SB50,5,2321601.31 (1) (nw) For issuing or renewing a license as a pharmacy services 22administrative organization under s. 601.57, an amount to be set by the 23commissioner by rule. SB50,13
1Section 13. 601.41 (14) of the statutes is created to read: SB50,6,72601.41 (14) Value-based diabetes medication pilot project. The 3commissioner shall develop a pilot project to direct a pharmacy benefit manager, as 4defined in s. 632.865 (1) (c), and a pharmaceutical manufacturer to create a value-5based, sole-source arrangement to reduce the costs of prescription medication used 6to treat diabetes. The commissioner may promulgate rules to implement this 7subsection. SB50,148Section 14. 601.415 (14) of the statutes is created to read: SB50,6,149601.415 (14) Patient pharmacy benefits tool. (a) From the appropriation 10under s. 20.145 (1) (a), beginning in the 2026-27 fiscal year, the office shall award 11grants in a total amount of up to $500,000 each fiscal year to health care providers 12to develop and implement a tool for prescribers to disclose the cost of prescription 13drugs for patients. The tool must be usable by physicians and other prescribers to 14determine the cost of prescription drugs for their patients. SB50,6,1715(b) Any health care provider that receives a grant under par. (a) shall 16contribute matching funds equal to at least 50 percent of the grant amount 17awarded. SB50,1518Section 15. 601.56 of the statutes is created to read: SB50,6,2019601.56 Pharmaceutical representatives. (1) Definitions. In this 20section: SB50,6,2321(a) “Health care professional” means a physician or other health care 22practitioner who is licensed to provide health care services or to prescribe 23pharmaceutical or biologic products. SB50,7,2
1(b) “Pharmaceutical” means a medication that may legally be dispensed only 2with a valid prescription from a health care professional. SB50,7,53(c) “Pharmaceutical representative” means an individual who markets or 4promotes pharmaceuticals to health care professionals on behalf of a 5pharmaceutical manufacturer for compensation. SB50,7,96(d) “Wholesale acquisition cost” means the most recently reported 7manufacturer list or catalog price for a brand-name or generic drug available to 8wholesalers or direct purchasers in the United States, before application of 9discounts, rebates, or reductions in price. SB50,7,1610(2) Licensure. (a) No individual may act as a pharmaceutical representative 11in this state without being licensed by the commissioner as a pharmaceutical 12representative under this section. In order to obtain or renew a license, the 13individual shall apply to the commissioner in the form and manner prescribed by 14the commissioner. The term of a license issued under this paragraph is one year 15and is renewable. The application to obtain or renew a license shall include all of 16the following information: SB50,7,18171. The applicant’s full name, residence address and telephone number, and 18business address and telephone number. SB50,7,19192. A description of the type of work in which the applicant will engage. SB50,7,20203. The fee under s. 601.31 (1) (nv). SB50,7,22214. An attestation that the applicant meets the professional education 22requirements under sub. (3). SB50,7,23235. Proof that the applicant has paid any assessed penalties and fees. SB50,8,1
16. Any other information required by the commissioner by rule. SB50,8,72(b) The pharmaceutical representative licensed under par. (a) shall notify the 3commissioner in writing of any change to the information submitted on an 4application under par. (a) or any material change to the pharmaceutical 5representative’s business operations or to any other information provided under 6this section. The pharmaceutical representative shall provide the notification no 7later than 4 business days after the change or material change occurs. SB50,8,108(c) A pharmaceutical representative licensed under par. (a) shall display the 9pharmaceutical representative’s license during each visit with a health care 10professional. SB50,8,1511(3) Professional education requirements. (a) In order to become initially 12licensed under sub. (2) (a), a pharmaceutical representative shall complete a 13professional education course approved by the commissioner. A pharmaceutical 14representative shall, upon request, provide the commissioner with proof that he or 15she has completed an approved professional education course. SB50,8,2116(b) In order to renew a license under sub. (2) (a), a pharmaceutical 17representative shall complete a minimum of 5 hours of continuing professional 18education courses. A pharmaceutical representative who has renewed a license 19under sub. (2) (a) shall, upon request, provide the commissioner with proof that he 20or she has completed a minimum of 5 hours of continuing professional education 21courses. SB50,9,222(c) The professional education coursework required under pars. (a) and (b) 23shall include training in ethical standards, whistleblower protections, laws and
