Bill Text: IA HSB685 | 2019-2020 | 88th General Assembly | Introduced


Bill Title: A bill for an act related to pharmacy benefits managers and prescription drug prices, and including applicability provisions.

Spectrum: Committee Bill

Status: (N/A - Dead) 2020-02-20 - Committee report, recommending passage. H.J. 320. [HSB685 Detail]

Download: Iowa-2019-HSB685-Introduced.html
House Study Bill 685 - Introduced HOUSE FILE _____ BY (PROPOSED COMMITTEE ON HUMAN RESOURCES BILL BY CHAIRPERSON LUNDGREN) A BILL FOR An Act related to pharmacy benefits managers and prescription 1 drug prices, and including applicability provisions. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 5787YC (1) 88 ko/rn
H.F. _____ Section 1. Section 510B.1, Code 2020, is amended to read as 1 follows: 2 510B.1 Definitions. 3 As used in this chapter , unless the context otherwise 4 requires: 5 1. “Biological product” means the same as defined in section 6 155A.3. 7 2. “Clean claim” means a claim that has no defect or 8 impropriety, including a lack of any required substantiating 9 documentation, or other circumstances requiring special 10 treatment, that prevents timely payment from being made on the 11 claim. 12 1. 3. “Commissioner” means the commissioner of insurance. 13 2. “Covered entity” means a nonprofit hospital or medical 14 services corporation, health insurer, health benefit plan, or 15 health maintenance organization; a health program administered 16 by a department or the state in the capacity of provider of 17 health coverage; or an employer, labor union, or other group of 18 persons organized in the state that provides health coverage. 19 “Covered entity” does not include a self-funded health coverage 20 plan that is exempt from state regulation pursuant to the 21 federal Employee Retirement Income Security Act of 1974 22 (ERISA) , as codified at 29 U.S.C. §1001 et seq. ; a plan issued 23 for health coverage for federal employees; or a health plan 24 that provides coverage only for accidental injury, specified 25 disease, hospital indemnity, Medicare supplemental, disability 26 income, or long-term care, or other limited benefit health 27 insurance policy or contract. 28 3. “Covered individual” means a member, participant, 29 enrollee, contract holder, policyholder, or beneficiary of a 30 covered entity who is provided health coverage by the covered 31 entity, and includes a dependent or other person provided 32 health coverage through a policy, contract, or plan for a 33 covered individual. 34 4. “Generic drug” means a chemically equivalent copy of a 35 -1- LSB 5787YC (1) 88 ko/rn 1/ 18
H.F. _____ brand-name drug with an expired patent. 1 5. “Labeler” means a person that receives prescription 2 drugs from a manufacturer or wholesaler and repackages those 3 drugs for later retail sale and that has a labeler code from 4 the federal food and drug administration pursuant to 21 C.F.R. 5 §207.20 . 6 6. “Maximum reimbursement amount” means the maximum 7 reimbursement amount for a therapeutically and pharmaceutically 8 equivalent multiple-source prescription drug that is listed in 9 the most recent edition of the publication entitled “Approved 10 Drug Products with Therapeutic Equivalence Evaluations”, 11 published by the United States food and drug administration, 12 otherwise known as the orange book. 13 4. “Contracted pharmacy” means a pharmacy that participates 14 in a pharmacy benefits manager’s network through a contract 15 with any of the following: 16 a. A pharmacy benefits manager. 17 b. A pharmacy services administration organization. 18 c. A pharmacy group purchasing organization. 19 5. “Cost-sharing” means any coverage limit, copayment, 20 coinsurance, deductible, or other out-of-pocket expense 21 obligation imposed on a covered person by a health benefit plan 22 providing for third-party payment or prepayment of health or 23 medical expenses. 24 6. “Covered person” means a policyholder, subscriber, or 25 other person participating in a health benefit plan that covers 26 prescription drugs. 27 7. “Drug” means all medicines and preparations recognized 28 in the official United States Pharmacopeia or the official 29 National Formulary as substances intended to be used for the 30 care, mitigation, or prevention of disease. 31 8. “Generically equivalent drug” means a drug that is 32 pharmaceutically and therapeutically equivalent to a drug that 33 is prescribed. 34 9. “Health benefit plan” means the same as defined in 35 -2- LSB 5787YC (1) 88 ko/rn 2/ 18
