,,ii #aahth ,,congress #ast ,session ,s4 #abfi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #be1 #bjbc,mrs4 ,shaheen 7for herself and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to reduce the price of insulin and provide for patient protections with respect to the cost of insulin4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,improving ,needed ,safeguards for ,users of ,lifesaving ,insulin ,now ,act of #bjbc or the ,,insulin ,act of #bjbc4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,commercial market patient protections,sec4 #aja4 ,requirements with respect to cost-sharing for certain insulin products4,sec4 #ajb4 ,application to retiree and certain small group plans4,sec4 #ajc4 ,administration4,,title ,,ii--,pharmacy benefit manager transparency and rebate reform,sec4 #bja4 ,full rebate on insulin pass-through to plan4,,title ,,iii--,biosimilar biological product and generic drug competition and affordability,sec4 #cja4 ,ensuring timely access to generics4,sec4 #cjb4 ,permitted mid-year changes in ,medicare part ,d plan formularies for certain biosimilar biological products and the reference product of such biosimilars4,sec4 #cjc4 ,expediting competitive biosimilar competition4,sec4 #cjd4 ,insulin competition report4 ,i ,commercial market patient protections #aja4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq47 is amended by adding at the end the following3 #bgii;,a-#aa4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbd1 a group health plan or health insurance issuer offering group or individual health insurance coverage shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing requirements in excess of1 per #cj-;day supply-- 7,a7 for any applicable plan year beginning before ,january #a1 #bjbe1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbe1 the lesser of-- 7i7 #ce2 or 7ii7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or issuer1 including price concessions received by or on behalf of third-party entities providing services to the plan or issuer1 such as pharmacy benefit management services or third party administrators4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means1 for any plan year beginning on or after ,january #a1 #bjbd1 at least one of each dosage form 7such as vial1 pen1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 and pre-mixed7 of insulin1 when such form is licensed and marketed1 as selected by the group health plan or health insurance issuer4 7#b7 ,insulin ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea and continues to be marketed pursuant to such licensure4 7c7 ,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 provider1 or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage4 7f7 ,other requirements ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall not impose1 directly or through an entity providing pharmacy benefit management services1 any prior authorization or other medical management requirement1 or other similar conditions1 on selected insulin products1 except as clinically justified for safety reasons1 to ensure reasonable quantity limits and as specified by the ,secretary4 4 7b7 ,no effect on other cost-,sharing ,section #acjb7;d77#b7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;d77#b77 is amended by adding at the end the following new subparagraph3 7,d7 ,special rule relating to insulin coverage ,for plans years beginning on or after ,january #a1 #bjbe1 the exemption of coverage of selected insulin products 7as defined in section #bgii;,a-#aa7;b7 of the ,public ,health ,service ,act7 from the application of any deductible pursuant to section #bgii;,a-#aa7;a77#a7 of such ,act1 section #gbf7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihbf7;a77#a7 of the ,internal ,revenue ,code of #aihf shall not be considered when determining the actuarial value of a qualified health plan under this subsection4 4 7c7 ,coverage of certain insulin products under catastrophic plans ,section #acjb7;e7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjbb7;e77 is amended by adding at the end the following3 7#d7 ,coverage of certain insulin products 7,a7 ,in general ,notwithstanding paragraph 7#a77;,b77i71 a health plan described in paragraph 7#a7 shall provide coverage of selected insulin products1 in accordance with section #bgii;,a-#aa of the ,public ,health ,service ,act1 before an enrolled individual has incurred1 during the plan year1 cost-sharing expenses in an amount equal to the annual limitation in effect under subsection 7c77#a7 for the plan year4 7,b7 ,terminology ,for purposes of subparagraph 7,a7-- 7i7 the term selected insulin products has the meaning given such term in section #bgii;,a-#aa7;b7 of the ,public ,health ,service ,act2 and 7ii7 the requirements of section #bgii;,a-#aa 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 7#a74 4 7d7 ,,erisa 7#a7 ,in general ,subpart ,b of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe et seq47 is amended by adding at the end the following3 #gbf4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbd1 a group health plan or health insurance issuer offering group health insurance coverage shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing requirements in excess of1 per #cj-;day supply-- 7,a7 for any applicable plan year beginning before ,january #a1 #bjbe1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbe1 the lesser of-- 7i7 #ce2 or 7ii7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan or issuer1 including price concessions received by or on behalf of third-party entities providing services to the plan or issuer1 such as pharmacy benefit management services or third party administrators4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means1 for any plan year beginning on or after ,january #a1 #bjbd1 at least one of each dosage form 7such as vial1 