No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6166 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 6166
To expand the drug price negotiation program under title XI of the
Social Security Act and repeal certain changes to the program made by
Public Law 119-21, to apply prescription drug inflation rebates under
the Medicare program to drugs furnished in the commercial market, and
to establish out-of-pocket limits on expenditures for prescription
drugs under private health insurance.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 20, 2025
Mr. Pallone (for himself, Mr. Neal, and Mr. Scott of Virginia)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Ways and
Means, and Education and Workforce, 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 expand the drug price negotiation program under title XI of the
Social Security Act and repeal certain changes to the program made by
Public Law 119-21, to apply prescription drug inflation rebates under
the Medicare program to drugs furnished in the commercial market, and
to establish out-of-pocket limits on expenditures for prescription
drugs under private health insurance.
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 ``Lowering Drug Costs for American
Families Act''.
TITLE I--DRUG PRICE NEGOTIATION PROGRAM
SEC. 101. EXPANDING THE DRUG PRICE NEGOTIATION PROGRAM.
(a) Increasing the Number of Drugs Subject to Negotiation.--Section
1192(a)(4) of the Social Security Act (42 U.S.C. 1320f-1(a)(4)) is
amended by striking ``20'' each place it appears and inserting ``50''
in each such place.
(b) Expansion of Definition of Maximum Fair Price Eligible
Individual.--Section 1191(c)(2) of the Social Security Act (42 U.S.C.
1320f(c)(2)) is amended--
(1) in subparagraph (A), by inserting ``, or a participant,
beneficiary, or enrollee who is enrolled under a group health
plan or health insurance coverage offered in the group or
individual market (as such terms are defined in section 2791 of
the Public Health Service Act) with respect to which there is
in effect an agreement with the Secretary under section 1197
with respect to such selected drug as so furnished or
dispensed'' after ``such selected drug''; and
(2) in subparagraph (B), by inserting ``, or a participant,
beneficiary, or enrollee who is enrolled under a group health
plan or health insurance coverage offered in the group or
individual market (as such terms are defined in section 2791 of
the Public Health Service Act) with respect to which there is
in effect an agreement with the Secretary under section 1197
with respect to such selected drug as so furnished or
administered'' after ``such selected drug''.
(c) Application of Administrative Procedures to New Maximum Fair
Price Eligible Individuals.--Section 1196(a)(3) of the Social Security
Act (42 U.S.C. 1320f-5(a)(3)) is amended--
(1) in subparagraph (A), by striking ``and'' at the end;
(2) in subparagraph (B), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(C) maximum fair price eligible individuals not
described in subparagraph (A) or (B).''.
(d) Health Insurer Agreements.--Part E of title XI of the Social
Security Act (42 U.S.C. 1320f et seq.) is amended--
(1) by redesignating sections 1197 and 1198 as sections
1198 and 1199, respectively; and
(2) by inserting after section 1196 the following new
section:
``SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER HEALTH PLANS.
``(a) Agreement To Participate Under Program.--
``(1) In general.--Subject to paragraph (2), under the
program under this part the Secretary shall be treated as
having in effect an agreement with a group health plan or
health insurance issuer offering group or individual health
insurance coverage (as such terms are defined in section 2791
of the Public Health Service Act), with respect to a price
applicability period and a selected drug with respect to such
period--
``(A) in the case such selected drug furnished or
dispensed at a pharmacy or by mail order service if
coverage is provided under such plan or coverage during
such period for such selected drug as so furnished or
dispensed; and
``(B) in the case such selected drug furnished or
administered by a hospital, physician, or other
provider of services or supplier if coverage is
provided under such plan or coverage during such period
for such selected drug as so furnished or administered.
``(2) Opting out of agreement.--The Secretary shall not be
treated as having in effect an agreement under the program
under this part with a group health plan or health insurance
issuer offering group or individual health insurance coverage
with respect to a price applicability period and a selected
drug with respect to such period if such a plan or issuer
affirmatively elects, through a process specified by the
Secretary, not to participate under the program with respect to
such period and drug.
