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