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STATE OF OKLAHOMA
1st Session of the 59th Legislature (2023)
SENATE BILL 768 By: Hicks
AS INTRODUCED
An Act relating to prescription drugs; defining
terms; requiring certain reports by cer tain pharmacy
benefits managers by certain date; requiring
notification by certain manufacturer to Insurance
Department by certain date; requ iring certain reports
by certain entities by certain date; providi ng for
certain information t o be subject to certa in
protections; authorizing registration process for
entities by Department; requiring certain fee
assessment for certain purpose to be deposited into
certain revolving fund; esta blishing deadline for
payment; requiring certification by entity of certain
reports; establishing civil penalty; providing for
audit process to be administered at the cost of the
entity at subject of certain audit; allowing
Department to establish processes deemed necessary
for act implementation; requiring Department to
publish certain report; allowing certain informati on
to be transmitted to Attorney General under certain
conditions; authorizing promulgation of ru les by
Department; amending 51 O.S. 2021, Section 24A.3, as
amended by Section 1, Chapter 402, O.S.L. 2022 (51
O.S. Supp. 2022, Section 24A.3) , which relates to
Open Records Act; modifying definition; providing for
codification; and providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6971 of Title 36, unless there
is created a duplication in nu mbering, reads as follows:
As used in this act:
1. “Brand-name drug” means a prescription drug approved under
21 U.S. Code Section 355(b), as amended, or 42 U.S. Code Section
262, as amended;
2. “Drug group” means a group of medications that work
similarly, have a similar che mical makeup, or treat similar
conditions;
3. “Insurer” means any entity authorized to provide hea lth
insurance or health benefits pursuant to the laws o f this state and
any entity or person engaged in the business of making contract s for
accident or health insurance;
4. “Manufacturer” means any person or entity that holds the
national drug code for a prescription drug and is either engaged in
the production, preparation, propagation, compounding, conversion,
or processing of dru g products in this state ;
5. “Market introduction” means the month and year in which the
manufacturer acquired or first marketed the drug for sale in the
United States;
6. “National drug code” means the numerical code maintained by
the Food and Drug Administration that include s the labeler code,
product code, and package code;
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7. “Pharmacy benefits manager” or “PBM” means a pharmacy
benefits manager as defined p ursuant to Section 6960 of Title 36 of
the Oklahoma Statues;
8. “Reporting entity” means any manufacturer, insurer, pharmacy
benefits manager, wholesale drug distributor , or any other entity
required to report to the Insurance Department under the provisions
of this act;
9. “Wholesale acquisition cost” means the list price of the
manufacturer charged to wholesalers or direct purchases in the
United States on December 31 of the reference year, as reported i n
the wholesale price guides or other publications of drug or
biological pricing data. This shall not include pr ompt pay or other
discounts, rebates, or reductions in price . The current or proposed
wholesale acquisition cost is the amount that requires reporting
under the provisions of this act;
10. “Wholesale acquisition cost unit” or “WAC unit” means the
lowest identifiable quantity of a drug or biological that is
dispensed, exclusive of any diluent without reference to volume
measures pertaining to liquids. I f reporting by drug group, it is
the total number of wholesa le acquisition cost units in the drug
group; and
11. “Wholesale drug distri butor” means a person or entity
engaging in the sale of presc ription drugs to persons o ther than a
consumer or patient and l icensed by the State Board of Pharmacy.
