1| STATE OF OKLAHOMA |
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2| 1st Session of the 60th Legislature (2025) |
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3|HOUSE BILL 2817 By: Marti |
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4| |
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5| |
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6| AS INTRODUCED |
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7| An Act relating to health care; creating the Oklahoma |
| Rebate Pass-Through and Pharmacy Benefits Manager |
8| Meaningful Transparency Act of 2025; providing cost |
| sharing calculation methodology, limitations, and |
9| requirements; creating penalties; clarifying |
| authority to take certain actions; prohibiting the |
10| disclosure of certain information; declaring that |
| certain information not be considered public record; |
11| amending 36 O.S. 2021, Section 6960, as last amended |
| by Section 1, Chapter 306, O.S.L. 2024 (36 O.S. Supp. |
12| 2024, Section 6960), which relates to definitions; |
| defining terms; creating PBM disclosures; amending 36 |
13| O.S. 2021, Section 6962, as last amended by Section |
| 2, Chapter 306, O.S.L. 2024 (36 O.S. Supp. 2024, |
14| Section 6962), which relates to pharmacy benefits |
| manager compliance; creating duties; amending 36 O.S. |
15| 2021, Section 6964, which relates to a formulary for |
| prescription drugs; creating agency duties; amending |
16| 59 O.S. 2021, Section 357, as amended by Section 4, |
| Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, Section |
17| 357), which relates to definitions; modifying |
| definitions; amending 59 O.S. 2021, Section 358, as |
18| amended by Section 5, Chapter 332, O.S.L. 2024 (59 |
| O.S. Supp. 2024, Section 358), which relates to |
19| pharmacy benefits management licensure, procedure, |
| and penalties; creating duties; creating licensing |
20| application requirements; providing for |
| noncodification; providing for codification; and |
21| providing an effective date. |
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22| |
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23| |
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24|BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: |
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Req. No. 11292 Page 1
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1| SECTION 1. NEW LAW A new section of law not to be |
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2|codified in the Oklahoma Statutes reads as follows: |
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3| This act shall be known and may be cited as the "Oklahoma Rebate |
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4|Pass-Through and Pharmacy Benefits Manager Meaningful Transparency |
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5|Act of 2025". |
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6| SECTION 2. NEW LAW A new section of law to be codified |
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7|in the Oklahoma Statutes as Section 6962.2 of Title 36, unless there |
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8|is created a duplication in numbering, reads as follows: |
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9| A. An enrollee's defined cost sharing for each prescription |
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10|drug shall be calculated at the point of sale based on a price that |
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11|is reduced by an amount equal to at least eighty-five percent (85%) |
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12|of all rebates received, or to be received, in connection with the |
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13|dispensing or administration of the prescription drug. |
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14| B. For any violation of this section, the Insurance |
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15|Commissioner may subject a pharmacy benefits manager (PBM) to an |
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16|administrative penalty of not less than One Hundred Dollars |
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17|($100.00) nor more than Ten Thousand Dollars ($10,000.00) for each |
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18|occurrence. Such administrative penalty may be enforced in the same |
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19|manner in which civil judgments may be enforced. |
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20| C. Nothing in subsections A and B of this section shall |
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21|preclude a PBM from decreasing an enrollee's defined cost sharing by |
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22|an amount greater than that required under subsection A of this |
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23|section. |
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24| |
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1| D. In implementing the requirements of this section, the state |
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2|shall only regulate a PBM to the extent permissible under applicable |
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3|law. |
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4| E. In complying with the provisions of this section, a PBM or |
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5|its agents shall not publish or otherwise reveal information |
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6|regarding the actual amount of rebates a PBM receives on a product |
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7|or therapeutic class of products, manufacturer, or pharmacy-specific |
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8|basis. Such information is protected as a trade secret, is not a |
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9|public record as defined in the Oklahoma Open Records Act, Section |
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10|24A.1 et seq. of Title 51 of the Oklahoma Statutes, and shall not be |
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11|disclosed directly or indirectly, or in a manner that would allow |
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12|for the identification of an individual product, therapeutic class |
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13|of products, or manufacturer, or in a manner that would have the |
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14|potential to compromise the financial, competitive, or proprietary |
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15|nature of the information. A PBM shall impose the confidentiality |
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16|protections of this section on any vendor or downstream third party |
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17|that performs health care or administrative services on behalf of |
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18|the insurer that may receive or have access to rebate information. |
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19| SECTION 3. NEW LAW A new section of law to be codified |
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20|in the Oklahoma Statutes as Section 6970 of Title 36, unless there |
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21|is created a duplication in numbering, reads as follows: |
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22| A. For purposes of this section: |
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23| |
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24| |
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1| 1. "Defined cost sharing" means a deductible payment or |
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2|coinsurance amount imposed on an enrollee for a covered prescription |
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3|drug under the enrollee's health plan; |
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4| 2. "Insurer" means any health insurance issuer that is subject |
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5|to state law regulating insurance and offers health insurance |