``(b) Publication of Election.--With respect to each price
applicability period and each selected drug with respect to such
period, the Secretary and the Secretary of Labor and the Secretary of
the Treasury, as applicable, shall make public a list of each group
health plan and each health insurance issuer offering group or
individual health insurance coverage, with respect to which coverage is
provided under such plan or coverage for such drug, that has elected
under subsection (a) not to participate under the program with respect
to such period and drug.''.
(e) Application to Group Health Plans and Health Insurance
Coverage.--
(1) PHSA.--Part D of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-111 et seq.) is amended by adding
at the end the following new section:
``SEC. 2799A-11. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF
MAXIMUM FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group or individual health insurance coverage
that is treated under section 1197 of the Social Security Act as having
in effect an agreement with the Secretary under the Drug Price
Negotiation Program under part E of title XI of such Act, with respect
to a price applicability period (as defined in section 1191(b) of such
Act) and a selected drug (as defined in section 1192(c) of such Act)
with respect to such period for which coverage is provided under such
plan or coverage--
``(1) the provisions of such part shall apply--
``(A) in the case the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
such plan or coverage, and to the participants,
beneficiaries, and enrollees enrolled under such plan
or coverage, during such period, with respect to such
selected drug, in the same manner as such provisions
apply to prescription drug plans and MA-PD plans, and
to participants, beneficiaries, and enrollees enrolled
under such prescription drug plans and MA-PD plans
during such period; and
``(B) in the case the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to such plan or
coverage, and to the participants, beneficiaries, and
enrollees enrolled under such plan or coverage, and to
hospitals, physicians, and other providers of services
and suppliers during such period, with respect to such
drug in the same manner as such provisions apply to the
Secretary, to participants, beneficiaries, and
enrollees entitled to benefits under part A of title
XVIII or enrolled under part B of such title, and to
hospitals, physicians, and other providers and
suppliers participating under title XVIII during such
period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, such participants,
beneficiaries, and enrollees so enrolled in such plans and
coverage, and such hospitals, physicians, and other providers
and suppliers participating in such plans and coverage.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group or individual health insurance coverage shall publicly
disclose, in a manner and in accordance with a process specified by the
Secretary, any election made under section 1197 of the Social Security
Act by such plan or issuer to not participate in the Drug Price
Negotiation Program under part E of title XI of such Act with respect
to a selected drug (as defined in section 1192(c) of such Act) for
which coverage is provided under such plan or coverage before the
beginning of the plan year for which such election was made.''.
(2) ERISA.--
(A) In general.--Subpart B of part 7 of subtitle B
of title I 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:
``SEC. 726. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group health insurance coverage that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary of Health and Human Services
under the Drug Price Negotiation Program under part E of title XI of
such Act, with respect to a price applicability period (as defined in
section 1191(b) of such Act) and a selected drug (as defined in section
1192(c) of such Act) with respect to such period for which coverage is
provided under such plan or coverage--
``(1) the provisions of such part shall apply, as
applicable--
``(A) in the case the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
such plan or coverage, and to the participants and
beneficiaries enrolled under such plan or coverage,
during such period, with respect to such selected drug,
in the same manner as such provisions apply to
prescription drug plans and MA-PD plans, and to
participants and beneficiaries enrolled under such
prescription drug plans and MA-PD plans during such
period; and
``(B) in the case the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the group health
plan or coverage offered by an issuer, to the
participants and beneficiaries enrolled under such
plans or coverage, and to hospitals, physicians, and
other providers of services and suppliers during such
period, with respect to such drug in the same manner as
such provisions apply to the Secretary of Health and
Human Services, to participants and beneficiaries
entitled to benefits under part A of title XVIII or
enrolled under part B of such title, and to hospitals,
physicians, and other providers and suppliers
participating under title XVIII during such period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, and such participants and
beneficiaries so enrolled in such plans.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group health insurance coverage shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
or issuer to not participate in the Drug Price Negotiation Program
under part E of title XI of such Act with respect to a selected drug
(as defined in section 1192(c) of such Act) for which coverage is
provided under such plan or coverage before the beginning of the plan
year for which such election was made.''.
