[Congressional Record Volume 165, Number 199 (Thursday, December 12, 2019)]
[House]
[Pages H10129-H10225]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    LOWER DRUG COSTS NOW ACT OF 2019

  The SPEAKER pro tempore (Ms. DelBene). Pursuant to House Resolution 
758 and rule XVIII, the Chair declares the House in the Committee of 
the Whole House on the state of the Union for the further consideration 
of the bill, H.R. 3.
  Will the gentlewoman from Texas (Mrs. Fletcher) kindly take the 
chair.

                              {time}  0915


                     In the Committee of the Whole

  Accordingly, the House resolved itself into the Committee of the 
Whole House on the state of the Union for the further 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, with Mrs. Fletcher (Acting Chair) in the chair.
  The Clerk read the title of the bill.
  The Acting CHAIR. When the Committee of the Whole rose on Wednesday, 
December 11, 2019, 60 minutes remained in general debate.
  The gentleman from Maryland (Mr. Hoyer) and the gentleman from Oregon 
(Mr. Walden) each have 30 minutes remaining.
  The Chair recognizes the gentleman from Maryland.
  Mr. HOYER. Madam Chair, I yield myself 1 minute.
  Madam Chair, with this legislation, Democrats are fulfilling our 
pledge to the American people in passing legislation that will bring 
down prescription drug costs for the people. That is one of the three 
central pillars of our For the People Agenda.
  With H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, we are 
delivering for the people. This legislation, named in memory of my dear 
friend and our colleague, Elijah Cummings, who fought so hard to lower 
the cost of prescription drugs, will give Medicare the power to 
negotiate directly with drug companies, which will help bring drug 
prices down, as we do now, Madam Chair, for our veterans.
  It will make those lower drug prices available to Americans with 
private insurance as well--not just Medicare, but with private 
insurance--and it will create a new out-of-pocket limit of $2,000, a 
cap on out-of-pocket expenses for prescription drugs for those on 
Medicare part D.
  According to the nonpartisan Congressional Budget Office, H.R. 3 will 
save American taxpayers approximately half a trillion dollars over the 
next 10 years.
  Now, H.R. 3 reinvests those savings, Madam Chair, in key initiatives, 
including expanding Medicare benefits to cover dental, vision, and 
hearing services; investing in new research, treatment, and cures; and 
combating the opioid crisis--all three objectives that the American 
public overwhelmingly support.
  President Trump, Madam Chair, promised in 2016, before his election, 
that he would work to negotiate lower drug prices, something this bill 
would give his administration the authority to do. For that reason, he 
ought to support it.
  He said in 2016: ``When it comes time to negotiate the cost of drugs, 
we are going to negotiate like crazy.'' He said that in a campaign 
setting. Hopefully, he still believes that today.
  I hope he will join in encouraging the Senate to take up H.R. 3, 
because in 2018, he said this: ``One common cancer drug is nearly seven 
times as expensive for Medicare as it is for other countries. . . . 
This happens because the government pays whatever price the drug 
companies set without any negotiation whatsoever.'' So said President 
Trump on October 25, 2018.
  He went on to say just 2 months ago, in October: ``. . . we want to 
bring our prices down to what other countries are paying, or at least 
close. . . .''
  Madam Chair, that is what this legislation does.
  President Trump went on to say: ``. . . and let the other countries 
pay more. Because they're setting such low prices that we're actually 
subsidizing other countries, and that's just not going to happen 
anymore.''
  Those were remarks before the Cabinet meeting on October 16, 2019, 
just a few weeks ago.
  That is what this legislation does. That is why the Senate ought to 
pass this legislation and the President ought to sign it. I hope he 
will join us in encouraging the Senate to take up H.R. 3 without delay 
and pass it. And I urge the President to reverse his opposition to this 
bill and sign it, his opposition being totally inconsistent with those 
three quotes that I just articulated.
  Too many Americans, Madam Chair, are struggling to pay for their 
prescription drugs. I have heard awful stories from constituents in my 
district, as I know every one of us has, about families rationing 
insulin and having to forego rent or food or other necessities in order 
to pay for their prescription drugs. That is not an option. Without 
them, their health will deteriorate, and, yes, they may die.
  One senior from Clinton, Maryland, in my district, wrote to tell me 
that one of her prescription drugs more than doubled in price, and she 
left the pharmacy empty-handed because she couldn't afford it.
  With H.R. 3, we can bring relief to people like her.
  With H.R. 3, we can lower the cost of prescription drugs so that 
Americans can live healthy lives and pursue their American Dream.
  Madam Chair, I want to thank Chairman Pallone, Chairman Neal, 
Chairman Scott, and their committees for working hard on this bill to 
help Americans lower their prescription drug costs and live longer and 
healthier lives.
  Madam Chair, this should not be a partisan issue. The President 
articulated the desire to achieve the objective of bringing prices 
down. That is what this bill does. That is what CBO says it does. So I 
urge my colleagues to support this.
  Now, Madam Chair, I know you could do this, but I want to do it 
because I am so proud not only of Haley Stevens herself, who is an 
extraordinary Member of the Congress of the United States, a wonderful 
member of the previous administration, and somebody who has worked 
in the private sector and the public sector and who has been elected 
president of your class, Madam Chair, the freshman class, an 
extraordinary group of 63 people, 64 if we count our friend Conor Lamb 
who was elected in a special election just before you--and he, of 
course, lords it over you that he is a senior member of the freshman 
class; I understand that.

  But Haley Stevens leads an extraordinary group of 64 people who have 
contributed so much to our society already in their lives, in their 
productive, constructive lives, and now have come to the Congress. And 
they came with a promise to do three things, at least:
  Number one, to help with wages and jobs and opportunities;
  Number two, to bring prescription costs down; and
  Number three, to invest in infrastructure.
  In this bill, we meet one-third of those promises, and they have made 
it possible.
  Madam Chair, I yield the balance of my time to the gentlewoman from 
Michigan (Ms. Stevens), the president of the freshman class, so she may 
manage the remainder of the time.
  Ms. STEVENS. Madam Chair, I reserve the balance of my time.
  Mr. WALDEN. Madam Chair, I yield myself such time as I may consume.
  I appreciate the distinguished majority leader's comments about 
President Trump.
  I have been around Congress for 21 years, and I have never seen a 
President of either party lean more forward in trying to get down the 
cost of prescription drugs, to give taxpayers more of their hard-earned 
income, to get an

[[Page H10130]]

economy up and running like we have never seen it before, to tackle the 
issue of unemployment and get unemployment numbers down to the lowest 
level in 50 years in every category all across the country, and to 
reduce the burdens of overregulation. President Trump has done all 
those things.
  He also has called for getting down the price of prescription drugs. 
I have been in several meetings where he has done that, and I share his 
passion for that, and I know he wants a bipartisan bill that can become 
law and be put on his desk.
  Everything you heard from the distinguished majority leader about 
President Trump's views are accurate, but he actually read H.R. 3. And 
if you read the Statement of Administration Policy, he recognizes that 
this goes too far and he would have to veto it, that it is a partisan-
only bill--partisan only.
  And here is part of the problem with H.R. 3: It hands the government 
a club. There is no negotiation in here. If you don't agree to what the 
government says the price should be, the government in Washington comes 
after your revenues, and up to 95 percent of your revenues for selling 
that drug they can just come and take.
  By the way, when you throw in the cost of taxation and everything 
else, it is well over 100 percent that a drug manufacturer who is 
innovating some new drug and has the patent for that great American 
innovation, the government says: If you don't sell it for what we want 
within a band, we are taking it. We are not taking your patent--well, 
they might come back and do that in another iteration, but: What we are 
doing is taking all the revenues. We will bankrupt you.
  That is why 138 different small innovative startup innovators in this 
space wrote to the Speaker and the Republican leader. And I want to 
quote from their letter, Madam Chair. It says: ``We represent the 
community of emerging biotechnology companies whose researchers and 
scientists strive daily to develop innovative life-changing therapies 
and cures for patients. We take pride that we are providing hope to 
patients and their families and changing the world through medical 
breakthroughs. These dreams will be shattered if H.R. 3, the Lower Drug 
Costs Now Act, is passed.''
  They went on to say: ``Unfortunately, H.R. 3 is an unprecedented and 
aggressive government intervention in the U.S. market of drug 
development and delivery that will limit patient access to these 
extraordinary advancements in healthcare.''
  Look, we all agree drug costs are too high, and we want to work 
together to stop the gaming and bring down the prices.
  Our alternative, which we will debate in a few minutes, does that, 
but it doesn't do it at the expense of completely upending the 
ecosystem that allows American innovators to do what no one else in the 
world does as well, and that is come up with new cures for diseases and 
make them available.
  Madam Chair, I enter into the Record the letter from 138 startup 
innovators in its full context.

                                                 December 5, 2019.
     Hon. Nancy Pelosi,
     Speaker of the House,
     Washington, DC.
     Hon. Kevin McCarthy,
     House Republican Leader,
     Washington, DC.
       Dear Speaker Pelosi and Republican Leader McCarthy: We 
     represent the community of emerging biotechnology companies 
     whose researchers and scientists strive daily to develop 
     innovative life-changing therapies and cures for patients. We 
     take pride that we are providing hope to patients and their 
     families and changing the world through medical 
     breakthroughs. These dreams will be shattered if H.R. 3, the 
     Lower Drug Costs Now Act, is passed.
       We are at an incredible inflection point in science and 
     technology that is bringing forth transformative treatments 
     and even cures for cancer, infectious diseases, and a myriad 
     of other serious and rare diseases. These advancements are 
     benefiting lives of millions of patients and alleviating 
     human suffering, while helping to reduce other more expensive 
     parts of our health care system, such as hospital spending. 
     Our continued success depends on maintaining an environment 
     that supports investment in tomorrow's discoveries.
       Unfortunately, H.R. 3 is an unprecedented and aggressive 
     government intervention in the U.S. market of drug 
     development and delivery that will limit patient access to 
     these extraordinary advancements in health care. This extreme 
     proposal will upend the ecosystem of U.S. biomedical 
     innovation, destroying our ability to attract private 
     investment dollars that allow us to develop new treatments 
     and change the course of healthcare delivery for so many 
     patients.
       We strongly urge you to abandon H.R. 3. Further, in order 
     to keep pace with this biomedical revolution and ensure 
     America remains the world leader in innovation, we hope that 
     you will pursue bipartisan, holistic policies that modernize 
     our health care payment system and lower drug costs for 
     patients.
       Sincerely,
         Adelene Perkins, Chair & CEO, Infinity Pharmaceuticals, 
           Inc.; Adrian Gottschalk, President & CEO, Foghorn 
           Therapeutics; Alden Pritchard, CEO, Kaio Therapy, Inc.; 
           Alex Nichols, PhD, President & CEO, Mythic 
           Therapeutics; Amit Munshi, President & CEO, Arena 
           Pharmaceuticals, Inc.; Andre Turenne, President & CEO, 
           Voyager Therapeutics, Inc.; Aprile Pilon, PhD, 
           President & CEO, Trove Therapeutics, Inc.; Armando 
           Anido, Chairman & CEO, Zynerba Pharmaceuticals; Axel 
           Bolte, Co-Founder, President & CEO, Inozyme Pharma; 
           Barry Quart, President & CEO, Heron Therapeutics.
         Bassil Dahiyat, President & CEO, Xencor, Inc.; Bill 
           Enright, CEO, Vaccitech, Ltd.; Bill Newell, CEO, Sutro 
           Biopharma; Blake Wise, CEO, Achaogen, Inc.; Bonnie 
           Anderson, Chairman & CEO, Veracyte, Inc.; Bradford 
           Zakes, President & CEO, Cerevast Therapeutics; Brandi 
           Simpson, CEO, Navigen, Inc.; Brian Windsor, CEO, Lung 
           Therapeutics, Inc.; Briggs W. Morrison, MD, CEO, Syndax 
           Pharmaceuticals; Bruce Clark, PhD, President & CEO, 
           Medicago, Inc.
         Casey Lynch, CEO, Cortexyme; Cedric Francois, Co-Founder, 
           CEO & President; Apellis Pharmaceuticals; Chris Gibson, 
           Co-Founder & CEO, Recursion; Christopher Barden, CEO, 
           Treventis Corporation; Christopher Burns, PhD, 
           President & CEO, VenatoRx Pharmaceuticals, Inc.; 
           Christopher Schaber, President & CEO, Soligenix, Inc.; 
           Ciara Kennedy, PhD, CEO, Amplyx Pharmaceuticals; Clay 
           Seigall, President, CEO & Chairman, Seattle Genetics, 
           Inc.; Craig Chambliss, President & CEO, Neurelis; David 
           Baker, President & CEO, Vallon Pharmaceuticals.
         David Bears, Founder & CEO, Tolero Pharmaceuticals; David 
           de Graaf, PhD, President & CEO, Comet Therapeutics, 
           Inc.; David Donabedian, PhD, Co-Founder & CEO, Axial 
           Biotherapeutics; David Lucchino, President & CEO, 
           Frequency Therapeutics, Inc.; David Mazzo, President & 
           CEO, Caladrius Biosciences; David Meeker, CEO, KSQ 
           Therapeutics; Doug Kahn, Chairman & CEO, TetraGenetics, 
           Inc.; Douglas Doerfler, President & CEO, MaxCyte, Inc.; 
           Dr. Elizabeth Poscillico, President & CEO, EluSys 
           Therapeutics, Inc.; Eric Dube, PhD, CEO, Retrophin, 
           Inc.
         Eric Schuur, President & CEO, HepaTx Corporation; Erika 
           Smith, CEO, ReNetX Bio; Franciso LePort, Founder & CEO, 
           Gordian Biotechnology; Gail Maderis, President & CEO, 
           Antiva Biosciences; Gary Phillips, President & CEO, 
           Orphomed, Inc.; Geno Germano, President & CEO, Elucida 
           Oncology, Inc.; George Scangos, CEO, VIR Biotechnology; 
           Gil Van Bokkelen, Founder, Chairman & CEO, Athersys, 
           Inc.; Greg Verdine, President & CEO, LifeMine 
           Therapeutics, Inc., FOG Pharmaceuticals, Inc.; Imran 
           Alibhai, CEO, Tvardi Therapeutics.
         James Breitmeyer, President & CEO, Octernal Therapeutics, 
           Inc.; James Flanigon, CEO, Honeycomb Biotechnologies; 
           James Sapirstein, President & CEO, AzurRx BioPharma; 
           Jay Evans, President & CEO, Inimmune Corporation; Jeb 
           Keiper, CEO, Nimbus Therapeutics; Jeff Cleland, PhD, 
           Executive Chair, Orpheris, Inc.; Jeff Jonker, President 
           & CEO, Ambys Medicines; Jeff Kindler, CEO, Centrexion 
           Therapeutics; Jeremy Levin, Chairman & CEO, Ovid 
           Therapeutics, Inc.; Joe Payne, President & CEO, 
           Arcturus Therapeutics, Inc..
         John Crowley, Chairman & CEO, Amicus Therapeutics, Inc.; 
           John Jacobs, President & CEO, Harmony Biosciences; John 
           Maraganore, CEO, Alnylam Pharmaceuticals; Julia Owens, 
           President & CEO, Millendo Therapeutics, Inc.; Justin 
           Gover, CEO & Executive Director, Greenwich Biosciences; 
           Keith Dionne, CEO, Casma Therapeutics; Keith Murphy, 
           Founder, CEO & President, Viscient Biosciences; Ken 
           Mills, CEO, REGENXBIO, Inc.; Ken Moch, President & CEO, 
           Cognition Therapeutics; Kent Savage, CEO, 
           PhotoPharmics, Inc.
         Kevin Gorman, CEO, Neurocrine Biosciences; Kiran Reddy, 
           MD, CEO, Praxis Medicines; Lawrence Brown, CEO, 
           Galactica Pharmaceuticals; Lorenzo Pellegrini, Founder, 
           Palladio Biosciences; Marc De Garidel, Chairman & CEO, 
           Corvidia Therapeutics; Marilyn Bruno, PhD, CEO, Aequor, 
           Inc.; Mark Leuchtenberger, Executive Chairman, Aleta 
           Biotherapeutics; Mark Pruzanski, MD, President & CEO, 
           Intercept Pharmaceuticals, Inc.; Mark Timney, CEO, The 
           Medicines Company; Markus Renschler, MD, President & 
           CEO, Cyteir Therapeutics.

[[Page H10131]]

         Martin Babier, CEO, Principia Biopharma; Melissa 
           Bradford-Klug, CEO, Mayfield Pharmaceuticals; Michael 
           Clayman, MD, CEO, Flexion Therapeutics; Michael J. 
           Karlin, Co-CEO, Ibex Biosciences, LLC; Michael Raab, 
           CEO, Ardelyx, Inc.; Mike Narachi, President & CEO, Coda 
           Biotherapeutics; Ming Wang, PhD, President & CEO, 
           Phanestra Therapeutics, Inc.; Morgan Brown, Executive 
           VP & CFO, Lipocine; Nancy Simonian, CEO, Syros 
           Pharmaceuticals; Olin Beck, CEO, Bastion Biologics.
         Pam Randhawa, President & CEO, Empiriko Corporation; Pat 
           McEnany, President & CEO, Catalyst Pharmaceuticals, 
           Inc.; Paul Bolno, MD, CEO, Wave Life Sciences; Paul 
           Boucher, President & CEO, Parion Sciences, Inc.; Paul 
           Hastings, CEO, Nkarta Therapeutics; Paul Laikind, 
           President & CEO, Viacyte; Peter Savas, CEO & Chairman, 
           LikeMinds, Inc.; Rachel King, Founder & CEO, 
           GlycoMimetics, Inc.; Randy Milby, Founder & CEO, 
           Hillstream BioPharma, Inc.; Rashida Karmali, PhD, 
           President & CEO, Tactical Therapeutics, Inc.
         Richard Markus, CEO, Dantari Pharmaceuticals; Richard 
           Pascoe, Chairman & CEO, Histogen, Inc.; Richard 
           Samulski, President, Asklepios BioPharmaceutical, Inc.; 
           Rick Russell, President, Minverva Neurosciences; Rick 
           Winningham, Chairman & CEO, Theravance Biopharma; Rob 
           Etherington, President & CEO, Clene Nanomedicine; 
           Robert Goodwin, PhD, CEO, Vibliome Therapeutics, Inc.; 
           Robert Gould, PhD, President & CEO, Fulcrom 
           Therapeutics; Robert M. Bernard, President & CEO, Ichor 
           Medical Systems; Robert Wills, Chairman, CymaBay 
           Therapeutics, Inc.
         Roger Tung, President & CEO, CoNCERT Pharmaceuticals; Ron 
           Cohen, Founder, President & CEO, Acorda Therapeutics, 
           Inc.; Russ Teichert, PhD, CEO, Scintillant Bioscience; 
           Russell Herndon, President & CEO, Hydra Biosciences, 
           LLC; Samantha S. Truex, CEO, Quench Bio; Sandy Macrae, 
           President & CEO, Sangamo Therapeutics, Inc.; Scott 
           Koenig, President & CEO, MacroGenics, Inc.; Sean 
           McCarthy, President, CEO & Chairman, CytomX; Sharon 
           Mates, Founder, Chairman & CEO, Intra-Cellular 
           Therapies; Shawn K. Singh, CEO, VistaGen Therapeutics, 
           Inc.
         Stan Abel, President & CEO, SiteOne Therapeutics, Inc.; 
           Stanley Erck, President & CEO, Novavak; Stephen Farr, 
           PhD, President & CEO, Zogenix, Inc.; Stephen R. Davis, 
           CEO, ACADIA Pharmaceuticals; Stephen Yoder, CEO & 
           President, Pieries Pharmaceuticals; Sue Washer, 
           President & CEO, AGTC; Sujal Shah, President & CEO, 
           CymaBay Therapeutics, Inc.; Ted Love, CEO, Global Blood 
           Therapeutics; Terry Tormey, CEO, Kibow Biotech.
         Thomas Wiggans, Founder, President & CEO, Dermira, Inc.; 
           Tia Lyles-Williams, Founder & CEO, LucasPye BIO; Tim 
           Bertram, CEO, inRegen & TC Bio; Timothy Walbert, 
           President & CEO, Horizon Therapeutics; Todd Brady, CEO, 
           Aldeyra Therapeutics; Vipin Garg, PhD, CEO, Altimmune; 
           Wendye Robbins, MD, President & CEO, Blade 
           Therapeutics; Will DeLoache, CEO, Novome 
           Biotechnologies; Zandy Forbes, CEO, MeiraGTx.

  Mr. WALDEN. Madam Chair, I know the Democrats yesterday said: We 
don't care. It is worth it. We don't need all those cures.
  That is, in effect, what they said.
  And then they said: Oh, those are just somebody's talking points.
  No. This is the Congressional Budget Office's independent analysis 
that said we will lose 38 cures right out of the gate in the next two 
decades because of H.R. 3, and that for every year thereafter in the 
2030s, we will lose 10 percent of what we otherwise would have.
  Is that the cure for Alzheimer's? rheumatoid arthritis? ALS? 
Parkinson's?
  That is what Democrats are saying they don't care about, that it is 
worth it to let those go in order to force the government price in this 
market.
  We don't think that has to be the case. I don't think it is an 
either/or choice. They are making it that with H.R. 3.
  I think we can have innovation without the heavy-handed club mugging 
innovation by taking the revenues of companies when they don't agree 
with what the government sets as the price.
  And we know in foreign countries that they want to model America 
after, upwards of 40 percent of cancer drugs are not available in those 
countries, and they are available here in the United States.
  You can go across every one of the six indicator countries, look at 
how they control drug costs, and, yes, they do have lower drug costs--
and that is why we have a trade negotiator, so we can get lower drug 
costs in these trade agreements and stop getting ripped off--but what 
they do to really control is they control access.
  There was a lot talked about in terms of death panels when ObamaCare 
was considered. This bill actually represents that.
  We are told that by the people who innovate in this space that they 
will not be able to continue to innovate as they have in the past and 
that drugs that save lives will not be available because they won't be 
invented.
  That is not just my words. That is the Congressional Budget Office; 
that is the Council of Economic Advisers.
  There isn't a think tank out there yet that I have seen, no 
independent analysis that says H.R. 3 is going to do anything but that.
  Innovation goes up on the rocks with H.R. 3. Lives will be lost; 
cures will never be found; and Americans won't be better off.
  It doesn't have to be that way. We have bipartisan legislation in our 
substitute that will bring down prices, bring down drug costs, bring 
about transparency, put a cap on what seniors spend on Medicare, 
address the insulin cost issue, and it can become law.
  Madam Chair, I reserve the balance of my time.

                              {time}  0930

  Ms. STEVENS. Madam Chair, I yield myself as much time as I may 
consume.
  Madam Chair, I want to thank our majority leader for designating his 
time in managing the floor on the heels of the passage of today's 
historic vote.
  Today is a beacon of hope for so many families who have been burdened 
by the outrageous costs of prescription drugs in this country.
  Lower Drug Costs Now Act lowers drug costs now for the families who 
are counting on us, the families who are burdened with exorbitant costs 
of prescription drugs that they cannot afford. Lower prescription drugs 
for the parents of a child with a rare disability who are wondering how 
they can afford to pay that bill. Lower prescription drugs for the 
retired American who worked all of their life and now cannot afford to 
pay for that medication. Lower prescription drugs now for the senior 
who is afraid to go to the pharmacy to pick up that prescription drug 
because of what it might cost. Lower prescription drugs for a third of 
Americans who do not get their prescription drugs because they cannot 
afford them. That is what we are here today to do.
  Some have chosen to listen to the drug companies. Some have chosen to 
take their cues. Take it from somebody who worked in an innovation 
research lab about the plight of research and development in this 
country and the investments that go into funding basic innovation 
research and how that gets done through public-private partnership. But 
do not put the American people at the expense of that plight because we 
know that our basic research dollars rest within the National 
Institutes of Health, that they rest within the work that we are doing 
in the Science, Space, and Technology Committee.
  This legislation today, my friends, this legislation appropriately 
named after our beloved colleague, Elijah E. Cummings, someone who was 
never afraid to stand up for what was right and who led by true and 
pure example, we were so blessed to have stood in his light. And while 
serving as the Chair of the Oversight Committee, he showed us the way 
by uncovering many of these corrupt practices that have caused drug 
prices to be out of reach for so many.
  I am also especially pleased to highlight provisions in this bill 
that were long championed by one of my great friends and mentors, 
former Congressman Sander Levin. These provisions for the first time 
will allow our Nation's older adults to receive coverage for dental, 
vision, and hearing under Medicare. I hope Mr. Levin is proudly 
watching as the House in which he served for 36 years, this very body, 
delivers on this effort.
  I can speak for members of the freshman class, who have stood on the 
shoulders of the Members who have come before us to say that we were 
sent to Washington with a mandate to bring down the cost of 
prescription drugs and to deliver for the American people.

[[Page H10132]]

  H.R. 3 is a long overdue change to the way we do business around 
here. This will untie the hands of the Federal Government to negotiate 
prices for the oldest and most expensive drugs in Medicare part D and 
apply those prices to all Americans.
  In my district, in Michigan's 11th District, southeastern Michigan, 
H.R. 3, the Lower Prescription Drugs Now Act stands to benefit over 
100,000 people enrolled in Medicare part D alone, as well as over 
600,000 people who are enrolled in private health insurance.
  We all know someone who has had their life impacted by cancer, 
whether it be a parent, a cousin, a relative, a dear friend. For the 
9,000 women diagnosed with breast cancer in Michigan this year, H.R. 3 
will lower their medication by 65 percent from $69,000 to $23,000 per 
year. For the 4,500 Michiganians diagnosed with prostate cancer this 
year, H.R. 3, the Lower Prescription Drugs Now Act will lower the cost 
of their medication from over $100,000 to $37,000 per year. And the 
list goes on.
  Many of these patients live as close as a 10-minute drive from Canada 
in Michigan where Canadians are paying cents on the dollar for the 
exact same drugs. We ask why should that be in a country as wealthy, as 
prosperous, as innovative, as creative, and successful as ours? Drugs 
like insulin. H.R. 3 will finally level the global playing field for 
Americans.
  The tremendous savings generated from H.R. 3, the Lower Prescription 
Drugs Now Act, will go right back into the research to develop new 
drugs with some of the savings also bringing us one step closer to 
stemming the devastating tide of the opioid epidemic.
  I ask my friends to join me in commandeering this opioid epidemic 
that is ravaging far too many communities across this beautiful 
country. Far too many communities. Where recent graduates from high 
school say we go to our high school reunions in graveyards, in 
cemeteries because of this opioid epidemic.
  I am proud that this historic piece of legislation also includes a 
bill that I had the privilege of authoring to lower prescription drug 
costs for lower-income, older adults, who are enrolled in the lowest 
cost part D plan that covers their medication needs.
  The time is now, and I urge my colleagues, I implore them, to follow 
the will of their constituents and pass H.R. 3, the Lower Drug Costs 
Now Act of 2019.
  Madam Chair, I reserve the balance of my time.
  Mr. WALDEN. Madam Chair, I yield myself such time as I may consume.
  It is important to know that in our substitute we cut the costs of 
cancer treatment for seniors in half, as well. There is bipartisan 
agreement on this. In fact, everything in our substitute is bipartisan.
  It is also important to note that in Canada it takes 14 months longer 
to get access to miracle new medicines compared to what we have in 
America. They have 52 percent of the medicines there that we have here. 
They have 60 percent of the cancer medicines. That means 40 percent of 
the cancer medicines, the latest cutting-edge ones, the ones we read 
about and see on ``60 Minutes'' that are curing cancer here in America, 
you can't get in Canada. I don't want to import that here.
  And when it comes to reducing access to drugs, basic research is 
essential. Nobody has done more to deal with that than the gentleman 
from Michigan, former chairman of the committee, Fred Upton, who led 
the effort with Cures to get more research in the National Institutes 
of Health.

  Madam Chair, I yield 3 minutes to the gentleman from Michigan (Mr. 
Upton).
  Mr. UPTON. Madam Chair, I thank the gentleman for yielding.
  I thank the Democratic leadership for, I think the first time this 
year, allowing our side to actually have a substitute to a major piece 
of legislation. And I thank our leadership, because that substitute is 
not a partisan substitute but, rather, a bipartisan substitute. In 
fact, every single provision in this bill has got strong bipartisan 
support, which was packaged together.
  Tomorrow will mark the third anniversary of President Obama's signing 
of 21st Century Cures, a bill that Diana DeGette and I helped shepherd 
through our committee on a unanimous vote, and we passed here in the 
House 392-26.
  21st Century Cures increased NIH funding by some $45 billion over a 
10-year span. It sped up the approval of drugs and devices, and just 
after 3 years we have seen the number of cell, gene, and nucleoid 
therapies have more than doubled. In fact, research this last year will 
actually exceed $13 billion. The FDA is predicted to approve as many as 
20 gene therapy drugs by the year 2025. That is wonderful news.
  We all want to do something about drug prices, and that is what a 
vote for our substitute, H.R. 19, will do. The President will sign that 
bill, but he is not going to sign this bill, H.R. 3, because it is 
going to slow down the ability to find the cures that we want to find 
for these awful diseases.
  Now, those aren't my words. That is the CBO, a nonpartisan group, it 
is the CEA, the Council of Economic Advisers.
  But in today's ``Wall Street Journal,'' the former director of the 
FDA, Scott Gottlieb, writes, ``This week the House will vote on 
legislation known as H.R. 3. The price-control approach would increase 
uncertainty and reduce returns from biotech investment, raising the 
cost of capital for these invaluable endeavors.'' He is right on. We 
want to find new cures. We want to find new technologies and to use 
those. We want precision medicine.
  Madam Chair, I include the ``Price Controls Would Stifle Biotech 
Innovation'' in the Record.

             Price Controls Would Stifle Biotech Innovation

       A House price-control bill would do the most damage to 
     transformative and lifesaving medications.

                   (By Scott Gottlieb, Dec. 11, 2019)

       Victoria Gray of Mississippi recently became the first U.S. 
     patient with a genetic disorder to be treated using the 
     Crispr gene-editing technique. Doctors used a novel drug to 
     overwrite the function of a faulty gene that gave rise to her 
     sickle-cell disease. Advances in life science can define this 
     century, but policy makers must resist the urge to adopt 
     policies that impose price controls and punish drugmakers for 
     taking risks.
       The convergence of information technology and biology 
     allows scientists to translate the human genome into digital 
     data that can accelerate diagnoses and cures. Over the next 
     decade, it is a near certainty that we will have gene-therapy 
     cures for deadly inherited disorders such as muscular 
     dystrophy. Cell-based and regenerative medicine can restore 
     human functions lost to disease, including returning some 
     sight to the blind. Gene editing will be used to alter DNA to 
     erase the origins of a range of debilitating inherited 
     disorders.
       These are only some of the opportunities at hand. Yet bad 
     policies could sap the risk-taking that brings forth the most 
     important innovations. For instance, the Lower Drug Costs Now 
     Act would expose the 250 costliest drugs to government price 
     controls. The high-cost drugs lawmakers target are often the 
     most innovative and potentially transformative new 
     medications. This week the House will vote on the 
     legislation, known as H.R. 3.
       The price-control approach would increase uncertainty and 
     reduce returns from biotech investment, raising the cost of 
     capital for these invaluable endeavors. It would alter 
     incentives and shift money from the most speculative but 
     highest-value science, including regenerative medicine and 
     gene editing. Money would flow instead to known disease areas 
     and well-characterized targets, using proven approaches such 
     as pill-form drugs.
       New and high-risk drug platforms like gene therapies are 
     often targeted first to treat rare and serious conditions; 
     after they are proven to work safely, they will be used to 
     treat morecommon maladies, such as heart disease. This is how 
     medicine advances. But if investors knew their returns would 
     be capped, they would direct their investments toward safer 
     projects with lesser payoffs. We would still get new drugs, 
     but the treatments would be very different.
       Fifteen years ago, the standard refrain from drug-industry 
     critics was that all the big drugmakers did was develop ``me 
     too'' medicines--the seventh version of a blood-pressure pill 
     or a cholesterol-lowering statin. In response, the federal 
     government took steps, some of which shaped Medicare Part D, 
     to encourage investment in ``specialty'' drugs that were more 
     novel.
       Since then, investment capital has shifted sharply. Cancer 
     and rare diseases receive substantially more attention and 
     resources. The number of cell, gene and nucleotide therapies 
     in development has more than doubled over the past three 
     years, while total investment in cell and gene therapies 
     eclipsed $13 billion last year.
       The Food and Drug Administration approved four gene 
     therapies in only the past three years, with 800 similar 
     kinds of products in various stages of development. An 
     assessment of the current pipeline and historical rates of 
     success in clinical trials suggests that by 2025 the FDA will 
     be approving 10 to 20 gene-therapy drugs a year. Progress

[[Page H10133]]

     is especially strong in oncology. The number of cancer drugs 
     in development has quadrupled since 1996.
       These specialty drugs often aren't cheap. They target 
     narrow conditions for which the cost of risk-taking and drug 
     development is amortized over a smaller number of eligible 
     patients. Highly novel drug platforms can also cost more 
     initially to perfect. Based on my informal survey of 
     companies, enrolling a single patient in a clinical trial for 
     a gene-altering drug often costs between $500,000 and 
     $700,000 and can reach as high as $1 million.
       To support this innovation, total spending on research and 
     development by the 15 biggest drugmakers topped $100 billion 
     in 2018, up 32 percent in the past five years. A cancer cure, 
     or a gene-therapy remedy, can sharply reduce the lifetime 
     cost of treating a debilitating disease. It can dramatically 
     alter the length and productivity of people's lives. But 
     high-cost treatments are pricing out a growing number of 
     underinsured patients, keeping them from using medications 
     that could alter their providence. This is unacceptable.
       There are ways to make specialty drugs more affordable 
     without eroding the incentives that drive capital into the 
     riskiest but most promising endeavors. One is to help second-
     to-market drugs get through the regulatory process.
       Once an effective drug is approved to treat a deadly 
     condition, introducing a second drug to treat the same 
     disease can be hard. It's tough to recruit patients with a 
     debilitating disease for a clinical trial when a proven 
     medicine is already available. Moreover, the smaller pool of 
     patients who will be newly diagnosed each year with the same 
     disease isn't always large enough to support the cost of 
     developing a second drug, reducing competition that can lower 
     pnces.
       We offer first-to-market breakthrough drugs an efficient 
     route through FDA review. We could give second-to-market 
     competing medicines the same regulatory benefits. Further, 
     when the biology of a drug target is very well understood, 
     and the basis for how it interacts with a disease firmly 
     established, we can create a new regulatory designation to 
     streamline development of a competing drug and shift data 
     collection to real-world, post-approval settings.
       Many drugs targeted by H.R. 3 for government price controls 
     are examples of the innovation we should try to encourage. In 
     fact, they are the investments that critics who griped about 
     me-too medicines said they wanted. Now the same crowd is 
     crafting policies that would shift investment back into the 
     more mundane endeavors they once lamented.

  Mr. UPTON. Madam Chair, I have served on the Health Subcommittee for 
all my days on the Energy and Commerce Committee, and we have seen 
firsthand the different families impacted by these awful diseases, 
whether it be Alzheimer's or sickle cell, cystic fibrosis.
  Just this last week, we witnessed real advancements, we think, in 
pancreatic cancer stage III, stage IV. SMA, spinal muscular atrophy, a 
disease that is often fatal by the year 9 or 10; we saw a woman who had 
been on a new drug for 15 days, and for the first time she could 
actually move her neck after more than 10 years literally trapped in a 
wheelchair.
  If we want to find the advancements and cures for these diseases, we 
need to pass H.R. 19.
  I urge my colleagues to vote for that substitute and get a bill to 
the President that he will actually sign, and we can get something 
done.
  Ms. STEVENS. Madam Chair, I yield 1\1/2\ minutes to the gentlewoman 
from Washington (Ms. DelBene).
  Ms. DelBENE. Madam Chair, I thank the gentlewoman for yielding.
  I rise today in support of H.R. 3, the Elijah E. Cummings Lower Drug 
Costs Now Act.
  The rising costs of prescription drugs is one of the top issues I 
hear about from my constituents, and it has been getting worse.
  This year alone, I have received nearly four times as many calls and 
letters about prescription drug prices than all of last year. And there 
are many, many stories, but I would like to share one today to remind 
us why this legislation is so necessary.
  A constituent of mine, Dana from Kenmore, Washington, has lived with 
type 1 diabetes for nearly 14 years. When Dana was first diagnosed, 
insulin cost her $50 each month. Today that same insulin costs over 
$600 per month. That is an 1,100 percent increase for the exact same 
product.
  We talked about innovation, but there have been virtually no changes 
to insulin since Dana's diagnosis, so the price spike is inexplicable.
  Dana is not only a diabetes patient, but she is also a nurse 
practitioner and a diabetes educator. And she has told me about her 
patients that go to Canada where they can get insulin for just $40 a 
month. She has also shared stories of her own patients who can't afford 
their medications, who ration their insulin, which we know can lead to 
poorer health, vision loss, kidney failure, and even death.
  H.R. 3 will finally give the Health and Human Services secretary the 
power to negotiate a fair price for insulin, which will dramatically 
help patients like Dana and all the patients that she serves.
  Madam Chair, I urge my colleagues to support this legislation.
  Mr. WALDEN. Madam Speaker, I yield 1\1/2\ minute to the gentleman 
from Georgia (Mr. Carter), Congress' only pharmacist.
  Mr. CARTER of Georgia. Madam Chair, I thank the gentleman for 
yielding.
  We have a situation here where we all want the same thing. We all 
want to bring down prescription drug prices. We want the same thing. We 
need the same thing. We can achieve the same thing. We can achieve the 
same thing without taking the risk of drugs not coming to the market.
  Physicians take an oath when they graduate from medical school, it is 
called the Hippocratic Oath. It says, ``first, do no harm.'' Now, 
whether you believe the Congressional Budget Office that it will be 
eight to 15 drugs, or whether you believe the Council of Economic 
Advisers that it will be over 100 drugs, even if it is one drug, that 
is one drug too many.

                              {time}  0945

  It is simply a chance we cannot afford to take. Every one of us in 
this body knows a story, knows someone who has suffered from that awful 
disease Alzheimer's. It is an awful disease.
  Barbara Lutz tells the story about her husband, Richard, who suffered 
from that disease. She tells the story about how she and her family 
suffered through that with him. Oftentimes, it is the caregivers who 
suffer so much.
  Finally, Richard has succumbed to that disease after a 7-year fight. 
Now, people who are diagnosed or who have family and loved ones who are 
diagnosed with Alzheimer's come up to Barbara and ask her: ``What do I 
do? What do I do?'' Barbara simply told me: ``All I can tell them is to 
pray for a cure.''
  This is not a Republican-Democratic issue. This is our issue. This is 
America's issue. We have to solve it together, and we can do that.
  Ms. STEVENS. Madam Chair, I think we are all here to make sure that 
every Alzheimer's patient and every family affected by Alzheimer's has 
access to the lowest, most affordable prescription drugs possible, 
which is why we are so pleased to be ushering in today's piece of 
legislation.
  Madam Chair, I yield 3 minutes to the gentleman from Nevada (Mr. 
Horsford).
  Mr. HORSFORD. Madam Chair, I thank my colleague from Michigan for her 
leadership and for guiding this debate on the floor today.
  Madam Chair, I rise to speak in support of H.R. 3, the Elijah E. 
Cummings Lower Drug Costs Now Act, named after a man who I have great 
respect for, who was a mentor of mine, and who fought so hard to hold 
Big Pharma accountable.
  Today is a big day for the American people because we are finally 
putting their health over the interests of Big Pharma's profits. I am 
speaking in support of this legislation for the hundreds, if not 
thousands, of constituents who have shared their stories with me 
throughout this year. This issue is the single most important issue in 
my district. I am speaking in support of people like my constituent 
Mario.
  About a year ago, Mario was diagnosed with diabetes and recently 
sought care for a lesion on his foot that wouldn't heal. Because he 
couldn't afford the proper medications, Mario ended up losing his toe 
and had to leave his job. His daughter had to drop out of college to 
work full time to help pay for Mario's medications.
  This is an issue that not only impacts the lives of the patients who 
are in desperate need of lifesaving medications to stay healthy, but it 
is also impacting those who love and care for them. It is altering the 
future of their families.
  As Chairman Cummings would say: ``We are better than this.'' We are 
better than this as a nation, to put the interests of Big Pharma and 
their profits

[[Page H10134]]

over the interests of the American people and their health.
  For far too long, American families have been forced to pay 4, 5, or 
even 10 times more for their prescriptions than patients in other 
countries.
  Do my colleagues on the other side think that that is right, that 
your constituents are subsidizing the healthcare for people across the 
world when you have people in your own neighborhood who are rationing 
their medications, making false choices to pay their rent, buy food, or 
take the necessary medication as prescribed by their doctors? Well, I 
don't. I don't think that that is a choice the American people should 
have to make.
  Today, we are taking the necessary action to move this legislation 
forward, and I hope that my colleagues on the other side will work with 
us and that the President will work with us.
  What my constituents tell me is not that they are Democrats, not that 
they are Republicans, not that they are Democrats, not that they are 
independents. They tell me that they have diabetes, that they have 
cancer, that they have heart disease, that they have asthma, that they 
have HIV and AIDS, that they are dying, and that they need the 
healthcare that they demand.
  Madam Chair, I ask us to pass H.R. 3.
  Mr. WALDEN. Madam Chair, may I inquire as to how much time each side 
has remaining.
  The Acting CHAIR. The gentleman from Oregon has 18 minutes remaining. 
The gentlewoman from Michigan has 17\1/2\ minutes remaining.
  Mr. WALDEN. Madam Chair, I yield 1\1/2\ minutes to the gentleman from 
North Carolina (Mr. Holding).
  Mr. HOLDING. Madam Chair, H.R. 3 is a shortsighted proposal and a bad 
deal for our constituents.
  It will compromise the strong legacy of innovation that our Nation is 
proud of. It will be a grave mistake to fundamentally change the market 
structure that makes America a viable market for cutting-edge 
innovation in biopharmaceuticals.
  Government price setting will kill innovation in clinical areas where 
it is most needed. The pricing scheme outlined in H.R. 3 would 
disincentivize research and development for drugs that are first in 
their class, such as the future cure for Alzheimer's or ASL.
  Government price controls will not only kill innovation but will also 
fundamentally change the doctor-patient relationship in this country. 
This bill would allow bureaucrats to make the most personal of choices 
about the course of treatment for our constituents. Treatment decisions 
in this country should be made between a patient and their physician 
and should not be based on the rationing of treatments by bureaucrats 
in foreign nations.
  In North Carolina, H.R. 3's pricing scheme would shatter the 
biopharmaceutical ecosystem that supports 40,000 jobs directly, 200,000 
jobs indirectly, and generates $13 billion in economic output annually. 
That is just in North Carolina.
  H.R. 3 would put small and midsized biotech firms out of business and 
threaten hundreds of thousands of our constituents' jobs. We should 
reject H.R. 3 and, instead, advance meaningful legislation that lowers 
patients' out-of-pocket costs, that protects innovation, and that would 
actually be signed into law.
  Ms. STEVENS. Madam Chair, I yield 3 minutes to the gentleman from 
Colorado (Mr. Crow).
  Mr. CROW. Madam Chair, I rise today to speak in favor of H.R. 3, the 
Elijah E. Cummings Lower Drug Costs Now Act, and I am eager to vote for 
this landmark piece of legislation today.
  I am proud that we are here boldly taking a stand against the 
influence of special interests in Congress and a stand for the American 
people, to help them afford critical lifesaving medications.
  Back home in Colorado's Sixth Congressional District, when I am 
hosting townhalls or roundtables with families, college students, or 
seniors, I hear the same thing: Prescription drugs are too expensive, 
and Congress needs to act now.
  Currently, as we stand here, one in three Coloradans can't afford to 
pay for their basic medications and are having to either ration their 
medication or stop taking it altogether. This needs to stop now.
  Thousands of Coloradans are diagnosed with cancer every year, and the 
treatments for these patients cost $100,000 or more. Instead of working 
to increase access and lower costs, the pharmaceutical companies are 
price gouging these patients, our constituents, across the country. 
This needs to stop now.
  I am proud to have worked with my freshman colleague, Representative 
Porter, to introduce H.R. 4663, the Freedom from Price Gouging Act, 
which has been included as a provision in H.R. 3. Our provision would 
hold these bad actors accountable and prevent them from raising the 
cost of prescription drugs past the rate of inflation. The CBO recently 
found that this measure would save American taxpayers $38 billion over 
the next decade.
  Importantly, H.R. 3 gives the Federal Government authority to 
negotiate prices for insulin and other lifesaving drugs. As I stand 
here today, 300,000 Coloradans with diabetes will save up to 75 percent 
on their insulin under H.R. 3. It also caps the exorbitant amount that 
seniors have to pay for drugs that simply improve the quality of their 
life.
  As I stand here today, hundreds of thousands of Coloradans with heart 
disease, asthma, arthritis, and cancer will directly benefit from H.R. 
3.
  On top of the drug pricing provisions, this bill invests billions in 
savings back into our healthcare system. $10 billion would go to our 
Nation's community health centers, which serve over 29 million 
Americans from underserved communities.
  It also invests $10 billion into the NIH and $2 billion into the FDA 
to promote research and drug safety. It invests another $10 billion to 
respond to our Nation's opioid epidemic, which has destroyed far too 
many American families.
  We cannot wait any longer while our neighbors' and family members' 
lives are at risk and while pharmaceutical companies continue to fill 
their pockets, making tens of billions of dollars, historic profits.
  Americans rightly expect us to deliver on our promise to fight and 
reduce the cost of prescription drugs. That is why I will cast my vote 
as a ``yes'' today to deliver relief for my constituents and the 
American people.
  Ms. STEVENS. Madam Chair, I yield myself 30 seconds.
  As a subtle point of clarification, today, as we embark on a historic 
moment, we are looking to pass the Elijah E. Cummings Lower Drug Costs 
Now legislation, not the invest in R&D act. Embracing the status quo 
for the millions of Americans who are counting on us is certainly fully 
and wholly unacceptable.
  Madam Chair, I reserve the balance of my time.
  Mr. WALDEN. Madam Chair, I yield myself 1\1/2\ minutes.
  Madam Chair, I want to make clear that I am always willing to come to 
the other side of the aisle to work these things out.
  All of us came here with similar cause and calling, to lower the 
price of prescription drugs, to stop the abuse and bad behavior of 
pharmaceutical companies when they keep generics from coming to market. 
But I don't think anybody came here to take away cures for patients who 
come to our offices every year begging for a cure for Alzheimer's, 
pancreatic cancer, or ASL, you name the disease.
  My mother died of ovarian cancer. My father had bladder cancer. My 
sister-in-law died of brain cancer. We lost a son to a heart defect. We 
all want cures.
  We know by independent analysis that H.R. 3 denies access to cures. 
That is a fact. It is a fact that the Council of Economic Advisers says 
up to 100 cures will be lost. The Congressional Budget Office says in 
the next two decades, 38 cures would be lost. It doesn't have to be 
that way.
  We can lower drug costs. We can incent innovation. My friend from 
Michigan talked about being involved in the innovation world. This is a 
letter from 138 leaders of these incredible American innovators who beg 
us not to shatter the dreams of Americans, which they say H.R. 3 will 
do by completely upending the process.

  That is why President Trump said he cannot sign this. No President 
has ever leaned further than President Trump.
  The Acting CHAIR. The time of the gentleman has expired.

[[Page H10135]]

  

  Mr. WALDEN. Madam Chair, I yield myself 15 additional seconds.
  We have an alternative. Everything in our substitute bill is 
bipartisan. Even if you feel like you have to vote for H.R. 3, there is 
no reason you should have to vote against the proposals in here. There 
is not a poison pill. They are all bipartisan. They will all bring 
meaningful relief to our folks at home, and nothing in here will reduce 
innovation.
  Ms. STEVENS. Madam Chair, I yield 2 minutes to the gentlewoman from 
Arizona (Mrs. Kirkpatrick).
  Mrs. KIRKPATRICK. Madam Chair, I thank the Congresswoman for 
yielding.
  I want to echo what I hear from my constituents: Do I put gas in my 
car, or do I buy my medication? Do I put food on the table for my 
family, or do I pay for my prescription drugs? Do I buy a generic drug 
here in the United States that costs $900, or do I drive to Mexico 
where I can buy it for $9?
  These are real, lifesaving, life-or-death issues that we are dealing 
with.
  I want you to know this is personal to me because, when I was a 19-
year-old waitress, I came home one night to my family, and my parents 
weren't home. They said, ``Your mom took your dad to the hospital,'' 
and I drove to the hospital.
  I said: ``Okay, I will go check on him.''
  As I was walking in the door, the doctor walked out, and he said: 
``Your dad is dead.''
  That was due to a lack of healthcare, including prescription drugs.

                              {time}  1000

  He had an undiagnosed heart disease that could have been treated, and 
in this day and age it would not have been an issue. So I fully support 
H.R. 3. This is something that is critical to American families and 
they are dealing with every day.
  A mother shouldn't have to decide if she is going to drive to Mexico, 
where she is not exactly sure if the drug she is purchasing for her 
child has the same standards and quality that she would get here in the 
United States.
  So, Madam Chair, I urge my colleagues to support H.R. 3. This is life 
or death.
  Mr. BRADY. Madam Chair, I yield 2 minutes to the gentleman from Ohio 
(Mr. Wenstrup), who is a key leader on healthcare on the Ways and Means 
Committee.
  Mr. WENSTRUP. Madam Chair, 26 years ago, my sister had two forms of 
leukemia that most people die from immediately; but because of earlier 
clinical trials and innovative treatments, there was a way to get some 
leukemia patients into remission.
  Then we developed bone marrow transplants, and I matched her for 
that.
  Five years later, they called her a cure.
  Today, my sister is alive, working, raising a family, and we have 
treatments for leukemia that lead to a cure without even needing bone 
marrow transplants.
  These treatments are just steps in finding cures; and, as we work to 
lower prescription drug prices, I want to make sure that we are looking 
at it from all angles. We need to be aware of the impacts on the 
quality of and access to care when considering effective solutions to 
lower drug prices.
  H.R. 3 threatens and, actually, puts a knife in the heart of the 
pillars of research and development that have helped make America the 
leader in health innovation.
  Relying on foreign countries to set our prices is misguided. I don't 
want to see the U.S. be controlled or manipulated by an arrangement 
some other cabal of countries makes to affect our markets and our 
patients. Other countries do not always share the same priorities we do 
on access to quality care and saving lives.
  What do we sacrifice with this bill? The best care? Cutting-edge 
research? A lifesaving drug?
  Unfortunately, the approach before us today is a dangerous one. 
Government price controls and a looming threat of a 95 percent tax will 
dramatically hurt our country's ability to research and innovate new 
cures. Estimates show that the bill would lead to the loss of dozens of 
new drugs. That means fewer lifesaving drugs and fewer American lives 
saved.
  As a physician, I can attest that every doctor's goal is to get the 
best treatment for their patients. We can do more without going and 
having this stop development and innovation.
  The Republican alternative to this bill, H.R. 19, is bipartisan, and 
it is an effort to lower prescription drug prices while also protecting 
patients' access to new medicines and cures.
  Americans deserve to have a healthcare system that delivers 
treatments when they need it most and makes care more affordable.
  Ms. STEVENS. Madam Chair, I yield 1 minute to the gentleman from 
California (Mr. Rouda).
  Mr. ROUDA. Madam Chair, I thank the gentlewoman from Michigan for 
yielding 1 minute.
  Madam Chair, I rise today in support of H.R. 3, the Elijah E. 
Cummings Lower Drug Costs Now Act.
  Earlier this year, Chairman Cummings convened our first Oversight and 
Reform Committee hearing to examine the impact of soaring prescription 
drug costs on our constituents. It is fitting we named this legislation 
to honor our friend who used his gavel to highlight the stories of 
Americans who are suffering and dying because they couldn't afford 
astronomical drug prices while living in the greatest and richest 
country in the world.
  This bill would institute negotiation for fair drug prices, lower 
out-of-pocket costs for seniors, improve coverage for Medicare 
beneficiaries, and invest in innovative new treatment in our fight 
against the addiction crisis.
  Madam Chair, I support this legislation because it would improve 
access to affordable prescription drugs for more than 600,000 of my 
constituents, and I urge my colleagues to support this legislation and 
ensure our constituents have access to lifesaving medication.
  Mr. BRADY. Madam Chair, I yield myself 2 minutes.
  So we have heard today that we should pass H.R. 3 because you can go 
to Canada and get medicines for pennies on the dollar. Here is what 
they don't tell you:
  There are lots of medicines you can get for zero in Canada because 
they are not available. Canadians have access to about half of the 
lifesaving cures available here in America.
  Guess where they come when they need that cure and that recent 
medical breakthrough? They come to America.
  What happens when we start acting and behaving like Canada? Who is 
going to be our safety net?
  Why should patients in America have to choose between affordable 
medicines and a lifesaving cure for Alzheimer's, ALS, Parkinson's, or 
cancer?
  Why should parents with sick children in America be forced to wait 
longer for the newest drug breakthrough that could save their life?
  Why should Americans face a shorter life?
  Because the costliest and most painful drug to me is the one that was 
never created.
  At the depths of Nancy Pelosi's drug bill is a dangerous trade-off: 
lower drug prices in the short term, but fewer lifesaving cures in the 
future.
  This is a cruel and false choice, which is why this bill will quickly 
die with no bipartisan support in the Senate.
  As Republicans, we believe we need to do both: lower drug prices and 
accelerate new lifesaving cures.
  Mr. Chairman, I reserve the balance of my time.
  Ms. STEVENS. Mr. Chairman, I yield myself 30 seconds.
  Mr. Chairman, it is a fact that pharmaceutical drug companies spend 
more on marketing than they do on R&D.
  It is a fact that life expectancy in this country is going down, and 
it has gone down for the third year in a row.
  It is a fact that we are in a moment of crisis, and now is the time 
for us to pass the Lower Drug Costs Now Act.
  Mr. Chairman, I yield 2 minutes to the gentlewoman from Nevada (Mrs. 
Lee), who is my good friend.
  Mrs. LEE of Nevada. Mr. Chairman, I thank the gentlewoman for 
yielding.
  Mr. Chairman, I am here to speak in support of the Elijah E. Cummings 
Lower Drug Costs Now Act, and, in particular, I want to speak in 
support of my bill which is included in the act, the Enhancing 
Retirement Security for Medicare Beneficiaries Act, which would 
guarantee that the disbursements of retirement savings are not counted 
when determining if someone qualifies for Medicare part D's low-income 
subsidy program.

[[Page H10136]]

  As a young girl, I learned the importance of saving money. My first 
job was running a paper route in my neighborhood in Canton, Ohio, at 
the age of 8. At the end of every week, I would put aside a quarter or 
two just to save up for a candy bar. It wasn't much, but it taught me 
the importance that saving money is worth it.
  Americans and our seniors should not be punished for saving for their 
retirement, but when retirement savings are counted towards eligibility 
for prescription drug assistance, we are punishing the very seniors who 
have been working hard and saving money.
  The fact is that no group of Nevadans relies more on prescription 
drugs than our seniors, and the rising cost of living is hard enough on 
older Americans. We should be making it easier for them to retire in 
dignity, and that means not forcing them to choose between buying 
groceries or lifesaving medication.
  Mr. Chairman, I am pleased that my bill was included in the 
underlying text of H.R. 3, and it is time that we lower prescription 
drug costs not just for seniors on Medicare, but for all Americans.
  Mr. BRADY. Mr. Chairman, I yield myself 30 seconds.
  It is a fact that drug companies in America spend three times as much 
on R&D than on marketing and advertising.
  It is a fact that the dangerous Pelosi drug bill robs up to $1 
trillion of research and development costs that will not be used for 
lifesaving cures in America.
  It is a fact, from the Congressional Budget Office, that we will lose 
at least 38 new cures as a result of this bill; the Council of Economic 
Advisers, 100 new cures; and the California Life Sciences Association 
says 9 out of 10 cures that they would be working on will never happen 
in America.
  Mr. Chairman, I yield 2 minutes to the gentleman from Texas (Mr. 
Arrington), who is a key leader on the Ways and Means Committee.
  Mr. ARRINGTON. Mr. Chairman, I thank my friend and ranking Republican 
on Ways and Means for the opportunity, and I thank him for his 
leadership on this important issue.
  Mr. Chairman, we all agree that the prices of drugs are too high. We 
agree that something needs to be done to fix this for all Americans, 
not just our seniors.
  The problem I have--and it is a big problem--is the way we go about 
doing this. It is like a rerun of ObamaCare. It is this government 
knows best, this top-down, government-controlled, let's tax, regulate, 
and mandate our way to a better system. It doesn't work.
  So we are doubling down on a failed philosophy on how to deliver 
affordable quality products to the American people.
  The approach should be more choices, more competition, a healthier 
market, and greater transparency.
  By the way, we have worked on those issues in a bipartisan fashion. I 
have introduced two pieces of legislation with my Democrat friends that 
would do just that.
  The problem here is not just this top-down, heavy-handed government 
knows best, let's fix the crisis and assume nothing bad will happen. It 
is that nothing is going to come of this H.R. 3. It is a messaging 
bill. It is purely political, and it won't help the people whom we all 
intend to help.
  I do not judge the motives of my colleagues. I think they want to 
help our seniors just as I do. But we can't do it with partisan 
messaging bills. We have to do it by working together.
  In a former life, I was vice chancellor at Texas Tech, and I was 
responsible for bringing new drug technologies, therapies, and 
biologics to market.
  Ms. STEVENS. Mr. Chairman, I yield 3 minutes to the gentlewoman from 
Michigan (Ms. Slotkin), who is my dear friend.
  Ms. SLOTKIN. Mr. Chair, for the last 2 years, the single most common 
issue that Michiganders raise with me is the price of prescription 
drugs. Michiganders, regardless of party, are demanding that Congress 
do something about it. People literally clutch my arm at the grocery 
store to tell me how their son is rationing his insulin or their 
daughter couldn't go to summer camp because she couldn't afford the 
inhalers.
  That is why shortly after being sworn in in January, I started 
working in earnest on the issue. I am very proud to stand behind my 
colleagues and support H.R. 3, the Lower Drug Costs Now Act. This 
important legislation will drive down the cost of the country's most 
expensive drugs by allowing our government to negotiate for the very 
best prices.
  To be clear, the VA does the exact same thing. I am on military 
insurance, and the VA can negotiate for drug prices. Why not allow 
Medicare to do the very same thing?
  To put this in perspective, there are over 800,000 Michiganders 
living with diabetes, and common insulin medications can cost somewhere 
between $1,200 and $20,000 a year. This includes Sarah, a woman who 
lives in Holly, Michigan, where I live, who literally says she is being 
priced out of her life. Her insulin costs are higher than her rent per 
month.
  This bill, if passed, would allow the government to negotiate, 
bringing the price down to as little as $400 a year. Once the price is 
negotiated, all Americans, including Medicare recipients, benefit from 
that price. The bill would also improve Medicare coverage for seniors 
and lower their out-of-pocket costs.

