,,ii #aafth ,,congress #ast ,session ,s4 #bjjd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bg1 #bjai ,ms4 ,smith 7for herself and ,mr4 ,cramer7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend the ,public ,health ,service ,act to establish insulin assistance programs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,emergency ,access to ,insulin ,act of #bjai4 #b4 ,insulin assistance programs 7a7 ,in general ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by adding at the end the following3 #cbj;,b4 ,insulin assistance programs 7a7 ,establishment of program of grants to ,states1 ,indian tribes1 and tribal organizations 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 not later than #a year after the date of enactment of this section1 make grants to ,states1 ,indian tribes1 and tribal organizations for the purpose of carrying out programs to assist eligible individuals in obtaining insulin in accordance with paragraph 7#d74 7#b7 ,grant and contract authority for ,states1 ,indian tribes1 and tribal organizations 7,a7 ,in general ,a ,state1 ,indian tribe1 or tribal organization receiving a grant under paragraph 7#a7 may1 subject to subparagraph 7,b71 expend the grant to carry out the purpose described in such paragraph through grants or contracts to public or private entities1 including local governments4 7,b7 ,certain applications ,if a nonprofit private entity and a private entity that is not a nonprofit entity both submit applications to a ,state1 ,indian tribe1 or tribal organization to receive an award of a grant or contract under subparagraph 7,a71 the ,state1 ,indian tribe1 or tribal organization may give priority to the application submitted by the nonprofit private entity in any case in which the ,state1 ,indian tribe1 or tribal organization determines that the quality of such application is equivalent to the quality of the application submitted by the other private entity4 7#c7 ,allotment ,each ,state1 ,indian tribe1 or tribal organization that applies for a grant in accordance with subsection 7e7 shall receive a grant under this section in an amount that is equal to the sum of-- 7,a7 a minimum amount determined by the ,secretary2 and 7,b7 an additional amount based on criteria established by the ,secretary1 which may include the ability of the ,state1 ,indian tribe1 or tribal organization to successfully assist individuals in seeking eligibility for ,federal or ,state-funded programs as described in paragraph 7#d77;,a77iv74 7#d7 ,program components 7,a7 ,in general ,a ,state1 ,indian tribe1 or tribal organization carrying out a program supported by a grant under this subsection shall use the grant funds to-- 7i7 purchase insulin2 7ii7 issue insulin cards to eligible individuals in accordance with subparagraph 7,b72 7iii7 enter into agreements with pharmacies-- 7,i7 for such pharmacies to fill prescriptions for individuals displaying valid insulin cards that are issued in accordance with subparagraph 7,b7 at no cost to such individuals2 and 7,,ii7 for the ,state1 ,indian tribe1 or tribal organization to pay such pharmacies for insulin filled for a prescription described in subclause 7,i72 and 7iv7 assist individuals in seeking eligibility for ,federal or ,state-funded programs which may provide coverage for insulin or otherwise assist such individuals in obtaining insulin4 7,b7 ,insulin cards 7i7 ,application ,an eligible individual seeking an insulin card through a program supported by a grant under this subsection shall submit an application to the ,state1 ,indian tribe1 or tribal organization receiving the grant1 at such time1 in such manner1 and containing such information as the ,state1 ,indian tribe1 or tribal organization may reasonably require for purposes of this subsection1 including-- 7,i7 documentation indicating proof of-- 7aa7 in the case of a grant awarded to a ,state1 residency in the ,state2 7bb7 in the case of a grant awarded to an ,indian tribe1 membership in the ,indian tribe2 or 7cc7 in the case of a grant awarded to a tribal organization1 membership in the ,indian tribe or ,indian community served by the tribal organization2 7,,ii7 a prescription for insulin that is prescribed to the individual2 7,,iii7 a statement that1 to the best of the individual's knowledge1 the individual is an uninsured individual or an underinsured individual2 and 7,,iv7 if the individual is an underinsured individual1 the name of the high-deductible health plan in which the individual is enrolled and any unique identifier of the plan1 such as a policy number4 7ii7 ,initial card 7,i7 ,in general ,a ,state1 ,indian tribe1 or tribal organization carrying out a program supported by a grant under this subsection shall issue an initial insulin card to each individual that submits an application to the ,state1 ,indian tribe1 or tribal organization meeting the requirements under clause 7i74 7,,ii7 ,timing ,a ,state1 ,indian tribe1 or tribal organization that receives an application under clause 7i7 from an individual shall issue an initial insulin card to such individual not later than #e business days after receiving such application4 7,,iii7 ,supply ,an initial insulin card issued to an individual under this clause shall be valid for an approximate #g-;day supply of insulin that is appropriate for the individual based on the prescription for the individual provided in the application under clause 7i7 and packaging and processing practices for insulin4 7iii7 #c-month cards ,not later