House File 526 - Introduced HOUSE FILE 526 BY COMMITTEE ON COMMERCE (SUCCESSOR TO HSB 46) A BILL FOR An Act relating to price transparency and cost-sharing for 1 prescription drugs, and including applicability provisions. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 1115HV (3) 89 ko/rn
H.F. 526 Section 1. NEW SECTION . 510D.1 Definitions. 1 As used in this chapter, unless the context otherwise 2 requires: 3 1. “Commissioner” means the commissioner of insurance. 4 2. “Dispenser” means the same as defined in 21 U.S.C. 5 §360eee(3). 6 3. “Established name” means the same as defined in 21 C.F.R. 7 299.4. 8 4. “Health benefit plan” means the same as defined in 9 514J.102. 10 5. “Pharmaceutical drug manufacturer” or “manufacturer” means 11 any person engaged in the business of producing, preparing, 12 converting, processing, packaging, labeling, or distributing 13 a prescription drug. “Pharmaceutical drug manufacturer” or 14 “manufacturer” does not include a wholesale distributor or a 15 dispenser. 16 6. “Prescription drug” means the same as defined in 21 17 U.S.C. §360eee(12). 18 7. “Wholesale acquisition cost” or “cost” means a 19 manufacturer’s list price for a prescription drug for 20 wholesalers or direct purchasers in the United States, not 21 including prompt pay or other discounts, rebates, or reductions 22 in price, for the most recent month for which the information 23 is available, as reported in wholesale price guides or other 24 publications of drug or biological pricing data. 25 8. “Wholesale distributor” means the same as defined in 21 26 U.S.C. §360eee(29). 27 Sec. 2. NEW SECTION . 510D.2 Pharmaceutical drug 28 manufacturers —— annual report. 29 Each manufacturer shall provide an annual report by 30 February 15 to the commissioner, in a format prescribed 31 by the commissioner, that contains the current wholesale 32 acquisition cost for each prescription drug manufactured by the 33 manufacturer that was sold to a person in this state in the 34 immediately preceding calendar year. Within thirty calendar 35 -1- LSB 1115HV (3) 89 ko/rn 1/ 17
H.F. 526 days of receipt, the commissioner shall publish the information 1 received by the commissioner on a publicly accessible internet 2 site. 3 Sec. 3. NEW SECTION . 510D.3 Wholesale acquisition cost 4 increase —— report. 5 1. If a prescription drug sold to a person in this state 6 has a wholesale acquisition cost of one hundred dollars or more 7 for a thirty-day supply and the cost increases forty percent 8 or more over the three preceding consecutive calendar years, 9 or increases fifteen percent or more in the preceding calendar 10 year, the manufacturer of the prescription drug shall file a 11 report with the commissioner within thirty calendar days of the 12 date on which the forty percent or the fifteen percent increase 13 in the cost occurs. The report shall be in the form and manner 14 prescribed by the commissioner and shall include all of the 15 following information: 16 a. The established name of the prescription drug. 17 b. All brand names, generic names, proprietary names, and 18 nonproprietary names for the prescription drug, as applicable. 19 c. The aggregate manufacturer-level research and development 20 costs related to the prescription drug for the most recent 21 calendar year for which third-party independent audit data for 22 manufacturer-level research and development costs is available. 23 d. All established names, brand names, generic names, 24 proprietary names, and nonproprietary names for each 25 prescription drug manufactured by the manufacturer that 26 received approval from the United States food and drug 27 administration in the immediately preceding three consecutive 28 calendar years. 29 e. All established names, brand names, generic names, 30 proprietary names, and nonproprietary names for each 31 prescription drug manufactured by the manufacturer for which 32 a patent or exclusivity expired in the immediately preceding 33 three consecutive calendar years. 34 f. A statement detailing the factor or factors that played 35 -2- LSB 1115HV (3) 89 ko/rn 2/ 17
H.F. 526 any role in the increase in cost of the prescription drug 1 and an explanation for the factor or factors’ impact on the 2 increase in cost of the prescription drug. 3 g. The aggregate manufacturer-level direct and 4 administrative costs related to marketing and advertising of 5 the prescription drug for the immediately preceding calendar 6 year. 7 2. All information and data a manufacturer submits to the 8 commissioner must be consistent in detail and quality with the 9 information and data submitted in the manufacturer’s annual 10 report filed with the United States securities and exchange 11 commission on form 10-k. 12 3. a. Information provided by a pharmaceutical drug 13 manufacturer to the commissioner pursuant to this section 14 that may reveal any of the following as related to a specific 15 prescription drug or class of prescription drugs shall 16 be considered a confidential record, and be recognized 17 and protected as a trade secret pursuant to section 22.7, 18 subsection 3: 19 (1) The amount the manufacturer charges a specific health 20 carrier, specific pharmacy benefit manager, or a specific 21 dispenser. 