  Two months ago, I cointroduced a bill that included vision coverage 
in Medicare. That means Medicare recipients, once every 2 years, will 
get an eye exam and one set of either glasses or contacts.
  I am very pleased that this was incorporated into this bigger bill 
along with other measures that would include hearing coverage and 
dental coverage for the first time. So, finally, preventive care will 
be part of the routine coverage for Medicare.
  To be clear, the bill pays for itself. Negotiation saves us, 
according to the CBO, $450 billion, which covers the additions to 
Medicare and still gives $10 billion for research and development to 
the National Institutes of Health.
  Mr. Chairman, you will hear my colleagues and Big Pharma say that you 
have to make a choice between research and lifesaving cures and the 
price of prescription drugs. That is a false choice, and anyone who 
watches TV and sees those annoying ads knows that the drug companies 
have plenty of places to cut their funding.

                              {time}  1015

  Members from both parties in the House and Senate, and indeed the 
President, have said the right things when it comes to lowering drug 
prices. Now it is time to walk the walk.
  Mr. BRADY. Mr. Chairman, I yield such time as he may consume to the 
gentleman from California (Mr. McCarthy), the Republican leader of the 
House.
  Mr. McCARTHY. Mr. Chairman, I thank the gentleman for yielding, but 
more importantly, I thank him for his work on this bill, and all the 
others, as well, in their committees.
  There is an urgent need to address the soaring cost of prescription 
drugs that burden too many American families. It is well past time that 
we offer a practical solution that actually lowers costs while ensuring 
new cures can reach Americans fighting disease and illness.
  This Congress in the past has spent a great deal of time making sure 
that we have cures for the future. That is why Republicans introduced 
this bill, Lower Costs, More Cures Act, and I urge all my colleagues to 
support it.
  The bill was written with a rule: each policy must be bipartisan. I 
know in this town and in this climate, that is not achieved very often, 
but for an issue as crucial as lowering the cost of prescription drugs 
for Americans, partisanship should be set aside.
  Later today, we will see which side and which bill is bipartisan. By 
drawing on the very best ideas, H.R. 19 makes crucial reforms that will 
lower out-of-pocket costs for Americans at drugstore counters. For 
seniors, it makes medication more affordable by capping their out-of-
pocket costs. It increases the availability of generics and biosimilar 
drugs by prohibiting drug companies from delaying the start of their 
exclusivity period. It speeds up the FDA approval process. It provides 
greater price transparency by requiring insurance companies to make 
information about drug costs available in the doctor's office before a 
prescription is written. And for diabetics who have

[[Page H10137]]

high deductibles in their plans, it allows insurance companies to cover 
the cost of insulin before meeting the plan's deductibility.
  While Republicans offer practical solutions, Democrats are catering 
to their progressive base by opening a door to a government takeover of 
our prescription drug market.
  Mr. Chairman, Speaker Pelosi's partisan plan, H.R. 3, will make our 
broken system worse by placing more barriers between Americans and 
their medication, including by reducing the number of new drugs on the 
market instead of helping them reach the patients. According to 
estimates from the Council of Economic Advisers, the Speaker's radical 
proposal could kill upwards of 100 new drugs over the next decade.
  Pause for one moment and think about that: 100 new drugs over the 
next decade will be killed by passing H.R. 3. That is one-third of the 
total number of new drugs expected to enter the market during that 
time.
  Moreover, the Council estimates that H.R. 3 would reduce America's 
average life expectancy by 4 months. Nearly a quarter of the projected 
gains in life expectancies over the next decade, simply because you 
want to appease the progressive base and have a partisan bill that 
denies us more cures and shortens our lifespan.
  But you will achieve one goal today: You will have one party vote for 
a bill that will not become law, but you will appease a base with this 
and impeachment.
  And it is not just the Council. The CBO reports that fewer drugs will 
be available because of the provisions in H.R. 3. The Democrat's plan 
is yet another example of how unnecessary government control harms the 
very people it claims to help.
  All of us have or know someone with a loved one who has fought a 
disease or an illness for which no cure has been found. Imagine how 
demoralizing it will be to cut off hope for a future cure. All of us 
have gone through this. My father never got to see the day I was 
elected because he lost his life to cancer. He battled it for 3 years. 
I would give anything to have found a cure for my father's cancer. But 
it is not just his.
  If we delay one cure, that is one cure too many. The best way to 
lower costs is not to lose the cures, even the loss of one.
  Mr. Chairman, Americans want their government to put the best 
available ideas into action. They deserve solutions, not political 
posturing filled with empty promises. The saddest part of today, we 
could have had prescription drug prices lowered on this floor even 
earlier in this year. There was a window of opportunity, a moment in 
time where you did not see the partisanship that we see today, a moment 
in the Committee on Energy and Commerce where every single Democrat and 
every single Republican voted on three bills to lower the price of 
prescription drugs.
  But as I learned as a child on ``Schoolhouse Rock,'' ``I am just a 
bill on Capitol Hill,'' at the time it goes from a committee and before 
it gets to the floor, it goes through leadership. And unfortunately for 
the Americans across this country, leadership changed that bill, not 
the Members in the House. They changed that bill so when it came to the 
floor it became partisan.
  And you know what? Our drugs were not lowered, the bill did not 
become law, and we are impeding the exact same thing today.
  You will have two choices: You will have a choice of H.R. 3, that, 
yes, had to be negotiated even this week with progressives on the other 
side to appease them to make sure this was as partisan as can be. It 
won't become law. It will be another talking point, a moment of time to 
try to explain why you wasted a majority on just investigations.
  But you will have another opportunity, a substitute. If you want to 
lower drug prices in 2019, vote for H.R. 19. You know why? Because 
every single provision in that bill is bipartisan.
  Can we not, with one issue, at one moment in one time put 
partisanship aside? Can we put people before politics? Can we expand 
our life expectancy? Can we find 100 more cures? Can we do that?

  I know you might upset a few in your party, but think about how many 
more lives we will save. There is always a moment in time that I have 
hope that this Congress will rise and keep the promises that I heard 
before an election took place, that we would be different, that we 
would govern together, that we would find bipartisanship.
  Today, on the floor, you will have that window. You will have a bill 
that has every single provision. You will have a report that says, No, 
we won't stop 100 new cures in the next decade. No, they will give hope 
to the American public that there will be opportunity to cure disease 
that you have today and live a long and full life.
  And you know what? It is the only bill on the floor today that could 
become law. So if you want to make a real change, you have a voting 
card to do it.
  Ms. STEVENS. Mr. Chairman, I yield 1 minute to the gentleman from New 
York (Mr. Rose), my friend.
  Mr. ROSE of New York. Mr. Chair, before I came to Congress, my job 
was to make sure that those without healthcare and those who could 
barely afford it, could have access.
  Every day, we would see doctors and nurses do the impossible in the 
worst system. And without fail, we all would wonder why no one would do 
anything to change it. Well, today we are. This bill does not cater to 
a base. This bill does not cater to Big Pharma, but this bill does 
cater to that family tonight who is going to have to choose between 
paying for prescription drugs or putting food on the table. This bill 
caters to the American people.
  Today, Big Pharma loses, and the American people win. Because what we 
are doing today is giving Medicare the power to negotiate skyrocketing 
costs of prescription drugs. This historic legislation also creates new 
out-of-pocket limits on prescription drug costs for Medicare 
beneficiaries. It reinvests savings so that we can create new 
breakthrough treatments and cures at NIH, and it provides $10 billion 
in funding to combat the opioid epidemic.
  For decades, Big Pharma and corporate PACs could count on their 
lobbyists and politicians to keep them safe at the expense of the 
American people. Not anymore. Today, the American people win. I urge 
all my colleagues to vote ``yes.''
  Mr. BRADY. Mr. Chairman, I yield 1 minute to the gentleman from 
Nebraska (Mr. Fortenberry), one of the leaders in healthcare.
  Mr. FORTENBERRY. Mr. Chair, I thank both leaders, first of all, for 
this debate. This is absolutely critical, and here is why:
  The other day, I went to the doctor--a kind of a common ailment. The 
doctor prescribed an antibiotic.
  I said, ``Doc, let's check the price before we use the credit card.''
  He said, ``Don't worry about it. It is going to be about $6. It is 
commonly used.''
  But guess what? The list price was about $430. It used to be $6 in 
2011; now, it is $430.
  We have a problem. We have a big problem in America. A very big 
Democrat, a very big Republican problem. I want to commend my 
Democratic colleagues for raising the issue, for putting this on the 
agenda, for making an attempt to propose something. There is strong 
disagreement with the nature of the policy proposal, but there ought to 
be unification around the idea that we have to do something.
  I commend my Republican colleagues for putting together a bill of all 
the bipartisan initiatives that are around here that we can agree on.
  So what is going to happen is we are going to get stuck again, 
really, really quickly. This bill now has a chance of going into law, 
the bipartisan bill. There is some opposition to it, and it could be 
fleshed out further.
  The President has called for negotiations. This is an important part 
of all of us. So let's get back to work after we get past this moment.
  Mr. Chair, I thank everyone for a spirited and good debate.
  Ms. STEVENS. Mr. Chairman, I yield 1 minute to the gentlewoman from 
California (Ms. Pelosi), the Speaker of the House.
  Ms. PELOSI. Mr. Chairman, I thank the gentlewoman from Michigan, a 
leader in the freshman class, for yielding time and for her 
extraordinary leadership in so many ways.
  It is just so invigorating to see the freshmen Members of this class 
taking

[[Page H10138]]

the lead on this important legislation. Many of us just came in from 
the steps of the Capitol where, again, the freshmen Members took the 
lead.
  Following up on a promise made last year during the election, For the 
People, we will lower the cost of healthcare in America by lowering the 
cost of prescription drugs. H.R. 3 does just that, named for our great 
and departed--may he rest in peace--Elijah E. Cummings Lower Drug Costs 
Now Drug Act.
  This is very, very important. And it may come as news to some of our 
Republican friends who were saying things to the contrary, but this is 
a product of the work of three committees in Congress.
  I thank Chairman Pallone of the Committee on Energy and Commerce, 
Chairman Richie Neal of the Committee on Ways and Means, and  Bobby 
Scott, chair of the Committee on Education and Labor, for their 
relentless and persistent work on this lifesaving legislation where 
many freshmen are speaking now, controlling the time.
  But in the course of the debate of yesterday, under the aegis of the 
committees of jurisdiction, many of them spoke at that time as well, 
demonstrating their leadership on this issue, making it a reality on 
the floor of the House. Again, I thank them for their bold urgency to 
lower the cost of drugs.
  The crushing burden of prescription drugs is an issue that impacts 
every family in America. Much talk is given around here about having a 
seat at the table. The most important seat at the most important table 
is the kitchen table of America's working families where they enjoy 
family, but also address challenges that face them, whether it is in 
their health or in their financial health and how that is related.

                              {time}  1030

  This legislation today speaks to that important table of concerns.
  In my travels across the country, I have seen grown men cry about how 
they cannot meet the needs of their families when it comes to 
prescription drug costs, a spouse with a long-term illness, children 
with chronic diseases, and the rest.
  Prescription drug prices are out of control. The price of insulin 
invented nearly a century ago--when people say we have to cover our 
research costs--doubled from 2012 to 2016 because of Big Pharma.
  Many people use it. A lot of people buy it. Let's increase our 
profits, they say.
  Americans are paying four times or more for what Big Pharma charges 
for the exact drugs in other countries.
  While Big Pharma companies reap record-breaking profits and 
multibillion-dollar windfalls from the GOP tax scam, 58 million 
Americans couldn't afford to fill a prescription they needed to stay 
healthy in the past year--58 million Americans.
  Thirty-four million Americans know a loved one who died from not 
being able to afford a treatment that they needed.
  We face medical, economic, and moral crises that demand that we act 
and that we act boldly.
  Yes, they have a motion to recommit. I think it was appropriate that 
the Republicans have the opportunity to put an alternative on the 
floor, incremental pieces, not going to the heart of the matter. How 
dare they ever think of enabling the Secretary to negotiate for lower 
prices, which is the heart of the matter.
  We have been trying to do this for a number of years. Today, we will.
  Last year, again, we made the promise For the People, that we would 
lower the cost of prescription drugs. We are finally giving Medicare 
the power to negotiate lower drug prices.
  Some Republicans say it is un-American for the Secretary to be able 
to negotiate for lower prices--un-American--then making those lower 
prices available to the hundreds of millions of Americans with private 
insurance, too.
  We are insisting that American seniors and families shouldn't have to 
pay more for our medicines than what Big Pharma charges for the same 
drug overseas. I say that again. H.R. 3 means lowering the cost of 
medication for Americans with leukemia by more than 70 percent. It 
means lowering the cost of medication for arthritis, which more than 50 
million Americans have, by almost 75 percent. It means lowering the 
cost of asthma medication for 25 million Americans with this condition 
from $1,500 to $270.
  Yesterday, we had Mr. Riordan testify at our press conference. The 
cost of his medication for asthma, in his case, was over $60,000 a 
month. Eighty percent of it was covered by Medicare, but he had to pay 
over $4,000 a month.
  Can you absorb that? $4,000 a month for a drug that you are supposed 
to take four times a month? He was taking it twice a month, once a 
month, or not at all, not a healthy thing to do, but reaping big 
profits for Big Pharma.
  Under H.R. 3, some commonly used insulins could cost as little as 
$400 a year.
  With the Elijah E. Cummings Lower Drug Costs Now Act of 2019, we put 
more money back into the pockets of seniors and hardworking families. 
We drive down insurance premiums, making it easier to afford coverage.
  When we lift the immense burden of drug costs on employers, the CBO 
says American businesses can expect bigger paychecks and salaries for 
their workers.
  H.R. 3 also represents the most transformative expansion of Medicare 
since its inception.
  Now, many people on the other side of the aisle did not support 
Medicare at its inception, but this is a vast improvement because we 
are investing more than a half-trillion dollars--that is with a T-R--a 
half-trillion dollars that we are saving by lowering out-of-control 
prices and investing in historic new benefits for vision, dental, and 
hearing for Medicare beneficiaries for the first time.
  With these huge savings, we are also investing in new research for 
new treatments and cures and fighting the opioid epidemic, as the 
gentleman from New York (Mr. Rose) pointed out, and in the community 
health centers that deliver quality healthcare to so many Americans.
  Advocacy groups representing tens of millions of Americans, seniors, 
retirees, patients, providers, faith leaders, businesses, and the men 
and women of labor, and more, support H.R. 3.
  AARP wrote to Members of Congress this week and said: ``This 
important legislation is a bold step toward lowering prescription drug 
prices and improving Medicare for seniors and families across the 
country. . . . H.R. 3 will help more Americans afford their 
prescription drugs and get the care they need to stay healthy.'' They 
said that in their support of the legislation.
  There is every reason in the world for Republicans to join us in 
passing this bill. The bill delivers on President Trump's promise to 
the American people. In his words, he said: ``When it comes time to 
negotiate the cost of drugs, we are going to negotiate like crazy.''
  Negotiation is what this bill is about. The Republican substitute is 
what this bill is not about, and that negotiation is the heart of the 
matter.
  The President also said: ``It's unacceptable that Americans pay 
vastly more than people in other countries for the exact same drugs, 
often made in the exact same place. This is wrong; this is unfair; and 
together, we will stop it.''
  Actually, in creating this bill, and working with the committees to 
do so, we were working with the interests of the White House, the 
administration, on all of this.
  I don't know where it happened, but somewhere along the way, 
negotiation and the rest fell by the by, and that, again, could be 
attributed to I don't know what.
  Democrats named H.R. 3, as I mentioned, in honor of Chairman Elijah 
Cummings, our North Star who worked across the aisle and down 
Pennsylvania Avenue--he met with the President--to lower prescription 
drug prices.

  In honor of Chairman Cummings, and for the sake of the millions of 
Americans struggling with high prescription drug costs, I urge a strong 
vote on H.R. 3 to lower drug costs now for all Americans, for the 
people. I urge an ``aye'' vote.
  Mr. BRADY. Mr. Chairman, I yield myself 30 seconds.
  When the Republican Congress, in 2003, joined with President Bush to 
create the affordable drug plan for seniors, then-Leader Nancy Pelosi 
and Democrats tried to kill it. She famously predicted that creating 
the part D program for seniors would end ``Medicare as we know it.''

[[Page H10139]]

  Can you imagine how many seniors' lives would have been lost if 
Democrats had succeeded in stopping the affordable Medicare drug 
program that 43 million seniors have come to depend upon? They were 
dangerously wrong then, and they are dangerously wrong again.
  Mr. Chair, I yield 2 minutes to the gentleman from California (Mr. 
Nunes), the leader of the Health Subcommittee for the Ways and Means 
Committee.
  Mr. NUNES. Mr. Chair, I thank the gentleman from Texas for yielding 
to me. I want to speak in opposition to H.R. 3.
  Saying that drug costs are too high for many Americans, Republicans 
and Democrats can agree on that. That is why we spent the better part 
of a year working toward a bipartisan solution to lower out-of-pocket 
prescription drug costs and crack down on overpriced drugs.
  Sadly, Democrats abandoned that effort in favor of the socialist 
policies in H.R. 3. For Democrats, the answer is always more 
government, and H.R. 3 is no exception.
  The bill gives the government sweeping new powers to allow government 
bureaucrats to arbitrarily set drug prices. Democrats keep calling it 
negotiation.
  Here is how negotiation works under H.R. 3. The Federal Government 
will tell a drug company what the drug price is going to be. If the 
drug company doesn't like it, they have two options: pay a 95 percent 
tax on their revenue or leave the U.S. market. That doesn't sound like 
negotiation to me.
  The Congressional Budget Office claims this will result in such low 
drug prices that some of the lifesaving cures won't even come to 
market. Under this arrangement, there is very little incentive for drug 
companies to invest the time and money it takes to create new cures and 
treatments. We know it takes $2.6 billion and 10 to 15 years, on 
average, to bring one drug to market.
  This bill's arbitrary action against drug companies carries a steep 
cost to the American people in the form of fewer future cures. What 
cures will those be? Alzheimer's? Cancer? Schizophrenia?
  Killing drug innovation and ending the development of lifesaving 
cures is unacceptable. We can't take that risk. We have to do better 
for sick Americans hoping and praying for a cure for themselves or 
their loved ones.
  We can solve this problem, but not with the Democrats' fewer cures 
act. We have to do this in a bipartisan way.
  Fortunately, there is an alternative to the Democrats' proposal. This 
week, Republicans have introduced H.R. 19.
  The Acting CHAIR (Mr. Rouda). The time of the gentleman has expired.
  Mr. BRADY. I yield the gentleman from California an additional 15 
seconds.
  Mr. NUNES. I have introduced H.R. 19, the Lower Cost, More Cures Act. 
This bill contains effective bipartisan policies that could become law 
right now.
  It cracks down on overpriced drugs and lowers costs for patients 
without crushing the hope of future lifesaving medicines.
  It is time to stop playing political games and start working toward 
solutions for the American people.
  H.R. 3 is a terrible idea that will drive drugs out of the U.S. 
market.
  Ms. STEVENS. Mr. Chairman, if the gentleman from Texas is prepared to 
close, I am prepared to close.
  I reserve the balance of my time.
  Mr. BRADY. Mr. Chairman, I yield myself the balance of my time.
  Imagine life under H.R. 3, the Democrats' fewer cures bill. There 
will be lower costs for some medicines, no doubt. Both bills do that. 
But if you have a rare disease, or your loved one does, whether it is 
ALS you are struggling with or dementia or Alzheimer's, if you were a 
dynamic person who now is struggling with Parkinson's, cancer, 
diabetes, pulmonary hypertension, the hope for your cure may never 
come. The waiting for your cure may be years, decades, or never.
  The truth of the matter is--and it is undeniable--H.R. 3, the 
Democrats' bill, will cause fewer cures here in America.
  Don't take my word for it. The Congressional Budget Office estimates 
38 cures lost over the next two decades, the Council of Economic 
Advisers, 100 cures lost over the next several decades.
  California Life Sciences Association said, if we do what Nancy 
Pelosi's bill does, nearly 9 out of 10 drugs we would have created will 
never exist. There will be fewer cures for Americans when we need it 
most.
  I will tell you, drug prices are too high in many cases. There is no 
excuse for these price spikes, none at all.
  But I will tell you what, the costliest drug ever is the one that is 
never created, that leaves the ravages of these diseases to these loved 
ones who are struggling with them.
  We already know this is the case because in Canada, France, these 
other countries that H.R. 3 wants to make us look like, they have about 
half the medicines we do. When they do get a medicine, they will wait a 
year or 2 longer to even get it.
  Well, if you have got ALS, if you have got a glioblastoma, you are 
done at that point. That is what that bill brings about.
  We know, fewer drugs in America, because today, we have created, over 
the last several years, 111 new drugs in America. France, this is the 
France drug pricing scheme, 11. 111 in America. Eleven in France.
  That is their vision of a day in the life of someone with a rare, 
deadly disease in America.
  Our bill, the Lower Cost, More Cures Act, lowers out-of-pocket costs 
for Americans because we crack down on overpriced drugs. We give 
seniors, for example, the power and the information to choose the right 
place for their medicines, which can lower their chemotherapy by half.
  We pull back the curtain on everyone involved in this drug pricing 
process. We force drug companies to pay more and shoulder more burden 
in the part D prescription plan. We force them to justify their 
increases. We force them to list their prices in the ad so we know.
  We accelerate; we don't kill lifesaving medical cures. We go further, 
further than H.R. 3. We permanently make it easier for Americans to 
deduct high medical expenses from their taxes, allowing them to use 
their HSAs for over-the-counter medicines, including feminine hygiene 
products. We save seniors over $300 a year in the popular Medicare 
prescription drug program.

                              {time}  1045

  All these ideas are bipartisan. All these can be passed by Congress. 
All can be signed by President Trump this year if Democrats abandon 
their partisan game and continue what was really good bipartisan work 
that got shelved for this bill that dies.
  When this is done, let's come back together. Let's work together. 
Everyone knows, in good faith, we have to tackle these drug prices. 
Let's prove to America that we can actually work together not for 
impeachment, not for the junk we are wasting our time on, but for 
things that really matter to families back home.
  Mr. Chair, I yield back the balance of my time.
  Ms. STEVENS. Mr. Speaker, I yield myself the balance of my time.
  Mr. Chairman, we have heard compelling argument today. We have heard 
compelling argument around the need and the reason to lower the costs 
of prescription drugs now. We are taking bold and reasonable steps 
today to bring down the costs of prescription drugs in this country. It 
is a significant and historic day that ushers in a beacon of hope for 
so many.
  The answer from our Democratic majority today is solutions, solutions 
based on fact, solutions based on the guiding principle of the people, 
who we represent, to deliver for them.
  The question is, when will we do something? Today, our legislation, 
the Elijah E. Cummings Lower Drug Costs Now Act, that is what we are 
going to be passing, lowering drug costs now for the people who cannot 
wait, for the child of parents who are pushed to the brink, for the 
older American who is afraid to go to the pharmacy to pick up their 
prescription drug because of what it might cost, for the senior who is 
afraid to go to the doctor just to get that prescription, for the one-
third of Americans who forgo their prescription drugs because of their 
costs.
  President Truman said that America is not built on fear. America is 
built on imagination. America is built on courage. And America is built 
on the willingness to do the job at hand.

[[Page H10140]]

  That, my friends, is what our majority is doing here today, tackling 
a solution for the millions of people, the countless number of people, 
whose voices only make their way into this Chamber by those who 
represent them, not the large multinational company that has more money 
than it knows what to do with. It is for the individual, hardworking 
American, which is why, today, I ask my colleagues to join me in 
passing the Elijah E. Cummings Lower Drug Costs Now Act for every 
American, for the people, by the people.
  This is a historic and proud day, Mr. Chairman, and this is what we 
came here for.
  Mr. Chairman, I yield back the balance of my time.
  Mr. DeFAZIO. Mr. Chair, today, I will vote in support of H.R. 3, the 
Elijah E. Cummings Lower Drug Costs Now Act.
  Because of pharmaceutical companies' price gouging, Americans pay 
more out-of-pocket for prescription drugs than individuals in any other 
country. Americans need lower drug prices now, and Congress has the 
ability to enact important reforms to deliver immediate relief.
  I believe H.R. 3 takes some important first steps towards delivering 
that relief and towards improving the health and financial security of 
American seniors and families.
  In particular, I am strongly supportive of provisions that will lower 
out-of-pocket prescription drug costs for Medicare Part D 
beneficiaries. The legislation also limits price increases under 
Medicare Part Band D by creating an inflation rebate. Specifically, if 
a drug company raises the price of a drug in Part B or D above the 2016 
rate of inflation, the company must lower the price or be required to 
pay the entire price above inflation in the form of a rebate back to 
the Treasury.
  After strong pushback from myself and other progressive members, I am 
pleased that House leadership restored language designed to prevent 
pharmaceutical price-gouging for upwards of 150 million Americans with 
private health care plans and increased the minimum number of drugs 
that must be negotiated per year from 25 to 50.
  While I believe these provisions will ultimately deliver relief to 
millions of Americans, I believe Congress can and must do more to 
combat rising drug prices and price-gouging pharmaceutical companies.
  Currently, pharmaceutical companies charge outrageous prices because 
there is no adequate law to prevent drug companies from reaping massive 
profits with drugs developed on the taxpayer's dime.
  To combat this ridiculous practice, I introduced H.R. 4640, the 
Affordable Drug Pricing for Taxpayer-Funded Prescription Drugs Act, 
which would end price gouging on prescription drugs developed with 
taxpayer-funded research by requiring federal agencies and federally-
funded non-profits to secure affordable pricing agreements from drug 
manufacturers before granting them exclusive rights to develop drugs or 
other health care products. Americans should not pay to develop a drug 
only to see it put on the shelves in the U.S. at a much higher price 
than other nations.
  I partnered with Rep. Doggett to offer an amendment to H.R. 3 that is 
similar to my legislation. While the amendment was not made in order, I 
will continue to push House leadership for full consideration of H.R. 
4640.
  Beyond this, I am a strong supporter of the Prescription Drug Price 
Relief Act, which would require the Secretary of Health and Human 
Services (HHS) to make sure that Americans don't pay more for 
prescription drugs than the median price of: Canada, the United 
Kingdom, France, Germany, and Japan. If pharmaceutical manufacturers 
refuse to negotiate, HHS would be required to approve cheaper generic 
versions of those drugs, regardless of any prior patents or market 
exclusivities. If Congress were to enact this legislation, prices of 
most brand name drugs would be significantly reduced.
  Furthermore, uninsured patients should have access to negotiated 
prices under H.R. 3. That's why I supported an amendment that would 
have guaranteed that any negotiated price savings could have been 
accessed by the most vulnerable in our country, those who lack health 
insurance. Unfortunately, this amendment was not included in the final 
bill, meaning uninsured patients will continue to face the highest 
price at the pharmacy counter--pharmaceutical companies' list price.
  I am also disappointed that an amendment I supported to allow the 
federal government to negotiate prescription drug prices for Medicare 
Part D was not made in order.
  In 2003, the House Republican majority passed Medicare Part D. While 
I have consistently been a leader in the fight to lower drug prices for 
seniors, I opposed this legislation because it included a provision 
that prevents the federal government from negotiating better 
prescription drug prices for Medicare recipients. This means that drug 
companies are free to charge Medicare recipients higher prices, more 
than anyone else in the world. This is unacceptable.
  The amendment offered to H.R. 3 would have authorized the federal 
government to negotiate prescription drug prices for Medicare Part D, 
and if drug companies refuse to negotiate, this legislation would 
enable the federal government to issue a competitive license to another 
company to produce the medication as a generic. The bottom line is that 
seniors shouldn't have to ration their pills or limit their dosage 
because they can't afford to pay for prescriptions each month.
  Mr. LARSON of Connecticut. Mr. Chair, I rise in support of H.R. 3, 
the ``Elijah E. Cummings Lower Drugs Costs Now Act,'' named after my 
dear friend and colleague Elijah Cummings who passed away earlier this 
year. I commend the Speaker, Chairman Neal, Chairman Pallone and 
Chairman Scott for their efforts to bring this historic legislation to 
the floor today.
  For too long Americans have seen prices for prescription drugs rise 
out of control, to the point where many must make the decision about 
whether they will spend limited income on their necessary 
prescriptions, or food, housing and transportation. How is it in the 
wealthiest country in the world this is happening?
  I've heard from many constituents who are indeed facing this very 
choice.
  Patricia, an 88 year old woman in Connecticut said, ``Do I have to 
lose my rent or stop eating in order to continue breathing? I don't 
want to end up in a nursing home on oxygen. I am not an ex-smoker. I am 
the proud daughter of a West Virginia coal miner. Please help me and 
other poor frail elderly.''
  Rosemary from Wethersfield wrote, ``The cost of the Epi-Pen is 
outrageous. Even with my insurance it is so expensive I couldn't get 
the prescription filled and took my chances. When I had an allergic 
reaction I called 911 instead.''
  Kevin from Manchester, a young man in his mid-30s who has a job and 
health insurance, also wrote, ``The annual cost of my medications is 
about $8,000 . . . I stop taking my medication. My asthma is noticeably 
worse. I worry that it's only a matter of time until I have a flare up 
and end up in the hospital.''
  H.R. 3 will allow the Secretary of Health and Human Services to 
negotiate for better prices on prescription drugs in Medicare, lowering 
prices for patients in Medicare and the private market.
  I have long advocated for negotiation of drug prices and have 
included it in the Medicare Buy In and Health Stabilization Act 
introduced with my colleague from New York, Rep. Brian Higgins, and 
with my colleague from Connecticut, Rep. Joe Courtney.
  The bill also caps Medicare beneficiaries' out-of-pocket spending on 
prescription drugs at $2,000. And for the first time, with the savings 
from Medicare reimbursement for drugs, we are able to expand Medicare 
to cover dental, hearing and vision services as a benefit to 
traditional Medicare. In my district alone, more than 100,000 people 
will benefit from adding these new services.
  It's time we implement these much-needed changes and make 
prescription drugs more affordable. It's time to pass the Lower Drug 
Costs Now Act.
  Ms. LEE of California. Mr. Chair, I rise today in strong support of 
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act.
  This bill takes on Big Pharma to help lower the cost of prescription 
drugs for everyday families. It is beyond outrageous that the U.S. 
government is not currently allowed to negotiate drug prices through 
Medicare. And it is shocking that Big Pharma is charging people in the 
United States, hundreds of times more than what they charge in other 
countries.
  But H.R. 3 will help fix that. It allows the government to negotiate 
drug pricing through Medicare, and expands Medicare to cover vision, 
dental and hearing for the first time, while also investing in 
community health centers and critical research.
  I'm especially pleased that this bill incorporates key provisions 
championed by our Progressive Caucus Co-Chairs Pramila Jayapal and Mark 
Pocan that increase the number of drugs that Medicare is able to 
negotiate and protect 150 million Americans with private health care 
plans from being price gouged by Big Pharma.
  I urge a YES vote on this important bill named for our beloved, 
departed colleague Elijah Cummings who fought day in and out for the 
people. We miss him.
  Ms. JOHNSON of Texas. Mr. Chair, today I rise in recognition of H.R. 
3, the Elijah E. Cummings Lower Drug Costs Now Act. This legislation 
will serve as a critical improvement towards ensuring that essential 
medications are finally affordable and accessible.
  As the first registered nurse elected to Congress, I know how the 
exorbitantly high prices of critical medications burden individuals and 
their families. Americans should not have to

[[Page H10141]]

pay more for their medicines, when compared to the same ones sold by 
pharmaceutical companies, for drastically lower prices in other 
countries. lt is why I rise today in support of this bill, which 
provides the authority, mandate, and tools for the Secretary of Health 
and Human Services to negotiate lower drug prices and caps annual out-
of-pocket costs in Medicare Part D.
  The Congressional Budget Office has scored the Elijah E. Cummings 
Lower Drug Costs Now Act to save our country $456 billion in the next 
ten years. With these savings generated from lowering drug costs, 
significant reinvestments will be made to reduce out-of-pocket costs, 
close coverage gaps for Medicare beneficiaries, invest in critical 
funding in innovative new treatments, and fight against our nation's 
opioid crisis.
  Specifically, I was very pleased to support the inclusion of Medicare 
Part B coverage for dental, vision, and hearing benefits. For the 
thousands of seniors in my district and throughout the state of Texas, 
it is undeniable that this expansion of coverage will be lifechanging, 
especially as our constituents encounter additional health challenges 
associated with aging.
  As a member of the Congressional Black Caucus, I am especially 
vigilant in ensuring that minority communities which face higher rates 
of diabetes can access life-saving medications and are not forced to 
resort to rationing their insulin out of desperation. People living 
with diabetes will be heartened to learn that the Lower Drug Costs Now 
Act could potentially save them more than $700 on an annual supply of 
certain types of insulin.
  The benefits of the Lower Drug Costs Now Act will even extend to the 
medical facilities we know and trust throughout our states. Our 
community health centers and nonprofit hospitals will be able to access 
the lowered negotiated drug prices because they qualify as providers of 
services, suppliers, and employers.
  This bill moves our nation forward in addressing the need for 
accessible and affordable medications. However, it is prudent to note 
that there remains much to be done. We must continue to advocate for 
the inclusion of the uninsured population in these savings. Texas has 
the highest rate of uninsured individuals in the nation. Therefore, the 
lowered drug costs achieved in this bill will have limited impact in my 
state for the uninsured.
  As members of this body, we should all stand in support to lower drug 
costs. I would like to especially honor the memory of my dear 
colleague, the Honorable Elijah E. Cummings. It is altogether very 
fitting that we recognize his long fight against high drug prices by 
passing H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, in his 
memory.
  Ms. SANCHEZ. Mr. Chair, I rise in support of H.R. 3, the Elijah E. 
Cummings Lower Drug Costs Now Act.
  I would like to thank Chairmen Neal, Pallone, and Scott for their 
tireless efforts to get this legislation passed.
  Prescriptions are not recommendations, Doctors have written them for 
a reason. Patients, our constituents, our friends, our family members, 
need these medications. They cannot afford to skip their medications.
  However, I have heard so many heartbreaking stories from individuals 
in my district. Alice in Whittier has to rely on her doctors for 
insulin samples because she cannot afford insulin. Adrian in Norwalk is 
choosing to pay his bills rather than his eight different medications. 
David in La Mirada is considering cutting his dosage because he cannot 
afford to refill his full dosage as often as he should. They, and so 
many others, are just making do. Frankly, that's not good enough for 
me.
  With H.R. 3, we are giving power back to the people in my district 
and to millions of Americans. The savings from this bill will also be 
given back to the public with reinvestments in innovation and the 
search for new cures and treatments.
  I look forward to this bill's passage today. It is time to act and 
lower the cost of prescription drugs now.
  The Acting CHAIR. All time for general debate has expired.
  In lieu of the amendments in the nature of a substitute recommended 
by the Committee on Education and Labor, Committee on Energy and 
Commerce, and the Committee on Ways and Means, printed in the bill, 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 
House Report 116-334, shall be considered as adopted and shall be 
considered as an original bill for purpose of further amendment under 
the 5-minute rule. The bill, as amended, shall be considered as read.
  The text of the bill, as amended, is as follows:

                                 H.R. 3

     Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Elijah E. 
     Cummings Lower Drug Costs Now Act''.
       (b) Table of Contents.--The table of contents is as 
     follows:

Sec. 1. Short title; table of contents.

      TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION

Sec. 101. Providing for lower prices for certain high-priced single 
              source drugs.
Sec. 102. Selected drug manufacturer excise tax imposed during 
              noncompliance periods.
Sec. 103. Fair Price Negotiation Implementation Fund.

  TITLE II--MEDICARE PARTS B AND D PRESCRIPTION DRUG INFLATION REBATES

Sec. 201. Medicare part B rebate by manufacturers.
Sec. 202. Medicare part D rebate by manufacturers.
Sec. 203. Provision regarding inflation rebates for group health plans 
              and group health insurance coverage.
Sec. 204. Annual report on drug costs in group health plans and group 
              health insurance coverage.
Sec. 205. Collection of data.

   TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR 
                         MEDICARE BENEFICIARIES

Sec. 301. Medicare part D benefit redesign.
Sec. 302. Allowing certain enrollees of prescription drugs plans and 
              MA-PD plans under Medicare program to spread out cost-
              sharing under certain circumstances.
Sec. 303. Establishment of pharmacy quality measures under Medicare 
              part D.

                   TITLE IV--DRUG PRICE TRANSPARENCY

Sec. 401. Drug price transparency.

  TITLE V--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES

Sec. 501. Dissemination to Medicare part D subsidy eligible individuals 
              of information comparing premiums of certain prescription 
              drug plans.
Sec. 502. Providing for intelligent assignment of certain subsidy 
              eligible individuals auto-enrolled under Medicare 
              prescription drug plans and MA-PD plans.
Sec. 503. Expanding eligibility for low-income subsidies under part D 
              of the Medicare program.
Sec. 504. Automatic eligibility of certain low-income territorial 
              residents for premium and cost-sharing subsidies under 
              the Medicare program; Sunset of enhanced allotment 
              program.
Sec. 505. Automatic qualification of certain Medicaid beneficiaries for 
              premium and cost-sharing subsidies under part D of the 
              Medicare program.
Sec. 506. Providing for certain rules regarding the treatment of 
              eligible retirement plans in determining the eligibility 
              of individuals for premium and cost-sharing subsidies 
              under part D of the Medicare program.
Sec. 507. Reducing cost-sharing and other program improvements for low-
              income beneficiaries.

TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE 
                            MEDICARE PROGRAM

Sec. 601. Dental and oral health care.
Sec. 602. Providing coverage for hearing care under the Medicare 
              program.
Sec. 603. Providing coverage for vision care under the Medicare 
              program.

                TITLE VII--NIH, FDA, AND OPIOIDS FUNDING

              Subtitle A--Biomedical Innovation Expansion

Sec. 701. NIH Innovation Initiatives.
Sec. 702. NIH clinical trial.

             Subtitle B--Investing in Safety and Innovation

Sec. 711. Food and Drug Administration.

                  Subtitle C--Opioid Epidemic Response

Sec. 721. Opioid Epidemic Response Fund.
Sec. 722. Substance Abuse and Mental Health Services Administration.
Sec. 723. Centers for Disease Control and Prevention.
Sec. 724. Food and Drug Administration.
Sec. 725. National Institutes of Health.
Sec. 726. Health Resources and Services Administration.
Sec. 727. Administration for Children and Families.

                       TITLE VIII--MISCELLANEOUS

Sec. 801. Guaranteed issue of certain Medigap policies.
Sec. 802. Reporting requirements for PDP sponsors regarding point-of-
              sale rejections under Medicare part D.
Sec. 803. Providing access to annual Medicare notifications in multiple 
              languages.
Sec. 804. Temporary increase in Medicare part B payment for certain 
              biosimilar biological products.
Sec. 805. Waiving medicare coinsurance for colorectal cancer screening 
              tests.
Sec. 806. Medicare coverage of certain lymphedema compression treatment 
              items.
Sec. 807. Physician fee update.
Sec. 808. Additional community health center funding.
Sec. 809. Grants to improve trauma support services and mental health 
              care for children and youth in educational settings.

[[Page H10142]]

Sec. 810. Pathway to Health Careers Act.
Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act.

      TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION

     SEC. 101. PROVIDING FOR LOWER PRICES FOR CERTAIN HIGH-PRICED 
                   SINGLE SOURCE DRUGS

       U.S.C. 1301 et seq.) is amended by adding at the end the 
     following new part:
     ``PART E--FAIR PRICE NEGOTIATION PROGRAM TO LOWER PRICES FOR 
     CERTAIN HIGH-PRICED SINGLE SOURCE DRUGS
     ``SEC. 1191. ESTABLISHMENT OF PROGRAM.
       ``(a) In General.--The Secretary shall establish a Fair 
     Price Negotiation Program (in this part referred to as the 
     `program'). Under the program, with respect to each price 
     applicability period, the Secretary shall--
       ``(1) publish a list of selected drugs in accordance with 
     section 1192;
       ``(2) enter into agreements with manufacturers of selected 
     drugs with respect to such period, in accordance with section 
     1193;
       ``(3) negotiate and, if applicable, renegotiate maximum 
     fair prices for such selected drugs, in accordance with 
     section 1194; and
       ``(4) carry out the administrative duties described in 
     section 1196.
       ``(b) Definitions Relating to Timing.--For purposes of this 
     part:
       ``(1) Initial price applicability year.--The term `initial 
     price applicability year' means a plan year (beginning with 
     plan year 2023) or, if agreed to in an agreement under 
     section 1193 by the Secretary and manufacturer involved, a 
     period of more than one plan year (beginning on or after 
     January 1, 2023).
       ``(2) Price applicability period.--The term `price 
     applicability period' means, with respect to a drug, the 
     period beginning with the initial price applicability year 
     with respect to which such drug is a selected drug and ending 
     with the last plan year during which the drug is a selected 
     drug.
       ``(3) Selected drug publication date.--The term `selected 
     drug publication date' means, with respect to each initial 
     price applicability year, April 15 of the plan year that 
     begins 2 years prior to such year.
       ``(4) Voluntary negotiation period.--The term `voluntary 
     negotiation period' means, with respect to an initial price 
     applicability year with respect to a selected drug, the 
     period--
       ``(A) beginning on the sooner of--
       ``(i) the date on which the manufacturer of the drug and 
     the Secretary enter into an agreement under section 1193 with 
     respect to such drug; or
       ``(ii) June 15 following the selected drug publication date 
     with respect to such selected drug; and
       ``(B) ending on March 31 of the year that begins one year 
     prior to the initial price applicability year.
       ``(c) Other Definitions.--For purposes of this part:
       ``(1) Fair price eligible individual.--The term `fair price 
     eligible individual' means, with respect to a selected drug--
       ``(A) in the case such drug is furnished or dispensed to 
     the individual at a pharmacy or by a mail order service--
       ``(i) an individual who is enrolled under a prescription 
     drug plan under part D of title XVIII or an MA-PD plan under 
     part C of such title if coverage is provided under such plan 
     for such selected drug; and
       ``(ii) an individual who is enrolled under a group health 
     plan or health insurance coverage offered in the group or 
     individual market (as such terms are defined in section 2791 
     of the Public Health Service Act) with respect to which there 
     is in effect an agreement with the Secretary under section 
     1197 with respect to such selected drug as so furnished or 
     dispensed; and
       ``(B) in the case such drug is furnished or administered to 
     the individual by a hospital, physician, or other provider of 
     services or supplier--
       ``(i) an individual who is entitled to benefits under part 
     A of title XVIII or enrolled under part B of such title if 
     such selected drug is covered under the respective part; and
       ``(ii) an individual who is enrolled under a group health 
     plan or health insurance coverage offered in the group or 
     individual market (as such terms are defined in section 2791 
     of the Public Health Service Act) with respect to which there 
     is in effect an agreement with the Secretary under section 
     1197 with respect to such selected drug as so furnished or 
     administered.
       ``(2) Maximum fair price.--The term `maximum fair price' 
     means, with respect to a plan year during a price 
     applicability period and with respect to a selected drug (as 
     defined in section 1192(c)) with respect to such period, the 
     price published pursuant to section 1195 in the Federal 
     Register for such drug and year.
       ``(3) Average international market price defined.--
       ``(A) In general.--The terms `average international market 
     price' and `AIM price' mean, with respect to a drug, the 
     average price (which shall be the net average price, if 
     practicable, and volume-weighted, if practicable) for a unit 
     (as defined in paragraph (4)) of the drug for sales of such 
     drug (calculated across different dosage forms and strengths 
     of the drug and not based on the specific formulation or 
     package size or package type), as computed (as of the date of 
     publication of such drug as a selected drug under section 
     1192(a)) in all countries described in clause (ii) of 
     subparagraph (B) that are applicable countries (as described 
     in clause (i) of such subparagraph) with respect to such 
     drug.
       ``(B) Applicable countries.--
       ``(i) In general.--For purposes of subparagraph (A), a 
     country described in clause (ii) is an applicable country 
     described in this clause with respect to a drug if there is 
     available an average price for any unit for the drug for 
     sales of such drug in such country.
       ``(ii) Countries described.--For purposes of this 
     paragraph, the following are countries described in this 
     clause:

       ``(I) Australia.
       ``(II) Canada.
       ``(III) France.
       ``(IV) Germany.
       ``(V) Japan.
       ``(VI) The United Kingdom.

       ``(4) Unit.--The term `unit' means, with respect to a drug, 
     the lowest identifiable quantity (such as a capsule or 
     tablet, milligram of molecules, or grams) of the drug that is 
     dispensed.

     ``SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS AS 
                   SELECTED DRUGS.

       ``(a) In General.--Not later than the selected drug 
     publication date with respect to an initial price 
     applicability year, the Secretary shall select and publish in 
     the Federal Register a list of--
       ``(1)(A) with respect to an initial price applicability 
     year during 2023, at least 25 negotiation-eligible drugs 
     described in subparagraphs (A) and (B), but not subparagraph 
     (C), of subsection (d)(1) (or, with respect to an initial 
     price applicability year during such period beginning after 
     2023, the maximum number (if such number is less than 25) of 
     such negotiation-eligible drugs for the year) with respect to 
     such year; and
       ``(B) with respect to an initial price applicability year 
     during 2024 or a subsequent year, at least 50 negotiation-
     eligible drugs described in subparagraphs (A) and (B), but 
     not subparagraph (C), of subsection (d)(1) (or, with respect 
     to an initial price applicability year during such period, 
     the maximum number (if such number is less than 50) of such 
     negotiation-eligible drugs for the year) with respect to such 
     year;
       ``(2) all negotiation-eligible drugs described in 
     subparagraph (C) of such subsection with respect to such 
     year; and
       ``(3) all new-entrant negotiation-eligible drugs (as 
     defined in subsection (g)(1)) with respect to such year.
     Each drug published on the list pursuant to the previous 
     sentence shall be subject to the negotiation process under 
     section 1194 for the voluntary negotiation period with 
     respect to such initial price applicability year (and the 
     renegotiation process under such section as applicable for 
     any subsequent year during the applicable price applicability 
     period). In applying this subsection, any negotiation-
     eligible drug that is selected under this subsection for an 
     initial price applicability year shall not count toward the 
     required minimum amount of drugs to be selected under 
     paragraph (1) for any subsequent year, including such a drug 
     so selected that is subject to renegotiation under section 
     1194.
       ``(b) Selection of Drugs.--In carrying out subsection 
     (a)(1) the Secretary shall select for inclusion on the 
     published list described in subsection (a) with respect to a 
     price applicability period, the negotiation-eligible drugs 
     that the Secretary projects will result in the greatest 
     savings to the Federal Government or fair price eligible 
     individuals during the price applicability period. In making 
     this projection of savings for drugs for which there is an 
     AIM price for a price applicability period, the savings shall 
     be projected across different dosage forms and strengths of 
     the drugs and not based on the specific formulation or 
     package size or package type of the drugs, taking into 
     consideration both the volume of drugs for which payment is 
     made, to the extent such data is available, and the amount by 
     which the net price for the drugs exceeds the AIM price for 
     the drugs.
       ``(c) Selected Drug.--For purposes of this part, each drug 
     included on the list published under subsection (a) with 
     respect to an initial price applicability year shall be 
     referred to as a `selected drug' with respect to such year 
     and each subsequent plan year beginning before the first plan 
     year beginning after the date on which the Secretary 
     determines two or more drug products--
       ``(1) are approved or licensed (as applicable)--
       ``(A) under section 505(j) of the Federal Food, Drug, and 
     Cosmetic Act using such drug as the listed drug; or
       ``(B) under section 351(k) of the Public Health Service Act 
     using such drug as the reference product; and
       ``(2) continue to be marketed.
       ``(d) Negotiation-Eligible Drug.--
       ``(1) In general.--For purposes of this part, the term 
     `negotiation-eligible drug' means, with respect to the 
     selected drug publication date with respect to an initial 
     price applicability year, a qualifying single source drug, as 
     defined in subsection (e), that meets any of the following 
     criteria:
       ``(A) Covered part d drugs.--The drug is among the 125 
     covered part D drugs (as defined in section 1860D-2(e)) for 
     which there was an estimated greatest net spending under 
     parts C and D of title XVIII, as determined by the Secretary, 
     during the most recent plan year prior to such drug 
     publication date for which data are available.
       ``(B) Other drugs.--The drug is among the 125 drugs for 
     which there was an estimated greatest net spending in the 
     United States (including the 50 States, the District of 
     Columbia, and the territories of the United States), as 
     determined by the Secretary, during the most recent plan year 
     prior to such drug publication date for which data are 
     available.
       ``(C) Insulin.--The drug is a qualifying single source drug 
     described in subsection (e)(3).
       ``(2) Clarification.--In determining whether a qualifying 
     single source drug satisfies any of the criteria described in 
     paragraph (1), the Secretary shall, to the extent 
     practicable, use data that is aggregated across dosage forms 
     and strengths of the drug and not based on the specific 
     formulation or package size or package type of the drug.
       ``(3) Publication.--Not later than the selected drug 
     publication date with respect to an initial price 
     applicability year, the Secretary

[[Page H10143]]

     shall publish in the Federal Register a list of negotiation-
     eligible drugs with respect to such selected drug publication 
     date.
       ``(e) Qualifying Single Source Drug.--For purposes of this 
     part, the term `qualifying single source drug' means any of 
     the following:
       ``(1) Drug products.--A drug that--
       ``(A) is approved under section 505(c) of the Federal Food, 
     Drug, and Cosmetic Act and continues to be marketed pursuant 
     to such approval; and
       ``(B) is not the listed drug for any drug that is approved 
     and continues to be marketed under section 505(j) of such 
     Act.
       ``(2) Biological products.--A biological product that--
       ``(A) is licensed under section 351(a) of the Public Health 
     Service Act, including any product that has been deemed to be 
     licensed under section 351 of such Act pursuant to section 
     7002(e)(4) of the Biologics Price Competition and Innovation 
     Act of 2009, and continues to be marketed under section 351 
     of such Act; and
       ``(B) is not the reference product for any biological 
     product that is licensed and continues to be marketed under 
     section 351(k) of such Act.
       ``(3) Insulin product.--Notwithstanding paragraphs (1) and 
     (2), any insulin product 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 the Public Health Service Act and continues to 
     be marketed under such section 505 or 351, including any 
     insulin product that has been deemed to be licensed under 
     section 351(a) of the Public Health Service Act pursuant to 
     section 7002(e)(4) of the Biologics Price Competition and 
     Innovation Act of 2009 and continues to be marketed pursuant 
     to such licensure.
     For purposes of applying paragraphs (1) and (2), a drug or 
     biological product that is marketed by the same sponsor or 
     manufacturer (or an affiliate thereof or a cross-licensed 
     producer or distributor) as the listed drug or reference 
     product described in such respective paragraph shall not be 
     taken into consideration.
       ``(f) Information on International Drug Prices.--For 
     purposes of determining which negotiation-eligible drugs to 
     select under subsection (a) and, in the case of such drugs 
     that are selected drugs, to determine the maximum fair price 
     for such a drug and whether such maximum fair price should be 
     renegotiated under section 1194, the Secretary shall use data 
     relating to the AIM price with respect to such drug as 
     available or provided to the Secretary and shall on an 
     ongoing basis request from manufacturers of selected drugs 
     information on the AIM price of such a drug.
       ``(g) New-entrant Negotiation-eligible Drugs.--
       ``(1) In general.--For purposes of this part, the term 
     `new-entrant negotiation-eligible drug' means, with respect 
     to the selected drug publication date with respect to an 
     initial price applicability year, a qualifying single source 
     drug--
       ``(A) that is first approved or licensed, as described in 
     paragraph (1), (2), or (3) of subsection (e), as applicable, 
     during the year preceding such selected drug publication 
     date; and
       ``(B) that the Secretary determines under paragraph (2) is 
     likely to be included as a negotiation-eligible drug with 
     respect to the subsequent selected drug publication date.
       ``(2) Determination.--In the case of a qualifying single 
     source drug that meets the criteria described in subparagraph 
     (A) of paragraph (1), with respect to an initial price 
     applicability year, if the wholesale acquisition cost at 
     which such drug is first marketed in the United States is 
     equal to or greater than the median household income (as 
     determined according to the most recent data collected by the 
     United States Census Bureau), the Secretary shall determine 
     before the selected drug publication date with respect to the 
     initial price applicability year, if the drug is likely to be 
     included as a negotiation-eligible drug with respect to the 
     subsequent selected drug publication date, based on the 
     projected spending under title XVIII or in the United States 
     on such drug. For purposes of this paragraph the term `United 
     States' includes the 50 States, the District of Columbia, and 
     the territories of the United States.

     ``SEC. 1193. MANUFACTURER AGREEMENTS.

       ``(a) In General.--For purposes of section 1191(a)(2), the 
     Secretary shall enter into agreements with manufacturers of 
     selected drugs with respect to a price applicability period, 
     by not later than June 15 following the selected drug 
     publication date with respect to such selected drug, under 
     which--
       ``(1) during the voluntary negotiation period for the 
     initial price applicability year for the selected drug, the 
     Secretary and manufacturer, in accordance with section 1194, 
     negotiate to determine (and, by not later than the last date 
     of such period and in accordance with subsection (c), agree 
     to) a maximum fair price for such selected drug of the 
     manufacturer in order to provide access to such price--
       ``(A) to fair price eligible individuals who with respect 
     to such drug are described in subparagraph (A) of section 
     1191(c)(1) and are furnished or dispensed such drug during, 
     subject to subparagraph (2), the price applicability period; 
     and
       ``(B) to hospitals, physicians, and other providers of 
     services and suppliers with respect to fair price eligible 
     individuals who with respect to such drug are described in 
     subparagraph (B) of such section and are furnished or 
     administered such drug during, subject to subparagraph (2), 
     the price applicability period;
       ``(2) the Secretary and the manufacturer shall, in 
     accordance with a process and during a period specified by 
     the Secretary pursuant to rulemaking, renegotiate (and, by 
     not later than the last date of such period and in accordance 
     with subsection (c), agree to) the maximum fair price for 
     such drug if the Secretary determines that there is a 
     material change in any of the factors described in section 
     1194(d) relating to the drug, including changes in the AIM 
     price for such drug, in order to provide access to such 
     maximum fair price (as so renegotiated)--
       ``(A) to fair price eligible individuals who with respect 
     to such drug are described in subparagraph (A) of section 
     1191(c)(1) and are furnished or dispensed such drug during 
     any year during the price applicability period (beginning 
     after such renegotiation) with respect to such selected drug; 
     and
       ``(B) to hospitals, physicians, and other providers of 
     services and suppliers with respect to fair price eligible 
     individuals who with respect to such drug are described in 
     subparagraph (B) of such section and are furnished or 
     administered such drug during any year described in 
     subparagraph (A);
       ``(3) the maximum fair price (including as renegotiated 
     pursuant to paragraph (2)), with respect to such a selected 
     drug, shall be provided to fair price eligible individuals, 
     who with respect to such drug are described in subparagraph 
     (A) of section 1191(c)(1), at the pharmacy or by a mail order 
     service at the point-of-sale of such drug;
       ``(4) the manufacturer, subject to subsection (d), submits 
     to the Secretary, in a form and manner specified by the 
     Secretary--
       ``(A) for the voluntary negotiation period for the price 
     applicability period (and, if applicable, before any period 
     of renegotiation specified pursuant to paragraph (2)) with 
     respect to such drug all information that the Secretary 
     requires to carry out the negotiation (or renegotiation 
     process) under this part, including information described in 
     section 1192(f) and section 1194(d)(1); and
       ``(B) on an ongoing basis, information on changes in prices 
     for such drug that would affect the AIM price for such drug 
     or otherwise provide a basis for renegotiation of the maximum 
     fair price for such drug pursuant to paragraph (2);
       ``(5) the manufacturer agrees that in the case the selected 
     drug of a manufacturer is a drug described in subsection (c), 
     the manufacturer will, in accordance with such subsection, 
     make any payment required under such subsection with respect 
     to such drug; and
       ``(6) the manufacturer complies with requirements imposed 
     by the Secretary for purposes of administering the program, 
     including with respect to the duties described in section 
     1196.
       ``(b) Agreement in Effect Until Drug Is No Longer a 
     Selected Drug.--An agreement entered into under this section 
     shall be effective, with respect to a drug, until such drug 
     is no longer considered a selected drug under section 
     1192(c).
       ``(c) Special Rule for Certain Selected Drugs Without AIM 
     Price.--
       ``(1) In general.--In the case of a selected drug for which 
     there is no AIM price available with respect to the initial 
     price applicability year for such drug and for which an AIM 
     price becomes available beginning with respect to a 
     subsequent plan year during the price applicability period 
     for such drug, if the Secretary determines that the amount 
     described in paragraph (2)(A) for a unit of such drug is 
     greater than the amount described in paragraph (2)(B) for a 
     unit of such drug, then by not later than one year after the 
     date of such determination, the manufacturer of such selected 
     drug shall pay to the Treasury an amount equal to the product 
     of--
       ``(A) the difference between such amount described in 
     paragraph (2)(A) for a unit of such drug and such amount 
     described in paragraph (2)(B) for a unit of such drug; and
       ``(B) the number of units of such drug sold in the United 
     States, including the 50 States, the District of Columbia, 
     and the territories of the United States, during the period 
     described in paragraph (2)(B).
       ``(2) Amounts described.--
       ``(A) Weighted average price before aim price available.--
     For purposes of paragraph (1), the amount described in this 
     subparagraph for a selected drug described in such paragraph, 
     is the amount equal to the weighted average manufacturer 
     price (as defined in section 1927(k)(1)) for such dosage 
     strength and form for the drug during the period beginning 
     with the first plan year for which the drug is included on 
     the list of negotiation-eligible drugs published under 
     section 1192(d) and ending with the last plan year during the 
     price applicability period for such drug with respect to 
     which there is no AIM price available for such drug.
       ``(B) Amount multiplier after aim price available.--For 
     purposes of paragraph (1), the amount described in this 
     subparagraph for a selected drug described in such paragraph, 
     is the amount equal to 200 percent of the AIM price for such 
     drug with respect to the first plan year during the price 
     applicability period for such drug with respect to which 
     there is an AIM price available for such drug.
       ``(d) Confidentiality of Information.--Information 
     submitted to the Secretary under this part by a manufacturer 
     of a selected drug that is proprietary information of such 
     manufacturer (as determined by the Secretary) may be used 
     only by the Secretary or disclosed to and used by the 
     Comptroller General of the United States or the Medicare 
     Payment Advisory Commission for purposes of carrying out this 
     part.
       ``(e) Regulations.--
       ``(1) In general.--The Secretary shall, pursuant to 
     rulemaking, specify, in accordance with paragraph (2), the 
     information that must be submitted under subsection (a)(4).
       ``(2) Information specified.--Information described in 
     paragraph (1), with respect to a selected drug, shall include 
     information on sales of the drug (by the manufacturer of the 
     drug or by another entity under license or other agreement 
     with the manufacturer, with respect to the sales of such 
     drug, regardless of the name under which the drug is sold) in 
     any foreign country

[[Page H10144]]

     that is part of the AIM price. The Secretary shall verify, to 
     the extent practicable, such sales from appropriate officials 
     of the government of the foreign country involved.
       ``(f) 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 section 
     1196(c)(1), as applicable, for purposes of administering the 
     program.

