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hb890_00_IN
As Introduced
136th
General Assembly
Regular
Session
H. B. No. 890
2025-2026
Representative Hall, D.
Cosponsors: Representatives
Piccolantonio, Brennan, White, E., Upchurch, McNally
To
enact sections
3901.85
,
3901.851
,
3901.852
,
3901.853
,
3901.854
,
3901.855
,
3901.856
,
3901.857
,
and
3901.858
and to repeal section 125.95 of the Revised Code
to
establish the Prescription Drug Affordability Board and Prescription
Drug Affordability Stakeholder Council, to authorize the
establishment of upper payment limits on certain prescription drug
products, to repeal the law establishing the Prescription Drug
Transparency and Affordability Advisory Council, and to name this act
the Prescription Relief and Inflation Cost Elimination or P.R.I.C.E.
Act.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section
1.
That
sections
3901.85
,
3901.851
,
3901.852
,
3901.853
,
3901.854
,
3901.855
,
3901.856
,
3901.857
,
and
3901.858
of the Revised Code be enacted to read as follows:
Sec.
3901.85.
As
used in sections 3901.85 to 3901.858 of the Revised Code:
(A)
"340B covered entity" has the same meaning as in section
5167.01 of the Revised Code.
(B)
"Biological product" and "biosimilar" have the
same meanings as in 42 U.S.C. 262.
(C)
"Brand name drug" means a drug that is produced or
distributed in accordance with an original new drug application
approved under 21 U.S.C. 355(c). "Brand name drug" does not
include an authorized generic as defined by 42 C.F.R. 447.502.
(D)
"Consumer price index" means the United States consumer
price index for all urban consumers as defined and reported by the
United States department of labor, bureau of labor statistics.
(E)
"Generic drug" means:
(1)
A retail drug that is marketed or distributed in accordance with an
abbreviated new drug application, approved under 21 U.S.C. 355(j);
(2)
An authorized generic as defined by 42 C.F.R. 447.502;
(3)
A drug that entered the market before 1962 and was not originally
marketed under a new drug application.
(F)
"Health benefit plan" has the same meaning as in section
3922.01 of the Revised Code.
(G)
"Manufacturer" means an entity that meets either of the
following:
(1)
Owns the patent to a prescription drug product or enters into a lease
with another manufacturer to market and distribute a prescription
drug product under the entity's own name and sets or changes the
wholesale acquisition cost of the prescription drug product it
manufactures or has leased the right to market;
(2)
Is the labeled entity of a generic drug at the point of manufacture
and sets or changes the wholesale acquisition cost of a generic drug
that it manufactures.
(H)
"Pharmacy" has the same meaning as in section 4729.01 of
the Revised Code.
(I)
"Pharmacy benefit manager" has the same meaning as in
section 3959.01 of the Revised Code.
(J)
"Prescription drug product" means a biological product,
biosimilar, brand name drug, or generic drug.
(K)
"Prescription drug product purchaser" means an entity that
purchases and takes ownership of a prescription drug product for
resale or providing to patients.
(L)
"Third-party payer" means a health benefit plan, the
department of medicaid, a person administering a self-funded plan, or
a pharmacy benefit manager.
(M)
"Wholesale acquisition cost" has the same meaning as in 42
U.S.C. 1395w-3a(c)(6)(B).
Sec.
3901.851.
(A)
The prescription drug affordability board is established in the
department of insurance. The board consists of nine members, each
appointed by the governor and confirmed by the senate. The members
shall collectively have expertise in health care economics, health
policy, health equity, and clinical medicine. At least one member of
the board shall be an individual who advocates for patients. A member
shall not be employed by, or serve as a board member of, consultant
to, or lobbyist for, a drug manufacturer or trade association of drug
manufacturers or have any personal or financial interest related to
drug manufacturing. Members shall be appointed not later than thirty
days after the effective date of this section.
(B)
Of the initial members, four shall be appointed for one-year terms
and five shall be appointed for two-year terms. Thereafter, each
membership term shall be for four years.
Members
may be removed by the governor at any time for good cause, including
incompetence, dereliction of duty, malfeasance, misfeasance, or
nonfeasance.
Members
may be reappointed, and vacancies shall be filled in the manner
provided for original appointments. Any member appointed to fill a
vacancy occurring before the expiration date of the term for which
the member's predecessor was appointed shall hold office as a member
for the remainder of that term.
Each
member shall be compensated for each day that the member is actually
engaged in the performance of board duties. Members also shall be
reimbursed for ordinary travel expenses, including meals and lodging
incurred in the performance of their duties.
(C)
The board's initial meeting shall take place at the call of the
governor. At the initial meeting, the board shall select from among
its members a chairperson and any other officers it considers
necessary or appropriate.
