[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>