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SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6972 of Title 36, unless there
is created a duplication in numb ering, reads as follows:
Any pharmacy benefits manager (PBM) that operates in t his state
shall, within sixty (60) days of receiving notice by the Insurance
Department pursuant to Section 3 of this act, and to the extent
allowed by law, report annuall y to the Department, indicating the
specific drugs for which reporting is requir ed, the following
information:
1. The minimum and maximum wholesale acquisition cost (WAC) for
each indicated drug and drug group for which the PBM has negotiated
directly with the manufacturer in the immediately p receding calendar
year;
2. The minimum and m aximum WAC for each indicated drug and drug
group for which the PBM has negotiated directly with the
manufacturer in the current calendar year;
3. The number of WAC unit s for which the PBM negotiated
directly with the manufacturer in the immediately prec eding calendar
year, for business in this state, in total and for e ach payer type
as deemed necessary by the Department;
4. The projected number of WAC units for which th e PBM expects
to negotiate directly with the manufacturer in the current calendar
year, for business in this state, in total and for each payer type
as deemed necessary by the Department;
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5. Total rebates, discounts, and price concessions received or
negotiated directly with the manufacturer in the immediately
preceding calendar year, for business in this state, in total and
for each payer type as deemed necessary by the Department;
6. Projected total rebates, discounts, and price concessions
that the PBM expects to receive or to negotiate direc tly with the
manufacturer in the current cal endar year, for business in this
state, in total and for each payer type as deemed necessary by the
Department;
7. Total discounts, dispensing fees, and other fees paid o r
allowed to pharmacies, prescription dru g networks, or pharmacy
services administrat ive organizations in the immediately preceding
calendar year, for b usiness in this state, in total and for each
payer type as deemed necessary by the Department;
8. Projected total discounts, dispensing fees, an d other fees
that the PBM expects to pay or allow to pharmacies, prescription
drug networks, or pharmacy servic es administrative organizations in
the current calendar year, for business in this state, in total and
for each payer type as deemed necessary by the Department;
9. Total net income receiv ed in the immediately preceding
calendar year for business in this state, in total and for each
payer type as deemed necessary by the Department;
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10. Projected net incom e that the PBM expects to receive in the
current calendar year for business in this s tate, in total and for
each payer type as deemed necessary by the D epartment; and
11. Any other information as prescribed by the Department.
SECTION 3. NEW LAW A new sec tion of law to be codified
in the Oklahoma Statutes as Secti on 6973 of Title 36, unless there
is created a duplication in numb ering, reads as follows:
A. 1. A manufacturer shall notify the Insurance Department if
it is increasing the wholesale acquisition cost of a brand-name drug
by more than twenty percent (20%) per wholesale acqu isition cost
unit (WAC unit) during any twelve -month period, or if it is
increasing the wholesale acquisition cost of a generic drug priced
at Ten Dollars ($10.00) or more per WAC unit by more than twenty
percent (20%) during any twelve month period. The notice shall be
provided, in writing, at least sixty (60) days prior to the planned
effective date of the increase.
2. A manufacturer that is required to notify the Department
under this subsection shall report to the Department , at least
thirty (30) days before the planned effective date of the increase,
the following:
a. drug identification details, including the drug group,
b. four (4) year sales history in WAC units for sales in
this state and in the United States,
c. the wholesale acquisition cost of the drug,
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d. four (4) year revenue history from sales in this state
and in the United States, and
e. cost associated with sales in the United States by
drug and drug group.
B. 1. A manufacturer shall notify the Department if it intends
to introduce a new drug in the United States that has a wholesa le
acquisition cost of more than Six Hundred Seventy Dollars ($670.00)
per WAC unit. The notice shall be p rovided, in writing, at least
sixty (60) days prior to market introduction.
2. A manufacturer that is required to notify the Department
under this subsection shall report to the Department , at least
thirty (30) days before the planned effective date of the increase,
the following:
a. drug identification details, including the drug group,
b. patient volume, revenue, and price, and
c. wholesale acquisition cost at introduction.
SECTION 4. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6974 of Title 36, unless there
is created a duplication in numb ering, reads as follows:
Any wholesale drug distributor operating in this sta te shall
report annually to the Insurance Department, within sixty (60) days
after receiving notice from the Department indicating the specific
drugs for which reporting is re quired, the following information:
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1. The minimum and maximum who lesale acquisition cost f or each
indicated drug and drug group for which the distributor has
negotiated directly with the manufacturer in the immediately
preceding calendar year, related to prescriptio ns under an insurance
policy issued in this state;
2. The minimum and maximum wholesale acquisition c ost for each
indicated drug and drug group for which the distributor has
negotiated directly with the manufacturer in the current calendar
year, related to prescriptions under an insurance policy issued in
this state;
3. The number of WAC units for which the distributor negotiated
directly with the manufacturer in the immedi ately preceding calendar
year, for business in this state , in total and for each pa yer type
as deemed necessary by the Department;
4. The projected number of WAC units for which the distributor
expects to negotiate directly with the manufacturer in the current
calendar year, for business in this state, in total and for each
payer type as deemed necessary b y the Department;
5. Total rebates, discounts, and price c oncessions received o r
negotiated directly with the manufacturer in the immediately
preceding calendar year, for business in this state, in total and
for each payer type as de emed necessary by the Department;
6. Projected total rebates, discounts, and pri ce concessions
that the distributor expects to receive or to negotiate directly
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with the manufacturer in the current calendar year, for business in
this state, in total and for each payer type as deemed necessary by
the Department;
7. Total discounts, dispensing fees, and other fees paid or
allowed to pharmacies, prescription drug net works, or pharmacy
services administrati ve organizations in the immediately preceding
calendar year, for business in this state, in total and for each
payer type as deemed nec essary by the Department;
8. Projected total di scounts, dispensing fees, and other fees
that the PBM expects to pay or allow to pharmacies, prescription
drug networks, or pharmacy services administrative organizations in
the current calendar year, for bus iness in this state, i n total and
for each payer type as deemed necessary by the Department;
9. Total net income received in the immediately preceding
calendar year for busines s in this state, in total and for e ach
payer type as deemed necessary by the De partment;
10. Projected net income that the distributor expects to
receive in the current c alendar year for business in this state, in
total and for each payer type as deemed necessary by the Department;