22 (2) The dollar value of the rebates the manufacturer 23 provides a specific health carrier, specific pharmacy benefit 24 manager, or a specific dispenser. 25 (3) The identity of a specific health carrier, specific 26 pharmacy benefit manager, or a specific dispenser. 27 b. Within sixty calendar days of receipt of the information 28 pursuant to this section, the commissioner shall publish all 29 nonconfidential information received by the commissioner on the 30 same publicly accessible internet site referenced in section 31 510D.2. 32 Sec. 4. NEW SECTION . 510D.4 Rules. 33 The commissioner shall adopt rules pursuant to chapter 17A 34 as necessary to administer this chapter. 35 -3- LSB 1115HV (3) 89 ko/rn 3/ 17
H.F. 526 Sec. 5. NEW SECTION . 510D.5 Summary enforcement. 1 1. Upon a determination by the commissioner that a 2 manufacturer or manufacturer’s agent has engaged, is engaging, 3 or is about to engage in any act or practice in violation of 4 this chapter, a rule adopted by the commissioner, or an order 5 issued by the commissioner under this chapter, the commissioner 6 may do any of the following: 7 a. Issue a summary order, including a brief statement 8 of findings of fact and conclusions of law, and direct the 9 manufacturer or manufacturer’s agent to cease and desist from 10 engaging in the act or practice. 11 b. Take other affirmative action that in the judgment of 12 the commissioner is necessary to ensure that the manufacturer 13 or manufacturer’s agent comply with this chapter, and rules 14 adopted and orders issued by the commissioner under this 15 chapter. 16 2. a. A manufacturer or manufacturer’s agent that has 17 been issued a summary order under this section may contest 18 the order by filing a request for a contested case proceeding 19 and hearing as provided in chapter 17A, and in accordance 20 with rules adopted by the commissioner. The manufacturer or 21 manufacturer’s agent shall have at least thirty calendar days 22 from the date that the summary order is issued to file the 23 request. If a hearing is not timely requested, the summary 24 order shall be final by operation of law. 25 b. Section 17A.18A shall not apply to a summary order issued 26 under this section. 27 c. A summary order issued pursuant to this section shall 28 remain effective from the date of issuance unless overturned by 29 a final decision of a presiding officer or by a final judgment 30 of the court. 31 3. A manufacturer or manufacturer’s agent violating 32 a summary order issued under this section shall be deemed 33 in contempt of that order. The commissioner may petition 34 the district court to enforce the order as certified by 35 -4- LSB 1115HV (3) 89 ko/rn 4/ 17
H.F. 526 the commissioner. The district court shall adjudge the 1 manufacturer or manufacturer’s agent in contempt of the order 2 if the court finds after hearing that the manufacturer or 3 manufacturer’s agent is not in compliance with the order. The 4 court may assess a civil penalty against the manufacturer or 5 manufacturer’s agent of not more than one thousand dollars 6 per day for each day that the manufacturer or manufacturer’s 7 agent is in violation of the order. A civil penalty collected 8 pursuant to this section shall be deposited as provided in 9 section 505.7. The court may issue further orders as the court 10 deems appropriate. 11 Sec. 6. NEW SECTION . 510D.6 Enforcement after hearing. 12 1. If, after a hearing and contested case proceeding 13 pursuant to section 510D.5, subsection 2, the commissioner 14 determines that a manufacturer or a manufacturer’s agent 15 violated this chapter, a rule adopted by the commissioner, or 16 an order issued by the commissioner under this chapter, the 17 commissioner shall reduce the findings to writing and shall 18 issue and cause to be served upon the manufacturer or the 19 manufacturer’s agent all of the following: 20 a. A copy of the commissioner’s findings. 21 b. An order requiring the manufacturer or the manufacturer’s 22 agent to cease and desist from violating this chapter, a 23 rule adopted by the commissioner, or an order issued by the 24 commissioner under this chapter. 25 2. The commissioner may take other affirmative action that 26 in the judgment of the commissioner is necessary to ensure that 27 the manufacturer or the manufacturer’s agent complies with this 28 chapter. The commissioner may also, at the commissioner’s 29 discretion, order payment of a civil penalty of not more than 30 five thousand dollars for each violation of this chapter by the 31 manufacturer or the manufacturer’s agent. 32 3. A manufacturer or a manufacturer’s agent that violates 33 an order of the commissioner, and while such order is in 34 effect, may, after notice and hearing and upon order of the 35 -5- LSB 1115HV (3) 89 ko/rn 5/ 17
