[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1269 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 1269

To reduce the price of insulin and provide for patient protections with 
                    respect to the cost of insulin.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 25, 2023

  Mrs. Shaheen (for herself and Ms. Collins) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To reduce the price of insulin and provide for patient protections with 
                    respect to the cost of insulin.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Improving Needed 
Safeguards for Users of Lifesaving Insulin Now Act of 2023'' or the 
``INSULIN Act of 2023''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
             TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS

Sec. 101. Requirements with respect to cost-sharing for certain insulin 
                            products.
Sec. 102. Application to retiree and certain small group plans.
Sec. 103. Administration.
   TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM

Sec. 201. Full rebate on insulin pass-through to plan.
 TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION 
                           AND AFFORDABILITY

Sec. 301. Ensuring timely access to generics.
Sec. 302. Permitted mid-year changes in Medicare part D plan 
                            formularies for certain biosimilar 
                            biological products and the reference 
                            product of such biosimilars.
Sec. 303. Expediting competitive biosimilar competition.
Sec. 304. Insulin competition report.

             TITLE I--COMMERCIAL MARKET PATIENT PROTECTIONS

SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN 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:

``SEC. 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; or
            ``(2) impose any cost-sharing requirements in excess of, 
        per 30-day supply--
                    ``(A) for any applicable plan year beginning before 
                January 1, 2025, $35; or
                    ``(B) for any plan year beginning on or after 
                January 1, 2025, the lesser of--
                            ``(i) $35; or
                            ``(ii) 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 issuer, 
                        including price concessions received by or on 
                        behalf of third-party entities providing 
                        services to the plan or issuer, such as 
                        pharmacy benefit management services or third 
                        party administrators.
    ``(b) Definitions.--In this section:
            ``(1) Selected insulin products.--The term `selected 
        insulin products' means, for any plan year beginning on or 
        after January 1, 2024, at least one of each dosage form (such 
        as vial, pen, or inhaler dosage forms) of each different type 
        (such as rapid-acting, short-acting, intermediate-acting, long-
        acting, and pre-mixed) of insulin, when such form is licensed 
        and marketed, as selected by the group health plan or health 
        insurance issuer.
            ``(2) Insulin.--The term `insulin' means insulin that is 
        licensed under subsection (a) or (k) of section 351 and 
        continues to be marketed pursuant to such licensure.
    ``(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.
    ``(f) Other Requirements.--A group health plan or health insurance 
issuer offering group or individual health insurance coverage shall not 
impose, directly or through an entity providing pharmacy benefit 
management services, any prior authorization or other medical 
management requirement, or other similar conditions, on selected 
insulin products, except as clinically justified for safety reasons, to 
ensure reasonable quantity limits and as specified by the Secretary.''.
    (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 plans years beginning on or after January 1, 2025, 
                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, before an enrolled individual has 
                incurred, during the plan year, 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:

``SEC. 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; or
            ``(2) impose any cost-sharing requirements in excess of, 
        per 30-day supply--
                    ``(A) for any applicable plan year beginning before 
                January 1, 2025, $35; or
                    ``(B) for any plan year beginning on or after 
                January 1, 2025, the lesser of--
                            ``(i) $35; or
                            ``(ii) 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 issuer, 
                        including price concessions received by or on 
                        behalf of third-party entities providing 
                        services to the plan or issuer, such as 
                        pharmacy benefit management services or third 
                        party administrators.
    ``(b) Definitions.--In this section:
            ``(1) Selected insulin products.--The term `selected 
        insulin products' means, for any plan year beginning on or 
        after January 1, 2024, at least one of each dosage form (such 
        as vial, pen, or inhaler dosage forms) of each different type 
        (such as rapid-acting, short-acting, intermediate-acting, long-
        acting, and pre-mixed) of insulin, when such form is licensed 
        and marketed, as selected by the group health plan or health 
        insurance issuer.
            ``(2) Insulin.--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 pursuant to such licensure.
    ``(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.
    ``(f) Other Requirements.--A group health plan or health insurance 
issuer offering group health insurance coverage shall not impose, 
directly or through an entity providing pharmacy benefit management 
services, any prior authorization or other medical management 
requirement, or other similar conditions, on selected insulin products, 
except as clinically justified for safety reasons, to ensure reasonable 
quantity limits and as specified by the Secretary.''.
            (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:

