Amendment SSA1-AB68

AB68-SSA1,1354,23 (2) Licensure. (a) No individual may act as a pharmaceutical representative in this state without obtaining a pharmaceutical representative license. In order to obtain a license, an individual shall apply to the commissioner, on a form prescribed by the commissioner. A license issued under this paragraph shall be renewed on an annual basis. The application to obtain or renew a license shall include all of the following information:

AB68-SSA1,1354,25 1. The applicant's full name, residence address and telephone number, and business address and telephone number.

AB68-SSA1,1355,1 2. A description of the type of work in which the applicant will engage.

AB68-SSA1,1355,2 3. The fee under s. 601.31 (1) (nv).

AB68-SSA1,1355,4 4. An attestation that the applicant meets the professional education requirements under sub. (3).

AB68-SSA1,1355,5 5. Proof that the applicant has paid any assessed penalties and fees.

AB68-SSA1,1355,6 6. Any other information required by the commissioner.

AB68-SSA1,1355,11 (b) The pharmaceutical representative shall report, in writing, to the commissioner any change to the information submitted on the application under par. (a) or any material change to the pharmaceutical representative's business operations or to any information provided under this section. The report shall be made no later than 4 business days after the change or material change occurs.

AB68-SSA1,1355,13 (c) A pharmaceutical representative shall display his or her license during each visit with a health care professional.

AB68-SSA1,1355,18 (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.

AB68-SSA1,1355,22 (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.

AB68-SSA1,1356,2 (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 areas that the commissioner may identify by rule.

AB68-SSA1,1356,4 (d) The commissioner shall regularly designate courses that fulfill the requirements under this subsection and publish a list of the designated courses.

AB68-SSA1,1356,9 (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.

AB68-SSA1,1356,13 (4) Disclosure to commissioner. (a) No later than June 1 of each year, a pharmaceutical representative shall provide to the commissioner, in the manner prescribed by the commissioner, all of the following information from the previous calendar year:

AB68-SSA1,1356,16 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.

AB68-SSA1,1356,20 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 provides information, and the value of any item, including a product sample, compensation, material, or gift, provided to the health care professional.

AB68-SSA1,1356,23 (b) The commissioner shall publish the information provided under par. (a) on the commissioner's Internet site in a manner in which individual health care professionals are not identifiable by name or other identifiers.

AB68-SSA1,1357,4 (5) Disclosure to health care professionals. During each contact with a health care professional, a pharmaceutical representative 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.

AB68-SSA1,1357,9 (6) Ethical standards. The commissioner shall promulgate a rule that contains ethical standards for pharmaceutical representatives and shall publish the ethical standards on the commissioner's Internet site. In addition to the ethical standards contained in the rule, a pharmaceutical representative may not do any of the following:

AB68-SSA1,1357,12 (a) Engage in deceptive or misleading marketing of a pharmaceutical, including the knowing concealment, suppression, omission, misleading representation, or misstatement of a material fact.

AB68-SSA1,1357,17 (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 a license to practice.

AB68-SSA1,1357,18 (c) Attend a patient examination without the patient's consent.

AB68-SSA1,1357,21 (7) Enforcement. (a) Any individual violating this section shall be fined not less than $1,000 nor more than $3,000 for each offense. Each day the violation continues shall constitute a separate offense.

AB68-SSA1,1358,2 (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 all violations related to the suspension or revocation have been remedied and all assessed penalties and fees have been paid. An individual whose pharmaceutical representative 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.

AB68-SSA1,1358,6 (c) A health care professional who meets with a pharmaceutical representative who does not display his or her license or share the information required under sub. (5) may report the pharmaceutical representative to the commissioner for further action.

AB68-SSA1,1358,7 (8) Rules. The commissioner may promulgate rules to implement this section.

AB68-SSA1,2997 Section 2997. 632.864 of the statutes is created to read:

AB68-SSA1,1358,10 632.864 Pharmacy services administrative organizations. (1) Definitions. In this section:

AB68-SSA1,1358,11 (a) “Administrative service” means any of the following:

AB68-SSA1,1358,12 1. Assisting with claims.

AB68-SSA1,1358,13 2. Assisting with audits.

AB68-SSA1,1358,14 3. Providing centralized payment.

AB68-SSA1,1358,15 4. Performing certification in a specialized care program.

AB68-SSA1,1358,16 5. Providing compliance support.

AB68-SSA1,1358,17 6. Setting flat fees for generic drugs.

AB68-SSA1,1358,18 7. Assisting with store layout.

AB68-SSA1,1358,19 8. Managing inventory.

AB68-SSA1,1358,20 9. Providing marketing support.

AB68-SSA1,1358,21 10. Providing management and analysis of payment and drug dispensing data.

AB68-SSA1,1358,22 11. Providing resources for retail cash cards.

AB68-SSA1,1358,25 (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.

AB68-SSA1,1359,1 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68-SSA1,1359,3 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

AB68-SSA1,1359,5 1. Contracts with an independent pharmacy to conduct business on the pharmacy's behalf with a 3rd-party payer.

AB68-SSA1,1359,8 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 pharmacy.

AB68-SSA1,1359,11 (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.

AB68-SSA1,1359,16 (2) Licensure. (a) A person may not operate as a pharmacy services administrative organization in this state without a pharmacy services administrative organization license. In order to obtain a license, a person shall apply to the commissioner in the form and manner prescribed by the commissioner. The application shall include all of the following:

AB68-SSA1,1359,18 1. The name, address, telephone number, and federal employer identification number of the applicant.

