[House Report 116-334]
[From the U.S. Government Publishing Office]


116th Congress }                                             { Report
                        HOUSE OF REPRESENTATIVES
 1st Session   }                                             { 116-334

======================================================================

 
 PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 3) TO ESTABLISH A FAIR 
PRICE NEGOTIATION PROGRAM, PROTECT THE MEDICARE PROGRAM FROM EXCESSIVE 
 PRICE INCREASES, AND ESTABLISH AN OUT-OF-POCKET MAXIMUM FOR MEDICARE 
 PART D ENROLLEES, AND FOR OTHER PURPOSES; PROVIDING FOR CONSIDERATION 
OF THE BILL (H.R. 5038) TO AMEND THE IMMIGRATION AND NATIONALITY ACT TO 
 PROVIDE FOR TERMS AND CONDITIONS FOR NONIMMIGRANT WORKERS PERFORMING 
 AGRICULTURAL LABOR OR SERVICES, AND FOR OTHER PURPOSES; AND PROVIDING 
 FOR CONSIDERATION OF THE CONFERENCE REPORT TO ACCOMPANY THE BILL (S. 
  1790) TO AUTHORIZE APPROPRIATIONS FOR FISCAL YEAR 2020 FOR MILITARY 
ACTIVITIES OF THE DEPARTMENT OF DEFENSE, FOR MILITARY CONSTRUCTION, AND 
   FOR DEFENSE ACTIVITIES OF THE DEPARTMENT OF ENERGY, TO PRESCRIBE 
   MILITARY PERSONNEL STRENGTHS FOR SUCH FISCAL YEAR, AND FOR OTHER 
                                PURPOSES

                                _______
                                

 December 10, 2019.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

               Ms. Shalala, from the Committee on Rules, 
                        submitted the following

                              R E P O R T

                       [To accompany H. Res. 758]

    The Committee on Rules, having had under consideration 
House Resolution 758, by a record vote of 8 to 3, report the 
same to the House with the recommendation that the resolution 
be adopted.

                SUMMARY OF PROVISIONS OF THE RESOLUTION

    The resolution provides for consideration of H.R. 3, the 
Elijah E. Cummings Lower Drug Costs Now Act, under a structured 
rule. The resolution provides four hours of general debate, 
with three hours equally divided among and controlled by the 
respective chairs and ranking minority members of the 
Committees on Education and Labor, Energy and Commerce, and 
Ways and Means, and one hour equally divided and controlled by 
the Majority Leader and the Minority Leader or their respective 
designees. The resolution waives all points of order against 
consideration of the bill. The resolution provides that an 
amendment in the nature of a substitute consisting of the text 
of Rules Committee Print 116-41, modified by the amendment 
printed in Part A of this report, shall be considered as 
adopted and the bill, as amended, shall be considered as read. 
The resolution waives all points of order against provisions in 
the bill, as amended. The resolution makes in order only those 
further amendments printed in Part B of this report. Each such 
further amendment may be offered only in the order printed in 
this report, may be offered only by a Member designated in this 
report, shall be considered as read, shall be debatable for the 
time specified in this report equally divided and controlled by 
the proponent and an opponent, shall not be subject to 
amendment, and shall not be subject to a demand for division of 
the question. The resolution waives all points of order against 
the amendments printed in Part B of this report. The resolution 
provides one motion to recommit with or without instructions. 
The resolution provides for consideration of H.R. 5038, the 
Farm Workforce Modernization Act of 2019, under a closed rule. 
The resolution provides one hour of general debate equally 
divided and controlled by the chair and ranking minority member 
of the Committee on the Judiciary. The resolution waives all 
points of order against consideration of the bill. The 
resolution provides that an amendment in the nature of a 
substitute consisting of the text of Rules Committee Print 116-
42, modified by the amendment printed in part C of this report, 
shall be considered as adopted and the bill, as amended, shall 
be considered as read. The resolution waives all points of 
order against provisions in the bill, as amended. The 
resolution provides one motion to recommit with or without 
instructions. The resolution provides for consideration of the 
conference report to accompany S. 1790, the National Defense 
Authorization Act for Fiscal Year 2020. The resolution waives 
all points of order against the conference report and against 
its consideration. The resolution provides that the conference 
report shall be considered as read. The resolution provides one 
hour of debate on the conference report, divided pursuant to 
clause 8(d) of rule XXII. The resolution provides one motion to 
recommit if applicable. The resolution provides that the chair 
of the Permanent Select Committee on Intelligence may insert in 
the Congressional Record not later than December 13, 2019, such 
material as he may deem explanatory of intelligence 
authorization measures for the fiscal years 2018, 2019, and 
2020. The resolution provides that it shall be in order at any 
time through the legislative day of December 20, 2019, for the 
Speaker to entertain motions that the House suspend the rules 
and that the Speaker or her designee shall consult with the 
Minority Leader or his designee on the designation of any 
matter for consideration pursuant to this section. The 
resolution waives clause 6(a) of rule XIII (requiring a two-
thirds vote to consider a rule on the same day it is reported 
from the Rules Committee) against any resolution reported from 
the Rules Committee through the legislative day of December 20, 
2019. Section 7 of the resolution provides that on any 
legislative day of the first session of the One Hundred and 
Sixteenth Congress after December 12, 2019: the Journal of the 
proceedings of the previous day shall be considered as 
approved; and the Chair may at any time declare the House 
adjourned to meet at a date and time, within the limits of 
clause 4, section 5, article I of the Constitution, to be 
announced by the Chair in declaring the adjournment. Section 8 
of the resolution provides that on any legislative day of the 
second session of the One Hundred Sixteenth Congress before 
January 7, 2020: the Speaker may dispense with organizational 
and legislative business; the Journal of the proceedings of the 
previous day shall be considered as approved if applicable; and 
the Chair may at any time declare the House adjourned to meet 
at a date and time, within the limits of clause 4, section 5, 
article I of the Constitution, to be announced by the Chair in 
declaring the adjournment. The resolution provides that the 
Speaker may appoint Members to perform the duties of the Chair 
for the duration of the periods addressed by sections 7 and 8 
of the resolution as though under clause 8(a) of rule I. The 
resolution provides that each day during the periods addressed 
by sections 7 and 8 shall not constitute calendar days for the 
purposes of section 7 of the War Powers Resolution (50 U.S.C. 
1546). The resolution provides that each day during the periods 
addressed by sections 7 and 8 shall not constitute a 
legislative day for purposes of clause 7 of rule XIII. The 
resolution provides that each day during the periods addressed 
by sections 7 and 8 shall not constitute a legislative day for 
purposes of clause 7 of rule XV.

                         EXPLANATION OF WAIVERS

    The waiver of all points of order against consideration of 
H.R. 3 includes waivers of the following:
     Clause 3(c)(4) of rule XIII, which requires 
committee reports to include a statement of general performance 
goals and objectives, including outcome-related goals and 
objectives for which the measure authorizes funding.
     Clause 3(d) of rule XIII, which requires the 
inclusion of a committee cost estimate in the committee report.
     Clause 10 of rule XXI, which prohibits 
consideration of a measure that has a net effect of increasing 
the deficit or reducing the surplus over the five- or 10-year 
period; however, the budgetary effects of the bill are fully 
offset over the 10-year period.
     Clause 12(a)(1) of rule XXI, which prohibits 
consideration of a bill unless there is a searchable electronic 
comparative print that shows how the bill proposes to change 
current law.
     Clause 12(b) of rule XXI, which prohibits 
consideration of a bill unless there is a searchable electronic 
comparative print that shows how the text of the bill as 
proposed to be considered differs from the text of the bill as 
reported.
     Section 302(f) of the Congressional Budget Act, 
which prohibits consideration of legislation providing new 
budget authority in excess of a 302(a) or 302(b) allocation of 
such authority.
    The waiver of all points of order against provisions in 
H.R. 3, as amended, includes a waiver of clause 4 of rule XXI, 
which prohibits reporting a bill carrying an appropriation from 
a committee not having jurisdiction to report an appropriation.
    The waiver of all points of order against the amendments 
printed in Part B of this report includes a waiver of clause 
12(a)(2) of rule XXI, which prohibits consideration of an 
amendment in the nature of a substitute unless there is a 
searchable electronic comparative print that shows how the 
amendment proposes to change current law. The waiver is 
necessary for the amendment in the nature of substitute #1, 
offered by Rep. Walden.
    The waiver of all points of order against consideration of 
H.R. 5038 includes waivers of the following:
     Clause 3(d)(1) of rule XIII, which requires the 
inclusion of committee cost estimate in a committee report.
     Clause 12(a)(1) of rule XXI, which prohibits 
consideration of a bill unless there is a searchable electronic 
comparative print that shows how the bill proposes to change 
current law.
     Clause 12(b) of rule XXI, which prohibits 
consideration of a bill unless there is a searchable electronic 
comparative print that shows how the text of the bill as 
proposed to be considered differs from the text of the bill as 
reported.
    The waiver of all points of order against provisions in 
H.R. 5038, as amended, includes waivers of the following:
     Clause 4 of rule XXI, which prohibits reporting a 
bill carrying an appropriation from a committee not having 
jurisdiction to report an appropriation.
     Clause 5(a) of rule XXI, which prohibits a bill or 
joint resolution carrying a tax or tariff measure from being 
reported by a committee not having jurisdiction to report tax 
or tariff measures.
    The waiver of all points of order against the conference 
report to accompany S. 1790 and its consideration includes 
waivers of the following:
     Section 302(f)(1) of the Congressional Budget Act, 
which prohibits consideration of legislation providing new 
budget authority in excess of a 302(a) or 302(b) allocation of 
such authority.
     Clause 10 of rule XXI, which prohibits 
consideration of a measure that has a net effect of increasing 
the deficit or reducing the surplus over the five- or 10-year 
period.
     Clause 8(a)(1)(A) of rule XXII, which prohibits 
the consideration of a conference report and the accompanying 
joint explanatory statement which has not been available for 72 
hours.
     Clause 9 of rule XXII, which prohibits the 
inclusion of matter in a conference report not committed to the 
conference by either House.

                            COMMITTEE VOTES

    The results of each record vote on an amendment or motion 
to report, together with the names of those voting for and 
against, are printed below:

Rules Committee record vote No. 217

    Motion by Mr. Cole to report an open rule for H.R. 5038. 
Defeated: 3-8

----------------------------------------------------------------------------------------------------------------
                Majority Members                      Vote               Minority Members               Vote
----------------------------------------------------------------------------------------------------------------
Mr. Hastings....................................          Nay   Mr. Cole..........................          Yea
Mrs. Torres.....................................  ............  Mr. Woodall.......................  ............
Mr. Perlmutter..................................          Nay   Mr. Burgess.......................          Yea
Mr. Raskin......................................          Nay   Mrs. Lesko........................          Yea
Ms. Scanlon.....................................          Nay
Mr. Morelle.....................................          Nay
Ms. Shalala.....................................          Nay
Mr. DeSaulnier..................................          Nay
Mr. McGovern, Chairman..........................          Nay
----------------------------------------------------------------------------------------------------------------

Rules Committee record vote No. 218

    Motion by Ms. Shalala to report the rule. Adopted: 8-3

----------------------------------------------------------------------------------------------------------------
                Majority Members                      Vote               Minority Members               Vote
----------------------------------------------------------------------------------------------------------------
Mr. Hastings....................................          Yea   Mr. Cole..........................          Nay
Mrs. Torres.....................................  ............  Mr. Woodall.......................  ............
Mr. Perlmutter..................................          Yea   Mr. Burgess.......................          Nay
Mr. Raskin......................................          Yea   Mrs. Lesko........................          Nay
Ms. Scanlon.....................................          Yea
Mr. Morelle.....................................          Yea
Ms. Shalala.....................................          Yea
Mr. DeSaulnier..................................          Yea
Mr. McGovern, Chairman..........................          Yea
----------------------------------------------------------------------------------------------------------------

   SUMMARY OF THE AMENDMENT TO H.R. 3 IN PART A CONSIDERED AS ADOPTED

    1. Pallone (NJ), Neal (MA), Scott, Bobby (VA): Makes 
technical change to the underlying bill, adjusts effective 
dates of certain provisions and makes changes to the Fair Drug 
Price Negotiation program.

      SUMMARY OF THE AMENDMENTS TO H.R. 3 IN PART B MADE IN ORDER

    1. Walden (OR), Brady (TX), Collins, Doug (GA), Foxx (NC): 
An amendment in the nature of a substitute, which include bi-
partisan provisions related to (1) Medicare Parts B & D, (2) 
drug price transparency, (3) Medicare Part D benefit redesign 
and other Part D provisions, (4) MedPAC, (5) Medicaid, (6) FDA 
(including CREATES Act; Pay-for-delay; BLOCKING Act; Purple 
Book; Orange Book; Advancing education on biosimilars; 
Streamlining transition of biological products; OTC monograph 
safety, innovation, and reform; and other provisions), (7) 
revenue provisions, and (8) other bi-partisan provisions. (10 
minutes)
    2. Tonko (NY): Requires CMS to create and implement a 
measure in the Star Ratings program evaluating Medicare 
Advantage and Part D plans on how well they provide access to 
biosimilar drugs. (10 minutes)
    3. Peters (CA), Cisneros (CA): To amend the Public Health 
Service Act to authorize a pilot program to develop, expand, 
and enhance the commercialization of biomedical products, and 
for other purposes. (10 minutes)
    4. Kennedy (MA): Requires another Senate confirmed officer 
with HHS to carry out the negotiation duties should the 
Secretary of HHS have a conflict of interest. The General 
Counsel of HHS would be responsible for identifying these 
conflicts. (10 minutes)
    5. O'Halleran (AZ), Axne (IA), Brindisi (NY), Bustos (IL), 
Cuellar (TX), Cunningham (SC), Davids (KS), Finkenauer (IA), 
Horn (OK), Lee, Susie (NV), Loebsack (IA), Peterson (MN), 
Schrader (OR), Spanberger (VA), Torres Small, Xochitl (NM), Van 
Drew (NJ), Kuster (NH), Correa (CA), Costa (CA), Blunt 
Rochester (DE): Creates a grant program within HHS for 
hospitals located in rural and medically underserved areas, 
including Critical Access Hospitals, to cover the start-up 
costs for establishing a Graduate Medical Education (GME) 
program or a partnership with a hospital that has an existing 
program. It includes a reporting requirement for GAO to analyze 
whether residents continue to practice in a rural or medically 
underserved area after completing their training. (10 minutes)
    6. Jackson Lee (TX): Expresses the Sense of Congress 
regarding the impact of the high cost of prescription drugs on 
communities of color and persons living in rural or sparsely 
populated areas of the United States. (10 minutes)
    7. Gottheimer (NJ): Requires an HHS study to identify 
conditions without an FDA-approved treatment where the 
development of a treatment would fill an unmet medical need for 
a serious or life-threatening condition or rare disease. 
Requires HHS to identify appropriate incentives that would lead 
to the development of such treatments. (10 minutes)
    8. Axne (IA): Establishes a grant program for states to 
reduce the burdens associated with health care administrative 
work and reduces HHS administrative costs by 50% over 10 years. 
(10 minutes)
    9. Finkenauer (IA): Requires drug companies to disclose 
truthful and non-misleading pricing information about 
prescription drugs and biological products when they advertise 
these products directly to consumers. (10 minutes)
    10. Luria (VA): Makes clear that federal employee health 
plans are covered by the price reduction provisions of the 
bill. (10 minutes)
    11. Cunningham (SC): Allows the Veteran's Administration to 
benefit from Maximum Fair Pricing guidelines. (10 minutes)
    12. Scanlon (PA): Increases funding for clinical trials at 
NIH and bans the use of spread pricing by PBMs as it relates to 
Medicaid. (10 minutes)

 SUMMARY OF THE AMENDMENT TO H.R. 5038 IN PART C CONSIDERED AS ADOPTED

    1. Nadler (NY): Sets the year-round visas for sheep and 
goat herding to 500.

       PART A--TEXT OF AMENDMENT TO H.R. 3 CONSIDERED AS ADOPTED

  Page 9, beginning on line 23, strike ``the period beginning 
with 2023 and ending with 2027'' and insert ``2023''.
  Page 10, line 6, add ``and'' after the semicolon.
  Page 10, beginning on line 8, strike ``the period beginning 
with 2028 and ending with 2032'' and insert ``2024 or a 
subsequent year''.
  Page 10, line 9, strike ``30'' and insert ``50''.
  Page 10, line 14, strike ``30'' and insert ``50''.
  Page 10, line 15, strike ``and'' at the end.
  Page 10, strike lines 16 through 23.
  Page 53, line 11, strike ``Drug'' after ``Fair''.
  Page 53, line 17, strike ``Drug'' after ``Fair''.
  Page 56, line 11, strike ``Drug'' after ``Fair''.
  Page 56, line 17, strike ``Drug'' after ``Fair''.
  Page 59, line 18, strike ``Drug'' after ``Fair''.
  Page 59, line 22, strike ``Drug'' after ``Fair''.
  Page 66, line 16, strike ``drug'' after ``fair'' (and conform 
the table of contents accordingly).
  Page 66, line 19, strike ``Drug''.
  Page 83, after line 17, insert the following:
          (3) Coordination with medicaid rebate information 
        disclosure.--Section 1927(b)(3)(D)(i) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(D)(i)) is amended 
        by striking ``or to carry out section 1847B'' and 
        inserting ``to carry out section 1847B or section 
        1834(x)''.
  Page 90, line 25 through page 91, line 1, strike ``each 
calendar quarter'' and insert ``each of the calendar 
quarters''.
  Page 91, line 6, insert ``each'' before ``such''.
  Page 91, line 6, strike ``the payment'' and inert ``such 
payment''.
  Page 91, line 10, strike ``the payment'' and insert ``such 
payment''.
  Page 98, after line 18, insert the following:
          (3) Coordination with medicaid rebate information 
        disclosure.--Section 1927(b)(3)(D)(i) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(D)(i)), as 
        amended by section 201(c)(3), is further amended by 
        striking ``or section 1834(x)'' and inserting ``, 
        section 1834(x), or section 1860D-14B''.
  Page 98, line 22, strike ``Not later than'' and insert the 
following:
  (a) In General.--Not later than
  Page 99, line 14, strike the semicolon and insert ``; and''.
  Page 99, line 22, strike ``; and'' and insert a period.
  Page 99, strike lines 22 through 25.
  In section 203, add at the end the following new subsection:
  (b) Regulations.--Not later than December 31, 2022, the 
Secretary of Labor shall, in consultation with the Secretary of 
Health and Human Services and the Secretary of the Treasury, 
promulgate regulations to implement a model described in 
subsection (a)(1) and a model described in subsection (a)(2), 
if the Secretary determines that--
          (1) the prices of a sufficient number (as determined 
        by the Secretary) of drugs described in subsection 
        (a)(1) have increased over a period of time (as 
        determined by the Secretary) at a percentage that 
        exceeds the percentage by which the consumer price 
        index for all urban consumers (United States city 
        average) has increased over such period; and
          (2) such model described in subsection (a)(1) and 
        such model described in subsection (a)(2) are feasible.
  Page 116, lines 21 through 22, strike ``are equal to or''.
  Page 118, line 17, strike ``furnished'' and insert 
``dispensed''.
  Page 119, line 19, strike ``at or''.
  Page 120, line 1, strike ``at or''.
  Page 148, line 16, strike ``2024'' and insert ``2022''.
  Page 148, line 25, strike ``2024'' and insert ``2022''.
  Page 154, line 16, strike ``2024'' and insert ``2022''.
  Page 155, line 1, strike ``2024'' and insert ``2022''.
  Page 155, line 12, insert ``, as described in section 
1612(a)(2)(A),'' after ``in kind''.
  Page 155, line 20, strike ``2024'' and insert ``2022''.
  Page 155, line 24, strike ``2024'' and insert ``2022''.
  Page 156, line 9, strike ``2023'' and insert ``2021''.
  Page 156, line 21, strike ``2024'' and insert ``2022''.
  Page 169, line 7, strike ``2024'' and insert ``2023''.
  Page 169, line 14, strike ``2024'' and insert ``2023''.
  Page 169, line 25, strike ``2024'' and insert ``2023''.
  Page 172, line 8, strike ``2024'' and insert ``2023''.
  Page 176, line 11, strike ``2024'' and insert ``2023''.
  Page 177, line 17, strike ``2024'' and insert ``2023''.
  Page 178, line 7, strike ``2024'' and insert ``2023''.
  Page 178, line 22, strike ``2024'' and insert ``2023''.
  Page 204, line 14, strike ``section 732'' and insert 
``section 722''.
  Page 204, line 19, strike ``section 733'' and insert 
``section 723''.
  Page 204, line 23, strike ``section 734'' and insert 
``section 724''.
  Page 205, line 3, strike ``section 735'' and insert ``section 
725''.
  Page 205, line 7, strike ``section 736'' and insert ``section 
726''.
  Page 205, line 11, strike ``section 737'' and insert 
``section 727''.
  Page 207, line 15, strike ``section 731(c)(1)'' and insert 
``section 721(c)(1)''.
  Page 209, line 1, strike ``section 731(c)(2)'' and insert 
``section 721(c)(2)''.
  Page 210, line 13, strike ``section 731(c)(2)'' and insert 
``section 721(c)(2)''.
  Page 210, line 18, strike ``section 731(c)(3)'' and insert 
``section 721(c)(3)''.
  Page 212, line 9, strike ``section 731(c)(4)'' and insert 
``section 721(c)(4)''.
  Page 213, line 6, strike ``section 731(c)(5)'' and insert 
``section 721(c)(5)''.
  Page 213, line 16, strike ``section 731(c)(6)'' and insert 
``section 721(c)(6)''.
  Page 232, line 15, strike ``2020 and 2021'' and insert ``each 
of 2020 through 2022''.
  Page 232, lines 17 through 18, strike ``2022 and each 
subsequent year through 2025'' and insert ``each of 2023 
through 2025''.

           PART B--TEXT OF AMENDMENTS TO H.R. 3 MADE IN ORDER

1. An Amendment To Be Offered by Representative Walden of Oregon or His 
                   Designee, Debatable for 10 Minutes

  Strike all after the enactment clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Lower Costs, More Cures Act of 
2019''.

SEC. 2. TABLE OF CONTENTS.

  The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
                    TITLE I--MEDICARE PARTS B AND D

                 Subtitle A--Medicare Part B Provisions

Sec. 101. Improvements to Medicare site-of-service transparency.
Sec. 102. Requiring manufacturers of certain single-dose container or 
                            single-use package drugs payable under part 
                            B of the Medicare program to provide 
                            refunds with respect to discarded amounts 
                            of such drugs.
Sec. 103. Providing for variation in payment for certain drugs covered 
                            under part B of the Medicare program.
Sec. 104. Establishment of maximum add-on payment for drugs and 
                            biologicals.
Sec. 105. Treatment of drug administration services furnished by 
                            certain excepted off-campus outpatient 
                            departments of a provider.
                  Subtitle B--Drug Price Transparency

Sec. 111. Reporting on explanation for drug price increases.
Sec. 112. Public disclosure of drug discounts.
Sec. 113. Study of pharmaceutical supply chain intermediaries and 
                            merger activity.
Sec. 114. Requiring certain manufacturers to report drug pricing 
                            information with respect to drugs under the 
                            Medicare program.
Sec. 115. Making prescription drug marketing sample information 
                            reported by manufacturers available to 
                            certain individuals and entities.
Sec. 116. Requiring prescription drug plan sponsors to include real-
                            time benefit information as part of such 
                            sponsor's electronic prescription program 
                            under the Medicare program.
Sec. 117. Sense of Congress regarding the need to expand commercially 
                            available drug pricing comparison 
                            platforms.
Sec. 118. Technical corrections.
              Subtitle C--Medicare Part D Benefit Redesign

Sec. 121. Medicare Part D Benefit Redesign.
              Subtitle D--Other Medicare Part D Provisions

Sec. 131. Transitional coverage and retroactive Medicare Part D 
                            coverage for certain low-income 
                            beneficiaries.
Sec. 132. Allowing the offering of additional prescription drug plans 
                            under Medicare part D.
Sec. 133. Allowing certain enrollees of prescription drugs plans and 
                            MA-PD plans under Medicare program to 
                            spread out cost-sharing under certain 
                            circumstances.
Sec. 134. Establishing a monthly cap on beneficiary incurred costs for 
                            insulin products and supplies under a 
                            prescription drug plan or MA-PD plan.
Sec. 135. Growth rate of Medicare part D out-of-pocket cost threshold.
                           Subtitle E--MedPAC

Sec. 141. Providing the Medicare Payment Advisory Commission and 
                            Medicaid and CHIP Payment and Access 
                            Commission with access to certain drug 
                            payment information, including certain 
                            rebate information.
                           TITLE II--MEDICAID

Sec. 201. Sunset of limit on maximum rebate amount for single source 
                            drugs and innovator multiple source drugs.
Sec. 202. Medicaid pharmacy and therapeutics committee improvements.
Sec. 203. GAO report on conflicts of interest in State Medicaid program 
                            drug use review boards and pharmacy and 
                            therapeutics (P&T) committees.
Sec. 204. Ensuring the accuracy of manufacturer price and drug product 
                            information under the Medicaid drug rebate 
                            program.
Sec. 205. Improving transparency and preventing the use of abusive 
                            spread pricing and related practices in 
                            Medicaid.
Sec. 206. T-MSIS drug data analytics reports.
Sec. 207. Risk-sharing value-based payment agreements for covered 
                            outpatient drugs under Medicaid.
Sec. 208. Applying Medicaid drug rebate requirement to drugs provided 
                            as part of outpatient hospital services.
                TITLE III--FOOD AND DRUG ADMINISTRATION

                        Subtitle A--CREATES Act

Sec. 301. Actions for delays of generic drugs and biosimilar biological 
                            products.
Sec. 302. Rems approval process for subsequent filers.
Sec. 303. Rule of construction.
                       Subtitle B--Pay-for-Delay

Sec. 311. Unlawful agreements.
Sec. 312. Notice and certification of agreements.
Sec. 313. Forfeiture of 180-day exclusivity period.
Sec. 314. Commission litigation authority.
Sec. 315. Statute of limitations.
                        Subtitle C--BLOCKING Act

Sec. 321. Change conditions of first generic exclusivity to spur access 
                            and competition.
                        Subtitle D--Purple Book

Sec. 331. Public Listing.
Sec. 332. Review and report on types of Information To be listed.
                        Subtitle E--Orange Book

Sec. 341. Orange Book.
Sec. 342. GAO report to Congress.
             Subtitle F--Advancing Education on Biosimilars

Sec. 351. Education on biological products.
       Subtitle G--Streamlining Transition of Biological Products

Sec. 361. Streamlining the transition of biological products.
 Subtitle H--Over-the-Counter Monograph Safety, Innovation, and Reform

Sec. 370. Short title; references in subtitle.
                        Part 1--OTC Drug Review

Sec. 371. Regulation of certain nonprescription drugs that are marketed 
                            without an approved drug application.
Sec. 372. Misbranding.
Sec. 373. Drugs excluded from the over-the-counter drug review.
Sec. 374. Treatment of Sunscreen Innovation Act.
Sec. 375. Annual update to Congress on appropriate pediatric indication 
                            for certain OTC cough and cold drugs.
Sec. 376. Technical corrections.
                           Part 2--User Fees

Sec. 381. Short title; finding.
Sec. 382. Fees relating to over-the-counter drugs.
                      Subtitle I--Other Provisions

Sec. 391. Protecting access to biological products.
Sec. 392. Orphan drug clarification.
Sec. 393. Conditions of use for biosimilar biological products.
Sec. 394. Clarifying the meaning of new chemical entity.
                      TITLE IV--REVENUE PROVISIONS

Sec. 401. Permanent extension of reduction in medical expense deduction 
                            floor.
Sec. 402. Safe harbor for high deductible health plans without 
                            deductible for insulin.
Sec. 403. Inclusion of certain over-the-counter medical products as 
                            qualified medical expenses.
                         TITLE V--MISCELLANEOUS

Sec. 501. Payment for biosimilar biological products during initial 
                            period.
Sec. 502. GAO study and report on average sales price.
Sec. 503. Requiring prescription drug plans and MA-PD plans to report 
                            potential fraud, waste, and abuse to the 
                            Secretary of HHS.
Sec. 504. Establishment of pharmacy quality measures under Medicare 
                            part D.
Sec. 505. Improving coordination between the Food and Drug 
                            Administration and the Centers for Medicare 
                            & Medicaid Services.
Sec. 506. Patient consultation in Medicare national and local coverage 
                            determinations in order to mitigate 
                            barriers to inclusion of such perspectives.
Sec. 507. MedPAC report on shifting coverage of certain Medicare part B 
                            drugs to Medicare part D.
Sec. 508. Requirement that direct-to-consumer advertisements for 
                            prescription drugs and biological products 
                            include truthful and non-misleading pricing 
                            information.
Sec. 509. Chief Pharmaceutical Negotiator at the Office of the United 
                            States Trade Representative.
Sec. 510. Waiving Medicare coinsurance for colorectal cancer screening 
                            tests.

                    TITLE I--MEDICARE PARTS B AND D


                 Subtitle A--Medicare Part B Provisions


SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE TRANSPARENCY.

  Section 1834(t) of the Social Security Act (42 U.S.C. 
1395m(t)) is amended--
          (1) in paragraph (1)--
                  (A) in the heading, by striking ``In 
                general'' and inserting ``Site payment'';
                  (B) in the matter preceding subparagraph 
                (A)--
                          (i) by striking ``or to'' and 
                        inserting ``, to'';
                          (ii) by inserting ``, or to a 
                        physician for services furnished in a 
                        physician's office'' and ``surgical 
                        center''; and
                          (iii) by inserting ``(or 2021 with 
                        respect to a physician for services 
                        furnished in a physician's office)'' 
                        after ``2018''; and
                  (C) in subparagraph (A)--
                          (i) by striking ``and the'' and 
                        inserting ``, the''; and
                          (ii) by inserting ``, and the 
                        physician fee schedule under section 
                        1848 (with respect to the practice 
                        expense component of such payment 
                        amount)'' after ``such section'';
          (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (3) through (5), respectively; and
          (3) by inserting after paragraph (1) the following 
        new paragraph:
          ``(2) Physician payment.--Beginning in 2021, the 
        Secretary shall expand the information included on the 
        Internet website described in paragraph (1) to 
        include--
                  ``(A) the amount paid to a physician under 
                section 1848 for an item or service for the 
                settings described in paragraph (1); and
                  ``(B) the estimated amount of beneficiary 
                liability applicable to the item or service.''.

SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SINGLE-DOSE CONTAINER OR 
                    SINGLE-USE PACKAGE DRUGS PAYABLE UNDER PART B OF 
                    THE MEDICARE PROGRAM TO PROVIDE REFUNDS WITH 
                    RESPECT TO DISCARDED AMOUNTS OF SUCH DRUGS.

  Section 1847A of the Social Security Act (42 U.S.C. 1395-3a) 
is amended by adding at the end the following new subsection:
  ``(h) Refund for Certain Discarded Single-dose Container or 
Single-use Package Drugs.--
          ``(1) Secretarial provision of information.--
                  ``(A) In general.--For each calendar quarter 
                beginning on or after July 1, 2021, the 
                Secretary shall, with respect to a refundable 
                single-dose container or single-use package 
                drug (as defined in paragraph (8)), report to 
                each manufacturer (as defined in subsection 
                (c)(6)(A)) of such refundable single-dose 
                container or single-use package drug the 
                following for the calendar quarter:
                          ``(i) Subject to subparagraph (C), 
                        information on the total number of 
                        units of the billing and payment code 
                        of such drug, if any, that were 
                        discarded during such quarter, as 
                        determined using a mechanism such as 
                        the JW modifier used as of the date of 
                        enactment of this subsection (or any 
                        such successor modifier that includes 
                        such data as determined appropriate by 
                        the Secretary).
                          ``(ii) The refund amount that the 
                        manufacturer is liable for pursuant to 
                        paragraph (3).
                  ``(B) Determination of discarded amounts.--
                For purposes of subparagraph (A)(i), with 
                respect to a refundable single-dose container 
                or single-use package drug furnished during a 
                quarter, the amount of such drug that was 
                discarded shall be determined based on the 
                amount of such drug that was unused and 
                discarded for each drug on the date of service.
                  ``(C) Exclusion of units of packaged drugs.--
                The total number of units of the billing and 
                payment code of a refundable single-dose 
                container or single-use package drug of a 
                manufacturer furnished during a calendar 
                quarter for purposes of subparagraph (A)(i), 
                and the determination of the estimated total 
                allowed charges for the drug in the quarter for 
                purposes of paragraph (3)(A)(ii), shall not 
                include such units that are packaged into the 
                payment amount for an item or service and are 
                not separately payable.
          ``(2) Manufacturer requirement.--For each calendar 
        quarter beginning on or after July 1, 2021, the 
        manufacturer of a refundable single-dose container or 
        single-use package drug shall, for such drug, provide 
        to the Secretary a refund that is equal to the amount 
        specified in paragraph (3) for such drug for such 
        quarter.
          ``(3) Refund amount.--
                  ``(A) In general.--The amount of the refund 
                specified in this paragraph is, with respect to 
                a refundable single-dose container or single-
                use package drug of a manufacturer assigned to 
                a billing and payment code for a calendar 
                quarter beginning on or after July 1, 2021, an 
                amount equal to the estimated amount (if any) 
                by which--
                          ``(i) the product of--
                                  ``(I) the total number of 
                                units of the billing and 
                                payment code for such drug that 
                                were discarded during such 
                                quarter (as determined under 
                                paragraph (1)); and
                                  ``(II)(aa) in the case of a 
                                refundable single-dose 
                                container or single-use package 
                                drug that is a single source 
                                drug or biological, the amount 
                                determined for such drug under 
                                subsection (b)(4); or
                                  ``(bb) in the case of a 
                                refundable single-dose 
                                container or single-use package 
                                drug that is a biosimilar 
                                biological product, the average 
                                sales price determined under 
                                subsection (b)(8)(A); exceeds
                          ``(ii) an amount equal to the 
                        applicable percentage (as defined in 
                        subparagraph (B)) of the estimated 
                        total allowed charges for such drug 
                        during the quarter.
                  ``(B) Applicable percentage defined.--
                          ``(i) In general.--For purposes of 
                        subparagraph (A)(ii), the term 
                        `applicable percentage' means--
                                  ``(I) subject to subclause 
                                (II), 10 percent; and
                                  ``(II) if applicable, in the 
                                case of a refundable single-
                                dose container or single-use 
                                package drug described in 
                                clause (ii), a percentage 
                                specified by the Secretary 
                                pursuant to such clause.
                          ``(ii) Treatment of drugs that have 
                        unique circumstances.--In the case of a 
                        refundable single-dose container or 
                        single-use package drug that has unique 
                        circumstances involving similar loss of 
                        product as that described in paragraph 
                        (8)(B), the Secretary, through notice 
                        and comment rulemaking, may increase 
                        the applicable percentage otherwise 
                        applicable under clause (i)(I) as 
                        determined appropriate by the 
                        Secretary.
          ``(4) Frequency.--Amounts required to be refunded 
        pursuant to paragraph (2) shall be paid in regular 
        intervals (as determined appropriate by the Secretary).
          ``(5) Refund deposits.--Amounts paid as refunds 
        pursuant to paragraph (2) shall be deposited into the 
        Federal Supplementary Medical Insurance Trust Fund 
        established under section 1841.
          ``(6) Enforcement.--
                  ``(A) Audits.--
                          ``(i) Manufacturer audits.--Each 
                        manufacturer of a refundable single-
                        dose container or single-use package 
                        drug that is required to provide a 
                        refund under this subsection shall be 
                        subject to periodic audit with respect 
                        to such drug and such refunds by the 
                        Secretary.
                          ``(ii) Provider audits.--The 
                        Secretary shall conduct periodic audits 
                        of claims submitted under this part 
                        with respect to refundable single-dose 
                        container or single-use package drugs 
                        in accordance with the authority under 
                        section 1833(e) to ensure compliance 
                        with the requirements applicable under 
                        this subsection.
                  ``(B) Civil money penalty.--
                          ``(i) In general.--The Secretary 
                        shall impose a civil money penalty on a 
                        manufacturer of a refundable single-
                        dose container or single-use package 
                        drug who has failed to comply with the 
                        requirement under paragraph (2) for 
                        such drug for a calendar quarter in an 
                        amount equal to the sum of--
                                  ``(I) the amount that the 
                                manufacturer would have paid 
                                under such paragraph with 
                                respect to such drug for such 
                                quarter; and
                                  ``(II) 25 percent of such 
                                amount.
                          ``(ii) Application.--The provisions 
                        of section 1128A (other than 
                        subsections (a) and (b)) shall apply to 
                        a civil money penalty under this 
                        subparagraph in the same manner as such 
                        provisions apply to a penalty or 
                        proceeding under section 1128A(a).
          ``(7) Implementation.--The Secretary shall implement 
        this subsection through notice and comment rulemaking.
          ``(8) Definition of refundable single-dose container 
        or single-use package drug.--
                  ``(A) In general.--Except as provided in 
                subparagraph (B), in this subsection, the term 
                `refundable single-dose container or single-use 
                package drug' means a single source drug or 
                biological (as defined in section 
                1847A(c)(6)(D)) or a biosimilar biological 
                product (as defined in section 1847A(c)(6)(H)) 
                for which payment is established under this 
                part and that is furnished from a single-dose 
                container or single-use package.
                  ``(B) Exclusions.--The term `refundable 
                single-dose container or single-use package 
                drug' does not include--
                          ``(i) a drug or biological that is 
                        either a radiopharmaceutical or an 
                        imaging agent;
                          ``(ii) a drug or biological for which 
                        dosage and administration instructions 
                        approved by the Commissioner of Food 
                        and Drugs require filtration during the 
                        drug preparation process, prior to 
                        dilution and administration, and 
                        require that any unused portion of such 
                        drug after the filtration process be 
                        discarded after the completion of such 
                        filtration process; or
                          ``(iii) a drug or biological approved 
                        by the Food and Drug Administration on 
                        or after the date of enactment of this 
                        subsection and with respect to which 
                        payment has been made under this part 
                        for less than 18 months.''.

SEC. 103. PROVIDING FOR VARIATION IN PAYMENT FOR CERTAIN DRUGS COVERED 
                    UNDER PART B OF THE MEDICARE PROGRAM.

  (a) In General.--Section 1847A(b) of the Social Security Act 
(42 U.S.C. 1395w-3a(b)) is amended--
          (1) in paragraph (1)--
                  (A) in subparagraph (A), by inserting after 
                ``or 106 percent'' the following: ``(or, for a 
                multiple source drug (other than autologous 
                cellular immunotherapy) furnished on or after 
                January 1, 2021, the applicable percent 
                specified in paragraph (9)(A) for the drug and 
                quarter involved)''; and
                  (B) in subparagraph (B) of paragraph (1), by 
                inserting after ``106 percent'' the following: 
                ``(or, for a single source drug or biological 
                (other than autologous cellular immunotherapy) 
                furnished on or after January 1, 2021, the 
                applicable percent specified in paragraph 
                (9)(A) for the drug or biological and quarter 
                involved)''; and
          (2) by adding at the end the following new paragraph:
          ``(9) Application of variable percentages based on 
        percentile ranking of per beneficiary allowed 
        charges.--
                  ``(A) Applicable percent to be applied.--
                          ``(i) In general.--Subject to clauses 
                        (ii), with respect to a drug or 
                        biological furnished in a calendar 
                        quarter beginning on or after January 
                        1, 2021, if the Secretary determines 
                        that the percentile rank of a drug or 
                        biological under subparagraph 
                        (B)(i)(III), with respect to per 
                        beneficiary allowed charges for all 
                        such drugs or biologicals, is--
                                  ``(I) at least equal to the 
                                85th percentile, the applicable 
                                percent for the drug for such 
                                quarter under this subparagraph 
                                is 104 percent;
                                  ``(II) at least equal to the 
                                70th percentile, but less than 
                                the 85th percentile, such 
                                applicable percent is 106 
                                percent;
                                  ``(III) at least equal to the 
                                50th percentile, but less than 
                                the 70th percentile, such 
                                applicable percent is 108 
                                percent; or
                                  ``(IV) less than the 50th 
                                percentile, such applicable 
                                percent is 110 percent.
                          ``(ii) Cases where data not 
                        sufficiently available to compute per 
                        beneficiary allowed charges.--Subject 
                        to clause (iii), in the case of a drug 
                        or biological furnished for which the 
                        amount of payment is determined under 
                        subparagraph (A) or (B) of paragraph 
                        (1) and not under subsection (c)(4), 
                        for calendar quarters during a period 
                        in which data are not sufficiently 
                        available to compute a per beneficiary 
                        allowed charges for the drug or 
                        biological, the applicable percent is 
                        106 percent.
                  ``(B) Determination of percentile rank of per 
                beneficiary allowed charges of drugs.--
                          ``(i) In general.--With respect to a 
                        calendar quarter beginning on or after 
                        January 1, 2021, for drugs and 
                        biologicals for which the amount of 
                        payment is determined under 
                        subparagraph (A) or (B) of paragraph 
                        (1), except for drugs or biologicals 
                        for which data are not sufficiently 
                        available, the Secretary shall--
                                  ``(I) compute the per 
                                beneficiary allowed charges (as 
                                defined in subparagraph (C)) 
                                for each such drug or 
                                biological;
                                  ``(II) adjust such per 
                                beneficiary allowed charges for 
                                the quarter, to the extent 
                                provided under subparagraph 
                                (D); and
                                  ``(III) array such adjusted 
                                per beneficiary allowed charges 
                                for all such drugs or 
                                biologicals from high to low 
                                and rank such drugs or 
                                biologicals by percentile of 
                                such arrayed per beneficiary 
                                allowed charges.
                          ``(ii) Frequency.--The Secretary 
                        shall make the computations under 
                        clause (i)(I) every 6 months (or, if 
                        necessary, as determined by the 
                        Secretary, every 9 or 12 months) and 
                        such computations shall apply to 
                        succeeding calendar quarters until a 
                        new computation has been made.
                          ``(iii) Applicable data period.--For 
                        purposes of this paragraph, the term 
                        `applicable data period' means the most 
                        recent period for which the data 
                        necessary for making the computations 
                        under clause (i) are available, as 
                        determined by the Secretary.
                  ``(C) Per beneficiary allowed charges 
                defined.--In this paragraph, the term `per 
                beneficiary allowed charges' means, with 
                respect to a drug or biological for which the 
                amount of payment is determined under 
                subparagraph (A) or (B) of paragraph (1)--
                          ``(i) the allowed charges for the 
                        drug or biological for which payment is 
                        so made for the applicable data period, 
                        as estimated by the Secretary; divided 
                        by
                          ``(ii) the number of individuals for 
                        whom any payment for the drug or 
                        biological was made under paragraph (1) 
                        for the applicable data period, as 
                        estimated by the Secretary.
                  ``(D) Adjustment to reflect changes in 
                average sales price.--In applying this 
                paragraph for a particular calendar quarter, 
                the Secretary shall adjust the per beneficiary 
                allowed charges for a drug or biological by 
                multiplying such per beneficiary allowed 
                charges under subparagraph (C) for the 
                applicable data period by the ratio of--
                          ``(i) the average sales price for the 
                        drug or biological for the most recent 
                        calendar quarter used under subsection 
                        (c)(5)(B); to
                          ``(ii) the average sales price for 
                        the drug or biological for the calendar 
                        quarter (or the weighted average for 
                        the quarters involved) included in the 
                        applicable data period.''.
  (b) Application of Judicial Review Provisions.--Section 
1847A(g) of the Social Security Act is amended--
          (1) by striking ``and'' at the end of paragraph (4);
          (2) by striking the period at the end of paragraph 
        (5) and inserting ``; and''; and
          (3) by adding at the end the following new paragraph:
          ``(6) the determination of per beneficiary allowed 
        charges of drugs or biologicals and ranking of such 
        charges under subsection (b)(9).''.

SEC. 104. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT FOR DRUGS AND 
                    BIOLOGICALS.

  (a) In General.--Section 1847A of the Social Security Act (42 
U.S.C. 1395w-3a), as amended by section 103, is further 
amended--
          (1) in subsection (b)--
                  (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by striking ``paragraph (7)'' 
                and inserting ``paragraphs (7) and (10)''; and
                  (B) by adding at the end the following new 
                paragraph:
          ``(10) Maximum add-on payment amount.--
                  ``(A) In general.--In determining the payment 
                amount under the provisions of subparagraph 
                (A), (B), or (C) of paragraph (1) of this 
                subsection, subsection (c)(4)(A)(ii), or 
                subsection (d)(3)(C) for a drug or biological 
                furnished on or after January 1, 2021, if the 
                applicable add-on payment (as defined in 
                subparagraph (B)) for each drug or biological 
                on a claim for a date of service exceeds the 
                maximum add-on payment amount specified under 
                subparagraph (C) for the drug or biological, 
                then the payment amount otherwise determined 
                for the drug or biological under those 
                provisions, as applicable, shall be reduced by 
                the amount of such excess.
                  ``(B) Applicable add-on payment defined.--In 
                this paragraph, the term `applicable add-on 
                payment' means the following amounts, 
                determined without regard to the application of 
                subparagraph (A):
                          ``(i) In the case of a multiple 
                        source drug, an amount equal to the 
                        difference between--
                                  ``(I) the amount that would 
                                otherwise be applied under 
                                paragraph (1)(A); and
                                  ``(II) the amount that would 
                                be applied under such paragraph 
                                if `100 percent' were 
                                substituted for the applicable 
                                percent (as defined in 
                                paragraph (9)) for such drug.
                          ``(ii) In the case of a single source 
                        drug or biological, an amount equal to 
                        the difference between--
                                  ``(I) the amount that would 
                                otherwise be applied under 
                                paragraph (1)(B); and
                                  ``(II) the amount that would 
                                be applied under such paragraph 
                                if `100 percent' were 
                                substituted for the applicable 
                                percent (as defined in 
                                paragraph (9)) for such drug or 
                                biological.
                          ``(iii) In the case of a biosimilar 
                        biological product, the amount 
                        otherwise determined under paragraph 
                        (8)(B).
                          ``(iv) In the case of a drug or 
                        biological during the initial period 
                        described in subsection (c)(4)(A), an 
                        amount equal to the difference 
                        between--
                                  ``(I) the amount that would 
                                otherwise be applied under 
                                subsection (c)(4)(A)(ii); and
                                  ``(II) the amount that would 
                                be applied under such 
                                subsection if `100 percent' 
                                were substituted, as 
                                applicable, for--
                                          ``(aa) `103 percent' 
                                        in subclause (I) of 
                                        such subsection; or
                                          ``(bb) any percent in 
                                        excess of 100 percent 
                                        applied under subclause 
                                        (II) of such 
                                        subsection.
                          ``(v) In the case of a drug or 
                        biological to which subsection 
                        (d)(3)(C) applies, an amount equal to 
                        the difference between--
                                  ``(I) the amount that would 
                                otherwise be applied under such 
                                subsection; and
                                  ``(II) the amount that would 
                                be applied under such 
                                subsection if `100 percent' 
                                were substituted, as 
                                applicable, for--
                                          ``(aa) any percent in 
                                        excess of 100 percent 
                                        applied under clause 
                                        (i) of such subsection; 
                                        or
                                          ``(bb) `103 percent' 
                                        in clause (ii) of such 
                                        subsection.
                  ``(C) Maximum add-on payment amount 
                specified.--For purposes of subparagraph (A), 
                the maximum add-on payment amount specified in 
                this subparagraph is--
                          ``(i) with respect to a drug or 
                        biological (other than autologous 
                        cellular immunotherapy)--
                                  ``(I) for each of 2021 
                                through 2028, $1,000; and
                                  ``(II) for a subsequent year, 
                                the amount specified in this 
                                subparagraph for the preceding 
                                year increased by the 
                                percentage increase in the 
                                consumer price index for all 
                                urban consumers (all items; 
                                United States city average) for 
                                the 12-month period ending with 
                                June of the previous year; or
                          ``(ii) with respect to a drug or 
                        biological consisting of autologous 
                        cellular immunotherapy--
                                  ``(I) for each of 2021 
                                through 2028, $2,000; and
                                  ``(II) for a subsequent year, 
                                the amount specified in this 
                                subparagraph for the preceding 
                                year increased by the 
                                percentage increase in the 
                                consumer price index for all 
                                urban consumers (all items; 
                                United States city average) for 
                                the 12-month period ending with 
                                June of the previous year.
                Any amount determined under this subparagraph 
                that is not a multiple of $10 shall be rounded 
                to the nearest multiple of $10.''
          (2) in subsection (c)(4)(A)(ii), by striking ``in the 
        case'' and inserting ``subject to subsection (b)(10), 
        in the case''.
  (b) Conforming Amendments Relating to Separately Payable 
Drugs.--
          (1) Opps.--Section 1833(t)(14) of the Social Security 
        Act (42 U.S.C. 1395l(t)(14)) is amended--
                  (A) in subparagraph (A)(iii)(II), by 
                inserting ``, subject to subparagraph (I)'' 
                after ``are not available''; and
                  (B) by adding at the end the following new 
                subparagraph:
                  ``(I) Application of maximum add-on payment 
                for separately payable drugs and biologicals.--
                In establishing the amount of payment under 
                subparagraph (A) for a specified covered 
                outpatient drug that is furnished as part of a 
                covered OPD service (or group of services) on 
                or after January 1, 2021, if such payment is 
                determined based on the average price for the 
                year established under section 1847A pursuant 
                to clause (iii)(II) of such subparagraph, the 
                provisions of subsection (b)(10) of section 
                1847A shall apply to the amount of payment so 
                established in the same manner as such 
                provisions apply to the amount of payment under 
                section 1847A.''.
          (2) Asc.--Section 1833(i)(2)(D) of the Social 
        Security Act (42 U.S.C. 1395l(i)(2)(D)) is amended--
                  (A) by moving clause (v) 6 ems to the left;
                  (B) by redesignating clause (vi) as clause 
                (vii); and
                  (C) by inserting after clause (v) the 
                following new clause:
                          ``(vi) If there is a separate payment 
                        under the system described in clause 
                        (i) for a drug or biological furnished 
                        on or after January 1, 2021, the 
                        provisions of subsection (t)(14)(I) 
                        shall apply to the establishment of the 
                        amount of payment for the drug or 
                        biological under such system in the 
                        same manner in which such provisions 
                        apply to the establishment of the 
                        amount of payment under subsection 
                        (t)(14)(A).''.