``SEC. 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; or
            ``(2) impose any cost-sharing requirements in excess of, 
        per 30-day supply--
                    ``(A) for any applicable plan year beginning before 
                January 1, 2025, $35; or
                    ``(B) for any plan year beginning on or after 
                January 1, 2025, the lesser of--
                            ``(i) $35; or
                            ``(ii) 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 
                        third party administrators.
    ``(b) Definitions.--In this section:
            ``(1) Selected insulin products.--The term `selected 
        insulin products' means, for any plan year beginning on or 
        after January 1, 2024, at least one of each dosage form (such 
        as vial, pen, or inhaler dosage forms) of each different type 
        (such as rapid-acting, short-acting, intermediate-acting, long-
        acting, and pre-mixed) of insulin, when such form is licensed 
        and marketed, as selected by the group health plan.
            ``(2) Insulin.--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 pursuant to such licensure.
    ``(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.
    ``(f) Other Requirements.--A group health plan shall not impose, 
directly or through an entity providing pharmacy benefit management 
services, any prior authorization or other medical management 
requirement, or other similar conditions, on selected insulin products, 
except as clinically justified for safety reasons, to ensure reasonable 
quantity limits and as specified by the Secretary''.
            (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of such Code, as amended by section 
        102(c)(2), is further amended by adding at the end the 
        following new item:

``Sec. 9827. Requirements with respect to cost-sharing for certain 
                            insulin products.''.

SEC. 102. APPLICATION TO RETIREE AND CERTAIN SMALL GROUP PLANS.

    (a) ERISA.--Section 732(a) of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by striking 
``section 711'' and inserting ``sections 711 and 726''.
    (b) IRC.--The Internal Revenue Code of 1986 is amended--
            (1) in section 9831(a), by adding at the end the following 
        flush text:
``Paragraph (2) shall not apply to the requirements under sections 9811 
and 9826.''; and
            (2) in section 4980D(d)(1), by striking ``section 9811'' 
        and inserting ``sections 9811 and 9826''.

SEC. 103. ADMINISTRATION.

    (a) Implementation.--Notwithstanding any other provision of law, 
the Secretary of Health and Human Services, the Secretary of Labor, and 
the Secretary of the Treasury may implement the provisions of, 
including the amendments made by, this title for plan years that begin 
on or after January 1, 2024, and end not later than January 1, 2027, by 
subregulatory guidance, program instruction, or otherwise.
    (b) Non-Application of the Paperwork Reduction Act.--Chapter 35 of 
title 44, United States Code (commonly referred to as the ``Paperwork 
Reduction Act of 1995''), shall not apply to the provisions of, 
including the amendments made by, this title.

   TITLE II--PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM

SEC. 201. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.

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

``SEC. 2729A. FULL REBATE ON INSULIN PASS-THROUGH TO PLAN.

    ``(a) In General.--A pharmacy benefits manager, a third-party 
administrator of a group health plan, a health insurance issuer 
offering group health insurance coverage, or an entity providing 
pharmacy benefits management services under such health plan or health 
insurance coverage shall remit 100 percent of rebates, fees, 
alternative discounts, and all other remuneration received from a 
pharmaceutical manufacturer, distributor or any other third party, that 
are related to utilization of insulin under such health plan or health 
insurance coverage, to the group health plan.
    ``(b) Form and Manner of Remittance.--Such rebates, fees, 
alternative discounts, and other remuneration shall be--
            ``(1) remitted to the group health plan in a timely fashion 
        after the period for which such rebates, fees, or other 
        remuneration is calculated, and in no case later than 90 days 
        after the end of such period;
            ``(2) fully disclosed and enumerated to the group health 
        plan sponsor; and
            ``(3) available for audit by the plan sponsor, or a third-
        party designated by a plan sponsor no less than once per plan 
        year.''.

 TITLE III--BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION 
                           AND AFFORDABILITY

SEC. 301. ENSURING TIMELY ACCESS TO GENERICS.

    Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(q)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)(i), by inserting ``, 
                10.31,'' after ``10.30'';
                    (B) in subparagraph (E)--
                            (i) by striking ``application and'' and 
                        inserting ``application or'';
                            (ii) by striking ``If the Secretary'' and 
                        inserting the following:
                            ``(i) In general.--If the Secretary''; and
                            (iii) by striking the second sentence and 
                        inserting the following:
                            ``(ii) Primary purpose of delaying.--
                                    ``(I) In general.--In determining 
                                whether a petition was submitted with 
                                the primary purpose of delaying an 
                                application, the Secretary may consider 
                                the following factors:
                                            ``(aa) Whether the petition 
                                        was submitted in accordance 
                                        with paragraph (2)(B), based on 
                                        when the petitioner knew or 
                                        reasonably should have known 
                                        the relevant information relied 
                                        upon to form the basis of such 
                                        petition.
                                            ``(bb) Whether the 
                                        petitioner has submitted 
                                        multiple or serial petitions or 
                                        supplements to petitions 
                                        raising issues that reasonably 
                                        could have been known to the 
                                        petitioner at the time of 
                                        submission of the earlier 
                                        petition or petitions.
                                            ``(cc) Whether the petition 
                                        was submitted close in time to 
                                        a known, first date upon which 
                                        an application under subsection 
                                        (b)(2) or (j) of this section 
                                        or section 351(k) of the Public 
                                        Health Service Act could be 
                                        approved.
                                            ``(dd) Whether the petition 
                                        was submitted without relevant 
                                        data or information in support 
                                        of the scientific positions 
                                        forming the basis of such 
                                        petition.
                                            ``(ee) Whether the petition 
                                        raises the same or 
                                        substantially similar issues as 
                                        a prior petition to which the 
                                        Secretary has responded 
                                        substantively already, 
                                        including if the subsequent 
                                        submission follows such 
                                        response from the Secretary 
                                        closely in time.
                                            ``(ff) Whether the petition 
                                        requests changing the 
                                        applicable standards that other 
                                        applicants are required to 
                                        meet, including requesting 
                                        testing, data, or labeling 
                                        standards that are more onerous 
                                        or rigorous than the standards 
                                        the Secretary has determined to 
                                        be applicable to the listed 
                                        drug, reference product, or 
                                        petitioner's version of the 
                                        same drug.
                                            ``(gg) The petitioner's 
                                        record of submitting petitions 
                                        to the Food and Drug 
                                        Administration that have been 
                                        determined by the Secretary to 
                                        have been submitted with the 
                                        primary purpose of delay.
                                            ``(hh) Other relevant and 
                                        appropriate factors, which the 
                                        Secretary shall describe in 
                                        guidance.
                                    ``(II) Guidance.--The Secretary may 
                                issue or update guidance, as 
                                appropriate, to describe factors the 
                                Secretary considers in accordance with 
                                subclause (I).'';
                    (C) by adding at the end the following:
                            ``(iii) Referral to the federal trade 
                        commission.--The Secretary shall establish 
                        procedures for referring to the Federal Trade 
                        Commission any petition or supplement to a 
                        petition that the Secretary determines was 
                        submitted with the primary purpose of delaying 
                        approval of an application. Such procedures 
                        shall include notification to the petitioner by 
                        the Secretary.'';
                    (D) by striking subparagraph (F);
                    (E) by redesignating subparagraphs (G) through (I) 
                as subparagraphs (F) through (H), respectively; and
                    (F) in subparagraph (H), as so redesignated, by 
                striking ``submission of this petition'' and inserting 
                ``submission of this document'';
            (2) in paragraph (2)--
                    (A) by redesignating subparagraphs (A) through (C) 
                as subparagraphs (C) through (E), respectively;
                    (B) by inserting before subparagraph (C), as so 
                redesignated, the following:
                    ``(A) In general.--A person shall submit a petition 
                to the Secretary under paragraph (1) before filing a 
                civil action in which the person seeks to set aside, 
                delay, rescind, withdraw, or prevent submission, 
                review, or approval of an application submitted under 
                subsection (b)(2) or (j) of this section or section 
                351(k) of the Public Health Service Act. Such petition 
                and any supplement to such a petition shall describe 
                all information and arguments that form the basis of 
                the relief requested in any civil action described in 
                the previous sentence.
                    ``(B) Timely submission of citizen petition.--A 
                petition and any supplement to a petition shall be 
                submitted within 60 days after the person knew, or 
                reasonably should have known, the information that 
                forms the basis of the request made in the petition or 
                supplement.'';
                    (C) in subparagraph (C), as so redesignated--
                            (i) in the heading, by striking ``within 
                        150 days'';
                            (ii) in clause (i), by striking ``during 
                        the 150-day period referred to in paragraph 
                        (1)(F),''; and
                            (iii) by amending clause (ii) to read as 
                        follows:
                            ``(ii) on or after the date that is 151 
                        days after the date of submission of the 
                        petition, the Secretary approves or has 
                        approved the application that is the subject of 
                        the petition without having made such a final 
                        decision.'';
                    (D) by amending subparagraph (D), as so 
                redesignated, to read as follows:
                    ``(D) Dismissal of certain civil actions.--
                            ``(i) Petition.--If a person files a civil 
                        action against the Secretary in which a person 
                        seeks to set aside, delay, rescind, withdraw, 
                        or prevent submission, review, or approval of 
                        an application submitted under subsection 
                        (b)(2) or (j) of this section or section 351(k) 
                        of the Public Health Service Act without 
                        complying with the requirements of subparagraph 
                        (A), the court shall dismiss without prejudice 
                        the action for failure to exhaust 
                        administrative remedies.
                            ``(ii) Timeliness.--If a person files a 
                        civil action against the Secretary in which a 
                        person seeks to set aside, delay, rescind, 
                        withdraw, or prevent submission, review, or 
                        approval of an application submitted under 
                        subsection (b)(2) or (j) of this section or 
                        section 351(k) of the Public Health Service Act 
                        without complying with the requirements of 
                        subparagraph (B), the court shall dismiss with 
                        prejudice the action for failure to timely file 
                        a petition.
                            ``(iii) Final response.--If a civil action 
                        is filed against the Secretary with respect to 
                        any issue raised in a petition timely filed 
                        under paragraph (1) in which the petitioner 
                        requests that the Secretary take any form of 
                        action that could, if taken, set aside, delay, 
                        rescind, withdraw, or prevent submission, 
                        review, or approval of an application submitted 
                        under subsection (b)(2) or (j) of this section 
                        or section 351(k) of the Public Health Service 
                        Act before the Secretary has taken final agency 
                        action on the petition within the meaning of 
                        subparagraph (C), the court shall dismiss 
                        without prejudice the action for failure to 
                        exhaust administrative remedies.''; and
                    (E) in clause (iii) of subparagraph (E), as so 
                redesignated, by striking ``as defined under 
                subparagraph (2)(A)'' and inserting ``within the 
                meaning of subparagraph (C)''; and
            (3) in paragraph (4)--
                    (A) by striking ``Exceptions'' and all that follows 
                through ``This subsection does'' and inserting 
                ``Exceptions.--This subsection does'';
                    (B) by striking subparagraph (B); and
                    (C) by redesignating clauses (i) and (ii) as 
                subparagraphs (A) and (B), respectively, and adjusting 
                the margins accordingly.

