,,ii #aaith ,,congress #b;d ,session ,s4 #dahi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #be1 #bjbf,mrs4 ,shaheen 7for herself1 ,ms4 ,collins1 ,mr4 ,warnock1 ,mr4 ,kennedy1 ,ms4 ,rosen1 ,mr4 ,tuberville1 ,mr4 ,king1 ,ms4 ,murkowski1 ,mr4 ,kelly1 ,mr4 ,grassley1 ,ms4 ,baldwin1 and ,mrs4 ,britt7 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 #bjbf or the ,,insulin ,act of #bjbf4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,sense of ,congress4,,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 ,expediting competitive biosimilar competition4,sec4 #cjc4 ,insulin competition report4,,title ,,iv--,programs for providing affordable insulin to uninsured individuals,sec4 #dja4 ,pilot program for providing affordable insulin to uninsured individuals4,sec4 #djb4 ,,gao study on uninsured individuals who use insulin4,sec4 #djc4 ,insulin resource center and hotline for uninsured individuals4 #b4 ,sense of ,congress ,it is the sense of ,congress that ,congress should enact subsequent legislation that provides for an offset for any costs to the ,federal ,government resulting from the enactment of this ,act4 ,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-#ab4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 #bjbh1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbh1 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 #bjbg1 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 issuer 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 #bjbh1 the exemption of coverage of selected insulin products 7as defined in section #bgii;,a-#ab7;b7 of the ,public ,health ,service ,act7 from the application of any deductible pursuant to section #bgii;,a-#ab7;a77#a7 of such ,act1 section #gbg7;a77#a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 or section #ihbg7;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 for plan years beginning on or after ,january #a1 #bjbg1 a health plan described in paragraph 7#a7 shall provide coverage of selected insulin products1 in accordance with section #bgii;,a-#ab 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-#ab7;b7 of the ,public ,health ,service ,act2 and 7ii7 the requirements of section #bgii;,a-#ab 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 #gbg4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 #bjbh1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbh1 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 #bjbg1 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 issuer 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 #gbf the following3 ,sec4 #gbg4 ,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 following3 #ihbg4 ,requirements with respect to cost-sharing for certain insulin products 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbg1 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 #bjbh1 #ce2 or 7,b7 for any plan year beginning on or after ,january #a1 #bjbh1 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 #bjbg1 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 ,secretary4 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of such ,code is 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 #gbg4 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 #ihbg4 2 and 7#b7 in section #dihj;,d7d77#a71 by striking section #ihaa and inserting section #ihaa or #ihbg4 #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 #bjbg1 and end not later than ,january #a1 #bjcj1 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 7a7 ,,phsa ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 as amended by section #aja1 is further amended by adding at the end the following3 #bgii;,a-#ac4 ,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 7b7 ,,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 seq471 as amended by section #aja1 is further amended by adding at the end the following3 #gbh4 ,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 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 seq471 as amended by section #aja1 is further amended by inserting after the item relating to section #gbg the following3 ,sec4 #gbh4 ,full rebate on insulin pass-through to plan4 4 7c7 ,internal ,revenue ,code 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #aja1 is further amended by adding at the end the following new section3 #ihbh4 ,full rebate on insulin pass-through to plan 7a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 or an entity providing pharmacy benefits management services under such health plan 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 plan1 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 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of such ,code1 as amended by section #aja1 is further amended by adding at the end the following new item3 ,sec4 #ihbh4 ,full rebate on insulin pass-through to plan4 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 ,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 #cjc4 ,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 ,,iv ,programs for providing affordable insulin to uninsured individuals #dja4 ,pilot program for providing affordable insulin to uninsured individuals ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#h4 ,pilot program for providing affordable insulin to uninsured individuals 7a7 ,in general ,the ,secretary shall conduct a #e-year pilot program under which the ,secretary awards grants to #aj ,states for purposes of providing affordable insulin to uninsured individuals4 7b7 ,awards ,the ,secretary shall award grants under this section to #aj ,states that-- 7#a7 submit an application to the ,secretary1 at such time1 in such