     ``SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS.

       ``(a) In General.--For purposes of this part, under an 
     agreement under section 1193 between the Secretary and a 
     manufacturer of a selected drug, with respect to the period 
     for which such agreement is in effect and in accordance with 
     subsections (b) and (c), the Secretary and the manufacturer--
       ``(1) shall during the voluntary negotiation period with 
     respect to the initial price applicability year for such 
     drug, in accordance with this section, negotiate a maximum 
     fair price for such drug for the purpose described in section 
     1193(a)(1); and
       ``(2) as applicable pursuant to section 1193(a)(2) and in 
     accordance with the process specified pursuant to such 
     section, renegotiate such maximum fair price for such drug 
     for the purpose described in such section.
       ``(b) Negotiating Methodology and Objective.--
       ``(1) In general.--The Secretary shall develop and use a 
     consistent methodology for negotiations under subsection (a) 
     that, in accordance with paragraph (2) and subject to 
     paragraph (3), achieves the lowest maximum fair price for 
     each selected drug while appropriately rewarding innovation.
       ``(2) Prioritizing factors.--In considering the factors 
     described in subsection (d) in negotiating (and, as 
     applicable, renegotiating) the maximum fair price for a 
     selected drug, the Secretary shall, to the extent 
     practicable, consider all of the available factors listed but 
     shall prioritize the following factors:
       ``(A) Research and development costs.--The factor described 
     in paragraph (1)(A) of subsection (d).
       ``(B) Market data.--The factor described in paragraph 
     (1)(B) of such subsection.
       ``(C) Unit costs of production and distribution.--The 
     factor described in paragraph (1)(C) of such subsection.
       ``(D) Comparison to existing therapeutic alternatives.--The 
     factor described in paragraph (2)(A) of such subsection.
       ``(3) Requirement.--
       ``(A) In general.--In negotiating the maximum fair price of 
     a selected drug, with respect to an initial price 
     applicability year for the selected drug, and, as applicable, 
     in renegotiating the maximum fair price for such drug, with 
     respect to a subsequent year during the price applicability 
     period for such drug, in the case that the manufacturer of 
     the selected drug offers under the negotiation or 
     renegotiation, as applicable, a price for such drug that is 
     not more than the target price described in subparagraph (B) 
     for such drug for the respective year, the Secretary shall 
     agree under such negotiation or renegotiation, respectively, 
     to such offered price as the maximum fair price.
       ``(B) Target price.--
       ``(i) In general.--Subject to clause (ii), the target price 
     described in this subparagraph for a selected drug with 
     respect to a year, is the average price (which shall be the 
     net average price, if practicable, and volume-weighted, if 
     practicable) for a unit of such drug for sales of such drug, 
     as computed (across different dosage forms and strengths of 
     the drug and not based on the specific formulation or package 
     size or package type of the drug) in the applicable country 
     described in section 1191(c)(3)(B) with respect to such drug 
     that, with respect to such year, has the lowest average price 
     for such drug as compared to the average prices (as so 
     computed) of such drug with respect to such year in the other 
     applicable countries described in such section with respect 
     to such drug.
       ``(ii) Selected drugs without aim price.--In applying this 
     paragraph in the case of negotiating the maximum fair price 
     of a selected drug for which there is no AIM price available 
     with respect to the initial price applicability year for such 
     drug, or, as applicable, renegotiating the maximum fair price 
     for such drug with respect to a subsequent year during the 
     price applicability period for such drug before the first 
     plan year for which there is an AIM price available for such 
     drug, the target price described in this subparagraph for 
     such drug and respective year is the amount that is 80 
     percent of the average manufacturer price (as defined in 
     section 1927(k)(1)) for such drug and year.
       ``(4) Annual report.--After the completion of each 
     voluntary negotiation period, the Secretary shall submit to 
     Congress a report on the maximum fair prices negotiated (or, 
     as applicable, renegotiated) for such period. Such report 
     shall include information on how such prices so negotiated 
     (or renegotiated) meet the requirements of this part, 
     including the requirements of this subsection.
       ``(c) Limitation.--
       ``(1) In general.--Subject to paragraph (2), the maximum 
     fair price negotiated (including as renegotiated) under this 
     section for a selected drug, with respect to each plan year 
     during a price applicability period for such drug, shall not 
     exceed 120 percent of the AIM price applicable to such drug 
     with respect to such year.
       ``(2) Selected drugs without aim price.--In the case of a 
     selected drug for which there is no AIM price available with 
     respect to the initial price applicability year for such 
     drug, for each plan year during the price applicability 
     period before the first plan year for which there is an AIM 
     price available for such drug, the maximum fair price 
     negotiated (including as renegotiated) under this section for 
     the selected drug shall not exceed the amount equal to 85 
     percent of the average manufacturer price for the drug with 
     respect to such year.
       ``(d) Considerations.--For purposes of negotiating and, as 
     applicable, renegotiating (including for purposes of 
     determining whether to renegotiate) the maximum fair price of 
     a selected drug under this part with the manufacturer of the 
     drug, the Secretary, consistent with subsection (b)(2), shall 
     take into consideration the factors described in paragraphs 
     (1), (2), (3), and (5), and may take into consideration the 
     factor described in paragraph (4):
       ``(1) Manufacturer-specific information.--The following 
     information, including as submitted by the manufacturer:
       ``(A) Research and development costs of the manufacturer 
     for the drug and the extent to which the manufacturer has 
     recouped research and development costs.
       ``(B) Market data for the drug, including the distribution 
     of sales across different programs and purchasers and 
     projected future revenues for the drug.
       ``(C) Unit costs of production and distribution of the 
     drug.
       ``(D) Prior Federal financial support for novel therapeutic 
     discovery and development with respect to the drug.
       ``(E) Data on patents and on existing and pending 
     exclusivity for the drug.
       ``(F) National sales data for the drug.
       ``(G) Information on clinical trials for the drug in the 
     United States or in applicable countries described in section 
     1191(c)(3)(B).
       ``(2) Information on alternative products.--The following 
     information:
       ``(A) The extent to which the drug represents a therapeutic 
     advance as compared to existing therapeutic alternatives and, 
     to the extent such information is available, the costs of 
     such existing therapeutic alternatives.
       ``(B) Information on approval by the Food and Drug 
     Administration of alternative drug products.
       ``(C) Information on comparative effectiveness analysis for 
     such products, taking into consideration the effects of such 
     products on specific populations, such as individuals with 
     disabilities, the elderly, terminally ill, children, and 
     other patient populations.
     In considering information described in subparagraph (C), the 
     Secretary shall not use evidence or findings from comparative 
     clinical effectiveness research in a manner that treats 
     extending the life of an elderly, disabled, or terminally ill 
     individual as of lower value than extending the life of an 
     individual who is younger, nondisabled, or not terminally 
     ill. Nothing in the previous sentence shall affect the 
     application or consideration of an AIM price for a selected 
     drug.
       ``(3) Foreign sales information.--To the extent available 
     on a timely basis, including as provided by a manufacturer of 
     the selected drug or otherwise, information on sales of the 
     selected drug in each of the countries described in section 
     1191(c)(3)(B).
       ``(4) VA drug pricing information.--Information disclosed 
     to the Secretary pursuant to subsection (f).
       ``(5) Additional information.--Information submitted to the 
     Secretary, in accordance with a process specified by the 
     Secretary, by other parties that are affected by the 
     establishment of a maximum fair price for the selected drug.
       ``(e) Request for Information.--For purposes of negotiating 
     and, as applicable, renegotiating (including for purposes of 
     determining whether to renegotiate) the maximum fair price of 
     a selected drug under this part with the manufacturer of the 
     drug, with respect to a price applicability period, and other 
     relevant data for purposes of this section--
       ``(1) the Secretary shall, not later than the selected drug 
     publication date with respect to the initial price 
     applicability year of such period, request drug pricing 
     information from the manufacturer of such selected drug, 
     including information described in subsection (d)(1); and
       ``(2) by not later than October 1 following the selected 
     drug publication date, the manufacturer of such selected drug 
     shall submit to the Secretary such requested information in 
     such form and manner as the Secretary may require.
     The Secretary shall request, from the manufacturer or others, 
     such additional information as may be needed to carry out the 
     negotiation and renegotiation process under this section.
       ``(f) Disclosure of Information.--For purposes of this 
     part, the Secretary of Veterans Affairs may disclose to the 
     Secretary of Health and Human Services the price of any 
     negotiation-eligible drug that is purchased pursuant to 
     section 8126 of title 38, United States Code.

     ``SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES.

       ``(a) In General.--With respect to an initial price 
     applicability year and selected drug with respect to such 
     year, not later than April 1 of the plan year prior to such 
     initial price applicability year, the Secretary shall publish 
     in the Federal Register the maximum fair price for such drug 
     negotiated under this part with the manufacturer of such 
     drug.
       ``(b) Updates.--
       ``(1) Subsequent year maximum fair prices.--For a selected 
     drug, for each plan year subsequent to the initial price 
     applicability year for such drug with respect to which an 
     agreement for such drug is in effect under section 1193, the 
     Secretary shall publish in the Federal Register--
       ``(A) subject to subparagraph (B), the amount equal to the 
     maximum fair price published for such drug for the previous 
     year, increased by the annual percentage increase in the 
     consumer price index for all urban consumers (all items; U.S. 
     city average) as of September of such previous year; or

[[Page H10145]]

       ``(B) in the case the maximum fair price for such drug was 
     renegotiated, for the first year for which such price as so 
     renegotiated applies, such renegotiated maximum fair price.
       ``(2) Prices negotiated after deadline.--In the case of a 
     selected drug with respect to an initial price applicability 
     year for which the maximum fair price is determined under 
     this part after the date of publication under this section, 
     the Secretary shall publish such maximum fair price in the 
     Federal Register by not later than 30 days after the date 
     such maximum price is so determined.

     ``SEC. 1196. ADMINISTRATIVE DUTIES; COORDINATION PROVISIONS.

       ``(a) Administrative Duties.--
       ``(1) In general.--For purposes of section 1191, the 
     administrative duties described in this section are the 
     following:
       ``(A) The establishment of procedures (including through 
     agreements with manufacturers under this part, contracts with 
     prescription drug plans under part D of title XVIII and MA-PD 
     plans under part C of such title, and agreements under 
     section 1197 with group health plans and health insurance 
     issuers of health insurance coverage offered in the 
     individual or group market) under which the maximum fair 
     price for a selected drug is provided to fair price eligible 
     individuals, who with respect to such drug are described in 
     subparagraph (A) of section 1191(c)(1), at pharmacies or by 
     mail order service at the point-of-sale of the drug for the 
     applicable price period for such drug and providing that such 
     maximum fair price is used for determining cost-sharing under 
     such plans or coverage for the selected drug.
       ``(B) The establishment of procedures (including through 
     agreements with manufacturers under this part and contracts 
     with hospitals, physicians, and other providers of services 
     and suppliers and agreements under section 1197 with group 
     health plans and health insurance issuers of health insurance 
     coverage offered in the individual or group market) under 
     which, in the case of a selected drug furnished or 
     administered by such a hospital, physician, or other provider 
     of services or supplier to fair price eligible individuals 
     (who with respect to such drug are described in subparagraph 
     (B) of section 1191(c)(1)), the maximum fair price for the 
     selected drug is provided to such hospitals, physicians, and 
     other providers of services and suppliers (as applicable) 
     with respect to such individuals and providing that such 
     maximum fair price is used for determining cost-sharing under 
     the respective part, plan, or coverage for the selected drug.
       ``(C) The establishment of procedures (including through 
     agreements and contracts described in subparagraphs (A) and 
     (B)) to ensure that, not later than 90 days after the 
     dispensing of a selected drug to a fair price eligible 
     individual 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 lesser of--

       ``(I) the wholesale acquisition cost of the drug;
       ``(II) the national average drug acquisition cost of the 
     drug; and
       ``(III) any other similar determination of pharmacy 
     acquisition costs of the drug, as determined by the 
     Secretary; and

       ``(ii) the maximum fair price for the drug.
       ``(D) The establishment of procedures to ensure that the 
     maximum fair price for a selected drug is applied before--
       ``(i) 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 fair price eligible 
     individuals as the Secretary may specify; and
       ``(ii) any other discounts.
       ``(E) The establishment of procedures to enter into 
     appropriate agreements and protocols for the ongoing 
     computation of AIM prices for selected drugs, including, to 
     the extent possible, to compute the AIM price for selected 
     drugs and including by providing that the manufacturer of 
     such a selected drug should provide information for such 
     computation not later than 3 months after the first date of 
     the voluntary negotiation period for such selected drug.
       ``(F) The establishment of procedures to compute and apply 
     the maximum fair price across different strengths and dosage 
     forms of a selected drug and not based on the specific 
     formulation or package size or package type of the drug.
       ``(G) The establishment of procedures to negotiate and 
     apply the maximum fair price in a manner that does not 
     include any dispensing or similar fee.
       ``(H) The establishment of procedures to carry out the 
     provisions of this part, as applicable, with respect to--
       ``(i) fair price eligible individuals who are enrolled 
     under a prescription drug plan under part D of title XVIII or 
     an MA-PD plan under part C of such title;
       ``(ii) fair price eligible individuals who are enrolled 
     under a group health plan or health insurance coverage 
     offered by a health insurance issuer in the individual or 
     group market with respect to which there is an agreement in 
     effect under section 1197; and
       ``(iii) fair price eligible individuals who are entitled to 
     benefits under part A of title XVIII or enrolled under part B 
     of such title.
       ``(I) The establishment of a negotiation process and 
     renegotiation process in accordance with section 1194, 
     including a process for acquiring information described in 
     subsection (d) of such section and determining amounts 
     described in subsection (b) of such section.
       ``(J) The provision of a reasonable dispute resolution 
     mechanism to resolve disagreements between manufacturers, 
     fair price eligible individuals, and the third party with a 
     contract under subsection (c)(1).
       ``(2) Monitoring compliance.--
       ``(A) In general.--The Secretary shall monitor compliance 
     by a manufacturer with the terms of an agreement under 
     section 1193, including by establishing a mechanism through 
     which violations of such terms may be reported.
       ``(B) Notification.--If a third party with a contract under 
     subsection (c)(1) 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 section 4192 of the Internal Revenue Code 
     of 1986 or section 1198, as applicable.
       ``(b) Collection of Data.--
       ``(1) From prescription drug plans and ma-pd plans.--The 
     Secretary may collect appropriate data from prescription drug 
     plans under part D of title XVIII and MA-PD plans under part 
     C of such title in a timeframe that allows for maximum fair 
     prices to be provided under this part for selected drugs.
       ``(2) From health plans.--The Secretary may collect 
     appropriate data from group health plans or health insurance 
     issuers offering group or individual health insurance 
     coverage in a timeframe that allows for maximum fair prices 
     to be provided under this part for selected drugs.
       ``(3) Coordination of data collection.--To the extent 
     feasible, as determined by the Secretary, the Secretary shall 
     ensure that data collected pursuant to this subsection is 
     coordinated with, and not duplicative of, other Federal data 
     collection efforts.
       ``(c) Contract With Third Parties.--
       ``(1) In general.--The Secretary may enter into a contract 
     with 1 or more third parties to administer the requirements 
     established by the Secretary in order to carry out this part. 
     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 part;
       ``(C) provide adequate and timely information to 
     manufacturers, consistent with the agreement with the 
     manufacturer under this part, as necessary for the 
     manufacturer to fulfill its obligations under this part; 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.
       ``(2) Performance requirements.--The Secretary shall 
     establish performance requirements for a third party with a 
     contract under paragraph (1) and safeguards to protect the 
     independence and integrity of the activities carried out by 
     the third party under the program under this part.

     ``SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER HEALTH PLANS.

       ``(a) Agreement to Participate Under Program.--
       ``(1) In general.--Subject to paragraph (2), under the 
     program under this part the Secretary shall be treated as 
     having in effect an agreement with a group health plan or 
     health insurance issuer offering group or individual health 
     insurance coverage (as such terms are defined in section 2791 
     of the Public Health Service Act), with respect to a price 
     applicability period and a selected drug with respect to such 
     period--
       ``(A) with respect to such selected drug furnished or 
     dispensed at a pharmacy or by mail order service if coverage 
     is provided under such plan or coverage during such period 
     for such selected drug as so furnished or dispensed; and
       ``(B) with respect to such selected drug furnished or 
     administered by a hospital, physician, or other provider of 
     services or supplier if coverage is provided under such plan 
     or coverage during such period for such selected drug as so 
     furnished or administered.
       ``(2) Opting out of agreement.--The Secretary shall not be 
     treated as having in effect an agreement under the program 
     under this part with a group health plan or health insurance 
     issuer offering group or individual health insurance coverage 
     with respect to a price applicability period and a selected 
     drug with respect to such period if such a plan or issuer 
     affirmatively elects, through a process specified by the 
     Secretary, not to participate under the program with respect 
     to such period and drug.
       ``(b) Publication of Election.--With respect to each price 
     applicability period and each selected drug with respect to 
     such period, the Secretary and the Secretary of Labor and the 
     Secretary of the Treasury, as applicable, shall make public a 
     list of each group health plan and each health insurance 
     issuer offering group or individual health insurance 
     coverage, with respect to which coverage is provided under 
     such plan or coverage for such drug, that has elected under 
     subsection (a) not to participate under the program with 
     respect to such period and drug.

     ``SEC. 1198. CIVIL MONETARY PENALTY.

       ``(a) Violations Relating To Offering of Maximum Fair 
     Price.--Any manufacturer of a selected drug that has entered 
     into an agreement under section 1193, with respect to a plan 
     year during the price applicability period for such drug, 
     that does not provide access to a price that is not more than 
     the maximum fair price (or a lesser price) for such drug for 
     such year--
       ``(1) to a fair price eligible individual who with respect 
     to such drug is described in subparagraph (A) of section 
     1191(c)(1) and who is furnished or dispensed such drug during 
     such year; or

[[Page H10146]]

       ``(2) to a hospital, physician, or other provider of 
     services or supplier with respect to fair price eligible 
     individuals who with respect to such drug is described in 
     subparagraph (B) of such section and is furnished or 
     administered such drug by such hospital, physician, or 
     provider or supplier during such year;
     shall be subject to a civil monetary penalty equal to ten 
     times the amount equal to the difference between the price 
     for such drug made available for such year by such 
     manufacturer with respect to such individual or hospital, 
     physician, provider, or supplier and the maximum fair price 
     for such drug for such year.
       ``(b) Violations of Certain Terms of Agreement.--Any 
     manufacturer of a selected drug that has entered into an 
     agreement under section 1193, with respect to a plan year 
     during the price applicability period for such drug, that is 
     in violation of a requirement imposed pursuant to section 
     1193(a)(6) shall be subject to a civil monetary penalty of 
     not more than $1,000,000 for each such violation.
       ``(c) Application.--The provisions of section 1128A (other 
     than subsections (a) and (b)) shall apply to a civil monetary 
     penalty under this section in the same manner as such 
     provisions apply to a penalty or proceeding under section 
     1128A(a).

     ``SEC. 1199. MISCELLANEOUS PROVISIONS.

       ``(a) Paperwork Reduction Act.--Chapter 35 of title 44, 
     United States Code, shall not apply to data collected under 
     this part.
       ``(b) National Academy of Medicine Study.--Not later than 
     December 31, 2025, the National Academy of Medicine shall 
     conduct a study, and submit to Congress a report, on 
     recommendations for improvements to the program under this 
     part, including the determination of the limits applied under 
     section 1194(c).
       ``(c) MedPAC Study.--Not later than December 31, 2025, the 
     Medicare Payment Advisory Commission shall conduct a study, 
     and submit to Congress a report, on the program under this 
     part with respect to the Medicare program under title XVIII, 
     including with respect to the effect of the program on 
     individuals entitled to benefits or enrolled under such 
     title.
       ``(d) Limitation on Judicial Review.--The following shall 
     not be subject to judicial review:
       ``(1) The selection of drugs for publication under section 
     1192(a).
       ``(2) The determination of whether a drug is a negotiation-
     eligible drug under section 1192(d).
       ``(3) The determination of the maximum fair price of a 
     selected drug under section 1194.
       ``(4) The determination of units of a drug for purposes of 
     section 1191(c)(3).
       ``(e) Coordination.--In carrying out this part with respect 
     to group health plans or health insurance coverage offered in 
     the group market that are subject to oversight by the 
     Secretary of Labor or the Secretary of the Treasury, the 
     Secretary of Health and Human Services shall coordinate with 
     such respective Secretary.
       ``(f) Data Sharing.--The Secretary shall share with the 
     Secretary of the Treasury such information as is necessary to 
     determine the tax imposed by section 4192 of the Internal 
     Revenue Code of 1986.
       ``(g) GAO Study.--Not later than December 31, 2025, the 
     Comptroller General of the United States shall conduct a 
     study of, and submit to Congress a report on, the 
     implementation of the Fair Price Negotiation Program under 
     this part.''.
       (b) Application of Maximum Fair Prices and Conforming 
     Amendments.--
       (1) Under medicare.--
       (A) Application to payments under part b.--Section 
     1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w-
     3a(b)(1)(B)) is amended by inserting ``or in the case of such 
     a drug or biological that is a selected drug (as defined in 
     section 1192(c)), with respect to a price applicability 
     period (as defined in section 1191(b)(2)), 106 percent of the 
     maximum fair price (as defined in section 1191(c)(2) 
     applicable for such drug and a plan year during such period'' 
     after ``paragraph (4)''.
       (B) Exception to part d non-interference.--Section 1860D-
     11(i) of the Social Security Act (42 U.S.C. 1395w-111(i)) is 
     amended by inserting ``, except as provided under part E of 
     title XI'' after ``the Secretary''.
       (C) Application as negotiated price under part d.--Section 
     1860D-2(d)(1) of the Social Security Act (42 U.S.C. 1395w-
     102(d)(1)) is amended--
       (i) in subparagraph (B), by inserting ``, subject to 
     subparagraph (D),'' after ``negotiated prices''; and
       (ii) by adding at the end the following new subparagraph:
       ``(D) Application of maximum fair price for selected 
     drugs.--In applying this section, in the case of a covered 
     part D drug that is a selected drug (as defined in section 
     1192(c)), with respect to a price applicability period (as 
     defined in section 1191(b)(2)), the negotiated prices used 
     for payment (as described in this subsection) shall be the 
     maximum fair price (as defined in section 1191(c)(2)) for 
     such drug and for each plan year during such period.''.
       (D) Information from prescription drug plans and ma-pd 
     plans required.--
       (i) Prescription drug plans.--Section 1860D-12(b) of the 
     Social Security Act (42 U.S.C. 1395w-112(b)) is amended by 
     adding at the end the following new paragraph:
       ``(8) Provision of information related to maximum fair 
     prices.--Each contract entered into with a PDP sponsor under 
     this part with respect to a prescription drug plan offered by 
     such sponsor shall require the sponsor to provide information 
     to the Secretary as requested by the Secretary in accordance 
     with section 1196(b).''.
       (ii) MA-PD plans.--Section 1857(f)(3) of the Social 
     Security Act (42 U.S.C. 1395w-27(f)(3)) is amended by adding 
     at the end the following new subparagraph:
       ``(E) Provision of information related to maximum fair 
     prices.--Section 1860D-12(b)(8).''.
       (2) Under group health plans and health insurance 
     coverage.--
       (A) PHSA.--Part A of title XXVII of the Public Health 
     Service Act is amended by inserting after section 2729 the 
     following new section:

     ``SEC. 2729A. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION 
                   OF MAXIMUM FAIR PRICES.

       ``(a) In General.--In the case of a group health plan or 
     health insurance issuer offering group or individual health 
     insurance coverage that is treated under section 1197 of the 
     Social Security Act as having in effect an agreement with the 
     Secretary under the Fair Price Negotiation Program under part 
     E of title XI of such Act, with respect to a price 
     applicability period (as defined in section 1191(b) of such 
     Act) and a selected drug (as defined in section 1192(c) of 
     such Act) with respect to such period with respect to which 
     coverage is provided under such plan or coverage--
       ``(1) the provisions of such part shall apply--
       ``(A) if coverage of such selected drug is provided under 
     such plan or coverage if the drug is furnished or dispensed 
     at a pharmacy or by a mail order service, to the plans or 
     coverage offered by such plan or issuer, and to the 
     individuals enrolled under such plans or coverage, during 
     such period, with respect to such selected drug, in the same 
     manner as such provisions apply to prescription drug plans 
     and MA-PD plans, and to individuals enrolled under such 
     prescription drug plans and MA-PD plans during such period; 
     and
       ``(B) if coverage of such selected drug is provided under 
     such plan or coverage if the drug is furnished or 
     administered by a hospital, physician, or other provider of 
     services or supplier, to the plans or coverage offered by 
     such plan or issuers, to the individuals enrolled under such 
     plans or coverage, and to hospitals, physicians, and other 
     providers of services and suppliers during such period, with 
     respect to such drug in the same manner as such provisions 
     apply to the Secretary, to individuals entitled to benefits 
     under part A of title XVIII or enrolled under part B of such 
     title, and to hospitals, physicians, and other providers and 
     suppliers participating under title XVIII during such period;
       ``(2) the plan or issuer shall apply any cost-sharing 
     responsibilities under such plan or coverage, with respect to 
     such selected drug, by substituting an amount not more than 
     the maximum fair price negotiated under such part E of title 
     XI for such drug in lieu of the drug price upon which the 
     cost-sharing would have otherwise applied, and such cost-
     sharing responsibilities with respect to such selected drug 
     may not exceed such maximum fair price; and
       ``(3) the Secretary shall apply the provisions of such part 
     E to such plan, issuer, and coverage, such individuals so 
     enrolled in such plans and coverage, and such hospitals, 
     physicians, and other providers and suppliers participating 
     in such plans and coverage.
       ``(b) Notification Regarding Nonparticipation in Fair Price 
     Negotiation Program.--A group health plan or a health 
     insurance issuer offering group or individual health 
     insurance coverage shall publicly disclose in a manner and in 
     accordance with a process specified by the Secretary any 
     election made under section 1197 of the Social Security Act 
     by the plan or issuer to not participate in the Fair Price 
     Negotiation Program under part E of title XI of such Act with 
     respect to a selected drug (as defined in section 1192(c) of 
     such Act) for which coverage is provided under such plan or 
     coverage before the beginning of the plan year for which such 
     election was made.''.
       (B) ERISA.--
       (i) In general.--Subpart B of part 7 of subtitle B of title 
     I of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1181 et. seq.) is amended by adding at the end the 
     following new section:

     ``SEC. 716. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION OF 
                   MAXIMUM FAIR PRICES.

       ``(a) In General.--In the case of a group health plan or 
     health insurance issuer offering group health insurance 
     coverage that is treated under section 1197 of the Social 
     Security Act as having in effect an agreement with the 
     Secretary under the Fair Price Negotiation Program under part 
     E of title XI of such Act, with respect to a price 
     applicability period (as defined in section 1191(b) of such 
     Act) and a selected drug (as defined in section 1192(c) of 
     such Act) with respect to such period with respect to which 
     coverage is provided under such plan or coverage--
       ``(1) the provisions of such part shall apply, as 
     applicable--
       ``(A) if coverage of such selected drug is provided under 
     such plan or coverage if the drug is furnished or dispensed 
     at a pharmacy or by a mail order service, to the plans or 
     coverage offered by such plan or issuer, and to the 
     individuals enrolled under such plans or coverage, during 
     such period, with respect to such selected drug, in the same 
     manner as such provisions apply to prescription drug plans 
     and MA-PD plans, and to individuals enrolled under such 
     prescription drug plans and MA-PD plans during such period; 
     and
       ``(B) if coverage of such selected drug is provided under 
     such plan or coverage if the drug is furnished or 
     administered by a hospital, physician, or other provider of 
     services or supplier, to the plans or coverage offered by 
     such plan or issuers, to the individuals enrolled under such 
     plans or coverage, and to hospitals, physicians, and other 
     providers of services and suppliers during such period, with 
     respect to such drug in the same manner as such provisions 
     apply to the Secretary, to individuals entitled to benefits 
     under part A of title XVIII or enrolled under

[[Page H10147]]

     part B of such title, and to hospitals, physicians, and other 
     providers and suppliers participating under title XVIII 
     during such period;
       ``(2) the plan or issuer shall apply any cost-sharing 
     responsibilities under such plan or coverage, with respect to 
     such selected drug, by substituting an amount not more than 
     the maximum fair price negotiated under such part E of title 
     XI for such drug in lieu of the drug price upon which the 
     cost-sharing would have otherwise applied, and such cost-
     sharing responsibilities with respect to such selected drug 
     may not exceed such maximum fair price; and
       ``(3) the Secretary shall apply the provisions of such part 
     E to such plan, issuer, and coverage, and such individuals so 
     enrolled in such plans.
       ``(b) Notification Regarding Nonparticipation in Fair Price 
     Negotiation Program.--A group health plan or a health 
     insurance issuer offering group health insurance coverage 
     shall publicly disclose in a manner and in accordance with a 
     process specified by the Secretary any election made under 
     section 1197 of the Social Security Act by the plan or issuer 
     to not participate in the Fair Price Negotiation Program 
     under part E of title XI of such Act with respect to a 
     selected drug (as defined in section 1192(c) of such Act) for 
     which coverage is provided under such plan or coverage before 
     the beginning of the plan year for which such election was 
     made.''.
       (ii) Application to retiree and certain small group health 
     plans.--Section 732(a) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by 
     striking ``section 711'' and inserting ``sections 711 and 
     716''.
       (iii) Clerical amendment.--The table of sections for 
     subpart B of part 7 of subtitle B of title I of the Employee 
     Retirement Income Security Act of 1974 is amended by adding 
     at the end the following:

       ``Sec. 716. Fair Price Negotiation Program and application 
           of maximum fair prices.''.
       (C) IRC.--
       (i) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986 is amended by adding at the end 
     the following new section:

     ``SEC. 9816. FAIR PRICE NEGOTIATION PROGRAM AND APPLICATION 
                   OF MAXIMUM FAIR PRICES.

       ``(a) In General.--In the case of a group health plan that 
     is treated under section 1197 of the Social Security Act as 
     having in effect an agreement with the Secretary under the 
     Fair Price Negotiation Program under part E of title XI of 
     such Act, with respect to a price applicability period (as 
     defined in section 1191(b) of such Act) and a selected drug 
     (as defined in section 1192(c) of such Act) with respect to 
     such period with respect to which coverage is provided under 
     such plan--
       ``(1) the provisions of such part shall apply, as 
     applicable--
       ``(A) if coverage of such selected drug is provided under 
     such plan if the drug is furnished or dispensed at a pharmacy 
     or by a mail order service, to the plan, and to the 
     individuals enrolled under such plan during such period, with 
     respect to such selected drug, in the same manner as such 
     provisions apply to prescription drug plans and MA-PD plans, 
     and to individuals enrolled under such prescription drug 
     plans and MA-PD plans during such period; and
       ``(B) if coverage of such selected drug is provided under 
     such plan if the drug is furnished or administered by a 
     hospital, physician, or other provider of services or 
     supplier, to the plan, to the individuals enrolled under such 
     plan, and to hospitals, physicians, and other providers of 
     services and suppliers during such period, with respect to 
     such drug in the same manner as such provisions apply to the 
     Secretary, to individuals entitled to benefits under part A 
     of title XVIII or enrolled under part B of such title, and to 
     hospitals, physicians, and other providers and suppliers 
     participating under title XVIII during such period;
       ``(2) the plan shall apply any cost-sharing 
     responsibilities under such plan, with respect to such 
     selected drug, by substituting an amount not more than the 
     maximum fair price negotiated under such part E of title XI 
     for such drug in lieu of the drug price upon which the cost-
     sharing would have otherwise applied, and such cost-sharing 
     responsibilities with respect to such selected drug may not 
     exceed such maximum fair price; and
       ``(3) the Secretary shall apply the provisions of such part 
     E to such plan and such individuals so enrolled in such plan.
       ``(b) Notification Regarding Nonparticipation in Fair Price 
     Negotiation Program.--A group health plan shall publicly 
     disclose in a manner and in accordance with a process 
     specified by the Secretary any election made under section 
     1197 of the Social Security Act by the plan to not 
     participate in the Fair Price Negotiation Program under part 
     E of title XI of such Act with respect to a selected drug (as 
     defined in section 1192(c) of such Act) for which coverage is 
     provided under such plan before the beginning of the plan 
     year for which such election was made.''.
       (ii) Application to retiree and certain small group health 
     plans.--Section 9831(a)(2) of the Internal Revenue Code of 
     1986 is amended by inserting ``other than with respect to 
     section 9816,'' before ``any group health plan''.
       (iii) Clerical amendment.--The table of sections for 
     subchapter B of chapter 100 of such Code is amended by adding 
     at the end the following new item:

       ``Sec. 9816. Fair Price Negotiation Program and application 
           of maximum fair prices.''.
       (3) Fair price negotiation program prices included in best 
     price and amp.--Section 1927 of the Social Security Act (42 
     U.S.C. 1396r-8) is amended--
       (A) in subsection (c)(1)(C)(ii)--
       (i) in subclause (III), by striking at the end ``; and'';
       (ii) in subclause (IV), by striking at the end the period 
     and inserting ``; and''; and
       (iii) by adding at the end the following new subclause:

       ``(V) in the case of a rebate period and a covered 
     outpatient drug that is a selected drug (as defined in 
     section 1192(c)) during such rebate period, shall be 
     inclusive of the price for such drug made available from the 
     manufacturer during the rebate period by reason of 
     application of part E of title XI to any wholesaler, 
     retailer, provider, health maintenance organization, 
     nonprofit entity, or governmental entity within the United 
     States.''; and

       (B) in subsection (k)(1)(B), by adding at the end the 
     following new clause:
       ``(iii) Clarification.--Notwithstanding clause (i), in the 
     case of a rebate period and a covered outpatient drug that is 
     a selected drug (as defined in section 1192(c)) during such 
     rebate period, any reduction in price paid during the rebate 
     period to the manufacturer for the drug by a wholesaler or 
     retail community pharmacy described in subparagraph (A) by 
     reason of application of part E of title XI shall be included 
     in the average manufacturer price for the covered outpatient 
     drug.''.

     SEC. 102. SELECTED DRUG MANUFACTURER EXCISE TAX IMPOSED 
                   DURING NONCOMPLIANCE PERIODS.

       (a) In General.--Subchapter E of chapter 32 of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following new section:

     ``SEC. 4192. SELECTED DRUGS DURING NONCOMPLIANCE PERIODS.

       ``(a) In General.--There is hereby imposed on the sale by 
     the manufacturer, producer, or importer of any selected drug 
     during a day described in subsection (b) a tax in an amount 
     such that the applicable percentage is equal to the ratio 
     of--
       ``(1) such tax, divided by
       ``(2) the sum of such tax and the price for which so sold.
       ``(b) Noncompliance Periods.--A day is described in this 
     subsection with respect to a selected drug if it is a day 
     during one of the following periods:
       ``(1) The period beginning on the June 16th immediately 
     following the selected drug publication date and ending on 
     the first date during which the manufacturer of the drug has 
     in place an agreement described in subsection (a) of section 
     1193 of the Social Security Act with respect to such drug.
       ``(2) The period beginning on the April 1st immediately 
     following the June 16th described in paragraph (1) and ending 
     on the first date during which the manufacturer of the drug 
     has agreed to a maximum fair price under such agreement.
       ``(3) In the case of a selected drug with respect to which 
     the Secretary of Health and Human Services has specified a 
     renegotiation period under such agreement, the period 
     beginning on the first date after the last date of such 
     renegotiation period and ending on the first date during 
     which the manufacturer of the drug has agreed to a 
     renegotiated maximum fair price under such agreement.
       ``(4) With respect to information that is required to be 
     submitted to the Secretary of Health and Human Services under 
     such agreement, the period beginning on the date on which 
     such Secretary certifies that such information is overdue and 
     ending on the date that such information is so submitted.
       ``(5) In the case of a selected drug with respect to which 
     a payment is due under subsection (c) of such section 1193, 
     the period beginning on the date on which the Secretary of 
     Health and Human Services certifies that such payment is 
     overdue and ending on the date that such payment is made in 
     full.
       ``(c) Applicable Percentage.--For purposes of this section, 
     the term `applicable percentage' means--
       ``(1) in the case of sales of a selected drug during the 
     first 90 days described in subsection (b) with respect to 
     such drug, 65 percent,
       ``(2) in the case of sales of such drug during the 91st day 
     through the 180th day described in subsection (b) with 
     respect to such drug, 75 percent,
       ``(3) in the case of sales of such drug during the 181st 
     day through the 270th day described in subsection (b) with 
     respect to such drug, 85 percent, and
       ``(4) in the case of sales of such drug during any 
     subsequent day, 95 percent.
       ``(d) Selected Drug.--For purposes of this section--
       ``(1) In general.--The term `selected drug' means any 
     selected drug (within the meaning of section 1192 of the 
     Social Security Act) which is manufactured or produced in the 
     United States or entered into the United States for 
     consumption, use, or warehousing.
       ``(2) United states.--The term `United States' has the 
     meaning given such term by section 4612(a)(4).
       ``(3) Coordination with rules for possessions of the united 
     states.--Rules similar to the rules of paragraphs (2) and (4) 
     of section 4132(c) shall apply for purposes of this section.
       ``(e) Other Definitions.--For purposes of this section, the 
     terms `selected drug publication date' and `maximum fair 
     price' have the meaning given such terms in section 1191 of 
     the Social Security Act.
       ``(f) Anti-Abuse Rule.--In the case of a sale which was 
     timed for the purpose of avoiding the tax imposed by this 
     section, the Secretary may treat such sale as occurring 
     during a day described in subsection (b).''.
       (b) No Deduction for Excise Tax Payments.--Section 275 of 
     the Internal Revenue Code of 1986 is amended by adding ``or 
     by section 4192'' before the period at the end of subsection 
     (a)(6).

[[Page H10148]]

       (c) Conforming Amendments.--
       (1) Section 4221(a) of the Internal Revenue Code of 1986 is 
     amended by inserting ``or 4192'' after ``section 4191''.
       (2) Section 6416(b)(2) of such Code is amended by inserting 
     ``or 4192'' after ``section 4191''.
       (d) Clerical Amendments.--
       (1) The heading of subchapter E of chapter 32 of the 
     Internal Revenue Code of 1986 is amended by striking 
     ``Medical Devices'' and inserting ``Other Medical Products''.
       (2) The table of subchapters for chapter 32 of such Code is 
     amended by striking the item relating to subchapter E and 
     inserting the following new item:

               ``subchapter e. other medical products''.

       (3) The table of sections for subchapter E of chapter 32 of 
     such Code is amended by adding at the end the following new 
     item:

       ``Sec. 4192. Selected drugs during noncompliance 
           periods.''.
       (e) Effective Date.--The amendments made by this section 
     shall apply to sales after the date of the enactment of this 
     Act.

     SEC. 103. FAIR PRICE NEGOTIATION IMPLEMENTATION FUND.

       (a) In General.--There is hereby established a Fair Price 
     Negotiation Implementation Fund (referred to in this section 
     as the ``Fund''). The Secretary of Health and Human Services 
     may obligate and expend amounts in the Fund to carry out this 
     title and titles II and III (and the amendments made by such 
     titles).
       (b) Funding.--There is authorized to be appropriated, and 
     there is hereby appropriated, out of any monies in the 
     Treasury not otherwise appropriated, to the Fund 
     $3,000,000,000, to remain available until expended, of 
     which--
       (1) $600,000,000 shall become available on the date of the 
     enactment of this Act;
       (2) $600,000,000 shall become available on October 1, 2020;
       (3) $600,000,000 shall become available on October 1, 2021;
       (4) $600,000,000 shall become available on October 1, 2022; 
     and
       (5) $600,000,000 shall become available on October 1, 2023.
       (c) Supplement Not Supplant.--Any amounts appropriated 
     pursuant to this section shall be in addition to any other 
     amounts otherwise appropriated pursuant to any other 
     provision of law.

  TITLE II--MEDICARE PARTS B AND D PRESCRIPTION DRUG INFLATION REBATES

     SEC. 201. MEDICARE PART B REBATE BY MANUFACTURERS.

       (a) In General.--Section 1834 of the Social Security Act 
     (42 U.S.C. 1395m) is amended by adding at the end the 
     following new subsection:
       ``(x) Rebate by Manufacturers for Single Source Drugs With 
     Prices Increasing Faster Than Inflation.--
       ``(1) Requirements.--
       ``(A) Secretarial provision of information.--Not later than 
     6 months after the end of each calendar quarter beginning on 
     or after July 1, 2021, the Secretary shall, for each part B 
     rebatable drug, report to each manufacturer of such part B 
     rebatable drug the following for such calendar quarter:
       ``(i) Information on the total number of units of the 
     billing and payment code described in subparagraph (A)(i) of 
     paragraph (3) with respect to such drug and calendar quarter.
       ``(ii) Information on the amount (if any) of the excess 
     average sales price increase described in subparagraph 
     (A)(ii) of such paragraph for such drug and calendar quarter.
       ``(iii) The rebate amount specified under such paragraph 
     for such part B rebatable drug and calendar quarter.
       ``(B) Manufacturer requirement.--For each calendar quarter 
     beginning on or after July 1, 2021, the manufacturer of a 
     part B rebatable drug shall, for such drug, not later than 30 
     days after the date of receipt from the Secretary of the 
     information described in subparagraph (A) for such calendar 
     quarter, provide to the Secretary a rebate that is equal to 
     the amount specified in paragraph (3) for such drug for such 
     calendar quarter.
       ``(2) Part b rebatable drug defined.--
       ``(A) In general.--In this subsection, the term `part B 
     rebatable drug' means a single source drug or biological (as 
     defined in subparagraph (D) of section 1847A(c)(6)), 
     including a biosimilar biological product (as defined in 
     subparagraph (H) of such section), paid for under this part, 
     except such term shall not include such a drug or 
     biological--
       ``(i) if the average total allowed charges for a year per 
     individual that uses such a drug or biological, as determined 
     by the Secretary, are less than, subject to subparagraph (B), 
     $100; or
       ``(ii) that is a vaccine described in subparagraph (A) or 
     (B) of section 1861(s)(10).
       ``(B) Increase.--The dollar amount applied under 
     subparagraph (A)(i)--
       ``(i) for 2022, shall be the dollar amount specified under 
     such subparagraph for 2021, increased by the percentage 
     increase in the consumer price index for all urban consumers 
     (United States city average) for the 12 month period ending 
     with June of the previous year; and
       ``(ii) for a subsequent year, shall be the dollar amount 
     specified in this clause (or clause (i)) for the previous 
     year, increased by the percentage increase in the consumer 
     price index for all urban consumers (United States city 
     average) for the 12 month period ending with June of the 
     previous year.
     Any dollar amount specified under this subparagraph that is 
     not a multiple of $10 shall be rounded to the nearest 
     multiple of $10.
       ``(3) Rebate amount.--
       ``(A) In general.--For purposes of paragraph (1), the 
     amount specified in this paragraph for a part B rebatable 
     drug assigned to a billing and payment code for a calendar 
     quarter is, subject to paragraph (4), the amount equal to the 
     product of--
       ``(i) subject to subparagraphs (B) and (G), the total 
     number of units of the billing and payment code for such part 
     B rebatable drug furnished under this part during the 
     calendar quarter; and
       ``(ii) the amount (if any) by which--

       ``(I) the payment amount under subparagraph (B) or (C) of 
     section 1847A(b)(1), as applicable, for such part B rebatable 
     drug during the calendar quarter; exceeds
       ``(II) the inflation-adjusted payment amount determined 
     under subparagraph (C) for such part B rebatable drug during 
     the calendar quarter.

       ``(B) Excluded units.--For purposes of subparagraph (A)(i), 
     the total number of units of the billing and payment code for 
     each part B rebatable drug furnished during a calendar 
     quarter shall not include--
       ``(i) units packaged into the payment for a procedure or 
     service under section 1833(t) or under section 1833(i) 
     (instead of separately payable under such respective 
     section);
       ``(ii) units included under the single payment system for 
     renal dialysis services under section 1881(b)(14); or
       ``(iii) units of a part B rebatable drug of a manufacturer 
     furnished to an individual, if such manufacturer, with 
     respect to the furnishing of such units of such drug, 
     provides for discounts under section 340B of the Public 
     Health Service Act or for rebates under section 1927.
       ``(C) Determination of inflation-adjusted payment amount.--
     The inflation-adjusted payment amount determined under this 
     subparagraph for a part B rebatable drug for a calendar 
     quarter is--
       ``(i) the payment amount for the billing and payment code 
     for such drug in the payment amount benchmark quarter (as 
     defined in subparagraph (D)); increased by
       ``(ii) the percentage by which the rebate period CPI-U (as 
     defined in subparagraph (F)) for the calendar quarter exceeds 
     the benchmark period CPI-U (as defined in subparagraph (E)).
       ``(D) Payment amount benchmark quarter.--The term `payment 
     amount benchmark quarter' means the calendar quarter 
     beginning January 1, 2016.
       ``(E) Benchmark period cpi-u.--The term `benchmark period 
     CPI-U' means the consumer price index for all urban consumers 
     (United States city average) for July 2015.
       ``(F) Rebate period cpi-u.--The term `rebate period CPI-U' 
     means, with respect to a calendar quarter described in 
     subparagraph (C), the greater of the benchmark period CPI-U 
     and the consumer price index for all urban consumers (United 
     States city average) for the first month of the calendar 
     quarter that is two calendar quarters prior to such described 
     calendar quarter.
       ``(G) Counting units.--
       ``(i) Cut-off period to count units.--For purposes of 
     subparagraph (A)(i), subject to clause (ii), to count the 
     total number of billing units for a part B rebatable drug for 
     a quarter, the Secretary may use a cut-off period in order to 
     exclude from such total number of billing units for such 
     quarter claims for services furnished during such quarter 
     that were not processed at an appropriate time prior to the 
     end of the cut-off period.
       ``(ii) Counting units for claims processed after cut-off 
     period.--If the Secretary uses a cut-off period pursuant to 
     clause (i), in the case of units of a part B rebatable drug 
     furnished during a quarter but pursuant to application of 
     such cut-off period excluded for purposes of subparagraph 
     (A)(i) from the total number of billing units for the drug 
     for such quarter, the Secretary shall count such units of 
     such drug so furnished in the total number of billing units 
     for such drug for a subsequent quarter, as the Secretary 
     determines appropriate.
       ``(4) Special treatment of certain drugs and exemption.--
       ``(A) Subsequently approved drugs.--Subject to subparagraph 
     (B), in the case of a part B rebatable drug first approved or 
     licensed by the Food and Drug Administration after July 1, 
     2015, clause (i) of paragraph (3)(C) shall be applied as if 
     the term `payment amount benchmark quarter' were defined 
     under paragraph (3)(D) as the third full calendar quarter 
     after the day on which the drug was first marketed and clause 
     (ii) of paragraph (3)(C) shall be applied as if the term 
     `benchmark period CPI-U' were defined under paragraph (3)(E) 
     as if the reference to `July 2015' under such paragraph were 
     a reference to `the first month of the first full calendar 
     quarter after the day on which the drug was first marketed'.
       ``(B) Timeline for provision of rebates for subsequently 
     approved drugs.--In the case of a part B rebatable drug first 
     approved or licensed by the Food and Drug Administration 
     after July 1, 2015, paragraph (1)(B) shall be applied as if 
     the reference to `July 1, 2021' under such paragraph were a 
     reference to the later of the 6th full calendar quarter after 
     the day on which the drug was first marketed or July 1, 2021.
       ``(C) Exemption for shortages.--The Secretary may reduce or 
     waive the rebate amount under paragraph (1)(B) with respect 
     to a part B rebatable drug that is described as currently in 
     shortage on the shortage list in effect under section 506E of 
     the Federal Food, Drug, and Cosmetic Act or in the case of 
     other exigent circumstances, as determined by the Secretary.
       ``(D) Selected drugs.--In the case of a part B rebatable 
     drug that is a selected drug (as defined in section 1192(c)) 
     for a price applicability period (as defined in section 
     1191(b)(2))--
       ``(i) for calendar quarters during such period for which a 
     maximum fair price (as defined in section 1191(c)(2)) for 
     such drug has been determined and is applied under part E of 
     title XI,

[[Page H10149]]

     the rebate amount under paragraph (1)(B) shall be waived; and
       ``(ii) in the case such drug is determined (pursuant to 
     such section 1192(c)) to no longer be a selected drug, for 
     each applicable year beginning after the price applicability 
     period with respect to such drug, clause (i) of paragraph 
     (3)(C) shall be applied as if the term `payment amount 
     benchmark quarter' were defined under paragraph (3)(D) as the 
     calendar quarter beginning January 1 of the last year 
     beginning during such price applicability period with respect 
     to such selected drug and clause (ii) of paragraph (3)(C) 
     shall be applied as if the term `benchmark period CPI-U' were 
     defined under paragraph (3)(E) as if the reference to `July 
     2015' under such paragraph were a reference to the July of 
     the year preceding such last year.
       ``(5) Application to beneficiary coinsurance.--In the case 
     of a part B rebatable drug, if the payment amount for a 
     quarter exceeds the inflation adjusted payment for such 
     quarter--
       ``(A) in computing the amount of any coinsurance applicable 
     under this title to an individual with respect to such drug, 
     the computation of such coinsurance shall be based on the 
     inflation-adjusted payment amount determined under paragraph 
     (3)(C) for such part B rebatable drug; and
       ``(B) the amount of such coinsurance is equal to 20 percent 
     of such inflation-adjusted payment amount so determined.
       ``(6) Rebate deposits.--Amounts paid as rebates under 
     paragraph (1)(B) shall be deposited into the Federal 
     Supplementary Medical Insurance Trust Fund established under 
     section 1841.
       ``(7) Civil money penalty.--If a manufacturer of a part B 
     rebatable drug has failed to comply with the requirements 
     under paragraph (1)(B) for such drug for a calendar quarter, 
     the manufacturer shall be subject to, in accordance with a 
     process established by the Secretary pursuant to regulations, 
     a civil money penalty in an amount equal to at least 125 
     percent of the amount specified in paragraph (3) for such 
     drug for such calendar quarter. 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 paragraph in the same manner 
     as such provisions apply to a penalty or proceeding under 
     section 1128A(a).
       ``(8) Study and report.--
       ``(A) Study.--The Secretary shall conduct a study of the 
     feasibility of and operational issues involved with the 
     following:
       ``(i) Including multiple source drugs (as defined in 
     section 1847A(c)(6)(C)) in the rebate system under this 
     subsection.
       ``(ii) Including drugs and biologicals paid for under MA 
     plans under part C in the rebate system under this 
     subsection.
       ``(iii) Including drugs excluded under paragraph (2)(A) and 
     units of the billing and payment code of the drugs excluded 
     under paragraph (3)(B) in the rebate system under this 
     subsection.
       ``(B) Report.--Not later than 3 years after the date of the 
     enactment of this subsection, the Secretary shall submit to 
     Congress a report on the study conducted under subparagraph 
     (A).
       ``(9) Application to multiple source drugs.--The Secretary 
     may, based on the report submitted under paragraph (8) and 
     pursuant to rulemaking, apply the provisions of this 
     subsection to multiple source drugs (as defined in section 
     1847A(c)(6)(C)), including, for purposes of determining the 
     rebate amount under paragraph (3), by calculating 
     manufacturer-specific average sales prices for the benchmark 
     period and the rebate period.''.
       (b) Amounts Payable; Cost-Sharing.--Section 1833 of the 
     Social Security Act (42 U.S.C. 1395l) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) in subparagraph (S), by striking ``with respect to'' 
     and inserting ``subject to subparagraph (DD), with respect 
     to'';
       (ii) by striking ``and (CC)'' and inserting ``(CC)''; and
       (iii) by inserting before the semicolon at the end the 
     following: ``, and (DD) with respect to a part B rebatable 
     drug (as defined in paragraph (2) of section 1834(x)) for 
     which the payment amount for a calendar quarter under 
     paragraph (3)(A)(ii)(I) of such section for such quarter 
     exceeds the inflation-adjusted payment under paragraph 
     (3)(A)(ii)(II) of such section for such quarter, the amounts 
     paid shall be the difference between (i) the payment amount 
     under paragraph (3)(A)(ii)(I) of such section for such drug, 
     and (ii) 20 percent of the inflation-adjusted payment amount 
     under paragraph (3)(A)(ii)(II) of such section for such 
     drug'';
       (B) by adding at the end of the flush left matter following 
     paragraph (9), the following:
     ``For purposes of applying paragraph (1)(DD), subsections 
     (i)(9) and (t)(8)(F), and section 1834(x)(5), the Secretary 
     shall make such estimates and use such data as the Secretary 
     determines appropriate, and notwithstanding any other 
     provision of law, may do so by program instruction or 
     otherwise.'';
       (2) in subsection (i), by adding at the end the following 
     new paragraph:
       ``(9) In the case of a part B rebatable drug (as defined in 
     paragraph (2) of section 1834(x)) for which payment under 
     this subsection is not packaged into a payment for a covered 
     OPD service (as defined in subsection (t)(1)(B)) (or group of 
     services) furnished on or after July 1, 2021, under the 
     system under this subsection, in lieu of calculation of 
     coinsurance and the amount of payment otherwise applicable 
     under this subsection, the provisions of section 1834(x)(5), 
     paragraph (1)(DD) of subsection (a), and the flush left 
     matter following paragraph (9) of subsection (a), shall, as 
     determined appropriate by the Secretary, apply under this 
     subsection in the same manner as such provisions of section 
     1834(x)(5) and subsection (a) apply under such section and 
     subsection.''; and
       (3) in subsection (t)(8), by adding at the end the 
     following new subparagraph:
       ``(F) Part b rebatable drugs.--In the case of a part B 
     rebatable drug (as defined in paragraph (2) of section 
     1834(x)) for which payment under this part is not packaged 
     into a payment for a service furnished on or after July 1, 
     2021, under the system under this subsection, in lieu of 
     calculation of coinsurance and the amount of payment 
     otherwise applicable under this subsection, the provisions of 
     section 1834(x)(5), paragraph (1)(DD) of subsection (a), and 
     the flush left matter following paragraph (9) of subsection 
     (a), shall, as determined appropriate by the Secretary, apply 
     under this subsection in the same manner as such provisions 
     of section 1834(x)(5) and subsection (a) apply under such 
     section and subsection.''.
       (c) Conforming Amendments.--
       (1) To part b asp calculation.--Section 1847A(c)(3) of the 
     Social Security Act (42 U.S.C. 1395w-3a(c)(3)) is amended by 
     inserting ``or section 1834(x)'' after ``section 1927''.
       (2) Excluding parts b drug inflation rebate from best 
     price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security 
     Act (42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)) is amended by 
     inserting ``or section 1834(x)'' after ``this section''.
       (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)''.

     SEC. 202. MEDICARE PART D REBATE BY MANUFACTURERS.

       (a) In General.--Part D of title XVIII of the Social 
     Security Act is amended by inserting after section 1860D-14A 
     (42 U.S.C. 1395w-114a) the following new section:

     ``SEC. 1860D-14B. MANUFACTURER REBATE FOR CERTAIN DRUGS WITH 
                   PRICES INCREASING FASTER THAN INFLATION.

