SLS 21RS-39 REENGROSSED 2021 Regular Session SENATE BILL NO. 218 BY SENATOR FRED MILLS Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. PHARMACEUTICALS. Provides relative to the payment of pharmacy claims. (See Act) 1 AN ACT 2 To amend and reenact R.S. 22:1856(B), 1856.1(A), the introductory paragraph of 1856.1(B), 3 1856.1(B)(2)(a), (3)(a), and (4)(a), (D)(1)(b), (E)(5), and (G), 1860(C), the 4 introductory paragraph of 1860.2(A), 1860.3(C) and (D), and 1867(A), R.S. 5 37:1256(B), and the introductory paragraph of R.S. 40:2868(A) and 2870(A)(4) and 6 to enact R.S. 22:1856(C)(16) and (17) and (G), 1856.1(H), 1856.2, 1860.3(E) and 7 (F), 1863(10) and (11), and 1864(C) and R.S. 40:2864(D) and 2870(A)(21), (22), and 8 (23), relative to the payment of pharmacy claims; to provide for pharmacy audits; to 9 provide for reimbursements; to provide for definitions; to prohibit spread pricing; to 10 provide for pharmacy benefit manager permits; to provide for the duties of pharmacy 11 benefit managers; to provide for prohibited acts; to provide for an effective date; and 12 to provide for related matters. 13 Be it enacted by the Legislature of Louisiana: 14 Section 1. R.S. 22:1856(B), 1856.1(A), the introductory paragraph of 1856.1(B), 15 1856.1(B)(2)(a), (3)(a), and (4)(a), (D)(1)(b), (E)(5), and (G), 1860(C), the introductory 16 paragraph of 1860.2(A), and 1860.3(C) and (D), and 1867(A) are hereby amended and 17 reenacted and R.S. 22:1856(C)(16) and (17) and (G), 1856.1(H), 1856.2, 1860.3(E) and (F), Page 1 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 1863(10) and (11), and 1864(C) are hereby enacted to read as follows: 2 §1856. Payment standard; limitations on claim filing and audits; remittance advice 3 * * * 4 B. Health insurance issuers that limit the period of time that a pharmacist or 5 pharmacy under contract for delivery of covered benefits has to submit claims for 6 payment under R.S. 22:1853 or 1854 shall have the same limited period of time 7 following payment of such claims to perform any review or audit for purposes of 8 reconsidering the validity of such claims. 9 A pharmacy record audit, reconsideration, or any other review of a 10 claim for delivery of covered benefits performed by a health insurance issuer 11 or their representative shall be done in accordance with R.S. 22:1856.1. 12 C. Each remittance advice generated by a health insurance issuer or its agent 13 to a pharmacist or his agent or pharmacy or its agent shall be sent on the date of 14 payment and shall include the following information, clearly identified and totaled 15 for each claim listed: 16 * * * 17 (16) On or after January 1, 2023, reimbursement paid to the health 18 insurance issuer. 19 (17) On or after January 1, 2023, reimbursement paid to the pharmacy. 20 * * * 21 G. The agent of a pharmacist or pharmacy, including but not limited to 22 a pharmacy services administrative organization, shall send the pharmacist or 23 pharmacy the complete remittance advice required by Subsection C of this 24 Section on the date of payment for each claim. 25 §1856.1. Pharmacy record audits; recoupment; appeals 26 A.(1) As used in this Section, "entity" means a managed care company, 27 insurance company, third-party payor, or the representative of the managed care 28 company including a pharmacy benefit manager, insurance company, or third-party 29 payor. Page 2 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 (2) Except for an alleged fraud, willful misrepresentation, or abuse audit 2 performed in accordance with R.S. 22:1856.1(G)(2), any entity that limits the 3 period of time that a pharmacist or pharmacy under contract for delivery of 4 covered benefits has to submit claims for payment pursuant to R.S. 22:1853 or 5 1854 shall have the same limited period of time following payment of the claims, 6 up to a maximum time period of one year from the date the claim was 7 adjudicated, to perform an audit, reconsideration, or any other review of a 8 claim. 9 B. Notwithstanding any other provision of law to the contrary, when an a 10 review, reconsideration, or any other audit of the records of a pharmacy is 11 conducted by an entity, the audit shall be conducted in accordance with the following 12 criteria: 13 * * * 14 (2)(a) No entity shall conduct an audit at a particular pharmacy more than 15 one time or for more than one hundred prescriptions annually. However, the 16 provisions of this Paragraph shall not apply when an entity must return to a 17 pharmacy to complete an audit already in progress, or there is an identified history 18 of errors, an identified activity which a reasonable man would believe to be 19 inappropriate, or illegal activity that the entity has brought to the attention of the 20 pharmacy owner or corporate headquarters of the pharmacy. 