HB 276: Prohibit certain actions re: reimbursing 340B covered entities
To amend sections 3902.50 and 3902.70; to amend, for the purpose of adopting a new section number as indicated in parentheses, section 3902.72 (3902.75); and to enact new section 3902.72 of the Revised Code to prohibit drug manufacturers from taking certain actions regarding reimbursements made to 340B covered entities.
| May. 21, 2025 | Referred to committee: Insurance |
| May. 14, 2025 | Introduced |
As Introduced
136th General Assembly
Regular Session
2025-2026
Representatives John, Holmes
To amend sections 3902.50 and 3902.70; to amend, ..... 1
for the purpose of adopting a new section number ..... 2
as indicated in parentheses, section 3902.72 ..... 3
(3902.75); and to enact new section 3902.72 of ..... 4
the Revised Code to prohibit drug manufacturers ..... 5
from taking certain actions regarding ..... 6
reimbursements made to 340B covered entities. ..... 7
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
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Section 1. That sections 3902.50 and 3902.70 be amended; .....
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section 3902.72 (3902.75) be amended for the purpose of adopting .....
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a new section number as indicated in parentheses; and new .....
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section 3902.72 of the Revised Code be enacted to read as .....
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follows: .....
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Sec. 3902.50. As used in sections 3902.50 to 3902.72 .....
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3902.75 of the Revised Code: .....
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(A) "Ambulance" has the same meaning as in section 4765.01 .....
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of the Revised Code. .....
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(B) "Clinical laboratory services" has the same meaning as .....
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in section 4731.65 of the Revised Code. .....
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(C) "Cost sharing" means the cost to a covered person .....
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under a health benefit plan according to any copayment, .....
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coinsurance, deductible, or other out-of-pocket expense .....
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requirement. .....
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(D) "Covered" or "coverage" means the provision of .....
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benefits related to health care services to a covered person in .....
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accordance with a health benefit plan. .....
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(E) "Covered person," "health benefit plan," "health care .....
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services," and "health plan issuer" have the same meanings as in .....
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section 3922.01 of the Revised Code. .....
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(F) "Drug" has the same meaning as in section 4729.01 of .....
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the Revised Code. .....
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(G) "Emergency facility" has the same meaning as in .....
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section 3701.74 of the Revised Code. .....
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(H) "Emergency services" means all of the following as .....
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described in 42 U.S.C. 1395dd: .....
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(1) Medical screening examinations undertaken to determine .....
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whether an emergency medical condition exists; .....
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(2) Treatment necessary to stabilize an emergency medical .....
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condition; .....
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(3) Appropriate transfers undertaken prior to an emergency .....
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medical condition being stabilized. .....
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(I) "Health care practitioner" has the same meaning as in .....
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section 3701.74 of the Revised Code. .....
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(J) "Pharmacy benefit manager" has the same meaning as in .....
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section 3959.01 of the Revised Code. .....
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(K) "Prior authorization requirement" means any practice .....
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implemented by a health plan issuer in which coverage of a .....
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health care service, device, or drug is dependent upon a covered .....
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person or a provider obtaining approval from the health plan .....
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issuer prior to the service, device, or drug being performed, .....
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received, or prescribed, as applicable. "Prior authorization .....
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requirement" includes prospective or utilization review .....
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procedures conducted prior to providing a health care service, .....
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device, or drug. .....
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(L) "Unanticipated out-of-network care" means health care .....
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services, including clinical laboratory services, that are .....
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covered under a health benefit plan and that are provided by an .....
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out-of-network provider when either of the following conditions .....
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applies: .....
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(1) The covered person did not have the ability to request .....
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such services from an in-network provider. .....
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(2) The services provided were emergency services. .....
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Sec. 3902.70. As used in this section and section-sections .....
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3902.71 and 3902.72 of the Revised Code: .....
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(A) "340B covered entity" and "third-party administrator" .....