       ``(a) In General.--
       ``(1) In general.--Subject to the provisions of this 
     section, in order for coverage to be available under this 
     part for a part D rebatable drug (as defined in subsection 
     (h)(1)) of a manufacturer (as defined in section 1927(k)(5)) 
     dispensed during an applicable year, the manufacturer must 
     have entered into and have in effect an agreement described 
     in subsection (b).
       ``(2)  Authorizing coverage for drugs not covered under 
     agreements.--Paragraph (1) shall not apply to the dispensing 
     of a covered part D drug if--
       ``(A) the Secretary has made a determination that the 
     availability of the drug is essential to the health of 
     beneficiaries under this part; or
       ``(B) the Secretary determines that in the period beginning 
     on January 1, 2022, and ending on December 31, 2022, there 
     were extenuating circumstances.
       ``(3) Applicable year.--For purposes of this section the 
     term `applicable year' means a year beginning with 2022.
       ``(b) Agreements.--
       ``(1) Terms of agreement.--An agreement described in this 
     subsection, with respect to a manufacturer of a part D 
     rebatable drug, is an agreement under which the following 
     shall apply:
       ``(A) Secretarial provision of information.--Not later than 
     9 months after the end of each applicable year with respect 
     to which the agreement is in effect, the Secretary, for each 
     part D rebatable drug of the manufacturer, shall report to 
     the manufacturer the following for such year:
       ``(i) Information on the total number of units (as defined 
     in subsection (h)(2)) for each dosage form and strength with 
     respect to such part D rebatable drug and year.
       ``(ii) Information on the amount (if any) of the excess 
     average manufacturer price increase described in subsection 
     (c)(1)(B) for each dosage form and strength with respect to 
     such drug and year.
       ``(iii) The rebate amount specified under subsection (c) 
     for each dosage form and strength with respect to such drug 
     and year.
       ``(B) Manufacturer requirements.--For each applicable year 
     with respect to which the agreement is in effect, the 
     manufacturer of the part D rebatable drug, for each dosage 
     form and strength with respect to such drug, not later than 
     30 days after the date of receipt from the Secretary of the 
     information described in subparagraph (A) for such year, 
     shall provide to the Secretary a rebate that is equal to the 
     amount specified in subsection (c) for such dosage form and 
     strength with respect to such drug for such year.
       ``(2) Length of agreement.--
       ``(A) In general.--An agreement under this section, with 
     respect to a part D rebatable drug, shall be effective for an 
     initial period of not less than one year and shall be 
     automatically renewed for a period of not less than one year 
     unless terminated under subparagraph (B).
       ``(B) Termination.--
       ``(i) By secretary.--The Secretary may provide for 
     termination of an agreement under this section for 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 of such termination. The 
     Secretary shall provide, upon request, a manufacturer with a 
     hearing concerning such a termination, but such hearing shall 
     not delay the effective date of the termination.
       ``(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 the 
     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 
     the plan year, as of the day after the end of the succeeding 
     plan year.

[[Page H10150]]

       ``(C) Effectiveness of termination.--Any termination under 
     this paragraph shall not affect rebates due under the 
     agreement under this section before the effective date of its 
     termination.
       ``(D) Delay before reentry.--In the case of any agreement 
     under this section with a manufacturer that is terminated in 
     a plan year, the Secretary may not enter into another such 
     agreement with the manufacturer (or a successor manufacturer) 
     before the subsequent plan year, unless the Secretary finds 
     good cause for an earlier reinstatement of such an agreement.
       ``(c) Rebate Amount.--
       ``(1) In general.--For purposes of this section, the amount 
     specified in this subsection for a dosage form and strength 
     with respect to a part D rebatable drug and applicable year 
     is, subject to subparagraphs (B) and (C) of paragraph (5), 
     the amount equal to the product of--
       ``(A) the total number of units of such dosage form and 
     strength with respect to such part D rebatable drug and year; 
     and
       ``(B) the amount (if any) by which--
       ``(i) the annual manufacturer price (as determined in 
     paragraph (2)) paid for such dosage form and strength with 
     respect to such part D rebatable drug for the year; exceeds
       ``(ii) the inflation-adjusted payment amount determined 
     under paragraph (3) for such dosage form and strength with 
     respect to such part D rebatable drug for the year.
       ``(2) Determination of annual manufacturer price.--The 
     annual manufacturer price determined under this paragraph for 
     a dosage form and strength, with respect to a part D 
     rebatable drug and an applicable year, is the sum of the 
     products of--
       ``(A) the average manufacturer price (as defined in 
     subsection (h)(6)) of such dosage form and strength, as 
     calculated for a unit of such drug, with respect to each of 
     the calendar quarters of such year; and
       ``(B) the ratio of--
       ``(i) the total number of units of such dosage form and 
     strength dispensed during each such calendar quarter of such 
     year; to
       ``(ii) the total number of units of such dosage form and 
     strength dispensed during such year.
       ``(3) Determination of inflation-adjusted payment amount.--
     The inflation-adjusted payment amount determined under this 
     paragraph for a dosage form and strength with respect to a 
     part D rebatable drug for an applicable year, subject to 
     subparagraphs (A) and (D) of paragraph (5), is--
       ``(A) the benchmark year manufacturer price determined 
     under paragraph (4) for such dosage form and strength with 
     respect to such drug and an applicable year; increased by
       ``(B) the percentage by which the applicable year CPI-U (as 
     defined in subsection (h)(5)) for the applicable year exceeds 
     the benchmark period CPI-U (as defined in subsection (h)(4)).
       ``(4) Determination of benchmark year manufacturer price.--
     The benchmark year manufacturer price determined under this 
     paragraph for a dosage form and strength, with respect to a 
     part D rebatable drug and an applicable year, is the sum of 
     the products of--
       ``(A) the average manufacturer price (as defined in 
     subsection (h)(6)) of such dosage form and strength, as 
     calculated for a unit of such drug, with respect to each of 
     the calendar quarters of the payment amount benchmark year 
     (as defined in subsection (h)(3)); and
       ``(B) the ratio of--
       ``(i) the total number of units of such dosage form and 
     strength dispensed during each such calendar quarter of such 
     payment amount benchmark year; to
       ``(ii) the total number of units of such dosage form and 
     strength dispensed during such payment amount benchmark year.
       ``(5) Special treatment of certain drugs and exemption.--
       ``(A) Subsequently approved drugs.--In the case of a part D 
     rebatable drug first approved or licensed by the Food and 
     Drug Administration after January 1, 2016, subparagraphs (A) 
     and (B) of paragraph (4) shall be applied as if the term 
     `payment amount benchmark year' were defined under subsection 
     (h)(3) as the first calendar year beginning after the day on 
     which the drug was first marketed by any manufacturer and 
     subparagraph (B) of paragraph (3) shall be applied as if the 
     term `benchmark period CPI-U' were defined under subsection 
     (h)(4) as if the reference to `January 2016' under such 
     subsection were a reference to `January of the first year 
     beginning after the date on which the drug was first marketed 
     by any manufacturer'.
       ``(B) Exemption for shortages.--The Secretary may reduce or 
     waive the rebate under paragraph (1) with respect to a part D 
     rebatable drug that is described as currently in shortage on 
     the shortage list in effect under section 506E of the Federal 
     Food, Drug, and Cosmetic Act or in the case of other exigent 
     circumstances, as determined by the Secretary.
       ``(C) Treatment of new formulations.--
       ``(i) In general.--In the case of a part D rebatable drug 
     that is a line extension of a part D rebatable drug that is 
     an oral solid dosage form, the Secretary shall establish a 
     formula for determining the amount specified in this 
     subsection with respect to such part D rebatable drug and an 
     applicable year with consideration of the original part D 
     rebatable drug.
       ``(ii) Line extension defined.--In this subparagraph, the 
     term `line extension' means, with respect to a part D 
     rebatable drug, a new formulation of the drug (as determined 
     by the Secretary), such as an extended release formulation, 
     but does not include an abuse-deterrent formulation of the 
     drug (as determined by the Secretary), regardless of whether 
     such abuse-deterrent formulation is an extended release 
     formulation.
       ``(D) Selected drugs.--In the case of a part D rebatable 
     drug that is a selected drug (as defined in section 1192(c)) 
     for a price applicability period (as defined in section 
     1191(b)(2))--
       ``(i) for plan years during such period for which a maximum 
     fair price (as defined in section 1191(c)(2)) for such drug 
     has been determined and is applied under part E of title XI, 
     the rebate under subsection (b)(1)(B) shall be waived; and
       ``(ii) in the case such drug is determined (pursuant to 
     such section 1192(c)) to no longer be a selected drug, for 
     each applicable year beginning after the price applicability 
     period with respect to such drug, subparagraphs (A) and (B) 
     of paragraph (4) shall be applied as if the term `payment 
     amount benchmark year' were defined under subsection (h)(3) 
     as the last year beginning during such price applicability 
     period with respect to such selected drug and subparagraph 
     (B) of paragraph (3) shall be applied as if the term 
     `benchmark period CPI-U' were defined under subsection (h)(4) 
     as if the reference to `January 2016' under such subsection 
     were a reference to January of the last year beginning during 
     such price applicability period with respect to such drug.
       ``(d) Rebate Deposits.--Amounts paid as rebates under 
     subsection (c) shall be deposited into the Medicare 
     Prescription Drug Account in the Federal Supplementary 
     Medical Insurance Trust Fund established under section 1841.
       ``(e) Information.--For purposes of carrying out this 
     section, the Secretary shall use information submitted by 
     manufacturers under section 1927(b)(3).
       ``(f) Civil Money Penalty.--In the case of a manufacturer 
     of a part D rebatable drug with an agreement in effect under 
     this section who has failed to comply with the terms of the 
     agreement under subsection (b)(1)(B) with respect to such 
     drug for an applicable year, the Secretary may impose a civil 
     money penalty on such manufacturer in an amount equal to 125 
     percent of the amount specified in subsection (c) for such 
     drug for such year. 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 subsection in the same manner as such 
     provisions apply to a penalty or proceeding under section 
     1128A(a).
       ``(g) Judicial Review.--There shall be no judicial review 
     of the following:
       ``(1) The determination of units under this section.
       ``(2) The determination of whether a drug is a part D 
     rebatable drug under this section.
       ``(3) The calculation of the rebate amount under this 
     section.
       ``(h) Definitions.--In this section:
       ``(1) Part d rebatable drug defined.--
       ``(A) In general.--The term `part D rebatable drug' means a 
     drug or biological that would (without application of this 
     section) be a covered part D drug, except such term shall, 
     with respect to an applicable year, not include such a drug 
     or biological if the average annual total cost under this 
     part for such year per individual who uses such a drug or 
     biological, as determined by the Secretary, is less than, 
     subject to subparagraph (B), $100, as determined by the 
     Secretary using the most recent data available or, if data is 
     not available, as estimated by the Secretary.
       ``(B) Increase.--The dollar amount applied under 
     subparagraph (A)--
       ``(i) for 2023, shall be the dollar amount specified under 
     such subparagraph for 2022, increased by the percentage 
     increase in the consumer price index for all urban consumers 
     (United States city average) for the 12-month period 
     beginning with January of 2022; and
       ``(ii) for a subsequent year, shall be the dollar amount 
     specified in this subparagraph for the previous year, 
     increased by the percentage increase in the consumer price 
     index for all urban consumers (United States city average) 
     for the 12-month period beginning with January of the 
     previous year.
     Any dollar amount specified under this subparagraph that is 
     not a multiple of $10 shall be rounded to the nearest 
     multiple of $10.
       ``(2) Unit defined.--The term `unit' means, with respect to 
     a part D rebatable drug, the lowest identifiable quantity 
     (such as a capsule or tablet, milligram of molecules, or 
     grams) of the part D rebatable drug that is dispensed to 
     individuals under this part.
       ``(3) Payment amount benchmark year.--The term `payment 
     amount benchmark year' means the year beginning January 1, 
     2016.
       ``(4) Benchmark period cpi-u.--The term `benchmark period 
     CPI-U' means the consumer price index for all urban consumers 
     (United States city average) for January 2016.
       ``(5) Applicable year cpi-u.--The term `applicable year 
     CPI-U' means, with respect to an applicable year, the 
     consumer price index for all urban consumers (United States 
     city average) for January of such year.
       ``(6) Average manufacturer price.--The term `average 
     manufacturer price' has the meaning, with respect to a part D 
     rebatable drug of a manufacturer, given such term in section 
     1927(k)(1), with respect to a covered outpatient drug of a 
     manufacturer for a rebate period under section 1927.''.
       (b) Conforming Amendments.--
       (1) To part b asp calculation.--Section 1847A(c)(3) of the 
     Social Security Act (42 U.S.C. 1395w-3a(c)(3)), as amended by 
     section 201(c)(1), is further amended by striking ``section 
     1927 or section 1834(x)'' and inserting ``section 1927, 
     section 1834(x), or section 1860D-14B''.
       (2) Excluding part d drug inflation rebate from best 
     price.--Section 1927(c)(1)(C)(ii)(I) of the Social Security 
     Act (42 U.S.C. 1396r-8(c)(1)(C)(ii)(I)), as amended by 
     section 201(c)(2), is further amended by striking ``or 
     section 1834(x)'' and inserting ``, section 1834(x), or 
     section 1860D-14B''.
       (3) Coordination with medicaid rebate information 
     disclosure.--Section

[[Page H10151]]

     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''.

     SEC. 203. PROVISION REGARDING INFLATION REBATES FOR GROUP 
                   HEALTH PLANS AND GROUP HEALTH INSURANCE 
                   COVERAGE.

       (a) In General.--Not later than December 31, 2021, the 
     Secretary of Labor, in consultation with the Secretary of 
     Health and Human Services and the Secretary of the Treasury, 
     shall submit to Congress a report on--
       (1) potential models for an agreement process with 
     manufacturers of prescription drugs under which such 
     manufacturers provide for inflation rebates with respect to 
     such drugs that are furnished or dispensed to participants 
     and beneficiaries of group health plans and health insurance 
     coverage offered in the group market in a manner similar to 
     how manufacturers provide for rebates under section 1834(x) 
     of the Social Security Act, as added by section 201, and 
     section 1860D-14B of such Act, as added by section 202, with 
     respect to prescription drugs that are furnished or dispensed 
     under part B of title XVIII of such Act and part D of such 
     title, respectively; and
       (2) potential models for enforcement mechanisms with 
     respect to such an agreement process that ensure that such 
     inflation rebates are proportionally distributed, with 
     respect to costs, to group health plans and health insurance 
     issuers offering health insurance coverage in the group 
     market, to participants and beneficiaries of such plans and 
     coverage, or to both.
       (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 process 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.

     SEC. 204. ANNUAL REPORT ON DRUG COSTS IN GROUP HEALTH PLANS 
                   AND GROUP HEALTH INSURANCE COVERAGE.

       (a) Initial Report.--Not later than December 31, 2021, the 
     Secretary of Labor shall, in consultation with the Secretary 
     of Health and Human Services and the Secretary of the 
     Treasury, submit to Congress a report, with respect to a 
     period (as determined by the Secretary of Labor), on--
       (1) whether the prices of prescription drugs that are 
     furnished or dispensed to participants and beneficiaries of 
     group health plans and health insurance coverage offered in 
     the group market during such period have increased at a 
     percentage that exceeds the percentage by which the consumer 
     price index for all urban consumers (United States city 
     average) increased for such period; and
       (2) whether there are mechanisms by which manufacturers of 
     prescription drugs have attempted to recover rebate payments 
     required of such manufacturers under section 1834(x) of the 
     Social Security Act, as added by section 201, and section 
     1860D-14B of such Act, as added by section 202, with respect 
     to prescription drugs that are furnished or dispensed under 
     part B of title XVIII of such Act and part D of such title, 
     respectively, through increased prices charged with respect 
     to drugs that are furnished or dispensed to participants and 
     beneficiaries of group health plans and health insurance 
     coverage offered in the group market during such period.
       (b) Annual Report.--Not later than December 31 of each year 
     following 2021, the Secretary of Labor shall, in consultation 
     with the Secretary of Health and Human Services and the 
     Secretary of the Treasury, submit to Congress a report 
     updating the information and analysis included in the report 
     required under subsection (a), reflecting, in part, new price 
     and cost information and data for the 12-month period after 
     the period on which the prior year's report was based.

     SEC. 205. COLLECTION OF DATA.

       (a) Manufacturers of Prescription Drugs.--Manufacturers of 
     prescription drugs shall submit to the Secretary of Health 
     and Human Services, Secretary of Labor, and the Secretary of 
     the Treasury appropriate data as necessary for the 
     Secretaries to obtain information needed to provide the 
     reports under sections 203 and 204.
       (b) Group Health Plans and Health Insurance Issuers 
     Offering Health Insurance Coverage in the Group Market.--
     Group health plans and health insurance issuers offering 
     health insurance coverage in the group market shall submit to 
     the Secretary of Health and Human Services, Secretary of 
     Labor, and the Secretary of the Treasury appropriate data as 
     necessary for the Secretaries to obtain information needed to 
     provide the reports under sections 203 and 204.

   TITLE III--PART D IMPROVEMENTS AND MAXIMUM OUT-OF-POCKET CAP FOR 
                         MEDICARE BENEFICIARIES

     SEC. 301. 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), 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)'';
       (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''; and
       (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 moving the margin of each such 
     redesignated item 2 ems to the right;
       (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), by striking ``clause (i)(I)'' and 
     inserting ``clause (i)(I)(aa)'';
       (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 $2,000; 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 years 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 by inserting after ``80 percent'' the 
     following: ``(or, with respect to a coverage year after 2021, 
     20 percent)''.
       (c) Manufacturer Discount Program.--
       (1) In general.--Part D of title XVIII of the Social 
     Security Act (42 U.S.C. 1395w-101 et seq.), as amended by 
     section 202, is further amended by inserting after section 
     1860D-14B the following new section:

     ``SEC. 1860D-14C. 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.
       ``(C) Timing of agreement.--
       ``(i) Special rule for 2022.--In order for an agreement 
     with a manufacturer to be in effect under this section with 
     respect to the period beginning on January 1, 2022, and 
     ending on December 31, 2022, the manufacturer shall enter 
     into such agreement not later than 30 days after the date of 
     the establishment of a model agreement under subsection (a).
       ``(ii) 2023 and subsequent years.--In order for an 
     agreement with a manufacturer to be in effect under this 
     section with respect to plan year 2023 or a subsequent plan 
     year, the manufacturer shall enter into such agreement (or 
     such agreement shall be renewed under paragraph (4)(A)) not 
     later than January 30 of the preceding year.
       ``(2) Provision of appropriate data.--Each manufacturer 
     with an agreement in effect under

[[Page H10152]]

     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.
       ``(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) Implementation.--Notwithstanding any other provision 
     of law, the Secretary may implement the program under this 
     section by program instruction or otherwise.
       ``(6) 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 may 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 equal to 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 an applicable drug (including a generic drug or a 
     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, as determined in accordance with 
     section 1860D-2(b)(4)(C), for covered part D drugs in the 
     year that exceed the annual deductible with respect to such 
     individual for such year, as specified in section 1860D-
     2(b)(1), section 1860D-14(a)(1)(B), or section 1860D-
     14(a)(2)(B), as applicable.
       ``(2) Applicable drug.--The term `applicable drug', with 
     respect to an applicable beneficiary--
       ``(A) means a covered part D drug--
       ``(i) 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; and
       ``(ii)(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; and
       ``(B) does not include a selected drug (as defined in 
     section 1192(c)) during a price applicability period (as 
     defined in section 1191(b)(2)) with respect to such drug.
       ``(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 dispensed 
     during a year to an applicable beneficiary--
       ``(i) who has not incurred costs, as determined in 
     accordance with section 1860D-2(b)(4)(C), for covered part D 
     drugs in the year that are equal to or exceed the annual out-
     of-pocket threshold specified in section 1860D-2(b)(4)(B)(i) 
     for the year, 90 percent of the negotiated price of such 
     drug; and
       ``(ii) who has incurred such costs, as so determined, in 
     the year that are equal to or exceed such threshold for the 
     year, 70 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 certain claims.--
       ``(i) 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

[[Page H10153]]

     does not fall 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 above such annual deductible.
       ``(ii) Claims spanning out-of-pocket threshold.--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 entirely below or 
     entirely above the annual out-of-pocket threshold specified 
     in section 1860D-2(b)(4)(B)(i) for the year, the manufacturer 
     of the applicable drug shall provide the discounted price--

       ``(I) in accordance with subparagraph (A)(i) on the portion 
     of the negotiated price of the applicable drug that falls 
     below such threshold; and
       ``(II) in accordance with subparagraph (A)(ii) on the 
     portion of such price of such drug that falls at or above 
     such threshold.

       ``(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 423.100 of title 42, 
     Code of Federal Regulations (or any successor regulation), 
     except that, with respect to an applicable drug, such 
     negotiated price shall not include any dispensing fee for the 
     applicable drug.
       ``(7) Qualified retiree prescription drug plan.--The term 
     `qualified retiree prescription drug plan' has the meaning 
     given such term in section 1860D-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 with respect 
     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-14C 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 inserted 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-14C;''.
       (d) 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), 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-14C.''.
       (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.
       (7) Section 1860D-43 of the Social Security Act (42 U.S.C. 
     1395w-153) is amended--
       (A) in subsection (a)--
       (i) by striking paragraph (1) and inserting the following:
       ``(1) participate in--
       ``(A) for 2011 through 2021, the Medicare coverage gap 
     discount program under section 1860D-14A; and
       ``(B) for 2022 and each subsequent year, the manufacturer 
     discount program under section 1860D-14C;'';
       (ii) by striking paragraph (2) and inserting the following:
       ``(2) have entered into and have in effect--
       ``(A) for 2011 through 2021, an agreement described in 
     subsection (b) of section 1860D-14A with the Secretary; and
       ``(B) for 2022 and each subsequent year, an agreement 
     described in subsection (b) of section 1860D-14C with the 
     Secretary; and''; and
       (iii) by striking paragraph (3) and inserting the 
     following:
       ``(3) have entered into and have in effect, under terms and 
     conditions specified by the Secretary--
       ``(A) for 2011 through 2021, a contract with a third party 
     that the Secretary has entered into a contract with under 
     subsection (d)(3) of section 1860D-14A; and
       ``(B) for 2022 and each subsequent year, a contract with a 
     third party that the Secretary has entered into a contract 
     with under subsection (d)(3) of section 1860D-14C.''; and
       (B) by striking subsection (b) and inserting the following:
       ``(b) Effective Date.--Paragraphs (1)(A), (2)(A), and 
     (3)(A) 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 (1)(B), (2)(B), and 
     (3)(B) of such subsection shall apply to covered part D drugs 
     dispensed under this part on or after January 1, 2022.''.
       (8) Section 1927 of the Social Security Act (42 U.S.C. 
     1396r-8) is amended--
       (A) in subsection (c)(1)(C)(i)(VI), by inserting before the 
     period at the end the following: ``or under the manufacturer 
     discount program under section 1860D-14C''; and
       (B) in subsection (k)(1)(B)(i)(V), by inserting before the 
     period at the end the following: ``or under section 1860D-
     14C''.
       (e) Effective Date.--The amendments made by this section 
     shall apply with respect to plan year 2022 and subsequent 
     plan years.

     SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIPTION DRUGS 
                   PLANS AND MA-PD PLANS UNDER MEDICARE PROGRAM TO 
                   SPREAD OUT COST-SHARING UNDER CERTAIN 
                   CIRCUMSTANCES.

       Section 1860D-2(b)(2) of the Social Security Act (42 U.S.C. 
     1395w-102(b)(2)), as amended by section 301, 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.--
     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 who is not a subsidy eligible 
     individual (as defined in section 1860D-14(a)(3)) and with 
     respect to whom the plan projects that the dispensing of the 
     first fill of a covered part D drug to such individual will 
     result in the individual incurring costs that are equal to or 
     above 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 the portion of such costs that 
     are not above such annual out-of-pocket threshold) in the 
     form of periodic installments over the remainder of such plan 
     year.''.

     SEC. 303. 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--
       (1) by redesignating the paragraph (6), as added by section 
     50354 of division E of the Bipartisan Budget Act of 2018 
     (Public Law 115-123), as paragraph (7); and
       (2) 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

[[Page H10154]]

     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, 2021, 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).''.

                   TITLE IV--DRUG PRICE TRANSPARENCY

     SEC. 401. DRUG PRICE TRANSPARENCY.

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

     ``SEC. 1150C. REPORTING ON DRUG PRICES.

       ``(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 the Public Health Service 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 the 
     Public Health Service 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; and
       ``(ii) not a preventative 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 or under a State Medicaid plan under title XIX 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).
       ``(b) Report.--
       ``(1) Report required.--The manufacturer of a qualifying 
     drug shall submit a report to the Secretary if, with respect 
     to the qualifying drug--
       ``(A) there is an increase in the price of the 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 12-month period beginning 
     on or after January 1, 2019; or
       ``(ii) 25 percent or more within a 36-month period 
     beginning on or after January 1, 2019;
       ``(B) the estimated price of the qualifying drug or 
     spending per individual or per user of such drug (as 
     estimated by the Secretary) for the applicable year (or per 
     course of treatment in such applicable year as determined by 
     the Secretary) is at least $26,000 beginning on or after 
     January 1, 2021; or
       ``(C) there was an increase in the price of the qualifying 
     drug that resulted in an increase in the wholesale 
     acquisition cost of that drug that is equal to--
       ``(i) 10 percent or more within a 12-month period that 
     begins and ends during the 5-year period preceding January 1, 
     2021; or
       ``(ii) 25 percent or more within a 36-month period that 
     begins and ends during the 5-year period preceding January 1, 
     2021.
       ``(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 the 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;
       ``(C) in the case of a report with respect to a qualifying 
     drug that meets the criteria under paragraph (1)(B), not 
     later than 30 days after such drug meets such criteria; and
       ``(D) in the case of a report with respect to an increase 
     in the price of a qualifying drug that occurs during a 12-
     month or 36-month period described in paragraph (1)(C), not 
     later than April 1, 2021.
       ``(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 12-
     month period or 36-month period as described in subsection 
     (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or (b)(1)(C)(ii), 
     as applicable, and the effective date of such price increase 
     or the cost associated with a qualifying drug if such drug 
     meets the criteria under subsection (b)(1)(B) and the 
     effective date at which such drug meets such criteria;
       ``(B) an explanation for, and description of, each price 
     increase for such drug that will occur during the 12-month 
     period or the 36-month period described in subsection 
     (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or (b)(1)(C)(ii), 
     as applicable;
       ``(C) an explanation for, and description of, the cost 
     associated with a qualifying drug if such drug meets the 
     criteria under subsection (b)(1)(B), as applicable;
       ``(D) 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 the 
     Pubic Health Service 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 the Public 
     Health Service Act;
       ``(E) 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 the Public Health Service 
     Act, or since the manufacturer acquired such approved 
     application or license, if applicable;
       ``(F) the current wholesale acquisition cost of the drug;
       ``(G) the total expenditures of the manufacturer on--
       ``(i) materials and manufacturing for such drug;
       ``(ii) acquiring patents and licensing for such drug; and
       ``(iii) purchasing or acquiring such drug from another 
     manufacturer, if applicable;
       ``(H) the percentage of total expenditures of the 
     manufacturer on research and development for such drug that 
     was derived from Federal funds;
       ``(I) 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 the Public 
     Health Service Act, as applicable;
       ``(J) 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 the Public Health Service Act;
       ``(K) 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;
       ``(L) 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 of the Public Health 
     Service Act, or since the manufacturer acquired such approved 
     application or license; and
       ``(M) 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 12-month period described in 
     subsection (b)(1)(A)(i) or (b)(1)(C)(i) or the 36-month 
     period described in subsection (b)(1)(A)(ii) or 
     (b)(1)(C)(ii), as applicable;
       ``(B) all stock-based performance metrics used by the 
     manufacturer to determine executive compensation for each of 
     the 12-month periods described in subsection (b)(1)(A)(i) or 
     (b)(1)(C)(i) or the 36-month periods described in subsection 
     (b)(1)(A)(ii) or (b)(1)(C)(ii), 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.
       ``(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) 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 $100,000 
     for each item of false information.
       ``(g) Public Posting.--
       ``(1) In general.--Subject to paragraph (4), 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

[[Page H10155]]

     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) List.--In addition to the reports submitted under 
     subsection (b), the Secretary shall also post a list of each 
     qualifying drug with respect to which the manufacturer was 
     required to submit such a report in the preceding year and 
     whether such manufacturer was required to submit such report 
     based on a qualifying price increase or whether such drug 
     meets the criteria under subsection (b)(1)(B).
       ``(4) Protected information.--In carrying out this section, 
     the Secretary shall enforce applicable law concerning the 
     protection of confidential commercial information and trade 
     secrets.

     ``SEC. 1150D. ANNUAL REPORT TO CONGRESS.

       ``(a) In General.--Subject to subsection (b), the Secretary 
     shall submit to the Committees on Energy and Commerce and 
     Ways and Means of the House of Representatives and the 
     Committees on Health, Education, Labor, and Pensions and 
     Finance of the Senate, 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 1150C;
       ``(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 1150C; 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.--In carrying out this section, 
     the Secretary shall enforce applicable law concerning the 
     protection of confidential commercial information and trade 
     secrets.''.

  TITLE V--PROGRAM IMPROVEMENTS FOR MEDICARE LOW-INCOME BENEFICIARIES

     SEC. 501. DISSEMINATION TO MEDICARE PART D SUBSIDY ELIGIBLE 
                   INDIVIDUALS OF INFORMATION COMPARING PREMIUMS 
                   OF CERTAIN PRESCRIPTION DRUG PLANS.

       Section 1860D-1(c)(3) of the Social Security Act (42 U.S.C. 
     1395w-101(c)(3)) is amended by adding at the end the 
     following new subparagraph:
       ``(C) Information on premiums for subsidy eligible 
     individuals.--
       ``(i) In general.--For plan year 2022 and each subsequent 
     plan year, the Secretary shall disseminate to each subsidy 
     eligible individual (as defined in section 1860D-14(a)(3)) 
     information under this paragraph comparing premiums that 
     would apply to such individual for prescription drug coverage 
     under LIS benchmark plans, including, in the case of an 
     individual enrolled in a prescription drug plan under this 
     part, information that compares the premium that would apply 
     if such individual were to remain enrolled in such plan to 
     premiums that would apply if the individual were to enroll in 
     other LIS benchmark plans.
       ``(ii) LIS benchmark plan.--For purposes of clause (i), the 
     term `LIS benchmark plan' means, with respect to an 
     individual, a prescription drug plan under this part that is 
     offered in the region in which the individual resides and--

       ``(I) that provides for a premium that is not more than the 
     low-income benchmark premium amount (as defined in section 
     1860D-14(b)(2)) for such region; or
       ``(II) with respect to which the premium would be waived as 
     de minimis pursuant to section 1860D-14(a)(5) for such 
     individual.''.

     SEC. 502. PROVIDING FOR INTELLIGENT ASSIGNMENT OF CERTAIN 
                   SUBSIDY ELIGIBLE INDIVIDUALS AUTO-ENROLLED 
                   UNDER MEDICARE PRESCRIPTION DRUG PLANS AND MA-
                   PD PLANS.

       (a) In General.--Section 1860D-1(b)(1) of the Social 
     Security Act (42 U.S.C. 1395w-101(b)(1)) is amended--
       (1) in subparagraph (C)--
       (A) by inserting after ``PDP region'' the following: ``or 
     through use of an intelligent assignment process that is 
     designed to maximize the access of such individual to 
     necessary prescription drugs while minimizing costs to such 
     individual and to the program under this part to the greatest 
     extent possible. In the case the Secretary enrolls such 
     individuals through use of an intelligent assignment process, 
     such process shall take into account the extent to which 
     prescription drugs necessary for the individual are covered 
     in the case of a PDP sponsor of a prescription drug plan that 
     uses a formulary, the use of prior authorization or other 
     restrictions on access to coverage of such prescription drugs 
     by such a sponsor, and the overall quality of a prescription 
     drug plan as measured by quality ratings established by the 
     Secretary''; and
       (B) by striking ``Nothing in the previous sentence'' and 
     inserting ``Nothing in this subparagraph''; and
       (2) in subparagraph (D)--
       (A) by inserting after ``PDP region'' the following: ``or 
     through use of an intelligent assignment process that is 
     designed to maximize the access of such individual to 
     necessary prescription drugs while minimizing costs to such 
     individual and to the program under this part to the greatest 
     extent possible. In the case the Secretary enrolls such 
     individuals through use of an intelligent assignment process, 
     such process shall take into account the extent to which 
     prescription drugs necessary for the individual are covered 
     in the case of a PDP sponsor of a prescription drug plan that 
     uses a formulary, the use of prior authorization or other 
     restrictions on access to coverage of such prescription drugs 
     by such a sponsor, and the overall quality of a prescription 
     drug plan as measured by quality ratings established by the 
     Secretary''; and
       (B) by striking ``Nothing in the previous sentence'' and 
     inserting ``Nothing in this subparagraph''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall apply with respect to plan years beginning with plan 
     year 2022.

     SEC. 503. EXPANDING ELIGIBILITY FOR LOW-INCOME SUBSIDIES 
                   UNDER PART D OF THE MEDICARE PROGRAM.

       Section 1860D-14(a) of the Social Security Act (42 U.S.C. 
     1395w-114(a)), as amended by section 301(d), is further 
     amended--
       (1) in the subsection heading, by striking ``Individuals'' 
     and all that follows through ``Line'' and inserting ``Certain 
     Individuals'';
       (2) in paragraph (1)--
       (A) by striking the paragraph heading and inserting 
     ``Individuals with certain low incomes''; and
       (B) in the matter preceding subparagraph (A), by inserting 
     ``(or, with respect to a plan year beginning on or after 
     January 1, 2022, 150 percent)'' after ``135 percent''; and
       (3) in paragraph (2)--
       (A) by striking the paragraph heading and inserting ``Other 
     low-income individuals''; and
       (B) in the matter preceding subparagraph (A), by striking 
     ``In the case of a subsidy'' and inserting ``With respect to 
     a plan year beginning before January 1, 2022, in the case of 
     a subsidy''.

     SEC. 504. AUTOMATIC ELIGIBILITY OF CERTAIN LOW-INCOME 
                   TERRITORIAL RESIDENTS FOR PREMIUM AND COST-
                   SHARING SUBSIDIES UNDER THE MEDICARE PROGRAM; 
                   SUNSET OF ENHANCED ALLOTMENT PROGRAM.

       (a) Automatic Eligibility of Certain Low-Income Territorial 
     Residents for Premium and Cost-Sharing Subsidies Under the 
     Medicare Program.--
       (1) In general.--Section 1860D-14(a)(3) of the Social 
     Security Act (42 U.S.C. 1395w-114(a)(3)) is amended--
       (A) in subparagraph (B)(v)--
       (i) in subclause (I), by striking ``and'' at the end;
       (ii) in subclause (II), by striking the period and 
     inserting ``; and''; and
       (iii) by inserting after subclause (II) the following new 
     subclause:

       ``(III) with respect to plan years beginning on or after 
     January 1, 2024, shall provide that any part D eligible 
     individual who is enrolled for medical assistance under the 
     State Medicaid plan of a territory (as defined in section 
     1935(f)) under title XIX (or a waiver of such a plan) shall 
     be treated as a subsidy eligible individual described in 
     paragraph (1).''; and

       (B) in subparagraph (F), by adding at the end the following 
     new sentence: ``The previous sentence shall not apply with 
     respect to eligibility determinations for premium and cost-
     sharing subsidies under this section made on or after January 
     1, 2024.''.
       (2) Conforming amendment.--Section 1860D-31(j)(2)(D) of the 
     Social Security Act (42 U.S.C. 1395w-141(j)(2)(D)) is amended 
     by adding at the end the following new sentence: ``The 
     previous sentence shall not apply with respect to amounts 
     made available to a State under this paragraph on or after 
     January 1, 2024.''.
       (b) Sunset of Enhanced Allotment Program.--
       (1) In general.--Section 1935(e) of the Social Security Act 
     (42 U.S.C. 1396u-5(e)) is amended--
       (A) in paragraph (1)(A), by inserting after ``such State'' 
     the following: ``before January 1, 2021''; and
       (B) in paragraph (3)--
       (i) in subparagraph (A), in the matter preceding clause 
     (i), by inserting after ``a year'' the following: ``(before 
     2024)''; and
       (ii) in subparagraph (B)(iii), by striking ``a subsequent 
     year'' and inserting ``each of fiscal years 2008 through 
     2023''.
       (2) Territory defined.--Section 1935 of the Social Security 
     Act (42 U.S.C. 1396u-5) is amended by adding at the end the 
     following new subsection:
       ``(f) Territory Defined.--In this section, the term 
     `territory' means Puerto Rico, the Virgin Islands, Guam, the 
     Northern Mariana Islands, and American Samoa.''.

     SEC. 505. AUTOMATIC QUALIFICATION OF CERTAIN MEDICAID 
                   BENEFICIARIES FOR PREMIUM AND COST-SHARING 
                   SUBSIDIES UNDER PART D OF THE MEDICARE PROGRAM.

       Clause (v) of section 1860D-14(a)(3)(B) of the Social 
     Security Act (42 U.S.C. 1395w-114(a)(3)(B)), as amended by 
     section 504, is further amended--
       (1) in subclause (II), by striking ``and'' at the end;
       (2) in subclause (III), by striking the period and 
     inserting ``; and''; and
       (3) by inserting after subclause (III) the following new 
     subclause:

       ``(IV) with respect to plan years beginning on or after 
     January 1, 2024, shall, notwithstanding the preceding clauses 
     of this subparagraph, provide that any part D eligible 
     individual not described in subclause (I), (II), or (III) who 
     is enrolled, as of the day before the date on which such 
     individual attains the age of 65, for medical assistance 
     under a State plan under title XIX (or a waiver of such plan) 
     pursuant to clause (i)(VIII) or (ii)(XX) of section 
     1902(a)(10)(A), and who has income below 200 percent of the 
     poverty line applicable to a family of the size involved, 
     shall be treated as a subsidy eligible individual described 
     in paragraph (1) for a limited period of time, as specified 
     by the Secretary.''.

[[Page H10156]]

  


     SEC. 506. PROVIDING FOR CERTAIN RULES REGARDING THE TREATMENT 
                   OF ELIGIBLE RETIREMENT PLANS IN DETERMINING THE 
                   ELIGIBILITY OF INDIVIDUALS FOR PREMIUM AND 
                   COST-SHARING SUBSIDIES UNDER PART D OF THE 
                   MEDICARE PROGRAM.

       Section 1860D-14(a)(3)(C)(i) of the Social Security Act (42 
     U.S.C. 1395w-114(a)(3)(C)(i)) is amended, by striking 
     ``except that support and maintenance furnished in kind shall 
     not be counted as income; and'' and inserting ``except that--

       ``(I) support and maintenance furnished in kind shall not 
     be counted as income; and
       ``(II) for plan years beginning on or after January 1, 
     2024, any distribution or withdrawal from an eligible 
     retirement plan (as defined in subparagraph (B) of section 
     402(c)(8) of the Internal Revenue Code of 1986, but excluding 
     any defined benefit plan described in clause (iv) or (v) of 
     such subparagraph and any qualified trust (as defined in 
     subparagraph (A) of such section) which is part of such a 
     defined benefit plan) shall be counted as income; and''.

     SEC. 507. REDUCING COST-SHARING AND OTHER PROGRAM 
                   IMPROVEMENTS FOR LOW-INCOME BENEFICIARIES.

       (a) Increase in Income Eligibility to 150 Percent of FPL 
     for Qualified Medicare Beneficiaries.--
       (1) In general.--Section 1905(p)(2)(A) of the Social 
     Security Act (42 U.S.C. 1396d(p)(2)(A)) is amended by 
     striking ``shall be at least the percent provided under 
     subparagraph (B) (but not more than 100 percent) of the 
     official poverty line'' and all that follows through the 
     period at the end and inserting the following: ``shall be--
       ``(i) before January 1, 2022, at least the percent provided 
     under subparagraph (B) (but not more than 100 percent) of the 
     official poverty line (as defined by the Office of Management 
     and Budget, and revised annually in accordance with section 
     673(2) of the Omnibus Budget Reconciliation Act of 1981) 
     applicable to a family of the size involved; and
       ``(ii) on or after January 1, 2022, equal to 150 percent of 
     the official poverty line (as so defined and revised) 
     applicable to a family of the size involved.''.
       (2) Not counting in-kind support and maintenance as 
     income.--Section 1905(p)(2)(D) of the Social Security Act (42 
     U.S.C. 1396d(p)(2)(D)) is amended by adding at the end the 
     following new clause:
       ``(iii) In determining income under this subsection, 
     support and maintenance furnished in kind, as described in 
     section 1612(a)(2)(A), shall not be counted as income.''.
       (3) Conforming amendments.--
       (A) Section 1902(a)(10)(E) of the Social Security Act (42 
     U.S.C. 1396a(a)(10)(E)) is amended--
       (i) in clause (iii), by striking ``for making medical'' and 
     inserting ``before January 1, 2022, for making medical''; and
       (ii) in clause (iv), by striking ``subject to sections'' 
     and inserting ``before January 1, 2022, subject to 
     sections''.
       (B) Section 1933 of the Social Security Act (42 U.S.C. 
     1396u-3) is amended--
       (i) in subsection (a), by striking ``A State plan'' and 
     inserting ``Subject to subsection (h), a State plan''; and
       (ii) by adding at the end the following new subsection:
       ``(h) Sunset.--The provisions of this section shall have no 
     force or effect after December 31, 2021.''.
       (b) 100 Percent FMAP.--Section 1905 of the Social Security 
     Act (42 U.S.C. 1396d) is amended by adding at the end the 
     following new subsection:
       ``(gg) Increased FMAP for Expanded Medicare Cost-Sharing 
     Populations.--
       ``(1) In general.--Notwithstanding subsection (b), with 
     respect to expenditures described in paragraph (2) the 
     Federal medical assistance percentage shall be equal to 100 
     percent.
       ``(2) Expenditures described.--The expenditures described 
     in this paragraph are expenditures made on or after January 
     1, 2022, for medical assistance for medicare cost-sharing 
     provided to any individual under clause (i) or (ii) of 
     section 1902(a)(10)(E) who would not have been eligible for 
     medicare cost-sharing under any such clause under the income 
     or resource eligibility standards in effect on October 1, 
     2018.''.

TITLE VI--PROVIDING FOR DENTAL, VISION, AND HEARING COVERAGE UNDER THE 
                            MEDICARE PROGRAM

     SEC. 601. DENTAL AND ORAL HEALTH CARE.

       (a) Coverage.--Section 1861(s)(2) of the Social Security 
     Act (42 U.S.C. 1395x(s)(2)) is amended--
       (1) in subparagraph (GG), by striking ``and'' after the 
     semicolon at the end;
       (2) in subparagraph (HH), by striking the period at the end 
     and adding ``; and''; and
       (3) by adding at the end the following new subparagraph:
       ``(II) dental and oral health services (as defined in 
     subsection (kkk));''.
       (b) Dental and Oral Health Services Defined.--Section 1861 
     of the Social Security Act (42 U.S.C. 1395x) is amended by 
     adding at the end the following new subsection:
       ``(kkk) Dental and Oral Health Services.--
       ``(1) In general.--The term `dental and oral health 
     services' means items and services (other than such items and 
     services for which payment may be made under part A as 
     inpatient hospital services) that are furnished during 2025 
     or a subsequent year, for which coverage was not provided 
     under part B as of the date of the enactment of this 
     subsection, and that are--
       ``(A) the preventive and screening services described in 
     paragraph (2) furnished by a doctor of dental surgery or of 
     dental medicine (as described in subsection (r)(2)) or an 
     oral health professional (as defined in paragraph (4)); or
       ``(B) the basic treatments specified for such year by the 
     Secretary pursuant to paragraph (3)(A) and the major 
     treatments specified for such year by the Secretary pursuant 
     to paragraph (3)(B) furnished by such a doctor or such a 
     professional.
       ``(2) Preventive and screening services.--The preventive 
     and screening services described in this paragraph are the 
     following:
       ``(A) Oral exams.
       ``(B) Dental cleanings.
       ``(C) Dental x-rays performed in the office of a doctor or 
     professional described in paragraph (1)(A).
       ``(D) Fluoride treatments.
       ``(3) Basic and major treatments.--For 2025 and each 
     subsequent year, the Secretary shall specify--
       ``(A) basic treatments (which may include basic tooth 
     restorations, basic periodontic services, tooth extractions, 
     and oral disease management services); and
       ``(B) major treatments (which may include major tooth 
     restorations, major periodontic services, bridges, crowns, 
     and root canals);
     that shall be included as dental and oral health services for 
     such year.
       ``(4) Oral health professional.--The term `oral health 
     professional' means, with respect to dental and oral health 
     services, a health professional who is licensed to furnish 
     such services, acting within the scope of such license, by 
     the State in which such services are furnished.''.
       (c) Payment; Coinsurance; and Limitations.--
       (1) In general.--Section 1833(a)(1) of the Social Security 
     Act (42 U.S.C. 1395l(a)(1)) is amended--
       (A) in subparagraph (N), by inserting ``and dental and oral 
     health services (as defined in section 1861(kkk))'' after 
     ``section 1861(hhh)(1))'';
       (B) by striking ``and'' before ``(CC)''; and
       (C) by inserting before the semicolon at the end the 
     following: ``, and (DD) with respect to dental and oral 
     health services (as defined in section 1861(kkk)), the amount 
     paid shall be the payment amount specified under section 
     1834(x)''.
       (2) Payment and limits specified.--Section 1834 of the 
     Social Security Act (42 U.S.C. 1395m) is amended by adding at 
     the end the following new subsection:
       ``(x) Payment and Limits for Dental and Oral Health 
     Services.--
       ``(1) In general.--The payment amount under this part for 
     dental and oral health services (as defined in section 
     1861(kkk)) shall be, subject to paragraph (3), the applicable 
     percent (specified in paragraph (2)) of the lesser of the 
     actual charge for the services or the amount determined under 
     the payment basis determined under section 1848. In 
     determining such amounts determined under such payment basis, 
     the Secretary shall consider payment rates paid to dentists 
     for comparable services under State plans under title XIX, 
     under the TRICARE program under chapter 55 of title 10 of the 
     United States Code, and by other health care payers, such as 
     Medicare Advantage plans under part C.
       ``(2) Applicable percent.--For purposes of paragraph (1), 
     the applicable percent specified in this paragraph is, with 
     respect to dental and oral health services (as defined in 
     section 1861(kkk)) furnished in a year--
       ``(A) that are preventive and screening services described 
     in paragraph (2) or basic treatments specified for such year 
     pursuant to paragraph (3)(A) of such section, 80 percent; and
       ``(B) that are major treatments specified for such year 
     pursuant to paragraph (3)(B) of such section--
       ``(i) in the case such services are furnished during 2025, 
     10 percent;
       ``(ii) in the case such services are furnished during 2026 
     or a subsequent year before 2029, the applicable percent 
     specified under this subparagraph for the previous year, 
     increased by 10 percentage points; and
       ``(iii) in the case such services are furnished during 2029 
     or a subsequent year, 50 percent.
       ``(3) Limitations.--With respect to dental and oral health 
     services that are--
       ``(A) preventive and screening oral exams, payment may be 
     made under this part for not more than two such exams during 
     a 12-month period;
       ``(B) dental cleanings, payment may be made under this part 
     for not more than two such cleanings during a 12-month 
     period; and
       ``(C) not described in subparagraph (A) or (B), payment may 
     be made under this part only at such frequencies and under 
     such circumstances determined appropriate by the 
     Secretary.''.
       (d) Payment Under Physician Fee Schedule.--
       (1) In general.--Section 1848(j)(3) of the Social Security 
     Act (42 U.S.C. 1395w-4(j)(3)) is amended by inserting 
     ``(2)(II),'' before ``(3)''.
       (2) Exclusion from mips.--Section 1848(q)(1)(C)(ii) of the 
     Social Security Act (42 U.S.C. 1395w-4(q)(1)(C)(ii)) is 
     amended--
       (A) in subclause (II), by striking ``or'' at the end;
       (B) in subclause (III), by striking the period at the end 
     and inserting ``; or''; and
       (C) by adding at the end the following new subclause:

       ``(IV) with respect to 2025 and each subsequent year, is a 
     doctor of dental surgery or of dental medicine (as described 
     in section 1861(r)(2)) or is an oral health professional (as 
     defined in section 1861(kkk)(4)).''.

       (3) Inclusion of oral health professionals as certain 
     practitioners.--Section 1842(b)(18)(C) of the Social Security 
     Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the 
     end the following new clause:
       ``(vii) With respect to 2025 and each subsequent year, an 
     oral health professional (as defined in section 
     1861(kkk)(4)).''.

[[Page H10157]]

       (e) Dentures.--
       (1) In general.--Section 1861(s)(8) of the Social Security 
     Act (42 U.S.C. 1395x(s)(8)) is amended--
       (A) by striking ``(other than dental)''; and
       (B) by inserting ``and excluding dental, except for a full 
     or partial set of dentures furnished on or after January 1, 
     2025'' after ``colostomy care''.
       (2) Special payment rules.--
       (A) Limitations.--Section 1834(h) of the Social Security 
     Act (42 U.S.C. 1395m(h)) is amended by adding at the end the 
     following new paragraph:
       ``(6) Special payment rule for dentures.--Payment may be 
     made under this part with respect to an individual for 
     dentures--
       ``(A) not more than once during any 5-year period (except 
     in the case that a doctor or professional described in 
     section 1861(kkk)(1)(A) determines such dentures do not fit 
     the individual); and
       ``(B) only to the extent that such dentures are furnished 
     pursuant to a written order of such a doctor or 
     professional.''.
       (B) Application of competitive acquisition.--
       (i) In general.--Section 1834(h)(1)(H) of the Social 
     Security Act (42 U.S.C. 1395m(h)(1)(H)) is amended--

       (I) in the subparagraph heading, by inserting ``, 
     dentures'' after ``orthotics'';
       (II) by inserting ``, of dentures described in paragraph 
     (2)(D) of such section,'' after ``2011,''; and
       (III) in clause (i), by inserting ``, such dentures'' after 
     ``orthotics''.

       (ii) Conforming amendment.--Section 1847(a)(2) of the 
     Social Security Act (42 U.S.C. 1395w-3(a)(2)) is amended by 
     adding at the end the following new subparagraph:
       ``(D) Dentures.--Dentures described in section 1861(s)(8) 
     for which payment would otherwise be made under section 
     1834(h).''.
       (iii) Exemption of certain items from competitive 
     acquisition.--Section 1847(a)(7) of the Social Security Act 
     (42 U.S.C. 1395w-3(a)(7)) is amended by adding at the end the 
     following new subparagraph:
       ``(C) Certain dentures.--Those items and services described 
     in paragraph (2)(D) if furnished by a physician or other 
     practitioner (as defined by the Secretary) to the physician's 
     or practitioner's own patients as part of the physician's or 
     practitioner's professional service.''.
       (f) Exclusion Modifications.--Section 1862(a) of the Social 
     Security Act (42 U.S.C. 1395y(a)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (O), by striking ``and'' at the end;
       (B) in subparagraph (P), by striking the semicolon at the 
     end and inserting ``, and''; and
       (C) by adding at the end the following new subparagraph:
       ``(Q) in the case of dental and oral health services (as 
     defined in section 1861(kkk)) that are preventive and 
     screening services described in paragraph (2) of such 
     section, which are furnished more frequently than provided 
     under section 1834(x)(3) and under circumstances other than 
     circumstances determined appropriate under such section;''; 
     and
       (2) in paragraph (12), by inserting before the semicolon at 
     the end the following: ``and except that payment may be made 
     under part B for dental and oral health services that are 
     covered under section 1861(s)(2)(II)''.
       (g) Certain Non-application.--
       (1) In general.--Paragraphs (1) and (4) of section 1839(a) 
     of the Social Security Act (42 U.S.C. 1395r(a)) are amended 
     by adding at the end of each such paragraphs the following: 
     ``In applying this paragraph there shall not be taken into 
     account benefits and administrative costs attributable to the 
     amendments made by section 601 (other than subsection (g)) of 
     the Elijah E. Cummings Lower Drug Costs Now Act and the 
     Government contribution under section 1844(a)(4)''.
       (2) Payment.--Section 1844(a) of such Act (42 U.S.C. 
     1395w(a)) is amended--
       (A) in paragraph (3), by striking the period at the end and 
     inserting ``; plus''; and
       (B) by adding at the end the following new paragraph:
       ``(4) a Government contribution equal to the amount that is 
     estimated to be payable for benefits and related 
     administrative costs incurred that are attributable to the 
     amendments made by section 601 (other than subsection (g)) of 
     the Elijah E. Cummings Lower Drug Costs Now Act.''.
       (h) Implementation Funding.--
       (1) In general.--The Secretary of Health and Human Services 
     (in this subsection referred to as the ``Secretary'') shall 
     provide for the transfer from the Federal Supplementary 
     Medical Insurance Trust Fund under section 1841 of the Social 
     Security Act (42 U.S.C. 1395t) to the Centers for Medicare & 
     Medicaid Services Program Management Account of--
       (A) $20,000,000 for each of fiscal years 2020 through 2025 
     for purposes of implementing the amendments made by this 
     section; and
       (B) such sums as determined appropriate by the Secretary 
     for each subsequent fiscal year for purposes of administering 
     the provisions of such amendments.
       (2) Availability and additional use of funds.--Funds 
     transferred pursuant to paragraph (1) shall remain available 
     until expended and may be used, in addition to the purpose 
     specified in paragraph (1)(A), to implement the amendments 
     made by sections 602 and 603.

     SEC. 602. PROVIDING COVERAGE FOR HEARING CARE UNDER THE 
                   MEDICARE PROGRAM.

       (a) Provision of Aural Rehabilitation and Treatment 
     Services by Qualified Audiologists.--Section 1861(ll)(3) of 
     the Social Security Act (42 U.S.C. 1395x(ll)(3)) is amended 
     by inserting ``(and, beginning January 1, 2023, such aural 
     rehabilitation and treatment services)'' after ``assessment 
     services''.
       (b) Coverage of Hearing Aids.--
       (1) Inclusion of hearing aids as prosthetic devices.--
     Section 1861(s)(8) of the Social Security Act (42 U.S.C. 
     1395x(s)(8)) is amended by inserting ``, and including 
     hearing aids furnished on or after January 1, 2023, to 
     individuals diagnosed with profound or severe hearing loss'' 
     before the semicolon at the end.
       (2) Payment limitations for hearing aids.--Section 1834(h) 
     of the Social Security Act (42 U.S.C. 1395m(h)), as amended 
     by section 601(e)(2)(A), is further amended by adding at the 
     end the following new paragraph:
       ``(7) Limitations for hearing aids.--Payment may be made 
     under this part with respect to an individual, with respect 
     to hearing aids furnished on or after January 1, 2023--
       ``(A) not more than once during a 5-year period;
       ``(B) only for types of such hearing aids that are not 
     over-the-counter hearing aids (as defined in section 
     520(q)(1) of the Federal Food, Drug, and Cosmetic Act) and 
     that are determined appropriate by the Secretary; and
       ``(C) only if furnished pursuant to a written order of a 
     physician or qualified audiologist (as defined in section 
     1861(ll)(4)(B)).''.
       (3) Application of competitive acquisition.--
       (A) In general.--Section 1834(h)(1)(H) of the Social 
     Security Act (42 U.S.C. 1395m(h)(1)(H)), as amended by 
     section 601(e)(2)(B)(i), is further amended--
       (i) in the header, by inserting ``, hearing aids'' after 
     ``dentures'';
       (ii) by inserting ``, of hearing aids described in 
     paragraph (2)(E) of such section,'' after ``paragraph (2)(D) 
     of such section''; and
       (iii) in clause (i), by inserting ``, such hearing aids'' 
     after ``such dentures''.
       (B) Conforming amendment.--
       (i) In general.--Section 1847(a)(2) of the Social Security 
     Act (42 U.S.C. 1395w-3(a)(2)), as amended by section 
     601(e)(2)(B)(ii), is further amended by adding at the end the 
     following new subparagraph:
       ``(E) Hearing aids.--Hearing aids described in section 
     1861(s)(8) for which payment would otherwise be made under 
     section 1834(h).''.
       (ii) Exemption of certain items from competitive 
     acquisition.--Section 1847(a)(7) of the Social Security Act 
     (42 U.S.C. 1395w-3(a)(7)), as amended by section 
     601(e)(2)(B)(iii), is further amended by adding at the end 
     the following new subparagraph:
       ``(D) Certain hearing aids.--Those items and services 
     described in paragraph (2)(E) if furnished by a physician or 
     other practitioner (as defined by the Secretary) to the 
     physician's or practitioner's own patients as part of the 
     physician's or practitioner's professional service.''.
       (4) Inclusion of audiologists as certain practitioners to 
     receive payment on an assignment-related basis.--Section 
     1842(b)(18)(C) of the Social Security Act (42 U.S.C. 
     1395u(b)(18)(C)), as amended by section 601(d)(4), is further 
     amended by adding at the end the following new clause:
       ``(viii) With respect to 2023 and each subsequent year, a 
     qualified audiologist (as defined in section 
     1861(ll)(4)(B)).''.
       (c) Exclusion Modification.--Section 1862(a)(7) of the 
     Social Security Act (42 U.S.C. 1395y(a)(7)) is amended by 
     inserting ``(except such hearing aids or examinations 
     therefor as described in and otherwise allowed under section 
     1861(s)(8))'' after ``hearing aids or examinations 
     therefor''.
       (d) Certain Non-application.--
       (1) In general.--The last sentence of section 1839(a)(1) of 
     the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by 
     section 601(g)(1), is amended by striking ``section 601 
     (other than subsection (g))'' and inserting ``sections 601 
     (other than subsection (g)), 602 (other than subsection 
     (d))''.
       (2) Payment.--Paragraph (4) of section 1844(a) of such Act 
     (42 U.S.C. 1395w(a)), as added by section 601(g)(2), is 
     amended by striking ``section 601 (other than subsection 
     (g))'' and inserting ``sections 601 (other than subsection 
     (g)), 602 (other than subsection (d))''.
       (e) Report; Regulations.--
       (1) Report.--Not later than the date that is 3 years after 
     the date of the enactment of this Act, the Inspector General 
     of the Department of Health and Human Services shall conduct 
     a study to assess (and submit to the Secretary of Health and 
     Human Services a report on) any program integrity or 
     overutilization risks with respect to allowing qualified 
     audiologists (as defined in paragraph (4)(B) of 1861(ll) of 
     the Social Security Act (42 U.S.C. 1395x(ll))) to furnish 
     audiology services (as defined in paragraph (3) of such 
     section) to individuals entitled to benefits under part A of 
     title XVIII of such Act (42 U.S.C. 1395c et seq.) and 
     enrolled for benefits under part B of such title (42 
     U.S.C.1395j et seq.) without such individuals being referred 
     by a physician (as defined in section 1861(r) of such Act (42 
     U.S.C. 1395x(r))) or practitioner (as described in section 
     602.32 of title 42, Code of Federal Regulations) to such 
     qualified audiologists. In conducting such study, the 
     Inspector General may take into account experiences with 
     audiologists furnishing audiology services to enrollees in 
     other Federal programs, including in a health benefit plan 
     under chapter 89 of title 5, United States Code or in health 
     care benefits under the TRICARE program under chapter 55 of 
     title 10 of the United States Code or under chapter 17 of 
     title 38 of such Code.
       (2) Regulations.--The Secretary of Health and Human 
     Services may promulgate regulations to allow qualified 
     audiologists (as so defined) to furnish audiology services 
     (as so defined) without a referral from a physician or 
     practitioner, consistent with the findings submitted to the 
     Secretary pursuant to paragraph (1)(B).