H.F. _____ section 514J.102. 1 10. “Health care professional” means the same as defined in 2 section 514J.102. 3 11. “Health carrier” means the same as defined in section 4 514J.102. 5 12. “Maximum allowable cost list” means a list of drugs 6 or other methodology used by a pharmacy benefits manager, 7 directly or indirectly, setting the maximum allowable payment 8 to a pharmacy for a generic drug, brand-name drug, biological 9 product, or other prescription drug. “Maximum allowable cost 10 list” includes without limitation all of the following: 11 a. Average acquisition cost, including the national average 12 drug acquisition cost. 13 b. Average manufacturer price. 14 c. Average wholesale price. 15 d. Brand effective rate. 16 e. Generic effective rate. 17 f. Discount indexing. 18 g. Federal upper limits. 19 h. Wholesale acquisition cost. 20 i. Any other term that a pharmacy benefits manager or a 21 health carrier may use to establish reimbursement rates to a 22 pharmacy for pharmacist services. 23 13. “Pharmaceutically equivalent” means drugs that have 24 identical amounts of the same active chemical ingredients in 25 the same dosage form and that meet the identical, compendious, 26 or other applicable standards of strength, quality, and purity 27 according to the official United States Pharmacopeia or other 28 nationally recognized compendium. 29 14. “Pharmacist services” means products, goods, and 30 services, or any combination of products, goods, and services, 31 provided as part of the practice of pharmacy. 32 7. 15. “Pharmacy” means pharmacy the same as defined in 33 section 155A.3 . 34 16. “Pharmacy acquisition cost” means the amount that a 35 -3- LSB 5787YC (1) 88 ko/rn 3/ 18
H.F. _____ pharmaceutical wholesaler charges for a drug as listed on the 1 pharmacy’s billing invoice. 2 17. “Pharmacy benefits manager affiliate” means a pharmacy 3 or pharmacist that directly or indirectly, through one or more 4 intermediaries, owns or controls, is owned or controlled by, or 5 is under common ownership or control with a pharmacy benefits 6 manager. 7 8. 18. “Pharmacy benefits management services means the 8 administration or management of prescription drug benefits 9 provided by a covered entity under the terms and conditions 10 of the contract between the pharmacy benefits manager and the 11 covered entity. provision of any of the following services on 12 behalf of a health carrier: 13 a. The procurement of prescription drugs at a negotiated 14 rate for dispensing within this state. 15 b. The processing of prescription drug claims. 16 c. The administration of payments related to prescription 17 drug claims. 18 9. 19. “Pharmacy benefits manager” means a person who 19 performs pharmacy benefits management services , pursuant to a 20 contract or other relationship with a health carrier, either 21 directly or through an intermediary, provides pharmacy benefits 22 management services for a health carrier . “Pharmacy benefits 23 manager” includes a person acting on behalf of a pharmacy 24 benefits manager in a contractual or employment relationship in 25 the performance of pharmacy benefits management services for a 26 covered entity. “Pharmacy benefits manager” does not include 27 a health insurer licensed in the state if the health insurer 28 or its subsidiary is providing pharmacy benefits management 29 services exclusively to its own insureds, or a public 30 self-funded pool or a private single employer self-funded 31 plan that provides such benefits or services directly to its 32 beneficiaries. 33 20. “Pharmacy services administrative organization” means 34 an organization that assists pharmacies, pharmacy benefits 35 -4- LSB 5787YC (1) 88 ko/rn 4/ 18