(B) Application to retiree and certain small group
health plans.--Section 732(a) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1191a(a)) is amended by striking ``section 711'' and
inserting ``sections 711 and 726''.
(C) Clerical amendment.--The table of contents in
section 1 of such Act is amended by inserting after the
item relating to section 725 the following new item:
``Sec. 726. Drug Price Negotiation Program and application of maximum
fair prices.''.
(3) IRC.--
(A) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at
the end the following new section:
``SEC. 9826. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary of Health and Human Services
under the Drug Price Negotiation Program under part E of title XI of
such Act, with respect to a price applicability period (as defined in
section 1191(b) of such Act) and a selected drug (as defined in section
1192(c) of such Act) with respect to such period for which coverage is
provided under such plan--
``(1) the provisions of such part shall apply, as
applicable--
``(A) if coverage of such selected drug is provided
under such plan if the drug is furnished or dispensed
at a pharmacy or by a mail order service, to the plan,
and to the participants and beneficiaries enrolled
under such plan during such period, with respect to
such selected drug, in the same manner as such
provisions apply to prescription drug plans and MA-PD
plans, and to participants and beneficiaries enrolled
under such prescription drug plans and MA-PD plans
during such period; and
``(B) if coverage of such selected drug is provided
under such plan if the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the plan, to the
participants and beneficiaries enrolled under such
plan, and to hospitals, physicians, and other providers
of services and suppliers during such period, with
respect to such drug in the same manner as such
provisions apply to the Secretary of Health and Human
Services, to participants and beneficiaries entitled to
benefits under part A of title XVIII or enrolled under
part B of such title, and to hospitals, physicians, and
other providers and suppliers participating under title
XVIII during such period;
``(2) the plan shall apply any cost-sharing
responsibilities under such plan, with respect to such selected
drug, by substituting an amount not more than the maximum fair
price negotiated under such part E of title XI for such drug in
lieu of the drug price upon which the cost-sharing would have
otherwise applied, and such cost-sharing responsibilities with
respect to such selected drug may not exceed such maximum fair
price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan and such participants and beneficiaries so
enrolled in such plan.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
to not participate in the Drug Price Negotiation Program under part E
of title XI of such Act with respect to a selected drug (as defined in
section 1192(c) of such Act) for which coverage is provided under such
plan before the beginning of the plan year for which such election was
made.''.
(B) Application to retiree and certain small group
health plans.--Section 9831(a)(2) of the Internal
Revenue Code of 1986 is amended by inserting ``other
than with respect to section 9826,'' before ``any group
health plan''.
(C) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue
Code of 1986 is amended by adding at the end the
following new item:
``Sec. 9826. Drug Price Negotiation Program and application of maximum
fair prices.''.
SEC. 102. REQUIRING CONSIDERATION OF AVERAGE INTERNATIONAL MARKET PRICE
UNDER DRUG PRICE NEGOTIATION PROGRAM.
(a) In General.--Section 1194(e) of the Social Security Act (42
U.S.C. 1320f-3(e)) is amended by adding at the end the following new
paragraph:
``(3) Average international market price.--
``(A) In general.--The average price (which shall
be the net average price, if practicable, and volume-
weighted, if practicable) for a unit (as defined in
subparagraph (C)) of such drug for sales of such drug
(calculated across different dosage forms and strengths
of the drug and not based on the specific formulation
or package size or package type), as computed (as of
the date of publication of such drug as a selected drug
under section 1192(a)) in all countries described in
clause (ii) of subparagraph (B) that are applicable
countries (as described in clause (i) of such
subparagraph) with respect to such drug.
