AB68: Bill Text

AB68,1537,25 (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:

AB68,1538,3 (a) Engage in deceptive or misleading marketing of a pharmaceutical, including the knowing concealment, suppression, omission, misleading representation, or misstatement of a material fact.

AB68,1538,8 (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.

AB68,1538,9 (c) Attend a patient examination without the patient's consent.

AB68,1538,12 (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.

AB68,1538,18 (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.

AB68,1538,22 (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.

AB68,1538,23 (8) Rules. The commissioner may promulgate rules to implement this section.

AB68,2958 Section 2958. 632.864 of the statutes is created to read:

AB68,1539,2 632.864 Pharmacy services administrative organizations. (1) Definitions. In this section:

AB68,1539,3 (a) “Administrative service” means any of the following:

AB68,1539,4 1. Assisting with claims.

AB68,1539,5 2. Assisting with audits.

AB68,1539,6 3. Providing centralized payment.

AB68,1539,7 4. Performing certification in a specialized care program.

AB68,1539,8 5. Providing compliance support.

AB68,1539,9 6. Setting flat fees for generic drugs.

AB68,1539,10 7. Assisting with store layout.

AB68,1539,11 8. Managing inventory.

AB68,1539,12 9. Providing marketing support.

AB68,1539,13 10. Providing management and analysis of payment and drug dispensing data.

AB68,1539,14 11. Providing resources for retail cash cards.

AB68,1539,17 (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.

AB68,1539,18 (c) “Pharmacy benefit manager” has the meaning given in s. 632.865 (1) (c).

AB68,1539,20 (d) “Pharmacy services administrative organization” means an entity operating in this state that does all of the following:

AB68,1539,22 1. Contracts with an independent pharmacy to conduct business on the pharmacy's behalf with a 3rd-party payer.

AB68,1539,25 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.

AB68,1540,3 (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.

AB68,1540,8 (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:

AB68,1540,10 1. The name, address, telephone number, and federal employer identification number of the applicant.

AB68,1540,12 2. The name, business address, and telephone number of a contact person for the applicant.

AB68,1540,13 3. The fee under s. 601.31 (1) (nw).

AB68,1540,14 4. Evidence of financial responsibility of at least $1,000,000.

AB68,1540,15 5. Any other information required by the commissioner.

AB68,1540,17 (b) The term of a license issued under par. (a) shall be 2 years from the date of issuance.

AB68,1540,21 (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:

AB68,1540,22 1. Provides pharmacy services.

AB68,1540,23 2. Provides prescription drug or device services.

AB68,1540,25 3. Manufactures, sells, or distributes prescription drugs, biologicals, or medical devices.

AB68,1541,3 (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).

AB68,1541,4 (4) Rules. The commissioner may promulgate rules to implement this section.

AB68,2959 Section 2959 . 632.865 (1) (a) of the statutes is renumbered 632.865 (1) (aw).

AB68,2960 Section 2960 . 632.865 (1) (ae) and (ak) of the statutes are created to read:

AB68,1541,7 632.865 (1) (ae) “Health benefit plan” has the meaning given in s. 632.745 (11).

AB68,1541,8 (ak) “Health care provider” has the meaning given in s. 146.81 (1).

AB68,2961 Section 2961 . 632.865 (1) (c) of the statutes is renumbered 632.865 (1) (c) (intro.) and amended to read:

AB68,1541,13 632.865 (1) (c) (intro.) “Pharmacy benefit manager" means an entity doing business in this state that contracts to administer or manage prescription drug benefits on behalf of any of the following:

AB68,1541,14 1. An insurer or other.

AB68,1541,16 3. Another entity that provides prescription drug benefits to residents of this state.

AB68,2962 Section 2962 . 632.865 (1) (c) 2. of the statutes is created to read:

AB68,1541,18 632.865 (1) (c) 2. A cooperative, as defined in s. 185.01 (2).

AB68,2963 Section 2963 . 632.865 (1) (dm) of the statutes is created to read:

AB68,1541,20 632.865 (1) (dm) “Prescription drug" has the meaning given in s. 450.01 (20).

AB68,2964 Section 2964. 632.865 (2m) of the statutes is created to read:

AB68,1541,25 632.865 (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.

AB68,1542,3 (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:

AB68,1542,5 1. The indirect profit received by the pharmacy benefit manager from owning any interest in a pharmacy or service provider.

AB68,1542,7 2. Any payment made by the pharmacy benefit manager to a consultant or broker who works on behalf of the health benefit plan sponsor.

AB68,1542,11 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.

AB68,1542,16 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.

AB68,2965 Section 2965 . 632.865 (3) to (7) of the statutes are created to read:

AB68,1542,20 632.865 (3) License required. No person may perform any activities of a pharmacy benefit manager without being licensed by the commissioner as an administrator or pharmacy benefit manager under s. 633.14.

