SLS 19RS-62 REENGROSSED 2019 Regular Session SENATE BILL NO. 41 BY SENATOR MILLS Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. PHARMACEUTICALS. Provides relative to the regulation of pharmacy benefit managers. (See Act) 1 AN ACT 2 To amend and reenact R.S. 22:1863(2) and to enact R.S. 22:1863(9) and 1867, Part VII of 3 Chapter 14 of Title 37 of the Louisiana Revised Statutes of 1950, to be comprised 4 of R.S. 37:1252 through 1254, and Chapter 36 of Title 40 of the Louisiana Revised 5 Statutes of 1950, to be comprised of R.S. 40:2861 through 2871, relative to 6 regulation of pharmacy benefit managers; to provide legislative intent and public 7 health policy; to provide for protection of the public; to provide for general 8 applicability; to provide for licensure by the Louisiana Department of Insurance; to 9 provide for permitting by the Louisiana Board of Pharmacy; to provide for minimum 10 licensure and permit criteria; to provide for rulemaking; to provide for penalties; to 11 provide for unfair trade practices; to provide for enforcement; to provide for 12 authority of the attorney general; to provide for written notice; to provide for a 13 hearing; to provide for an appeal; to provide for a cause of action under the Unfair 14 Trade Practices and Consumer Protection Law; to provide for severability; to provide 15 for an effective date; and to provide for related matters. 16 Be it enacted by the Legislature of Louisiana: 17 Section 1. R.S. 22:1863(2) is hereby amended and reenacted and R.S. 22:1863(9) Page 1 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 and 1867 are hereby enacted to read as follows: 2 §1863. Definitions 3 As used in this Subpart, the following definitions apply: 4 * * * 5 (2) "Maximum Allowable Cost List" means a listing of the National Drug 6 Code used by a pharmacy benefit manager setting the maximum allowable cost on 7 which reimbursement to a pharmacy or pharmacist may be based. "Maximum 8 Allowable Cost List" shall include any term that a pharmacy benefit manager 9 or a healthcare insurer may use to establish reimbursement rates for generic 10 and multi-source brand drugs to a pharmacist or pharmacy for pharmacist 11 services. The term "Maximum Allowable Cost List" shall not include any rate 12 mutually agreed to and set forth in writing in the contract between the 13 pharmacy benefit manager and the pharmacy. However, this definition shall not 14 be interpreted to preclude a pharmacy benefit manager from establishing 15 effective rate pricing for a pharmacist or pharmacy that is not a local pharmacy 16 or local pharmacist as defined in R.S. 46:460.36(A)(3). 17 * * * 18 (9) "Spread pricing" means any amount a pharmacy benefit manager 19 charges or claims from a health plan provider or managed care organization for 20 payment of a prescription or for pharmacy services that is different than the 21 amount the pharmacy benefit manager paid to the pharmacist or pharmacy 22 who filled the prescription or provided the pharmacy services. 23 * * * 24 §1867. Prohibition on spread pricing; notice exception 25 A. A pharmacy benefit manager is prohibited from conducting or 26 participating in spread pricing in this state unless the pharmacy benefit 27 manager provides written notice as provided in Subsection B of this Section. 28 B. The notice issued by a pharmacy benefit manager, or a health 29 insurance issuer where the health insurance issuer has agreed to issue the Page 2 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 notice, that utilizes spread pricing shall be: 2 (1) Required for each health insurance issuer or plan provider in which 3 the pharmacy benefit manager engaged or participated in spread pricing. 4 (2) Delivered to the policyholder. 5 (3) Provided at least biannually. 6 (4) The aggregate amount of spread pricing charged by the pharmacy 7 benefit manager during the period. 8 (5) Written in plain, simple, and understandable English. 9 C. Any violation of this Section that is committed or performed with such 10 frequency as to indicate a general business practice shall be subject to the 11 provisions of the Unfair Trade Practices and Consumer Protection Law, R.S. 12 51:1401 et seq. 13 * * * 14 Section 2. Part VII of Chapter 14 of Title 37 of the Louisiana Revised Statutes of 15 1950, comprised of R.S. 37:1252 through 1254, is hereby enacted to read as follows: 16 PART VII. PHARMACY BENEF IT MANAGERS 17 §1252. Louisiana Board of Pharmacy; authority to regulate pharmacy benefit 18 managers 19 A. Pursuant to the authority vested in the board in this Chapter and as 20 specifically provided for in the Pharmacy Benefit Manager Licensing Law, R.S. 21 40:2861 et seq., the board shall create and issue a permit for pharmacy benefit 22 managers as defined in R.S. 40:2863. 23 B. A pharmacy benefit manager may be but is not required to be 24 permitted under Part IV of this Chapter if it administers, develops, maintains, 25 performs, or provides one or more pharmacy services in this state or that affects 26 one or more beneficiaries of a pharmacy benefit management plan administered 27 by the pharmacy benefit manager, as set forth in R.S. 40:2868. 28 §1253. Pharmacy benefit managers; permit; annual report; fees 29 A. The board shall promulgate rules and regulations to implement the Page 3 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 provisions of this Part and the applicable provisions of the Pharmacy Benefit 2 Manager Licensing Law. 3 B. The board shall have the authority to promulgate rules and 4 regulations to specify the annual reporting requirements for the pharmacy 5 benefit manager. 6 C. The board has the authority and responsibility to assess fees upon any 7 entity practicing pharmacy in this state in accordance with R.S. 37:1184. 8 §1254. Pharmacy benefit managers; enforcement 9 Enforcement of the provisions of this Part by the board shall be as 10 provided for in this Chapter and R.S. 40:2871. 