1rules applicable to pharmaceutical marketing, and other subjects that the 2commissioner identifies by rule. SB50,9,43(d) The commissioner shall regularly designate courses that fulfill the 4requirements under this subsection and publish a list of the designated courses. SB50,9,95(e) The professional education coursework required under this subsection may 6not be provided by the employer of a pharmaceutical representative or be funded, in 7any way, by the pharmaceutical industry or a 3rd party funded by the 8pharmaceutical industry. A provider of a course designated under par. (d) shall 9disclose any conflict of interest to the commissioner. SB50,9,1310(4) Disclosure to commissioner. (a) No later than June 1 of each year, a 11pharmaceutical representative licensed under sub. (2) (a) shall provide to the 12commissioner, in the manner prescribed by the commissioner, all of the following 13information from the previous calendar year: SB50,9,16141. The total number of times the pharmaceutical representative contacted 15health care professionals in this state and the specialties of the health care 16professionals contacted. SB50,9,20172. For each contact with a health care professional in this state, the location 18and duration of the contact, the pharmaceuticals for which the pharmaceutical 19representative provided information, and the value of any item, including a product 20sample, compensation, material, or gift, provided to the health care professional. SB50,9,2321(b) The commissioner shall publish the information received under par. (a) on 22the commissioner’s website in a manner in which individual health care 23professionals are not identifiable by name or other identifiers. SB50,10,6
1(5) Disclosure to health care professionals. During each contact with a 2health care professional, a pharmaceutical representative licensed under sub. (2) 3(a) shall disclose the wholesale acquisition cost of any pharmaceutical for which the 4pharmaceutical representative provides information and the names of at least 3 5generic prescription drugs from the same therapeutic class or, if 3 are not available, 6as many as are available for prescriptive use. SB50,10,117(6) Ethical standards. The commissioner shall promulgate rules that 8contain ethical standards for pharmaceutical representatives and shall publish the 9ethical standards on the commissioner’s website. A pharmaceutical representative 10licensed under sub. (2) (a) shall comply with the ethical standards contained in the 11rules and may not do any of the following: SB50,10,1412(a) Engage in deceptive or misleading marketing of a pharmaceutical, 13including the knowing concealment, suppression, omission, misleading 14representation, or misstatement of a material fact. SB50,10,1915(b) Use a title or designation that could reasonably lead a licensed health care 16professional, or an employee or representative of a licensed health care professional, 17to believe that the pharmaceutical representative is licensed to practice medicine, 18nursing, dentistry, optometry, pharmacy, or other similar health occupation in this 19state unless the pharmaceutical representative holds that license to practice. SB50,10,2020(c) Attend a patient examination without the patient’s consent. SB50,10,2321(7) Enforcement. (a) Any individual who violates this section shall be 22required to forfeit not less than $1,000 nor more than $3,000 for each offense. Each 23day of continued violation constitutes a separate offense. SB50,11,6
1(b) The commissioner may suspend or revoke the license of a pharmaceutical 2representative who violates this section. A suspended or revoked license may not be 3reinstated until the pharmaceutical representative remedies all violations related 4to the suspension or revocation and pays all assessed penalties and fees. A 5pharmaceutical representative whose license is revoked for any cause may not be 6issued a license under sub. (2) (a) until at least 2 years after the date of revocation. SB50,11,107(c) A health care professional who meets with a pharmaceutical 8representative who does not display the pharmaceutical representative’s license or 9share the information required under sub. (5) may report the pharmaceutical 10representative to the commissioner. SB50,11,1211(8) Rules. The commissioner may promulgate rules to implement this 12section. SB50,1613Section 16. 601.57 of the statutes is created to read: SB50,11,1514601.57 Pharmacy services administrative organizations. (1) 15Definitions. In this section: SB50,11,1616(a) “Administrative service” means any of the following: SB50,11,17171. Assisting with claims. SB50,11,18182. Assisting with audits. SB50,11,19193. Providing centralized payment. SB50,11,20204. Performing certification in a specialized care program. SB50,11,21215. Providing compliance support. SB50,11,22226. Setting flat fees for generic drugs. SB50,11,23237. Assisting with store layout. SB50,12,1
18. Managing inventory. SB50,12,229. Providing marketing support. SB50,12,4310. Providing management and analysis of payment and drug dispensing 4data. SB50,12,5511. Providing resources for retail cash cards. SB50,12,86(b) “Independent pharmacy” means a pharmacy operating in this state that is 7licensed under s. 450.06 or 450.065 and is under common ownership with no more 8than 2 other pharmacies. SB50,12,99(c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c). SB50,12,1110(d) “Pharmacy services administrative organization” means an entity 11operating in this state that does all of the following: SB50,12,13121. Contracts with an independent pharmacy to conduct business on the 13independent pharmacy’s behalf with a 3rd-party payer. SB50,12,16142. Provides at least one administrative service to an independent pharmacy 15and negotiates and enters into a contract with a 3rd-party payer or pharmacy 16benefit manager on behalf of the independent pharmacy. SB50,12,1917(e) “Third-party payer” means an entity, including a plan sponsor, health 18maintenance organization, or insurer, operating in this state that pays or insures 19health, medical, or prescription drug expenses on behalf of beneficiaries. SB50,13,220(2) Licensure. (a) No person may operate as a pharmacy services 21administrative organization in this state without being licensed by the 22commissioner as a pharmacy services administrative organization under this 23section. In order to obtain or renew a license, the person shall apply to the