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6|coverage, as defined in 42 U.S.C., Section 300gg-91, or any state or |
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7|local governmental employer plan; |
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8| 3. "Price protection rebate" means a negotiated price |
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9|concession that accrues directly or indirectly to the insurer, or |
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10|other party on behalf of the insurer, in the event of an increase in |
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11|the wholesale acquisition cost of a drug above a specified |
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12|threshold; |
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13| 4. "Rebate" means: |
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14| a. negotiated price concessions including, but not |
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15| limited to, base price concessions (whether described |
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16| as a rebate or otherwise) and reasonable estimates of |
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17| any price protection rebates and performance-based |
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18| price concessions that may accrue directly or |
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19| indirectly to the insurer during the coverage year |
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20| from a manufacturer, dispensing pharmacy, or other |
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21| party in connection with the dispensing or |
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22| administration of a prescription drug, and |
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23| b. reasonable estimates of any negotiated price |
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24| concessions, fees, and other administrative costs that |
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Req. No. 11292 Page 4
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1| are passed through, or are reasonably anticipated to |
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2| be passed through, to the insurer and serve to reduce |
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3| the insurer's liabilities for a prescription drug. |
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4| B. An enrollee's defined cost sharing for each prescription |
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5|drug shall be calculated at the point of sale based on a price that |
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6|is reduced by an amount equal to at least eighty-five percent (85%) |
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7|of all rebates received, or to be received, in connection with the |
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8|dispensing or administration of the prescription drug. |
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9| C. For any violation of this section, the Insurance |
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10|Commissioner may subject an insurer to an administrative penalty of |
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11|not less than One Hundred Dollars ($100.00) nor more than Ten |
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12|Thousand Dollars ($10,000.00) for each occurrence. Such |
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13|administrative penalty may be enforced in the same manner in which |
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14|civil judgments may be enforced. |
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15| D. Nothing in subsections A through C of this section shall |
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16|preclude an insurer from decreasing an enrollee's defined cost |
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17|sharing by an amount greater than that required under subsection B |
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18|of this section. |
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19| E. In implementing the requirements of this section, the state |
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20|shall only regulate an insurer to the extent permissible under |
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21|applicable law. |
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22| F. In complying with the provisions of this section, an insurer |
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23|or its agents shall not publish or otherwise reveal information |
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24|regarding the actual amount of rebates an insurer receives on a |
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1|product or therapeutic class of products, manufacturer, or |
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2|pharmacy-specific basis. Such information is protected as a trade |
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3|secret, is not a public record as defined in the Oklahoma Open |
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4|Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma |
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5|Statutes, and shall not be disclosed directly or indirectly, or in a |
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6|manner that would allow for the identification of an individual |
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7|product, therapeutic class of products, or manufacturer, or in a |
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8|manner that would have the potential to compromise the financial, |
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9|competitive, or proprietary nature of the information. An insurer |
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10|shall impose the confidentiality protections of this section on any |
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11|vendor or downstream third party that performs health care or |
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12|administrative services on behalf of the insurer and that may |
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13|receive or have access to rebate information. |
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14| SECTION 4. AMENDATORY 36 O.S. 2021, Section 6960, as |
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15|last amended by Section 1, Chapter 306, O.S.L. 2024 (36 O.S. Supp. |
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16|2024, Section 6960), is amended to read as follows: |
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17| Section 6960. A. For purposes of the Patient's Right to |
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18|Pharmacy Choice Act: |
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19| 1. "Administrative fees" means fees or payments from |
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20|pharmaceutical manufacturers to, or otherwise retained by, a |
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21|pharmacy benefits manager (PBM) or its designee pursuant to a |
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22|contract between a PBM or affiliate and the manufacturer in |
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23|connection with the PBM's administering, invoicing, allocating, and |
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24|collecting the rebates; |
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1| 2. "Aggregate retained rebate percentage" means the percentage |
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2|of all rebates received by a PBM from all pharmaceutical |
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3|manufacturers which is not passed on to the PBM's health plan or |
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4|health insurer clients. Aggregate retained rebate percentage shall |
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5|be expressed without disclosing any identifying information |
