[Congressional Record Volume 164, Number 154 (Monday, September 17, 2018)]
[Senate]
[Pages S6179-S6180]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PATIENT RIGHT TO KNOW DRUG PRICES ACT
The PRESIDING OFFICER. Under the previous order, the Senate will
proceed to the consideration of S. 2554, which the clerk will report.
The legislative clerk read as follows:
A bill (S. 2554) to ensure that health insurance issuers
and group health plans do not prohibit pharmacy providers
from providing certain information to enrollees.
Amendment No. 4011
The PRESIDING OFFICER. Under the previous order, the clerk will
report the Lee amendment.
The legislative clerk read as follows:
The Senator from Tennessee [Mr. Alexander] for Mr. Lee
proposes an amendment numbered 4011.
The amendment is as follows:
(Purpose: To limit application of the gag clause to self-insured group
health plans)
On page 4, strike line 2 and all that follows through line
6 on page 5 and insert the following:
``(a) In General.--A self-insured group health plan shall--
``(1) not restrict, directly or indirectly, any pharmacy
that dispenses a prescription drug to an enrollee in the plan
from informing (or penalize such pharmacy for informing) an
enrollee of any differential between the enrollee's out-of-
pocket cost under the plan with respect to acquisition of the
drug and the amount an individual would pay for acquisition
of the drug without using the plan; and
``(2) ensure that any entity that provides pharmacy
benefits management services under a contract with any such
health plan does not, with respect to such plan, restrict,
directly or indirectly, a pharmacy that dispenses a
prescription drug from informing (or penalize such pharmacy
for informing) an enrollee of any differential between the
enrollee's out-of-pocket cost under the plan with respect to
acquisition of the drug and the amount an individual would
pay for acquisition of the drug without using the plan.
``(b) Definition.--For purposes of this section, the term
`out-of-pocket cost', with respect to acquisition of a drug,
means the amount to be paid by the enrollee under the health
plan, including any cost-sharing (including any deductible,
copayment, or coinsurance) and, as determined by the
Secretary, any other expenditure.''.
The PRESIDING OFFICER. The question now occurs on agreeing to
amendment No. 4011.
Mr. LEE. I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.
The clerk will call the roll.
The result was announced--yeas 11, nays 89, as follows:
[Rollcall Vote No. 208 Leg.]
YEAS--11
Crapo
Daines
Flake
Hatch
Hyde-Smith
Johnson
Lee
Risch
Sasse
Scott
Toomey
NAYS--89
Alexander
Baldwin
Barrasso
Bennet
Blumenthal
Blunt
Booker
Boozman
Brown
Burr
Cantwell
Capito
Cardin
Carper
Casey
Cassidy
Collins
Coons
Corker
Cornyn
Cortez Masto
Cotton
Cruz
Donnelly
Duckworth
Durbin
Enzi
Ernst
Feinstein
Fischer
Gardner
Gillibrand
Graham
Grassley
Harris
Hassan
Heinrich
Heitkamp
Heller
Hirono
Hoeven
Inhofe
Isakson
Jones
Kaine
Kennedy
King
Klobuchar
Kyl
Lankford
Leahy
Manchin
Markey
McCaskill
McConnell
Menendez
Merkley
Moran
Murkowski
Murphy
Murray
Nelson
Paul
Perdue
Peters
Portman
Reed
Roberts
Rounds
Rubio
Sanders
Schatz
Schumer
Shaheen
Shelby
Smith
Stabenow
Sullivan
Tester
Thune
Tillis
Udall
Van Hollen
Warner
Warren
Whitehouse
Wicker
Wyden
Young
The amendment (No. 4011) was rejected.
The PRESIDING OFFICER. The Senator from Tennessee.
Mr. ALEXANDER. Mr. President, I ask unanimous consent that the
committee-reported substitute amendment to S. 2554 be agreed to.
The PRESIDING OFFICER. Is there objection?
Without objection, it is so ordered.
The committee amendment in the nature of a substitute was agreed to
as follows:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Right to Know Drug
Prices Act''.
SEC. 2. PROHIBITION ON LIMITING CERTAIN INFORMATION ON DRUG
PRICES.
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. 2729. INFORMATION ON PRESCRIPTION DRUGS.