SEC. 105. TREATMENT OF DRUG ADMINISTRATION SERVICES FURNISHED BY 
                    CERTAIN EXCEPTED OFF-CAMPUS OUTPATIENT DEPARTMENTS 
                    OF A PROVIDER.

  Section 1833(t)(16) of the Social Security Act (42 12 U.S.C. 
1395l(t)(16)) is amended by adding at the end the following new 
subparagraph:
                  ``(G) Special payment rule for drug 
                administration services furnished by an 
                excepted department of a provider.--
                          ``(i) In general.--In the case of a 
                        covered OPD service that is a drug 
                        administration service (as defined by 
                        the Secretary) furnished by a 
                        department of a provider described in 
                        clause (ii) or (iv) of paragraph 
                        (21)(B), the payment amount for such 
                        service furnished on or after January 
                        1, 2021, shall be the same payment 
                        amount (as determined in paragraph 
                        (21)(C)) that would apply if the drug 
                        administration service was furnished by 
                        an off-campus outpatient department of 
                        a provider (as defined in paragraph 
                        (21)(B)).
                          ``(ii) Application without regard to 
                        budget neutrality.--The reductions made 
                        under this subparagraph--
                                  ``(I) shall not be considered 
                                an adjustment under paragraph 
                                (2)(E); and
                                  ``(II) shall not be 
                                implemented in a budget neutral 
                                manner.''.

                  Subtitle B--Drug Price Transparency


SEC. 111. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.

  (a) In General.--Title III of the Public Health Service Act 
(42 U.S.C. 241 et seq.) is amended by adding at the end the 
following:

            ``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND

``SEC. 399OO. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.

  ``(a) Definitions.--In this section:
          ``(1) Manufacturer.--The term `manufacturer' means 
        the person--
                  ``(A) that holds the application for a drug 
                approved under section 505 of the Federal Food, 
                Drug, and Cosmetic Act or licensed under 
                section 351 of this Act; or
                  ``(B) who is responsible for setting the 
                wholesale acquisition cost for the drug.
          ``(2) Qualifying drug.--The term `qualifying drug' 
        means any drug that is approved under subsection (c) or 
        (j) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act or licensed under subsection (a) or (k) of 
        section 351 of this Act--
                  ``(A) that has a wholesale acquisition cost 
                of $100 or more, adjusted for inflation 
                occurring after the date of enactment of this 
                section, for a month's supply or a typical 
                course of treatment that lasts less than a 
                month, and is--
                          ``(i) subject to section 503(b)(1) of 
                        the Federal Food, Drug, and Cosmetic 
                        Act;
                          ``(ii) administered or otherwise 
                        dispensed to treat a disease or 
                        condition affecting more than 200,000 
                        persons in the United States; and
                          ``(iii) not a vaccine; and
                  ``(B) for which, during the previous calendar 
                year, at least 1 dollar of the total amount of 
                sales were for individuals enrolled under the 
                Medicare program under title XVIII of the 
                Social Security Act (42 U.S.C. 1395 et seq.) or 
                under a State Medicaid plan under title XIX of 
                such Act (42 U.S.C. 1396 et seq.) or under a 
                waiver of such plan.
          ``(3) Wholesale acquisition cost.--The term 
        `wholesale acquisition cost' has the meaning given that 
        term in section 1847A(c)(6)(B) of the Social Security 
        Act (42 U.S.C. 1395w-3a(c)(6)(B)).
  ``(b) Report.--
          ``(1) Report required.--The manufacturer of a 
        qualifying drug shall submit a report to the 
        Secretary--
                  ``(A) for each increase in the price of a 
                qualifying drug that results in an increase in 
                the wholesale acquisition cost of that drug 
                that is equal to--
                          ``(i) 10 percent or more within a 
                        single calendar year beginning on or 
                        after January 1, 2019; or
                          ``(ii) 25 percent or more within 
                        three consecutive calendar years for 
                        which the first such calendar year 
                        begins on or after January 1, 2019; and
                  ``(B) in the case that the qualifying drug is 
                first covered under title XVIII with respect to 
                an applicable year, if the estimated cost or 
                spending under such title per individual or per 
                user of such drug (as estimated by the 
                Secretary) for such applicable year (or per 
                course of treatment in such applicable year, as 
                defined by the Secretary) is at least $26,000.
          ``(2) Report deadline.--Each report described in 
        paragraph (1) shall be submitted to the Secretary--
                  ``(A) in the case of a report with respect to 
                an increase in the price of a qualifying drug 
                that occurs during the period beginning on 
                January 1, 2019, and ending on the day that is 
                60 days after the date of enactment of this 
                section, not later than 90 days after such date 
                of enactment;
                  ``(B) in the case of a report with respect to 
                an increase in the price of a qualifying drug 
                that occurs after the period described in 
                subparagraph (A), not later than 30 days prior 
                to the planned effective date of such price 
                increase for such qualifying drug; and
                  ``(C) in the case of a report with respect to 
                a qualifying drug that meets the criteria 
                described in paragraph (1)(B), not later than 
                30 days after such drug meets such criteria.
  ``(c) Contents.--A report under subsection (b), consistent 
with the standard for disclosures described in section 213.3(d) 
of title 12, Code of Federal Regulations (as in effect on the 
date of enactment of this section), shall, at a minimum, 
include--
          ``(1) with respect to the qualifying drug--
                  ``(A) the percentage by which the 
                manufacturer will raise the wholesale 
                acquisition cost of the drug within the 
                calendar year or three consecutive calendar 
                years as described in subsection (b)(1)(A) or 
                (b)(1)(B), if applicable, and the effective 
                date of such price increase;
                  ``(B) an explanation for, and description of, 
                each price increase for such drug that will 
                occur during the calendar year period described 
                in subsection (b)(1)(A) or the three 
                consecutive calendar year period described in 
                subsection (b)(1)(B), as applicable;
                  ``(C) if known and different from the 
                manufacturer of the qualifying drug, the 
                identity of--
                          ``(i) the sponsor or sponsors of any 
                        investigational new drug applications 
                        under section 505(i) of the Federal 
                        Food, Drug, and Cosmetic Act for 
                        clinical investigations with respect to 
                        such drug, for which the full reports 
                        are submitted as part of the 
                        application--
                                  ``(I) for approval of the 
                                drug under section 505 of such 
                                Act; or
                                  ``(II) for licensure of the 
                                drug under section 351 of this 
                                Act; and
                          ``(ii) the sponsor of an application 
                        for the drug approved under such 
                        section 505 of the Federal Food, Drug, 
                        and Cosmetic Act or licensed under 
                        section 351 of this Act;
                  ``(D) a description of the history of the 
                manufacturer's price increases for the drug 
                since the approval of the application for the 
                drug under section 505 of the Federal Food, 
                Drug, and Cosmetic Act or the issuance of the 
                license for the drug under section 351 of this 
                Act, or since the manufacturer acquired such 
                approved application or license, if applicable;
                  ``(E) the current wholesale acquisition cost 
                of the drug;
                  ``(F) the total expenditures of the 
                manufacturer on--
                          ``(i) materials and manufacturing for 
                        such drug; and
                          ``(ii) acquiring patents and 
                        licensing for such drug;
                  ``(G) the percentage of total expenditures of 
                the manufacturer on research and development 
                for such drug that was derived from Federal 
                funds;
                  ``(H) the total expenditures of the 
                manufacturer on research and development for 
                such drug that is necessary to demonstrate that 
                it meets applicable statutory standards for 
                approval under section 505 of the Federal Food, 
                Drug, and Cosmetic Act or licensure under 
                section 351 of this Act, as applicable;
                  ``(I) the total expenditures of the 
                manufacturer on pursuing new or expanded 
                indications or dosage changes for such drug 
                under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or section 351 of this Act;
                  ``(J) the total expenditures of the 
                manufacturer on carrying out postmarket 
                requirements related to such drug, including 
                under section 505(o)(3) of the Federal Food, 
                Drug, and Cosmetic Act;
                  ``(K) the total revenue and the net profit 
                generated from the qualifying drug for each 
                calendar year since the approval of the 
                application for the drug under section 505 of 
                the Federal Food, Drug, and Cosmetic Act or the 
                issuance of the license for the drug under 
                section 351, or since the manufacturer acquired 
                such approved application or license; and
                  ``(L) the total costs associated with 
                marketing and advertising for the qualifying 
                drug;
          ``(2) with respect to the manufacturer--
                  ``(A) the total revenue and the net profit of 
                the manufacturer for each of the 1-year period 
                described in subsection (b)(1)(A) or the 3-year 
                period described in subsection (b)(1)(B), as 
                applicable;
                  ``(B) all stock-based performance metrics 
                used by the manufacturer to determine executive 
                compensation for each of the 1-year period 
                described in subsection (b)(1)(A) or the 3-year 
                period described in subsection (b)(1)(B), as 
                applicable; and
                  ``(C) any additional information the 
                manufacturer chooses to provide related to drug 
                pricing decisions, such as total expenditures 
                on--
                          ``(i) drug research and development; 
                        or
                          ``(ii) clinical trials, including on 
                        drugs that failed to receive approval 
                        by the Food and Drug Administration; 
                        and
          ``(3) such other related information as the Secretary 
        considers appropriate and as specified by the Secretary 
        through notice-and-comment rulemaking.
  ``(d) Information Provided.--The manufacturer of a qualifying 
drug that is required to submit a report under subsection (b), 
shall ensure that such report and any explanation for, and 
description of, each price increase described in subsection 
(c)(1)(B) shall be truthful, not misleading, and accurate.
  ``(e) Civil Monetary Penalty.--Any manufacturer of a 
qualifying drug that fails to submit a report for the drug as 
required by this section, following notification by the 
Secretary to the manufacturer that the manufacturer is not in 
compliance with this section, shall be subject to a civil 
monetary penalty of $75,000 for each day on which the violation 
continues.
  ``(f) False Information.--Any manufacturer that submits a 
report for a drug as required by this section that knowingly 
provides false information in such report is subject to a civil 
monetary penalty in an amount not to exceed $75,000 for each 
item of false information.
  ``(g) Public Posting.--
          ``(1) In general.--Subject to paragraph (3), the 
        Secretary shall post each report submitted under 
        subsection (b) on the public website of the Department 
        of Health and Human Services the day the price increase 
        of a qualifying drug is scheduled to go into effect.
          ``(2) Format.--In developing the format in which 
        reports will be publicly posted under paragraph (1), 
        the Secretary shall consult with stakeholders, 
        including beneficiary groups, and shall seek feedback 
        from consumer advocates and readability experts on the 
        format and presentation of the content of such reports 
        to ensure that such reports are--
                  ``(A) user-friendly to the public; and
                  ``(B) written in plain language that 
                consumers can readily understand.
          ``(3) Protected information.--Nothing in this section 
        shall be construed to authorize the public disclosure 
        of information submitted by a manufacturer that is 
        prohibited from disclosure by applicable laws 
        concerning the protection of trade secrets, commercial 
        information, and other information covered under such 
        laws.

``SEC. 399OO-1. ANNUAL REPORT TO CONGRESS.

  ``(a) In General.--Subject to subsection (b), the Secretary 
shall submit to Congress, and post on the public website of the 
Department of Health and Human Services in a way that is user-
friendly to the public and written in plain language that 
consumers can readily understand, an annual report--
          ``(1) summarizing the information reported pursuant 
        to section 399OO;
          ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to such 
        section;
          ``(3) detailing the costs and expenditures incurred 
        by the Department of Health and Human Services in 
        carrying out section 399OO; and
          ``(4) explaining how the Department of Health and 
        Human Services is improving consumer and provider 
        information about drug value and drug price 
        transparency.
  ``(b) Protected Information.--Nothing in this section shall 
be construed to authorize the public disclosure of information 
submitted by a manufacturer that is prohibited from disclosure 
by applicable laws concerning the protection of trade secrets, 
commercial information, and other information covered under 
such laws.''.
  (b) Effective Date.--The amendment made by subsection (a) 
takes effect on the date of enactment of this Act.

SEC. 112. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.

  Section 1150A of the Social Security Act (42 U.S.C. 1320b-23) 
is amended--
          (1) in subsection (c), in the matter preceding 
        paragraph (1), by inserting ``(other than as permitted 
        under subsection (e))'' after ``disclosed by the 
        Secretary''; and
          (2) by adding at the end the following new 
        subsection:
  ``(e) Public Availability of Certain Information.--
          ``(1) In general.--In order to allow the comparison 
        of PBMs' ability to negotiate rebates, discounts, 
        direct and indirect remuneration fees, administrative 
        fees, and price concessions and the amount of such 
        rebates, discounts, direct and indirect remuneration 
        fees, administrative fees, and price concessions that 
        are passed through to plan sponsors, beginning January 
        1, 2020, the Secretary shall make available on the 
        Internet website of the Department of Health and Human 
        Services the information with respect to the second 
        preceding calendar year provided to the Secretary on 
        generic dispensing rates (as described in paragraph (1) 
        of subsection (b)) and information provided to the 
        Secretary under paragraphs (2) and (3) of such 
        subsection that, as determined by the Secretary, is 
        with respect to each PBM.
          ``(2) Availability of data.--In carrying out 
        paragraph (1), the Secretary shall ensure the 
        following:
                  ``(A) Confidentiality.--The information 
                described in such paragraph is displayed in a 
                manner that prevents the disclosure of 
                information, with respect to an individual drug 
                or an individual plan, on rebates, discounts, 
                direct and indirect remuneration fees, 
                administrative fees, and price concessions.
                  ``(B) Class of drug.--The information 
                described in such paragraph is made available 
                by class of drug, using an existing 
                classification system, but only if the class 
                contains such number of drugs, as specified by 
                the Secretary (but not fewer than three drugs), 
                to ensure confidentiality of proprietary 
                information or other information that is 
                prevented to be disclosed under subparagraph 
                (A).''.

SEC. 113. STUDY OF PHARMACEUTICAL SUPPLY CHAIN INTERMEDIARIES AND 
                    MERGER ACTIVITY.

  (a) Initial Report.--Not later than 1 year after the date of 
enactment of this Act, the Commission shall submit to the 
appropriate committees of Congress a report that--
          (1) addresses at minimum--
                  (A) whether pharmacy benefit managers--
                          (i) charge payers a higher price than 
                        the reimbursement rate at which the 
                        pharmacy benefit managers reimburse 
                        competing pharmacies;
                          (ii) steer patients for 
                        anticompetitive purposes to any 
                        pharmacies, including retail, mail-
                        order, or any other type of pharmacy, 
                        in which the pharmacy benefit manager 
                        has an ownership interest;
                          (iii) audit or review proprietary 
                        data, including acquisition costs, 
                        patient information, or dispensing 
                        information, of competing pharmacies 
                        that can be used for anticompetitive 
                        purposes; or
                          (iv) use formulary designs to 
                        increase the market share of higher 
                        cost prescription drugs and depress the 
                        market share of lower cost prescription 
                        drugs (each net of rebates and 
                        discounts);
                  (B) how companies and payers assess the 
                benefits, costs, and risks of contracting with 
                intermediaries, including pharmacy services 
                administrative organizations, and whether more 
                information about the roles of intermediaries 
                should be available to consumers and payers; 
                and
                  (C) whether there are any specific legal or 
                regulatory obstacles the Commission currently 
                faces in ensuring a competitive and transparent 
                marketplace in the pharmaceutical supply chain, 
                including the pharmacy benefit manager 
                marketplace and pharmacy services 
                administrative organizations; and
          (2) provides--
                  (A) observations or conclusions drawn from 
                the November 2017 roundtable entitled 
                ``Understanding Competition in Prescription 
                Drug Markets: Entry and Supply Chain 
                Dynamics'', and any similar efforts;
                  (B) specific actions the Commission intends 
                to take as a result of the November 2017 
                roundtable, and any similar efforts, including 
                a detailed description of relevant forthcoming 
                actions, additional research or roundtable 
                discussions, consumer education efforts, or 
                enforcement actions; and
                  (C) policy or legislative recommendations 
                to--
                          (i) improve transparency and 
                        competition in the pharmaceutical 
                        supply chain;
                          (ii) prevent and deter 
                        anticompetitive behavior in the 
                        pharmaceutical supply chain; and
                          (iii) best ensure that consumers 
                        benefit from any cost savings or 
                        efficiencies that may result from 
                        mergers and consolidations.
  (b) Interim Report.--Not later than 180 days after the date 
of enactment of this Act, the Commission shall submit to the 
appropriate committees of Congress an interim report on the 
progress of the report required by subsection (a), along with 
preliminary findings and conclusions based on information 
collected to that date.
  (c) Definitions.--In this section:
          (1) Appropriate committees of congress.--The term 
        ``appropriate committees of Congress'' means--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on the Judiciary of the 
                Senate; and
                  (C) the Committee on the Judiciary of the 
                House of Representatives.
          (2) Commission.--The term ``Commission'' means the 
        Federal Trade Commission.

SEC. 114. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING 
                    INFORMATION WITH RESPECT TO DRUGS UNDER THE 
                    MEDICARE PROGRAM.

  (a) In General.--Section 1847A of the Social Security Act (42 
U.S.C. 1395w-3a) is amended--
          (1) in subsection (b)--
                  (A) in paragraph (2)(A), by inserting ``or 
                subsection (f)(2), as applicable'' before the 
                period at the end;
                  (B) in paragraph (3), in the matter preceding 
                subparagraph (A), by inserting ``or subsection 
                (f)(2), as applicable,'' before ``determined 
                by''; and
                  (C) in paragraph (6)(A), in the matter 
                preceding clause (i), by inserting ``or 
                subsection (f)(2), as applicable,'' before 
                ``determined by''; and
          (2) in subsection (f)--
                  (A) by striking ``For requirements'' and 
                inserting the following:
          ``(1) In general.--For requirements''; and
                  (B) by adding at the end the following new 
                paragraph:
          ``(2) Manufacturers without a rebate agreement under 
        title xix.--
                  ``(A) In general.--If the manufacturer of a 
                drug or biological described in subparagraph 
                (C), (E), or (G) of section 1842(o)(1) or in 
                section 1881(b)(14)(B) that is payable under 
                this part has not entered into and does not 
                have in effect a rebate agreement described in 
                subsection (b) of section 1927, for calendar 
                quarters beginning on or after January 1, 2020, 
                such manufacturer shall report to the Secretary 
                the information described in subsection 
                (b)(3)(A)(iii) of such section 1927 with 
                respect to such drug or biological in a time 
                and manner specified by the Secretary. For 
                purposes of applying this paragraph, a drug or 
                biological described in the previous sentence 
                includes items, services, supplies, and 
                products that are payable under this part as a 
                drug or biological.
                  ``(B) Audit.--Information reported under 
                subparagraph (A) is subject to audit by the 
                Inspector General of the Department of Health 
                and Human Services.
                  ``(C) Verification.--The Secretary may survey 
                wholesalers and manufacturers that directly 
                distribute drugs described in subparagraph (A), 
                when necessary, to verify manufacturer prices 
                and manufacturer's average sales prices 
                (including wholesale acquisition cost) if 
                required to make payment reported under 
                subparagraph (A). The Secretary may impose a 
                civil monetary penalty in an amount not to 
                exceed $100,000 on a wholesaler, manufacturer, 
                or direct seller, if the wholesaler, 
                manufacturer, or direct seller of such a drug 
                refuses a request for information about charges 
                or prices by the Secretary in connection with a 
                survey under this subparagraph or knowingly 
                provides false information. The provisions of 
                section 1128A (other than subsections (a) (with 
                respect to amounts of penalties or additional 
                assessments) and (b)) shall apply to a civil 
                money penalty under this subparagraph in the 
                same manner as such provisions apply to a 
                penalty or proceeding under section 1128A(a).
                  ``(D) Confidentiality.--Notwithstanding any 
                other provision of law, information disclosed 
                by manufacturers or wholesalers under this 
                paragraph (other than the wholesale acquisition 
                cost for purposes of carrying out this section) 
                is confidential and shall not be disclosed by 
                the Secretary in a form which discloses the 
                identity of a specific manufacturer or 
                wholesaler or prices charged for drugs by such 
                manufacturer or wholesaler, except--
                          ``(i) as the Secretary determines to 
                        be necessary to carry out this section 
                        (including the determination and 
                        implementation of the payment amount), 
                        or to carry out section 1847B;
                          ``(ii) to permit the Comptroller 
                        General of the United States to review 
                        the information provided; and
                          ``(iii) to permit the Director of the 
                        Congressional Budget Office to review 
                        the information provided.''.
  (b) Enforcement.--Section 1847A of such Act (42 U.S.C. 1395w-
3a) is further amended--
          (1) in subsection (d)(4)--
                  (A) in subparagraph (A), by striking ``In 
                general'' and inserting ``Misrepresentation'';
                  (B) in subparagraph (B), by striking 
                ``subparagraph (B)'' and inserting 
                ``subparagraph (A), (B), or (C)'';
                  (C) by redesignating subparagraph (B) as 
                subparagraph (D); and
                  (D) by inserting after subparagraph (A) the 
                following new subparagraphs:
                  ``(B) Failure to provide timely 
                information.--If the Secretary determines that 
                a manufacturer described in subsection (f)(2) 
                has failed to report on information described 
                in section 1927(b)(3)(A)(iii) with respect to a 
                drug or biological in accordance with such 
                subsection, the Secretary shall apply a civil 
                money penalty in an amount of $10,000 for each 
                day the manufacturer has failed to report such 
                information and such amount shall be paid to 
                the Treasury.
                  ``(C) False information.--Any manufacturer 
                required to submit information under subsection 
                (f)(2) that knowingly provides false 
                information is subject to a civil money penalty 
                in an amount not to exceed $100,000 for each 
                item of false information. Such civil money 
                penalties are in addition to other penalties as 
                may be prescribed by law.''; and
          (2) in subsection (c)(6)(A), by striking the period 
        at the end and inserting ``, except that, for purposes 
        of subsection (f)(2), the Secretary may, if the 
        Secretary determines appropriate, exclude repackagers 
        of a drug or biological from such term.''.
  (c) Manufacturers With a Rebate Agreement.--
          (1) In general.--Section 1927(b)(3)(A) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by 
        adding at the end the following new sentence: ``For 
        purposes of applying clause (iii), a drug or biological 
        described in the flush matter following such clause 
        includes items, services, supplies, and products that 
        are payable under this part as a drug or biological.''.
          (2) Technical amendment.--Section 1927(b)(3)(A)(iii) 
        of the Social Security Act (42 U.S.C. 1396r-
        8(b)(3)(A)(iii)) is amended by striking ``section 
        1881(b)(13)(A)(ii)'' and inserting ``section 
        1881(b)(14)(B)''.
  (d) Report.--Not later than January 1, 2021, the Inspector 
General of the Department of Health and Human Services shall 
assess and submit to Congress a report on the accuracy of 
average sales price information submitted by manufacturers 
under section 1847A of the Social Security Act (42 U.S.C. 
1395w-3a). Such report shall include any recommendations on how 
to improve the accuracy of such information.

SEC. 115. MAKING PRESCRIPTION DRUG MARKETING SAMPLE INFORMATION 
                    REPORTED BY MANUFACTURERS AVAILABLE TO CERTAIN 
                    INDIVIDUALS AND ENTITIES.

  (a) In General.--Section 1128H of the Social Security Act (42 
U.S.C. 1320a-7i) is amended--
          (1) by redesignating subsection (b) as subsection 
        (e); and
          (2) by inserting after subsection (a) the following 
        new subsections:
  ``(b) Data Sharing Agreements.--
          ``(1) In general.--The Secretary shall enter into 
        agreements with the specified data sharing individuals 
        and entities described in paragraph (2) under which--
                  ``(A) upon request of such an individual or 
                entity, as applicable, the Secretary makes 
                available to such individual or entity the 
                information submitted under subsection (a) by 
                manufacturers and authorized distributors of 
                record; and
                  ``(B) such individual or entity agrees to not 
                disclose publicly or to another individual or 
                entity any information that identifies a 
                particular practitioner or health care 
                facility.
          ``(2) Specified data sharing individuals and 
        entities.--For purposes of paragraph (1), the specified 
        data sharing individuals and entities described in this 
        paragraph are the following:
                  ``(A) Oversight agencies.--Health oversight 
                agencies (as defined in section 164.501 of 
                title 45, Code of Federal Regulations), 
                including the Centers for Medicare & Medicaid 
                Services, the Office of the Inspector General 
                of the Department of Health and Human Services, 
                the Government Accountability Office, the 
                Congressional Budget Office, the Medicare 
                Payment Advisory Commission, and the Medicaid 
                and CHIP Payment and Access Commission.
                  ``(B) Researchers.--Individuals who conduct 
                scientific research (as defined in section 
                164.501 of title 45, Code of Federal 
                Regulations) in relevant areas as determined by 
                the Secretary.
                  ``(C) Payers.--Private and public health care 
                payers, including group health plans, health 
                insurance coverage offered by health insurance 
                issuers, Federal health programs, and State 
                health programs.
          ``(3) Exemption from freedom of information act.--
        Except as described in paragraph (1), the Secretary may 
        not be compelled to disclose the information submitted 
        under subsection (a) to any individual or entity. For 
        purposes of section 552 of title 5, United States Code 
        (commonly referred to as the Freedom of Information 
        Act), this paragraph shall be considered a statute 
        described in subsection (b)(3)(B) of such section.
  ``(c) Penalties.--
          ``(1) Data sharing agreements.--Subject to paragraph 
        (3), any specified data sharing individual or entity 
        described in subsection (b)(2) that violates the terms 
        of a data sharing agreement the individual or entity 
        has with the Secretary under subsection (b)(1) shall be 
        subject to a civil money penalty of not less than 
        $1,000, but not more than $10,000, for each such 
        violation. Such penalty shall be imposed and collected 
        in the same manner as civil money penalties under 
        subsection (a) of section 1128A are imposed and 
        collected under that section.
          ``(2) Failure to report.--Subject to paragraph (3), 
        any manufacturer or authorized distributor of record of 
        an applicable drug under subsection (a) that fails to 
        submit information required under such subsection in a 
        timely manner in accordance with rules or regulations 
        promulgated to carry out such subsection shall be 
        subject to a civil money penalty of not less than 
        $1,000, but not more than $10,000, for each such 
        failure. Such penalty shall be imposed and collected in 
        the same manner as civil money penalties under 
        subsection (a) of section 1128A are imposed and 
        collected under that section.
          ``(3) Limitation.--The total amount of civil money 
        penalties imposed under paragraph (1) or (2) with 
        respect to a year and an individual or entity described 
        in paragraph (1) or a manufacturer or distributor 
        described in paragraph (2), respectively, shall not 
        exceed $150,000.
  ``(d) Drug Sample Distribution Information.--
          ``(1) In general.--Not later than January 1 of each 
        year (beginning with 2021), the Secretary shall 
        maintain a list containing information related to the 
        distribution of samples of applicable drugs. Such list 
        shall provide the following information with respect to 
        the preceding year:
                  ``(A) The name of the manufacturer or 
                authorized distributor of record of an 
                applicable drug for which samples were 
                requested or distributed under this section.
                  ``(B) The quantity and class of drug samples 
                requested.
                  ``(C) The quantity and class of drug samples 
                distributed.
          ``(2) Public availability.--The Secretary shall make 
        the information in such list available to the public on 
        the Internet website of the Food and Drug 
        Administration.''.
  (b) FDA Maintenance of Information.--The Food and Drug 
Administration shall maintain information available to affected 
reporting companies to ensure their ability to fully comply 
with the requirements of section 1128H of the Social Security 
Act.
  (c) Prohibition on Distribution of Samples of Opioids.--
Section 503(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(d)) is amended--
          (1) by moving the margin of paragraph (4) 2 ems to 
        the left; and
          (2) by adding at the end the following:
  ``(5) No person may distribute a drug sample of a drug that 
is--
          ``(A) an applicable drug (as defined in section 
        1128H(e) of the Social Security Act);
          ``(B) a controlled substance (as defined in section 
        102 of the Controlled Substances Act) for which the 
        findings required under section 202(b)(2) of such Act 
        have been made; and
          ``(C) approved under section 505 for use in the 
        management or treatment of pain (other than for the 
        management or treatment of a substance use 
        disorder).''.
  (d) MedPAC Report.--Not later than 3 years after the date of 
the enactment of this Act, the Medicare Payment Advisory 
Commission shall conduct a study on the impact of drug samples 
on provider prescribing practices and health care costs and 
may, as the Commission deems appropriate, make recommendations 
on such study.

SEC. 116. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS TO INCLUDE REAL-
                    TIME BENEFIT INFORMATION AS PART OF SUCH SPONSOR'S 
                    ELECTRONIC PRESCRIPTION PROGRAM UNDER THE MEDICARE 
                    PROGRAM.

  Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C. 
1395w-104(e)(2)) is amended--
          (1) in subparagraph (D), by striking ``To the 
        extent'' and inserting ``Except as provided in 
        subparagraph (F), to the extent''; and
          (2) by adding at the end the following new 
        subparagraph:
                  ``(F) Real-time benefit information.--
                          ``(i) In general.--Not later than 
                        January 1, 2021, the program shall 
                        implement real-time benefit tools that 
                        are capable of integrating with a 
                        prescribing health care professional's 
                        electronic prescribing or electronic 
                        health record system for the 
                        transmission of formulary and benefit 
                        information in real time to prescribing 
                        health care professionals. With respect 
                        to a covered part D drug, such tools 
                        shall be capable of transmitting such 
                        information specific to an individual 
                        enrolled in a prescription drug plan. 
                        Such information shall include the 
                        following:
                                  ``(I) A list of any 
                                clinically-appropriate 
                                alternatives to such drug 
                                included in the formulary of 
                                such plan.
                                  ``(II) Cost-sharing 
                                information for such drug and 
                                such alternatives, including a 
                                description of any variance in 
                                cost-sharing based on the 
                                pharmacy dispensing such drug 
                                or such alternatives.
                                  ``(III) Information relating 
                                to whether such drug is 
                                included in the formulary of 
                                such plan and any prior 
                                authorization or other 
                                utilization management 
                                requirements applicable to such 
                                drug and such alternatives so 
                                included.
                          ``(ii) Electronic transmission.--The 
                        provisions of subclauses (I) and (II) 
                        of clause (ii) of subparagraph (E) 
                        shall apply to an electronic 
                        transmission described in clause (i) in 
                        the same manner as such provisions 
                        apply with respect to an electronic 
                        transmission described in clause (i) of 
                        such subparagraph.
                          ``(iii) Special rule for 2021.--The 
                        program shall be deemed to be in 
                        compliance with clause (i) for 2021 if 
                        the program complies with the 
                        provisions of section 423.160(b)(7) of 
                        title 42, Code of Federal Regulations 
                        (or a successor regulation), for such 
                        year.
                          ``(iv) Rule of construction.--Nothing 
                        in this subparagraph shall be construed 
                        as to allow a real-time benefits tool 
                        to steer an individual, without the 
                        consent of the individual, to a 
                        particular pharmacy or pharmacy setting 
                        over their preferred pharmacy setting 
                        nor prohibit the designation of a 
                        preferred pharmacy under such tool.''.

SEC. 117. SENSE OF CONGRESS REGARDING THE NEED TO EXPAND COMMERCIALLY 
                    AVAILABLE DRUG PRICING COMPARISON PLATFORMS.

  It is the sense of Congress that--
          (1) commercially available drug pricing comparison 
        platforms can, at no cost, help patients find the 
        lowest price for their medications at their local 
        pharmacy;
          (2) such platforms should be integrated, to the 
        maximum extent possible, in the health care delivery 
        ecosystem; and
          (3) pharmacy benefit managers should work to disclose 
        generic and brand name drug prices to such platforms to 
        ensure that--
                  (A) patients can benefit from the lowest 
                possible price available to them; and
                  (B) overall drug prices can be reduced as 
                more educated purchasing decisions are made 
                based on price transparency.

SEC. 118. TECHNICAL CORRECTIONS.

  (a) In General.--Section 3022(b) of the Public Health Service 
Act (42 U.S.C. 300jj-52(b)) is amended by adding at the end the 
following new paragraph:
          ``(4) Application of authorities under inspector 
        general act of 1978.--In carrying out this subsection, 
        the Inspector General shall have the same authorities 
        as provided under section 6 of the Inspector General 
        Act of 1978 (5 U.S.C. App.).''.
  (b) Effective Date.--The amendment made by subsection (a) 
shall take effect as if included in the enactment of the 21st 
Century Cures Act (Public Law 114-255).

              Subtitle C--Medicare Part D Benefit Redesign


SEC. 121. MEDICARE PART D BENEFIT REDESIGN.

  (a) Benefit Structure Redesign.--Section 1860D-2(b) of the 
Social Security Act (42 U.S.C. 1395w- 102(b)) is amended--
          (1) in paragraph (2)--
                  (A) in subparagraph (A)--
                          (i) in the matter preceding clause 
                        (i), by inserting ``for a year 
                        preceding 2022 and for costs above the 
                        annual deductible specified in 
                        paragraph (1) and up to the annual out-
                        of-pocket threshold specified in 
                        paragraph (4)(B) for 2022 and each 
                        subsequent year'' after ``paragraph 
                        (3)''; and
                          (ii) in clause (i), by inserting 
                        after ``25 percent'' the following: 
                        ``(or, for 2022 and each subsequent 
                        year, 15 percent)'';
                  (B) in subparagraph (C)--
                          (i) in clause (i), in the matter 
                        preceding subclause (I), by inserting 
                        ``for a year preceding 2022,'' after 
                        ``paragraph (4),''; and
                          (ii) in clause (ii)(III), by striking 
                        ``and each subsequent year'' and 
                        inserting ``and 2021''; and
                  (C) in subparagraph (D)--
                          (i) in clause (i)--
                                  (I) in the matter preceding 
                                subclause (I), by inserting 
                                ``for a year preceding 2022,'' 
                                after ``paragraph (4),''; and
                                  (II) in subclause (I)(bb), by 
                                striking ``a year after 2018'' 
                                and inserting ``each of years 
                                2018 through 2021''; and
                          (ii) in clause (ii)(V), by striking 
                        ``2019 and each subsequent year'' and 
                        inserting ``each of years 2019 through 
                        2021'';
          (2) in paragraph (3)(A)--
                  (A) in the matter preceding clause (i), by 
                inserting ``for a year preceding 2022,'' after 
                ``and (4),''; and
                  (B) in clause (ii), by striking ``for a 
                subsequent year'' and inserting ``for each of 
                years 2007 through 2021'';
          (3) in paragraph (4)--
                  (A) in subparagraph (A)--
                          (i) in clause (i)--
                                  (I) by redesignating 
                                subclauses (I) and (II) as 
                                items (aa) and (bb), 
                                respectively, and indenting 
                                appropriately;
                                  (II) in the matter preceding 
                                item (aa), as redesignated by 
                                subclause (I), by striking ``is 
                                equal to the greater of--'' and 
                                inserting ``is equal to--
                                  ``(I) for a year preceding 
                                2022, the greater of--''.
                                  (III) by striking the period 
                                at the end of item (bb), as 
                                redesignated by subclause (I), 
                                and inserting ``; and''; and
                                  (IV) by adding at the end the 
                                following:
                                  ``(II) for 2022 and each 
                                succeeding year, $0.''; and
                          (ii) in clause (ii)--
                                  (I) by striking ``clause 
                                (i)(I)'' and inserting ``clause 
                                (i)(I)(aa)''; and
                                  (II) by adding at the end the 
                                following new sentence: ``The 
                                Secretary shall continue to 
                                calculate the dollar amounts 
                                specified in clause (i)(I)(aa), 
                                including with the adjustment 
                                under this clause, after 2021 
                                for purposes of section 1860D-
                                14(a)(1)(D)(iii).'';
                  (B) in subparagraph (B)--
                          (i) in clause (i)--
                                  (I) in subclause (V), by 
                                striking ``or'' at the end;
                                  (II) in subclause (VI)--
                                          (aa) by striking 
                                        ``for a subsequent 
                                        year'' and inserting 
                                        ``for 2021''; and
                                          (bb) by striking the 
                                        period at the end and 
                                        inserting a semicolon; 
                                        and
                                  (III) by adding at the end 
                                the following new subclauses:
                                  ``(VII) for 2022, is equal to 
                                $3,100; or
                                  ``(VIII) for a subsequent 
                                year, is equal to the amount 
                                specified in this subparagraph 
                                for the previous year, 
                                increased by the annual 
                                percentage increase described 
                                in paragraph (6) for the year 
                                involved.''; and
                          (ii) in clause (ii), by striking 
                        ``clause (i)(II)'' and inserting 
                        ``clause (i)'';
                  (C) in subparagraph (C)(i), by striking ``and 
                for amounts'' and inserting ``and for a year 
                preceding 2022 for amounts''; and
                  (D) in subparagraph (E), by striking ``In 
                applying'' and inserting ``For each of 2011 
                through 2021, in applying''.
  (b) Decreasing Reinsurance Payment Amount.--Section 1860D-
15(b)(1) of the Social Security Act (42 U.S.C. 1395w-115(b)(1)) 
is amended--
          (1) by striking ``equal to 80 percent'' and inserting 
        ``equal to-
                  ``(A) for a year preceding 2022, 80 
                percent'';
          (2) in subparagraph (A), as added by paragraph (1), 
        by striking the period at the end and inserting ``; 
        and''; and
          (3) by adding at the end the following new 
        subparagraph:
                  ``(B) for 2022 and each subsequent year, the 
                sum of--
                          ``(i) an amount equal to 20 percent 
                        of the allowable reinsurance costs (as 
                        specified in paragraph (2)) 
                        attributable to that portion of gross 
                        covered prescription drug costs as 
                        specified in paragraph (3) incurred in 
                        the coverage year after such individual 
                        has incurred costs that exceed the 
                        annual out-of-pocket threshold 
                        specified in section 1860D-2(b)(4)(B) 
                        with respect to applicable drugs (as 
                        defined in section 1860D-14B(g)(2)); 
                        and
                          ``(ii) an amount equal to 30 percent 
                        of the allowable reinsurance costs (as 
                        specified in paragraph (2)) 
                        attributable to that portion of gross 
                        covered prescription drug costs as 
                        specified in paragraph (3) incurred in 
                        the coverage year after such individual 
                        has incurred costs that exceed the 
                        annual out-of-pocket threshold 
                        specified in section 1860D-2(b)(4)(B) 
                        with respect to covered part D drugs 
                        that are not applicable drugs (as so 
                        defined).''.
  (c) Manufacturer Discount Program.--
          (1) In general.--Part D of title XVIII of the Social 
        Security Act is amended by inserting after section 
        1860D-14A (42 U.S.C. 1495w-114) the following new 
        section:

``SEC. 1860D-14B. MANUFACTURER DISCOUNT PROGRAM.

  ``(a) Establishment.--The Secretary shall establish a 
manufacturer discount program (in this section referred to as 
the `program'). Under the program, the Secretary shall enter 
into agreements described in subsection (b) with manufacturers 
and provide for the performance of the duties described in 
subsection (c). The Secretary shall establish a model agreement 
for use under the program by not later than January 1, 2021, in 
consultation with manufacturers, and allow for comment on such 
model agreement.
  ``(b) Terms of Agreement.--
          ``(1) In general.--
                  ``(A) Agreement.--An agreement under this 
                section shall require the manufacturer to 
                provide applicable beneficiaries access to 
                discounted prices for applicable drugs of the 
                manufacturer that are dispensed on or after 
                January 1, 2022.
                  ``(B) Provision of discounted prices at the 
                point-of-sale.--The discounted prices described 
                in subparagraph (A) shall be provided to the 
                applicable beneficiary at the pharmacy or by 
                the mail order service at the point-of-sale of 
                an applicable drug.
          ``(2) Provision of appropriate data.--Each 
        manufacturer with an agreement in effect under this 
        section shall collect and have available appropriate 
        data, as determined by the Secretary, to ensure that it 
        can demonstrate to the Secretary compliance with the 
        requirements under the program.
          ``(3) Compliance with requirements for administration 
        of program.--Each manufacturer with an agreement in 
        effect under this section shall comply with 
        requirements imposed by the Secretary or a third party 
        with a contract under subsection (d)(3), as applicable, 
        for purposes of administering the program, including 
        any determination under subparagraph (A) of subsection 
        (c)(1) or procedures established under such subsection 
        (c)(1).
          ``(4) Length of agreement.--
                  ``(A) In general.--An agreement under this 
                section shall be effective for an initial 
                period of not less than 12 months and shall be 
                automatically renewed for a period of not less 
                than 1 year unless terminated under 
                subparagraph (B).
                  ``(B) Termination.--
                          ``(i) By the secretary.--The 
                        Secretary may provide for termination 
                        of an agreement under this section for 
                        a knowing and willful violation of the 
                        requirements of the agreement or other 
                        good cause shown. Such termination 
                        shall not be effective earlier than 30 
                        days after the date of notice to the 
                        manufacturer of such termination. The 
                        Secretary shall provide, upon request, 
                        a manufacturer with a hearing 
                        concerning such a termination, and such 
                        hearing shall take place prior to the 
                        effective date of the termination with 
                        sufficient time for such effective date 
                        to be repealed if the Secretary 
                        determines appropriate.
                          ``(ii) By a manufacturer.--A 
                        manufacturer may terminate an agreement 
                        under this section for any reason. Any 
                        such termination shall be effective, 
                        with respect to a plan year--
                                  ``(I) if the termination 
                                occurs before January 30 of a 
                                plan year, as of the day after 
                                the end of the plan year; and
                                  ``(II) if the termination 
                                occurs on or after January 30 
                                of a plan year, as of the day 
                                after the end of the succeeding 
                                plan year.
                          ``(iii) Effectiveness of 
                        termination.--Any termination under 
                        this subparagraph shall not affect 
                        discounts for applicable drugs of the 
                        manufacturer that are due under the 
                        agreement before the effective date of 
                        its termination.
                          ``(iv) Notice to third party.--The 
                        Secretary shall provide notice of such 
                        termination to a third party with a 
                        contract under subsection (d)(3) within 
                        not less than 30 days before the 
                        effective date of such termination.
          ``(5) Effective date of agreement.--An agreement 
        under this section shall take effect on a date 
        determined appropriate by the Secretary, which may be 
        at the start of a calendar quarter.
  ``(c) Duties Described.--The duties described in this 
subsection are the following:
          ``(1) Administration of program.--Administering the 
        program, including--
                  ``(A) the determination of the amount of the 
                discounted price of an applicable drug of a 
                manufacturer;
                  ``(B) the establishment of procedures under 
                which discounted prices are provided to 
                applicable beneficiaries at pharmacies or by 
                mail order service at the point-of-sale of an 
                applicable drug;
                  ``(C) the establishment of procedures to 
                ensure that, not later than the applicable 
                number of calendar days after the dispensing of 
                an applicable drug by a pharmacy or mail order 
                service, the pharmacy or mail order service is 
                reimbursed for an amount equal to the 
                difference between--
                          ``(i) the negotiated price of the 
                        applicable drug; and
                          ``(ii) the discounted price of the 
                        applicable drug;
                  ``(D) the establishment of procedures to 
                ensure that the discounted price for an 
                applicable drug under this section is applied 
                before any coverage or financial assistance 
                under other health benefit plans or programs 
                that provide coverage or financial assistance 
                for the purchase or provision of prescription 
                drug coverage on behalf of applicable 
                beneficiaries as the Secretary may specify; and
                  ``(E) providing a reasonable dispute 
                resolution mechanism to resolve disagreements 
                between manufacturers, applicable 
                beneficiaries, and the third party with a 
                contract under subsection (d)(3).
          ``(2) Monitoring compliance.--
                  ``(A) In general.--The Secretary shall 
                monitor compliance by a manufacturer with the 
                terms of an agreement under this section.
                  ``(B) Notification.--If a third party with a 
                contract under subsection (d)(3) determines 
                that the manufacturer is not in compliance with 
                such agreement, the third party shall notify 
                the Secretary of such noncompliance for 
                appropriate enforcement under subsection (e).
          ``(3) Collection of data from prescription drug plans 
        and ma-pd plans.--The Secretary may collect appropriate 
        data from prescription drug plans and MA-PD plans in a 
        timeframe that allows for discounted prices to be 
        provided for applicable drugs under this section.
  ``(d) Administration.--
          ``(1) In general.--Subject to paragraph (2), the 
        Secretary shall provide for the implementation of this 
        section, including the performance of the duties 
        described in subsection (c).
          ``(2) Limitation.--In providing for the 
        implementation of this section, the Secretary shall not 
        receive or distribute any funds of a manufacturer under 
        the program.
          ``(3) Contract with third parties.--The Secretary 
        shall enter into a contract with 1 or more third 
        parties to administer the requirements established by 
        the Secretary in order to carry out this section. At a 
        minimum, the contract with a third party under the 
        preceding sentence shall require that the third party--
                  ``(A) receive and transmit information 
                between the Secretary, manufacturers, and other 
                individuals or entities the Secretary 
                determines appropriate;
                  ``(B) receive, distribute, or facilitate the 
                distribution of funds of manufacturers to 
                appropriate individuals or entities in order to 
                meet the obligations of manufacturers under 
                agreements under this section;
                  ``(C) provide adequate and timely information 
                to manufacturers, consistent with the agreement 
                with the manufacturer under this section, as 
                necessary for the manufacturer to fulfill its 
                obligations under this section; and
                  ``(D) permit manufacturers to conduct 
                periodic audits, directly or through contracts, 
                of the data and information used by the third 
                party to determine discounts for applicable 
                drugs of the manufacturer under the program.
          ``(4) Performance requirements.--The Secretary shall 
        establish performance requirements for a third party 
        with a contract under paragraph (3) and safeguards to 
        protect the independence and integrity of the 
        activities carried out by the third party under the 
        program under this section.
          ``(5) Administration.--Chapter 35 of title 44, United 
        States Code, shall not apply to the program under this 
        section.
  ``(e) Enforcement.--
          ``(1) Audits.--Each manufacturer with an agreement in 
        effect under this section shall be subject to periodic 
        audit by the Secretary.
          ``(2) Civil money penalty.--
                  ``(A) In general.--The Secretary shall impose 
                a civil money penalty on a manufacturer that 
                fails to provide applicable beneficiaries 
                discounts for applicable drugs of the 
                manufacturer in accordance with such agreement 
                for each such failure in an amount the 
                Secretary determines is commensurate with the 
                sum of--
                          ``(i) the amount that the 
                        manufacturer would have paid with 
                        respect to such discounts under the 
                        agreement, which will then be used to 
                        pay the discounts which the 
                        manufacturer had failed to provide; and
                          ``(ii) 25 percent of such amount.
                  ``(B) Application.--The provisions of section 
                1128A (other than subsections (a) and (b)) 
                shall apply to a civil money penalty under this 
                paragraph in the same manner as such provisions 
                apply to a penalty or proceeding under section 
                1128A(a).
  ``(f) Clarification Regarding Availability of Other Covered 
Part D Drugs.--Nothing in this section shall prevent an 
applicable beneficiary from purchasing a covered part D drug 
that is not on the formulary of the prescription drug plan or 
MA-PD plan that the applicable beneficiary is enrolled in.
  ``(g) Definitions.--In this section:
          ``(1) Applicable beneficiary.--The term `applicable 
        beneficiary' means an individual who, on the date of 
        dispensing a covered part D drug--
                  ``(A) is enrolled in a prescription drug plan 
                or an MA-PD plan;
                  ``(B) is not enrolled in a qualified retiree 
                prescription drug plan; and
                  ``(C) has incurred costs for covered part D 
                drugs in the year that are equal to or exceed 
                the annual deductible specified in section 
                1860D-2(b)(1) for such year.
          ``(2) Applicable drug.--The term `applicable drug' 
        means, with respect to an applicable beneficiary, a 
        covered part D drug--
                  ``(A) approved under a new drug application 
                under section 505(c) of the Federal Food, Drug, 
                and Cosmetic Act or, in the case of a biologic 
                product, licensed under section 351 of the 
                Public Health Service Act (including a product 
                licensed under subsection (k) of such section); 
                and
                  ``(B)(i) if the PDP sponsor of the 
                prescription drug plan or the MA organization 
                offering the MA-PD plan uses a formulary, which 
                is on the formulary of the prescription drug 
                plan or MA-PD plan that the applicable 
                beneficiary is enrolled in;
                  ``(ii) if the PDP sponsor of the prescription 
                drug plan or the MA organization offering the 
                MA-PD plan does not use a formulary, for which 
                benefits are available under the prescription 
                drug plan or MA-PD plan that the applicable 
                beneficiary is enrolled in; or
                  ``(iii) is provided through an exception or 
                appeal.
          ``(3) Applicable number of calendar days.--The term 
        `applicable number of calendar days' means--
                  ``(A) with respect to claims for 
                reimbursement submitted electronically, 14 
                days; and
                  ``(B) with respect to claims for 
                reimbursement submitted otherwise, 30 days.
          ``(4) Discounted price.--
                  ``(A) In general.--The term `discounted 
                price' means, with respect to an applicable 
                drug of a manufacturer furnished during a year 
                to an applicable beneficiary, 90 percent of the 
                negotiated price of such drug.
                  ``(B) Clarification.--Nothing in this section 
                shall be construed as affecting the 
                responsibility of an applicable beneficiary for 
                payment of a dispensing fee for an applicable 
                drug.
                  ``(C) Special case for claims spanning 
                deductible.--In the case where the entire 
                amount of the negotiated price of an individual 
                claim for an applicable drug with respect to an 
                applicable beneficiary does not fall at or 
                above the annual deductible specified in 
                section 1860D-2(b)(1) for the year, the 
                manufacturer of the applicable drug shall 
                provide the discounted price under this section 
                on only the portion of the negotiated price of 
                the applicable drug that falls at or above such 
                annual deductible.
          ``(5) Manufacturer.--The term `manufacturer' means 
        any entity which is engaged in the production, 
        preparation, propagation, compounding, conversion, or 
        processing of prescription drug products, either 
        directly or indirectly by extraction from substances of 
        natural origin, or independently by means of chemical 
        synthesis, or by a combination of extraction and 
        chemical synthesis. Such term does not include a 
        wholesale distributor of drugs or a retail pharmacy 
        licensed under State law.
          ``(6) Negotiated price.--The term `negotiated price' 
        has the meaning given such term in section 1860D-
        2(d)(1)(B), except that such negotiated price shall not 
        include any dispensing fee for an applicable drug.
          ``(7) Qualified retiree prescription drug plan.--The 
        term `qualified retiree prescription drug plan' has the 
        meaning given such term in section 11860D-22(a)(2).''.
          (2) Sunset of medicare coverage gap discount 
        program.--Section 1860D-14A of the Social Security Act 
        (42 U.S.C. 1395-114a) is amended--
                  (A) in subsection (a), in the first sentence, 
                by striking ``The Secretary'' and inserting 
                ``Subject to subsection (h), the Secretary''; 
                and
                  (B) by adding at the end the following new 
                subsection:
  ``(h) Sunset of Program.--
          ``(1) In general.--The program shall not apply to 
        applicable drugs dispensed on or after January 1, 2022, 
        and, subject to paragraph (2), agreements under this 
        section shall be terminated as of such date.
          ``(2) Continued application for applicable drugs 
        dispensed prior to sunset.--The provisions of this 
        section (including all responsibilities and duties) 
        shall continue to apply after January 1, 2022, with 
        respect to applicable drugs dispensed prior to such 
        date.''.
          (3) Inclusion of actuarial value of manufacturer 
        discounts in bids.--Section 1860D-11 of the Social 
        Security Act (42 U.S.C. 1395w-111) is amended--
                  (A) in subsection (b)(2)(C)(iii)--
                          (i) by striking ``assumptions 
                        regarding the reinsurance'' and 
                        inserting ``assumptions regarding--
                                  ``(I) the reinsurance''; and
                          (ii) by adding at the end the 
                        following:
                                  ``(II) for 2022 and each 
                                subsequent year, the 
                                manufacturer discounts provided 
                                under section 1860D- 14B 
                                subtracted from the actuarial 
                                value to produce such bid; 
                                and''; and
                  (B) in subsection (c)(1)(C)--
                          (i) by striking ``an actuarial 
                        valuation of the reinsurance'' and 
                        inserting ``an actuarial valuation of--
                          ``(i) the reinsurance'';
                          (ii) in clause (i), as added by 
                        clause (i) of this subparagraph, by 
                        adding ``and'' at the end; and
                          (iii) by adding at the end the 
                        following:
                          ``(ii) for 2022 and each subsequent 
                        year, the manufacturer discounts 
                        provided under section 1860D-14B;''.
  (d) Determination of Allowable Reinsurance Costs.--Section 
1860D-15(b) of the Social Security Act (42 U.S.C. 1395w-115(b)) 
is amended--
          (1) in paragraph (2)--
                  (A) by striking ``Costs.--For purposes'' and 
                inserting ``Costs.--
                  ``(A) In general.--Subject to subparagraph 
                (B), for purposes''.
                  (B) by adding at the end the following new 
                subparagraph:
                  ``(B) Inclusion of manufacturer discounts on 
                applicable drugs.--For purposes of applying 
                subparagraph (A), the term `allowable 
                reinsurance costs' shall include the portion of 
                the negotiated price (as defined in section 
                1860D-14B(g)(6)) of an applicable drug (as 
                defined in section 1860D-14(g)(2)) that was 
                paid by a manufacturer under the manufacturer 
                discount program under section 1860D-14B.''; 
                and
          (2) in paragraph (3)--
                  (A) in the first sentence, by striking ``For 
                purposes'' and inserting ``Subject to paragraph 
                (2)(B), for purposes''; and
                  (B) in the second sentence, by inserting 
                ``or, in the case of an applicable drug, by a 
                manufacturer'' after ``by the individual or 
                under the plan''.
  (e) Updating Risk Adjustment Methodologies to Account for 
Part D Modernization Redesign.--Section 1860D-15(c) of the 
Social Security Act (42 U.S.C. 1395w-115(c)) is amended by 
adding at the end the following new paragraph:
          ``(3) Updating risk adjustment methodologies to 
        account for part d modernization redesign.--The 
        Secretary shall update the risk adjustment model used 
        to adjust bid amounts pursuant to this subsection as 
        appropriate to take into account changes in benefits 
        under this part pursuant to the amendments made by 
        section 121 of the Lower Costs, More Cures Act of 
        2019.''.
  (f) Conditions for Coverage of Drugs Under This Part.--
Section 1860D-43 of the Social Security Act (42 U.S.C. 1395w-
153) is amended--
          (1) in subsection (a)--
                  (A) in paragraph (2), by striking ``and'' at 
                the end;
                  (B) in paragraph (3), by striking the period 
                at the end and inserting a semicolon; and
                  (C) by adding at the end the following new 
                paragraphs:
          ``(4) participate in the manufacturer discount 
        program under section 1860D-14B;
          ``(5) have entered into and have in effect an 
        agreement described in subsection (b) of such section 
        1860D-14B with the Secretary; and
          ``(6) have entered into and have in effect, under 
        terms and conditions specified by the Secretary, a 
        contract with a third party that the Secretary has 
        entered into a contract with under subsection (d)(3) of 
        such section 1860D-14B.'';
          (2) by striking subsection (b) and inserting the 
        following:
  ``(b) Effective Date.--Paragraphs (1) through (3) of 
subsection (a) shall apply to covered part D drugs dispensed 
under this part on or after January 1, 2011, and before January 
1, 2022, and paragraphs (4) through (6) of such subsection 
shall apply to covered part D drugs dispensed on or after 
January 1, 2022.''; and
          (3) in subsection (c), by striking paragraph (2) and 
        inserting the following:
          ``(2) the Secretary determines that in the period 
        beginning on January 1, 2011, and ending on December 
        31, 2011 (with respect to paragraphs (1) through (3) of 
        subsection (a)) or the period beginning on January 1, 
        2022, and ending December 31, 2022 (with respect to 
        paragraphs (4) through (6) of such subsection), there 
        were extenuating circumstances.''.
  (g) Conforming Amendments.--
          (1) Section 1860D-2 of the Social Security Act (42 
        U.S.C. 1395w-102) is amended--
                  (A) in subsection (a)(2)(A)(i)(I), by 
                striking ``, or an increase in the initial'' 
                and inserting ``or for a year preceding 2022 an 
                increase in the initial'';
                  (B) in subsection (c)(1)(C)--
                          (i) in the subparagraph heading, by 
                        striking ``at initial coverage limit''; 
                        and
                          (ii) by inserting ``for a year 
                        preceding 2022 or the annual out-of-
                        pocket threshold specified in 
                        subsection (b)(4)(B) for the year for 
                        2022 and each subsequent year'' after 
                        ``subsection (b)(3) for the year'' each 
                        place it appears; and
                  (C) in subsection (d)(1)(A), by striking ``or 
                an initial'' and inserting ``or for a year 
                preceding 2022, an initial''.
          (2) Section 1860D-4(a)(4)(B)(i) of the Social 
        Security Act (42 U.S.C. 1395w-104(a)(4)(B)(i)) is 
        amended by striking ``the initial'' and inserting ``for 
        a year preceding 2022, the initial''.
          (3) Section 1860D-14(a) of the Social Security Act 
        (42 U.S.C. 1395w-114(a)) is amended--
                  (A) in paragraph (1)--
                          (i) in subparagraph (C), by striking 
                        ``The continuation'' and inserting 
                        ``For a year preceding 2022, the 
                        continuation'';
                          (ii) in subparagraph (D)(iii), by 
                        striking ``1860D-2(b)(4)(A)(i)(I)'' and 
                        inserting ``1860D-
                        2(b)(4)(A)(i)(I)(aa)''; and
                          (iii) in subparagraph (E), by 
                        striking ``The elimination'' and 
                        inserting ``For a year preceding 2022, 
                        the elimination''; and
                  (B) in paragraph (2)--
                          (i) in subparagraph (C), by striking 
                        ``The continuation'' and inserting 
                        ``For a year preceding 2022, the 
                        continuation''; and
                          (ii) in subparagraph (E)--
                                  (I) by inserting ``for a year 
                                preceding 2022,'' after 
                                ``subsection (c)''; and
                                  (II) by striking ``1860D- 
                                2(b)(4)(A)(i)(I)'' and 
                                inserting ``1860D-
                                2(b)(4)(A)(i)(I)(aa)''.
          (4) Section 1860D-21(d)(7) of the Social Security Act 
        (42 U.S.C. 1395w-131(d)(7)) is amended by striking 
        ``section 1860D-2(b)(4)(B)(i)'' and inserting ``section 
        1860D-2(b)(4)(C)(i)''.
          (5) Section 1860D-22(a)(2)(A) of the Social Security 
        Act (42 U.S.C. 1395w-132(a)(2)(A)) is amended--
                  (A) by striking ``the value of any discount'' 
                and inserting the following: ``the value of--
                          ``(i) for years prior to 2022, any 
                        discount'';
                  (B) in clause (i), as inserted by 
                subparagraph (A) of this paragraph, by striking 
                the period at the end and inserting ``; and''; 
                and
                  (C) by adding at the end the following new 
                clause:
                          ``(ii) for 2022 and each subsequent 
                        year, any discount provided pursuant to 
                        section 1860D-14B.''.
          (6) Section 1860D-41(a)(6) of the Social Security Act 
        (42 U.S.C. 1395w-151(a)(6)) is amended--
                  (A) by inserting ``for a year before 2022'' 
                after ``1860D-2(b)(3)''; and
                  (B) by inserting ``for such year'' before the 
                period.
  (h) Effective Date.--The amendments made by this section 
shall apply to plan year 2022 and subsequent plan years.

