[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2554 Reported in Senate (RS)]
<DOC>
Calendar No. 549
115th CONGRESS
2d Session
S. 2554
To ensure that health insurance issuers and group health plans do not
prohibit pharmacy providers from providing certain information to
enrollees.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 14, 2018
Ms. Collins (for herself, Mrs. McCaskill, Mr. Barrasso, Ms. Stabenow,
Mr. Cassidy, Ms. Smith, Mr. Donnelly, Mrs. Feinstein, Ms. Murkowski,
Mr. Menendez, Ms. Baldwin, Mr. Kennedy, Ms. Hassan, and Mr. Blumenthal)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
July 31, 2018
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To ensure that health insurance issuers and group health plans do not
prohibit pharmacy providers from providing certain information to
enrollees.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Patient Right to Know Drug
Prices Act''.</DELETED>
<DELETED>SEC. 2. PROHIBITION ON LIMITING CERTAIN INFORMATION ON DRUG
PRICES.</DELETED>
<DELETED> (a) Exchange Plans.--Section 1311(e) of the Patient
Protection and Affordable Care Act (42 U.S.C. 18031(e)) is amended by
adding at the end the following:</DELETED>
<DELETED> ``(4) Information on prescription drugs.--The
Exchange shall require health plans seeking certification as
qualified health plans to ensure that--</DELETED>
<DELETED> ``(A) the health insurance issuer does not
restrict 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 price of the drug to the
enrollee under the plan and the price the individual
would pay for the drug if the enrollee obtained the
drug without using any health insurance coverage;
and</DELETED>
<DELETED> ``(B) any entity that provides pharmacy
benefits management services under a contract with any
such health plan does not, with respect to such plan or
any health benefits plan that the entity contracts with
to provide pharmacy benefits management services and
that is offered by an entity other than such sponsor or
organization, restrict a pharmacy that dispenses a
prescription drug from informing (or penalize such
pharmacy for informing) an enrollee of any differential
between the price of the drug to the enrollee under the
plan and the price the individual would pay for the
drug if the enrollee obtained the drug without using
any health insurance coverage.''.</DELETED>
<DELETED> (b) Other Health Plans.--The provisions of section
1311(e)(4) of the Patient Protection and Affordable Care Act (as added
by subsection (a)) shall apply to all health insurance issuers with
respect to health insurance coverage and to all group health plans (as
such terms are defined in section 2791 of the Public Health Service Act
(42 U.S.C. 300gg-91)).</DELETED>
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:
``(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''.
Calendar No. 549
115th CONGRESS
2d Session
S. 2554
_______________________________________________________________________
A BILL
To ensure that health insurance issuers and group health plans do not
prohibit pharmacy providers from providing certain information to
enrollees.
_______________________________________________________________________
July 31, 2018
Reported with an amendment