``(B) Applicable countries.--
``(i) In general.--For purposes of
subparagraph (A), a country described in clause
(ii) is an applicable country described in this
clause with respect to a drug if there is
available an average price for any unit for the
drug for sales of such drug in such country.
``(ii) Countries described.--For purposes
of this paragraph, the following are countries
described in this clause:
``(I) Australia.
``(II) Canada.
``(III) France.
``(IV) Germany.
``(V) Japan.
``(VI) The United Kingdom.
``(C) Unit defined.--For purposes of this
paragraph, term `unit' means, with respect to a drug,
the lowest identifiable quantity (such as a capsule or
tablet, milligram of molecules, or grams) of the drug
that is dispensed.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply with respect to negotiations under the Drug Price Negotiation
Program under part E of title XI of the Social Security Act (42 U.S.C.
1320f et seq.) for initial price applicability years beginning on or
after January 1, 2028, and renegotiations under such program for years
beginning on or after such date.
SEC. 103. REPEALING CERTAIN CHANGES TO THE DRUG PRICE NEGOTIATION
PROGRAM MADE BY PUBLIC LAW 119-21.
Section 71203 of the Act titled ``An Act to provide for
reconciliation pursuant to title II of H. Con. Res. 14'' (Public Law
119-21) is repealed, and the provisions of law amended by such section
are hereby restored as if such section had not been enacted into law.
TITLE II--PRESCRIPTION DRUG INFLATION REBATES
SEC. 201. APPLICATION OF PRESCRIPTION DRUG INFLATION REBATES TO DRUGS
FURNISHED IN THE COMMERCIAL MARKET.
(a) Part B Drugs.--
(1) Application of prescription drug inflation rebates to
drugs furnished in the commercial market.--Section 1847A(i) of
the Social Security Act (42 U.S.C. 1395w-3a(i)) is amended--
(A) in paragraph (1)(A)(i), by striking ``units''
and inserting ``billing units'';
(B) in paragraph (2)(A), by striking ``for which
payment is made under this part'' and inserting ``that
would be payable under this part if such drug were
furnished to an individual enrolled under this part'';
and
(C) in paragraph (3)--
(i) in subparagraph (A)(i), by striking
``units'' and inserting ``billing units''; and
(ii) by striking subparagraph (B) and
inserting the following:
``(B) Total number of billing units.--For purposes
of subparagraph (A)(i), the total number of billing
units with respect to a part B rebatable drug is
determined as follows:
``(i) Determine the total number of units
equal to--
``(I) the total number of units, as
reported under subsection (c)(1)(B) for
each National Drug Code of such drug
during the calendar quarter that is two
calendar quarters prior to the calendar
quarter as described in subparagraph
(A), minus
``(II) the total number of units
with respect to each National Drug Code
of such drug for which payment was made
under a State plan under title XIX (or
waiver of such plan), as reported by
States under section 1927(b)(2)(A) for
the rebate period that is the same
calendar quarter as described in
subclause (I).
``(ii) Convert the units determined under
clause (i) to billing units for the billing and
payment code of such drug, using a methodology
similar to the methodology used under this
section, by dividing the units determined under
clause (i) for each National Drug Code of such
drug by the billing unit for the billing and
payment code of such drug.
``(iii) Compute the sum of the billing
units for each National Drug Code of such drug
in clause (ii).''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to calendar quarters beginning after
the date of the enactment of this Act.
