

AB50-ASA2-AA16,73,21 (n) The program shall have an audit function that ensures all of the following:

AB50-ASA2-AA16,73,23 1. The commissioner has a sound methodology to determine the most cost- effective prescription drugs to include in the program.

AB50-ASA2-AA16,74,2 2. The commissioner has a process in place to select Canadian suppliers that are high quality, high performing, and in full compliance with Canadian laws.

AB50-ASA2-AA16,74,4 3. Prescription drugs imported under the program are pure, unadulterated, potent, and safe.

AB50-ASA2-AA16,74,5 4. The program is complying with the requirements of this subsection.

AB50-ASA2-AA16,74,7 5. The program is adequately financed to support administrative functions of the program while generating significant cost savings to residents of this state.

AB50-ASA2-AA16,74,9 6. The program does not put residents of this state at a higher risk than if the program did not exist.

AB50-ASA2-AA16,74,11 7. The program provides and is projected to continue to provide substantial cost savings to residents of this state.

AB50-ASA2-AA16,74,14 (2) Anticompetitive behavior. The commissioner, in consultation with the attorney general, shall identify the potential for and monitor anticompetitive behavior in industries affected by a prescription drug importation program.