11 Section 3. Chapter 36 of Title 40 of the Louisiana Revised Statutes of 1950, 12 comprised of R.S. 40:2861 through 2871, is hereby enacted to read as follows: 13 CHAPTER 36. REGULATION OF PHARMACY BENEF IT MANAGERS 14 §2861. Legislative intent and public health policy 15 It is the intent of the legislature that the purpose of this Chapter is to 16 license, permit, and monitor pharmacy benefit managers to provide for the 17 effective control and regulation of their activities, maintain and enforce order 18 regarding the prescribing, dispensing, marketing, selling, managing, and use of 19 prescription drugs in this state, and to protect the health, safety, and general 20 welfare of the citizens and residents of this state. 21 §2862. Short title 22 This Chapter shall be known and may be cited as the "Pharmacy Benefit 23 Manager Licensing Law". 24 §2863. Definitions 25 As used in this Chapter, the following definitions shall apply: 26 (1) "Attorney general" means the Louisiana attorney general. 27 (2) "Beneficiary" means a person who resides or is employed in this state 28 and is covered or is eligible to be covered by a health plan. 29 (3) "Board of Pharmacy" means the Louisiana Board of Pharmacy. Page 4 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 (4) "Commissioner of insurance" means the Louisiana commissioner of 2 insurance. 3 (5) "Department of Insurance" means the Louisiana Department of 4 Insurance. 5 (6) "Department of Justice" means the Louisiana Department of Justice. 6 (7) "Health plan" means an individual or group plan or program, 7 whether commercial, self-insured, or mandated or sponsored by any federal, 8 state, or local government, which is established by contract, certificate, law, 9 plan, policy, subscriber agreement, or by any other method and which is 10 entered into, issued, or offered for the purpose of arranging for, delivering, 11 paying for, providing, or reimbursing any of the costs of health or medical care, 12 including pharmacy services, drugs, or devices. 13 (8) "Pharmacy benefit management plan" or "pharmacy benefits 14 program" means a plan or program that pays for, reimburses, covers the cost 15 of, or otherwise provides for pharmacist services, drugs, or devices to 16 individuals who reside in or are employed in Louisiana. 17 (9) "Pharmacy benefit manager" or "PBM" means any person or 18 business who administers the prescription drug or device program of one or 19 more health plans on behalf of a third party in accordance with a pharmacy 20 benefit program. This term includes any agent or representative of a pharmacy 21 benefit manager hired or contracted by the pharmacy benefit manager to assist 22 in the administering of the drug program and any wholly or partially owned or 23 controlled subsidiary of a pharmacy benefit manager. 24 §2864. Duties of pharmacy benefit managers 25 A. A pharmacy benefit manager shall owe the beneficiaries of any 26 pharmacy benefit management plan administered by the pharmacy benefit 27 manager and to the entities that have entered into a contract with the pharmacy 28 benefit manager the duties of good faith, honesty, trust, confidence, and candor. 29 B. The standard for the fulfillment of a pharmacy benefit manager's Page 5 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 duties shall be to act with a high degree of care, skill, prudence, and diligence 2 required of a reasonable and prudent person with substantial experience and 3 expertise in the management of pharmacy benefit management programs and 4 payment of claims. 5 C. Failure of a pharmacy benefit manager to satisfy the duties 6 established in this Section shall not create a separate or independent cause of 7 action nor shall it be construed to prohibit any cause of action established by or 8 recognized in federal or state law. 9 §2865. General licensing and permitting requirements 10 A. Every pharmacy benefit manager that does business in this state or 11 pays for benefits to a beneficiary through a pharmacy benefit management plan 12 shall be licensed or permitted as required by this Chapter. 13 B. No license or permit shall be issued to a pharmacy benefit manager 14 who has not registered with the Louisiana secretary of state to conduct business 15 within the state. 16 C. Each license and permit shall be valid only for the applicant listed on 17 the application. 18 D. A pharmacy benefit manager license or permit is not transferable. 19 (1) No license or permit shall be subject to sale, assignment or other 20 transfer, voluntary or involuntary. 21 (2) In the event the ownership of the pharmacy benefit manager changes 22 by fifty percent or more after the initial issuance of the license or permit, the 23 ownership shall be deemed sufficiently different as to require a new pharmacy 24 benefit manager license or permit. 25 (3) The continued operation of a pharmacy benefit manager under a 26 license or permit issued pursuant to this Chapter after its ownership has 27 changed by fifty percent or more shall constitute sufficient basis for finding that 28 the pharmacy benefit manager is operating in this state without a valid license 29 or permit in violation of this Chapter. Page 6 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 §2866. General applicability 2 A. The licensure and regulation requirements set forth pursuant to this 3 Chapter shall apply generally to any pharmacy benefit manager regardless of 4 plan or benefit financing. 5 B. Nothing in this Chapter shall be construed to require coverage of any 6 specific drug in any health plan, but shall apply once a drug is covered or 7 included on a health plan formulary. 8 §2867. Pharmacy benefit manager; regulation by commissioner of insurance; 9 applicability of the Louisiana Insurance Code 10 A. Every pharmacy benefit manager that does business in this state shall 11 be licensed as required by the Louisiana Insurance Code. 12 B. Every pharmacy benefit manager licensed by the commissioner of 13 insurance shall abide by the provisions of the Louisiana Insurance Code and the 14 rules and regulations of the insurance commissioner and the Department of 15 Insurance regarding the pharmacy benefit manager's business regulated by the 16 commissioner of insurance. 