``(a) In General.--A group health plan or a health
insurance issuer offering group or individual health
insurance coverage shall--
``(1) not restrict, directly or indirectly, any pharmacy
that dispenses a prescription drug to an enrollee in the plan
or coverage from informing (or penalize such pharmacy for
informing) an enrollee of any differential between the
enrollee's out-of-pocket cost under the plan or coverage with
respect to acquisition of the drug and the amount an
individual would pay for acquisition of the drug without
using any health plan or health insurance coverage; and
``(2) ensure that any entity that provides pharmacy
benefits management services under a contract with any such
health plan or health insurance coverage does not, with
respect to such plan or coverage, restrict, directly or
indirectly, a pharmacy that dispenses a prescription drug
from informing (or penalize such pharmacy for informing) an
enrollee of any differential between the enrollee's out-of-
pocket cost under the plan or coverage with respect to
acquisition of the drug and the amount an individual would
pay for acquisition of the drug without using any health plan
or health insurance coverage.
``(b) Definition.--For purposes of this section, the term
`out-of-pocket cost', with respect to acquisition of a drug,
means the amount to be paid by the enrollee under the plan or
coverage, including any cost-sharing (including any
deductible, copayment, or coinsurance) and, as determined by
the Secretary, any other expenditure.''.
SEC. 3. MODERNIZING THE REPORTING OF BIOLOGICAL AND
BIOSIMILAR PRODUCTS.
Subtitle B of title XI of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (Public Law 108-
173) is amended--
(1) in section 1111--
(A) by redesignating paragraphs (3) through (8) as
paragraphs (6) through (11), respectively;
(B) by inserting after paragraph (2) the following:
``(3) Biosimilar biological product.--The term `biosimilar
biological product' means a biological product for which an
application under section 351(k) of the Public Health Service
Act is approved.
``(4) Biosimilar biological product applicant.--The term
`biosimilar biological product applicant' means a person who
has filed or received approval for a biosimilar biological
product under section 351(k) of the Public Health Service
Act.
``(5) Biosimilar biological product application.--The term
`biosimilar biological product application' means an
application for licensure of a biological product under
section 351(k) of the Public Health Service Act.'';
(C) in paragraph (6), as so redesignated, by inserting ``,
or a biological product for which an application is approved
under section 351(a) of the Public Health Service Act''
before the period;
(D) in paragraph (7), as so redesignated--
(i) by striking ``paragraph (3)'' and inserting ``paragraph
(6)'';
(ii) by inserting ``or a reference product in a biosimilar
biological product application'' after ``ANDA''; and
(iii) by inserting ``or under section 351(a) of the Public
Health Service Act'' before the period; and
(E) by adding at the end the following:
``(12) Reference product.--The term `reference product'
means a brand name drug for which a license is in effect
under section 351(a) of the Public Health Service Act.'';
(2) in section 1112--
(A) in subsection (a)--
(i) in paragraph (1)--
(I) by inserting ``or a biosimilar biological product
applicant who has submitted a biosimilar biological product
application for which a statement under section
351(l)(3)(B)(ii)(I) of the Public Health Service Act has been
provided'' after ``Federal Food, Drug, and Cosmetic Act'';
and
(II) by inserting ``or the biosimilar biological product
that is the subject of the biosimilar biological product
application, as applicable'' after ``the ANDA''; and
(ii) in paragraph (2)--
(I) in the matter preceding subparagraph (A), by inserting
``or a biosimilar biological product applicant'' after
``generic drug applicant'';
(II) in subparagraph (A)--
(aa) by striking ``marketing'' and inserting
``marketing,''; and
(bb) by inserting ``or the reference product in the
biosimilar biological product application'' before
``involved'';
(III) in subparagraph (B), by inserting ``or of the
biosimilar biological product for which the biosimilar
biological product application was submitted'' after
``submitted''; and
(IV) by amending subparagraph (C) to read as follows:
[[Page S6180]]
``(C) as applicable--
``(i) the 180-day period referred to in section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
as it applies to such ANDA or to any other ANDA based on the
same brand name drug; or
``(ii) the 1-year period referred to in section
351(k)(6)(A) of the Public Health Service Act as it applies
to such biosimilar biological product application or to any
other biosimilar biological product application based on the
same brand name drug.''; and
(B) in subsection (b)--
(i) by amending paragraph (1) to read as follows:
``(1) Requirement.--
``(A) Generic drugs.--A generic drug applicant that has
submitted an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic
Act with respect to a listed drug and another generic drug
applicant that has submitted an ANDA containing such a
certification for the same listed drug shall each file the
agreement in accordance with subsection (c). The agreement
shall be filed prior to the date of the first commercial
marketing of either of the generic drugs for which such ANDAs
were submitted.
