PATIENT RIGHT TO KNOW DRUG PRICES ACT; Congressional Record Vol. 164, No. 154
(Senate - September 17, 2018)

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[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.

                          ____________________