and
11. Any other information as prescribed by th e Department.
SECTION 5. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as S ection 6975 of Title 36, unless there
is created a duplication in numbering, reads as follows:
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A. Each insurer designat ed by the Insurance Department as a
reporting entity shall report annually to the Department, to the
extent allowed by law, spending on prescription drugs before
enrollee cost sharing, in tota l and per prescription drug user, and
spending on the top twenty-five (25) prescription drugs prescribed
in this state, in total and individually, as determined by the
Insurance Department. The repor t shall include:
1. The greatest total spending before enrollee cost sharing in
the immediately preceding calendar year;
2. The greatest total spending per user of any drug before
enrollee cost sharing in the immediately preceding calendar year;
3. The highest year-over-year increase in total spending before
enrollee cost sharing; and
4. The highest year-over-year increase in total spend ing per
user of any drug before enrollee cost sharing.
B. For each drug and drug group, the insurer shall report to
the Department, within sixty (60) days of the close of ea ch calendar
year, the following information:
1. For drugs that accounted for the highest total spending
before enrollee cost sharing in the last calendar year:
a. total spending before enrollee cost sharing in the
immediately preceding calendar year,
b. projected total spending before enrollee cost sharing
in the current calendar year,
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c margins and fees paid directly to pharmacy benefit
managers (PBMs) or pharmacy services administrative
organizations in the immediately preceding calendar
year, and
d. other allowed retail discounts, pr ice concessions, and
fees paid in the immediately preceding calendar year;
2. For drugs that accounted for the highest year-over-year
change in total spending before enrollee cost sharing:
a. year-over-year change in total spending before
enrollee cost sharing,
b. total spending before enrollee cost sharing in the
immediately preceding calendar year,
c. projected total spending before enrollee cost sh aring
in the current calendar year,
d. margins and fees paid di rectly to PBMs or pharmacy
services administrative organizations in the
immediately preceding calendar year, and
e. other allowed retail discounts, price con cessions, and
fees paid in the immediately preceding calendar year;
3. For drugs that accounted fo r the highest total spending per
user before enrollee cost sharing in the imm ediately preceding
calendar year:
a. total spending per user before enrollee cost sharing
in the immediately preceding calendar year,
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b. total spending before enrollee cost sharin g in the
immediately preceding calendar year,
c. number of users in the immediately preceding calendar
year,
d. projected total spending per user before enrollee cost
sharing in the current calendar year ,
e. margins and fees paid directly to PBMs or pharma cy
services administrative organizations in the
immediately preceding calendar year, and
f. other allowed retail discounts, price con cessions, and
fees paid in the immediately preceding calendar year;
and
4. For drugs that accounted for the highest year -over-year
change in total spending per user before enrollee cost sharing in
the immediately preceding calen dar year:
a. year-over-year change in total sp ending per user
before enrollee cost sharing,
b. total spending per user before enrollee cost sharing
in the immediately preceding calendar year ,
c. number of users in the immediately preceding calendar
year,
d. projected total spending per user before enrollee cost
sharing in the current c alendar year,
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e. margins and fees paid directly to PBM s or pharmacy
services administrative organizations in the
immediately preceding calend ar year, and
f. other allowed retail discounts, pr ice concessions, and
fees in the last calendar year.