manner1 and containing such information as the ,secretary may require2 and 7#b7 have high rates of uninsured individuals and individuals diagnosed with diabetes1 which may include high rates of newly diagnosed diabetes4 7c7 ,use of funds ,a ,state shall use the grant funds received under this section for any of the following purposes3 7#a7 ,to assist in the purchase or dispensing of insulin1 through ,federally qualified health centers and retail community pharmacies1 for uninsured individuals4 7#b7 ,to enroll individuals in programs under which drug manufacturers provide financial or medication assistance to low-income individuals1 in order to assist such individuals in obtaining insulin4 7#c7 ,to allow ,federally qualified health centers to establish new1 or maintain or expand existing1 on-site pharmacies owned and operated by the health center that provide low-cost insulin to patients1 and to allow retail community pharmacies to provide low-cost insulin to patients4 7#d7 ,to engage in other activities to assist uninsured individuals in obtaining insulin1 as the ,secretary determines appropriate4 7d7 ,formula ,the ,secretary shall establish a formula for purposes of determining the grant amount under this section for each ,state4 ,such formula shall-- 7#a7 provide for a minimum amount that will be provided to each ,state2 and 7#b7 take into account the rates of individuals with type #a or type #b1 insulin-dependent diabetes and of uninsured individuals in each ,state for purposes of determining any additional amounts provided to a ,state4 7e7 ,accountability and ,oversight ,a ,state receiving a grant under this section shall1 not later than #a year after receiving the grant1 submit a report to the ,secretary that includes-- 7#a7 a description of the purposes for which the grant funds received by the ,state were expended in the preceding fiscal year1 and the activities of the ,state under the grant during such year2 and 7#b7 the number of individuals served through the grant4 7f7 ,definitions ,in this section3 7#a7 ,affordable ,the term affordable1 with respect to insulin1 means that the out-of-pocket cost to the individual for the insulin is not more than #ce per #a-month supply4 7#b7 ,federally-qualified health center ,the term ,federally-qualified health center has the meaning given such term in section #aije7l77#b7 of the ,social ,security ,act4 7#c7 ,insulin ,the term insulin means insulin that is licensed under subsection 7a7 or 7k7 of section #cea and continues to be marketed under such section4 7#d7 ,retail community pharmacy ,the term retail community pharmacy has the meaning given such term in section #aibg7k77#aj7 of the ,social ,security ,act4 7#e7 ,uninsured individual ,the term uninsured individual means an individual who-- 7,a7 is a citizen of the ,united ,states or a qualified alien 7as defined in section #dca7;b7 of the ,personal ,responsibility and ,work ,opportunity ,reconciliation ,act of #aiif72 7,b7 does not qualify for coverage under a ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act71 the health program established under chapter #hi of title #e1 ,united ,states ,code1 or a group health plan or group health insurance coverage 7as defined in section #bgia72 and 7,c7 is not entitled to a premium assistance tax credit under section #cf;,b of the ,internal ,revenue ,code of #aihf4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #ajj1jjj1jjj for fiscal year #bjbg1 to remain available until expended4 4 #djb4 ,,gao study on uninsured individuals who use insulin 7a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study1 in consultation with patient1 clinical1 and provider groups and other experts1 and not later than #b years after the date of enactment of this ,act1 issue a report1 on the characteristics of uninsured individuals who use insulin4 ,such study and report shall1 to the extent data is available1 include consideration of-- 7#a7 any ,states or regions in which there is a higher prevalence of such individuals2 7#b7 any identifiable potential reasons for uninsured status2 7#c7 demographic characteristics of such individuals1 such as race and ethnicity2 and 7#d7 income level of such individuals4 7b7 ,definitions ,in this section1 the terms insulin and uninsured individual have the meanings given such terms in section #cii,v-#h of the ,public ,health ,service ,act1 as added by section #dja4 #djc4 ,insulin resource center and hotline for uninsured individuals 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall award a grant to an eligible entity for purposes of-- 7#a7 establishing and maintaining a resource center of assistance programs offered by manufactures or other entities that are available to uninsured individuals seeking affordable insulin2 and 7#b7 conducting the public education activities described in subsection 7c77#g74 7b7 ,eligible entities ,to be eligible to receive the grant under subsection 7a71 an entity shall-- 7#a7 be a trade1 industry1 or professional association1 community- and consumer-focused nonprofit entity1 or other entity1 as determined by the ,secretary that-- 7,a7 is capable of carrying out the duties described in subsection 7c72 7,b7 meets the standards described in subsection 7e72 and 7,c7 provides information consistent with the standards developed under subsection 7f72 and 7#b7 submit an application to the ,secretary1 at such time1 in such manner1 and containing such information as the ,secretary may require1 including information demonstrating that the entity-- 7,a7 has existing relationships1 or could readily establish relationships1 with consumers 7including uninsured individuals71 