After
the initial meeting, the board shall meet at least four times a year.
The board also may meet at other times specified by the call of the
chairperson or a majority of board members.
A
majority of board members constitutes a quorum and is required for
the transaction of official board business, except that when one or
more members have recused themselves, two-thirds of the members
present and serving are required for official board business.
(D)(1)
The following actions by the board shall be conducted in accordance
with section 121.22 of the Revised Code:
(a)
Any deliberation as to whether to conduct a cost review of a
prescription drug;
(b)
Any decision or deliberation toward a decision on any matter before
the board except as provided in division (D)(2) of this section.
(2)
The board may meet in executive session to discuss information
relating to a trade secret.
(E)
Any writing that is prepared, owned, used, in the possession of, or
retained by the board in performing official business is a public
record, except that the board shall keep strictly confidential any
information it collects, uses, or relies upon if the information is
confidential, proprietary, or a trade secret.
Sec.
3901.852.
(A)
The prescription drug affordability board may enter into a contract
with a qualified, independent third party for any service necessary
to carry out the powers and duties of the board. Unless permission is
granted by the board, a third party hired by the board may not
release, publish, or otherwise use any information to which the third
party has access under its contract.
(B)
The board shall adopt rules as necessary to implement this chapter.
All rules shall be adopted in accordance with Chapter 119. of the
Revised Code.
Sec.
3901.853.
(A)(1)
The prescription drug affordability stakeholder council is
established in the department of insurance. The purpose of the
council is to provide stakeholder input to the prescription drug
affordability board established under section 3901.851 of the Revised
Code, in order to assist the board in making decisions as required by
this chapter. The stakeholder council consists of the following
twenty-three members:
(a)
The superintendent of insurance or the superintendent's designee, but
only if the designee is part of the department of insurance's
executive leadership;
(b)
The medicaid director or the director's designee, but only if the
designee is part of the department of medicaid's executive
leadership;
(c)
A member of the board of pharmacy, appointed by resolution adopted by
the board of pharmacy;
(d)
An individual representing manufacturers of brand name drugs,
appointed by the governor;
(e)
Three individuals representing the general public, each appointed by
the governor;
(f)
An individual representing manufacturers of generic drugs, appointed
by the governor;
(g)
An individual representing employers and businesses from the
prescription drug industry, appointed by the governor;
(h)
An individual representing pharmacy benefit managers, appointed by
the governor;
(i)
An individual representing pharmacists, appointed by the governor;
(j)
An individual representing physicians, appointed by the governor;
(k)
An individual representing nurses, appointed by the governor;
(l)
An individual representing hospitals, appointed by the governor;
(m)
An individual representing a managed care organization, appointed by
the governor, except that the managed care organization shall not be
controlled or formerly controlled by, either directly or indirectly,
a mutual insurance company;
(n)
An individual representing clinical researchers, appointed by the
governor;
(o)
An individual representing a statewide organization that advocates
for senior citizens, appointed by the governor;
(p)
An individual representing a statewide organization that advocates
for health care, appointed by the governor;
(q)
An individual representing a statewide organization that advocates
for diversity within communities, appointed by the governor;
(r)
An individual representing a statewide organization that advocates
for consumer rights, appointed by the governor;
(s)
An individual from a labor union that represents prescription drug
industry employees, appointed by the governor;
(t)
An individual representing researchers who specialize in prescription
drug products, appointed by the governor;
(u)
An individual representing a mutual insurance company, appointed by
the governor, except that the mutual insurance company shall not be
controlled or formerly controlled by, either directly or indirectly,
a managed care organization.
The
members described in division (A)(1) of this section shall be
appointed as soon as practicable after the effective date of this
section.
(2)
For each of the following topics, at least one member from among the
members appointed by the governor as described in division (A)(1) of
this section shall have knowledge in that topic:
(a)
The pharmaceutical business model;
(b)
Supply chain business models;
(c)
The practice of medicine or clinical training;
(d)
Consumer or patient perspectives;
(e)
Health care cost trends;
(f)
Clinical and health services research.
(B)
Of the initial members described in divisions (A)(1)(c) to (u) of
this section, seven shall serve terms of one year, seven shall serve
terms of two years, and seven shall serve terms of three years.
Thereafter,
each membership term shall be for three years.
Members
may be removed by the governor at any time for good cause, including
incompetence, dereliction of duty, malfeasance, misfeasance, or
nonfeasance.
Members
may be reappointed, and vacancies shall be filled in the manner
provided for original appointments. Any member appointed to fill a
vacancy occurring prior to the expiration of the term for which the
member's predecessor was appointed shall hold office as a member for
the remainder of that term.
(C)
Members of the stakeholder council shall not be compensated for their
service but shall be reimbursed for ordinary travel expenses,
including meals and lodging incurred in the performance of their
duties.