pen1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 and pre-mixed7 of insulin1 when such form is licensed and marketed1 as selected by the group health plan or health insurance issuer4 7#b7 ,insulin ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and continues to be marketed pursuant to such licensure4 7c7 ,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 provider1 or precludes a plan or issuer that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan or health insurance coverage from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage4 7f7 ,other requirements ,a group health plan or health insurance issuer offering group health insurance coverage shall not impose1 directly or through an entity providing pharmacy benefit management services1 any prior authorization or other medical management requirement1 or other similar conditions1 on selected insulin products1 except as clinically justified for safety reasons1 to ensure reasonable quantity limits and as specified by the ,secretary4 4 7#b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gbe the following3 ,sec4 #gbf4 ,requirements with respect to cost-sharing for certain insulin products4 4 7e7 ,internal ,revenue ,code 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #ihbf4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbd1 a group health plan shall provide coverage of selected insulin products1 and with respect to such products1 shall not-- 7#a7 apply any deductible2 or 7#b7 impose any cost-sharing requirements in excess of1 per #cj-;day supply-- 7,a7 for any applicable plan year beginning before ,january #a1 #bjbe1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbe1 the lesser of-- 7i7 #ce2 or 7ii7 the amount equal to #be percent of the negotiated price of the selected insulin product net of all price concessions received by or on behalf of the plan1 including price concessions received by or on behalf of third-party entities providing services to the plan1 such as pharmacy benefit management services or third party administrators4 7b7 ,definitions ,in this section3 7#a7 ,selected insulin products ,the term selected insulin products means1 for any plan year beginning on or after ,january #a1 #bjbd1 at least one of each dosage form 7such as vial1 pen1 or inhaler dosage forms7 of each different type 7such as rapid-acting1 short-acting1 intermediate-acting1 long-acting1 and pre-mixed7 of insulin1 when such form is licensed and marketed1 as selected by the group health plan4 7#b7 ,insulin ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and continues to be marketed pursuant to such licensure4 7c7 ,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 provider1 or precludes a plan that has a network of providers from imposing higher cost-sharing than the levels specified in subsection 7a7 for selected insulin products described in this section that are delivered by an out-of-network provider4 7d7 ,rule of construction ,subsection 7a7 shall not be construed to require coverage of1 or prevent a group health plan from imposing cost-sharing other than the levels specified in subsection 7a7 on1 insulin products that are not selected insulin products1 to the extent that such coverage is not otherwise required and such cost-sharing is otherwise permitted under ,federal and applicable ,state law4 7e7 ,application of cost-,sharing towards deductibles and out-of-,pocket maximums ,any cost-sharing payments made pursuant to subsection 7a77#b7 shall be counted toward any deductible or out-of-pocket maximum that applies under the plan4 7f7 ,other requirements ,a group health plan shall not impose1 directly or through an entity providing pharmacy benefit management services1 any prior authorization or other medical management requirement1 or other similar conditions1 on selected insulin products1 except as clinically justified for safety reasons1 to ensure reasonable quantity limits and as specified by the ,secretary 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of such ,code1 as amended by section #ajb7;c77#b71 is further amended by adding at the end the following new item3 ,sec4 #ihbg4 ,requirements with respect to cost-sharing for certain insulin products4 4 #ajb4 ,application to retiree and certain small group plans 7a7 ,,erisa ,section #gcb7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaia;a7a77 is amended by striking section #gaa and inserting sections #gaa and #gbf4 7b7 ,,irc ,the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in section #ihca7;a71 by adding at the end the following flush text3 ,paragraph 7#b7 shall not apply to the requirements under sections #ihaa and #ihbf4 2 and 7#b7 in section #dihj;,d7d77#a71 by striking section #ihaa and inserting sections #ihaa and #ihbf4 #ajc4 ,administration 7a7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may implement the provisions of1 including the amendments made by1 this title for plan years that begin on or after ,january #a1 #bjbd1 and end not later than ,january #a1 #bjbg1 by subregulatory guidance1 program instruction1 or otherwise4 7b7 ,non-,application of the ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act of #aiie71 shall not apply to the provisions of1 including the amendments made by1 this title4 ,,ii ,pharmacy benefit manager transparency and rebate reform #bja4 ,full rebate on insulin pass-through to plan ,part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is further amended by adding at the end the following3 #bgbi;,a4 ,full rebate on insulin pass-through to plan 7a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit #ajj percent of rebates1 fees1 alternative discounts1 and all other remuneration received from a pharmaceutical manufacturer1 distributor or any other third party1 that are related to utilization of insulin under such health plan or health insurance coverage1 to