than #ab business days after an individual submits an application under clause 7i7 to a ,state1 ,indian tribe1 or tribal organization1 the ,state1 ,indian tribe1 or tribal organization shall-- 7,i7 determine whether the individual is an eligible individual2 and 7,,ii7 if the individual is an eligible individual1 issue the individual an insulin card that is valid for an approximate #ij-;day supply of insulin that is appropriate for the individual based on the prescription provided in the application under clause 7i7 and packaging and processing practices for insulin4 7iv7 ,renewal of cards 7,i7 #c-month cards ,an eligible individual that is issued an insulin card under clause 7iii7 may apply to renew such card in accordance with a process established by the ,state1 ,indian tribe1 or tribal organization4 7,,ii7 ,limitation ,an individual that submits an application under clause 7i7 and is denied an insulin card under clause 7ii7 or 7iii7 may not submit another application under clause 7i7 for the #a-year period beginning on the date on which the individual is denied such card4 7b7 ,requirement of matching funds 7#a7 ,in general ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees1 with respect to the costs to be incurred by the ,state1 ,indian tribe1 or tribal organization in carrying out the purpose described in subsection 7a77#a71 to make available non-,federal contributions 7in cash or in kind under paragraph 7#b77 toward such costs in an amount equal to not less than #a for each #c of ,federal funds provided in the grant4 ,such contributions may be made directly or through donations from public or private entities4 7#b7 ,determination of amount of non-federal contribution 7,a7 ,in general ,non-,federal contributions required in paragraph 7#a7 may be in cash or in kind1 fairly evaluated1 including equipment or services 7and excluding indirect or overhead costs74 ,amounts provided by the ,federal ,government1 or services assisted or subsidized to any significant extent by the ,federal ,government1 may not be included in determining the amount of such non-,federal contributions4 7,b7 ,maintenance of effort ,in making a determination of the amount of non-,federal contributions for purposes of paragraph 7#a71 the ,secretary may include only non-,federal contributions in excess of the average amount of non-,federal contributions made by the ,state1 ,indian tribe1 or tribal organization involved toward the purpose described in subsection 7a77#a7 for the #b-year period preceding the first fiscal year for which the ,state1 ,indian tribe1 or tribal organization is applying to receive a grant under subsection 7a74 7,c7 ,inclusion of relevant non-federal contributions for medicaid ,in making a determination of the amount of non-,federal contributions for purposes of paragraph 7#a71 the ,secretary shall1 subject to subparagraphs 7,a7 and 7,b7 of this paragraph1 include any non-,federal amounts expended pursuant to title ,,xix of the ,social ,security ,act by the ,state1 ,indian tribe1 or tribal organization related to insulin dispensed to individuals eligible for medical assistance under such title4 7c7 ,additional required agreements 7#a7 ,statewide provision of services 7,a7 ,in general ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees that services and activities under the grant will be made available throughout the ,state 7including availability to members of any ,indian tribe or tribal organization in the ,state71 ,indian tribe1 or tribal organization4 7,b7 ,waiver 7i7 ,in general ,the ,secretary may waive the requirement established in subparagraph 7,a7 for a ,state1 ,indian tribe1 or tribal organization if the ,secretary determines that compliance by the ,state1 ,indian tribe1 or tribal organization with the requirement would result in an inefficient allocation of resources with respect to carrying out the purpose described in subsection 7a77#a74 7ii7 ,indian tribes and tribal organizations ,if an ,indian tribe or tribal organization is receiving a grant under subsection 7a7 and the ,state in which the tribe or organization is located is receiving a grant under subsection 7a71 the requirement under subparagraph 7,a7 for the ,state regarding availability to the tribe or organization is deemed to have been waived under this subparagraph4 7#b7 ,relationship to items and services under other programs 7,a7 ,in general ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made1 or can reasonably be expected to be made1 with respect to such item or service-- 7i7 except as provided in subparagraph 7,b71 under any ,state compensation program1 under an insurance policy1 or under any ,federal or ,state health benefits program2 or 7ii7 by an entity that provides health services on a prepaid basis4 7,b7 ,exception ,the requirement under subparagraph 7,a77i7 shall not apply with respect to coverage under a high-deductible health plan4 7#c7 ,limitation on administrative expenses ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees that not more than #aj percent of the grant will be expended for administrative expenses with respect to the grant4 7#d7 ,records and audits ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees that-- 7,a7 the ,state1 ,indian tribe1 or tribal organization will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of1 and accounting for1 amounts received by the ,state1 ,indian tribe1 or tribal organization under such subsection2 7,b7 upon request1 the ,state1 ,indian tribe1 or tribal