(D)
The council's initial meeting shall take place at the call of the
chairperson of the prescription drug affordability board established
under section 3901.851 of the Revised Code. At the initial meeting,
the council shall select from among its members a chairperson and any
other officers it considers necessary or appropriate.
After
the initial meeting, the council shall meet at least four times a
year. The council also may meet at other times at the call of the
chairperson or by request of at least seven council members.
A
majority of council members constitutes a quorum, and a majority of
the members present and serving are required for the transaction of
official council business. The council shall transact official
council business in accordance with section 121.22 of the Revised
Code.
Any
writing that is prepared, owned, used, in the possession of, or
retained by the council in transacting official business is a public
record, except that the council shall keep strictly confidential any
information it collects, uses, or relies upon if the information is
proprietary, a trade secret, or otherwise confidential under law.
Sec.
3901.854.
(A)
Beginning eighteen months after the effective date of this section,
the prescription drug affordability board, in consultation with the
prescription drug affordability stakeholder council, shall select one
or more prescription drug products based on the following criteria:
(1)
The prescription drug product is a brand name drug or biological
product that, as adjusted annually for inflation in accordance with
the consumer price index, has a wholesale acquisition cost of sixty
thousand dollars or more per year or course of treatment or a
wholesale acquisition cost increase of three thousand dollars or more
in any twelve-month period.
(2)
The prescription drug product is a biosimilar that has a wholesale
acquisition cost that is not at least fifteen per cent lower than the
referenced brand biologic.
(3)
The prescription drug product is a generic drug that, as adjusted
annually for inflation in accordance with the consumer price index,
has a wholesale acquisition cost of at least one hundred dollars for
a thirty-day supply that lasts a patient for a period of thirty
consecutive days based on the recommended dosage approved for
labeling by the United States food and drug administration, for a
supply that lasts a patient for fewer than thirty days based on the
recommended dosage approved for labeling by the United States food
and drug administration, or for one unit of the drug if the labeling
approved by the United States food and drug administration does not
recommend a finite dosage, and that increased by two hundred per cent
or more during the preceding twelve-month period, as determined by
the difference between the resulting wholesale acquisition cost and
the average of the wholesale acquisition reported over the preceding
twelve months.
(4)
The prescription drug product may create affordability challenges for
this state's hospitals and health care systems or patients, including
a drug to address a public health emergency.
(B)
The board is not required to select every prescription drug that
meets the criteria of division (A) of this section.
(C)
The board shall determine whether to conduct a cost and affordability
review for each prescription drug product selected under division (A)
of this section. In making a determination under this division, the
board shall consider input from the prescription drug affordability
stakeholder council and the average patient cost share for each
prescription drug product.
(D)
If the board conducts a review of the cost and affordability of a
prescription drug product, the board may consider any document or
research related to the manufacturer's selection of the introductory
price or price increase of the prescription drug product including
life cycle management, net average price in this state, market
competition, projected revenue, and the estimated cost-effectiveness
of the prescription drug product. In its review, the board shall
determine whether use of the prescription drug product in a manner
that is fully consistent with the labeling approved by the United
States food and drug administration or standard medical practice has
led or will lead to affordability challenges for this state's
hospitals and health care systems or high out-of-pocket costs for
patients.
(E)
In making its determination under this section, the board shall
consider any information that a manufacturer chooses to provide to
the board and, to the extent practicable, all of the following
factors:
(1)
The wholesale acquisition cost for the prescription drug product sold
in this state;
(2)
The average monetary price concession, discount, or rebate that the
manufacturer provides to health benefit plans and pharmacy benefit
managers in this state or is expected to provide to health benefit
plans and pharmacy benefit managers in this state, expressed as a per
cent of the wholesale acquisition cost for the prescription drug
product under review;
(3)
The price at which therapeutic alternatives for the prescription drug
product have been sold in this state;
(4)
The average monetary concession, discount, or rebate that another
manufacturer provides or is expected to provide to health benefit
plans and pharmacy benefit managers in this state for therapeutic
alternatives;
(5)
The cost to health benefit plans based on patient access consistent
with United States food and drug administration labeled indications
or recognized standard medical practice;
(6)
The impact on patient access resulting from the cost of the
prescription drug product relative to insurance benefit design;
(7)
The current or expected dollar value of drug-specific patient access
programs that are supported by the manufacturer;
(8)
The relative financial impact to health, medical, or social service
costs as can be quantified and compared to baseline effects of
existing therapeutic alternatives;
(9)
The average patient copay or other cost sharing for the prescription
drug product in this state;
(10)
The impact on hospital access to the prescription drug product,
prescription drug product shortage concerns, and the impact on the
cost to hospitals purchasing the prescription drug product;
(11)
Any other factor established by the board by rule.