the group health plan4 7b7 ,form and manner of remittance ,such rebates1 fees1 alternative discounts1 and other remuneration shall be-- 7#a7 remitted to the group health plan in a timely fashion after the period for which such rebates1 fees1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7#b7 fully disclosed and enumerated to the group health plan sponsor2 and 7#c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor no less than once per plan year4 4 ,,iii ,biosimilar biological product and generic drug competition and affordability #cja4 ,ensuring timely access to generics ,section #eje7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a77i71 by inserting 1 #aj4ca1 after #aj4cj2 7,b7 in subparagraph 7,e7-- 7i7 by striking application and and inserting application or2 7ii7 by striking ,if the ,secretary and inserting the following3 7i7 ,in general ,if the ,secretary 2 and 7iii7 by striking the second sentence and inserting the following3 7ii7 ,primary purpose of delaying 7,i7 ,in general ,in determining whether a petition was submitted with the primary purpose of delaying an application1 the ,secretary may consider the following factors3 7aa7 ,whether the petition was submitted in accordance with paragraph 7#b77;,b71 based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition4 7bb7 ,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 petitions4 7cc7 ,whether the petition was submitted close in time to a known1 first date upon which an application under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act could be approved4 7dd7 ,whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition4 7ee7 ,whether the petition raises the same or substantially similar issues as a prior petition to which the ,secretary has responded substantively already1 including if the subsequent submission follows such response from the ,secretary closely in time4 7ff7 ,whether the petition requests changing the applicable standards that other applicants are required to meet1 including requesting testing1 data1 or labeling standards that are more onerous or rigorous than the standards the ,secretary has determined to be applicable to the listed drug1 reference product1 or petitioner's version of the same drug4 7gg7 ,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 delay4 7hh7 ,other relevant and appropriate factors1 which the ,secretary shall describe in guidance4 7,,ii7 ,guidance ,the ,secretary may issue or update guidance1 as appropriate1 to describe factors the ,secretary considers in accordance with subclause 7,i74 2 7,c7 by adding at the end the following3 7iii7 ,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 application4 ,such procedures shall include notification to the petitioner by the ,secretary4 2 7,d7 by striking subparagraph 7,f72 7,e7 by redesignating subparagraphs 7,g7 through 7,i7 as subparagraphs 7,f7 through 7,h71 respectively2 and 7,f7 in subparagraph 7,h71 as so redesignated1 by striking submission of this petition and inserting submission of this document2 7#b7 in paragraph 7#b7-- 7,a7 by redesignating subparagraphs 7,a7 through 7,c7 as subparagraphs 7,c7 through 7,e71 respectively2 7,b7 by inserting before subparagraph 7,c71 as so redesignated1 the following3 7,a7 ,in general ,a person shall submit a petition to the ,secretary under paragraph 7#a7 before filing a civil action in which the person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act4 ,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 sentence4 7,b7 ,timely submission of citizen petition ,a petition and any supplement to a petition shall be submitted within #fj days after the person knew1 or reasonably should have known1 the information that forms the basis of the request made in the petition or supplement4 2 7,c7 in subparagraph 7,c71 as so redesignated-- 7i7 in the heading1 by striking within #aej days2 7ii7 in clause 7i71 by striking during the #aej-;day period referred to in paragraph 7#a77;,f712 and 7iii7 by amending clause 7ii7 to read as follows3 7ii7 on or after the date that is #aea days after the date of submission of the petition1 the ,secretary approves or has approved the application that is the subject of the petition without having made such a final decision4 2 7,d7 by amending subparagraph 7,d71 as so redesignated1 to read as follows3 7,d7 ,dismissal of certain civil actions 7i7 ,petition ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,a71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 7ii7 ,timeliness ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,b71 the court shall dismiss with prejudice the action for failure to timely file a petition4 7iii7 ,final response ,if a civil action is filed against the ,secretary with respect to any issue raised in a petition timely filed under paragraph 7#a7 in which the petitioner requests that the ,secretary take any form of action that could1 if taken1 set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act before the ,secretary has taken final agency action on the petition within the meaning of subparagraph 7,c71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 2 and 7,e7 in clause 7iii7 of subparagraph 7,e71 as so redesignated1 by striking as defined under subparagraph 7#b77;,a7 and inserting within the meaning of subparagraph 7,c72 and 7#c7 in paragraph 7#d7-- 7,a7 by striking ,exceptions and all that follows through ,this subsection does and inserting ,exceptions4--,this subsection does2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and adjusting the margins accordingly4 #cjb4 ,permitted mid-year changes in ,medicare part ,d plan formularies for certain biosimilar biological products and the reference product of such biosimilars 7a7 ,in general ,section #ahfj;,d-#d7;b7 of the ,social ,security ,act 7#db #e ,u4,s4,c4 #aciew-#ajd7;b77 is amended by adding at the end the