              Subtitle D--Other Medicare Part D Provisions


SEC. 131. TRANSITIONAL COVERAGE AND RETROACTIVE MEDICARE PART D 
                    COVERAGE FOR CERTAIN LOW-INCOME BENEFICIARIES.

   Section 1860D-14 of the Social Security Act (42 U.S.C. 
1395w-114) is amended--
          (1) by redesignating subsection (e) as subsection 
        (f); and
          (2) by adding after subsection (d) the following new 
        subsection:
  ``(e) Limited Income Newly Eligible Transition Program.--
          ``(1) In general.--Beginning not later than January 
        1, 2021, the Secretary shall carry out a program to 
        provide transitional coverage for covered part D drugs 
        for LI NET eligible individuals in accordance with this 
        subsection.
          ``(2) Li net eligible individual defined.--For 
        purposes of this subsection, the term `LI NET eligible 
        individual' means a part D eligible individual who--
                  ``(A) meets the requirements of clauses (ii) 
                and (iii) of subsection (a)(3)(A); and
                  ``(B) has not yet enrolled in a prescription 
                drug plan or an MA-PD plan, or, who has so 
                enrolled, but with respect to whom coverage 
                under such plan has not yet taken effect.
          ``(3) Transitional coverage.--For purposes of this 
        subsection, the term `transitional coverage' means, 
        with respect to an LI NET eligible individual--
                  ``(A) immediate access to covered part D 
                drugs at the point-of-sale during the period 
                that begins on the first day of the month such 
                individual is determined to meet the 
                requirements of clauses (ii) and (iii) of 
                subsection (a)(3)(A) and ends on the date that 
                coverage under a prescription drug plan or MA-
                PD plan takes effect with respect to such 
                individual; and
                  ``(B) in the case of an LI NET eligible 
                individual who is a full-benefit dual eligible 
                individual (as defined in section 1935(c)(6)) 
                or a recipient of supplemental security income 
                benefits under title XVI, retroactive coverage 
                (in the form of reimbursement of the amounts 
                that would have been paid under this part had 
                such individual been enrolled in a prescription 
                drug plan or MA-PD plan) of covered part D 
                drugs purchased by such individual during the 
                period that begins on the date that is the 
                later of--
                          ``(i) the date that such individual 
                        was first eligible for a low-income 
                        subsidy under this part; or
                          ``(ii) the date that is 36 months 
                        prior to the date such individual 
                        enrolls in a prescription drug plan or 
                        MA-PD plan, and ends on the date that 
                        coverage under such plan takes effect.
          ``(4) Program administration.--
                  ``(A) Single point of contact.--The Secretary 
                shall, to the extent feasible, administer the 
                program under this subsection through a 
                contract with a single program administrator.
                  ``(B) Benefit design.--The Secretary shall 
                ensure that the transitional coverage provided 
                to LI NET eligible individuals under this 
                subsection--
                          ``(i) provides access to all covered 
                        part D drugs under an open formulary;
                          ``(ii) permits all pharmacies 
                        determined by the Secretary to be in 
                        good standing to process claims under 
                        the program;
                          ``(iii) is consistent with such 
                        requirements as the Secretary considers 
                        necessary to improve patient safety and 
                        ensure appropriate dispensing of 
                        medication; and
                          ``(iv) meets such other requirements 
                        as the Secretary may establish.
          ``(5) Relationship to other provisions of this title; 
        waiver authority.--
                  ``(A) In general.--The following provisions 
                shall not apply with respect to the program 
                under this subsection:
                          ``(i) Paragraphs (1) and (3)(B) of 
                        section 1860D-4(a) (relating to 
                        dissemination of general information; 
                        availability of information on changes 
                        in formulary through the internet).
                          ``(ii) Subparagraphs (A) and (B) of 
                        section 1860D-4(b)(3) (relating to 
                        requirements on development and 
                        application of formularies; formulary 
                        development).
                          ``(iii) Paragraphs (1)(C) and (2) of 
                        section 1860D-4(c) (relating to 
                        medication therapy management program).
                  ``(B) Waiver authority.--The Secretary may 
                waive such other requirements of title XI and 
                this title as may be necessary to carry out the 
                purposes of the program established under this 
                subsection.''.

SEC. 132. ALLOWING THE OFFERING OF ADDITIONAL PRESCRIPTION DRUG PLANS 
                    UNDER MEDICARE PART D.

  (a) Rescinding and Issuance of New Guidance.--Not later than 
one year after the date of the enactment of this Act, the 
Secretary of Health and Human Services (in this section 
referred to as the ``Secretary'') shall--
          (1) rescind sections of any sub-regulatory guidance 
        that limit the number of prescription drug plans in 
        each PDP region that may be offered by a PDP sponsor 
        under part D of title XVIII of the Social Security Act 
        (42 U.S.C. 1395w-101 et seq.); and
          (2) issue new guidance specifying that a PDP sponsor 
        may offer up to 4 (or a greater number if determined 
        appropriate by the Secretary) prescription drug plans 
        in each PDP region, except in cases where the PDP 
        sponsor may offer up to 2 additional plans in a PDP 
        region pursuant to section 1860D-11(d)(4) of the Social 
        Security Act (42 U.S.C. 1395w-111(d)(4)), as added by 
        subsection (b).
  (b) Offering of Additional Plans.--Section 1860D-11(d) of the 
Social Security Act (42 U.S.C. 1395w-111(d)) is amended by 
adding at the end the following new paragraph:
          ``(4) Offering of additional plans.--
                  ``(A) In general.--For plan year 2022 and 
                each subsequent plan year, a PDP sponsor may 
                offer up to 2 additional prescription drug 
                plans in a PDP region (in addition to any limit 
                established by the Secretary under this part) 
                provided that the PDP sponsor complies with 
                subparagraph (B) with respect to at least one 
                such prescription drug plan.
                  ``(B) Requirements.--In order to be eligible 
                to offer up to 2 additional plans in a PDP 
                region pursuant to subparagraph (A), a PDP 
                sponsor must ensure that, with respect to at 
                least one such prescription drug plan, the 
                sponsor or any entity that provides pharmacy 
                benefits management services under a contract 
                with any such sponsor or plan does not receive 
                direct or indirect remuneration, as defined in 
                section 423.308 of title 42, Code of Federal 
                Regulations (or any successor regulation), 
                unless at least 25 percent of the aggregate 
                reductions in price or other remuneration 
                received by the PDP sponsor or entity from drug 
                manufacturers with respect to the plan and plan 
                year--
                          ``(i) are reflected at the point-of-
                        sale to the enrollee; or
                          ``(ii) are used to reduce total 
                        beneficiary cost-sharing estimated by 
                        the PDP sponsor for prescription drug 
                        coverage under the plan in the annual 
                        bid submitted by the PDP sponsor under 
                        section 1860D-11(b).
                  ``(C) Definition of reductions in price.--For 
                purposes of subparagraph (B), the term 
                `reductions in price' refers only to 
                collectible amounts, as determined by the 
                Secretary, which excludes amounts which after 
                adjudication and reconciliation with pharmacies 
                and manufacturers are duplicate in nature, 
                contrary to other contractual clauses, or 
                otherwise ineligible (such as due to 
                beneficiary disenrollment or coordination of 
                benefits).''.
  (c) Rule of Construction.--Nothing in the provisions of, or 
amendments made by, this section shall be construed as limiting 
the ability of the Secretary to increase any limit otherwise 
applicable on the number of prescription drug plans that a PDP 
sponsor may offer, at the discretion of the PDP sponsor, in a 
PDP region under part D of title XVIII of the Social Security 
Act (42 U.S.C. 1395w-101 et seq.).

SEC. 133. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUGS PLANS AND 
                    MA-PD PLANS UNDER MEDICARE PROGRAM TO SPREAD OUT 
                    COST-SHARING UNDER CERTAIN CIRCUMSTANCES.

  (a) Standard Prescription Drug Coverage.--Section 1860D-
2(b)(2) of the Social Security Act (42 U.S.C. 1395w-102(b)(2)), 
as amended by section 121, is further amended--
          (1) in subparagraph (A), by striking ``Subject to 
        subparagraphs (C) and (D)'' and inserting ``Subject to 
        subparagraphs (C), (D), and (E)''; and
          (2) by adding at the end the following new 
        subparagraph:
                  ``(E) Enrollee option regarding spreading 
                cost-sharing.--
                          ``(i) In general.--The Secretary 
                        shall establish by regulation a process 
                        under which, with respect to plan year 
                        2022 and subsequent plan years, a 
                        prescription drug plan or an MA-PD plan 
                        shall, in the case of a part D eligible 
                        individual enrolled with such plan for 
                        such plan year with respect to whom the 
                        plan projects that the dispensing of a 
                        covered part D drug to such individual 
                        will result in the individual incurring 
                        costs within a 30-day period that are 
                        equal to a significant percentage (as 
                        specified by the Secretary pursuant to 
                        such regulation) of the annual out-of-
                        pocket threshold specified in paragraph 
                        (4)(B) for such plan year, provide such 
                        individual with the option to make the 
                        coinsurance payment required under 
                        subparagraph (A) for such costs in the 
                        form of equal monthly installments over 
                        the remainder of such plan year.
                          ``(ii) Significant percentage 
                        limitations.--In specifying a 
                        significant percentage pursuant to the 
                        regulation established by the Secretary 
                        under clause (i), the Secretary may not 
                        specify a percentage that is less than 
                        30 percent or greater than 100 
                        percent.''.
  (b) Alternative Prescription Drug Coverage.--Section 1860D-
2(c) of the Social Security Act (42 U.S.C. 1395w-102(c)) is 
amended by adding at the end the following new paragraph:
          ``(4) Same enrollee option regarding spreading cost-
        sharing.--For plan year 2022 and subsequent plan years, 
        the coverage provides the enrollee option regarding 
        spreading cost-sharing described in and required under 
        subsection (b)(2)(E).''.

SEC. 134. ESTABLISHING A MONTHLY CAP ON BENEFICIARY INCURRED COSTS FOR 
                    INSULIN PRODUCTS AND SUPPLIES UNDER A PRESCRIPTION 
                    DRUG PLAN OR MA-PD PLAN.

  (a) In General.--Section 1860D-2 of the Social Security Act 
(42 U.S.C. 1395w-102), as amended by sections 121 and 133, is 
further amended--
          (1) in subsection (b)(2)--
                  (A) in subparagraph (A), by striking ``and 
                (E)'' and inserting ``(E), and (F)'';
                  (B) in subparagraph (B), by striking ``and 
                (D)'' and inserting ``(D), and (F)''; and
                  (C) by adding at the end the following new 
                subparagraph:
                  ``(F) Cap on incurred costs for insulin 
                products and supplies.--
                          ``(i) In general.--The coverage 
                        provides benefits, for costs above the 
                        annual deductible specified in 
                        paragraph (1) and up to the annual out-
                        of-pocket threshold described in 
                        paragraph (4)(B) and with respect to a 
                        month (beginning with January of 2022), 
                        with cost sharing that is equal to $0 
                        for a specified covered part D drug (as 
                        defined in clause (iii)) furnished to 
                        an individual who has incurred costs 
                        during such month with respect to 
                        specified covered part D drugs equal 
                        to--
                                  ``(I) for months occurring in 
                                2022, $50; or
                                  ``(II) for months occurring 
                                in a subsequent year, the 
                                amount applicable under this 
                                clause for months occurring in 
                                the year preceding such 
                                subsequent year, increased by 
                                the annual percentage increase 
                                specified in paragraph (6) for 
                                such subsequent year and 
                                rounded to the nearest dollar.
                          ``(ii) Application.--The provisions 
                        of clauses (i) through (iii) of 
                        paragraph (4)(C) shall apply with 
                        respect to the determination of the 
                        incurred costs for specified covered 
                        part D drugs for purposes of clause (i) 
                        in the same manner as such provisions 
                        apply with respect to the determination 
                        of incurred costs for covered part D 
                        drugs for purposes of paragraph (4)(A).
                          ``(iii) Specified covered part d 
                        drug.--For purposes of this 
                        subparagraph, the term `specified 
                        covered part D drug' means a covered 
                        part D drug that is--
                                  ``(I) insulin; or
                                  ``(II) a medical supply 
                                associated with the injection 
                                of insulin (as defined in 
                                regulations of the Secretary 
                                promulgated pursuant to 
                                subsection (e)(1)(B)).''; and
          (2) in subsection (c), by adding at the end the 
        following new paragraph:
          ``(5) Same protection with respect to expenditures 
        for insulin and certain medical supplies.--The coverage 
        provides the coverage required under subsection 
        (b)(2)(F).''.
  (b) Conforming Amendments.--
          (1) In general.--Section 1860D-14(a)(1)(D) of the 
        Social Security Act (42 U.S.C. 1395w-114(a)(1)(D)), as 
        amended by section 121, is further amended--
                  (A) in clause (ii), by striking ``section 
                1860D-2(b)(2)'' and inserting ``section 1860D-
                2(b)(2)(A)''; and
                  (B) in clause (iii), by striking ``section 
                1860D-2(b)(2)'' and inserting ``section 1860D-
                2(b)(2)(A)''.
          (2) Effective date.--The amendments made by paragraph 
        (1) shall apply with respect to plan year 2022 and each 
        subsequent plan year.

SEC. 135. GROWTH RATE OF MEDICARE PART D OUT-OF-POCKET COST THRESHOLD.

  (a) Providing Medicare Part D Beneficiaries With Certain 2020 
Offset Payments.--Section 1860D-2(b)(4) of the Social Security 
Act (42 U.S.C. 1395w-102(b)(4)) is amended by adding at the end 
the following new subparagraph:
                  ``(F) 2020 offset payments.--
                          ``(i) In general.--Subject to clause 
                        (iv), the Secretary shall provide for 
                        payment from the Medicare Prescription 
                        Drug Account as follows:
                                  ``(I) In the case of a 
                                specified individual (as 
                                defined in clause (ii)(I)) who 
                                as of the last day of a 
                                calendar quarter in 2020 has 
                                incurred costs for covered part 
                                D drugs so that the individual 
                                has exceeded the annual out-of-
                                pocket threshold applied under 
                                subparagraph (B)(i)(V) for 
                                2020, payment to the individual 
                                by not later than 15th day of 
                                the third month following the 
                                end of such quarter of the 
                                amount by which such threshold 
                                so applied exceeded the target 
                                threshold for 2020.
                                  ``(II) In the case of a 
                                specified individual who is not 
                                described in subclause (I) and 
                                who as of the last day of 2020 
                                has incurred costs for covered 
                                part D drugs so that the 
                                individual has exceeded the 
                                target threshold for 2020, 
                                payment to the individual by 
                                not later than December 31, 
                                2021 of the amount by which 
                                such incurred costs exceeded 
                                the target threshold for 2020.
                          ``(ii) Definitions.--For purposes of 
                        this subparagraph:
                                  ``(I) Specified individual.--
                                The term `specified individual' 
                                means an individual who--
                                          ``(aa) is enrolled in 
                                        a prescription drug 
                                        plan or an MA- PD plan;
                                          ``(bb) is not 
                                        enrolled in a qualified 
                                        retiree prescription 
                                        drug plan; and
                                          ``(cc) is not 
                                        entitled to an income-
                                        related subsidy under 
                                        section 1860D-14(a).
                                  ``(II) Target threshold for 
                                2020.--the term `target 
                                threshold for 2020' means the 
                                annual out-of-pocket threshold 
                                that would have been applied 
                                under subparagraph (B)(i) for 
                                2020 if such threshold had been 
                                determined in accordance with 
                                subclause (IV) of such 
                                subparagraph instead of 
                                subclause (V) of such 
                                subparagraph.
                          ``(iii) Notification.--In the case of 
                        any specified individual who during 
                        2020 has incurred costs for covered 
                        part D drugs so that the individual has 
                        exceeded the target threshold for 2020, 
                        the Secretary shall, not later than 
                        September 30, 2021, provide to such 
                        individual a notification informing 
                        such individual of such individual's 
                        right to a payment described in clause 
                        (i) and the estimated timing of such 
                        payment.
                          ``(iv) Clarification.--The Secretary 
                        shall provide only 1 payment under this 
                        subparagraph with respect to any 
                        individual.
                          ``(v) Implementation.--The Secretary 
                        may implement this subparagraph by 
                        program instruction or otherwise.''.
  (b) Reduced Growth Rate for 2021 of Medicare Part D Out-of-
pocket Cost Threshold.--Section 1860D-2(b)(4)(B)(i) of the 
Social Security Act (42 U.S.C. 1395w-102(b)(4)(B)(i)) is 
amended--
          (1) in subclause (V), by striking at the end ``or'';
          (2) by redesignating subclause (VI) as subclause 
        (VIII); and
          (3) by inserting after subclause (V) the following 
        new subclauses:
                                  ``(VI) for 2021, is equal to 
                                the amount that would have been 
                                applied under this subparagraph 
                                for 2020 if such amount had 
                                been determined in accordance 
                                with subclause (IV) instead of 
                                subclause (V), increased by the 
                                lesser of--
                                          ``(aa) the annual 
                                        percentage increase 
                                        described in paragraph 
                                        (7) for 2021, plus 2 
                                        percentage points; or
                                          ``(bb) the annual 
                                        percentage increase 
                                        described in paragraph 
                                        (6) for 2021;
                                  ``(VII) for 2022, is equal to 
                                the amount that would have been 
                                applied under this subparagraph 
                                for 2022 if the amendments made 
                                by section 1101(d)(1) of the 
                                Health Care and Education 
                                Reconciliation Act of 2010 and 
                                by section 135 of the Lower 
                                Costs, More Cures Act of 2019 
                                had not been enacted; or''.

                           Subtitle E--MedPAC


SEC. 141. PROVIDING THE MEDICARE PAYMENT ADVISORY COMMISSION AND 
                    MEDICAID AND CHIP PAYMENT AND ACCESS COMMISSION 
                    WITH ACCESS TO CERTAIN DRUG PAYMENT INFORMATION, 
                    INCLUDING CERTAIN REBATE INFORMATION.

  (a) Access to Certain Part D Payment Data.--Section 1860D-
15(f) of the Social Security Act (42 U.S.C. 1395w-115(f)) is 
amended--
          (1) in paragraph (2)--
                  (A) in subparagraph (A)(ii), by striking 
                ``and'' at the end;
                  (B) in subparagraph (B), by striking the 
                period at the end and inserting ``; and''; and
                  (C) by inserting at the end the following new 
                subparagraph:
                  ``(C) by the Executive Director of the 
                Medicare Payment Advisory Commission for 
                purposes of monitoring, making recommendations, 
                and analysis of the program under this title 
                and by the Executive Director of the Medicaid 
                and CHIP Payment and Access Commission for 
                purposes of monitoring, making recommendations, 
                and analysis of the Medicaid program 
                established under title XIX and the Children's 
                Health Insurance Program under title XXI.''; 
                and
          (2) by adding at the end the following new paragraph:
          ``(3) Additional restrictions on disclosure of 
        information.--The Executive Directors described in 
        paragraph (2)(C) shall not disclose any of the 
        following information disclosed to such Executive 
        Directors or obtained by such Executive Directors 
        pursuant to such paragraph, with respect to a 
        prescription drug plan offered by a PDP sponsor:
                  ``(A) The specific amounts or the identity of 
                the source of any rebates, price concessions, 
                or other forms of direct or indirect 
                remuneration under such prescription drug plan.
                  ``(B) Information submitted with the bid 
                submitted under section 1860D-11 by such PDP 
                sponsor.
                  ``(C) In the case of such information from 
                prescription drug event records, in a form that 
                would not be permitted under section 423.505(m) 
                of title 42, Code of Federal Regulations, or 
                any successor regulation, if made by the 
                Centers for Medicare & Medicaid Services.''.
  (b) Access to Certain Rebate and Payment Data Under Medicare 
and Medicaid.--Section 1927(b)(3)(D) of the Social Security Act 
(42 U.S.C. 1396r-8(b)(3)(D)) is amended--
          (1) in the matter before clause (i), by striking 
        ``subsection (a)(6)(A)(ii)'' and inserting ``subsection 
        (a)(6)(A)'';
          (2) in clause (v), by striking ``and'' at the end;
          (3) in clause (vi), by striking the period at the end 
        and inserting ``, and'';
          (4) by inserting after clause (vi) the following new 
        clause:
                          ``(vii) to permit the Executive 
                        Director of the Medicare Payment 
                        Advisory Commission and the Executive 
                        Director of the Medicaid and CHIP 
                        Payment and Access Commission to review 
                        the information provided.'';
          (5) in the matter at the end, by striking ``1860D-
        4(c)(2)(E)'' and inserting ``1860D-4(c)(2)(G)''; and
          (6) by adding at the end the following new sentence: 
        ``Any information disclosed to the Executive Director 
        of the Medicare Payment Advisory Commission or the 
        Executive Director of the Medicaid and CHIP Payment and 
        Access Commission pursuant to this subparagraph shall 
        not be disclosed by either such Executive Director in a 
        form which discloses the identity of a specific 
        manufacturer or wholesaler or prices charged for drugs 
        by such manufacturer or wholesaler.''.

                           TITLE II--MEDICAID


SEC. 201. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT FOR SINGLE SOURCE 
                    DRUGS AND INNOVATOR MULTIPLE SOURCE DRUGS.

  Section 1927(c)(2)(D) of the Social Security Act (42 U.S.C. 
1396r-8(c)(2)(D)) is amended by inserting after ``December 31, 
2009,'' the following: ``and before January 1, 2023,''.

SEC. 202. MEDICAID PHARMACY AND THERAPEUTICS COMMITTEE IMPROVEMENTS.

  (a) In General.--Subparagraph (A) of section 1927(d)(4) of 
the Social Security Act (42 U.S.C. 1396r-8(d)(4)) is amended to 
read as follows:
                  ``(A)(i) The formulary is developed and 
                reviewed by a pharmacy and therapeutics 
                committee consisting of physicians, 
                pharmacists, and other appropriate individuals 
                appointed by the Governor of the State.
                  ``(ii) Subject to clause (vi), the State 
                establishes and implements a conflict of 
                interest policy for the pharmacy and 
                therapeutics committee that--
                          ``(I) is publicly accessible;
                          ``(II) requires all committee members 
                        to complete, on at least an annual 
                        basis, a disclosure of relationships, 
                        associations, and financial dealings 
                        that may affect their independence of 
                        judgement in committee matters; and
                          ``(III) contains clear processes, 
                        such as recusal from voting or 
                        discussion, for those members who 
                        report a conflict of interest, along 
                        with appropriate processes to address 
                        any instance where a member fails to 
                        report a conflict of interest.
                  ``(iii) The membership of the pharmacy and 
                therapeutics committee--
                          ``(I) includes at least 1 actively 
                        practicing physician and at least 1 
                        actively practicing pharmacist, each of 
                        whom--
                                  ``(aa) is independent and 
                                free of conflict with respect 
                                to manufacturers and Medicaid 
                                participating plans or 
                                subcontractors, including 
                                pharmacy benefit managers; and
                                  ``(bb) has expertise in the 
                                care of 1 or more Medicaid-
                                specific populations such as 
                                elderly or disabled 
                                individuals, children with 
                                complex medical needs, or low-
                                income individuals with chronic 
                                illnesses; and
                          ``(II) is made publicly available.
                  ``(iv) At the option of the State, the 
                State's drug use review board established under 
                subsection (g)(3) may serve as the pharmacy and 
                therapeutics committee provided the State 
                ensures that such board meets the requirements 
                of clauses (ii) and (iii).
                  ``(v) The State reviews and has final 
                approval of the formulary established by the 
                pharmacy and therapeutics committee.
                  ``(vi) If the Secretary determines it 
                appropriate or necessary based on the findings 
                and recommendations of the Comptroller General 
                of the United States in the report submitted to 
                Congress under section 203 of the Lower Costs, 
                More Cures Act of 2019, the Secretary shall 
                issue guidance that States must follow for 
                establishing conflict of interest policies for 
                the pharmacy and therapeutics committee in 
                accordance with the requirements of clause 
                (ii), including appropriate standards and 
                requirements for identifying, addressing, and 
                reporting on conflicts of interest.''.
  (b) Application to Medicaid Managed Care Organizations.--
Clause (xiii) of section 1903(m)(2)(A) of the Social Security 
Act (42 U.S.C. 1396b(m)(2)(A)) is amended--
          (1) by striking ``and (III)'' and inserting 
        ``(III)'';
          (2) by striking the period at the end and inserting 
        ``, and (IV) any formulary used by the entity for 
        covered outpatient drugs dispensed to individuals 
        eligible for medical assistance who are enrolled with 
        the entity is developed and reviewed by a pharmacy and 
        therapeutics committee that meets the requirements of 
        clauses (ii) and (iii) of section 1927(d)(4)(A).''; and
          (3) by moving the left margin 2 ems to the left.
  (c) Effective Date.--The amendments made by this section 
shall take effect on the date that is 1 year after the date of 
enactment of this Act.

SEC. 203. GAO REPORT ON CONFLICTS OF INTEREST IN STATE MEDICAID PROGRAM 
                    DRUG USE REVIEW BOARDS AND PHARMACY AND 
                    THERAPEUTICS (P&T) COMMITTEES.

  (a) Investigation.--The Comptroller General of the United 
States shall conduct an investigation of potential or existing 
conflicts of interest among members of State Medicaid program 
State drug use review boards (in this section referred to as 
``DUR Boards'') and pharmacy and therapeutics committees (in 
this section referred to as ``P&T Committees'').
  (b) Report.--Not later than 24 months after the date of 
enactment of this Act, the Comptroller General shall submit to 
Congress a report on the investigation conducted under 
subsection (a) that includes the following:
          (1) A description outlining how DUR Boards and P&T 
        Committees operate in States, including details with 
        respect to--
                  (A) the structure and operation of DUR Boards 
                and statewide P&T Committees;
                  (B) States that operate separate P&T 
                Committees for their fee-for-service Medicaid 
                program and their Medicaid managed care 
                organizations or other Medicaid managed care 
                arrangements (collectively referred to in this 
                section as ``Medicaid MCOs)''; and
                  (C) States that allow Medicaid MCOs to have 
                their own P&T Committees and the extent to 
                which pharmacy benefit managers administer or 
                participate in such P&T Committees.
          (2) A description outlining the differences between 
        DUR Boards established in accordance with section 
        1927(g)(3) of the Social Security Act (42 U.S.C. 
        1396r(g)(3)) and P&T Committees.
          (3) A description outlining the tools P&T Committees 
        may use to determine Medicaid drug coverage and 
        utilization management policies.
          (4) An analysis of whether and how States or P&T 
        Committees establish participation and independence 
        requirements for DUR Boards and P&T Committees, 
        including with respect to entities with connections 
        with drug manufacturers, State Medicaid programs, 
        managed care organizations, and other entities or 
        individuals in the pharmaceutical industry.
          (5) A description outlining how States, DUR Boards, 
        or P&T Committees define conflicts of interest.
          (6) A description of how DUR Boards and P&T 
        Committees address conflicts of interest, including who 
        is responsible for implementing such policies.
          (7) A description of the tools, if any, States use to 
        ensure that there are no conflicts of interest on DUR 
        Boards and P&T Committees.
          (8) An analysis of the effectiveness of tools States 
        use to ensure that there are no conflicts of interest 
        on DUR Boards and P&T Committees and, if applicable, 
        recommendations as to how such tools could be improved.
          (9) A review of strategies States may use to guard 
        against conflicts of interest on DUR Boards and P&T 
        Committees and to ensure compliance with the 
        requirements of titles XI and XIX of the Social 
        Security Act (42 U.S.C. 1301 et seq., 1396 et seq.) and 
        access to effective, clinically appropriate, and 
        medically necessary drug treatments for Medicaid 
        beneficiaries, including recommendations for such 
        legislative and administrative actions as the 
        Comptroller General determines appropriate.

SEC. 204. ENSURING THE ACCURACY OF MANUFACTURER PRICE AND DRUG PRODUCT 
                    INFORMATION UNDER THE MEDICAID DRUG REBATE PROGRAM.

  (a) Audit of Manufacturer Price and Drug Product 
Information.--
          (1) In general.--Subparagraph (B) of section 
        1927(b)(3) of the Social Security Act (42 U.S.C. 1396r-
        8(b)(3)) is amended to read as follows:
                  ``(B) Audits and surveys of manufacturer 
                price and drug product information.--
                          ``(i) Audits.--The Secretary shall 
                        conduct ongoing audits of the price and 
                        drug product information reported by 
                        manufacturers under subparagraph (A) 
                        for the most recently ended rebate 
                        period to ensure the accuracy and 
                        timeliness of such information. In 
                        conducting such audits, the Secretary 
                        may employ evaluations, surveys, 
                        statistical sampling, predictive 
                        analytics and other relevant tools and 
                        methods.
                          ``(ii) Verifications surveys of 
                        average manufacturer price and 
                        manufacturer's average sales price.--In 
                        addition to the audits required under 
                        clause (i), the Secretary may survey 
                        wholesalers and manufacturers 
                        (including manufacturers that directly 
                        distribute their covered outpatient 
                        drugs (in this subparagraph referred to 
                        as `direct sellers')), when necessary, 
                        to verify manufacturer prices and 
                        manufacturer's average sales prices 
                        (including wholesale acquisition cost) 
                        to make payment reported under 
                        subparagraph (A).
                          ``(iii) Penalties.--In addition to 
                        other penalties as may be prescribed by 
                        law, including under subparagraph (C) 
                        of this paragraph, the Secretary may 
                        impose a civil monetary penalty in an 
                        amount not to exceed $185,000 on an 
                        annual basis on a wholesaler, 
                        manufacturer, or direct seller, if the 
                        wholesaler, manufacturer, or direct 
                        seller of a covered outpatient drug 
                        refuses a request for information about 
                        charges or prices by the Secretary in 
                        connection with an audit or survey 
                        under this subparagraph or knowingly 
                        provides false information. The 
                        provisions of section 1128A (other than 
                        subsections (a) (with respect to 
                        amounts of penalties or additional 
                        assessments) and (b)) shall apply to a 
                        civil money penalty under this clause 
                        in the same manner as such provisions 
                        apply to a penalty or proceeding under 
                        section 1128A(a).
                          ``(iv) Reports.--
                                  ``(I) Report to congress.--
                                The Secretary shall, not later 
                                than 18 months after date of 
                                enactment of this subparagraph, 
                                submit a report to the 
                                Committee on Energy and 
                                Commerce of the House of 
                                Representatives and the 
                                Committee on Finance of the 
                                Senate regarding additional 
                                regulatory or statutory changes 
                                that may be required in order 
                                to ensure accurate and timely 
                                reporting and oversight of 
                                manufacturer price and drug 
                                product information, including 
                                whether changes should be made 
                                to reasonable assumption 
                                requirements to ensure such 
                                assumptions are reasonable and 
                                accurate or whether another 
                                methodology for ensuring 
                                accurate and timely reporting 
                                of price and drug product 
                                information should be 
                                considered to ensure the 
                                integrity of the drug rebate 
                                program under this section.
                                  ``(II) Annual reports.--The 
                                Secretary shall, on at least an 
                                annual basis, submit a report 
                                to the Committee on Energy and 
                                Commerce of the House of 
                                Representatives and the 
                                Committee on Finance of the 
                                Senate summarizing the results 
                                of the audits and surveys 
                                conducted under this 
                                subparagraph during the period 
                                that is the subject of the 
                                report.
                                  ``(III) Content.--Each report 
                                submitted under subclause (II) 
                                shall, with respect to the 
                                period that is the subject of 
                                the report, include summaries 
                                of--
                                          ``(aa) error rates in 
                                        the price, drug 
                                        product, and other 
                                        relevant information 
                                        supplied by 
                                        manufacturers under 
                                        subparagraph (A);
                                          ``(bb) the timeliness 
                                        with which 
                                        manufacturers, 
                                        wholesalers, and direct 
                                        sellers provide 
                                        information required 
                                        under subparagraph (A) 
                                        or under clause (i) or 
                                        (ii) of this 
                                        subparagraph;
                                          ``(cc) the number of 
                                        manufacturers, 
                                        wholesalers, and direct 
                                        sellers and drug 
                                        products audited under 
                                        this subparagraph;
                                          ``(dd) the types of 
                                        price and drug product 
                                        information reviewed 
                                        under the audits 
                                        conducted under this 
                                        subparagraph;
                                          ``(ee) the tools and 
                                        methodologies employed 
                                        in such audits;
                                          ``(ff) the findings 
                                        of such audits, 
                                        including which 
                                        manufacturers, if any, 
                                        were penalized under 
                                        this subparagraph; and
                                          ``(gg) such other 
                                        relevant information as 
                                        the Secretary shall 
                                        deem appropriate.
                                  ``(IV) Protection of 
                                information.--In preparing a 
                                report required under subclause 
                                (II), the Secretary shall 
                                redact such proprietary 
                                information as the Secretary 
                                determines appropriate to 
                                prevent disclosure of, and to 
                                safeguard, such information.
                          ``(v) Authorization of 
                        appropriations.--For purposes of 
                        carrying out this subparagraph, there 
                        is authorized to be appropriated 
                        $2,000,000 for fiscal year 2020 and 
                        each fiscal year thereafter.''.
          (2) Effective date.--The amendments made by this 
        subsection shall take effect on the first day of the 
        first fiscal quarter that begins after the date of 
        enactment of this Act.
  (b) Increased Penalties for Noncompliance With Reporting 
Requirements.--
          (1) Increased penalty for late reporting of 
        information.--Section 1927(b)(3)(C)(i) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(C)(i)) is amended 
        by striking ``increased by $10,000 for each day in 
        which such information has not been provided and such 
        amount shall be paid to the Treasury'' and inserting 
        ``, for each covered outpatient drug with respect to 
        which such information is not provided, $50,000 for the 
        first day that such information is not provided on a 
        timely basis and $19,000 for each subsequent day that 
        such information is not provided''.
          (2) Increased penalty for knowingly reporting false 
        information.--Section 1927(b)(3)(C)(ii) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(C)(ii)) is 
        amended by striking ``$100,000'' and inserting 
        ``$500,000''.
          (3) Effective date.--The amendments made by this 
        subsection shall take effect on the first day of the 
        first fiscal quarter that begins after the date of 
        enactment of this Act.

SEC. 205. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE 
                    SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.

  (a) Pass-through Pricing Required.--
          (1) In general.--Section 1927(e) of the Social 
        Security Act (42 U.S.C. 1396r-8(e)) is amended by 
        adding at the end the following:
          ``(6) Pass-through pricing required.--A contract 
        between the State and a pharmacy benefit manager 
        (referred to in this paragraph as a `PBM'), or a 
        contract between the State and a managed care entity or 
        other specified entity (as such terms are defined in 
        section 1903(m)(9)(D)) that includes provisions making 
        the entity responsible for coverage of covered 
        outpatient drugs dispensed to individuals enrolled with 
        the entity, shall require that payment for such drugs 
        and related administrative services (as applicable), 
        including payments made by a PBM on behalf of the State 
        or entity, is based on a pass-through pricing model 
        under which--
                  ``(A) any payment made by the entity of the 
                PBM (as applicable) for such a drug--
                          ``(i) is limited to--
                                  ``(I) ingredient cost; and
                                  ``(II) a professional 
                                dispensing fee that is not less 
                                than the professional 
                                dispensing fee that the State 
                                plan or waiver would pay if the 
                                plan or waiver was making the 
                                payment directly;
                          ``(ii) is passed through in its 
                        entirety by the entity or PBM to the 
                        pharmacy that dispenses the drug; and
                          ``(iii) is made in a manner that is 
                        consistent with section 1902(a)(30)(A) 
                        and sections 447.512, 447.514, and 
                        447.518 of title 42, Code of Federal 
                        Regulations (or any successor 
                        regulation) as if such requirements 
                        applied directly to the entity or the 
                        PBM;
                  ``(B) payment to the entity or the PBM (as 
                applicable) for administrative services 
                performed by the entity or PBM is limited to a 
                reasonable administrative fee that covers the 
                reasonable cost of providing such services;
                  ``(C) the entity or the PBM (as applicable) 
                shall make available to the State, and the 
                Secretary upon request, all costs and payments 
                related to covered outpatient drugs and 
                accompanying administrative services incurred, 
                received, or made by the entity or the PBM, 
                including ingredient costs, professional 
                dispensing fees, administrative fees, post-sale 
                and post-in-voice fees. Discounts, or related 
                adjustments such as direct and indirect 
                remuneration fees, and any and all 
                remuneration; and
                  ``(D) any form of spread pricing whereby any 
                amount charged or claimed by the entity or the 
                PBM (as applicable) is in excess of the amount 
                paid to the pharmacies on behalf of the entity, 
                including any post-sale or post-invoice fees, 
                discounts, or related adjustments such as 
                direct and indirect remuneration fees or 
                assessments (after allowing for a reasonable 
                administrative fee as described in subparagraph 
                (B)) is not allowable for purposes of claiming 
                Federal matching payments under this title.''.
          (2) Conforming amendment.--Clause (xiii) of section 
        1903(m)(2)(A) of such Act (42 U.S.C. 1396b(m)(2)(A)), 
        as amended by section 202, is further amended--
                  (A) by striking ``and (IV)'' and inserting 
                ``(IV)''; and
                  (B) by inserting before the period at the end 
                the following: ``, and (V) pharmacy benefit 
                management services provided by the entity, or 
                provided by a pharmacy benefit manager on 
                behalf of the entity under a contract or other 
                arrangement between the entity and the pharmacy 
                benefit manager, shall comply with the 
                requirements of section 1927(e)(6)''.
          (3) Effective date.--The amendments made by this 
        subsection apply to contracts between States and 
        managed care entities, other specified entities, or 
        pharmacy benefits managers that are entered into or 
        renewed on or after the date that is 18 months after 
        the date of enactment of this Act.
  (b) Survey of Retail Prices.--
          (1) In general.--Section 1927(f) of the Social 
        Security Act (42 U.S.C. 1396r-8(f)) is amended--
                  (A) by striking ``and'' after the semicolon 
                at the end of paragraph (1)(A)(i) and all that 
                precedes it through ``(1)'' and inserting the 
                following:
          ``(1) Survey of retail prices.--The Secretary shall 
        conduct a survey of retail community drug prices, to 
        include at least the national average drug acquisition 
        cost, as follows:
                  ``(A) Use of vendor.--The Secretary may 
                contract services for--
                          ``(i) with respect to retail 
                        community pharmacies, the determination 
                        on a monthly basis of retail survey 
                        prices of the national average drug 
                        acquisition cost for covered outpatient 
                        drugs for such pharmacies, net of all 
                        discounts and rebates (to the extent 
                        any information with respect to such 
                        discounts and rebates is available), 
                        the average reimbursement received for 
                        such drugs by such pharmacies from all 
                        sources of payment, including third 
                        parties, and, to the extent available, 
                        the usual and customary charges to 
                        consumers for such drugs; and'';
                  (B) by adding at the end of paragraph (1) the 
                following:
                  ``(F) Survey reporting.--In order to meet the 
                requirement of section 1902(a)(54), a State 
                shall require that any retail community 
                pharmacy in the State that receives any 
                payment, administrative fee, discount, or 
                rebate related to the dispensing of covered 
                outpatient drugs to individuals receiving 
                benefits under this title, regardless of 
                whether such payment, fee, discount, or rebate 
                is received from the State or a managed care 
                entity directly or from a pharmacy benefit 
                manager or another entity that has a contract 
                with the State or a managed care entity, shall 
                respond to surveys of retail prices conducted 
                under this subsection.
                  ``(G) Survey information.--Information on 
                retail community prices obtained under this 
                paragraph shall be made publicly available and 
                shall include at least the following:
                          ``(i) The monthly response rate of 
                        the survey including a list of 
                        pharmacies not in compliance with 
                        subparagraph (F).
                          ``(ii) The sampling frame and number 
                        of pharmacies sampled monthly.
                          ``(iii) Characteristics of reporting 
                        pharmacies, including type (such as 
                        independent or chain), geographic or 
                        regional location, and dispensing 
                        volume.
                          ``(iv) Reporting of a separate 
                        national average drug acquisition cost 
                        for each drug for independent retail 
                        pharmacies and chain operated 
                        pharmacies.
                          ``(v) Information on price 
                        concessions including on and off 
                        invoice discounts, rebates, and other 
                        price concessions.
                          ``(vi) Information on average 
                        professional dispensing fees paid.
                  ``(H) Penalties.--
                          ``(i) Failure to provide timely 
                        information.--A retail community 
                        pharmacy that fails to respond to a 
                        survey conducted under this subsection 
                        on a timely basis may be subject to a 
                        civil monetary penalty in the amount of 
                        $10,000 for each day in which such 
                        information has not been provided.
                          ``(ii) False information.--A retail 
                        community pharmacy that knowingly 
                        provides false information in response 
                        to a survey conducted under this 
                        subsection may be subject to a civil 
                        money penalty in an amount not to 
                        exceed $100,000 for each item of false 
                        information.
                          ``(iii) Other penalties.--Any civil 
                        money penalties imposed under this 
                        subparagraph shall be in addition to 
                        other penalties as may be prescribed by 
                        law. The provisions of section 1128A 
                        (other than subsections (a) and (b)) 
                        shall apply to a civil money penalty 
                        under this subparagraph in the same 
                        manner as such provisions apply to a 
                        penalty or proceedings under section 
                        1128A(a).
                  ``(I) Report on specialty pharmacies.--
                          ``(i) In general.--Not later than 1 
                        year after the effective date of this 
                        subparagraph, the Secretary shall 
                        submit a report to Congress examining 
                        specialty drug coverage and 
                        reimbursement under this title.
                          ``(ii) Content of report.--Such 
                        report shall include a description of 
                        how State Medicaid programs define 
                        specialty drugs, how much State 
                        Medicaid programs pay for specialty 
                        drugs, how States and managed care 
                        plans determine payment for specialty 
                        drugs, the settings in which specialty 
                        drugs are dispensed (such as retail 
                        community pharmacies or specialty 
                        pharmacies), whether acquisition costs 
                        for specialty drugs are captured in the 
                        national average drug acquisition cost 
                        survey, and recommendations as to 
                        whether specialty pharmacies should be 
                        included in the survey of retail prices 
                        to ensure national average drug 
                        acquisition costs capture drugs sold at 
                        specialty pharmacies and how such 
                        specialty pharmacies should be 
                        defined.'';
                  (C) in paragraph (2)--
                          (i) in subparagraph (A), by inserting 
                        ``, including payments rates under 
                        Medicaid managed care plans,'' after 
                        ``under this title''; and
                          (ii) in subparagraph (B), by 
                        inserting ``and the basis for such 
                        dispensing fees'' before the semicolon; 
                        and
                  (D) in paragraph (4), by inserting ``, and 
                $5,000,000 for fiscal year 2020 and each fiscal 
                year thereafter,'' after ``2010''.
          (2) Effective date.--The amendments made by this 
        subsection take effect on the 1st day of the 1st 
        quarter that begins on or after the date that is 18 
        months after the date of enactment of this Act.
  (c) Manufacturer Reporting of Wholesale Acquisition Cost.--
Section 1927(b)(3) of such Act (42 U.S.C. 1396r-8(b)(3)), as 
amended by section 141, is further amended--
          (1) in subparagraph (A)(i)--
                  (A) in subclause (I), by striking ``and'' 
                after the semicolon;
                  (B) in subclause (II), by adding ``and'' 
                after the semicolon;
                  (C) by moving the left margins of subclause 
                (I) and (II) 2 ems to the right; and
                  (D) by adding at the end the following:
                                  ``(III) in the case of rebate 
                                periods that begin on or after 
                                the date of enactment of this 
                                subclause, on the wholesale 
                                acquisition cost (as defined in 
                                section 1847A(c)(6)(B)) for 
                                covered outpatient drugs for 
                                the rebate period under the 
                                agreement (including for all 
                                such drugs that are sold under 
                                a new drug application approved 
                                under section 505(c) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act);''; and
          (2) in subparagraph (D)--
                  (A) in the matter preceding clause (i), by 
                inserting ``and clause (vii) of this 
                subparagraph'' after ``1847A'';
                  (B) in clause (vi), by striking ``and'' after 
                the comma;
                  (C) in clause (vii), by striking the period 
                and inserting ``, and''; and
                  (D) by inserting after clause (vii) the 
                following:
                          ``(viii) to the Secretary to disclose 
                        (through a website accessible to the 
                        public) the most recently reported 
                        wholesale acquisition cost (as defined 
                        in section 1847A(c)(6)(B)) for each 
                        covered outpatient drug (including for 
                        all such drugs that are sold under a 
                        new drug application approved under 
                        section 505(c) of the Federal Food, 
                        Drug, and Cosmetic Act), as reported 
                        under subparagraph (A)(i)(III).''.