17 §2868. Pharmacy benefit manager; regulation by Board of Pharmacy; 18 requirements for permitting 19 A. A pharmacy benefit manager may obtain and maintain a permit from 20 the Board of Pharmacy if the pharmacy benefit manager administers, develops, 21 maintains, performs, or provides one or more of the following pharmacy 22 services in this state or that affects one or more beneficiaries of a pharmacy 23 benefit management plan administered by the pharmacy benefit manager: 24 (1) Adjudication of appeals or grievances related to prescription drug 25 coverage. 26 (2) Disease management programs. A "disease management program" 27 means a program adopted to guide and care for beneficiaries with chronic 28 health problems to improve the quality of healthcare provided to them and 29 prevent future need for medical resources by using an integrated Page 7 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 comprehensive approach. 2 (3) Drug formularies. A "drug formulary" means a list of prescription 3 medications or pharmaceutical products developed and approved by each 4 health plan that may be dispensed to a beneficiary through participating 5 pharmacies. Drug formulary may also be referred to as a "preferred drug list", 6 "prior authorization list", or "pharmacopeia". 7 (4) Drug regimen reviews. A "drug regimen review" means third-party 8 review of all medications a beneficiary is currently using, whether prescribed 9 or over the counter, and administered by any method. 10 (5) Prescription drug management programs. A "prescription drug 11 management program" means a program developed and designed to administer 12 the prescription drug benefit as part of a health plan, and as part of such 13 administration a PBM may contract with pharmacies for implementation and 14 dispensing drugs in accordance with the program. 15 (6) Processing of prior authorization requests. "Processing of prior 16 authorization requests" means making a determination regarding payment 17 coverage based on an advance approval request submitted by a physician or 18 other healthcare provider before a specific procedure, service, device, supply, 19 or medication is delivered to the beneficiary. 20 (7) Quality care dosing services. "Quality care dosing services" means 21 electronically checking prescription medications before they are filled at the 22 pharmacy to ensure that the quantity and dosage is consistent with the 23 recommendations of the Food and Drug Administration (FDA) and others. 24 (8) Step therapy procedures. A "step therapy procedure" means 25 protocols and policies that establish a specific sequence in which prescription 26 drugs for a medical condition are approved for coverage by a health plan for a 27 beneficiary which generally requires cheaper drugs to be used before more 28 costly drugs. Step therapy may also be referred to as "fail first" protocol. 29 (9) Utilization management and utilization reviews. "Utilization Page 8 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 management" and "utilization review" mean third-party review and approval 2 of appropriateness and necessity of care that a healthcare provider has 3 indicated for a beneficiary prior to delivery and coverage of such care. 4 (10) Any other act, service, operation, or transaction incidental to or 5 forming a part of the compounding, filling, dispensing, exchanging, giving, 6 offering for sale, or selling drugs, medicines, poisons, or devices in this state by 7 pharmacists or pharmacies, pursuant to a prescription or an order of 8 physicians, dentists, veterinarians, or other licensed practitioners, requiring, 9 involving, or employing the science or art of any branch of the pharmacy 10 profession, study, or training. 11 B. Every pharmacy benefit manager permitted by the Board of 12 Pharmacy shall abide by the applicable provisions of the Louisiana Pharmacy 13 Practice Act and the rules and regulations of the Board of Pharmacy. 14 §2869. Pharmacy benefit manager monitoring advisory council; membership; 15 functions 16 A. There is hereby created a pharmacy benefit manager monitoring 17 advisory council, hereinafter referred to as "advisory council", that shall consist 18 of the following members, each of whom may appoint a designee: 19 (1) The commissioner of the Department of Insurance. 20 (2) The president of the Louisiana State Board of Medical Examiners. 21 (3) The president of the Louisiana Board of Pharmacy. 22 (4) The attorney general. 23 (5) The director of the Louisiana Department of Justice Consumer 24 Affairs Division. 25 (6) The secretary of the Louisiana Department of Health. 26 (7) The president of the Louisiana Academy of Physicians Assistants. 27 (8) The president of the Louisiana State Medical Society. 28 (9) The president of the Louisiana Association of Nurse Practitioners. 29 (10) The president of the Louisiana Pharmacists Association. Page 9 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 (11) The president of the Louisiana Independent Pharmacies Association. 2 (12) The president of the National Association of Chain Drug Stores. 3 (13) The president of the Pharmaceutical Research and Manufacturers 4 of America. 5 (14) The president of the Louisiana Academy of Medical Psychologists. 6 (15) The president of the Louisiana Association of Health Plans. 7 (16) The president of a pharmacy benefit manager licensed by the 8 Louisiana Board of Pharmacy, selected by the Louisiana affiliate of the 9 Pharmaceutical Care Management Association from a list of interested and 10 qualified individuals. 11 (17) The president of the Louisiana Association of Business and Industry. 12 (18) The chief executive officer of the Louisiana Business Group on 13 Health. 14 (19) The president of America's Health Insurance Plans. 