C. Disclosure of all information repo rted under this section is
subject to the protections described in Section 6 of this act.
SECTION 6. NEW LAW A new s ection of law to be codified
in the Oklahoma Statutes as Section 6976 of Title 36, unless there
is created a duplication in numbering, reads as foll ows:
A. Beginning on January 1, 2024, each reporti ng entity shall
register with the Insurance De partment no later th an January 31 of
each calendar year, in a form and manner specifi ed by the
Department.
B. 1. Each reporting entity shall pay an annual a ssessment, in
an amount to be determined by the Department but not to be less than
One Hundred Dollars ($100.00) for each individual entity required to
pay an assessment under this act, to support the operational costs
of the Department in implementing the provisions of this act. The
costs shall include staff salaries, administrative expe nses, data
system expenses, and consulting fees of the De partment. The total
annual assessments shall be based on the total annual allocation
authorized by the Legislature for the operational costs of the
Department under this act, as indicated in t he fiscal year budget of
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the Department. The amount to be assessed shall be reduced by the
difference between the total annual authorized allocation for the
next fiscal year and the beginning fund balance in the Department’s
account for the prior fiscal year. Any assessment reduction s hall
be applied proportiona tely to the categorical groups assesse d.
2. The assessments shall be p laced in State Insurance
Commissioner Revolving Fund pursuant to Section 307.3 of Title 36 of
the Oklahoma Statutes.
C. The Department shall send request for payment of the
assessment to all reporting entities under this act by certified
mail beginning July 1, 2024, and annually thereafter. All
assessments shall be due to the Department within thirty (30) days
of receipt of the request for payment. Any reporting entity that
fails to pay the assessment pursuant to th is act shall be subject to
the penalties described under Section 7 of this act.
SECTION 7. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6977 of Title 36, unless there
is created a duplication in numb ering, reads as follows:
A. The reporting entity sha ll certify required reporting under
this act as accurate under penalty of perjury.
B. Failure of a reporting entity to comply with the provisions
of this act may result in a civil penalty, at the discr etion of the
Insurance Commissioner. Civil penalties under this act shall not
exceed Thirty Thousand Dollars ($30,000.00) per day that the
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reporting entity is found to be in violation of the provisions of
this act.
C. The Insurance Department may audit the data submitted to the
Department by a reporting ent ity pursuant to the provisions of th is
act, in a form and manner to be specifi ed by the Department. The
reporting entity shall pay all costs associated with the audit .
D. The Department may require a reporting entity to subm it a
corrective action plan, i n a form and manner to be specified by the
Department, to correct deficiencies in reporting pursuant to the
provisions of this act.
E. The Department is au thorized to call one or more public
hearings on the price of prescription drugs in this state and may
subpoena any reporting entity pursuant to the provisions of this
act.
SECTION 8. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 6978 of Title 36, unless there
is created a duplication in numb ering, reads as follows:
A. Not later than July 1, 2024, the Insurance Department shall
develop and publish on its websi te a report on emerging trends in
prescription drug prices in this state and conduct an annual public
hearing based on the report findings. To make clear the main
components of prescription drug pricing along the supply chain, the
report shall include, bu t not be limited to, ana lyses of
manufacturer prices and price increases as reported under th is act,
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information reported under th is act by insurers, pharmacy benefits
managers, and wholesale drug distributors, and the impacts on
insurance premiums and consumer cost sharing. The data in the
report shall not reveal information specific to any individual
reporting entity.
B. Except as provided in this section, the Department shall
keep confidential all information submitted by an individual
reporting entity and protect it from public disclosure. The
Department may share such information with the Attorney General;
provided, however that the Attorney General shall keep confidential
any information shared by the Insurance Depa rtment. The information
shall not be considered a record under the Oklahoma Open Records Act
as defined pursuant to Section 24A.3 of Title 51 o f the Oklahoma
Statutes.
C. The Insurance Department shall promulgate rules to
effectuate the provisions of this act.