H.F. _____ managers, or third-party payers in achieving administrative 1 efficiencies, including contracting and payment efficiencies. 2 10. 21. “Prescription drug” means prescription drug the 3 same as defined in section 155A.3 . 4 11. 22. “Prescription drug order” means prescription drug 5 order the same as defined in section 155A.3 . 6 23. “Spread pricing” means a model of prescription drug 7 pricing in which a pharmacy benefits manager charges a health 8 benefit plan a contracted price for a prescription drug, and 9 the contracted price for the prescription drug differs from the 10 amount the pharmacy benefits manager directly or indirectly 11 pays a pharmacy for the same prescription drug. 12 24. “Therapeutically equivalent” means drugs from the same 13 therapeutic class that if administered in appropriate amounts 14 will provide the same therapeutic effect, identical in duration 15 and intensity. 16 Sec. 2. Section 510B.2, Code 2020, is amended to read as 17 follows: 18 510B.2 Certification as a third-party administrator required . 19 A pharmacy benefits manager doing business in this state 20 shall obtain a certificate of registration as a third-party 21 administrator under chapter 510 pursuant to section 510.21 , and 22 the provisions relating to a third-party administrator pursuant 23 to chapter 510 shall apply to a pharmacy benefits manager. 24 Sec. 3. Section 510B.4, Code 2020, is amended to read as 25 follows: 26 510B.4 Performance of duties —— good faith —— conflict of 27 interest. 28 1. A pharmacy benefits manager shall perform the pharmacy 29 benefits manager’s duties exercising exercise good faith and 30 fair dealing in the performance of its the pharmacy benefits 31 manager’s contractual obligations toward the covered entity a 32 health carrier or a pharmacy . 33 2. A pharmacy benefits manager shall notify the covered 34 entity a health carrier or a pharmacy in writing of any 35 -5- LSB 5787YC (1) 88 ko/rn 5/ 18
H.F. _____ activity, policy, practice ownership interest, or affiliation 1 of the pharmacy benefits manager that presents any conflict of 2 interest. 3 Sec. 4. Section 510B.5, Code 2020, is amended to read as 4 follows: 5 510B.5 Contacting covered individual —— requirements. 6 A pharmacy benefits manager, unless authorized pursuant to 7 the terms of its contract with a covered entity health carrier , 8 shall not contact any covered individual person without 9 the express written permission of the covered entity health 10 carrier . 11 Sec. 5. Section 510B.6, Code 2020, is amended to read as 12 follows: 13 510B.6 Dispensing of substitute prescription drug for 14 prescribed drug drugs . 15 1. The following provisions shall apply when if a pharmacy 16 benefits manager requests the dispensing of a substitute 17 prescription drug for a prescribed prescription drug prescribed 18 to a covered individual person : 19 a. The pharmacy benefits manager may request the 20 substitution of a lower priced generic and therapeutically 21 equivalent prescription drug for a higher priced prescribed 22 prescription drug. 23 b. If the substitute prescription drug’s net cost to 24 the covered individual person or covered entity the health 25 carrier exceeds the cost of the prescribed prescription drug, 26 the substitution shall be made only for medical reasons that 27 benefit the covered individual person as determined by the 28 covered person’s prescribing health care professional . 29 2. A pharmacy benefits manager shall obtain the approval of 30 the prescribing practitioner health care professional prior to 31 requesting any substitution under this section . 32 3. A pharmacy benefits manager shall not substitute an 33 equivalent prescription drug contrary to a prescription drug 34 order that prohibits a substitution. 35 -6- LSB 5787YC (1) 88 ko/rn 6/ 18
H.F. _____ Sec. 6. Section 510B.7, Code 2020, is amended by striking 1 the section and inserting in lieu thereof the following: 2 510B.7 Health carrier termination of contract —— notice. 3 If a pharmacy benefits manager receives notice from a health 4 carrier of termination of the health carrier’s contract with 5 the pharmacy benefits manager, the pharmacy benefits manager 6 shall notify all contracted pharmacies of the effective date 7 of the termination within ten working days of receipt of the 8 notice. 9 Sec. 7. Section 510B.8, Code 2020, is amended by striking 10 the section and inserting in lieu thereof the following: 11 510B.8 Maximum allowable cost lists —— requirements. 