[Pages S4092-S4095]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2670. Mrs. SHAHEEN (for herself and Ms. Collins) submitted an 
amendment intended to be proposed to amendment SA 2360 proposed by Mr. 
Thune (for Mr. Graham) to the bill H.R. 1, to provide for 
reconciliation pursuant to title II of H. Con. Res. 14; which was 
ordered to lie on the table; as follows:

       Strike section 70523 and insert the following:

     SEC. __. 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, 2026, 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, 2027, $35; or
       ``(B) for any plan year beginning on or after January 1, 
     2027, 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, 2026, 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

[[Page S4093]]

     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, 2027, 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, 2026, 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, 2027, $35; or
       ``(B) for any plan year beginning on or after January 1, 
     2027, 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, 2026, 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, 2026, 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, 2027, $35; or
       ``(B) for any plan year beginning on or after January 1, 
     2027, 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, 2026, 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

[[Page S4094]]

     such Code, as amended by this Act, 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. __. 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. ___. 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, 2026, and end not later than January 1, 2029, 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.

     SEC. ___. 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.''.

     SEC. __. 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. __. 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

[[Page S4095]]

     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. ___. 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.
                                 ______