Title: Emergency Access to Insulin Act of 2019
Policy area: Health

Summary:
Emergency Access to Insulin Act of 2019
This bill reduces the marketing exclusivity period for biological drug products from 12 to 7 years and establishes policies and programs designed to increase access to prescription insulin. Specifically, the bill requires the Centers for Disease Control and Prevention to award grants to states to create insulin card programs, which provide uninsured or underinsured individuals with insulin at no cost for specified time periods. Payments for insulin prescriptions made through the program must count toward an underinsured individual’s health plan deductible. Further, the Department of Health and Human Services (HHS) must collect annual fees from insulin manufacturers, based on each manufacturer’s market share, equal to the total estimated expenditures under the insulin grants program.
Subject to certain exceptions, the bill also establishes an excise tax on insulin manufacturers when the price of an insulin product spikes. The tax amount is a specified percentage of the revenue a manufacturer received as a result of the price spike. The tax amount increases in tiers based on the percentage of the price spike for that product.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4010 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 4010

To amend the Public Health Service Act to establish insulin assistance 
                   programs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 25, 2019

Ms. Craig (for herself and Mr. Phillips) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to establish insulin assistance 
                   programs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Emergency Access to Insulin Act of 
2019''.

SEC. 2. INSULIN ASSISTANCE PROGRAMS.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended by adding at the end the 
following:

``SEC. 320B. INSULIN ASSISTANCE PROGRAMS.