21 * * * 22 (3)(a) The entity or any vendor or subcontractor of the entity which conducts 23 the initial audit shall give the pharmacy notice and a comprehensive list of claims 24 by prescription number to be audited at least two weeks before conducting the 25 initial audit for each audit cycle. The entity or vendor or subcontractor of the 26 entity shall not receive payment nor compensate the auditor based on the 27 amount directly or indirectly recovered. 28 * * * 29 (4)(a)(i) Any clerical or record-keeping error, such as a typographical error, Page 3 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 scrivener's error, or computer error, regarding a required document or record shall 2 not necessarily constitute fraud. 3 (ii) A claim arising pursuant to the provisions of this Section may be subject 4 to recoupment. 5 * * * 6 D.(1) No pharmacy shall be subject to recoupment of any portion of the 7 reimbursement for the dispensed product of a prescription unless one or more of the 8 following has occurred at the point of adjudication: 9 * * * 10 (b) The pharmacy has engaged in dispensing in excess of the benefit design, 11 as established by the plan sponsor, or has not filled prescriptions in accordance 12 with the prescriber's order, unless the only commercially available package size 13 exceeds the maximum days' supply or the prescription is for unit-of-use items 14 up to the manufacturer's recommendations. 15 * * * 16 E. * * * 17 (5) Notwithstanding any other provision of law to the contrary, the agency 18 entity conducting the audit shall not use the accounting practice of extrapolation in 19 calculating recoupment or penalties for audits, unless otherwise agreed to by the 20 pharmacy or mandated by a government agency or in the case of fraud. 21 * * * 22 G. This Section shall not apply to: 23 (1) Any quality assurance review, as defined by the time period prior to the 24 reimbursement by the entity to the pharmacy dispensing of the prescription. 25 (2) An investigation that is initiated based on or that involves suspected or 26 alleged fraud, willful misrepresentation, or abuse. The entity conducting the audit 27 shall provide notice of any investigation initiated pursuant to this Subsection to 28 the division of insurance fraud of the Department of Insurance prior to auditing 29 the pharmacy. Page 4 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 H. If, upon investigation, the commissioner of insurance finds a violation 2 of this Section has occurred, either on his own initiative or in response to a 3 complaint filed with the Department of Insurance, the commissioner shall 4 suspend or revoke the license of the entity or, in lieu thereof, impose a fine. 5 §1856.2. Pharmacy record auditors; testing 6 On or after January 1, 2022, no individual shall perform an audit on 7 behalf of an entity pursuant to R.S. 22:1856.1 or any other provision of this 8 Subpart unless the individual has passed an examination which tests the 9 knowledge of the individual concerning pharmacy record audits and the 10 insurance laws and regulations of this state. Examinations shall be developed 11 and conducted in accordance with the rules and regulations promulgated by the 12 commissioner of insurance. 13 * * * 14 §1860. Violations; cease and desist orders; penalties 15 * * * 16 C. An aggrieved party, which may include a pharmacy benefit manager, 17 affected by the commissioner's decision, act, or order may demand a hearing in 18 accordance with Chapter 12 of this Title, R.S. 22:2191 et seq. 19 * * * 20 §1860.2. Certain pharmacy claims fees prohibited 21 A. A health insurance issuer, or a pharmacy benefit manager, or pharmacy 22 services administrative organization shall not directly or indirectly charge or hold 23 a pharmacist or pharmacy responsible for any fee related to a claim that is any of the 24 following: 25 * * * 26 §1860.3. Reimbursements 27 * * * 28 C.(1) No pharmacy benefit manager, pharmacy services administration 29 organization, or any person acting for or on behalf of a pharmacy benefit Page 5 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 manager or pharmacy services administration organization shall make or allow 2 any direct or indirect reduction of payment to a pharmacist or pharmacy for 3 a drug, device, or service under a reconciliation process to an effective rate of 4 reimbursement, including but not limited to generic effective rates, brand 5 effective rates, direct and indirect remuneration fees, or any other reduction or 6 aggregate reduction of payment. 7 (2) The provisions of Paragraph (1) of this Subsection shall only apply 8 to a local pharmacy as defined in R.S. 22:1863. 