12 1. Before a pharmacy benefits manager places or continues a 13 particular drug on a maximum allowable cost list, all of the 14 following requirements must be satisfied: 15 a. If the drug is a generically equivalent drug, the 16 drug shall be listed as therapeutically equivalent and 17 pharmaceutically equivalent “A” or “B” rated in the most recent 18 edition of the publication entitled “Approved Drug Products 19 with Therapeutic Equivalence Evaluations”, published by the 20 United States food and drug administration, otherwise known as 21 the orange book, or have an NR or NA rating by a nationally 22 recognized reference. 23 b. The drug shall be available for purchase by each pharmacy 24 in this state from a national or regional wholesaler licensed 25 pursuant to section 155A.17. 26 c. The drug shall not be obsolete. 27 2. A pharmacy benefits manager shall comply with all of the 28 following requirements: 29 a. The pharmacy benefits manager must provide each pharmacy 30 subject to a maximum allowable cost list access to the maximum 31 allowable cost list. 32 b. The pharmacy benefits manager must update the maximum 33 allowable cost list within seven calendar days of any of the 34 following dates: 35 -7- LSB 5787YC (1) 88 ko/rn 7/ 18
H.F. _____ (1) The date of an increase in the pharmacy acquisition 1 cost. 2 (2) The date of a change in the methodology on which the 3 maximum allowable cost list is based. 4 (3) The date of a change in any value of any variable 5 involved in the methodology on which the maximum allowable cost 6 list is based. 7 c. The pharmacy benefits manager must provide a process 8 for each pharmacy subject to the maximum allowable cost list 9 to receive prompt notification of any update to the maximum 10 allowable cost list. 11 d. The pharmacy benefits manager shall not reimburse any 12 pharmacy in this state for a prescription drug in an amount 13 less than the amount that the pharmacy benefits manager 14 reimburses a pharmacy benefits manager affiliate for providing 15 the same prescription drug. The amount shall be calculated on 16 a per unit basis based on the same generic product identifier 17 or generic code number. 18 3. A pharmacy may decline to provide pharmacist services 19 to a pharmacy benefits manager or to a covered person if, as a 20 result of a maximum allowable cost list, a pharmacy is to be 21 paid less than that pharmacy’s pharmacy acquisition cost for 22 the pharmacist services. 23 Sec. 8. NEW SECTION . 510B.8A Maximum allowable cost lists 24 —— appeal procedure. 1. A pharmacy benefits manager shall provide an appeal 26 procedure to allow a pharmacy to challenge a maximum allowable 27 cost list, and any reimbursement made under a maximum allowable 28 cost list, for a specific drug for any of the following 29 reasons: 30 a. Failure to meet the requirements of section 510B.8. 31 b. The maximum allowable cost falls below the pharmacy 32 acquisition cost. 33 2. The appeal procedure shall include all of the following: 34 a. A dedicated telephone number, email address, and internet 35 -8- LSB 5787YC (1) 88 ko/rn 8/ 18
H.F. _____ site for the pharmacy to submit appeals. 1 b. The ability to submit an appeal directly to the 2 pharmacy benefits manager or directly to the pharmacy service 3 administration organization. 4 c. A time limit of no less than thirty business days to 5 submit an appeal from the date of any of the following: 6 (1) Access to a maximum allowable cost list pursuant to 7 section 510B.8, subsection 2, paragraph “a” . 8 (2) A reimbursement that falls below the pharmacy 9 acquisition cost for a drug. 10 3. A pharmacy benefits manager shall respond in writing to 11 a pharmacy’s appeal within ten business days of the date of 12 receipt of the appeal. 13 4. If a pharmacy benefits manager upholds a pharmacy’s 14 appeal, the pharmacy benefits manager shall comply with all of 15 the following: 16 a. The pharmacy benefits manager shall permit the 17 challenging pharmacy to reverse and rebill the claim in 18 question. 19 b. The pharmacy benefits manager shall make a change in the 20 maximum allowable cost list for the drug that is the subject of 21 the appeal so that the reimbursement for such drug is at least 22 equal to the pharmacy acquisition cost. 23 c. The pharmacy benefits manager shall provide the pharmacy 24 with the national drug code that is the basis for the increase 25 or change in the price of the drug. 26 d. The pharmacy benefits manager shall make the changes 27 pursuant to paragraphs “a” and “b” immediately effective for all 28 similarly situated pharmacies in this state. 29 5. If a pharmacy benefits manager denies a pharmacy’s 30 appeal, the pharmacy benefits manager shall comply with all of 31 the following: 32 a. The pharmacy benefits manager shall provide the appealing 33 pharmacy the national drug code and the name of a national or 34 regional wholesaler licensed pursuant to section 155A.17 that 35 -9- LSB 5787YC (1) 88 ko/rn 9/ 18
