1 STATE OF OKLAHOMA
1
2 2nd Session of the 59th Legislature (2024)
2
3 HOUSE BILL 3379 By: McEntire
3
4
4
5
5
6 AS INTRODUCED
6
7 An Act relating to prescriptions; creating the
7 Oklahoma Health Care Safety Net and Affordable
8 Prescriptions Accessibility Act; defining terms;
8 prohibiting certain discriminatory actions related to
9 reimbursement of certain entities; prohibiting
9 certain discriminatory actions by a manufacturer or
10 distributor related to certain entities; providing
10 for enforcement by the Attorney General and Insurance
11 Commissioner; providing for violations; providing for
11 federal preemption; providing for codification; and
12 providing an effective date.
12
13
13
14
14
15 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
15
16 SECTION 1. NEW LAW A new section of law to be codified
16
17 in the Oklahoma Statutes as Section 5400 of Title 36, unless there
17
18 is created a duplication in numbering, reads as follows:
18
19 This act shall be known and may be cited as the "Oklahoma Health
19
20 Care Safety Net and Affordable Prescriptions Accessibility Act".
20
21 SECTION 2. NEW LAW A new section of law to be codified
21
22 in the Oklahoma Statutes as Section 5401 of Title 36, unless there
22
23 is created a duplication in numbering, reads as follows:
23
24 As used in this act:
24
Req. No. 9195 Page 1
 1 1. "340B drug" means a drug that has been subject to any offer
1
2 for reduced prices by a manufacturer pursuant to Section 256b of
2
3 Title 42 of the United States Code and is purchased by a covered
3
4 entity as defined in Section 256b(a)(4) of Title 42 of the United
4
5 States Code;
5
6 2. "340B entity" means an entity participating or authorized to
6
7 participate in the federal 340B drug discount program, as described
7
8 in Section 256b of Title 42 of the United States Code, including its
8
9 pharmacy, or any pharmacy contracted with the participating entity
9
10 to dispense drugs purchased through the 340B drug discount program;
10
11 3. "Pharmacy" means a pharmacy licensed by the Oklahoma State
11
12 Board of Pharmacy, except that patients who are provided pharmacy
12
13 care shall be physically located in the state; and
13
14 4. "Pharmacy benefit manager" means a person that performs
14
15 pharmacy benefits management and any other person acting for such
15
16 person under a contractual or employment relationship in the
16
17 performance of pharmacy benefits management for a managed care
17
18 company, nonprofit hospital, medical service organization, insurance
18
19 company, third-party payor or a health program administered by a
19
20 department of this state.
20
21 SECTION 3. NEW LAW A new section of law to be codified
21
22 in the Oklahoma Statutes as Section 5402 of Title 36, unless there
22
23 is created a duplication in numbering, reads as follows:
23
24
24
Req. No. 9195 Page 2
 1 A. 1. With respect to reimbursement to a 340B entity for 340B
1
2 drugs, a health insurance issuer, pharmacy benefit manager, other
2
3 third-party payor, or its agent shall not:
3
4 a. reimburse a 340B entity for 340B drugs at a rate lower
4
5 than that paid for the same drug to entities that are
5
6 not 340B entities or lower reimbursement for a claim
6
7 on the basis that the claim is for a 340B drug,
7
8 b. impose any terms or conditions on any 340B entity with
8
9 respect to any of the following that differ from such
9
10 terms or conditions applied to non-340B entities on
10
11 the basis that the entity participates in the federal
11
12 340B drug discount program set forth in Section 256b
12
13 of Title 42 of the United States Code or that a drug
13
14 is a 340B drug including, without limitation, any of
14
15 the following:
15
16 (1) fees, charges, clawbacks, or other adjustments or
16
17 assessments. For purposes of this subsection,
17
18 the term "other adjustments" includes placing any
18
19 additional requirements, restrictions, or
19
20 unnecessary burdens upon the 340B entity that
20
21 result in administrative costs or fees to the
21
22 340B entity that are not placed upon other
22
23 entities that do not participate in the 340B drug
23
24 discount program, including affiliate pharmacies
24
Req. No. 9195 Page 3
 1 of the health insurance issuer, pharmacy benefit
1
2 manager, or other third-party payor,
2
3 (2) dispensing fees that are less than the dispensing
3
4 fees for non-340B entities,
4
5 (3) restrictions or requirements regarding
5
6 participation in standard or preferred pharmacy
6
7 networks,
7
8 (4) requirements relating to the frequency or scope
8
9 of audits of inventory management systems,
9
10 (5) requirements that a claim for a drug include any
10
11 identification, billing modifier, attestation, or
11
12 other indication that a drug is a 340B drug in
12
13 order to be processed or resubmitted unless it is
13
14 required by the Centers for Medicare and Medicaid
14
15 Services or the Oklahoma Health Care Authority
15
16 for the administration of the Oklahoma Medicaid
16
17 program, or
17
18 (6) any other restrictions, conditions, practices, or
18
19 policies that are not imposed on non-340B
19
20 entities.