    ``(a) Establishment of Program of Grants to States, Indian Tribes, 
and Tribal Organizations.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall, not later than 1 year after the date of enactment of 
        this section, make grants to States, Indian tribes, and tribal 
        organizations for the purpose of carrying out programs to 
        assist eligible individuals in obtaining insulin in accordance 
        with paragraph (4).
            ``(2) Grant and contract authority for states, indian 
        tribes, and tribal organizations.--
                    ``(A) In general.--A State, Indian tribe, or tribal 
                organization receiving a grant under paragraph (1) may, 
                subject to subparagraph (B), expend the grant to carry 
                out the purpose described in such paragraph through 
                grants or contracts to public or private entities, 
                including local governments.
                    ``(B) Certain applications.--If a nonprofit private 
                entity and a private entity that is not a nonprofit 
                entity both submit applications to a State, Indian 
                tribe, or tribal organization to receive an award of a 
                grant or contract under subparagraph (A), the State, 
                Indian tribe, or tribal organization may give priority 
                to the application submitted by the nonprofit private 
                entity in any case in which the State, Indian tribe, or 
                tribal organization determines that the quality of such 
                application is equivalent to the quality of the 
                application submitted by the other private entity.
            ``(3) Allotment.--Each State, Indian tribe, or tribal 
        organization that applies for a grant in accordance with 
        subsection (e) shall receive a grant under this section in an 
        amount that is equal to the sum of--
                    ``(A) a minimum amount determined by the Secretary; 
                and
                    ``(B) an additional amount based on criteria 
                established by the Secretary, which may include the 
                ability of the State, Indian tribe, or tribal 
                organization to successfully assist individuals in 
                seeking eligibility for Federal or State-funded 
                programs as described in paragraph (4)(A)(iv).
            ``(4) Program components.--
                    ``(A) In general.--A State, Indian tribe, or tribal 
                organization carrying out a program supported by a 
                grant under this subsection shall use the grant funds 
                to--
                            ``(i) purchase insulin;
                            ``(ii) issue insulin cards to eligible 
                        individuals in accordance with subparagraph 
                        (B);
                            ``(iii) enter into agreements with 
                        pharmacies--
                                    ``(I) for such pharmacies to fill 
                                prescriptions for individuals 
                                displaying valid insulin cards that are 
                                issued in accordance with subparagraph 
                                (B) at no cost to such individuals; and
                                    ``(II) for the State, Indian tribe, 
                                or tribal organization to pay such 
                                pharmacies for insulin filled for a 
                                prescription described in subclause 
                                (I); and
                            ``(iv) assist individuals in seeking 
                        eligibility for Federal or State-funded 
                        programs which may provide coverage for insulin 
                        or otherwise assist such individuals in 
                        obtaining insulin.
                    ``(B) Insulin cards.--
                            ``(i) Application.--An eligible individual 
                        seeking an insulin card through a program 
                        supported by a grant under this subsection 
                        shall submit an application to the State, 
                        Indian tribe, or tribal organization receiving 
                        the grant, at such time, in such manner, and 
                        containing such information as the State, 
                        Indian tribe, or tribal organization may 
                        reasonably require for purposes of this 
                        subsection, including--
                                    ``(I) documentation indicating 
                                proof of--
                                            ``(aa) in the case of a 
                                        grant awarded to a State, 
                                        residency in the State;
                                            ``(bb) in the case of a 
                                        grant awarded to an Indian 
                                        tribe, membership in the Indian 
                                        tribe; or
                                            ``(cc) in the case of a 
                                        grant awarded to a tribal 
                                        organization, membership in the 
                                        Indian tribe or Indian 
                                        community served by the tribal 
                                        organization;
                                    ``(II) a prescription for insulin 
                                that is prescribed to the individual;
                                    ``(III) a statement that, to the 
                                best of the individual's knowledge, the 
                                individual is an uninsured individual 
                                or an underinsured individual; and
                                    ``(IV) if the individual is an 
                                underinsured individual, the name of 
                                the high-deductible health plan in 
                                which the individual is enrolled and 
                                any unique identifier of the plan, such 
                                as a policy number.
                            ``(ii) Initial card.--
                                    ``(I) In general.--A State, Indian 
                                tribe, 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 
                                State, Indian tribe, or tribal 
                                organization meeting the requirements 
                                under clause (i).
                                    ``(II) Timing.--A State, Indian 
                                tribe, or tribal organization that 
                                receives an application under clause 
                                (i) from an individual shall issue an 
                                initial insulin card to such individual 
                                not later than 5 business days after 
                                receiving such application.
                                    ``(III) Supply.--An initial insulin 
                                card issued to an individual under this 
                                clause shall be valid for an 
