[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.
____________________