1commissioner in the form and manner prescribed by the commissioner. The 2application shall include all of the following: SB50,13,431. The name, address, telephone number, and federal employer identification 4number of the applicant. SB50,13,652. The name, business address, and telephone number of a contact person for 6the applicant. SB50,13,773. The fee under s. 601.31 (1) (nw). SB50,13,884. Evidence of financial responsibility of at least $1,000,000. SB50,13,995. Any other information required by the commissioner by rule. SB50,13,1110(b) The term of a license issued under par. (a) shall be 2 years from the date of 11issuance. SB50,13,1512(3) Disclosure to the commissioner. (a) A pharmacy services 13administrative organization licensed under sub. (2) shall disclose to the 14commissioner the extent of any ownership or control of the pharmacy services 15administrative organization by an entity that does any of the following: SB50,13,16161. Provides pharmacy services. SB50,13,17172. Provides prescription drug or device services. SB50,13,19183. Manufactures, sells, or distributes prescription drugs, biologicals, or 19medical devices. SB50,13,2220(b) A pharmacy services administrative organization licensed under sub. (2) 21shall notify the commissioner in writing within 5 days of any material change in its 22ownership or control relating to an entity described in par. (a). SB50,14,2
1(4) Rules. The commissioner may promulgate rules to implement this 2section. SB50,173Section 17. 601.575 of the statutes is created to read: SB50,14,94601.575 Prescription drug importation program. (1) Importation 5program requirements. The commissioner, in consultation with persons 6interested in the sale and pricing of prescription drugs and appropriate officials 7and agencies of the federal government, shall design and implement a prescription 8drug importation program for the benefit of residents of this state, that generates 9savings for residents, and that satisfies all of the following: SB50,14,1210(a) The commissioner shall designate a state agency to become a licensed 11wholesale distributor or to contract with a licensed wholesale distributor and shall 12seek federal certification and approval to import prescription drugs. SB50,14,1413(b) The program shall comply with relevant requirements of 21 USC 384, 14including safety and cost savings requirements. SB50,14,1615(c) The program shall import prescription drugs from Canadian suppliers 16regulated under any appropriate Canadian or provincial laws. SB50,14,1817(d) The program shall have a process to sample the purity, chemical 18composition, and potency of imported prescription drugs. SB50,14,2219(e) The program shall import only those prescription drugs for which 20importation creates substantial savings for residents of this state and only those 21prescription drugs that are not brand-name drugs and that have fewer than 4 22competitor prescription drugs in the United States. SB50,15,2
1(f) The commissioner shall ensure that prescription drugs imported under the 2program are not distributed, dispensed, or sold outside of this state. SB50,15,33(g) The program shall ensure all of the following: SB50,15,541. Participation by any pharmacy or health care provider in the program is 5voluntary. SB50,15,762. Any pharmacy or health care provider participating in the program has the 7appropriate license or other credential in this state. SB50,15,1083. Any pharmacy or health care provider participating in the program charges 9a consumer or health plan the actual acquisition cost of the imported prescription 10drug that is dispensed. SB50,15,1411(h) The program shall ensure that a payment by a health plan or health 12insurance policy for a prescription drug imported under the program reimburses no 13more than the actual acquisition cost of the imported prescription drug that is 14dispensed. SB50,15,1615(i) The program shall ensure that any health plan or health insurance policy 16participating in the program does all of the following: SB50,15,18171. Maintains a formulary and claims payment system with current 18information on prescription drugs imported under the program. SB50,15,21192. Bases cost-sharing amounts for participants or insureds under the plan or 20policy on no more than the actual acquisition cost of the prescription drug imported 21under the program that is dispensed to the participant or insured. SB50,16,2223. Demonstrates to the commissioner or a state agency designated by the
1commissioner how premiums under the plan or policy are affected by savings on 2prescription drugs imported under the program.
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