Requirements with respect to cost-sharing for insulin products

(a)

In general

Part D of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–111 et seq.) is amended by adding at the end the following:

2799A–11.

Requirements with respect to cost-sharing for certain insulin products

(a)

In general

For plan years beginning on or after January 1, 2024, a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; (2)impose any cost-sharing requirement in excess of the lesser of, per 30-day supply—(A)$25; or(B)the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services; or(3)impose any utilization management practices such as prior authorization, step therapy protocols, or other similar conditions on such products, except as clinically justified and as specified by the Secretary. (b)

Definitions

In this section:(1)

Selected insulin products

The term selected insulin products means at least one of each dosage form (such as vial, pump, or inhaler dosage forms) of each different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin (as defined below), when available, as selected by the group health plan or health insurance issuer.(2)

Insulin defined

The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 and continues to be marketed under such section.(c)

Out-of-Network providers

Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider.(d)

Rule of construction

Subsection (a) shall not be construed to require coverage of, or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.(e)

Application of cost-Sharing towards deductibles and out-of-Pocket maximums

Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.

(b)

No effect on other cost-Sharing

Section 1302(d)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is amended by adding at the end the following new subparagraph:

(D)

Special rule relating to insulin coverage

For plan years beginning on or after January 1, 2024, the exemption of coverage of selected insulin products (as defined in section 2799A–11(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–11(a)(1) of such Act, section 726(a)(1) of the Employee Retirement Income Security Act of 1974, or section 9826(a)(1) of the Internal Revenue Code of 1986 shall not be considered when determining the actuarial value of a qualified health plan under this subsection.

(c)

Coverage of certain insulin products under catastrophic plans

Section 1302(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(e)) is amended by adding at the end the following:

(4)

Coverage of certain insulin products

(A)

In general

Notwithstanding paragraph (1)(B)(i), a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2799A–11 of the Public Health Service Act, for a plan year before an enrolled individual has incurred cost-sharing expenses in an amount equal to the annual limitation in effect under subsection (c)(1) for the plan year.(B)

Terminology

For purposes of subparagraph (A)—(i)the term selected insulin products has the meaning given such term in section 2799A–11(b) of the Public Health Service Act; and(ii)the requirements of section 2799A–11 of such Act shall be applied by deeming each reference in such section to individual health insurance coverage to be a reference to a plan described in paragraph (1).

(d)

ERISA

(1)

In general

Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following:

726.

Requirements with respect to cost-sharing for certain insulin products

(a)

In general

For plan years beginning on or after January 1, 2024, a group health plan or health insurance issuer offering group health insurance coverage shall provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; (2)impose any cost-sharing requirement in excess of the lesser of, per 30-day supply—(A)$25; or(B)the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services; or(3)impose any utilization management practices such as prior authorization, step therapy protocols, or other similar conditions on such products, except as clinically justified and as specified by the Secretary.(b)

Definitions

In this section:(1)

Selected insulin products

Insulin defined

The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section.(c)

Out-of-Network providers

Rule of construction

Application of cost-Sharing towards deductibles and out-of-Pocket maximums

Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.

(2)

Clerical amendment

The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.) is amended by inserting after the item relating to section 725 the following:

Sec. 726 Requirements with respect to cost-sharing for certain insulin products.

(e)

Internal Revenue Code

(1)

In general

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:

9826.

Requirements with respect to cost-sharing for certain insulin products

(a)

In general

For plan years beginning on or after January 1, 2024, a group health plan shall provide coverage of selected insulin products, and with respect to such products, shall not—(1)apply any deductible; (2)impose any cost-sharing requirement in excess of the lesser of, per 30-day supply—(A)$25; or(B)the amount equal to 25 percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan, including price concessions received by or on behalf of third-party entities providing services to the plan, such as pharmacy benefit management services; or(3)impose any utilization management practices such as prior authorization, step therapy protocols, or other similar conditions on such products, except as clinically justified and as specified by the Secretary.(b)

Definitions

In this section:(1)

Selected insulin products

Insulin defined

The term insulin means insulin that is licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262) and continues to be marketed under such section.(c)

Out-of-Network providers

Nothing in this section requires a plan that has a network of providers to provide benefits for selected insulin products described in this section that are delivered by an out-of-network provider, or precludes a plan that has a network of providers from imposing higher cost-sharing than the levels specified in subsection (a) for selected insulin products described in this section that are delivered by an out-of-network provider.(d)

Rule of construction

Subsection (a) shall not be construed to require coverage of, or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection (a) on, insulin products that are not selected insulin products, to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under Federal and applicable State law.(e)

Application of cost-Sharing towards deductibles and out-of-Pocket maximums

Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan.

(2)

Clerical amendment

The table of sections for subchapter B of chapter 100 of such Code is amended by adding at the end the following new item:

Sec. 9826 Requirements with respect to cost-sharing for certain insulin products.

(f)

Implementation

The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury shall implement the provisions of this section, including the amendments made by this section, through subregulatory guidance or program instruction.