SEC. 302. PERMITTED MID-YEAR CHANGES IN MEDICARE PART D PLAN 
              FORMULARIES FOR CERTAIN BIOSIMILAR BIOLOGICAL PRODUCTS 
              AND THE REFERENCE PRODUCT OF SUCH BIOSIMILARS.

    (a) In General.--Section 1860D-4(b) of the Social Security Act (42 
5 U.S.C. 1395w-104(b)) is amended by adding at the end the following 
new paragraph:
            ``(5) Mid-year changes in formularies permitted for certain 
        biosimilar biological products and the reference product of 
        such biosimilars.--If a PDP sponsor of a prescription drug plan 
        uses a formulary (including the use of tiered cost-sharing), 
        the following shall apply:
                    ``(A) In general.--For plan year 2024, and 
                subsequent plan years, in the case of a covered part D 
                drug that is the reference biological product (as 
                defined in section 1847A(c)(6)(I)) with respect to a 
                biosimilar biological product (as defined in section 
                1847A(c)(6)(H)), the PDP sponsor may, with respect to a 
                formulary, at any time after the first 60 days of the 
                plan year, subject to paragraph (3)(E), change the 
                preferred or tiered cost-sharing status of such 
                reference biological product if such PDP sponsor adds, 
                at the same time, to such formulary such biosimilar 
                biological product at the same or a higher preferred 
                status, or to the same or lower cost-sharing tier, as 
                that of such reference biological product immediately 
                prior to such change.
                    ``(B) Request for approval of change.--Prior to 
                making a change described in clause (i), the PDP 
                sponsor shall submit to the Secretary a request to make 
                such change. If the Secretary approves the request or 
                has not provided a decision to the PDP sponsor 
                regarding such request within 30 days of receiving such 
                request, such PDP sponsor may make such change.''.
    (b) Administration.--
            (1) Implementation.--Notwithstanding any other provision of 
        law, the Secretary of Health and Human Services may implement 
        the amendment made by subsection (a) by subregulatory guidance, 
        program instruction, or otherwise.
            (2) Non-application of the paperwork reduction act.--
        Chapter 35 of title 44, United States Code (commonly referred 
        to as the ``Paperwork Reduction Act of 1995''), shall not apply 
        to the implementation of the amendment made by subsection (a).