                                approximate 7-day supply of insulin 
                                that is appropriate for the individual 
                                based on the prescription for the 
                                individual provided in the application 
                                under clause (i) and packaging and 
                                processing practices for insulin.
                            ``(iii) 3-month cards.--Not later than 12 
                        business days after an individual submits an 
                        application under clause (i) to a State, Indian 
                        tribe, or tribal organization, the State, 
                        Indian tribe, or tribal organization shall--
                                    ``(I) determine whether the 
                                individual is an eligible individual; 
                                and
                                    ``(II) if the individual is an 
                                eligible individual, issue the 
                                individual an insulin card that is 
                                valid for an approximate 90-day supply 
                                of insulin that is appropriate for the 
                                individual based on the prescription 
                                provided in the application under 
                                clause (i) and packaging and processing 
                                practices for insulin.
                            ``(iv) Renewal of cards.--
                                    ``(I) 3-month cards.--An eligible 
                                individual that is issued an insulin 
                                card under clause (iii) may apply to 
                                renew such card in accordance with a 
                                process established by the State, 
                                Indian tribe, or tribal organization.
                                    ``(II) Limitation.--An individual 
                                that submits an application under 
                                clause (i) and is denied an insulin 
                                card under clause (ii) or (iii) may not 
                                submit another application under clause 
                                (i) for the 1-year period beginning on 
                                the date on which the individual is 
                                denied such card.
    ``(b) Requirement of Matching Funds.--
            ``(1) In general.--The Secretary may not make a grant under 
        subsection (a) unless the State, Indian tribe, or tribal 
        organization involved agrees, with respect to the costs to be 
        incurred by the State, Indian tribe, or tribal organization in 
        carrying out the purpose described in subsection (a)(1), to 
        make available non-Federal contributions (in cash or in-kind 
        under paragraph (2)) toward such costs in an amount equal to 
        not less than $1 for each $3 of Federal funds provided in the 
        grant. Such contributions may be made directly or through 
        donations from public or private entities.
            ``(2) Determination of amount of non-federal 
        contribution.--
                    ``(A) In general.--Non-Federal contributions 
                required in paragraph (1) may be in cash or in-kind, 
                fairly evaluated, including equipment or services (and 
                excluding indirect or overhead costs). Amounts provided 
                by the Federal Government, or services assisted or 
                subsidized to any significant extent by the Federal 
                Government, may not be included in determining the 
                amount of such non-Federal contributions.
                    ``(B) Maintenance of effort.--In making a 
                determination of the amount of non-Federal 
                contributions for purposes of paragraph (1), the 
                Secretary may include only non-Federal contributions in 
                excess of the average amount of non-Federal 
                contributions made by the State, Indian tribe, or 
                tribal organization involved toward the purpose 
                described in subsection (a)(1) for the 2-year period 
                preceding the first fiscal year for which the State, 
                Indian tribe, or tribal organization is applying to 
                receive a grant under subsection (a).
                    ``(C) Inclusion of relevant non-federal 
                contributions for medicaid.--In making a determination 
                of the amount of non-Federal contributions for purposes 
                of paragraph (1), the Secretary shall, subject to 
                subparagraphs (A) and (B) of this paragraph, include 
                any non-Federal amounts expended pursuant to title XIX 
                of the Social Security Act by the State, Indian tribe, 
                or tribal organization related to insulin dispensed to 
                individuals eligible for medical assistance under such 
                title.
    ``(c) Additional Required Agreements.--
            ``(1) Statewide provision of services.--
                    ``(A) In general.--The Secretary may not make a 
                grant under subsection (a) unless the State, Indian 
                tribe, or tribal organization involved agrees that 
                services and activities under the grant will be made 
                available throughout the State (including availability 
                to members of any Indian tribe or tribal organization 
                in the State), Indian tribe, or tribal organization.
                    ``(B) Waiver.--
                            ``(i) In general.--The Secretary may waive 
                        the requirement established in subparagraph (A) 
                        for a State, Indian tribe, or tribal 
                        organization if the Secretary determines that 
                        compliance by the State, Indian tribe, or 
                        tribal organization with the requirement would 
                        result in an inefficient allocation of 
                        resources with respect to carrying out the 
                        purpose described in subsection (a)(1).
                            ``(ii) Indian tribes and tribal 
                        organizations.--If an Indian tribe or tribal 
                        organization is receiving a grant under 
                        subsection (a) and the State in which the tribe 
                        or organization is located is receiving a grant 
                        under subsection (a), the requirement under 
                        subparagraph (A) for the State regarding 
                        availability to the tribe or organization is 
                        deemed to have been waived under this 
                        subparagraph.
            ``(2) Relationship to items and services under other 
        programs.--
                    ``(A) In general.--The Secretary may not make a 
                grant under subsection (a) unless the State, Indian 
                tribe, 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 made, or 
                can reasonably be expected to be made, with respect to 
                such item or service--