organization will provide records maintained pursuant to subparagraph 7,a7 to the ,secretary or the ,comptroller ,general of the ,united ,states for purposes of auditing the expenditures by the ,state1 ,indian tribe1 or tribal organization of the grant2 and 7,c7 the ,state1 ,indian tribe1 or tribal organization will keep such records as the ,secretary shall prescribe1 including-- 7i7 records that fully disclose-- 7,i7 the amount and disposition by the ,state1 ,indian tribe1 or tribal organization of the proceeds of such grant2 7,,ii7 the total cost of the project or undertaking intended to be carried out through the grant2 and 7,,iii7 the amount of that portion of the cost of the project or undertaking supplied by sources other than the grant2 and 7ii7 such other records as the ,secretary determines appropriate for facilitating an effective audit of grants awarded under this section4 7#e7 ,reports 7,a7 ,reports to the ,secretary ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees to submit to the ,secretary such reports as the ,secretary may require with respect to the grant1 including a report on-- 7i7 the types of problems and inquiries encountered by individuals applying for or receiving insulin through a program supported by such grant2 7ii7 the number of insulin products dispensed and the unit costs for those products during the period covered by the report2 7iii7 the number of pharmacies participating in the program during the period covered by the report2 7iv7 summary data on the individuals applying for or receiving insulin through the program2 and 7v7 any other information the ,secretary shall determine necessary to provide oversight of the grants made under this section4 7,b7 ,high-deductible health plans ,the ,secretary may not make a grant under subsection 7a7 unless the ,state1 ,indian tribe1 or tribal organization involved agrees to1 as soon as practicable after each time the ,state1 ,indian tribe1 or tribal organization provides payment to a pharmacy for insulin for an underinsured individual1 submit to the high-deductible health plan in which the individual is enrolled information on the amount of such payment in order for such plan to comply with the requirements under section #bgaj4 7d7 ,description of intended uses of grant ,the ,secretary may not make a grant under subsection 7a7 unless-- 7#a7 the ,state1 ,indian tribe1 or tribal organization involved submits to the ,secretary a description of the purposes for which the ,state1 ,indian tribe1 or tribal organization intends to expend the grant2 7#b7 the description identifies the populations1 areas1 and localities in the ,state1 or under the jurisdiction of the ,indian tribe or tribal organization1 with a need for a program to assist individuals in obtaining insulin in accordance with subsection 7a72 7#c7 the description provides information relating to the services and activities to be provided1 including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or private entities2 and 7#d7 the description provides assurances that the grant funds will be used in the most cost-effective manner4 7e7 ,requirement of submission of application ,the ,secretary may not make a grant under subsection 7a7 unless an application for the grant is submitted to the ,secretary1 the application contains the description of intended uses required under subsection 7d71 and the application is in such form1 is made in such manner1 and contains such agreements1 assurances1 and information as the ,secretary determines to be necessary to carry out this section4 7f7 ,technical assistance and provision of supplies and services in lieu of grant funds 7#a7 ,technical assistance ,the ,secretary may provide training and technical assistance with respect to the planning1 development1 and operation of any program or service carried out pursuant to subsection 7a74 ,the ,secretary may provide such technical assistance directly or through grants to1 or contracts with1 public or private entities4 7#b7 ,provision of supplies and services in lieu of grant funds 7,a7 ,in general ,upon the request of a ,state1 ,indian tribe1 or tribal organization receiving a grant under subsection 7a71 the ,secretary may1 subject to subparagraph 7,b71 provide supplies1 equipment1 and services for the purpose of aiding the ,state1 ,indian tribe1 or tribal organization in carrying out such subsection and1 for such purpose1 may detail to the ,state1 ,indian tribe1 or tribal organization any officer or employee of the ,department of ,health and ,human ,services4 7,b7 ,corresponding reduction in payments ,with respect to a request described in subparagraph 7,a71 the ,secretary shall reduce the amount of payments under the grant under subsection 7a7 to the ,state1 ,indian tribe1 or tribal organization involved by an amount equal to the costs of detailing personnel 7including pay1 allowances1 and travel expenses7 and the fair market value of any supplies1 equipment1 or services provided by the ,secretary4 ,the ,secretary shall1 for the payment of expenses incurred in complying with such request1 expend the amounts withheld4 7g7 ,evaluations and reports 7#a7 ,evaluations ,the ,secretary shall1 directly or through contracts with public or private entities1 provide for annual evaluations of programs carried out pursuant to subsection 7a74 ,such evaluations shall include evaluations of-- 7,a7 the extent to which ,states1 ,indian tribes1 and tribal organizations carrying out such programs are in compliance with subsection 7a7 and with subsection 7c77#a72 and 7,b7 the extent to which each ,state1 ,indian tribe1 or tribal organization receiving a grant under this section is in compliance with subsection 7b71 including identification of-- 7i7 the amount of the non-,federal contributions by the ,state1 ,indian tribe1 or tribal organization for the preceding fiscal year1 disaggregated according to the source of the contributions2 and 7ii7 the proportion of such amount of non-,federal contributions relative to the amount of ,federal funds provided through the grant to the ,state1 ,indian tribe1 or tribal organization for the preceding fiscal year4 7#b7 ,reports to ,congress ,the ,secretary shall1 not later than #a year after the date of the enactment of the ,emergency ,access to ,insulin ,act of #bjai1 and annually thereafter1 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report summarizing evaluations carried out under paragraph 7#a7 during the preceding fiscal year and making such recommendations for administrative and legislative initiatives with respect to this section as the ,secretary determines to be appropriate1 including recommendations regarding compliance by the ,states1 ,indian tribes1 and tribal organizations with subsection 7a7 and with subsection 7c77#a74 7h7 ,funding for general program 7#a7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated such sums as may be necessary4 7#b7 ,set-aside for technical assistance and provision of supplies and services ,of the amounts appropriated under paragraph 7#a7 for a fiscal year1 the ,secretary shall reserve not more than #bj percent for carrying out subsection 7f74 7i7 ,sunset ,the authority to award grants under subsection 7a7 shall be effective beginning on the date of enactment of the ,emergency ,access to ,insulin ,act of #bjai and ending on the date that is #e years after such date4 7j7 ,definitions ,for purposes of this section3 7#a7 ,eligible individual ,the term eligible individual1 with respect to a program supported by a ,state1 ,indian tribe1 or tribal organization receiving a grant under this section1 means an uninsured individual or an underinsured individual-- 7,a7 7i7 in the case of a grant to a ,state1 who is a resident of the ,state2 7ii7 in the case of a grant to an ,indian tribe1 who is a member of such tribe2 or 7iii7 in the case of a grant to a tribal organization1 who is a member of the ,indian tribe or ,indian community served by the tribal organization2 and 7,b7 who has a valid prescription for insulin that is prescribed to such individual4 7#b7 ,group health insurance coverage2 group health plan2 health insurance issuer ,the terms group health insurance coverage1 group health plan1 and health insurance issuer have the meanings given such terms in section #bgia4 7#c7 ,high-deductible health plan ,the term high-deductible health plan means a group health plan or group or individual health insurance coverage 7offered by a health insurance issuer7 that meets criteria established by the ,secretary4 7#d7 ,indian tribe ,the term ,indian tribe has the meaning given such term in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc74 7#e7 ,individual health insurance coverage ,the term individual health insurance coverage has the meaning given such term in section #bgia4 7#f7 ,tribal organization ,the term tribal organization has the meaning given such term in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc74 7#g7 ,underinsured individual ,the term underinsured individual means an individual who is enrolled in a high-deductible health plan4 7#h7 ,uninsured individual ,the term uninsured individual means an individual who does not have minimum essential coverage as defined in section #ejjj;,a7f77#a7 of the ,internal ,revenue ,code of #aihf or coverage under a medical care program of the ,indian ,health ,service or of a tribal organization or urban ,indian organization4 7#i7 ,urban ,indian organization ,the term urban ,indian organization has the meaning given such term in section #d of the ,indian ,health ,care ,improvement ,act4 4 7b7 ,exempting prices used under an insulin assistance program from best price and average manufacturer price under the ,medicaid drug rebate program ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended-- 7#a7 in subsection 7c77#a77;,c77i77,,iii71 by inserting or under an insulin assistance program supported under section #cbj;,b of the ,public ,health ,service ,act after ,state pharmaceutical assistance program2 and 7#b7 in subsection 7k77#a77;,b77i7-- 7,a7 in subclause 7,,iv71 by striking 2 and and inserting a semicolon2 7,b7 in subclause 7,v71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new subclause3 7,,vi7 any prices used under an insulin assistance program supported under section #cbj;,b of the ,public ,health ,service ,act4 4 7c7 ,deductibles for underinsured individuals participating in insulin assistance programs ,subpart ,i of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended by adding at the end the following3 #bgaj4 ,deductibles for underinsured individuals participating in insulin assistance programs 7a7 ,in general ,a group health plan that is a high-deductible health plan and a health insurance issuer offering a high-deductible health plan shall1 with respect to any individual who is enrolled in such plan and obtains insulin during a plan year through an insulin card issued to the individual by a ,state1 ,indian tribe1 or tribal organization carrying out an insulin assistance program under section #cbj;,b1 count the amount the ,state1 ,indian tribe1 or tribal organization pays a pharmacy for insulin for such individual for such plan year towards any deductible or other out-of-pocket expenses required to be paid under the plan4 7b7 ,high-,deductible health plan ,for purposes of this section1 the term high-deductible health plan has the meaning given such term in section #cbj;,b7j74 4 #c4 ,annual fees applicable to insulin manufacturers 7a7 ,definitions ,for purposes of this section3 7#a7 ,annual payment date ,the term annual payment date means1 with respect to a calendar year1 the date determined by the ,secretary1 but in no event later than ,september #cj of such calendar year4 7#b7 ,covered entity ,the term covered entity1 with respect to a calendar year1 means an entity that-- 7,a7 is the holder of an application approved under subsection 7c7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or of a license issued under subsection 7a7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 for an insulin product2 and 7,b7 during the preceding calendar year1 manufactured any insulin product that was sold in commerce and covered by a ,federal health program at least once during such preceding calendar year4 7#c7 ,inspector ,general ,the term ,inspector ,general means the ,inspector ,general of the ,department of ,health and ,human ,services4 7#d7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7b7 ,imposition of fee ,each covered entity for a calendar year1 beginning in #bjbj and ending in #bjbd1 shall pay to the ,secretary not later than the annual payment date of such calendar year a fee in an amount determined under subsection 7c74 7c7 ,amount of fees 7#a7 ,total amount ,the ,secretary shall ensure that the total amount in fees assessed under subsection 7b7-- 7,a7 for calendar year #bjbj1 equals the total amount the ,secretary estimates as the total expenditures for carrying out section #cbj;,b of the ,public ,health ,service ,act for such calendar year2 and 7,b7 for each of calendar years #bjba through #bjbd1 equals the total amount of expenditures the ,secretary determines for carrying out such section for the preceding calendar year4 7#b7 ,determination of fees for each manufacturer 7,a7 ,formula ,with respect to each covered entity1 the fee under this section for a calendar year shall be equal to an amount that bears the same ratio to the total amount assessed under subsection 7b7 for such year as the covered entity's sales of insulin products taken into account during the preceding calendar year1 bears to the aggregate sales of insulin products of all covered entities taken into account during such preceding calendar year4 7,b7 ,sales of insulin products 7i7 ,in general ,for purposes of this paragraph1 the sales of insulin products taken into account during any calendar year with respect to any covered entity shall be determined based on the total number of units of the insulin product which were sold in commerce in the preceding calendar year based on-- 7,i7 for a fee assessed for calendar year #bjbj1 information obtained by the ,secretary under clause 7ii72 and 7,,ii7 for a fee assessed for each of calendar years #bjba through #bjbd1 the information provided in the annual reports issued by the ,inspector ,general and made public under section #d7;e77#a74 7ii7 ,fees assessed for calendar year #bjbj ,for purposes of clause 7i77,i71 the ,secretary shall require each covered entity to submit to the ,secretary information on the total number of units of the insulin product manufactured by the entity that were sold in commerce in calendar year #bjai4 7d7 ,deposit ,the ,secretary shall deposit amounts received through fees assessed under subsection 7b7 into the general fund of the ,treasury4 7e7 ,enforcement ,the ,secretary may bring an action in any court of competent jurisdiction to recover the amount of any fee that is assessed under subsection 7b7 for a calendar year and not paid by the annual payment date4 #d4 ,identification of insulin price spikes2 application of excise tax 7a7 ,definitions ,in this section3 7#a7 ,applicable entity ,the term applicable entity means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or of a license issued under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 for an insulin product4 7#b7 ,commerce ,the term commerce has the meaning given such term in section #d of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd74 7#c7 ,inspector ,general ,the term ,inspector ,general means the ,inspector ,general of the ,department of ,health and ,human ,services4 7#d7 ,price spike 7,a7 ,in general ,the term price spike means an increase in the wholesale acquisition cost in commerce of an insulin product for which the price spike percentage is equal to or greater than the applicable price increase allowance4 7,b7 ,price spike percentage ,the price spike percentage is the percentage 7if any7 by which-- 7i7 the wholesale acquisition cost of an insulin product in commerce for the calendar year2 exceeds 7ii7 the wholesale acquisition cost of such insulin product in commerce for the calendar year preceding such year4 7,c7 ,applicable price increase allowance ,the applicable price increase allowance for any calendar year is the percentage 7rounded to the nearest one-tenth of #a percent7 by which the ,c-,,cpi-,u 7as defined in section #a7;f77#f7 of the ,internal ,revenue ,code of #aihf7 for that year exceeds the ,c-,,cpi-,u for the preceding calendar