H.F. 526 commissioner, be subject to a civil penalty of not more than 1 ten thousand dollars for each violation of the commissioner’s 2 order. A manufacturer or a manufacturer’s agent violating an 3 order issued by the commissioner under this section shall be 4 deemed in contempt of the order. A civil penalty collected 5 pursuant to this subsection shall be deposited as provided in 6 section 505.7. 7 4. A manufacturer or a manufacturer’s agent may seek 8 judicial review of an action of the commissioner pursuant to 9 chapter 17A. To the extent that a decision or order of the 10 commissioner is affirmed in a judicial review proceeding, the 11 court shall issue an order directing that the manufacturer 12 or the manufacturer’s agent complies with the terms of the 13 commissioner’s decision or order. 14 5. If the period for judicial review of an order of the 15 commissioner has expired and no petition for judicial review 16 has been filed, upon request of the commissioner, the attorney 17 general shall proceed in the district court to enforce the 18 order of the commissioner. The court shall issue an order 19 directing that the manufacturer or the manufacturer’s agent 20 comply with the terms of the commission’s order. 21 6. Upon request of the commissioner, the attorney general 22 shall petition the district court to enforce an order as 23 certified by the commissioner. The district court shall 24 adjudge a manufacturer or a manufacturer’s agent in contempt 25 of the commissioner’s order if the court finds after hearing 26 that the manufacturer or the manufacturer’s agent is not in 27 compliance with the commissioner’s order. For each day of 28 noncompliance, the court may order a civil penalty of not more 29 than one thousand dollars against the manufacturer or the 30 manufacturer’s agent and may issue further orders as the court 31 deems appropriate. 32 Sec. 7. NEW SECTION . 510E.1 Definitions. 33 As used in this chapter unless the context otherwise 34 requires: 35 -6- LSB 1115HV (3) 89 ko/rn 6/ 17
H.F. 526 1. “Commissioner” means the commissioner of insurance. 1 2. “Covered person” means the same as defined in section 2 514J.102. 3 3. “Dispenser” means the same as defined in 21 U.S.C. 4 §360eee(3). 5 4. “Health benefit plan” means the same as defined in 6 section 514J.102. 7 5. “Health care professional” means the same as defined in 8 section 514J.102. 9 6. “Health carrier” means the same as defined in section 10 514J.102. 11 7. “Pharmaceutical drug manufacturer” or “manufacturer” means 12 any person engaged in the business of producing, preparing, 13 converting, processing, packaging, labeling, or distributing 14 a prescription drug. “Pharmaceutical drug manufacturer” or 15 “manufacturer” does not include a wholesale distributor or a 16 dispenser. 17 8. “Prescription drug” means the same as defined in 21 18 U.S.C. §360eee(12). 19 9. “Prescription drug benefit” means a health benefit plan 20 providing for third-party payment or prepayment of prescription 21 drugs. 22 10. “Specialty drug” means a prescription drug that a health 23 carrier has designated as a specialty drug and that has either 24 of the following characteristics: 25 a. The United States food and drug administration has 26 designated the prescription drug an orphan drug. 27 b. The manufacturer of the prescription drug, or the United 28 States food and drug administration, restricts distribution of 29 the prescription drug to a limited number of distributors. 30 11. “Utilization review” means the same as defined in 31 section 514F.7. 32 12. “Utilization review organization” means the same as 33 defined in section 514F.7. 34 Sec. 8. NEW SECTION . 510E.2 Health carriers —— annual 35 -7- LSB 1115HV (3) 89 ko/rn 7/ 17