15 (20) The president of the Louisiana AFL-CIO. 16 (21) The president of the Louisiana Association of Health Underwriters. 17 B. The members of the advisory council shall serve at the pleasure of 18 their respective appointing authorities. Seven members shall constitute a 19 quorum for the transaction of all business. The members shall elect a chairman 20 and vice chairman whose duties shall be established by the advisory council. 21 The member elected to serve as chairman shall fix a time and place for regular 22 meetings of the advisory council, which shall meet at least quarterly. The 23 advisory council shall establish policies and procedures necessary to carry out 24 its duties. Expenses for the administrative staffing of the advisory council shall 25 be provided for from the licensing fees paid by pharmacy benefit managers and 26 may be transferred between state agencies by memorandum of understanding 27 or cooperative endeavor agreement. 28 C. The commissioner and the board of pharmacy may utilize the full 29 advisory council or individual member agency expertise for the purpose of Page 10 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 investigating a complaint against a pharmacy benefit manager or conducting 2 an audit of a pharmacy benefit manager. In exercising the authority provided 3 for in this Subsection, the same provisions of confidentiality applicable to the 4 Department of Insurance and Louisiana Board of Pharmacy during an 5 investigation shall apply to the advisory council or individual member agencies 6 whose expertise is being utilized. The advisory council may meet in executive 7 session, as necessary, to discuss matters involving an active investigation. 8 D. The advisory council shall provide monitoring of pharmacy benefit 9 managers in Louisiana to advise the legislature, commissioner of insurance, and 10 Louisiana Board of Pharmacy on the most effective and efficient manner of 11 regulation of pharmacy benefit managers to ensure the protection of the public. 12 Any licensed pharmacy benefit manager operating in Louisiana shall provide 13 full cooperation with the advisory council on matters including but not limited 14 to those set forth in Subsection E of this Section. 15 E. The advisory council shall advise on matters that include but are not 16 limited to the licensure and regulation of pharmacy benefit managers set forth 17 in Title 22, Title 37, and Title 40 of the Louisiana Revised Statutes of 1950, 18 applicable rules and regulations of state agencies, and federal laws or rules 19 relative to pharmacy benefit managers. 20 §2870. Prohibited acts; unfair and deceptive trade practices 21 A. A pharmacy benefit manager in Louisiana shall not: 22 (1) Commit any unfair and deceptive trade practice prohibited by R.S. 23 22:1964(15). 24 (2) Perform any act that violates the duties, obligations, and 25 responsibilities imposed under the Louisiana Insurance Code on a pharmacy 26 benefit manager. 27 (3) Buy, sell, transfer, or provide personal healthcare or contact 28 information of any beneficiary to any other party for any purpose with one 29 exception. A pharmacy benefit manager may provide such information Page 11 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 regarding beneficiaries of a health plan to that health plan provider if requested 2 by the health plan provider. 3 (4) Conduct or participate in "spread pricing" as defined in R.S. 4 22:1863(9) without providing the notice required by R.S. 22:1867. 5 (5)(a) Directly or indirectly engage in patient steering to a pharmacy in 6 which the pharmacy benefit manager maintains an ownership interest or 7 control, without making a written disclosure and receiving acknowledgment 8 from the patient. The disclosure required by this Paragraph shall provide notice 9 that the pharmacy benefit manager has an ownership interest in the pharmacy, 10 and that the patient has the right under the law to use any alternate pharmacy 11 that they choose. The pharmacy benefit manager is prohibited from retaliation 12 or further attempts to influence the patient, or treat the patient or the patient's 13 claim any differently if the patient chooses to use the alternate pharmacy. 14 (b) The provisions of this Paragraph shall not apply to employers, 15 unions, associations, or other persons who employ, own, operate, control, or 16 contract directly with a pharmacy or pharmacist for the purpose of managing 17 or controlling prescription costs paid for the benefit of an employee or member 18 or those covered by the employee or member's plan, or when the persons 19 contract with a pharmacy benefit manager to steer employees or members to 20 pharmacists or pharmacies which the person owns, operates, or controls. 21 (6) Penalize a beneficiary or provide an inducement to the beneficiary 22 for the purpose of getting the beneficiary to use specific retail, mail order 23 pharmacy, or another network pharmacy provider in which a pharmacy benefit 24 manager has an ownership interest or that has an ownership interest in a 25 pharmacy benefit manager. 26 (a) For purposes of this Section "inducement" means the providing of 27 financial incentives, including variations in premiums, deductibles, copayments, 28 or coinsurance. 29 (b) The provisions of this Paragraph shall not apply to employers, Page 12 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 unions, associations, or other persons who employ, own, operate, control, or 2 contract directly with a pharmacy or pharmacist for the purpose of managing 3 or controlling prescription costs paid for the benefit of an employee or member 4 or those covered by the employee or member's plan, or when the persons 5 contract with a pharmacy benefit manager to steer employees or members to 6 pharmacists or pharmacies which the person owns, operates, or controls. 7 (7) Retroactively denying or reducing a claim of a pharmacist or 8 pharmacy for payment or demanding repayment of all or part of a claim, after 9 the claim has been approved by the pharmacy benefit manager as authorized 10 by R.S. 22:1856.1. 