9 D. No new agreements or extensions of existing agreements for the 10 provision of pharmacy benefit manager services allowing for the 11 reimbursement of a pharmacy or pharmacist in an amount less than the amount 12 that the pharmacy benefit manager was paid by the health plan provider for the 13 same claim shall be entered into after January 1, 2022. 14 C.E. The commission of any act prohibited by this Section shall be 15 considered an unfair method of competition and unfair practice or act which shall 16 subject the violator to any and all actions, including investigative demands, private 17 actions, remedies, and penalties, provided for in the unfair trade practices 18 provisions of the Louisiana Insurance Code, R.S. 22:1961 et seq., or the Unfair 19 Trade Practices and Consumer Protection Law, R.S. 51:1401 et seq. 20 D.F. Any provision of a contract that is contrary to any provision of this 21 Section shall be null, void, and unenforceable in this state. 22 * * * 23 §1863. Definitions 24 As used in this Subpart, the following definitions apply: 25 * * * 26 (10) "Local pharmacy" means any pharmacy domiciled in at least one 27 Louisiana parish that has fewer than ten retail outlets under its corporate 28 umbrella. 29 (11) "Specialty Drug" means a prescription drug that is not readily Page 6 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 available at a retail pharmacy, is prescribed for a person with a chronic, 2 complex, life-threatening, or rare medical condition, and requires either of the 3 following: 4 (a) Specialized product handling or administration by the dispensing 5 pharmacy. 6 (b) Specialized clinical care, including requirement dosing adjustments, 7 intensive clinical monitoring, or expanded services for patients. For the 8 purposes of this Paragraph, "expanded services" may include intensive patient 9 counseling, education, or ongoing clinical support beyond traditional dispensing 10 actives such as individualized disease and therapy management to support 11 improved health outcomes. 12 §1864. Requirements for use of the National Drug Code by a pharmacy benefit 13 manager 14 * * * 15 C. A pharmacy benefits manager under contract with a health insurance 16 issuer shall use a single maximum amount to be paid by the health insurance 17 issuer to a pharmacy for a generic drug or a brand name drug that has at least 18 one generic alternative available. A health insurance issuer or pharmacy 19 benefits manager under contract with a health insurance issuer shall use the 20 same maximum allowable cost list for each pharmacy. 21 * * * 22 §1867. Prohibition on spread pricing; notice exception 23 A. A On or before December 31, 2024, a pharmacy benefit manager or 24 pharmacy services administrative organization is prohibited from conducting or 25 participating in spread pricing in this state unless the pharmacy benefit manager 26 provides written notice as provided in Subsection B of this Section. Effective 27 January 1, 2022, no new agreement or extension of an existing agreement for 28 the provision of pharmacy benefit manager services shall allow for spread 29 pricing. Page 7 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 * * * 2 Section 2. R.S. 37:1256(B) is hereby amended and reenacted to read as follows: 3 §1256. Louisiana Board of Pharmacy; authority to regulate pharmacy benefit 4 managers 5 * * * 6 B. A pharmacy benefit manager may be but is not required to be permitted 7 under shall obtain a permit pursuant to Part IV of this Chapter if it administers, 8 develops, maintains, performs, or provides one or more pharmacy services in this 9 state or that affects one or more beneficiaries of a pharmacy benefit management 10 plan administered by the pharmacy benefit manager, as set forth in R.S. 40:2868. 11 Section 3. The introductory paragraph of R.S. 40:2868(A) and 2870(A)(4) are 12 hereby amended and reenacted and R.S. 40:2864(D) and 2870(A)(21), (22), and (23) are 13 hereby enacted to read as follows: 14 §2864. Duties of pharmacy benefit managers 15 * * * 16 D. A pharmacy benefit manager shall notify a health insurance issuer 17 in writing of any activity, policy, or practice of the pharmacy benefit manager 18 that directly or indirectly presents a conflict of interest with the duties provided 19 for in this Chapter. 