SECTION 9. AMENDATORY 51 O.S. 2021, Section 24A.3, as
amended by Section 1, Chapter 402, O.S.L. 2022 (51 O.S. Supp. 2022,
Section 24A.3), is amend ed to read as follows:
Section 24A.3. As used in the Oklahoma Open Records Act:
1. “Record” means all documents including, but not limited to,
any book, paper, photograph, microfilm, data files created by or
used with computer software, computer tape, di sk, record, sound
recording, film recording, video record or other material regardless
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of physical form or charact eristic, created by, received by, under
the authority of, or coming into the custody, control or possession
of public officials, public bodies or their representatives in
connection with the transaction of public bus iness, the expenditure
of public funds or the administering of public property. “Record”
Record does not mean:
a. computer software,
b. nongovernment personal effects,
c. unless public disclosure is required by other laws or
regulations, vehicle movement records of the Oklahoma
Transportation Authorit y obtained in connection with
the Authority’s electronic toll collection system,
d. personal financial information, credit reports or
other financial data obtained by or submitted to a
public body for the purpose of evaluating credit
worthiness, obtaining a license, permit or for the
purpose of becoming qualified to contract with a
public body,
e. any digital audio/video recordings of the toll
collection and safeguarding activities of the Oklahoma
Transportation Authority,
f. any personal information provid ed by a guest at any
facility owned or operated by the Oklahoma Tourism and
Recreation Department to obtain any service at t he
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facility or by a purchaser of a product sold by or
through the Oklahoma Tourism and Recreation
Department,
g. a Department of Defense Form 214 (DD Form 214) filed
with a county clerk including any DD Form 214 filed
before July 1, 2002,
h. except as provided for in Section 2-110 of Title 47 of
the Oklahoma Statutes,
(1) any record in connection with a Motor Vehicle
Report issued by the Department of Public Safety,
as prescribed in Secti on 6-117 of Title 47 of the
Oklahoma Statutes, or
(2) personal information within driver records, as
defined by the Driver ’s Privacy Protection Act,
18 United States Code, Sections 2721 through
2725, which are stored and maintained by the
Department of Public Safety, or
i. any portion of any document or information provided to
an agency or entity of the state or a political
subdivision to obtain licensure under the laws of this
state or a political subdivision that contains an
applicant’s personal address, personal phone number,
personal electronic mail address or other contact
information. Provided, however, lists of persons
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licensed, the existence of a license of a per son, or a
business or commercial address, or other business or
commercial information disclosable under state law
submitted with an application for licensure shall be
public record, or
j. information relating to prescription drugs as
submitted by a reporting entity to the Insurance
Department under this act;
2. “Public body” shall include, but not be limited to, any
office, department, board, bureau, commission, agency, trusteeship,
authority, council, committee, trust or any entity created by a
trust, county, city, village, town, township, d istrict, school
district, fair board, court, executive office, advisory group, task
force, study group or any subdivision thereof, s upported in whole or
in part by public fund s or entrusted with the expenditure of public
funds or administering or operating public property, and all
committees, or subcommittees thereof. Except for the records
required by Section 24A.4 of this title, “public body” public body
does not mean judges , justices, the Council on Judicia l Complaints,
the Legislature or legislators. “Public body” Public body shall not
include an organization that is exempt from federal income tax under
Section 501(c)(3) of the Internal Revenue Code of 1986, as amended,
and whose sole beneficiary is a college or university, or an
affiliated entity of the college or university, that is a member of
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The Oklahoma State Sys tem of Higher Education . Such organization
shall not receive di rect appropriations from the Oklahoma
Legislature. The following persons shall not b e eligible to serve
as a voting member of the governing bo ard of the organization:
a. a member, officer, or employee of the Oklahoma State
Regents for Higher Education ,
b. a member of the board of regents or other governing
board of the college or university th at is the sole
beneficiary of the organization, or
c. an officer or employee of the college or university
that is the sole beneficiary of the organizati on;
3. “Public office” means the physical lo cation where public
bodies conduct business or keep record s;
4. “Public official” means any official or employee of any
public body as defined herein; and
5. “Law enforcement agency” means any public body charged with
enforcing state or local criminal laws and initiating criminal
prosecutions including, but not limited to, police dep artments,
county sheriffs, the Depar tment of Public Safety, the Oklahoma State
Bureau of Narcotics and Dangerous Drugs Control, the Alcoholic
Beverage Laws Enforcement Commi ssion, and the Oklahoma State Bureau
of Investigation.
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SECTION 10. This act shall become effective Nove mber 1, 2023.
59-1-1217 RD 1/18/2023 6:46:17 PM