SEC. 206. T-MSIS DRUG DATA ANALYTICS REPORTS.

  (a) In General.--Not later than May 1 of each calendar year 
beginning with calendar year 2021, the Secretary of Health and 
Human Services (in this section referred to as the 
``Secretary'') shall publish on a website of the Centers for 
Medicare & Medicaid Services that is accessible to the public a 
report of the most recently available data on provider 
prescribing patterns under the Medicaid program.
  (b) Content of Report.--
          (1) Required content.--Each report required under 
        subsection (a) for a calendar year shall include the 
        following information with respect to each State (and, 
        to the extent available, with respect to Puerto Rico, 
        the United States Virgin Islands, Guam, the Northern 
        Mariana Islands, and American Samoa):
                  (A) A comparison of covered outpatient drug 
                (as defined in section 1927(k)(2) of the Social 
                Security Act (42 U.S.C. 1396r-8(k)(2))) 
                prescribing patterns under the State Medicaid 
                plan or waiver of such plan (including drugs 
                prescribed on a fee-for-service basis and drugs 
                prescribed under managed care arrangements 
                under such plan or waiver)--
                          (i) across all forms or models of 
                        reimbursement used under the plan or 
                        waiver;
                          (ii) within specialties and 
                        subspecialties, as defined by the 
                        Secretary;
                          (iii) by episodes of care for--
                                  (I) each chronic disease 
                                category, as defined by the 
                                Secretary, that is represented 
                                in the 10 conditions that 
                                accounted for the greatest 
                                share of total spending under 
                                the plan or waiver during the 
                                year that is the subject of the 
                                report;
                                  (II) procedural groupings; 
                                and
                                  (III) rare disease diagnosis 
                                codes;
                          (iv) by patient demographic 
                        characteristics, including race (to the 
                        extent that the Secretary determines 
                        that there is sufficient data available 
                        with respect to such characteristic in 
                        a majority of States), gender, and age;
                          (v) by patient high-utilizer or risk 
                        status; and
                          (vi) by high and low resource 
                        settings by facility and place of 
                        service categories, as determined by 
                        the Secretary.
                  (B) In the case of medical assistance for 
                covered outpatient drugs (as so defined) 
                provided under a State Medicaid plan or waiver 
                of such plan in a managed care setting, an 
                analysis of the differences in managed care 
                prescribing patterns when a covered outpatient 
                drug is prescribed in a managed care setting as 
                compared to when the drug is prescribed in a 
                fee-for-service setting.
          (2) Additional content.--A report required under 
        subsection (a) for a calendar year may include State-
        specific information about prescription utilization 
        management tools under State Medicaid plans or waivers 
        of such plans, including--
                  (A) a description of prescription utilization 
                management tools under State programs to 
                provide long-term services and supports under a 
                State Medicaid plan or a waiver of such plan;
                  (B) a comparison of prescription utilization 
                management tools applicable to populations 
                covered under a State Medicaid plan waiver 
                under section 1115 of the Social Security Act 
                (42 U.S.C. 1315) and the models applicable to 
                populations that are not covered under the 
                waiver;
                  (C) a comparison of the prescription 
                utilization management tools employed by 
                different Medicaid managed care organizations, 
                pharmacy benefit managers, and related entities 
                within the State;
                  (D) a comparison of the prescription 
                utilization management tools applicable to each 
                enrollment category under a State Medicaid plan 
                or waiver; and
                  (E) a comparison of the prescription 
                utilization management tools applicable under 
                the State Medicaid plan or waiver by patient 
                high-utilizer or risk status.
          (3) Additional analysis.--To the extent practicable, 
        the Secretary shall include in each report published 
        under subsection (a)--
                  (A) analyses of national, State, and local 
                patterns of Medicaid population-based 
                prescribing behaviors; and
                  (B) recommendations for administrative or 
                legislative action to improve the effectiveness 
                of, and reduce costs for, covered outpatient 
                drugs under Medicaid while ensuring timely 
                beneficiary access to medically necessary 
                covered outpatient drugs.
  (c) Use of T-MSIS Data.--Each report required under 
subsection (a) shall--
          (1) be prepared using data and definitions from the 
        Transformed Medicaid Statistical Information System (T-
        MSIS) data set (or a successor data set) that is not 
        more than 24 months old on the date that the report is 
        published; and
          (2) as appropriate, include a description with 
        respect to each State of the quality and completeness 
        of the data, as well as any necessary caveats 
        describing the limitations of the data reported to the 
        Secretary by the State that are sufficient to 
        communicate the appropriate uses for the information.
  (d) Preparation of Report.--Each report required under 
subsection (a) shall be prepared by the Administrator for the 
Centers for Medicare & Medicaid Services.
  (e) Authorization of Appropriations.--For purposes of 
carrying out this section, there is authorized to be 
appropriated $2,000,000 for fiscal year 2020 and each fiscal 
year thereafter.

SEC. 207. RISK-SHARING VALUE-BASED PAYMENT AGREEMENTS FOR COVERED 
                    OUTPATIENT DRUGS UNDER MEDICAID.

  (a) In General.--Section 1927 of the Social Security Act (42 
U.S.C. 1396r-8) is amended by adding at the end the following 
new subsection:
  ``(l) State Option to Pay for Covered Outpatient Drugs 
Through Risk-sharing Value-based Agreements.--
          ``(1) In general.--Beginning January 1, 2022, a State 
        shall have the option to pay (whether on a fee-for-
        service or managed care basis) for covered outpatient 
        drugs that are potentially curative treatments intended 
        for one-time use that are administered to individuals 
        under this title by entering into a risk-sharing value-
        based payment agreement with the manufacturer of the 
        drug in accordance with the requirements of this 
        subsection.
          ``(2) Secretarial approval.--
                  ``(A) In general.--A State shall submit a 
                request to the Secretary to enter into a risk-
                sharing value based payment agreement, and the 
                Secretary shall not approve a proposed risk-
                sharing value-based payment agreement between a 
                State and a manufacturer for payment for a 
                covered outpatient drug of the manufacturer 
                unless the following requirements are met:
                          ``(i) Manufacturer is party to rebate 
                        agreement and in compliance with 
                        requirements.--The manufacturer has a 
                        rebate agreement in effect as required 
                        under subsection (a) and (b) of this 
                        section and is in compliance with all 
                        applicable requirements under this 
                        title.
                          ``(ii) No increase to projected net 
                        federal spending.--
                                  ``(I) In general.--The Chief 
                                Actuary certifies that the 
                                projected payments for each 
                                covered outpatient drug under 
                                such proposed agreement would 
                                not result in greater estimated 
                                Federal spending under this 
                                title than the net Federal 
                                spending that would result in 
                                the absence of the agreement.
                                  ``(II) Net federal spending 
                                defined.--For purposes of this 
                                subsection, the term `net 
                                Federal spending' means the 
                                amount of Federal payments the 
                                Chief Actuary estimates would 
                                be made under this title for 
                                administering a covered 
                                outpatient drug to an 
                                individual eligible for medical 
                                assistance under a State plan 
                                or a waiver of such plan, 
                                reduced by the amount of all 
                                rebates the Chief Actuary 
                                estimates would be paid with 
                                respect to the administering of 
                                such drug, including all 
                                rebates under this title and 
                                any supplemental or other 
                                additional rebates, in the 
                                absence of such an agreement.
                                  ``(III) Information.--The 
                                Chief Actuary shall make the 
                                certifications required under 
                                this clause based on the most 
                                recently available and reliable 
                                drug pricing and product 
                                information. The State and 
                                manufacturer shall provide the 
                                Secretary and the Chief Actuary 
                                with all necessary information 
                                required to make the estimates 
                                needed for such certifications.
                          ``(iii) Launch and list price 
                        justifications.--The manufacturer 
                        submits all relevant information and 
                        supporting documentation necessary for 
                        pricing decisions as deemed appropriate 
                        by the Secretary, which shall be 
                        truthful and non-misleading, including 
                        manufacturer information and supporting 
                        documentation for launch price or list 
                        price increases, and any applicable 
                        justification required under section 
                        1128L.
                          ``(iv) Confidentiality of 
                        information; penalties.--The provisions 
                        of subparagraphs (C) and (D) of 
                        subsection (b)(3) shall apply to a 
                        manufacturer that fails to submit the 
                        information and documentation required 
                        under clauses (ii) and (iii) on a 
                        timely basis, or that knowingly 
                        provides false or misleading 
                        information, in the same manner as such 
                        provisions apply to a manufacturer with 
                        a rebate agreement under this section.
                  ``(B) Consideration of state request for 
                approval.--
                          ``(i) In general.--The Secretary 
                        shall treat a State request for 
                        approval of a risk-sharing value-based 
                        payment agreement in the same manner 
                        that the Secretary treats a State plan 
                        amendment, and subpart B of part 430 of 
                        title 42, Code of Federal Regulations, 
                        including, subject to clause (ii), the 
                        timing requirements of section 430.16 
                        of such title (as in effect on the date 
                        of enactment of this subsection), shall 
                        apply to a request for approval of a 
                        risk-sharing value-based payment 
                        agreement in the same manner as such 
                        subpart applies to a State plan 
                        amendment.
                          ``(ii) Timing.--The Secretary shall 
                        consult with the Commissioner of Food 
                        and Drugs as required under 
                        subparagraph (C) and make a 
                        determination on whether to approve a 
                        request from a State for approval of a 
                        proposed risk-sharing value-based 
                        payment agreement (or request 
                        additional information necessary to 
                        allow the Secretary to make a 
                        determination with respect to such 
                        request for approval) within the time 
                        period, to the extent practicable, 
                        specified in section 430.16 of title 
                        42, Code of Federal Regulations (as in 
                        effect on the date of enactment of this 
                        subsection), but in no case shall the 
                        Secretary take more than 180 days after 
                        the receipt of such request for 
                        approval or response to such request 
                        for additional information to make such 
                        a determination (or request additional 
                        information).
                  ``(C) Consultation with the commissioner of 
                food and drugs.--In considering whether to 
                approve a risk-sharing value-based payment 
                agreement, the Secretary, to the extent 
                necessary, shall consult with the Commissioner 
                of Food and Drugs to determine whether the 
                relevant clinical parameters specified in such 
                agreement are appropriate.
          ``(3) Installment-based payment structure.--
                  ``(A) In general.--A risk-sharing value-based 
                payment agreement shall provide for a payment 
                structure under which, for every installment 
                year of the agreement (subject to subparagraph 
                (B)), the State shall pay the total installment 
                year amount in equal installments to be paid at 
                regular intervals over a period of time that 
                shall be specified in the agreement.
                  ``(B) Requirements for installment 
                payments.--
                          ``(i) Timing of first payment.--The 
                        State shall make the first of the 
                        installment payments described in 
                        subparagraph (A) for an installment 
                        year not later than 30 days after the 
                        end of such year.
                          ``(ii) Length of installment 
                        period.--The period of time over which 
                        the State shall make the installment 
                        payments described in subparagraph (A) 
                        for an installment year shall not be 
                        longer than 5 years.
                          ``(iii) Nonpayment or reduced payment 
                        of installments following a failure to 
                        meet clinical parameter.--If, prior to 
                        the payment date (as specified in the 
                        agreement) of any installment payment 
                        described in subparagraph (A) or any 
                        other alternative date or time frame 
                        (as otherwise specified in the 
                        agreement), the covered outpatient drug 
                        which is subject to the agreement fails 
                        to meet a relevant clinical parameter 
                        of the agreement, the agreement shall 
                        provide that--
                                  ``(I) the installment payment 
                                shall not be made; or
                                  ``(II) the installment 
                                payment shall be reduced by a 
                                percentage specified in the 
                                agreement that is based on the 
                                outcome achieved by the drug 
                                relative to the relevant 
                                clinical parameter.
          ``(4) Notice of intent.--
                  ``(A) In general.--Subject to subparagraph 
                (B), a manufacturer of a covered outpatient 
                drug shall not be eligible to enter into a 
                risk-sharing value-based payment agreement 
                under this subsection with respect to such drug 
                unless the manufacturer notifies the Secretary 
                that the manufacturer is interested in entering 
                into such an agreement with respect to such 
                drug. The decision to submit and timing of a 
                request to enter into a proposed risk-sharing 
                value-based payment agreement shall remain 
                solely within the discretion of the State and 
                shall only be effective upon Secretarial 
                approval as required under this subsection.
                  ``(B) Treatment of subsequently approved 
                drugs.--
                          ``(i) In general.--In the case of a 
                        manufacturer of a covered outpatient 
                        drug approved under section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        licensed under section 351 of the 
                        Public Health Service Act after the 
                        date of enactment of this subsection, 
                        not more than 90 days after meeting 
                        with the Food and Drug Administration 
                        following phase II clinical trials for 
                        such drug (or, in the case of a drug 
                        described in clause (ii), not later 
                        than March 31, 2022), the manufacturer 
                        must notify the Secretary of the 
                        manufacturer's intent to enter into a 
                        risk-sharing value-based payment 
                        agreement under this subsection with 
                        respect to such drug. If no such 
                        meeting has occurred, the Secretary may 
                        use discretion as to whether a 
                        potentially curative treatment intended 
                        for one-time use may qualify for a 
                        risk-sharing value-based payment 
                        agreement under this section. A 
                        manufacturer notification of interest 
                        shall not have any influence on a 
                        decision for approval by the Food and 
                        Drug Administration.
                          ``(ii) Application to certain 
                        subsequently approved drugs.--A drug 
                        described in this clause is a covered 
                        outpatient drug of a manufacturer--
                                  ``(I) that is approved under 
                                section 505 of the Federal 
                                Food, Drug, and Cosmetic Act or 
                                licensed under section 351 of 
                                the Public Health Service Act 
                                after the date of enactment of 
                                this subsection; and
                                  ``(II) with respect to which, 
                                as of January 1, 2022, more 
                                than 90 days have passed after 
                                the manufacturer's meeting with 
                                the Food and Drug 
                                Administration following phase 
                                II clinical trials for such 
                                drug.
                          ``(iii) Parallel approval.--The 
                        Secretary, in coordination with the 
                        Administrator of the Centers for 
                        Medicare & Medicaid Services and the 
                        Commissioner of Food and Drugs, shall, 
                        to the extent practicable, approve a 
                        State's request to enter into a 
                        proposed risk-sharing value-based 
                        payment agreement that otherwise meets 
                        the requirements of this subsection at 
                        the time that such a drug is approved 
                        by the Food and Drug Administration to 
                        help provide that no State that wishes 
                        to enter into such an agreement is 
                        required to pay for the drug in full at 
                        one time if the State is seeking to pay 
                        over a period of time as outlined in 
                        the proposed agreement.
                          ``(iv) Rule of construction.--Nothing 
                        in this paragraph shall be applied or 
                        construed to modify or affect the 
                        timeframes or factors involved in the 
                        Secretary's determination of whether to 
                        approve or license a drug under section 
                        505 of the Federal Food, Drug, and 
                        Cosmetic Act or section 351 of the 
                        Public Health Service Act.
          ``(5) Special payment rules.--
                  ``(A) In general.--Except as otherwise 
                provided in this paragraph, with respect to an 
                individual who is administered a unit of a 
                covered outpatient drug that is purchased under 
                a State plan by a State Medicaid agency under a 
                risk-sharing value-based payment agreement in 
                an installment year, the State shall remain 
                liable to the manufacturer of such drug for 
                payment for such unit without regard to whether 
                the individual remains enrolled in the State 
                plan under this title (or a waiver of such 
                plan) for each installment year for which the 
                State is to make installment payments for 
                covered outpatient drugs purchased under the 
                agreement in such year.
                  ``(B) Death.--In the case of an individual 
                described in subparagraph (A) who dies during 
                the period described in such subparagraph, the 
                State plan shall not be liable for any 
                remaining payment for the unit of the covered 
                outpatient drug administered to the individual 
                which is owed under the agreement described in 
                such subparagraph.
                  ``(C) Withdrawal of approval.--In the case of 
                a covered outpatient drug that is the subject 
                of a risk-sharing value-based agreement between 
                a State and a manufacturer under this 
                subsection, including a drug approved in 
                accordance with section 506(c) of the Federal 
                Food, Drug, and Cosmetic Act, and such drug is 
                the subject of an application that has been 
                withdrawn by the Secretary, the State plan 
                shall not be liable for any remaining payment 
                that is owed under the agreement.
                  ``(D) Alternative arrangement under 
                agreement.--Subject to approval by the 
                Secretary, the terms of a proposed risk-sharing 
                value-based payment agreement submitted for 
                approval by a State may provide that 
                subparagraph (A) shall not apply.
                  ``(E) Guidance.--Not later than January 1, 
                2022, the Secretary shall issue guidance to 
                States establishing a process for States to 
                notify the Secretary when an individual who is 
                administered a unit of a covered outpatient 
                drug that is purchased by a State plan under a 
                risk-sharing value-based payment agreement 
                ceases to be enrolled under the State plan 
                under this title (or a waiver of such plan) or 
                dies before the end of the installment period 
                applicable to such unit under the agreement.
          ``(6) Treatment of payments under risk-sharing value-
        based agreements for purposes of average manufacturer 
        price; best price.--The Secretary shall treat any 
        payments made to the manufacturer of a covered 
        outpatient drug under a risk-sharing value-based 
        payment agreement under this subsection during a rebate 
        period in the same manner that the Secretary treats 
        payments made under a State supplemental rebate 
        agreement under sections 447.504(c)(19) and 
        447.505(c)(7) of title 42, Code of Federal Regulations 
        (or any successor regulations) for purposes of 
        determining average manufacturer price and best price 
        under this section with respect to the covered 
        outpatient drug and a rebate period and for purposes of 
        offsets required under subsection (b)(1)(B).
          ``(7) Assessments and report to congress.--
                  ``(A) Assessments.--
                          ``(i) In general.--Not later than 180 
                        days after the end of each assessment 
                        period of any risk-sharing value-based 
                        payment agreement for a State approved 
                        under this subsection, the Secretary 
                        shall conduct an evaluation of such 
                        agreement which shall include an 
                        evaluation by the Chief Actuary to 
                        determine whether program spending 
                        under the risk-sharing value-based 
                        payment agreement aligned with the 
                        projections for the agreement made 
                        under paragraph (2)(A)(ii), including 
                        an assessment of whether actual Federal 
                        spending under this title under the 
                        agreement was less or more than net 
                        Federal spending would have been in the 
                        absence of the agreement.
                          ``(ii) Assessment period.--For 
                        purposes of clause (i)--
                                  ``(I) the first assessment 
                                period for a risk-sharing 
                                value-based payment agreement 
                                shall be the period of time 
                                over which payments are 
                                scheduled to be made under the 
                                agreement for the first 10 
                                individuals who are 
                                administered covered outpatient 
                                drugs under the agreement 
                                except that such period shall 
                                not exceed the 5-year period 
                                after the date on which the 
                                Secretary approves the 
                                agreement; and
                                  ``(II) each subsequent 
                                assessment period for a risk-
                                sharing value-based payment 
                                agreement shall be the 5-year 
                                period following the end of the 
                                previous assessment period.
                  ``(B) Results of assessments.--
                          ``(i) Termination option.--If the 
                        Secretary determines as a result of the 
                        assessment by the Chief Actuary under 
                        subparagraph (A) that the actual 
                        Federal spending under this title for 
                        any covered outpatient drug that was 
                        the subject of the State's risk-sharing 
                        value-based payment agreement was 
                        greater than the net Federal spending 
                        that would have resulted in the absence 
                        of the agreement, the Secretary may 
                        terminate approval of such agreement 
                        and shall immediately conduct an 
                        assessment under this paragraph of any 
                        other ongoing risk-sharing value-based 
                        payment agreement to which the same 
                        manufacturer is a party.
                          ``(ii) Repayment required.--
                                  ``(I) In general.--If the 
                                Secretary determines as a 
                                result of the assessment by the 
                                Chief Actuary under 
                                subparagraph (A) that the 
                                Federal spending under the 
                                risk-sharing value-based 
                                agreement for a covered 
                                outpatient drug that was 
                                subject to such agreement was 
                                greater than the net Federal 
                                spending that would have 
                                resulted in the absence of the 
                                agreement, the manufacturer 
                                shall repay the difference to 
                                the State and Federal 
                                governments in a timely manner 
                                as determined by the Secretary.
                                  ``(II) Termination for 
                                failure to pay.--The failure of 
                                a manufacturer to make 
                                repayments required under 
                                subclause (I) in a timely 
                                manner shall result in 
                                immediate termination of all 
                                risk-sharing value-based 
                                agreements to which the 
                                manufacturer is a party.
                                  ``(III) Additional 
                                penalties.--In the case of a 
                                manufacturer that fails to make 
                                repayments required under 
                                subclause (I), the Secretary 
                                may treat such manufacturer in 
                                the same manner as a 
                                manufacturer that fails to pay 
                                required rebates under this 
                                section, and the Secretary 
                                may--
                                          ``(aa) suspend or 
                                        terminate the 
                                        manufacturer's rebate 
                                        agreement under this 
                                        section; and
                                          ``(bb) pursue any 
                                        other remedy that would 
                                        be available if the 
                                        manufacturer had failed 
                                        to pay required rebates 
                                        under this section.
                  ``(C) Report to congress.--Not later than 5 
                years after the first risk-sharing value-based 
                payment agreement is approved under this 
                subsection, the Secretary shall submit to 
                Congress and make available to the public a 
                report that includes--
                          ``(i) an assessment of the impact of 
                        risk-sharing value-based payment 
                        agreements on access for individuals 
                        who are eligible for benefits under a 
                        State plan or waiver under this title 
                        to medically necessary covered 
                        outpatient drugs and related 
                        treatments;
                          ``(ii) an analysis of the impact of 
                        such agreements on overall State and 
                        Federal spending under this title;
                          ``(iii) an assessment of the impact 
                        of such agreements on drug prices, 
                        including launch price and price 
                        increases; and
                          ``(iv) such recommendations to 
                        Congress as the Secretary deems 
                        appropriate.
          ``(8) Guidance and regulations.--
                  ``(A) In general.--Not later than January 1, 
                2022, the Secretary shall issue guidance to 
                States seeking to enter into risk-sharing 
                value-based payment agreements under this 
                subsection that includes a model template for 
                such agreements. The Secretary may issue any 
                additional guidance or promulgate regulations 
                as necessary to implement and enforce the 
                provisions of this subsection.
                  ``(B) Model agreements.--
                          ``(i) In general.--If a State 
                        expresses an interest in pursuing a 
                        risk-sharing value-based payment 
                        agreement under this subsection with a 
                        manufacturer for the purchase of a 
                        covered outpatient drug, the Secretary 
                        may share with such State any risk-
                        sharing value-based agreement between a 
                        State and the manufacturer for the 
                        purchase of such drug that has been 
                        approved under this subsection. While 
                        such shared agreement may serve as a 
                        template for a State that wishes to 
                        propose, the use of a previously 
                        approved agreement shall not affect the 
                        submission and approval process for 
                        approval of a proposed risk-sharing 
                        value-based payment agreement under 
                        this subsection, including the 
                        requirements under paragraph (2)(A).
                          ``(ii) Confidentiality.--In the case 
                        of a risk-sharing value-based payment 
                        agreement that is disclosed to a State 
                        by the Secretary under this 
                        subparagraph and that is only in effect 
                        with respect to a single State, the 
                        confidentiality of information 
                        provisions described in subsection 
                        (b)(3)(D) shall apply to such 
                        information.
                  ``(C) OIG consultation.--
                          ``(i) In general.--The Secretary 
                        shall consult with the Office of the 
                        Inspector General of the Department of 
                        Health and Human Services to determine 
                        whether there are potential program 
                        integrity concerns with agreement 
                        approvals or templates and address 
                        accordingly.
                          ``(ii) OIG policy updates as 
                        necessary.--The Inspector General of 
                        the Department of Health and Human 
                        Services shall review and update, as 
                        necessary, any policies or guidelines 
                        of the Office of the Inspector General 
                        of the Department of Human Services 
                        (including policies related to the 
                        enforcement of section 1128B) to 
                        accommodate the use of risk-sharing 
                        value-based payment agreements in 
                        accordance with this section.
          ``(9) Rules of construction.--
                  ``(A) Modifications.--Nothing in this 
                subsection or any regulations promulgated under 
                this subsection shall prohibit a State from 
                requesting a modification from the Secretary to 
                the terms of a risk-sharing value-based payment 
                agreement. A modification that is expected to 
                result in any increase to projected net State 
                or Federal spending under the agreement shall 
                be subject to recertification by the Chief 
                Actuary as described in paragraph (2)(A)(ii) 
                before the modification may be approved.
                  ``(B) Rebate agreements.--Nothing in this 
                subsection shall be construed as requiring a 
                State to enter into a risk-sharing value-based 
                payment agreement or as limiting or superseding 
                the ability of a State to enter into a 
                supplemental rebate agreement for a covered 
                outpatient drug.
                  ``(C) FFP for payments under risk-sharing 
                value-based payment agreements.--Federal 
                financial participation shall be available 
                under this title for any payment made by a 
                State to a manufacturer for a covered 
                outpatient drug under a risk-sharing value-
                based payment agreement in accordance with this 
                subsection, except that no Federal financial 
                participation shall be available for any 
                payment made by a State to a manufacturer under 
                such an agreement on and after the effective 
                date of a disapproval of such agreement by the 
                Secretary.
                  ``(D) Continued application of other 
                provisions.--Except as expressly provided in 
                this subsection, nothing in this subsection or 
                in any regulations promulgated under this 
                subsection shall affect the application of any 
                other provision of this Act.
          ``(10) Authorization of appropriations.--For purposes 
        of carrying out this subsection, there is authorized to 
        be appropriated $5,000,000 for fiscal year 2020 and 
        each fiscal year thereafter.
          ``(11) Definitions.--In this subsection:
                  ``(A) Chief actuary.--The term `Chief 
                Actuary' means the Chief Actuary of the Centers 
                for Medicare & Medicaid Services.
                  ``(B) Installment year.--The term 
                `installment year' means, with respect to a 
                risk-sharing value-based payment agreement, a 
                12-month period during which a covered 
                outpatient drug is administered under the 
                agreement.
                  ``(C) Potentially curative treatment intended 
                for one-time use.--The term `potentially 
                curative treatment intended for one-time use' 
                means a treatment that consists of the 
                administration of a covered outpatient drug 
                that--
                          ``(i) is a form of gene therapy for a 
                        rare disease, as defined by the 
                        Commissioner of Food and Drugs, 
                        designated under section 526 of the 
                        Federal Food, Drug, and Cosmetics Act, 
                        and approved under section 505 of such 
                        Act or licensed under subsection (a) or 
                        (k) of section 351 of the Public Health 
                        Service Act to treat a serious or life-
                        threatening disease or condition;
                          ``(ii) if administered in accordance 
                        with the labeling of such drug, is 
                        expected to result in either--
                                  ``(I) the cure of such 
                                disease or condition; or
                                  ``(II) a reduction in the 
                                symptoms of such disease or 
                                condition to the extent that 
                                such disease or condition is 
                                not expected to lead to early 
                                mortality; and
                          ``(iii) is expected to achieve a 
                        result described in clause (ii), which 
                        may be achieved over an extended period 
                        of time, after not more than 3 
                        administrations.
                  ``(D) Relevant clinical parameter.--The term 
                `relevant clinical parameter' means, with 
                respect to a covered outpatient drug that is 
                the subject of a risk-sharing value-based 
                payment agreement--
                          ``(i) a clinical endpoint specified 
                        in the drug's labeling or supported by 
                        one or more of the compendia described 
                        in section 1861(t)(2)(B)(ii)(I) that--
                                  ``(I) is able to be measured 
                                or evaluated on an annual basis 
                                for each year of the agreement 
                                on an independent basis by a 
                                provider or other entity; and
                                  ``(II) is required to be 
                                achieved (based on observed 
                                metrics in patient populations) 
                                under the terms of the 
                                agreement; or
                          ``(ii) a surrogate endpoint (as 
                        defined in section 507(e)(9) of the 
                        Federal Food, Drug, and Cosmetic Act), 
                        including those developed by patient-
                        focused drug development tools, that--
                                  ``(I) is able to be measured 
                                or evaluated on an annual basis 
                                for each year of the agreement 
                                on an independent basis by a 
                                provider or other entity; and
                                  ``(II) has been qualified by 
                                the Food and Drug 
                                Administration.
                  ``(E) Risk-sharing value-based payment 
                agreement.--The term `risk-sharing value-based 
                payment agreement' means an agreement between a 
                State plan and a manufacturer--
                          ``(i) for the purchase of a covered 
                        outpatient drug of the manufacturer 
                        that is a potentially curative 
                        treatment intended for one-time use;
                          ``(ii) under which payment for such 
                        drug shall be made pursuant to an 
                        installment-based payment structure 
                        that meets the requirements of 
                        paragraph (3);
                          ``(iii) which conditions payment on 
                        the achievement of at least 2 relevant 
                        clinical parameters (as defined in 
                        subparagraph (C));
                          ``(iv) which provides that--
                                  ``(I) the State plan will 
                                directly reimburse the 
                                manufacturer for the drug; or
                                  ``(II) a third party will 
                                reimburse the manufacture in a 
                                manner approved by the 
                                Secretary; and
                          ``(v) is approved by the Secretary in 
                        accordance with paragraph (2).
                  ``(F) Total installment year amount.--The 
                term `total installment year amount' means, 
                with respect to a risk-sharing value-based 
                payment agreement for the purchase of a covered 
                outpatient drug and an installment year, an 
                amount equal to the product of--
                          ``(i) the unit price of the drug 
                        charged under the agreement; and
                          ``(ii) the number of units of such 
                        drug administered under the agreement 
                        during such installment year.''.
  (b) Conforming Amendments.--
          (1) Section 1903(i)(10)(A) of the Social Security Act 
        (42 U.S.C. 1396b(i)(10)(A)) is amended by striking ``or 
        unless section 1927(a)(3) applies'' and inserting ``, 
        section 1927(a)(3) applies with respect to such drugs, 
        or such drugs are the subject of a risk-sharing value-
        based payment agreement under section 1927(l)''.
          (2) Section 1927(b) of the Social Security Act (42 
        U.S.C. 1396r-8(b)) is amended--
                  (A) in paragraph (1)(A), by inserting 
                ``(except for drugs for which payment is made 
                by a State under a risk-sharing value-based 
                payment agreement under subsection (l))'' after 
                ``under the State plan for such period''; and
                  (B) in paragraph (3)--
                          (i) in subparagraph (C)(i), by 
                        inserting ``or subsection (l)(2)(A)'' 
                        after ``subparagraph (A)''; and
                          (ii) in subparagraph (D), in the 
                        matter preceding clause (i), by 
                        inserting ``, under subsection 
                        (l)(2)(A),'' after ``under this 
                        paragraph''.

SEC. 208. APPLYING MEDICAID DRUG REBATE REQUIREMENT TO DRUGS PROVIDED 
                    AS PART OF OUTPATIENT HOSPITAL SERVICES.

  (a) In General.--Section 1927(k)(3) of the Social Security 
Act (42 U.S.C. 1396r-8(k)(3)) is amended to read as follows:
          ``(3) Limiting definition.--
                  ``(A) In general.--The term `covered 
                outpatient drug' does not include any drug, 
                biological product, or insulin provided as part 
                of, or as incident to and in the same setting 
                as, any of the following (and for which payment 
                may be made under this title as part of payment 
                for the following and not as direct 
                reimbursement for the drug):
                          ``(i) Inpatient hospital services.
                          ``(ii) Hospice services.
                          ``(iii) Dental services, except that 
                        drugs for which the State plan 
                        authorizes direct reimbursement to the 
                        dispensing dentist are covered 
                        outpatient drugs.
                          ``(iv) Physicians' services.
                          ``(v) Outpatient hospital services.
                          ``(vi) Nursing facility services and 
                        services provided by an intermediate 
                        care facility for the mentally 
                        retarded.
                          ``(vii) Other laboratory and x-ray 
                        services.
                          ``(viii) Renal dialysis.
                  ``(B) Other exclusions.--Such term also does 
                not include any such drug or product for which 
                a National Drug Code number is not required by 
                the Food and Drug Administration or a drug or 
                biological used for a medical indication which 
                is not a medically accepted indication.
                  ``(C) State option.--At the option of a 
                State, such term may include any drug, 
                biological product, or insulin for which the 
                State is the primary payer under this title or 
                a demonstration project concerning this title, 
                and that is provided on an outpatient basis as 
                part of, or as incident to and in the same 
                setting as, described in clause (iv) or (v) of 
                subparagraph (A) and for which payment is made 
                as part of payment for such services.
                  ``(D) No effect on best price.--Any drug, 
                biological product, or insulin excluded from 
                the definition of such term as a result of this 
                paragraph shall be treated as a covered 
                outpatient drug for purposes of determining the 
                best price (as defined in subsection (c)(1)(C)) 
                for such drug, biological product, or 
                insulin.''.
  (b) Effective Date; Implementation Guidance.--
          (1) In general.--The amendment made by subsection (a) 
        shall take effect on the date that is 1 year after the 
        date of enactment of this Act.
          (2) Implementation and guidance.--Not later than 1 
        year after the date of enactment of this Act, the 
        Secretary of Health and Human Services shall issue 
        guidance and relevant informational bulletins for 
        States, manufacturers (as defined in section 1927(k)(5) 
        of the Social Security Act (42 U.S.C. 1396r-8(k)(5)), 
        and other relevant stakeholders, including health care 
        providers, regarding implementation of the amendment 
        made by subsection (a).

                TITLE III--FOOD AND DRUG ADMINISTRATION


                        Subtitle A--CREATES Act


SEC. 301. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL 
                    PRODUCTS.

  (a) Definitions.--In this section--
          (1) the term ``commercially reasonable, market-based 
        terms'' means--
                  (A) a nondiscriminatory price for the sale of 
                the covered product at or below, but not 
                greater than, the most recent wholesale 
                acquisition cost for the drug, as defined in 
                section 1847A(c)(6)(B) of the Social Security 
                Act (42 U.S.C. 1395w-3a(c)(6)(B));
                  (B) a schedule for delivery that results in 
                the transfer of the covered product to the 
                eligible product developer consistent with the 
                timing under subsection (b)(2)(A)(iv); and
                  (C) no additional conditions are imposed on 
                the sale of the covered product;
          (2) the term ``covered product''--
                  (A) means--
                          (i) any drug approved under 
                        subsection (c) or (j) of section 505 of 
                        the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 355) or biological 
                        product licensed under subsection (a) 
                        or (k) of section 351 of the Public 
                        Health Service Act (42 U.S.C. 262);
                          (ii) any combination of a drug or 
                        biological product described in clause 
                        (i); or
                          (iii) when reasonably necessary to 
                        support approval of an application 
                        under section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355), 
                        or section 351 of the Public Health 
                        Service Act (42 U.S.C. 262), as 
                        applicable, or otherwise meet the 
                        requirements for approval under either 
                        such section, any product, including 
                        any device, that is marketed or 
                        intended for use with such a drug or 
                        biological product; and
                  (B) does not include any drug or biological 
                product that appears on the drug shortage list 
                in effect under section 506E of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 356e), 
                unless--
                          (i) the drug or biological product 
                        has been on the drug shortage list in 
                        effect under such section 506E 
                        continuously for more than 6 months; or
                          (ii) the Secretary determines that 
                        inclusion of the drug or biological 
                        product as a covered product is likely 
                        to contribute to alleviating or 
                        preventing a shortage;
          (3) the term ``device'' has the meaning given the 
        term in section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321);
          (4) the term ``eligible product developer'' means a 
        person that seeks to develop a product for approval 
        pursuant to an application for approval under 
        subsection (b)(2) or (j) of section 505 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355) or for 
        licensing pursuant to an application under section 
        351(k) of the Public Health Service Act (42 U.S.C. 
        262(k));
          (5) the term ``license holder'' means the holder of 
        an application approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355) or the holder of a license under 
        subsection (a) or (k) of section 351 of the Public 
        Health Service Act (42 U.S.C. 262) for a covered 
        product;
          (6) the term ``REMS'' means a risk evaluation and 
        mitigation strategy under section 505-1 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355-1);
          (7) the term ``REMS with ETASU'' means a REMS that 
        contains elements to assure safe use under section 505-
        1(f) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355-1(f));
          (8) the term ``Secretary'' means the Secretary of 
        Health and Human Services;
          (9) the term ``single, shared system of elements to 
        assure safe use'' means a single, shared system of 
        elements to assure safe use under section 505-1(f) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355-1(f)); and
          (10) the term ``sufficient quantities'' means an 
        amount of a covered product that the eligible product 
        developer determines allows it to--
                  (A) conduct testing to support an application 
                under--
                          (i) subsection (b)(2) or (j) of 
                        section 505 of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 355); or
                          (ii) section 351(k) of the Public 
                        Health Service Act (42 U.S.C. 262(k)); 
                        and
                  (B) fulfill any regulatory requirements 
                relating to approval of such an application.
  (b) Civil Action for Failure to Provide Sufficient Quantities 
of a Covered Product.--
          (1) In general.--An eligible product developer may 
        bring a civil action against the license holder for a 
        covered product seeking relief under this subsection in 
        an appropriate district court of the United States 
        alleging that the license holder has declined to 
        provide sufficient quantities of the covered product to 
        the eligible product developer on commercially 
        reasonable, market-based terms.
          (2) Elements.--
                  (A) In general.--To prevail in a civil action 
                brought under paragraph (1), an eligible 
                product developer shall prove, by a 
                preponderance of the evidence--
                          (i) that--
                                  (I) the covered product is 
                                not subject to a REMS with 
                                ETASU; or
                                  (II) if the covered product 
                                is subject to a REMS with 
                                ETASU--
                                          (aa) the eligible 
                                        product developer has 
                                        obtained a covered 
                                        product authorization 
                                        from the Secretary in 
                                        accordance with 
                                        subparagraph (B); and
                                          (bb) the eligible 
                                        product developer has 
                                        provided a copy of the 
                                        covered product 
                                        authorization to the 
                                        license holder;
                          (ii) that, as of the date on which 
                        the civil action is filed, the product 
                        developer has not obtained sufficient 
                        quantities of the covered product on 
                        commercially reasonable, market-based 
                        terms;
                          (iii) that the eligible product 
                        developer has submitted a written 
                        request to purchase sufficient 
                        quantities of the covered product to 
                        the license holder and such request--
                                  (I) was sent to a named 
                                corporate officer of the 
                                license holder;
                                  (II) was made by certified or 
                                registered mail with return 
                                receipt requested;
                                  (III) specified an individual 
                                as the point of contact for the 
                                license holder to direct 
                                communications related to the 
                                sale of the covered product to 
                                the eligible product developer 
                                and a means for electronic and 
                                written communications with 
                                that individual; and
                                  (IV) specified an address to 
                                which the covered product was 
                                to be shipped upon reaching an 
                                agreement to transfer the 
                                covered product; and
                          (iv) that the license holder has not 
                        delivered to the eligible product 
                        developer sufficient quantities of the 
                        covered product on commercially 
                        reasonable, market-based terms--
                                  (I) for a covered product 
                                that is not subject to a REMS 
                                with ETASU, by the date that is 
                                31 days after the date on which 
                                the license holder received the 
                                request for the covered 
                                product; and
                                  (II) for a covered product 
                                that is subject to a REMS with 
                                ETASU, by 31 days after the 
                                later of--
                                          (aa) the date on 
                                        which the license 
                                        holder received the 
                                        request for the covered 
                                        product; or
                                          (bb) the date on 
                                        which the license 
                                        holder received a copy 
                                        of the covered product 
                                        authorization issued by 
                                        the Secretary in 
                                        accordance with 
                                        subparagraph (B).
                  (B) Authorization for covered product subject 
                to a rems with etasu.--
                          (i) Request.--An eligible product 
                        developer may submit to the Secretary a 
                        written request for the eligible 
                        product developer to be authorized to 
                        obtain sufficient quantities of an 
                        individual covered product subject to a 
                        REMS with ETASU.
                          (ii) Authorization.--Not later than 
                        120 days after the date on which a 
                        request under clause (i) is received, 
                        the Secretary shall, by written notice, 
                        authorize the eligible product 
                        developer to obtain sufficient 
                        quantities of an individual covered 
                        product subject to a REMS with ETASU 
                        for purposes of--
                                  (I) development and testing 
                                that does not involve human 
                                clinical trials, if the 
                                eligible product developer has 
                                agreed to comply with any 
                                conditions the Secretary 
                                determines necessary; or
                                  (II) development and testing 
                                that involves human clinical 
                                trials, if the eligible product 
                                developer has--
                                          (aa)(AA) submitted 
                                        protocols, informed 
                                        consent documents, and 
                                        informational materials 
                                        for testing that 
                                        include protections 
                                        that provide safety 
                                        protections comparable 
                                        to those provided by 
                                        the REMS for the 
                                        covered product; or
                                          (BB) otherwise 
                                        satisfied the Secretary 
                                        that such protections 
                                        will be provided; and
                                          (bb) met any other 
                                        requirements the 
                                        Secretary may 
                                        establish.
                          (iii) Notice.--A covered product 
                        authorization issued under this 
                        subparagraph shall state that the 
                        provision of the covered product by the 
                        license holder under the terms of the 
                        authorization will not be a violation 
                        of the REMS for the covered product.
          (3) Affirmative defense.--In a civil action brought 
        under paragraph (1), it shall be an affirmative 
        defense, on which the defendant has the burden of 
        persuasion by a preponderance of the evidence--
                  (A) that, on the date on which the eligible 
                product developer requested to purchase 
                sufficient quantities of the covered product 
                from the license holder--
                          (i) neither the license holder nor 
                        any of its agents, wholesalers, or 
                        distributors was engaged in the 
                        manufacturing or commercial marketing 
                        of the covered product; and
                          (ii) neither the license holder nor 
                        any of its agents, wholesalers, or 
                        distributors otherwise had access to 
                        inventory of the covered product to 
                        supply to the eligible product 
                        developer on commercially reasonable, 
                        market-based terms;
                  (B) that--
                          (i) the license holder sells the 
                        covered product through agents, 
                        distributors, or wholesalers;
                          (ii) the license holder has placed no 
                        restrictions, explicit or implicit, on 
                        its agents, distributors, or 
                        wholesalers to sell covered products to 
                        eligible product developers; and
                          (iii) the covered product can be 
                        purchased by the eligible product 
                        developer in sufficient quantities on 
                        commercially reasonable, market-based 
                        terms from the agents, distributors, or 
                        wholesalers of the license holder; or
                  (C) that the license holder made an offer to 
                the individual specified pursuant to paragraph 
                (2)(A)(iii)(III), by a means of communication 
                (electronic, written, or both) specified 
                pursuant to such paragraph, to sell sufficient 
                quantities of the covered product to the 
                eligible product developer at commercially 
                reasonable market-based terms--
                          (i) for a covered product that is not 
                        subject to a REMS with ETASU, by the 
                        date that is 14 days after the date on 
                        which the license holder received the 
                        request for the covered product, and 
                        the eligible product developer did not 
                        accept such offer by the date that is 7 
                        days after the date on which the 
                        eligible product developer received 
                        such offer from the license holder; or
                          (ii) for a covered product that is 
                        subject to a REMS with ETASU, by the 
                        date that is 20 days after the date on 
                        which the license holder received the 
                        request for the covered product, and 
                        the eligible product developer did not 
                        accept such offer by the date that is 
                        10 days after the date on which the 
                        eligible product developer received 
                        such offer from the license holder.
          (4) Remedies.--
                  (A) In general.--If an eligible product 
                developer prevails in a civil action brought 
                under paragraph (1), the court shall--
                          (i) order the license holder to 
                        provide to the eligible product 
                        developer without delay sufficient 
                        quantities of the covered product on 
                        commercially reasonable, market-based 
                        terms;
                          (ii) award to the eligible product 
                        developer reasonable attorney's fees 
                        and costs of the civil action; and
                          (iii) award to the eligible product 
                        developer a monetary amount sufficient 
                        to deter the license holder from 
                        failing to provide eligible product 
                        developers with sufficient quantities 
                        of a covered product on commercially 
                        reasonable, market-based terms, if the 
                        court finds, by a preponderance of the 
                        evidence--
                                  (I) that the license holder 
                                delayed providing sufficient 
                                quantities of the covered 
                                product to the eligible product 
                                developer without a legitimate 
                                business justification; or
                                  (II) that the license holder 
                                failed to comply with an order 
                                issued under clause (i).
                  (B) Maximum monetary amount.--A monetary 
                amount awarded under subparagraph (A)(iii) 
                shall not be greater than the revenue that the 
                license holder earned on the covered product 
                during the period--
                          (i) beginning on--
                                  (I) for a covered product 
                                that is not subject to a REMS 
                                with ETASU, the date that is 31 
                                days after the date on which 
                                the license holder received the 
                                request; or
                                  (II) for a covered product 
                                that is subject to a REMS with 
                                ETASU, the date that is 31 days 
                                after the later of--
                                          (aa) the date on 
                                        which the license 
                                        holder received the 
                                        request; or
                                          (bb) the date on 
                                        which the license 
                                        holder received a copy 
                                        of the covered product 
                                        authorization issued by 
                                        the Secretary in 
                                        accordance with 
                                        paragraph (2)(B); and
                          (ii) ending on the date on which the 
                        eligible product developer received 
                        sufficient quantities of the covered 
                        product.
                  (C) Avoidance of delay.--The court may issue 
                an order under subparagraph (A)(i) before 
                conducting further proceedings that may be 
                necessary to determine whether the eligible 
                product developer is entitled to an award under 
                clause (ii) or (iii) of subparagraph (A), or 
                the amount of any such award.
  (c) Limitation of Liability.--A license holder for a covered 
product shall not be liable for any claim under Federal, State, 
or local law arising out of the failure of an eligible product 
developer to follow adequate safeguards to assure safe use of 
the covered product during development or testing activities 
described in this section, including transportation, handling, 
use, or disposal of the covered product by the eligible product 
developer.
  (d) No Violation of Rems.--Section 505-1 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355-1) is amended by adding 
at the end the following new subsection:
  ``(l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product to an eligible 
product developer (as those terms are defined in section 301(a) 
of the Lower Costs, More Cures Act of 2019) shall not be 
considered a violation of the requirements of any risk 
evaluation and mitigation strategy that may be in place under 
this section for such drug.''.
  (e) Rule of Construction.--
          (1) Definition.--In this subsection, the term 
        ``antitrust laws''--
                  (A) has the meaning given the term in 
                subsection (a) of the first section of the 
                Clayton Act (15 U.S.C. 12); and
                  (B) includes section 5 of the Federal Trade 
                Commission Act (15 U.S.C. 45) to the extent 
                that such section applies to unfair methods of 
                competition.
          (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of 
        the antitrust laws.