year4 7#e7 ,price spike revenue 7,a7 ,in general ,the price spike revenue for any calendar year is an amount equal to-- 7i7 the gross price spike revenue1 minus 7ii7 the adjustment amount4 7,b7 ,gross price spike revenue ,the gross price spike revenue for any calendar year is an amount equal to the product of-- 7i7 an amount equal to the difference between clause 7i7 of paragraph 7#d77;,b7 and clause 7ii7 of such paragraph2 and 7ii7 the total number of units of the insulin product which were sold in commerce in such calendar year4 7,c7 ,adjustment amount ,the adjustment amount is the amount1 if any1 of the gross price spike revenue which the ,inspector ,general has determined is due solely to an increase in the cost of the inputs necessary to manufacture the insulin product subject to the price spike4 7b7 ,submission by pharmaceutical companies of information to ,inspector ,general 7#a7 ,in general ,for each insulin product1 the applicable entity shall submit to the ,inspector ,general a quarterly report that includes the following3 7,a7 ,for each insulin product of the applicable entity-- 7i7 the total number of units of the insulin product which were sold in commerce in the preceding calendar quarter2 7ii7 the average and median wholesale acquisition cost per unit of such insulin product in commerce in the preceding calendar quarter1 disaggregated by month2 and 7iii7 the gross revenues from sales of such insulin product in commerce in the preceding calendar quarter4 7,b7 ,such information related to increased input costs or public health considerations as the applicable entity may wish the ,inspector ,general to consider in making a determination under clause 7ii7 of subsection 7c77#b77;,b7 or an assessment in clause 7iii7 of such subsection for the preceding calendar quarter4 7,c7 ,such information related to any anticipated increased input costs for the subsequent calendar quarter as the applicable entity may wish the ,inspector ,general to consider in making a determination under clause 7ii7 of subsection 7c77#b77;,b7 or an assessment in clause 7iii7 of such subsection for such calendar quarter4 7#b7 ,penalty for failure to submit 7,a7 ,in general ,an applicable entity described in paragraph 7#a7 that fails to submit information to the ,inspector ,general regarding an insulin product1 as required by such paragraph1 before the date specified in paragraph 7#c7 shall be liable for a civil penalty1 as determined under subparagraph 7,b74 7,b7 ,amount of penalty ,the amount of the civil penalty shall be equal to the product of-- 7i7 an amount1 as determined appropriate by the ,inspector ,general1 which is-- 7,i7 not less than #j4e percent of the gross revenues from sales of the insulin product described in subparagraph 7,a7 for the preceding calendar year2 and 7,,ii7 not greater than #a percent of the gross revenues from sales of such insulin product for the preceding calendar year2 and 7ii7 the number of days in the period between-- 7,i7 the applicable date specified in paragraph 7#c72 and 7,,ii7 the date on which the ,inspector ,general receives the information described in paragraph 7#a7 from the applicable entity4 7#c7 ,submission deadline ,an applicable entity shall submit each quarterly report described in paragraph 7#a7 not later than ,january #ag1 ,april #ah1 ,june #ae1 and ,september #ae of each calendar year4 7c7 ,assessment by ,inspector ,general 7#a7 ,in general ,not later than the last day in ,february of each year1 the ,inspector ,general1 in consultation with other relevant ,federal agencies 7including the ,federal ,trade ,commission71 shall-- 7,a7 complete an assessment of the information the ,inspector ,general received pursuant to subsection 7b77#a7 with respect to sales of insulin products in the preceding calendar year2 and 7,b7 in the case of any insulin product which satisfies the conditions described in paragraph 7#a7 or 7#b7 of subsection 7d71 submit a recommendation to the ,secretary of ,health and ,human ,services that such insulin product be exempted from application of the tax imposed under section #daib of the ,internal ,revenue ,code of #aihf 7as added by subsection 7g77 for such year4 7#b7 ,elements ,the assessment required by paragraph 7#a77;,a7 shall include the following3 7,a7 ,identification of each price spike relating to an insulin product in the preceding calendar year4 7,b7 ,for each price spike identified under subparagraph 7,a7-- 7i7 a determination of the price spike revenue2 7ii7 a determination regarding the accuracy of the information submitted by the applicable entity regarding increased input costs2 and 7iii7 an assessment of the rationale of the applicable entity for the price spike4 7d7 ,exemption of certain insulin products 7#a7 ,in general ,the ,secretary of ,health and ,human ,services1 upon recommendation of the ,inspector ,general pursuant to subsection 7c77#a77;,b71 may exempt any insulin product which has been subject to a price spike during the preceding calendar year from application of the tax imposed under section #daib of the ,internal ,revenue ,code of #aihf for such year1 if the ,secretary determines that1 based on information submitted pursuant to subsection 7b77#a77;,b71 a for-cause price increase exemption should apply4 7#b7 ,clarification ,in considering1 under paragraph 7#a77;,a71 information submitted pursuant to subsection 7b77#a77;,b71 the ,secretary-- 7,a7 has the discretion to determine that such information does not warrant a for-cause