[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4813 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 4813

   To limit the price of insulin drugs accessible for participants, 
  beneficiaries, and enrollees enrolled in group or individual health 
insurance coverage and group health plans and for uninsured individuals 
               who have diabetes, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 29, 2021

 Mr. Fortenberry (for himself and Ms. Craig) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
in addition to the Committee on Education and Labor, 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 limit the price of insulin drugs accessible for participants, 
  beneficiaries, and enrollees enrolled in group or individual health 
insurance coverage and group health plans and for uninsured individuals 
               who have diabetes, 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 ``Matt's Act''.

SEC. 2. INSULIN NET PRICE PROTECTION.

    (a) Publishing of Net Price by Manufacturers.--
            (1) In general.--A manufacturer of an insulin drug shall, 
        on a quarterly basis, publish on the internet website of such 
        manufacturer the average net price of each such insulin drug 
        for the preceding calendar quarter.
            (2) Enforcement.--In the case that a manufacturer of an 
        insulin drug fails to comply with paragraph (1), a Federal 
        agency or program may not make payment for such insulin drug of 
        such until such manufacturer complies with such paragraph.
    (b) Net Price for Insulin Drugs for Certain Individuals.--
            (1) Application to phsa plans.--Subpart 1 of part A of the 
        Public Health Service Act (42 U.S.C. 300gg et seq.) is amended 
        by adding at the end the following new section:

``SEC. 2730. NET PRICE FOR INSULIN DRUGS.

    ``(a) Availability of Net Price.--With respect to plan years 
beginning on and after January 1, 2022, a health insurance issuer 
offering group or individual health insurance coverage shall provide a 
participant, beneficiary, or enrollee who has diabetes access to an 
insulin drug at--
            ``(1) the lesser of--
                    ``(A) the 10 percent of the average net price for 
                such drug published pursuant to section 2(a) of Matt's 
                Act, plus the average charges for distribution and 
                dispensing described in subsection (c) for such drug;
                    ``(B) the coinsurance amount for an insulin drug 
                under the health insurance coverage under which such an 
                individual is a participant, beneficiary, or enrollee 
                would otherwise be responsible notwithstanding this 
                section; or
                    ``(C) $20; or
            ``(2) $0, in the case such a participant, beneficiary, or 
        enrollee is enrolled in a high deductible health plan (as 
        defined in section 223(c)(2) of the Internal Revenue Code of 
        1986).
    ``(b) Waiver of Deductible.--In applying subsection (a), such a 
participant, beneficiary, or enrollee shall have access to an insulin 
drug without regard to a deductible.
    ``(c) Charges for Distributing and Dispensing.--
            ``(1) In general.--For purposes of subsection (a), charges 
        for distribution and dispensing described in this subsection--
                    ``(A) are charges associated with the transactions, 
                with respect to an insulin drug, between wholesalers, 
                distributors, retailers, and pharmacies; and
                    ``(B) may not exceed 10 percent of the average net 
                price of such an insulin drug.
            ``(2) Reporting requirement for plans.--In the case that a 
        health insurance issuer offering group or individual health 
        insurance coverage charges a participant, beneficiary, or 
        enrollee for average charges for distribution and dispensing 
        pursuant to subsection (a)(1), the health insurance issuer 
        shall submit to the Inspector General of the Department of 
        Health and Human Services information with respect to such 
        charges and the amount of the charges.
            ``(3) Report to congress by inspector general.--Beginning 
        January 1, 2023, and annually thereafter, the Inspector General 
        shall review the charges described in paragraph (2) and submit 
        to Congress a report on such on review.
    ``(d) Definitions.--In this section:
            ``(1) Insulin.--
                    ``(A) In general.--The term `insulin' means a 
                prescription drug containing insulin that is approved 
                by the Food and Drug Administration to improve glycemic 
                control in patients with diabetes mellitus (and may 
                include any medical supplies included with such drug or 
                associated with the injection of such drug).
                    ``(B) Exclusion.--Such term does not include any 
                medical supplies that provides for the monitoring of 
                insulin levels.
            ``(2) List price.--The term `list price' has the meaning 
        given the term wholesale acquisition cost in section 
        1847A(c)(6)(B) of the Social Security Act.
            ``(3) Net price.--The term `net price' means, with respect 
        to prescription drug coverage under group or individual health 
        insurance coverage offered by a health insurance issuer, the 
        list price of the drug net all rebates, discounts, concessions, 
        and other adjustments applied to the cost paid by the health 
        insurance issuer, or by any other entity that provides pharmacy 
        benefit management services under a contract with any such 
        health insurance issuer, regardless of whether such adjustments 
        are prospective or retrospective.
            ``(4) Prescription drug.--The term `prescription drug' mean 
        a drug, as defined in section 201(g) of the Federal Food, Drug, 
        and Cosmetic Act, that is subject to section 503(b)(1) of such 
        Act.''.
            (2) Application to erisa plans.--Subpart A of part 7 of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 
        et seq.) is amended by adding at the end the following new 
        section (and amending the table of contents accordingly):

``SEC. 704. NET PRICE FOR INSULIN DRUGS.

    ``(a) Availability of Net Price.--With respect to plan years 
beginning on and after January 1, 2022, a group health plan shall 
provide a participant, beneficiary, or enrollee who has diabetes access 
to an insulin drug at--
            ``(1) the lesser of--
                    ``(A) the 10 percent of the average net price for 
                such drug published pursuant to section 2(a) of Matt's 
                Act, plus the average charges for distribution and 
                dispensing described in subsection (c) for such drug;
                    ``(B) the coinsurance amount for an insulin drug 
                under the group health plan which such an individual is 
                a participant, beneficiary, or enrollee would otherwise 
                be responsible notwithstanding this section; or
                    ``(C) $20; or
            ``(2) $0, in the case such a participant, beneficiary, or 
        enrollee is enrolled in a high deductible health plan (as 
        defined in section 223(c)(2) of the Internal Revenue Code of 
        1986).
    ``(b) Waiver of Deductible.--In applying subsection (a), such a 
participant, beneficiary, or enrollee shall have access to an insulin 
drug without regard to a deductible.
    ``(c) Charges for Distributing and Dispensing.--
            ``(1) In general.--For purposes of subsection (a), charges 
        for distribution and dispensing described in this subsection--
                    ``(A) are charges associated with the transactions, 
                with respect to an insulin drug, between wholesalers, 
                distributors, retailers, and pharmacies; and
                    ``(B) may not exceed 10 percent of the average net 
                price of such an insulin drug.
            ``(2) Reporting requirement for plans.--In the case that a 
        group health plan charges a participant, beneficiary, or 
        enrollee for average charges for distribution and dispensing 
        pursuant to subsection (a)(1), the group health plan shall 
        submit to the Inspector General of the Department of Health and 
        Human Services information with respect to such charges and the 
        amount of the charges.
            ``(3) Report to congress by inspector general.--Beginning 
        January 1, 2023, and annually thereafter, the Inspector General 
        shall review the charges described in paragraph (2) and submit 
        to Congress a report on such on review.
    ``(d) Definitions.--In this section:
            ``(1) Insulin.--
                    ``(A) In general.--The term `insulin' means a 
                prescription drug containing insulin that is approved 
                by the Food and Drug Administration to improve glycemic 
                control in patients with diabetes mellitus (and may 
                include any medical supplies included with such drug or 
                associated with the injection of such drug).
                    ``(B) Exclusion.--Such term does not include any 
                medical supplies that provides for the monitoring of 
                insulin levels.
            ``(2) List price.--The term `list price' has the meaning 
        given the term wholesale acquisition cost in section 
        1847A(c)(6)(B) of the Social Security Act.
            ``(3) Net price.--The term `net price' means, with respect 
        to prescription drug coverage under a group health plan , the 
        list price of the drug net all rebates, discounts, concessions, 
        and other adjustments applied to the cost paid by the group 
        health plan, or by any other entity that provides pharmacy 
        benefit management services under a contract with any such 
        group health plan, regardless of whether such adjustments are 
        prospective or retrospective.
            ``(4) Prescription drug.--The term `prescription drug' mean 
        a drug, as defined in section 201(g) of the Federal Food, Drug, 
        and Cosmetic Act, that is subject to section 503(b)(1) of such 
        Act.''.
            (3) Uninsured individuals.--
                    (A) In general.--Beginning on and after January 1, 
                2022, a pharmacy shall provide to any individual who 
                has diabetes and is not enrolled in any health plan 
                access to an insulin drug at the average net price for 
                such drug published pursuant to subsection (a), plus 
                the average charges for the distribution and dispensing 
                described in subparagraph (C) for such drug.
                    (B) Review of charges.--Beginning January 1, 2023, 
                and annually thereafter, the Inspector General of the 
                Department of Health and Human Services shall review 
                the amount of charges paid by an individual described 
                in subparagraph (A) and submit to Congress a report on 
                such review.
                    (C) Charges for distributing and dispensing.--For 
                purposes of subparagraph (A), charges for distribution 
                and dispensing described in this subsection--
                            (i) are charges associated with the 
                        transactions, with respect to an insulin drug, 
                        between wholesalers, distributors, retailers, 
                        and pharmacies; and
                            (ii) may not exceed 10 percent of the 
                        average net price of such an insulin drug.
                    (D) Definitions.--In this section:
                            (i) Insulin.--
                                    (I) In general.--The term 
                                ``insulin'' means a prescription drug 
                                containing insulin that is approved by 
                                the Food and Drug Administration to 
                                improve glycemic control in patients 
                                with diabetes mellitus (and may include 
                                any medical supplies included with such 
                                drug or associated with the injection 
                                of such drug).
                                    (II) Exclusion.--Such term does not 
                                include any medical supplies that 
                                provides for the monitoring of insulin 
                                levels.
                            (ii) List price.--The term ``list price'' 
                        has the meaning given the term wholesale 
                        acquisition cost in section 1847A(c)(6)(B) of 
                        the Social Security Act (42 U.S.C. 1395w-
                        3a(c)(6)(B)).
                            (iii) Net price.--The term ``net price'' 
                        means, with respect to prescription drug 
                        coverage under a group health plan , the list 
                        price of the drug net all rebates, discounts, 
                        concessions, and other adjustments applied to 
                        the cost paid by the group health plan, or by 
                        any other entity that provides pharmacy benefit 
                        management services under a contract with any 
                        such group health plan, regardless of whether 
                        such adjustments are prospective or 
                        retrospective.
                            (iv) Prescription drug.--The term 
                        ``prescription drug'' mean a drug, as defined 
                        in section 201(g) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 321(g)), that is 
                        subject to section 503(b)(1) of such Act (21 
                        U.S.C. 353(b)(1)).
                                 <all>