H.F. _____ has the drug currently in stock at a price below the maximum 1 allowable cost list. 2 b. If the national drug code provided by the pharmacy 3 benefits manager is not available pursuant to paragraph 4 “a” , the pharmacy benefits manager shall adjust the maximum 5 allowable cost list for the drug that is the basis of the 6 appeal to a price greater than the appealing pharmacy’s 7 pharmacy acquisition cost for that drug, and permit the 8 appealing pharmacy to reverse and rebill each claim affected 9 by the pharmacy’s inability to procure the drug at a cost that 10 is equal to or less than the previously challenged maximum 11 allowable cost. 12 Sec. 9. NEW SECTION . 510B.8B Prohibited actions and 13 activities. 14 1. A pharmacy benefits manager or a health carrier shall 15 not, as a condition of payment, reimbursement, or network 16 participation, require any of the following of a pharmacy: 17 a. To meet accreditation, certification, or credentialing 18 standards that are inconsistent with, more stringent than, or 19 in addition to the federal and state requirements applicable to 20 a pharmacy in this state. 21 b. To satisfy any insurance, surety bond, or other 22 financial guarantee requirements that are inconsistent with, 23 more stringent than, or in addition to the federal and state 24 requirements applicable to a pharmacy in this state. 25 2. A pharmacy benefits manager or a health carrier shall not 26 directly or indirectly charge or hold a pharmacy responsible 27 for a fee related to a claim in any of the following 28 circumstances: 29 a. The fee is not readily apparent to the pharmacy at the 30 time the pharmacy submits the claim. 31 b. The fee is not reported on the remittance advice of an 32 adjudicated claim. 33 c. The fee is not processed at the time a claim is 34 adjudicated at the point of sale. 35 -10- LSB 5787YC (1) 88 ko/rn 10/ 18
H.F. _____ 3. A pharmacy benefits manager is prohibited from 1 conducting spread pricing in this state. 2 4. A pharmacy benefits manager shall not terminate a 3 contracted pharmacy solely on the basis that the contracted 4 pharmacy offers or provides store-direct delivery or mail 5 prescriptions as an ancillary service to a covered person. 6 Sec. 10. Section 510B.9, Code 2020, is amended to read as 7 follows: 8 510B.9 Submission, approval, and use of prior Prior 9 authorization form . 10 A pharmacy benefits manager shall file with and have 11 approved by the commissioner a single prior authorization 12 form as provided in section 505.26 comply with all applicable 13 prior authorization requirements pursuant to section 505.26 . 14 A pharmacy benefits manager shall use the single prior 15 authorization form as provided in section 505.26 . 16 Sec. 11. Section 510B.10, Code 2020, is amended by striking 17 the section and inserting in lieu thereof the following: 18 510B.10 Disclosure of lower-cost options —— pharmacists. 19 1. A pharmacy benefits manager shall not require a covered 20 person to make a cost-sharing payment at the point of sale 21 for a prescription drug in an amount that exceeds the amount 22 the covered person would pay for the prescription drug if the 23 covered person purchased the prescription drug without using 24 the covered person’s health benefit plan. 25 2. A pharmacy benefits manager shall not prohibit a 26 contracted pharmacy from disclosing, and shall not apply a 27 penalty or any other type of disincentive to a contracted 28 pharmacy that discloses, lower-cost prescription drug options 29 to a covered person including those options that are available 30 to the covered person if the covered person purchases the 31 prescription drug without using the covered person’s health 32 benefit plan. 33 3. Any amount paid by a covered person for a prescription 34 drug purchased without using the covered person’s health 35 -11- LSB 5787YC (1) 88 ko/rn 11/ 18
