SB719: Bill Text

SB719,,57 (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 commissioner 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 commissioner shall do all of the following to implement the 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:

SB719,,58 (a) Become a licensed wholesale distributor, designate another state agency to become a licensed wholesale distributor, or contract with a licensed wholesale distributor.

SB719,,59 (b) Contract with one or more Canadian suppliers that meet the criteria in sub. (1) (c) and (n).

SB719,,60 (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 this state on participating in the program.

SB719,,61 (d) Develop and implement a registration process for health plans and health insurance policies, pharmacies, and health care providers interested in participating in the program.

SB719,,62 (e) Create a publicly accessible source for listing prices of prescription drugs imported under the program.

SB719,,63 (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.

SB719,,64 (g) Establish the audit functions under sub. (1) (n) with a timeline to complete each audit function every 2 years.

SB719,,65 (h) Conduct any other activities determined by the commissioner to be important to successful implementation of the program.

SB719,,66 (5) Report. By January 1 and July 1 of each year, the commissioner shall submit to the joint committee on finance a report including all of the following:

SB719,,67 (a) A list of prescription drugs included in the prescription drug importation program under this section.

SB719,,68 (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.

SB719,,69 (c) The estimated amount of savings to residents of this 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.

SB719,,70 (d) Findings of any audit functions under sub. (1) (n) completed since the date of the previous report under this subsection.

SB719,,71 (6) Rulemaking. The commissioner may promulgate any rules necessary to implement this section.

SB719,13 Section 13. 609.83 of the statutes is amended to read:

SB719,,73 609.83 Coverage of drugs and devices. Limited service health organizations, preferred provider plans, and defined network plans are subject to ss. 632.853, 632.861, and 632.895 (6) (b), (16t), and (16v).

SB719,14 Section 14. 632.863 of the statutes is created to read:

SB719,,75 632.863 Pharmaceutical representatives. (1) Definitions. In this section:

SB719,,76 (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.

SB719,,77 (b) “Pharmaceutical” means a medication that may legally be dispensed only with a valid prescription from a health care professional.

SB719,,78 (c) “Pharmaceutical representative” means an individual who markets or promotes pharmaceuticals to health care professionals on behalf of a pharmaceutical manufacturer for compensation.

SB719,,79 (d) “Wholesale acquisition cost” means the most recently reported manufacturer list or catalog price for a brand-name or generic drug available to wholesalers or direct purchasers in the United States, before application of discounts, rebates, or reductions in price.

SB719,,80 (2) Licensure. (a) No individual may act as a pharmaceutical representative in this state without being licensed by the commissioner as a pharmaceutical representative under this section. In order to obtain a license, the individual shall apply to the commissioner in the form and manner prescribed by the commissioner. The term of a license issued under this paragraph is one year and is renewable. The application to obtain or renew a license shall include all of the following information:

SB719,,81 1. The applicant’s full name, residence address and telephone number, and business address and telephone number.

SB719,,82 2. A description of the type of work in which the applicant will engage.

SB719,,83 3. The fee under s. 601.31 (1) (nv).

SB719,,84 4. An attestation that the applicant meets the professional education requirements under sub. (3).

SB719,,85 5. Proof that the applicant has paid any assessed penalties and fees.

SB719,,86 6. Any other information required by the commissioner.

SB719,,87 (b) The pharmaceutical representative licensed under par. (a) shall report, in writing, to the commissioner any change to the information submitted on an application under par. (a) or any material change to the pharmaceutical representative’s business operations or to any information provided under this section. The pharmaceutical representative shall make the report no later than 4 business days after the change or material change occurs.

SB719,,88 (c) A pharmaceutical representative licensed under par. (a) shall display the pharmaceutical representative’s license during each visit with a health care professional.

SB719,,89 (3) Professional education requirements. (a) In order to become initially licensed under sub. (2) (a), a pharmaceutical representative shall complete a professional education course as determined by the commissioner. A pharmaceutical representative shall, upon request, provide the commissioner with proof of the coursework’s completion.

SB719,,90 (b) In order to renew a license under sub. (2) (a), a pharmaceutical representative shall complete a minimum of 5 hours of continuing professional education courses. A pharmaceutical representative shall, upon request, provide the commissioner with proof of the coursework’s completion.

SB719,,91 (c) The professional education coursework required under pars. (a) and (b) shall include training in ethical standards, whistleblower protections, laws and rules applicable to pharmaceutical marketing, and other subjects that the commissioner may identify by rule.

SB719,,92 (d) The commissioner shall regularly designate courses that fulfill the requirements under this subsection and publish a list of the designated courses.

SB719,,93 (e) The professional education coursework required under this subsection may not be provided by the employer of a pharmaceutical representative or be funded, in any way, by the pharmaceutical industry or a 3rd party funded by the pharmaceutical industry. A provider of a course designated under par. (d) shall disclose any conflict of interest.