SEC. 302. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.

  Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1), as amended by section 301, is further amended--
          (1) in subsection (g)(4)(B)--
                  (A) in clause (i) by striking ``or'' after 
                the semicolon;
                  (B) in clause (ii) by striking the period at 
                the end and inserting ``; or''; and
                  (C) by adding at the end the following:
                          ``(iii) accommodate different, 
                        comparable aspects of the elements to 
                        assure safe use for a drug that is the 
                        subject of an application under section 
                        505(j), and the applicable listed 
                        drug.'';
          (2) in subsection (i)(1), by striking subparagraph 
        (C) and inserting the following:
                  ``(C)(i) Elements to assure safe use, if 
                required under subsection (f) for the listed 
                drug, which, subject to clause (ii), for a drug 
                that is the subject of an application under 
                section 505(j) may use--
                                  ``(I) a single, shared system 
                                with the listed drug under 
                                subsection (f); or
                                  ``(II) a different, 
                                comparable aspect of the 
                                elements to assure safe use 
                                under subsection (f).
                          ``(ii) The Secretary may require a 
                        drug that is the subject of an 
                        application under section 505(j) and 
                        the listed drug to use a single, shared 
                        system under subsection (f), if the 
                        Secretary determines that no different, 
                        comparable aspect of the elements to 
                        assure safe use could satisfy the 
                        requirements of subsection (f).'';
          (3) in subsection (i), by adding at the end the 
        following:
          ``(3) Shared rems.--If the Secretary approves, in 
        accordance with paragraph (1)(C)(i)(II), a different, 
        comparable aspect of the elements to assure safe use 
        under subsection (f) for a drug that is the subject of 
        an abbreviated new drug application under section 
        505(j), the Secretary may require that such different 
        comparable aspect of the elements to assure safe use 
        can be used with respect to any other drug that is the 
        subject of an application under section 505(j) or 
        505(b) that references the same listed drug.''; and
          (4) by adding at the end the following:
  ``(m) Separate Rems.--When used in this section, the terms 
`different, comparable aspect of the elements to assure safe 
use' or `different, comparable approved risk evaluation and 
mitigation strategies' means a risk evaluation and mitigation 
strategy for a drug that is the subject of an application under 
section 505(j) that uses different methods or operational means 
than the strategy required under subsection (a) for the 
applicable listed drug, or other application under section 
505(j) with the same such listed drug, but achieves the same 
level of safety as such strategy.''.

SEC. 303. RULE OF CONSTRUCTION.

  (a) In General.--Nothing in this subtitle, the amendments 
made by this subtitle, or in section 505-1 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355-1), shall be construed 
as--
          (1) prohibiting a license holder from providing an 
        eligible product developer access to a covered product 
        in the absence of an authorization under this subtitle; 
        or
          (2) in any way negating the applicability of a REMS 
        with ETASU, as otherwise required under such section 
        505-1, with respect to such covered product.
  (b) Definitions.--In this section, the terms ``covered 
product'', ``eligible product developer'', ``license holder'', 
and ``REMS with ETASU'' have the meanings given such terms in 
section 301(a).

                       Subtitle B--Pay-for-Delay


SEC. 311. UNLAWFUL AGREEMENTS.

  (a) Agreements Prohibited.--Subject to subsections (b) and 
(c), it shall be unlawful for an NDA or BLA holder and a 
subsequent filer (or for two subsequent filers) to enter into, 
or carry out, an agreement resolving or settling a covered 
patent infringement claim on a final or interim basis if under 
such agreement--
          (1) a subsequent filer directly or indirectly 
        receives from such holder (or in the case of such an 
        agreement between two subsequent filers, the other 
        subsequent filer) anything of value, including a 
        license; and
          (2) the subsequent filer agrees to limit or forego 
        research on, or development, manufacturing, marketing, 
        or sales, for any period of time, of the covered 
        product that is the subject of the application 
        described in subparagraph (A) or (B) of subsection 
        (g)(8).
  (b) Exclusion.--It shall not be unlawful under subsection (a) 
if a party to an agreement described in such subsection 
demonstrates by clear and convincing evidence that the value 
described in subsection (a)(1) is compensation solely for other 
goods or services that the subsequent filer has promised to 
provide.
  (c) Limitation.--Nothing in this section shall prohibit an 
agreement resolving or settling a covered patent infringement 
claim in which the consideration granted by the NDA or BLA 
holder to the subsequent filer (or from one subsequent filer to 
another) as part of the resolution or settlement includes only 
one or more of the following:
          (1) The right to market the covered product that is 
        the subject of the application described in 
        subparagraph (A) or (B) of subsection (g)(8) in the 
        United States before the expiration of--
                  (A) any patent that is the basis of the 
                covered patent infringement claim; or
                  (B) any patent right or other statutory 
                exclusivity that would prevent the marketing of 
                such covered product.
          (2) A payment for reasonable litigation expenses not 
        to exceed $7,500,000 in the aggregate.
          (3) A covenant not to sue on any claim that such 
        covered product infringes a patent.
  (d) Enforcement by Federal Trade Commission.--
          (1) General application.--The requirements of this 
        section apply, according to their terms, to an NDA or 
        BLA holder or subsequent filer that is--
                  (A) a person, partnership, or corporation 
                over which the Commission has authority 
                pursuant to section 5(a)(2) of the Federal 
                Trade Commission Act (15 U.S.C. 45(a)(2)); or
                  (B) a person, partnership, or corporation 
                over which the Commission would have authority 
                pursuant to such section but for the fact that 
                such person, partnership, or corporation is not 
                organized to carry on business for its own 
                profit or that of its members.
          (2) Unfair or deceptive acts or practices enforcement 
        authority.--
                  (A) In general.--A violation of this section 
                shall be treated as an unfair or deceptive act 
                or practice in violation of section 5(a)(1) of 
                the Federal Trade Commission Act (15 U.S.C. 
                45(a)(1)).
                  (B) Powers of commission.--Except as provided 
                in subparagraph (C) and paragraphs (1)(B) and 
                (3)--
                          (i) the Commission shall enforce this 
                        section in the same manner, by the same 
                        means, and with the same jurisdiction, 
                        powers, and duties as though all 
                        applicable terms and provisions of the 
                        Federal Trade Commission Act (15 U.S.C. 
                        41 et seq.) were incorporated into and 
                        made a part of this section; and
                          (ii) any NDA or BLA holder or 
                        subsequent filer that violates this 
                        section shall be subject to the 
                        penalties and entitled to the 
                        privileges and immunities provided in 
                        the Federal Trade Commission Act.
                  (C) Judicial review.--In the case of a cease 
                and desist order issued by the Commission under 
                section 5 of the Federal Trade Commission Act 
                (15 U.S.C. 45) for violation of this section, a 
                party to such order may obtain judicial review 
                of such order as provided in such section 5, 
                except that--
                          (i) such review may only be obtained 
                        in--
                                  (I) the United States Court 
                                of Appeals for the District of 
                                Columbia Circuit;
                                  (II) the United States Court 
                                of Appeals for the circuit in 
                                which the ultimate parent 
                                entity, as defined in section 
                                801.1(a)(3) of title 16, Code 
                                of Federal Regulations, or any 
                                successor thereto, of the NDA 
                                or BLA holder (if any such 
                                holder is a party to such 
                                order) is incorporated as of 
                                the date that the application 
                                described in subparagraph (A) 
                                or (B) of subsection (g)(8) or 
                                an approved application that is 
                                deemed to be a license for a 
                                biological product under 
                                section 351(k) of the Public 
                                Health Service Act (42 U.S.C. 
                                262(k)) pursuant to section 
                                7002(e)(4) of the Biologics 
                                Price Competition and 
                                Innovation Act of 2009 (Public 
                                Law 111-148; 124 Stat. 817) is 
                                submitted to the Commissioner 
                                of Food and Drugs; or
                                  (III) the United States Court 
                                of Appeals for the circuit in 
                                which the ultimate parent 
                                entity, as so defined, of any 
                                subsequent filer that is a 
                                party to such order is 
                                incorporated as of the date 
                                that the application described 
                                in subparagraph (A) or (B) of 
                                subsection (g)(8) is submitted 
                                to the Commissioner of Food and 
                                Drugs; and
                          (ii) the petition for review shall be 
                        filed in the court not later than 30 
                        days after such order is served on the 
                        party seeking review.
          (3) Additional enforcement authority.--
                  (A) Civil penalty.--The Commission may 
                commence a civil action to recover a civil 
                penalty in a district court of the United 
                States against any NDA or BLA holder or 
                subsequent filer that violates this section.
                  (B) Special rule for recovery of penalty if 
                cease and desist order issued.--
                          (i) In general.--If the Commission 
                        has issued a cease and desist order in 
                        a proceeding under section 5 of the 
                        Federal Trade Commission Act (15 U.S.C. 
                        45) for violation of this section--
                                  (I) the Commission may 
                                commence a civil action under 
                                subparagraph (A) to recover a 
                                civil penalty against any party 
                                to such order at any time 
                                before the expiration of the 1-
                                year period beginning on the 
                                date on which such order 
                                becomes final under section 
                                5(g) of such Act (15 U.S.C. 
                                45(g)); and
                                  (II) in such civil action, 
                                the findings of the Commission 
                                as to the material facts in 
                                such proceeding shall be 
                                conclusive, unless--
                                          (aa) the terms of 
                                        such order expressly 
                                        provide that the 
                                        Commission's findings 
                                        shall not be 
                                        conclusive; or
                                          (bb) such order 
                                        became final by reason 
                                        of section 5(g)(1) of 
                                        such Act (15 U.S.C. 
                                        45(g)(1)), in which 
                                        case such findings 
                                        shall be conclusive if 
                                        supported by evidence.
                          (ii) Relationship to penalty for 
                        violation of an order.--The penalty 
                        provided in clause (i) for violation of 
                        this section is separate from and in 
                        addition to any penalty that may be 
                        incurred for violation of an order of 
                        the Commission under section 5(l) of 
                        the Federal Trade Commission Act (15 
                        U.S.C. 45(l)).
                  (C) Amount of penalty.--
                          (i) In general.--The amount of a 
                        civil penalty imposed in a civil action 
                        under subparagraph (A) on a party to an 
                        agreement described in subsection (a) 
                        shall be sufficient to deter violations 
                        of this section, but in no event 
                        greater than--
                                  (I) if such party is the NDA 
                                or BLA holder (or, in the case 
                                of an agreement between two 
                                subsequent filers, the 
                                subsequent filer who gave the 
                                value described in subsection 
                                (a)(1)), the greater of--
                                          (aa) 3 times the 
                                        value received by such 
                                        NDA or BLA holder (or 
                                        by such subsequent 
                                        filer) that is 
                                        reasonably attributable 
                                        to the violation of 
                                        this section; or
                                          (bb) 3 times the 
                                        value given to the 
                                        subsequent filer (or to 
                                        the other subsequent 
                                        filer) reasonably 
                                        attributable to the 
                                        violation of this 
                                        section; and
                                  (II) if such party is the 
                                subsequent filer (or, in the 
                                case of an agreement between 
                                two subsequent filers, the 
                                subsequent filer who received 
                                the value described in 
                                subsection (a)(1)), 3 times the 
                                value received by such 
                                subsequent filer that is 
                                reasonably attributable to the 
                                violation of this section.
                          (ii) Factors for consideration.--In 
                        determining such amount, the court 
                        shall take into account--
                                  (I) the nature, 
                                circumstances, extent, and 
                                gravity of the violation;
                                  (II) with respect to the 
                                violator, the degree of 
                                culpability, any history of 
                                violations, the ability to pay, 
                                any effect on the ability to 
                                continue doing business, 
                                profits earned by the NDA or 
                                BLA holder (or, in the case of 
                                an agreement between two 
                                subsequent filers, the 
                                subsequent filer who gave the 
                                value described in subsection 
                                (a)(1)), compensation received 
                                by the subsequent filer (or, in 
                                the case of an agreement 
                                between two subsequent filers, 
                                the subsequent filer who 
                                received the value described in 
                                subsection (a)(1)), and the 
                                amount of commerce affected; 
                                and
                                  (III) other matters that 
                                justice requires.
                  (D) Injunctions and other equitable relief.--
                In a civil action under subparagraph (A), the 
                United States district courts are empowered to 
                grant mandatory injunctions and such other and 
                further equitable relief as they deem 
                appropriate.
          (4) Remedies in addition.--Remedies provided in this 
        subsection are in addition to, and not in lieu of, any 
        other remedy provided by Federal law.
          (5) Preservation of authority of commission.--Nothing 
        in this section shall be construed to affect any 
        authority of the Commission under any other provision 
        of law.
  (e) Federal Trade Commission Rulemaking.--The Commission may, 
in its discretion, by rule promulgated under section 553 of 
title 5, United States Code, exempt from this section certain 
agreements described in subsection (a) if the Commission finds 
such agreements to be in furtherance of market competition and 
for the benefit of consumers.
  (f) Antitrust Laws.--Nothing in this section shall modify, 
impair, limit, or supersede the applicability of the antitrust 
laws as defined in subsection (a) of the first section of the 
Clayton Act (15 U.S.C. 12(a)), and of section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the extent that such 
section 5 applies to unfair methods of competition. Nothing in 
this section shall modify, impair, limit, or supersede the 
right of a subsequent filer to assert claims or counterclaims 
against any person, under the antitrust laws or other laws 
relating to unfair competition.
  (g) Definitions.--In this section:
          (1) Agreement resolving or settling a covered patent 
        infringement claim.--The term ``agreement resolving or 
        settling a covered patent infringement claim'' means 
        any agreement that--
                  (A) resolves or settles a covered patent 
                infringement claim; or
                  (B) is contingent upon, provides for a 
                contingent condition for, or is otherwise 
                related to the resolution or settlement of a 
                covered patent infringement claim.
          (2) Commission.--The term ``Commission'' means the 
        Federal Trade Commission.
          (3) Covered patent infringement claim.--The term 
        ``covered patent infringement claim'' means an 
        allegation made by the NDA or BLA holder to a 
        subsequent filer (or, in the case of an agreement 
        between two subsequent filers, by one subsequent filer 
        to another), whether or not included in a complaint 
        filed with a court of law, that--
                  (A) the submission of the application 
                described in subparagraph (A) or (B) of 
                paragraph (9), or the manufacture, use, 
                offering for sale, sale, or importation into 
                the United States of a covered product that is 
                the subject of such an application--
                          (i) in the case of an agreement 
                        between an NDA or BLA holder and a 
                        subsequent filer, infringes any patent 
                        owned by, or exclusively licensed to, 
                        the NDA or BLA holder of the covered 
                        product; or
                          (ii) in the case of an agreement 
                        between two subsequent filers, 
                        infringes any patent owned by the 
                        subsequent filer; or
                  (B) in the case of an agreement between an 
                NDA or BLA holder and a subsequent filer, the 
                covered product to be manufactured under such 
                application uses a covered product as claimed 
                in a published patent application.
          (4) Covered product.--The term ``covered product'' 
        means a drug (as defined in section 201(g) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(g))), including a biological product (as defined in 
        section 351(i) of the Public Health Service Act (42 
        U.S.C. 262(i)).
          (5) NDA or bla holder.--The term ``NDA or BLA 
        holder'' means--
                  (A) the holder of--
                          (i) an approved new drug application 
                        filed under section 505(b)(1) of the 
                        Federal Food, Drug, and Cosmetic Act 
                        (21 U.S.C. 355(b)(1)) for a covered 
                        product; or
                          (ii) a biologics license application 
                        filed under section 351(a) of the 
                        Public Health Service Act (42 U.S.C. 
                        262(a)) with respect to a biological 
                        product;
                  (B) a person owning or controlling 
                enforcement of the patent on--
                          (i) the list published under section 
                        505(j)(7) of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 355(j)(7)) 
                        in connection with the application 
                        described in subparagraph (A)(i); or
                          (ii) any list published under section 
                        351 of the Public Health Service Act 
                        (42 U.S.C. 262) comprised of patents 
                        associated with biologics license 
                        applications filed under section 351(a) 
                        of such Act (42 U.S.C. 262(a)); or
                  (C) the predecessors, subsidiaries, 
                divisions, groups, and affiliates controlled 
                by, controlling, or under common control with 
                any entity described in subparagraph (A) or (B) 
                (such control to be presumed by direct or 
                indirect share ownership of 50 percent or 
                greater), as well as the licensees, licensors, 
                successors, and assigns of each of the 
                entities.
          (6) Patent.--The term ``patent'' means a patent 
        issued by the United States Patent and Trademark 
        Office.
          (7) Statutory exclusivity.--The term ``statutory 
        exclusivity'' means those prohibitions on the 
        submission or approval of drug applications under 
        clauses (ii) through (iv) of section 505(c)(3)(E) (5- 
        and 3-year exclusivity), clauses (ii) through (iv) of 
        section 505(j)(5)(F) (5-year and 3-year exclusivity), 
        section 505(j)(5)(B)(iv) (180-day exclusivity), section 
        527 (orphan drug exclusivity), section 505A (pediatric 
        exclusivity), or section 505E (qualified infectious 
        disease product exclusivity) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 
        355(j)(5)(B)(iv), 355(j)(5)(F), 360cc, 355a, 355f), or 
        prohibitions on the submission or licensing of 
        biologics license applications under section 351(k)(6) 
        (interchangeable biological product exclusivity) or 
        section 351(k)(7) (biological product reference product 
        exclusivity) of the Public Health Service Act (42 
        U.S.C. 262(k)(6), (7)).
          (8) Subsequent filer.--The term ``subsequent filer'' 
        means--
                  (A) in the case of a drug, a party that owns 
                or controls an abbreviated new drug application 
                submitted pursuant to section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)) or a new drug application submitted 
                pursuant to section 505(b)(2) of the Federal 
                Food, Drug, and Cosmetic Act (21U.S.C. 
                355(b)(2)) and filed under section 505(b)(1) of 
                such Act (21 U.S.C. 355(b)(1)) or has the 
                exclusive rights to distribute the covered 
                product that is the subject of such 
                application; or
                  (B) in the case of a biological product, a 
                party that owns or controls an application 
                filed with the Food and Drug Administration 
                under section 351(k) of the Public Health 
                Service Act (42 U.S.C. 262(k)) or has the 
                exclusive rights to distribute the biological 
                product that is the subject of such 
                application.
  (h) Effective Date.--This section applies with respect to 
agreements described in subsection (a) entered into on or after 
the date of the enactment of this Act.

SEC. 312. NOTICE AND CERTIFICATION OF AGREEMENTS.

  (a) Notice of All Agreements.--Section 1111(7) of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 (21 U.S.C. 355 note) is amended by inserting ``or the 
owner of a patent for which a claim of infringement could 
reasonably be asserted against any person for making, using, 
offering to sell, selling, or importing into the United States 
a biological product that is the subject of a biosimilar 
biological product application'' before the period at the end.
  (b) Certification of Agreements.--Section 1112 of such Act 
(21 U.S.C. 355 note) is amended by adding at the end the 
following:
  ``(d) Certification.--The Chief Executive Officer or the 
company official responsible for negotiating any agreement 
under subsection (a) or (b) that is required to be filed under 
subsection (c) shall, within 30 days of such filing, execute 
and file with the Assistant Attorney General and the Commission 
a certification as follows: `I declare that the following is 
true, correct, and complete to the best of my knowledge: The 
materials filed with the Federal Trade Commission and the 
Department of Justice under section 1112 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, 
with respect to the agreement referenced in this 
certification--
          ```(1) represent the complete, final, and exclusive 
        agreement between the parties;
          ```(2) include any ancillary agreements that are 
        contingent upon, provide a contingent condition for, 
        were entered into within 30 days of, or are otherwise 
        related to, the referenced agreement; and
          ```(3) include written descriptions of any oral 
        agreements, representations, commitments, or promises 
        between the parties that are responsive to subsection 
        (a) or (b) of such section 1112 and have not been 
        reduced to writing.'.''.

SEC. 313. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

  Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by 
inserting ``section 311 of the Lower Costs, More Cures Act of 
2019 or'' after ``that the agreement has violated''.

SEC. 314. COMMISSION LITIGATION AUTHORITY.

  Section 16(a)(2) of the Federal Trade Commission Act (15 
U.S.C. 56(a)(2)) is amended--
          (1) in subparagraph (D), by striking ``or'' after the 
        semicolon;
          (2) in subparagraph (E), by inserting ``or'' after 
        the semicolon; and
          (3) by inserting after subparagraph (E) the 
        following:
                  ``(F) under section 311(d)(3)(A) of the Lower 
                Costs, More Cures Act of 2019;''.

SEC. 315. STATUTE OF LIMITATIONS.

  (a) In General.--Except as provided in subsection (b), the 
Commission shall commence any administrative proceeding or 
civil action to enforce section 311 of this Act not later than 
6 years after the date on which the parties to the agreement 
file the Notice of Agreement as provided by section 1112(c)(2) 
and (d) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note).
  (b) Civil Action After Issuance of Cease and Desist Order.--
If the Commission has issued a cease and desist order under 
section 5 of the Federal Trade Commission Act (15 U.S.C. 45) 
for violation of section 311 of this Act and the proceeding for 
the issuance of such order was commenced within the period 
required by subsection (a) of this section, such subsection 
does not prohibit the commencement, after such period, of a 
civil action under section 311(d)(3)(A) against a party to such 
order or a civil action under subsection (l) of such section 5 
for violation of such order.

                        Subtitle C--BLOCKING Act


SEC. 321. CHANGE CONDITIONS OF FIRST GENERIC EXCLUSIVITY TO SPUR ACCESS 
                    AND COMPETITION.

  (a) In General.--Section 505(j)(5)(B)(iv) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is 
amended--
          (1) in subclause (I), by striking ``180 days after'' 
        and all that follows through the period at the end and 
        inserting the following: ``180 days after the earlier 
        of--
                                  ``(aa) the date of the first 
                                commercial marketing of the 
                                drug (including the commercial 
                                marketing of the listed drug) 
                                by any first applicant; or
                                  ``(bb) the applicable date 
                                specified in subclause 
                                (III).''; and
          (2) by adding at the end the following new subclause:
                          ``(III) Applicable date.--The 
                        applicable date specified in this 
                        subclause, with respect to an 
                        application for a drug described in 
                        subclause (I), is the date on which 
                        each of the following conditions is 
                        first met:
                                  ``(aa) The approval of such 
                                an application could be made 
                                effective, but for the 
                                eligibility of a first 
                                applicant for 180-day 
                                exclusivity under this clause.
                                  ``(bb) At least 30 months 
                                have passed since the date of 
                                submission of an application 
                                for the drug by at least one 
                                first applicant.
                                  ``(cc) Approval of an 
                                application for the drug 
                                submitted by at least one first 
                                applicant is not precluded 
                                under clause (iii).
                                  ``(dd) No application for the 
                                drug submitted by any first 
                                applicant is approved at the 
                                time the conditions under items 
                                (aa), (bb), and (cc) are all 
                                met, regardless of whether such 
                                an application is subsequently 
                                approved.''.
  (b) Information.--The Secretary of Health and Human Services 
shall--
          (1) not later than 120 days after the date of 
        enactment of this Act, publish, as appropriate and 
        available, information sufficient to allow applicants 
        to assess whether the conditions described in section 
        505(j)(5)(B)(iv)(III) of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsection (a)) are satisfied 
        for all applications where the exclusivity period under 
        clause (iv)(I) of section 505(j)(5)(B) of the Federal 
        Food, Drug, and Cosmetic Act (as amended by such 
        subsection) has not expired; and
          (2) publish updates to such information to reflect 
        the most recent information available to the Secretary.

                        Subtitle D--Purple Book


SEC. 331. PUBLIC LISTING.

  Section 351(k) of the Public Health Service Act (42 U.S.C. 
262(k)) is amended by adding at the end the following:
          ``(9) Public listing.--
                  ``(A) In general.--
                          ``(i) Initial publication.--Not later 
                        than 180 days after the date of 
                        enactment of the Lower Costs, More 
                        Cures Act of 2019, the Secretary shall 
                        publish and make available to the 
                        public in a searchable, electronic 
                        format--
                                  ``(I) a list in alphabetical 
                                order of the nonproprietary or 
                                proper name of each biological 
                                product for which a biologics 
                                license under subsection (a) or 
                                this subsection is in effect, 
                                or that has been deemed to be 
                                licensed under this section 
                                pursuant to section 7002(e)(4) 
                                of the Biologics Price 
                                Competition and Innovation Act 
                                of 2009, as of such date of 
                                enactment;
                                  ``(II) the date of approval 
                                of the marketing application 
                                and the application number; and
                                  ``(III) the marketing or 
                                licensure status of the 
                                biological product for which a 
                                biologics license under 
                                subsection (a) or this 
                                subsection is in effect or that 
                                has been deemed to be licensed 
                                under this section pursuant to 
                                section 7002(e)(4) of the 
                                Biologics Price Competition and 
                                Innovation Act of 2009.
                          ``(ii) Revisions.--Every 30 days 
                        after the publication of the first list 
                        under clause (i), the Secretary shall 
                        revise the list to include each 
                        biological product which has been 
                        licensed under subsection (a) or this 
                        subsection during the 30-day period.
                          ``(iii) Patent information.--Not 
                        later than 30 days after a list of 
                        patents under subsection (l)(3)(A), or 
                        a supplement to such list under 
                        subsection (l)(7), has been provided by 
                        the reference product sponsor to the 
                        subsection (k) applicant respecting a 
                        biological product included on the list 
                        published under this subparagraph, the 
                        reference product sponsor shall provide 
                        such list of patents (or supplement 
                        thereto) and their corresponding expiry 
                        dates to the Secretary, and the 
                        Secretary shall, in revisions made 
                        under clause (ii), include such 
                        information for such biological 
                        product. Within 30 days of providing 
                        any subsequent or supplemental list of 
                        patents to any subsequent subsection 
                        (k) applicant under subsection 
                        (l)(3)(A) or (l)(7), the reference 
                        product sponsor shall update the 
                        information provided to the Secretary 
                        under this clause with any additional 
                        patents from such subsequent or 
                        supplemental list and their 
                        corresponding expiry dates.
                          ``(iv) Listing of exclusivities.--For 
                        each biological product included on the 
                        list published under this subparagraph, 
                        the Secretary shall specify each 
                        exclusivity period that is applicable 
                        and has not concluded under paragraph 
                        (6) or paragraph (7).
                  ``(B) Withdrawal or suspension of 
                licensure.--If the licensing of a biological 
                product was withdrawn or suspended for safety, 
                purity, or potency reasons, it may not be 
                published in the list under subparagraph (A). 
                If the withdrawal or suspension occurred after 
                its publication in such list, the reference 
                product sponsor shall notify the Secretary 
                that--
                          ``(i) the biological product shall be 
                        immediately removed from such list--
                                  ``(I) for the same period as 
                                the withdrawal or suspension; 
                                or
                                  ``(II) if the biological 
                                product has been withdrawn from 
                                sale, for the period of 
                                withdrawal from sale or, if 
                                earlier, the period ending on 
                                the date the Secretary 
                                determines that the withdrawal 
                                from sale is not for safety, 
                                purity, or potency reasons; and
                          ``(ii) a notice of the removal shall 
                        be published in the Federal 
                        Register.''.

SEC. 332. REVIEW AND REPORT ON TYPES OF INFORMATION TO BE LISTED.

  Not later than 3 years after the date of enactment of this 
Act, the Secretary of Health and Human Services shall--
          (1) solicit public comment regarding the type of 
        information, if any, that should be added to or removed 
        from the list required by paragraph (9) of section 
        351(k) of the Public Health Service Act (42 U.S.C. 
        262(k)), as added by section 331; and
          (2) transmit to Congress an evaluation of such 
        comments, including any recommendations about the types 
        of information that should be added to or removed from 
        the list.

                        Subtitle E--Orange Book


SEC. 341. ORANGE BOOK.

  (a) Submission of Patent Information for Brand Name Drugs.--
Paragraph (1) of section 505(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)) is amended to read as follows:
  ``(b)(1) Any person may file with the Secretary an 
application with respect to any drug subject to the provisions 
of subsection (a). Such persons shall submit to the Secretary 
as part of the application--
          ``(A) full reports of investigations which have been 
        made to show whether or not such drug is safe for use 
        and whether such drug is effective in use;
          ``(B) a full list of the articles used as components 
        of such drug;
          ``(C) a full statement of the composition of such 
        drug;
          ``(D) a full description of the methods used in, and 
        the facilities and controls used for, the manufacture, 
        processing, and packing of such drug;
          ``(E) such samples of such drug and of the articles 
        used as components thereof as the Secretary may 
        require;
          ``(F) specimens of the labeling proposed to be used 
        for such drug;
          ``(G) any assessments required under section 505B; 
        and
          ``(H) patent information, with respect to each patent 
        for which a claim of patent infringement could 
        reasonably be asserted if a person not licensed by the 
        owner engaged in the manufacture, use, or sale of the 
        drug, and consistent with the following requirements:
                  ``(i) The applicant shall file with the 
                application the patent number and the 
                expiration date of--
                          ``(I) any patent which claims the 
                        drug for which the applicant submitted 
                        the application and is a drug substance 
                        (including active ingredient) patent or 
                        a drug product (including formulation 
                        and composition) patent; and
                          ``(II) any patent which claims the 
                        method of using such drug.
                  ``(ii) If an application is filed under this 
                subsection for a drug and a patent of the type 
                described in clause (i) which claims such drug 
                or a method of using such drug is issued after 
                the filing date but before approval of the 
                application, the applicant shall amend the 
                application to include such patent information.
Upon approval of the application, the Secretary shall publish 
the information submitted under subparagraph (H). The Secretary 
shall, in consultation with the Director of the National 
Institutes of Health and with representatives of the drug 
manufacturing industry, review and develop guidance, as 
appropriate, on the inclusion of women and minorities in 
clinical trials required by subparagraph (A).''.
  (b) Conforming Changes to Requirements for Subsequent 
Submission of Patent Information.--Section 505(c)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is 
amended--
          (1) by inserting after ``the patent number and the 
        expiration date of any patent which'' the following: 
        ``fulfills the criteria in subsection (b) and'';
          (2) by inserting after the first sentence the 
        following: ``Patent information that is not the type of 
        patent information required by subsection (b) shall not 
        be submitted.''; and
          (3) by inserting after ``could not file patent 
        information under subsection (b) because no patent'' 
        the following: ``of the type required to be submitted 
        in subsection (b)''.
  (c) Listing of Exclusivities.--Subparagraph (A) of section 
505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(7)) is amended by adding at the end the 
following:
  ``(iv) For each drug included on the list, the Secretary 
shall specify each exclusivity period that is applicable and 
has not concluded under--
          ``(I) clause (ii), (iii), or (iv) of subsection 
        (c)(3)(E) of this section;
          ``(II) clause (iv) or (v) of paragraph (5)(B) of this 
        subsection;
          ``(III) clause (ii), (iii), or (iv) of paragraph 
        (5)(F) of this subsection;
          ``(IV) section 505A;
          ``(V) section 505E; or
          ``(VI) section 527(a).''.
  (d) Removal of Invalid Patents.--
          (1) In general.--Section 505(j)(7) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is 
        amended by adding at the end the following:
  ``(D)(i) The holder of an application approved under 
subsection (c) for a drug on the list shall notify within 14 
days the Secretary in writing if either of the following 
occurs:
          ``(I) The Patent Trial and Appeals Board issues a 
        decision from which no appeal has been or can be taken 
        that a patent for such drug is invalid.
          ``(II) A court issues a decision from which no appeal 
        has been or can be taken that a patent for such drug is 
        invalid.
  ``(ii) The holder of an approved application shall include in 
any notification under clause (i) a copy of the decision 
described in subclause (I) or (II) of clause (i).
  ``(iii) The Secretary shall remove from the list any patent 
that is determined to be invalid in a decision described in 
subclause (I) or (II) of clause (i)--
          ``(I) promptly; but
          ``(II) not before the expiration of any 180-day 
        exclusivity period under paragraph (5)(B)(iv) that 
        relies on a certification described in paragraph 
        (2)(A)(vii)(IV) that such patent was invalid.''.
          (2) Applicability.--Subparagraph (D) of section 
        505(j)(7) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)(7)), as added by paragraph (1), 
        applies only with respect to a decision described in 
        such subparagraph that is issued on or after the date 
        of enactment of this Act.
  (e) Review and Report.--Not later than one year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall--
          (1) solicit public comment regarding the types of 
        patent information that should be included on the list 
        under section 507(j)(7) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)(7)); and
          (2) transmit to the Congress an evaluation of such 
        comments, including any recommendations about the types 
        of patent information that should be included on or 
        removed from such list.

SEC. 342. GAO REPORT TO CONGRESS.

  (a) In General.--Not later than one year after the date of 
enactment of this Act, the Comptroller General of the United 
States (referred to in this section as the ``Comptroller 
General'') shall submit to the Committee on Energy and Commerce 
of the House of Representatives a report on the patents 
included in the list published under section 505(j)(7) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)), 
including an analysis and evaluation of the types of patents 
included in such list and the claims such patents make about 
the products they claim.
  (b) Contents.--The Comptroller General shall include in the 
report under subsection (a)--
          (1) data on the number of--
                  (A) patents included in the list published 
                under paragraph (7) of section 505(j) of the 
                Federal Food, Drug and Cosmetic Act (21 U.S.C. 
                355(j)), that claim the active ingredient or 
                formulation of a drug in combination with a 
                device that is used for delivery of the drug, 
                together comprising the finished dosage form of 
                the drug; and
                  (B) claims in each patent that claim a device 
                that is used for the delivery of the drug, but 
                do not claim such device in combination with an 
                active ingredient or formulation of a drug;
          (2) data on the date of inclusion in the list under 
        paragraph (7) of such section 505(j) for all patents 
        under such list, as compared to patents that claim a 
        method of using the drug in combination with a device;
          (3) an analysis regarding the impact of including on 
        the list under paragraph (7) of such section 505(j) 
        certain types of patent information for drug product 
        applicants and approved application holders, including 
        an analysis of whether--
                  (A) the listing of the patents described in 
                paragraph (1)(A) delayed the market entry of 
                one or more drugs approved under such section 
                505(j); and
                  (B) not listing the patents described in 
                paragraph (1)(A) would delay the market entry 
                of one or more such drugs; and
          (4) recommendations about which kinds of patents 
        relating to devices described in paragraph (1)(A) 
        should be submitted to the Secretary of Health and 
        Human Services for inclusion on the list under 
        paragraph (7) of such section 505(j) and which patents 
        should not be required to be so submitted.

             Subtitle F--Advancing Education on Biosimilars


SEC. 351. EDUCATION ON BIOLOGICAL PRODUCTS.

  (a) Website; Continuing Education.--Subpart 1 of part F of 
title III of the Public Health Service Act (42 U.S.C. 262 et 
seq.) is amended by adding at the end the following:

``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.

  ``(a) Internet Website.--
          ``(1) In general.--The Secretary shall maintain and 
        operate an internet website to provide educational 
        materials for health care providers, patients, and 
        caregivers, regarding the meaning of the terms, and the 
        standards for review and licensing of, biological 
        products, including biosimilar biological products and 
        interchangeable biosimilar biological products.
          ``(2) Content.--Educational materials provided under 
        paragraph (1) may include--
                  ``(A) explanations of key statutory and 
                regulatory terms, including `biosimilar' and 
                `interchangeable', and clarification regarding 
                the use of interchangeable biosimilar 
                biological products;
                  ``(B) information related to development 
                programs for biological products, including 
                biosimilar biological products and 
                interchangeable biosimilar biological products 
                and relevant clinical considerations for 
                prescribers, which may include, as appropriate 
                and applicable, information related to the 
                comparability of such biological products;
                  ``(C) an explanation of the process for 
                reporting adverse events for biological 
                products, including biosimilar biological 
                products and interchangeable biosimilar 
                biological products; and
                  ``(D) an explanation of the relationship 
                between biosimilar biological products and 
                interchangeable biosimilar biological products 
                licensed under section 351(k) and reference 
                products (as defined in section 351(i)), 
                including the standards for review and 
                licensing of each such type of biological 
                product.
          ``(3) Format.--The educational materials provided 
        under paragraph (1) may be--
                  ``(A) in formats such as webinars, continuing 
                medical education modules, videos, fact sheets, 
                infographics, stakeholder toolkits, or other 
                formats as appropriate and applicable; and
                  ``(B) tailored for the unique needs of health 
                care providers, patients, caregivers, and other 
                audiences, as the Secretary determines 
                appropriate.
          ``(4) Other information.--In addition to the 
        information described in paragraph (2), the Secretary 
        shall continue to publish the following information:
                  ``(A) The action package of each biological 
                product licensed under subsection (a) or (k).
                  ``(B) The summary review of each biological 
                product licensed under subsection (a) or (k).
          ``(5) Confidential and trade secret information.--
        This subsection does not authorize the disclosure of 
        any trade secret, confidential commercial or financial 
        information, or other matter described in section 
        552(b) of title 5.
  ``(b) Continuing Education.--The Secretary shall advance 
education and awareness among health care providers regarding 
biological products, including biosimilar biological products 
and interchangeable biosimilar biological products, as 
appropriate, including by developing or improving continuing 
education programs that advance the education of such providers 
on the prescribing of, and relevant clinical considerations 
with respect to, biological products, including biosimilar 
biological products and interchangeable biosimilar biological 
products.''.
  (b) Application Under the Medicare Merit-Based Incentive 
Payment System.--Section 1848(q)(5)(C) of the Social Security 
Act (42 U.S.C. 1395w-4(q)(5)(C)) is amended by adding at the 
end the following new clause:
                          ``(iv) Clinical medical education 
                        program on biosimilar biological 
                        products.--Completion of a clinical 
                        medical education program developed or 
                        improved under section 352A(b) of the 
                        Public Health Service Act by a MIPS 
                        eligible professional during a 
                        performance period shall earn such 
                        eligible professional one-half of the 
                        highest potential score for the 
                        performance category described in 
                        paragraph (2)(A)(iii) for such 
                        performance period. A MIPS eligible 
                        professional may only count the 
                        completion of such a program for 
                        purposes of such category one time 
                        during the eligible professional's 
                        lifetime.''.

       Subtitle G--Streamlining Transition of Biological Products


SEC. 361. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.

  Section 7002(e)(4) of the Biologics Price Competition and 
Innovation Act of 2009 (Public Law 111-148) is amended--
          (1) by striking ``An approved application'' and 
        inserting the following:
                  ``(A) In general.--An approved application'';
          (2) by adding at the end the following:
                  ``(B) Treatment of certain applications.--
                          ``(i) In general.--With respect to an 
                        application for a biological product 
                        submitted under subsection (b) or (j) 
                        of section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355) 
                        that is filed not later than March 23, 
                        2019, the Secretary shall continue to 
                        review such application under such 
                        section 505, even if such review 
                        continues after March 23, 2020.
                          ``(ii) Effect on listed drugs.--Only 
                        for purposes of carrying out clause 
                        (i), with respect to any applicable 
                        listed drug with respect to such 
                        application, the following shall apply:
                                  ``(I) Any drug that is a 
                                biological product that has 
                                been deemed licensed under 
                                section 351 of the Public 
                                Health Service Act (42 U.S.C. 
                                262) pursuant to subparagraph 
                                (A) and that is referenced in 
                                an application described in 
                                clause (i), shall continue to 
                                be identified as a listed drug 
                                on the list published pursuant 
                                to section 505(j)(7) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act, and the 
                                information for such drug on 
                                such list shall not be revised 
                                after March 20, 2020, until--
                                          ``(aa) such drug is 
                                        removed from such list 
                                        in accordance with 
                                        subclause (III) or 
                                        subparagraph (C) of 
                                        such section 505(j)(7); 
                                        or
                                          ``(bb) this 
                                        subparagraph no longer 
                                        has force or effect.
                                  ``(II) Any drug that is a 
                                biological product that has 
                                been deemed licensed under 
                                section 351 of the Public 
                                Health Service Act (42 U.S.C. 
                                262) pursuant to subparagraph 
                                (A) and that is referenced in 
                                an application described in 
                                clause (i) shall be subject 
                                only to requirements applicable 
                                to biological products licensed 
                                under such section.
                                  ``(III) Upon approval under 
                                subsection (c) or (j) of 
                                section 505 of the Federal 
                                Food, Drug, and Cosmetic Act of 
                                an application described in 
                                clause (i), the Secretary shall 
                                remove from the list published 
                                pursuant to section 505(j)(7) 
                                of the Federal Food, Drug, and 
                                Cosmetic Act any listed drug 
                                that is a biological product 
                                that has been deemed licensed 
                                under section 351 of the Public 
                                Health Service Act pursuant to 
                                subparagraph (A) and that is 
                                referenced in such approved 
                                application, unless such listed 
                                drug is referenced in one or 
                                more additional applications 
                                described in clause (i).
                          ``(iii) Deemed licensure.--Upon 
                        approval of an application described in 
                        clause (i), such approved application 
                        shall be deemed to be a license for the 
                        biological product under section 351 of 
                        the Public Health Service Act, pursuant 
                        to subparagraph (A), and any period of 
                        exclusivity, as applicable, shall be 
                        determined in accordance with such 
                        section.
                          ``(iv) Rule of construction.--
                                  ``(I) Application of certain 
                                provisions.--
                                          ``(aa) Patent 
                                        certification or 
                                        statement.--An 
                                        application described 
                                        in clause (i) shall 
                                        contain a patent 
                                        certification or 
                                        statement described in, 
                                        as applicable, section 
                                        505(b)(2) of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act or clauses 
                                        (vii) and (viii) of 
                                        section 505(j)(2)(A) of 
                                        such Act and, with 
                                        respect to any listed 
                                        drug referenced in such 
                                        application, comply 
                                        with related 
                                        requirements concerning 
                                        any timely filed patent 
                                        information listed 
                                        pursuant to section 
                                        505(j)(7).
                                          ``(bb) Date of 
                                        approval.--The earliest 
                                        possible date on which 
                                        any pending application 
                                        described in clause (i) 
                                        may be approved shall 
                                        be determined based 
                                        on--
                                          ``(AA) the last 
                                        expiration date of any 
                                        applicable period of 
                                        exclusivity that would 
                                        prevent such approval 
                                        and that is described 
                                        in section 
                                        505(c)(3)(E), 
                                        505(j)(5)(B)(iv), 
                                        505(j)(5)(F), 505A, 
                                        505E, or 527 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act; and
                                          ``(BB) if the 
                                        application was 
                                        submitted under section 
                                        505(b)(2) of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act and 
                                        references any listed 
                                        drug, the last 
                                        applicable date 
                                        determined under 
                                        subparagraph (A), (B), 
                                        or (C) of section 
                                        505(c)(3) of such Act, 
                                        or, if the application 
                                        was submitted under 
                                        section 505(j) of such 
                                        Act, the last 
                                        applicable date 
                                        determined under clause 
                                        (i), (ii), or (iii) of 
                                        section 505(j)(5)(B).
                                          ``(II) Rule of 
                                        construction with 
                                        respect to 
                                        exclusivity.--Nothing 
                                        in this subparagraph 
                                        shall be construed to 
                                        affect section 
                                        351(k)(7)(D) of the 
                                        Public Health Service 
                                        Act.
                          ``(v) Authorized disclosure.--The 
                        Secretary may continue to review an 
                        application after March 23, 2020, 
                        pursuant to clause (i), and continue to 
                        identify any applicable listed drug 
                        pursuant to clause (ii) on the list 
                        published pursuant to section 505(j)(7) 
                        of the Federal Food, Drug, and Cosmetic 
                        Act, even if such review or listing may 
                        reveal the existence of such 
                        application and the identity of any 
                        listed drug for which the 
                        investigations described in section 
                        505(b)(1)(A) of the Federal Food, Drug, 
                        and Cosmetic Act are relied upon by the 
                        applicant for approval of the pending 
                        application. Nothing in this 
                        subparagraph shall be construed as 
                        authorizing the Secretary to disclose 
                        any other information that is a trade 
                        secret or confidential information 
                        described in section 552(b)(4) of title 
                        5, United States Code.
                          ``(vi) Sunset.--Beginning on October 
                        1, 2022, this subparagraph shall have 
                        no force or effect and any applications 
                        described in clause (i) that have not 
                        been approved shall be deemed 
                        withdrawn.''.

 Subtitle H--Over-the-Counter Monograph Safety, Innovation, and Reform


SEC. 370. SHORT TITLE; REFERENCES IN SUBTITLE.

  (a) Short Title.--This subtitle may be cited as the ``Over-
the-Counter Monograph Safety, Innovation, and Reform Act of 
2019''.
  (b) References.--Except as otherwise specified, any reference 
to ``this Act'' contained in this subtitle shall be treated as 
referring only to the provisions of this subtitle.

                        PART 1--OTC DRUG REVIEW

SEC. 371. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED 
                    WITHOUT AN APPROVED DRUG APPLICATION.

  (a) In General.--Chapter V of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 505F of such 
Act (21 U.S.C. 355g) the following:

``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE 
                    MARKETED WITHOUT AN APPROVED DRUG APPLICATION.