(b) Covered Part D Drugs.--
(1) Application of prescription drug inflation rebates to
drugs furnished in the commercial market.--Section 1860D-14B of
the Social Security Act (42 U.S.C. 1395w-114b) is amended--
(A) in subsection (b)--
(i) in paragraph (1)--
(I) in subparagraph (A)(i), by
striking ``the total number of units''
and all that follows through the
semicolon and inserting the following:
``the total number of units that are
used to calculate the average
manufacturer price of such dosage form
and strength with respect to such part
D rebatable drug, as reported by the
manufacturer of such drug under section
1927 for each month, with respect to
such period;''; and
(II) by striking subparagraph (B)
and inserting the following:
``(B) Excluded units.--For purposes of subparagraph
(A)(i), the Secretary shall exclude from the total
number of units for a dosage form and strength with
respect to a part D rebatable drug, with respect to an
applicable period, the following:
``(i) Units of each dosage form and
strength of such part D rebatable drug for
which payment was made under a State plan under
title XIX (or waiver of such plan), as reported
by States under section 1927(b)(2)(A).
``(ii) Units of each dosage form and
strength of such part D rebatable drug for
which a rebate is paid under section 1847A(i).
``(iii) Beginning with plan year 2026,
units of each dosage form and strength of such
part D rebatable drug for which the
manufacturer provides a discount under the
program under section 340B of the Public Health
Service Act.''; and
(ii) in paragraph (6), by striking
``information'' and all that follows through
``rebatable covered part D drug dispensed'' and
inserting the following: ``AMP reports.--The
Secretary shall provide for a method and
process under which, in the case of a
manufacturer of a part D rebatable drug that
submits revisions to information submitted
under section 1927 by the manufacturer with
respect to such drug''; and
(B) by striking subsection (d) and inserting the
following:
``(d) Information.--For purposes of carrying out this section, the
Secretary shall use information submitted by manufacturers under
section 1927(b)(3) and information submitted by States under section
1927(b)(2)(A).''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to applicable periods (as defined in
section 1860D-14B(g)(7) of the Social Security Act (42 U.S.C.
1395w-114b(g)(7))) beginning after the date of the enactment of
this Act.
TITLE III--OUT-OF-POCKET LIMITS FOR PRESCRIPTION DRUGS
SEC. 301. ESTABLISHING AN OUT-OF-POCKET LIMIT ON EXPENDITURES FOR
PRESCRIPTION DRUGS UNDER GROUP HEALTH PLANS AND GROUP AND
INDIVIDUAL HEALTH INSURANCE COVERAGE.
(a) PHSA.--Title XXVII of the Public Health Service Act (42 U.S.C.
300gg et seq.), as amended by section 101, is further amended--
(1) in section 2707, by adding at the end the following new
subsection:
``(e) Sunset.--The preceding provisions of this section shall not
apply with respect to plan years beginning on or after January 1,
2027.''; and
(2) in part D, by adding at the end the following new
section:
``SEC. 2799A-12. COMPREHENSIVE COVERAGE.
``(a) Coverage for Essential Health Benefits Package.--A health
insurance issuer that offers health insurance coverage in the
individual or small group market shall ensure that such coverage
includes the essential health benefits package required under section
1302(a) of the Patient Protection and Affordable Care Act.
``(b) Cost-Sharing Limitation.--
``(1) In general.--A group health plan and a health
insurance issuer offering group or individual health insurance
coverage shall ensure that--
``(A) any annual cost-sharing imposed under the
plan or coverage (including any such cost-sharing so
imposed with respect to prescription drugs) does not
exceed the dollar amounts specified in paragraph (2);
and
``(B) any annual cost-sharing imposed under the
plan or coverage with respect to prescription drugs
does not exceed the dollar amounts specified in
paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027,
$2,000; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2026 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan or coverage.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(c) Child-Only Plans.--If a health insurance issuer offers health
insurance coverage in any level of coverage specified under section
1302(d) of the Patient Protection and Affordable Care Act, the issuer
shall also offer such coverage in that level as a plan in which the
only enrollees are individuals who, as of the beginning of a plan year,
have not attained the age of 21.
``(d) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(b) ERISA.--
(1) In general.--Subpart B of part 7 of subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.), as amended by section 101, is further
amended by adding at the end the following new section:
``SEC. 727. COMPREHENSIVE COVERAGE.