20
21 c. require a 340B entity to reverse, resubmit, or clarify
21
22 a claim after the initial adjudication unless these
22
23 actions are in the normal course of pharmacy business
23
24 and not related to 340B drug pricing,
24
Req. No. 9195 Page 4
 1 d. discriminate against a 340B entity in a manner that
1
2 prevents or interferes with any patient's choice to
2
3 receive such drugs from the 340B entity, including the
3
4 administration of such drugs. For purposes of this
4
5 subsection, it is considered a discriminatory practice
5
6 that prevents or interferes with a patient's choice to
6
7 receive drugs at a 340B entity if a health insurance
7
8 issuer, pharmacy benefit manager, or other third-party
8
9 payor places any additional requirements,
9
10 restrictions, or unnecessary burdens upon the 340B
10
11 entity that results in administrative costs or fees to
11
12 the 340B entity, including but not limited to,
12
13 requiring a claim for a drug to include any
13
14 identification, billing modifier, attestation, or
14
15 other indication that a drug is a 340B drug in order
15
16 to be processed or resubmitted unless it is required
16
17 by the Centers for Medicare and Medicaid Services or
17
18 the Oklahoma Health Care Authority in administration
18
19 of the Oklahoma Medicaid program,
19
20 e. include any other provision in a contract between a
20
21 health insurance issuer, pharmacy benefit manager, or
21
22 other third-party payor and a 340B entity that
22
23 discriminates against the 340B entity or prevents or
23
24 interferes with an individual's choice to receive a
24
Req. No. 9195 Page 5
 1 prescription drug from a 340B entity, including the
1
2 administration of the drug, in person or via direct
2
3 delivery, mail, or other form of shipment, or creation
3
4 of a restriction or additional charge on a patient who
4
5 chooses to receive drugs from a 340B entity,
5
6 f. require or compel the submission of ingredient costs
6
7 or pricing data pertaining to 340B drugs to any health
7
8 insurance issuer, pharmacy benefit manager, or other
8
9 third-party payor,
9
10 g. exclude any 340B entity from the health insurance
10
11 issuer, pharmacy benefit manager, or other third-party
11
12 payor network on the basis that the 340B entity
12
13 dispenses drugs subject to an agreement under Section
13
14 256b of Title 42 of the United State Code, or refusing
14
15 to contract with a 340B entity for reasons other than
15
16 those that apply equally to non-340B entities.
16
17 B. Nothing in this section applies to the Oklahoma Medicaid
17
18 program as payor when Medicaid provides reimbursement for covered
18
19 outpatient drugs as defined in section 1396r-8(k) of Title 42 of the
19
20 United States Code.
20
21 SECTION 4. NEW LAW A new section of law to be codified
21
22 in the Oklahoma Statutes as Section 5403 of Title 36, unless there
22
23 is created a duplication in numbering, reads as follows:
23
24
24
Req. No. 9195 Page 6
 1 A. A manufacturer or distributor shall not deny, restrict,
1
2 prohibit, or otherwise interfere with, either directly or
2
3 indirectly, the acquisition of a 340B drug by, or delivery of a 340B
3
4 drug to, a pharmacy that is under contract with a 340B entity and is
4
5 authorized under such contract to receive and dispense 340B drugs on
5
6 behalf of the covered entity unless such receipt is prohibited by
6
7 the United States Department of Health and Human Services.
7
8 B. A manufacturer or distributor shall not interfere with a
8
9 pharmacy contracted with a 340B entity.
9
10 SECTION 5. NEW LAW A new section of law to be codified
10
11 in the Oklahoma Statutes as Section 5404 of Title 36, unless there
11
12 is created a duplication in numbering, reads as follows:
12
13 The Attorney General may make rules and regulations interpreting
13
14 the provisions of this act, and shall make recommendations to the
14
15 Oklahoma Insurance Commissioner for enforcement with the
15
16 jurisdiction of the Insurance Commissioner.
16
17 The Insurance Commissioner may censure, suspend, revoke, or
17
18 refuse to issue or renew a license of or levy a civil penalty
18
19 against any person licensed under the insurance laws of this state
19
20 for any violation of this act.
20
21 In addition to or in lieu of any applicable censure, suspension
21
22 or revocation of a license, a manufacturer, distributor, health
22
23 insurance issuer, pharmacy benefit manager, other third-party payor,
23
24 or its agent may be subject to a civil fine of not less than One
24
Req. No. 9195 Page 7
 1 Hundred Dollars ($100.00) and not greater than Ten Thousand Dollars
1
2 ($10,000.00) for each violation of the provisions of this act.
2
3 A violation occurs each time a prohibited act is committed.
3
4 SECTION 6. NEW LAW A new section of law to be codified
4
5 in the Oklahoma Statutes as Section 5405 of Title 36, unless there
5
6 is created a duplication in numbering, reads as follows:
6
7 A. Nothing in this section is to be construed or applied to be
7
8 less restrictive than federal law for a person or entity regulated
8
9 by this act.
9
10 B. Nothing in this act is to be construed or applied to be in
10
11 conflict with any of the following:
11
12 1. Applicable federal law and related regulations; or
12
13 2. Other laws of this state if the state law is compatible with
13
14 applicable federal law.
14
15 C. Limited distribution of a drug required under section 355-1
15
16 of Title 21 of the United States Code is not to be construed as a
16
17 violation of this section.
17
18 SECTION 7. This act shall become effective November 1, 2024.
18
19
19
20 59-2-9195 TJ 01/06/24
20
21
21
22
22
23
23
24
24
Req. No. 9195 Page 8