‘‘SEC. 320B. INSULIN ASSISTANCE PROGRAMS. 
‘‘(a) ESTABLISHMENT OF PROGRAM OF GRANTS TO 
STATES, INDIAN
TRIBES, 
AND
TRIBAL
ORGANIZA-
TIONS.— 
‘‘(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 organiza-
tions for the purpose of carrying out programs to as-
sist eligible individuals in obtaining insulin in ac-
cordance with paragraph (4). 
‘‘(2) GRANT AND CONTRACT AUTHORITY FOR 
STATES, INDIAN
TRIBES, AND
TRIBAL
ORGANIZA-
TIONS.— 
‘‘(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 non-
profit private entity and a private entity that is 
not a nonprofit entity both submit applications 
to a State, Indian tribe, or tribal organization 
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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 pri-
vate entity in any case in which the State, In-
dian tribe, or tribal organization determines 
that the quality of such application is equiva-
lent 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 ac-
cordance 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 cri-
teria established by the Secretary, which may 
include the ability of the State, Indian tribe, or 
tribal organization to successfully assist individ-
uals in seeking eligibility for Federal or State- 
funded programs as described in paragraph 
(4)(A)(iv). 
‘‘(4) PROGRAM COMPONENTS.— 
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‘‘(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 in-
dividuals in accordance with subparagraph 
(B); 
‘‘(iii) enter into agreements with phar-
macies— 
‘‘(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 pre-
scription described in subclause (I); 
and 
‘‘(iv) assist individuals in seeking eli-
gibility for Federal or State-funded pro-
grams which may provide coverage for in-
sulin or otherwise assist such individuals in 
obtaining insulin. 
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‘‘(B) INSULIN CARDS.— 
‘‘(i) APPLICATION.—An eligible indi-
vidual 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 organiza-
tion receiving the grant, at such time, in 
such manner, and containing such infor-
mation 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, mem-
bership 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; 
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‘‘(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, In-
dian tribe, or tribal organization car-
rying out a program supported by a 
grant under this subsection shall issue 
an initial insulin card to each indi-
vidual that submits an application to 
the State, Indian tribe, or tribal orga-
nization meeting the requirements 
under clause (i). 
‘‘(II) TIMING.—A State, Indian 
tribe, or tribal organization that re-
ceives an application under clause (i) 
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from an individual shall issue an ini-
tial insulin card to such individual not 
later than 5 business days after re-
ceiving such application. 
‘‘(III) SUPPLY.—An initial insu-
lin card issued to an individual under 
this clause shall be valid for an ap-
proximate 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 proc-
essing 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 organiza-
tion, the State, Indian tribe, or tribal orga-
nization shall— 
‘‘(I) determine whether the indi-
vidual is an eligible individual; and 
‘‘(II) if the individual is an eligi-
ble individual, issue the individual an 
insulin card that is valid for an ap-
proximate 90-day supply of insulin 
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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 eligi-
ble 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, In-
dian tribe, or tribal organization. 
‘‘(II) 
LIMITATION.—An 
indi-
vidual that submits an application 
under clause (i) and is denied an insu-
lin card under clause (ii) or (iii) may 
not submit another application under 
clause (i) for the 1-year period begin-
ning on the date on which the indi-
vidual 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, 
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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 contribu-
tions 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 contribu-
tions 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 Gov-
ernment, or services assisted or subsidized to 
any significant extent by the Federal Govern-
ment, 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, 
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Indian tribe, or tribal organization involved to-
ward 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-FED-
ERAL
CONTRIBUTIONS
FOR
MEDICAID.—In 
making a determination of the amount of non- 
Federal contributions for purposes of paragraph 
(1), the Secretary shall, subject to subpara-
graphs (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 re-
lated 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 through-
out the State (including availability to members 
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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 de-
termines that compliance by the State, In-
dian tribe, or tribal organization with the 
requirement would result in an inefficient 
allocation of resources with respect to car-
rying out the purpose described in sub-
section (a)(1). 
‘‘(ii) INDIAN TRIBES AND TRIBAL OR-
GANIZATIONS.—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 require-
ment 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.— 
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‘‘(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 ex-
pended to make payment for any item or serv-
ice 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 subpara-
graph (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 re-
spect to coverage under a high-deductible health 
plan. 
‘‘(3) LIMITATION
ON
ADMINISTRATIVE
EX-
PENSES.—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. 
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‘‘(4) RECORDS
AND
AUDITS.—The Secretary 
may not make a grant under subsection (a) unless 
the State, Indian tribe, or tribal organization in-
volved agrees that— 
‘‘(A) the State, Indian tribe, or tribal orga-
nization will establish such fiscal control and 
fund accounting procedures as may be nec-
essary 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 main-
tained pursuant to subparagraph (A) to the 
Secretary or the Comptroller General of the 
United States for purposes of auditing the ex-
penditures by the State, Indian tribe, or tribal 
organization of the grant; and 
‘‘(C) the State, Indian tribe, or tribal orga-
nization 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 
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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 under-
taking supplied by sources other than 
the grant; and 
‘‘(ii) such other records as the Sec-
retary determines appropriate for facili-
tating an effective audit of grants awarded 
under this section. 
‘‘(5) REPORTS.— 
‘‘(A) REPORTS TO THE SECRETARY.—The 
Secretary may not make a grant under sub-
section (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 inquir-
ies encountered by individuals applying for 
or receiving insulin through a program 
supported by such grant; 
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section (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 re-
ceiving a grant under subsection (a), the Sec-
retary may, subject to subparagraph (B), pro-
vide supplies, equipment, and services for the 
purpose of aiding the State, Indian tribe, or 
tribal organization in carrying out such sub-
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section 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 PAY-
MENTS.—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 Sec-
retary shall, for the payment of expenses in-
curred in complying with such request, expend 
the amounts withheld. 
‘‘(g) EVALUATIONS AND REPORTS.— 
‘‘(1) EVALUATIONS.—The Secretary shall, di-
rectly or through contracts with public or private en-
tities, provide for annual evaluations of programs 
carried out pursuant to subsection (a). Such evalua-
tions shall include evaluations of— 
‘‘(A) the extent to which States, Indian 
tribes, and tribal organizations carrying out 
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such programs are in compliance with sub-
section (a) and with subsection (c)(1); and 
‘‘(B) the extent to which each State, In-
dian 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 en-
actment of the Emergency Access to Insulin Act of 
2019, and annually thereafter, submit to the Com-
mittee 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 para-
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graph (1) during the preceding fiscal year and mak-
ing such recommendations for administrative and 
legislative initiatives with respect to this section as 
the Secretary determines to be appropriate, includ-
ing 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 
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a grant under this section, means an uninsured indi-
vidual 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 or-
ganization, who is a member of the Indian tribe 
or Indian community served by the tribal orga-
nization; and 
‘‘(B) who has a valid prescription for insu-
lin that is prescribed to such individual. 
‘‘(2) GROUP
HEALTH
INSURANCE
COVERAGE; 
GROUP
HEALTH
PLAN; 
HEALTH
INSURANCE 
ISSUER.—The terms ‘group health insurance cov-
erage’, ‘group health plan’, and ‘health insurance 
issuer’ have the meanings given such terms in sec-
tion 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 
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Indian Health Care Improvement Act (25 U.S.C. 
1603). 
‘‘(5) INDIVIDUAL
HEALTH
INSURANCE
COV-
ERAGE.—The term ‘individual health insurance cov-
erage’ 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 ‘un-
insured individual’ means an individual who does not 
have minimum essential coverage as defined in sec-
tion 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.’’. 
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(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 pro-
gram’’; 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 
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Service Act (42 U.S.C. 300gg et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 2710. DEDUCTIBLES FOR UNDERINSURED INDIVID-
UALS PARTICIPATING IN INSULIN ASSIST-
ANCE 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 organi-
zation 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 pur-
poses 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 MANUFAC-
TURERS. 
(a) DEFINITIONS.—For purposes of this section: 
(1) ANNUAL PAYMENT DATE.—The term ‘‘an-
nual payment’’ date means, with respect to a cal-
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endar year, the date determined by the Secretary, 
but in no event later than September 30 of such cal-
endar year. 
(2) COVERED ENTITY.—The term ‘‘covered en-
tity’’, with respect to a calendar year, means an en-
tity that— 
(A) is the holder of an application ap-
proved 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 sub-
section (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 ‘‘Inspec-
tor General’’ means the Inspector General of the De-
partment 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, 
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shall pay to the Secretary not later than the annual pay-
ment date of such calendar year a fee in an amount deter-
mined under subsection (c). 
(c) AMOUNT OF FEES.— 
(1) TOTAL AMOUNT.—The Secretary shall en-
sure 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 ex-
penditures the Secretary determines for car-
rying out such section for the preceding cal-
endar year. 
(2) DETERMINATION OF FEES FOR EACH MAN-
UFACTURER.— 
(A) FORMULA.—With respect to each cov-
ered entity, the fee under this section for a cal-
endar year shall be equal to an amount that 
bears the same ratio to the total amount as-
sessed under subsection (b) for such year as the 
covered entity’s sales of insulin products taken 
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into account during the preceding calendar 
year, bears to the aggregate sales of insulin 
products of all covered entities taken into ac-
count during such preceding calendar year. 
(B) SALES OF INSULIN PRODUCTS.— 
(i) IN
GENERAL.—For purposes of 
this paragraph, the sales of insulin prod-
ucts taken into account during any cal-
endar year with respect to any covered en-
tity shall be determined based on the total 
number of units of the insulin product 
which were sold in commerce in the pre-
ceding 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 an-
nual reports issued by the Inspector 
General and made public under sec-
tion 4(e)(1). 
(ii) FEES ASSESSED FOR CALENDAR 
YEAR 2020.—For purposes of clause (i)(I), 
the Secretary shall require each covered 
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entity to submit to the Secretary informa-
tion on the total number of units of the in-
sulin 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 ac-
tion 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; APPLI-
CATION OF EXCISE TAX. 
(a) DEFINITIONS.—In this section: 
(1) APPLICABLE ENTITY.—The term ‘‘applica-
ble entity’’ means the holder of an application ap-
proved 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 Serv-
ice Act (42 U.S.C. 262), for an insulin product. 
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(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 ‘‘Inspec-
tor General’’ means the Inspector General of the De-
partment 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 allow-
ance. 
(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 cal-
endar year; exceeds 
(ii) the wholesale acquisition cost of 
such insulin product in commerce for the 
calendar year preceding such year. 
(C) APPLICABLE PRICE INCREASE ALLOW-
ANCE.—The applicable price increase allowance 
for any calendar year is the percentage (round-
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ed 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 pre-
ceding 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 com-
merce in such calendar year. 
(C) ADJUSTMENT AMOUNT.—The adjust-
ment 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 
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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 fol-
lowing: 
(A) For each insulin product of the appli-
cable entity— 
(i) the total number of units of the in-
sulin 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 cal-
endar 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 
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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 antici-
pated increased input costs for the subsequent 
calendar quarter as the applicable entity may 
wish the Inspector General to consider in mak-
ing a determination under clause (ii) of sub-
section (c)(2)(B) or an assessment in clause 
(iii) of such subsection for such calendar quar-
ter. 
(2) PENALTY FOR FAILURE TO SUBMIT.— 
(A) IN GENERAL.—An applicable entity de-
scribed in paragraph (1) that fails to submit in-
formation to the Inspector General regarding 
an insulin product, as required by such para-
graph, before the date specified in paragraph 
(3) shall be liable for a civil penalty, as deter-
mined 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 appro-
priate by the Inspector General; which is— 
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(I) not less than 0.5 percent of 
the gross revenues from sales of the 
insulin product described in subpara-
graph (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 cal-
endar 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 In-
spector General receives the informa-
tion described in paragraph (1) from 
the applicable entity. 
(3) SUBMISSION DEADLINE.—An applicable en-
tity 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 
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consultation with other relevant Federal agencies 
(including the Federal Trade Commission), shall— 
(A) complete an assessment of the infor-
mation the Inspector General received pursuant 
to subsection (b)(1) with respect to sales of in-
sulin products in the preceding calendar year; 
and 
(B) in the case of any insulin product 
which satisfies the conditions described in para-
graph (1) or (2) of subsection (d), submit a rec-
ommendation 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 relat-
ing to an insulin product in the preceding cal-
endar year. 
(B) For each price spike identified under 
subparagraph (A)— 
(i) a determination of the price spike 
revenue; 
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(ii) a determination regarding the ac-
curacy 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 In-
spector General pursuant to subsection (c)(1)(B), 
may exempt any insulin product which has been sub-
ject to a price spike during the preceding calendar 
year from application of the tax imposed under sec-
tion 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 
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(B) shall exclude from such consideration 
any information submitted by the applicable en-
tity 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 sub-
paragraph (C), the Inspector General shall 
issue a report containing the information de-
scribed in subparagraph (B) to be made avail-
able 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 pre-
ceding calendar year. 
(ii) The price spikes identified under 
subparagraph (A) of subsection (c)(2). 
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(iii) The price spike revenue deter-
minations made under subparagraph (B)(i) 
of such subsection. 
(iv) The determinations and assess-
ments made under clauses (ii) and (iii) of 
subparagraph (B) of such subsection. 
(C) PROPRIETARY INFORMATION.—The In-
spector General shall ensure that any informa-
tion made public in accordance with subpara-
graph (A) excludes trade secrets and confiden-
tial commercial information. 
(2) REPORT
TO
INTERNAL
REVENUE
SERV-
ICE.— 
(A) IN
GENERAL.—Subject to subpara-
graph (C), not later than the last day in Feb-
ruary of each year, the Inspector General shall 
transmit to the Internal Revenue Service a re-
port 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. 
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(B) CONTENTS.—The report transmitted 
under subparagraph (A) shall include the infor-
mation described in paragraph (1)(B). 
(C) NOTICE AND OPPORTUNITY FOR HEAR-
ING.— 
(i) IN GENERAL.—No report shall be 
transmitted to the Internal Revenue Serv-
ice 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 assess-
ment. 
(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.—Sub-
ject to clause (v), an applicable entity may 
request a hearing before the Secretary of 
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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 re-
quests a hearing pursuant to clause (iii), 
the Secretary of Health and Human Serv-
ices 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 assess-
ment; 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 Sec-
retary of the Treasury shall provide, each applicable entity 
in regard to any insulin product which has been deter-
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mined to have been subject to a price spike during the 
preceding calendar year and the amount of the tax im-
posed 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 applica-
ble 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 cumu-
lative price spike tax for such insulin product. 
‘‘(2) LIMITATION.—In the case of a taxable in-
sulin product for which the applicable period (as de-
termined under subsection (c)(2)(E)(i)) is less than 
2 calendar years, the cumulative price spike tax shall 
not apply. 
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‘‘(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 per-
centage 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 prod-
uct which has been subject to a price spike per-
centage greater than the applicable price in-
crease 
allowance 
(as 
defined 
in 
section 
4(a)(4)(C) of the Emergency Access to Insulin 
Act of 2019) but less than 15 percent, 50 per-
cent, 
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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 percent-
age shall be determined in accordance with the 
following table: 
‘‘Number of years in applicable period 
First 
multi-year 
percentage 
Second 
multi-year 
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 appli-
cable 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. 
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‘‘(ii) BASE
YEAR.—The base year 
shall be the calendar year immediately pre-
ceding 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 com-
merce for the preceding calendar year, 
minus 
‘‘(II) the wholesale acquisition 
cost of such insulin product in com-
merce for the base year, and 
‘‘(ii) the total number of units of such 
insulin product which were sold in com-
merce 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 
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Insulin Act of 2019 for each calendar year dur-
ing 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 en-
tity’, ‘price spike’, ‘price spike percentage’, and 
‘price spike revenue’ have the same meaning given 
such terms under section 4(a) of the Emergency Ac-
cess to Insulin Act of 2019.’’. 
(2) CLERICAL AMENDMENTS.— 
(A) The heading of subchapter E of chap-
ter 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’’. 
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(C) The table of sections for subchapter E 
of chapter 32 of such Code is amended by add-
ing 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 Pub-
lic Health Service Act (42 U.S.C. 262(k)(7)(A)) is amend-
ed 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’’. 
Æ 
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