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6|regarding any health plan, prescription drug, or therapeutic class, |
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7|and shall be calculated by dividing: |
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8| a. the aggregate dollar amount of all rebates that the |
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9| PBM received during the prior calendar year from all |
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10| pharmaceutical manufacturers and did not pass through |
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11| to the PBM's health plan or health insurer clients, by |
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12| b. the aggregate dollar amount of all rebates that the |
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13| pharmacy benefits manager received during the prior |
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14| calendar year from all pharmaceutical manufacturers; |
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15| 3. "Covered entity" means a nonprofit hospital or medical |
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16|service organization, for-profit hospital or medical service |
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17|organization, insurer, health benefit plan, health maintenance |
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18|organization, health program administered by the state in the |
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19|capacity of providing health coverage, or an employer, labor union, |
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20|or other group of persons that provides health coverage to persons |
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21|in this state. This term does not include a health plan that |
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22|provides coverage only for accidental injury, specified disease, |
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23|hospital indemnity, disability income, or other limited benefit |
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24| |
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1|health insurance policies and contracts that do not include |
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2|prescription drug coverage; |
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3| 4. "Defined cost sharing" means a deductible payment or |
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4|coinsurance amount imposed on an enrollee for a covered prescription |
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5|drug under the enrollee's health plan; |
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6| 5. "Formulary" means a list of prescription drugs, as well as |
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7|accompanying tiering and other coverage information, that has been |
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8|developed by an issuer, a health plan, or the designee of a health |
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9|insurer or health plan, which the health insurer, health plan, or |
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10|designee of the health insurer or health plan references in |
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11|determining applicable coverage and benefit levels; |
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12| 6. "Generic equivalent" means a drug that is designated to be |
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13|therapeutically equivalent, as indicated by the United States Food |
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14|and Drug Administration's "Approved Drug Products with Therapeutic |
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15|Equivalence Evaluations"; provided, however, that a drug shall not |
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16|be considered a generic equivalent until the drug becomes nationally |
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17|available; |
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18| 2. 7. "Health insurer" means any corporation, association, |
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19|benefit society, exchange, partnership or individual subject to |
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20|state law required insurance and licensed by under the Oklahoma |
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21|Insurance Code; |
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22| 8. "Health insurer administrative service fees" means fees or |
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23|payments from a health insurer or a designee of the health insurer |
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24|to, or otherwise retained by, a PBM or its designee pursuant to a |
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1|contract between a PBM or affiliate, and the health insurer or |
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2|designee of the health insurer in connection with the PBM managing |
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3|or administering the pharmacy benefit and administering, invoicing, |
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4|allocating, and collecting rebates; |
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5| 3. 9. "Health insurer payor" means a health insurance company, |
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6|health maintenance organization, union, hospital and medical |
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7|services organization or any entity providing or administering a |
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8|self-funded health benefit plan; |
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9| 10. "Health plan" means a policy, contract, certification, or |
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10|agreement offered or issued by a health insurer to provide, deliver, |
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11|arrange for, pay for, or reimburse any of the costs of health |
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12|services; |
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13| 4. 11. "Mail-order pharmacy" means a pharmacy licensed by this |
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14|state that primarily dispenses and delivers covered drugs via common |
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15|carrier; |
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16| 12. "Pharmacy and therapeutics committee" or "P&T committee" |
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17|means a committee at a hospital or a health insurance plan that |
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18|decides which drugs will appear on that entity's drug formulary; |
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19| 5. 13. "Pharmacy benefits manager" or "PBM" means a person, |
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20|business, or other entity that, either directly or through an |
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21|intermediary, performs pharmacy benefits management, as defined in |
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22|paragraph 6 of Section 357 of Title 59 of the Oklahoma Statutes. |
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23|The term shall include a person or entity acting on behalf of a PBM |
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24|in a contractual or employment relationship in the performance of |
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1|pharmacy benefits management for a managed care company, nonprofit |
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2|hospital, medical service organization, insurance company, |
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3|third-party payor or a health program administered by a department |
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4|of this state. PBM does not include a Pharmacy Services |
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5|Administrative Organization; |
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6| 6. 14. "Pharmacy benefits management" means a service provided |