(F)
If the board determines that spending on a prescription drug product
reviewed under this section has led or will lead to affordability
challenges to hospitals and health care systems in this state or high
out-of-pocket costs for patients in this state, the board shall
establish by rule an upper payment limit on that drug. In
establishing an upper payment limit under this division, the board
shall consider both of the following:
(1)
Relevant administrative costs related to supplying or stocking the
prescription drug product;
(2)
The impact of an upper payment limit for the prescription drug
product on 340B covered entities.
(G)
An upper payment limit established under this section shall not
include professional dispensing fees. An upper payment limit shall
not be established for any prescription drug product that is listed
as currently in shortage in the drug shortage database maintained by
the United States food and drug administration.
(H)
If the board considers the estimated cost-effectiveness of a
prescription drug product under this section, the board shall comply
with both of the following:
(1)
The board shall not use a cost-per-quality adjusted life year, or a
similar measure, to identify a subpopulation for which a prescription
drug product would be less cost-effective due to severity of illness,
age, or preexisting disability.
(2)
If the board uses a cost-effectiveness analysis for a prescription
drug product that extends an individual's life, the board shall use a
cost-effectiveness analysis that weighs the value of all additional
lifetime gained equally for any individual, no matter the severity of
illness, age, or preexisting disability.
(I)
An upper payment limit established under this section takes effect on
the date prescribed by the board by rule but not earlier than six
months after the date the upper payment limit is established.
Sec.
3901.855.
(A)
Except as provided in division (B) of this section, if the
prescription drug affordability board establishes an upper payment
limit under section 3901.854 of the Revised Code for a prescription
drug product, then beginning on the effective date of the upper
payment limit, a prescription drug product purchaser or third-party
payer shall not purchase, bill, or reimburse for the prescription
drug product in an amount that exceeds the upper payment limit,
regardless of whether the prescription drug product is dispensed or
distributed in person, by mail, or by other means.
(B)
A prescription drug product purchaser or third-party payer shall not
reimburse any of the following prescription drug product purchasers
for a prescription drug product in an amount less than an upper
payment limit established under section 3901.854 of the Revised Code
for the prescription drug product:
(1)
An independent pharmacy;
(2)
A hospital pharmacy;
(3)
A hospital, including one that provides behavioral health care;
(4)
A 340B covered entity.
Sec.
3901.856.
(A)
The attorney general may investigate a violation of section 3901.855
of the Revised Code and may commence a civil action against a person
for appropriate relief, including injunctive relief, for a violation
of that section.
(B)
A person aggrieved by a decision of the board may appeal the decision
in accordance with Chapter 119. of the Revised Code.
Sec.
3901.857.
The
prescription drug affordability fund is created in the state
treasury. All money appropriated for purposes of administering
sections 3901.85 to 3901.858 of the Revised Code or collected from
any other source for such purposes shall be deposited into the state
treasury to the credit of the fund. All investment earnings of the
fund shall be credited to the fund. The department of insurance shall
use the money in the fund to support the prescription drug
affordability board and prescription drug affordability stakeholder
council in the performance of their duties under sections 3901.85 to
3901.858 of the Revised Code.
Sec.
3901.858.
(A)
Not later than the thirty-first day of December of each year, the
prescription drug affordability board shall prepare and submit to the
general assembly a report that includes all of the following
information:
(1)
Price trends for prescription drug products;
(2)
The number of prescription drug products reviewed by the board,
including the results of the reviews and the number and disposition
of appeals and judicial reviews of board decisions;
(3)
Recommendations, if any, for legislative changes to address
prescription drug affordability in this state.
(B)
The report shall be submitted to the general assembly in accordance
with section 101.68 of the Revised Code.
Section
2.
That
section 125.95 of the Revised Code is hereby repealed.
Section
3.
(A)
The Prescription Drug Affordability Board shall review the operation
of the United States market for generic drugs. The review shall
address all of the following topics:
(1)
The prices of generic drugs on a year-to-year basis;
(2)
The degree to which generic drug prices affect yearly insurance
premium charges;
(3)
Annual changes in cost sharing for generic drugs;
(4)
The potential for and history of generic drug shortages;
(5)
The degree to which the prices of generic drugs affect annual
Medicaid spending in this state;
(6)
The impact of an upper payment limit on 340B covered entities;
(7)
Any other topic the board considers relevant to generic drug prices.
(B)
Not later than one year after the effective date of this section, the
Board shall submit a report of its findings to the General Assembly
in accordance with section 101.68 of the Revised Code.
Section
4.
This
act shall be known as the Prescription Relief and Inflation Cost
Elimination or P.R.I.C.E. Act.