AB68-SSA1,1359,20 2. The name, business address, and telephone number of a contact person for the applicant.

AB68-SSA1,1359,21 3. The fee under s. 601.31 (1) (nw).

AB68-SSA1,1359,22 4. Evidence of financial responsibility of at least $1,000,000.

AB68-SSA1,1359,23 5. Any other information required by the commissioner.

AB68-SSA1,1359,25 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

AB68-SSA1,1360,4 (3) Disclosure to the commissioner. (a) A pharmacy services administrative organization 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:

AB68-SSA1,1360,5 1. Provides pharmacy services.

AB68-SSA1,1360,6 2. Provides prescription drug or device services.

AB68-SSA1,1360,8 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

AB68-SSA1,1360,11 (b) A pharmacy services administrative organization 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).

AB68-SSA1,1360,12 (4) Rules. The commissioner may promulgate rules to implement this section.

AB68-SSA1,2998 Section 2998. 632.865 (2m) of the statutes is created to read:

AB68-SSA1,1360,17 632.865 (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.

AB68-SSA1,1360,20 (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:

AB68-SSA1,1360,22 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

AB68-SSA1,1360,24 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

AB68-SSA1,1361,4 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.

AB68-SSA1,1361,9 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.

AB68-SSA1,2999 Section 2999. 632.8655 of the statutes is created to read:

AB68-SSA1,1361,11 632.8655 Hospital drug cost reporting. (1) Definitions. In this section:

AB68-SSA1,1361,13 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68-SSA1,1361,15 (b) “Covered hospital” means an entity described in 42 USC 256b (a) (4) (L) to (N) that participates in the federal drug pricing program under 42 USC 256b.

AB68-SSA1,1361,16 (c) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68-SSA1,1361,20 (d) “Margin” means, for a covered hospital, the difference between the net cost of a brand-name drug or generic drug covered under the federal drug pricing program under 42 USC 256b and the net payment by the covered hospital for that brand-name drug or generic drug.

AB68-SSA1,1361,22 (e) “Net payment” means the amount paid for a brand-name drug or generic drug after all discounts and rebates have been applied.

AB68-SSA1,1362,2 (2) Hospital margin spending. By March 1 annually, each covered hospital operating in this state shall report to the commissioner the per unit margin for each drug covered under the federal drug pricing program under 42 USC 256b dispensed in the previous year multiplied by the number of units dispensed at that margin and how the margin revenue was used.

AB68-SSA1,1362,8 (3) Public reporting. The commissioner shall publicly post covered hospital documentation of how each hospital spends the margin revenue. The commissioner shall analyze data collected under this section and publish annually a report including an analysis on hospital-specific margins and how that revenue is spent or allocated on a hospital-specific basis. The commissioner shall keep any trade secret or proprietary information confidential.

AB68-SSA1,3000 Section 3000. 632.8665 of the statutes is created to read:

AB68-SSA1,1362,11 632.8665 Prescription drug cost reporting. (1) Definitions. In this section:

AB68-SSA1,1362,13 (a) “Brand-name drug” means a prescription drug approved under 21 USC 355 (b) or 42 USC 262.

AB68-SSA1,1362,14 (b) “Generic drug” means a prescription drug approved under 21 USC 355 (j).

AB68-SSA1,1362,17 (c) “Manufacturer” has the meaning given in s. 450.01 (12). “Manufacturer” does not include an entity that is engaged only in the dispensing, as defined in s. 450.01 (7), of a brand-name drug or generic drug.

AB68-SSA1,1362,21 (d) “Manufacturer-sponsored assistance program” means a program offered by a manufacturer or an intermediary under contract with a manufacturer through which a brand-name drug or generic drug is provided to a patient at no charge or at a discount.

AB68-SSA1,1362,22 (e) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68-SSA1,1363,2 (f) “Pharmacy services administrative organization” means an entity that provides contracting and other administrative services to a pharmacy to assist the pharmacy in interactions with a 3rd-party payer, pharmacy benefit manager, wholesale drug distributor, or other entity.

AB68-SSA1,1363,6 (g) “Wholesale acquisition cost” means the most recently reported manufacturer list or catalog price for a brand-name drug or generic drug available to wholesalers or direct purchasers in the United States, before application of discounts, rebates, or reductions in price.

AB68-SSA1,1363,12 (2) Price increase or introduction notice; justification report. (a) A manufacturer shall notify the commissioner if it is increasing the wholesale acquisition cost of a brand-name drug on the market in this state by more than 10 percent or by more than $10,000 during any 12-month period or if it intends to introduce to market in this state a brand-name drug that has an annual wholesale acquisition cost of $30,000 or more.

AB68-SSA1,1363,16 (b) A manufacturer shall notify the commissioner if it is increasing the wholesale acquisition cost of a generic drug by more than 25 percent or by more than $300 during any 12-month period or if it intends to introduce to market a generic drug that has an annual wholesale acquisition cost of $3,000 or more.

AB68-SSA1,1363,22 (c) The manufacturer shall provide the notice under par. (a) or (b) in writing at least 30 days before the planned effective date of the cost increase or drug introduction with a justification that includes all documents and research related to the manufacturer's selection of the cost increase or introduction price and a description of life cycle management, market competition and context, and estimated value or cost-effectiveness of the product.

AB68-SSA1,1364,2 (3) Net prices paid by pharmacy benefit managers. By March 1 annually, the manufacturer shall report to the commissioner the value of price concessions, expressed as a percentage of the wholesale acquisition cost, provided to each pharmacy benefit manager for each drug sold in this state.