[[Page H10158]]

       (f) Implementation Funding.--
       (1) In general.--The Secretary of Health and Human Services 
     (in this subsection referred to as the ``Secretary'') shall 
     provide for the transfer from the Federal Supplementary 
     Medical Insurance Trust Fund under section 1841 of the Social 
     Security Act (42 U.S.C. 1395t) to the Centers for Medicare & 
     Medicaid Services Program Management Account of--
       (A) $20,000,000 for each of fiscal years 2020 through 2024 
     for purposes of implementing the amendments made by this 
     section; and
       (B) such sums as determined appropriate by the Secretary 
     for each subsequent fiscal year for purposes of administering 
     the provisions of such amendments.
       (2) Availability and additional use of funds.--Funds 
     transferred pursuant to paragraph (1) shall remain available 
     until expended and may be used, in addition to the purpose 
     specified in paragraph (1)(A), to implement the amendments 
     made by sections 601 and 603.

     SEC. 603. PROVIDING COVERAGE FOR VISION CARE UNDER THE 
                   MEDICARE PROGRAM.

       (a) Coverage.--Section 1861(s)(2) of the Social Security 
     Act (42 U.S.C. 1395x(s)(2)), as amended by section 601(a), is 
     further amended--
       (1) in subparagraph (HH), by striking ``and'' after the 
     semicolon at the end;
       (2) in subparagraph (II), by striking the period at the end 
     and adding ``; and''; and
       (3) by adding at the end the following new subparagraph:
       ``(JJ) vision services (as defined in subsection (lll));''.
       (b) Vision Services Defined.--Section 1861 of the Social 
     Security Act (42 U.S.C. 1395x), as amended by section 601(b), 
     is further amended by adding at the end the following new 
     subsection:
       ``(lll) Vision Services.--The term `vision services' 
     means--
       ``(1) routine eye examinations to determine the refractive 
     state of the eyes, including procedures performed during the 
     course of such examination; and
       ``(2) contact lens fitting services;

     furnished on or after January 1, 2023, by or under the direct 
     supervision of an optometrist or ophthalmologist who is 
     legally authorized to furnish such examinations, procedures, 
     or fitting services (as applicable) under State law (or the 
     State regulatory mechanism provided by State law) of the 
     State in which the examinations, procedures, or fitting 
     services are furnished.''.
       (c) Payment Limitations.--Section 1834 of the Social 
     Security Act (42 U.S.C. 1395m), as amended by section 
     601(c)(2), is further amended by adding at the end the 
     following new subsection:
       ``(y) Limitation for Vision Services.--With respect to 
     vision services (as defined in section 1861(lll)) and an 
     individual, payment may be made under this part for only 1 
     routine eye examination described in paragraph (1) of such 
     section and 1 contact lens fitting service described in 
     paragraph (2) of such section during a 2-year period.''.
       (d) Payment Under Physician Fee Schedule.--Section 
     1848(j)(3) of the Social Security Act (42 U.S.C. 1395w-
     4(j)(3)), as amended by section 601(d)(1), is further amended 
     by inserting ``(2)(JJ),'' before ``(3)''.
       (e) Coverage of Conventional Eyeglasses and Contact 
     Lenses.--Section 1861(s)(8) of the Social Security Act (42 
     U.S.C. 1395x(s)(8)), as amended by section 602(b)(1), is 
     further amended by striking ``, and including one pair of 
     conventional eyeglasses or contact lenses furnished 
     subsequent to each cataract surgery with insertion of an 
     intraocular lens'' and inserting ``, including one pair of 
     conventional eyeglasses or contact lenses furnished 
     subsequent to each cataract surgery with insertion of an 
     intraocular lens, if furnished before January 1, 2023, 
     including conventional eyeglasses or contact lenses, whether 
     or not furnished subsequent to such a surgery, if furnished 
     on or after January 1, 2024''.
       (f) Special Payment Rules for Eyeglasses and Contact 
     Lenses.--
       (1) Limitations.--Section 1834(h) of the Social Security 
     Act (42 U.S.C. 1395m(h)), as amended by section 601(e)(2)(A) 
     and section 602(b)(2), is further amended by adding at the 
     end the following new paragraph:
       ``(8) Payment limitations for eyeglasses and contact 
     lenses.--
       ``(A) In general.--With respect to eyeglasses and contact 
     lenses furnished to an individual on or after January 1, 
     2023, subject to subparagraph (B), payment may be made under 
     this part only--
       ``(i) during a 2-year period, for either 1 pair of 
     eyeglasses (including lenses and frames) or not more than a 
     2-year supply of contact lenses that is provided in not more 
     than 180-day increments;
       ``(ii) with respect to amounts attributable to the lenses 
     and frames of such a pair of eyeglasses or amounts 
     attributable to such a 2-year supply of contact lenses, in an 
     amount not greater than--

       ``(I) for a pair of eyeglasses furnished in, or a 2-year 
     supply of contact lenses beginning in, 2023--

       ``(aa) $85 for the lenses of such pair of eyeglasses and 
     $85 for the frames of such pair of eyeglasses; or
       ``(bb) $85 for such 2-year supply of contact lenses; and

       ``(II) for the lenses and frames of a pair of eyeglasses 
     furnished in, or a 2-year supply of contact lenses beginning 
     in, a subsequent year, the dollar amounts specified under 
     this subparagraph for the previous year, increased by the 
     percentage change in the consumer price index for all urban 
     consumers (United States city average) for the 12-month 
     period ending with June of the previous year;

       ``(iii) for types of eyeglass lenses, and for types of 
     contact lenses, as determined appropriate by the Secretary;
       ``(iv) if furnished pursuant to a written order of a 
     physician described in section 1861(lll); and
       ``(v) if during the 2-year period described in clause (i), 
     the individual did not already receive (as described in 
     subparagraph (B)) one pair of conventional eyeglasses or 
     contact lenses subsequent to a cataract surgery with 
     insertion of an intraocular lens furnished during such 
     period.
       ``(B) Exception.--With respect to a 2-year period described 
     in subparagraph (A)(i), in the case of an individual who 
     receives cataract surgery with insertion of an intraocular 
     lens, notwithstanding subparagraph (A), payment may be made 
     under this part for one pair of conventional eyeglasses or 
     contact lenses furnished subsequent to such cataract surgery 
     during such period.''.
       (2) Application of competitive acquisition.--
       (A) In general.--Section 1834(h)(1)(H) of the Social 
     Security Act (42 U.S.C. 1395m(h)(1)(H)), as amended by 
     section 601(e)(2)(B)(i) and section 602(b)(3)(A), is further 
     amended--
       (i) in the header by inserting ``, eyeglasses, and contact 
     lenses'' after ``hearing aids'';
       (ii) by inserting ``and of eyeglasses and contact lenses 
     described in paragraph (2)(F) of such section,'' after 
     ``paragraph (2)(E) of such section,''; and
       (iii) in clause (i), by inserting ``, or such eyeglasses 
     and contact lenses'' after ``such hearing aids''.
       (B) Conforming amendment.--
       (i) In general.--Section 1847(a)(2) of the Social Security 
     Act (42 U.S.C. 1395w-3(a)(2)), as amended by section 
     601(e)(2)(B)(ii) and section 602(b)(3)(B)(i), is further 
     amended by adding at the end the following new subparagraph:
       ``(F) Eyeglasses and contact lenses.--Eyeglasses and 
     contact lenses described in section 1861(s)(8) for which 
     payment would otherwise be made under section 1834(h).''.
       (ii) Exemption of certain items from competitive 
     acquisition.--Section 1847(a)(7) of the Social Security Act 
     (42 U.S.C. 1395w-3(a)(7)), as amended by section 
     601(e)(2)(B)(iii) and section 602(b)(3)(B)(ii), is further 
     amended by adding at the end the following new subparagraph:
       ``(E) Certain eyeglasses and contact lenses.--Those items 
     and services described in paragraph (2)(F) if furnished by a 
     physician or other practitioner (as defined by the Secretary) 
     to the physician's or practitioner's own patients as part of 
     the physician's or practitioner's professional service.''.
       (g) Exclusion Modifications.--Section 1862(a) of the Social 
     Security Act (42 U.S.C. 1395y(a)), as amended by section 
     601(f), is further amended--
       (1) in paragraph (1)--
       (A) in subparagraph (P), by striking ``and'' at the end;
       (B) in subparagraph (Q), by striking the semicolon at the 
     end and inserting ``, and''; and
       (C) by adding at the end the following new subparagraph:
       ``(R) in the case of vision services (as defined in section 
     1861(lll)) that are routine eye examinations and contact lens 
     fitting services (as described in paragraph (1) or (2), 
     respectively, of such section), which are furnished more 
     frequently than once during a 2-year period;''; and
       (2) in paragraph (7)--
       (A) by inserting ``(other than such an examination that is 
     a vision service that is covered under section 
     1861(s)(2)(JJ))'' after ``eye examinations''; and
       (B) by inserting ``(other than such a procedure that is a 
     vision service that is covered under section 
     1861(s)(2)(JJ))'' after ``refractive state of the eyes''.
       (h) Certain Non-application.--
       (1) In general.--The last sentence of section 1839(a)(1) of 
     the Social Security Act (42 U.S.C. 1395r(a)(1)), as added by 
     section 601(g)(1) and amended by section 602(d)(1), is 
     further amended by inserting ``, and 603 (other than 
     subsection (h))'' after ``602 (other than subsection (d))''.
       (2) Payment.--Paragraph (4) of section 1844(a) of such Act 
     (42 U.S.C. 1395w(a)), as added by section 601(g)(2) and 
     amended by section 602(d)(2), is further amended by inserting 
     ``, and 603 (other than subsection (h))'' after ``602 (other 
     than subsection (d))''.
       (i) Implementation Funding.--
       (1) In general.--The Secretary of Health and Human Services 
     (in this subsection referred to as the ``Secretary'') shall 
     provide for the transfer from the Federal Supplementary 
     Medical Insurance Trust Fund under section 1841 of the Social 
     Security Act (42 U.S.C. 1395t) to the Centers for Medicare & 
     Medicaid Services Program Management Account of--
       (A) $20,000,000 for each of fiscal years 2020 through 2024 
     for purposes of implementing the amendments made by this 
     section; and
       (B) such sums as determined appropriate by the Secretary 
     for each subsequent fiscal year for purposes of administering 
     the provisions of such amendments.
       (2) Availability and additional use of funds.--Funds 
     transferred pursuant to paragraph (1) shall remain available 
     until expended and may be used, in addition to the purpose 
     specified in paragraph (1)(A), to implement the amendments 
     made by sections 601 and 602.

                TITLE VII--NIH, FDA, AND OPIOIDS FUNDING

              Subtitle A--Biomedical Innovation Expansion

     SEC. 701. NIH INNOVATION INITIATIVES.

       (a) NIH Innovation Account.--
       (1) In general.--Section 1001(b) of the 21st Century Cures 
     Act (Public Law 114-255) is amended by adding at the end the 
     following:
       ``(5) Supplemental funding and additional activities.--

[[Page H10159]]

       ``(A) In general.--In addition to the funds made available 
     under paragraph (2), there are authorized to be appropriated, 
     and are hereby appropriated, to the Account, out of any 
     monies in the Treasury not otherwise appropriated, to be 
     available until expended without further appropriation, the 
     following:
       ``(i) For fiscal year 2021, $255,400,000.
       ``(ii) For fiscal year 2022, $260,400,000.
       ``(iii) For fiscal year 2023, $163,400,000.
       ``(iv) For fiscal year 2024, $547,000,000.
       ``(v) For fiscal year 2025, $848,000,000.
       ``(vi) For fiscal year 2026, $842,400,000.
       ``(vii) For fiscal year 2027, $1,089,600,000.
       ``(viii) For fiscal year 2028, $1,115,600,000.
       ``(ix) For fiscal year 2029, $1,170,600,000.
       ``(x) For fiscal year 2030, $1,207,600,000.
       ``(B) Supplemental funding for certain projects.--Of the 
     total amounts made available under subparagraph (A) for each 
     of fiscal years 2021 through 2030, a total amount not to 
     exceed the following shall be made available for the 
     following categories of NIH Innovation Projects:
       ``(i) For projects described in paragraph (4)(A), an amount 
     not to exceed a total of $2,070,600,000 as follows:

       ``(I) For each of fiscal years 2021 and 2022, $50,000,000.
       ``(II) For fiscal year 2024, $100,000,000.
       ``(III) For each of fiscal years 2025 and 2026, 
     $300,000,000.
       ``(IV) For each of fiscal years 2027 through 2029, 
     $317,000,000.
       ``(V) For fiscal year 2030, $319,600,000.

       ``(ii) For projects described in paragraph (4)(B), an 
     amount not to exceed a total of $2,041,900,000 as follows:

       ``(I) For each of fiscal years 2021 and 2022, $50,000,000.
       ``(II) For fiscal year 2024, $128,000,000.
       ``(III) For fiscal year 2025, $209,000,000.
       ``(IV) For fiscal year 2026, $100,000,000.
       ``(V) For fiscal year 2027, $325,000,000.
       ``(VI) For fiscal year 2028, $350,000,000.
       ``(VII) For fiscal year 2029, $400,000,000.
       ``(VIII) For fiscal year 2030, $429,900,000.

       ``(iii) For projects described in paragraph (4)(C), an 
     amount not to exceed a total of $1,558,400,000 as follows:

       ``(I) For each of fiscal years 2024 and 2025, $151,200,000.
       ``(II) For each of fiscal years 2026 through 2030, 
     $251,200,000.

       ``(iv) For projects described in paragraph (4)(D), an 
     amount not to exceed $15,400,000 for each of fiscal years 
     2021 through 2030.
       ``(C) Additional nih innovation projects.--In addition to 
     funding NIH Innovation Projects pursuant to subparagraph (B), 
     of the total amounts made available under subparagraph (A), a 
     total amount not to exceed the following shall be made 
     available for the following categories of NIH Innovation 
     Projects:
       ``(i) To support research related to combating 
     antimicrobial resistance and antibiotic resistant bacteria, 
     including research into new treatments, diagnostics, and 
     vaccines, research, in consultation with the Centers for 
     Disease Control and Prevention, into stewardship, and the 
     development of strategies, in coordination with the 
     Biomedical Advanced Research and Development Authority under 
     section 319L of the Public Health Service Act, to support 
     commercialization of new antibiotics, not to exceed a total 
     of 1,144,500,000, as follows:

       ``(I) For each of fiscal years 2021 through 2024, 
     $100,000,000.
       ``(II) For each of fiscal years 2025 and 2026, 
     $120,000,000.
       ``(III) For each of fiscal years 2027 through 2029, 
     $125,000,000.
       ``(IV) For fiscal year 2030, $129,500,000.

       ``(ii) To support research and research activities related 
     to rare diseases or conditions, including studies or analyses 
     that help to better understand the natural history of a rare 
     disease or condition and translational studies related to 
     rare diseases or conditions, not to exceed a total of 
     $530,600,000, as follows:

       ``(I) For fiscal year 2021, $40,000,000.
       ``(II) For fiscal year 2022, $45,000,000.
       ``(III) For fiscal year 2023, $48,000,000.
       ``(IV) For each of fiscal years 2024 and 2025, $52,400,000.
       ``(V) For fiscal year 2026, $55,800,000.
       ``(VI) For fiscal year 2027, $56,000,000.
       ``(VII) For fiscal year 2028, $57,000,000.
       ``(VIII) For each of fiscal years 2029 and 2030, 
     $62,000,000.''.

       (2) Conforming amendments.--Section 1001 of the 21st 
     Century Cures Act (Public Law 114-255) is amended--
       (A) in subsection (a), by striking ``subsection (b)(4)'' 
     and inserting ``subsections (b)(4) and (b)(5)'';
       (B) in subsection (b)(1), by striking ``paragraph (4)'' and 
     inserting ``paragraphs (4) and (5)''; and
       (C) in subsection (c)(2)(A)(ii), by inserting ``or pursuant 
     to subsection (b)(5)'' after ``subsection (b)(3)''; and
       (D) in subsection (d), by inserting ``or pursuant to 
     subsection (b)(5)'' after ``subsection (b)(3)''.
       (b) Workplan.--Section 1001(c)(1) of the 21st Century Cures 
     Act (Public Law 114-255) is amended by adding at the end the 
     following:
       ``(D) Updates.--The Director of NIH shall , after seeking 
     recommendations in accordance with the process described in 
     subparagraph (C), update the work plan submitted under this 
     subsection for each of fiscal years 2021 through 2030 to 
     reflect the amendments made to this section by the Elijah E. 
     Cummings Lower Drug Costs Now Act.''.
       (c) Annual Reports.--Section 1001(c)(2)(A) of the 21st 
     Century Cures Act (Public Law 114-255) is amended by striking 
     ``2027'' and inserting ``2030''.
       (d) Sunset.--Section 1001(e) of the 21st Century Cures Act 
     (Public Law 114-255) is amended by striking ``September 30, 
     2026'' and inserting ``September 30, 2030''.

     SEC. 702. NIH CLINICAL TRIAL.

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

     ``SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIATIVE.

       ``(a) Establishment of Pilot Program.--The Secretary, 
     acting through the Director of the National Institutes of 
     Health, shall, not later than 2 years after the date of 
     enactment of this Act, establish and implement a pilot 
     program to award multi-year contracts to eligible entities to 
     support phase II clinical trials and phase III clinical 
     trials--
       ``(1) to promote innovation in treatments and technologies 
     supporting the advanced research and development and 
     production of high need cures; and
       ``(2) to provide support for the development of medical 
     products and therapies.
       ``(b) Eligible Entities.--To be eligible to receive 
     assistance under the pilot program established under 
     subsection (a), an entity shall--
       ``(1) be seeking to market a medical product or therapy 
     that is the subject of clinical trial or trials to be 
     supported using such assistance;
       ``(2) be a public or private entity, which may include a 
     private or public research institution, a contract research 
     organization, an institution of higher education (as defined 
     in section 101 of the Higher Education Act of 1965 (20 U.S.C. 
     1001)), a medical center, a biotechnology company, or an 
     academic research institution; and
       ``(3) comply with requirements of the Federal Food, Drug, 
     and Cosmetic Act or section 351 of this Act at all stages of 
     development, manufacturing, review, approval, and safety 
     surveillance of a medical product.
       ``(c) Duties.--The Secretary, acting through the Director 
     of National Institutes of Health, shall--
       ``(1) in establishing the pilot program under subsection 
     (a), consult with--
       ``(A) the Director of the National Center for Advancing 
     Translational Sciences and the other national research 
     institutes in considering their requests for new or expanded 
     clinical trial support efforts; and
       ``(B) the Commissioner of Food and Drugs and any other head 
     of a Federal agency as the Secretary determines to be 
     appropriate to ensure coordination and efficiently advance 
     clinical trial activities;
       ``(2) in implementing the pilot program under subsection 
     (a), consider consulting with patients and patient advocates; 
     and
       ``(3) in awarding contracts under the pilot program under 
     subsection (a), consider--
       ``(A) the expected health impacts of the clinical trial or 
     trials to be supported under the contract; and
       ``(B) the the degree to which the medical product or 
     therapy that is the subject of such clinical trial or trials 
     is a high need cure.
       ``(d) Exclusion.--A contract may not be awarded under the 
     pilot program under subsection (a) if the drug that is the 
     subject of the clinical trial or trials to be supported under 
     the contract is a drug designated under section 526 of the 
     Federal Food, Drug, and Cosmetic Act as a drug for a rare 
     disease or condition.
       ``(e) NIH Clinical Trial Accelerator Account.--
       ``(1) Establishment.--There is established in the Treasury 
     an account, to be known as the `NIH Clinical Trial 
     Accelerator Account' (referred to in this section as the 
     `Account'), for purposes of carrying out this section.
       ``(2) Transfer of direct spending savings.--There shall be 
     transferred to the Account from the general fund of the 
     Treasury, $500,000,000 for each of fiscal years 2021 through 
     2025, to be available until expended without further 
     appropriation.
       ``(3) Work plan.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary 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 work plan that includes the 
     proposed implementation of this section and the proposed 
     allocation of funds in the Account.
       ``(f) Reports to Congress.--Not later than October 1 of 
     each fiscal year, the Secretary 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--
       ``(1) the implementation of this section;
       ``(2) any available results on phase II clinical trials and 
     phase III clinical trials supported under this section during 
     such fiscal year; and
       ``(3) the extent to which Federal funds are obligated to 
     support such clinical trials, including the specific amount 
     of such support and awards pursuant to an allocation from the 
     Account under subsection (e).
       ``(g) Definitions.--In this section:
       ``(1) Phase ii clinical trial.--The term `phase II clinical 
     trial' means a phase II clinical investigation, as described 
     in section 312.21 of title 21, Code of Federal Regulations 
     (or any successor regulations).
       ``(2) Phase iii clinical trials.--The term `phase III 
     clinical trial' means a phase III clinical investigation, as 
     described in section 312.21 of title 21, Code of Federal 
     Regulations (or any successor regulations).
       ``(3) High need cure.--The term `high need cure' has the 
     meaning given such term in section 480(a)(3).''.

             Subtitle B--Investing in Safety and Innovation

     SEC. 711. FOOD AND DRUG ADMINISTRATION.

       (a) FDA Innovation Account.--
       (1) In general.--Section 1002(b) of the 21st Century Cures 
     Act (Public Law 114-255) is amended--
       (A) in paragraph (1), by striking ``paragraph (4)'' and 
     inserting ``paragraphs (4) and (5)''; and

[[Page H10160]]

       (B) by adding at the end the following new paragraph:
       ``(5) Supplemental funding and additional activities.--
       ``(A) In general.--In addition to the funds made available 
     under paragraph (2), there are authorized to be appropriated, 
     and are hereby appropriated, to the Account, out of any 
     monies in the Treasury not otherwise appropriated, to be 
     available until expended without further appropriation, the 
     following:
       ``(i) For fiscal year 2020, $417,500,000.
       ``(ii) For each of fiscal years 2021 and 2022, 
     $157,500,000.
       ``(iii) For each of fiscal years 2023 through 2025, 
     $152,500,000.
       ``(iv) For each of fiscal years 2026 through 2029, 
     $202,500,000.
       ``(B) Supplemental funding for certain activities.--Of the 
     total amounts made available under subparagraph (A) for each 
     of fiscal years 2026 through 2029, a total amount not to 
     exceed $50,000,000 for each such fiscal year, shall be made 
     available for the activities under subtitles A through F 
     (including the amendments made by such subtitles) of title 
     III of this Act and section 1014 of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 3073 of this Act.
       ``(C) Additional fda activities.--In addition to funding 
     activities pursuant to subparagraph (B), of the total amounts 
     made available under subparagraph (A), a total amount not to 
     exceed the following shall be made available for the 
     following categories of activities:
       ``(i) For modernization of the technical infrastructure of 
     the Food and Drug Administration, including enhancements such 
     as interoperability across the agency, and additional 
     capabilities to develop an advanced information technology 
     infrastructure to support the agency's regulatory mission:

       ``(I) For fiscal year 2020, $180,000,000.
       ``(II) For each of fiscal years 2021 through 2029, $60,000.

       ``(ii) For support for continuous manufacturing of drugs 
     and biological products, including complex biological 
     products such as regenerative medicine therapies, through 
     grants to institutions of higher education and nonprofit 
     organizations and other appropriate mechanisms, for each of 
     fiscal years 2020 through 2029, $20,000,000.
       ``(iii) For support for the Commissioner of Food and Drugs 
     to engage experts, such as through the formation and 
     operation of public-private partnerships or other appropriate 
     collaborative efforts, to advance the development and 
     delivery of individualized human gene therapy products:

       ``(I) For fiscal year 2020, $50,000,000.
       ``(II) For each of fiscal years 2021 through 2029, 
     $10,000,000.

       ``(iv) For support for inspections, enforcement, and 
     quality surveillance activities across the Food and Drug 
     Administration, including foreign and domestic inspections 
     across products, for each of fiscal years 2020 through 2029, 
     $20,000,000.
       ``(v) For support for activities of the Food and Drug 
     Administration related to customs and border protection to 
     provide improvements to technologies, inspection capacity, 
     and sites of import (including international mail facilities) 
     in which the Food and Drug Administration operates, for each 
     of fiscal years 2020 through 2029, $10,000,000.
       ``(vi) To further advance the development of a coordinated 
     postmarket surveillance system for all medical products, 
     including drugs, biological products, and devices, linked to 
     electronic health records in furtherance of the Food and Drug 
     Administration's postmarket surveillance capabilities:

       ``(I) For fiscal year 2020, $112,500,000.
       ``(II) For each of fiscal years 2021 through 2029, 
     $12,500,000.

       ``(vii) For support for Food and Drug Administration 
     activities to keep pace with the projected product 
     development of regenerative therapies, including cellular and 
     somatic cell gene therapy products:

       ``(I) For each of fiscal years 2020 through 2022, 
     $10,000,000.
       ``(II) For each of fiscal years 2023 through 2029, 
     $5,000,000.

       ``(viii) For carrying out section 714A of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379d-3a; relating to hiring 
     authority for scientific, technical, and professional 
     personnel), for each of fiscal years 2020 through 2029, 
     $2,500,000.
       ``(ix) For the Food and Drug Administration to support 
     improvements to the technological infrastructure for 
     reporting and analysis of adverse events associated with the 
     use of drugs and biological products, for each of fiscal 
     years 2020 through 2029, $12,500,000.''.
       (2) Conforming amendments.--Section 1002 of the 21st 
     Century Cures Act (Public Law 114-255) is amended--
       (A) in subsection (a), by inserting before the period at 
     the end the following: ``or pursuant to subparagraph (A) of 
     subsection (b)(5) to carry out the activities described in 
     subparagraphs (B) and (C) of such subsection''; and
       (B) in subsection (d)--
       (i) by inserting ``or pursuant to subparagraph (A) of 
     subsection (b)(5)'' after ``subsection (b)(3)''; and
       (ii) by striking ``subsection (b)(4)'' and inserting 
     ``subsections (b)(4) and (b)(5)''.
       (b) Annual Report.--Section 1002(c)(2)(A) of the 21st 
     Century Cures Act (Public Law 114-255) is amended, in the 
     matter preceding clause (i), by striking ``2026'' and 
     inserting ``2030''.
       (c) Sunset.--Section 1002(e) of the 21st Century Cures Act 
     (Public Law 114-255) is amended by striking ``September 30, 
     2025'' and inserting ``September 30, 2030''.

                  Subtitle C--Opioid Epidemic Response

     SEC. 721. OPIOID EPIDEMIC RESPONSE FUND.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall use 
     any funds made available pursuant to subsection (b) to carry 
     out the programs and activities described in subsection (c) 
     to address the opioid and substance use disorder epidemic. 
     Such funds shall be in addition to any funds which are 
     otherwise available to carry out such programs and 
     activities.
       (b) Opioid Epidemic Response Fund.--
       (1) Establishment of account.--There is established in the 
     Treasury an account, to be known as the Opioid Epidemic 
     Response Fund (referred to in this section as the ``Fund''), 
     for purposes of funding the programs and activities described 
     in subsection (c).
       (2) Funding.--There is authorized to be appropriated, and 
     there is appropriated, to the Fund, out of any monies in the 
     Treasury not otherwise appropriated $1,980,000,000 for each 
     of fiscal years 2021 through 2025.
       (3) Availability.--Amounts made available by paragraph (2) 
     shall be made available to the agencies specified in 
     subsection (c) in accordance with such subsection. Amounts 
     made available to an agency pursuant to the preceding 
     sentence for a fiscal year shall remain available until 
     expended.
       (c) Programs and Activities.--Of the total amount in the 
     Fund for each of fiscal years 2021 through 2025, such amount 
     shall be allocated as follows:
       (1) SAMHSA.--For the Substance Abuse and Mental Health 
     Services Administration to carry out programs and activities 
     pursuant to section 722, $1,500,000,000 for each of fiscal 
     years 2021 through 2025.
       (2) CDC.--For the Centers for Disease Control and 
     Prevention to carry out programs and activities pursuant to 
     section 723, $120,000,000 for each of fiscal years 2021 
     through 2025.
       (3) FDA.--For the Food and Drug Administration to carry out 
     programs and activities pursuant to section 724, $10,000,000 
     for each of fiscal years 2021 through 2025.
       (4) NIH.--For the National Institutes of Health to carry 
     out programs and activities pursuant to section 725, 
     $240,000,000 for each of fiscal years 2021 through 2025.
       (5) HRSA.--For the Health Resources and Services 
     Administration to carry out programs and activities pursuant 
     to section 726, $90,000,000 for each of fiscal years 2021 
     through 2025.
       (6) ACF.--For the Administration for Children and Families 
     to carry out programs and activities pursuant to section 727, 
     $20,000,000 for each of fiscal years 2021 through 2025.
       (d) Accountability and Oversight.--
       (1) Work plan.--
       (A) In general.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the Committee on Health, Education, 
     Labor, and Pensions and the Committee on Appropriations of 
     the Senate and the Committee on Energy and Commerce, the 
     Committee on Appropriations, and the Committee on Education 
     and Labor of the House of Representatives, a work plan 
     including the proposed allocation of funds made available 
     pursuant to subsection (b) for each of fiscal years 2021 
     through 2025 and the contents described in subparagraph (B).
       (B) Contents.--The work plan submitted under subparagraph 
     (A) shall include--
       (i) the amount of money to be obligated or expended out of 
     the Fund in each fiscal year for each program and activity 
     described in subsection (c); and
       (ii) a description and justification of each such program 
     and activity.
       (2) Annual reports.--Not later than October 1 of each of 
     fiscal years 2022 through 2026, the Secretary of Health and 
     Human Services shall submit to the Committee on Health, 
     Education, Labor, and Pensions and the Committee on 
     Appropriations of the Senate and the Committee on Energy and 
     Commerce, the Committee on Appropriations, and the Committee 
     on Education and Labor of the House of Representatives, a 
     report including--
       (A) the amount of money obligated or expended out of the 
     Fund in the prior fiscal year for each program and activity 
     described in subsection (c);
       (B) a description of all programs and activities using 
     funds made available pursuant to subsection (b); and
       (C) how the programs and activities are responding to the 
     opioid and substance use disorder epidemic.
       (e) Limitations.--Notwithstanding any authority in this 
     subtitle or any appropriations Act, any funds made available 
     pursuant to subsection (b) may not be used for any purpose 
     other than the programs and activities described in 
     subsection (c).

     SEC. 722. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES 
                   ADMINISTRATION.

       (a) In General.--The entirety of the funds made available 
     pursuant to section 721(c)(1) shall be for the Assistant 
     Secretary for Mental Health and Substance Use to continue to 
     award the State Opioid Response Grants funded by the heading 
     ``Substance Abuse And Mental Health Services Administration--
     Substance Abuse Treatment'' in title II of the Departments of 
     Labor, Health and Human Services, and Education, and Related 
     Agencies Appropriations Act, 2018 (Public Law 115-141). 
     Subject to subsections (b) and (c), such grants shall be 
     awarded in the same manner and subject to the same conditions 
     as were applicable to such grants for fiscal year 2018.
       (b) Requirement That Treatment Be Evidence-based.--As a 
     condition on receipt of a grant pursuant to subsection (a), a 
     grantee shall agree that--
       (1) treatments, practices, or interventions funded through 
     the grant will be evidence-based; and

[[Page H10161]]

       (2) such treatments, practices, and interventions will 
     include medication-assisted treatment for individuals 
     diagnosed with opioid use disorder, using drugs only if the 
     drugs have been approved or licensed by the Food and Drug 
     Administration 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).
       (c) Reservations.--Of the amount made available pursuant to 
     section 731(c)(1) for a fiscal year--
       (1) not less than $75,000,000 shall be reserved to make 
     grants under subsection (a) to Indian Tribes or Tribal 
     organizations; and
       (2) not less than $50,000,000 shall be reserved to make 
     grants under subsection (a) to political subdivisions of 
     States, such as counties, cities, or towns.

     SEC. 723. CENTERS FOR DISEASE CONTROL AND PREVENTION.

       (a) Addressing Opioid Use Disorder.--The entirety of the 
     funds made available pursuant to section 721(c)(2) shall be 
     for the Director of the Centers for Disease Control and 
     Prevention, pursuant to applicable authorities in the Public 
     Health Service Act (42 U.S.C. 201 et seq.), to continue and 
     expand programs of the Centers for Disease Control and 
     Prevention to address opioid and substance use disorder, 
     including by--
       (1) improving the timeliness and quality of data on the 
     opioid use disorder epidemic, including improvement of--
       (A) data on fatal and nonfatal overdoses;
       (B) syndromic surveillance;
       (C) data on long-term sequelae (including neonatal 
     abstinence syndrome); and
       (D) cause of death reporting related to substance abuse or 
     opioid overdose;
       (2) expanding and strengthening evidence-based prevention 
     and education strategies;
       (3) supporting responsible prescribing practices, including 
     through development and dissemination of prescriber 
     guidelines;
       (4) improving access to and use of effective prevention, 
     treatment, and recovery support, including through grants and 
     the provision of technical assistance to States and 
     localities;
       (5) strengthening partnerships with first responders, 
     including to protect their safety;
       (6) considering the needs of vulnerable populations;
       (7) addressing infectious diseases linked to the opioid 
     crisis;
       (8) strengthening prescription drug monitoring programs; 
     and
       (9) providing financial and technical assistance to State 
     and local health department efforts to treat and prevent 
     substance use disorder.
       (b) Limitation.--Of the funds made available pursuant to 
     section 721(c)(2) for carrying out this section, not more 
     than 20 percent may be used for intramural purposes.

     SEC. 724. FOOD AND DRUG ADMINISTRATION.

       The entirety of the funds made available pursuant to 
     section 721(c)(3) shall be for the Commissioner of Food and 
     Drugs, pursuant to applicable authorities in the Public 
     Health Service Act (42 U.S.C. 201 et seq.) or the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and 
     other applicable law, to support widespread innovation in 
     non-opioid and non-addictive medical products for pain 
     treatment, access to opioid addiction treatments, appropriate 
     use of approved opioids, and efforts to reduce illicit 
     importation of opioids. Such support may include the 
     following:
       (1) Facilitating the development of non-opioid and non-
     addictive pain treatments.
       (2) Advancing guidance documents for sponsors of non-opioid 
     pain products.
       (3) Developing evidence to inform the potential for 
     nonprescription overdose therapies.
       (4) Examining expanded labeling indications for medication-
     assisted treatment.
       (5) Conducting public education and outreach, including 
     public workshops or public meetings, regarding the benefits 
     of medication-assisted treatment, including all drugs 
     approved by the Food and Drug Administration, and device 
     treatment options approved or cleared by the Food and Drug 
     Administration.
       (6) Exploring the expansion and possible mandatory nature 
     of prescriber education regarding pain management and 
     appropriate opioid prescribing through authorities under 
     section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355-1).
       (7) Examining options to limit the duration of opioid 
     prescriptions for acute pain, including through packaging 
     options.
       (8) Increasing staff and infrastructure capacity to inspect 
     and analyze packages at international mail facilities and 
     pursue criminal investigations.

     SEC. 725. NATIONAL INSTITUTES OF HEALTH.

       The entirety of the funds made available pursuant to 
     section 721(c)(4) shall be for the Director of the National 
     Institutes of Health, pursuant to applicable authorities in 
     the Public Health Service Act (42 U.S.C. 201 et seq.), to 
     carry out activities related to--
       (1) accelerating research for addressing the opioid use 
     disorder epidemic, including developing non-opioid 
     medications and interventions, including non-addictive 
     medications, to manage pain, as well as developing 
     medications and interventions to treat and to prevent 
     substance use disorders;
       (2) conducting and supporting research on which treatments 
     (in terms of pain management as well as treating and 
     preventing substance use disorders) are optimal for which 
     patients; and
       (3) conducting and supporting research on creating longer-
     lasting or faster-acting antidotes for opioid overdose, 
     particularly in response to the prevalence of fentanyl and 
     carfentanyl overdoses.

     SEC. 726. HEALTH RESOURCES AND SERVICES ADMINISTRATION.

       The entirety of the funds made available pursuant to 
     section 721(c)(5) shall be for the Administrator of the 
     Health Resources and Services Administration, pursuant to 
     applicable authorities in titles III, VII, and VIII of the 
     Public Health Service Act (42 U.S.C. 241 et seq.), to carry 
     out activities that increase the availability and capacity of 
     the behavioral health workforce. Such activities shall 
     include providing loan repayment assistance for substance use 
     disorder treatment providers.

     SEC. 727. ADMINISTRATION FOR CHILDREN AND FAMILIES.

       Of the funds made available pursuant to section 721(c)(6) 
     for each of fiscal years 2021 through 2025, $20,000,000 for 
     each such fiscal year shall be for the Secretary of Health 
     and Human Services to carry out title I of the Child Abuse 
     Prevention and Treatment Act (42 U.S.C. 5101 et seq.).

                       TITLE VIII--MISCELLANEOUS

     SEC. 801. GUARANTEED ISSUE OF CERTAIN MEDIGAP POLICIES.

       (a) Guaranteed Issue of Medigap Policies to All Medigap-
     Eligible Medicare Beneficiaries.--
       (1) In general.--Section 1882(s) of the Social Security Act 
     (42 U.S.C. 1395ss(s)) is amended--
       (A) in paragraph (2)(A), by striking ``65 years of age or 
     older and is enrolled for benefits under part B'' and 
     inserting ``entitled to, or enrolled for, benefits under part 
     A and enrolled for benefits under part B'';
       (B) in paragraph (2)(D), by striking ``who is 65 years of 
     age or older as of the date of issuance and'';
       (C) in paragraph (3)(B)(ii), by striking ``is 65 years of 
     age or older and''; and
       (D) in paragraph (3)(B)(vi), by striking ``at age 65''.
       (2) Additional enrollment period for certain individuals.--
       (A) One-time enrollment period.--
       (i) In general.--In the case of a specified individual, the 
     Secretary shall establish a one-time enrollment period 
     described in clause (iii) during which such an individual may 
     enroll in any medicare supplemental policy of the 
     individual's choosing.
       (ii) Application.--The provisions of--

       (I) paragraph (2) of section 1882(s) of the Social Security 
     Act (42 U.S.C. 1395ss(s)) shall apply with respect to a 
     specified individual who is described in subclause (I) of 
     subparagraph (B)(iii) as if references in such paragraph (2) 
     to the 6 month period described in subparagraph (A) of such 
     paragraph were references to the one-time enrollment period 
     established under clause (i); and
       (II) paragraph (3) of such section shall apply with respect 
     to a specified individual who is described in subclause (II) 
     of subparagraph (B)(iii) as if references in such paragraph 
     (3) to the period specified in subparagraph (E) of such 
     paragraph were references to the one-time enrollment period 
     established under clause (i).

       (iii) Period.--The enrollment period established under 
     clause (i) shall be the 6-month period beginning on January 
     1, 2024.
       (B) Specified individual.--For purposes of this paragraph, 
     the term ``specified individual'' means an individual who--
       (i) is entitled to hospital insurance benefits under part A 
     of title XVIII of the Social Security Act (42 U.S.C. 1395c et 
     seq.) pursuant to section 226(b) or section 226A of such Act 
     (42 U.S.C. 426(b); 426-1);
       (ii) is enrolled for benefits under part B of such Act (42 
     U.S.C. 1395j et seq.); and
       (iii)(I) would not, but for the amendments made by 
     subparagraphs (A) and (B) of paragraph (1) and the provisions 
     of this paragraph (if such provisions applied to such 
     individual), be eligible for the guaranteed issue of a 
     medicare supplemental policy under paragraph (2) of section 
     1882(s) of such Act (42 U.S.C. 1395ss(s)); or
       (II) would not, but for the amendments made by 
     subparagraphs (C) and (D) of paragraph (1) and the provisions 
     of this paragraph (if such provisions applied to such 
     individual), be eligible for the guaranteed issue of a 
     medicare supplemental policy under paragraph (3) of such 
     section.
       (C) Outreach plan.--
       (i) In general.--The Secretary shall develop an outreach 
     plan to notify specified individuals of the one-time 
     enrollment period established under subparagraph (A).
       (ii) Consultation.--In implementing the outreach plan 
     developed under clause (i), the Secretary shall consult with 
     consumer advocates, brokers, insurers, the National 
     Association of Insurance Commissioners, and State Health 
     Insurance Assistance Programs.
       (3) Effective date.--The amendments made by paragraph (1) 
     shall apply to medicare supplemental policies effective on or 
     after January 1, 2024.
       (b) Guaranteed Issue of Medigap Policies for Medicare 
     Advantage Enrollees.--
       (1) In general.--Section 1882(s)(3) of the Social Security 
     Act (42 U.S.C. 1395ss(s)(3)), as amended by subsection (a), 
     is further amended--
       (A) in subparagraph (B), by adding at the end the following 
     new clause:
       ``(vii) The individual--
       ``(I) was enrolled in a Medicare Advantage plan under part 
     C for not less than 12 months;
       ``(II) subsequently disenrolled from such plan;
       ``(III) elects to receive benefits under this title through 
     the original Medicare fee-for-service program under parts A 
     and B; and
       ``(IV) has not previously elected to receive benefits under 
     this title through the original Medicare fee-for-service 
     program pursuant to disenrollment from a Medicare Advantage 
     plan under part C.'';
       (B) by striking subparagraph (C)(iii) and inserting the 
     following:

[[Page H10162]]

       ``(iii) Subject to subsection (v)(1), for purposes of an 
     individual described in clause (vi) or (vii) of subparagraph 
     (B), a medicare supplemental policy described in this 
     subparagraph shall include any medicare supplemental 
     policy.''; and
       (C) in subparagraph (E)--
       (i) in clause (iv), by striking ``and'' at the end;
       (ii) in clause (v), by striking the period at the end and 
     inserting ``; and''; and
       (iii) by adding at the end the following new clause--
       ``(vi) in the case of an individual described in 
     subparagraph (B)(vii), the annual, coordinated election 
     period (as defined in section 1851(e)(3)(B)) or a continuous 
     open enrollment period (as defined in section 1851(e)(2)) 
     during which the individual disenrolls from a Medicare 
     Advantage plan under part C.''.
       (2) Effective date.--The amendments made by paragraph (1) 
     shall apply to medicare supplemental policies effective on or 
     after January 1, 2024.

     SEC. 802. REPORTING REQUIREMENTS FOR PDP SPONSORS REGARDING 
                   POINT-OF-SALE REJECTIONS UNDER MEDICARE PART D.

       Section 1860D-4(g) of the Social Security Act (42 U.S.C. 
     1395w-104(g)) is amended by adding at the end the following 
     new paragraph:
       ``(3) Reporting requirements regarding point-of-sale 
     rejections.--
       ``(A) In general.--With respect to a plan year beginning on 
     or after January 1, 2020, a PDP sponsor offering a 
     prescription drug plan shall submit to the Secretary, in a 
     form and manner specified by the Secretary, information on 
     point-of-sale rejections made during a period of time 
     occurring in such plan year (as specified by the Secretary), 
     including each of the following:
       ``(i) The reason for each point-of-sale rejection.
       ``(ii) Identifying information for each drug with respect 
     to which a point-of-sale rejection was made.
       ``(iii) With respect to applicable types of point-of-sale 
     rejections (as specified by the Secretary), each of the 
     following:

       ``(I) Whether such a rejection was consistent with the 
     formulary of the plan (as approved by the Secretary).
       ``(II) Whether a coverage determination or appeal of a 
     coverage determination was requested for the drug with 
     respect to which such a rejection was made.
       ``(III) The outcome of any such coverage determination or 
     appeal of a coverage determination.
       ``(IV) The length of time between when such a rejection was 
     made and when the drug with respect to which such rejection 
     was made is dispensed, as applicable.

       ``(B) Public availability of information.--The Secretary 
     shall make publicly available on the public website of the 
     Centers for Medicare & Medicaid Services information 
     submitted under subparagraph (A).
       ``(C) Use of information.--The Secretary may use 
     information submitted under subparagraph (A), as determined 
     appropriate, in developing measures for the 5-star rating 
     system under section 1853(o)(4).
       ``(D) Implementation.--Notwithstanding any other provision 
     of law, the Secretary may implement this paragraph through 
     program instruction or otherwise.
       ``(E) Funding.--The are authorized to be appropriated to 
     the Secretary from the Federal Supplementary Medical 
     Insurance Trust Fund under section 1841 such sums as may be 
     necessary to implement this paragraph.''.

     SEC. 803. PROVIDING ACCESS TO ANNUAL MEDICARE NOTIFICATIONS 
                   IN MULTIPLE LANGUAGES.

       (a) In General.--Section 1804 of the Social Security Act 
     (42 U.S.C. 1395b-2) is amended by adding at the end the 
     following new subsection:
       ``(e) The notice provided under subsection (a) shall be 
     translated into languages in addition to English and Spanish. 
     In carrying out the previous sentence, the Secretary shall 
     prioritize translation of the notice into languages in which 
     documents provided by the Commissioner of Social Security are 
     translated and language that are the most frequently 
     requested for translation for purposes of applying for old-
     age insurance benefits under title II.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to notices distributed prior to each Medicare 
     open enrollment period beginning after January 1, 2020.

     SEC. 804. TEMPORARY INCREASE IN MEDICARE PART B PAYMENT FOR 
                   CERTAIN BIOSIMILAR BIOLOGICAL PRODUCTS.

       Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 
     1395w-3a(b)(8)) is amended--
       (1) by redesignating subparagraphs (A) and (B) as clauses 
     (i) and (ii), respectively, and moving the margin of each 
     such redesignated clause 2 ems to the right;
       (2) by striking ``product.--The amount'' and inserting the 
     following: ``product.--
       ``(A) In general.--Subject to subparagraph (B), the 
     amount''; and
       (3) by adding at the end the following new subparagraph:
       ``(B) Temporary payment increase.--
       ``(i) In general.--In the case of a qualifying biosimilar 
     biological product that is furnished during the applicable 5-
     year period for such product, the amount specified in this 
     paragraph for such product with respect to such period is the 
     sum determined under subparagraph (A), except that clause 
     (ii) of such subparagraph shall be applied by substituting `8 
     percent' for `6 percent'.
       ``(ii) Applicable 5-year period.--For purposes of clause 
     (i), the applicable 5-year period for a biosimilar biological 
     product is--

       ``(I) in the case of such a product for which payment was 
     made under this paragraph as of December 31, 2019, the 5-year 
     period beginning on January 1, 2020; and
       ``(II) in the case of such a product for which payment is 
     first made under this paragraph during a calendar quarter 
     during the period beginning January 1, 2020, and ending 
     December 31, 2024, the 5-year period beginning on the first 
     day of such calendar quarter during which such payment is 
     first made.

       ``(iii) Qualifying biosimilar biological product defined.--
     For purposes of this subparagraph, the term `qualifying 
     biosimilar biological product' means a biosimilar biological 
     product described in paragraph (1)(C) with respect to which--

       ``(I) in the case of a product described in clause (ii)(I), 
     the average sales price is not more than the average sales 
     price for the reference biological product; and
       ``(II) in the case of a product described in clause 
     (ii)(II), the wholesale acquisition cost is not more than the 
     wholesale acquisition cost for the reference biological 
     product.''.

     SEC. 805. 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) in the second sentence, by striking ``section 1834(0)'' 
     and inserting ``section 1834(o)'';
       (2) by moving such second sentence 2 ems to the left; and
       (3) by inserting the following third sentence following 
     such second sentence: ``For 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.''.

     SEC. 806. MEDICARE COVERAGE OF CERTAIN LYMPHEDEMA COMPRESSION 
                   TREATMENT ITEMS.

       (a) Coverage.--
       (1) In general.--Section 1861 of the Social Security Act 
     (42 U.S.C. 1395x), as amended by section 601 and section 603, 
     is further amended--
       (A) in subsection (s)(2)--
       (i) in subparagraph (II), by striking ``and'' after the 
     semicolon at the end;
       (ii) in subparagraph (JJ), by striking the period at the 
     end and inserting ``; and''; and
       (iii) by adding at the end the following new subparagraph:
       ``(KK) lymphedema compression treatment items (as defined 
     in subsection (mmm));''; and
       (B) by adding at the end the following new subsection:
       ``(mmm) Lymphedema Compression Treatment Items.--The term 
     `lymphedema compression treatment items' means compression 
     garments, devices, bandaging systems, components, and 
     supplies, including multilayer compression bandaging systems, 
     standard fit gradient compression garments, and other 
     compression garments, devices, bandaging systems, components, 
     or supplies (as determined by the Secretary), that are--
       ``(1) furnished on or after January 1, 2022, to an 
     individual with a diagnosis of lymphedema for the treatment 
     of such condition;
       ``(2) primarily and customarily used in the medical 
     treatment of lymphedema, as determined by the Secretary; and
       ``(3) prescribed by a physician (or a physician assistant, 
     nurse practitioner, or a clinical nurse specialist (as those 
     terms are defined in section 1861(aa)(5)) to the extent 
     authorized under State law).''.
       (2) Payment.--
       (A) In general.--Section 1833(a)(1) of the Social Security 
     Act (42 U.S.C. 1395l(a)(1)), as amended by section 601(c)(1), 
     is further amended--
       (i) by striking ``and'' before ``(DD)''; and
       (ii) by inserting before the semicolon at the end the 
     following: ``, and (EE) with respect to lymphedema 
     compression treatment items (as defined in section 
     1861(mmm)), the amount paid shall be equal to 80 percent of 
     the lesser of the actual charge or the amount determined 
     under the payment basis determined under section 1834(z)''.
       (B) Payment basis and limitations.--Section 1834 of the 
     Social Security Act (42 U.S.C. 1395m), as amended by sections 
     601(c)(2) and 603(c), is further amended by adding at the end 
     the following new subsection:
       ``(z) Payment for Lymphedema Compression Treatment Items.--
       ``(1) In general.--The Secretary shall determine an 
     appropriate payment basis for lymphedema compression 
     treatment items (as defined in section 1861(mmm)). In making 
     such a determination, the Secretary may take into account 
     payment rates for such items under State plans (or waivers of 
     such plans) under title XIX, the Veterans Health 
     Administration, and group health plans and health insurance 
     coverage (as such terms are defined in section 2791 of the 
     Public Health Service Act), and such other information as the 
     Secretary determines appropriate.
       ``(2) Frequency limitation.--No payment may be made under 
     this part for lymphedema compression treatment items 
     furnished other than at such frequency as the Secretary may 
     establish.
       ``(3) Application of competitive acquisition.--In the case 
     of lymphedema compression treatment items that are included 
     in a competitive acquisition program in a competitive 
     acquisition area under section 1847(a)--
       ``(A) the payment basis under this subsection for such 
     items furnished in such area shall be the payment basis 
     determined under such competitive acquisition program; and
       ``(B) the Secretary may use information on the payment 
     determined under such competitive acquisition programs to 
     adjust the payment amount otherwise determined under this 
     subsection for an area that is not a competitive acquisition 
     area under section 1847, and in the

[[Page H10163]]

     case of such adjustment, paragraphs (8) and (9) of section 
     1842(b) shall not be applied.''.
       (3) Conforming amendments.--
       (A) Exclusions.--Section 1862(a)(1) of the Social Security 
     Act (42 U.S.C. 1395y(a)(1)), as amended by section 601(f) and 
     section 603(g), is further amended--
       (i) in subparagraph (Q), by striking ``and'' at the end;
       (ii) in subparagraph (R), by striking the semicolon and 
     inserting ``, and''; and
       (iii) by adding at the end the following new subparagraph:
       ``(S) in the case of lymphedema compression treatment items 
     (as defined in section 1861(mmm)), which are furnished more 
     frequently than is established pursuant to section 
     1834(z)(2);''.
       (B) Application of competitive acquisition.--
       (i) In general.--Section 1847(a)(2) of the Social Security 
     Act (42 U.S.C. 1395w-3(a)(2)), as amended by sections 
     601(e)(2)(B)(ii), 602(b)(3)(B)(i), and 603(f)(2)(B), is 
     further amended by adding at the end the following new 
     subparagraph:
       ``(G) Lymphedema compression treatment items.--Lymphedema 
     compression treatment items (as defined in section 1861(mmm)) 
     for which payment would otherwise be made under section 
     1834(z).''.
       (b) Inclusion in Requirements for Suppliers of Medical 
     Equipment and Supplies.--Section 1834(j)(5) of the Social 
     Security Act (42 U.S.C. 1395m(j)(5)) is amended--
       (1) by redesignating subparagraphs (E) and (F) as 
     subparagraphs (F) and (G), respectively; and
       (2) by inserting after subparagraph (D) the following new 
     subparagraph:
       ``(E) lymphedema compression treatment items (as defined in 
     section 1861(mmm));''.
       (c) Study and Report on Implementation.--
       (1) Study.--The Secretary of Health and Human Services (in 
     this section referred to as the ``Secretary'') shall conduct 
     a study on the implementation of Medicare coverage of certain 
     lymphedema compression treatment items under the amendments 
     made by this Act. Such study shall include an evaluation of 
     the following:
       (A) Medicare beneficiary utilization of items and services 
     under parts A and B of title XVIII of the Social Security Act 
     as a result of the implementation of such amendments.
       (B) Whether the Secretary has determined, pursuant to 
     section 1861(mmm) of the Social Security Act, as added by 
     subsection (a)(1), that lymphedema compression treatment 
     items other than compression bandaging systems and standard 
     fit gradient compression garments are covered under such 
     section.
       (2) Report.--Not later than January 1, 2024, the Secretary 
     shall submit to Congress and make available to the public a 
     report on the study conducted under paragraph (1).

     SEC. 807. PHYSICIAN FEE UPDATE.

       Section 1848(d)(19) of the Social Security Act (42 U.S.C. 
     1395w-4(d)(19)) is amended to read as follows:
       ``(19) Update for 2020 through 2025.--The update to the 
     single conversion factor established in paragraph (1)(C)--
       ``(A) for each of 2020 through 2022 shall be 0.5 percent; 
     and
       ``(B) for each of 2023 through 2025 shall be 0.0 
     percent.''.

     SEC. 808. ADDITIONAL COMMUNITY HEALTH CENTER FUNDING.

       Section 10503 of the Patient Protection and Affordable Care 
     Act (42 U.S.C. 254b-2) is amended by striking subsection (c) 
     and inserting the following:
       ``(c) Additional Enhanced Funding; Capital Projects.--There 
     is authorized to be appropriated, and there is appropriated, 
     out of any monies in the Treasury not otherwise appropriated, 
     to the CHC Fund--
       ``(1) to be transferred to the Secretary of Health and 
     Human Services to provide additional enhanced funding for the 
     community health center program under section 330 of the 
     Public Health Service Act, $1,000,000,000 for each of fiscal 
     years 2021 through 2025; and
       ``(2) to be transferred to the Secretary of Health and 
     Human Services for capital projects of the community health 
     center program under section 330 of the Public Health Service 
     Act, $5,000,000,000 for the period of fiscal years 2021 
     through 2025.''.

     SEC. 809. GRANTS TO IMPROVE TRAUMA SUPPORT SERVICES AND 
                   MENTAL HEALTH CARE FOR CHILDREN AND YOUTH IN 
                   EDUCATIONAL SETTINGS.