  ``(a) Nonprescription Drugs Marketed Without an Approved 
Application.--Nonprescription drugs marketed without an 
approved drug application under section 505, as of the date of 
the enactment of this section, shall be treated in accordance 
with this subsection.
          ``(1) Drugs subject to a final monograph; category i 
        drugs subject to a tentative final monograph.--A drug 
        is deemed to be generally recognized as safe and 
        effective under section 201(p)(1), not a new drug under 
        section 201(p), and not subject to section 503(b)(1), 
        if--
                  ``(A) the drug is--
                          ``(i) in conformity with the 
                        requirements for nonprescription use of 
                        a final monograph issued under part 330 
                        of title 21, Code of Federal 
                        Regulations (except as provided in 
                        paragraph (2)), the general 
                        requirements for nonprescription drugs, 
                        and conditions or requirements under 
                        subsections (b), (c), and (k); and
                          ``(ii) except as permitted by an 
                        order issued under subsection (b) or, 
                        in the case of a minor change in the 
                        drug, in conformity with an order 
                        issued under subsection (c), in a 
                        dosage form that, immediately prior to 
                        the date of the enactment of this 
                        section, has been used to a material 
                        extent and for a material time under 
                        section 201(p)(2); or
                  ``(B) the drug is--
                          ``(i) classified in category I for 
                        safety and effectiveness under a 
                        tentative final monograph that is the 
                        most recently applicable proposal or 
                        determination issued under part 330 of 
                        title 21, Code of Federal Regulations;
                          ``(ii) in conformity with the 
                        proposed requirements for 
                        nonprescription use of such tentative 
                        final monograph, any applicable 
                        subsequent determination by the 
                        Secretary, the general requirements for 
                        nonprescription drugs, and conditions 
                        or requirements under subsections (b), 
                        (c), and (k); and
                          ``(iii) except as permitted by an 
                        order issued under subsection (b) or, 
                        in the case of a minor change in the 
                        drug, in conformity with an order 
                        issued under subsection (c), in a 
                        dosage form that, immediately prior to 
                        the date of the enactment of this 
                        section, has been used to a material 
                        extent and for a material time under 
                        section 201(p)(2).
          ``(2) Treatment of sunscreen drugs.--With respect to 
        sunscreen drugs subject to this section, the applicable 
        requirements in terms of conformity with a final 
        monograph, for purposes of paragraph (1)(A)(i), shall 
        be the requirements specified in part 352 of title 21, 
        Code of Federal Regulations, as published on May 21, 
        1999, beginning on page 27687 of volume 64 of the 
        Federal Register, except that the applicable 
        requirements governing effectiveness and labeling shall 
        be those specified in section 201.327 of title 21, Code 
        of Federal Regulations.
          ``(3) Category iii drugs subject to a tentative final 
        monograph; category i drugs subject to proposed 
        monograph or advance notice of proposed rulemaking.--A 
        drug that is not described in paragraph (1), (2), or 
        (4) is not required to be the subject of an application 
        approved under section 505, and is not subject to 
        section 503(b)(1), if--
                  ``(A) the drug is--
                          ``(i) classified in category III for 
                        safety or effectiveness in the preamble 
                        of a proposed rule establishing a 
                        tentative final monograph that is the 
                        most recently applicable proposal or 
                        determination for such drug issued 
                        under part 330 of title 21, Code of 
                        Federal Regulations;
                          ``(ii) in conformity with--
                                  ``(I) the conditions of use, 
                                including indication and dosage 
                                strength, if any, described for 
                                such category III drug in such 
                                preamble or in an applicable 
                                subsequent proposed rule;
                                  ``(II) the proposed 
                                requirements for drugs 
                                classified in such tentative 
                                final monograph in category I 
                                in the most recently proposed 
                                rule establishing requirements 
                                related to such tentative final 
                                monograph and in any final rule 
                                establishing requirements that 
                                are applicable to the drug; and
                                  ``(III) the general 
                                requirements for 
                                nonprescription drugs and 
                                conditions or requirements 
                                under subsection (b) or (k); 
                                and
                          ``(iii) in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, had been 
                        used to a material extent and for a 
                        material time under section 201(p)(2); 
                        or
                  ``(B) the drug is--
                          ``(i) classified in category I for 
                        safety and effectiveness under a 
                        proposed monograph or advance notice of 
                        proposed rulemaking that is the most 
                        recently applicable proposal or 
                        determination for such drug issued 
                        under part 330 of title 21, Code of 
                        Federal Regulations;
                          ``(ii) in conformity with the 
                        requirements for nonprescription use of 
                        such proposed monograph or advance 
                        notice of proposed rulemaking, any 
                        applicable subsequent determination by 
                        the Secretary, the general requirements 
                        for nonprescription drugs, and 
                        conditions or requirements under 
                        subsection (b) or (k); and
                          ``(iii) in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, has been 
                        used to a material extent and for a 
                        material time under section 201(p)(2).
          ``(4) Category ii drugs deemed new drugs.--A drug 
        that is classified in category II for safety or 
        effectiveness under a tentative final monograph or that 
        is subject to a determination to be not generally 
        recognized as safe and effective in a proposed rule 
        that is the most recently applicable proposal issued 
        under part 330 of title 21, Code of Federal 
        Regulations, shall be deemed to be a new drug under 
        section 201(p), misbranded under section 502(ee), and 
        subject to the requirement for an approved new drug 
        application under section 505 beginning on the day that 
        is 180 calendar days after the date of the enactment of 
        this section, unless, before such day, the Secretary 
        determines that it is in the interest of public health 
        to extend the period during which the drug may be 
        marketed without such an approved new drug application.
          ``(5) Drugs not grase deemed new drugs.--A drug that 
        the Secretary has determined not to be generally 
        recognized as safe and effective under section 
        201(p)(1) under a final determination issued under part 
        330 of title 21, Code of Federal Regulations, shall be 
        deemed to be a new drug under section 201(p), 
        misbranded under section 502(ee), and subject to the 
        requirement for an approved new drug application under 
        section 505.
          ``(6) Other drugs deemed new drugs.--Except as 
        provided in subsection (m), a drug is deemed to be a 
        new drug under section 201(p) and misbranded under 
        section 502(ee) if the drug--
                  ``(A) is not subject to section 503(b)(1); 
                and
                  ``(B) is not described in paragraph (1), (2), 
                (3), (4), or (5), or subsection (b)(1)(B).
  ``(b) Administrative Orders.--
          ``(1) In general.--
                  ``(A) Determination.--The Secretary may, on 
                the initiative of the Secretary or at the 
                request of one or more requestors, issue an 
                administrative order determining whether there 
                are conditions under which a specific drug, a 
                class of drugs, or a combination of drugs, is 
                determined to be--
                          ``(i) not subject to section 
                        503(b)(1); and
                          ``(ii) generally recognized as safe 
                        and effective under section 201(p)(1).
                  ``(B) Effect.--A drug or combination of drugs 
                shall be deemed to not require approval under 
                section 505 if such drug or combination of 
                drugs--
                          ``(i) is determined by the Secretary 
                        to meet the conditions specified in 
                        clauses (i) and (ii) of subparagraph 
                        (A);
                          ``(ii) is marketed in conformity with 
                        an administrative order under this 
                        subsection;
                          ``(iii) meets the general 
                        requirements for nonprescription drugs; 
                        and
                          ``(iv) meets the requirements under 
                        subsections (c) and (k).
                  ``(C) Standard.--The Secretary shall find 
                that a drug is not generally recognized as safe 
                and effective under section 201(p)(1) if--
                          ``(i) the evidence shows that the 
                        drug is not generally recognized as 
                        safe and effective under section 
                        201(p)(1); or
                          ``(ii) the evidence is inadequate to 
                        show that the drug is generally 
                        recognized as safe and effective under 
                        section 201(p)(1).
          ``(2) Administrative orders initiated by the 
        secretary.--
                  ``(A) In general.--In issuing an 
                administrative order under paragraph (1) upon 
                the Secretary's initiative, the Secretary 
                shall--
                          ``(i) make reasonable efforts to 
                        notify informally, not later than 2 
                        business days before the issuance of 
                        the proposed order, the sponsors of 
                        drugs who have a listing in effect 
                        under section 510(j) for the drugs or 
                        combination of drugs that will be 
                        subject to the administrative order;
                          ``(ii) after any such reasonable 
                        efforts of notification--
                                  ``(I) issue a proposed 
                                administrative order by 
                                publishing it on the website of 
                                the Food and Drug 
                                Administration and include in 
                                such order the reasons for the 
                                issuance of such order; and
                                  ``(II) publish a notice of 
                                availability of such proposed 
                                order in the Federal Register;
                          ``(iii) except as provided in 
                        subparagraph (B), provide for a public 
                        comment period with respect to such 
                        proposed order of not less than 45 
                        calendar days; and
                          ``(iv) if, after completion of the 
                        proceedings specified in clauses (i) 
                        through (iii), the Secretary determines 
                        that it is appropriate to issue a final 
                        administrative order--
                                  ``(I) issue the final 
                                administrative order, together 
                                with a detailed statement of 
                                reasons, which order shall not 
                                take effect until the time for 
                                requesting judicial review 
                                under paragraph (3)(D)(ii) has 
                                expired;
                                  ``(II) publish a notice of 
                                such final administrative order 
                                in the Federal Register;
                                  ``(III) afford requestors of 
                                drugs that will be subject to 
                                such order the opportunity for 
                                formal dispute resolution up to 
                                the level of the Director of 
                                the Center for Drug Evaluation 
                                and Research, which initially 
                                must be requested within 45 
                                calendar days of the issuance 
                                of the order, and, for 
                                subsequent levels of appeal, 
                                within 30 calendar days of the 
                                prior decision; and
                                  ``(IV) except with respect to 
                                drugs described in paragraph 
                                (3)(B), upon completion of the 
                                formal dispute resolution 
                                procedure, inform the persons 
                                which sought such dispute 
                                resolution of their right to 
                                request a hearing.
                  ``(B) Exceptions.--When issuing an 
                administrative order under paragraph (1) on the 
                Secretary's initiative proposing to determine 
                that a drug described in subsection (a)(3) is 
                not generally recognized as safe and effective 
                under section 201(p)(1), the Secretary shall 
                follow the procedures in subparagraph (A), 
                except that--
                          ``(i) the proposed order shall 
                        include notice of--
                                  ``(I) the general categories 
                                of data the Secretary has 
                                determined necessary to 
                                establish that the drug is 
                                generally recognized as safe 
                                and effective under section 
                                201(p)(1); and
                                  ``(II) the format for 
                                submissions by interested 
                                persons;
                          ``(ii) the Secretary shall provide 
                        for a public comment period of no less 
                        than 180 calendar days with respect to 
                        such proposed order, except when the 
                        Secretary determines, for good cause, 
                        that a shorter period is in the 
                        interest of public health; and
                          ``(iii) any person who submits data 
                        in such comment period shall include a 
                        certification that the person has 
                        submitted all evidence created, 
                        obtained, or received by that person 
                        that is both within the categories of 
                        data identified in the proposed order 
                        and relevant to a determination as to 
                        whether the drug is generally 
                        recognized as safe and effective under 
                        section 201(p)(1).
          ``(3) Hearings; judicial review.--
                  ``(A) In general.--Only a person who 
                participated in each stage of formal dispute 
                resolution under subclause (III) of paragraph 
                (2)(A)(iv) of an administrative order with 
                respect to a drug may request a hearing 
                concerning a final administrative order issued 
                under such paragraph with respect to such drug. 
                If a hearing is sought, such person must submit 
                a request for a hearing, which shall be based 
                solely on information in the administrative 
                record, to the Secretary not later than 30 
                calendar days after receiving notice of the 
                final decision of the formal dispute resolution 
                procedure.
                  ``(B) No hearing required with respect to 
                orders relating to certain drugs.--
                          ``(i) In general.--The Secretary 
                        shall not be required to provide notice 
                        and an opportunity for a hearing 
                        pursuant to paragraph (2)(A)(iv) if the 
                        final administrative order involved 
                        relates to a drug--
                                  ``(I) that is described in 
                                subsection (a)(3)(A); and
                                  ``(II) with respect to which 
                                no human or non-human data 
                                studies relevant to the safety 
                                or effectiveness of such drug 
                                have been submitted to the 
                                administrative record since the 
                                issuance of the most recent 
                                tentative final monograph 
                                relating to such drug.
                          ``(ii) Human data studies and non-
                        human data defined.--In this 
                        subparagraph:
                                  ``(I) The term `human data 
                                studies' means clinical trials 
                                of safety or effectiveness 
                                (including actual use studies), 
                                pharmacokinetics studies, or 
                                bioavailability studies.
                                  ``(II) The term `non-human 
                                data' means data from testing 
                                other than with human subjects 
                                which provides information 
                                concerning safety or 
                                effectiveness.
                  ``(C) Hearing procedures.--
                          ``(i) Denial of request for 
                        hearing.--If the Secretary determines 
                        that information submitted in a request 
                        for a hearing under subparagraph (A) 
                        with respect to a final administrative 
                        order issued under paragraph (2)(A)(iv) 
                        does not identify the existence of a 
                        genuine and substantial question of 
                        material fact, the Secretary may deny 
                        such request. In making such a 
                        determination, the Secretary may 
                        consider only information and data that 
                        are based on relevant and reliable 
                        scientific principles and 
                        methodologies.
                          ``(ii) Single hearing for multiple 
                        related requests.--If more than one 
                        request for a hearing is submitted with 
                        respect to the same administrative 
                        order under subparagraph (A), the 
                        Secretary may direct that a single 
                        hearing be conducted in which all 
                        persons whose hearing requests were 
                        granted may participate.
                          ``(iii) Presiding officer.--The 
                        presiding officer of a hearing 
                        requested under subparagraph (A) 
                        shall--
                                  ``(I) be designated by the 
                                Secretary;
                                  ``(II) not be an employee of 
                                the Center for Drug Evaluation 
                                and Research; and
                                  ``(III) not have been 
                                previously involved in the 
                                development of the 
                                administrative order involved 
                                or proceedings relating to that 
                                administrative order.
                          ``(iv) Rights of parties to 
                        hearing.--The parties to a hearing 
                        requested under subparagraph (A) shall 
                        have the right to present testimony, 
                        including testimony of expert 
                        witnesses, and to cross-examine 
                        witnesses presented by other parties. 
                        Where appropriate, the presiding 
                        officer may require that cross-
                        examination by parties representing 
                        substantially the same interests be 
                        consolidated to promote efficiency and 
                        avoid duplication.
                          ``(v) Final decision.--
                                  ``(I) At the conclusion of a 
                                hearing requested under 
                                subparagraph (A), the presiding 
                                officer of the hearing shall 
                                issue a decision containing 
                                findings of fact and 
                                conclusions of law. The 
                                decision of the presiding 
                                officer shall be final.
                                  ``(II) The final decision may 
                                not take effect until the 
                                period under subparagraph 
                                (D)(ii) for submitting a 
                                request for judicial review of 
                                such decision expires.
                  ``(D) Judicial review of final administrative 
                order.--
                          ``(i) In general.--The procedures 
                        described in section 505(h) shall apply 
                        with respect to judicial review of 
                        final administrative orders issued 
                        under this subsection in the same 
                        manner and to the same extent as such 
                        section applies to an order described 
                        in such section except that the 
                        judicial review shall be taken by 
                        filing in an appropriate district court 
                        of the United States in lieu of the 
                        appellate courts specified in such 
                        section.
                          ``(ii) Period to submit a request for 
                        judicial review.--A person eligible to 
                        request a hearing under this paragraph 
                        and seeking judicial review of a final 
                        administrative order issued under this 
                        subsection shall file such request for 
                        judicial review not later than 60 
                        calendar days after the latest of--
                                  ``(I) the date on which 
                                notice of such order is 
                                published;
                                  ``(II) the date on which a 
                                hearing with respect to such 
                                order is denied under 
                                subparagraph (B) or (C)(i);
                                  ``(III) the date on which a 
                                final decision is made 
                                following a hearing under 
                                subparagraph (C)(v); or
                                  ``(IV) if no hearing is 
                                requested, the date on which 
                                the time for requesting a 
                                hearing expires.
          ``(4) Expedited procedure with respect to 
        administrative orders initiated by the secretary.--
                  ``(A) Imminent hazard to the public health.--
                          ``(i) In general.--In the case of a 
                        determination by the Secretary that a 
                        drug, class of drugs, or combination of 
                        drugs subject to this section poses an 
                        imminent hazard to the public health, 
                        the Secretary, after first making 
                        reasonable efforts to notify, not later 
                        than 48 hours before issuance of such 
                        order under this subparagraph, sponsors 
                        who have a listing in effect under 
                        section 510(j) for such drug or 
                        combination of drugs--
                                  ``(I) may issue an interim 
                                final administrative order for 
                                such drug, class of drugs, or 
                                combination of drugs under 
                                paragraph (1), together with a 
                                detailed statement of the 
                                reasons for such order;
                                  ``(II) shall publish in the 
                                Federal Register a notice of 
                                availability of any such order; 
                                and
                                  ``(III) shall provide for a 
                                public comment period of at 
                                least 45 calendar days with 
                                respect to such interim final 
                                order.
                          ``(ii) Nondelegation.--The Secretary 
                        may not delegate the authority to issue 
                        an interim final administrative order 
                        under this subparagraph.
                  ``(B) Safety labeling changes.--
                          ``(i) In general.--In the case of a 
                        determination by the Secretary that a 
                        change in the labeling of a drug, class 
                        of drugs, or combination of drugs 
                        subject to this section is reasonably 
                        expected to mitigate a significant or 
                        unreasonable risk of a serious adverse 
                        event associated with use of the drug, 
                        the Secretary may--
                                  ``(I) make reasonable efforts 
                                to notify informally, not later 
                                than 48 hours before the 
                                issuance of the interim final 
                                order, the sponsors of drugs 
                                who have a listing in effect 
                                under section 510(j) for such 
                                drug or combination of drugs;
                                  ``(II) after reasonable 
                                efforts of notification, issue 
                                an interim final administrative 
                                order in accordance with 
                                paragraph (1) to require such 
                                change, together with a 
                                detailed statement of the 
                                reasons for such order;
                                  ``(III) publish in the 
                                Federal Register a notice of 
                                availability of such order; and
                                  ``(IV) provide for a public 
                                comment period of at least 45 
                                calendar days with respect to 
                                such interim final order.
                          ``(ii) Content of order.--An interim 
                        final order issued under this 
                        subparagraph with respect to the 
                        labeling of a drug may provide for new 
                        warnings and other information required 
                        for safe use of the drug.
                  ``(C) Effective date.--An order under 
                subparagraph (A) or (B) shall take effect on a 
                date specified by the Secretary.
                  ``(D) Final order.--After the completion of 
                the proceedings in subparagraph (A) or (B), the 
                Secretary shall--
                          ``(i) issue a final order in 
                        accordance with paragraph (1);
                          ``(ii) publish a notice of 
                        availability of such final 
                        administrative order in the Federal 
                        Register; and
                          ``(iii) afford sponsors of such drugs 
                        that will be subject to such an order 
                        the opportunity for formal dispute 
                        resolution up to the level of the 
                        Director of the Center for Drug 
                        Evaluation and Research, which must 
                        initially be within 45 calendar days of 
                        the issuance of the order, and for 
                        subsequent levels of appeal, within 30 
                        calendar days of the prior decision.
                  ``(E) Hearings.--A sponsor of a drug subject 
                to a final order issued under subparagraph (D) 
                and that participated in each stage of formal 
                dispute resolution under clause (iii) of such 
                subparagraph may request a hearing on such 
                order. The provisions of subparagraphs (A), 
                (B), and (C) of paragraph (3), other than 
                paragraph (3)(C)(v)(II), shall apply with 
                respect to a hearing on such order in the same 
                manner and to the same extent as such 
                provisions apply with respect to a hearing on 
                an administrative order issued under paragraph 
                (2)(A)(iv).
                  ``(F) Timing.--
                          ``(i) Final order and hearing.--The 
                        Secretary shall--
                                  ``(I) not later than 6 months 
                                after the date on which the 
                                comment period closes under 
                                subparagraph (A) or (B), issue 
                                a final order in accordance 
                                with paragraph (1); and
                                  ``(II) not later than 12 
                                months after the date on which 
                                such final order is issued, 
                                complete any hearing under 
                                subparagraph (E).
                          ``(ii) Dispute resolution request.--
                        The Secretary shall specify in an 
                        interim final order issued under 
                        subparagraph (A) or (B) such shorter 
                        periods for requesting dispute 
                        resolution under subparagraph (D)(iii) 
                        as are necessary to meet the 
                        requirements of this subparagraph.
                  ``(G) Judicial review.--A final order issued 
                pursuant to subparagraph (F) shall be subject 
                to judicial review in accordance with paragraph 
                (3)(D).
          ``(5) Administrative order initiated at the request 
        of a requestor.--
                  ``(A) In general.--In issuing an 
                administrative order under paragraph (1) at the 
                request of a requestor with respect to certain 
                drugs, classes of drugs, or combinations of 
                drugs--
                          ``(i) the Secretary shall, after 
                        receiving a request under this 
                        subparagraph, determine whether the 
                        request is sufficiently complete and 
                        formatted to permit a substantive 
                        review;
                          ``(ii) if the Secretary determines 
                        that the request is sufficiently 
                        complete and formatted to permit a 
                        substantive review, the Secretary 
                        shall--
                                  ``(I) file the request; and
                                  ``(II) initiate proceedings 
                                with respect to issuing an 
                                administrative order in 
                                accordance with paragraphs (2) 
                                and (3); and
                          ``(iii) except as provided in 
                        paragraph (6), if the Secretary 
                        determines that a request does not meet 
                        the requirements for filing or is not 
                        sufficiently complete and formatted to 
                        permit a substantive review, the 
                        requestor may demand that the request 
                        be filed over protest, and the 
                        Secretary shall initiate proceedings to 
                        review the request in accordance with 
                        paragraph (2)(A).
                  ``(B) Request to initiate proceedings.--
                          ``(i) In general.--A requestor 
                        seeking an administrative order under 
                        paragraph (1) with respect to certain 
                        drugs, classes of drugs, or 
                        combinations of drugs, shall submit to 
                        the Secretary a request to initiate 
                        proceedings for such order in the form 
                        and manner as specified by the 
                        Secretary. Such requestor may submit a 
                        request under this subparagraph for the 
                        issuance of an administrative order--
                                  ``(I) determining whether a 
                                drug is generally recognized as 
                                safe and effective under 
                                section 201(p)(1), exempt from 
                                section 503(b)(1), and not 
                                required to be the subject of 
                                an approved application under 
                                section 505; or
                                  ``(II) determining whether a 
                                change to a condition of use of 
                                a drug is generally recognized 
                                as safe and effective under 
                                section 201(p)(1), exempt from 
                                section 503(b)(1), and not 
                                required to be the subject of 
                                an approved application under 
                                section 505, if, absent such a 
                                changed condition of use, such 
                                drug is--
                                          ``(aa) generally 
                                        recognized as safe and 
                                        effective under section 
                                        201(p)(1) in accordance 
                                        with subsection (a)(1), 
                                        (a)(2), or an order 
                                        under this subsection; 
                                        or
                                          ``(bb) subject to 
                                        subsection (a)(3), but 
                                        only if such requestor 
                                        initiates such request 
                                        in conjunction with a 
                                        request for the 
                                        Secretary to determine 
                                        whether such drug is 
                                        generally recognized as 
                                        safe and effective 
                                        under section 
                                        201(p)(1), which is 
                                        filed by the Secretary 
                                        under subparagraph 
                                        (A)(ii).
                          ``(ii) Exception.--The Secretary is 
                        not required to complete review of a 
                        request for a change described in 
                        clause (i)(II) if the Secretary 
                        determines that there is an inadequate 
                        basis to find the drug is generally 
                        recognized as safe and effective under 
                        section 201(p)(1) under paragraph (1) 
                        and issues a final order announcing 
                        that determination.
                          ``(iii) Withdrawal.--The requestor 
                        may withdraw a request under this 
                        paragraph, according to the procedures 
                        set forth pursuant to subsection 
                        (d)(2)(B). Notwithstanding any other 
                        provision of this section, if such 
                        request is withdrawn, the Secretary may 
                        cease proceedings under this 
                        subparagraph.
                  ``(C) Exclusivity.--
                          ``(i) In general.--A final 
                        administrative order issued in response 
                        to a request under this section shall 
                        have the effect of authorizing solely 
                        the order requestor (or the licensees, 
                        assignees, or successors in interest of 
                        such requestor with respect to the 
                        subject of such order), for a period of 
                        18 months following the effective date 
                        of such final order and beginning on 
                        the date the requestor may lawfully 
                        market such drugs pursuant to the 
                        order, to market drugs--
                                  ``(I) incorporating changes 
                                described in clause (ii); and
                                  ``(II) subject to the 
                                limitations under clause (iv).
                          ``(ii) Changes described.--A change 
                        described in this clause is a change 
                        subject to an order specified in clause 
                        (i), which--
                                  ``(I) provides for a drug to 
                                contain an active ingredient 
                                (including any ester or salt of 
                                the active ingredient) not 
                                previously incorporated in a 
                                drug described in clause (iii); 
                                or
                                  ``(II) provides for a change 
                                in the conditions of use of a 
                                drug, for which new human data 
                                studies conducted or sponsored 
                                by the requestor (or for which 
                                the requestor has an exclusive 
                                right of reference) were 
                                essential to the issuance of 
                                such order.
                          ``(iii) Drugs described.--The drugs 
                        described in this clause are drugs--
                                  ``(I) specified in subsection 
                                (a)(1), (a)(2), or (a)(3);
                                  ``(II) subject to a final 
                                order issued under this 
                                section;
                                  ``(III) subject to a final 
                                sunscreen order (as defined in 
                                section 586(2)(A)); or
                                  ``(IV) described in 
                                subsection (m)(1), other than 
                                drugs subject to an active 
                                enforcement action under 
                                chapter III of this Act.
                          ``(iv) Limitations on exclusivity.--
                                  ``(I) In general.--Only one 
                                18-month period under this 
                                subparagraph shall be granted, 
                                under each order described in 
                                clause (i), with respect to 
                                changes (to the drug subject to 
                                such order) which are either--
                                          ``(aa) changes 
                                        described in clause 
                                        (ii)(I), relating to 
                                        active ingredients; or
                                          ``(bb) changes 
                                        described in clause 
                                        (ii)(II), relating to 
                                        conditions of use.
                                  ``(II) No exclusivity 
                                allowed.--No exclusivity shall 
                                apply to changes to a drug 
                                which are--
                                          ``(aa) the subject of 
                                        a Tier 2 OTC monograph 
                                        order request (as 
                                        defined in section 
                                        744L);
                                          ``(bb) safety-related 
                                        changes, as defined by 
                                        the Secretary, or any 
                                        other changes the 
                                        Secretary considers 
                                        necessary to assure 
                                        safe use; or
                                          ``(cc) changes 
                                        related to methods of 
                                        testing safety or 
                                        efficacy.
                          ``(v) New human data studies 
                        defined.--In this subparagraph, the 
                        term `new human data studies' means 
                        clinical trials of safety or 
                        effectiveness (including actual use 
                        studies), pharmacokinetics studies, or 
                        bioavailability studies, the results of 
                        which--
                                  ``(I) have not been relied on 
                                by the Secretary to support--
                                          ``(aa) a proposed or 
                                        final determination 
                                        that a drug described 
                                        in subclause (I), (II), 
                                        or (III) of clause 
                                        (iii) is generally 
                                        recognized as safe and 
                                        effective under section 
                                        201(p)(1); or
                                          ``(bb) approval of a 
                                        drug that was approved 
                                        under section 505; and
                                  ``(II) do not duplicate the 
                                results of another study that 
                                was relied on by the Secretary 
                                to support--
                                          ``(aa) a proposed or 
                                        final determination 
                                        that a drug described 
                                        in subclause (I), (II), 
                                        or (III) of clause 
                                        (iii) is generally 
                                        recognized as safe and 
                                        effective under section 
                                        201(p)(1); or
                                          ``(bb) approval of a 
                                        drug that was approved 
                                        under section 505.
          ``(6) Information regarding safe nonprescription 
        marketing and use as condition for filing a generally 
        recognized as safe and effective request.--
                  ``(A) In general.--In response to a request 
                under this section that a drug described in 
                subparagraph (B) be generally recognized as 
                safe and effective, the Secretary--
                          ``(i) may file such request, if the 
                        request includes information specified 
                        under subparagraph (C) with respect to 
                        safe nonprescription marketing and use 
                        of such drug; or
                          ``(ii) if the request fails to 
                        include information specified under 
                        subparagraph (C), shall refuse to file 
                        such request and require that 
                        nonprescription marketing of the drug 
                        be pursuant to a new drug application 
                        as described in subparagraph (D).
                  ``(B) Drug described.--A drug described in 
                this subparagraph is a nonprescription drug 
                which contains an active ingredient not 
                previously incorporated in a drug--
                          ``(i) specified in subsection (a)(1), 
                        (a)(2), or (a)(3);
                          ``(ii) subject to a final order under 
                        this section; or
                          ``(iii) subject to a final sunscreen 
                        order (as defined in section 
                        586(2)(A)).
                  ``(C) Information demonstrating prima facie 
                safe nonprescription marketing and use.--
                Information specified in this subparagraph, 
                with respect to a request described in 
                subparagraph (A)(i), is--
                          ``(i) information sufficient for a 
                        prima facie demonstration that the drug 
                        subject to such request has a 
                        verifiable history of being marketed 
                        and safely used by consumers in the 
                        United States as a nonprescription drug 
                        under comparable conditions of use;
                          ``(ii) if the drug has not been 
                        previously marketed in the United 
                        States as a nonprescription drug, 
                        information sufficient for a prima 
                        facie demonstration that the drug was 
                        marketed and safely used under 
                        comparable conditions of marketing and 
                        use in a country listed in section 
                        802(b)(1)(A) or designated by the 
                        Secretary in accordance with section 
                        802(b)(1)(B)--
                                  ``(I) for such period as 
                                needed to provide reasonable 
                                assurances concerning the safe 
                                nonprescription use of the 
                                drug; and
                                  ``(II) during such time was 
                                subject to sufficient 
                                monitoring by a regulatory body 
                                considered acceptable by the 
                                Secretary for such monitoring 
                                purposes, including for adverse 
                                events associated with 
                                nonprescription use of the 
                                drug; or
                          ``(iii) if the Secretary determines 
                        that information described in clause 
                        (i) or (ii) is not needed to provide a 
                        prima facie demonstration that the drug 
                        can be safely marketed and used as a 
                        nonprescription drug, such other 
                        information the Secretary determines is 
                        sufficient for such purposes.
                  ``(D) Marketing pursuant to new drug 
                application.--In the case of a request 
                described in subparagraph (A)(ii), the drug 
                subject to such request may be resubmitted for 
                filing only if--
                          ``(i) the drug is marketed as a 
                        nonprescription drug, under conditions 
                        of use comparable to the conditions 
                        specified in the request, for such 
                        period as the Secretary determines 
                        appropriate (not to exceed 5 
                        consecutive years) pursuant to an 
                        application approved under section 505; 
                        and
                          ``(ii) during such period, 1,000,000 
                        retail packages of the drug, or an 
                        equivalent quantity as determined by 
                        the Secretary, were distributed for 
                        retail sale, as determined in such 
                        manner as the Secretary finds 
                        appropriate.
                  ``(E) Rule of application.--Except in the 
                case of a request involving a drug described in 
                section 586(9), as in effect on January 1, 
                2017, if the Secretary refuses to file a 
                request under this paragraph, the requestor may 
                not file such request over protest under 
                paragraph (5)(A)(iii).
          ``(7) Packaging.--An administrative order issued 
        under paragraph (2), (4)(A), or (5) may include 
        requirements for the packaging of a drug to encourage 
        use in accordance with labeling. Such requirements may 
        include unit dose packaging, requirements for products 
        intended for use by pediatric populations, requirements 
        to reduce risk of harm from unsupervised ingestion, and 
        other appropriate requirements. This paragraph does not 
        authorize the Food and Drug Administration to require 
        standards or testing procedures as described in part 
        1700 of title 16, Code of Federal Regulations.
          ``(8) Final and tentative final monographs for 
        category i drugs deemed final administrative orders.--
                  ``(A) In general.--A final monograph or 
                tentative final monograph described in 
                subparagraph (B) shall be deemed to be a final 
                administrative order under this subsection and 
                may be amended, revoked, or otherwise modified 
                in accordance with the procedures of this 
                subsection.
                  ``(B) Monographs described.--For purposes of 
                subparagraph (A), a final monograph or 
                tentative final monograph is described in this 
                subparagraph if it--
                          ``(i) establishes conditions of use 
                        for a drug described in paragraph (1) 
                        or (2) of subsection (a); and
                          ``(ii) represents the most recently 
                        promulgated version of such conditions, 
                        including as modified, in whole or in 
                        part, by any proposed or final rule.
                  ``(C) Deemed orders include harmonizing 
                technical amendments.--The deemed establishment 
                of a final administrative order under 
                subparagraph (A) shall be construed to include 
                any technical amendments to such order as the 
                Secretary determines necessary to ensure that 
                such order is appropriately harmonized, in 
                terms of terminology or cross-references, with 
                the applicable provisions of this Act (and 
                regulations thereunder) and any other orders 
                issued under this section.
  ``(c) Procedure for Minor Changes.--
          ``(1) In general.--Minor changes in the dosage form 
        of a drug that is described in paragraph (1) or (2) of 
        subsection (a) or the subject of an order issued under 
        subsection (b) may be made by a requestor without the 
        issuance of an order under subsection (b) if--
                  ``(A) the requestor maintains such 
                information as is necessary to demonstrate that 
                the change--
                          ``(i) will not affect the safety or 
                        effectiveness of the drug; and
                          ``(ii) will not materially affect the 
                        extent of absorption or other exposure 
                        to the active ingredient in comparison 
                        to a suitable reference product; and
                  ``(B) the change is in conformity with the 
                requirements of an applicable administrative 
                order issued by the Secretary under paragraph 
                (3).
          ``(2) Additional information.--
                  ``(A) Access to records.--A sponsor shall 
                submit records requested by the Secretary 
                relating to such a minor change under section 
                704(a)(4), within 15 business days of receiving 
                such a request, or such longer period as the 
                Secretary may provide.
                  ``(B) Insufficient information.--If the 
                Secretary determines that the information 
                contained in such records is not sufficient to 
                demonstrate that the change does not affect the 
                safety or effectiveness of the drug or 
                materially affect the extent of absorption or 
                other exposure to the active ingredient, the 
                Secretary--
                          ``(i) may so inform the sponsor of 
                        the drug in writing; and
                          ``(ii) if the Secretary so informs 
                        the sponsor, shall provide the sponsor 
                        of the drug with a reasonable 
                        opportunity to provide additional 
                        information.
                  ``(C) Failure to submit sufficient 
                information.--If the sponsor fails to provide 
                such additional information within a time 
                prescribed by the Secretary, or if the 
                Secretary determines that such additional 
                information does not demonstrate that the 
                change does not--
                          ``(i) affect the safety or 
                        effectiveness of the drug; or
                          ``(ii) materially affect the extent 
                        of absorption or other exposure to the 
                        active ingredient in comparison to a 
                        suitable reference product,
                the drug as modified is a new drug under 
                section 201(p) and shall be deemed to be 
                misbranded under section 502(ee).
          ``(3) Determining whether a change will affect safety 
        or effectiveness.--
                  ``(A) In general.--The Secretary shall issue 
                one or more administrative orders specifying 
                requirements for determining whether a minor 
                change made by a sponsor pursuant to this 
                subsection will affect the safety or 
                effectiveness of a drug or materially affect 
                the extent of absorption or other exposure to 
                an active ingredient in the drug in comparison 
                to a suitable reference product, together with 
                guidance for applying those orders to specific 
                dosage forms.
                  ``(B) Standard practices.--The orders and 
                guidance issued by the Secretary under 
                subparagraph (A) shall take into account 
                relevant public standards and standard 
                practices for evaluating the quality of drugs, 
                and may take into account the special needs of 
                populations, including children.
  ``(d) Confidentiality of Information Submitted to the 
Secretary.--
          ``(1) In general.--Subject to paragraph (2), any 
        information, including reports of testing conducted on 
        the drug or drugs involved, that is submitted by a 
        requestor in connection with proceedings on an order 
        under this section (including any minor change under 
        subsection (c)) and is a trade secret or confidential 
        information subject to section 552(b)(4) of title 5, 
        United States Code, or section 1905 of title 18, United 
        States Code, shall not be disclosed to the public 
        unless the requestor consents to that disclosure.
          ``(2) Public availability.--
                  ``(A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall--
                          ``(i) make any information submitted 
                        by a requestor in support of a request 
                        under subsection (b)(5)(A) available to 
                        the public not later than the date on 
                        which the proposed order is issued; and
                          ``(ii) make any information submitted 
                        by any other person with respect to an 
                        order requested (or initiated by the 
                        Secretary) under subsection (b), 
                        available to the public upon such 
                        submission.
                  ``(B) Limitations on public availability.--
                Information described in subparagraph (A) shall 
                not be made public if--
                          ``(i) the information pertains to 
                        pharmaceutical quality information, 
                        unless such information is necessary to 
                        establish standards under which a drug 
                        is generally recognized as safe and 
                        effective under section 201(p)(1);
                          ``(ii) the information is submitted 
                        in a requestor-initiated request, but 
                        the requestor withdraws such request, 
                        in accordance with withdrawal 
                        procedures established by the 
                        Secretary, before the Secretary issues 
                        the proposed order;
                          ``(iii) the Secretary requests and 
                        obtains the information under 
                        subsection (c) and such information is 
                        not submitted in relation to an order 
                        under subsection (b); or
                          ``(iv) the information is of the type 
                        contained in raw datasets.
  ``(e) Updates to Drug Listing Information.--A sponsor who 
makes a change to a drug subject to this section shall submit 
updated drug listing information for the drug in accordance 
with section 510(j) within 30 calendar days of the date when 
the drug is first commercially marketed, except that a sponsor 
who was the order requestor with respect to an order subject to 
subsection (b)(5)(C) (or a licensee, assignee, or successor in 
interest of such requestor) shall submit updated drug listing 
information on or before the date when the drug is first 
commercially marketed.
  ``(f) Approvals Under Section 505.--The provisions of this 
section shall not be construed to preclude a person from 
seeking or maintaining the approval of an application for a 
drug under sections 505(b)(1), 505(b)(2), and 505(j). A 
determination under this section that a drug is not subject to 
section 503(b)(1), is generally recognized as safe and 
effective under section 201(p)(1), and is not a new drug under 
section 201(p) shall constitute a finding that the drug is safe 
and effective that may be relied upon for purposes of an 
application under section 505(b)(2), so that the applicant 
shall be required to submit for purposes of such application 
only information needed to support any modification of the drug 
that is not covered by such determination under this section.
  ``(g) Public Availability of Administrative Orders.--The 
Secretary shall establish, maintain, update (as determined 
necessary by the Secretary but no less frequently than 
annually), and make publicly available, with respect to orders 
issued under this section--
          ``(1) a repository of each final order and interim 
        final order in effect, including the complete text of 
        the order; and
          ``(2) a listing of all orders proposed and under 
        development under subsection (b)(2), including--
                  ``(A) a brief description of each such order; 
                and
                  ``(B) the Secretary's expectations, if 
                resources permit, for issuance of proposed 
                orders over a 3-year period.
  ``(h) Development Advice to Sponsors or Requestors.--The 
Secretary shall establish procedures under which sponsors or 
requestors may meet with appropriate officials of the Food and 
Drug Administration to obtain advice on the studies and other 
information necessary to support submissions under this section 
and other matters relevant to the regulation of nonprescription 
drugs and the development of new nonprescription drugs under 
this section.
  ``(i) Participation of Multiple Sponsors or Requestors.--The 
Secretary shall establish procedures to facilitate efficient 
participation by multiple sponsors or requestors in proceedings 
under this section, including provision for joint meetings with 
multiple sponsors or requestors or with organizations nominated 
by sponsors or requestors to represent their interests in a 
proceeding.
  ``(j) Electronic Format.--All submissions under this section 
shall be in electronic format.
  ``(k) Effect on Existing Regulations Governing 
Nonprescription Drugs.--
          ``(1) Regulations of general applicability to 
        nonprescription drugs.--Except as provided in this 
        subsection, nothing in this section supersedes 
        regulations establishing general requirements for 
        nonprescription drugs, including regulations of general 
        applicability contained in parts 201, 250, and 330 of 
        title 21, Code of Federal Regulations, or any successor 
        regulations. The Secretary shall establish or modify 
        such regulations by means of rulemaking in accordance 
        with section 553 of title 5, United States Code.
          ``(2) Regulations establishing requirements for 
        specific nonprescription drugs.--
                  ``(A) The provisions of section 310.545 of 
                title 21, Code of Federal Regulations, as in 
                effect on the day before the date of the 
                enactment of this section, shall be deemed to 
                be a final order under subsection (b).
                  ``(B) Regulations in effect on the day before 
                the date of the enactment of this section, 
                establishing requirements for specific 
                nonprescription drugs marketed pursuant to this 
                section (including such requirements in parts 
                201 and 250 of title 21, Code of Federal 
                Regulations), shall be deemed to be final 
                orders under subsection (b), only as they apply 
                to drugs--
                          ``(i) subject to paragraph (1), (2), 
                        (3), or (4) of subsection (a); or
                          ``(ii) otherwise subject to an order 
                        under this section.
          ``(3) Withdrawal of regulations.--The Secretary shall 
        withdraw regulations establishing final monographs and 
        the procedures governing the over-the-counter drug 
        review under part 330 and other relevant parts of title 
        21, Code of Federal Regulations (as in effect on the 
        day before the date of the enactment of this section), 
        or make technical changes to such regulations to ensure 
        conformity with appropriate terminology and cross 
        references. Notwithstanding subchapter II of chapter 5 
        of title 5, United States Code, any such withdrawal or 
        technical changes shall be made without public notice 
        and comment and shall be effective upon publication 
        through notice in the Federal Register (or upon such 
        date as specified in such notice).
  ``(l) Guidance.--The Secretary shall issue guidance that 
specifies--
          ``(1) the procedures and principles for formal 
        meetings between the Secretary and sponsors or 
        requestors for drugs subject to this section;
          ``(2) the format and content of data submissions to 
        the Secretary under this section;
          ``(3) the format of electronic submissions to the 
        Secretary under this section;
          ``(4) consolidated proceedings for appeal and the 
        procedures for such proceedings where appropriate; and
          ``(5) for minor changes in drugs, recommendations on 
        how to comply with the requirements in orders issued 
        under subsection (c)(3).
  ``(m) Rule of Construction.--
          ``(1) In general.--This section shall not affect the 
        treatment or status of a nonprescription drug--
                  ``(A) that is marketed without an application 
                approved under section 505 as of the date of 
                the enactment of this section;
                  ``(B) that is not subject to an order issued 
                under this section; and
                  ``(C) to which paragraphs (1), (2), (3), (4), 
                or (5) of subsection (a) do not apply.
          ``(2) Treatment of products previously found to be 
        subject to time and extent requirements.--
                  ``(A) Notwithstanding subsection (a), a drug 
                described in subparagraph (B) may only be 
                lawfully marketed, without an application 
                approved under section 505, pursuant to an 
                order issued under this section.
                  ``(B) A drug described in this subparagraph 
                is a drug which, prior to the date of the 
                enactment of this section, the Secretary 
                determined in a proposed or final rule to be 
                ineligible for review under the OTC drug review 
                (as such phrase `OTC drug review' was used in 
                section 330.14 of title 21, Code of Federal 
                Regulations, as in effect on the day before the 
                date of the enactment of this section).
          ``(3) Preservation of authority.--
                  ``(A) Nothing in paragraph (1) shall be 
                construed to preclude or limit the 
                applicability of any provision of this Act 
                other than this section.
                  ``(B) Nothing in subsection (a) shall be 
                construed to prohibit the Secretary from 
                issuing an order under this section finding a 
                drug to be not generally recognized as safe and 
                effective under section 201(p)(1), as the 
                Secretary determines appropriate.
  ``(n) Investigational New Drugs.--A drug is not subject to 
this section if an exemption for investigational use under 
section 505(i) is in effect for such drug.
  ``(o) Inapplicability of Paperwork Reduction Act.--Chapter 35 
of title 44, United States Code, shall not apply to collections 
of information made under this section.
  ``(p) Inapplicability of Notice and Comment Rulemaking and 
Other Requirements.--The requirements of subsection (b) shall 
apply with respect to orders issued under this section instead 
of the requirements of subchapter II of chapter 5 of title 5, 
United States Code.
  ``(q) Definitions.--In this section:
          ``(1) The term `nonprescription drug' refers to a 
        drug not subject to the requirements of section 
        503(b)(1).
          ``(2) The term `sponsor' refers to any person 
        marketing, manufacturing, or processing a drug that--
                  ``(A) is listed pursuant to section 510(j); 
                and
                  ``(B) is or will be subject to an 
                administrative order under this section of the 
                Food and Drug Administration.
          ``(3) The term `requestor' refers to any person or 
        group of persons marketing, manufacturing, processing, 
        or developing a drug.''.
  (b) GAO Study.--Not later than 4 years after the date of 
enactment of this Act, the Comptroller General of the United 
States shall submit a study to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate addressing 
the effectiveness and overall impact of exclusivity under 
section 505G of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a), and section 586C of such Act (21 
U.S.C. 360fff-3), including the impact of such exclusivity on 
consumer access. Such study shall include--
          (1) an analysis of the impact of exclusivity under 
        such section 505G for nonprescription drug products, 
        including--
                  (A) the number of nonprescription drug 
                products that were granted exclusivity and the 
                indication for which the nonprescription drug 
                products were determined to be generally 
                recognized as safe and effective;
                  (B) whether the exclusivity for such drug 
                products was granted for--
                          (i) a new active ingredient 
                        (including any ester or salt of the 
                        active ingredient); or
                          (ii) changes in the conditions of use 
                        of a drug, for which new human data 
                        studies conducted or sponsored by the 
                        requestor were essential;
                  (C) whether, and to what extent, the 
                exclusivity impacted the requestor's or 
                sponsor's decision to develop the drug product;
                  (D) an analysis of the implementation of the 
                exclusivity provision in such section 505G, 
                including--
                          (i) the resources used by the Food 
                        and Drug Administration;
                          (ii) the impact of such provision on 
                        innovation, as well as research and 
                        development in the nonprescription drug 
                        market;
                          (iii) the impact of such provision on 
                        competition in the nonprescription drug 
                        market;
                          (iv) the impact of such provision on 
                        consumer access to nonprescription drug 
                        products;
                          (v) the impact of such provision on 
                        the prices of nonprescription drug 
                        products; and
                          (vi) whether the administrative 
                        orders initiated by requestors under 
                        such section 505G have been sufficient 
                        to encourage the development of 
                        nonprescription drug products that 
                        would likely not be otherwise 
                        developed, or developed in as timely a 
                        manner; and
                  (E) whether the administrative orders 
                initiated by requestors under such section 505G 
                have been sufficient incentive to encourage 
                innovation in the nonprescription drug market; 
                and
          (2) an analysis of the impact of exclusivity under 
        such section 586C for sunscreen ingredients, 
        including--
                  (A) the number of sunscreen ingredients that 
                were granted exclusivity and the specific 
                ingredient that was determined to be generally 
                recognized as safe and effective;
                  (B) whether, and to what extent, the 
                exclusivity impacted the requestor's or 
                sponsor's decision to develop the sunscreen 
                ingredient;
                  (C) whether, and to what extent, the 
                sunscreen ingredient granted exclusivity had 
                previously been available outside of the United 
                States;
                  (D) an analysis of the implementation of the 
                exclusivity provision in such section 586C, 
                including--
                          (i) the resources used by the Food 
                        and Drug Administration;
                          (ii) the impact of such provision on 
                        innovation, as well as research and 
                        development in the sunscreen market;
                          (iii) the impact of such provision on 
                        competition in the sunscreen market;
                          (iv) the impact of such provision on 
                        consumer access to sunscreen products;
                          (v) the impact of such provision on 
                        the prices of sunscreen products; and
                          (vi) whether the administrative 
                        orders initiated by requestors under 
                        such section 505G have been utilized by 
                        sunscreen ingredient sponsors and 
                        whether such process has been 
                        sufficient to encourage the development 
                        of sunscreen ingredients that would 
                        likely not be otherwise developed, or 
                        developed in as timely a manner; and
                  (E) whether the administrative orders 
                initiated by requestors under such section 586C 
                have been sufficient incentive to encourage 
                innovation in the sunscreen market.
  (c) Conforming Amendment.--Section 751(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379r(d)(1)) is 
amended--
          (1) in the matter preceding subparagraph (A)--
                  (A) by striking ``final regulation 
                promulgated'' and inserting ``final order under 
                section 505G''; and
                  (B) by striking ``and not misbranded''; and
          (2) in subparagraph (A), by striking ``regulation in 
        effect'' and inserting ``regulation or order in 
        effect''.

SEC. 372. MISBRANDING.

  Section 502 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) is amended by adding at the end the following:
  ``(ee) If it is a nonprescription drug that is subject to 
section 505G, is not the subject of an application approved 
under section 505, and does not comply with the requirements 
under section 505G.
  ``(ff) If it is a drug and it was manufactured, prepared, 
propagated, compounded, or processed in a facility for which 
fees have not been paid as required by section 744M.''.

SEC. 373. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG REVIEW.

  (a) In General.--Nothing in this Act (or the amendments made 
by this Act) shall apply to any nonprescription drug (as 
defined in section 505G(q) of the Federal Food, Drug, and 
Cosmetic Act, as added by section 1001 of this Act) which was 
excluded by the Food and Drug Administration from the Over-the-
Counter Drug Review in accordance with the paragraph numbered 
25 on page 9466 of volume 37 of the Federal Register, published 
on May 11, 1972.
  (b) Rule of Construction.--Nothing in this section shall be 
construed to preclude or limit the applicability of any other 
provision of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.).

SEC. 374. TREATMENT OF SUNSCREEN INNOVATION ACT.

  (a) Review of Nonprescription Sunscreen Active Ingredients.--
          (1) Applicability of section 505g for pending 
        submissions.--
                  (A) In general.--A sponsor of a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients that, as of the date of enactment 
                of this Act, is subject to a proposed sunscreen 
                order under section 586C of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360fff-3) may 
                elect, by means of giving written notification 
                to the Secretary of Health and Human Services 
                within 180 calendar days of the enactment of 
                this Act, to transition into the review of such 
                ingredient or combination of ingredients 
                pursuant to the process set out in section 505G 
                of the Federal Food, Drug, and Cosmetic Act, as 
                added by section 1001 of this Act.
                  (B) Election exercised.--Upon receipt by the 
                Secretary of Health and Human Services of a 
                timely notification under subparagraph (A)--
                          (i) the proposed sunscreen order 
                        involved is deemed to be a request for 
                        an order under subsection (b) of 
                        section 505G of the Federal Food, Drug, 
                        and Cosmetic Act, as added by section 
                        1001 of this Act; and
                          (ii) such order is deemed to have 
                        been accepted for filing under 
                        subsection (b)(6)(A)(i) of such section 
                        505G.
                  (C) Election not exercised.--If a 
                notification under subparagraph (A) is not 
                received by the Secretary of Health and Human 
                Services within 180 calendar days of the date 
                of enactment of this Act, the review of the 
                proposed sunscreen order described in 
                subparagraph (A)--
                          (i) shall continue under section 586C 
                        of the Federal Food, Drug, and Cosmetic 
                        Act (21 U.S.C. 360fff-3); and
                          (ii) shall not be eligible for review 
                        under section 505G, added by section 
                        1001 of this Act.
          (2) Definitions.--In this subsection, the terms 
        ``sponsor'', ``nonprescription'', ``sunscreen active 
        ingredient'', and ``proposed sunscreen order'' have the 
        meanings given to those terms in section 586 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360fff).
  (b) Amendments to Sunscreen Provisions.--
          (1) Final sunscreen orders.--Paragraph (3) of section 
        586C(e) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360fff-3(e)) is amended to read as follows:
          ``(3) Relationship to orders under section 505g.--A 
        final sunscreen order shall be deemed to be a final 
        order under section 505G.''.
          (2) Meetings.--Paragraph (7) of section 586C(b) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360fff-3(b)) is amended--
                  (A) by striking ``A sponsor may request'' and 
                inserting the following:
                  ``(A) In general.--A sponsor may request''; 
                and
                  (B) by adding at the end the following:
                  ``(B) Confidential meetings.--A sponsor may 
                request one or more confidential meetings with 
                respect to a proposed sunscreen order, 
                including a letter deemed to be a proposed 
                sunscreen order under paragraph (3), to discuss 
                matters relating to data requirements to 
                support a general recognition of safety and 
                effectiveness involving confidential 
                information and public information related to 
                such proposed sunscreen order, as appropriate. 
                The Secretary shall convene a confidential 
                meeting with such sponsor in a reasonable time 
                period. If a sponsor requests more than one 
                confidential meeting for the same proposed 
                sunscreen order, the Secretary may refuse to 
                grant an additional confidential meeting 
                request if the Secretary determines that such 
                additional confidential meeting is not 
                reasonably necessary for the sponsor to advance 
                its proposed sunscreen order, or if the request 
                for a confidential meeting fails to include 
                sufficient information upon which to base a 
                substantive discussion. The Secretary shall 
                publish a post-meeting summary of each 
                confidential meeting under this subparagraph 
                that does not disclose confidential commercial 
                information or trade secrets. This subparagraph 
                does not authorize the disclosure of 
                confidential commercial information or trade 
                secrets subject to 552(b)(4) of title 5, United 
                States Code, or section 1905 of title 18, 
                United States Code.''.
          (3) Exclusivity.--Section 586C of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360fff-3) is amended 
        by adding at the end the following:
  ``(f) Exclusivity.--
          ``(1) In general.--A final sunscreen order shall have 
        the effect of authorizing solely the order requestor 
        (or the licensees, assignees, or successors in interest 
        of such requestor with respect to the subject of such 
        request and listed under paragraph (5)) for a period of 
        18 months, to market a sunscreen ingredient under this 
        section incorporating changes described in paragraph 
        (2) subject to the limitations under paragraph (4), 
        beginning on the date the requestor (or any licensees, 
        assignees, or successors in interest of such requestor 
        with respect to the subject of such request and listed 
        under paragraph (5)) may lawfully market such sunscreen 
        ingredient pursuant to the order.
          ``(2) Changes described.--A change described in this 
        paragraph is a change subject to an order specified in 
        paragraph (1) that permits a sunscreen to contain an 
        active sunscreen ingredient not previously incorporated 
        in a marketed sunscreen listed in paragraph (3).
          ``(3) Marketed sunscreen.--The marketed sunscreen 
        ingredients described in this paragraph are sunscreen 
        ingredients--
                  ``(A) marketed in accordance with a final 
                monograph for sunscreen drug products set forth 
                at part 352 of title 21, Code of Federal 
                Regulations (as published at 64 Fed. Reg. 
                27687); or
                  ``(B) marketed in accordance with a final 
                order issued under this section.
          ``(4) Limitations on exclusivity.--Only one 18-month 
        period may be granted per ingredient under paragraph 
        (1).
          ``(5) Listing of licensees, assignees, or successors 
        in interest.--Requestors shall submit to the Secretary 
        at the time when a drug subject to such request is 
        introduced or delivered for introduction into 
        interstate commerce, a list of licensees, assignees, or 
        successors in interest under paragraph (1).''.
          (4) Sunset provision.--Subchapter I of chapter V of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360fff et seq.) is amended by adding at the end the 
        following:

``SEC. 586H. SUNSET.