AB68,1543,2 (4) Accreditation for network participation. A pharmacy benefit manager or a representative of a pharmacy benefit manager shall provide to a pharmacy, within 30 days of receipt of a written request from the pharmacy, a written notice of any certification or accreditation requirements used by the pharmacy benefit manager or its representative as a determinant of network participation. A pharmacy benefit manager or a representative of a pharmacy benefit manager may change its accreditation requirements no more frequently than once every 12 months.

AB68,1543,5 (5) Retroactive claim reduction. Unless required otherwise by federal law, a pharmacy benefit manager may not retroactively deny or reduce a pharmacist's or pharmacy's claim after adjudication of the claim unless any of the following is true:

AB68,1543,6 (a) The original claim was submitted fraudulently.

AB68,1543,9 (b) The payment for the original claim was incorrect. Recovery for an incorrect payment under this paragraph is limited to the amount that exceeds the allowable claim.

AB68,1543,10 (c) The pharmacy services were not rendered by the pharmacist or pharmacy.

AB68,1543,12 (d) In making the claim or performing the service that is the basis for the claim, the pharmacist or pharmacy violated state or federal law.

AB68,1543,14 (e) The reduction is permitted in a contract between a pharmacy and a pharmacy benefit manager and is related to a quality program.

AB68,1543,15 (6) Audits of pharmacies or pharmacists. (a) Definitions. In this subsection:

AB68,1543,18 1. “Audit” means a review of the accounts and records of a pharmacy or pharmacist by or on behalf of an entity that finances or reimburses the cost of health care services or prescription drugs.

AB68,1543,22 2. “Entity” means a defined network plan, as defined in s. 609.01 (1b), insurer, self-insured health plan, or pharmacy benefit manager or a person acting on behalf of a defined network plan, insurer, self-insured health plan, or pharmacy benefit manager.

AB68,1543,23 3. “Self-insured health plan” has the meaning given in s. 632.85 (1) (c).

AB68,1543,25 (b) Procedures. An entity conducting an on-site or desk audit of pharmacist or pharmacy records shall do all of the following:

AB68,1544,3 1. If the audit is an audit on the premises of the pharmacist or pharmacy, notify the pharmacist or pharmacy in writing of the audit at least 2 weeks before conducting the audit.

AB68,1544,6 2. Refrain from auditing a pharmacist or pharmacy within the first 5 business days of a month unless the pharmacist or pharmacy consents to an audit during that time.

AB68,1544,8 3. If the audit involves clinical or professional judgment, conduct the audit by or in consultation with a pharmacist licensed in any state.

AB68,1544,10 4. Limit the audit review to no more than 250 separate prescriptions. For purposes of this subdivision, a refill of a prescription is not a separate prescription.

AB68,1544,12 5. Limit the audit review to claims submitted no more than 2 years before the date of the audit, unless required otherwise by state or federal law.

AB68,1544,18 6. Allow the pharmacist or pharmacy to use authentic and verifiable records of a hospital, physician, or other health care provider to validate the pharmacist's or pharmacy's records relating to delivery of a prescription drug and use any valid prescription that complies with requirements of the pharmacy examining board to validate claims in connection with a prescription, refill of a prescription, or change in prescription.

AB68,1544,21 7. Allow the pharmacy or pharmacist to document the delivery of a prescription drug or pharmacist services to an enrollee under a health benefit plan using either paper or electronic signature logs.

AB68,1544,24 8. Before leaving the pharmacy after concluding the on-site portion of an audit, provide to the representative of the pharmacy or the pharmacist a complete list of the pharmacy records reviewed.

AB68,1545,2 (c) Results of audit. An entity that has conducted an audit of a pharmacist or pharmacy shall do all of the following:

AB68,1545,10 1. Deliver to the pharmacist or pharmacy a preliminary report of the audit within 60 days after the date the auditor departs from an on-site audit or the pharmacy or pharmacist submits paperwork for a desk audit. A preliminary report under this subdivision shall include claim-level information for any discrepancy reported, the estimated total amount of claims subject to recovery, and contact information for the entity or person that completed the audit so the pharmacist or pharmacy subject to the audit may review audit results, procedures, and discrepancies.

AB68,1545,13 2. Allow a pharmacist or pharmacy that is the subject of an audit to provide documentation to address any discrepancy found in the audit within 30 days after the date the pharmacist or pharmacy receives the preliminary report.

AB68,1545,19 3. Deliver to the pharmacist or pharmacy a final audit report, which may be delivered electronically, within 90 days of the date the pharmacist or pharmacy receives the preliminary report or the date of the final appeal of the audit, whichever is later. The final audit report under this subdivision shall include any response provided to the auditor by the pharmacy or pharmacist and consider and address the pharmacy's or pharmacist's response.

AB68,1545,22 4. Refrain from assessing a recoupment or other penalty on a pharmacist or pharmacy until the appeal process is exhausted and the final report under subd. 3. is delivered to the pharmacist or pharmacy.

AB68,1545,24 5. Refrain from accruing or charging interest between the time the notice of the audit is given under par. (b) 1. and the final report under subd. 3. has been delivered.

AB68,1545,25 6. Exclude dispensing fees from calculations of overpayments.