       (a) Grants, Contracts, and Cooperative Agreements 
     Authorized.--The Secretary, in coordination with the 
     Assistant Secretary for Mental Health and Substance Use, is 
     authorized to award grants to, or enter into contracts or 
     cooperative agreements with, State educational agencies, 
     local educational agencies, Indian Tribes (as defined in 
     section 4 of the Indian Self-Determination and Education 
     Assistance Act) or their tribal educational agencies, a 
     school operated by the Bureau of Indian Education, a Regional 
     Corporation, or a Native Hawaiian educational organization, 
     for the purpose of increasing student access to evidence-
     based trauma support services and mental health care by 
     developing innovative initiatives, activities, or programs to 
     link local school systems with local trauma-informed support 
     and mental health systems, including those under the Indian 
     Health Service.
       (b) Duration.--With respect to a grant, contract, or 
     cooperative agreement awarded or entered into under this 
     section, the period during which payments under such grant, 
     contract, or agreement are made to the recipient may not 
     exceed 4 years.
       (c) Use of Funds.--An entity that receives a grant, 
     contract, or cooperative agreement under this section shall 
     use amounts made available through such grant, contract, or 
     cooperative agreement for evidence-based activities, which 
     shall include any of the following:
       (1) Collaborative efforts between school-based service 
     systems and trauma-informed support and mental health service 
     systems to provide, develop, or improve prevention, 
     screening, referral, and treatment and support services to 
     students, such as providing trauma screenings to identify 
     students in need of specialized support.
       (2) To implement schoolwide positive behavioral 
     interventions and supports, or other trauma-informed models 
     of support.
       (3) To provide professional development to teachers, 
     teacher assistants, school leaders, specialized instructional 
     support personnel, and mental health professionals that--
       (A) fosters safe and stable learning environments that 
     prevent and mitigate the effects of trauma, including through 
     social and emotional learning;
       (B) improves school capacity to identify, refer, and 
     provide services to students in need of trauma support or 
     behavioral health services; or
       (C) reflects the best practices for trauma-informed 
     identification, referral, and support developed by the 
     Interagency Task Force on Trauma-Informed Care.
       (4) Services at a full-service community school that 
     focuses on trauma-informed supports, which may include a 
     full-time site coordinator, or other activities consistent 
     with section 4625 of the Elementary and Secondary Education 
     Act of 1965 (20 U.S.C. 7275).
       (5) Engaging families and communities in efforts to 
     increase awareness of child and youth trauma, which may 
     include sharing best practices with law enforcement regarding 
     trauma-informed care and working with mental health 
     professionals to provide interventions, as well as longer 
     term coordinated care within the community for children and 
     youth who have experienced trauma and their families.
       (6) To provide technical assistance to school systems and 
     mental health agencies.
       (7) To evaluate the effectiveness of the program carried 
     out under this section in increasing student access to 
     evidence-based trauma support services and mental health 
     care.
       (8) To establish partnerships with or provide subgrants to 
     Head Start agencies (including Early Head Start agencies), 
     public and private preschool programs, child care programs 
     (including home-based providers), or other entities described 
     in subsection (a), to include such entities described in this 
     paragraph in the evidence-based trauma initiatives, 
     activities, support services, and mental health systems 
     established under this section in order to provide, develop, 
     or improve prevention, screening, referral, and treatment and 
     support services to young children and their families.
       (d) Applications.--To be eligible to receive a grant, 
     contract, or cooperative agreement under this section, an 
     entity described in subsection (a) shall submit an 
     application to the Secretary at such time, in such manner, 
     and containing such information as the Secretary may 
     reasonably require, which shall include the following:
       (1) A description of the innovative initiatives, 
     activities, or programs to be funded under the grant, 
     contract, or cooperative agreement, including how such 
     program will increase access to evidence-based trauma support 
     services and mental health care for students, and, as 
     applicable, the families of such students.
       (2) A description of how the program will provide 
     linguistically appropriate and culturally competent services.
       (3) A description of how the program will support students 
     and the school in improving the school climate in order to 
     support an environment conducive to learning.
       (4) An assurance that--
       (A) persons providing services under the grant, contract, 
     or cooperative agreement are adequately trained to provide 
     such services; and
       (B) teachers, school leaders, administrators, specialized 
     instructional support personnel, representatives of local 
     Indian Tribes or tribal organizations as appropriate, other 
     school personnel, and parents or guardians of students 
     participating in services under this section will be engaged 
     and involved in the design and implementation of the 
     services.
       (5) A description of how the applicant will support and 
     integrate existing school-based services with the program in 
     order to provide mental health services for students, as 
     appropriate.
       (6) A description of the entities in the community with 
     which the applicant will partner or to which the applicant 
     will provide subgrants in accordance with subsection (c)(8).
       (e) Interagency Agreements.--
       (1) Local interagency agreements.--To ensure the provision 
     of the services described in subsection (c), a recipient of a 
     grant, contract, or cooperative agreement under this section, 
     or their designee, shall establish a local interagency 
     agreement among local educational agencies, agencies 
     responsible for early childhood education programs, Head 
     Start agencies (including Early Head Start agencies), 
     juvenile justice authorities, mental health agencies, child 
     welfare agencies, and other relevant agencies, authorities, 
     or entities in the community that will be involved in the 
     provision of such services.
       (2) Contents.--In ensuring the provision of the services 
     described in subsection (c), the local interagency agreement 
     shall specify with respect to each agency, authority, or 
     entity that is a party to such agreement--
       (A) the financial responsibility for the services;
       (B) the conditions and terms of responsibility for the 
     services, including quality, accountability, and coordination 
     of the services; and
       (C) the conditions and terms of reimbursement among such 
     agencies, authorities, or entities, including procedures for 
     dispute resolution.

[[Page H10164]]

       (f) Evaluation.--The Secretary shall reserve not more than 
     3 percent of the funds made available under subsection (l) 
     for each fiscal year to--
       (1) conduct a rigorous, independent evaluation of the 
     activities funded under this section; and
       (2) disseminate and promote the utilization of evidence-
     based practices regarding trauma support services and mental 
     health care.
       (g) Distribution of Awards.--The Secretary shall ensure 
     that grants, contracts, and cooperative agreements awarded or 
     entered into under this section are equitably distributed 
     among the geographical regions of the United States and among 
     tribal, urban, suburban, and rural populations.
       (h) Rule of Construction.--Nothing in this section shall be 
     construed--
       (1) to prohibit an entity involved with a program carried 
     out under this section from reporting a crime that is 
     committed by a student to appropriate authorities; or
       (2) to prevent Federal, State, and tribal law enforcement 
     and judicial authorities from exercising their 
     responsibilities with regard to the application of Federal, 
     tribal, and State law to crimes committed by a student.
       (i) Supplement, Not Supplant.--Any services provided 
     through programs carried out under this section shall 
     supplement, and not supplant, existing mental health 
     services, including any special education and related 
     services provided under the Individuals with Disabilities 
     Education Act (20 U.S.C. 1400 et seq.).
       (j) Consultation With Indian Tribes.--In carrying out 
     subsection (a), the Secretary shall, in a timely manner, 
     meaningfully consult with Indian Tribes and their 
     representatives to ensure notice of eligibility.
       (k) Definitions.--In this section:
       (1) Elementary school.--The term ``elementary school'' has 
     the meaning given such term in section 8101 of the Elementary 
     and Secondary Education Act of 1965 (20 U.S.C. 7801).
       (2) Evidence-based.--The term ``evidence-based'' has the 
     meaning given such term in section 8101(21)(A)(i) of the 
     Elementary and Secondary Education Act of 1965 (20 U.S.C. 
     7801(21)(A)(i)).
       (3) Native hawaiian educational organization.--The term 
     ``Native Hawaiian educational organization'' has the meaning 
     given such term in section 6207 of the Elementary and 
     Secondary Education Act of 1965 (20 U.S.C. 7517).
       (4) Local educational agency.--The term ``local educational 
     agency'' has the meaning given such term in section 8101 of 
     the Elementary and Secondary Education Act of 1965 (20 U.S.C. 
     7801).
       (5) Regional corporation.--The term ``Regional 
     Corporation'' has the meaning given the term in section 3 of 
     the Alaska Native Claims Settlement Act (43 U.S.C. 1602).
       (6) School.--The term ``school'' means a public elementary 
     school or public secondary school.
       (7) School leader.--The term ``school leader'' has the 
     meaning given such term in section 8101 of the Elementary and 
     Secondary Education Act of 1965 (20 U.S.C. 7801).
       (8) Secondary school.--The term ``secondary school'' has 
     the meaning given such term in section 8101 of the Elementary 
     and Secondary Education Act of 1965 (20 U.S.C. 7801).
       (9) Secretary.--The term ``Secretary'' means the Secretary 
     of Education.
       (10) Specialized instructional support personnel.--The term 
     ``specialized instructional support personnel'' has the 
     meaning given such term in section 8101 of the Elementary and 
     Secondary Education Act of 1965 (20 U.S.C. 7801).
       (11) State educational agency.--The term ``State 
     educational agency'' has the meaning given such term in 
     section 8101 of the Elementary and Secondary Education Act of 
     1965 (20 U.S.C. 7801).
       (l) Authorization of Appropriations.--There is authorized 
     to be appropriated, and there is appropriated, out of any 
     money in the Treasury not otherwise appropriated, to carry 
     out this section, $20,000,000 for each of fiscal years 2021 
     through 2025.

     SEC. 810. PATHWAY TO HEALTH CAREERS ACT.

       (a) Short Title.--This section may be cited as the 
     ``Pathways to Health Careers Act''.
       (b) Extension Through Fiscal Year 2020 of Funding for 
     Demonstration Projects to Address Health Professions 
     Workforce Needs.--
       (1) In general.--Section 2008(c)(1) of the Social Security 
     Act (42 U.S.C. 1397g(c)(1)) is amended by striking ``2019.'' 
     and inserting ``2020, and to provide technical assistance and 
     cover administrative costs associated with implementing the 
     successor to this section $15,000,000 for fiscal year 
     2020.''.
       (2) Availability of other funds.--Upon the date of the 
     enactment of this section--
       (A) amounts expended pursuant to section 1501 of division B 
     of Public Law 116-59, or any other prior law making amounts 
     available for fiscal year 2020 for activities authorized by 
     section 2008 of the Social Security Act, shall be charged to 
     the appropriation made by subsection (c)(1) of such section 
     2008 for fiscal year 2020 (not including the amount for 
     technical assistance and administrative costs); and
       (B) if such enactment occurs on or before November 21, 
     2019, the availability of funds appropriated in, and the 
     authority provided under, such section 1501 shall terminate.
       (c) Career Pathways Through Health Profession Opportunity 
     Grants.--Effective October 1, 2020, section 2008 of the 
     Social Security Act (42 U.S.C. 1397g) is amended to read as 
     follows:

     ``SEC. 2008. CAREER PATHWAYS THROUGH HEALTH PROFESSION 
                   OPPORTUNITY GRANTS.

       ``(a) Application Requirements.--An eligible entity 
     desiring a grant under this section for a project shall 
     submit to the Secretary an application for the grant, that 
     includes the following:
       ``(1) A description of how the applicant will use a career 
     pathways approach to train eligible individuals for health 
     professions that pay well or will put eligible individuals on 
     a career path to an occupation that pays well, under the 
     project.
       ``(2) A description of the adult basic education and 
     literacy activities, work readiness activities, training 
     activities, and case management and career coaching services 
     that the applicant will use to assist eligible individuals to 
     gain work experience, connection to employers, and job 
     placement, and a description of the plan for recruiting, 
     hiring, and training staff to provide the case management, 
     mentoring, and career coaching services, under the project 
     directly or through local governmental, apprenticeship, 
     educational, or charitable institutions.
       ``(3) In the case of an application for a grant under this 
     section for a demonstration project described in subsection 
     (c)(2)(B)(i)(I)--
       ``(A) a demonstration that the State in which the 
     demonstration project is to be conducted has in effect 
     policies or laws that permit certain allied health and 
     behavioral health care credentials to be awarded to people 
     with certain arrest or conviction records (which policies or 
     laws shall include appeals processes, waivers, certificates, 
     and other opportunities to demonstrate rehabilitation to 
     obtain credentials, licensure, and approval to work in the 
     proposed health careers), and a plan described in the 
     application that will use a career pathway to assist 
     participants with such a record in acquiring credentials, 
     licensing, and employment in the specified careers;
       ``(B) a discussion of how the project or future strategic 
     hiring decisions will demonstrate the experience and 
     expertise of the project in working with job seekers who have 
     arrest or conviction records or employers with experience 
     working with people with arrest or conviction records;
       ``(C) an identification of promising innovations or best 
     practices that can be used to provide the training;
       ``(D) a proof of concept or demonstration that the 
     applicant has done sufficient research on workforce shortage 
     or in-demand jobs for which people with certain types of 
     arrest or conviction records can be hired;
       ``(E) a plan for recruiting students who are eligible 
     individuals into the project; and
       ``(F) a plan for providing post-employment support and 
     ongoing training as part of a career pathway under the 
     project.
       ``(4) In the case of an application for a grant under this 
     section for a demonstration project described in subsection 
     (c)(2)(B)(i)(II)--
       ``(A) a description of the partnerships, strategic staff 
     hiring decisions, tailored program activities, or other 
     programmatic elements of the project, such as training plans 
     for doulas and other community health workers and training 
     plans for midwives and other allied health professions, that 
     are designed to support a career pathway in pregnancy, birth, 
     or post-partum services; and
       ``(B) a demonstration that the State in which the 
     demonstration project is to be conducted recognizes doulas or 
     midwives, as the case may be.
       ``(5) A demonstration that the applicant has experience 
     working with low-income populations, or a description of the 
     plan of the applicant to work with a partner organization 
     that has the experience.
       ``(6) A plan for providing post-employment support and 
     ongoing training as part of a career pathway under the 
     project.
       ``(7) A description of the support services that the 
     applicant will provide under the project, including a plan 
     for how child care and transportation support services will 
     be guaranteed and, if the applicant will provide a cash 
     stipend or wage supplement, how the stipend or supplement 
     would be calculated and distributed.
       ``(8) A certification by the applicant that the project 
     development included--
       ``(A) consultation with a local workforce development board 
     established under section 107 of the Workforce Innovation and 
     Opportunity Act;
       ``(B) consideration of apprenticeship and pre-
     apprenticeship models registered under the Act of August 16, 
     1937 (also known as the `National Apprenticeship Act');
       ``(C) consideration of career pathway programs in the State 
     in which the project is to be conducted; and
       ``(D) a review of the State plan under section 102 or 103 
     of the Workforce Innovation and Opportunity Act.
       ``(9) A description of the availability and relevance of 
     recent labor market information and other pertinent evidence 
     of in-demand jobs or worker shortages.
       ``(10) A certification that the applicant will directly 
     provide or contract for the training services described in 
     the application.
       ``(11) A commitment by the applicant that, if the grant is 
     made to the applicant, the applicant will--
       ``(A) during the planning period for the project, provide 
     the Secretary with any information needed by the Secretary to 
     establish adequate data reporting and administrative 
     structure for the project;
       ``(B) hire a person to direct the project not later than 
     the end of the planning period applicable to the project;
       ``(C) accept all technical assistance offered by the 
     Secretary with respect to the grant;
       ``(D) participate in such in-person grantee conferences as 
     are regularly scheduled by the Secretary;
       ``(E) provide all data required by the Secretary under 
     subsection (g); and
       ``(F) notify the local disabled veterans' outreach program 
     specialists under section 4103A of title 38, United States 
     Code, and the local veterans' employment representatives 
     under section 4104 of such title, of the grantee's outreach 
     plan

[[Page H10165]]

     for advertising training opportunities to potential 
     participants in the project.
       ``(b) Preferences in Considering Applications.--In 
     considering applications for a grant under this section, the 
     Secretary shall give preference to--
       ``(1) applications submitted by applicants to whom a grant 
     was made under this section or any predecessor to this 
     section;
       ``(2) applications submitted by applicants who have 
     business and community partners in each of the following 
     categories:
       ``(A) State and local government agencies and social 
     service providers, including a State or local entity that 
     administers a State program funded under part A of this 
     title;
       ``(B) institutions of higher education, apprenticeship 
     programs, and local workforce development boards established 
     under section 107 of the Workforce Innovation and Opportunity 
     Act; and
       ``(C) health care employers, health care industry or sector 
     partnerships, labor unions, and labor-management 
     partnerships;
       ``(3) applications that include opportunities for mentoring 
     or peer support, and make career coaching available, as part 
     of the case management plan;
       ``(4) applications which describe a project that will serve 
     a rural area in which--
       ``(A) the community in which the individuals to be enrolled 
     in the project reside is located;
       ``(B) the project will be conducted; or
       ``(C) an employer partnership that has committed to hiring 
     individuals who successfully complete all activities under 
     the project is located;
       ``(5) applications that include a commitment to providing 
     project participants with a cash stipend or wage supplement; 
     and
       ``(6) applications which have an emergency cash fund to 
     assist project participants financially in emergency 
     situations.
       ``(c) Grants.--
       ``(1) Competitive grants.--
       ``(A) Grant authority.--
       ``(i) In general.--The Secretary, in consultation with the 
     Secretary of Labor and the Secretary of Education, may make a 
     grant in accordance with this paragraph to an eligible entity 
     whose application for the grant is approved by the Secretary, 
     to conduct a project designed to train low-income individuals 
     for allied health professions, health information technology, 
     physicians assistants, nursing assistants, registered nurse, 
     advanced practice nurse, and other professions considered 
     part of a health care career pathway model.
       ``(ii) Guarantee of grantees in each state and the district 
     of columbia.--For each grant cycle, the Secretary shall award 
     a grant under this paragraph to at least 2 eligible entities 
     in each State that is not a territory, to the extent there 
     are a sufficient number of applications submitted by the 
     entities that meet the requirements applicable with respect 
     to such a grant. If, for a grant cycle, there are fewer than 
     2 such eligible entities in a State, the Secretary shall 
     include that information in the report required by subsection 
     (g)(2) that covers the fiscal year.
       ``(B) Guarantee of grants for indian populations.--From the 
     amount reserved under subsection (i)(2)(B) for each fiscal 
     year, the Secretary shall award a grant under this paragraph 
     to at least 10 eligible entities that are an Indian tribe, a 
     tribal organization, or a tribal college or university, to 
     the extent there are a sufficient number of applications 
     submitted by the entities that meet the requirements 
     applicable with respect to such a grant.
       ``(C) Guarantee of grantees in the territories.--From the 
     amount reserved under subsection (i)(2)(C) for each fiscal 
     year, the Secretary shall award a grant under this paragraph 
     to at least 2 eligible entities that are located in a 
     territory, to the extent there are a sufficient number of 
     applications submitted by the entities that meet the 
     requirements applicable with respect to such a grant.
       ``(2) Grants for demonstration projects.--
       ``(A) Grant authority.--The Secretary, in consultation with 
     the Secretary of Labor and the Secretary of Education (and, 
     with respect to demonstration projects of the type described 
     in subparagraph (B)(i)(I), the Attorney General) shall make a 
     grant in accordance with this subsection to an eligible 
     entity whose application for the grant is approved by the 
     Secretary, to conduct a demonstration project that meets the 
     requirements of subparagraph (B).
       ``(B) Requirements.--The requirements of this subparagraph 
     are the following:
       ``(i) Type of project.--The demonstration project shall be 
     of 1 of the following types:

       ``(I) Individuals with arrest or conviction records 
     demonstration.--The demonstration project shall be of a type 
     designed to provide education and training for eligible 
     individuals with arrest or conviction records to enter and 
     follow a career pathway in the health professions through 
     occupations that pay well and are expected to experience a 
     labor shortage or be in high demand.
       ``(II) Pregnancy and childbirth career pathway 
     demonstration.--The demonstration project shall be of a type 
     designed to provide education and training for eligible 
     individuals to enter and follow a career pathway in the field 
     of pregnancy, childbirth, or post-partum, in a State that 
     recognizes doulas or midwives and that provides payment for 
     services provided by doulas or midwives, as the case may be, 
     under private or public health insurance plans.

       ``(ii) Duration.--The demonstration project shall be 
     conducted for not less than 5 years.
       ``(C) Minimum allocation of funds for each type of 
     demonstration project.--
       ``(i) Individuals with arrest or conviction records 
     demonstrations.--Not less than 25 percent of the amounts made 
     available for grants under this paragraph shall be used to 
     make grants for demonstration projects of the type described 
     in subparagraph (B)(i)(I).
       ``(ii) Pregnancy and childbirth career pathway 
     demonstrations.--Not less than 25 percent of the amounts made 
     available for grants under this paragraph shall be used to 
     make grants for demonstration projects of the type described 
     in subparagraph (B)(i)(II).
       ``(3) Grant cycle.--The grant cycle under this section 
     shall be not less than 5 years, with a planning period of not 
     more than the 1st 12 months of the grant cycle. During the 
     planning period, the amount of the grant shall be in such 
     lesser amount as the Secretary determines appropriate.
       ``(d) Use of Grant.--
       ``(1) In general.--An entity to which a grant is made under 
     this section shall use the grant in accordance with the 
     approved application for the grant.
       ``(2) Support to be provided.--
       ``(A) Required support.--A project for which a grant is 
     made under this section shall include the following:
       ``(i) An assessment for adult basic skill competency, and 
     provision of adult basic skills education if necessary for 
     lower-skilled eligible individuals to enroll in the project 
     and go on to enter and complete post-secondary training, 
     through means including the following:

       ``(I) Establishing a network of partners that offer pre-
     training activities for project participants who need to 
     improve basic academic skills or English language proficiency 
     before entering a health occupational training career pathway 
     program.
       ``(II) Offering resources to enable project participants to 
     continue advancing adult basic skill proficiency while 
     enrolled in a career pathway program.
       ``(III) Embedding adult basic skill maintenance as part of 
     ongoing post-graduation career coaching and mentoring.

       ``(ii) A guarantee that child care is an available and 
     affordable support service for project participants through 
     means such as the following;

       ``(I) Referral to, and assistance with, enrollment in a 
     subsidized child care program.
       ``(II) Direct payment to a child care provider if a slot in 
     a subsidized child care program is not available or 
     reasonably accessible.
       ``(III) Payment of co-payments or associated fees for child 
     care.

       ``(iii) Case management plans that include career coaching 
     (with the option to offer appropriate peer support and 
     mentoring opportunities to help develop soft skills and 
     social capital), which may be offered on an ongoing basis 
     before, during, and after initial training as part of a 
     career pathway model.
       ``(iv) A plan to provide project participants with 
     transportation through means such as the following:

       ``(I) Referral to, and assistance with enrollment in, a 
     subsidized transportation program.
       ``(II) If a subsidized transportation program is not 
     reasonably available, direct payments to subsidize 
     transportation costs.

     For purposes of this clause, the term `transportation' 
     includes public transit, or gasoline for a personal vehicle 
     if public transit is not reasonably accessible or available.
       ``(v) In the case of a demonstration project of the type 
     described in subsection (c)(2)(B)(i)(I), access to legal 
     assistance for project participants for the purpose of 
     addressing arrest or conviction records and associated 
     workforce barriers.
       ``(B) Allowed support.--The goods and services provided 
     under a project for which a grant is made under this section 
     may include the following:
       ``(i) A cash stipend that is at least monthly.
       ``(ii) A reserve fund for financial assistance to project 
     participants in emergency situations.
       ``(iii) Tuition, and training materials such as books, 
     software, uniforms, shoes, and hair nets.
       ``(iv) In-kind resource donations such as interview 
     clothing and conference attendance fees.
       ``(v) Assistance with accessing and completing high school 
     equivalency or adult basic education courses as necessary to 
     achieve success in the project and make progress toward 
     career goals.
       ``(vi) Assistance with programs and activities, including 
     legal assistance, deemed necessary to address arrest or 
     conviction records as an employment barrier.
       ``(vii) Other support services as deemed necessary for 
     family well-being, success in the project, and progress 
     toward career goals.
       ``(C) Treatment of support for purposes of means-tested 
     programs.--Any goods or services provided to an eligible 
     individual participating in a project for which a grant is 
     made under this section shall not be considered income, and 
     shall not be taken into account for purposes of determining 
     the eligibility of the individual for, or amount of benefits 
     to be provided to the individual, under any means-tested 
     program.
       ``(3) Training.--The number of hours of training provided 
     to an eligible individual under a project for which a grant 
     is made under this section, for a recognized postsecondary 
     credential, including an industry-recognized credential, 
     which is awarded in recognition of attainment of measurable 
     technical or occupational skills necessary to gain employment 
     or advance within an occupation (including a certificate 
     awarded by a local workforce development board established 
     under section 107 of the Workforce Innovation and Opportunity 
     Act), shall be--
       ``(A) not less than the number of hours of training 
     required for certification in that level of skill by the 
     State in which the project is conducted; or
       ``(B) if there is no such requirement, such number of hours 
     of training as the Secretary finds is necessary to achieve 
     that skill level.
       ``(4) Income limitation.--An entity to which a grant is 
     made under this section shall not use

[[Page H10166]]

     the grant to provide support to a person who is not an 
     eligible individual.
       ``(5) Inclusion of tanf recipients.--In the case of a 
     project for which a grant is made under this section that is 
     conducted in a State that has a program funded under part A 
     of title IV, at least 10 percent of the eligible individuals 
     to whom support is provided under the project shall meet the 
     income eligibility requirements under that State program, 
     without regard to whether the individuals receive benefits or 
     services directly under that State program.
       ``(6) Prohibition.--An entity to which a grant is made 
     under this section shall not use the grant for purposes of 
     entertainment, except that case management and career 
     coaching services may include celebrations of specific 
     career-based milestones such as completing a semester, 
     graduation, or job placement.
       ``(e) Technical Assistance.--
       ``(1) In general.--The Secretary shall provide technical 
     assistance--
       ``(A) to assist eligible entities in applying for grants 
     under this section;
       ``(B) that is tailored to meet the needs of grantees at 
     each stage of the administration of projects for which grants 
     are made under this section;
       ``(C) that is tailored to meet the specific needs of Indian 
     tribes, tribal organizations, and tribal colleges and 
     universities;
       ``(D) that is tailored to meet the specific needs of the 
     territories;
       ``(E) that is tailored to meet the specific needs of 
     eligible entities in carrying out demonstration projects for 
     which a grant is made under this section; and
       ``(F) to facilitate the exchange of information among 
     eligible entities regarding best practices and promising 
     practices used in the projects.
       ``(2) Continuation of peer technical assistance 
     conferences.--The Secretary shall continue to hold peer 
     technical assistance conferences for entities to which a 
     grant is made under this section or was made under the 
     immediate predecessor of this section.
       ``(f) Evaluation of Demonstration Projects.--
       ``(1) In general.--The Secretary shall, by grant, contract, 
     or interagency agreement, conduct rigorous and well-designed 
     evaluations of the demonstration projects for which a grant 
     is made under this section.
       ``(2) Requirement applicable to individuals with arrest or 
     conviction records demonstration.--In the case of a project 
     of the type described in subsection (c)(2)(B)(i)(I), the 
     evaluation shall include identification of successful 
     activities for creating opportunities for developing and 
     sustaining, particularly with respect to low-income 
     individuals with arrest or conviction records, a health 
     professions workforce that has accessible entry points, that 
     meets high standards for education, training, certification, 
     and professional development, and that provides increased 
     wages and affordable benefits, including health care 
     coverage, that are responsive to the needs of the workforce.
       ``(3) Requirement applicable to pregnancy and childbirth 
     career pathway demonstration.--In the case of a project of 
     the type described in subsection (c)(2)(B)(i)(II), the 
     evaluation shall include identification of successful 
     activities for creating opportunities for developing and 
     sustaining, particularly with respect to low-income 
     individuals and other entry-level workers, a career pathway 
     that has accessible entry points, that meets high standards 
     for education, training, certification, and professional 
     development, and that provides increased wages and affordable 
     benefits, including health care coverage, that are responsive 
     to the needs of the birth, pregnancy, and post-partum 
     workforce.
       ``(4) Rule of interpretation.--Evaluations conducted 
     pursuant to this subsection may include a randomized 
     controlled trial, but this subsection shall not be 
     interpreted to require an evaluation to include such a trial.
       ``(g) Reports.--
       ``(1) To the secretary.--An eligible entity awarded a grant 
     to conduct a project under this section shall submit interim 
     reports to the Secretary on the activities carried out under 
     the project, and, on the conclusion of the project, a final 
     report on the activities. Each such report shall include data 
     on participant outcomes related to earnings, employment in 
     health professions, graduation rate, graduation timeliness, 
     credential attainment, participant demographics, and other 
     data specified by the Secretary.
       ``(2) To the congress.--During each Congress, the Secretary 
     shall submit to the Committee on Ways and Means of the House 
     of Representatives and the Committee on Finance of the Senate 
     a report--
       ``(A) on the demographics of the participants in the 
     projects for which a grant is made under this section;
       ``(B) on the rate of which project participants completed 
     all activities under the projects;
       ``(C) on the employment credentials acquired by project 
     participants;
       ``(D) on the employment of project participants on 
     completion of activities under the projects, and the earnings 
     of project participants at entry into employment;
       ``(E) on best practices and promising practices used in the 
     projects;
       ``(F) on the nature of any technical assistance provided to 
     grantees under this section;
       ``(G) on, with respect to the period since the period 
     covered in the most recent prior report submitted under this 
     paragraph--
       ``(i) the number of applications submitted under this 
     section, with a separate statement of the number of 
     applications referred to in subsection (b)(5);
       ``(ii) the number of applications that were approved, with 
     a separate statement of the number of such applications 
     referred to in subsection (b)(5); and
       ``(iii) a description of how grants were made in any case 
     described in the last sentence of subsection (c)(1)(A)(ii); 
     and
       ``(H) that includes an assessment of the effectiveness of 
     the projects with respect to addressing health professions 
     workforce shortages or in-demand jobs.
       ``(h) Definitions.--In this section:
       ``(1) Allied health profession.--The term `allied health 
     profession' has the meaning given in section 799B(5) of the 
     Public Health Service Act.
       ``(2) Career pathway.--The term `career pathway' has the 
     meaning given that term in section 3(7) of the Workforce 
     Innovation and Opportunity Act.
       ``(3) Doula.--The term `doula' means an individual who--
       ``(A) is certified by an organization that has been 
     established for not less than 5 years and that requires the 
     completion of continuing education to maintain the 
     certification, to provide non-medical advice, information, 
     emotional support, and physical comfort to an individual 
     during the individual's pregnancy, childbirth, and post-
     partum period; and
       ``(B) maintains the certification by completing the 
     required continuing education.
       ``(4) Eligible entity.--The term `eligible entity' means 
     any of the following entities that demonstrates in an 
     application submitted under this section that the entity has 
     the capacity to fully develop and administer the project 
     described in the application:
       ``(A) A local workforce development board established under 
     section 107 of the Workforce Innovation and Opportunity Act.
       ``(B) A State or territory, a political subdivision of a 
     State or territory, or an agency of a State, territory, or 
     such a political subdivision, including a State or local 
     entity that administers a State program funded under part A 
     of this title.
       ``(C) An Indian tribe, a tribal organization, or a tribal 
     college or university.
       ``(D) An institution of higher education (as defined in the 
     Higher Education Act of 1965).
       ``(E) A hospital (as defined in section 1861(e)).
       ``(F) A high-quality skilled nursing facility.
       ``(G) A Federally qualified health center (as defined in 
     section 1861(aa)(4)).
       ``(H) A nonprofit organization described in section 
     501(c)(3) of the Internal Revenue Code of 1986, a labor 
     organization, or an entity with shared labor-management 
     oversight, that has a demonstrated history of providing 
     health profession training to eligible individuals.
       ``(I) In the case of a demonstration project of the type 
     provided for in subsection (c)(2)(B)(i)(II) of this section, 
     an entity recognized by a State, Indian tribe, or tribal 
     organization as qualified to train doulas or midwives, if 
     midwives or doulas, as the case may be, are permitted to 
     practice in the State involved.
       ``(J) An opioid treatment program (as defined in section 
     1861(jjj)(2)), and other high quality comprehensive addiction 
     care providers.
       ``(5) Eligible individual.--The term `eligible individual' 
     means an individual whose family income does not exceed 200 
     percent of the Federal poverty level.
       ``(6) Federal poverty level.--The term `Federal poverty 
     level' means the poverty line (as defined in section 673(2) 
     of the Omnibus Budget Reconciliation Act of 1981, including 
     any revision required by such section applicable to a family 
     of the size involved).
       ``(7) Indian tribe; tribal organization.--The terms `Indian 
     tribe' and `tribal organization' have the meaning given the 
     terms in section 4 of the Indian Self-Determination and 
     Education Assistance Act (25 U.S.C. 450b).
       ``(8) Institution of higher education.--The term 
     `institution of higher education' has the meaning given the 
     term in section 101 or 102(a)(1)(B) of the Higher Education 
     Act of 1965.
       ``(9) Territory.--The term `territory' means the 
     Commonwealth of Puerto Rico, the United States Virgin 
     Islands, Guam, the Northern Mariana Islands, and American 
     Samoa.
       ``(10) Tribal college or university.--The term `tribal 
     college or university' has the meaning given the term in 
     section 316(b) of the Higher Education Act of 1965.
       ``(i) Funding.--
       ``(1) In general.--Out of any funds in the Treasury of the 
     United States not otherwise appropriated, there are 
     appropriated to the Secretary to carry out this section 
     $425,000,000 for each of fiscal years 2021 through 2025.
       ``(2) Allocation of funds.--Of the amount appropriated for 
     a fiscal year under paragraph (1) of this subsection--
       ``(A) 75 percent shall be available for grants under 
     subsection (c)(1)(A);
       ``(B) 4 percent shall be reserved for grants under 
     subsection (c)(1)(B);
       ``(C) 5 percent shall be reserved for grants under 
     subsection (c)(1)(C);
       ``(D) 6 percent shall be available for demonstration 
     project grants under subsection (c)(2);
       ``(E) 6 percent, plus all amounts referred to in 
     subparagraphs (A) through (D) of this paragraph that remain 
     unused after all grant awards are made for the fiscal year, 
     shall be available for the provision of technical assistance 
     and associated staffing; and
       ``(F) 4 percent shall be available for studying the effects 
     of the demonstration and non-demonstration projects for which 
     a grant is made under this section, and for associated 
     staffing, for the purpose of supporting the rigorous 
     evaluation of the demonstration projects, and supporting the 
     continued study of the short-, medium-, and long-term effects 
     of all such projects, including the effectiveness of new or 
     added elements of the non-demonstration projects.
       ``(j) Nonapplicability of Preceding Sections of This 
     Subtitle.--
       ``(1) In general.--Except as provided in paragraph (2), the 
     preceding sections of this subtitle shall not apply to a 
     grant awarded under this section.

[[Page H10167]]

       ``(2) Exception for certain limitations on use of grants.--
     Section 2005(a) (other than paragraphs (2), (3), (5), (6), 
     and (8)) shall apply to a grant awarded under this section to 
     the same extent and in the same manner as such section 
     applies to payments to States under this subtitle.''.

     SEC. 811. HOME VISITING TO REDUCE MATERNAL MORTALITY AND 
                   MORBIDITY ACT.

       (a) Short Title.--This section may be cited as the ``Home 
     Visiting to Reduce Maternal Mortality and Morbidity Act''.
       (b) Increase in Tribal Set-aside Percentage.--
       (1) In general.--Section 511(j)(2)(A) of the Social 
     Security Act (42 U.S.C. 711(j)(2)(A)) is amended by striking 
     ``3'' and inserting ``6''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect on October 1, 2020.
       (c) Increase in Funding.--Section 511(j)(1) of such Act (42 
     U.S.C. 711(j)(1)) is amended--
       (1) by striking ``and'' at the end of subparagraph (G); and
       (2) by striking subparagraph (H) and inserting the 
     following:
       ``(H) $400,000,000 for each of fiscal years 2017 through 
     2020;
       ``(I) $600,000,000 for fiscal year 2021; and
       ``(J) $800,000,000 for fiscal year 2022.''.
       (d) Use of Additional Funds.--Section 511(c) of such Act 
     (42 U.S.C. 711(c)) is amended by adding at the end the 
     following:
       ``(6) Use of certain funds to provide additional resources 
     to address high rates of maternal mortality and morbidity, 
     support unmet needs identified by the needs assessment, or 
     increase allocations to states and territories based on 
     relative population or poverty.--The Secretary shall ensure 
     that any amounts exceeding $400,000,000 that are used for 
     grants under this subsection for a fiscal year are used to--
       ``(A) provide additional funding priority to States, 
     tribes, and territories to address high rates of maternal 
     mortality and morbidity;
       ``(B) address unmet needs identified by a needs assessment 
     conducted under subsection (b); or
       ``(C) increase the amounts allocated under this section to 
     States and to Puerto Rico, Guam, the Virgin Islands, the 
     Northern Mariana Islands, and American Samoa, based on the 
     proportion of children who have not attained 5 years of age 
     and are living in poverty.''.

  The Acting CHAIR. No further amendment to the bill, as amended, shall 
be in order except those printed in part B of House Report 116-334. 
Each such further amendment may be offered only in the order printed in 
the report, by a Member designated in the report, shall be considered 
read, shall be debatable for the time specified in the 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.


                 Amendment No. 1 Offered by Mr. Walden

  The Acting CHAIR. It is now in order to consider amendment No. 1 
printed in part B of House Report 116-334.
  Mr. WALDEN. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.

[[Page H10168]]

                           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.--

[[Page H10169]]

       ``(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

[[Page H10170]]

     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;

[[Page H10171]]

       ``(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.

[[Page H10172]]

  


     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

[[Page H10173]]

     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

[[Page H10174]]

     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

[[Page H10175]]

     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)''.

[[Page H10176]]

       (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

[[Page H10177]]

     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.''.

[[Page H10178]]

  


                           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

[[Page H10179]]

     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,

[[Page H10180]]

     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

[[Page H10181]]

     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).

[[Page H10182]]

       ``(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--

[[Page H10183]]

       ``(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--

[[Page H10184]]

       (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:

[[Page H10185]]

       ``(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.

[[Page H10186]]

       (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).

[[Page H10187]]

       (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.

[[Page H10188]]

     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

[[Page H10189]]

     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

[[Page H10190]]

     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

[[Page H10191]]

       ``(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

[[Page H10192]]

     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.

[[Page H10193]]

       ``(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;

[[Page H10194]]

       (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

[[Page H10195]]

     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

[[Page H10196]]

       ``(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)).

[[Page H10197]]

       ``(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

[[Page H10198]]

     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.

[[Page H10199]]

       (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

[[Page H10200]]

     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

[[Page H10201]]

     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.''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from Oregon (Mr. Walden) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from Oregon.
  Mr. WALDEN. Mr. Chairman, I yield myself 2 minutes.
  I rise in support of the substitute amendment, H.R. 19, the Lower 
Costs, More Cures Act.
  There is a better way, ladies and gentlemen. We can reduce the high 
costs of drugs. We can improve health and lower long-term costs without 
stifling innovation and restricting patients' access to new, lifesaving 
medications.
  H.R. 19, the Lower Costs, More Cures Act, is the bipartisan solution 
that can be signed into law this year and immediately begin to provide 
relief to patients and seniors from high prescription costs.
  This bill lowers out-of-pocket spending. It protects access to new 
medicines and cures. It strengthens transparency and accountability and 
champions competition.
  Every single proposal in this substitute is bipartisan, Democrats and 
Republicans coming together.
  First, H.R. 19 encourages innovation of groundbreaking new cures and 
promotes the introduction of more low-cost generic and biosimilar 
competition to the marketplace faster, through inclusion of the CREATES 
Act, which streamlines the regulation of over-the-counter products, 
stopping the pay-for-delay agreements and patent system gamesmanship.
  These policies unanimously passed the Energy and Commerce Committee 
earlier this year. They would have unanimously passed on this House 
floor, had a poison pill not been put in up in the Rules Committee.
  H.R. 19 also has a critical provision to make insulin more affordable 
by requiring insurance companies to cap the costs of insulin for 
seniors at $50 a month.
  H.R. 19 increases transparency and removes uncertainty at the 
pharmacy counter by requiring insurance companies to make information 
about drug costs available in the doctor's office before a prescription 
is written.
  It reduces the cost of drug administration, including for cancer 
treatment. We can cut that in half. We will pay for quality, not sites.
  H.R. 19, for the first time, places a cap on seniors' out-of-pocket 
costs for the year.
  Critically, it stops the U.S. from subsidizing other freeloader 
foreign countries by having a strong trade rep to negotiate better 
deals for Americans.
  This will lower costs, and it will bring about cures.
  Mr. Chairman, I urge bipartisan support, and I reserve the balance of 
my time.
  Ms. PORTER. Mr. Chair, I rise in opposition to the amendment.
  The Acting CHAIR (Mr. Phillips). The gentlewoman from California is 
recognized for 5 minutes.
  Ms. PORTER. Mr. Chairman, I yield myself such time as I may consume.
  I made a promise to my constituents when I was elected that I would 
lower drug prices, and that requires a strong, robust plan for 
negotiating fair prices for Americans.
  Our constituents are demanding lower drug prices, and this amendment 
fails to deliver. It does nothing to address the root causes of high 
drug prices and would let pharma companies continue to raise prices 
unreasonably for the same drug year after year.
  I have a bill to stop that, which is included in H.R. 3. The Freedom 
from Price Gouging Act recovers taxpayer dollars from pharmaceutical 
companies when they try to hike their prices not just once per year but 
multiple times every year in order to boost their profits.
  This legislation has bipartisan support. It is included in Republican 
Senator Grassley's drug pricing package in the Senate.
  Without a way to hold drug price increases to at most the rate of 
inflation, drug companies can just counter your amendment's required 
discounts by jacking up drug prices and setting sky-high launch prices. 
They can continue to raise those prices year after year, and the 
American people will have no choice but to pay those prices because 
without a way to truly hold drug companies accountable, nothing will 
change.
  I believe we need real, substantive reforms, and for a while, so did 
our President. Though he has recently walked back this commitment, he 
once promised the American people that he would authorize the HHS 
Secretary to negotiate a fair deal on drugs. Do you know why he did 
that? Because drug price negotiation only upsets Big Pharma's CEOs. 
Everybody else--in fact, 90 percent of Americans--support giving the 
Secretary the power to negotiate prices for drugs, Democrats, 
Republicans, independents alike.
  H.R. 3 does just that. It pairs real reforms on drug pricing with a 
Medicare part D redesign that caps out-of-pocket expenses for seniors 
and more equitably shares the responsibility to determine prices among 
the Federal Government part D plans and drug manufacturers.
  The Walden amendment fails to achieve that goal. This amendment 
doesn't help the 150 million Americans with employer insurance, and 
many of those Americans even with good insurance still can't afford 
their medications. This amendment will gut protections in H.R. 3 and 
leave us with legislation that doesn't do nearly enough to rein in the 
costs of prescription drugs.
  It is time for all of us to take real action to lower drug prices for 
our constituents.
  Mr. Chair, I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, I yield 1\1/2\ minutes to the gentleman 
from Texas (Mr. Brady), the leading Republican on the powerful House 
Ways and Means Committee.
  Mr. BRADY. Mr. Chairman, I thank the gentleman for yielding and for 
his strong leadership on this. It has been invaluable.
  Like impeachment, Speaker Pelosi's fewer cures bill was written in 
secret, highly partisan, and is dead when it goes to the Senate. The 
President won't sign it. The Senate won't take it up. It is losing 
support every day.

  Here is an idea. Let's pass a bill. Let's come together. The only 
bill that has bipartisan provisions, bicameral provisions, a bill that 
lowers prices, deserves to become law, a bill you can be proud of, the 
Lower Costs, More Cures Act, our Republican bill.
  It doesn't kill cures; it accelerates them. It makes it easier for 
patients to use their personal healthcare plans to lower costs for 
medicines, holds pharma accountable by insisting they pay more of the 
drug costs for seniors. It pulls back the curtain on drug pricing. It 
forces these companies to justify their prices. It can help seniors 
lower their medicine costs by $300 a year.
  Every Member of Congress who pledged to deliver lower costs for 
families and seniors and who truly wants more cures for diseases will 
fulfill that promise with H.R. 19. I urge support.
  Ms. PORTER. Mr. Chairman, I agree with my Republican colleagues that 
we do need bipartisan action on drug pricing. Negotiating drug prices 
is not partisan to the American people; it is common sense.
  But let's be clear. The amendment to this bill is not bipartisan. 
Only Republicans have cosponsored this amendment.
  Mr. WALDEN. Will the gentlewoman yield?
  Ms. PORTER. I yield to the gentleman from Oregon.
  Mr. WALDEN. That is true on the bipartisan, but every provision in 
the bill has Democratic support as individual bills in other sectors. 
We brought only bipartisan bills into this alternative.

[[Page H10202]]

  Mr. Chair, I yield back the balance of my time.
  Ms. PORTER. Mr. Chairman, the gentleman is correct that there are 
many provisions in the amendment that do have strong bipartisan 
support, including, for example, making permanent the medical expense 
tax deduction.
  The problem with the amendment is it doesn't tackle the fundamental 
problem, which is reducing drug prices. This amendment fails to solve 
the main problem of actually lowering drug prices.
  This is why Senator Grassley has been a sponsor on the Republican 
side in the Senate of the kinds of things I have worked on that are 
included in this bill that would address price gouging, the ability of 
pharmaceutical companies to raise prices multiple times in a single 
year. This bill, H.R. 3, would let us capture the taxpayer savings from 
that.
  The GAO found that fewer than one in five new drugs are truly 
innovative. It is true that we need new cures, new cures for 
Alzheimer's, new cures for ALS, but H.R. 3 makes sure not just that we 
have new cures by increasing science research, but makes sure that 
those new cures are going to be affordable and can actually get into 
the hands of Americans.
  Mr. Chair, I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, let me say in response, the CBO also said 
38 new cures as a result of H.R. 3 will never come about. The Council 
of Economic Advisers says 100 new cures will never come about.
  H.R. 3, the underlying bill the majority wants to put into law, 
actually denies people who are desperately hoping for cures, that 
innovation.
  To answer further your question, there are 138 different Democratic 
sponsors of the bill that we have put together here.
  Mr. Chair, I yield 2 minutes to the gentlewoman from North Carolina 
(Ms. Foxx).
  Ms. FOXX of North Carolina. Mr. Chairman, Democrats are putting 
politics over progress by advancing a socialist drug pricing scheme 
that will hurt the development of money-saving treatments and, more 
importantly, people's lives.
  Sadly, workers and families are being let down by Democrats. That is 
why I am proud to sponsor and support H.R. 19, the Lower Costs, More 
Cures Act. This legislation includes 40 provisions backed by Democrats 
and Republicans, and it can go to the President's desk today.

                              {time}  1100

  Unlike H.R. 3, which the nonpartisan Congressional Budget Office 
predicts will result in 38 fewer cures, H.R. 19 protects access to new 
medicines and cures. It also lowers out-of-pocket spending, strengthens 
transparency and accountability, and champions competition.
  Mr. Chair, the Lower Costs, More Cures Act is policy that acts in the 
interests of hardworking Americans. I urge my colleagues to support 
this bipartisan, commonsense amendment.
  Ms. PORTER. Mr. Chair, claims that H.R. 3 will devastate research and 
stop cures are fearmongering.
  H.R. 3 makes substantial investment in public research to help create 
new cures and, most importantly, will make sure those cures actually 
can help people in their lives.
  It is only fair that the government, elected by the taxpayers, and 
the administration, appointed by elected officials, should get to 
negotiate drug prices, and it will not come at the expense of 
innovation.
  Mr. Chair, may I inquire as to how much time remains.
  The Acting CHAIR. The gentlewoman has 30 seconds remaining.
  Ms. PORTER. Mr. Chair, I look forward to working with my colleagues 
on both sides of the aisle to continue to come up with ways to support 
drug innovation and support the kind of innovation that is happening in 
Orange County, the area that I represent.
  But we have to tackle the fundamental problem here, which is that 
pharmaceutical companies are gouging Americans; they are overcharging 
them; and they are leaving lifesaving drugs out of the hands of the 
American people each and every day. This amendment does not tackle that 
fundamental problem. Today, 9 out of 10 big pharmaceutical companies 
spend more on marketing, sales, and overhead than they do on research.
  I am proud to support the package of H.R. 3 because it will tackle 
the fundamental problem of permitting price negotiation and making 
drugs more affordable for Americans.
  Mr. Chair, I yield back the balance of my time.
  Mr. WALDEN. Mr. Chairman, I yield myself such time as I may consume.
  I appreciate the gentlewoman's comments.
  Ours is the only bipartisan bill. Thirty-six different provisions 
passed out of either the Ways and Means or Energy and Commerce 
Committee with unanimous, bipartisan support, all these provisions 
cosponsored by Democrats. Seventeen different bills passed out of the 
House of Representatives with bipartisan support in here. This is the 
bipartisan package.
  I have always worked across the line to get things done, whether it 
was in opioids or 21st Century Cures or modernizing the FDA. I pledge 
to continue to do that.
  The partisan bill on the floor today is H.R. 3. The facts of the 
matter show that it will deny new innovation in America and new cures 
for patients whose lives are on the line.
  Mr. Chair, I urge a ``no'' vote on H.R. 3 and a ``yes'' on the 
substitute.
  Mr. Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Oregon (Mr. Walden).
  The question was taken; and the Acting Chair announced that the noes 
appeared to have it.
  Mr. WALDEN. Mr. Chairman, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentleman from Oregon will 
be postponed.


                  Amendment No. 2 Offered by Mr. Tonko

  The Acting CHAIR. It is now in order to consider amendment No. 2 
printed in part B of House Report 116-334.
  Mr. TONKO. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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

[[Page H10203]]

     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).

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from New York (Mr. Tonko) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from New York.
  Mr. TONKO. Mr. Chair, I yield myself as much time as I may consume.
  Despite the passage in 2010 of the Biologics Price Competition and 
Innovation Act through the Affordable Care Act, which created the 
modern pathway for bringing biosimilar drugs to market, consumers in 
the United States are still not reaping the cost-saving benefits that a 
full, mature biosimilars market would provide. As of May, only 19 
biosimilars had been approved by the FDA, and many of those that have 
been approved are not on the market for a number of reasons.
  Economics 101 teaches us that, when more competition is introduced 
into the market, prices come down. We have seen this with the 
overwhelming success of the generic pharmaceuticals market here at 
home, and we are seeing it with biosimilars in other parts of the 
globe.
  In Europe, for example, the introduction of biosimilar competition 
for Humira led to the brand manufacturer dropping the price by more 
than 80 percent in some countries.
  Unfortunately, here in the United States, biosimilars still face very 
low market share and utilization, despite the fact they could generate 
much-needed savings for patients and for taxpayers.
  If we want to continue to meaningfully lower drug costs for American 
patients, Congress can, and should, do more to create a policy 
environment that is ripe for greater biosimilar adoption.
  That is the underlying rationale behind my amendment, which is based 
on legislation I introduced with Congressman   Bob Gibbs, known as the 
Star Ratings for Biosimilars Act.
  This amendment would require the Department of Health and Human 
Services to incorporate into the existing Star Ratings system for 
Medicare Advantage and part D plans a measure that evaluates how plans 
promote access to biosimilar drugs.
  In creating such a measure, HHS would look at things such as coverage 
on a plan's formulary, tier placement, cost sharing, and other 
utilization management techniques.
  By evaluating plans on biosimilar access, this amendment would 
motivate health plans to improve performance and implement changes to 
improve access to biosimilars, creating a policy environment ripe for 
further biosimilar development. A similar measure has already been 
adopted by the Senate Finance Committee as they worked through their 
prescription drug legislation.
  I have heard from some criticism that the Star Ratings system has 
traditionally not been used for this type of measure. To that, I would 
contend that star ratings have already been used in several ways to 
influence plan behavior and improve plan quality, such as evaluating 
plans on how well they provide cancer screenings, care coordination, 
and Medicaid management, for example.
  All of these metrics are designed to incent plans into behavior that 
will improve plan transparency and beneficiary health.
  Likewise, access to affordable medications has significant 
implications for beneficiary health, as patients will abstain from 
needed medications if costs are simply too high. The CBO score for the 
underlying legislation makes this connection crystal clear.
  By evaluating plans on biosimilar access, we are ensuring that 
patients have the information they need that will allow them to live 
healthier lives.
  In closing, Mr. Chair, I would simply urge my colleagues to support 
this important amendment that will help lay the groundwork for greater 
biosimilar adoption and continue to lower drug costs for patients, 
obviously a common cause for each and every person in this Chamber.
  Mr. Chair, I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, I rise in opposition to the amendment.
  The Acting CHAIR. The gentleman from Oregon is recognized for 5 
minutes.
  Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume.
  Mr. Chair, I commend my friend, and he is my friend, Mr. Tonko. He is 
a very thoughtful legislator, and we have worked together on a lot of 
different bills.
  He offered and withdrew this amendment at full committee markup of 
H.R. 3, and I continue to extend the offer to sit down and try to work 
out the differences in the language.
  Unfortunately, as it is currently constructed, though, this could 
have unintended consequences, we believe, including actually increasing 
drug prices, which none of us wants, which I know is not the 
gentleman's goal either.
  Star ratings to measure the quality of an insurance plan or a 
specific benefit are a good tool for consumers and the government, but 
to apply an automatic star rating change to a plan's coverage of 
biosimilars could give a manufacturer too much negotiating leverage, 
and we don't want to do that.
  This would be a major shift in the type of quality measure the plans 
would be rated on and would actually affect the way they would 
negotiate with manufacturers and, unfortunately, we believe, not 
necessarily be in a way that lowers costs for consumers in Medicare 
Advantage.
  Star ratings are an important factor consumers consider when they are 
choosing their plan. If a plan knows they will be rated and reimbursed 
based on coverage of one biosimilar, they do not have much ground to 
stand on if they want to negotiate the cost of that drug down to 
benefit the patient.
  That means the manufacturer of the biosimilar has all the leverage 
and they can keep the price high, knowing they will likely still be 
placed on the plan's formulary because the plan is being rated on it.
  But the gentleman is right. We should do more to incentivize 
biosimilar development and coverage in this country. This is an 
important issue. And, again, I would be happy to work with him and 
others on the other side of the aisle on this and many other 
provisions.

  Mr. Chair, how much time do I have remaining?
  The Acting CHAIR. The gentleman from Oregon has 3\1/2\ minutes 
remaining.
  Mr. WALDEN. Mr. Chair, I yield 3 minutes to the gentleman from 
Montana (Mr. Gianforte).
  Mr. GIANFORTE. Mr. Chair, I thank the gentleman for yielding, and I 
appreciate the intent that the gentleman has here with this bill.
  The costs of prescription drugs have continued to rise, putting 
Montanans with critical health issues in jeopardy.
  I recently heard from a senior in Libby, Montana, with colon cancer. 
He was diagnosed in 2010, and his disease has bankrupted his family.
  He confided that the cancer drug he takes costs $17,000 per month. It 
is the only drug that works for his cancer, and Medicare only covers 
$11,000. He is forced to either give up his fight against cancer or pay 
an extra $6,000 a month for a lifesaving drug. That is an extra $72,000 
a year.
  As he put it: ``I find it rather disconcerting that one must sell his 
home and all his possessions just to survive cancer.''
  I agree. This has to stop. No one should have to end up like my 
constituent in Libby.
  The fact is that we could lower prescription costs while capping 
seniors' out-of-pocket costs by the end of 2019. It is also 
disheartening that Republicans have been working in good faith all year 
on a bipartisan basis to do just that.
  Unfortunately, House Democrats, led by Speaker Nancy Pelosi, are 
putting partisan politics in front of patients. Her plan would have 
devastating consequences for Montanans. It will lead to rationing of 
lifesaving medication, Big Government price fixing, and government 
bureaucrats between you and your medication.
  The truth is her partisan bill will never move past the House floor.
  We have heard from Majority Leader McConnell that the Pelosi plan is 
dead on arrival in the Senate, and it doesn't have a chance of being 
signed into law by President Trump.
  Unfortunately, as we wait on Democrats to act in a bipartisan way, 
costs

[[Page H10204]]

continue to rise and hardworking Montanans continue to choose between 
their needed medication and paying their bills.
  On the other hand, Republicans have introduced the Lower Costs, More 
Cures Act. This is a bipartisan bill that could be signed into law by 
the end of 2019. This bill increases transparency, encourages 
innovation for new drugs and cures, and places a cap on seniors' out-
of-pocket costs.
  I have also been working to lower costs and shed light on the true 
cost of prescription drugs. Last week, I introduced bipartisan 
legislation to bring much-needed transparency into the practice of 
middlemen in the pharmaceutical supply chain, called pharmacy benefit 
managers. My bill increases competition between PBMs and lowers costs 
for patients. It is truly a win-win.
  Waiting any longer to pass bills that lower costs for patients to 
score political points is unacceptable. Enough is enough. Let's stop 
the political theater and get back to work.
  Mr. TONKO. Mr. Chair, we have no further speakers on this side, and I 
am prepared to close.
  Mr. Chair, I respect the opinions of Mr. Walden. We have worked in a 
bipartisan fashion on several issues before in Energy and Commerce, but 
I believe the claim that this would increase costs is simply false. 
Like the Senate Finance Committee that is moving forward with this 
proposition on biosimilars, we believe it is a way to lower costs.
  To date, the nine biosimilars accessible to patients are at an 
average discount of 28 percent. It is simply a false claim that a 
biosimilar would not launch at a lower price.
  Certainly, we must do better. We are reminded constantly that we can 
do better and we must do better. As the namesake of this legislation 
had constantly implored, Representative Elijah Cummings always knew 
that we must score for the public. That is why we must pass this 
amendment.
  Mr. Chair, I yield back the balance of my time.
  Mr. WALDEN. Mr. Chairman, I understand my friend's comments. None of 
us wants to accidentally create a situation where prices go up rather 
than down, and I know that is not his intent. We have that concern on 
this side.
  Perhaps we can work this out along the way and get to the same place 
here, because I think we share a similar goal.
  Mr. Chair, I yield back the balance of my time.

                              {time}  1115

  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from New York (Mr. Tonko).
  The amendment was agreed to.