``(B) Biosimilar biological products.--A biosimilar
biological product applicant that has submitted a biosimilar
biological product application for which a statement under
section 351(l)(3)(B)(ii)(I) of the Public Health Service Act
has been provided with respect to a reference product and
another biosimilar biological product applicant that has
submitted a biosimilar biological product application for
which such a statement for the same reference product has
been provided shall each file the agreement in accordance
with subsection (c). The agreement shall be filed prior to
the date of the first commercial marketing of either of the
biosimilar biological products for which such biosimilar
biological product applications were submitted.''; and
(ii) in paragraph (2)--
(I) by striking ``between two generic drug applicants is an
agreement'' and inserting ``is, as applicable, an agreement
between 2 generic drug applicants''; and
(II) by inserting ``, or an agreement between 2 biosimilar
biological product applicants regarding the 1-year period
referred to in section 351(k)(6)(A) of the Public Health
Service Act as it applies to the biosimilar biological
product applications with which the agreement is concerned''
before the period;
(3) in section 1115, by striking ``or generic drug
applicant'' each place such term appears and inserting ``,
generic drug applicant, or biosimilar biological product
applicant''; and
(4) in section 1117, by striking ``, or any agreement
between generic drug applicants'' and inserting ``or a
biosimilar biological product applicant, any agreement
between generic drug applicants, or any agreement between
biosimilar biological product applicants''.
Mr. ALEXANDER. Mr. President, the next vote is on Senator Collins'
amendment on the gag rule with Senator McCaskill.
Following that, we will vote on the Opioid Crisis Act of 2018, which
has the contributions of 72 Senators.
I would like to especially thank Senator McConnell and Senator
Schumer for creating an environment in which we could get this done.
Mr. President, I ask unanimous consent that the votes following the
first vote in this series be 10 minutes in length.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will read the title of the bill for the third time.
The bill, as amended, was ordered to be engrossed for a third reading
and was read the third time.
The PRESIDING OFFICER. The bill having been read the third time, the
question is, Shall the bill pass?
Mr. ALEXANDER. I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be a sufficient second.
The clerk will call the roll.
The assistant bill clerk called the roll.
The result was announced--yeas 98, nays 2, as follows:
[Rollcall Vote No. 209 Leg.]
YEAS--98
Alexander
Baldwin
Barrasso
Bennet
Blumenthal
Blunt
Booker
Boozman
Brown
Burr
Cantwell
Capito
Cardin
Carper
Casey
Cassidy
Collins
Coons
Corker
Cornyn
Cortez Masto
Cotton
Crapo
Cruz
Daines
Donnelly
Duckworth
Durbin
Enzi
Ernst
Feinstein
Fischer
Flake
Gardner
Gillibrand
Graham
Grassley
Harris
Hassan
Hatch
Heinrich
Heitkamp
Heller
Hirono
Hoeven
Hyde-Smith
Inhofe
Isakson
Johnson
Jones
Kaine
Kennedy
King
Klobuchar
Kyl
Lankford
Leahy
Manchin
Markey
McCaskill
McConnell
Menendez
Merkley
Moran
Murkowski
Murphy
Murray
Nelson
Perdue
Peters
Portman
Reed
Risch
Roberts
Rounds
Rubio
Sanders
Sasse
Schatz
Schumer
Scott
Shaheen
Shelby
Smith
Stabenow
Sullivan
Tester
Thune
Tillis
Toomey
Udall
Van Hollen
Warner
Warren
Whitehouse
Wicker
Wyden
Young
NAYS--2
Lee
Paul
The bill (S. 2554), as amended, was passed.
____________________