following new paragraph3 7#e7 ,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 7including the use of tiered cost-sharing71 the following shall apply3 7,a7 ,in general ,for plan year #bjbd1 and subsequent plan years1 in the case of a covered part ,d drug that is the reference biological product 7as defined in section #ahdg;,a7c77#f77;,i77 with respect to a biosimilar biological product 7as defined in section #ahdg;,a7c77#f77;,h771 the ,,pdp sponsor may1 with respect to a formulary1 at any time after the first #fj days of the plan year1 subject to paragraph 7#c77;,e71 change the preferred or tiered cost-sharing status of such reference biological product if such ,,pdp sponsor adds1 at the same time1 to such formulary such biosimilar biological product at the same or a higher preferred status1 or to the same or lower cost-sharing tier1 as that of such reference biological product immediately prior to such change4 7,b7 ,request for approval of change ,prior to making a change described in clause 7i71 the ,,pdp sponsor shall submit to the ,secretary a request to make such change4 ,if the ,secretary approves the request or has not provided a decision to the ,,pdp sponsor regarding such request within #cj days of receiving such request1 such ,,pdp sponsor may make such change4 4 7b7 ,administration 7#a7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendment made by subsection 7a7 by subregulatory guidance1 program instruction1 or otherwise4 7#b7 ,non-application of the ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act of #aiie71 shall not apply to the implementation of the amendment made by subsection 7a74 #cjc4 ,expediting competitive biosimilar competition 7a7 ,in general ,section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 is amended by adding at the end the following3 7#aj7 ,expediting competitive biosimilar competition 7,a7 ,in general ,the ,secretary may1 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 7b71 expedite the development and review of such application under this subsection4 7,b7 ,designation process 7i7 ,request ,the sponsor of an application under this subsection may request the ,secretary to designate the drug as a competitive biosimilar therapy4 ,a request for such designation may be made concurrently with1 or at any time prior to1 the submission of a biosimilar biological product license application under this subsection4 7ii7 ,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 competition4 7iii7 ,designation ,not later than #fj calendar days after the receipt of a request under clause 7i71 the ,secretary may-- 7,i7 determine whether the biosimilar biological product that is the subject of the request meets the criteria described in clause 7ii72 and 7,,ii7 if the ,secretary finds that such product meets such criteria1 designate the biosimilar biological product as a competitive biosimilar therapy4 7,c7 ,actions ,in expediting the development and review of an application under subparagraph 7,a71 the ,secretary may1 as requested by the applicant1 take actions including the following3 7i7 ,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 subsection4 7ii7 ,provide timely advice to1 and interactive communication with1 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 practicable4 7iii7 ,involve senior managers and experienced review staff1 as appropriate1 in a collaborative1 coordinated review of such application1 including with respect to biological product-device combination products and other complex products4 7iv7 ,assign a cross-disciplinary project lead-- 7,i7 to facilitate an efficient review of the development program and application1 including manufacturing inspections2 and 7,,ii7 to serve as a scientific liaison between the review team and the applicant4 7,d7 ,inspections ,with respect to an application described in subparagraph 7,a71 in the case of an inspection report that finds approval of such biological product is dependent upon remediation of a facility1 if the applicant attests that necessary changes have been made to the facility1 the ,secretary shall expedite reinspection of such facility1 including establishing a set timeline to reinspect the facility or make a determination about the response of the applicant and whether to approve the application4 7,e7 ,reporting requirement ,not later than #a 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 paragraph1 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 licensure4 7,f7 ,inadequate biosimilar competition ,in this paragraph1 the term inadequate biosimilar competition means1 with respect to a biological product1 there are fewer than #c licensed biological products on the list published under paragraph 7#i77;,a7 7not including biological products on the discontinued section of such list7 that are biosimilar biological products with the same reference product4 4 #cjd4 ,insulin competition report ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in collaboration with the ,administrator for the ,centers for ,medicare ,medicaid ,services and the ,commissioner of ,food and ,drugs1 shall-- 7#a7 complete a study to determine the extent of1 and causes of1 delays in getting insulin products to market1 and the market dynamics and extent biosimilar biological product development and competition could increase1 or is increasing1 the number of biological products approved and available to patients1 including by examining barriers to-- 7,a7 placement of biosimilar biological products on health insurance formularies2 7,b7 market entry of insulin product in the ,united ,states1 as compared to other highly developed nations2 and 7,c7 patient and provider education around biosimilar biological products2 and 7#b7 submit a report to ,congress that describes the results of the study conducted pursuant to paragraph 7#a7 and recommended policy solutions4