H.F. 526 report. 1 1. a. Each health carrier shall submit an annual report 2 by February 15 to the commissioner, in the form and manner 3 prescribed by the commissioner, that contains the following 4 information for the immediately preceding calendar year, across 5 all of the health carrier’s health benefit plans that offer a 6 prescription drug benefit: 7 (1) The brand name of the twenty-five prescription drugs 8 most frequently covered by the prescription drug benefits 9 offered by the health carrier. 10 (2) The percent increase in annual spending by the health 11 carrier to provide all prescription drug benefits offered by 12 the health carrier. 13 (3) The percent increase in premiums paid by covered persons 14 attributable to all prescription drug benefits offered by the 15 health carrier. 16 (4) The percentage of specialty drugs included in all 17 prescription drug benefits offered by the health carrier that 18 are subject to utilization review conducted by a utilization 19 review organization. 20 (5) The percent decrease in premiums paid by covered persons 21 attributable to specialty drugs that are subject to utilization 22 review conducted by a utilization review organization that 23 are included in all prescription drug benefits offered by the 24 health carrier. 25 b. An authorized insurer or an authorized third-party 26 administrator that administers a multiple employer welfare 27 arrangement pursuant to section 507A.4, subsection 9, paragraph 28 “a” , subparagraph (1), shall submit the report required in 29 paragraph “a” on behalf of the multiple employer welfare 30 arrangement that the authorized insurer or the authorized 31 third-party administrator administers. 32 2. Any information a health carrier provides, or an 33 authorized insurer or an authorized third-party administrator 34 provides on behalf of a multiple employer welfare arrangement, 35 -8- LSB 1115HV (3) 89 ko/rn 8/ 17
H.F. 526 to the commissioner pursuant to subsection 1 that may reveal 1 any of the following shall be considered a confidential record, 2 and be recognized and protected as a trade secret pursuant to 3 section 22.7, subsection 3: 4 a. The identity of a specific health benefit plan. 5 b. The identity of the specific price charged by a specific 6 manufacturer, pharmacy benefit manager, or dispenser for a 7 specific prescription drug or class of prescription drugs. 8 c. The dollar value of the rebates a specific manufacturer, 9 a specific pharmacy benefit manager, or a specific dispenser 10 provides to the health carrier. 11 3. Prior to May 1 of each calendar year, the commissioner 12 shall publish the nonconfidential data received by the 13 commissioner pursuant to this section on the same publicly 14 accessible internet site referenced in section 510D.2. The 15 data shall be aggregated from all annual reports submitted 16 pursuant to subsection 1, and the information shall be 17 made available to the public in a format that complies with 18 subsection 2. 19 Sec. 9. NEW SECTION . 510E.3 Rules. 20 The commissioner shall adopt rules pursuant to chapter 17A 21 as necessary to administer this chapter. 22 Sec. 10. NEW SECTION . 510E.4 Summary enforcement. 23 1. Upon a determination by the commissioner that a health 24 carrier or a health carrier’s agent has engaged, is engaging, 25 or is about to engage in any act or practice in violation of 26 this chapter, a rule adopted by the commissioner, or an order 27 issued by the commissioner under this chapter, the commissioner 28 may do any of the following: 29 a. Issue a summary order, including a brief statement of 30 findings of fact and conclusions of law, and direct the health 31 carrier or health carrier’s agent to cease and desist from 32 engaging in the act or practice. 33 b. Take other affirmative action that in the judgment 34 of the commissioner is necessary to ensure that the health 35 -9- LSB 1115HV (3) 89 ko/rn 9/ 17
H.F. 526 carrier or health carrier’s agent comply with this chapter, and 1 rules adopted and orders issued by the commissioner under this 2 chapter. 3 2. a. A health carrier or health carrier’s agent that has 4 been issued a summary order under this section may contest 5 the order by filing a request for a contested case proceeding 6 and hearing as provided in chapter 17A, and in accordance 7 with rules adopted by the commissioner. The health carrier 8 or health carrier’s agent shall have at least thirty calendar 9 days from the date that the summary order is issued to file the 10 request. If a hearing is not timely requested, the summary 11 order shall be final by operation of law. 12 b. Section 17A.18A shall not apply to a summary order issued 13 under this section. 14 c. A summary order issued pursuant to this section shall 15 remain effective from the date of issuance unless overturned by 16 a final decision of a presiding officer or by a final judgment 17 of the court. 18 3. A health carrier or health carrier’s agent violating 19 a summary order issued under this section shall be deemed 20 in contempt of that order. The commissioner may petition 21 the district court to enforce the order as certified by the 22 commissioner. The district court shall adjudge the health 23 carrier or health carrier’s agent in contempt of the order if 24 the court finds after hearing that the health carrier or health 25 carrier’s agent is not in compliance with the order. The court 26 may assess a civil penalty against the health carrier or health 27 carrier’s agent of not more than one thousand dollars per 28 day for each day that the health carrier or health carrier’s 29 agent is in violation of the order. A civil penalty collected 30 pursuant to this section shall be deposited as provided in 31 section 505.7. The court may issue further orders as the court 32 deems appropriate. 33 Sec. 11. NEW SECTION . 510E.5 Enforcement after hearing. 34 1. If, after a hearing and contested case proceeding 35 -10- LSB 1115HV (3) 89 ko/rn 10/ 17