11 (8) Fail to reimburse a local pharmacist or local pharmacy, as defined 12 in R.S. 46:460.36(A)(3), an amount that is not greater than or equal to the 13 amount it reimburses chain pharmacies, mail-order pharmacies, specialty 14 pharmacies or affiliates of the pharmacy benefit manager for the same drug or 15 device or for the same pharmacy service in this state. 16 (9) Fail to update prices as required by R.S. 22:1857. 17 (10) Fail to honor maximum allowable cost (MAC) prices as set forth in 18 R.S. 22:1863 et seq. 19 (a) A pharmacy benefit manager shall not require a pharmacist or 20 pharmacy to purchase drugs from any particular wholesaler. However, if a 21 pharmacy benefit manager recommends or provides a wholesaler, then that 22 wholesaler must be willing and able to honor the pharmacy benefit manager's 23 MAC price, ship the order, and have receipt of the order within two business 24 days with no additional charge to the pharmacist. 25 (b) The wholesaler with the lowest price, which is listed as the MAC 26 price, is not obligated to sell or ship to a nonmember pharmacist or pharmacy. 27 If the wholesaler chooses not to sell the drug to the pharmacist or pharmacy, 28 then the MAC price set by the pharmacy benefit manager must be adjusted to 29 the price available to the pharmacist or pharmacy through another wholesaler. Page 13 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 (11) Fail to meet the payment standards established in R.S. 22:1856. 2 (12) Fail to provide detailed remittance advice to pharmacists and 3 pharmacies in compliance with R.S. 22:1856. 4 (13) Fail to pay any state or local sales tax imposed on any drug, device, 5 or pharmacy services or to remit the sales tax to the appropriate pharmacist or 6 pharmacy for the tax proceeds to be forwarded to the sales tax authority. 7 (a) A pharmacy benefit manager who does not pay the sales tax shall be 8 liable for the tax, interest, penalties, and any other fees or costs imposed by law 9 for failure to pay sales taxes. 10 (b) No pharmacy benefit manager shall deduct the taxes from any 11 amount due to a pharmacist or pharmacy for a drug, device, or pharmacy 12 service or charge or pay anyone a fee or surcharge for paying any sales tax or 13 remitting any sales tax proceeds to a pharmacist or pharmacy if that fee or 14 surcharge would be imposed directly or indirectly on the pharmacist or 15 pharmacy. 16 (c) All pharmacy benefit managers who pay any out-of-state pharmacist 17 or pharmacy for drugs or devices shipped to a beneficiary in this state or for 18 pharmacy services rendered to a beneficiary which is taxable in this state shall 19 remit the tax directly to the appropriate taxing authority. 20 (d) Any pharmacist or pharmacy who does not receive sales tax proceeds 21 from a pharmacy benefit manager for any drug, device, or pharmacy service 22 which is subject to sales taxes shall have no responsibility for payment of the 23 taxes if the pharmacist or pharmacy provides written notification to the 24 appropriate taxing authority of the pharmacy benefit manager's failure to remit 25 the sales taxes at the time the next sales tax return is due to be filed. 26 (e) State or local sales taxes and other applicable state imposed taxes or 27 fees shall be considered as part of the allowable cost and shall be included in the 28 claim submitted by a pharmacist or pharmacy. 29 (14) Restrict early refills on maintenance drugs to an amount less than Page 14 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 seven days for a prescription of at least a thirty-day supply. 2 (15) Require a beneficiary to follow a plan's step therapy protocol if the 3 prescribed drug is on the health plan's prescription drug formulary, the 4 beneficiary has tried the step therapy required prescription drug while under 5 his current or previous health plan, and the provider has submitted a 6 justification and supporting clinical documentation that such prescription drug 7 was discontinued due to lack of efficacy or effectiveness, diminished effect, or 8 an adverse effect or event. 9 (16) Delay a decision on a request for authorization to dispense a 10 prescription drug for more than seventy-two hours, or twenty-four hours in 11 exigent circumstances in which the patient, in the opinion of the prescribing 12 provider, pharmacy, or pharmacist submitting the authorization request, is 13 suffering from a health condition that may seriously jeopardize the patient's 14 life, health, or ability to regain maximum function. A request for authorization 15 shall include relevant data or appropriate documentation to render a decision 16 on a request for authorization. 17 (17) Exploit prescription drug information obtained from beneficiaries 18 for monetary gain or economic power over beneficiaries, pharmacists, or 19 pharmacies. 20 (18) Sell, exchange, or use in any manner prescription drug information 21 regarding a beneficiary obtained through a beneficiary's use of a prescription 22 for purposes of marketing, solicitation, consumer steering, referral, or any other 23 practice or act, except as otherwise provided for in this Section, that provides 24 the pharmacy benefit manager or any of its affiliates or subsidiaries economic 25 power or control over pharmacists or pharmacies or interfer in the free choice 26 of a beneficiary. 27 (19) Engage in drug repackaging and markups. A pharmacy benefit 28 manager that owns or controls a mail-order pharmacy shall not allow the 29 mail-order pharmacy to repackage drugs and sell the repackaged items at Page 15 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 higher prices than the original average wholesale price unless beneficiaries who 2 may buy the repackaged drugs are informed in writing that the drugs have been 3 repackaged and are being sold at the higher price. 