                            ``(i) except as provided in subparagraph 
                        (B), under any State compensation program, 
                        under an insurance policy, or under any Federal 
                        or State health benefits program; or
                            ``(ii) by an entity that provides health 
                        services on a prepaid basis.
                    ``(B) Exception.--The requirement under 
                subparagraph (A)(i) shall not apply with respect to 
                coverage under a high-deductible health plan.
            ``(3) Limitation on administrative expenses.--The Secretary 
        may not make a grant under subsection (a) unless the State, 
        Indian tribe, or tribal organization involved agrees that not 
        more than 10 percent of the grant will be expended for 
        administrative expenses with respect to the grant.
            ``(4) Records and audits.--The Secretary may not make a 
        grant under subsection (a) unless the State, Indian tribe, or 
        tribal organization involved agrees that--
                    ``(A) the State, Indian tribe, or tribal 
                organization will establish such fiscal control and 
                fund accounting procedures as may be necessary to 
                ensure the proper disbursal of, and accounting for, 
                amounts received by the State, Indian tribe, or tribal 
                organization under such subsection;
                    ``(B) upon request, the State, Indian tribe, or 
                tribal organization will provide records maintained 
                pursuant to subparagraph (A) to the Secretary or the 
                Comptroller General of the United States for purposes 
                of auditing the expenditures by the State, Indian 
                tribe, or tribal organization of the grant; and
                    ``(C) the State, Indian tribe, or tribal 
                organization will keep such records as the Secretary 
                shall prescribe, including--
                            ``(i) records that fully disclose--
                                    ``(I) the amount and disposition by 
                                the State, Indian tribe, or tribal 
                                organization of the proceeds of such 
                                grant;
                                    ``(II) the total cost of the 
                                project or undertaking intended to be 
                                carried out through the grant; and
                                    ``(III) the amount of that portion 
                                of the cost of the project or 
                                undertaking supplied by sources other 
                                than the grant; and
                            ``(ii) such other records as the Secretary 
                        determines appropriate for facilitating an 
                        effective audit of grants awarded under this 
                        section.
            ``(5) Reports.--
                    ``(A) Reports to the secretary.--The Secretary may 
                not make a grant under subsection (a) unless the State, 
                Indian tribe, or tribal organization involved agrees to 
                submit to the Secretary such reports as the Secretary 
                may require with respect to the grant, including a 
                report on--
                            ``(i) the types of problems and inquiries 
                        encountered by individuals applying for or 
                        receiving insulin through a program supported 
                        by such grant;
                            ``(ii) the number of insulin products 
                        dispensed and the unit costs for those products 
                        during the period covered by the report;
                            ``(iii) the number of pharmacies 
                        participating in the program during the period 
                        covered by the report;
                            ``(iv) summary data on the individuals 
                        applying for or receiving insulin through the 
                        program; and
                            ``(v) any other information the Secretary 
                        shall determine necessary to provide oversight 
                        of the grants made under this section.
                    ``(B) High-deductible health plans.--The Secretary 
                may not make a grant under subsection (a) unless the 
                State, Indian tribe, or tribal organization involved 
                agrees to, as soon as practicable after each time the 
                State, Indian tribe, or tribal organization provides 
                payment to a pharmacy for insulin for an underinsured 
                individual, 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 2710.
    ``(d) Description of Intended Uses of Grant.--The Secretary may not 
make a grant under subsection (a) unless--
            ``(1) the State, Indian tribe, or tribal organization 
        involved submits to the Secretary a description of the purposes 
        for which the State, Indian tribe, or tribal organization 
        intends to expend the grant;
            ``(2) the description identifies the populations, areas, 
        and localities in the State, or under the jurisdiction of the 
        Indian tribe or tribal organization, with a need for a program 
        to assist individuals in obtaining insulin in accordance with 
        subsection (a);
            ``(3) the description provides information relating to the 
        services and activities to be provided, 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 entities; and
            ``(4) the description provides assurances that the grant 
        funds will be used in the most cost-effective manner.
    ``(e) Requirement of Submission of Application.--The Secretary may 
not make a grant under subsection (a) unless an application for the 
grant is submitted to the Secretary, the application contains the 
description of intended uses required under subsection (d), and the 
application is in such form, is made in such manner, and contains such 
agreements, assurances, and information as the Secretary determines to 
be necessary to carry out this section.
    ``(f) Technical Assistance and Provision of Supplies and Services 
in Lieu of Grant Funds.--
            ``(1) Technical assistance.--The Secretary may provide 
        training and technical assistance with respect to the planning, 
        development, and operation of any program or service carried 
        out pursuant to subsection (a). The Secretary may provide such 
        technical assistance directly or through grants to, or 
        contracts with, public or private entities.
            ``(2) Provision of supplies and services in lieu of grant 
        funds.--
                    ``(A) In general.--Upon the request of a State, 
                Indian tribe, or tribal organization receiving a grant 
                under subsection (a), the Secretary may, subject to 
                subparagraph (B), provide supplies, equipment, and 
                services for the purpose of aiding the State, Indian 
                tribe, or tribal organization in carrying out such 
                subsection and, for such purpose, may detail to the 
