[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4906 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 4906
To provide patient protections with respect to the cost of insulin.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 29, 2019
Ms. DeGette (for herself and Mr. Reed) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on Ways and Means, 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 provide patient protections with respect to the cost of insulin.
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 ``Insulin Price Reduction Act''.
SEC. 2. INSULIN PRICE PROTECTIONS.
(a) In General.--Subpart II of part A of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at
the end the following:
``SEC. 2729A. INSULIN PRICE PROTECTIONS.
``(a) Contracting Requirements.--
``(1) In general.--
``(A) Requirement.--Except as provided in
subparagraph (B), a group health plan or a health
insurance issuer offering group or individual health
insurance coverage shall not, and shall ensure that any
entity that provides pharmacy benefits management
services under a contract with any such health plan or
health insurance coverage does not, directly or
indirectly, receive from a manufacturer of certified
insulin a rebate, reduction in price, or other
remuneration with respect to such insulin received by
an enrollee in the plan or coverage and covered by the
plan or coverage.
``(B) Exception.--The requirement under
subparagraph (A) shall not apply to--
``(i) any such reduction in price that is
reflected at the point of sale to the enrollee;
or
``(ii) any remuneration that is a flat fee-
based service fee that a manufacturer of such
insulin pays to a pharmacy benefit manager for
services rendered to the manufacturer that
relate to arrangements by the pharmacy benefit
manager to provide pharmacy benefit management
services to a health plan or health insurance
issuer, if certain conditions established by
the Secretary are met, including requirements
that the fees are transparent to the health
plan or health insurance issuer.
``(2) Applicability.--The restriction under paragraph (1)
shall apply with respect to insulin described in paragraph (1),
for which the manufacturer has certified the list price in
accordance with section 5(b) of the Insulin Price Reduction Act
with respect to--
``(A) any plan year in which the list price for
insulin is certified under section 5(b)(2)(A) of the
Insulin Price Reduction Act; and
``(B) each subsequent plan year during which the
manufacturer limits any increase in the list price to
the price that gave rise to the restriction under
paragraph (1), adjusted by not more than the price
change in the medical care component of the consumer
price index for all urban consumers (U.S. city
average), as certified under section 5(b)(2)(B) of the
Insulin Price Reduction Act.
``(b) Deductible Limitation.--A group health plan or a health
insurance issuer offering group or individual health insurance coverage
shall not apply any deductible amount that otherwise is applicable to
prescription drugs with respect to coverage of certified insulin under
such plan or coverage, during the period described in subsection
(a)(2).
``(c) Hold Harmless.--During the period beginning on the date a
certification is first made under section 5(b)(2)(A) of the Insulin
Price Reduction Act and ending on the last day of the second plan year
beginning on or after such date, a group health plan or a health
insurance issuer offering group or individual health insurance coverage
shall not, and shall ensure that any entity that provides pharmacy
benefits management services under a contract with such health plan or
health insurance coverage does not--
``(1) restrict or disadvantage such insulin from the
formulary applicable to the plan or coverage relative to any
other insulin or similar formulation;
``(2) impose higher cost-sharing with respect to such
insulin than the cost-sharing that applied with respect to the
insulin in the year in which the list price reduction
certification was provided under section 5(b)(2)(A) of the
Insulin Price Reduction Act;
``(3) impose any prior authorization requirements for
coverage of such insulin that were not applied during the year
in which the list price reduction certification was provided
under such section 5(b)(2)(A); or
``(4) establish a step therapy requirement for such insulin
that was not applied during the year in which the list price
reduction certification was provided under such section
5(b)(2)(A).
``(d) Definitions.--In this section--
``(1) the term `certified insulin' means, with respect to a
year, insulin that has been certified under section 5(b) of the
Insulin Price Reduction Act for the year;
``(2) the term `insulin' means any insulin product approved
by the Food and Drug Administration to improve glycemic control
in patients with diabetes mellitus;
``(3) the term `list price' has the meaning given the term
`wholesale acquisition cost' in section 1847A(c)(6)(B) of the
Social Security Act; and
``(4) the term `rebate' means any discount, price
concession, or fee, other than the fee described in section
(a)(1)(B), the terms of which are fixed at the time of the sale
and disclosed, but which is not received at the time of the
sale.''.
(b) Conforming Amendment.--Paragraph (2) of section 223(d) of the
Internal Revenue Code of 1986 is amended by redesignating subparagraph
(D) as subparagraph (E) and by inserting after subparagraph (C) the
following new subparagraph:
``(D) Safe harbor for absence of deductible for
insulin.--A plan shall not fail to be treated as a high
deductible health plan by reason of exempting insulin
from any deductible pursuant to section 2729A(b) of the
Public Health Service Act during the period described
in section 2729A(a)(2) of such Act.''.
(c) Effective Date.--The amendments made by subsections (a) and (b)
shall take effect with respect to plan years beginning on or after
January 1, 2022.
SEC. 3. INSULIN PRICE PROTECTIONS UNDER MEDICARE PART D.
Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-104) is
amended--
(1) by redesignating the subsection (m) as added by section
6063(c) of the SUPPORT for Patients and Communities Act (Public
Law 115-271) as subsection (n); and
(2) by adding at the end the following new subsection:
``(o) Limitation on Rebates, Price Reductions, or Other
Remuneration for Certified Insulin.--
``(1) Limitation.--
``(A) In general.--Subject to subparagraphs (B) and
(C), for plan year 2022 and subsequent plan years, a
PDP sponsor and a Medicare Advantage organization shall
ensure that each prescription drug plan or MA-PD plan
offered by the sponsor or organization, and any entity
that provides pharmacy benefits management services
under a contract with the prescription drug plan or MA-
PD plan offered by the sponsor or organization, does
not, directly or indirectly, receive from a
manufacturer of certified insulin a rebate, reduction
in price, or other remuneration with respect to
certified insulin that is covered by the plan.
``(B) Exception.--The requirement under
subparagraph (A) shall not apply to--
``(i) any such reduction in price that is
reflected at the point of sale to the
beneficiary; or
``(ii) any remuneration that is a flat fee-
based service fee that a manufacturer of such
certified insulin pays to a pharmacy benefit
manager for services rendered to the
manufacturer that relate to arrangements by the
pharmacy benefit manager to provide pharmacy
benefit management services to a prescription
drug plan or MA-PD plan, if certain conditions
established by the Secretary are met, including
requirements that the fees are transparent to
the prescription drug plan or MA-PD plan.
``(C) Hold harmless for first 2 years that an
insulin is certified.--In the first 2 plan years during
which paragraph (2) applies with respect to a certified
insulin, a PDP sponsor and a Medicare Advantage
organization shall not, and shall ensure that any
entity that provides pharmacy benefits management
services under a contract with such sponsor or
organization does not--
``(i) remove such insulin from the
formulary applicable to the prescription drug
plan or MA-PD plan;
``(ii) impose higher cost-sharing with
respect to such insulin than the cost-sharing
that applied with respect to the certified
insulin in the year in which the list price
reduction certification was provided under
section 5(b)(2)(A) of the Insulin Price
Reduction Act;
``(iii) impose any prior authorization
requirements for coverage of the certified
insulin that were not applied during the year
in which the list price reduction certification
was provided under such section 5(b)(2)(A); or
``(iv) establish a step therapy requirement
for the certified insulin that was not applied
during the year in which the list price
reduction certification was provided under such
section 5(b)(2)(A).
``(2) Definitions.--In this section:
``(A) Certified insulin.--The term `certified
insulin' means, with respect to a year, insulin that
has been certified under section 5(b) of the Insulin
Price Reduction Act for the year.
``(B) Insulin.--The term `insulin' means any
insulin product approved by the Food and Drug
Administration to improve glycemic control in patients
with diabetes mellitus.
``(C) List price.--The term `list price' has the
meaning given the term `wholesale acquisition cost' in
section 1847A(c)(6)(B).
``(D) Rebate.--The term `rebate' means any
discount, price concession, or fee, other than the fee
described in paragraph (1)(B), the terms of which are
fixed at the time of the sale and disclosed, but which
is not received at the time of the sale.''.
SEC. 4. APPLICABILITY OF PRE-LIST PRICE REDUCTION AMP TO MEDICAID
MINIMUM REBATE AMOUNTS.
Section 1927(c) of the Social Security Act (42 U.S.C. 1396r-8(c))
is amended--
(1) in paragraph (1)(A), in the matter preceding clause
(i), by inserting ``and paragraph (5)'' after ``paragraph
(2)'';
(2) in paragraph (3)(A), in the matter preceding clause
(i), by inserting ``and paragraph (5)'' after ``subparagraph
(C)''; and
(3) by adding at the end the following new paragraph:
``(5) Special rule for determining minimum basic rebates
for insulin.--
``(A) In general.--In determining the amount of the
rebate specified in this subsection for a dosage form
and strength of a covered outpatient drug described in
subparagraph (B) for any rebate period occurring after
April 30, 2020, paragraph (1)(A)(ii)(II) or paragraph
(3)(A)(i) (as applicable) shall be applied by
substituting--
``(i) the pre-reduction average
manufacturer price (as defined in subparagraph
(C)) for the dosage form and strength of the
drug for the rebate period; for
``(ii) the average manufacturer price for
the dosage form and strength of the drug for
the rebate period.
``(B) Drugs described.--A covered outpatient drug
is described in this subparagraph for a rebate period
if the drug is insulin for which, throughout such
rebate period, the manufacturer has certified the list
price for each dosage form and strength of such drug in
accordance with section 5(b) of the Insulin Price
Reduction Act.
``(C) Pre-reduction average manufacturer price.--
For purposes of this paragraph, the term `pre-reduction
average manufacturer price' means, with respect to each
dosage form and strength of a covered outpatient drug
described in subparagraph (B) and a rebate period--
``(i) the average manufacturer price for
such drug for the calendar quarter beginning
July 1, 2019; increased by
``(ii) the percentage by which the consumer
price index for all urban consumers (United
States city average) for the month before the
month in which the rebate period begins exceeds
such index for September 2019.''.
SEC. 5. LIST PRICE DATA SUBMISSIONS.