price increase exemption2 and 7,b7 shall exclude from such consideration any information submitted by the applicable entity threatening to curtail or limit production of the insulin product if the ,secretary does not grant an exemption from the application of the tax under section #daib of the ,internal ,revenue ,code of #aihf4 7e7 ,reports by ,inspector ,general 7#a7 ,public report 7,a7 ,in general ,not later than the last day in ,february of each year1 subject to subparagraph 7,c71 the ,inspector ,general shall issue a report containing the information described in subparagraph 7,b7 to be made available to the public1 including on the ,internet website of the ,inspector ,general4 7,b7 ,contents ,the report issued under subparagraph 7,a7 shall include the following3 7i7 ,the information received under subsection 7b77#a7 with respect to the preceding calendar year4 7ii7 ,the price spikes identified under subparagraph 7,a7 of subsection 7c77#b74 7iii7 ,the price spike revenue determinations made under subparagraph 7,b77i7 of such subsection4 7iv7 ,the determinations and assessments made under clauses 7ii7 and 7iii7 of subparagraph 7,b7 of such subsection4 7,c7 ,proprietary information ,the ,inspector ,general shall ensure that any information made public in accordance with subparagraph 7,a7 excludes trade secrets and confidential commercial information4 7#b7 ,report to ,internal ,revenue ,service 7,a7 ,in general ,subject to subparagraph 7,c71 not later than the last day in ,february of each year1 the ,inspector ,general shall transmit to the ,internal ,revenue ,service a report on the findings of the ,inspector ,general with respect to the information the ,inspector ,general received under subsection 7b77#a7 with respect to the preceding calendar year and the assessment carried out by the ,inspector ,general under subsection 7c77#a77;,a7 with respect to such information4 7,b7 ,contents ,the report transmitted under subparagraph 7,a7 shall include the information described in paragraph 7#a77;,b74 7,c7 ,notice and opportunity for hearing 7i7 ,in general ,no report shall be transmitted to the ,internal ,revenue ,service under subparagraph 7,a7 with respect to an insulin product unless the ,inspector ,general has provided the applicable entity with-- 7,i7 the assessment of such insulin product under subsection 7c77#a77;,a72 and 7,,ii7 notice of their right to a hearing in regards to such assessment4 7ii7 ,notice ,the notice required under clause 7i7 shall be provided to the applicable entity not later than #cj days after completion of the assessment under subsection 7c77#a77;,a74 7iii7 ,request for hearing ,subject to clause 7v71 an applicable entity may request a hearing before the ,secretary of ,health and ,human ,services not later than #cj days after the date on which the notice under clause 7ii7 is received4 7iv7 ,completion of hearing ,in the case of an applicable entity which requests a hearing pursuant to clause 7iii71 the ,secretary of ,health and ,human ,services shall1 not later than #ab months after the date on which the assessment under subsection 7c77#a77;,a7 was completed by the ,inspector ,general-- 7,i7 make a final determination in regards to the accuracy of such assessment2 and 7,,ii7 provide the report described in subparagraph 7,b7 to the ,internal ,revenue ,service4 7v7 ,limitation ,an applicable entity may request a hearing under clause 7iii7 with respect to a particular insulin product only once within a #e-year period4 7f7 ,notification ,the ,secretary of the ,treasury shall notify1 at such time and in such manner as the ,secretary of the ,treasury shall provide1 each applicable entity in regard to any insulin product which has been determined to have been subject to a price spike during the preceding calendar year and the amount of the tax imposed on such applicable entity pursuant to section #daib of the ,internal ,revenue ,code of #aihf4 7g7 ,excise tax on insulin products subject to price spikes 7#a7 ,in general ,subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #daib4 ,insulin products subject to price spikes 7a7 ,imposition of tax 7#a7 ,in general ,subject to paragraph 7#c71 for each taxable insulin product sold by an applicable entity during the calendar year1 there is hereby imposed on such entity a tax equal to the greater of-- 7,a7 the annual price spike tax for such insulin product1 or 7,b7 subject to paragraph 7#b71 the cumulative price spike tax for such insulin product4 7#b7 ,limitation ,in the case of a taxable insulin product for which the applicable period 7as determined under subsection 7c77#b77;,e77i77 is less than #b calendar years1 the cumulative price spike tax shall not apply4 7#c7 ,exemption ,for any calendar year in which the ,secretary of ,health and ,human ,services has provided an exemption for a taxable insulin product pursuant to section #d7;d7 of the ,emergency ,access to ,insulin ,act of #bjai1 the amount of the tax determined under paragraph 7#a7 for such insulin product for such calendar year shall be reduced to zero4 7b7 ,annual price spike tax 7#a7 ,in general ,the amount of the annual price spike tax shall be equal to the applicable percentage of the price spike revenue received by the applicable entity on the sale of the taxable insulin product during the calendar year4 7#b7 ,applicable percentage ,for purposes of paragraph 7#a71 the applicable percentage shall be equal to-- 7,a7 in the case of a taxable insulin product which has been subject to a