H.F. _____ benefit plan pursuant to subsection 2 shall be applied to any 1 deductible imposed by the covered person’s health benefit plan 2 in accordance with the covered person’s health benefit plan 3 coverage documents. 4 4. Any provision of a contract that conflicts with 5 subsection 1 or 2 shall be void and unenforceable. 6 5. A violation of this section shall be an unlawful practice 7 and shall be a violation of section 507B.4. 8 Sec. 12. NEW SECTION . 510B.11 Clean claims —— retroactive 9 reductions. 10 1. After the date of receipt of a clean claim for payment 11 made by a contracted pharmacy, a pharmacy benefits manager 12 shall not retroactively reduce payment on the claim, either 13 directly or indirectly, through an aggregated effective rate, 14 direct or indirect remuneration, a quality assurance program, 15 or any other means, except if the claim is found not to be 16 a clean claim during the course of a routine audit performed 17 pursuant to an agreement between the pharmacy benefits manager 18 and the contracted pharmacy. 19 2. If a contracted pharmacy adjudicates a claim at the point 20 of sale, the reimbursement amount provided to the contracted 21 pharmacy by the pharmacy benefits manager shall constitute a 22 final reimbursement amount. 23 3. Nothing in this section shall be construed to prohibit 24 any retroactive increase in payment to a contracted pharmacy 25 pursuant to a contract between a pharmacy benefits manager and 26 a pharmacy services administration organization, or between a 27 pharmacy benefits manager and a pharmacy. 28 4. A pharmacy benefits manager shall not recoup funds from a 29 contracted pharmacy in connection with any claims for which the 30 contracted pharmacy has already been paid unless the recoupment 31 is a result of any of the following: 32 a. The recoupment is otherwise permitted or required by law. 33 b. The recoupment is based on an audit performed pursuant 34 to a contract between the pharmacy benefits manager and the 35 -12- LSB 5787YC (1) 88 ko/rn 12/ 18
H.F. _____ contracted pharmacy. 1 c. The recoupment is a result of an audit performed pursuant 2 to a contract between the pharmacy benefits manager and a 3 designated pharmacy services administrative organization. 4 5. The provisions of this section shall not apply to 5 an investigative audit of a contracted pharmacy’s records 6 conducted by a pharmacy benefits manager in any of the 7 following circumstances: 8 a. Fraud, waste, abuse, or other intentional misconduct is 9 indicated by a review of the contracted pharmacy’s claims data 10 or statements. 11 b. Other investigative methods utilized by the pharmacy 12 benefits manager indicate that the contracted pharmacy is 13 or has been engaged in criminal wrongdoing, fraud, or other 14 intentional or willful misrepresentation. 15 Sec. 13. NEW SECTION . 510B.12 Compensation program —— 16 commissioner approval. 17 The commissioner may review and approve the compensation 18 program of a pharmacy benefits manager for a health carrier to 19 ensure that the reimbursement for pharmacist services provided 20 by a contracted pharmacy is fair, reasonable, and appropriate 21 to provide an adequate pharmacy benefits manager’s network for 22 the health carrier. 23 Sec. 14. NEW SECTION . 510B.13 Rules. 24 The commissioner shall adopt rules pursuant to chapter 17A 25 to administer this chapter. 26 Sec. 15. NEW SECTION . 510B.14 Enforcement. 27 1. The commissioner shall take any enforcement action under 28 the commissioner’s authority to enforce compliance with this 29 chapter. 30 2. After notice and hearing, the commissioner may impose 31 any or all of the sanctions pursuant to section 507B.7 and may 32 suspend or revoke a pharmacy benefits manager’s certificate of 33 registration as a third-party administrator upon a finding that 34 the pharmacy benefits manager violated any of the requirements 35 -13- LSB 5787YC (1) 88 ko/rn 13/ 18