20 * * * 21 §2868. Pharmacy benefit manager; regulation by the Louisiana Board of Pharmacy; 22 requirements for permitting 23 A. A pharmacy benefit manager may shall obtain and maintain a permit 24 from the Louisiana Board of Pharmacy if the pharmacy benefit manager 25 administers, develops, maintains, performs, or provides one or more of the following 26 pharmacy services in this state or that affects one or more beneficiaries of a 27 pharmacy benefit management plan administered by the pharmacy benefit manager: 28 * * * 29 §2870. Prohibited acts; unfair and deceptive trade practices Page 8 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 A. A pharmacy benefit manager in Louisiana shall not: 2 * * * 3 (4) Conduct On or before December 31, 2024, conduct or participate in 4 spread pricing as defined in R.S. 22:1863(9) without providing the notice required 5 by R.S. 22:1867 or, effective January 1, 2022, enter into a new agreement or 6 extension of an existing agreement for the provision of pharmacy manager 7 benefit services allowing for spread pricing. 8 * * * 9 (21) Cause or knowingly permit the use of any advertisement, promotion, 10 solicitation, representation, proposal, or offer that is untrue, deceptive, or 11 misleading. 12 (22) Prohibit a pharmacy or pharmacist from offering and providing 13 delivery services to a covered individual as an ancillary service of the pharmacy. 14 (23) On or after January 1, 2025, reimburse a pharmacy or pharmacist 15 in this state an amount less than the amount that the pharmacy benefit manager 16 was paid by the health plan provider for the same claim or, effective January 17 1, 2022, enter into a new agreement or extension of an existing agreement for 18 the provision of pharmacy benefit manager services allowing for the 19 reimbursement of a pharmacy or pharmacist in an amount less than the amount 20 that the pharmacy benefit manager was paid by the health plan provider for the 21 same claim. 22 Section 4. Provisions of this Act shall not invalidate or impede the enforcement of 23 contacts existing at the time of the effective date of this Act. Effective January 1, 2022, no 24 new agreement or extension of an existing agreement for the provision of pharmacy benefit 25 manager services shall allow for spread pricing. 26 Section 5. The provisions of R.S. 22:1856.1, as enacted by this Act, shall become 27 effective on July 1, 2022. 28 Section 6. Except as provided in Section 5 of this Act, the provisions of this Act 29 shall become effective upon signature by the governor or, if not signed by the governor, Page 9 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 1 upon expiration of the time for bills to become law without signature by the governor, as 2 provided by Article III, Section 18 of the Constitution of Louisiana. If vetoed by the 3 governor and subsequently approved by the legislature, this Act shall become effective on 4 the day following such approval. The original instrument and the following digest, which constitutes no part of the legislative instrument, were prepared by Brandi Cannon. DIGEST SB 218 Reengrossed 2021 Regular Session Fred Mills Present law provides for the payment for prescription drugs, other products and supplies, and pharmacist services submitted by a pharmacist or pharmacy under a contract for the provision of covered benefits with a health insurance issuer. Present law provides for the remittance advice generated by a health insurance issuer to a pharmacist or pharmacy to be sent on the date of payment and containing certain enumerated information, clearly identified and totaled for each claim listed. Proposed law adds, effective January 1, 2023, the requirement to include the amount of reimbursement paid to the health insurance issuer and the reimbursement paid to the pharmacy. Present law provides that health insurance issuers that limit the period of time that a pharmacist or pharmacy has to submit claims for payment shall have the same limited period of time following payment of the claims to reconsider the validity of the claims. Proposed law provides that, except in cases of alleged fraud, willful misrepresentation, or abuse, the time period shall not exceed one year from the date a claim was adjudicated to perform any review, reconsideration, or any other audit of the claim. Present law provides for the audit of pharmacy records and prohibits the conducting of an audit at a particular pharmacy more than one time annually. Proposed law also prohibits an audit for more than one hundred prescriptions annually. Present law provides that the entity which conducts the initial audit shall give the pharmacy notice at least two weeks before conducting the initial audit except in cases of alleged fraud or willful misrepresentation when notice before the initial audit could impede the audit, review, or investigation. Proposed law adds the requirement for the auditor to provide a comprehensive list of claims by prescription number to be audited. Proposed law provides that the auditor shall not receive payment nor be compensated based on the amount directly or indirectly recovered. Proposed law provides that the auditor shall provide notice of any investigation initiated based upon fraud to the division of insurance fraud of the Department of Insurance prior to auditing the pharmacy. Proposed law requires the commissioner of insurance to take appropriate enforcement action. Proposed law provides that, effective January 1, 2022, no individual shall perform an audit unless the individual has passed an examination which tests the knowledge of the individual concerning pharmacy record audits and the insurance laws and regulations of this state. Proposed law provides that no pharmacy benefit manager (PBM) or pharmacy services administration organization (PSAO) shall make or allow any direct or indirect reduction of payment to a pharmacist or pharmacy for a drug, device, or service under a reconciliation process to an effective rate of reimbursement. Proposed law applies only to local Page 10 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED pharmacies. Proposed law provides that, effective January 1, 2025, no PBM shall reimburse a pharmacy or pharmacist in this state an amount less than the amount that the PBM was paid by the health plan provider for the same claim. Present law provides that, until December 31, 2024, a PBM is prohibited from conducting or participating in spread pricing in this state unless written notice is provided to the policyholders. Proposed law removes the written notice exception and prohibits spread pricing after January 1, 2025. Present law provides that a PBM has the duties of good faith, honesty, trust, confidence, and candor and provides for the standard for the fulfillment of the PBM's duties. Proposed law provides for a PBM to notify a health insurance issuer in writing of any activity, policy, or practice of the PBM that directly or indirectly presents a conflict of interest. Present law provides that a PBM may obtain and maintain a permit from the La. Board of Pharmacy if the PBM provides certain pharmacy services. Proposed law requires a PBM to obtain and maintain the permit. Present law provides for certain prohibited acts or unfair and deceptive trade practices by PBMs. Proposed law adds the actions of causing or knowingly permitting the use of any advertisement, promotion, solicitation, representation, proposal, or offer that is untrue, deceptive, or misleading, prohibiting a pharmacy from offering delivery services, and reimbursing a pharmacy less than the amount paid by the health plan. Proposed law shall not invalidate or impede the enforcement of contracts for the provision of pharmacy benefit manager services existing at the time of the effective date of proposed law. Proposed law provides that, effective January 1, 2022, no new agreement or extension of an existing agreement for the provision of pharmacy benefit manager services shall allow for spread pricing. Proposed law provides for various effective dates. (Amends R.S. 22:1856(B), 1856.1(A), 1856.1(B)(intro para), (B)(2)(a), (3)(a), and (4)(a), (D)(1)(b), (E)(5), and (G), 1860(C), 1860.2(A)(intro para), 1860.3(C) and (D), and 1867(A), R.S. 37:1256(B), and R.S. 40:2868(A)(intro para) and 2870(A)(4); adds R.S. 22:1856(C)(16) and (17), and (G), 1856.1(H), 1856.2, 1860.3(E) and (F), 1863(10) and (11), and 1864(C) and R.S. 40:2864(D) and 2870(A)(21), (22), and (23)) Summary of Amendments Adopted by Senate Committee Amendments Proposed by Senate Committee on Health and Welfare to the original bill 1. Adds reimbursement amounts to the required content of a remittance advice. 2. Clarifies the permitted enforcement actions of the commissioner of insurance. 3. Restores present law relative to the review and audit of pharmacy claims. 4. Requires an individual to pass a test prior to conducting an audit. 5. Deletes proposed law relative to the fiduciary duty of a PBM. Page 11 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 218 SLS 21RS-39 REENGROSSED 6. Deletes the proposed repeal of the pharmacy benefit manager monitoring advisory council. 7. Provides for various effective dates. 8. Makes technical changes. Senate Floor Amendments to engrossed bill 1. Provides for effective dates. 2. Deletes provision relative to enforcement by the commissioner of insurance. 3. Deletes definition of entity. 4. Specifies that the remittance advice is to be sent on the date of payment for each claim. 5. Specifies that the prohibition on direct or indirect reduction of payment to an effective rate of reimbursement applies only to local pharmacies. 6. Adds definitions for local pharmacy and specialty drug. 7. Makes technical changes. Page 12 of 12 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions.