‘‘(ii) such other records as the Sec-
retary determines appropriate for facili-
tating an effective audit of grants awarded 
under this section; and 
‘‘(C) upon request, the State, Indian tribe, 
or tribal organization will provide records main-
tained pursuant to subparagraphs (A) and (B) 
to the Secretary or the Comptroller General of 
the United States for purposes of auditing the 
expenditures by the State, Indian tribe, or trib-
al organization of the grant. 
‘‘(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; 
‘‘(ii) the number of insulin products 
dispensed through such program and the 
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unit costs for those products during the 
period covered by the report; 
‘‘(iii) the number of pharmacies par-
ticipating 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 Sec-
retary 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-de-
ductible 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. 
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‘‘(d) 
DESCRIPTION
OF
INTENDED
USES
OF 
GRANT.—The Secretary may not make a grant under sub-
section (a) unless— 
‘‘(1) the State, Indian tribe, or tribal organiza-
tion 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 juris-
diction 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 relat-
ing to the services and activities to be provided, in-
cluding a description of the manner in which the 
services and activities will be coordinated with any 
similar services or activities of public or private enti-
ties; and 
‘‘(4) the description provides assurances that 
the grant funds will be used in the most cost-effec-
tive manner. 
‘‘(e) REQUIREMENT OF SUBMISSION OF APPLICA-
TION.—The Secretary may not make a grant under sub-
section (a) unless an application for the grant is submitted 
to the Secretary, the application contains the description 
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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-
section and, for such purpose, may detail to the 
State, Indian tribe, or tribal organization any 
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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 
such programs are in compliance with sub-
section (a) and with subsection (c)(1); and 
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‘‘(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 enact-
ment of the Emergency Access to Insulin Act of 
2023, 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-
graph (1) during the preceding fiscal year and mak-
ing such recommendations for administrative and 
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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 2023 
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 indi-
vidual or an underinsured individual— 
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‘‘(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 
Indian Health Care Improvement Act (25 U.S.C. 
1603). 
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‘‘(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.’’. 
(b) EXEMPTING PRICES USED UNDER AN INSULIN 
ASSISTANCE PROGRAM FROM BEST PRICE AND AVERAGE 
MANUFACTURER PRICE UNDER THE MEDICAID DRUG 
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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 320C 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 inserting a semi-
colon at the end; 
(B) in subclause (VII), by striking ‘‘; and’’ 
and inserting a semicolon; 
(C) in subclause (VIII), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(D) by adding at the end the following new 
subclause: 
‘‘(IX) any prices used under an 
insulin assistance program supported 
under section 320C 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 add-
ing at the end the following: 
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‘‘SEC. 2710. DEDUCTIBLES AND OTHER OUT-OF-POCKET EX-
PENSES 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 organi-
zation carrying out an insulin assistance program under 
section 320C, 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 320C(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-
endar year, the date determined by the Secretary, 
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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 2024 and ending in 2028, 
shall pay to the Secretary not later than the annual pay-
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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 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 2024, information obtained by 
the Secretary under clause (ii); and 
(II) for a fee assessed for each of 
calendar years 2025 through 2028, 
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 2024.—For purposes of clause (i)(I), 
the Secretary shall require each covered 
entity to submit to the Secretary informa-
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tion on the total number of units of the in-
sulin product manufactured by the entity 
that were sold in commerce in calendar 
year 2023. 
(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. 
(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). 
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(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 term 
‘‘price spike percentage’’ means 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 term ‘‘applicable price increase al-
lowance’’, with respect to a calendar year, 
means 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 
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Revenue Code of 1986) for that year exceeds 
the C–CPI–U (as so defined) for the preceding 
calendar year. 
(5) PRICE SPIKE REVENUE.— 
(A) IN GENERAL.—The term ‘‘price spike 
revenue’’, with respect to a calendar year, 
means an amount equal to— 
(i) the gross price spike revenue, 
minus 
(ii) the adjustment amount. 
(B) GROSS PRICE SPIKE REVENUE.—The 
term ‘‘gross price spike revenue’’, with respect 
to a calendar year, means 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 term 
‘‘adjustment amount’’ means 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 nec-
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essary to manufacture the insulin product sub-
ject 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 each of the 
following: 
(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 4191 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 each of 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 4191 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), 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 4191 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 each of the fol-
lowing: 
(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 to the accuracy of such as-
sessment; 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 4191 
of the Internal Revenue Code of 1986. 
(g) EXCISE TAX ON INSULIN PRODUCTS SUBJECT TO 
PRICE SPIKES.— 
(1) IN GENERAL.—Chapter 32 of the Internal 
Revenue Code of 1986 is amended by inserting after 
subchapter D the following new subchapter: 
‘‘Subchapter E—Certain Insulin Products 
‘‘Sec. 4191. Insulin products subject to price spikes. 
‘‘SEC. 4191. 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 
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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 2023, 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 
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Act of 2023) but less than 15 percent, 50 per-
cent, 
‘‘(B) in the case of a taxable insulin prod-
uct which has been subject to a price spike per-
centage equal to or greater than 15 percent but 
less than 20 percent, 75 percent, and 
‘‘(C) in the case of a taxable insulin prod-
uct which has been subject to a price spike per-
centage equal to or greater than 20 percent, 
100 percent. 
‘‘(c) CUMULATIVE PRICE SPIKE TAX.— 
‘‘(1) IN GENERAL.—The amount of the cumu-
lative price spike tax shall be equal to the applicable 
percentage of the cumulative price spike revenue re-
ceived by the applicable entity on the sale of the tax-
able insulin product during the calendar year. 
‘‘(2) APPLICABLE PERCENTAGE.— 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1), the applicable percentage shall be 
equal to— 
‘‘(i) in the case of a taxable insulin 
product which has been subject to a cumu-
lative price spike percentage greater than 
the cumulative price increase allowance but 
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less than the first multi-year percentage, 
50 percent, 
‘‘(ii) in the case of a taxable insulin 
product which has been subject to a cumu-
lative price spike percentage equal to or 
greater than the first multi-year percent-
age 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 cumu-
lative price spike percentage equal to or 
greater than the second multi-year percent-
age, 100 percent. 
‘‘(B) CUMULATIVE PRICE SPIKE PERCENT-
AGE.—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
AL-
LOWANCE.—For purposes of clause (i) of sub-
paragraph (A), the cumulative price increase al-
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lowance 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 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 
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