H.F. _____ of this chapter, or of chapter 510 pertaining to third-party 1 administrators. 2 3. A pharmacy benefits manager, as an agent or vendor of a 3 health carrier, is subject to the commissioner’s authority to 4 conduct an examination pursuant to chapter 507. The procedures 5 set forth in chapter 507 regarding examination reports shall 6 apply to an examination of a pharmacy benefits manager under 7 this chapter. 8 4. A pharmacy benefits manager is subject to the 9 commissioner’s authority to conduct an investigation pursuant 10 to chapter 507B. The procedures set forth in chapter 507B 11 regarding investigations shall apply to an investigation of a 12 pharmacy benefits manager under this chapter. 13 5. A pharmacy benefits manager is subject to the 14 commissioner’s authority to conduct an examination, audit, 15 or inspection pursuant to chapter 510 for third-party 16 administrators. The procedures set forth in chapter 510 for 17 third-party administrators shall apply to an examination, 18 audit, or inspection of a pharmacy benefits manager under this 19 chapter. 20 6. If the commissioner conducts an examination of a pharmacy 21 benefits manager under chapter 507; a proceeding under chapter 22 507B; or an examination, audit, or inspection under chapter 23 510, all information received from the pharmacy benefits 24 manager, and all notes, work papers, or other documents 25 related to the examination, investigation, audit, or inspection 26 of the pharmacy benefits manager, shall be confidential 27 records pursuant to chapter 22 and shall be accorded the same 28 confidentiality as notes, work papers, investigatory materials, 29 or other documents related to the examination of an insurer as 30 provided in section 507.14. 31 Sec. 16. NEW SECTION . 510B.15 Severability. 32 If any provision of this chapter or the application 33 thereof to any person or circumstances is held invalid, the 34 invalidity shall not affect other provisions or applications 35 -14- LSB 5787YC (1) 88 ko/rn 14/ 18
H.F. _____ of the chapter which can be given effect without the invalid 1 provisions or application and, to this end, the provisions of 2 this chapter are severable. 3 Sec. 17. REPEAL. Section 510B.3, Code 2020, is repealed. 4 Sec. 18. APPLICABILITY. This Act applies to a pharmacy 5 benefits manager providing pharmacy benefits management 6 services in this state on or after the effective date of this 7 Act. 8 EXPLANATION 9 The inclusion of this explanation does not constitute agreement with 10 the explanation’s substance by the members of the general assembly. 11 This bill relates to pharmacy benefits managers and 12 prescription drug prices. 13 “Pharmacy benefits manager” (PBM) is defined in the bill as 14 a person who, pursuant to a contract or other relationship with 15 a health carrier, either directly or through an intermediary, 16 provides pharmacy benefits management services for the 17 health carrier. “Pharmacy benefits management services” is 18 defined as, on behalf of a health carrier, the procurement of 19 prescription drugs at a negotiated rate for dispensing within 20 this state, the processing of prescription drug claims, or the 21 administration of payments related to prescription drug claims. 22 The bill details the requirements that must be satisfied 23 before a PBM places a particular drug on a maximum allowable 24 cost list, or continues a particular drug on a maximum 25 allowable cost list. “Maximum allowable cost list” (MAC list) 26 is defined in the bill as a list of drugs or other methodology 27 used by a PBM, directly or indirectly, setting the maximum 28 allowable payment to a pharmacy for a generic drug, brand-name 29 drug, biological product, or other prescription drug. A PBM 30 cannot place a drug on the MAC list unless the PBM first 31 complies with the requirements in the bill, including ensuring 32 that the drug is available for purchase by each pharmacy in 33 this state for a national or regional wholesaler licensed in 34 this state. 35 -15- LSB 5787YC (1) 88 ko/rn 15/ 18
H.F. _____ A PBM must allow a pharmacy that is subject to a MAC list 1 to have access to the list. The PBM is required to update a 2 MAC list within seven calendar days of the date of an increase 3 in the pharmacy acquisition cost, a change in methodology on 4 which the MAC is based, or a change in any value of any variable 5 involved in the methodology on which the MAC list is based. 