                State, Indian tribe, or tribal organization any officer 
                or employee of the Department of Health and Human 
                Services.
                    ``(B) Corresponding reduction in payments.--With 
                respect to a request described in subparagraph (A), the 
                Secretary shall reduce the amount of payments under the 
                grant under subsection (a) to the State, Indian tribe, 
                or tribal organization involved by an amount equal to 
                the costs of detailing personnel (including pay, 
                allowances, and travel expenses) and the fair market 
                value of any supplies, equipment, or services provided 
                by the Secretary. The Secretary shall, for the payment 
                of expenses incurred in complying with such request, 
                expend the amounts withheld.
    ``(g) Evaluations and Reports.--
            ``(1) Evaluations.--The Secretary shall, directly or 
        through contracts with public or private entities, provide for 
        annual evaluations of programs carried out pursuant to 
        subsection (a). Such evaluations shall include evaluations of--
                    ``(A) the extent to which States, Indian tribes, 
                and tribal organizations carrying out such programs are 
                in compliance with subsection (a) and with subsection 
                (c)(1); and
                    ``(B) the extent to which each State, Indian tribe, 
                or tribal organization receiving a grant under this 
                section is in compliance with subsection (b), including 
                identification of--
                            ``(i) the amount of the non-Federal 
                        contributions by the State, Indian tribe, or 
                        tribal organization for the preceding fiscal 
                        year, disaggregated according to the source of 
                        the contributions; and
                            ``(ii) the proportion of such amount of 
                        non-Federal contributions relative to the 
                        amount of Federal funds provided through the 
                        grant to the State, Indian tribe, or tribal 
                        organization for the preceding fiscal year.
            ``(2) Reports to congress.--The Secretary shall, not later 
        than 1 year after the date of the enactment of the Emergency 
        Access to Insulin Act of 2019, and annually thereafter, submit 
        to the Committee on Health, Education, Labor, 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 (1) 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 appropriate, including 
        recommendations regarding compliance by the States, Indian 
        tribes, and tribal organizations with subsection (a) and with 
        subsection (c)(1).
    ``(h) Funding for General Program.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this section, there are authorized to be 
        appropriated such sums as may be necessary.
            ``(2) Set-aside for technical assistance and provision of 
        supplies and services.--Of the amounts appropriated under 
        paragraph (1) for a fiscal year, the Secretary shall reserve 
        not more than 20 percent for carrying out subsection (f).
    ``(i) Sunset.--The authority to award grants under subsection (a) 
shall be effective beginning on the date of enactment of the Emergency 
Access to Insulin Act of 2019 and ending on the date that is 5 years 
after such date.
    ``(j) Definitions.--For purposes of this section:
            ``(1) Eligible individual.--The term `eligible individual', 
        with respect to a program supported by a State, Indian tribe, 
        or tribal organization receiving a grant under this section, 
        means an uninsured individual or an underinsured individual--
                    ``(A)(i) in the case of a grant to a State, who is 
                a resident of the State;
                    ``(ii) in the case of a grant to an Indian tribe, 
                who is a member of such tribe; or
                    ``(iii) in the case of a grant to a tribal 
                organization, who is a member of the Indian tribe or 
                Indian community served by the tribal organization; and
                    ``(B) who has a valid prescription for insulin that 
                is prescribed to such individual.
            ``(2) Group health insurance coverage; group health plan; 
        health insurance issuer.--The terms `group health insurance 
        coverage', `group health plan', and `health insurance issuer' 
        have the meanings given such terms in section 2791.
            ``(3) High-deductible health plan.--The term `high-
        deductible health plan' means a group health plan or group or 
        individual health insurance coverage (offered by a health 
        insurance issuer) that meets criteria established by the 
        Secretary.
            ``(4) Indian tribe.--The term `Indian tribe' has the 
        meaning given such term in section 4 of the Indian Health Care 
        Improvement Act (25 U.S.C. 1603).
            ``(5) Individual health insurance coverage.--The term 
        `individual health insurance coverage' has the meaning given 
        such term in section 2791.
            ``(6) Tribal organization.--The term `tribal organization' 
        has the meaning given such term in section 4 of the Indian 
        Health Care Improvement Act (25 U.S.C. 1603).
            ``(7) Underinsured individual.--The term `underinsured 
        individual' means an individual who is enrolled in a high-
        deductible health plan.
            ``(8) Uninsured individual.--The term `uninsured 
        individual' means an individual who does not have minimum 
        essential coverage as defined in section 5000A(f)(1) of the 
        Internal Revenue Code of 1986 or coverage under a medical care 
        program of the Indian Health Service or of a tribal 
        organization or urban Indian organization.
            ``(9) Urban indian organization.--The term `urban Indian 
        organization' has the meaning given such term in section 4 of 
        the Indian Health Care Improvement Act.''.
    (b) Exempting Prices Used Under an Insulin Assistance Program From 
Best Price and Average Manufacturer Price Under the Medicaid Drug 
Rebate Program.--Section 1927 of the Social Security Act (42 U.S.C. 
1396r-8) is amended--
            (1) in subsection (c)(1)(C)(i)(III), by inserting ``or 
        under an insulin assistance program supported under section 
        320B of the Public Health Service Act'' after ``State 
        pharmaceutical assistance program''; and
            (2) in subsection (k)(1)(B)(i)--
                    (A) in subclause (IV), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subclause (V), by striking the period at the 
                end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subclause:
                                    ``(VI) any prices used under an 
                                insulin assistance program supported 
                                under section 320B of the Public Health 
                                Service Act.''.
    (c) Deductibles for Underinsured Individuals Participating in 
Insulin Assistance Programs.--Subpart I of part A of title XXVII of the 
Public Health Service Act (42 U.S.C. 300gg et seq.) is amended by 
adding at the end the following:

``SEC. 2710. DEDUCTIBLES FOR UNDERINSURED INDIVIDUALS PARTICIPATING IN 
              INSULIN ASSISTANCE PROGRAMS.

    ``(a) In General.--A group health plan that is a high-deductible 
health plan and a health insurance issuer offering a high-deductible 
health plan shall, 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 State, Indian tribe, or tribal 
organization carrying out an insulin assistance program under section 
320B, count the amount the State, Indian tribe, 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 plan.
    ``(b) High-Deductible Health Plan.--For purposes of this section, 
the term `high-deductible health plan' has the meaning given such term 
in section 320B(j).''.

SEC. 3. ANNUAL FEES APPLICABLE TO INSULIN MANUFACTURERS.

    (a) Definitions.--For purposes of this section:
            (1) Annual payment date.--The term ``annual payment'' date 
        means, with respect to a calendar year, the date determined by 
        the Secretary, but in no event later than September 30 of such 
        calendar year.
            (2) Covered entity.--The term ``covered entity'', with 
        respect to a calendar year, means an entity that--
                    (A) is the holder of an application approved under 
                subsection (c) of section 505 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355), or of a license 
                issued under subsection (a) of section 351 of the 
                Public Health Service Act (42 U.S.C. 262), for an 
                insulin product; and
                    (B) during the preceding calendar year, 
                manufactured any insulin product that was sold in 
                commerce and covered by a Federal health program at 
                least once during such preceding calendar year.
            (3) Inspector general.--The term ``Inspector General'' 
        means the Inspector General of the Department of Health and 
        Human Services.
            (4) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Imposition of Fee.--Each covered entity for a calendar year, 
beginning in 2020 and ending in 2024, shall pay to the Secretary not 
later than the annual payment date of such calendar year a fee in an 
amount determined under subsection (c).
    (c) Amount of Fees.--
            (1) Total amount.--The Secretary shall ensure that the 
        total amount in fees assessed under subsection (b)--
                    (A) for calendar year 2020, equals the total amount 
                the Secretary estimates as the total expenditures for 
                carrying out section 320B of the Public Health Service 
                Act for such calendar year; and
                    (B) for each of calendar years 2021 through 2024, 
                equals the total amount of expenditures the Secretary 
                determines for carrying out such section for the 
                preceding calendar year.
            (2) Determination of fees for each manufacturer.--
                    (A) Formula.--With respect to each covered entity, 
                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 (b) for such 
                year as the covered entity's sales of insulin products 
                taken into account during the preceding calendar year, 
                bears to the aggregate sales of insulin products of all 
                covered entities taken into account during such 
                preceding calendar year.
                    (B) Sales of insulin products.--
                            (i) In general.--For purposes of this 
                        paragraph, 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--
                                    (I) for a fee assessed for calendar 
                                year 2020, information obtained by the 
                                Secretary under clause (ii); and
                                    (II) for a fee assessed for each of 
                                calendar years 2021 through 2024, the 
                                information provided in the annual 
                                reports issued by the Inspector General 
                                and made public under section 4(e)(1).
                            (ii) Fees assessed for calendar year 
                        2020.--For purposes of clause (i)(I), 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 2019.
    (d) Deposit.--The Secretary shall deposit amounts received through 
fees assessed under subsection (b) into the general fund of the 
Treasury.
    (e) 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 (b) for a calendar year and not paid by the 
annual payment date.

SEC. 4. IDENTIFICATION OF INSULIN PRICE SPIKES; APPLICATION OF EXCISE 
              TAX.

    (a) Definitions.--In this section:
            (1) Applicable entity.--The term ``applicable entity'' 
        means the holder of an application approved under subsection 
        (c) or (j) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), or of a license issued under 
        subsection (a) or (k) of section 351 of the Public Health 
        Service Act (42 U.S.C. 262), for an insulin product.
            (2) Commerce.--The term ``commerce'' has the meaning given 
        such term in section 4 of the Federal Trade Commission Act (15 
        U.S.C. 44).
            (3) Inspector general.--The term ``Inspector General'' 
        means the Inspector General of the Department of Health and 
        Human Services.
            (4) Price spike.--
                    (A) 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 allowance.
                    (B) Price spike percentage.--The price spike 
                percentage is the percentage (if any) by which--
                            (i) the wholesale acquisition cost of an 
                        insulin product in commerce for the calendar 
                        year; exceeds
                            (ii) the wholesale acquisition cost of such 
                        insulin product in commerce for the calendar 
                        year preceding such year.
                    (C) Applicable price increase allowance.--The 
                applicable price increase allowance for any calendar 
                year is the percentage (rounded to the nearest one-
                tenth of 1 percent) by which the C-CPI-U (as defined in 
                section 1(f)(6) of the Internal Revenue Code of 1986) 
                for that year exceeds the C-CPI-U for the preceding 
                calendar year.
            (5) Price spike revenue.--
                    (A) In general.--The price spike revenue for any 
                calendar year is an amount equal to--
                            (i) the gross price spike revenue; minus
                            (ii) the adjustment amount.
                    (B) Gross price spike revenue.--The gross price 
                spike revenue for any calendar year is an amount equal 
                to the product of--
                            (i) an amount equal to the difference 
                        between clause (i) of paragraph (4)(B) and 
                        clause (ii) of such paragraph; and
                            (ii) the total number of units of the 
                        insulin product which were sold in commerce in 
                        such calendar year.
                    (C) Adjustment amount.--The adjustment amount is 
                the amount, if any, 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 spike.
    (b) Submission by Pharmaceutical Companies of Information to 
Inspector General.--
            (1) In general.--For each insulin product, the applicable 
        entity shall submit to the Inspector General a quarterly report 
        that includes the following:
                    (A) For each insulin product of the applicable 
                entity--
                            (i) the total number of units of the 
                        insulin product which were sold in commerce in 
                        the preceding calendar quarter;
                            (ii) the average and median wholesale 
                        acquisition cost per unit of such insulin 
                        product in commerce in the preceding calendar 
                        quarter, disaggregated by month; and
                            (iii) the gross revenues from sales of such 
                        insulin product in commerce in the preceding 
                        calendar quarter.
                    (B) 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 (ii) of subsection 
                (c)(2)(B) or an assessment in clause (iii) of such 
                subsection for the preceding calendar quarter.
                    (C) 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 (ii) of subsection (c)(2)(B) or an assessment in 
                clause (iii) of such subsection for such calendar 
                quarter.
            (2) Penalty for failure to submit.--
                    (A) In general.--An applicable entity described in 
                paragraph (1) that fails to submit information to the 
                Inspector General regarding an insulin product, as 
                required by such paragraph, before the date specified 
                in paragraph (3) shall be liable for a civil penalty, 
                as determined under subparagraph (B).
                    (B) Amount of penalty.--The amount of the civil 
                penalty shall be equal to the product of--
                            (i) an amount, as determined appropriate by 
                        the Inspector General; which is--
                                    (I) not less than 0.5 percent of 
                                the gross revenues from sales of the 
                                insulin product described in 
                                subparagraph (A) for the preceding 
                                calendar year; and
                                    (II) not greater than 1 percent of 
                                the gross revenues from sales of such 
                                insulin product for the preceding 
                                calendar year; and
                            (ii) the number of days in the period 
                        between--
                                    (I) the applicable date specified 
                                in paragraph (3); and
                                    (II) the date on which the 
                                Inspector General receives the 
                                information described in paragraph (1) 
                                from the applicable entity.
            (3) Submission deadline.--An applicable entity shall submit 
        each quarterly report described in paragraph (1) not later than 
        January 17, April 18, June 15, and September 15 of each 
        calendar year.
    (c) Assessment by Inspector General.--
            (1) In general.--Not later than the last day in February of 
        each year, the Inspector General, in consultation with other 
        relevant Federal agencies (including the Federal Trade 
        Commission), shall--
                    (A) complete an assessment of the information the 
                Inspector General received pursuant to subsection 
                (b)(1) with respect to sales of insulin products in the 
                preceding calendar year; and
                    (B) in the case of any insulin product which 
                satisfies the conditions described in paragraph (1) or 
                (2) of subsection (d), 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 4192 of the Internal Revenue Code 
                of 1986 (as added by subsection (g)) for such year.
            (2) Elements.--The assessment required by paragraph (1)(A) 
        shall include the following:
                    (A) Identification of each price spike relating to 
                an insulin product in the preceding calendar year.
                    (B) For each price spike identified under 
                subparagraph (A)--
                            (i) a determination of the price spike 
                        revenue;
                            (ii) a determination regarding the accuracy 
                        of the information submitted by the applicable 
                        entity regarding increased input costs; and
                            (iii) an assessment of the rationale of the 
                        applicable entity for the price spike.
    (d) Exemption of Certain Insulin Products.--
            (1) In general.--The Secretary of Health and Human 
        Services, upon recommendation of the Inspector General pursuant 
        to subsection (c)(1)(B), 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 4192 of 
        the Internal Revenue Code of 1986 for such year, if the 
        Secretary determines that, based on information submitted 
        pursuant to subsection (b)(1)(B), a for-cause price increase 
        exemption should apply.
            (2) Clarification.--In considering, under paragraph (1)(A), 
        information submitted pursuant to subsection (b)(1)(B), the 
        Secretary--
                    (A) has the discretion to determine that such 
                information does not warrant a for-cause price increase 
                exemption; and
                    (B) 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 
                4192 of the Internal Revenue Code of 1986.
    (e) Reports by Inspector General.--
            (1) Public report.--
                    (A) In general.--Not later than the last day in 
                February of each year, subject to subparagraph (C), the 
                Inspector General shall issue a report containing the 
                information described in subparagraph (B) to be made 
                available to the public, including on the Internet 
                website of the Inspector General.
                    (B) Contents.--The report issued under subparagraph 
                (A) shall include the following:
                            (i) The information received under 
                        subsection (b)(1) with respect to the preceding 
                        calendar year.
                            (ii) The price spikes identified under 
                        subparagraph (A) of subsection (c)(2).
                            (iii) The price spike revenue 
                        determinations made under subparagraph (B)(i) 
                        of such subsection.
                            (iv) The determinations and assessments 
                        made under clauses (ii) and (iii) of 
                        subparagraph (B) of such subsection.
                    (C) Proprietary information.--The Inspector General 
                shall ensure that any information made public in 
                accordance with subparagraph (A) excludes trade secrets 
                and confidential commercial information.
            (2) Report to internal revenue service.--
                    (A) In general.--Subject to subparagraph (C), not 
                later than the last day in February of each year, 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 (b)(1) with 
                respect to the preceding calendar year and the 
                assessment carried out by the Inspector General under 
                subsection (c)(1)(A) with respect to such information.
                    (B) Contents.--The report transmitted under 
                subparagraph (A) shall include the information 
                described in paragraph (1)(B).
                    (C) Notice and opportunity for hearing.--
                            (i) In general.--No report shall be 
                        transmitted to the Internal Revenue Service 
                        under subparagraph (A) with respect to an 
                        insulin product unless the Inspector General 
                        has provided the applicable entity with--
                                    (I) the assessment of such insulin 
                                product under subsection (c)(1)(A); and
                                    (II) notice of their right to a 
                                hearing in regards to such assessment.
                            (ii) Notice.--The notice required under 
                        clause (i) shall be provided to the applicable 
                        entity not later than 30 days after completion 
                        of the assessment under subsection (c)(1)(A).
                            (iii) Request for hearing.--Subject to 
                        clause (v), an applicable entity may request a 
                        hearing before the Secretary of Health and 
                        Human Services not later than 30 days after the 
                        date on which the notice under clause (ii) is 
                        received.
                            (iv) Completion of hearing.--In the case of 
                        an applicable entity which requests a hearing 
                        pursuant to clause (iii), the Secretary of 
                        Health and Human Services shall, not later than 
                        12 months after the date on which the 
                        assessment under subsection (c)(1)(A) was 
                        completed by the Inspector General--
                                    (I) make a final determination in 
                                regards the accuracy of such 
                                assessment; and
                                    (II) provide the report described 
                                in subparagraph (B) to the Internal 
                                Revenue Service.
                            (v) Limitation.--An applicable entity may 
                        request a hearing under clause (iii) with 
                        respect to a particular insulin product only 
                        once within a 5-year period.
    (f) Notification.--The Secretary of the Treasury shall notify, at 
such time and in such manner as the Secretary of the Treasury shall 
provide, 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 4192 of the Internal Revenue Code 
of 1986.
    (g) Excise Tax on Insulin Products Subject to Price Spikes.--
            (1) In general.--Subchapter E of chapter 32 of the Internal 
        Revenue Code of 1986 is amended by adding at the end the 
        following new section:

``SEC. 4192. INSULIN PRODUCTS SUBJECT TO PRICE SPIKES.

    ``(a) Imposition of Tax.--
            ``(1) In general.--Subject to paragraph (3), for each 
        taxable insulin product sold by an applicable entity during the 
        calendar year, there is hereby imposed on such entity a tax 
        equal to the greater of--
                    ``(A) the annual price spike tax for such insulin 
                product, or
                    ``(B) subject to paragraph (2), the cumulative 
                price spike tax for such insulin product.
            ``(2) Limitation.--In the case of a taxable insulin product 
        for which the applicable period (as determined under subsection 
        (c)(2)(E)(i)) is less than 2 calendar years, the cumulative 
        price spike tax shall not apply.
            ``(3) 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 
        4(d) of the Emergency Access to Insulin Act of 2019, the amount 
        of the tax determined under paragraph (1) for such insulin 
        product for such calendar year shall be reduced to zero.
    ``(b) Annual Price Spike Tax.--
            ``(1) 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 year.
            ``(2) Applicable percentage.--For purposes of paragraph 
        (1), the applicable percentage shall be equal to--
                    ``(A) in the case of a taxable insulin product 
                which has been subject to a price spike percentage 
                greater than the applicable price increase allowance 
                (as defined in section 4(a)(4)(C) of the Emergency 
                Access to Insulin Act of 2019) but less than 15 
                percent, 50 percent,
                    ``(B) in the case of a taxable insulin product 
                which has been subject to a price spike percentage 
                equal to or greater than 15 percent but less than 20 
                percent, 75 percent, and
                    ``(C) in the case of a taxable insulin product 
                which has been subject to a price spike percentage 
                equal to or greater than 20 percent, 100 percent.
    ``(c) Cumulative Price Spike Tax.--
            ``(1) 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 year.
            ``(2) Applicable percentage.--
                    ``(A) In general.--For purposes of paragraph (1), 
                the applicable percentage shall be equal to--
                            ``(i) 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 percentage, 50 
                        percent,
                            ``(ii) 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 percentage, 75 percent, 
                        and
                            ``(iii) 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 percentage, 100 percent.
                    ``(B) Cumulative price spike percentage.--The 
                cumulative price spike percentage is the percentage (if 
                any) by which--
                            ``(i) the wholesale acquisition cost of the 
                        taxable insulin product in commerce for the 
                        preceding calendar year, exceeds
                            ``(ii) the wholesale acquisition cost of 
                        such insulin product in commerce for the base 
                        year.
                    ``(C) Cumulative price increase allowance.--For 
                purposes of clause (i) of subparagraph (A), the 
                cumulative price increase allowance for any calendar 
                year is the percentage (rounded to the nearest one-
                tenth of 1 percent) by which the C-CPI-U (as defined in 
                section 1(f)(6)) for that year exceeds the C-CPI-U for 
                the base year.
                    ``(D) Multi-year percentages.--For purposes of 
                subparagraph (A), the first multi-year percentage and 
                second multi-year percentage shall be determined in 
                accordance with the following table:


------------------------------------------------------------------------
                                                   First        Second
    ``Number of years in applicable period       multi-year   multi-year
                                                 percentage   percentage
------------------------------------------------------------------------
2 years.......................................         17.5         22.5
3 years.......................................         20.0         25.0
4 years.......................................         22.5         27.5
5 years.......................................         25.0        30.0.
------------------------------------------------------------------------

                    ``(E) Applicable period and base year.--
                            ``(i) Applicable period.--The applicable 
                        period shall be the lesser of--
                                    ``(I) the 5 preceding calendar 
                                years,
                                    ``(II) all calendar years beginning 
                                after the date of enactment of this 
                                section, or
                                    ``(III) all calendar years in which 
                                the taxable insulin product was sold in 
                                commerce.
                            ``(ii) Base year.--The base year shall be 
                        the calendar year immediately preceding the 
                        applicable period.
            ``(3) Cumulative price spike revenue.--For purposes of 
        paragraph (1), the cumulative price spike revenue for any 
        taxable insulin product shall be an amount equal to--
                    ``(A) an amount equal to the product of--
                            ``(i) an amount (not less than zero) equal 
                        to--
                                    ``(I) the wholesale acquisition 
                                cost of such insulin product in 
                                commerce for the preceding calendar 
                                year, minus
                                    ``(II) the wholesale acquisition 
                                cost of such insulin product in 
                                commerce for the base year, and
                            ``(ii) the total number of units of such 
                        insulin product which were sold in commerce in 
                        the preceding calendar year, minus
                    ``(B) an amount equal to the sum of the adjustment 
                amounts, if any, determined under section 4(a)(5)(C) of 
                the Emergency Access to Insulin Act of 2019 for each 
                calendar year during the applicable period.
    ``(d) Definitions.--For purposes of this section--
            ``(1) 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 
        Services, under section 4(c)(2)(A) of the Emergency Access to 
        Insulin Act of 2019, as being subject to a price spike.
            ``(2) Other terms.--The terms `applicable entity', `price 
        spike', `price spike percentage', and `price spike revenue' 
        have the same meaning given such terms under section 4(a) of 
        the Emergency Access to Insulin Act of 2019.''.
            (2) Clerical amendments.--
                    (A) The heading of subchapter E of chapter 32 of 
                the Internal Revenue Code of 1986 is amended by 
                striking ``Medical Devices'' and inserting ``Certain 
                Medical Devices and Insulin Products''.
                    (B) The table of subchapters for chapter 32 of such 
                Code is amended by striking the item relating to 
                subchapter E and inserting the following new item:

    ``subchapter e. certain medical devices and insulin products''.

                    (C) The table of sections for subchapter E of 
                chapter 32 of such Code is amended by adding at the end 
                the following new item:

``Sec. 4192. Insulin products subject to price spikes.''.
            (3) Effective date.--The amendments made by this subsection 
        shall apply to sales after the date of the enactment of this 
        Act.

SEC. 5. BIOLOGICAL PRODUCT EXCLUSIVITY.

    (a) In General.--Section 351(k)(7)(A) of the Public Health Service 
Act (42 U.S.C. 262(k)(7)(A)) is amended by striking ``12 years'' and 
inserting ``7 years''.
    (b) Conforming Amendments.--Paragraphs (2)(A) and (3)(A) of section 
351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended 
by striking ``12 years'' each place it appears and inserting ``7 
years''.
                                 <all>