SEC. 303. EXPEDITING COMPETITIVE BIOSIMILAR COMPETITION.

    (a) In General.--Section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) is amended by adding at the end the following:
            ``(10) Expediting competitive biosimilar competition.--
                    ``(A) In general.--The Secretary may, at the 
                request of the sponsor of an application under this 
                subsection for a biosimilar biological product that is 
                designated as a competitive biosimilar therapy pursuant 
                to subsection (b), expedite the development and review 
                of such application under this subsection.
                    ``(B) Designation process.--
                            ``(i) Request.--The sponsor of an 
                        application under this subsection may request 
                        the Secretary to designate the drug as a 
                        competitive biosimilar therapy. A request for 
                        such designation may be made concurrently with, 
                        or at any time prior to, the submission of a 
                        biosimilar biological product license 
                        application under this subsection.
                            ``(ii) Criteria.--A biological product is 
                        eligible for designation as a competitive 
                        biosimilar therapy under this paragraph if the 
                        Secretary determines that there is inadequate 
                        biosimilar competition.
                            ``(iii) Designation.--Not later than 60 
                        calendar days after the receipt of a request 
                        under clause (i), the Secretary may--
                                    ``(I) determine whether the 
                                biosimilar biological product that is 
                                the subject of the request meets the 
                                criteria described in clause (ii); and
                                    ``(II) if the Secretary finds that 
                                such product meets such criteria, 
                                designate the biosimilar biological 
                                product as a competitive biosimilar 
                                therapy.
                    ``(C) Actions.--In expediting the development and 
                review of an application under subparagraph (A), the 
                Secretary may, as requested by the applicant, take 
                actions including the following:
                            ``(i) Hold meetings with the sponsor and 
                        the review team throughout the development of 
                        the biosimilar biological product prior to 
                        submission of the application under this 
                        subsection.
                            ``(ii) Provide timely advice to, and 
                        interactive communication with, the sponsor 
                        regarding the development of the drug to ensure 
                        that the development program to gather the data 
                        necessary for approval is as efficient as 
                        practicable.
                            ``(iii) Involve senior managers and 
                        experienced review staff, as appropriate, in a 
                        collaborative, coordinated review of such 
                        application, including with respect to 
                        biological product-device combination products 
                        and other complex products.
                            ``(iv) Assign a cross-disciplinary project 
                        lead--
                                    ``(I) to facilitate an efficient 
                                review of the development program and 
                                application, including manufacturing 
                                inspections; and
                                    ``(II) to serve as a scientific 
                                liaison between the review team and the 
                                applicant.
                    ``(D) Inspections.--With respect to an application 
                described in subparagraph (A), in the case of an 
                inspection report that finds approval of such 
                biological product is dependent upon remediation of a 
                facility, if the applicant attests that necessary 
                changes have been made to the facility, the Secretary 
                shall expedite reinspection of such facility, including 
                establishing a set timeline to reinspect the facility 
                or make a determination about the response of the 
                applicant and whether to approve the application.
                    ``(E) Reporting requirement.--Not later than 1 year 
                after the date of licensure under this subsection with 
                respect to a biosimilar biological product for which 
                the development and review is expedited under this 
                paragraph, the holder of the license of such biosimilar 
                biological product shall report to the Secretary on 
                whether the biosimilar biological product has been 
                marketed in interstate commerce since the date of such 
                licensure.
                    ``(F) Inadequate biosimilar competition.--In this 
                paragraph, the term `inadequate biosimilar competition' 
                means, with respect to a biological product, there are 
                fewer than 3 licensed biological products on the list 
                published under paragraph (9)(A) (not including 
                biological products on the discontinued section of such 
                list) that are biosimilar biological products with the 
                same reference product.''.

SEC. 304. INSULIN COMPETITION REPORT.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services, in collaboration with the 
Administrator for the Centers for Medicare & Medicaid Services and the 
Commissioner of Food and Drugs, shall--
            (1) complete a study to determine the extent of, and causes 
        of, delays in getting insulin products to market, and the 
        market dynamics and extent biosimilar biological product 
        development and competition could increase, or is increasing, 
        the number of biological products approved and available to 
        patients, including by examining barriers to--
                    (A) placement of biosimilar biological products on 
                health insurance formularies;
                    (B) market entry of insulin product in the United 
                States, as compared to other highly developed nations; 
                and
                    (C) patient and provider education around 
                biosimilar biological products; and
            (2) submit a report to Congress that describes the results 
        of the study conducted pursuant to paragraph (1) and 
        recommended policy solutions.
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