6 The PBM must provide a pharmacy subject to a MAC list with 7 prompt notification of any updates to the MAC list. 8 The bill provides that a PBM cannot reimburse a pharmacy in 9 this state for a prescription drug in an amount less than the 10 amount that the PBM reimburses a PBM affiliate for providing 11 the same prescription drug. A pharmacy may decline to provide 12 pharmacist services to a PBM or to a covered person if, as a 13 result of a maximum allowable cost list, a pharmacy is to be 14 paid less than that pharmacy’s pharmacy acquisition cost for 15 the prescription drug. 16 The bill requires a PBM to provide an appeal procedure to 17 allow a pharmacy to challenge a maximum allowable cost list, 18 and any reimbursement made under a maximum allowable cost 19 list. The appeal procedure must include a dedicated telephone 20 number, email address, and internet site for a pharmacy to 21 submit appeals, and must include the ability to submit an 22 appeal directly to the PBM or directly to the pharmacy service 23 administration organization. Additional requirements for the 24 appeals process, including the PBM’s obligations if an appeal 25 is upheld or denied, are detailed in the bill. 26 The bill prohibits a PBM or a health carrier from, as a 27 condition of payment, reimbursement, or network participation, 28 requiring a pharmacy to meet accreditation, certification, 29 or credentialing standards that are inconsistent with, more 30 stringent than, or in addition to the federal and state 31 requirements applicable to a pharmacy in this state; or 32 to satisfy any insurance, surety bond, or other financial 33 guarantee requirements that are inconsistent with, more 34 stringent than, or in addition to the federal and state 35 -16- LSB 5787YC (1) 88 ko/rn 16/ 18
H.F. _____ requirements applicable to a pharmacy in this state. The bill 1 also prohibits the PBM from charging or holding a pharmacy 2 responsible for certain fees as detailed in the bill. 3 A PBM or a health carrier also cannot directly or indirectly 4 charge or hold a pharmacy responsible for a fee related to a 5 claim in any of the circumstances detailed in the bill. A 6 PBM is additionally prohibited from conducting spread pricing 7 in this state. “Spread pricing” is defined as a model of 8 prescription drug pricing in which a PBM charges a health 9 benefit plan a contracted price for a prescription drug, and 10 the contracted price for the prescription drug differs from the 11 amount the PBM directly or indirectly pays a pharmacy for the 12 prescription drug. 13 The bill prohibits a PBM from terminating a contracted 14 pharmacy for providing direct delivery or delivery by mail for 15 prescriptions to covered persons. 16 After the date of receipt of a clean claim for payment 17 from a contracted pharmacy, the bill prohibits a PBM from 18 retroactively reducing payment on the claim, either directly 19 or indirectly, through an aggregated effective rate, direct 20 or indirect remuneration, a quality assurance program, or any 21 other means unless the claim is found not to be a clean claim 22 during the course of a routine audit performed by the PBM. The 23 bill provides that if a contracted pharmacy adjudicates a claim 24 at the point of sale, the reimbursement amount provided to the 25 pharmacy by the PBM is the final reimbursement amount. A PBM 26 cannot recoup funds from a contracted pharmacy in connection 27 with claims for which the pharmacy has already been paid except 28 in circumstances outlined in the bill. 29 The bill authorizes the commissioner of insurance to review 30 and approve the compensation program of a PBM for a health 31 carrier to ensure that the reimbursement for services provided 32 by a contracted pharmacy is fair, reasonable, and appropriate 33 to provide an adequate PBM network for the health carrier. 34 The bill requires the commissioner to adopt rules to 35 -17- LSB 5787YC (1) 88 ko/rn 17/ 18
H.F. _____ administer the provisions of the bill and to take any 1 enforcement action under the commissioner’s authority to 2 enforce compliance with the provisions of the bill. 3 The bill provides that if any provision of the bill is held 4 invalid, the invalidity shall not affect other provisions or 5 applications of the bill which can be given effect without the 6 invalid provisions. 7 The bill repeals Code section 510B.3, relating to current 8 enforcement and rulemaking authority, and makes conforming 9 changes throughout Code chapter 510B. 10 The bill applies to a PBM providing pharmacy benefits 11 management services in this state on or after the effective 12 date of the bill. 13 -18- LSB 5787YC (1) 88 ko/rn 18/ 18
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