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7|to covered entities to facilitate the provisions of prescription |
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8|drug benefits to covered individuals within the state, including, |
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9|but not limited to, negotiating pricing and other terms with drug |
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10|manufacturers and providers. Pharmacy benefits management may |
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11|include any or all of the following services: |
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12| a. claims processing, retail network management, and |
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13| payment of claims to pharmacies for prescription drugs |
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14| dispensed to covered individuals, |
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15| b. administration or management of pharmacy discount |
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16| cards or programs, |
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17| c. clinical formulary development and management |
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18| services, or |
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19| d. rebate contracting and administration; |
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20| 15. "Price protection rebate" means a negotiated price |
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21|concession that accrues directly or indirectly to the health |
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22|insurer, or other party on behalf of the health insurer, in the |
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23|event of an increase in the wholesale acquisition of a drug above a |
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24|specified threshold; |
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1| 7. 16. "Provider" means a pharmacy, as defined in Section 353.1 |
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2|of Title 59 of the Oklahoma Statutes or an agent or representative |
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3|of a pharmacy; |
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4| 17. "Rebates" means: |
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5| a. negotiated price concessions including, but not |
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6| limited to, base price concessions (whether described |
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7| as a rebate or otherwise) and reasonable estimates of |
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8| any price protection rebates and performance-based |
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9| price concessions that may accrue directly or |
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10| indirectly to a health insurer, health plan, or PBM |
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11| during the coverage year from a manufacturer, |
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12| dispensing pharmacy, or other party in connection with |
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13| the dispensing or administration of a prescription |
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14| drug, and |
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15| b. reasonable estimates of any price concessions, fees, |
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16| and other administrative costs that are passed |
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17| through, or are reasonably anticipated to be passed |
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18| through, to a health insurer, health plan, or PBM and |
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19| serve to reduce the health insurer, health plan, or |
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20| PBM's liabilities for a prescription drug; |
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21| 8. 18. "Retail pharmacy network" means retail pharmacy |
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22|providers contracted with a PBM in which the pharmacy primarily |
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23|fills and sells prescriptions via a retail, storefront location; |
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24| |
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1| 9. 19. "Rural service area" means a five-digit ZIP code in |
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2|which the population density is less than one thousand (1,000) |
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3|individuals per square mile; |
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4| 10. 20. "Spread pricing" means a prescription drug pricing |
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5|model utilized by a pharmacy benefits manager in which the PBM |
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6|charges a health benefit plan a contracted price for prescription |
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7|drugs that differs from the amount the PBM directly or indirectly |
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8|pays the pharmacy or pharmacist for providing pharmacy services; |
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9| 11. 21. "Suburban service area" means a five-digit ZIP code in |
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10|which the population density is between one thousand (1,000) and |
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11|three thousand (3,000) individuals per square mile; and |
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12| 12. 22. "Urban service area" means a five-digit ZIP code in |
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13|which the population density is greater than three thousand (3,000) |
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14|individuals per square mile. |
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15| B. Nothing in the definitions of pharmacy benefits manager or |
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16|pharmacy benefits management as such terms are defined in the |
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17|Patient's Right to Pharmacy Choice Act, the Pharmacy Audit Integrity |
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18|Act, or Sections 357 through 360 of Title 59 of the Oklahoma |
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19|Statutes shall be construed to deem the following entities to be a |
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20|pharmacy benefits manager: |
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21| 1. An employer of its own self-funded health benefit plan, |
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22|except, to the extent permitted by applicable law, where the |
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23|employer without the utilization of a third party and unrelated to |
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24|the employer's own pharmacy: |
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Req. No. 11292 Page 12
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1| a. negotiates directly with drug manufacturers, |
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2| b. processes claims on behalf of its members, or |
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3| c. manages its own retail network of pharmacies; or |
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4| 2. A pharmacy that provides a patient with a discount card or |
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5|program that is for exclusive use at the pharmacy offering the |
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6|discount. |
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7| SECTION 5. AMENDATORY 36 O.S. 2021, Section 6962, as |
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8|last amended by Section 2, Chapter 306, O.S.L. 2024 (36 O.S. Supp. |
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9|2024, Section 6962), is amended to read as follows: |