  ``This subchapter shall cease to be effective at the end of 
fiscal year 2022.''.
          (5) Treatment of final sunscreen order.--The Federal 
        Food, Drug, and Cosmetic Act is amended by striking 
        section 586E of such Act (21 U.S.C. 360fff-5).
  (c) Treatment of Authority Regarding Finalization of 
Sunscreen Monograph.--
          (1) In general.--
                  (A) Revision of final sunscreen order.--Not 
                later than November 26, 2019, the Secretary of 
                Health and Human Services (referred to in this 
                subsection as the ``Secretary'') shall amend 
                and revise the final administrative order 
                concerning nonprescription sunscreen (referred 
                to in this subsection as the ``sunscreen 
                order'') for which the content, prior to the 
                date of enactment of this Act, was represented 
                by the final monograph for sunscreen drug 
                products set forth in part 352 of title 21, 
                Code of Federal Regulations (as in effect on 
                May 21, 1999).
                  (B) Issuance of revised sunscreen order; 
                effective date.--A revised sunscreen order 
                described in subparagraph (A) shall be--
                          (i) issued in accordance with the 
                        procedures described in section 
                        505G(c)(2) of the Federal Food, Drug, 
                        and Cosmetic Act;
                          (ii) issued in proposed form not 
                        later than May 28, 2019;
                          (iii) effective not later than 
                        November 26, 2020; and
                          (iv) issued by the Secretary at least 
                        1 year prior to the effective date of 
                        the revised order.
          (2) Reports.--If a revised sunscreen order issued 
        under paragraph (1) does not include provisions related 
        to the effectiveness of various sun protection factor 
        levels, and does not address all dosage forms known to 
        the Secretary to be used in sunscreens marketed in the 
        United States without a new drug application approved 
        under section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), the Secretary shall 
        submit a report to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on 
        Health, Education, Labor, and Pensions of the Senate on 
        the rationale for omission of such provisions from such 
        order, and a plan and timeline to compile any 
        information necessary to address such provisions 
        through such order.
  (d) Treatment of Non-sunscreen Time and Extent 
Applications.--
          (1) In general.--Any application described in section 
        586F of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360fff-6) that was submitted to the Secretary 
        pursuant to section 330.14 of title 21, Code of Federal 
        Regulations, as such provisions were in effect 
        immediately prior to the date of enactment date of this 
        Act, shall be extinguished as of such date of 
        enactment, subject to paragraph (2).
          (2) Order request.--Nothing in paragraph (1) 
        precludes the submission of an order request under 
        section 505G(b) of the Federal Food, Drug, and Cosmetic 
        Act, as added by section 1001 of this Act, with respect 
        to a drug that was the subject of an application 
        extinguished under paragraph (1).

SEC. 375. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC INDICATION 
                    FOR CERTAIN OTC COUGH AND COLD DRUGS.

  (a) In General.--Subject to subsection (c), the Secretary of 
Health and Human Services shall, beginning not later than 1 
year after the date of enactment of this Act, annually submit 
to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a letter describing the progress of 
the Food and Drug Administration--
          (1) in evaluating the cough and cold monograph 
        described in subsection (b) with respect to children 
        under age 6; and
          (2) as appropriate, revising such cough and cold 
        monograph to address such children through the order 
        process under section 505G(b) of the Federal Food, 
        Drug, and Cosmetic Act, as added by section 1001 of 
        this Act.
  (b) Cough and Cold Monograph Described.--The cough and cold 
monograph described in this subsection consists of the 
conditions under which nonprescription drugs containing 
antitussive, expectorant, nasal decongestant, or antihistamine 
active ingredients (or combinations thereof) are generally 
recognized as safe and effective, as specified in part 341 of 
title 21, Code of Federal Regulations (as in effect immediately 
prior to the date of enactment of this Act), and included in an 
order deemed to be established under section 505G(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 1001 
of this Act.
  (c) Duration of Authority.--The requirement under subsection 
(a) shall terminate as of the date of a letter submitted by the 
Secretary of Health and Human Services pursuant to such 
subsection in which the Secretary indicates that the Food and 
Drug Administration has completed its evaluation and revised, 
in a final order, as applicable, the cough and cold monograph 
as described in subsection (a)(2).

SEC. 376. TECHNICAL CORRECTIONS.

  (a) Imports and Exports.--Section 801(e)(4)(E)(iii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(e)(4)(E)(iii)) is amended by striking ``subparagraph'' each 
place such term appears and inserting ``paragraph''.
  (b) FDA Reauthorization Act of 2017.--
          (1) In general.--Section 905(b)(4) of the FDA 
        Reauthorization Act of 2017 (Public Law115-52) is 
        amended by striking ``Section 744H(e)(2)(B)'' and 
        inserting ``Section 744H(f)(2)(B)''.
          (2) Effective date.--The amendment made by paragraph 
        (1) shall take effect as of the enactment of the FDA 
        Reauthorization Act of 2017 (Public Law 115-52).

                           PART 2--USER FEES

SEC. 381. SHORT TITLE; FINDING.

  (a) Short Title.--This part may be cited as the ``Over-the-
Counter Monograph User Fee Act of 2019''.
  (b) Finding.--The Congress finds that the fees authorized by 
the amendments made in this part will be dedicated to OTC 
monograph drug activities, as set forth in the goals identified 
for purposes of part 10 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act, in the letters from the 
Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the 
Congressional Record.

SEC. 382. FEES RELATING TO OVER-THE-COUNTER DRUGS.

  Subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by inserting 
after part 9 the following:

           ``PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS

``SEC. 744L. DEFINITIONS.

  ``In this part:
          ``(1) The term `affiliate' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  ``(A) one business entity controls, or has 
                the power to control, the other business 
                entity; or
                  ``(B) a third party controls, or has power to 
                control, both of the business entities.
          ``(2) The term `contract manufacturing organization 
        facility' means an OTC monograph drug facility where 
        neither the owner of such manufacturing facility nor 
        any affiliate of such owner or facility sells the OTC 
        monograph drug produced at such facility directly to 
        wholesalers, retailers, or consumers in the United 
        States.
          ``(3) The term `costs of resources allocated for OTC 
        monograph drug activities' means the expenses in 
        connection with OTC monograph drug activities for--
                  ``(A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and costs related to contracts 
                with such contractors;
                  ``(B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  ``(C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  ``(D) collecting fees under section 744M and 
                accounting for resources allocated for OTC 
                monograph drug activities.
          ``(4) The term `FDA establishment identifier' is the 
        unique number automatically generated by Food and Drug 
        Administration's Field Accomplishments and Compliance 
        Tracking System (FACTS) (or any successor system).
          ``(5) The term `OTC monograph drug' means a 
        nonprescription drug without an approved new drug 
        application which is governed by the provisions of 
        section 505G.
          ``(6) The term `OTC monograph drug activities' means 
        activities of the Secretary associated with OTC 
        monograph drugs and inspection of facilities associated 
        with such products, including the following activities:
                  ``(A) The activities necessary for review and 
                evaluation of OTC monographs and OTC monograph 
                order requests, including--
                          ``(i) orders proposing or finalizing 
                        applicable conditions of use for OTC 
                        monograph drugs;
                          ``(ii) orders affecting status 
                        regarding general recognition of safety 
                        and effectiveness of an OTC monograph 
                        ingredient or combination of 
                        ingredients under specified conditions 
                        of use;
                          ``(iii) all OTC monograph drug 
                        development and review activities, 
                        including intra-agency collaboration;
                          ``(iv) regulation and policy 
                        development activities related to OTC 
                        monograph drugs;
                          ``(v) development of product 
                        standards for products subject to 
                        review and evaluation;
                          ``(vi) meetings referred to in 
                        section 505G(i);
                          ``(vii) review of labeling prior to 
                        issuance of orders related to OTC 
                        monograph drugs or conditions of use; 
                        and
                          ``(viii) regulatory science 
                        activities related to OTC monograph 
                        drugs.
                  ``(B) Inspections related to OTC monograph 
                drugs.
                  ``(C) Monitoring of clinical and other 
                research conducted in connection with OTC 
                monograph drugs.
                  ``(D) Safety activities with respect to OTC 
                monograph drugs, including--
                          ``(i) collecting, developing, and 
                        reviewing safety information on OTC 
                        monograph drugs, including adverse 
                        event reports;
                          ``(ii) developing and using improved 
                        adverse event data-collection systems, 
                        including information technology 
                        systems; and
                          ``(iii) developing and using improved 
                        analytical tools to assess potential 
                        safety risks, including access to 
                        external databases.
                  ``(E) Other activities necessary for 
                implementation of section 505G.
          ``(7) The term `OTC monograph order request' means a 
        request for an order submitted under section 
        505G(b)(5).
          ``(8) The term `Tier 1 OTC monograph order request' 
        means any OTC monograph order request not determined to 
        be a Tier 2 OTC monograph order request.
          ``(9)(A) The term `Tier 2 OTC monograph order 
        request' means, subject to subparagraph (B), an OTC 
        monograph order request for--
                  ``(i) the reordering of existing information 
                in the drug facts label of an OTC monograph 
                drug;
                  ``(ii) the addition of information to the 
                other information section of the drug facts 
                label of an OTC monograph drug, as limited by 
                section 201.66(c)(7) of title 21, Code of 
                Federal Regulations (or any successor 
                regulations);
                  ``(iii) modification to the directions for 
                use section of the drug facts label of an OTC 
                monograph drug, if such changes conform to 
                changes made pursuant to section 505G(c)(3)(A);
                  ``(iv) the standardization of the 
                concentration or dose of a specific finalized 
                ingredient within a particular finalized 
                monograph;
                  ``(v) a change to ingredient nomenclature to 
                align with nomenclature of a standards-setting 
                organization; or
                  ``(vi) addition of an interchangeable term in 
                accordance with section 330.1 of title 21, Code 
                of Federal Regulations (or any successor 
                regulations).
          ``(B) The Secretary may, based on program 
        implementation experience or other factors found 
        appropriate by the Secretary, characterize any OTC 
        monograph order request as a Tier 2 OTC monograph order 
        request (including recharacterizing a request from Tier 
        1 to Tier 2) and publish such determination in a 
        proposed order issued pursuant to section 505G.
          ``(10)(A) The term `OTC monograph drug facility' 
        means a foreign or domestic business or other entity 
        that--
                  ``(i) is--
                          ``(I) under one management, either 
                        direct or indirect; and
                          ``(II) at one geographic location or 
                        address engaged in manufacturing or 
                        processing the finished dosage form of 
                        an OTC monograph drug;
                  ``(ii) includes a finished dosage form 
                manufacturer facility in a contractual 
                relationship with the sponsor of one or more 
                OTC monograph drugs to manufacture or process 
                such drugs; and
                  ``(iii) does not include a business or other 
                entity whose only manufacturing or processing 
                activities are one or more of the following: 
                production of clinical research supplies, 
                testing, or placement of outer packaging on 
                packages containing multiple products, for such 
                purposes as creating multipacks, when each 
                monograph drug product contained within the 
                overpackaging is already in a final packaged 
                form prior to placement in the outer 
                overpackaging.
          ``(B) For purposes of subparagraph (A)(i)(II), 
        separate buildings or locations within close proximity 
        are considered to be at one geographic location or 
        address if the activities conducted in such buildings 
        or locations are--
                  ``(i) closely related to the same business 
                enterprise;
                  ``(ii) under the supervision of the same 
                local management; and
                  ``(iii) under a single FDA establishment 
                identifier and capable of being inspected by 
                the Food and Drug Administration during a 
                single inspection.
          ``(C) If a business or other entity would meet 
        criteria specified in subparagraph (A), but for being 
        under multiple management, the business or other entity 
        is deemed to constitute multiple facilities, one per 
        management entity, for purposes of this paragraph.
          ``(11) The term `OTC monograph drug meeting' means 
        any meeting regarding the content of a proposed OTC 
        monograph order request.
          ``(12) The term `person' includes an affiliate of a 
        person.
          ``(13) The terms `requestor' and `sponsor' have the 
        meanings given such terms in section 505G.

``SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.

  ``(a) Types of Fees.--Beginning with fiscal year 2019, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          ``(1) Facility fee.--
                  ``(A) In general.--Each person that owns a 
                facility identified as an OTC monograph drug 
                facility on December 31 of the fiscal year or 
                at any time during the preceding 12-month 
                period shall be assessed an annual fee for each 
                such facility as determined under subsection 
                (c).
                  ``(B) Exceptions.--
                          ``(i) A fee shall not be assessed 
                        under subparagraph (A) if the 
                        identified OTC monograph drug 
                        facility--
                                  ``(I) has ceased all 
                                activities related to OTC 
                                monograph drugs prior to 
                                January 31, 2019, for the first 
                                program year, and December 31 
                                of the fiscal year for 
                                subsequent fiscal years; and
                                  ``(II) has updated its 
                                registration to reflect such 
                                change under the requirements 
                                for drug establishment 
                                registration set forth in 
                                section 510.
                          ``(ii) The amount of the fee for a 
                        contract manufacturing organization 
                        facility shall be equal to two-thirds 
                        of the amount of the fee for an OTC 
                        monograph drug facility that is not a 
                        contract manufacturing organization 
                        facility.
                  ``(C) Amount.--The amount of fees established 
                under subparagraph (A) shall be established 
                under subsection (c).
                  ``(D) Due date.--
                          ``(i) For first program year.--For 
                        fiscal year 2019, the facility fees 
                        required under subparagraph (A) shall 
                        be due 45 calendar days after 
                        publication of the Federal Register 
                        notice provided for under subsection 
                        (c)(4)(A).
                          ``(ii) Subsequent fiscal years.--For 
                        each fiscal year after fiscal year 
                        2019, the facility fees required under 
                        subparagraph (A) shall be due on the 
                        later of--
                                  ``(I) the first business day 
                                of June of such year; or
                                  ``(II) the first business day 
                                after the enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section for such year.
          ``(2) OTC monograph order request fee.--
                  ``(A) In general.--Each person that submits 
                an OTC monograph order request shall be subject 
                to a fee for an OTC monograph order request. 
                The amount of such fee shall be--
                          ``(i) for a Tier 1 OTC monograph 
                        order request, $500,000, adjusted for 
                        inflation for the fiscal year (as 
                        determined under subsection (c)(1)(B)); 
                        and
                          ``(ii) for a Tier 2 OTC monograph 
                        order request, $100,000 adjusted for 
                        inflation for the fiscal year (as 
                        determined under subsection (c)(1)(B)).
                  ``(B) Due date.--The OTC monograph order 
                request fees required under subparagraph (A) 
                shall be due on the date of submission of the 
                OTC monograph order request.
                  ``(C) Exception for certain safety changes.--
                A person who is named as the requestor in an 
                OTC monograph order shall not be subject to a 
                fee under subparagraph (A) if the Secretary 
                finds that the OTC monograph order request 
                seeks to change the drug facts labeling of an 
                OTC monograph drug in a way that would add to 
                or strengthen--
                          ``(i) a contraindication, warning, or 
                        precaution;
                          ``(ii) a statement about risk 
                        associated with misuse or abuse; or
                          ``(iii) an instruction about dosage 
                        and administration that is intended to 
                        increase the safe use of the OTC 
                        monograph drug.
                  ``(D) Refund of fee if order request is 
                recategorized as a tier 2 otc monograph order 
                request.--If the Secretary determines that an 
                OTC monograph request initially characterized 
                as Tier 1 shall be re-characterized as a Tier 2 
                OTC monograph order request, and the requestor 
                has paid a Tier 1 fee in accordance with 
                subparagraph (A)(i), the Secretary shall refund 
                the requestor the difference between the Tier 1 
                and Tier 2 fees determined under subparagraphs 
                (A)(i) and (A)(ii), respectively.
                  ``(E) Refund of fee if order request refused 
                for filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee 
                paid under subparagraph (B) for any order 
                request which is refused for filing or was 
                withdrawn before being accepted or refused for 
                filing.
                  ``(F) Fees for order requests previously 
                refused for filing or withdrawn before 
                filing.--An OTC monograph order request that 
                was submitted but was refused for filing, or 
                was withdrawn before being accepted or refused 
                for filing, shall be subject to the full fee 
                under subparagraph (A) upon being resubmitted 
                or filed over protest.
                  ``(G) Refund of fee if order request 
                withdrawn.--If an order request is withdrawn 
                after the order request was filed, the 
                Secretary may refund the fee or a portion of 
                the fee if no substantial work was performed on 
                the order request after the application was 
                filed. The Secretary shall have the sole 
                discretion to refund a fee or a portion of the 
                fee under this subparagraph. A determination by 
                the Secretary concerning a refund under this 
                subparagraph shall not be reviewable.
          ``(3) Refunds.--
                  ``(A) In general.--Other than refunds 
                provided pursuant to any of subparagraphs (D) 
                through (G) of paragraph (2), the Secretary 
                shall not refund any fee paid under paragraph 
                (1) except as provided in subparagraph (B).
                  ``(B) Disputes concerning fees.--To qualify 
                for the return of a fee claimed to have been 
                paid in error under paragraph (1) or (2), a 
                person shall submit to the Secretary a written 
                request justifying such return within 180 
                calendar days after such fee was paid.
          ``(4) Notice.--Within the timeframe specified in 
        subsection (c), the Secretary shall publish in the 
        Federal Register the amount of the fees under paragraph 
        (1) for such fiscal year.
  ``(b) Fee Revenue Amounts.--
          ``(1) Fiscal year 2019.--For fiscal year 2019, fees 
        under subsection (a)(1) shall be established to 
        generate a total facility fee revenue amount equal to 
        the sum of--
                  ``(A) the annual base revenue for fiscal year 
                2019 (as determined under paragraph (3));
                  ``(B) the dollar amount equal to the 
                operating reserve adjustment for the fiscal 
                year, if applicable (as determined under 
                subsection (c)(2)); and
                  ``(C) additional direct cost adjustments (as 
                determined under subsection (c)(3)).
          ``(2) Subsequent fiscal years.--For each of the 
        fiscal years 2020 through 2023, fees under subsection 
        (a)(1) shall be established to generate a total 
        facility fee revenue amount equal to the sum of--
                  ``(A) the annual base revenue for the fiscal 
                year (as determined under paragraph (3));
                  ``(B) the dollar amount equal to the 
                inflation adjustment for the fiscal year (as 
                determined under subsection (c)(1));
                  ``(C) the dollar amount equal to the 
                operating reserve adjustment for the fiscal 
                year, if applicable (as determined under 
                subsection (c)(2));
                  ``(D) additional direct cost adjustments (as 
                determined under subsection (c)(3)); and
                  ``(E) additional dollar amounts for each 
                fiscal year as follows:
                          ``(i) $7,000,000 for fiscal year 
                        2020.
                          ``(ii) $6,000,000 for fiscal year 
                        2021.
                          ``(iii) $7,000,000 for fiscal year 
                        2022.
                          ``(iv) $3,000,000 for fiscal year 
                        2023.
          ``(3) Annual base revenue.--For purposes of 
        paragraphs (1)(A) and (2)(A), the dollar amount of the 
        annual base revenue for a fiscal year shall be--
                  ``(A) for fiscal year 2019, $8,000,000; and
                  ``(B) for fiscal years 2020 through 2023, the 
                dollar amount of the total revenue amount 
                established under this subsection for the 
                previous fiscal year, not including any 
                adjustments made under subsection (c)(2) or 
                (c)(3).
  ``(c) Adjustments; Annual Fee Setting.--
          ``(1) Inflation adjustment.--
                  ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for 
                fiscal year 2020 and each subsequent fiscal 
                year shall be equal to the product of--
                          ``(i) such annual base revenue for 
                        the fiscal year under subsection 
                        (b)(2); and
                          ``(ii) the inflation adjustment 
                        percentage under subparagraph (C).
                  ``(B) OTC monograph order request fees.--For 
                purposes of subsection (a)(2), the dollar 
                amount of the inflation adjustment to the fee 
                for OTC monograph order requests for fiscal 
                year 2020 and each subsequent fiscal year shall 
                be equal to the product of--
                          ``(i) the applicable fee under 
                        subsection (a)(2) for the preceding 
                        fiscal year; and
                          ``(ii) the inflation adjustment 
                        percentage under subparagraph (C).
                  ``(C) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to--
                          ``(i) for each of fiscal years 2020 
                        and 2021, the average annual percent 
                        change that occurred in the Consumer 
                        Price Index for urban consumers 
                        (Washington-Baltimore, DC-MD-VA-WV; Not 
                        Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the 
                        preceding 4 years of available data; 
                        and
                          ``(ii) for each of fiscal years 2022 
                        and 2023, the sum of--
                                  ``(I) the average annual 
                                percent change in the cost, per 
                                full-time equivalent position 
                                of the Food and Drug 
                                Administration, of all 
                                personnel compensation and 
                                benefits paid with respect to 
                                such positions for the first 3 
                                years of the preceding 4 fiscal 
                                years, multiplied by the 
                                proportion of personnel 
                                compensation and benefits costs 
                                to total costs of OTC monograph 
                                drug activities for the first 3 
                                years of the preceding 4 fiscal 
                                years; and
                                  ``(II) the average annual 
                                percent change that occurred in 
                                the Consumer Price Index for 
                                urban consumers (Washington-
                                Baltimore, DC-MD-VA-WV; Not 
                                Seasonally Adjusted; All items; 
                                Annual Index) for the first 3 
                                years of the preceding 4 years 
                                of available data multiplied by 
                                the proportion of all costs 
                                other than personnel 
                                compensation and benefits costs 
                                to total costs of OTC monograph 
                                drug activities for the first 3 
                                years of the preceding 4 fiscal 
                                years.
          ``(2) Operating reserve adjustment.--
                  ``(A) In general.--For fiscal year 2019 and 
                subsequent fiscal years, for purposes of 
                subsections (b)(1)(B) and (b)(2)(C), the 
                Secretary may, in addition to adjustments under 
                paragraph (1), further increase the fee revenue 
                and fees if such an adjustment is necessary to 
                provide operating reserves of carryover user 
                fees for OTC monograph drug activities for not 
                more than the number of weeks specified in 
                subparagraph (B).
                  ``(B) Number of weeks.--The number of weeks 
                specified in this subparagraph is--
                          ``(i) 3 weeks for fiscal year 2019;
                          ``(ii) 7 weeks for fiscal year 2020;
                          ``(iii) 10 weeks for fiscal year 
                        2021;
                          ``(iv) 10 weeks for fiscal year 2022; 
                        and
                          ``(v) 10 weeks for fiscal year 2023.
                  ``(C) Decrease.--If the Secretary has 
                carryover balances for such process in excess 
                of 10 weeks of the operating reserves referred 
                to in subparagraph (A), the Secretary shall 
                decrease the fee revenue and fees referred to 
                in such subparagraph to provide for not more 
                than 10 weeks of such operating reserves.
                  ``(D) Rationale for adjustment.--If an 
                adjustment under this paragraph is made, the 
                rationale for the amount of the increase or 
                decrease (as applicable) in fee revenue and 
                fees shall be contained in the annual Federal 
                Register notice under paragraph (4) 
                establishing fee revenue and fees for the 
                fiscal year involved.
          ``(3) Additional direct cost adjustment.--The 
        Secretary shall, in addition to adjustments under 
        paragraphs (1) and (2), further increase the fee 
        revenue and fees for purposes of subsection (b)(2)(D) 
        by an amount equal to--
                  ``(A) $14,000,000 for fiscal year 2019;
                  ``(B) $7,000,000 for fiscal year 2020;
                  ``(C) $4,000,000 for fiscal year 2021;
                  ``(D) $3,000,000 for fiscal year 2022; and
                  ``(E) $3,000,000 for fiscal year 2023.
          ``(4) Annual fee setting.--
                  ``(A) Fiscal year 2019.--The Secretary shall, 
                not later than the second Monday in March of 
                2019--
                          ``(i) establish OTC monograph drug 
                        facility fees for fiscal year 2019 
                        under subsection (a), based on the 
                        revenue amount for such year under 
                        subsection (b) and the adjustments 
                        provided under this subsection; and
                          ``(ii) publish fee revenue, facility 
                        fees, and OTC monograph order requests 
                        in the Federal Register.
                  ``(B) Subsequent fiscal years.--The Secretary 
                shall, not later than the second Monday in 
                March of each fiscal year that begins after 
                September 30, 2019--
                          ``(i) establish for each such fiscal 
                        year, based on the revenue amounts 
                        under subsection (b) and the 
                        adjustments provided under this 
                        subsection--
                                  ``(I) OTC monograph drug 
                                facility fees under subsection 
                                (a)(1); and
                                  ``(II) OTC monograph order 
                                request fees under subsection 
                                (a)(2); and
                          ``(ii) publish such fee revenue 
                        amounts, facility fees, and OTC 
                        monograph order request fees in the 
                        Federal Register.
  ``(d) Identification of Facilities.--Each person that owns an 
OTC monograph drug facility shall submit to the Secretary the 
information required under this subsection each year. Such 
information shall, for each fiscal year--
          ``(1) be submitted as part of the requirements for 
        drug establishment registration set forth in section 
        510; and
          ``(2) include for each such facility, at a minimum, 
        identification of the facility's business operation as 
        that of an OTC monograph drug facility.
  ``(e) Effect of Failure To Pay Fees.--
          ``(1) OTC monograph drug facility fee.--
                  ``(A) In general.--Failure to pay the fee 
                under subsection (a)(1) within 20 calendar days 
                of the due date as specified in subparagraph 
                (D) of such subsection shall result in the 
                following:
                          ``(i) The Secretary shall place the 
                        facility on a publicly available 
                        arrears list.
                          ``(ii) All OTC monograph drugs 
                        manufactured in such a facility or 
                        containing an ingredient manufactured 
                        in such a facility shall be deemed 
                        misbranded under section 502(ff).
                  ``(B) Application of penalties.--The 
                penalties under this paragraph shall apply 
                until the fee established by subsection (a)(1) 
                is paid.
          ``(2) Order requests.--An OTC monograph order request 
        submitted by a person subject to fees under subsection 
        (a) shall be considered incomplete and shall not be 
        accepted for filing by the Secretary until all fees 
        owed by such person under this section have been paid.
          ``(3) Meetings.--A person subject to fees under this 
        section shall be considered ineligible for OTC 
        monograph drug meetings until all such fees owed by 
        such person have been paid.
  ``(f) Crediting and Availability of Fees.--
          ``(1) In general.--Fees authorized under subsection 
        (a) shall be collected and available for obligation 
        only to the extent and in the amount provided in 
        advance in appropriations Acts. Such fees are 
        authorized to remain available until expended.
          ``(2) Collections and appropriation acts.--
                  ``(A) In general.--Subject to subparagraph 
                (C), the fees authorized by this section shall 
                be collected and available in each fiscal year 
                in an amount not to exceed the amount specified 
                in appropriation Acts, or otherwise made 
                available for obligation, for such fiscal year.
                  ``(B) Use of fees and limitation.--The fees 
                authorized by this section shall be available 
                to defray increases in the costs of the 
                resources allocated for OTC monograph drug 
                activities (including increases in such costs 
                for an additional number of full-time 
                equivalent positions in the Department of 
                Health and Human Services to be engaged in such 
                activities), only if the Secretary allocates 
                for such purpose an amount for such fiscal year 
                (excluding amounts from fees collected under 
                this section) no less than $12,000,000, 
                multiplied by the adjustment factor applicable 
                to the fiscal year involved under subsection 
                (c)(1).
                  ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (B) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for OTC monograph drug activities are not more 
                than 15 percent below the level specified in 
                such subparagraph.
                  ``(D) Provision for early payments in 
                subsequent years.--Payment of fees authorized 
                under this section for a fiscal year (after 
                fiscal year 2019), prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          ``(3) Authorization of appropriations.--For each of 
        the fiscal years 2019 through 2023, there is authorized 
        to be appropriated for fees under this section an 
        amount equal to the total amount of fees assessed for 
        such fiscal year under this section.
  ``(g) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 calendar days after it is due, such 
fee shall be treated as a claim of the United States Government 
subject to subchapter II of chapter 37 of title 31, United 
States Code.
  ``(h) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in OTC monograph 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.

``SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.

  ``(a) Performance Report.--Beginning with fiscal year 2019, 
and not later than 120 calendar days after the end of each 
fiscal year thereafter for which fees are collected under this 
part, the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 2001(b) of the Over-the-Counter Monograph 
Safety, Innovation, and Reform Act of 2019 during such fiscal 
year and the future plans of the Food and Drug Administration 
for meeting such goals.
  ``(b) Fiscal Report.--Not later than 120 calendar days after 
the end of fiscal year 2019 and each subsequent fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  ``(c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the internet website of the Food and Drug 
Administration.
  ``(d) Reauthorization.--
          ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals 
        described in subsection (a), and plans for meeting the 
        goals, for OTC monograph drug activities for the first 
        5 fiscal years after fiscal year 2023, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  ``(A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  ``(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  ``(C) scientific and academic experts;
                  ``(D) health care professionals;
                  ``(E) representatives of patient and consumer 
                advocacy groups; and
                  ``(F) the regulated industry.
          ``(2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  ``(A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  ``(B) publish such recommendations in the 
                Federal Register;
                  ``(C) provide for a period of 30 calendar 
                days for the public to provide written comments 
                on such recommendations;
                  ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  ``(E) after consideration of such public 
                views and comments, revise such recommendations 
                as necessary.
          ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2023, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (2), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and 
        comments.''.

                      Subtitle I--Other Provisions


SEC. 391. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS.

  Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 
262(k)(7)) is amended by adding at the end the following:
                  ``(D) Deemed licenses.--
                          ``(i) No additional exclusivity 
                        through deeming.--An approved 
                        application that is deemed to be a 
                        license for a biological product under 
                        this section pursuant to section 
                        7002(e)(4) of the Biologics Price 
                        Competition and Innovation Act of 2009 
                        shall not be treated as having been 
                        first licensed under subsection (a) for 
                        purposes of subparagraphs (A) and (B).
                          ``(ii) Application of limitations on 
                        exclusivity.--Subparagraph (C) shall 
                        apply with respect to a reference 
                        product referred to in such 
                        subparagraph that was the subject of an 
                        approved application that was deemed to 
                        be a license pursuant to section 
                        7002(e)(4) of the Biologics Price 
                        Competition and Innovation Act of 2009.
                          ``(iii) Applicability.--The 
                        exclusivity periods described in 
                        section 527, section 505A(b)(1)(A)(ii), 
                        and section 505A(c)(1)(A)(ii) of the 
                        Federal Food, Drug, and Cosmetic Act 
                        shall continue to apply to a biological 
                        product after an approved application 
                        for the biological product is deemed to 
                        be a license for the biological product 
                        under subsection (a) pursuant to 
                        section 7002(e)(4) of the Biologics 
                        Price Competition and Innovation Act of 
                        2009.''.

SEC. 392. ORPHAN DRUG CLARIFICATION.

  Section 527(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360cc(c)) is amended by adding at the end the 
following:
          ``(3) Applicability.--This subsection applies to any 
        drug designated under section 526 for which an 
        application was approved under section 505 of this Act 
        or licensed under section 351 of the Public Health 
        Service Act after the date of enactment of the FDA 
        Reauthorization Act of 2017, regardless of the date on 
        which such drug was designated under section 526.''.

SEC. 393. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

  Section 351(k)(2)(A)(iii) of the Public Health Service Act 
(42 U.S.C. 262(k)(2)(A)(iii) is amended--
          (1) in subclause (I), by striking ``; and'' and 
        inserting a semicolon;
          (2) in subclause (II), by striking the period and 
        inserting ``; and'' ; and
          (3) by adding at the end the following:
                                  ``(III) may include 
                                information to show that the 
                                conditions of use prescribed, 
                                recommended, or suggested in 
                                the labeling proposed for the 
                                biological product have been 
                                previously approved for the 
                                reference product.''.

SEC. 394. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

  Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended--
          (1) in section 505 (21 U.S.C. 355)--
                  (A) in subsection (c)(3)(E)--
                          (i) in clause (ii), by striking 
                        ``active ingredient (including any 
                        ester or salt of the active 
                        ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in 
                        section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations))''; and
                          (ii) in clause (iii), by striking 
                        ``active ingredient (including any 
                        ester or salt of the active 
                        ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in 
                        section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations))'';
                  (B) in subsection (j)(5)(F)--
                          (i) in clause (ii), by striking 
                        ``active ingredient (including any 
                        ester or salt of the active 
                        ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in 
                        section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations))''; and
                          (ii) in clause (iii), by striking 
                        ``active ingredient (including any 
                        ester or salt of the active 
                        ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in 
                        section 314.3 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations))'';
                  (C) in subsection (l)(2)(A)(i), by striking 
                ``active ingredient (including any ester or 
                salt of the active ingredient)'' and inserting 
                ``active moiety (as defined by the Secretary in 
                section 314.3 of title 21, Code of Federal 
                Regulations (or any successor regulations))'';
                  (D) in subsection (s), in the matter 
                preceding paragraph (1), by striking ``active 
                ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active 
                moiety (as defined by the Secretary in section 
                314.3 of title 21, Code of Federal Regulations 
                (or any successor regulations))''; and
                  (E) in subsection (u)(1), in the matter 
                preceding subparagraph (A)--
                          (i) by striking ``active ingredient 
                        (including any ester or salt of the 
                        active ingredient)'' and inserting 
                        ``active moiety (as defined by the 
                        Secretary in section 314.3 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulations))''; and
                          (ii) by striking ``same active 
                        ingredient'' and inserting ``same 
                        active moiety'';
          (2) in section 512(c)(2)(F) (21 U.S.C. 
        360b(c)(2)(F))--
                  (A) in clause (i), by striking ``active 
                ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active 
                moiety (as defined by the Secretary in section 
                314.3 of title 21, Code of Federal Regulations 
                (or any successor regulations))'';
                  (B) in clause (ii), by striking ``active 
                ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active 
                moiety (as defined by the Secretary in section 
                314.3 of title 21, Code of Federal Regulations 
                (or any successor regulations))''; and
                  (C) in clause (v), by striking ``active 
                ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active 
                moiety (as defined by the Secretary in section 
                314.3 of title 21, Code of Federal Regulations 
                (or any successor regulations))'';
          (3) in section 524(a)(4)(C) (21 U.S.C. 
        360n(a)(4)(C)), by striking ``active ingredient 
        (including any ester or salt of the active 
        ingredient)'' and inserting ``active moiety (as defined 
        by the Secretary in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations))'';
          (4) in section 529(a)(4)(A)(ii) (21 U.S.C. 
        360ff(a)(4)(A)(ii)), by striking ``active ingredient 
        (including any ester or salt of the active 
        ingredient)'' and inserting ``active moiety (as defined 
        by the Secretary in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations))''; 
        and
          (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb-
        4a(a)(4)(D)), by striking ``active ingredient 
        (including any ester or salt of the active 
        ingredient)'' and inserting ``active moiety (as defined 
        by the Secretary in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations))''.

                      TITLE IV--REVENUE PROVISIONS


SEC. 401. PERMANENT EXTENSION OF REDUCTION IN MEDICAL EXPENSE DEDUCTION 
                    FLOOR.

  (a) In General.--Section 213(a) of the Internal Revenue Code 
of 1986 is amended by striking ``10 percent'' and inserting 
``7.5 percent''.
  (b) Conforming Amendments.--
          (1) Section 213 of such Code is amended by striking 
        subsection (f).
          (2) Section 56(b)(1) of such Code is amended by 
        striking subparagraph (B) and by redesignating 
        subparagraphs (C), (D), (E), and (F), as subparagraphs 
        (B), (C), (D), and (E), respectively.
  (c) Effective Date.--The amendment made by this section shall 
apply to taxable years ending after December 31, 2018.

SEC. 402. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH PLANS WITHOUT 
                    DEDUCTIBLE FOR INSULIN.

  (a) In General.--Section 223(c)(2)(C) of the Internal Revenue 
Code of 1986 is amended by inserting ``or for insulin or any 
device for the delivery of insulin'' before the period at the 
end.
  (b) Effective Date.--The amendment made by this section shall 
apply to months beginning after the date of the enactment of 
this Act.

SEC. 403. INCLUSION OF CERTAIN OVER-THE-COUNTER MEDICAL PRODUCTS AS 
                    QUALIFIED MEDICAL EXPENSES.

  (a) HSAs.--Section 223(d)(2) of the Internal Revenue Code of 
1986 is amended--
          (1) by striking the last sentence of subparagraph (A) 
        and inserting the following: ``For purposes of this 
        subparagraph, amounts paid for menstrual care products 
        shall be treated as paid for medical care.''; and
          (2) by adding at the end the following new 
        subparagraph:
                  ``(D) Menstrual care product.--For purposes 
                of this paragraph, the term `menstrual care 
                product' means a tampon, pad, liner, cup, 
                sponge, or similar product used by individuals 
                with respect to menstruation or other genital-
                tract secretions.''.
  (b) Archer MSAs.--Section 220(d)(2)(A) of such Code is 
amended by striking the last sentence and inserting the 
following: ``For purposes of this subparagraph, amounts paid 
for menstrual care products (as defined in section 
223(d)(2)(D)) shall be treated as paid for medical care.''.
  (c) Health Flexible Spending Arrangements and Health 
Reimbursement Arrangements.--Section 106 of such Code is 
amended by striking subsection (f) and inserting the following 
new subsection:
  ``(f) Reimbursements for Menstrual Care Products.--For 
purposes of this section and section 105, expenses incurred for 
menstrual care products (as defined in section 223(d)(2)(D)) 
shall be treated as incurred for medical care.''.
  (d) Effective Dates.--
          (1) Distributions from savings accounts.--The 
        amendment made by subsections (a) and (b) shall apply 
        to amounts paid after December 31, 2019.
          (2) Reimbursements.--The amendment made by subsection 
        (c) shall apply to expenses incurred after December 31, 
        2019.

                         TITLE V--MISCELLANEOUS


SEC. 501. PAYMENT FOR BIOSIMILAR BIOLOGICAL PRODUCTS DURING INITIAL 
                    PERIOD.

  Section 1847A(c)(4) of the Social Security Act (42 U.S.C. 
1395w-3a(c)(4)) is amended--
          (1) in each of subparagraphs (A) and (B), by 
        redesignating clauses (i) and (ii) as subclauses (I) 
        and (II), respectively, and moving such subclauses 2 
        ems to the right;
          (2) by redesignating subparagraphs (A) and (B) as 
        clauses (i) and (ii) and moving such clauses 2 ems to 
        the right;
          (3) by striking ``unavailable.--In the case'' and 
        inserting ``unavailable.--
                  ``(A) In general.--Subject to subparagraph 
                (B), in the case''; and
          (4) by adding at the end the following new 
        subparagraph:
                  ``(B) Limitation on payment amount for 
                biosimilar biological products during initial 
                period.--In the case of a biosimilar biological 
                product furnished on or after July 1, 2020, in 
                lieu of applying subparagraph (A) during the 
                initial period described in such subparagraph 
                with respect to the biosimilar biological 
                product, the amount payable under this section 
                for the biosimilar biological product is the 
                lesser of the following:
                          ``(i) The amount determined under 
                        clause (ii) of such subparagraph for 
                        the biosimilar biological product.
                          ``(ii) The amount determined under 
                        subsection (b)(1)(B) for the reference 
                        biological product.''.

SEC. 502. GAO STUDY AND REPORT ON AVERAGE SALES PRICE.

  (a) Study.--
          (1) In general.--The Comptroller General of the 
        United States (in this section referred to as the 
        ``Comptroller General'') shall conduct a study on 
        spending for applicable drugs under part B of title 
        XVIII of the Social Security Act.
          (2) Applicable drugs defined.--In this section, the 
        term ``applicable drugs'' means drugs and biologicals--
                  (A) for which reimbursement under such part B 
                is based on the average sales price of the drug 
                or biological; and
                  (B) that account for the largest percentage 
                of total spending on drugs and biologicals 
                under such part B (as determined by the 
                Comptroller General, but in no case less that 
                25 drugs or biologicals).
          (3) Requirements.--The study under paragraph (1) 
        shall include an analysis of the following:
                  (A) The extent to which each applicable drug 
                is paid for--
                          (i) under such part B for Medicare 
                        beneficiaries; or
                          (ii) by private payers in the 
                        commercial market.
                  (B) Any change in Medicare spending or 
                Medicare beneficiary cost-sharing that would 
                occur if the average sales price of an 
                applicable drug was based solely on payments by 
                private payers in the commercial market.
                  (C) The extent to which drug manufacturers 
                provide rebates, discounts, or other price 
                concessions to private payers in the commercial 
                market for applicable drugs, which the 
                manufacturer includes in its average sales 
                price calculation, for--
                          (i) formulary placement;
                          (ii) utilization management 
                        considerations; or
                          (iii) other purposes.
                  (D) Barriers to drug manufacturers providing 
                such price concessions for applicable drugs.
                  (E) Other areas determined appropriate by the 
                Comptroller General.
  (b) Report.--Not later than 2 years after the date of the 
enactment of this Act, the Comptroller General shall submit to 
Congress a report on the study conducted under subsection (a), 
together with recommendations for such legislation and 
administrative action as the Secretary determines appropriate.

SEC. 503. REQUIRING PRESCRIPTION DRUG PLANS AND MA-PD PLANS TO REPORT 
                    POTENTIAL FRAUD, WASTE, AND ABUSE TO THE SECRETARY 
                    OF HHS.

  Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-
104) is amended by adding at the end the following new 
subsection:
  ``(p) Reporting Potential Fraud, Waste, and Abuse.--Beginning 
January 1, 2021, the PDP sponsor of a prescription drug plan 
shall report to the Secretary, as specified by the Secretary--
          ``(1) any substantiated or suspicious activities (as 
        defined by the Secretary) with respect to the program 
        under this part as it relates to fraud, waste, and 
        abuse; and
          ``(2) any steps made by the PDP sponsor after 
        identifying such activities to take corrective 
        actions.''.

SEC. 504. ESTABLISHMENT OF PHARMACY QUALITY MEASURES UNDER MEDICARE 
                    PART D.

  Section 1860D-4(c) of the Social Security Act (42 U.S.C. 
1395w-104(c)) is amended by adding at the end the following new 
paragraph:
          ``(8) Application of pharmacy quality measures.--
                  ``(A) In general.--A PDP sponsor that 
                implements incentive payments to a pharmacy or 
                price concessions paid by a pharmacy based on 
                quality measures shall use measures established 
                or approved by the Secretary under subparagraph 
                (B) with respect to payment for covered part D 
                drugs dispensed by such pharmacy.
                  ``(B) Standard pharmacy quality measures.--
                The Secretary shall establish or approve 
                standard quality measures from a consensus and 
                evidence-based organization for payments 
                described in subparagraph (A). Such measures 
                shall focus on patient health outcomes and be 
                based on proven criteria measuring pharmacy 
                performance.
                  ``(C) Effective date.--The requirement under 
                subparagraph (A) shall take effect for plan 
                years beginning on or after January 1, 2023, or 
                such earlier date specified by the Secretary if 
                the Secretary determines there are sufficient 
                measures established or approved under 
                subparagraph (B) to meet the requirement under 
                subparagraph (A).''.

SEC. 505. IMPROVING COORDINATION BETWEEN THE FOOD AND DRUG 
                    ADMINISTRATION AND THE CENTERS FOR MEDICARE & 
                    MEDICAID SERVICES.

  (a) In General.--
          (1) Public meeting.--
                  (A) In general.--Not later than 12 months 
                after the date of the enactment of this Act, 
                the Secretary of Health and Human Services 
                (referred to in this section as the 
                ``Secretary'') shall convene a public meeting 
                for the purposes of discussing and providing 
                input on improvements to coordination between 
                the Food and Drug Administration and the 
                Centers for Medicare & Medicaid Services in 
                preparing for the availability of novel medical 
                products described in subsection (c) on the 
                market in the United States.
                  (B) Attendees.--The public meeting shall 
                include--
                          (i) representatives of relevant 
                        Federal agencies, including 
                        representatives from each of the 
                        medical product centers within the Food 
                        and Drug Administration and 
                        representatives from the coding, 
                        coverage, and payment offices within 
                        the Centers for Medicare & Medicaid 
                        Services;
                          (ii) stakeholders with expertise in 
                        the research and development of novel 
                        medical products, including 
                        manufacturers of such products;
                          (iii) representatives of commercial 
                        health insurance payers;
                          (iv) stakeholders with expertise in 
                        the administration and use of novel 
                        medical products, including physicians; 
                        and
                          (v) stakeholders representing 
                        patients and with expertise in the 
                        utilization of patient experience data 
                        in medical product development.
                  (C) Topics.--The public meeting shall include 
                a discussion of--
                          (i) the status of the drug and 
                        medical device development pipeline 
                        related to the availability of novel 
                        medical products;
                          (ii) the anticipated expertise 
                        necessary to review the safety and 
                        effectiveness of such products at the 
                        Food and Drug Administration and 
                        current gaps in such expertise, if any;
                          (iii) the expertise necessary to make 
                        coding, coverage, and payment decisions 
                        with respect to such products within 
                        the Centers for Medicare & Medicaid 
                        Services, and current gaps in such 
                        expertise, if any;
                          (iv) trends in the differences in the 
                        data necessary to determine the safety 
                        and effectiveness of a novel medical 
                        product and the data necessary to 
                        determine whether a novel medical 
                        product meets the reasonable and 
                        necessary requirements for coverage and 
                        payment under title XVIII of the Social 
                        Security Act pursuant to section 
                        1862(a)(1)(A) of such Act (42 U.S.C. 
                        1395y(a)(1)(A));
                          (v) the availability of information 
                        for sponsors of such novel medical 
                        products to meet each of those 
                        requirements; and
                          (vi) the coordination of information 
                        related to significant clinical 
                        improvement over existing therapies for 
                        patients between the Food and Drug 
                        Administration and the Centers for 
                        Medicare & Medicaid Services with 
                        respect to novel medical products.
                  (D) Trade secrets and confidential 
                information.--No information discussed as a 
                part of the public meeting under this paragraph 
                shall be construed as authorizing the Secretary 
                to disclose any information that is a trade 
                secret or confidential information subject to 
                section 552(b)(4) of title 5, United States 
                Code.
          (2) Improving transparency of criteria for medicare 
        coverage.--
                  (A) Draft guidance.--Not later than 18 months 
                after the public meeting under paragraph (1), 
                the Secretary shall update the final guidance 
                titled ``National Coverage Determinations with 
                Data Collection as a Condition of Coverage: 
                Coverage with Evidence Development'' to address 
                any opportunities to improve the availability 
                and coordination of information as described in 
                clauses (iv) through (vi) of paragraph (1)(C).
                  (B) Final guidance.--Not later than 12 months 
                after issuing draft guidance under subparagraph 
                (A), the Secretary shall finalize the updated 
                guidance to address any such opportunities.
  (b) Report on Coding, Coverage, and Payment Processes Under 
Medicare for Novel Medical Products.--Not later than 12 months 
after the date of the enactment of this Act, the Secretary 
shall publish a report on the Internet website of the 
Department of Health and Human Services regarding processes 
under the Medicare program under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.) with respect to the 
coding, coverage, and payment of novel medical products 
described in subsection (c). Such report shall include the 
following:
          (1) A description of challenges in the coding, 
        coverage, and payment processes under the Medicare 
        program for novel medical products.
          (2) Recommendations to--
                  (A) incorporate patient experience data (such 
                as the impact of a disease or condition on the 
                lives of patients and patient treatment 
                preferences) into the coverage and payment 
                processes within the Centers for Medicare & 
                Medicaid Services;
                  (B) decrease the length of time to make 
                national and local coverage determinations 
                under the Medicare program (as those terms are 
                defined in subparagraph (A) and (B), 
                respectively, of section 1862(l)(6) of the 
                Social Security Act (42 U.S.C. 1395y(l)(6));
                  (C) streamline the coverage process under the 
                Medicare program and incorporate input from 
                relevant stakeholders into such coverage 
                determinations; and
                  (D) identify potential mechanisms to 
                incorporate novel payment designs similar to 
                those in development in commercial insurance 
                plans and State plans under title XIX of such 
                Act (42 U.S.C. 1396 et seq.) into the Medicare 
                program.
  (c) Novel Medical Products Described.--For purposes of this 
section, a novel medical product described in this subsection 
is a medical product, including a drug, biological (including 
gene and cell therapy), or medical device, that has been 
designated as a breakthrough therapy under section 506(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)), a 
breakthrough device under section 515B of such Act (21 U.S.C. 
360e-3), or a regenerative advanced therapy under section 
506(g) of such Act (21 U.S.C. 356(g)).

SEC. 506. PATIENT CONSULTATION IN MEDICARE NATIONAL AND LOCAL COVERAGE 
                    DETERMINATIONS IN ORDER TO MITIGATE BARRIERS TO 
                    INCLUSION OF SUCH PERSPECTIVES.

  Section 1862(l) of the Social Security Act (42 U.S.C. 
1395y(l)) is amended by adding at the end the following new 
paragraph:
          ``(7) Patient consultation in national and local 
        coverage determinations.--The Secretary may consult 
        with patients and organizations representing patients 
        in making national and local coverage 
        determinations.''.

SEC. 507. MEDPAC REPORT ON SHIFTING COVERAGE OF CERTAIN MEDICARE PART B 
                    DRUGS TO MEDICARE PART D.