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have the same meanings as in section 5167.01 of the Revised .....
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Code. .....
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(B) .....
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"340B drug pricing program" means the program authorized .....
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by section 340B of the "Public Health Service Act," 42 U.S.C. .....
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256b. .....
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(C) "Terminal distributor of dangerous drugs," has- .....
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"manufacturer of dangerous drugs," "repackager of dangerous .....
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drugs," and "third-party logistics provider," have the same .....
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meaning-meanings as in section 4729.01 of the Revised Code. .....
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(D) "Package" has the same meaning as in 21 U.S.C. 360 eee. .....
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Sec. 3902.72. (A) As used in this section: .....
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(1) "340B drug" means a drug that meets all of the following criteria: .....
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(a) The drug is a covered outpatient drug under the 340B drug pricing program. .....
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(b) The drug is subject to any offer for reduced prices by a manufacturer pursuant to the 340B drug pricing program. .....
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(c) The drug is purchased by a 340B grantee or would have been purchased by a 340B grantee if not for an action prohibited under this section. .....
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(2) "340B grantee" means an entity described in section 340B(a)(4)(A)-(K) of the "Public Health Service Act," 42 U.S.C. 256b(a)(4)(A)-(K) that is designated as an active entity under the health resources and services administration covered entity daily report. .....
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(B) No manufacturer of dangerous drugs, repackager of dangerous drugs, or third-party logistics provider, or an agent or affiliate of any of those entities, shall do either of the following: .....
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(1) Deny, prohibit, restrict, discriminate against, or otherwise limit the acquisition of a 340B drug by or delivery of a 340B drug to a 340B grantee, unless the purchase or delivery is prohibited by the United States department of health and human services; .....
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(2) Require a 340B grantee to submit any claims or utilization data as a condition for allowing the acquisition of a 340B drug by or delivery of a 340B drug to a 340B grantee, unless the claims or utilization data sharing is required by the .....
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United States department of health and human services. .....
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(C) (1) Whoever violates this section engages in an unfair .....
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and deceptive insurance act or practice under sections 3901.19 .....
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to 3901.26 of the Revised Code, and is subject to proceedings .....
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pursuant to those sections. If the superintendent, by written .....
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order, finds that any person is about to engage, is engaging, or .....
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has engaged in a violation of this section, the superintendent, .....
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in addition to the administrative remedies set forth in section .....
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3901.22 of the Revised Code, may impose a civil penalty of fifty .....
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thousand dollars for each such violation, not to exceed ten .....
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million dollars annually. Each package of 340B drugs determined .....
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by the superintendent to be subject to a prohibited act under .....
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division (C) of this section constitutes a separate violation. .....
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(2) In addition to the civil penalty, the superintendent .....
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of insurance may refer any complaint of a violation of division .....
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(C) of this section to the state board of pharmacy for the board .....
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to consider one or more of the sanctions set forth in division .....
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(A) (1) of section 4729.56 of the Revised Code. .....
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(D) The superintendent of insurance may adopt rules, or .....
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may delegate authority to the board of pharmacy to adopt rules, .....
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pursuant to Chapter 119. of the Revised Code to implement the .....
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provisions of this section. .....
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(E) Nothing in this section shall be construed to conflict .....
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with or be less restrictive than applicable federal law or .....
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regulations, including 21 U.S.C. 355-1, or applicable laws or .....
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regulations of this state. .....
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Sec. 3902-72 3902.75. (A) As used in this section, "health .....
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care provider" has the same meaning as in section 3701.74 of the .....
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Revised Code. .....
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(B) A health plan issuer, including a pharmacy benefit .....
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manager, shall, upon request of a covered person, the covered .....
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person's health care provider, or the third-party .....
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representative, furnish the following data for any and all drugs .....
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covered under a related health benefit plan: .....
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(1) The covered person's eligibility information for any .....
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and all covered drugs; .....
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(2) Cost-sharing information for any and all covered .....