                 Amendment No. 3 Offered by Mr. Peters

  The Acting CHAIR. It is now in order to consider amendment No. 3 
printed in part B of House Report 116-334.
  Mr. PETERS. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from California (Mr. Peters) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from California.
  Mr. PETERS. Mr. Chair, I yield myself such time as I may consume.
  H.R. 3 is not perfect. No bill is. But I will support it today 
because it is our best chance to get moving on the very pressing issue 
of high prescription drug prices. I hope the Senate will work with us 
in a good-faith manner to come up with a final bill that both lowers 
prices and preserves incentives for innovation.
  The concerns and some outstanding questions about the effect of this 
bill on innovation in the private sector are legitimate. My colleagues 
have referenced the CBO studies. Also, the California Life Sciences 
Association released a report in October that predicted that H.R. 3 
would make drug development particularly challenging for small and 
emerging companies in California.
  The amendment I offer today will go a long way toward preserving and 
supporting biopharmaceutical innovation, and that is not an 
abstraction. It can be measured in jobs, breakthrough cures, and even 
state-of-the-art research facilities.
  Innovation, research, and development are the economic lifeblood of 
California and, particularly, San Diego. Over the past decade, 
California firms have received more than 30 percent of total biotech 
investment in the country, and in San Diego County there are over 
48,000 jobs in the life sciences sector supported by $1.5 billion in 
venture capital.
  In San Diego alone, we have five institutions that rank among the top 
recipients of National Institutes of Health funding in the country, and 
they are doing amazing things.
  One La Jolla-based research and development facility in my district 
recently launched a one-time gene replacement therapy that essentially 
halts the progression of a rare and deadly genetic childhood disorder: 
spinal muscular atrophy. This company is also currently investing in 
research to cure a genetic form of ALS.
  If we aren't careful, we might put those kinds of breakthrough 
therapies at risk of never treating a single patient.
  From the NIH and academic research institutions to philanthropy and 
biopharmaceutical industry, there is a network of capital today in the 
public and private sectors that supports innovation.
  At the risk of oversimplifying, the NIH focuses on basic biomedical 
science, investigating the underlying mechanisms of disease, while 
smaller biotech companies supported by institutional investors take the 
basic science to the preclinical and early-phase stages of drug 
development.
  Drug companies conduct later-stage research, fund clinical trials, 
and invest in startups. These financial backers, like drug companies 
and venture capitalists, are important because they can help close the 
funding gap that exists between preclinical research and the early-and 
later-stage clinical trials.
  If H.R. 3 changes investor behavior as some predict, that could widen 
the gap for smaller biotech companies, the so-called ``valley of 
death.'' I think we can all agree that these are consequences we want 
to avoid.
  Securing funding for the high cost of clinical trials is often cited 
as the key hurdle facing smaller biotech companies at the precipice of 
the so-called valley of death.
  While the biopharmaceutical industry and the Federal Government both 
fund clinical trials, NIH's ability to bring drugs to market is 
constrained by its limited budget and a mandate to carry out its core 
mission of advancing biomedical research, which is not necessarily the 
same as bringing drugs to market.
  Over time, these limitations have resulted in the declining number of 
NIH-

[[Page H10205]]

sponsored clinical trials. The biopharma industry is really good at 
bringing drugs to market because it can afford expensive failures. The 
Federal Government is really good at research and development because 
it can ignore constraining signals of the commercial market.
  We do patients no favors by pitting biopharma against government. And 
I want to thank Chairman Pallone and his staff on the Energy and 
Commerce Committee for working with me to include two priorities of 
mine in his bill.
  I establish a pilot program that will award multiyear contracts to 
public and private entities like research institutions, medical 
centers, and biotech companies to support phase 2 and phase 3 clinical 
trials. That pilot program will receive $500 million every year for 5 
years.
  The bill also includes this amendment No. 3 before you today, which 
is based on my bill, the Innovation and Capital Network Act of 2019.
  My amendment creates an innovation startup fund at NIH that will 
support the commercialization stage of research, later-stage research 
and development, as well as technology, transfer, and technical 
assistance. Specifically, it directs $500 million over 5 years to 
incentivize incubators, accelerators, and other financial backers to 
support biotech companies through early- to mid-stage clinical studies.
  These two things are mutually reinforcing. NIH is free to do more 
drug development, and more small to midsize biotech companies can 
freely follow the science. In other words, these small biotechs can 
pursue unforeseen opportunities that could lead to a cure for cancer.
  Whether you vote for H.R. 3 or not, we must continue to support and 
strengthen the network of capital that sustains innovation.
  Mr. Chair, I hope my colleagues will support this amendment and the 
freedom to follow science, and I yield back the balance of my time.
  Mr. WALDEN. Mr. Chair, I am opposed to the amendment and seek time in 
opposition.
  The Acting CHAIR. The gentleman from Oregon is recognized for 5 
minutes.

  Mr. WALDEN. Mr. Chairman, I appreciate my colleague's amendment on 
this. I understand it. And I think it is important because it does 
strike at the heart of the issue and the concerns many of us on this 
side of the aisle have.
  The California Life Sciences Association told us that, if enacted, 
H.R. 3's Medicare part D foreign reference pricing proposal would 
reduce by 88 percent the number of drugs brought to market by small and 
emerging companies in California alone due to changed investor 
behavior.
  So they think up to 88 percent of the great innovations and cures 
they are working on will never come to market. They also think it would 
eliminate 80,000 biotech R&D jobs nationwide and reduce revenues by $71 
billion a year.
  So, these are the people, predominantly out in California, that do 
this every day, that are living in this world of trying to create 
innovation and new lifesaving drugs. And they are saying up to 88 
percent of the new drugs they are working on would never come to 
market. These are the small startups.
  We have heard a lot from others on the floor in the last 24 hours 
about Big Pharma. Well, we are not talking about Big Pharma here. We 
are talking about small, little startups, American entrepreneurs. If 
you think about Silicon Valley in the high-tech world, this is the 
equivalent in the biotech world.
  These are individuals who have an idea and a big brain, and they are 
coming together to come up with a cure to these diseases like SMA, 
Alzheimer's, sickle cell anemia, and things like that that we all 
struggle with in our communities.
  Our fear on this side of the aisle, as Republicans, is we know, based 
on the facts and the independent analysis of our Congressional Budget 
Office, based on the Council of Economic Advisers, based on the input 
of the very people who are in the trenches every day in these 
laboratories across America, where two-thirds of the world's innovation 
comes from in this space, that H.R. 3 will significantly reduce new 
cures coming to market.
  Now, we are all for lowering drug prices. I think we would have a 
unanimous vote on the provisions in our alternative here if we had a 
fair opportunity to take these one at a time. We are glad we have the 
opportunity to have the vote.
  I think, because there are 138 Democrats on the measures that are in 
what I would call our bipartisan proposal here, that we could get 
bipartisan support for it. And we could lower drug costs. We can stop 
the gaming in the system. And we can continue to have more cures in 
America, not less.
  And, let's face it--I do not believe it is an overstatement to say 
people will die if we have fewer cures. We know that to be a fact. It 
is not just a talking point. It is a fact. It is a truth. And in a time 
when we should rely on more facts, this is one we should think about 
seriously before we vote on H.R. 3.
  That is why, Mr. Chairman, we came up with this combination of really 
thoughtful proposals, some of which have passed out of committees in 
the House or in the Senate--bipartisan support for them.
  Now, on the Peters amendment itself: It is a laudable amendment. It 
will not be able to substitute for the destruction, however, of the 
American biomedical industry under H.R. 3.
  The Congressional Budget Office says the effects on the new drug 
introductions from increased Federal spending under the bill on 
biomedical research would be modest. That is CBO.
  I will let our Members vote as they want. Certainly, we all want to 
do more to invest in our National Institutes of Health.
  I have no real objection to the gentleman's amendment, but the 
underlying bill eviscerates what he is trying to accomplish here in 
terms of medical research and breakthrough cures.
  Mr. Chairman, with that, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from California (Mr. Peters).
  The amendment was agreed to.


                 Amendment No. 4 Offered by Mr. Kennedy

  The Acting CHAIR. It is now in order to consider amendment No. 4 
printed in part B of House Report 116-334.
  Mr. KENNEDY. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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;''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from Massachusetts (Mr. Kennedy) and a Member opposed each will control 
5 minutes.
  The Chair recognizes the gentleman from Massachusetts.
  Mr. KENNEDY. Mr. Chair, I yield myself such time as I may consume.
  I want to thank Speaker Pelosi, Chairman Pallone, Chairman Neal,

[[Page H10206]]

and Chairman Scott for their extraordinary leadership on this 
legislation and for helping bring this historic reform of our 
prescription drug system to the floor today.
  In the last few years, President Trump has demonstrated how quickly 
the revolving door between industry lobbyists and high-ranking 
government officials and offices can spin.
  It is a practice that may not have started when he entered office, 
but it is certainly one that he has perfected. Even after promising to 
drain the swamp, President Trump has appointed more former industry 
lobbyists to his cabinet in under 3 years than both President Obama and 
President Bush did in their entire time in office.
  With those appointments, conflicts of interest run rampant, and 
corruption has not been hard to find. That is what this amendment 
attempts to address. It is about good, clean, ethical governance.
  If we are giving the Secretary of Health and Human Services the 
authority to negotiate drug prices, which we absolutely should, we must 
ensure that those negotiations cannot be tainted by past business 
relationships or potential personal financial gain, because it is not 
fair for a secretary to be put into a position where his or her motives 
may be questioned. And it is certainly not fair to the public to be 
forced to question the intentions of that secretary.
  Put simply, a secretary who was previously responsible for price 
increases on insulin and numerous other drugs while working for a Big 
Pharma company may be inclined to choose profits of that former 
employer over the patients he now serves. That same secretary may 
choose to increase those prices higher or negotiate in something other 
than good faith based on inside knowledge, past relationships, or a 
potential future return to that same job after his government service 
has ended.
  That would give patients rightful doubt that their interests will 
guide the negotiations taking place on their behalf.
  Mr. Chair, I reserve the balance of my time.
  Mr. BRADY. Mr. Chairman, I would like to claim time in opposition to 
the amendment.
  The Acting CHAIR. The gentleman from Texas is recognized for 5 
minutes.
  Mr. BRADY. Mr. Chair, at first glance, Mr. Kennedy's amendment sounds 
like a good idea. Of course Republicans don't want administration 
officials to have a conflict of interest in carrying out their official 
duties on behalf of the American people.
  But, in reality, this amendment is narrowly tailored to be a petty 
jab at the current Secretary of Health and Human Services.
  Look, people want more cures and lower drug costs. They don't want 
more cheap political shots. Luckily, the underlying bill, H.R. 3, 
stands no chance of becoming law, so this amendment means nothing.
  We do, as Republicans, oppose H.R. 3's government price-setting 
regime because it will kill lifesaving cures for Americans struggling 
with the ravages of Alzheimer's and dementia, ALS, Parkinson's, the 
many cancers we face, leukemia, pulmonary hypertension--all those 
costly and stubborn diseases.

                              {time}  1130

  We know, and the Congressional Budget Office has already confirmed, 
at least 38 fewer medicines and cures the next two decades. The Council 
of Economic Advisers estimates it will be close to 100 lost cures. Even 
in the Speaker's home State of California, the California Life Sciences 
Association, those small firms that do three-fourths of our clinical 
trials to bring new drugs to America, they modeled the gentlewoman's 
bill and said nearly 9 out of 10 of the drugs that they would be 
working on would never come to market if this Democratic drug bill 
becomes laws.
  We think, rather than kill cures, you should accelerate it. Because 
when you look at the ravages to these families and our loved ones, 
really the costliest drug is the one that never gets developed. That is 
what we strongly oppose.
  For those reasons, I urge my colleagues to oppose this amendment. I 
reserve the balance of my time.
  Mr. KENNEDY. Mr. Chairman, how much time do I have remaining?
  The Acting CHAIR. The gentleman from Massachusetts has 2\1/2\ minutes 
remaining.
  Mr. KENNEDY. Mr. Chair, I yield 1\1/2\ minutes to the gentlewoman 
from Michigan (Mrs. Dingell.)
  Mrs. DINGELL. Mr. Chairman, I thank my colleague, Representative 
Kennedy, for adding an amendment to this bill that will tighten it even 
further. I also thank Speaker Pelosi, Chairman Pallone, Chairman Neal, 
and Chairman Scott for their leadership and efforts on this historic 
legislation, which brings desperately needed relief to America's 
patients and seniors from the high drug prices that are scaring too 
many of them.
  There is a reason that we pay nearly four times more for prescription 
drugs than other industrialized nations. They use negotiation to lower 
drug prices. We don't.
  Negotiating lower drug prices is a promise that the President, 
Democrats, and Republicans have made, and the Elijah E. Cummings Lower 
Drug Costs Now Act makes good to this commitment.
  Representative Kennedy's amendment further strengthens this provision 
to ensure that the Secretary of Health and Human Services, who is 
responsible for these negotiations, is free from conflicts of interest. 
A public office is a public trust, and America's seniors and patients 
deserve to have confidence that the Secretary's interests are aligned 
with theirs.
  That is why this amendment is so important. It puts American people 
first when negotiating drug prices so that they receive the best deal 
possible.
  I urge my colleagues to support this amendment, which will ensure 
that the American people, not special interests, are represented in 
drug price negotiations.
  Mr. KENNEDY. Mr. Chairman, I would like to close by stating a couple 
of things.
  First, to my friend, the chairman from Texas, the intent of this 
amendment is not directed at any one individual. It is directed at an 
intent, which I think we do share, to ensure the integrity of a 
position and an office that is focused on the well-being of every 
American.
  Second, nobody here wants to do anything that is somehow going to 
hinder anyone's cure or the potential for a new cure to come to market.
  We do, however, have to wrestle with the fact that 26 percent of the 
patients across this country in need of insulin ration it. We have to 
reconcile the fact that 55 percent of the counties in this country do 
not have a single practicing psychiatrist, psychologist, or social 
worker. We have to wrestle with the fact that one-third of the 
donations on GoFundMe are for healthcare costs.
  The existing system that we have is failing American families day in 
and day out. They are asking for this for a reason, and we are 
delivering it. I urge my colleagues to vote ``yes.''
  Mr. Chair, I yield back the balance of my time.
  Mr. BRADY. Mr. Chairman, let me talk about the underlying bill here.
  I was on the Ways and Means Committee when we worked with President 
Bush to create the first affordable drug plan for seniors. Then-leader 
Pelosi and Democrats tried their best to kill it. They all voted 
against it.
  The gentlewoman famously predicted that creating the part D drug 
program for our seniors would end ``Medicare as we know it.'' Can you 
imagine how many seniors' lives would have been lost if Democrats had 
succeeded in stopping the affordable Medicare drug program that 43 
million seniors have come to depend upon?
  Nancy Pelosi and Democrats were dangerously wrong then. Can Americans 
afford the pain and lost lives of our loved ones when they are 
dangerously wrong again?
  We oppose this amendment, and we oppose the underlying bill. I yield 
back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Massachusetts (Mr. Kennedy).
  The amendment was agreed to.


               Amendment No. 5 Offered by Mr. O'Halleran

  The Acting CHAIR. It is now in order to consider amendment No. 5 
printed in part B of House Report 116-334.
  Mr. O'HALLERAN. I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.

[[Page H10207]]

  The text of the amendment is as follows:

       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.''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from Arizona (O'Halleran) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentleman from Arizona.
  Mr. O'HALLERAN. Mr. Chairman, today, I rise in support of my 
amendment to H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act.
  I would first like to thank Chairman Pallone and Chairman Neal for 
committing to work with me on this amendment and the committee staff 
for their efforts as well.
  I am proud to represent Arizona's First Congressional District. Our 
district is larger than the State of Illinois and is one of the most 
rural in the country.
  This year, I have held 26 townhalls across the vast district. At each 
and every one, I heard from rural residents struggling to access 
quality healthcare close to home. That is why I introduced my 
amendment.
  My amendment would reward grants to hospitals in rural and medically 
underserved areas so these hospitals are able to establish a graduate 
medical education program or partner with an approved hospital to host 
residents.
  According to the Congressional Research Service, more than half of 
family medicine physicians reside within 100 miles of where they 
trained as residents. My amendment will incentivize doctors to stay in 
practice in our rural communities by providing opportunities to bring 
medical students to rural areas for residency training. Hospitals are 
not reimbursed for hosting graduate medical education programs until 
they are fully established.
  The grants awarded under my amendment would cover associated startup 
costs for hospitals, including necessary infrastructure, equipment, and 
fees.
  My amendment also requires the nonpartisan Government Accountability 
Office to issue a report on the success of the changes that this 
education will implement, including analysis of whether residents 
stayed in the rural communities where they trained.
  According to the Association of American Medical Colleges, our 
country will suffer a shortage of over 120,000 physicians by the year 
2032. We are already losing physicians across rural America, and rural 
areas will be hit especially hard.
  I am offering my amendment today to mitigate the effects that those 
seeking care in rural areas will experience. As we move forward with 
H.R. 3, we must not leave our rural communities on the back burner. Our 
rural communities will not be able to access their medications in the 
first place if they cannot access providers.
  My amendment takes an all-of-the-above approach to improving rural 
healthcare by expanding access and revamping the ways we recruit 
qualified medical professionals in the area where we need them most. I 
reserve the balance of my time.
  Mr. BRADY. Mr. Chairman, I claim the time in opposition to the 
amendment.
  The Acting Chair. The gentleman from Arizona is recognized for 5 
minutes.
  Mr. BRADY. Mr. Chair, this amendment requires the Secretary of Health 
and Human Services to award grants to hospitals, including critical 
access hospitals, located in rural or medically underserved areas to 
establish and improve medical residency training programs. The goals in 
this amendment are laudable.
  But like so much around here, bipartisan work in this area has been 
stopped because of impeachment. The rush to impeachment has created a 
toxic atmosphere and prevented parties from working on the people's 
business, creating a constitutional crisis for purely political 
reasons.
  It is a nice change to hear this discussion because earlier this 
year, we offered in the Ways and Means Committee an amendment to 
reallocate these GME slots exactly to these rural and medically 
underserved areas. Unfortunately, those amendments were rejected on a 
largely partisan basis. I wish the gentleman from Arizona would have 
been with us that day because almost all Democrats voted no.
  That said, I do have real concerns. This amendment provides more 
Medicare-funded payments to hospitals for these GME slots but without 
making any immediate reforms that everyone knows need to happen. An 
Institute of Medicine report called for innovative approaches to 
finance these slots in order to improve the match between the physician 
workforce that we need and national healthcare needs.

[[Page H10208]]

  Just last week, the Journal of American Medical Association Internal 
Medicine published a study and found Medicare is overpaying for GME and 
that this wasted money could actually be used to address the physician 
shortages in underserved areas.
  According to the study's lead author, Medicare GME may be overpaying 
some hospitals up to $1.28 billion annually. So instead of creating 
another grant program on a bill that is deader than a doornail, let's 
make a serious attempt at GME reform.
  After impeachment is over, if it wastes all of next year as well as 
this, maybe we can build upon MedPAC recommendations, establish a 
permanent performance-based incentive program that actually reaches 
what I think we as Democrats and Republicans want and create the 
standards needed for these rural underserved areas.
  These overpayments identified in the report could actually go toward 
expanding the teaching health center program, which would be terrific 
because that focuses on training in community-based primary care 
settings. That is where healthcare providers are needed the most. That 
is where they tend to stay to serve the community. That is a win-win 
for everyone.
  While I look forward to working with the gentleman from Arizona on 
ways to reform graduate medical education, I urge my colleagues to 
oppose the amendment, and I reserve the balance of my time.
  Mr. O'HALLERAN. Mr. Chairman, I yield 1 minute to the gentlewoman 
from New Mexico (Ms. Torres Small), my colleague.
  Ms. TORRES SMALL of New Mexico. Mr. Chair, I thank the gentleman from 
Arizona for yielding and for his tireless work fighting for improved 
healthcare in rural communities.

  Congressman O'Halleran's amendment, which I am proud to cosponsor, is 
vital in rural areas like those in New Mexico's Second Congressional 
District. Hospitals often run on small margins and do not have the 
necessary resources to establish new residency training programs.
  This is especially problematic given the shortage of up to more than 
100,000 physicians by 2030 in the United States. Rural communities, in 
particular, already struggle to attract and keep medical professionals. 
Therefore, it is only fitting that the Federal Government invests a 
portion of the savings earned by H.R. 3 into rural areas to improve 
healthcare accessibility, and this amendment would do just that.
  As we continue debating healthcare legislation, I urge my colleagues 
to support initiatives that provide rural residents greater access to 
basic healthcare. I ask my colleagues to join me in support of this 
amendment and the underlying bill.
  Mr. BRADY. Mr. Chairman, I am prepared to close after the gentleman 
from Arizona finishes his remarks. I reserve the balance of my time.
  Mr. O'HALLERAN. Mr. Chairman, how much time do I have remaining?
  The Acting CHAIR. The gentleman from Arizona has 1 minute remaining.
  Mr. O'HALLERAN. Mr. Chair, I thank Representative Torres Small, and I 
thank all of my colleagues for standing with me today in support of 
this important amendment that has received an endorsement from the 
National Association of Rural Health Clinics. I look forward to joining 
my colleagues to vote for the Elijah E. Cummings Lower Drug Costs Now 
Act later today.
  This sweeping legislation will lower high-cost prescription drugs, 
enable Medicare to negotiate prices, and save real dollars that can be 
reinvested for drug research and development. This bill has the 
potential to better the lives of countless American seniors, veterans, 
and families. No family should have to choose between the medication 
they need and putting food on the table.
  I urge my colleagues on both sides of the aisle to vote in support of 
my amendment and H.R. 3 later today, and I yield back the balance of my 
time.
  Mr. BRADY. Mr. Chairman, impeachment has really ruined most of these 
bipartisan efforts in healthcare, including the underlying bill. 
Democrats and Republicans were working well together. Speaker Pelosi 
shut it all down for this partisan, secretly written bill. Impeachment 
has stopped most of this.
  When and if impeachment is ever done, finished--and I know that 
Congressman Green, my colleague, has said that they can impeach again 
multiple times--when all of that foolish wasted time finishes, maybe we 
can work together. I think it would be tremendous.
  I have rural areas, underserved areas. They need these GME slots, and 
the whole thing needs to be reformed in a positive way.
  Mr. Chair, I oppose the amendment and the underlying bill, and I 
yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Arizona (Mr. O'Halleran).
  The question was taken; and the Acting Chair announced that the ayes 
appeared to have it.
  Mr. O'HALLERAN. Mr. Chair, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentleman from Arizona will 
be postponed.

                              {time}  1145


                 Amendment No. 6 Offered by Mr. Kennedy

  The Acting CHAIR. It is now in order to consider amendment No. 6 
printed in part B of House Report 116-334.
  Mr. KENNEDY. Mr. Chairman, as the designee of Ms. Jackson Lee, I have 
an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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).

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from Massachusetts (Mr. Kennedy) and a Member opposed each will control 
5 minutes.
  The Chair recognizes the gentleman from Massachusetts.
  Mr. KENNEDY. Mr. Chairman, I yield myself such time as I may consume.
  Mr. Chairman, I rise today as the designee of my esteemed colleague 
Sheila Jackson Lee from Houston to offer this amendment. She was 
unavoidably detained at the Judiciary Committee to consider Articles of 
Impeachment against our President.
  Mr. Chairman, I am grateful for this opportunity to discuss the 
Jackson Lee amendment to the Elijah E. Cummings Lower Drug Prices Now 
Act.
  Let me also express my gratitude to the chairmen of the committees of 
jurisdiction for their hard work in crafting this important 
legislation: Chairman Pallone of Energy and Commerce, Chairman Neal of 
Ways and Means, and Chairman Scott of Education and Labor.
  The Elijah E. Cummings Lower Drug Prices Now Act levels the playing 
field for American patients and taxpayers by:
  One, giving Medicare the power to negotiate directly with the drug 
companies and creating powerful new tools to force drug companies to 
the table to

[[Page H10209]]

agree to real price reductions, while ensuring seniors never lose 
access to the prescriptions they need;
  Two, making the lower drug prices negotiated by Medicare available to 
Americans with private insurance, not just Medicare beneficiaries;
  Three, stopping drug companies from ripping off Americans while 
charging other countries less for the same drugs and limiting the 
maximum price for any negotiated drug to be in line with the average 
price in countries like ours;
  Four, creating a new, $2,000 out-of-pocket limit on prescription drug 
costs for Medicare beneficiaries;
  Five, reinvesting in the most transformational improvement to 
Medicare since its creation--delivering vision, dental, and hearing 
benefits--and turbocharging the search for new cures.
  High drug prices are harmful. Medical costs and out-of-pocket 
expenses result in high rates of bankruptcies, and 10 to 25 percent of 
patients either delay, abandon, or compromise treatments because of 
financial constraints.
  Survival is also compromised. For example, in chronic myeloid 
leukemia, the 8- to 10-year survival rate is 80 percent in Europe where 
treatment is universally affordable, but the 5-year survival rate is 
only 60 percent in the United States.
  The high out-of-pocket expenses discourages patients from seeking 
care or purchasing drugs. In a recent survey, one-third of insured 
persons in Ms. Jackson Lee's home State of Texas delayed or did not 
pursue care because of high out-of-pocket expenses.
  The Jackson Lee amendment is simple and straightforward. The Jackson 
Lee amendment improves the bill by expressing the sense of Congress 
regarding the harmful 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.
  According to the Center for American Progress, the negotiation 
authority provided in H.R. 3 could save some diabetics more than $700 
on an annual supply of certain types of insulin. Moreover, negotiations 
could bring down the net price for other types of drugs that are 
particularly needed in minority and poor communities--including 
expensive treatments for cancer and multiple sclerosis--by thousands 
every month.
  Reform is desperately needed, and nearly one in four Americans 
currently taking prescription drugs find them difficult to afford. Some 
people struggling to afford medication for chronic illnesses even turn 
to drug rationing in desperation, which can be lethal. In fact, a 
recent study found that one in four patients with diabetes rations 
their insulin in response to rising prices.
  The American public overwhelmingly agrees that it is time to allow 
the government to negotiate with pharmaceutical companies: 85 percent 
of Americans support this tactic to reduce prices for Medicare and 
private insurance.
  Mr. Chairman, I am grateful for the opportunity to explain the 
Jackson Lee amendment. I urge our colleagues to agree to the amendment, 
and I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, I claim the time in opposition.
  The Acting CHAIR. The gentleman from Oregon is recognized for 5 
minutes.
  Mr. WALDEN. Mr. Chairman, I recognize the serious impact prescription 
drug prices have on all Americans. We all have constituents facing the 
same problem: drug prices are too high. We all want to come together to 
find a way to lower drug prices.
  Where we separate is our proposal would lower drug prices, put a cap 
on what seniors pay, and, for the first time, in Medicare part D, 
reduce their insulin costs but not end the kind of incredible 
innovation in America we see today. It would not cost 88,000 American 
innovators their jobs, and it would not reduce this innovation that is 
producing two-thirds of the world's cures.
  Unfortunately, H.R. 3 would do that. H.R. 3--the underlying bill that 
is a very disappointingly partisan bill--would cost patients cures to 
their diseases. We know that.
  It is not my conclusion. These are the people who innovate in this 
space. These are Congressional Budget Office analysts and the Council 
of Economic Advisers. There has not been a single piece of evidence 
presented on this floor that says that H.R. 3 will do anything but 
reduce investment and outcome of overall new cures.
  In fact, a colleague of mine and I were talking during the last 
amendment debate. In effect, we are trading $1 trillion in private-
sector investment in new innovation in America for medical cures for 
$100 million--in this case, the Peters amendment--in taxpayer money.
  So you are trading $100 million for $1 trillion, and $1 trillion is 
private-sector investment coming in, because we know a lot of these new 
paths that our innovators pick to go down to find a cure just simply 
end up being a dry hole and all that money is lost. So it takes a lot 
to find a cure, but we stand on the cusp of something big and bold, and 
that is cures for diseases where there is none today. We do have a 
problem in America trying to figure out how to pay for that.
  I am going to be retiring at the end of this Congress, and I know my 
colleague is going off to the Senate at the end of this Congress if 
voters in Massachusetts have their way, but together, we still, as a 
country, have to come together and figure out with precision medicine 
that may produce a cure for you and you only: How are we going to pay 
for that?
  We don't have a lot of answers. I don't think giving the government 
the biggest club in history to take 95 percent of revenues if you don't 
agree with what the government wants to pay for something is the right 
approach. That is what H.R. 3 does. We know it takes $1 trillion out of 
the pipeline of investment in innovation in America and costs 80-some 
thousand jobs in innovation.
  But in terms of the Jackson Lee amendment which was so ably brought 
and described by Mr. Kennedy, I share the concern about what the costs 
of medicines are putting as a burden on people, especially in rural 
areas. My district would stretch from the Atlantic to Ohio--we could 
put a lot of Massachusetts in my district--and our people are 
suffering.
  So I look forward to a day when, after our substitute becomes law, we 
can continue to work together on these other issues.
  I hope my friend will support our substitute because I think it is 
all bipartisan; 138 Democrats have supported provisions in our 
substitute amendment. There isn't a single partisan poison pill in our 
substitute amendment. I think that is why it is attracting support on 
both sides of the aisle.
  Mr. Chairman, I know we have a lot of business to do. I appreciate 
Mr. Kennedy bringing this to the floor on behalf of Ms. Jackson Lee, 
and I yield back the balance of my time.
  Mr. KENNEDY. Mr. Chairman, I urge our colleagues to vote ``yes'' on 
the amendment, and I yield back the balance of my time.
  Ms. JACKSON LEE. Mr. Chair, thank you for this opportunity to discuss 
the Jackson Lee Amendment to the Elijah E. Cummings Lower Drug Prices 
Now Act.
  Let me also express my thanks to the chairmen of the committees of 
jurisdiction for their hard work in crafting this critically important 
legislation: Chairman Pallone of Energy and Commerce; Chairman Neal of 
Ways and Means; and Chairman Scott of Education and Labor.
  The Elijah E. Cummings Lower Drug Prices Now Act levels the playing 
field for American patients and taxpayers by:
  1. Giving Medicare the power to negotiate directly with the drug 
companies and creating powerful new tools to force drug companies to 
the table to agree to real price reductions, while ensuring seniors 
never lose access to the prescriptions they need.
  2. Making the lower drug prices negotiated by Medicare available to 
Americans with private insurance, not just Medicare beneficiaries.
  3. Stopping drug companies from ripping off Americans while charging 
other countries less for the same drugs and limiting the maximum price 
for any negotiated drug to be in line with the average price in 
countries like ours;
  4. Creating a new, $2,000 out-of-pocket limit on prescription drug 
costs for Medicare beneficiaries; and
  5. Reinvesting in most transformational improvement to Medicare since 
its creation--delivering vision, dental and hearing benefits--and 
turbocharging the search for new cures.
  High drug prices are harmful. Medical costs and out-of-pocket 
expenses result in high

[[Page H10210]]

rates of bankruptcies, and 10 to 25 percent of patients either delay, 
abandon or compromise treatments because of financial constraints.
  Survival is also compromised.
  For example, in chronic myeloid leukemia, the 8 to 10 year survival 
rate is 80 percent in Europe (where treatment is universally 
affordable), but the 5-year survival rate is only 60 percent in the 
United States.
  The high out-of-pocket expenses discourages patients from seeking 
care or purchasing drugs.
  And in a recent survey, one-third of insured persons in my home state 
of Texas delayed or did not pursue care because of high out-of-pocket 
expenses.
  The Jackson Lee Amendment is simple and straightforward.
  The Jackson Lee Amendment improves the bill by expressing the Sense 
of Congress regarding the harmful 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.
  According to the Center for American Progress, the negotiation 
authority provided in H.R. 3 could save some diabetics more than $700 
on an annual supply of certain types of insulin.
  Moreover, negotiation could bring down the net price for other types 
of drugs that are particularly needed in minority and poor 
communities--including expensive treatments for cancer and multiple 
sclerosis--by thousands per month.
  Reform is desperately needed and nearly 1 in 4 Americans currently 
taking prescription drugs find them difficult to afford.
  Some people struggling to afford medication for chronic illnesses 
even turn to drug rationing in desperation, which can be lethal.
  In fact, a recent study found that 1 in 4 patients with diabetes 
ration their insulin in response to rising prices.
  The American public overwhelmingly agrees that it is time to allow 
the government to negotiate with pharmaceutical companies: 85 percent 
of Americans support this tactic to reduce prices for Medicare and 
private insurance.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from Massachusetts (Mr. Kennedy).
  The amendment was agreed to.


               Amendment No. 7 Offered by Mr. Gottheimer

  The Acting CHAIR. It is now in order to consider amendment No. 7 
printed in part B of House Report 116-334.
  Mr. GOTTHEIMER. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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).

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from New Jersey (Mr. Gottheimer) and a Member opposed each will control 
5 minutes.
  The Chair recognizes the gentleman from New Jersey.
  Mr. GOTTHEIMER. Mr. Chairman, I yield myself such time as I may 
consume.
  Mr. Chairman, I rise today in support of my amendment to H.R. 3, the 
Elijah E. Cummings Lower Drug Costs Now Act of 2019.
  My amendment will ensure continued innovation and research to further 
the development of lifesaving medicines for rare diseases, including 
cancer, Alzheimer's, ALS, and rare disorders.
  The challenge now is that, at best, only 1 out of every 20 clinical 
trials result in a cure. This, of course, means that manufacturers 
invest billions before they can find a medicine that can go to market 
to help save lives. They don't just bet on the winners; they have to 
also bet and take a lot of risks that don't turn out to succeed and get 
to market.
  America has the best medical innovators in the world. When our health 
is on the line, we can't stop taking those risks to make sure that we 
find those cures. We can't risk falling behind.
  My amendment provides investment in qualified clinical testing for 
drug applications that address unmet medical needs to treat rare and 
life-threatening diseases, diseases that may go unaddressed without 
extra incentives. My amendment requires HHS to conduct a study to 
identify diseases without an FDA-approved treatment and where the 
development of a treatment would fill an unmet medical need for these 
rare diseases.
  My amendment also requires HHS to identify appropriate incentives 
that would ensure the continued investment in the development of these 
treatments, treatments that will save lives of the children, adults, 
and seniors of our families.
  The Congressional Budget Office and other studies have shown 
potential reductions in the number of drug approvals each year as a 
potential risk of H.R. 3. This amendment helps address that concern.
  Targeted therapies and medicines serving smaller populations stand to 
lose the most from this blow to R&D. These are areas where the science 
is the most difficult but also the most important, such as cancers and 
other rare diseases. Cures for these horrific diseases could always be 
just around the corner, but not if we are forced to abandon what might 
be the next cure.
  While I appreciate the intention of H.R. 3 to reinvest savings in 
medical research, including at NIH and FDA, without this amendment, 
there would still be no clear answer to explain what might happen to 
the incredible research and development work that occurs every day in 
the private sector. This amendment addresses that.
  I know how critical NIH funding is and have consistently advocated 
for increasing the investment in research there. However, NIH does not 
manufacture medication, and neither does the FDA. The private sector, 
including all the research being done every day in my home State of New 
Jersey, manufactures the lifesaving medications that Americans rely on 
every single day.
  It is also why my Republican colleague from Michigan, Fred Upton, and 
I introduced bipartisan legislation this week, the Protecting America's 
Life Saving Medicines Act, to ensure that life sciences companies 
continue to invest in these innovative drugs with a tax credit for 
qualified clinical research, again, to ensure that this research keeps 
getting done and that they keep making the bets on moonshot drugs that, 
without those investments, might not save lives like they do today, 
again, in the greatest country in the world where we innovate like no 
one else.
  It is critical that we never give up hope that the next cure is 
within our reach. My amendment today will help us to reach the goal of 
curing our most life-threatening diseases.
  Mr. Chairman, I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, I claim the time in opposition.
  The Acting CHAIR. The gentleman from Oregon is recognized for 5 
minutes.
  Mr. WALDEN. Mr. Chairman, I thank the gentleman for offering his 
amendment today, and I really do. We work a lot of with Mr. Gottheimer 
on a number of issues before the Congress, and I appreciate his 
commitment to this cause.
  Republicans fully support the goal of the amendment: to identify 
those diseases and conditions in which there is an unmet medical need 
and exploring ways to further incentivize getting treatments to market.
  In fact, a study in unmet medical needs is especially timely with the 
consideration of this underlying bill, H.R. 3, because we believe it 
will crush development and hope for new treatments.
  We are not alone. We have come to this conclusion based on others' 
factual evaluation of the bill. There is no shortage of sources warning 
us that H.R. 3 will lead to fewer cures. In fact, independently, the 
Council of Economic Advisers estimates as many as

[[Page H10211]]

100 new treatments will be lost over the next decade under the partisan 
H.R. 3.
  I think the most disturbing, Mr. Chairman, is that the California 
Life Sciences Association, the great innovators in America who come up 
with these new cures that we all are counting on, predicts an 88 
percent reduction in the number of drugs brought to market by small and 
emerging companies. And that is only in California, apparently.
  The nonpartisan Congressional Budget Office, another source here, our 
third independent source, estimates that, under H.R. 3, we will have 
nearly 40 fewer drugs over, roughly, the next two decades; and then, 
after that, you would see an annual--every year--reduction of 10 
percent in the number of drugs entering the market in the later years.

                              {time}  1200

  That is what has led so many of us Republicans to oppose H.R. 3. We 
support the goal of getting drug prices down. We think there are other 
ways to do that, and we are open to working on those issues.
  No President has ever leaned further forward on this matter and taken 
the pharma companies' CEOs head on than President Trump. But even he, 
after reading through the bill, said it goes too far. And you can't 
sacrifice innovation and lifesaving cures for what else is in the bill.
  H.R. 3 will undoubtedly lead to an increase in patients with unmet 
medical needs, fewer drugs. Republicans believe the value of fostering 
innovation is essential, that is why we led on 21st Century Cures, and 
passed it into law, led by my friend from Michigan, Mr. Upton, and my 
friend from Colorado, Diana DeGette, a bipartisan effort.
  But we know there are diseases out there that still long for a cure. 
This is why our bipartisan solution to lower drug prices, the 
substitute amendment, H.R. 19, will lower costs, but also promote 
innovation, and promote it from the private sector side. We want that 
private venture capital money to continue to flow into this pipeline.
  H.R. 3, we are told, the independent analysis tells us, a trillion 
dollars in private sector money will leave this sector because the 
punishment is so harsh.
  Can you imagine, you are working your whole life, you have gone to 
college, you have got this great degree, this big brain, you are coming 
up with a solution to ALS or something, you finally get it done. It 
goes through all the trials. It is perfected. It works. You get a 
patent.
  And then the government says, We are going to set the price, and if 
you don't agree to that price, we are going to take 95 percent of the 
revenues for wherever else you sell this.
  By the way, Congressional Research Services warned Congress, and we 
have had other constitutional experts tell us for sure, H.R. 3 is so 
punitive and so unfair, it would violate the Fifth Amendment of the 
Constitution and the Eighth Amendment of the Constitution.
  So the underlying bill, as we have been told, is unconstitutional. We 
all stand down here and take an oath of office to uphold the 
Constitution. We are being told by our own Congressional Research 
Service it likely upends, is in violation of, the Constitution. We have 
other experts say for sure it is.
  I appreciate the gentleman's amendment. I do. We know there are unmet 
needs that need to be dealt with. I think it makes a lot of sense.
  Mr. Chairman, I reserve the balance of my time.
  Mr. GOTTHEIMER. Mr. Chair, I thank the ranking member for his 
thoughtful comments and his thoughts about what I think is clearly an 
unmet need and one we need to continue to invest in, so I thank him for 
his leadership, too, sir.
  Before I finish, let me just say that I urge all my colleagues to 
vote ``yes'' on this amendment, because we need to keep making those 
investments to keep our leadership as a country when it comes to R&D 
innovation. It is one of the reasons why our country is so great and 
why so many lives have been saved and so many families and children 
helped.
  We need to make sure that we get drug prices down overall, which is 
why this legislation is so important, to make sure we have competition, 
more development of generics in the marketplace and, of course, overall 
the best quality healthcare in the world. It is critical for our 
country.
  Mr. Chairman, I yield back the balance of my time.
  Mr. WALDEN. Mr. Chairman, may I inquire how much time I have 
remaining?
  The Acting CHAIR (Mr. Cartwright). The gentleman from Oregon has 30 
seconds remaining.
  Mr. WALDEN. Mr. Chair, I yield myself such time as I may consume.
  Again, I appreciate the gentleman's hard work on this issue. I know 
we share a common goal of getting drug prices down and meeting unmet 
needs of cures. But, tragically, the Democrat bill, H.R. 3, is a very 
partisan bill.
  We are told by the California Life Sciences Association that, if 
enacted, you could see an 88 percent reduction in the number of drugs 
brought to market by small and emerging companies in California alone. 
That is their estimate. These are the people who do this work. They 
also estimate we would lose 80,000--that is a lot--80,000 biotech R&D 
jobs nationwide. That is what H.R. 3 does.
  So, if you are for cutting jobs in America in biotechnical research, 
and if you are for 88 percent fewer drugs coming to market from small 
and emerging innovators in California, then I guess you are going to 
vote for H.R. 3. I am not going to. I think we can do better.
  Mr. Chairman, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from New Jersey (Mr. Gottheimer).
  The question was taken; and the Acting Chair announced that the ayes 
appeared to have it.
  Mr. GOTTHEIMER. Mr. Chair, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentleman from New Jersey 
will be postponed.


                  Amendment No. 8 Offered by Mrs. Axne

  The Acting CHAIR. It is now in order to consider amendment No. 8 
printed in part B of House Report 116-334.
  Mrs. AXNE. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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

[[Page H10212]]

     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.

[[Page H10213]]

       ``(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.''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentlewoman 
from Iowa (Mrs. Axne) and a Member opposed each will control 5 minutes.
  The Chair recognizes the gentlewoman from Iowa.
  Mrs. AXNE. Mr. Chair, I yield myself such time as I may consume.
  Mr. Chair, as a mom, I have spent hours in doctors' offices with sick 
kids. Nothing is more frustrating than when a doctor has to spend more 
time looking at their computer screen than helping our children.
  I have taken time off work only to end up sitting in waiting rooms 
because a doctor is running behind, all because of a mountain of 
paperwork that they must do for every single person that they see. And 
I have seen doctors who are frustrated at their computers trying to 
find the information they need.
  I have also heard from my constituents in Iowa that when they go to 
the doctor's office, they don't want to feel like it is an oil change, 
a quick ``check under the hood'' and then a mountain of forms. And it 
is not the doctor's fault. They have to comply with all of these 
administrative rules and codes.
  Parents like myself, those doctors, and everyone in the healthcare 
industry, know that something has to change. And that is why I am 
offering my amendment today.
  My goal is to create a grants program to help reduce all this 
excessive and unnecessary paperwork on doctors and healthcare workers. 
It will help doctors spend more time with their patients, including 
children like mine and those across Iowa. It will save money, because 
it makes required medical administration more efficient. My amendment 
will reduce the time crying kids have to wait for their parents to fill 
out that paperwork before they go into the doctor's office. And my 
amendment will cut red tape and Federal spending.
  This amendment cuts Federal healthcare administrative work by 50 
percent in 10 years. I spent 10 years working for the State of Iowa, 
and I focused on making government more efficient, so I absolutely know 
how to find government waste and how to cut it, and I think it is 
important that we look at that.
  As an efficiency expert and a mom of two boys, I am proud to 
introduce this amendment today. Health administration costs are out of 
control. We spend $500 billion on all types of duplicate administration 
every year. My amendment creates $250 million in grants for States each 
year, because when excess administrative work costs nearly $250 billion 
per year, that is 1,000 times more. In other words, if we reduce 
administrative waste by more than 0.1 percent, these grants would 
already pay for themselves. And this amendment is going to cut away way 
more waste than 0.1 percent.
  I have the opportunity to travel all 16 counties in my district every 
month, and I have met with doctors, nurses, and physician assistants, 
they have all told me how exhausting and unnecessary all that extra 
work is.
  In 2016 doctors said they are spending almost twice as much time on 
administrative work than they are with their patients. That is just 
wrong. And that same study also found that when a doctor is in the exam 
room, more than one-third of that time is spent on desk work.
  Our rural and small communities are struggling to hire enough 
doctors, and I am already working on attracting doctors to our State, 
but we also need to protect and keep the doctors that we have, and 
doctors want to help patients, not do paperwork.
  Last month, the Centers for Medicare and Medicaid Services released 
new guidance to help reduce documentation burdens and ensure doctors 
have more time with their patients. That was the first time in 25 years 
we have updated these regulations with the specific purpose of reducing 
paperwork. My amendment creates grant programs to get that done.

[[Page H10214]]

  Look, I get it, Mr. Chair, if you are filling out 30 pages of 
paperwork, you probably won't like this amendment if you like doing 
that. If your favorite place is a doctor's waiting room and you want to 
spend more time there, I will understand you not wanting to support my 
amendment. Or if you always dreamed of being treated like you are a 
computer code and not a patient, then you can vote ``no'' on this 
amendment.
  But I am pretty confident you are like me and you hate those things. 
So vote ``yes'' if you want doctors to focus on your kids. Vote ``yes'' 
if you want shorter wait times and more time with your doctor. Vote 
``yes'' for all that, while you are also saving Federal Government 
money. And by the way, if you are going to miss the waiting room, I 
would be happy to sign you up for a ``Highlights'' magazine 
subscription to come to your home.
  Mr. Chairman, I reserve the balance of my time.
  Mr. BRADY. Mr. Chairman, I claim the time in opposition to the 
amendment, even though I am not opposed to it.
  The Acting CHAIR. Without objection, the gentleman from Texas is 
recognized for 5 minutes.
  There was no objection.
  Mr. BRADY. Mr. Chair, though I oppose the dangerous fewer cures act 
by Speaker Pelosi because it was written in secret, it is partisan and 
it will delay or kill the cures that our patients are hoping and 
praying for with Alzheimer's, ALS, Parkinson's, and so many cancers.
  This amendment reduces unnecessary costs, administrative burdens 
across the healthcare system. I share this goal with my colleague from 
Iowa. This amendment includes a lot of just smart ways to achieve this 
goal, including identifying best practices, reviewing existing 
regulations to see if they are adding unnecessary burdens, and studying 
how we might be able to standardize and just automate certain of these 
administrative actions.
  All of this is pretty good common sense. This amendment would help 
the public and, I think, the private sectors and the Federal Government 
and States work better together. I hope Mrs. Axne offers this amendment 
again on another legislation, maybe one that will become law, because, 
obviously, H.R. 3 will not.
  And, of course, impeachment has poisoned the water and delayed so 
many bipartisan things that are important to the American people. I 
hope she continues to offer it. I imagine that that ``Highlights'' 
magazine on the doctor's table will be all about impeachment. We want 
to make it all about healthcare.
  Mr. Chair, I urge my colleagues to support the amendment, and I yield 
back the balance of my time. Let's vote.
  Mrs. AXNE. Mr. Chairman, I thank Representative Brady for his support 
for this amendment.
  I appreciate anybody who also wants to look at efficiencies within 
government. It is something that we need to spend more time on, so I am 
grateful for your support and I look forward to working with you and 
moving this agenda forward.
  Mr. Chair, I would still continue to urge all of my colleagues to 
vote for H.R. 3, so that we can make this a reality, and I yield back 
the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from Iowa (Mrs. Axne).
  The amendment was agreed to.


               Amendment No. 9 Offered by Ms. Finkenauer

  The Acting CHAIR. It is now in order to consider amendment No. 9 
printed in part B of House Report 116-334.
  Ms. FINKENAUER. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentlewoman 
from Iowa (Ms. Finkenauer) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentlewoman from Iowa.
  Ms. FINKENAUER. Mr. Chair, I yield myself such time as I may consume.
  Mr. Chair, I wanted to start, before I get to the amendment, to 
actually talk about why all of this is so important here today.
  You see, I hold prescription drug roundtables all across the 
district, and there is a recent one that comes to mind and a story that 
I want this body to hear.
  We were doing a roundtable in Dubuque, where we invited folks to come 
and talk about their issues with drug prices and how that is impacting 
their lives personally. And there was a family that came, a young woman 
who was in her teens, with her mom and her dad. You see, she has 
diabetes, and they struggle every month to try to figure out how they 
are going to keep affording insulin and her meters, and different 
meters with different insurances happen almost every single year.
  And they are telling me these stories, and in the middle of the 
roundtable, the young woman and her mother had to leave to go to a 
doctor's appointment, and it was her dad that stayed for the rest of 
it. And as I am going around saying ``thank you for coming and sharing 
your story today,'' I shook the dad's hand, and he looked at me and he 
said, ``Please do everything you can to fight for my daughter and fight 
to make sure that she is going to be able to afford the care that she 
needs.''
  He told me he is very worried about when she turns 26, and if she is 
not on their insurance what does that look like. Is she going to be 
able to keep affording it? And he told me that he wanted to be able to 
walk his daughter down the aisle one day at her wedding, not her 
funeral.

                              {time}  1215

  I will never forget that conversation, and I will never stop fighting 
to make sure that we lower the costs of these lifesaving medications 
that so many folks across our country and in my district need and rely 
on.
  It is why I am so proud to support the Elijah E. Cummings Lower Drug 
Costs Now Act of 2019, which puts measures in place to make sure that 
drug companies aren't charging us double, triple, or quadruple what 
countries like Canada and Australia currently pay.
  However, H.R. 3 is currently missing a bipartisan drug pricing reform 
that has been supported by Senator Grassley, by President Trump, and 
Members of both parties alike. It is requiring drug companies to 
disclose pricing information on prescription drugs when they advertise 
directly to consumers like us and folks in my district.
  We have all seen the TV commercials that promote prescription drugs. 
What we may not realize is that pharmaceutical companies spend billions 
on this advertising. Last year, they spent over $6 billion, and a lot 
of that was actually to encourage people to get expensive, brand-name 
drugs.
  My amendment would require TV advertisements for prescription drugs 
to include the list price for a 30-day regimen or a typical course of 
treatment. With this transparency, we can all be empowered to make 
informed choices

[[Page H10215]]

and bring down costs to our healthcare system.
  When drug companies use advertising to boost demand for drugs whose 
prices just keep going up, the American people deserve to know what 
these drugs cost. My amendment will ensure that we get a complete 
picture of the prescription drug options we see on TV.
  Mr. Chair, I urge my colleagues today to support this amendment, 
support this bill, and I reserve the balance of my time.
  Mr. BRADY. Mr. Chair, I would like to claim the time in opposition, 
even though I support the amendment.
  The Acting CHAIR. Without objection, the gentleman from Texas is 
recognized for 5 minutes.
  There was no objection.
  Mr. BRADY. Mr. Chair, this is a good amendment. It would require H.R. 
3 include a provision requiring each drug ad on TV to include the list 
price of the drug.
  I support this policy; Republicans do, as well. It is just a simple 
way to increase openness in healthcare, transparency that patients are, 
I think, searching for.
  In fact, this bipartisan approach is already in the Republican bill 
in front of us today, H.R. 19. I don't know why it was rejected in the 
initial Democrats' bill. I think perhaps it was written in secret. It 
was all partisan measures.
  We know, at the end of the day, it is deader than a doornail. But I 
think, after that is done, after impeachment--I don't know how many 
years that thing goes on and wastes our lives. But after all that 
foolishness is done, I hope our Democrat friends will come back to the 
negotiating table so we can work on more commonsense, bipartisan ideas 
like this one.
  Despite my strong opposition to H.R. 3--it is such a cruel and false 
choice to force people to choose between lower drugs and lifesaving 
cures for Alzheimer's, ALS, Parkinson's, and so many cancers; that is 
just wrong--I do support this amendment. I urge my colleagues to 
support it, too.
  And I hope the gentlewoman from Iowa will continue to demonstrate her 
support for more openness by also supporting the bipartisan H.R. 19 
when it comes to a vote later today.
  Let's vote.
  Mr. Chair, I yield back the balance of my time.
  Ms. FINKENAUER. Mr. Chair, may I check the balance of my time?
  The Acting CHAIR. The gentlewoman from Iowa has 1\1/2\ minutes 
remaining.
  Ms. FINKENAUER. Mr. Chair, I yield myself the balance of my time.
  I am happy to hear that my colleagues across the aisle will be 
supporting this important amendment, and I would like to end with 
another story that I heard at another roundtable, one from one of our 
farmers in our district who came to our Waterloo roundtable and came 
with his wife, Heidi, who is battling MS, and was so concerned about 
how he was going to continue to make it with the ongoing trade war with 
China that has been taking his soybean markets, and the attacks on 
renewable fuels that have been hurting him every single day as a corn 
grower as well, and the $80,000 every 6 months that they were going to 
have to pay for the MS medication that he went to his lawyer and asked 
his lawyer how is he going to keep the farm and make sure his wife gets 
what she needs. His lawyer looked at him and said: If you want to keep 
your farm, you should consider divorcing your wife.
  That is another story that I will never forget. These are the reasons 
we are here today, that we fight for legislation like this, that we get 
these things done, and that we put our constituents and people over the 
politics that we continue to see here from folks who like to divide us 
instead of unite us.
  Mr. Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from Iowa (Ms. Finkenauer).
  The amendment was agreed to.


                 Amendment No. 10 Offered by Mrs. Luria

  The Acting CHAIR. It is now in order to consider amendment No. 10 
printed in part B of House Report 116-334.
  Ms. LURIA. Mr. Chairman, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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).''.
  The Acting CHAIR. Pursuant to House Resolution 758, the gentlewoman 
from Virginia (Mrs. Luria) and a Member opposed each will control 5 
minutes.
  The Chair recognizes the gentlewoman from Virginia.
  Mrs. LURIA. Mr. Chair, I yield myself such time as I may consume.
  Mr. Chair, I rise in support of my amendment to H.R. 3, the Elijah E. 
Cummings Lower Drug Costs Now Act of 2019. My amendment would ensure 
that Federal employees benefit from the same contracting practices as 
stated in the fair price negotiation program established by the 
underlying bill.
  Close to 30,000 of our constituents in Virginia's Second 
Congressional District are Federal employees, and they should all be 
able to benefit from this monumental legislation to lower prescription 
drug costs.
  Making healthcare more affordable is among my top priorities in 
Congress. As the costs of prescription drugs seem to skyrocket, I know 
I must do everything I can to ease that burden on coastal Virginians. 
Nobody should need to choose between lifesaving medications or 
bankruptcy.
  A vote in favor of this amendment is one to support broader access to 
affordable prescription drugs. I urge all of my colleagues to support 
my amendment and the underlying bill, and I reserve the balance of my 
time.
  Mr. UPTON. Mr. Chair, I seek time in opposition to the amendment.
  The Acting CHAIR. The gentleman from Michigan is recognized for 5 
minutes.
  Mr. UPTON. Mr. Chair, I do rise in opposition to the amendment. I 
would like to make a couple of points.
  According to the Office of Personnel Management, OPM, the FEHB 
program, the Federal Employee Health Benefits program, is, in fact, the 
largest employer-sponsored group health insurance program in the world. 
It covers nearly 9 million--9 million--Federal employees and their 
families.
  This amendment says that any private health plan that chooses to 
offer coverage in the FEHB program must accept the government price 
controls for prescription drugs established under this bill, H.R. 3.
  So, clearly, we are not satisfied in this amendment with only setting 
prices for Medicare and private businesses. It also creates another 
harmful mandate and expands the already-radical scope of H.R. 3 to 
other programs as well.
  As my colleagues have noted again and again today and yesterday, 
governments don't negotiate; they dictate. Taxing up to 95 percent of a 
drug manufacturer's revenue if it refuses to agree with a government-
mandated price is not free market negotiation.
  And, as we have heard from both the CBO--nonpartisan body, 
Congressional Budget Office--and the CEA, they tell us that we are 
going to lose drugs that will solve cures, as they just won't happen 
with this bill.
  Government price controls lead to lower and fewer cures; and, as the 
CEA said, nearly 100 cures for rare and difficult diseases likes 
Alzheimer's, ALS, and cancer just aren't going to happen, or they are 
going to be much delayed under H.R. 3.
  So I would ask my colleagues to vote ``no'' on this amendment, and I 
reserve the balance of my time.
  Mrs. LURIA. Mr. Chair, I yield myself such time as I may consume.
  I stand here today in strong support of H.R. 3, in opposition to my 
colleague.
  If, in fact, we are going to offer lower prescription drug costs to 
those covered by Medicare and private insurance, it is the least that 
we can do to include our Federal employees in these cost-saving 
benefits.
  Federal employees live in nearly every district in this country, and 
we must ensure that they, too, can benefit

[[Page H10216]]

from lower drug prices secured by this landmark legislation.
  I urge my colleagues to support my amendment, as well as the 
underlying bill, and I yield back the balance of my time.
  Mr. UPTON. Mr. Chair, I yield myself the balance of my time.
  I would also just like to say that the CRS, Congressional Research 
Service, has found that price controls in this bill, H.R. 3, the 
underlying bill, may be unconstitutional under the Fifth Amendment's 
Takings Clause and the Eighth Amendment Excessive Fines Clause.
  So, instead of considering yet another amendment which expands 
radical government-mandated price controls at the expense of developing 
lifesaving cures, our time would be better spent considering bipartisan 
policies such as what is in the substitute, H.R. 19.
  So I would encourage my colleagues to, instead, vote for the 
amendment on H.R. 19 and vote against H.R. 3.
  Mr. Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from Virginia (Mrs. Luria).
  The question was taken; and the Acting Chair announced that the ayes 
appeared to have it.
  Mr. WALDEN. Mr. Chair, I demand a recorded vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentlewoman from Virginia 
will be postponed.


               Amendment No. 11 Offered by Mr. Cunningham

  The Acting CHAIR. It is now in order to consider amendment No. 11 
printed in part B of House Report 116-334.
  Mr. CUNNINGHAM. Mr. Chair, I have an amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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.''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentleman 
from South Carolina (Mr. Cunningham) and a Member opposed each will 
control 5 minutes.
  The Chair recognizes the gentleman from South Carolina.
  Mr. CUNNINGHAM. Mr. Chair, I rise today in support of my amendment to 
ensure that the VA and the veterans that it serves are able to take 
advantage of lower drug prices made possible by H.R. 3.
  I am proud to support the underlying bill, which will result in lower 
drug prices for millions of Americans, but we cannot forget those who 
have sacrificed so much for our country. Veterans have earned our 
support, and they should never have to compromise on healthcare.
  H.R. 3 will establish a fair price negotiation program which will 
enable the Secretary of Health and Human Services to negotiate with 
drug companies and obtain a fair price for Medicare recipients as well 
as the privately insured. My amendment would simply allow the VA to 
purchase drugs at the same price if it is lower than what they would 
otherwise pay on their own.

                              {time}  1230

  Put simply, everyone deserves to pay a fair price for their 
lifesaving medication.
  This is not just about fiscal responsibility. It is about moral 
responsibility. The hard-earned tax dollars Americans are willing to 
put toward caring for their veterans should be spent on veterans, not 
on lining the pockets of drug companies.
  The Lowcountry is home to over 80,000 veterans, and I want them to 
know that when they seek VA care, they are receiving the best care at 
the best price. I, for one, refuse to allow Big Pharma to profit off 
our veterans. I ask my colleagues on both sides of the aisle to join me 
in ensuring our veterans have access to the lowest possible drug 
prices.
  Mr. Chairman, I reserve the balance of my time.
  Mr. DAVID P. ROE of Tennessee. Mr. Chairman, I rise in opposition to 
the amendment.
  The Acting CHAIR. The gentleman is recognized for 5 minutes.
  Mr. DAVID P. ROE of Tennessee. Mr. Chairman, there is no question 
that prescription drug prices in this country are too high and that too 
many Americans cannot afford the lifesaving medications that they need, 
and I wish the bill we were debating today would solve that problem. 
Sadly, it does not.
  The premise of this amendment is that the VA should be able to lower 
drug costs if the savings predicted materialize. But make no mistake 
about it, a bill that stops cures from coming to market and discourages 
innovation is bad for veterans and bad for America, regardless of the 
effects of this amendment.
  Further, with this amendment, we would be putting the brave men and 
women who have served our Armed Forces and are seeking care from the 
Department of VA at risk. Congressman Cunningham's amendment would 
expand the scope of this bill to include the prescription drugs 
provided by VA. As well intentioned as Congressman Cunningham's 
amendment might be, this is the wrong thing for veterans.
  Mr. Chairman, let me reminisce a little bit. When I graduated from 
medical school, there was a disease out there we did not know the name 
of. We didn't even know the name of it. We later discovered it was 
hepatitis C. We have gone from not even knowing the name of this 
disease to being able to cure it in 8 to 12 weeks.
  Let me tell you what this incredible innovation has done for our 
Nation's veterans. The VA has cured more than 100,000 veterans of 
hepatitis C since 2014, remarkable, cutting the death rate by 50 
percent.
  That is innovation that has done that. Because of this treatment, 
veterans cured are estimated to have a 72 percent less likely chance of 
developing cancer of the liver. Fewer than 25,000 veterans out there 
are now untested that are at risk, and the VA is to be applauded for 
this.
  Let me digress to my first pediatric rotation in medical school in 
Memphis many years ago. My first inpatient rotation was St. Jude 
Children's Hospital. At that time when I saw those children, 80 percent 
of them, Mr. Chairman, died of their disease. Because of innovation and 
research, and doctors and nurses and others who went in every day and 
saw these children die, today, 80 percent of those children live. If we 
don't stifle innovation, my prayer is that 100 percent of these 
children live.
  My concern with this bill, H.R. 3, is not what it will do. It is what 
will be left undone when we don't have these cures. I know that is not 
the intent of my friend. We serve on the committee together, and I know 
that is not his intent. My concern is that is exactly what will happen.