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10| Section 6962. A. The Attorney General shall review and approve |
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11|retail pharmacy network access for all pharmacy benefits managers |
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12|(PBMs) to ensure compliance with Section 6961 of this title. |
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13| B. A PBM, or an agent of a PBM, shall not: |
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14| 1. Cause or knowingly permit the use of advertisement, |
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15|promotion, solicitation, representation, proposal or offer that is |
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16|untrue, deceptive or misleading; |
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17| 2. Charge a pharmacist or pharmacy a fee related to the |
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18|adjudication of a claim including without limitation a fee for: |
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19| a. the submission of a claim, |
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20| b. enrollment or participation in a retail pharmacy |
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21| network, or |
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22| c. the development or management of claims processing |
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23| services or claims payment services related to |
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24| participation in a retail pharmacy network; |
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1| 3. Reimburse a pharmacy or pharmacist in the state an amount |
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2|less than the amount that the PBM reimburses a pharmacy owned by or |
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3|under common ownership with a PBM for providing the same covered |
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4|services. The reimbursement amount paid to the pharmacy shall be |
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5|equal to the reimbursement amount calculated on a per-unit basis |
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6|using the same generic product identifier or generic code number |
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7|paid to the PBM-owned or PBM-affiliated pharmacy; |
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8| 4. Deny a provider the opportunity to participate in any |
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9|pharmacy network at preferred participation status if the provider |
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10|is willing to accept the terms and conditions that the PBM has |
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11|established for other providers as a condition of preferred network |
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12|participation status; |
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13| 5. Deny, limit or terminate a provider's contract based on |
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14|employment status of any employee who has an active license to |
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15|dispense, despite probation status, with the State Board of |
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16|Pharmacy; |
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17| 6. Retroactively deny or reduce reimbursement for a covered |
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18|service claim after returning a paid claim response as part of the |
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19|adjudication of the claim, unless: |
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20| a. the original claim was submitted fraudulently, or |
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21| b. to correct errors identified in an audit, so long as |
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22| the audit was conducted in compliance with Sections |
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23| 356.2 and 356.3 of Title 59 of the Oklahoma Statutes; |
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24| |
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1| 7. Fail to make any payment due to a pharmacy or pharmacist for |
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2|covered services properly rendered in the event a PBM terminates a |
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3|provider from a pharmacy benefits manager network; |
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4| 8. Conduct or practice Either directly or through an |
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5|intermediary, agent, or affiliate, engage in, facilitate, or enter |
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6|into a contract with another person involving spread pricing, as |
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7|defined in Section 6960 of this title, in this state; or |
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8| 9. Charge a pharmacist or pharmacy a fee related to |
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9|participation in a retail pharmacy network including but not limited |
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10|to the following: |
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11| a. an application fee, |
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12| b. an enrollment or participation fee, |
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13| c. a credentialing or re-credentialing fee, |
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14| d. a change of ownership fee, or |
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15| e. a fee for the development or management of claims |
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16| processing services or claims payment services; or |
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17| 10. Prohibit or penalize a pharmacy or pharmacist for: |
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18| a. disclosing to an individual information regarding the |
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19| existence and clinical efficacy of a generic |
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20| equivalent that would be less expensive to the |
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21| enrollee: |
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22| (1) under his or her health plan prescription drug |
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23| benefit, or |
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24| |
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Req. No. 11292 Page 15
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1| (2) outside his or her health plan prescription drug |
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2| benefit, without requesting any health plan |
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3| reimbursement, than the drug that was originally |
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4| prescribed, or |
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5| b. selling to an individual, instead of a particular |
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6| prescribed drug, a therapeutically equivalent drug |
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7| that would be less expensive to the enrollee: |
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8| (1) under his or her health plan prescription drug |
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9| benefit, or |
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10| (2) outside his or her health plan prescription drug |
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11| benefit, without requesting any health plan |
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12| reimbursement, than the drug that was originally |
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13| prescribed. |
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14| C. The prohibitions under this section shall apply to contracts |
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15|between pharmacy benefits managers and providers for participation |