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drugs, including a description of any variance in cost-sharing .....
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based on pharmacy, whether retail or mail order, or health care .....
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provider dispensing or administering the drugs; .....
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(3) Any applicable utilization management requirements for .....
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any and all covered drugs, including prior authorization .....
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requirements, step therapy, quantity limits, and site-of-service .....
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restrictions. .....
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(C) A health plan issuer, including a pharmacy benefit .....
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manager, providing the data required under division (B) of this .....
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section shall ensure that the data meets all of the following: .....
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(1) It is current not later than one business day after .....
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any change is made. .....
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(2) It is provided in real time. .....
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(3) It is provided in the same format that the request is .....
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made by the covered person, the covered person's health care .....
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provider, or the third-party representative. .....
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(D) The format in which a health plan issuer, including a .....
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pharmacy benefit manager, replies to a request made under .....
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division (B) of this section shall use established industry .....
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content and transport standards published by either of the .....
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following: .....
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(1) A standards developing organization accredited by the .....
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American national standards institute, including the national .....
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council for prescription drug programs, ASC X12, health level 7; .....
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(2) A relevant federal or state governing body, including .....
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the centers for medicare and medicaid services or the office of .....
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the national coordinator for health information technology. .....
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(E) A health plan issuer, including a pharmacy benefit .....
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manager, shall furnish the data required under division (B) of .....
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this section regardless of whether the request is made using the .....
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drug's unique billing code, such as a national drug code or .....
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health care common procedure coding system code, or a .....
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descriptive term, such as the brand or generic name of the drug. .....
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(F) A health plan issuer, including a pharmacy benefit .....
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manager, shall not deny or delay a request as a method of .....
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blocking the data required under division (B) of this section .....
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from being shared based on how the drug was requested. .....
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(G) A health plan issuer, including a pharmacy benefit .....
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manager, furnishing the data required under division (B) of this .....
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section shall not do any of the following: .....
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(1) Restrict, prohibit, or otherwise hinder, in any way, a .....
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health care provider from communicating or sharing any of the .....
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following: .....
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(a) Any of the data required under division (B) of this .....
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section; .....
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(b) Additional information on any lower-cost or clinically .....
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appropriate alternatives, whether or not they are covered under .....
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the covered person's health benefit plan; .....
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(c) Additional payment or cost-sharing information that .....
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may reduce the covered person's out-of-pocket costs, such as .....
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cash price or patient assistance and support programs whether .....
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sponsored by a manufacturer, foundation, or other entity. .....
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(2) Except as may be required by law, interfere with, .....
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prevent, or materially discourage access, exchange, or use of .....
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the data required under division (B) of this section, including .....
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any of the following: .....
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(a) Charging fees; .....
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(b) Not responding to a request at the time the request is .....
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made, if such a response is reasonably possible; .....
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(c) Implementing technology in nonstandard ways; .....
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(d) Instituting covered person consent requirements, .....
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processes, policies, procedures, or renewals that are likely to .....
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substantially increase the complexity or burden of accessing, .....
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exchanging, or using such data. .....
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(3) Penalize a health care provider for disclosing such .....
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data to a covered person or for prescribing, administering, or .....
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ordering a clinically appropriate or lower-cost alternative. .....
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(H) (1) A health plan issuer, including a pharmacy benefit .....
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manager, shall treat a personal representative of a covered .....
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person as the covered person for purposes of this section. .....
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(2) If under applicable law a person has authority to act .....
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on behalf of a covered person in making decisions related to .....
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health care, a health plan issuer, including a pharmacy benefit .....
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manager, or its affiliates or entities acting on its behalf, .....
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shall treat such person as a personal representative under this .....
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section. .....
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(I) Divisions (A) to (H) of this section take effect .....
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January 1, 2022. .....
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Section 2. That existing sections 3902.50, 3902.70, and .....
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3902.72 of the Revised Code are hereby repealed. .....