H.F. 526 pursuant to section 510E.4, subsection 2, the commissioner 1 determines that a health carrier or a health carrier’s agent 2 violated this chapter, a rule adopted by the commissioner, or 3 an order issued by the commissioner under this chapter, the 4 commissioner shall reduce the findings to writing and shall 5 issue and cause to be served upon the health carrier or the 6 health carrier’s agent all of the following: 7 a. A copy of the commissioner’s findings. 8 b. An order requiring the health carrier or the health 9 carrier’s agent to cease and desist from violating this 10 chapter, a rule adopted by the commissioner, or an order issued 11 by the commissioner under this chapter. 12 2. The commissioner may take other affirmative action that 13 in the judgment of the commissioner is necessary to ensure that 14 a health carrier or a health carrier’s agent complies with this 15 chapter. The commissioner may also, at the commissioner’s 16 discretion, order payment of a civil penalty of not more than 17 five thousand dollars for each violation of this chapter by a 18 health carrier or a health carrier’s agent. 19 3. A health carrier or a health carrier’s agent that 20 violates an order of the commissioner, and while such order is 21 in effect, may, after notice and hearing and upon order of the 22 commissioner, be subject to a civil penalty of not more than 23 ten thousand dollars for each violation of the commissioner’s 24 order. A health carrier or a health carrier’s agent that 25 violates an order issued by the commissioner under this section 26 shall be deemed in contempt of the order. A civil penalty 27 collected pursuant to this subsection shall be deposited as 28 provided in section 505.7. 29 4. A health carrier or a health carrier’s agent may seek 30 judicial review of an action of the commissioner pursuant to 31 chapter 17A. To the extent that a decision or order of the 32 commissioner is affirmed in a judicial review proceeding, the 33 court shall issue an order directing that the health carrier 34 or the health carrier’s agent comply with the terms of the 35 -11- LSB 1115HV (3) 89 ko/rn 11/ 17
H.F. 526 commissioner’s decision or order. 1 5. If the period for judicial review of an order of the 2 commissioner has expired and no petition for judicial review 3 has been filed, upon request of the commissioner, the attorney 4 general shall proceed in the district court to enforce the 5 order of the commissioner. The court shall issue an order 6 directing that the health carrier or the health carrier’s agent 7 comply with the terms of the commission’s order. 8 6. Upon request of the commissioner, the attorney general 9 shall petition the district court to enforce an order as 10 certified by the commissioner. The district court shall 11 adjudge a health carrier or a health carrier’s agent in 12 contempt of the commissioner’s order if the court finds after 13 hearing that the health carrier or the health carrier’s agent 14 is not in compliance with the commissioner’s order. For each 15 day of noncompliance, the court may order a civil penalty of 16 not more than one thousand dollars against a health carrier or 17 a health carrier’s agent and may issue further orders as the 18 court deems appropriate. 19 Sec. 12. NEW SECTION . 514M.1 Definitions. 20 1. “Carrier” means an entity subject to the insurance laws 21 and regulations of this state, or subject to the jurisdiction 22 of the commissioner, that offers at least one health plan in 23 this state. 24 2. “Cost-sharing requirement” means any copayment, 25 coinsurance, deductible, or other out-of-pocket expense 26 obligation required of or on behalf of an enrollee in order 27 for the enrollee to receive a specific health care service, 28 including a prescription drug, covered by the enrollee’s health 29 plan. 30 3. “Enrollee” means an individual who is eligible to obtain 31 health care services under a health plan. 32 4. “Health care services” means an item or service for the 33 prevention, treatment, cure, or healing of an illness, injury, 34 or physical disability. 35 -12- LSB 1115HV (3) 89 ko/rn 12/ 17