(a) Initial Submission.--
(1) In general.--Not later than April 30, 2020, any
manufacturer of insulin wishing to receive certification under
this section shall submit to the Secretary--
(A) data on the list price of any insulin
manufactured by the manufacturer during the period
beginning on January 1, 2000 (or the first date on
which such manufacturer begins manufacturing such
insulin), through the list price applicable at the time
of the report; and
(B) a certification that such data is accurate.
(2) Later submissions.--Any manufacturer of insulin that
does not submit the information described in paragraph (1) by
the date described in such paragraph may later submit the
information described in subparagraphs (A) and (B) of paragraph
(1) to the Secretary. Such a manufacturer who submits such
information pursuant to this paragraph is eligible to certify
its list price for the applicable insulin under subsection
(b)(2)(A)(ii) with respect to the first plan year that begins
at least 15 months after the date of submission under this
paragraph.
(b) Annual Price Certification.--
(1) In general.--Any manufacturer of insulin who submits
information in accordance with subsection (a) is eligible for
certification under this subsection.
(2) Requirements.--
(A) First certification.--
(i) Initial eligibility for
certification.--A manufacturer of insulin who
submits information under subsection (a)(1) is
considered certified under this subsection for
plan year 2022 if such manufacturer, not later
than September 30, 2020, submits to the
Secretary a certification that the manufacturer
reduced its list price for insulin to an amount
that is no greater than the list price for the
same insulin that applied as of July 1, 2006.
(ii) Later certification.--A manufacturer
of insulin that submitted information under
subsection (a)(2) not later than September 30
of the calendar year that is 2 years prior to
the applicable plan year, is considered
certified under this subsection for the
applicable plan year if such manufacturer
submits to the Secretary a certification, not
later than September 30 of such calendar year,
that the manufacturer reduced its list price
for insulin to the amount that is no greater
than the list price for the same insulin that
applied as of July 1, 2006, increased by not
more than the rate by which the medical care
component of the consumer price index for all
urban consumers (U.S. city average) increased
between September 30, 2020, and the date on
which the certification is submitted.
(B) Subsequent certification.--For plan year 2023
and each plan year thereafter, a manufacturer of
insulin who previously submitted a certification under
clause (i) or (ii) of subparagraph (A) is considered
certified under this subsection for the applicable plan
year if such manufacturer submits, not later than
September 30 of the calendar year that is 2 years prior
to the applicable plan year, a certification that the
manufacturer did not increase the list price for
insulin previously certified under clause (i) or (ii)
of subparagraph (A), by more than the rate by which the
medical care component of the consumer price index for
all urban consumers (U.S. city average) increased since
the initial certification under such clause (i) or
(ii).
(3) Special rule for certain insulin.--
(A) In general.--In the case of a manufacturer of
insulin that did not manufacture a particular insulin
in 2006, such manufacturer may be certified under this
subsection with respect to such insulin by submitting
information under paragraph (2)(A) certifying that the
list price of such insulin is no greater than the
weighted average list price, in 2006, of, as
applicable--
(i)(I) all short-acting insulins;
(II) all rapid-acting insulins; or
(III) all long-acting insulins; or
(ii) such other insulin categories, as the
Secretary determines appropriate.
(B) Increase.--The weighted averages under
subparagraph (A) shall be increased in accordance with
paragraph (2)(A)(ii), as applicable.
(4) Application to authorized generic insulin.--In the case
of an insulin that is classified as an authorized generic drug,
as defined in section 505(t)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(t)(3)), the manufacturer of such
insulin may be certified under this section by submitting
information under paragraph (1)(A) certifying that the list
price of such authorized generic insulin is no greater than the
list price, as of July 1, 2006, of the listed drug insulin
product upon which the authorized generic drug was based under
section 505(t) of the Federal Food, Drug, and Cosmetic Act. The
certification pursuant to this paragraph applies only to the
authorized generic drug insulin, and does not apply with
respect to the applicable listed drug insulin.
(c) Audits and Penalties.--The Inspector General of the Department
of Health and Human Services may audit the financial records and other
relevant records of any manufacturer submitting data under subsections
(a) and (b), and any manufacturer or officer, director, agent, or
managing employee of such manufacturer that knowingly submits false or
incomplete data shall be subject to a civil penalty for each insulin
for which false or incomplete data are submitted in an amount not to
exceed the greater of--
(1) an amount equal to 2 times the total amount of rebates
paid by the manufacturer to State Medicaid plans for the
insulin for rebate periods occurring in calendar year 2018
under section 1927 of the Social Security Act (42 U.S.C. 1396r-
8); or
(2) an alternative amount to be determined by the
Secretary.
(d) Definitions.--In this section--
(1) the term ``insulin'' means any insulin product approved
by the Food and Drug Administration to improve glycemic control
in patients with diabetes mellitus;
(2) the term ``list price'' has the meaning given the term
``wholesale acquisition cost'' in section 1847A(c)(6)(B) of the
Social Security Act (42 U.S.C. 1395w-3a(c)(6)(B)); and
(3) the term ``Secretary'' means the Secretary of Health
and Human Services.
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