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16|in retail pharmacy networks. |
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17| 1. A PBM contract shall: |
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18| a. not restrict, directly or indirectly, any pharmacy |
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19| that dispenses a prescription drug from informing, or |
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20| penalize such pharmacy for informing, an individual of |
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21| any differential between the individual's |
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22| out-of-pocket cost or coverage with respect to |
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23| acquisition of the drug and the amount an individual |
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24| would pay to purchase the drug directly, and |
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Req. No. 11292 Page 16
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1| b. ensure that any entity that provides pharmacy |
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2| benefits management services under a contract with any |
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3| such health plan or health insurance coverage does |
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4| not, with respect to such plan or coverage, restrict, |
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5| directly or indirectly, a pharmacy that dispenses a |
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6| prescription drug from informing, or penalize such |
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7| pharmacy for informing, a covered individual of any |
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8| differential between the individual's out-of-pocket |
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9| cost under the plan or coverage with respect to |
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10| acquisition of the drug and the amount an individual |
| |
11| would pay for acquisition of the drug without using |
| |
12| any health plan or health insurance coverage. |
| |
13| 2. A pharmacy benefits manager's contract with a provider shall |
| |
14|not prohibit, restrict, or limit disclosure of information or |
| |
15|documents to the Attorney General, law enforcement or state and |
| |
16|federal governmental officials investigating or examining a |
| |
17|complaint or conducting a review of a pharmacy benefits manager's |
| |
18|compliance with the requirements under the Patient's Right to |
| |
19|Pharmacy Choice Act, the Pharmacy Audit Integrity Act, and Sections |
| |
20|357 through 360 of Title 59 of the Oklahoma Statutes. |
| |
21| D. A pharmacy benefits manager shall: |
| |
22| 1. Establish and maintain an electronic claim inquiry |
| |
23|processing system using the National Council for Prescription Drug |
| |
24| |
| |
Req. No. 11292 Page 17
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1|Programs' current standards to communicate information to pharmacies |
| |
2|submitting claim inquiries; |
| |
3| 2. Fully disclose to insurers, self-funded employers, unions or |
| |
4|other PBM clients the existence of the respective aggregate |
| |
5|prescription drug discounts, rebates received from drug |
| |
6|manufacturers and pharmacy audit recoupments; |
| |
7| 3. Provide the Attorney General, insurers, self-funded employer |
| |
8|plans and unions unrestricted audit rights of and access to the |
| |
9|respective PBM pharmaceutical manufacturer and provider contracts, |
| |
10|plan utilization data, plan pricing data, pharmacy utilization data |
| |
11|and pharmacy pricing data; |
| |
12| 4. Maintain, for no less than three (3) years, documentation of |
| |
13|all network development activities including but not limited to |
| |
14|contract negotiations and any denials to providers to join networks. |
| |
15| This documentation shall be made available to the Attorney General |
| |
16|upon request; and |
| |
17| 5. Report to the Attorney General, on a quarterly basis for |
| |
18|each health insurer payor, on the following information: |
| |
19| a. the aggregate amount of rebates received by the PBM, |
| |
20| b. the aggregate amount of rebates distributed to the |
| |
21| appropriate health insurer payor, |
| |
22| c. the aggregate amount of rebates passed on to the |
| |
23| enrollees of each health insurer payor at the point of |
| |
24| |
| |
Req. No. 11292 Page 18
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1| sale that reduced the applicable deductible, |
| |
2| copayment, coinsure or other cost sharing amount of |
| |
3| the enrollee, |
| |
4| d. the individual and aggregate amount paid by the |
| |
5| health insurer payor to the PBM for pharmacy services |
| |
6| itemized by pharmacy, drug product and service |
| |
7| provided, and |
| |
8| e. the individual and aggregate amount a PBM paid a |
| |
9| provider for pharmacy services itemized by pharmacy, |
| |
10| drug product and service provided. |
| |
11| E. Nothing in the Patient's Right to Pharmacy Choice Act shall |
| |
12|prohibit the Attorney General from requesting and obtaining detailed |
| |
13|data, including raw data, in response to the information provided by |
| |
14|a PBM in the quarterly reports required by this section. The |
| |
15|Attorney General may alter the frequency of the reports required by |
| |
16|this section at his or her sole discretion. |
| |
17| F. The Attorney General may promulgate rules to implement the |
| |
18|provisions of the Patient's Right to Pharmacy Choice Act, the |
| |
19|Pharmacy Audit Integrity Act, and Sections 357 through 360 of Title |
| |
20|59 of the Oklahoma Statutes. |
| |
21| SECTION 6. AMENDATORY 36 O.S. 2021, Section 6964, is |
| |
22|amended to read as follows: |
| |
23| Section 6964. A. A health insurer's insurer or its agent's, |
| |
24|including pharmacy benefits managers, pharmacy and therapeutics |
| |
Req. No. 11292 Page 19
___________________________________________________________________________
1|committee (P&T committee) shall establish a formulary, which shall |
| |
2|be a list of prescription drugs, both generic and brand name, used |
| |
3|by practitioners to identify drugs that offer the greatest overall |
| |
4|value. |
| |
5| B. A health insurer shall prohibit conflicts of interest for |
| |
6|members of the P&T committee. The P&T committee shall review the |
| |
7|formulary annually and must meet the following requirements: |
| |
8| 1. A person may not serve on a P&T committee if the person is |
| |
9|currently employed or was employed within the preceding year by a |
| |
10|pharmaceutical manufacturer, developer, labeler, wholesaler or |
| |
11|distributor. A majority of P&T committee members shall be |
| |
12|practicing physicians, practicing pharmacists, or both, and shall be |
| |
13|licensed in Oklahoma; |
| |
14| 2. A health insurer shall require any member of the P&T |
| |
15|committee to disclose any compensation or funding from a |
| |
16|pharmaceutical manufacturer, developer, labeler, wholesaler or |
| |
17|distributor. Such P&T committee member shall be recused from voting |
| |
18|on any product manufactured or sold by such pharmaceutical |
| |
19|manufacturer, developer, labeler, wholesaler or distributor. P&T |
| |
20|committee members shall practice in various clinical specialties |
| |
21|that adequately represent the needs of health plan enrollees, and |
| |
22|there shall be an adequate number of high-volume specialists and |
| |
23|specialists treating rare and orphan diseases; |
| |
24| |
| |
Req. No. 11292 Page 20
___________________________________________________________________________
1| 3. The P&T committee shall meet no less frequently than on a |
| |
2|quarterly basis; |
| |
3| 4. P&T committee formulary development shall be conducted |
| |
4|pursuant to a transparent process, and formulary decisions and |
| |
5|rationale shall be documented in writing, with any records and |
| |
6|documents relating to the process available upon request to the |
| |
7|health plan, subject to the conditions in subsection C of this |
| |