4 (20) Operate in Louisiana without being registered with and in good 5 standing with the Louisiana secretary of state to do business in Louisiana or 6 without being licensed by and in good standing with the commissioner of 7 insurance, as provided by this Chapter. 8 B. The commission of any of the acts or any combination of acts 9 prohibited by this Section shall be considered an unfair method of competition 10 and unfair practice or act in accordance with the Unfair Trade Practices and 11 Consumer Protection Law, R.S. 51:1401 et seq., if the violations are committed 12 or performed with such frequency as to indicate a general business practice. 13 Notwithstanding any provision of law to the contrary, the private right of action 14 created by R.S. 51:1409 shall not apply to this Section. 15 (1) For purposes of this Section, a violation shall be considered to have 16 occurred each time a prohibited act is committed. 17 (2) Each day that a pharmacy benefit manager operates without being 18 registered with and in good standing with the secretary of state to do business 19 in Louisiana or without being licensed by and in good standing with the 20 commissioner of insurance, as provided by this Chapter shall be considered a 21 separate violation. 22 C.(1) Nothing in this Section shall be construed to interfere or violate a 23 consumer's right to know where the consumer may have access to the lowest 24 cost drugs, whether a consumer is utilizing insurance or other third-party 25 reimbursement or not. 26 (2) Nothing in this Section shall be construed to interfere with the 27 requirement that consumers receive notice of changes to pharmacy networks, 28 such as the inclusion of new pharmacies, or removal of existing pharmacies 29 from networks. Page 16 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 §2871. Enforcement 2 A. Notwithstanding any provision of law to the contrary, enforcement of 3 the Pharmacy Benefit Manager Licensing Law shall be as follows: 4 (1) The commissioner of insurance and the Louisiana Board of 5 Pharmacy, hereinafter referred to in this Section as "regulatory bodies", shall 6 be responsible for conducting random compliance audits relative to ensure 7 compliance with this Chapter. 8 (2) A pharmacy benefit manager doing business in Louisiana shall make 9 itself open and available to comply with compliance audit data requests. 10 (3) Compliance audits may be desk audits conducted based on data 11 provided by the pharmacy benefit manager. 12 B. The regulatory bodies shall be responsible for conducting complaint 13 investigations as expeditiously as possible upon receipt of a complaint that a 14 pharmacy benefit manager is in violation of this Chapter, the Insurance Code, 15 or the Louisiana Pharmacy Practice Act. 16 (1) Each regulatory body shall be responsible for investigating 17 complaints that fall within the jurisdiction of that regulatory body. 18 (2) If a regulatory body receives a complaint that it believes is outside its 19 jurisdiction, then that regulatory body shall refer it to the appropriate 20 regulatory body. 21 (3) On the first day of every month the regulatory bodies shall submit 22 to the attorney general a report of complaints received against pharmacy 23 benefit managers and the date the complaint was received during the prior 24 calendar month in a format prescribed by the attorney general. The report shall 25 include a cumulative list of all complaints received against pharmacy benefit 26 managers until final disposition. 27 C. Upon completion of a compliance audit or complaint investigation, the 28 regulatory body may recommend to the attorney general: 29 (1) No action against the pharmacy benefit manager. Page 17 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 (2) Probation, suspension, or revocation of a license or permit. 2 D. Upon completion of a compliance audit or complaint investigation the 3 entire investigation case file and recommendation of the regulatory body shall 4 be submitted to the Louisiana Department of Justice Consumer Affairs Division 5 for review and action by the attorney general. 6 E. Upon receipt of the compliance audit or investigation case file, or 7 upon lapse of action by the regulatory body for one hundred eighty days after 8 receipt of a complaint, the attorney general shall obtain full jurisdiction over 9 the matter. 10 F. The attorney general may take the following action upon receipt of a 11 file: 12 (1) Accept the recommendation of the regulatory body if that body's 13 recommendation is to take no action. 14 (2) Find, based on the regulatory body's file, that no action is warranted 15 and close the file. 16 (3) Conduct an independent review or investigation of the complaint to 17 determine if an administrative adjudicatory hearing is warranted. 18 (4) Direct that an administrative adjudicatory hearing be conducted to 19 determine if one or more violations have occurred. 20 G. The attorney general shall have all the powers granted to him under 21 R.S. 51:1413 to enforce his investigative demands and issue subpoenas. 22 H. If the attorney general believes that one or more violations have 23 occurred then he shall conduct an administrative adjudicatory hearing to 24 determine if one or more violations have occurred. 25 (1) The administrative adjudicatory hearing shall be conducted in 26 accordance with the provisions of the Louisiana Administrative Procedure Act. 27 (2) The attorney general may preside as the hearing officer or designate 28 an assistant attorney general to preside as the hearing officer. If the attorney 29 general is not the hearing officer then the hearing officer shall file a proposed Page 18 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED 1 findings of fact and conclusions of law with the attorney general along with his 2 recommendation of any penalty to be imposed. 3 (3) The regulatory body with jurisdiction over the matter in the 4 complaint shall prosecute the action before the attorney general. 