[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2554 Enrolled Bill (ENR)]
S.2554
One Hundred Fifteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, two thousand and eighteen
An Act
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,
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''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.