[[Page H10217]]

  I submit for the Record this list of drugs right now that the VA does 
not have on its formulary because it is closed.

  Top Medicare Part B Drugs NOT Covered by the VA (excluding vaccines)


                        Brand Name/Generic Name

       Remodulin/Treprostinil Sodium
       Provenge/Sipuleucel-T/Lactated Ringers
       Soliris/Eculizumab
       Synvisc/Hylan G-F 20
       Tyvaso/Treprostinil
       Abraxane/Paclitaxel Protein-Bound
       Actemra/Tocilizumab
       Advate/Antihemophil.FVIII, full Length
       Aloxi/Palonosetron HCL
       Brovana/Arformoterol Tartrate
       Budesonide/Budesonide
       Entyvio/Vedolizumab
       Erbitux/Cetuximab
       Faslodex/Fulvestrant
       Injectafer/Ferric Carboxymaltose
       Kadcyla/Ado-Trastuzumab Emtansine
       Neulasta/Pegfilgrastim
       NPlate/Romiplostim
       Orencia/Abatacept
       Prolia/Denosumab
       Remicade/Infliximab
       Simponi Aria/Golimumab
       Xolair/Omalizumab
       Yervoy/Ipilimumab
  Mr. DAVID P. ROE of Tennessee. Mr. Chairman, further with this 
amendment, we have a system now that works, and I would encourage my 
colleagues to not support this amendment.
  Mr. Chairman, I reserve the balance of my time.
  Mr. CUNNINGHAM. Mr. Chairman, I thank my colleagues on the Committees 
on Energy and Commerce, Ways and Means, and Education and Labor for 
their work on this historic piece of legislation, which will save 
lives. I also thank Chairman McGovern and my colleagues on the Rules 
Committee for ruling my amendment in order.
  I urge all of my colleagues to vote to lower the exorbitant cost of 
prescription drugs for every single American.
  Mr. Chairman, I yield back the balance of my time.
  Mr. DAVID P. ROE of Tennessee. Mr. Chairman, I agree with my 
colleagues that we should do everything possible to lower prescription 
drug costs, but I can tell you that H.R. 3 will not do it. One of the 
problems I have with this bill is to stifle the incredible innovation 
that I have seen in my career.
  Let me give another example before I close, Mr. Chairman. I had a 
professor in medical school, Dr. Lemuel Diggs, my hematology professor. 
He spent his entire career trying to cure sickle-cell anemia. I have 
sat by the bedside of pregnant women and done exchange transfusions on 
women nearing term who have sickle-cell disease so they can deliver a 
baby that is well and the mother would be healthy. I have done that.
  Dr. Diggs passed before we found out incredible research that has 
been done, that we can do alterations of the HIV virus, an attenuated 
virus it is called, and place the right code in the genetic code and 
potentially cure sickle-cell disease for African Americans. We do not 
want to stifle this innovation.
  Mr. Chairman, I oppose this amendment, and I yield back the balance 
of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentleman from South Carolina (Mr. Cunningham).
  The question was taken; and the Acting Chair announced that the ayes 
appeared to have it.
  Mr. DAVID P. ROE of Tennessee. Mr. Chairman, I demand a recorded 
vote.
  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further 
proceedings on the amendment offered by the gentleman from South 
Carolina will be postponed.


                Amendment No. 12 Offered by Ms. Houlahan

  The Acting CHAIR. It is now in order to consider amendment No. 12 
printed in part B of House Report 116-334.
  Ms. HOULAHAN. Mr. Chairman, as the designee of Ms. Scanlon, I have an 
amendment at the desk.
  The Acting CHAIR. The Clerk will designate the amendment.
  The text of the amendment is as follows:

       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-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) 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:

[[Page H10218]]

       ``(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''.

  The Acting CHAIR. Pursuant to House Resolution 758, the gentlewoman 
from Pennsylvania (Ms. Houlahan) and a Member opposed each will control 
5 minutes.
  The Chair recognizes the gentlewoman from Pennsylvania.
  Ms. HOULAHAN. Mr. Chair, I yield myself such time as I may consume.
  Mr. Chairman, I rise to offer this amendment sponsored today by my 
friend and neighbor, Ms. Scanlon from Pennsylvania. This commonsense 
amendment has two parts.
  First, it would require pharmacy benefit managers, or PBMs, to pass 
discounts on drugs through to State Medicaid programs. PBMs are an 
important part of our drug pricing system, but Republicans and 
Democrats alike agree on the need for PBM reform. This provision is a 
feature of the Senate's bipartisan drug pricing bill.
  According to the Pennsylvania Department of Human Services, 
Pennsylvania taxpayers paid $2.86 billion to PBMs for Medicaid 
enrollees in 2017. That is a 100 percent increase over 4 years. Under 
current law, PBMs can bill Medicaid one price for a drug, reimburse the 
pharmacy at a lower price, and profit, as a result, millions from the 
difference.
  This amendment would stop that practice from Medicaid plans and 
simply require PBMs to pass along any discounts they get from 
pharmaceutical companies to the State's Medicaid program.
  The amendment also requires pharmacies to participate in the CMS 
survey of acquisition costs for drugs so that States, consumers, and 
lawmakers alike all can have greater transparency into what these 
prescription drugs should cost.
  Again, this is a feature of the Republican drug pricing proposals 
included in Mr. Walden's proposal, and it is all about increasing 
transparency into costs, especially PBM pricing.
  Lastly, this amendment invests in NIH research for new cures and 
treatments, especially for high-need conditions.
  I am a proud cosponsor of my friend Ms. Sherrill's Biomedical 
Innovation Expansion Act, which would invest $10 billion over 10 years 
in the NIH. As an engineer and former chemistry teacher, I know how 
important both basic and applied research is to advancing science and 
medicine. I am very pleased that this bill builds off Ms. Sherrill's 
legislation and establishes a pilot program at NIH that provides 
additional funding for clinical trials.
  This stage of development is often costly and complicated, and this 
amendment would provide $900 million to this important program. With 
this investment, we are boosting support for an initiative that will 
assist the development of new cures and treatments.
  Mr. Chairman, for our Medicaid beneficiaries, for the patient out 
there right now with a condition that has no cure, I ask that my 
colleagues on both sides of the aisle support this amendment.
  Mr. Chairman, I reserve the balance of my time.
  Mr. WALDEN. Mr. Chairman, I rise in opposition to this amendment.
  The Acting CHAIR. The gentleman is recognized for 5 minutes.
  Mr. WALDEN. Mr. Chairman, I reserve the balance of my time.
  Ms. HOULAHAN. Mr. Chairman, I stand here in strong support of Ms. 
Scanlon's amendment to H.R. 3 and in strong support of H.R. 3, as well.
  I can say, as a freshman Member of this delegation and this Congress, 
the number one thing that all of our constituents ask of us each and 
every day is to address this issue of prescription drug pricing and 
transparency into that process.
  This bill and the underlying amendment therein support and affirm 
both those things. I urge my colleagues on both sides of the aisle to 
support this bill and its underlying amendment.
  Mr. Chairman, I yield back the balance of my time.
  Mr. WALDEN. Mr. Chair, we certainly support clinical trials at the 
National Institutes of Health. In fact, the Republicans have led on 
this issue. In fact, Republicans have led for decades in increasing the 
funding for NIH, going clear back to about 1995 when then-Speaker 
Gingrich led an effort to double the funding for the NIH.
  Our colleague Mr. Upton from Michigan led the effort to dramatically 
increase the funding for NIH. We know that is extraordinarily important 
to do.
  Of course, while that is important, it is kind of the basic science. 
The real

[[Page H10219]]

work that gets done takes that and then turns it into drugs eventually 
through a whole clinical trial process with lots more innovation and 
investment.
  Tragically, H.R. 3 rips $1 trillion out of that innovation funding 
cycle. That is why, for the life of me, I can't understand why my 
friends are voting for that knowing that, and how they can vote for 
H.R. 3 knowing that upward of 100 or more cures, lifesaving drugs, 
medicines never will be developed.

  Those aren't my numbers. Those are the numbers of the Council of 
Economic Advisers. Those are the numbers from CBO. They tell us in 
literally the next 20 years, 38 new drugs will never be developed, at a 
minimum, upward of 38. It could be more. I suppose it could be less. 
After that, it is 10 percent every year that don't get developed. We 
think it is actually higher than that, but those are the facts. Those 
are facts.
  I want to emphasize that the ban on spread pricing in Medicaid 
offered here as a Democratic amendment is actually, as my friend 
recognizes, in H.R. 19. We agree. There are 138 Democrats who have 
sponsored different provisions that are bipartisan in the substitute 
amendment, and it should do no damage.
  Why would you vote against your own stuff? I mean, it is in here. It 
is good policy. It is bipartisan. I hope that some will have the 
opportunity to be strong and vote for really good bipartisan 
legislation. I would argue that H.R. 19, the substitute, is the most 
bipartisan bill on the floor today, the only bipartisan bill on the 
floor today.
  This comprehensive collection of bipartisan policies from both the 
House and the Senate are contained in the substitute, H.R. 19. We 
looked a lot at the work that Senator Grassley and my own State Senator 
Ron Wyden put together in their legislation. We probably got 90 percent 
of that one way or the other incorporated in here.
  I have learned over the years, from the time I got here as a freshman 
until now, you don't get everything. Sometimes, you can make more 
progress by getting together and getting what you can agree on done and 
then continuing to work on the issues where you don't agree, and I 
would say that is an issue that we face right now.
  We have before us a substitute that could become law, and the 
President basically indicated he would sign it. He clearly has 
indicated he will veto H.R. 3. We have had word out of the Senate that 
they have no plans to take up H.R. 3. To me, it makes it a nonstarter.
  I also believe it is dangerous to innovation. It will cost 88,000 
jobs U.S.-wide, and 80-something percent of new drugs coming out of 
California won't be developed. That is according to the people who do 
this work, California Life Sciences.

                              {time}  1245

  I don't think you have to trade that reduction in innovation and new 
cures for lower prices. I think you can actually have both.
  We have a common commitment here to lower drug prices. We have a 
common commitment here to increase investment in NIH and to stop the 
bad behaviors by the pharmaceutical companies, to stop them from 
withholding samples so that generics don't get to market or actually 
paying all generic brands not to come to market.
  I wrote the legislation last Congress that modernized the FDA's 
approval process for medical devices, generic devices, so we couldn't 
get stuck--that is a bit of a pun--by another EpiPen issue. Because 
there was no competitor, they raised the price the way they wanted to, 
and they stuck it to people like my wife, who used to use an EpiPen, 
and many other consumers.
  We now have competition in that space, and the FDA has approved more 
generic drugs as a result of our unanimous work on the FDA reform. More 
generic drugs in the last year than at any time in the history of the 
FDA were approved, over 1,100 new generic drugs, because, I think, when 
you get more competition in the market, consumers benefit with more 
choice and lower price.
  Now, there is still some gaming that goes on, and we agree on that, 
and we are putting a stop to that wherever we can find it. But I don't 
want to vote for H.R. 3 as an unconstitutional measure, as we have been 
warned by our own Congressional Research Service lawyers who looked at 
it. They said it likely violates two provisions of the Constitution 
because it is so punitive and damaging.
  We had the outside science people look at it and say it is going to 
cost cures.
  Mr. Chair, I yield back the balance of my time.
  The Acting CHAIR. The question is on the amendment offered by the 
gentlewoman from Pennsylvania (Ms. Houlahan).
  The amendment was agreed to.


                    Announcement by the Acting Chair

  The Acting CHAIR. Pursuant to clause 6 of rule XVIII, proceedings 
will now resume on those amendments printed in part B of House Report 
116-334 on which further proceedings were postponed, in the following 
order:
  Amendment No. 1 by Mr. Walden of Oregon.
  Amendment No. 5 by Mr. O'Halleran of Arizona.
  Amendment No. 7 by Mr. Gottheimer of New Jersey.
  Amendment No. 10 by Ms. Luria of Virginia.
  Amendment No. 11 by Mr. Cunningham of South Carolina.
  The Chair will reduce to 2 minutes the minimum time for any 
electronic vote after the first vote in this series.


                 Amendment No. 1 Offered by Mr. Walden

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentleman from Oregon 
(Mr. Walden) on which further proceedings were postponed and on which 
the noes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The vote was taken by electronic device, and there were--ayes 201, 
noes 223, not voting 12, as follows:

                             [Roll No. 676]

                               AYES--201

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Armstrong
     Arrington
     Babin
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Bergman
     Biggs
     Bilirakis
     Bishop (NC)
     Bishop (UT)
     Bost
     Brady
     Brindisi
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Cheney
     Cline
     Cloud
     Cole
     Collins (GA)
     Comer
     Conaway
     Cook
     Crawford
     Crenshaw
     Curtis
     Davidson (OH)
     Davis, Rodney
     DesJarlais
     Diaz-Balart
     Duncan
     Dunn
     Emmer
     Estes
     Ferguson
     Fitzpatrick
     Fleischmann
     Flores
     Fortenberry
     Foxx (NC)
     Fulcher
     Gaetz
     Gallagher
     Gianforte
     Gibbs
     Gohmert
     Gonzalez (OH)
     Gooden
     Gottheimer
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green (TN)
     Griffith
     Grothman
     Guest
     Guthrie
     Hagedorn
     Harris
     Hartzler
     Hern, Kevin
     Herrera Beutler
     Hice (GA)
     Higgins (LA)
     Hill (AR)
     Holding
     Hollingsworth
     Hudson
     Huizenga
     Hurd (TX)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Jordan
     Joyce (OH)
     Joyce (PA)
     Katko
     Keller
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Latta
     Lesko
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Marchant
     Marshall
     Mast
     McAdams
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     Meadows
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Mullin
     Murphy (NC)
     Newhouse
     Norman
     Nunes
     Olson
     Palazzo
     Palmer
     Pence
     Perry
     Peters
     Posey
     Radewagen
     Ratcliffe
     Reed
     Reschenthaler
     Rice (SC)
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose, John W.
     Rouda
     Rouzer
     Roy
     Rutherford
     Scalise
     Schrader
     Schweikert
     Scott, Austin
     Sensenbrenner
     Shimkus
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smucker
     Spano
     Stauber
     Stefanik
     Steil
     Steube
     Stewart
     Stivers
     Suozzi
     Taylor
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Turner
     Upton
     Van Drew
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Waltz
     Watkins
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yoho
     Young

                               NOES--223

     Adams
     Aguilar
     Allred
     Axne
     Barragan
     Bass
     Beatty
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Boyle, Brendan F.
     Brown (MD)
     Brownley (CA)
     Bustos
     Butterfield
     Carbajal
     Cardenas
     Carson (IN)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)

[[Page H10220]]


     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Finkenauer
     Fletcher
     Foster
     Frankel
     Fudge
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Golden
     Gomez
     Gonzalez (TX)
     Gonzalez-Colon (PR)
     Green, Al (TX)
     Grijalva
     Haaland
     Harder (CA)
     Hastings
     Hayes
     Heck
     Higgins (NY)
     Himes
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (TX)
     Kaptur
     Keating
     Kelly (IL)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Massie
     Matsui
     McBath
     McCollum
     McEachin
     McGovern
     Meeks
     Meng
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Norcross
     Norton
     O'Halleran
     Ocasio-Cortez
     Omar
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Peterson
     Phillips
     Pingree
     Plaskett
     Pocan
     Porter
     Pressley
     Price (NC)
     Quigley
     Raskin
     Rice (NY)
     Richmond
     Rose (NY)
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrier
     Scott (VA)
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Sires
     Slotkin
     Smith (WA)
     Soto
     Spanberger
     Speier
     Stanton
     Stevens
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Underwood
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wasserman Schultz
     Waters
     Watson Coleman
     Welch
     Wexton
     Wild
     Wilson (FL)
     Yarmuth

                             NOT VOTING--12

     Burchett
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     McNerney
     Rooney (FL)
     Sablan
     San Nicolas
     Serrano
     Zeldin

                              {time}  1318

  Mses. SLOTKIN, PLASKETT, Messrs. GALLEGO, CASTRO of Texas, CLEAVER, 
Ms. SANCHEZ, Mr. DOGGETT, Mses. BONAMICI, DeLAURO, Miss GONZALEZ-COLON 
of Puerto Rico, and Mrs. MURPHY of Florida changed their vote from 
``aye'' to ``no.''
  Messrs. BROOKS of Alabama, SCHWEIKERT, PETERS, and SUOZZI changed 
their vote from ``no'' to ``aye.''
  So the amendment was rejected.
  The result of the vote was announced as above recorded.
  Stated against:
  Mr. McNERNEY. Mr. Chair, had I been present, I would have voted 
``nay'' on rollcall No. 676.


               Amendment No. 5 Offered by Mr. O'Halleran

  The Acting CHAIR (Mr. Cartwright). The unfinished business is the 
demand for a recorded vote on the amendment offered by the gentleman 
from Arizona (Mr. O'Halleran) on which further proceedings were 
postponed and on which the ayes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The Acting CHAIR. This will be a 2-minute vote.
  The vote was taken by electronic device, and there were--ayes 351, 
noes 73, not voting 12, as follows:

                             [Roll No. 677]

                               AYES--351

     Adams
     Aguilar
     Allen
     Allred
     Amodei
     Armstrong
     Axne
     Baird
     Balderson
     Banks
     Barr
     Barragan
     Bass
     Beatty
     Bera
     Bergman
     Beyer
     Bilirakis
     Bishop (GA)
     Bishop (UT)
     Blumenauer
     Blunt Rochester
     Bonamici
     Bost
     Boyle, Brendan F.
     Brindisi
     Brooks (IN)
     Brown (MD)
     Brownley (CA)
     Buchanan
     Bucshon
     Burgess
     Bustos
     Butterfield
     Calvert
     Carbajal
     Cardenas
     Carson (IN)
     Carter (GA)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chabot
     Cheney
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Cline
     Clyburn
     Cohen
     Cole
     Collins (GA)
     Connolly
     Cook
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Curtis
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Davis, Rodney
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DesJarlais
     Deutch
     Diaz-Balart
     Dingell
     Doggett
     Doyle, Michael F.
     Duncan
     Dunn
     Emmer
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Ferguson
     Finkenauer
     Fitzpatrick
     Fleischmann
     Fletcher
     Fortenberry
     Foster
     Frankel
     Fudge
     Gallagher
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Gianforte
     Gibbs
     Gohmert
     Golden
     Gomez
     Gonzalez (TX)
     Gonzalez-Colon (PR)
     Gottheimer
     Graves (LA)
     Graves (MO)
     Green (TN)
     Green, Al (TX)
     Griffith
     Grijalva
     Guest
     Guthrie
     Haaland
     Hagedorn
     Harder (CA)
     Hartzler
     Hastings
     Hayes
     Heck
     Herrera Beutler
     Higgins (LA)
     Higgins (NY)
     Himes
     Hollingsworth
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Huizenga
     Hurd (TX)
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (OH)
     Johnson (SD)
     Johnson (TX)
     Joyce (OH)
     Kaptur
     Katko
     Keating
     Keller
     Kelly (IL)
     Kelly (MS)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     King (IA)
     King (NY)
     Kinzinger
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Kustoff (TN)
     LaMalfa
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Latta
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Lesko
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Long
     Loudermilk
     Lowenthal
     Lowey
     Lucas
     Luetkemeyer
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Marshall
     Matsui
     McAdams
     McBath
     McCaul
     McCollum
     McEachin
     McGovern
     McKinley
     McNerney
     Meeks
     Meng
     Meuser
     Moolenaar
     Mooney (WV)
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Mullin
     Murphy (FL)
     Murphy (NC)
     Nadler
     Napolitano
     Neal
     Neguse
     Newhouse
     Norcross
     Norton
     O'Halleran
     Ocasio-Cortez
     Omar
     Palazzo
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Pence
     Perlmutter
     Peters
     Peterson
     Phillips
     Pingree
     Plaskett
     Pocan
     Porter
     Posey
     Pressley
     Price (NC)
     Quigley
     Radewagen
     Raskin
     Reed
     Reschenthaler
     Rice (NY)
     Rice (SC)
     Richmond
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose (NY)
     Rose, John W.
     Rouda
     Rouzer
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrader
     Schrier
     Scott (VA)
     Scott, Austin
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Simpson
     Sires
     Slotkin
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smith (WA)
     Smucker
     Soto
     Spanberger
     Spano
     Stanton
     Stauber
     Stefanik
     Steil
     Stevens
     Stewart
     Stivers
     Suozzi
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Thompson (PA)
     Thornberry
     Tipton
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Turner
     Underwood
     Upton
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wagner
     Walberg
     Walden
     Walorski
     Waltz
     Wasserman Schultz
     Waters
     Watkins
     Watson Coleman
     Webster (FL)
     Welch
     Wenstrup
     Wexton
     Wild
     Wilson (FL)
     Wilson (SC)
     Wittman
     Woodall
     Yarmuth
     Yoho
     Zeldin

                                NOES--73

     Abraham
     Aderholt
     Amash
     Arrington
     Babin
     Bacon
     Biggs
     Bishop (NC)
     Brady
     Brooks (AL)
     Buck
     Budd
     Byrne
     Carter (TX)
     Cloud
     Comer
     Conaway
     Crawford
     Crenshaw
     Davidson (OH)
     Estes
     Flores
     Foxx (NC)
     Fulcher
     Gaetz
     Gonzalez (OH)
     Gooden
     Granger
     Graves (GA)
     Grothman
     Harris
     Hern, Kevin
     Hice (GA)
     Hill (AR)
     Holding
     Hudson
     Johnson (LA)
     Jordan
     Joyce (PA)
     Kelly (PA)
     LaHood
     Lamborn
     Marchant
     Massie
     Mast
     McCarthy
     McClintock
     McHenry
     Meadows
     Miller
     Mitchell
     Norman
     Nunes
     Olson
     Palmer
     Perry
     Ratcliffe
     Roy
     Rutherford
     Scalise
     Schweikert
     Sensenbrenner
     Shimkus
     Steube
     Taylor
     Timmons
     Walker
     Weber (TX)
     Westerman
     Williams
     Womack
     Wright
     Young

                             NOT VOTING--12

     Burchett
     DeSaulnier
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     Rooney (FL)
     Sablan
     San Nicolas
     Serrano
     Speier


                    Announcement by the Acting Chair

  The Acting CHAIR (Mr. McGovern) (during the vote). There is 1 minute 
remaining.

                              {time}  1324

  Mr. JOYCE of Pennsylvania changed his vote from ``aye'' to ``no.''
  Mr. WALBERG changed his vote from ``no'' to ``aye.''
  So the amendment was agreed to.

[[Page H10221]]

  The result of the vote was announced as above recorded.


               Amendment No. 7 Offered by Mr. Gottheimer

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentleman from New Jersey 
(Mr. Gottheimer) on which further proceedings were postponed and on 
which the ayes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The Acting CHAIR. This will be a 2-minute vote.
  The vote was taken by electronic device, and there were--ayes 380, 
noes 45, not voting 11, as follows:

                             [Roll No. 678]

                               AYES--380

     Abraham
     Adams
     Aguilar
     Allen
     Allred
     Amodei
     Arrington
     Axne
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Barragan
     Bass
     Beatty
     Bera
     Bergman
     Beyer
     Bilirakis
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Bost
     Boyle, Brendan F.
     Brady
     Brindisi
     Brooks (AL)
     Brooks (IN)
     Brown (MD)
     Brownley (CA)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Bustos
     Butterfield
     Calvert
     Carbajal
     Carson (IN)
     Carter (GA)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chabot
     Cheney
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Cline
     Clyburn
     Cohen
     Cole
     Collins (GA)
     Comer
     Connolly
     Cook
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crenshaw
     Crist
     Crow
     Cuellar
     Cunningham
     Curtis
     Davids (KS)
     Davidson (OH)
     Davis (CA)
     Davis, Danny K.
     Davis, Rodney
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     DesJarlais
     Deutch
     Diaz-Balart
     Dingell
     Doyle, Michael F.
     Duncan
     Dunn
     Emmer
     Engel
     Escobar
     Eshoo
     Espaillat
     Estes
     Evans
     Finkenauer
     Fitzpatrick
     Fleischmann
     Fletcher
     Fortenberry
     Foster
     Foxx (NC)
     Frankel
     Fudge
     Fulcher
     Gaetz
     Gallagher
     Gallego
     Garamendi
     Garcia (TX)
     Gianforte
     Gibbs
     Golden
     Gomez
     Gonzalez (OH)
     Gonzalez (TX)
     Gonzalez-Colon (PR)
     Gooden
     Gottheimer
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green, Al (TX)
     Griffith
     Grijalva
     Grothman
     Guest
     Guthrie
     Haaland
     Hagedorn
     Harder (CA)
     Hartzler
     Hastings
     Hayes
     Heck
     Hern, Kevin
     Herrera Beutler
     Higgins (LA)
     Higgins (NY)
     Hill (AR)
     Himes
     Hollingsworth
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Hudson
     Huffman
     Huizenga
     Hurd (TX)
     Jackson Lee
     Jeffries
     Johnson (GA)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Johnson (TX)
     Joyce (OH)
     Joyce (PA)
     Kaptur
     Katko
     Keating
     Keller
     Kelly (IL)
     Kelly (MS)
     Kelly (PA)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     King (IA)
     King (NY)
     Kinzinger
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Latta
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Lesko
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Long
     Loudermilk
     Lowenthal
     Lowey
     Lucas
     Luetkemeyer
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Marshall
     Mast
     Matsui
     McAdams
     McBath
     McCarthy
     McCaul
     McCollum
     McEachin
     McGovern
     McHenry
     McKinley
     McNerney
     Meadows
     Meeks
     Meng
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Mullin
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Newhouse
     Norcross
     Norman
     Norton
     Nunes
     O'Halleran
     Ocasio-Cortez
     Omar
     Palazzo
     Pallone
     Palmer
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Peters
     Peterson
     Phillips
     Pingree
     Plaskett
     Porter
     Posey
     Pressley
     Price (NC)
     Quigley
     Radewagen
     Raskin
     Reed
     Reschenthaler
     Rice (NY)
     Rice (SC)
     Richmond
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose (NY)
     Rose, John W.
     Rouda
     Rouzer
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scalise
     Scanlon
     Schiff
     Schneider
     Schrader
     Schrier
     Schweikert
     Scott (VA)
     Scott, Austin
     Scott, David
     Sensenbrenner
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Simpson
     Sires
     Slotkin
     Smith (MO)
     Smith (NJ)
     Smith (WA)
     Smucker
     Soto
     Spanberger
     Spano
     Speier
     Stanton
     Stauber
     Stefanik
     Steil
     Stevens
     Stewart
     Stivers
     Suozzi
     Swalwell (CA)
     Takano
     Taylor
     Thompson (CA)
     Thompson (MS)
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Turner
     Underwood
     Upton
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wagner
     Walberg
     Walden
     Walorski
     Waltz
     Wasserman Schultz
     Waters
     Watkins
     Watson Coleman
     Webster (FL)
     Welch
     Wenstrup
     Westerman
     Wexton
     Wild
     Williams
     Wilson (FL)
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yarmuth
     Yoho
     Young
     Zeldin

                                NOES--45

     Aderholt
     Amash
     Armstrong
     Babin
     Biggs
     Bishop (NC)
     Bishop (UT)
     Byrne
     Carter (TX)
     Cloud
     Conaway
     Crawford
     Doggett
     Ferguson
     Flores
     Garcia (IL)
     Gohmert
     Granger
     Green (TN)
     Harris
     Hice (GA)
     Holding
     Jayapal
     Jordan
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Marchant
     Massie
     McClintock
     Murphy (NC)
     Olson
     Pence
     Perry
     Pocan
     Ratcliffe
     Roy
     Rutherford
     Schakowsky
     Shimkus
     Smith (NE)
     Steube
     Walker
     Weber (TX)

                             NOT VOTING--11

     Burchett
     Cardenas
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     Rooney (FL)
     Sablan
     San Nicolas
     Serrano


                    Announcement by the Acting Chair

  The Acting CHAIR (during the vote). There is 1 minute remaining.

                              {time}  1328

  Mr. WALBERG changed his vote from ``no'' to ``aye.''
  So the amendment was agreed to.
  The result of the vote was announced as above recorded.


                 Amendment No. 10 Offered by Mrs. Luria

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentlewoman from Virginia 
(Mrs. Luria) on which further proceedings were postponed and on which 
the ayes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The Acting CHAIR. This will be a 2-minute vote.
  The vote was taken by electronic device, and there were--ayes 231, 
noes 192, not voting 13, as follows:

                             [Roll No. 679]

                               AYES--231

     Adams
     Aguilar
     Allred
     Axne
     Barragan
     Bass
     Beatty
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Boyle, Brendan F.
     Brindisi
     Brown (MD)
     Brownley (CA)
     Bustos
     Butterfield
     Carbajal
     Cardenas
     Carson (IN)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Finkenauer
     Fitzpatrick
     Fletcher
     Fortenberry
     Foster
     Frankel
     Fudge
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Golden
     Gomez
     Gonzalez (TX)
     Gottheimer
     Green, Al (TX)
     Grijalva
     Haaland
     Harder (CA)
     Hastings
     Hayes
     Heck
     Higgins (NY)
     Himes
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (TX)
     Kaptur
     Keating
     Kelly (IL)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan
     Luria
     Lynch
     Maloney, Carolyn B.
     Maloney, Sean
     Matsui
     McAdams
     McBath
     McCollum
     McEachin
     McGovern
     McNerney
     Meng
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Norcross
     Norton
     O'Halleran
     Ocasio-Cortez
     Omar
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Perry
     Peters
     Peterson
     Phillips
     Pingree
     Plaskett
     Pocan
     Porter
     Pressley
     Price (NC)
     Quigley
     Raskin
     Rice (NY)
     Richmond
     Rose (NY)
     Rouda
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrader
     Schrier
     Scott (VA)
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Sires
     Slotkin
     Smith (WA)
     Soto
     Spanberger
     Speier
     Stanton
     Stevens

[[Page H10222]]


     Suozzi
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Underwood
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wasserman Schultz
     Waters
     Watson Coleman
     Welch
     Wexton
     Wild
     Wilson (FL)
     Yarmuth

                               NOES--192

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Armstrong
     Arrington
     Babin
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Bergman
     Biggs
     Bilirakis
     Bishop (NC)
     Bishop (UT)
     Bost
     Brady
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Cheney
     Cline
     Cloud
     Cole
     Collins (GA)
     Comer
     Conaway
     Cook
     Crawford
     Crenshaw
     Curtis
     Davidson (OH)
     Davis, Rodney
     DesJarlais
     Diaz-Balart
     Duncan
     Dunn
     Emmer
     Estes
     Ferguson
     Fleischmann
     Flores
     Foxx (NC)
     Fulcher
     Gaetz
     Gallagher
     Gianforte
     Gibbs
     Gohmert
     Gonzalez (OH)
     Gonzalez-Colon (PR)
     Gooden
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green (TN)
     Griffith
     Grothman
     Guest
     Guthrie
     Hagedorn
     Harris
     Hartzler
     Hern, Kevin
     Herrera Beutler
     Hice (GA)
     Higgins (LA)
     Hill (AR)
     Holding
     Hollingsworth
     Hudson
     Huizenga
     Hurd (TX)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Jordan
     Joyce (OH)
     Joyce (PA)
     Katko
     Keller
     Kelly (MS)
     Kelly (PA)
     King (IA)
     Kinzinger
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Latta
     Lesko
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Marchant
     Marshall
     Massie
     Mast
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     Meadows
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Mullin
     Murphy (NC)
     Newhouse
     Norman
     Nunes
     Olson
     Palazzo
     Palmer
     Pence
     Posey
     Radewagen
     Ratcliffe
     Reed
     Reschenthaler
     Rice (SC)
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose, John W.
     Rouzer
     Roy
     Rutherford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Shimkus
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smucker
     Spano
     Stauber
     Stefanik
     Steil
     Steube
     Stewart
     Stivers
     Taylor
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Turner
     Upton
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Waltz
     Watkins
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yoho
     Young
     Zeldin

                             NOT VOTING--13

     Burchett
     Gabbard
     Gosar
     Hunter
     King (NY)
     Lewis
     Lieu, Ted
     Malinowski
     Meeks
     Rooney (FL)
     Sablan
     San Nicolas
     Serrano


                    Announcement by the Acting Chair

  The Acting CHAIR (during the vote). There is 1 minute remaining.

                              {time}  1332

  So the amendment was agreed to.
  The result of the vote was announced as above recorded.


               Amendment No. 11 Offered by Mr. Cunningham

  The Acting CHAIR. The unfinished business is the demand for a 
recorded vote on the amendment offered by the gentleman from South 
Carolina (Mr. Cunningham) on which further proceedings were postponed 
and on which the ayes prevailed by voice vote.
  The Clerk will redesignate the amendment.
  The Clerk redesignated the amendment.


                             Recorded Vote

  The Acting CHAIR. A recorded vote has been demanded.
  A recorded vote was ordered.
  The Acting CHAIR. This is a 2-minute vote.
  The vote was taken by electronic device, and there were--ayes 234, 
noes 192, not voting 10, as follows:

                             [Roll No. 680]

                               AYES--234

     Adams
     Aguilar
     Allred
     Axne
     Barragan
     Bass
     Beatty
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Boyle, Brendan F.
     Brindisi
     Brown (MD)
     Brownley (CA)
     Bustos
     Butterfield
     Carbajal
     Cardenas
     Carson (IN)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Davis, Rodney
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Finkenauer
     Fitzpatrick
     Fletcher
     Fortenberry
     Foster
     Frankel
     Fudge
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Golden
     Gomez
     Gonzalez (TX)
     Gottheimer
     Green, Al (TX)
     Grijalva
     Haaland
     Harder (CA)
     Hastings
     Hayes
     Heck
     Higgins (NY)
     Himes
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (TX)
     Kaptur
     Katko
     Keating
     Kelly (IL)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Matsui
     McAdams
     McBath
     McCollum
     McEachin
     McGovern
     McNerney
     Meeks
     Meng
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Norcross
     Norton
     O'Halleran
     Ocasio-Cortez
     Omar
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Peters
     Peterson
     Phillips
     Pingree
     Plaskett
     Pocan
     Porter
     Pressley
     Price (NC)
     Quigley
     Raskin
     Rice (NY)
     Richmond
     Rose (NY)
     Rouda
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrader
     Schrier
     Scott (VA)
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Sires
     Slotkin
     Smith (WA)
     Soto
     Spanberger
     Speier
     Stanton
     Stevens
     Suozzi
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Underwood
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wasserman Schultz
     Waters
     Watson Coleman
     Welch
     Wexton
     Wild
     Wilson (FL)
     Yarmuth

                               NOES--192

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Armstrong
     Arrington
     Babin
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Bergman
     Biggs
     Bilirakis
     Bishop (NC)
     Bishop (UT)
     Bost
     Brady
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Cheney
     Cline
     Cloud
     Cole
     Collins (GA)
     Comer
     Conaway
     Cook
     Crawford
     Crenshaw
     Curtis
     Davidson (OH)
     DesJarlais
     Diaz-Balart
     Duncan
     Dunn
     Emmer
     Estes
     Ferguson
     Fleischmann
     Flores
     Foxx (NC)
     Fulcher
     Gaetz
     Gallagher
     Gianforte
     Gibbs
     Gohmert
     Gonzalez (OH)
     Gonzalez-Colon (PR)
     Gooden
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green (TN)
     Griffith
     Grothman
     Guest
     Guthrie
     Hagedorn
     Harris
     Hartzler
     Hern, Kevin
     Herrera Beutler
     Hice (GA)
     Higgins (LA)
     Hill (AR)
     Holding
     Hollingsworth
     Hudson
     Huizenga
     Hurd (TX)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Jordan
     Joyce (OH)
     Joyce (PA)
     Keller
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Latta
     Lesko
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Marchant
     Marshall
     Massie
     Mast
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     Meadows
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Mullin
     Murphy (NC)
     Newhouse
     Norman
     Nunes
     Olson
     Palazzo
     Palmer
     Pence
     Perry
     Posey
     Radewagen
     Ratcliffe
     Reed
     Reschenthaler
     Rice (SC)
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose, John W.
     Rouzer
     Roy
     Rutherford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Shimkus
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smucker
     Spano
     Stauber
     Stefanik
     Steil
     Steube
     Stewart
     Stivers
     Taylor
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Turner
     Upton
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Waltz
     Watkins
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yoho
     Young
     Zeldin

                             NOT VOTING--10

     Burchett
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     Rooney (FL)
     Sablan
     San Nicolas
     Serrano


                    Announcement by the Acting Chair

  The Acting CHAIR (during the vote). There is 1 minute remaining.

                              {time}  1339

  So the amendment was agreed to.
  The result of the vote was announced as above recorded.
  The Acting CHAIR (Mr. Payne). There being no further amendments, 
under the rule, the committee rises.
  Accordingly, the Committee rose; and the Speaker pro tempore (Mr. 
McGovern) having assumed the chair,

[[Page H10223]]

Mr. Payne, Acting Chair of the Committee of the Whole House on the 
state of the Union, reported that that Committee, having had under 
consideration 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, and, pursuant to House Resolution 758, he 
reported the bill, as amended by that resolution, back to the House 
with sundry further amendments adopted in the Committee of the Whole.
  The SPEAKER pro tempore. Under the rule, the previous question is 
ordered.
  Is a separate vote demanded on any amendment reported from the 
Committee of the Whole? If not, the Chair will put them en gros.
  The amendments were agreed to.
  The SPEAKER pro tempore. The question is on the engrossment and third 
reading of the bill.
  The bill was ordered to be engrossed and read a third time, and was 
read the third time.


                           Motion to Recommit

  Mr. UPTON. Mr. Speaker, I have a motion to recommit at the desk.
  The SPEAKER pro tempore. Is the gentleman opposed to the bill?
  Mr. UPTON. I am in its current form.
  The SPEAKER pro tempore. The Clerk will report the motion to 
recommit.
  The Clerk read as follows:

       Mr. Upton moves to recommit the bill H.R. 3 to the 
     Committee on Energy and Commerce with instructions to report 
     the same back to the House forthwith with the following 
     amendment:
       At the end of title VIII, insert the following new section 
     (and update the table of sections accordingly):

     SEC. ___. EFFECTIVE DATE CONDITIONED ON CERTIFICATION.

       Notwithstanding any other provision of this Act, none of 
     the provisions of this Act shall go into effect unless the 
     Secretary of Health and Human Services certifies that the 
     implementation of such provisions are not projected to result 
     in fewer new drug applications with respect to unmet medical 
     needs and life saving cures.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan is recognized for 5 minutes in support of his motion.
  Mr. UPTON. Mr. Speaker, here is the beef: Tomorrow marks the third 
anniversary of the enactment of 21st Century Cures, a bill that passed 
this House at 392-26. In looking back at that legislation now, 3 years 
later, we have made wonderful strides in finding the cures for the 
diseases that have impacted every family, be it cystic fibrosis, 
Alzheimer's and pancreatic cancer, just to name a few.
  And just last week, a number of us met with a young girl who had been 
in a trial for SMA. That is often a fatal disease known as spinal 
muscular atrophy. She was in a wheelchair, barely able to talk. But 
after 15 days on this trial, she could actually move her head and her 
neck for the first time in more than a decade, all really because of 
what we did on 21st Century Cures.
  The CBO/CEA and Scott Gottlieb, in today's ``Wall Street Journal'' 
writes that H.R. 3, the underlying bill: ``The price-control approach 
would increase uncertainty and reduce returns from biotech investment, 
raising the cost of capital for these invaluable endeavors.''
  You know, we are on the cusp of gene therapy for deadly inherited 
diseases like MS, literally, finding cures to solve blindness. But 
let's not stop. Let's build on what we did.
  The language in this motion to recommit assures that cures will not 
be slowed down, because we have the requirement that unless the 
Secretary of HHS certifies the implementation of such provisions are 
not projected to result in fewer new drug applications. That is what 
this amendment is about.
  We want to make sure that we have the resources to develop the cures 
that all of us want for the thousands of diseases where we don't have a 
cure.
  Mr. Speaker, I would yield to the gentleman from Texas to talk about 
his personal story, that many of us did not know until this bill came 
up in the last couple of days.
  Mr. Speaker, I yield to the gentleman from Texas (Mr. Wright).
  Mr. WRIGHT. Mr. Speaker, I rise today in staunch opposition to H.R. 
3.
  I can add to what my colleagues have said with statistics and 
legalese, but I would rather offer you my personal experience.
  I was diagnosed with Stage 4 lung cancer. I was told that the average 
life expectancy was 16 months. That was 16 months ago. By the grace of 
Almighty God and American biotech ingenuity, I am still here, and I 
will get to spend another Christmas with my family.
  I was prescribed a rigorous regimen of chemotherapy and an 
immunotherapy wonder-drug called Keytruda, which had only just been 
approved for my regimen in May of 2017. Keytruda's discovery is as a 
result of significant financial investment by the private sector, not 
the government. Today, I feel great. My last CAT scan showed nothing in 
my liver and lymph nodes, and the primary tumor had shrunk to about the 
size of a raisin.
  Now, 5 years ago, my diagnosis would have been a death sentence. 
Today, I am beating it. Millions of Americans are diagnosed with life-
threatening illnesses every year. And thanks to medical innovation in 
the United States, miraculous outcomes like mine are not uncommon 
either.
  If H.R. 3 becomes law, stories like mine would be rare. If these 
socialist policies had been implemented earlier, I probably would not 
be here. For too many in this Chamber, this has become part of their 
political agenda, but for me and millions of Americans, this is a 
matter of life or death.
  H.R. 3 will not save American lives. It will end them. I urge my 
colleagues to think of their loved ones who will face deadly diseases 
in the future. Many cures are on the horizon. We cannot stop. We cannot 
slow down. We cannot stifle research and development of new cures by 
onerous government control. Too many lives hang in the balance.
  Mr. Speaker, I beg my colleagues to support this motion to recommit, 
and let's take action that will actually save lives.
  Mr. UPTON. Mr. Speaker, I yield back the balance of my time.
  Ms. SCHRIER. Mr. Speaker, I rise in opposition to the motion.
  The SPEAKER pro tempore. The gentlewoman from Washington is 
recognized for 5 minutes
  Ms. SCHRIER. Mr. Speaker, I am so glad that my colleague from Texas, 
Mr. Wright, is well and I am so glad that he could afford the treatment 
that he needed.
  But we have people suffering from the cost of prescription drugs now, 
and intentionally holding up this bill hurts them. We absolutely must 
remain the leader in the world in innovation, but the thing is, we can 
reduce drug prices and still have money for research.
  The money U.S.-based drug companies made in 2015 by charging 
Americans high prices was nearly double what was needed to fund their 
global R&D. An H.R. 3 uses the savings to reinvest billions in the 
research and clinical trials needed to get cures faster.
  I am so excited about H.R. 3, the Elijah E. Cummings Lower Drug Costs 
Now Act. I am the first pediatrician ever elected to Congress, and 
currently the only female doctor here. I am also a patient with type 1 
diabetes. My life depends on insulin, so the high cost of prescription 
drugs affects me and people like me every day.
  I have driven over 7,000 miles this year traversing my district 
talking to people about what matters to them. And you know what the 
biggest thing is? The cost of prescription drugs. Because it doesn't 
matter if you are a Democrat or Republican if you cannot afford your 
medication.
  I understand this issue both as a doctor and a patient, because it is 
not theoretical for me or for my patients. When we talk about the cost 
of insulin, I have felt that personally. I have seen the price of my 
insulin go from $40 a bottle to $300. That is the price for a bottle 
that holds 10 milliliters, 2 teaspoons.
  Before being elected to Congress, I worked for nearly 20 years as a 
pediatrician in the suburbs of Seattle, just 3 hours from the Canadian 
border. Mostly, I sent electronic prescriptions, but when patients 
asked for paper ones, I knew it was because they were going to Canada 
to fill it. EpiPens are $600 here; $50 there. In Canada, insulin costs 
$50.

  Right now, we pay three to four times what our colleagues overseas 
pay, and that is why we must use the negotiating power of Medicare to 
bring prices down. Our districts are alike.

[[Page H10224]]

And we need to take on this out-of-control pricing. The people who sent 
us here asked us to do it. Let's deliver today. I encourage my 
colleagues to vote ``no'' on this MTR and ``yes'' on H.R. 3.
  Mr. Speaker, I yield to the gentlewoman from Delaware (Ms. Blunt 
Rochester), my colleague, a champion of this bill.
  Ms. BLUNT ROCHESTER. Mr. Speaker, I thank the gentlewoman for 
yielding.
  I respect my Committee on Energy and Commerce colleagues, but I 
cannot support this motion to recommit. What we have today is an 
opportunity to live up to our promise.
  Democrats promised.
  Republicans promised.
  Even the President promised to lower prescription drug costs.
  Let's not get this confused or mixed up. Colleagues, I want to just 
make it plain: The Elijah E. Cummings Lower Drug Costs Now Act, H.R. 3, 
is about three things: Fairness, hope, and legacy.
  Fairness: Is it fair that the United States pays 2, 3, or 60 times 
more for the same drug as other countries?
  Is it fair that in a capitalist country our government can't 
negotiate? We can negotiate for planes, but we can't negotiate for 
insulin?
  The Congressional Budget Office says that H.R. 3 will lower out-of-
pocket costs and premiums for those on Medicare and it will reduce 
premiums for 180 million Americans who have private insurance. American 
households will save $120 billion over 10 years.
  Let me put it another way: These same Americans will see their cash 
wages increase by $116 billion. It is about fairness. H.R. 3 is about 
hope.
  As AARP has shared, it gives seniors hope that with savings from this 
bill, we will modernize and expand Medicare and cap part D out-of-
pocket costs. The $2,000 cap could be the difference between a 
lifesaving pill and somebody's rent.
  Hope: With the savings generated from this bill, we can expand 
Medicare coverage to include hearing, vision, and dental.
  Hope: We can accelerate the great American tradition of innovative 
research for scientific breakthroughs and cures for the National 
Institutes of Health.
  And with H.R. 3, we will provide patients like David Mitchell, who 
testified before our committee about his personal experience with 
cancer. And what he said is that it taught him something: Drugs don't 
work if people can't afford them. In other words, if you can't afford 
it, you don't have it.
  So, lastly, this will provide us a legacy.
  Ms. SCHRIER. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. Without objection, the previous question is 
ordered on the motion to recommit.
  There was no objection.
  The SPEAKER pro tempore. The question is on the motion to recommit.
  The question was taken; and the Speaker pro tempore announced that 
the noes appeared to have it.
  Mr. UPTON. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 9 of rule XX, the Chair 
will reduce to 5 minutes the minimum time for any electronic vote on 
the question of passage.
  The vote was taken by electronic device, and there were--yeas 196, 
nays 226, not voting 8, as follows:

                             [Roll No. 681]

                               YEAS--196

     Abraham
     Aderholt
     Allen
     Amodei
     Armstrong
     Arrington
     Babin
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Bergman
     Biggs
     Bilirakis
     Bishop (NC)
     Bishop (UT)
     Bost
     Brady
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Cheney
     Cline
     Cloud
     Cole
     Collins (GA)
     Comer
     Conaway
     Cook
     Crawford
     Crenshaw
     Curtis
     Davidson (OH)
     Davis, Rodney
     DesJarlais
     Diaz-Balart
     Duncan
     Dunn
     Emmer
     Estes
     Ferguson
     Fitzpatrick
     Fleischmann
     Flores
     Fortenberry
     Foxx (NC)
     Fulcher
     Gaetz
     Gallagher
     Gianforte
     Gibbs
     Gohmert
     Gonzalez (OH)
     Gooden
     Gottheimer
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green (TN)
     Griffith
     Grothman
     Guest
     Guthrie
     Hagedorn
     Harris
     Hartzler
     Hern, Kevin
     Herrera Beutler
     Hice (GA)
     Higgins (LA)
     Hill (AR)
     Holding
     Hollingsworth
     Hudson
     Huizenga
     Hurd (TX)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Jordan
     Joyce (OH)
     Joyce (PA)
     Katko
     Keller
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Latta
     Lesko
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Marchant
     Marshall
     Massie
     Mast
     McAdams
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     Meadows
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Mullin
     Murphy (NC)
     Newhouse
     Norman
     Nunes
     Olson
     Palazzo
     Palmer
     Pence
     Perry
     Posey
     Ratcliffe
     Reed
     Reschenthaler
     Rice (SC)
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose, John W.
     Rouzer
     Roy
     Rutherford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Sherrill
     Shimkus
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smucker
     Spano
     Stauber
     Stefanik
     Steil
     Steube
     Stewart
     Stivers
     Taylor
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Turner
     Upton
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Waltz
     Watkins
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yoho
     Young
     Zeldin

                               NAYS--226

     Adams
     Aguilar
     Allred
     Amash
     Axne
     Barragan
     Bass
     Beatty
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Boyle, Brendan F.
     Brindisi
     Brown (MD)
     Brownley (CA)
     Bustos
     Butterfield
     Carbajal
     Cardenas
     Carson (IN)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Finkenauer
     Fletcher
     Foster
     Frankel
     Fudge
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Golden
     Gomez
     Gonzalez (TX)
     Green, Al (TX)
     Grijalva
     Haaland
     Harder (CA)
     Hastings
     Hayes
     Heck
     Higgins (NY)
     Himes
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (TX)
     Kaptur
     Keating
     Kelly (IL)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Matsui
     McBath
     McCollum
     McEachin
     McGovern
     McNerney
     Meeks
     Meng
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Norcross
     O'Halleran
     Ocasio-Cortez
     Omar
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Peters
     Peterson
     Phillips
     Pingree
     Pocan
     Porter
     Pressley
     Price (NC)
     Quigley
     Raskin
     Rice (NY)
     Richmond
     Rose (NY)
     Rouda
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrader
     Schrier
     Scott (VA)
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sires
     Slotkin
     Smith (WA)
     Soto
     Spanberger
     Speier
     Stanton
     Stevens
     Suozzi
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Underwood
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wasserman Schultz
     Waters
     Watson Coleman
     Welch
     Wexton
     Wild
     Wilson (FL)
     Yarmuth

                             NOT VOTING--8

     Burchett
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     Rooney (FL)
     Serrano


                Announcement by the Speaker Pro Tempore

  The SPEAKER pro tempore (during the vote). There are 2 minutes 
remaining.

                              {time}  1401

  Mrs. DEMINGS changed her vote from ``yea'' to ``nay.''
  So the motion to recommit was rejected.
  The result of the vote was announced as above recorded.
  The SPEAKER pro tempore. The question is on the passage of the bill.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.
  Mr. WALDEN. Mr. Speaker, on that I demand the yeas and nays.

[[Page H10225]]

  The yeas and nays were ordered.
  The SPEAKER pro tempore (Ms. Craig). This will be a 5-minute vote.
  The vote was taken by electronic device, and there were--yeas 230, 
nays 192, not voting 8, as follows:

                             [Roll No. 682]

                               YEAS--230

     Adams
     Aguilar
     Allred
     Axne
     Barragan
     Bass
     Beatty
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Blunt Rochester
     Bonamici
     Boyle, Brendan F.
     Brindisi
     Brown (MD)
     Brownley (CA)
     Bustos
     Butterfield
     Carbajal
     Cardenas
     Carson (IN)
     Cartwright
     Case
     Casten (IL)
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Cisneros
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Cooper
     Correa
     Costa
     Courtney
     Cox (CA)
     Craig
     Crist
     Crow
     Cuellar
     Cunningham
     Davids (KS)
     Davis (CA)
     Davis, Danny K.
     Dean
     DeFazio
     DeGette
     DeLauro
     DelBene
     Delgado
     Demings
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Engel
     Escobar
     Eshoo
     Espaillat
     Evans
     Finkenauer
     Fitzpatrick
     Fletcher
     Foster
     Frankel
     Fudge
     Gallego
     Garamendi
     Garcia (IL)
     Garcia (TX)
     Golden
     Gomez
     Gonzalez (TX)
     Gottheimer
     Green, Al (TX)
     Grijalva
     Haaland
     Harder (CA)
     Hastings
     Hayes
     Heck
     Herrera Beutler
     Higgins (NY)
     Himes
     Horn, Kendra S.
     Horsford
     Houlahan
     Hoyer
     Huffman
     Jackson Lee
     Jayapal
     Jeffries
     Johnson (GA)
     Johnson (TX)
     Kaptur
     Keating
     Kelly (IL)
     Kennedy
     Khanna
     Kildee
     Kilmer
     Kim
     Kind
     Kirkpatrick
     Krishnamoorthi
     Kuster (NH)
     Lamb
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lawson (FL)
     Lee (CA)
     Lee (NV)
     Levin (CA)
     Levin (MI)
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan
     Luria
     Lynch
     Malinowski
     Maloney, Carolyn B.
     Maloney, Sean
     Matsui
     McAdams
     McBath
     McCollum
     McEachin
     McGovern
     McNerney
     Meeks
     Meng
     Moore
     Morelle
     Moulton
     Mucarsel-Powell
     Murphy (FL)
     Nadler
     Napolitano
     Neal
     Neguse
     Norcross
     O'Halleran
     Ocasio-Cortez
     Omar
     Pallone
     Panetta
     Pappas
     Pascrell
     Payne
     Perlmutter
     Peters
     Peterson
     Phillips
     Pingree
     Pocan
     Porter
     Pressley
     Price (NC)
     Quigley
     Raskin
     Rice (NY)
     Richmond
     Rose (NY)
     Rouda
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan
     Sanchez
     Sarbanes
     Scanlon
     Schakowsky
     Schiff
     Schneider
     Schrader
     Schrier
     Scott (VA)
     Scott, David
     Sewell (AL)
     Shalala
     Sherman
     Sherrill
     Sires
     Slotkin
     Smith (WA)
     Soto
     Spanberger
     Speier
     Stanton
     Stevens
     Suozzi
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tlaib
     Tonko
     Torres (CA)
     Torres Small (NM)
     Trahan
     Trone
     Underwood
     Van Drew
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Wasserman Schultz
     Waters
     Watson Coleman
     Welch
     Wexton
     Wild
     Wilson (FL)
     Yarmuth

                               NAYS--192

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Armstrong
     Arrington
     Babin
     Bacon
     Baird
     Balderson
     Banks
     Barr
     Bergman
     Biggs
     Bilirakis
     Bishop (NC)
     Bishop (UT)
     Bost
     Brady
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Budd
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Cheney
     Cline
     Cloud
     Cole
     Collins (GA)
     Comer
     Conaway
     Cook
     Crawford
     Crenshaw
     Curtis
     Davidson (OH)
     Davis, Rodney
     DesJarlais
     Diaz-Balart
     Duncan
     Dunn
     Emmer
     Estes
     Ferguson
     Fleischmann
     Flores
     Fortenberry
     Foxx (NC)
     Fulcher
     Gaetz
     Gallagher
     Gianforte
     Gibbs
     Gohmert
     Gonzalez (OH)
     Gooden
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Green (TN)
     Griffith
     Grothman
     Guest
     Guthrie
     Hagedorn
     Harris
     Hartzler
     Hern, Kevin
     Hice (GA)
     Higgins (LA)
     Hill (AR)
     Holding
     Hollingsworth
     Hudson
     Huizenga
     Hurd (TX)
     Johnson (LA)
     Johnson (OH)
     Johnson (SD)
     Jordan
     Joyce (OH)
     Joyce (PA)
     Katko
     Keller
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger
     Kustoff (TN)
     LaHood
     LaMalfa
     Lamborn
     Latta
     Lesko
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Marchant
     Marshall
     Massie
     Mast
     McCarthy
     McCaul
     McClintock
     McHenry
     McKinley
     Meadows
     Meuser
     Miller
     Mitchell
     Moolenaar
     Mooney (WV)
     Mullin
     Murphy (NC)
     Newhouse
     Norman
     Nunes
     Olson
     Palazzo
     Palmer
     Pence
     Perry
     Posey
     Ratcliffe
     Reed
     Reschenthaler
     Rice (SC)
     Riggleman
     Roby
     Rodgers (WA)
     Roe, David P.
     Rogers (AL)
     Rogers (KY)
     Rose, John W.
     Rouzer
     Roy
     Rutherford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Shimkus
     Simpson
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smucker
     Spano
     Stauber
     Stefanik
     Steil
     Steube
     Stewart
     Stivers
     Taylor
     Thompson (PA)
     Thornberry
     Timmons
     Tipton
     Turner
     Upton
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Waltz
     Watkins
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Williams
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Wright
     Yoho
     Young
     Zeldin

                             NOT VOTING--8

     Burchett
     Gabbard
     Gosar
     Hunter
     Lewis
     Lieu, Ted
     Rooney (FL)
     Serrano

                              {time}  1408

  So the bill was passed.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.

                          ____________________