5 (4) The attorney general shall issue the final decision in the matter. 6 (5) The attorney general may impose any or all of the following penalties: 7 (a) Suspension or revocation of any or all of the licenses and permits 8 issued by the commissioner of insurance and the Louisiana Board of Pharmacy. 9 (b) Placement of any or all of the licenses and permits on probation. 10 (6) The decision of the attorney general shall be appealable in accordance 11 with the Louisiana Administrative Procedure Act. 12 I. If a license or permit is suspended, revoked, or placed on probation by 13 the attorney general then the regulatory body that issued the license or permit 14 shall immediately take the appropriate action to enforce the decision of the 15 attorney general. 16 J. Nothing in this Section shall be construed as a limitation on the 17 attorney general's power to negotiate and enter into a stipulation or consent 18 decree with a pharmacy benefit manager in lieu of proceeding to a hearing on 19 the matter relative to violations of this Chapter. 20 Section 4. If any provision or item of this Act, or the application thereof, is held 21 invalid, such invalidity shall not affect other provisions, items, or applications of the act 22 which can be given effect without the invalid provision, item, or application and to this end 23 the provisions of this Act are hereby declared severable. 24 Section 5. The provisions of R.S. 40:2869, as enacted by this Act, shall become 25 effective on August 1, 2019. 26 Section 6. Except as provided in Section 5 of this Act, the provisions of this Act shall 27 become effective on July 1, 2020. Page 19 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED The original instrument and the following digest, which constitutes no part of the legislative instrument, were prepared by Christine Arbo Peck. DIGEST SB 41 Reengrossed 2019 Regular Session Mills Present law provides that pharmacy benefit managers must be licensed by the Louisiana Department of Insurance as third party administrators. Proposed law requires pharmacy benefit managers to be licensed by the Commissioner of Insurance, registered with the Louisiana secretary of state to do business in Louisiana, and may require permitting by the Louisiana Board of Pharmacy if the pharmacy benefit manager performs certain services identified in proposed law. Proposed law establishes the Louisiana "Pharmacy Benefit Manager Licensing Law" to provide substantive requirements for obtaining and maintaining a license or permit to operate in Louisiana in order to protect the health, safety, and welfare of our citizens, to regulate the practice of pharmacy and actions that threaten pharmacy access, and to regulate actions that impede medical decisions. Proposed law defines "maximum allowable cost list" and "spread pricing". Proposed law prohibits spread pricing in Louisiana unless the pharmacy benefit manager provides biannual notice to the policyholder of the aggregate amount of spread pricing charged by the pharmacy benefit manager during the notice period. Proposed law provides for rulemaking by the Louisiana Board of Pharmacy and provides that the board has the authority and responsibility to assess fees pursuant to present law. Proposed law provides for creation of a pharmacy benefit manager monitoring advisory council and provides for membership, functions, and matters for the council to advise the commissioner of insurance and the board of pharmacy on relative to regulation of pharmacy benefit managers. Proposed law provides that the commissioner of insurance and board of pharmacy may utilize the expertise of the council to investigate complaints against pharmacy benefit managers. Proposed law provides legislative intent and public health policy findings. Proposed law provides definitions. Proposed law establishes a duty to the beneficiaries of any pharmacy benefit management plan and to the entities that have entered into a contract with the pharmacy benefit manager. Proposed law provides that the duty imposed by proposed law does not create a separate or independent cause of action. Proposed law provides general licensing and permitting requirements. Proposed law provides for general applicability. Proposed law prohibits "patient steering" to a pharmacy in which the pharmacy benefit manager has an ownership interest without making a written disclosure to the patient and informing them that they have the right to use an alternate pharmacy. Proposed law provides that the prohibition against "patient steering" does not apply to employers or other persons identified in proposed law that employ, own, operate, control, or contract directly with a pharmacy or pharmacist for the purpose of managing or controlling prescription costs. Proposed law provides a listing of acts or omissions that are deemed unfair and deceptive trade practices. Proposed law provides that commission of any of the unfair and deceptive trade practices shall subject the pharmacy benefit manager to investigative actions by the Department of Insurance or board of pharmacy if the act is committed with such frequency Page 20 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED that it indicates a general business practice. Proposed law provides for remedies and penalties under the Unfair Trade Practices and Consumer Protection Law. Proposed law provides that a claim under the Unfair Trade Practices and Consumer Protection Law does not provide a private right of action Proposed law provides that noting in proposed law shall be construed to interfere or violate a consumer's right to know where the consumer may have access to the lowest cost drugs, whether a consumer is utilizing insurance or other third-party reimbursement or not. Proposed law provides that nothing in proposed law shall be construed to interfere with the requirement that consumers receive notice of changes to pharmacy networks, such as the inclusion of new pharmacies, or removal of existing pharmacies from networks. Proposed law