``(a) Coverage for Essential Health Benefits Package.--A health
insurance issuer that offers health insurance coverage in the small
group market shall ensure that such coverage includes the essential
health benefits package required under section 1302(a) of the Patient
Protection and Affordable Care Act.
``(b) Cost-Sharing Limitation.--
``(1) In general.--A group health plan and a health
insurance issuer offering group health insurance coverage shall
ensure that--
``(A) any annual cost-sharing imposed under the
plan or coverage (including any such cost-sharing so
imposed with respect to prescription drugs) does not
exceed the dollar amounts specified in paragraph (2);
and
``(B) any annual cost-sharing imposed under the
plan or coverage with respect to prescription drugs
does not exceed the dollar amounts specified in
paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027,
$2,000; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2026 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan or coverage.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(c) Child-Only Plans.--If a health insurance issuer offers health
insurance coverage in any level of coverage specified under section
1302(d) of the Patient Protection and Affordable Care Act, the issuer
shall also offer such coverage in that level as a plan in which the
only enrollees are individuals who, as of the beginning of a plan year,
have not attained the age of 21.
``(d) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(2) Clerical amendment.--The table of contents in section 1
of such Act is amended by inserting after the item relating to
section 726 (as inserted by section 101) the following new
item:
``Sec. 727. Comprehensive coverage.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by section 101, is
further amended by adding at the end the following new section:
``SEC. 9827. COMPREHENSIVE COVERAGE.
``(a) Cost-Sharing Limitation.--
``(1) In general.--A group health plan shall ensure that--
``(A) any annual cost-sharing imposed under the
plan (including any such cost-sharing so imposed with
respect to prescription drugs) does not exceed the
dollar amounts specified in paragraph (2); and
``(B) any annual cost-sharing imposed under the
plan with respect to prescription drugs does not exceed
the dollar amounts specified in paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2027,
$2,000; and
``(ii) for plan years beginning in 2028 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2027 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2026 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(b) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986, as amended by section 101, is further amended by adding
at the end the following new item:
``Sec. 9827. Comprehensive coverage.''.
(d) Conforming Amendments.--The Patient Protection and Affordable
Care Act (Public Law 111-148) is amended--
(1) in section 1302--
(A) in subsection (a)(2), by inserting ``with
respect to plan years beginning before January 1,
2027,'' before ``limits cost-sharing''; and
(B) in subsection (e)(1)(B)(i)--
(i) by inserting ``(or, with respect to
plan years beginning on or after January 1,
2027, in effect under section 2799A-
12(b)(1)(A)) of the Public Health Service
Act)'' after ``subsection (c)(1)''; and
(ii) by inserting ``and except, with
respect to plan years beginning on or after
January 1, 2027, in the case of an individual
who has incurred cost-sharing expenses with
respect to prescription drugs in an amount
equal to the annual limitation in effect under
section 2799A-12(b)(1)(B) of such Act, for
benefits consisting of prescription drugs''
after ``section 2713''; and
(2) in section 1402(c)(1)(A), by inserting ``(or, with
respect to plan years beginning on or after January 1, 2027,
the applicable out-of-pocket limit under section 2799A-
12(b)(1)(A) of the Public Health Service Act)'' after ``section
1302(c)(1)''.
(e) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2027.
SEC. 302. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR INSULIN
PRODUCTS.
(a) PHSA.--Part D of title XXVII of the Public Health Service Act
(42 U.S.C. 300gg-111 et seq.), as amended by sections 101 and 301, is
further amended by adding at the end the following new section:
``SEC. 2799A-13. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2027, a group health plan or health insurance issuer offering group or
individual health insurance coverage shall provide coverage of selected
insulin products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan or coverage, including price concessions received
by or on behalf of third-party entities providing
services to the plan or coverage, such as pharmacy
benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan or
health insurance issuer.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 and
continues to be marketed under such section, including any
insulin product that has been deemed to be licensed under
section 351(a) pursuant to section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of 2009 (Public Law 111-
148) and continues to be marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.''.
(b) ERISA.--
(1) In general.--Subpart B of part 7 of subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.), as amended by sections 101 and 301, is
further amended by adding at the end the following new section:
``SEC. 728. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2027, a group health plan or health insurance issuer offering group
health insurance coverage shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan or coverage, including price concessions received
by or on behalf of third-party entities providing
services to the plan or coverage, such as pharmacy
benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan or
health insurance issuer.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 of
the Public Health Service Act (42 U.S.C. 262) and continues to
be marketed under such section, including any insulin product
that has been deemed to be licensed under section 351(a) of
such Act pursuant to section 7002(e)(4) of the Biologics Price
Competition and Innovation Act of 2009 (Public Law 111-148) and
continues to be marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.''.
(2) Clerical amendment.--The table of contents in section 1
of such Act is amended by inserting after the item relating to
section 727 (as inserted by section 301) the following new
item:
``Sec. 728. Requirements with respect to cost-sharing for certain
insulin products.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by sections 101 and
301, is further amended by adding at the end the following new
section:
``SEC. 9828. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2027, a group health plan shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan, including price concessions received by or on
behalf of third-party entities providing services to
the plan, such as pharmacy benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 of
the Public Health Service Act (42 U.S.C. 262) and continues to
be marketed under such section, including any insulin product
that has been deemed to be licensed under section 351(a) of
such Act pursuant to section 7002(e)(4) of the Biologics Price
Competition and Innovation Act of 2009 (Public Law 111-148) and
continues to be marketed pursuant to such licensure.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan that has a network of providers to provide benefits for selected
insulin products described in this section that are delivered by an
out-of-network provider, or precludes a plan that has a network of
providers from imposing higher cost-sharing than the levels specified
in subsection (a) for selected insulin products described in this
section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan from imposing
cost-sharing other than the levels specified in subsection (a) on,
insulin products that are not selected insulin products, to the extent
that such coverage is not otherwise required and such cost-sharing is
otherwise permitted under Federal and applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986, as amended by sections 101 and 301, is further amended by
adding at the end the following new item:
``Sec. 9828. Requirements with respect to cost-sharing for certain
insulin products.''.
(d) No Effect on Other Cost-Sharing.--Section 1302(d)(2) of the
Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is
amended by adding at the end the following new subparagraph:
``(D) Special rule relating to insulin coverage.--
The exemption of coverage of selected insulin products
(as defined in section 2799A-13(b) of the Public Health
Service Act) from the application of any deductible
pursuant to section 2799A-13(a)(1) of such Act, section
728(a)(1) of the Employee Retirement Income Security
Act of 1974, or section 9828(a)(1) of the Internal
Revenue Code of 1986 shall not be considered when
determining the actuarial value of a qualified health
plan under this subsection.''.
(e) Coverage of Certain Insulin Products Under Catastrophic
Plans.--Section 1302(e) of the Patient Protection and Affordable Care
Act (42 U.S.C. 18022(e)) is amended by adding at the end the following
new paragraph:
``(4) Coverage of certain insulin products.--
``(A) In general.--Notwithstanding paragraph
(1)(B)(i), a health plan described in paragraph (1)
shall provide coverage of selected insulin products, in
accordance with section 2799A-13 of the Public Health
Service Act, for a plan year before an enrolled
individual has incurred cost-sharing expenses in an
amount equal to the annual limitation in effect under
subsection (c)(1) for the plan year.
``(B) Terminology.--For purposes of subparagraph
(A)--
``(i) the term `selected insulin products'
has the meaning given such term in section
2799A-13(b) of the Public Health Service Act;
and
``(ii) the requirements of section 2799A-13
of such Act shall be applied by deeming each
reference in such section to `individual health
insurance coverage' to be a reference to a plan
described in paragraph (1).''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
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