8|section. In the case of P&T committee decisions that relate to |
| |
9|Medicaid managed care organizations' prescription drug coverage |
| |
10|policies, if the P&T committee relies upon any third party to |
| |
11|provide cost-effectiveness analysis or research, the P&T committee |
| |
12|shall: |
| |
13| a. disclose to the health benefit plan, the state, and |
| |
14| the general public the name of the relevant third |
| |
15| party, and |
| |
16| b. provide a process through which patients and |
| |
17| providers potentially impacted by the third party's |
| |
18| analysis or research may provide input to the P&T |
| |
19| committee; |
| |
20| 5. Specialists with current clinical expertise who actively |
| |
21|treat patients in a specific therapeutic area, and the specific |
| |
22|conditions within a therapeutic area, shall participate in formulary |
| |
23|decisions regarding each therapeutic area and specific condition; |
| |
24| |
| |
Req. No. 11292 Page 21
___________________________________________________________________________
1| 6. The P&T committee shall base its clinical decisions on the |
| |
2|strength of scientific evidence, standards of practice, and |
| |
3|nationally accepted treatment guidelines; |
| |
4| 7. The P&T committee shall consider whether a particular drug |
| |
5|has a clinically meaningful therapeutic advantage over other drugs |
| |
6|in terms of safety, effectiveness, or clinical outcome for patient |
| |
7|populations who may be treated with the drug; |
| |
8| 8. The P&T committee shall evaluate and analyze treatment |
| |
9|protocols and procedures related to the health plan's formulary at |
| |
10|least annually; |
| |
11| 9. The P&T committee shall review formulary management |
| |
12|activities, including exceptions and appeals processes, prior |
| |
13|authorization, step therapy, quantity limits, generic substitutions, |
| |
14|therapeutic interchange, and other drug utilization management |
| |
15|activities for clinical appropriateness and consistency with |
| |
16|industry standards and patient and provider organization guidelines; |
| |
17| 10. The P&T committee shall annually review and provide a |
| |
18|written report to the pharmacy benefits manager on: |
| |
19| a. the percentage of prescription drugs on formulary |
| |
20| subject to each of the types of utilization management |
| |
21| described in paragraph 9 of this subsection, |
| |
22| b. rates of adherence and nonadherence to medicines by |
| |
23| therapeutic area, |
| |
24| |
| |
Req. No. 11292 Page 22
___________________________________________________________________________
1| c. rates of abandonment of medicines by therapeutic |
| |
2| area, |
| |
3| d. recommendations for improved adherence and reduced |
| |
4| abandonment, |
| |
5| e. recommendations for improvement in formulary |
| |
6| management practices consistent with patient and |
| |
7| provider organization and other clinical guidelines; |
| |
8| provided that the report shall be subject to the |
| |
9| conditions in subsection C of this section; |
| |
10| 11. The P&T committee shall review and make a formulary |
| |
11|decision on a new U.S. Food and Drug Administration approved drug |
| |
12|within ninety (90) days of such drug's approval, or shall provide a |
| |
13|clinical justification if this time frame is not met; |
| |
14| 12. The P&T committee shall review procedures for medical |
| |
15|review of, and transitioning new plan enrollees to, appropriate |
| |
16|formulary alternatives to ensure that such procedures appropriately |
| |
17|address situations involving enrollees stabilized on drugs that are |
| |
18|not on the health plan formulary (or that are on formulary but |
| |
19|subject to prior authorization, step therapy, or other utilization |
| |
20|management requirements). |
| |
21| C. The health insurer, its agents, including pharmacy benefits |
| |
22|managers, and the Department shall not publish or otherwise disclose |
| |
23|any confidential, proprietary information, including, but not |
| |
24|limited to, any information that would reveal the identity of a |
| |
Req. No. 11292 Page 23
___________________________________________________________________________
1|specific health plan, the prices charged for a specific drug or |
| |
2|class of drugs, the amount of any rebates provided for a specific |
| |
3|drug or class of drugs, the manufacturer, or that would otherwise |
| |
4|have the potential to compromise the financial, competitive, or |
| |
5|proprietary nature of the information. Any such information shall |
| |
6|be protected from disclosure as confidential and proprietary |
| |
7|information, is not a public record as defined in the Oklahoma Open |
| |
8|Records Act, Section 24A.1 et seq. of Title 51 of the Oklahoma |
| |
9|Statutes, and shall not be disclosed directly or indirectly. A |
| |
10|health insurer shall impose the confidentiality protections of this |
| |
11|section on any vendor or downstream third party that performs health |
| |
12|care or administrative services on behalf of the pharmacy benefits |
| |
13|manager that may receive or have access to rebate information. |
| |
14| SECTION 7. AMENDATORY 59 O.S. 2021, Section 357, as |
| |
15|amended by Section 4, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
| |
16|Section 357), is amended to read as follows: |
| |
17| Section 357. A. As used in Sections 357 through 360 of this |
| |
18|title: |
| |
19| 1. "Covered entity" means a nonprofit hospital or medical |
| |
20|service organization, for-profit hospital or medical service |
| |
21|organization, insurer, health benefit plan, health maintenance |
| |
22|organization, health program administered by the state in the |
| |
23|capacity of providing health coverage, or an employer, labor union, |
| |
24|or other group of persons that provides health coverage to persons |
| |
Req. No. 11292 Page 24
___________________________________________________________________________
1|in this state. This term does not include a health benefit plan |
| |
2|that provides coverage only for accidental injury, specified |
| |
3|disease, hospital indemnity, disability income, or other limited |
| |
4|benefit health insurance policies and contracts that do not include |
| |
5|prescription drug coverage; |
| |
6| 2. "Covered individual" means a member, participant, enrollee, |
| |
7|contract holder or policy holder or beneficiary of a covered entity |
| |
8|who is provided health coverage by the covered entity. A covered |
| |
9|individual includes any dependent or other person provided health |
| |
10|coverage through a policy, contract or plan for a covered |
| |
11|individual; |
| |
12| 3. "Department" means the Insurance Department; |
| |
13| 4. "Maximum allowable cost", "MAC", or "MAC list" means the |
| |
14|list of drug products delineating the maximum per-unit reimbursement |
| |
15|for multiple-source prescription drugs, medical product, or device; |
| |
16| 5. "Multisource drug product reimbursement" (reimbursement) |
| |
17|means the total amount paid to a pharmacy inclusive of any reduction |
| |
18|in payment to the pharmacy, excluding prescription dispense fees; |
| |
19| 6. "Office" means the Office of the Attorney General; |
| |
20| 7. "Pharmacy benefits management" means a service provided to |
| |
21|covered entities to facilitate the provision of prescription drug |
| |
22|benefits to covered individuals within the state, including |
| |
23|negotiating pricing and other terms with drug manufacturers and |
| |
24| |
| |
Req. No. 11292 Page 25
___________________________________________________________________________
1|providers. Pharmacy benefits management may include any or all of |
| |
2|the following services: |
| |
3| a. claims processing, performance of drug utilization |
| |
4| review, processing of drug prior authorization |
| |
5| requests, retail network management and payment of |
| |
6| claims to pharmacies for prescription drugs dispensed |
| |
7| to covered individuals, |
| |
8| b. clinical formulary development and management |
| |
9| services, or |
| |
10| c. rebate contracting and administration, |
| |
11| d. adjudication of appeals and grievances related to the |
| |
12| prescription drug benefit, or |
| |
13| e. controlling the cost of prescription drugs; |
| |
14| 8. "Pharmacy benefits manager" or "PBM" means a person, |
| |
15|business, or other entity that, either directly or through an |
| |
16|intermediary, performs pharmacy benefits management. The term shall |
| |
17|include a person or entity acting on behalf of a PBM in a |
| |
18|contractual or employment relationship in the performance of |
| |
19|pharmacy benefits management for a managed care company, nonprofit |
| |
20|hospital, medical service organization, insurance company, |
| |
21|third-party payor, or a health program administered by an agency or |
| |
22|department of this state. PBM does not include a Pharmacy Services |
| |
23|Administrative Organization; |
| |
24| |
| |
Req. No. 11292 Page 26
___________________________________________________________________________
1| 9. "Plan sponsor" means the employers, insurance companies, |
| |
2|unions and health maintenance organizations or any other entity |
| |
3|responsible for establishing, maintaining, or administering a health |
| |
4|benefit plan on behalf of covered individuals; and |
| |
5| 10. "Provider" means a pharmacy licensed by the State Board of |
| |
6|Pharmacy, or an agent or representative of a pharmacy, including, |
| |
7|but not limited to, the pharmacy's contracting agent, which |
| |
8|dispenses prescription drugs or devices to covered individuals. |
| |
9| B. Nothing in the definition of pharmacy benefits management or |
| |
10|pharmacy benefits manager in the Patient's Right to Pharmacy Choice |
| |
11|Act, Pharmacy Audit Integrity Act, or Sections 357 through 360 of |
| |
12|this title shall deem an employer a "pharmacy benefits manager" of |
| |
13|its own self-funded health benefit plan, except, to the extent |
| |
14|permitted by applicable law, where the employer, without the |
| |
15|utilization of a third party and unrelated to the employer's own |
| |
16|pharmacy: |
| |
17| a. negotiates directly with drug manufacturers, |
| |
18| b. processes claims on behalf of its members, or |
| |
19| c. manages its own retail network of pharmacies. |
| |
20| SECTION 8. AMENDATORY 59 O.S. 2021, Section 358, as |
| |
21|amended by Section 5, Chapter 332, O.S.L. 2024 (59 O.S. Supp. 2024, |
| |
22|Section 358), is amended to read as follows: |
| |
23| Section 358. A. In order to provide pharmacy benefits |
| |
24|management or any of the services included under the definition of |
| |
Req. No. 11292 Page 27
___________________________________________________________________________
1|pharmacy benefits management in this state, a pharmacy benefits |
| |
2|manager or any entity acting as one in a contractual or employment |
| |
3|relationship for a covered entity shall first obtain a license from |
| |
4|the Insurance Department, and the Department may charge a fee for |
| |
5|such licensure. |
| |
6| B. The Department shall establish, by regulation, licensure |
| |
7|procedures, required disclosures for pharmacy benefits managers |
| |
8|(PBMs) and other rules as may be necessary for carrying out and |
| |
9|enforcing the provisions of this title. The licensure procedures |
| |
10|shall, at a minimum, include the completion of an application form |
| |
11|that shall include the name and address of an agent for service of |
| |
12|process, the payment of a requisite fee, and evidence of the |
| |
13|procurement of a surety bond the following: |
| |
14| 1. The name, address, and telephone contact number of the PBM; |
| |
15| 2. The name and address of the PBM's agent for service of |
| |
16|process in the state; |
| |
17| 3. The name and address of each person with management or |
| |
18|control over the PBM; |
| |
19| 4. Evidence of the procurement of a surety bond; |
| |
20| 5. The name and address of each person with a beneficial |
| |
21|ownership interest in the PBM; |
| |
22| 6. In the case of a PBM applicant that is a partnership or |
| |
23|other unincorporated association, limited liability corporation, or |
| |
24| |
| |
Req. No. 11292 Page 28
___________________________________________________________________________
1|corporation, and has five or more partners, members, or |
| |
2|stockholders: |
| |
3| a. the applicant shall specify its legal structure and |
| |
4| the total number of partners, members, or |
| |
5| stockholders, |
| |
6| b. the applicant shall specify the name, address, usual |
| |
7| occupation, and professional qualifications of the |
| |
8| five partners, members, or stockholders with the five |
| |
9| largest ownership interests in the PBM, and |
| |
10| c. the applicant shall agree that, upon request by the |
| |
11| Department, it shall furnish the Department with |
| |
12| information regarding the name, address, usual |
| |
13| occupation, and professional qualifications of any |
| |
14| other partners, members, or stockholders; |
| |
15| 7. A signed statement indicating that the PBM has not been |
| |
16|convicted of a felony and has not violated any of the requirements |
| |
17|of the Oklahoma Pharmacy Act and the Patient's Right to Pharmacy |
| |
18|Choice Act, or, if the applicant cannot provide such a statement, a |
| |
19|signed statement describing all relevant convictions or violations; |
| |
20|and |
| |
21| 8. Any other information the Commissioner deems necessary to |
| |
22|review. |
| |
23| C. The Department or the Office of the Attorney General may |
| |
24|subpoena witnesses and information. Its compliance officers may |
| |
Req. No. 11292 Page 29
___________________________________________________________________________
1|take and copy records for investigative use and prosecutions. |
| |
2|Nothing in this subsection shall limit the Office of the Attorney |
| |
3|General from using its investigative demand authority to investigate |
| |
4|and prosecute violations of the law. |
| |
5| D. The Department may suspend, revoke or refuse to issue or |
| |
6|renew a license for noncompliance with any of the provisions hereby |
| |
7|established or with the rules promulgated by the Department; for |
| |
8|conduct likely to mislead, deceive or defraud the public or the |
| |
9|Department; for unfair or deceptive business practices or for |
| |
10|nonpayment of an application or renewal fee or fine. The Department |
| |
11|may also levy administrative fines for each count of which a PBM has |
| |
12|been convicted in a Department hearing. |
| |
13| E. 1. The Office of the Attorney General, after notice and |
| |
14|opportunity for hearing, may instruct the Insurance Commissioner |
| |
15|that the PBM's license be censured, suspended, or revoked for |
| |
16|conduct likely to mislead, deceive, or defraud the public or the |
| |
17|State of Oklahoma; or for unfair or deceptive business practices, or |
| |
18|for any violation of the Patient's Right to Pharmacy Choice Act, the |
| |
19|Pharmacy Audit Integrity Act, or Sections 357 through 360 of this |
| |
20|title. The Office of the Attorney General may also levy |
| |
21|administrative fines for each count of which a PBM has been |
| |
22|convicted following a hearing before the Attorney General. If the |
| |
23|Attorney General makes such instruction, the Commissioner shall |
| |
24|enforce the instructed action within thirty (30) calendar days. |
| |
Req. No. 11292 Page 30
___________________________________________________________________________
1| 2. In addition to or in lieu of any censure, suspension, or |
| |
2|revocation of a license by the Commissioner, the Attorney General |
| |
3|may levy a civil or administrative fine of not less than One Hundred |
| |
4|Dollars ($100.00) and not greater than Ten Thousand Dollars |
| |
5|($10,000.00) for each violation of this subsection and/or assess any |
| |
6|other penalty or remedy authorized by this section. For purposes of |
| |
7|this section, each day a PBM fails to comply with an investigation |
| |
8|or inquiry may be considered a separate violation. |
| |
9| F. The Attorney General may promulgate rules to implement the |
| |
10|provisions of Sections 357 through 360 of this title. |
| |
11| SECTION 9. This act shall become effective November 1, 2025. |
| |
12| |
| |
13| 60-1-11292 TJ 12/13/24 |
| |
14| |
| |
15| |
| |
16| |
| |
17| |
| |
18| |
| |
19| |
| |
20| |
| |
21| |
| |
22| |
| |
23| |
| |
24| |
| |
Req. No. 11292 Page 31