H.F. 526 5. “Health plan” means a policy, contract, certificate, or 1 agreement offered or issued by a carrier to provide, deliver, 2 arrange for, pay for, or reimburse any of the costs of health 3 care services. 4 6. “Interchangeable biological product” means the same as 5 defined in section 155A.3. 6 7. “Internal Revenue Code” means the Internal Revenue Code 7 as defined in section 422.3. 8 8. “Person” means a natural person, corporation, mutual 9 company, unincorporated association, partnership, joint 10 venture, limited liability corporation, trust, estate, 11 foundation, not-for-profit organization, government or 12 governmental subdivision, or government or governmental agency. 13 9. “Specialty drug” means the same as defined in section 14 510E.1. 15 Sec. 13. NEW SECTION . 514M.2 Cost-sharing calculation. 16 1. A carrier shall include all cost-sharing amounts paid by 17 an enrollee, or need-based payments paid by another person on 18 behalf of the enrollee, as part of the carrier’s calculation 19 of an enrollee’s contribution to the enrollee’s applicable 20 cost-sharing requirement. This requirement does not apply 21 to cost-sharing amounts paid by an enrollee, or by another 22 person on behalf of an enrollee, for a specialty drug or a 23 prescription drug for which a medically appropriate A-rated 24 generic equivalent or an interchangeable biological product is 25 available to the enrollee. 26 2. Subsection 1 shall not apply to a state-regulated 27 high-deductible health plan to the extent it results in the 28 plan’s failure to qualify as a high-deductible health plan 29 pursuant to section 223 of the Internal Revenue Code. 30 3. If a provision of subsection 1 conflicts with a federal 31 law or regulation as applied to a specific carrier or to a 32 specific circumstance, the provision shall remain in full force 33 and effect for all carriers and in all circumstances in which 34 the federal conflict does not exist. 35 -13- LSB 1115HV (3) 89 ko/rn 13/ 17
H.F. 526 Sec. 14. NEW SECTION . 514M.3 Applicability. 1 This chapter applies to all health plans delivered, issued 2 for delivery, continued, or renewed in this state on or after 3 January 1, 2022. 4 Sec. 15. RETROACTIVE APPLICABILITY. 5 1. The section of this Act that requires a pharmaceutical 6 drug manufacturer to submit an annual report to the 7 commissioner containing the current wholesale acquisition cost 8 for each of the manufacturer’s prescription drugs is applicable 9 to all manufacturers that manufactured any prescription drug 10 that is sold to a person in this state on or after January 1, 11 2021. 12 2. The section of this Act that requires a pharmaceutical 13 drug manufacturer to submit a report to the commissioner 14 containing information related to an increase in the wholesale 15 acquisition cost of a prescription drug manufactured by 16 the manufacturer is applicable to all manufacturers that 17 manufactured any prescription drug that is sold to a person in 18 this state on or after January 1, 2021. 19 3. The section of this Act that requires a health carrier 20 to submit an annual report to the commissioner related to all 21 of the health carrier’s health benefit plans that offer a 22 prescription drug benefit is applicable to all health benefit 23 plans providing for third-party payment or prepayment of health 24 or medical expenses that provide a prescription drug benefit 25 that have been delivered, issued for delivery, continued, or 26 renewed in this state on or after January 1, 2021. 27 EXPLANATION 28 The inclusion of this explanation does not constitute agreement with 29 the explanation’s substance by the members of the general assembly. 30 This bill relates to price transparency and cost-sharing for 31 prescription drugs. 32 The bill requires a manufacturer to file an annual report 33 with the commissioner of insurance (commissioner) that 34 discloses the wholesale acquisition cost for all prescription 35 -14- LSB 1115HV (3) 89 ko/rn 14/ 17
H.F. 526 drugs manufactured by the manufacturer that were sold to a 1 person in this state in the immediately preceding calendar 2 year. “Wholesale acquisition cost” or “cost” is defined in the 3 bill as the manufacturer’s list price for a prescription drug 4 for wholesalers or direct purchasers in the United States, not 5 including prompt pay or other discounts, rebates, or reductions 6 in price, for the most recent month for which the information 7 is available, as reported in wholesale price guides or other 8 publications of drug or biological pricing data. Within 30 9 calendar days of receipt, the commissioner is required to 10 publish the information from the annual reports on a publicly 11 accessible internet site. 12 If a prescription drug sold to a person in this state 13 has a cost of $100 or more for a 30-day supply and the cost 14 increases 40 percent or more over the three preceding calendar 15 years, or increases 15 percent or more in the preceding 16 calendar year, the manufacturer of the prescription drug must 17 file a report with the commissioner within 30 calendar days 18 of the date on which the 40 or 15 percent increase in cost 19 occurs. This requirement is applicable to all manufacturers 20 that manufactured prescription drugs that are sold to a 21 person in this state on or after January 1, 2021. The report 22 must include the information detailed in the bill. Certain 23 information provided by a manufacturer, as detailed in the 24 bill, is considered a confidential record and is required 25 to be protected as a trade secret. Within 60 calendar days 26 of receipt, the commissioner is required to publish the 27 nonconfidential information on the same publicly accessible 28 internet site on which the manufacturer’s annual report 29 information is published. 