price spike percentage greater than the applicable price increase allowance 7as defined in section #d7;a77#d77;,c7 of the ,emergency ,access to ,insulin ,act of #bjai7 but less than #ae percent1 #ej percent1 7,b7 in the case of a taxable insulin product which has been subject to a price spike percentage equal to or greater than #ae percent but less than #bj percent1 #ge percent1 and 7,c7 in the case of a taxable insulin product which has been subject to a price spike percentage equal to or greater than #bj percent1 #ajj percent4 7c7 ,cumulative price spike tax 7#a7 ,in general ,the amount of the cumulative price spike tax shall be equal to the applicable percentage of the cumulative price spike revenue received by the applicable entity on the sale of the taxable insulin product during the calendar year4 7#b7 ,applicable percentage 7,a7 ,in general ,for purposes of paragraph 7#a71 the applicable percentage shall be equal to-- 7i7 in the case of a taxable insulin product which has been subject to a cumulative price spike percentage greater than the cumulative price increase allowance but less than the first multi-year percentage1 #ej percent1 7ii7 in the case of a taxable insulin product which has been subject to a cumulative price spike percentage equal to or greater than the first multi-year percentage but less than the second multi-year percentage1 #ge percent1 and 7iii7 in the case of a taxable insulin product which has been subject to a cumulative price spike percentage equal to or greater than the second multi-year percentage1 #ajj percent4 7,b7 ,cumulative price spike percentage ,the cumulative price spike percentage is the percentage 7if any7 by which-- 7i7 the wholesale acquisition cost of the taxable insulin product in commerce for the preceding calendar year1 exceeds 7ii7 the wholesale acquisition cost of such insulin product in commerce for the base year4 7,c7 ,cumulative price increase allowance ,for purposes of clause 7i7 of subparagraph 7,a71 the cumulative price increase allowance for any calendar year is the percentage 7rounded to the nearest one-tenth of #a percent7 by which the ,c-,,cpi-,u 7as defined in section #a7;f77#f77 for that year exceeds the ,c-,,cpi-,u for the base year4 7,d7 ,multi-year percentages ,for purposes of subparagraph 7,a71 the first multi-year percentage and second multi-year percentage shall be determined in accordance with the following table3 ,number of years in applicable period,first multi-year percentage,second multi-year percentage#b years#ag4ebb4ec years#bj4jbe4jd years#bb4ebg4ee years#be4jcj4j4 7,e7 ,applicable period and base year 7i7 ,applicable period ,the applicable period shall be the lesser of-- 7,i7 the #e preceding calendar years1 7,,ii7 all calendar years beginning after the date of enactment of this section1 or 7,,iii7 all calendar years in which the taxable insulin product was sold in commerce4 7ii7 ,base year ,the base year shall be the calendar year immediately preceding the applicable period4 7#c7 ,cumulative price spike revenue ,for purposes of paragraph 7#a71 the cumulative price spike revenue for any taxable insulin product shall be an amount equal to-- 7,a7 an amount equal to the product of-- 7i7 an amount 7not less than zero7 equal to-- 7,i7 the wholesale acquisition cost of such insulin product in commerce for the preceding calendar year1 minus 7,,ii7 the wholesale acquisition cost of such insulin product in commerce for the base year1 and 7ii7 the total number of units of such insulin product which were sold in commerce in the preceding calendar year1 minus 7,b7 an amount equal to the sum of the adjustment amounts1 if any1 determined under section #d7;a77#e77;,c7 of the ,emergency ,access to ,insulin ,act of #bjai for each calendar year during the applicable period4 7d7 ,definitions ,for purposes of this section-- 7#a7 ,taxable insulin product ,the term taxable insulin product means an insulin product which has been identified by the ,inspector ,general of the ,department of ,health and ,human ,services1 under section #d7;c77#b77;,a7 of the ,emergency ,access to ,insulin ,act of #bjai1 as being subject to a price spike4 7#b7 ,other terms ,the terms applicable entity1 price spike1 price spike percentage1 and price spike revenue have the same meaning given such terms under section #d7;a7 of the ,emergency ,access to ,insulin ,act of #bjai4 4 7#b7 ,clerical amendments 7,a7 ,the heading of subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by striking ,medical devices and inserting ,certain medical devices and insulin products4 7,b7 ,the table of subchapters for chapter #cb of such ,code is amended by striking the item relating to subchapter ,e and inserting the following new item3 ,subchapter ,e4 ,certain medical devices and insulin products 4 7,c7 ,the table of sections for subchapter ,e of chapter #cb of such ,code is amended by adding at the end the following new item3 ,sec4 #daib4 ,insulin products subject to price spikes4 4 7#c7 ,effective date ,the amendments made by this subsection shall apply to sales after the date of the enactment of this ,act4 #e4 ,biological product exclusivity 7a7 ,in general ,section #cea7k77#g77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77;,a77 is amended by striking #ab years and inserting #g years4 7b7 ,conforming amendments ,paragraphs 7#b77;,a7 and 7#c77;,a7 of section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 is amended by striking #ab years each place it appears and inserting #g years4