SB719,,94 (4) Disclosure to commissioner. (a) No later than June 1 of each year, a pharmaceutical representative licensed under sub. (2) (a) shall provide to the commissioner, in the manner prescribed by the commissioner, all of the following information from the previous calendar year:

SB719,,95 1. The total number of times the pharmaceutical representative contacted health care professionals in this state and the specialties of the health care professionals contacted.

SB719,,96 2. For each contact with a health care professional in this state, the location and duration of the contact, the pharmaceuticals for which the pharmaceutical representative provided information, and the value of any item, including a product sample, compensation, material, or gift, provided to the health care professional.

SB719,,97 (b) The commissioner shall publish the information received under par. (a) on the commissioner’s website in a manner in which individual health care professionals are not identifiable by name or other identifiers.

SB719,,98 (5) Disclosure to health care professionals. During each contact with a health care professional, a pharmaceutical representative licensed under sub. (2) (a) shall disclose the wholesale acquisition cost of any pharmaceutical for which the pharmaceutical representative provides information and the names of at least 3 generic prescription drugs from the same therapeutic class or, if 3 are not available, as many as are available for prescriptive use.

SB719,,99 (6) Ethical standards. The commissioner shall promulgate rules that contain ethical standards for pharmaceutical representatives and shall publish the ethical standards on the commissioner’s website. A pharmaceutical representative licensed under sub. (2) (a) shall comply with the ethical standards contained in the rules and may not do any of the following:

SB719,,100 (a) Engage in deceptive or misleading marketing of a pharmaceutical, including the knowing concealment, suppression, omission, misleading representation, or misstatement of a material fact.

SB719,,101 (b) Use a title or designation that could reasonably lead a licensed health care professional, or an employee or representative of a licensed health care professional, to believe that the pharmaceutical representative is licensed to practice medicine, nursing, dentistry, optometry, pharmacy, or other similar health occupation in this state unless the pharmaceutical representative holds that license to practice.

SB719,,102 (c) Attend a patient examination without the patient’s consent.

SB719,,103 (7) Enforcement. (a) Any individual who violates 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.

SB719,,104 (b) The commissioner may suspend or revoke the license of a pharmaceutical representative who violates this section. A suspended or revoked license may not be reinstated until the pharmaceutical representative remedies all violations related to the suspension or revocation and pays all assessed penalties and fees. A pharmaceutical representative whose license is revoked for any cause may not be issued a license under sub. (2) (a) until at least 2 years after the date of revocation.

SB719,,105 (c) A health care professional who meets with a pharmaceutical representative who does not display the pharmaceutical representative’s license or share the information required under sub. (5) may report the pharmaceutical representative to the commissioner.

SB719,,106 (8) Rules. The commissioner may promulgate rules to implement this section.

SB719,15 Section 15. 632.864 of the statutes is created to read:

SB719,,108 632.864 Pharmacy services administrative organizations. (1) Definitions. In this section:

SB719,,109 (a) “Administrative service” means any of the following:

SB719,,110 1. Assisting with claims.

SB719,,111 2. Assisting with audits.

SB719,,112 3. Providing centralized payment.

SB719,,113 4. Performing certification in a specialized care program.

SB719,,114 5. Providing compliance support.

SB719,,115 6. Setting flat fees for generic drugs.

SB719,,116 7. Assisting with store layout.

SB719,,117 8. Managing inventory.

SB719,,118 9. Providing marketing support.

SB719,,119 10. Providing management and analysis of payment and drug dispensing data.

SB719,,120 11. Providing resources for retail cash cards.

SB719,,121 (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.

SB719,,122 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

SB719,,123 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

SB719,,124 1. Contracts with an independent pharmacy to conduct business on the independent pharmacy’s behalf with a 3rd-party payer.

SB719,,125 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.

SB719,,126 (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.

SB719,,127 (2) Licensure. (a) No person may operate as a pharmacy services administrative organization in this state without being licensed by the commissioner as a pharmacy services administrative organization under this section. In order to obtain a license, the person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application shall include all of the following:

SB719,,128 1. The name, address, telephone number, and federal employer identification number of the applicant.

SB719,,129 2. The name, business address, and telephone number of a contact person for the applicant.

SB719,,130 3. The fee under s. 601.31 (1) (nw).

SB719,,131 4. Evidence of financial responsibility of at least $1,000,000.

SB719,,132 5. Any other information required by the commissioner.

SB719,,133 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

SB719,,134 (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:

SB719,,135 1. Provides pharmacy services.

SB719,,136 2. Provides prescription drug or device services.

SB719,,137 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

SB719,,138 (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).

SB719,,139 (4) Rules. The commissioner may promulgate rules to implement this section.

SB719,16 Section 16. 632.865 (2m) of the statutes is created to read:

SB719,,141 632.865 (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.

SB719,,142 (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:

SB719,,143 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

SB719,,144 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

SB719,,145 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.