health care providers1 manufacturers of insulin1 social service providers1 pharmacies1 and other experts that the ,secretary determines appropriate1 to meet the goals of this section2 and 7,b7 has1 or will establish1 partnerships with1 and solicit feedback from1 other entities in other industries1 professional associations1 and community- and consumer-focused nonprofit organizations1 to meet the goals of this section4 7c7 ,duties ,an entity that receives a grant under this section shall-- 7#a7 distribute fair and impartial information concerning eligibility for manufacturer1 foundational1 and other assistance programs available to patients seeking affordable insulin2 7#b7 facilitate enrollment in manufacturer assistance programs or other assistance programs for uninsured individuals2 7#c7 make available to the public1 through a standardized website1 a clearinghouse of support available to patients1 including-- 7,a7 a link to ,federally qualified health centers and other providers1 by ,,zip ,code2 7,b7 a link to retail community pharmacies1 by ,,zip ,code2 and 7,c7 information about how to enroll in health insurance2 7#d7 provide information in a manner that is culturally and linguistically appropriate2 7#e7 establish a hotline through which individuals may reach experts with questions about access to insulin1 and that-- 7,a7 is a #bd_/g real-time hotline2 7,b7 provides voice and text support2 and 7,c7 is staffed by navigators or licensed health care professionals2 7#f7 provide guidance to hospitals on how to share the website and hotline with patients2 and 7#g7 conduct public education activities1 in collaboration with the ,department of ,health and ,human ,services1 to raise awareness of the availability of all manufacturer1 foundational1 and other assistance programs available to patients seeking affordable insulin1 with a focus on uninsured individuals2 including by-- 7,a7 partnering with community health centers1 hospitals1 retail community pharmacies1 and community-based organizations with a focus on access to affordable medicine2 and 7,b7 working with ,state and local health departments to target the programs carried out using the grant to underserved communities4 7d7 ,duties of the ,secretary ,the ,secretary shall-- 7#a7 ensure adequate maintenance of the resource center established by the entity receiving a grant under subsection 7a72 7#b7 publicize such resource center on the website of the ,department of ,health and ,human ,services and across ,federal agencies1 as the ,secretary determines appropriate2 and 7#c7 ensure that such resource center meets the standards under subsection 7e71 and withdraw the grant and make an award to a different eligible entity in the case that an eligible entity fails to meet such standards4 7e7 ,standards ,the ,secretary shall establish standards for the resource center under this section1 including provisions to ensure that the entity receiving a grant under this section is qualified to engage in the activities described in this section and to avoid conflicts of interest4 ,under such standards1 such entity-- 7#a7 shall not-- 7,a7 be a manufacturer of insulin products2 or 7,b7 receive any consideration directly or indirectly from any manufacturer of insulin products in connection with the enrollment of any individuals in an assistance program2 and 7#b7 shall provide information that is fair1 accurate1 and impartial4 7f7 ,data collection and evaluations ,the ,secretary may collect data and conduct evaluations with respect to the services provided by the resource center described in this section for purposes of assessing the extent to which the provision of the services-- 7#a7 reduces out of pocket insulin costs for uninsured individuals2 7#b7 increases awareness of assistance programs or foundational support available for uninsured individuals2 and 7#c7 improves utilization of the resources described in paragraph 7#b7 by uninsured individuals4 7g7 ,reports to ,congress ,the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 and make publicly available1 annual reports on the activities carried out under this section1 including any changes in the availability or scope of assistance programs offered by insulin manufacturers and information about the number of individuals who use the resource center1 including the website or hotline4 7h7 ,definitions ,in this section-- 7#a7 the term assistance program means a program to assist patients in obtaining a drug at a reduced cost1 and includes third-party payments1 financial assistance1 discounts1 product vouchers1 and other reductions in out-of-pocket expenses2 7#b7 the term ,federally-qualified health center has the meaning given such term in section #aije7l77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7l77#b772 7#c7 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 licensure2 7#d7 the term retail community pharmacy has the meaning given such term in section #aibg7k77#aj7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#aj772 and 7#e7 the term uninsured individual means an individual who-- 7,a7 does not qualify for coverage under a ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f7771 the health program established under chapter #hi of title #e1 ,united ,states ,code1 or a group health plan or group health insurance coverage 7as defined in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia772 and 7,b7 is not entitled to a premium assistance tax credit under section #cf;,b of the ,internal ,revenue ,code of #aihf4 7i7 ,funding ,to carry out this section1 there are authorized to be appropriated #b1jjj1jjj for each of fiscal years #bjbg through #bjcb4