  (a) Study.--The Medicare Payment Advisory Commission (in this 
section referred to as the ``Commission'') shall conduct a 
study on shifting coverage of certain drugs and biologicals for 
which payment is currently made under part B of title XVIII of 
the Social Security Act (42 U.S.C. 1395j et seq.) to part D of 
such title (42 U.S.C. 1395w-21 et seq.). Such study shall 
include an analysis of--
          (1) differences in program structures and payment 
        methods for drugs and biologicals covered under such 
        parts B and D, including effects of such a shift on 
        program spending, beneficiary cost-sharing liability, 
        and utilization management techniques for such drugs 
        and biologicals; and
          (2) the feasibility and policy implications of 
        shifting coverage of drugs and biologicals for which 
        payment is currently made under such part B to such 
        part D.
  (b) Report.--
          (1) In general.--Not later than June 30, 2021, the 
        Commission shall submit to Congress a report containing 
        the results of the study conducted under subsection 
        (a).
          (2) Contents.--The report under paragraph (1) shall 
        include information, and recommendations as the 
        Commission deems appropriate, regarding--
                  (A) formulary design under such part D;
                  (B) the ability of the benefit structure 
                under such part D to control total spending on 
                drugs and biologicals for which payment is 
                currently made under such part B;
                  (C) changes to the bid process under such 
                part D, if any, that may be necessary to 
                integrate coverage of such drugs and 
                biologicals into such part D; and
                  (D) any other changes to the program that 
                Congress should consider in determining whether 
                to shift coverage of such drugs and biologicals 
                from such part B to such part D.
                  (E) the feasibility and policy implications 
                of creating a methodology to preserve the 
                healthcare provider's ability to take title of 
                the drug, including a methodology under which--
                          (i) prescription drug plans negotiate 
                        reimbursement rates and other 
                        arrangements with drug manufacturers on 
                        behalf of a wholesaler;
                          (ii) wholesalers purchase the drugs 
                        from the manufacturers at the 
                        negotiated rate and ship them through 
                        distributors to physicians to 
                        administer to patients;
                          (iii) physicians and hospitals 
                        purchase the drug from the wholesaler 
                        via the distributor;
                          (iv) after administering the drug, 
                        the physician submits a claim to the 
                        MAC for their drug administration fee;
                          (v) to be reimbursed for the purchase 
                        of the drug from the distributor, the 
                        physician furnishes the claim for the 
                        drug itself to the wholesaler and the 
                        wholesaler would refund the cost of the 
                        drug to the physician; and
                          (vi) the wholesaler passes this claim 
                        to the PDP to receive reimbursement.

SEC. 508. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS FOR 
                    PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS INCLUDE 
                    TRUTHFUL AND NON-MISLEADING PRICING INFORMATION.

  Part A of title XI of the Social Security Act is amended by 
adding at the end the following new section:

``SEC. 1150C. REQUIREMENT THAT DIRECT-TO-CONSUMER ADVERTISEMENTS FOR 
                    PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS INCLUDE 
                    TRUTHFUL AND NON-MISLEADING PRICING INFORMATION.

  ``(a) In General.--The Secretary shall require that each 
direct-to-consumer advertisement for a prescription drug or 
biological product for which payment is available under title 
XVIII or XIX includes an appropriate disclosure of truthful and 
non-misleading pricing information with respect to the drug or 
product.
  ``(b) Determination by CMS.--The Secretary, acting through 
the Administrator of the Centers for Medicare & Medicaid 
Services, shall determine the components of the requirement 
under subsection (a), such as the forms of advertising, the 
manner of disclosure, the price point listing, and the price 
information for disclosure.''.

SEC. 509. CHIEF PHARMACEUTICAL NEGOTIATOR AT THE OFFICE OF THE UNITED 
                    STATES TRADE REPRESENTATIVE.

  (a) In General.--Section 141 of the Trade Act of 1974 (19 
U.S.C. 2171) is amended--
          (1) in subsection (b)(2)--
                  (A) by striking ``and one Chief Innovation 
                and Intellectual Property Negotiator'' and 
                inserting ``one Chief Innovation and 
                Intellectual Property Negotiator, and one Chief 
                Pharmaceutical Negotiator'';
                  (B) by striking ``or the Chief Innovation and 
                Intellectual Property Negotiator'' and 
                inserting ``the Chief Innovation and 
                Intellectual Property Negotiator, or the Chief 
                Pharmaceutical Negotiator''; and
                  (C) by striking ``and the Chief Innovation 
                and Intellectual Property Negotiator'' and 
                inserting ``the Chief Innovation and 
                Intellectual Property Negotiator, and the Chief 
                Pharmaceutical Negotiator''; and
          (2) in subsection (c), by adding at the end the 
        following new paragraph:
          ``(7) The principal function of the Chief 
        Pharmaceutical Negotiator shall be to conduct trade 
        negotiations and to enforce trade agreements relating 
        to United States pharmaceutical products and services. 
        The Chief Pharmaceutical Negotiator shall be a vigorous 
        advocate on behalf of United States pharmaceutical 
        interests. The Chief Pharmaceutical Negotiator shall 
        perform such other functions as the United States Trade 
        Representative may direct.''.
  (b) Compensation.--Section 5314 of title 5, United States 
Code, is amended by striking ``Chief Innovation and 
Intellectual Property Negotiator, Office of the United States 
Trade Representative.'' and inserting the following:
          ``Chief Innovation and Intellectual Property 
        Negotiator, Office of the United States Trade 
        Representative.
          ``Chief Pharmaceutical Negotiator, Office of the 
        United States Trade Representative.''.
  (c) Report Required.--Not later than the date that is one 
year after the appointment of the first Chief Pharmaceutical 
Negotiator pursuant to paragraph (2) of section 141(b) of the 
Trade Act of 1974, as amended by subsection (a), and annually 
thereafter, the United States Trade Representative shall submit 
to the Committee on Finance of the Senate and the Committee on 
Ways and Means of the House of Representatives a report 
describing in detail--
          (1) enforcement actions taken by the United States 
        Trade Representative during the one-year period 
        preceding the submission of the report to ensure the 
        protection of United States pharmaceutical products and 
        services; and
          (2) other actions taken by the United States Trade 
        Representative to advance United States pharmaceutical 
        products and services.

SEC. 510. WAIVING MEDICARE COINSURANCE FOR COLORECTAL CANCER SCREENING 
                    TESTS.

  Section 1833(a) of the Social Security Act (42 U.S.C. 
1395l(a)) is amended--
          (1) by moving the flush text following paragraph (9) 
        2 ems to the left; and
          (2) by adding at the end of such flush text the 
        following new sentence: ``For items and services 
        furnished on or after January 1, 2021, paragraph (1)(Y) 
        shall apply with respect to a colorectal cancer 
        screening test regardless of the code that is billed 
        for the establishment of a diagnosis as a result of the 
        test, or for the removal of tissue or other matter or 
        other procedure that is furnished in connection with, 
        as a result of, and in the same clinical encounter as 
        the screening test.''.
                              ----------                              


 2. An Amendment To Be Offered by Representative Tonko of New York or 
                 His Designee, Debatable for 10 Minutes

  Add at the end of title VIII the following (and conform the 
table of contents accordingly):

SEC. 812. ADDITION OF NEW MEASURES BASED ON ACCESS TO BIOSIMILAR 
                    BIOLOGICAL PRODUCTS TO THE 5-STAR RATING SYSTEM 
                    UNDER MEDICARE ADVANTAGE.

  (a) In General.--Section 1853(o)(4) of the Social Security 
Act (42 U.S.C. 1395w-23(o)(4)) is amended by adding at the end 
the following new subparagraph:
                  ``(E) Addition of new measures based on 
                access to biosimilar biological products.--
                          ``(i) In general.--For 2021 and 
                        subsequent years, the Secretary shall 
                        add a new set of measures to the 5-star 
                        rating system based on access to 
                        biosimilar biological products covered 
                        under part B and, in the case of MA-PD 
                        plans, such products that are covered 
                        part D drugs. Such measures shall 
                        assess the impact a plan's benefit 
                        structure may have on enrollees' 
                        utilization of or ability to access 
                        biosimilar biological products, 
                        including in comparison to the 
                        reference biological product, and shall 
                        include measures, as applicable, with 
                        respect to the following:
                                  ``(I) Coverage.--Assessing 
                                whether a biosimilar biological 
                                product is on the plan 
                                formulary in lieu of or in 
                                addition to the reference 
                                biological product.
                                  ``(II) Preferencing.--
                                Assessing tier placement or 
                                cost-sharing for a biosimilar 
                                biological product relative to 
                                the reference biological 
                                product.
                                  ``(III) Utilization 
                                management tools.--Assessing 
                                whether and how utilization 
                                management tools are used with 
                                respect to a biosimilar 
                                biological product relative to 
                                the reference biological 
                                product.
                                  ``(IV) Utilization.--
                                Assessing the percentage of 
                                enrollees prescribed the 
                                biosimilar biological product 
                                when the reference biological 
                                product is also available.
                          ``(ii) Definitions.--In this 
                        subparagraph, the terms `biosimilar 
                        biological product' and `reference 
                        biological product' have the meaning 
                        given those terms in section 
                        1847A(c)(6).
                          ``(iii) Protecting patient 
                        interests.--In developing such 
                        measures, the Secretary shall ensure 
                        that each measure developed to address 
                        coverage, preferencing, or utilization 
                        management is constructed such that 
                        patients retain equal access to 
                        appropriate therapeutic options without 
                        undue administrative burden.''.
  (b) Clarification Regarding Application to Prescription Drug 
Plans.--To the extent the Secretary of Health and Human 
Services applies the 5-star rating system under section 
1853(o)(4) of the Social Security Act (42 U.S.C. 1395w-
23(o)(4)), or a similar system, to prescription drug plans 
under part D of title XVIII of such Act, the provisions of 
subparagraph (E) of such section, as added by subsection (a) of 
this section, shall apply under the system with respect to such 
plans in the same manner as such provisions apply to the 5-star 
rating system under such section 1853(o)(4).
                              ----------                              


3. An Amendment To Be Offered by Representative Peters of California or 
                 His Designee, Debatable for 10 Minutes

  Page 195, line 9, strike ``$500,000,000'' and insert 
``$400,000,000''.
  At the end of subtitle A of title VII, add the following:

SEC. 703. INNOVATION NETWORK.

  Part A of title IV of the Public Health Service Act (42 
U.S.C. 281 et seq.), as amended by section 702, is further 
amended by adding at the end the following:

``SEC. 404P. INNOVATION NETWORK.

  ``(a) Funds.--The Director of NIH shall award grants or 
contracts to eligible entities to develop, expand, and enhance 
the commercialization of biomedical products.
  ``(b) Eligible Entity.--In this section, the term `eligible 
entity' means an entity receiving funding under--
          ``(1) the Small Business Innovation Research program 
        of the National Institutes of Health; or
          ``(2) the Small Business Technology Transfer program 
        of the National Institutes of Health.
  ``(c) Use of Funds.--An eligible entity shall use the funds 
received through such grant or contract to support--
          ``(1) the Commercialization Readiness Pilot program 
        of the National Institutes of Health;
          ``(2) the Innovation Corps program of the National 
        Institutes of Health;
          ``(3) the Commercialization Accelerator program of 
        the National Institutes of Health;
          ``(4) the Commercialization Assistance program of the 
        National Institutes of Health; and
          ``(5) such other programs and activities as the 
        Director of NIH determines to be appropriate, to 
        support the commercialization stage of research, later 
        stage research and development, technology transfer, 
        and commercialization technical assistance.
  ``(d) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $100,000,000 for 
each of fiscal years 2021 through 2025, to be available until 
expended.''.
                              ----------                              


      4. An Amendment To Be Offered by Representative Kennedy of 
        Massachusetts or His Designee, Debatable for 10 Minutes

  In section 1192 of the Social Security Act, as proposed to be 
added by section 101(a)--
          (1) in subsection (a), strike ``the Secretary shall'' 
        and insert ``subject to subsection (h), the Secretary 
        shall''; and
          (2) by adding at the end the following new 
        subsection:
  ``(h) Conflict of Interest.--
          ``(1) In general.--In the case the Inspector General 
        of the Department of Health and Human Services 
        determines the Secretary has a conflict, with respect 
        to a matter described in paragraph (2), the individual 
        described in paragraph (3) shall carry out the duties 
        of the Secretary under this part, with respect to a 
        negotiation-eligible drug, that would otherwise be such 
        a conflict.
          ``(2) Matter described.--A matter described in this 
        paragraph is--
                  ``(A) a financial interest (as described in 
                section 2635.402 of title 5, Code of Federal 
                Regulations (except for an interest described 
                in subsection (b)(2)(iv) of such section)) on 
                the date of the selected drug publication date, 
                with respect the price applicability year (as 
                applicable);
                  ``(B) a personal or business relationship (as 
                described in section 2635.502 of such title) on 
                the date of the selected drug publication date, 
                with respect the price applicability year;
                  ``(C) employment by a manufacturer of a 
                negotiation-eligible drug during the preceding 
                10-year period beginning on the date of the 
                selected drug publication date, with respect to 
                each price applicability year; and
                  ``(D) any other matter the General Counsel 
                determines appropriate.
          ``(3) Individual described.--An individual described 
        in this paragraph is--
                  ``(A) the highest-ranking officer or employee 
                of the Department of Health and Human Services 
                (as determined by the organizational chart of 
                the Department) that does not have a conflict 
                under this subsection; and
                  ``(B) is nominated by the President and 
                confirmed by the Senate with respect to the 
                position;''.
                              ----------                              


 5. An Amendment To Be Offered by Representative O'Halleran of Arizona 
               or His Designee, Debatable for 10 Minutes

  Add at the end of title VIII the following new section (and 
conform the table of contents accordingly):

SEC. 812. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND 
                    UNDERSERVED COMMUNITIES.

  Part P of title III of the Public Health Service Act (42 
U.S.C. 280g et seq.) is amended by adding at the end the 
following new section:

``SEC. 399V-7. GRADUATE MEDICAL EDUCATION IMPROVEMENTS IN RURAL AND 
                    UNDERSERVED COMMUNITIES.

  ``(a) Rural and Underserved Community GME Grant Program.--Not 
later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services (in this section 
referred to as the `Secretary'), acting through the 
Administrator of the Health Resources and Services 
Administration, shall establish a rural and underserved 
community graduate medical education grant program under which 
the Secretary shall award grants to specified hospitals (as 
defined in subsection (b)) that have not established an 
approved medical residency training program (as defined for 
purposes of section 1886(h) of the Social Security Act (42 
U.S.C. 1395ww(h))) in order to encourage such hospitals to 
establish such a program, or to establish an affiliation with a 
hospital that has established such a program in order to host 
residents under such program.
  ``(b) Use of Funds.--Grants awarded under subsection (a) may 
be used by a specified hospital for any initial costs 
associated with establishing such a program or such an 
affiliation, including costs associated with faculty 
development, administration, infrastructure, supplies, and 
legal and consultant services.
  ``(c) Specified Hospital Defined.--For purposes of subsection 
(a), the term `specified hospital' means a hospital or critical 
access hospital (as such terms are defined in section 1861 of 
the Social Security Act (42 U.S.C. 1395x)) that--
          ``(1) is--
                  ``(A) located in a rural area (as defined in 
                section 1886(d)(2)(D) of such Act (42 U.S.C. 
                1395ww(d)(2)(D))); or
                  ``(B) treated as being located in a rural 
                area pursuant to section 1886(d)(8)(E) of such 
                Act (42 U.S.C. 1395ww(d)(8)(E)); and
          ``(2) is located in a medically underserved area (as 
        defined in section 330I(a) of the Public Health Service 
        Act (42 U.S.C. 254c-14(a))).
  ``(d) Critical Access Hospital Grant Program.--Not later than 
1 year after the date of the enactment of this Act, the 
Secretary, acting through the Administrator of the Health 
Resources and Services Administration, shall establish a grant 
program under which the Secretary awards grants to critical 
access hospitals (as defined in section 1861 of the Social 
Security Act (42 U.S.C. 1395x)) that do not have in effect an 
affiliation with a hospital with an approved medical residency 
training program to host residents of such program in order to 
assist such critical access hospitals in setting up such 
affiliations in order to host such residents.
  ``(e) Limitation on Grant Amounts.--No hospital may receive 
an aggregate amount of grants under this section in excess of 
$250,000.
  ``(f) Reports.--
          ``(1) HHS.--Not later than 5 years after the date of 
        the enactment of this Act, the Secretary of Health and 
        Human Services shall submit to the Committee on Energy 
        and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate a report on graduate medical residency 
        training programs of hospitals that received a grant 
        under subsection (a) or (d). Such report shall include 
        the following:
                  ``(A) The number of hospitals that applied 
                for a grant under this section.
                  ``(B) The number of hospitals that were 
                awarded such a grant.
                  ``(C) The number of residency positions 
                created by hospitals receiving such a grant.
                  ``(D) An estimate of the number of such 
                positions such hospitals will create after the 
                date of the submission of such report.
                  ``(E) A description of any challenges faced 
                by hospitals in applying for such a grant or 
                using funds awarded under such a grant.
          ``(2) GAO.--Not later than 10 years after the date of 
        the enactment of this Act, the Comptroller General of 
        the United States shall submit to Congress a report 
        containing an analysis of--
                  ``(A) the number of residents who trained at 
                a hospital or critical access hospital that 
                received a grant under subsection (a) or (d); 
                and
                  ``(B) whether such residents continued to 
                practice medicine in a rural area (as defined 
                in section 1886(d)(2)(D) of the Social Security 
                Act (42 U.S.C. 1395ww(d)(2)(D))) or in a 
                medically underserved area (as defined in 
                section 330I(a) of the Public Health Service 
                Act (42 U.S.C. 254c-14(a))) after completing 
                such training.
  ``(g) Funding.--There are authorized to be appropriated such 
sums as are necessary for purposes of making grants under this 
section for each of fiscal years 2020 through 2029.''.
                              ----------                              


6. An Amendment To Be Offered by Representative Jackson Lee of Texas or 
                 Her Designee, Debatable for 10 Minutes

  At the end of title VIII, add the following new section (and 
update the table of sections accordingly):

SEC. ___. SENSE OF CONGRESS REGARDING THE IMPACT OF THE HIGH COST OF 
                    PRESCRIPTION DRUGS ON COMMUNITIES OF COLOR AND 
                    PERSONS LIVING IN RURAL OR SPARSELY POPULATED AREAS 
                    OF THE UNITED STATES.

  It is the sense of the Congress that--
          (1) the United States has the highest drug prices in 
        the world and for millions of Americans the cost of 
        prescription drugs is increasing as a barrier to proper 
        disease treatment, especially for communities of color 
        and for persons living in rural or sparsely populated 
        areas of the nation;
          (2) the Patient Protection and Affordable Care Act 
        (Public Law 111-148) substantially reduced the number 
        of uninsured Americans, but over 28 million Americans 
        remain without insurance and approximately 55 percent 
        of uninsured Americans under the age of 65 are persons 
        of color;
          (3) without health insurance, paying retail prices 
        for medications is invariably burdensome or financially 
        impossible;
          (4) the median net worth of Caucasian households in 
        2016 was 9.7 times higher than African-American 
        households and 8.3 times higher than Hispanic 
        households, which contributes to disparities in 
        negative health consequences, including for example the 
        underuse of insulin among insured adults with diabetes; 
        and
          (5) due to the high cost of prescription drugs to 
        communities of color and for persons living in rural or 
        sparsely populated areas of the nation, this Act should 
        positively impact such communities and persons (and the 
        Secretaries of Health and Human Services, Labor, and 
        Treasury should monitor such impact).
                              ----------                              


   7. An Amendment To Be Offered by Representative Gottheimer of New 
            Jersey or His Designee, Debatable for 10 Minutes

  At the end of subtitle B of title VII, insert the following:

SEC. 712. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS.

  (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human 
Services shall conduct a study to identify--
          (1) diseases or conditions that lack a treatment 
        approved by the Food and Drug Administration and 
        instances in which development of a treatment for such 
        diseases or conditions could fill an unmet medical need 
        for the treatment of a serious or life-threatening 
        disease or condition or a rare disease or condition; 
        and
          (2) appropriate incentives that would lead to the 
        development, approval, and marketing of such 
        treatments.
  (b) Report to Congress; Recommendations.--Not later than one 
year after the date of enactment of this Act, the Secretary 
shall submit to the Congress a report that includes--
          (1) findings from the study under subsection (a); and
          (2) recommendations regarding legislation necessary 
        to create appropriate incentives identified pursuant to 
        subsection (a)(2).
                              ----------                              


  8. An Amendment To Be Offered by Representative Axne of Iowa or Her 
                   Designee, Debatable for 10 Minutes

  At the end of title VII, add the following:

  Subtitle D--Reducing Administrative Costs and Burdens in Health Care


SEC. 731. REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE.

  Title II of the Public Health Service Act (42 U.S.C. 202 et 
seq.) is amended by adding at the end the following:

   ``PART E--REDUCING ADMINISTRATIVE COSTS AND BURDENS IN HEALTH CARE

``SEC. 281. ELIMINATING UNNECESSARY ADMINISTRATIVE BURDENS AND COSTS.

  ``(a) Reducing Administrative Burdens and Costs.--The 
Secretary, in consultation with providers of health services, 
health care suppliers of services, health care payers, health 
professional societies, health vendors and developers, health 
care standard development organizations and operating rule 
entities, health care quality organizations, health care 
accreditation organizations, public health entities, States, 
patients, and other appropriate entities, shall, in accordance 
with subsection (b)--
          ``(1) establish a goal of reducing unnecessary costs 
        and administrative burdens across the health care 
        system, including the Medicare program under title 
        XVIII of the Social Security Act, the Medicaid program 
        under title XIX of such Act, and the private health 
        insurance market, by at least half over a period of 10 
        years from the date of enactment of this section;
          ``(2) develop strategies and benchmarks for meeting 
        the goal established under paragraph (1);
          ``(3) develop recommendations for meeting the goal 
        established under paragraph (1); and
          ``(4) take action to reduce unnecessary costs and 
        administrative burdens based on recommendations 
        identified in this subsection.
  ``(b) Strategies, Recommendations, and Actions.--
          ``(1) In general.--To achieve the goal established 
        under subsection (a)(1), the Secretary, in consultation 
        with the entities described in such subsection, shall 
        not later than 1 year after the date of enactment of 
        this section, develop strategies and recommendations 
        and take actions to meet such goal in accordance with 
        this subsection. No strategies, recommendation, or 
        action shall undermine the quality of patient care or 
        patient health outcomes.
          ``(2) Strategies.--The strategies developed under 
        paragraph (1) shall address unnecessary costs and 
        administrative burdens. Such strategies shall include 
        broad public comment and shall prioritize--
                  ``(A) recommendations identified as a result 
                of efforts undertaken to implement section 
                3001;
                  ``(B) recommendations and best practices 
                identified as a result of efforts undertaken 
                under this part;
                  ``(C) a review of regulations, rules, and 
                requirements of the Department of Health and 
                Human Services that could be modified or 
                eliminated to reduce unnecessary costs and 
                administrative burden imposed on patients, 
                providers, payers, and other stakeholders 
                across the health care system; and
                  ``(D) feedback from stakeholders in rural or 
                frontier areas on how to reduce unnecessary 
                costs and administrative burdens on the health 
                care system in those areas.
          ``(3) Recommendations.--The recommendations developed 
        under paragraph (1) shall include--
                  ``(A) actions that improve the 
                standardization and automation of 
                administrative transactions;
                  ``(B) actions that integrate clinical and 
                administrative functions;
                  ``(C) actions that improve patient care and 
                reduce unnecessary costs and administrative 
                burdens borne by patients, their families, and 
                other caretakers;
                  ``(D) actions that advance the development 
                and adoption of open application programming 
                interfaces and other emerging technologies to 
                increase transparency and interoperability, 
                empower patients, and facilitate better 
                integration of clinical and administrative 
                functions;
                  ``(E) actions to be taken by the Secretary 
                and actions that need to be taken by other 
                entities; and
                  ``(F) other areas, as the Secretary 
                determines appropriate, to reduce unnecessary 
                costs and administrative burdens required of 
                health care providers.
          ``(4) Consistency.--Any improvements in electronic 
        processes proposed by the Secretary under this section 
        should leverage existing information technology 
        definitions under Federal Law. Specifically, any 
        electronic processes should not be construed to include 
        a facsimile, a proprietary payer portal that does not 
        meet standards specified by the Secretary, or an 
        electronic form image.
          ``(5) Actions.--The Secretary shall take action to 
        achieve the goal established under subsection (a)(1), 
        and, not later than 1 year after the date of enactment 
        of this section, and biennially thereafter, submit to 
        Congress and make publically available, a report 
        describing the actions taken by the Secretary pursuant 
        to goals, strategies, and recommendations described in 
        this subsection.
          ``(6) FACA.--The Federal Advisory Committee Act (5 
        U.S.C. App.) shall not apply to the development of the 
        goal, strategies, recommendations, or actions described 
        in this section.
          ``(7) Rule of construction.--Nothing in this 
        subsection shall be construed to authorize, or be used 
        by, the Federal Government to inhibit or otherwise 
        restrain efforts made to reduce waste, fraud, and abuse 
        across the health care system.

``SEC. 282. GRANTS TO STATES TO DEVELOP AND IMPLEMENT RECOMMENDATIONS 
                    TO ACCELERATE STATE INNOVATION TO REDUCE HEALTH 
                    CARE ADMINISTRATIVE COSTS.

  ``(a) Grants.--
          ``(1) In general.--Not later than 6 months after the 
        date of enactment of this section, the Secretary shall 
        award grants to at least 15 States, and one 
        coordinating entity designated as provided for under 
        subsection (e), to enable such States to establish and 
        administer private-public multi-stakeholder commissions 
        for the purpose of reducing health care administrative 
        costs and burden within and across States. Not less 
        than 3 of such grants shall be awarded to States that 
        are primarily rural, frontier, or a combination 
        thereof, in nature.
          ``(2) Entities.--For purposes of this section, the 
        term `State' means a State, a State designated entity, 
        or a multi-State collaborative (as defined by the 
        Secretary).
          ``(3) Priority.--In awarding grants under this 
        section, the Secretary shall give priority to 
        applications submitted by States that propose to carry 
        out a pilot program or support the adoption of 
        electronic health care transactions and operating 
        rules.
  ``(b) Application.--
          ``(1) In general.--To be eligible to receive a grant 
        under subsection (a) a State shall submit to the 
        Secretary an application in such a manner and 
        containing such information as the Secretary may 
        reasonably require, including the information described 
        in paragraph (2).
          ``(2) Required information.--In addition to any 
        additional information required by the Secretary under 
        this subsection, an application shall include a 
        description of--
                  ``(A) the size and composition of the 
                commission to be established under the grant, 
                including the stakeholders represented and the 
                degree to which the commission reflects 
                important geographic and population 
                characteristics of the State;
                  ``(B) the relationship of the commission to 
                the State official responsible for coordinating 
                and implementing the recommendations resulting 
                from the commission, and the role and 
                responsibilities of the State with respect to 
                the commission, including any participation, 
                review, oversight, implementation or other 
                related functions;
                  ``(C) the history and experience of the State 
                in addressing health care administrative costs, 
                and any experience similar to the purpose of 
                the commission to improve health care 
                administrative processes and the exchange of 
                health care administrative data;
                  ``(D) the resources and expertise that will 
                be made available to the commission by 
                commission members or other possible sources, 
                and how Federal funds will be used to leverage 
                and complement these resources;
                  ``(E) the governance structure and procedures 
                that the commission will follow to make, 
                implement, and pilot recommendations;
                  ``(F) the proposed objectives relating to the 
                simplification of administrative transactions 
                and operating rules, increased standardization, 
                and the efficiency and effectiveness of the 
                transmission of health information;
                  ``(G) potential cost savings and other 
                improvements in meeting the objectives 
                described in subparagraph (F); and
                  ``(H) the method or methods by which the 
                recommendations described in subsection (c) 
                will be reviewed, tested, adopted, implemented, 
                and updated as needed.
  ``(c) Multi-Stakeholder Commission.--
          ``(1) In general.--Not later than 90 days after the 
        date on which a grant is awarded to a State under this 
        section, the State official described in subsection 
        (b)(2)(B), the State insurance commissioner, or other 
        appropriate State official shall convene a multi-
        stakeholder commission, in accordance with this 
        subsection.
          ``(2) Membership.--The commission convened under 
        paragraph (1) shall include representatives from health 
        plans, health care providers, health vendors, relevant 
        State agencies, health care standard development 
        organizations, and operating rule entities, relevant 
        professional and trade associations, patients, and 
        other entities determined appropriate by the State.
          ``(3) Recommendations.--Not later than one year after 
        the date on which a grant is awarded to a State under 
        this section, the commission shall make recommendations 
        and plans, consistent with the application submitted by 
        the State under subsection (b), and intended to meet 
        the objectives defined in the application. Such 
        recommendations shall comply with, and build upon, all 
        relevant Federal requirements and regulations, and may 
        include--
                  ``(A) common, uniform specifications, best 
                practices, and conventions, for the efficient, 
                effective exchange of administrative 
                transactions adopted pursuant to the Health 
                Insurance Portability and Accountability Act of 
                1996 (Public Law 104-191);
                  ``(B) the development of streamlined business 
                processes for the exchange and use of health 
                care administrative data; and
                  ``(C) specifications, incentives, 
                requirements, tools, mechanisms, and resources 
                to improve--
                          ``(i) the access, exchange, and use 
                        of health care administrative 
                        information through electronic means;
                          ``(ii) the implementation of 
                        utilization management protocols; and
                          ``(iii) compliance with Federal and 
                        State laws.
  ``(d) Use of Funds for Implementation.--A State may use 
amounts received under a grant under this section for one or 
more of the following:
          ``(1) The development, implementation, and best use 
        of shared data infrastructure that supports the 
        electronic transmission of administrative data.
          ``(2) The development and provision of training and 
        educational materials, forums, and activities as well 
        as technical assistance to effectively implement, use, 
        and benefit from electronic health care transactions 
        and operating rules.
          ``(3) To accelerate the early adoption and 
        implementation of administrative transactions and 
        operating rules designated by the Secretary and that 
        have been adopted pursuant to the Health Insurance 
        Portability and Accountability Act of 1996 (Public Law 
        104-191), including transactions and operating rules 
        described in section 1173(a)(2) of the Social Security 
        Act.
          ``(4) To accelerate the early adoption and 
        implementation of additional or updated administrative 
        transactions, operating rules, and related data 
        exchange standards that are being considered for 
        adoption under the Health Insurance Portability and 
        Accountability Act of 1996 or are adopted pursuant to 
        such Act, or as designated by the Secretary, including 
        the electronic claim attachment.
          ``(5) To conduct pilot projects to test approaches to 
        implement and use the electronic health care 
        transactions and operating rules in practice under a 
        variety of different settings. With respect to the 
        electronic attachment transaction, priority shall be 
        given to pilot projects that test and evaluate methods 
        and mechanisms to most effectively incorporate patient 
        health data from electronic health records and other 
        electronic sources with the electronic attachment 
        transaction.
          ``(6) To assess barriers to the adoption, 
        implementation, and effective use of electronic health 
        care transactions and operating rules, as well as to 
        explore, identify, and plan options, approaches, and 
        resources to address barriers and make improvements.
          ``(7) The facilitation of public and private 
        initiatives to reduce administrative costs and 
        accelerate the adoption, implementation, and effective 
        use of electronic health care transactions and 
        operating rules for State programs.
          ``(8) Developing, testing, implementing, and 
        assessing additional data exchange specifications, 
        operating rules, incentives, requirements, tools, 
        mechanisms, and resources to accelerate the adoption 
        and effective use of the transactions and operating 
        rules.
          ``(9) Ongoing needs assessments and planning related 
        to the development and implementation of administrative 
        simplification initiatives.
  ``(e) Coordinating Entity.--
          ``(1) Functions.--Not later than 6 months after the 
        date of enactment of this section, the Secretary shall 
        designate a coordinating entity under this subsection 
        for the purpose of--
                  ``(A) providing technical assistance to 
                States relating to the simplification of 
                administrative transactions and operating 
                rules, increased standardization, and the 
                efficiency and effectiveness of the 
                transmission of health care information;
                  ``(B) evaluating pilot projects and other 
                efforts conducted under this section for impact 
                and best practices to inform broader national 
                use;
                  ``(C) using consistent evaluation 
                methodologies to compare return on investment 
                across efforts conducted under this section;
                  ``(D) compiling, synthesizing, disseminating, 
                and adopting lessons learned to promote the 
                adoption of electronic health care transactions 
                and operating rules across the health care 
                system; and
                  ``(E) making recommendations to the Secretary 
                and the National Committee on Vital and Health 
                Statistics regarding the national adoption of 
                efforts conducted under this section.
          ``(2) Eligibility.--The entity designated under 
        paragraph (1) shall be a qualified nonprofit entity 
        that--
                  ``(A) focuses its mission on administrative 
                simplification;
                  ``(B) has demonstrated experience using a 
                multi-stakeholder and consensus-based process 
                for the development of common, uniform 
                specifications, operating rules, best 
                practices, and conventions, for the efficient, 
                effective exchange of administrative 
                transactions that includes representation by or 
                participation from health plans, health care 
                providers, vendors, States, relevant Federal 
                agencies, and other health care standard 
                development organizations;
                  ``(C) has demonstrated experience providing 
                technical assistance to health plans, health 
                care providers, vendors, and States relating to 
                the simplification of administrative 
                transactions and operating rules, increased 
                standardization, and the efficiency and 
                effectiveness of the transmission of health 
                care information;
                  ``(D) has demonstrated experience evaluating 
                and measuring the adoption and return on 
                investment of administrative transactions and 
                operating rules;
                  ``(E) has demonstrated experience gathering, 
                synthesizing, and adopting common, uniform 
                specifications, operating rules, best 
                practices, and conventions for national use 
                based on lessons learned to promote the 
                adoption of electronic health care transactions 
                and operating rules across the health care 
                system;
                  ``(F) has a public set of guiding principles 
                that ensure processes are open and transparent, 
                and supports nondiscrimination and conflict of 
                interest policies that demonstrate a commitment 
                to open, fair, and nondiscriminatory practices;
                  ``(G) builds on the transaction standards 
                issued under Health Insurance Portability and 
                Accountability Act of 1996; and
                  ``(H) allows for public review and updates of 
                common, uniform specifications, operating 
                rules, best practices, and conventions to 
                support administrative simplification.
  ``(f) Period and Amount.--A grant awarded to a State under 
this section shall be for a period of 5 years and shall not 
exceed $50,000,000 for such 5-year period. A grant awarded to 
the coordinating entity designated by the Secretary under 
subsection (e) shall be for a period of 5 years and shall not 
exceed $15,000,000 for such 5-year period.
  ``(g) Reports.--
          ``(1) States.--Not later than 1 year after receiving 
        a grant under this section, and biennially thereafter, 
        a State shall submit to the Secretary a report on the 
        outcomes experienced by the State under the grant.
          ``(2) Coordinating entity.--Not later than 1 year 
        after receiving a grant under this section, and at 
        least biennially thereafter, the coordinating entity 
        shall submit to the Secretary and the National 
        Committee on Vital and Health Statistics a report of 
        evaluations conducted under the grant under this 
        section and recommendations regarding the national 
        adoption of efforts conducted under this section.
          ``(3) Secretary.--Not later than 6 months after the 
        date on which the States and coordinating entity submit 
        the report required under paragraphs (1) and (2), the 
        Secretary, in consultation with National Committee on 
        Vital and Health Statistics, shall submit to the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, a report on the outcomes 
        achieved under the grants under this section.
          ``(4) GAO.--Not later than 6 months after the date on 
        which the Secretary submits the final report under 
        paragraph (3), the Comptroller General of the United 
        States shall conduct a study, and submit to the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, a report on the outcomes 
        of the activities carried out under this section which 
        shall contain a list of best practices and 
        recommendations to States concerning administrative 
        simplification.
  ``(h) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section, $250,000,000 for 
the 5-fiscal-year period beginning with fiscal year 2020.''.
                              ----------                              


 9. An Amendment To Be Offered by Representative Finkenauer of Iowa or 
                 Her Designee, Debatable for 10 Minutes

  Add at the end of the bill the following new section (and 
conform the table of contents accordingly):

SEC. 812. REGULATIONS REQUIRING DIRECT-TO-CONSUMER ADVERTISEMENTS FOR 
                    PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS TO 
                    INCLUDE TRUTHFUL AND NOT MISLEADING PRICING 
                    INFORMATION.

  (a) In General.--Not later than the date that is one year 
after the date of the enactment of the Elijah E. Cummings Lower 
Drug Costs Now Act, the Secretary of Health and Human Services, 
acting through the Administrator of the Centers for Medicare & 
Medicaid Services (referred to in this section as the 
``Administrator''), shall promulgate final regulations 
requiring each direct-to-consumer advertisement on television 
(including broadcast, cable, streaming, and satellite 
television) for a prescription drug or biological product for 
which payment is available under title XVIII or XIX of the 
Social Security Act to include a textual statement, which shall 
be truthful and not misleading, indicating the list price, as 
determined on the first day of the quarter during which the 
advertisement is being aired or otherwise broadcast, for a 
typical 30-day regimen or typical course of treatment 
(whichever is most appropriate).
  (b) Determinations.--In promulgating final regulations under 
subsection (a), the Administrator shall determine--
          (1) whether such regulations should apply with 
        respect to additional forms of advertising;
          (2) the manner and format of textual statements 
        described in such subsection;
          (3) appropriate enforcement mechanisms; and
          (4) whether such textual statements should include 
        any other price information, as appropriate.
                              ----------                              


 10. An Amendment To Be Offered by Representative Luria of Virginia or 
                 Her Designee, Debatable for 10 Minutes

  At the end of section 101(b), add the following:
          (3) FEHBP.--Section 8902 of title 5, United States 
        Code, is amended by adding at the end the following:
  ``(p) A contract may not be made or a plan approved under 
this chapter with any carrier that has affirmatively elected, 
pursuant to section 1197 of the Social Security Act, not to 
participate in the Fair Price Negotiation Program established 
under section 1191 of such Act for any selected drug (as that 
term is defined in section 1192(c) of such Act).''.
                              ----------                              


 11. An Amendment To Be Offered by Representative Cunningham of South 
           Carolina or His Designee, Debatable for 10 Minutes

  Page 62, after line 2, insert the following:
          (4) Option of secretary of veterans affairs to 
        purchase covered drugs at maximum fair prices.--Section 
        8126 of title 38, United States Code, is amended--
                  (A) in subsection (a)(2), by inserting ``, 
                subject to subsection (j),'' after ``may not 
                exceed'';
                  (B) in subsection (d), in the matter 
                preceding paragraph (1), by inserting ``, 
                subject to subsection (j)'' after ``for the 
                procurement of the drug''; and
                  (C) by adding at the end the following new 
                subsection:
  ``(j)(1) In the case of a covered drug that is a selected 
drug, for any year during the price applicability period for 
such drug, if the Secretary determines that the maximum fair 
price of such drug for such year is less than the price for 
such drug otherwise in effect pursuant to this section 
(including after application of any reduction under subsection 
(a)(2) and any discount under subsection (c)), at the option of 
the Secretary, in lieu of the maximum price (determined after 
application of the reduction under subsection (a)(2) and any 
discount under subsection (c), as applicable) that would be 
permitted to be charged during such year for such drug pursuant 
to this section without application of this subsection, the 
maximum price permitted to be charged during such year for such 
drug pursuant to this section shall be such maximum fair price 
for such drug and year.
  ``(2) For purposes of this subsection:
          ``(A) The term `maximum fair price' means, with 
        respect to a selected drug and year during the price 
        applicability period for such drug, the maximum fair 
        price (as defined in section 1191(c)(2) of the Social 
        Security Act) for such drug and year.
          ``(B) The term `negotiation eligible drug' has the 
        meaning given such term in section 1192(d)(1) of the 
        Social Security Act.
          ``(C) The term `price applicability period' has, with 
        respect to a selected drug, the meaning given such term 
        in section 1191(b)(2) of such Act
          ``(D) The term `selected drug' means, with respect to 
        a year, a drug that is a selected drug under section 
        1192(c) of such Act for such year.''.
                              ----------                              


      12. An Amendment To Be Offered by Representative Scanlon of 
         Pennsylvania or Her Designee, Debatable for 10 Minutes

  Add at the end of title VIII the following new section (and 
conform the table of contents accordingly):

SEC. 812. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE 
                    SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.

  (a) Pass-through Pricing Required.--
          (1) In general.--Section 1927(e) of the Social 
        Security Act (42 U.S.C. 1396r-8(e)) is amended by 
        adding at the end the following:
          ``(6) Pass-through pricing required.--A contract 
        between the State and a pharmacy benefit manager 
        (referred to in this paragraph as a `PBM'), or a 
        contract between the State and a managed care entity or 
        other specified entity (as such terms are defined in 
        section 1903(m)(9)(D)) that includes provisions making 
        the entity responsible for coverage of covered 
        outpatient drugs dispensed to individuals enrolled with 
        the entity, shall require that payment for such drugs 
        and related administrative services (as applicable), 
        including payments made by a PBM on behalf of the State 
        or entity, is based on a pass-through pricing model 
        under which--
                  ``(A) any payment made by the entity or the 
                PBM (as applicable) for such a drug--
                          ``(i) is limited to--
                                  ``(I) ingredient cost; and
                                  ``(II) a professional 
                                dispensing fee that is not less 
                                than the professional 
                                dispensing fee that the State 
                                plan or waiver would pay if the 
                                plan or waiver was making the 
                                payment directly;
                          ``(ii) is passed through in its 
                        entirety by the entity or PBM to the 
                        pharmacy that dispenses the drug; and
                          ``(iii) is made in a manner that is 
                        consistent with section 1902(a)(30)(A) 
                        and sections 447.512, 447.514, and 
                        447.518 of title 42, Code of Federal 
                        Regulations (or any successor 
                        regulation) as if such requirements 
                        applied directly to the entity or the 
                        PBM;
                  ``(B) payment to the entity or the PBM (as 
                applicable) for administrative services 
                performed by the entity or PBM is limited to a 
                reasonable administrative fee that covers the 
                reasonable cost of providing such services;
                  ``(C) the entity or the PBM (as applicable) 
                shall make available to the State, and the 
                Secretary upon request, all costs and payments 
                related to covered outpatient drugs and 
                accompanying administrative services incurred, 
                received, or made by the entity or the PBM, 
                including ingredient costs, professional 
                dispensing fees, administrative fees, post-sale 
                and post-invoice fees. Discounts, or related 
                adjustments such as direct and indirect 
                remuneration fees, and any and all 
                remuneration; and
                  ``(D) any form of spread pricing whereby any 
                amount charged or claimed by the entity or the 
                PBM (as applicable) that is in excess of the 
                amount paid to the pharmacies on behalf of the 
                entity, including any post-sale or post-invoice 
                fees, discounts, or related adjustments such as 
                direct and indirect remuneration fees or 
                assessments (after allowing for a reasonable 
                administrative fee as described in subparagraph 
                (B)), is not allowable for purposes of claiming 
                Federal matching payments under this title.''.
          (2) Conforming amendment.--Clause (xiii) of section 
        1903(m)(2)(A) of such Act (42 U.S.C. 1396b(m)(2)(A)) is 
        amended--
                  (A) by striking ``and (III)'' and inserting 
                ``(III)''; and
                  (B) by inserting before the period at the end 
                the following: ``, and (IV) pharmacy benefit 
                management services provided by the entity, or 
                provided by a pharmacy benefit manager on 
                behalf of the entity under a contract or other 
                arrangement between the entity and the pharmacy 
                benefit manager, shall comply with the 
                requirements of section 1927(e)(6)''.
          (3) Effective date.--The amendments made by this 
        subsection apply to contracts between States and 
        managed care entities, other specified entities, or 
        pharmacy benefits managers that are entered into or 
        renewed on or after the date that is 18 months after 
        the date of enactment of this Act.
  (b) Survey of Retail Prices.--
          (1) In general.--Section 1927(f) of the Social 
        Security Act (42 U.S.C. 1396r-8(f)) is amended--
                  (A) by striking ``and'' after the semicolon 
                at the end of paragraph (1)(A)(i) and all that 
                precedes it through ``(1)'' and inserting the 
                following:
          ``(1) Survey of retail prices.--The Secretary shall 
        conduct a survey of retail community drug prices, to 
        include at least the national average drug acquisition 
        cost, as follows:
                  ``(A) Use of vendor.--The Secretary may 
                contract services for--
                          ``(i) with respect to retail 
                        community pharmacies, the determination 
                        on a monthly basis of retail survey 
                        prices of the national average drug 
                        acquisition cost for covered outpatient 
                        drugs for such pharmacies, net of all 
                        discounts and rebates (to the extent 
                        any information with respect to such 
                        discounts and rebates is available), 
                        the average reimbursement received for 
                        such drugs by such pharmacies from all 
                        sources of payment, including third 
                        parties, and, to the extent available, 
                        the usual and customary charges to 
                        consumers for such drugs; and'';
                  (B) by adding at the end of paragraph (1) the 
                following:
                  ``(F) Survey reporting.--In order to meet the 
                requirement of section 1902(a)(54), a State 
                shall require that any retail community 
                pharmacy in the State that receives any 
                payment, administrative fee, discount, or 
                rebate related to the dispensing of covered 
                outpatient drugs to individuals receiving 
                benefits under this title, regardless of 
                whether such payment, fee, discount, or rebate 
                is received from the State or a managed care 
                entity directly or from a pharmacy benefit 
                manager or another entity that has a contract 
                with the State or a managed care entity, shall 
                respond to surveys of retail prices conducted 
                under this subsection.
                  ``(G) Survey information.--Information on 
                retail community prices obtained under this 
                paragraph shall be made publicly available and 
                shall include at least the following:
                          ``(i) The monthly response rate of 
                        the survey including a list of 
                        pharmacies not in compliance with 
                        subparagraph (F).
                          ``(ii) The sampling frame and number 
                        of pharmacies sampled monthly.
                          ``(iii) Characteristics of reporting 
                        pharmacies, including type (such as 
                        independent or chain), geographic or 
                        regional location, and dispensing 
                        volume.
                          ``(iv) Reporting of a separate 
                        national average drug acquisition cost 
                        for each drug for independent retail 
                        pharmacies and chain operated 
                        pharmacies.
                          ``(v) Information on price 
                        concessions including on and off 
                        invoice discounts, rebates, and other 
                        price concessions.
                          ``(vi) Information on average 
                        professional dispensing fees paid.
                  ``(H) Penalties.--
                          ``(i) Failure to provide timely 
                        information.--A retail community 
                        pharmacy that fails to respond to a 
                        survey conducted under this subsection 
                        on a timely basis may be subject to a 
                        civil monetary penalty in the amount of 
                        $10,000 for each day in which such 
                        information has not been provided.
                          ``(ii) False information.--A retail 
                        community pharmacy that knowingly 
                        provides false information in response 
                        to a survey conducted under this 
                        subsection may be subject to a civil 
                        money penalty in an amount not to 
                        exceed $100,000 for each item of false 
                        information.
                          ``(iii) Other penalties.--Any civil 
                        money penalties imposed under this 
                        subparagraph shall be in addition to 
                        other penalties as may be prescribed by 
                        law. The provisions of section 1128A 
                        (other than subsections (a) and (b)) 
                        shall apply to a civil money penalty 
                        under this subparagraph in the same 
                        manner as such provisions apply to a 
                        penalty or proceedings under section 
                        1128A(a).
                  ``(I) Report on specialty pharmacies.--
                          ``(i) In general.--Not later than 1 
                        year after the effective date of this 
                        subparagraph, the Secretary shall 
                        submit a report to Congress examining 
                        specialty drug coverage and 
                        reimbursement under this title.
                          ``(ii) Content of report.--Such 
                        report shall include a description of 
                        how State Medicaid programs define 
                        specialty drugs, how much State 
                        Medicaid programs pay for specialty 
                        drugs, how States and managed care 
                        plans determine payment for specialty 
                        drugs, the settings in which specialty 
                        drugs are dispensed (such as retail 
                        community pharmacies or specialty 
                        pharmacies), whether acquisition costs 
                        for specialty drugs are captured in the 
                        national average drug acquisition cost 
                        survey, and recommendations as to 
                        whether specialty pharmacies should be 
                        included in the survey of retail prices 
                        to ensure national average drug 
                        acquisition costs capture drugs sold at 
                        specialty pharmacies and how such 
                        specialty pharmacies should be 
                        defined.'';
                  (C) in paragraph (2)--
                          (i) in subparagraph (A), by inserting 
                        ``, including payments rates under 
                        Medicaid managed care plans,'' after 
                        ``under this title''; and
                          (ii) in subparagraph (B), by 
                        inserting ``and the basis for such 
                        dispensing fees'' before the semicolon; 
                        and
                  (D) in paragraph (4), by inserting ``, and 
                $5,000,000 for fiscal year 2020 and each fiscal 
                year thereafter,'' after ``2010''.
          (2) Effective date.--The amendments made by this 
        subsection take effect on the 1st day of the 1st 
        quarter that begins on or after the date that is 18 
        months after the date of enactment of this Act.
  (c) Manufacturer Reporting of Wholesale Acquisition Cost.--
Section 1927(b)(3) of such Act (42 U.S.C. 1396r-8(b)(3)) is 
amended--
          (1) in subparagraph (A)(i)--
                  (A) in subclause (I), by striking ``and'' 
                after the semicolon;
                  (B) in subclause (II), by adding ``and'' 
                after the semicolon;
                  (C) by moving the left margins of subclause 
                (I) and (II) 2 ems to the right; and
                  (D) by adding at the end the following:
                                  ``(III) in the case of rebate 
                                periods that begin on or after 
                                the date of enactment of this 
                                subclause, on the wholesale 
                                acquisition cost (as defined in 
                                section 1847A(c)(6)(B)) for 
                                covered outpatient drugs for 
                                the rebate period under the 
                                agreement (including for all 
                                such drugs that are sold under 
                                a new drug application approved 
                                under section 505(c) of the 
                                Federal Food, Drug, and 
                                Cosmetic Act);''; and
          (2) in subparagraph (D)--
                  (A) in the matter preceding clause (i), by 
                inserting ``and clause (vii) of this 
                subparagraph'' after ``1847A'';
                  (B) in clause (v), by striking ``and'' after 
                the comma;
                  (C) in clause (vi), by striking the period 
                and inserting ``, and''; and
                  (D) by inserting after clause (vi) the 
                following:
                          ``(vii) to the Secretary to disclose 
                        (through a website accessible to the 
                        public) the most recently reported 
                        wholesale acquisition cost (as defined 
                        in section 1847A(c)(6)(B)) for each 
                        covered outpatient drug (including for 
                        all such drugs that are sold under a 
                        new drug application approved under 
                        section 505(c) of the Federal Food, 
                        Drug, and Cosmetic Act), as reported 
                        under subparagraph (A)(i)(III).''.
  Page 195, line 9, strike ``$500,000,000'' and insert 
``$680,000,000''.
                              ----------                              


      PART C--TEXT OF AMENDMENT TO H.R. 5038 CONSIDERED AS ADOPTED

  Page 87, line 18, strike ``2,500'' and insert ``500''.
  Page 87, line 25, strike ``2,500'' and insert ``500''.