30 The bill requires each health carrier to submit an annual 31 report by February 15 to the commissioner that contains 32 information as detailed in the bill across all of the health 33 carrier’s health benefit plans. An authorized insurer or 34 an authorized third-party administrator that administers a 35 -15- LSB 1115HV (3) 89 ko/rn 15/ 17
H.F. 526 multiple employer welfare arrangement must submit the required 1 report on behalf of the multiple employer welfare arrangement 2 that the insurer or the third-party administrator administers. 3 This requirement is applicable to all health benefit plans 4 providing for third-party payment or prepayment of health or 5 medical expenses that provide a prescription drug benefit that 6 have been delivered, issued for delivery, continued, or renewed 7 in this state on or after January 1, 2021. “Health carrier” is 8 defined in the bill as an entity subject to the insurance laws 9 and regulations of this state, or subject to the jurisdiction 10 of the commissioner, including an insurance company offering 11 sickness and accident plans, a health maintenance organization, 12 a nonprofit health service corporation, a plan established 13 pursuant to Code chapter 509A for public employees, or any 14 other entity providing a plan of health insurance, health 15 care benefits, or health care services. As detailed in the 16 bill, certain information provided by a health carrier, or an 17 authorized insurer or an authorized third-party administrator 18 on behalf of a multiple employer welfare arrangement, is 19 considered a confidential record and must be protected as a 20 trade secret. Prior to May 1 of each year, the commissioner 21 must publish the nonconfidential data received by the 22 commissioner on the same publicly accessible internet site on 23 which the manufacturers’ information is published. The data 24 must be aggregated from the annual reports submitted by all 25 health carriers. 26 The bill directs the commissioner to adopt rules as 27 necessary to administer the requirements outlined in the 28 bill. The bill details the commissioner’s authority, and 29 the process to enforce that authority, for manufacturers’, 30 manufacturers’ agents’, health carriers’ or health carriers’ 31 agents’ violations of a provision of the bill, a rule adopted 32 by the commissioner, or of an order issued by the commissioner. 33 The bill also allows the commissioner, or the court, to 34 order payment of penalties for certain violations as outlined 35 -16- LSB 1115HV (3) 89 ko/rn 16/ 17
H.F. 526 in the bill. Manufacturers, manufacturer’s agents, health 1 carriers, and health carrier’s agents may request a contested 2 case proceeding, or seek judicial review of an action of the 3 commissioner, in certain circumstances as detailed in the bill. 4 The bill also requires a carrier to include all cost-sharing 5 amounts paid by an enrollee of a health plan, or by another 6 person on behalf of an enrollee, as part of the carrier’s 7 calculation of an enrollee’s contribution to the enrollee’s 8 applicable cost-sharing requirement. This does not 9 apply to cost-sharing incurred for a specialty drug or a 10 prescription drug for which an A-rated generic equivalent or an 11 interchangeable biological product is available. “Cost-sharing 12 requirement” is defined in the bill as any copayment, 13 coinsurance, deductible, or other out-of-pocket expense 14 obligation required of or on behalf of an enrollee in order 15 for the enrollee to receive a specific health care service, 16 including a prescription drug, covered by the enrollee’s health 17 plan. This requirement applies to all health plans delivered, 18 issued for delivery, continued, or renewed in this state on 19 or after January 1, 2022. The bill excludes state-regulated 20 high-deductible health plans (HDHP) from the requirement if 21 it will result in the plan not qualifying as an HDHP under 22 section 223 of the Internal Revenue Code. The bill also 23 prohibits application of the requirement to a carrier or to a 24 circumstance in a manner that will conflict with a federal law 25 or a federal regulation. 26 -17- LSB 1115HV (3) 89 ko/rn 17/ 17