provides for enforcement of the Pharmacy Benefit Manager Licensing Law. Proposed law authorizes the regulatory bodies to conduct random compliance audits and complaint investigations. Proposed law requires a monthly report of opened complaints received against pharmacy benefit managers to be submitted to the Louisiana Department of Justice Consumer Affairs Division. Proposed law grants enforcement authority to the attorney general. Proposed law provides for a review process, administrative hearing, administrative ruling, and penalties that may be assessed by the attorney general. Proposed law provides for the decision of the attorney general to be appealable in accordance with the Louisiana Administrative Procedure Act. Proposed law provides that nothing in proposed law shall be construed as a limitation on the power of the attorney general to negotiate or enter into a stipulation or consent decree with a pharmacy benefit manager. Proposed law provides for severability. Proposed law provides that the provisions of proposed law establishing the pharmacy benefit manager monitoring advisory council become effective August 1, 2019. Effective July 1, 2020. (Amends R.S. 22:1863(2); adds R.S. 22:1863(9) and 1867, R.S. 37:1252-1254, and R.S. 40:2861-2871) Summary of Amendments Adopted by Senate Committee Amendments Proposed by Senate Committee on Health and Welfare to the original bill 1. Removes all provisions granting the Louisiana State Board of Medical Examiners authority to regulate pharmacy benefit managers. 2. Defines and clarifies what is considered a "maximum allowable cost list". 3. Defines and prohibits "spread pricing". 4. Provides that a duty is owed to beneficiaries and those contracted with pharmacy benefit managers to act with good faith, honesty, trust, confidence, and candor. 5. Creates the pharmacy benefit manager monitoring advisory council; provides for membership, functions, and authority. 6. Clarifies that the Louisiana Department of Insurance issues a license and the Page 21 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED Louisiana Board of Pharmacy issues a permit. 7. Removes certain provisions of legislative intent. 8. Makes technical corrections. Senate Floor Amendments to engrossed bill 1. Makes revisions to the definition of "maximum allowable cost list". 2. Makes revisions to the definition of "spread pricing". 3. Provides an exception to the prohibition on spread pricing. 4. Provides for notice required by a pharmacy benefit manager that utilizes spread pricing. 5. Provides that the imposition of duties on the pharmacy benefit manager does not create a separate or independent cause of action. 6. Provides that a pharmacy benefit manager may require permitting by the board of pharmacy if they perform certain services. 7. Removes requirement for attestation in the event that a pharmacy benefit manager does not perform the services identified in proposed law. 8. Removes certain authority of the board of pharmacy to impose penalties on a pharmacy benefit manager. 9. Adds additional members to the pharmacy benefit manager monitoring advisory council. 10.Clarifies that the expertise of the pharmacy benefit manager monitoring advisory council may be utilized by the commissioner of insurance and board of pharmacy to investigate complaints against pharmacy benefit managers. 11.Provides that "patient steering" is prohibited to a pharmacy in which the pharmacy benefit manager has an ownership interest without making a written disclosure to the patient and informing them that they have the right to use an alternate pharmacy. 12.Provides that the prohibition against patient steering and inducement does not apply to employers or other persons that employ, own, operate, control, or contract directly with a pharmacy or pharmacist for the purpose of managing or controlling prescription costs. 13.Removes certain provisions relative to discriminatory reimbursement and clarifies that a pharmacy benefit manager shall not reimburse a local pharmacist or local pharmacy less than the amount it reimburses chain pharmacies, mail-order pharmacies, specialty pharmacies or affiliates of the pharmacy benefit manager for the same drug or device or for the same pharmacy service in this state. 14.Removes requirement for separate data on remittance advices. 15.Removes requirement that the pharmacy benefit manager is liable for paying all sales taxes due to any taxing authority. 16.Prohibits the pharmacy benefit manager from charging a fee for payment of Page 22 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 41 SLS 19RS-62 REENGROSSED any required sales tax. 17.Provides that state or local taxes are considered part of the allowable cost on a claim submitted by a pharmacist. 18.Clarifies that prior authorization shall occur within 72 hours or 24 hours in exigent circumstances. 19.Clarifies that violations of the Unfair Trade Practices and Consumer Protection Law do not provide a private right of action. 20.Clarifies that implementation shall not be construed to interfere with a consumer's right to know where the consumer may have access to the lowest cost drugs, whether a consumer is utilizing insurance or other third-party reimbursement or not. 21.Clarifies that implementation shall not be construed to interfere with the requirement that consumers receive notice of changes to pharmacy networks, such as the inclusion of new pharmacies, or removal of existing pharmacies from networks. 22.Clarifies that the complaint reporting requirement applies only to complaints against pharmacy benefit managers. 23. Removes authority of the attorney general to impose monetary fines. 24.Provides that the creation of the pharmacy benefit manager monitoring advisory council shall become effective August 1, 2019. 25.Provides that the effective date for all other provisions of the Act shall be July 1, 2020. 26.Makes technical corrections. Page 23 of 23 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions.