[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


             DIAGNOSING THE PROBLEM: EXPLORING THE EF-
              FECTS OF CONSOLIDATION AND ANTICOMPETI-
              TIVE CONDUCT IN HEALTHCARE MARKETS

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

                                HEARING

                               BEFORE THE

                SUBCOMMITTEE ON ANTITRUST, COMMERCIAL AND 
                             ADMINISTRATIVE LAW

                                 OF THE

                       COMMITTEE ON THE JUDICIARY

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 7, 2019

                               __________

                            Serial No. 116-8

                               __________

         Printed for the use of the Committee on the Judiciary
         
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]         


               Available via: http://judiciary.house.gov
               
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
45-318 PDF                 WASHINGTON : 2021                     
          
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                       COMMITTEE ON THE JUDICIARY

                    JERROLD NADLER, New York, Chair
               MARY GAY SCANLON, Pennsylvania, Vice-Chair

ZOE LOFGREN, California              DOUG COLLINS, Georgia, Ranking 
SHEILA JACKSON LEE, Texas                Member
STEVE COHEN, Tennessee               VERONICA ESCOBAR, Texas
HENRY C. ``HANK'' JOHNSON, Jr.,      F. JAMES SENSENBRENNER, Jr., 
    Georgia                              Wisconsin
THEODORE E. DEUTCH, Florida          STEVE CHABOT, Ohio
KAREN BASS, California               LOUIE GOHMERT, Texas
CEDRIC L. RICHMOND, Louisiana        JIM JORDAN, Ohio
HAKEEM S. JEFFRIES, New York         KEN BUCK, Colorado
DAVID N. CICILLINE, Rhode Island     JOHN RATCLIFFE, Texas
ERIC SWALWELL, California            MARTHA ROBY, Alabama
TED LIEU, California                 MATT GAETZ, Florida
JAMIE RASKIN, Maryland               MIKE JOHNSON, Louisiana
PRAMILA JAYAPAL, Washington          ANDY BIGGS, Arizona
VAL BUTLER DEMINGS, Florida          TOM McCLINTOCK, California
J. LUIS CORREA, California           DEBBIE LESKO, Arizona
SYLVIA R. GARCIA, Texas              GUY RESCHENTHALER, Pennsylvania
JOE NEGUSE, Colorado                 BEN CLINE, Virginia
LUCY McBATH, Georgia                 KELLY ARMSTRONG, North Dakota
GREG STANTON, Arizona                W. GREGORY STEUBE, Florida
MADELEINE DEAN, Pennsylvania
DEBBIE MUCARSEL-POWELL, Florida

        PERRY APELBAUM, Majority Staff Director & Chief Counsel
                BRENDAN BELAIR, Minority Staff Director
                                 ------                                

               SUBCOMMITTEE ON ANTITRUST, COMMERCIAL AND
                           ADMINISTRATIVE LAW

                DAVID N. CICILLINE, Rhode Island, Chair
                    JOE NEGUSE, Colorado, Vice-Chair

HENRY C. ``HANK'' JOHNSON, Jr.,      F. JAMES SENSENBRENNER, Jr., 
    Georgia                              Wisconsin, Ranking Member
JAMIE RASKIN, Maryland               KEN BUCK, Colorado
PRAMILA JAYAPAL, Washington          MATT GAETZ, Florida
VAL BUTLER DEMINGS, Florida          KELLY ARMSTRONG, North Dakota
MARY GAY SCANLON, Pennsylvania       W. GREGORY STEUBE, Florida
LUCY McBATH, Georgia

                       SLADE BOND, Chief Counsel
                    DANIEL FLORES, Minority Counsel
                            
                            
                            C O N T E N T S

                        THURSDAY, MARCH 7, 2019

                                                                   Page

                           OPENING STATEMENTS

The Honorable David Cicilline, Chair of the Subcommittee on 
  Antitrust, Commercial and Administrative Law from the State of 
  Rhode Island...................................................     1
The Honorable James Sensenbrenner, Ranking Member of the 
  Subcommittee on Antitrust, Commercial and Administrative Law 
  from the State of Wisconsin....................................     3
The Honorable Jerrold Nadler, Chair of the Committee on the 
  Judiciary from the State of New York...........................    12
The Honorable Doug Collins, Ranking Member of the Committee on 
  the Judiciary from the State of Georgia........................    14

                               WITNESSES

Fiona Scott Morton, Theodore Nierenberg Professor of Economics at 
  Yale University School of Management
  Oral Testimony.................................................    17
  Prepared Testimony.............................................    19
Michael Kades, Director, Markets and Competition Policy, 
  Washington Center for Equitable Growth
  Oral Testimony.................................................    26
  Prepared Testimony.............................................    28
Martin Gaynor, E.J. Barone University Professor of Economics and 
  Public Policy Heinz College, Carnegie Mellon University
  Oral Testimony.................................................    55
  Prepared Testimony.............................................    57
Craig L. Garthwaite, Ph.D., Director of Program on Healthcare at 
  Kellogg (HCAK), Kellogg School of Management, Northwestern 
  University
  Oral Testimony.................................................    95
  Prepared Testimony.............................................    98

          LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING

Statement from the National Community Pharmacists Association, 
  submitted by the Honorable James Sensenbrenner, Ranking Member 
  a Member of the Subcommittee on Antitrust, Commercial and 
  Administrative Law from the State of Wisconsin for the record..     6
Statement for the record from the American Hospital Association..   150
Responses to Questions by Martin Gaynor submitted by the 
  Honorable Ken Buck, a member of the Subcommittee on Antitrust, 
  Commercial and Administrative Law from the State of Colorado 
  for the record.................................................   156
Responses to Questions by Martin Gaynor submitted by the 
  Honorable Doug Collins, Ranking Member of the Committee on the 
  Judiciary from the State of Georgia for the Record.............   159
Responses to Questions by Martin Gaynor from submitted by the 
  Honorable Mike Johnson, a member of the Subcommittee on 
  Antitrust, Commercial and Administrative Law from the State of 
  Louisiana for the record.......................................   163
Response to Questions by Michael Kades for the record............   165
Response to Questions by Fiona Scott Morton submitted by the 
  Honorable Ken Buck, a member of the Subcommittee on Antitrust, 
  Commercial and Administrative Law from the State of Colorado 
  for the record.................................................   170

 
  DIAGNOSING THE PROBLEM: EXPLORING THE EFFECTS OF CONSOLIDATION AND 
             ANTICOMPETITIVE CONDUCT IN HEALTHCARE MARKETS

                              ----------                              


                        THURSDAY, MARCH 7, 2019

                        House of Representatives

               Subcommittee on Antitrust, Commercial and

                           Administrative Law

                       Committee on the Judiciary

                             Washington, DC

    The Subcommittee met, pursuant to call, at 2:01 p.m., in 
Room 2141, Rayburn Office Building, Hon. David Cicilline 
[chairman of the subcommittee] presiding.
    Present: Representatives Cicilline, Nadler, H. Johnson, 
Jayapal, Demings, Scanlon, Neguse, McBath, Sensenbrenner, 
Collins, Gaetz, Buck, and Armstrong.
    Staff present: Slade Bond, Chief Counsel; Amanda Lewis, 
Counsel on Detail from the FTC; Madeline Strasser, Chief Clerk; 
Josephy Van Wye, Professional Staff; Julian Gerson, Staff 
Assistant; Susan Jensen, Parliamentarian; Moh Sharma, Member 
Services and Outreach Advisor; Daniel Flores, Minority Counsel; 
Andrea Woodard, Professional Staff.
    Mr. Cicilline. The Subcommittee will come to order. Without 
objection, the chair is authorized to declare a recess of the 
Committee at any time.
    We welcome everyone to today's hearing on Diagnosing the 
Problem: Exploring the Effects of Consolidation and 
Anticompetitive Conduct in Healthcare Markets.
    I thank our witnesses for being here and I also want to say 
that it is our first meeting of this Subcommittee and I 
particularly want to acknowledge the presence of the Ranking 
Member, Jim Sensenbrenner, who I look forward to continuing to 
work with who has done a lot of important work in the 
jurisdiction of this Subcommittee and will bring great wisdom 
to our collective effort.
    Mr. Sensenbrenner. If you say so.
    Mr. Cicilline. Yes, absolutely. Without objection.
    Our healthcare system is in a State of crisis. The costs of 
prescription medicine have increased by 200 percent over the 
past decade.
    Americans spend, roughly $1,200 on average on prescription 
drugs every year, which is more than people in any other 
country. The average cost of a hospital stay for a child with 
cancer is $40,000.
    The price for many types of organ transplants and post-
operation treatment is more than a million dollars. Even a 
short ambulance ride to the hospital without medical care may 
cost patients thousands of dollars.
    These outrageous, unsustainable, and immoral costs are 
ruining lives. Prices are skyrocketing and people are dying or 
bankrupted as a result.
    Kaiser Health reports that a quarter of Americans cannot 
afford their medicine while many, and I quote, ``cancer 
patients are delaying care, cutting their pills in half, or 
skipping drug treatment entirely,'' end quote.
    Despite decades of rising costs, the United States ranks 
dead last in health outcomes among other high-income countries. 
For too many Americans it is a dark reality that the life of a 
loved one depends on whether they can raise enough money on a 
crowdfunding platform to pay for treatment before it is too 
late.
    Faced with no other options, Americans are left to plead to 
strangers for help to keep their loved ones alive. This must 
end.
    The American people deserve a government that is in their 
corner fighting for them to take on drug profiteering and other 
barriers to affordable healthcare. Ending this moral crisis is 
a top priority of mine as chairman of the Antitrust 
Subcommittee and a top priority for House Democrats to keep our 
promise to work for the people and to make healthcare 
affordable for everyone.
    Our competition system is the backbone of promoting open 
and fair markets. This competition is absolutely essential in 
healthcare markets. For drug prices, the entry of generic drug 
competitors can reduce the cost of branded drugs significantly 
and hospital and health insurance markets consolidation 
threaten the quality and affordability of care.
    In too many cases, effective antitrust enforcement takes 
far too long to deliver meaningful results to people in need. 
For example, some branded drug companies have abused safety 
protocols to thwart generics and to preserve their monopoly for 
more than a decade.
    As Professor Robin Feldman has noted, even months of delay 
can be worth hundreds of millions of dollars in additional 
monopoly revenues as the generic sits on the sideline.
    While this anticompetitive conduct should violate the 
antitrust laws, even successful cases are often too time 
consuming to provide effective relief, as the Federal Trade 
Commission testified before the Subcommittee last Congress.
    That is why I have introduced the CREATES Act with Chair 
Nadler and Ranking Member Sensenbrenner and Collins to end 
these delay tactics. The CREATES Act establishes a tailored 
path for generic drug manufacturers to bring low-cost drugs to 
market.
    The Congressional Budget Office estimates that the bill 
would result in nearly $4 billion in federal savings along with 
an additional $5.4 billion in savings for consumers, according 
to private estimates.
    It is also imperative that we examine and address other 
anticompetitive tactics that lead to higher drug prices. Last 
week, the FTC settled a complaint against a drug company for 
paying off its competitor to keep out of the marketplace.
    According to a 2010 report by the Commission, this type of 
conduct, also called a ``pay for delay'' settlement, costs 
about $3.5 billion per year in the form of higher drug prices.
    This settlement occurred nearly seven years after the 
Supreme Court's landmark decision in Actavis where it held that 
these settlements risk significantly anticompetitive effects 
and more than 10 years after the FTC originally filed its 
complaint.
    It is unacceptable that it took a full decade to address 
this abuse of our patent system. Moreover, this egregious 
behavior is still taking place today.
    As Dr. Aaron Kesselheim of Harvard Medical School noted in 
his testimony before the Subcommittee last Congress, 
corporations continue to engage in ``pay for delay'' 
settlements in the wake of Actavis decision, driving up the 
cost of prescription drugs.
    I look forward to working with Chair Nadler and Senators 
Klobuchar and Grassley on legislation to confront and reverse 
this problem.
    In closing, today's hearing is an important opportunity to 
examine other competitive threats that raise costs, lower 
quality, and reduce choices in healthcare markets.
    It is my hope that our discussion today can focus on 
continuing our work to diagnose the problems associated with 
consolidation and anticompetitive conduct in healthcare markets 
as well as finding solutions to provide a better deal for 
hardworking Americans on prescription drugs and other 
healthcare costs.
    I thank our esteemed witnesses today for appearing before 
the subcommittee. It is now my great pleasure to recognize the 
Ranking Member of the subcommittee, Mr. Sensenbrenner of 
Wisconsin.
    Mr. Sensenbrenner. Thank you, Mr. Chair, and I thank you 
and extend a warm welcome to all my colleagues, our witnesses, 
and the audience Members.
    It is a pleasure to begin the subcommittee's proceedings 
for this term of Congress. I look forward to working with Chair 
Cicilline to accomplish as much as we can together to meet the 
needs of the American people.
    Today's hearing focuses on the issues of vital importance. 
According to the Centers for Medicare and Medicaid Services, 
American spending on healthcare now accounts for 17.8 percent 
of the United States' GDP. That is over $3.6 trillion, or over 
$10,000 per person.
    These astronomical costs are the result of many factors. 
Lurking always is the misguided Obamacare legislation. Sold as 
a means to protect patients and make healthcare affordable, it 
has produced just the opposite.
    Rising costs, loss of doctors and insurance policies, and 
increasingly monopolized hospital and insurance markets in 
states and counties all across the nation.
    Today's hearing offers us a chance to focus on some of the 
other important factors in the healthcare cost problems. These 
include obstacles to patients' access to low-cost generic 
drugs, anticompetitive practices engaged by pharmacy benefit 
managers, and rising consolidation in hospital and insurance 
markets.
    To help tackle the first of these problems, Chair Cicilline 
and I have introduced in the first weeks of this Congress the 
Creating and Restoring Equal Access to Equivalent Samples Act--
a mouthful--also known as the CREATES Act.
    Our bill is strong and bipartisan legislation that will 
prefer branded pharmaceutical companies from manipulating test 
sample availability to block cheaper generic alternatives from 
obtaining FDA approval and entering the marketplace.
    The CREATES Act will lead to lower costs for patients by 
assuring that they have faster access to safe and effective 
FDA-approved generic drugs.
    The CBO has estimated that our bill would produce a multi-
billion-dollar decrease in the federal deficit. Savings to 
consumers and private insurers will likely be greater than that 
amount.
    I look forward to hearing the witnesses' testimony on the 
CREATES Act and other important issues the Subcommittee will 
examine today.
    I would like unanimous consent to insert into the record at 
this point a statement by the National Community Pharmacists 
Association--statement for the record and also pharma's 
statement to the House of Representatives on the topic of this 
hearing today.
    Mr. Cicilline. Without objection.
    [The information follows:]

                   JAMES SENSENBRENNER FOR THE RECORD

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

[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Mr. Sensenbrenner. I yield back.
    Mr. Cicilline. Thank you to the Ranking Member.
    Now, it is my pleasure to recognize Chair of the full 
committee, the gentleman from New York, Mr. Nadler, for his 
opening statement.
    Mr. Nadler. Thank you, Mr. Chair.
    The Judiciary Committee has a strong tradition of 
bipartisan efforts to promote competition in healthcare 
markets, particularly with respect to helping to make 
prescription drugs and other healthcare services more 
affordable through the full benefits of competition.
    Over the past several years, the Subcommittee has held 
numerous hearings in this area examining the topics of 
consolidation in the market for health insurance, competition 
in the drug supply chain, and anticompetitive practices by 
prescription drug companies.
    It is essential that we continue this important work 
through today's hearing and throughout this Congress as we seek 
to provide meaningful relief to Americans who struggle every 
day with the high cost of medicine, insurance premiums, and 
hospital bills.
    Today, one-quarter of Americans report that it is difficult 
to afford their medicines--one-quarter. Exorbitant medical 
bills are one of the major causes of why Americans seek 
bankruptcy relief.
    It is painfully clear that the soaring costs of healthcare 
are bad for the health and well being of American families. It 
is unacceptable that seniors cannot afford the arthritis 
medication they need to perform everyday tasks such as 
buttoning their coats or opening a jar without excruciating 
pain.
    It is unacceptable that hundreds of thousands of cancer 
patients are reportedly delaying life-saving care, cutting 
their pills in half or skipping drug treatment entirely because 
of high drug prices.
    It is unacceptable that those suffering from diabetes have 
to worry about the life-threatening consequences of not being 
able to afford insulin because of its unaffordable costs.
    Last week, when confronted with the facts surrounding 
skyrocketing prescription drug prices, executives of seven 
major drug manufacturers responded by pointing fingers 
somewhere else, including insurers and pharmacy benefit 
managers.
    As many experts have noted, including some of the witnesses 
who will testify here today, a lack of competition in 
healthcare markets is one of the primary causes of escalating 
costs.
    In fact, the CEOs of some major drug companies acknowledge 
that--acknowledge that competition plays a key role in driving 
down prices.
    For example, one testified just last week that, quote, 
``Competition is a key component to reducing costs,'' end 
quote. Frankly, we didn't need him to tell us that. Louis 
Brandeis told us that a long time ago.
    The significance of competition from lower-priced generic 
drugs in particular cannot be overstated. According to the 
Federal Trade Commission, the first generic competitor's 
product is typically offered at a price 20 to 30 percent below 
the branded product's price.
    Subsequent generic entry creates greater price competition 
with price drops reaching 85 percent or more off the brand 
price.
    Similarly, the Congressional Budget Office reported in 2010 
that the retail price of a generic is 75 percent lower on 
average--75 percent lower than the retail price of a brand name 
drug.
    In response to the threat of generic entry which, of 
course, threatens the ability of branded drug companies to 
charge monopoly prices, these companies, or some of them, have 
engaged in numerous anticompetitive tactics.
    This Committee has been and will continue to be active in 
stopping drug companies from reaping monopoly profits at the 
expense of the health of working American families.
    For example, I am proud to be an original co-sponsor of 
H.R. 965, the Creating and Restoring Equal Access to Equivalent 
Samples Act of 2019, or the CREATES Act.
    This bipartisan legislation, introduced last month by 
Subcommittee Chair Cicilline and Ranking Member Sensenbrenner, 
seeks to remove an obstacle to generic competition by making it 
easier for generic drug companies to obtain the samples they 
need to enter the marketplace.
    Another concern involves so-called ``pay for delay'' 
settlements which occur when a branded drug firm pays a 
potential generic competitor to abandon a patent challenge and 
thereby delay entering the market with a lower cost generic 
product.
    These agreements can be a win for both drug companies. The 
brand name drug company gets to keep its monopoly and the 
generic gets paid off with a portion of the monopoly profits. 
The consumers lose.
    According to an FTC study, ``pay for delay'' agreements are 
estimated to cost American consumers $3.5 billion per year, $35 
billion over the decade from 2010 to 2020.
    That is why I plan to introduce bipartisan legislation this 
Congress to help end ``pay for delay'' settlements. As we all 
know, a lack of competition and anticompetitive conduct is not 
just limited to the pharmaceutical marketplace.
    These problems show up in hospital markets as well. For 
example, it is well documented that hospital mergers can lead 
to higher prices and lower quality of care.
    Hospital consolidation also results in fewer options for 
patients. This is especially harmful for expecting mothers or 
women seeking reproductive health services who depend on a full 
range of options for care and may be faced by a regional 
hospital that doesn't give a full range of options.
    I hope that our discussion today will continue our 
bipartisan work to diagnose the problems associated with 
consolidation and anticompetitive conduct in healthcare markets 
as well as break new ground on confronting the harmful effects 
of hospital consolidation.
    Accordingly, I look forward to hearing from our witnesses 
today. I thank them for their participation and yield back the 
balance of my time.
    Mr. Cicilline. I thank the gentleman.
    Now, I am pleased to recognize the Ranking Member of the 
full committee, the gentleman from Georgia, Mr. Collins, for 
his opening statement.
    Mr. Collins. Thank you, Chair Cicilline and Ranking Member 
Sensenbrenner, for holding this hearing. I would also like to 
thank both of you for the works in the CREATES Act and I 
believe this legislation is a good starting point and I look 
forward to continuing to work with both of you to ultimately 
get this bill signed into law this term.
    Over the past decade, consolidation across healthcare and 
prescription drug markets have been rapidly increasing. Nowhere 
is this more prevalent than in the pharmacy benefit manager 
marketplace.
    PBMs, in theory, should bring down the cost for consumers. 
However, they are not doing that. There are only three major 
PBM companies and they control 85 percent of the marketplace, 
which yields each company a great deal of power, and these 
companies have consolidated horizontally as well as vertically, 
as they go forward, and they have merged vertically with major 
pharmacies and health insurers.
    That means patients' insurers have financial incentives to 
push the patients toward their pharmacies. This consolidation 
has enabled PBMs to engage in anticompetitive behavior by 
targeting competing pharmacies with unfair audits and under 
reimbursement.
    These audits provide PBMs with the pharmacies' acquisition 
cost and patient data. PBMs then use this data to steer 
patients to their own pharmacies and reimburse competitive 
pharmacies at a much lower rate.
    This results in PBMs lining their own wallets. It harms 
community pharmacists who have decided--have to decide between 
losing money and filling a prescription or losing customers to 
big-box pharmacies owned by PBMs.
    If you look at Ohio, CVS, and OptumRX charge that State 
more than $400,000,000 more than they paid out to pharmacies. 
It is just amazing to me that we will continue to turn an eye 
and not have the discussion.
    If we wanted to lower drug costs in this country right now, 
start with the PBMs. Start right where they are at. I have been 
talking about this for six years. I just laid it out.
    They are going full throttle trying to kill independent 
pharmacists and pharmacies in our communities. They offer 
little more than anecdotal evidence that will save you money. 
In fact, when others have actually--states such as Texas and 
companies such as Caterpillar and others have actually gone 
away from their PBM system they saved money.
    PBMs--it is just amazing having immense control over 
patient formularies, allowing them to push patients to a high-
cost medication because these medications give the PBM higher 
rebates.
    As a result, PBMs increase patient co-pays and incentivize 
manufacturers to increase drug costs to pay PBMs higher rebate 
demands. So, PBMs are actually costing patients money.
    PBMs' role as an intermediary also allows them to extract 
rebates and price concessions for competing pharmacies and 
manufacturers without passing them on to the patients.
    You know what is really amazing about them and talking 
about these six years? I have never had a PBM come in and deny 
what I say. Never. They just don't like the way I talk about 
them. They don't care that their practices are bad.
    They just don't like that I call them out for it. It is 
amazing. This lack of transparency in the price concessions are 
often withheld from patients and payers and increasing PBM 
profits while failing to decrease drug costs.
    I recently introduced legislation called the Fair Pricing 
Act with Representative Gonzalez a Democrat from Texas, and 
also Senator John Kennedy from Louisiana.
    This legislation will require PBMs to pass pharmacy rebates 
and price concessions on to patients at the point of sale. That 
will save patients an estimated $9.2 billion over the next 10 
years.
    Key provisions from my legislation are also included in the 
proposed Rule from the Department of Health and Human Services 
Secretary Alex Azar.
    Additionally, states across the country, including my home 
State of Georgia, have realized this lack of transparency in 
the marketplace and legislators are passing laws requiring 
transparency for PBMs regarding the rebates prices concessions 
they are receiving from pharmacies and manufacturers. These 
laws aim to ensure that patients are receiving and seeing the 
savings PBMs claim to be offering and negotiated on their 
behalf.
    I do want to talk, Mr. Chair, about another issue that is 
dear, especially in Georgia, and that is hospital consolidation 
that the full Committee chair also talked about in rural 
communities.
    These communities often already have few options for 
quality care so when hospital consolidation is increased over 
the past 10 years rural communities like my own have been hurt 
the most.
    At times, these mergers and acquisitions can help rural 
communities by keeping facilities open. They result in full or 
partial closes and shifting patients from nearby facilities to 
those hours away.
    This doesn't benefit patients. Instead, it hurts them 
because they are unable to receive the lifesaving treatment 
they need. In some areas of my state, we have seen mergers 
limit emergency care, increase patient travel time by hours.
    Imagine if a woman has a difficult labor but had to travel 
hours to a healthcare facility. These changes can literally 
mean the difference in life and death.
    I have also seen hospitals acquire other pharmacy and 
physician practices in their area to steer patients away from 
their competitors. I am concerned that these practices will 
result in fewer options for patients, higher cost, and a lower 
quality of care.
    I want to commend this Subcommittee for reviewing the 
consolidation and anticompetitive practice across the 
healthcare marketplace and I am looking forward to working with 
the Chair and others on this across the aisle to find real 
solutions because we must decrease the cost of our healthcare 
and prescription drugs while increasing patients' access to the 
best care possible and that means taking a look at everything 
on the table and it is time the pharmacy benefit managers 
realize your time of terrorizing this marketplace is over.
    With that, I yield back to Chair.
    Mr. Cicilline. Thank you, Mr. Collins.
    It is now my pleasure to introduce today's witnesses. Our 
first witness on today's panel is Dr. Fiona Scott Morton, the 
Theodore Nierenberg Professor of Economics at Yale University 
School of Management.
    Dr. Scott Morton is nationally recognized as a leading 
scholar on issues of competition and has published articles 
that range widely across industries and leading economic 
journals.
    From 2011 to 2012, she served as the deputy assistant 
attorney general for economics at the Antitrust Division in the 
U.S. Department of Justice where she helped enforce the 
nation's antitrust laws.
    Dr. Scott Morton received her BA from Yale and her Ph.D. 
from the Massachusetts Institute of Technology. Welcome.
    Our next witness is Michael Kades, the director of markets 
and competition policy at the Washington Center for Equitable 
Growth. Prior to joining Equitable Growth, Mr. Kades served as 
antitrust counsel for Senator Amy Klobuchar and before that as 
an attorney at the Federal Trade Commission for 20 years.
    His work on anticompetitive pharmaceutical patent 
settlements led to the Commission's victory before the Supreme 
Court in FTC v. Actavis. During his time at the Commission, he 
was also an attorney advisor to Chair Jon Leibowitz and the 
deputy trial counsel.
    Prior to working at the Commission, Mr. Kades clerked for 
the Honorable John Reynolds at the United States District Court 
for the Eastern District of Wisconsin and is a graduate of Yale 
University and the University of Wisconsin Law School.
    Our third witness is Dr. Martin Gaynor, the E.J. Barone 
Professor of Economics and Health Policy at Carnegie Mellon 
University. Dr. Gaynor is widely recognized as a leading 
scholar on competition and, in particular, the study of 
consolidation and market power within hospital markets and 
healthcare systems.
    Dr. Gaynor previously served as the director of the Federal 
Trade Commission's Bureau of Economics and is a research fellow 
at the National Bureau of Economic research. He received his BA 
from the University of California San Diego and his Ph.D. in 
economics for Northwestern University.
    Our final witness in today's hearing is Dr. Craig 
Garthwaite, the Herman Smith Research Professor in Hospital and 
Health Service and the director of the program on healthcare at 
the Kellogg School of Management at Northwestern University.
    Dr. Garthwaite's research examines the effects of 
government policies with a focus on health and 
biopharmaceutical sectors. He has appeared as a guest on 
various television and radio shows such as NPR Marketplace and 
has appeared in journals like the American Economic Review and 
Health Affairs. Dr. Garthwaite received his BA and Master's in 
public policy from the University of Michigan and his Ph.D. in 
economics from the University of Maryland.
    So, we welcome all of the distinguished witnesses and thank 
them very much for participating in today's hearing.
    Now, if you would please rise I will begin our hearing by 
administering the oath and swearing you in. Please rise your 
right hands.
    Do you swear or affirm under penalty of perjury that the 
testimony you are about to give is true and correct to the best 
of your knowledge, information, and belief, so help you God?
    [A chorus of ayes.]
    Mr. Cicilline. The record should reflect that the witnesses 
answered in the affirmative. You may be seated. Thank you very 
much.
    Please note that each of your written statements will be 
entered into the record in its entirety. Accordingly, I ask 
that you summarize your testimony in five minutes.
    To help you stay within that time, there is a timing light 
on your table. When the light switches from green to yellow you 
have about a minute to conclude your testimony. When the light 
turns red it signals that your five minutes has expired and I 
would ask you to please conclude.
    We will begin with Dr. Scott Morton. If you would just hit 
the button so we can--

              TESTIMONY OF DR. FIONA SCOTT MORTON

    Ms. Scott Morton. Thank you, Mr. Chair, and Members of the 
Committee for the invitation to testify.
    Today in the United States we are choosing to use the 
private sector to provide healthcare without establishing 
enough rules to ensure competition. The result is that we have 
providers who are profit seeking without the restraint imposed 
by competition.
    My belief is that if we do not fix this that the ever-
increasing costs are going to lead to a different kind of 
solution, which is just price regulation by the government.
    That is not my preferred solution. I think markets would be 
much better, but they have to be working markets. It is not 
obvious that price regulation would be worse than unrestrained 
private monopolies, which is what we are faced with today.
    You will hear from the other Members at my table is that we 
have good news. High prices in many areas of pharmaceutical and 
medical care are eminently fixable. It is not rocket science 
what we are going to tell you.
    There is a great deal of evidence about how to bring down 
these prices. The bad news is that the providers, whose prices 
will come down should they face vigorous competition, are going 
to lobby for any--against any changes in the law and, 
historically, have been very successful at doing that.
    For the conservatives in the room, if you claim to like 
markets and you like market solutions over government, this is 
what you are going to hear today. I think all of us want 
markets, but we want working markets, ones that enable 
competition.
    I have two main points to discuss from my testimony. The 
first is the area of biologics and physician-administered 
drugs. This is the area with the most growth currently. These 
are very high-priced products. They are growing very quickly 
both in terms of price and in terms of quantity.
    We procure these drugs primarily through the Part B program 
as well as on the commercial side. This is run quite 
differently from Part D. Part D, like dog, okay, that is the 
one where we outsource to private insurance companies who have 
a formulary, and they bargain to get low prices.
    Part B, like boy, that is the one where we do nothing. We 
allow the manufacturer to announce a price and then the 
government pays that. Okay. So, it is not really very 
surprising that it is only 18 percent of GDP we spend on 
healthcare. Probably should be more.
    So, why--what is the restraint? Well, the manufacturer does 
have to sell in the commercial marketplace and as prices get 
higher that gets difficult. There is no restraint on the 
government side.
    So, this is something that Congress should fix. We should 
be procuring Part B drugs in a way that is competitive. One way 
to do that would be to change the system of J-Codes.
    Currently, if there is a branded product that is a biologic 
and biosimilars enter, each of those manufacturers gets their 
own reference price--their own J-Code. So, if the brand costs 
$1,000 and the biosimilar costs $600, a doctor that dispenses 
the biosimilar gets paid $600 plus a markup and the one that 
chooses the brand gets paid $1,000 plus a markup.
    If we had one payment for all the drugs that are the same, 
all the same molecule, then the branded drug would have to come 
down or else the doctors would all pick the biosimilar because 
they would be being reimbursed at $600. They would not choose 
to buy a $1,000 drug.
    That same principle works in other areas. We, for a brief 
while, had a low-cost alternative in the area of prostrate 
drugs. That caused doctors to go out and actually seek the 
lowest cost therapy in that class and the result of that was 
such good competition that the brands in question sued the 
government and--over the fact that the government--CMS did not 
have the authority to procure drugs in that competitive a 
manner, and they won.
    So, it would be useful if Congress would enable the 
government to procure drugs in that cost-effective manner.
    My second point is about consumer out-of-pocket costs. 
These have gotten very high with the popularity of high 
deductible plans. When you have an out-of-pocket cost that is 
based on the list price of the drug this generates kind of 
negative insurance.
    You buy insurance and instead of paying market price for 
the drug--let us say, $300, and you pay list price for the 
drug, $600. So, you are getting the opposite of what insurance 
is supposed to do, which is to smooth these financial shocks 
when you get sick.
    The HHS solution, which makes consumers' out-of-pocket 
costs depend on the net price, I think something like that is a 
good idea. It could be the true net price.
    It could be some well-defined average to make the net price 
continue to be confidential, which is very important for 
getting low prices in general, or it could just be below--equal 
to or below the net price so that a plan could choose to have a 
$50 out-of-pocket cost and we would never know what the net 
price was and that would also be fine.
    The important thing about this solution that HHS has come 
up with is that it is going to restrain competition between 
manufacturers. I believe this is why manufacturers are in favor 
of this rule, because it is not going to intensify price 
competition. It is going to lessen price competition.
    Why? Because there won't be able to be performance-based 
rebates where a plan says, I will deliver you a high market 
share from Drug A to Drug B, and Drug B says, okay, if you 
deliver that high market share, I am willing to sell to you at 
a low price.
    We don't know until the end of the year if the market share 
gets delivered and therefore what the price should be. So there 
needs to be built into whatever the safe harbor is the ability 
for the plan to negotiate that way with the manufacturer, 
extract a really low price, and then--sorry, I will stop--and 
then--and then deliver that to the patient. So that is key.
    [The statement of Ms. Scott Morton follows:]

               STATEMENT OF FIONA M. SCOTT MORTON

                            Framing

    Why are U.S. healthcare costs rising so fast? \1\ One 
reason is a lack of competition. The narrative that healthcare 
costs are high because we use markets, rather than government, 
to provide healthcare is not correct in my view. Rather, 
healthcare costs are high because we do not have competitive 
markets for these services. Private providers that are not 
subject to competitive forces create the worst of both worlds. 
Because the sector is so regulated there are many ways for 
private healthcare providers to successfully lobby for 
regulations and practices that shield themselves from 
competition. For the last decade or so, Congress has been 
explicitly enabling this lack of competition by designing, or 
failing to correct, the methods by which the public sector 
procures drugs and controls access to markets so as to benefit 
providers. The good news, therefore, is that high prices in 
many areas of pharmaceutical and medical care are eminently 
fixable and there is a great deal of evidence about what 
policies will bring down prices. The bad news is that the 
providers whose prices will come down--should they have to 
vigorously compete for business--will lobby against any changes 
in the law, and have historically been very successful at doing 
that.
---------------------------------------------------------------------------
    \1\ For example, see Professor Martin Gaynor's previous House 
testimony: https://docs.house .gov/meetings/IF/IF02/20180214/106855/
HHRG-115-IF02-Wstate-GaynorM-20180214.pdf. For recent work on hospital 
prices see Cooper, Zack, Stuart V. Craig, Martin Gaynor, John Van 
Reenen (2019). ``The Price Ain't Right? Hospital Prices and Health 
Spending on the Privately Insured, The Quarterly Journal of Economics 
134(1):51-107.
---------------------------------------------------------------------------
    Some of the behaviors detailed below are violations of 
existing antitrust law. However, antitrust enforcement has 
become weak in the U.S. for a variety of reasons and, in 
addition, it is a slow and expensive way to deal with many 
healthcare markets that regularly experience new product entry. 
Even if the leadership of the antitrust agencies found 
increasing competition in healthcare markets to be a priority, 
they likely do not have the resources to address all the known 
competition problems, much less new problems driven by changing 
regulations and new technologies or products.
    Congress could significantly lower healthcare costs and 
restrain cost increases with some relatively simple statutes 
that create more competition in this sector. Congress could 
also instruct--and fund--the FTC to pursue particular 
enforcement projects in this sector that Congress finds 
critical to restraining healthcare costs. Significant increases 
in the budgets of the antitrust enforcement agencies are 
absolutely necessary if Congress wishes to have more 
competition in any market, including in healthcare markets. 
Those funds would be leveraged, and therefore more effective, 
if combined with some statutory changes recommended below.
    The sources of market power in many healthcare markets come 
from both intellectual property and the nature of government 
programs. My colleague and co-author, Professor Craig 
Garthwaite, has provided the background reasons for market 
power in his statement. I will not repeat that material here, 
but rather move on to particular solutions.

                        Specific Topics

    1. Behavior That Could Be a Violation of Antitrust Laws

    When brands try to use FDA regulations concerning provision 
of samples or protection of consumers from dangerous drugs as a 
means to improperly exclude generic entrants, they may be 
violating antitrust laws. The CREATES Act requires brands to 
sell generic and biosimilar firms samples under reasonable 
terms and prevents abuse of a REMS restricted distribution 
system. This new legislation will help keep brands from 
hampering and delaying the entry of generics and biosimilars 
after the brand's patent has expired. It should be enacted 
promptly. The abuse of citizens' petitions should also be 
addressed by Congress.
    The Supreme Court's Actavis decision \2\ is helpful in 
preventing pay-for-delay schemes and therefore promoting new 
generic and biosimilar entry that lowers prices. However, firms 
continue to enter into these agreements and the FTC continues 
to expend resources investigating and litigating against this 
abusive behavior. Congress could end this wasteful situation by 
passing more specific laws against pay for delay in both small 
molecule and biologic markets.
---------------------------------------------------------------------------
    \2\ FTC v. Actavis, Inc., 570 U.S. 136 (2013).
---------------------------------------------------------------------------
    This would save enforcement resources in the drug markets, 
and also control a practice that is spreading to the biologics 
markets.\3\ Enforcement is weaker in biologics because 
competition among biosimilars and the reference biologic 
product are slightly different than the well-studied small 
molecule drug case, and therefore there is uncertainty about 
how courts will Rule on these cases. In the United States, 
biologics grew from just 13% of biopharmaceutical spending in 
2006 to 27% in 2016, and growth continues, so timely entry of 
biosimilar (clinically equivalent) products at patent 
expiration is critical to limiting biopharmaceutical 
expenditures.\4\
---------------------------------------------------------------------------
    \3\ Feldman, Robin and Misra, Prianka, The Fatal Attraction of Pay-
for-Delay (January 15, 2019). Chicago--Kent Journal of Intellectual 
Property, Forthcoming. Available at SSRN: https://ssrn.com/
abstract=3316339.
    \4\ https://www.brookings.edu/wp-content/uploads/2017/05/
wp30_scottmorton_competition inpharma1.pdf (pages 5-6, and figure 2).
---------------------------------------------------------------------------
    Another industry tactic that insulates a reference biologic 
or branded small molecule product with a large and durable 
market share from price competition is a loyalty rebate. A 
loyalty rebate gives a customer a large ex post rebate on its 
drug purchases, but only if the customer has stayed loyal to 
the brand (either exclusively or with a high share such as 
90%), meaning the buyer has not purchased any significant share 
from the generic or biosimilar entrant. A loyalty rebate 
successfully excludes the newest entrants when the brand has an 
entrenched share of the market (known as non-contestable 
share). Non-contestable share is the segment of the market that 
the generic or entrant cannot serve (perhaps it is a version 
they do not make, an indication they are not approved for, or 
the segment of chronic patients that are taking the brand and 
are stable and happy on it). The generic or biosimilar entrant 
cannot compete for all the business of the buyer because of 
this non-contestable share, so it competes for only part--but 
at a lower price. The new entrant comes in with a lower price 
for the contestable share, but critically, it cannot compete 
for 100% of the needs of the buyer. This is where the loyalty 
rebate has a harmful effect on competition. A brand with large 
and durable market share will create a rebate in exchange for 
the buyer making purchases (or adopting formularies) that 
exclude entirely a new entrant or reduce the share of the new 
entrant.
    Buyers (plans or PBMs) that must purchase the brand to 
serve their non-contestable share (e.g., the patients 
stabilized on the brand) realize they will be buying those 
branded units on unfavorable terms--unless they agree to the 
loyalty rebate. The buyer faces a choice between staying loyal 
(buying 100% from the brand and receiving the rebate on all 
those purchases) or buying the contestable share from the 
entrant at a low price and the balance of their needs from the 
brand at a high price (forfeiting the rebate). An 
anticompetitive loyalty rebate scheme causes buyers to avoid 
purchasing from the new entrant for no reason related to the 
entrant's quality or price, but because of the brand's ability 
to withhold a rebate on the share of purchases the new entrant 
cannot supply. The entrant therefore earns less share than it 
would under competition on the merits. Loyalty rebates can be 
designed so that even if the new entrant charges zero for its 
product, the buyer still pays more in total by forgoing the 
rebates on the noncontestable share. Such rebates generate a 
larger share for the brand than it would have secured through 
competition on the merits, dose by dose.\5\
---------------------------------------------------------------------------
    \5\ Scott Morton, Fiona and Zachary Abrahamson (2017), ``A Unifying 
Analytical Framework for Loyalty Rebates,'' Antitrust Law Journal 
81(3): 777-836.
---------------------------------------------------------------------------
    There are now two biosimilar infliximab molecules that 
compete with the brand, Remicade. Those biosimilars offer 
prices 30% below the branded price and yet, combined, have a 7% 
market share.\6\ Why is it that demand does not shift to an 
almost identical product with a lower price? On the public side 
it is likely due to Medicare reimbursement (explained below) 
and on the commercial side it is likely due to anticompetitive 
loyalty rebate contracts. By way of contrast, the U.S. Veterans 
Administration has a financial incentive to procure drugs at 
the lowest possible price and controls physician prescribing. 
The U.S. VA has been able to negotiate more than an 80% lower 
price for a biosimilar as compared to the reference product.\7\ 
Data from Europe demonstrate similar levels of savings. Given 
the ease of enabling competition in this sector, these are 
savings that Congress is choosing to forgo on behalf of U.S. 
taxpayers and patients.
---------------------------------------------------------------------------
    \6\ Ronny Gal, Sanford Bernstein (Feb. 26, 2019), Global Specialty 
Pharma & U.S. Biotech, ``Biosimilars: adoption update in EU & U.S.--Dec 
'18 data: Herceptin & Rituxan moving; Remicade U.S. will not adopt in 
2019.''
    \7\ AB Bernstein report 18 January 2019.
---------------------------------------------------------------------------
    A second way that reference biologics exclude biosimilar 
entrants is by continually updating their FDA application file. 
A biologic medication may have its BLA approved by the FDA and 
therefore be selling on the market while its manufacturer 
continues to make changes to its file. Those changes then 
become part of the reference product. Thus a biosimilar, 
instead of attempting to imitate a product that is fixed at the 
moment of launch, is chasing a moving target. The reference 
product can choose to make changes at any time that make 
imitation more difficult or costly. In particular, the 
reference biologic can patent the changes it makes and in that 
way create a thicket of dozens of patents that take decades to 
expire. The migration of the reference product in this way is a 
huge barrier to entry for competing products. Biologics already 
have 12 years of market exclusivity (granted to them because 
they claimed to the government that their patents would be weak 
and so the market exclusivity would be a necessary substitute). 
Instead we see products on the market with 30 or more years of 
patent protection. There are 17 biosimilar products approved by 
the FDA that cannot launch because of patent issues. For 
example, the biosimilar competitors of Humira, a product that 
sells over 13 billion per year in the U.S., have settled with 
Abbvie that they will launch in 2023 in the U.S.\8\ In Europe, 
these biosimilars are already on the market and Abbvie has 
offered discounts of 80% in order to retain its market share. 
These are cost savings the United States is foregoing with its 
suboptimal regulation.\9\
---------------------------------------------------------------------------
    \8\ Abbvie Press Release: AbbVie Reports Full-Year and Fourth-
Quarter 2018 Financial Results (Jan 25, 2019), https://news.abbvie.com/
news/abbvie-reports-full-year-and-fourth-quarter-2018-financial-
results.htm; Peter Loftus, AbbVie, By Adding Patents, Drugmaker Keeps 
Cheaper Humira Copies Out of U.S., Wall St. Journal (Oct. 16, 2018), 
https://www.wsj.com/articles/biosimilar-humira-goes-on-sale-in-europe-
widening-gap-with-u-s-11539687603.
    \9\ A/B Bernstein reports 18 Jan 2019 and 26 Feb 2019.
---------------------------------------------------------------------------
    The solution is straightforward. A new regulation 
stipulates that at the time of launch the file constituting the 
reference product's BLA is fixed; and this product is the one 
the biosimilar must match. Any additional improvement the 
reference product maker would like to make can become an 
improved, different, product as is normally done in small 
molecule drugs. Any intellectual property needed to make the 
reference product would be notified to the FDA at the time of 
the original BLA; any subsequent products could have subsequent 
intellectual property attached to them. This would prevent the 
migration of the reference product and its role as a barrier to 
entry.

           2. Pharmaceutical Procurement Is a Problem

    Medicare Part B is a growing area of expenditure--due to 
biologics and oncology drugs \10\--and yet Medicare procures 
these drugs in a way that avoids almost all competitive forces. 
Physicians typically purchase the drugs and are reimbursed by 
Part B for whatever they choose to give the patient. Because 
physicians are paid a markup over the average cost of 
purchasing the drug, they have no incentive to consider equally 
effective, but lower-priced product.\11\ Indeed, because the 
physician earns a percentage margin on the medication, a 
physician has a financial incentive to use a higher priced 
branded product. Demand from Medicare patients does not decline 
appreciably with high prices (many enrollees are insured for 
their 20% copay, so their costs are zero), so a manufacturer 
wants to set a high list price when it anticipates high 
Medicare sales. That high list price must then be paid by 
commercial customers. The manufacturer faces a strong incentive 
not to give discounts in order to sustain its high price to 
Medicare. So the Part B procurement policy is actively harmful 
to privately insured patients.
---------------------------------------------------------------------------
    \10\ ``61% of Part B drugs approved by the FDA in 2006-2013 were 
biologics, and two-thirds of all biologics approved by FDA during this 
time were paid for by Part B.'' (p10) ``Expenditures for the 75 new 
Part B drugs for which we identified claims in 2013 were concentrated 
among a small number of drugs. The 20 highest expenditure drugs 
accounted for 92 percent of 2013 expenditures on new Part B drugs and 
26 percent of total Part B drug expenditures. Biologics accounted for 
13 of the top 20 highest expenditure new Part B drugs and 82 percent of 
expenditures for these 20 drugs (see table 2).'' Page 14 of Medicare 
Part B, Expenditures for New Drugs Concentrated among a Few Drugs, and 
Most Were Costly for Beneficiaries, Report to the Ranking Member, 
Committee on the Budget, House of Representatives (Government 
Accountability Office, October 2015), https://www.gao.gov/assets/680/
673304.pdf, at 10, 14.
    \11\ Medicare Part B, Expenditures for New Drugs Concentrated among 
a Few Drugs, and Most Were Costly for Beneficiaries, Report to the 
Ranking Member, Committee on the Budget, House of Representatives 
(Government Accountability Office, October 2015), https://www.gao.gov/
assets/680/673304.pdf, at 10 and note 27.
---------------------------------------------------------------------------
    The situation is particularly bad when a reference biologic 
experiences entry and competition from a much cheaper, but 
clinically identical, biosimilar. Under current Medicare rules 
each manufacturer of a biologic gets its own reimbursement 
price from Medicare. Each product is labeled with a different 
``J-code'' and associated price. A physician that continues 
buying a $1,000 reference product rather than switching to the 
$600 biosimilar need not worry about payment because he or she 
gets reimbursed the full $1000 for using the brand. The entry 
of a cheaper version of the same product has no impact on 
Medicare's payment for the brand. In particular, the way 
Medicare pays the doctor means she has zero incentive to use a 
lower priced product in a case when there is choice. The 
solution here is to adopt one reimbursement amount (one ``J-
code'') for Medicare to pay for any of either the reference 
biologic or its competing biosimilars.\12\ These are all the 
same molecule that deliver the same therapeutic benefit and 
should therefore be competition with one another, but current 
regulations insulate them from this price competition. This is 
a massive waste of Medicare funds. If there were one price 
across the group, a physician would be reimbursed that fixed 
amount for administering any one of those products, and would 
therefore care about seeking out a manufacturer charging a low 
price. This in turn would cause manufacturers to compete by 
lowering prices.
---------------------------------------------------------------------------
    \12\ MEDPAC, Medicare Part B drug payment policy issues, (June 
2017) (``Require the Secretary to use a common billing code to pay for 
a reference biologic and its biosimilars). Available at http://
www.medpac.gov/docs/default-source/reports/jun17_ch2.pdf?sfvrsn=0.
---------------------------------------------------------------------------
    Secondly, Congress should authorize Medicare to use ``least 
costly alternative'' models of payment for Medicare Part B 
drugs where several equivalent competing therapies (possibly 
still under patent protection) are grouped and one payment 
amount is set for the group. This causes expensive drugs that 
are not superior in efficacy to lose sales--or lower their 
price. OIG has studied this way of procuring drugs and found it 
delivers large cost savings.\13\
---------------------------------------------------------------------------
    \13\ Least Costly Alternative Policies: Impact on Prostate Cancer 
Drugs Covered Under Medicare Part B, Department of Health and Human 
Services (Office of Inspector General, November 2012), https://
oig.hhs.gov/oei/reports/oei-12-12-00210.pdf, at 12.
---------------------------------------------------------------------------
    Part D purchases drugs using the technique of a formulary 
run by a private insurer. This allows for much stronger 
negotiation of prices for some drugs. However, the protected 
classes in Part D most effectively `protect' manufacturers from 
competition. Requiring Part D plans to have a robust formulary 
that offers covered options for every patient is critical, but 
that regulation can be paired with a relaxation of rigid 
protected class rules. In addition, the Part D catastrophic 
region appears to create incentives that cause higher list 
prices and consumer costs, and needs to be reformed as 
suggested by Craig Garthwaite.

       3. High Consumer Out-of-Pocket Costs are a Problem

    High out-of-pocket costs for drugs are inconsistent with 
one purpose of insurance, which is to smooth financial shocks 
over time by paying a regular premium to cover infrequent 
healthcare expenditures. If a person has pharmaceutical 
insurance we ideally want it to reduce her out-of-pocket costs 
below the market price for the drug, not make them more than 
the market price for the drug. For example, if the list price 
of a drug is $600 while a plan has negotiated a price of $300, 
a consumer with a $1000 deductible will pay the full $600 list 
price. Her plan will receive a $300 rebate from the 
manufacturer, but will have paid out nothing for the claim. In 
this situation, not only is the patient paying more than the 
competitive price for the medication, but the employer or plan 
has made a profit on the claim. This practice generates a 
transfer from the sick to the healthy, which is the opposite of 
the purpose of insurance. The solution is a regulation that 
requires insurers to design their insurance so that patients' 
out of pocket payments in the deductible are equal or less than 
the final net price of the medication incurred by the insurer 
(or perhaps less than some kind of average of that final net 
price).
    The recent HHS Rule would effectively require any patient 
out-of-pocket payment that depends on the list price of the 
drug be calculated based on the net price after rebates. This 
Rule will do at least two helpful things: lower patient out-of-
pocket prices and reduce the ability to exclude with a loyalty 
rebate contract. However, the Rule is likely to weaken price 
competition between branded products, and this may be why 
pharmaceutical manufacturers are in favor of the Rule change. 
The way in which the Rule change would soften price competition 
works as follows (as far as I understand the Rule at present). 
First, a patient payment that is a function of the negotiated 
price has the potential to reveal negotiated prices, which is 
likely to reduce discounts (as described in Craig Garthwaite's 
testimony). However, a plan could design out-of-pocket payments 
to be fixed amounts (e.g., $25) rather than percentages of a 
medication's price. More importantly, the Rule may prevent 
performance-based contracts. A PBM that commits to move 50% 
share from drug A to drug B in a calendar year in exchange for 
a low price may not succeed. The maker of drug B might not want 
to offer a very low price because it worries that the PBM will 
not deliver its end of the deal. That manufacturer may want to 
offer one price in case the PBM does not move 50% share, and a 
lower price if it does--a performance-based contract. Consumers 
could not be charged that lower price before either side knows 
if it is in fact the true net price. If such contracts are 
ruled out by the change in the safe harbor definition, then 
price competition will become less vigorous. Prices will rise 
in equilibrium when PBMs cannot condition low prices on 
achieving certain shares. Higher prices will raise manufacturer 
profits, which may be the analysis manufacturers have carried 
out, and the reason they support the rule. The Rule should be 
structured so that the safe harbor still applies if the 
patient's out-of-pocket costs are fixed, if the patient's out-
of-pocket costs are a function of a price that is below the 
final net price the plan pays, or if they are a function of a 
well-defined average price the plan expects to pay. In this way 
performance-based contracts and confidential price discounts 
will both be permitted and will bring down prices.
    The HHS proposed Rule would also encourage intermediaries 
in the supply chain to be paid in some way that is not as a 
percentage of the list price. A wholesaler that is transporting 
drugs could be paid a dollar amount per box, for example, and 
would then no longer have an incentive to support higher list 
prices.
    Recent evidence demonstrates another method by which drug 
manufacturers avoid competition; they use various techniques to 
make side payments to patients in order to undo the incentives 
created by the PBM and thereby shift consumption toward more 
expensive branded drugs. These side payments can take the form 
of coupons, in-kind benefits provided under the guise of 
marketing, or charitable assistance programs. For example, a 
brand gives a patient a coupon for $80 that reduces the 
patient's co-pay from $90 down to $10. Suppose that in the 
consumer's plan the generic equivalent has a copay of $10. Now 
the patient is happy to choose the brand (which has a much 
higher list price, e.g., $250) because both options cost her 
$10.
    Meanwhile healthcare costs have risen because the plan is 
paying for a $250 brand instead of a $15 generic. In addition, 
the plan loses bargaining leverage with manufacturers and must 
acquiesce to higher prices. Why? Because when the coupons or 
financial aid undo the financial incentives put in place by the 
plan, it has lost one of its main tools to move patients to the 
cheaper drug. Without being able to ``shift share'' in response 
to price, the plan doesn't have bargaining power. With less 
plan bargaining power, pharmaceutical prices rise. It is 
important to note that these coupons are banned in the Medicare 
and Medicaid programs because they are a violation of the anti-
kickback statues and raise costs to the government. However, 
they are permitted in commercial insurance where we have no 
reason to believe the effects are any different. Indeed, the 
research finding that coupons lead to higher drug costs and 
less generic competition studied the time when Massachusetts 
banned these coupons.\14\
---------------------------------------------------------------------------
    \14\ Dafny, Leemore, Christopher Ody, and Matt Schmitt (2017), 
``When Discounts Raise Costs: The Effect of Copay Coupons on Generic 
Utilization,'' American Economic Journal: Economic Policy, 9(2): 91-
123; Scott Morton, Fiona and Lysle T. Boller (2017), ``Enabling 
Competition in Pharmaceutical Markets,'' Brookings Institution, 
Hutchins Center Working Paper No. 30, https://www.brookings.edu/wp-
content/uploads/2017/05/wp30_scottmorton_competitionin pharma1.pdf, at 
26-27.
---------------------------------------------------------------------------
    Such practices are particularly extensive and problematic 
in populations with high per-patient expenditure, such as 
hemophilia, that are often treated with biologics. Insurance 
companies cannot typically see exactly what source of funds is 
used for a co-payment and therefore cannot monitor these 
kickbacks. In addition, by driving the effective price borne by 
patients to zero, manufacturers can encourage over-consumption 
of their drug, increasing costs for insurers and driving up 
premiums.\15\
---------------------------------------------------------------------------
    \15\ Scott Morton, Fiona and Lysle T. Boller (2017), ``Enabling 
Competition in Pharmaceutical Markets,'' Brookings Institution, 
Hutchins Center Working Paper No. 30, https://www .brookings.edu/wp-
content/uploads/2017/05/wp30_scottmorton_competitioninpharma1.pdf, at 
26-27.
---------------------------------------------------------------------------
    The solution to this problem is to implement two policies 
simultaneously: First, a ban on any kind of manufacturer 
payment to patients whether coupons, financial aid, wrap-around 
services, etc., paired with a limit on out of pocket 
expenditure per prescription (or 30 day supply) at some 
reasonable level such as $200. The limit on out of pocket 
expenditure protects the patient who has purchased insurance; 
the ban on coupons and financial aid to patients empowers the 
PBM to create formularies that can shift share and drive down 
prices while preventing manufacturers from ``buying'' sales 
they cannot achieve on the merits. A plan will be able to shift 
share by adjusting the out of pocket payment between zero and 
$200 and thus be well positioned to bargain for lower prices 
from manufacturers.
    A solution to tackle the problem of high out-of-pocket 
consumer costs that also promotes competition, such as the 
proposal above, is more desirable than one that reduces 
competition, such as the HHS rule. The HHS rule, by reducing 
competition between drugs, will lead to higher equilibrium 
prices.

                       4. PBM's Dual Role

    PBMs can play a good role in today's pharmaceutical 
markets, and also, potentially, a bad one. The good role of the 
PBM is to create price competition among branded and generic 
treatments. In pharmaceutical and device markets, final 
consumers are generally both uninformed and insured, so on 
their own they cannot respond to a price discount by moving 
their purchases, nor are they able to ask for one as 
individuals. The institutional innovation that creates 
competition in pharmaceuticals is the PBM. The PBM is informed 
about available substitute treatments, is sensitive to price, 
and controls a large group of final consumers. Of course, the 
PBM has far less bargaining power in markets where there is 
insufficient competition, for example, a monopoly market 
structure or a government requirement to buy a particular 
product. In a market with competitive alternatives the PBM has 
the ability to negotiate for lower prices in exchange for 
market share. Those lower prices take the form of a rebate from 
the manufacturer back to the PBM (because the patient has 
purchased the drug at a pharmacy that typically serves many 
different PBMs). The PBM's role of seeking out discounts from 
manufacturers is critical because it is one of the few agents 
in our commercial pharmaceutical marketplace that creates price 
competition.
    It is also key that these rebates stay confidential. 
Suppose a small staff-model HMO says it will be able to move 
99% of patients to a substitute drug and, with that threat of 
walking away, obtains a huge rebate on the drug. If that 
discount were to become public, other buyers who cannot move as 
much share would nonetheless demand the same discount, and 
those bargaining costs would likely stop the manufacturer from 
offering it to the small HMO in the first place. We have seen 
this dynamic before in the Medicaid MFN rules.\16\ One reason 
pharmaceutical manufacturers like restrictions on rebates, such 
as those in the proposed HHS rule, is that such restrictions 
suppress price competition and less price competition increase 
manufacturer profits.
---------------------------------------------------------------------------
    \16\ Scott Morton, Fiona (1997), ``The Strategic Response by 
Pharmaceutical Firms to the Medicaid Most-Favored-Customer Rules,'' The 
RAND Journal of Economics 28(2): 269-290.
---------------------------------------------------------------------------
    The side of PBMs that needs policy attention is their 
increasing consolidation and market power; however, this is 
fixable and may already be weakening. The FTC has allowed many 
PBM mergers over the last 20 years while there may not have 
been enough competition among PBMs to protect end consumers, 
particularly given PBMs' use of MFNs, limited information 
disclosures, and other practices detailed in the Garthwaite 
testimony. Under these conditions, some PBMs may have stopped 
being good agents for final consumers without losing business.
    This a phenomenon Craig Garthwaite and I wrote about 18 
months ago.\17\ If the rebate process is opaque, the PBM may 
find that a good way to raise prices is to keep more of the 
rebate dollars. This in turn leads to an incentive for the PBM 
to encourage the manufacturer to raise the list price of the 
drug (e.g., by $100), increase the rebate (e.g., by $80 so that 
the manufacturer gains an extra $20), thereby allowing the PBM 
to pass only some of the increased rebate to the customer 
(e.g., $50 so that the PBM's profits rise by $30). This tactic 
leads to rising list prices, rising net prices, and rising 
rebates, the last of which benefits the PBM. There are a number 
of possible solutions. Congress could require a PBM to have a 
fiduciary duty to its clients.
---------------------------------------------------------------------------
    \17\ Garthwaite, Craig and Fiona Scott Morton, ``Perverse Market 
Incentives Encourage High Prescription Drug Prices,'' Pro-Market blog 
(November 1, 2017), Stigler Center at the University of Chicago Booth 
School of Business, https://promarket.org/perverse-market-incentives-
encourage-high-prescription-drug-prices.
---------------------------------------------------------------------------
    Alternatively, PBM contracts could require all payments 
from the manufacturer, whether labeled as rebates, 
administrative fees, consulting fees, marketing fees, or any 
other title, flow directly to the end client (the employer). 
Indeed, there could be a safe harbor for payments from the 
manufacturer to the end client, rather than to the PBM. If the 
employer and PBM so choose, they can specify in a contract how 
to share them with the PBM. A third point is that competition 
in the health insurance market may improve the agency of PBMs. 
Due to recent mergers between PBMs and health insurers, all the 
large PBMs in the U.S. are now vertically integrated. This 
integration may be due to both parties' interest in 
internalizing the externalities between pharmaceutical 
consumption and medical care. Between the mergers and 
significant public exposure, the agency problems outlined above 
may be on the wane already.

           5. Many Past Mergers Were Anticompetitive

    Unlike many other sectors, healthcare providers often have 
geographically spaced facilities that limit the extent to which 
company activities can be combined and made more efficient in 
the event of a merger. This integration is often referred to as 
``scrambling the eggs'' because such it is difficult to undo 
after a merger. Because there is no time limit on Clayton Act 
violations, Congress could instruct the FTC to open a unit to 
revisit healthcare mergers that have harmed competition. A 
substantial literature concludes that there have been many 
anticompetitive hospital mergers over the last 30 years.\18\
---------------------------------------------------------------------------
    \18\ See, e.g., Fulton, Brent D. (2017), ``Healthcare Market 
Concentration Trends in the United States: Evidence and Policy 
Responses,'' Health Affairs 36(9):1530-1538; Cutler, David M. and Fiona 
Scott Morton (2013), ``Hospitals, Market Share, and Consolidation,'' 
JAMA 310(18): 1964-1970; Cooper, Zack, et al. (2019), ``The Price Ain't 
Right? Hospital Prices and Health Spending on the Privately Insured,'' 
Quarterly Journal of Economics 134(1): 51-107; Gaynor, Martin and 
Robert Town (2012), The Impact of Hospital Consolidation--Update, 
Robert Wood Johnson Foundation Synthesis Project, https://www.rwjf.org/
content/dam/farm/reports/issue_briefs/2012/rwjf73261. See also Cuellar, 
Alison Evans and Paul J. Gertler (2003), ``Trends in Hospital 
Consolidation: The Formation of Local Systems,'' Health Affairs 22(6): 
77-87.
---------------------------------------------------------------------------
    A second area of focus for consummated anticompetitive 
mergers are transactions that fall below the Hart-Scott-Rodino 
Antitrust Improvements Act (``HSR'') threshold. Professors 
Thomas Wollmann (University of Chicago) and Paul Eliason 
(Brigham Young) have work in the area of dialysis clinics that 
shows the harm from mergers.\19\ Wollmann's dialysis paper 
shows that when a transaction falls below the HSR threshold, 
the FTC essentially requires no divestitures. This is true 
regardless of the geographic overlap of the clinics; in 
particular it is true when a similar case reported under HSR 
would be required to divest in order to merge.\20\ The paper 
shows that the bulk of the increase in concentration in the 
dialysis industry comes from these small, unreported mergers. 
Revisiting those past transactions and requiring appropriate 
divestitures of dialysis clinics could increase competition.
---------------------------------------------------------------------------
    \19\ Eliason, Paul J., et al. (2018), ``How Acquisitions Affect 
Firm Behavior and Performance: Evidence from the Dialysis Industry,'' 
Manuscript, available at https://www.ftc.gov/system/files/documents/
public_events/1349883/eliasonheebshmcdevittroberts.pdf.
    \20\ Wollmann, Thomas (2018), ``Stealth Consolidation: Evidence 
from an amendment to the Hart-Scott-Rodino Act,'' Manuscript, http://
faculty.chicagobooth.edu/thomas.wollmann/docs/
stealth_consolidation_2_19.pdf and Wollman, Thomas (2019) ``Getting 
away with merger: The case of dialysis clinics in the United States.''
---------------------------------------------------------------------------
    Lowering the HSR threshold for merger review going forward 
would also allow for more vigorous enforcement. Indeed, if an 
automated process were adopted, a very low threshold could also 
be cost-effective. For example, Congress could instruct the FTC 
to design a form ``EZ-merge'' for mergers between $2 and $20 m, 
with a standard HSR process for anything larger.mBusinesses 
could choose their type (e.g., auto tire retailer, primary care 
physicians, or funeral home) from a drop-down menu and enter 
the zipcodes of their customers. An algorithm could determine 
if, for example, two small orthopedic groups serve the same 
geographic area, or two dialysis clinics are in the same town. 
Flagged mergers could be passed on to FTC staff for further 
review. We know that simply notifying a merger to federal 
authorities creates a deterrent effect; therefore, the simple 
adoption of Form EZ-merge might cause dialysis clinics and 
other local businesses in the same town to stop proposing 
anticompetitive mergers.

                         6. Nonprofits

    U.S. competition laws should apply to nonprofits just as 
they do for for-profit companies. In Healthcare, many hospitals 
and insurers are nonprofits, but their nonprofit status exempts 
them from the Federal Trade Commission Act and its prohibition 
on unfair methods of competition and unfair and deceptive acts 
or practices. (The FTC has jurisdiction over nonprofits for 
section 7 violations.) Congress should eliminate this 
exemption.

    Mr. Cicilline. Great. Thank you so much, Doctor.
    I now recognize Mr. Kades for five minutes.

                   TESTIMONY OF MICHAEL KADES

    Mr. Kades. Thank you, Chair Cicilline and Ranking Member 
Sensenbrenner and full committee--Mr. Nadler stepped out.
    So, I just want to start with Ranking Member 
Sensenbrenner--just would for the record--
    Mr. Cicilline. Mr. Kades, would you just pull your 
microphone close to you so folks can hear it? Yeah.
    Mr. Kades. So, Ranking Member Sensenbrenner, I just want to 
State for the record I was born and raised in Beloit, 
Wisconsin, fairly close to your 5th District, and when you have 
said Wisconsin, you have said it all.
    It is an honor to testify before this Subcommittee on 
competition in prescription drug prices. This issue is vital to 
the healthcare system and affects all Americans.
    I am Michael Kades, the director of Market and Competition 
Policy at the Washington Center for Equitable Growth. We seek 
to advance evidence-based ideas and policies that promote 
strong, stable, and broad-based economic growth.
    The exploitation of monopoly power is the kind of 
inequality that is at the core of the most important challenges 
that our economy and Nation face. Prescription drug costs are 
and continue to be a burden.
    In 2017, the United States spent $333 billion on 
prescription drugs. That is over $2,600 per family. Three out 
of 10 Americans are not taking prescriptions as directed 
because of cost. So, this isn't just about money. It is about 
people's health and well being.
    No silver bullet exists to ensuring prescription medicine 
is affordable. It requires a broad range of policies. Increased 
competition should be part of the answer.
    Stopping anticompetitive conduct will both lower prices and 
promote innovation. For 20 years at the Federal Trade 
Commission, I was on the front line of what has been and 
continues to be a never-ending struggle to protect competition 
in pharmaceutical markets.
    I litigated and investigated dozens of pharmaceutical 
antitrust matters and I am here to tell you the system is 
broken. The incentives for anticompetitive activity in these 
markets is substantial.
    For example, delaying competition on a blockbuster drug for 
just a year can mean hundreds of millions if not billions of 
dollars in additional profit.
    The antitrust laws should stand as a bulwark against 
anticompetitive conduct. Unfortunately, courts have stripped 
those laws of their potency, narrowing the scope of the law and 
imposing ever-higher burdens of proof.
    Easy cases have become hard and hard cases escape 
condemnation. Companies have been emboldened to push the limits 
of business conduct because the rewards are great and the risks 
are minimal. Even if they get caught, the penalties are low.
    The result? Consumers pay hundreds if not thousands of 
dollars more each month for their prescriptions.
    I want to focus on three practical policies that would help 
focus competition in the pharmaceutical markets, which this 
Committee can work on this year.
    First, pass the CREATES Act. Chair and Ranking Member 
Cicilline, Sensenbrenner, Nadler, and Collins, this bill--this, 
obviously, bipartisan but also a bicameral supported bill would 
stop one of the most egregious strategies that limits 
competition.
    Sometimes it is hard to explain. I like to put it down into 
one simple phrase. No samples, no competition. Break that chain 
and you will save billions of dollars for the government and 
American citizens.
    Second, pass legislation to stop branded companies paying 
generic companies not to compete in the marketplace--what is 
called a ``pay for delay'' patent settlement.
    Despite the Supreme Court's clear signal that these deals 
can be anticompetitive, the FTC still expends substantial 
resources challenging clear antitrust violations.
    Chair Cicilline, you referred to the Actavis case which 
just got settled. When that case was filed, my daughter was 
learning how to read. She is coming home for her spring break 
of her first year of college. That is how long it took to get a 
resolution of that case. That is too long.
    Enacting a law with clear standards such as the Preserve 
Access to Affordable Generics Act would deter this practice and 
free up limited resources to attack other anticompetitive 
conduct.
    Third, make bad actors pay a real penalty. The key to 
deterring anticompetitive conduct is that when somebody 
violates the law, they shouldn't benefit from it. In the world 
of antitrust law we call this disgorgement. You make them give 
up their profits.
    Even in this area, the federal Third Circuit of Appeals 
just last week, ignoring 35 years of precedent, clipped the 
ability of the FTC to obtain this type of relief.
    This Congress should modify the Federal Trade Commission 
Act to clarify explicitly that the FTC can obtain this type of 
relief. It is critical to deterring highly probable--
profitable, I am sorry--anticompetitive conduct.
    Thank you, and I look forward to listen to your questions.
    [The statement of Mr. Kades follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Cicilline. Thank you, Mr. Kades.
    I now recognize Dr. Gaynor for five minutes.

                   TESTIMONY OF MARTIN GAYNOR

    Mr. Gaynor. Thank you. Chair Cicilline, Ranking Member 
Sensenbrenner, and Members of the subcommittee, thank you for 
holding a hearing on this vitally important topic and for 
giving me the opportunity to testify in front of you today.
    The focus of my testimony is on healthcare--hospitals, 
doctors, insurers--which, collectively, account for almost 60 
percent of all of U.S. healthcare spending. Over the next few 
minutes, I will briefly summarize for the Committee the basic 
facts about healthcare markets, the considerable research on 
competition in healthcare, and my views on steps that can be 
taken to help make these markets work for the benefit of 
consumers.
    Healthcare is a very large and important sector of our 
economy. Not only is it almost one-fifth of the entire economy, 
but it also has a critical impact on our health and well being.
    Our healthcare system is based on markets. That system is 
only going to work as well as the markets that underpin it. 
Unfortunately, these markets do not function as well as they 
could or should.
    Prices are high and rising. There are egregious pricing 
practices. Quality is suboptimal and the sector is sluggish and 
unresponsive, in contrast to the innovation and dynamism that 
characterize much of the rest of our economy.
    Lack of competition has a lot to do with these problems. 
There has been a great deal of consolidation in healthcare. 
There have been nearly 1,600 hospital mergers in the past 20 
years.
    The result is the majority of local areas are now dominated 
by one large powerful healthcare system such as Pittsburgh, my 
home, by University of Pittsburgh Medical Center, Boston by 
Partners, and San Francisco Bay Area by Sutter.
    The same is true of health insurance markets. The two 
largest insurers have 70 percent of the market and over one-
half of all local insurance markets. Physician services markets 
have also become increasingly more concentrated. Two-thirds of 
specialist physician markets are concentrated and 29 percent 
are primary care physicians.
    Moreover, there were nearly 31,000 physician practice 
acquisitions by hospitals from 2008 to 2012 and about a third--
at least a third--of all doctors are now in hospital-owned 
practices. This massive consolidation in healthcare has not 
delivered for Americans. It has not given us better care or 
enhanced efficiency.
    On the contrary, extensive research shows us that 
consolidation between close competitors results in higher 
prices and patient quality of care suffers from lack of 
competition.
    Moreover, competition affects the form of payment. 
Hospitals with fewer competitors negotiate more favorable forms 
of payment and reject those they dislike. This poses a serious 
challenge for payment reform.
    Hospital mergers can also harm competition in labor 
markets. They can depress wages, distort hiring decisions, and 
harm incentives for investment in human capital. Recent 
evidence shows impacts of hospital mergers is consistent with 
these concerns.
    There are also concerns about anticompetitive conduct. 
Firms who have acquired market power want to keep it. Some 
dominant health systems have been using restrictive contracts 
with insurers to try and hamper the free flow of patients to 
competitors, thereby harming competition and enhancing their 
market power.
    There are extensive reports of health systems engaging in 
data blocking, impeding the flow of patient information to 
providers outside the system. This has the potential to harm 
competition by making it more difficult for patients to switch 
providers.
    Now that most hospital markets are dominated by one large 
health system, there is considerable potential for this kind of 
conduct to seriously harm competition. All of this is causing 
serious harm to patients and to the healthcare system as a 
whole.
    Policies are needed to support and promote competition in 
healthcare markets. These include ending policies that 
unintentionally incentivize consolidation, ending policies that 
impede new competitors and impede competition, focusing and 
strengthening antitrust enforcement, in particular, giving the 
DOJ and FTC resources so that not only can they do more 
enforcement in existing areas but can proactively invest to 
address new and developing issues.
    Permit the FTC to enforce against anticompetitive conduct 
by not-for-profits. Permit the FTC to use its section 6(b) 
authority to study the insurance industry. Require simple 
reporting of small transactions that fall below the Hart-Scott-
Rodino reporting requirements to the enforcement agencies can 
track physician practice mergers--they currently can't--and 
hospital acquisitions of physician practices.
    Study vertical aspects of hospital physician acquisitions 
and develop theory and evidence on competitive impacts. Study 
anticompetitive conduct and develop theories and evidence.
    Last, consider legislation to alter the antitrust laws, 
specifically, changing the standard plaintiffs have to meet and 
changing criteria to be met for presumption of harm to 
competition.
    Thank you very much.
    [The statement of Mr. Gaynor follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Cicilline. Thank you, Dr. Gaynor.
    I now recognize Dr. Garthwaite for five minutes.

                 TESTIMONY OF CRAIG GARTHWAITE

    Mr. Garthwaite. Thank you, Chair Cicilline, Ranking Member 
Sensenbrenner, and Members of the Committee for holding a 
hearing to examine the role of competition in healthcare.
    I am here today to talk about why markets can work in 
healthcare with a particular focus on the pharmaceutical 
sector. I have prepared a longer written statement outlining 
more specific details that I have submitted to the committee.
    Unlike most other developed countries, the United States 
primarily relies on lightly regulated private markets for the 
provision of healthcare services. This choice makes sense 
because private firms respond to market incentives and create 
products and services that maximize welfare either by lowering 
costs or by increasing quality.
    In this way, the profit-seeking motives of private firms 
benefit society in ways that even the most benevolent 
government entities cannot. Optimal healthcare policy then 
harnesses these market forces while maintaining no illusions 
about the motivations of the firms we employ to efficiently 
provide these goods and services.
    However, relying on the private market for the provision of 
such a vital set of goods and services requires recognizing two 
key facts.
    First, healthcare markets, like any other markets, can 
fail, and second, all markets require vigilant protection of 
the structures and institutions that support robust and 
vigorous competition.
    Complicating matters is the uniquely public-private nature 
of the U.S. healthcare system where even government-financed 
social insurance and medical services are increasingly the 
domain of private firms reacting to these market incentives.
    While I think the benefit of the markets is clear, I fear 
there are a number of areas where a combination of the market 
structure and poorly developed regulations limit the ability of 
the market to deliver its most efficient outcome.
    There are many areas of healthcare where this is true, 
which all the witnesses have already testified to. Today, I 
will concentrate my remarks on pharmaceutical markets, a sector 
that generates meaningful value but all too often attracts the 
ire of policymakers and the general public.
    It is not surprising that such negative attention is 
focused on the pharmaceutical sector. Certainly, some of this 
is the result of bad actors by some industry participants. Poor 
behavior is hardly unique to this sector. Far more is about the 
simple fact that the products are sold for many multiples at 
marginal cost.
    However, claims that these prices solely represent 
corporate greed ignore the vital societal tradeoff where we 
accept limited access to drugs' high prices today in order to 
provide incentives for the development of new and innovative 
products in the future.
    That said, our goal is not to give firms unlimited profits 
but instead to provide a time-limited period of increased 
market power in order to encourage innovative firms to make the 
necessary investments.
    During this time period of exclusivity we want to ensure 
that firms offering therapeutic substitutes still compete for 
patients and, therefore, the greatest profits go to the firms 
that have the most uniquely valuable products.
    Following exclusivity welfare is then maximized by a robust 
and competitive generic market. Today I will briefly highlight 
some specific proposals I believe sensibly address these 
concerns.
    The first set of proposals are for generic markets. First, 
as Mr. Kades said, Congress should immediately pass the CREATES 
Act in order to facilitate the availability of necessary 
product samples for potential generic entrants.
    Second, Congress should authorize regulators to investigate 
the abuse of citizen petitions, which artificially delay the 
entry of generic competitors.
    Third, Congress should create a new form of generic 
exclusivity targeting molecules with small patient populations. 
Markets that are too small to attract multiple competitors 
allow incumbent firms to set prices as natural monopolists. 
This was most apparent in the case of Martin Shkreli and Turing 
Pharmaceuticals. This practice is now widespread across many 
firms.
    The FDA should create an RFP process where firms can apply 
to be the sole supplier of these small markets at a fixed 
margin over production costs.
    The next proposals are for the branded market where 
policies should facilitate robust competition between 
therapeutic substitutes. This competition currently takes the 
forms of rebates negotiated by pharmacy benefit managers, or 
PBMs.
    While confidential rebates have become a much maligned part 
of the system, they are actually a vital component that results 
in large discounts. When rebates are confidential, firms are 
more willing to give large discounts in the first place and 
less able to tacitly collude on high prices.
    That said, there are some improvements that can be made to 
the rebate system and I would highlight two particular 
suggestions.
    First, we must provide a means of passing along the rebates 
to consumers at the point of sale--a way that supports 
competition and confidentiality while restoring the insurance 
benefit to these sick patients.
    This can be accomplished by basing cost sharing not on the 
list price of the drug but on some other discounted price such 
as the average price across payers for the molecule.
    Second, we must provide the structure to ensure that PBMs 
Act as good agents for their payers. Currently, many 
policymakers are worried this is not occurring. In particular, 
they are worried that PBMs are capturing an inappropriately 
large amount of the discounts that are provided by the 
manufacturers.
    In order to improve competition, I propose, along with Dr. 
Scott Morton, that we increase the amount of information payers 
have about the money flowing between PBMs and manufacturers.
    For example, Congress could ban payments directly between 
PBMs and manufacturers and require all discounts and fees be 
paid first to the final payer. Payers and PBMs can then 
negotiate about efficient distribution of that surplus.
    While I understand the temptation to abandon markets in the 
favor of a greater use of government purchasing power and 
regulated prices, such policies are shortsighted and they 
ultimately through the baby out with the bath water.
    Thank you.
    [The statement of Mr. Garthwaite follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Cicilline. Thank you, Doctor. Thank you to all of our 
witnesses for your opening statements. We will now proceed 
under the five-minute Rule with questions and I will begin by 
recognizing the gentleman from Georgia, Mr. Johnson.
    Mr. Johnson of Georgia. Thank you, Mr. Chair, and thank the 
witnesses for your appearance today.
    Drug prices are rising every day and the burden is being 
felt most acutely at the lowest level, the consumer. Yes, this 
problem is complex and unwieldy with a variety of competing 
interests, and it seems that these competing interests threaten 
any incentive to keep costs down.
    Lack of competition in the market is driving prices up and 
every day Americans are paying a higher and higher amount for 
lifesaving medications.
    Ms. Morton, do you believe that the American government is 
utilizing our antitrust protections in the drug-pricing chain 
properly?
    Ms. Scott Morton. No.
    Mr. Johnson of Georgia. Why do you think antitrust 
enforcement has weakened?
    Ms. Scott Morton. The answer to that is probably longer 
than we have for time today. Mr. Kades' remarks about the 
CREATES Act, about defending ``pay for delay,'' citizens 
petitions, blocking of biosimilar entry in various ways--all of 
these are potentially anticompetitive behavior that the FTC 
could go after.
    The FTC is limited by the courts' negative views of 
antitrust enforcement, the limits of the FTC on nonprofits, and 
other areas that are highlighted in his testimony. I think 
Congress could fix many of those things.
    Mr. Johnson of Georgia. So, more laws and more regulations 
would be the fix?
    Ms. Scott Morton. I think more laws making it clear what 
the antitrust law is supposed to capture and giving the FTC 
authority to go after those cases.
    Mr. Johnson of Georgia. Now, it wasn't the Affordable Care 
Act passage that caused this dilemma, is it?
    Ms. Scott Morton. No.
    Mr. Johnson of Georgia. In fact, the tens of millions of 
people who were brought into the healthcare system upon passage 
of the Affordable Care Act, that is not the cause of these--of 
consolidation in the insurance and the hospital industries and 
in terms of the high cost of prescription drugs. Is that 
correct?
    Ms. Scott Morton. To the best of my knowledge, that is 
correct.
    Mr. Johnson of Georgia. Well, let me ask you this question 
about prescription drugs. Federal law prohibits itself from 
negotiating with drug manufacturers over the cost of 
prescription drugs for Medicare Part D enrollees.
    Would removing this handcuff result in lower costs for 
Medicare Part D employees and the Medicare program?
    Ms. Scott Morton. Medicare Part D is run as an outsourced 
privatized program where insurance companies negotiate with 
drug manufacturers.
    Mr. Johnson of Georgia. Instead of--
    Ms. Scott Morton. So, they do pretty well. They have a 
formulary. They can walk away. I think it is very difficult for 
the secretary of Health and Human Services to walk away from a 
drug manufacturer and say, I am sorry, Drug A will not be 
available to anybody--any of America's seniors.
    That is a hard thing to say. It is not very credible. 
Whereas, an individual insurance company can say, oh, we are 
going to put Drug A low on a high tier with a high co-pay and 
Drug B is going to be our preferred drug.
    So, I think Part D works pretty well. It is Part B that is 
really not good.
    Mr. Johnson of Georgia. Do you think the handcuffs on Part 
B should be removed?
    Ms. Scott Morton. Correct.
    Mr. Johnson of Georgia. That would lower costs for the 15 
percent of consumers enrolled in that program?
    Ms. Scott Morton. Well, we all pay the taxes for it.
    Mr. Johnson of Georgia. Well, you are right about that.
    Well, let me ask you this question also. With respect to 
consolidation in the health insurance industry, would passage 
of legislation that allowed for what is known as the public 
option--passage of that legislation--would it result in a 
competition that would lower prices for consumers?
    Ms. Scott Morton. The public option has a lot of different 
definitions but, certainly, anything we can do to make the 
Affordable Care Act marketplaces more competitive with more 
choices for consumers, that would be a great help and it would 
lead to lower prices.
    Mr. Johnson of Georgia. Thank you. So, the constant 
attempts to destroy the Affordable Care Act, which enabled tens 
of millions of people to have access to the system don't do 
anything to cut the consolidation in the hospital and insurance 
industries or the rise in prescription drug prices. Do you all 
agree with that?
    Yes, yes, yes, and yes?
    [A chorus of ayes.]
    Ms. Scott Morton. Yes.
    Mr. Johnson of Georgia. Okay. Well, let the record show 
everybody agrees with that.
    With that, I will yield back.
    Mr. Cicilline. Thank you, Mr. Johnson.
    The chair now recognizes the gentleman from Wisconsin, Mr. 
Sensenbrenner, for five minutes.
    Mr. Sensenbrenner. Thank you, Mr. Chair.
    I have some questions for Dr. Gaynor. First, you note in 
your written testimony that Americans who live in rural areas 
are vulnerable to harms from hospital consolidations and 
anticompetitive behavior.
    My home State of Wisconsin has been particularly affected 
by rural hospital mergers with 19 mergers taken place between 
2005 and 2016.
    Why does this happen more in rural areas than in urban 
areas?
    Mr. Gaynor. Thanks for your question, Member Sensenbrenner.
    I don't know that I can answer why it is happening more 
frequently in rural than in urban areas at this point in time. 
I am happy to consider it further and submit an answer in 
written testimony.
    Nonetheless, there are quite a few mergers that are 
happening across the board, not just in rural areas, and there 
are lots of things that are driving those mergers.
    As we all know, there is a merger wave in the U.S. economy 
happening that is affecting what is happening in healthcare. 
There are motives on the part of merging parties to enhance 
their negotiating positions by merging and eliminating or 
harming competition.
    There is sometimes a game of musical chairs that happens 
where they see everybody else merging and they don't want to be 
the last one left standing when the music stops.
    Nonetheless, Americans that live in rural areas are 
particularly vulnerable because if there only one provider or 
dominant provider it is very difficult for them to go 
elsewhere. So they can be particularly harmed by the mergers 
that enhance or consolidate market power in the areas that they 
live.
    Mr. Sensenbrenner. Okay. Second, in your written testimony 
you explain that some states have regulations that 
unintentionally make it difficult for new care providers to 
enter the market and that the negative impacts of these laws 
can particularly affect residents of rural areas.
    Can you tell me what kind of State regulations or laws make 
it difficult for new hospitals or other providers to offer 
healthcare services and, again, why does this happen more often 
in rural areas than in urban areas?
    Mr. Gaynor. Thanks again for your question, Ranking Member 
Sensenbrenner.
    So, there are a number of examples of this. There are a set 
of laws called certificate of need laws. About 26 states in the 
Union still have certificate of need laws.
    Mr. Sensenbrenner. We had them in Wisconsin and repealed 
them.
    Mr. Gaynor. Yes. Yes. Pennsylvania, for example, had such a 
law. It sunset about '95 or '96. About half of all states still 
have them and that requires review and approval by a regulatory 
commission to create a new facility or expand a new facility, 
whether it is a hospital, an ambulatory surgery center--that 
sort of thing.
    Another area that is particularly important has to do with 
the decisions of State licensing boards about what sorts of 
entities are allowed to practice and provide healthcare.
    Telehealth is one example where State licensing boards have 
discretion over the provision of telehealth. The scope of 
practice for nurses is another area--what nurses are allowed to 
do and not do, what sort of supervision is required. Last but 
not least, independent pharmacists are also subject to these 
regulations.
    Now, the regulations are statewide but why might they 
affect folks in rural areas particularly more? Well, telehealth 
is easy to see. If you live in an area where there are not a 
lot of providers physically, the ability to obtain care through 
telehealth for some kinds of services can greatly expand the 
opportunities for care.
    If nurses can do more, if pharmacists are allowed to do 
more, that expands the supply of healthcare professionals and 
so creates more opportunities, more care, and more competition 
in those areas.
    Mr. Sensenbrenner. Thank you very much. I yield back.
    Mr. Cicilline. Thank you, Mr. Sensenbrenner.
    The chair now recognizes the distinguished gentlelady from 
Washington State, Ms. Jayapal, for five minutes.
    Ms. Jayapal. Thank you, Mr. Chair, and thank you so much 
for having this hearing. Thank you all for your testimony 
today.
    I think it is important that we remind people that might be 
watching what we are talking about which undergirds everything 
you have said, which is that today in the United States we 
spend about 18 percent of our GDP on healthcare, which is 
double what every other major industrialized country--almost 
double what every other major industrialized country in the 
world spends on healthcare.
    You might think, if you were listening to this, that that 
means we have great outcomes. In fact, the United States is 
worst of our peer countries on maternal mortality. That is moms 
that die in childbirth.
    We are worst in terms of infant mortality. That is kids 
that die when they are young. We are worst in terms of life 
expectancy. We have the lowest life expectancy.
    So, this is a marketplace that truly is broken and I think 
you all have raised important considerations. I wanted to point 
out that this is also a marketplace where the top five private 
health insurance companies bring an annual profit of $90 
billion a year.
    The top pharmaceutical companies bring in $75 billion a 
year, and this is as people are dying because they can't afford 
insulin or cancer treatments.
    So, I have introduced our Medicare for All bill here in the 
House and have 106 distinguished original co-sponsors. So, I 
wanted to just turn, Professor Gaynor, to you first.i
    You are an expert on competition and antitrust policy and 
particularly in the healthcare markets, as was evident from 
your testimony, and you stated that the U.S. healthcare system 
is functioning at a subpar level which has resulted in this 
egregious pricing that we see and the poor quality of care.
    You attribute that largely to the lack of competition 
caused by a highly consolidated healthcare market. So, can you 
just explain in the simplest terms why this consolidation is 
occurring? Why are all these firms merging and what is driving 
that?
    Mr. Gaynor. Representative Jayapal, thank you for your 
question.
    There are multiple reasons. So, one reason that 
consolidation occurs is very simple. The consolidating firms 
want and can get negotiating power, get higher prices, and have 
higher profits, and sometimes the executives of these firms 
actually admit that in public.
    That is rather rare. Usually, the lawyers are none too 
pleased. For example, Toby Cosgrove, a very, very accomplished 
CEO--former CEO of the Cleveland Clinic, was interviewed by the 
Wall Street Journal in 2012 and said as much--that is exactly 
why we do those things.
    So, that is one reason, and though there are others, I 
think that is important. Another reason has to do with sort of 
a--not a virtuous but a vicious cycle in which consolidation 
can happen on one side of the market and then the providers or 
the insurance on the other side feel that their negotiating 
position has been harmed so they consolidate in order to try 
and shore that up, and this can go back and forth and back and 
forth in a vicious cycle.
    Ms. Jayapal. Right.
    Mr. Gaynor. As I said previously, there can also be a 
musical chairs--
    Ms. Jayapal. I am going to--I am so sorry.
    Mr. Gaynor. No. That is fine.
    Ms. Jayapal. I want to ask you a couple other questions and 
I am going to run out of time.
    Mr. Gaynor. Of course. Yeah, we could go on for some time.
    Ms. Jayapal. Really important, I just want to emphasize. 
So, merging is happening because when you merge you have 
greater negotiating power, which means you can drive up prices 
and profit really simply.
    So, do you believe that the goal of the healthcare system 
should be to serve patients and improve health and not to 
increase profits?
    Mr. Gaynor. Absolutely.
    Ms. Jayapal. Okay. Great. Is this increasing concentration 
in our healthcare markets targeted at improving patient 
outcomes at that primary goal of getting better patient 
outcomes, better healthcare, and making care more affordable?
    Mr. Gaynor. No.
    Ms. Jayapal. So, who is paying for the rapidly increasing 
prices that we are seeing from these hospital and healthcare 
consolidations? Is it just patients? Who is paying for that?
    Mr. Gaynor. Ultimately, actually it is all of us. When we 
have prices go up in healthcare, we don't see it directly in 
the same way if, say, there is a merger of grocery stores or 
paper supplier, or that kind of thing.
    Nonetheless, it comes back to all of our wallets. For 
example, just simple statistics--over the past 20 years worker 
contributions to health insurance have risen by 239 percent. 
Over that period wages rose by 68 percent.
    So, what happens when prices go up, costs go up to health 
insurance companies. Health insurance premiums are 80 to 90 
percent of greater medical expenses. So, health insurance 
premiums go up. What happens?
    Well, employers pay higher health insurance premiums. Their 
healthcare costs go up. They are not going to alter total 
compensation to workers.
    I am only worth a certain amount to Carnegie Mellon 
University, although you are free to tell my dean I am not 
getting paid enough. Yes. Dean Ramayya Krishnan.
    [Laughter.]
    Ms. Jayapal. So, wages go down because, basically, any 
money that is in the system is going to pay for these 
increasing healthcare costs.
    Mr. Gaynor. Something has got--exactly. Something has to 
give. If the employer is faced with higher healthcare costs, 
what happens? Wages fall or they don't rise as much as they 
otherwise would, workers pay more of health insurance 
contributions, or benefits are cut. In some cases, in the past 
anyhow, workers lose coverage entirely.
    Ms. Jayapal. Thank you so much. I think it is important 
that everybody understands that small businesses, employers, 
and patients are footing the bill and they are already paying 
these enormous costs.
    Thank you, Dr. Gaynor. I yield back.
    Mr. Cicilline. Thank you.
    I now recognize the gentleman from Florida, Mr. Gaetz, for 
five minutes.
    Mr. Gaetz. Thank you, Mr. Chair.
    I want to begin by praising your leadership and thanking 
you for this important subcommittee, and while I know the 
important work of the full Judiciary Committee has been 
flavored a bit partisan at times, as I look at the work you 
have done on lowering prescription drug prices, taking on the 
excesses of bit tech, I think that this Subcommittee is poised 
for some major bipartisan successes and I thank you for your 
efforts.
    Specifically, as it relates to the subject matter before us 
here, I am hopeful that the substance of the CREATES Act will 
ultimately be marked up in Committee and I am also hopeful that 
some of the PBM transparency issues that we have discussed are 
able to be fully exposed.
    I also want to praise Florida's governor, Ron DeSantis. 
Right now, one of the major challenges we face is Florida is 
the rising cost of prescription drugs creates a massive cost 
structure on our corrections system and there is currently a 
real opportunity for Florida and other states to import drugs 
from foreign markets and then to be able to lower costs 
substantially.
    That is allowed under current law in Florida. We are 
currently working toward that with President Trump. So, I would 
implore President Trump to look favorably on Governor 
DeSantis's request and that other states might be able to 
unlock the potential of lower drug prices.
    Mr. Chair, as we are gathered here talking about the 
anticompetitive practices in medicine, it is really noteworthy 
to me that one of the most anticompetitive things that occurs 
is the heavy hand of the Federal Government constraining access 
to medical cannabis.
    As we look at the types of prescription drugs that are 
sought to deal with opioids in particular, we continue to see 
evidence--substantial evidence, in fact, according to the 
National Academy of Sciences--that cannabis is helpful in 
dealing with chronic pain, treatment of chemotherapy and 
vomiting, and multiple sclerosis symptoms.
    So, it is my sincere hope with all the energy and passion 
among my Democrat colleagues on the Judiciary Committee that in 
looking at prescription drug use, prescription drug abuse, and 
prescription drug cost we unlock the potential of medical 
cannabis and that we get the government out of the way so that 
it is not impairing the relationship between physicians and 
patients.
    I want to take a moment to ask Mr. Garthwaite, in this 
broader discussion we are having about consolidation what role 
does the Federal Government have in spurring consolidation 
through excessive regulation of the health marketplace?
    By that, I mean, as the Federal Government becomes more and 
more involved in what qualifies for draw downs to states in the 
provision of healthcare does that excessive regulation and the 
compliance cost it drives, is that a contributing factor in 
your review of maybe a consolidation incentive?
    Mr. Garthwaite. I think part of what you are getting at is 
there is some fixed cost with dealing with regulations and 
compliance. I think at the State of the sort of landscape at 
this point, most of these firms are big enough that they are 
able to cover that fixed cost and I would agree with Dr. Gaynor 
that a lot of this is not about being driven by federal 
regulation. It is being driven by either attempts to seek 
higher prices or attempts to coordinate care.
    Mr. Gaetz. Dr. Gaynor, would you reflect on the role that 
PBMs have in the health of the prescription drug marketplace?
    Mr. Gaynor. I wasn't asked to prepare testimony on that 
topic. I am happy to reflect on it and submit a written 
response to your question.
    Mr. Gaetz. Great. Thank you.
    Those are my questions, Mr. Chair. I will yield back.
    Mr. Cicilline. Thank you very much.
    I now recognize the gentlelady from Florida, Mrs. Demings, 
for five minutes.
    Mrs. Demings. Thank you so much, Mr. Chair, and thank you 
to our witnesses for being here with us today as we discuss 
this very, very important topic.
    I am reminded of a quote from Dr. King, who said, ``Of all 
of the injustices, and there are many that exist, the lack of 
healthcare is the most inhumane.''
    So, this is a critical subject to all of our districts and 
our communities. My colleague, the Ranking Member, talked about 
the merger--the number of mergers that have occurred in rural 
areas and I know, Dr. Gaynor, you mentioned that it is not just 
occurring in rural areas but across our nation.
    I do believe that in rural areas the effects can be much 
more devastating because the lack of access, quality of care, 
access to services--all of those dynamics.
    So, could you just please talk about the extra harm, if you 
will, that mergers do or have the effects--the negative impact 
that they have on rural communities?
    Mr. Gaynor. Representative Demings, thank you for--thanks 
for your question. Yes.
    Well, because folks in rural communities live much farther 
from other healthcare providers--hospitals, doctors, nurses, et 
cetera--if there are mergers in rural areas that leave them 
with few alternatives, their next best alternative can often be 
miles and miles away.
    Of course, for some kinds of care it is either very 
difficult or impossible for people to travel--emergency care 
and obstetric delivery. Even if they are willing to travel it 
is a long way.
    So, that imposes real costs on them and that means that if 
there are providers in the area they have more ability to have 
higher prices. They are under much less pressure to do better 
and have better quality, provide better service, better access, 
and better community benefits.
    I think that those of us in America who live in rural areas 
are particularly vulnerable to these kinds of harms.
    Mrs. Demings. Could you also talk about what type of 
positions in terms of employees when hospitals mergers occur 
who--what type of employee or hospital worker is really the 
most vulnerable in that environment?
    Mr. Gaynor. Well, it is the folks who have skills as 
workers that are most specific to working in a hospital because 
if their best alternative is to working in a given hospital and 
now there is a merger and the next hospital over is no longer 
available to move to because they are now one firm, then they 
don't have such great alternatives.
    If their workers who have very general skills--so, if you 
are a food service worker in a hospital you might not prefer to 
work somewhere else, but you could go and work at another 
company and be a food service worker there.
    So, when a hospital merger happens, the hospitals can't 
squeeze your wages or your working conditions too much. If you 
are an OR nurse, where else are you going to go? You may be 
able to go elsewhere, but it won't be as good a job.
    Mrs. Demings. Finally, Dr. Morton, would you just, again, 
please describe for me what is the connection between a lack of 
competition and the rising cost of healthcare?
    Ms. Scott Morton. Lack of competition means that providers 
of various kinds of drugs, devices, hospitals, and doctors 
don't have to compete with one another for the business of 
patients, and competition generates both lower prices and also 
more innovation and more quality, more choice for all the 
consumers of healthcare.
    When we don't have competition we have higher prices and 
lower quality and that just hurts everybody, both the patients 
and the taxpayers.
    Mrs. Demings. Thank you.
    Mr. Chair, I yield back.
    Mr. Cicilline. I thank the gentlelady for yielding back.
    I now recognize the gentleman from North Dakota, Mr. 
Armstrong, for five minutes.
    Mr. Armstrong. Thank you, Mr. Chair.
    I guess my first question is for Dr. Gaynor. So, we have--
and North Dakota has been a little different since 2010. We 
have had an actual boom in our economy. So, prior to that, we 
were suffering the same type of problems the rest of rural 
America was facing.
    We have noticed a lack of workforce shortage. We probably 
have--if not the best one of the best rural hospitals in the 
country, because it is brand new and it is fantastic, but we 
are having trouble staffing it and so when we are talking about 
these consolidations in rural areas, we have seen it.
    They move into the--yes, we have urban areas in North 
Dakota--the more urban areas. These aren't all motivated by 
anticompetitive behavior. Factors such as worker shortage, 
nurse shortage, provider shortage, resources, and financing are 
part of this equation, aren't they?
    Mr. Gaynor. So, as I said, there are multiple motives for 
mergers and acquisition. I don't know that labor market issues 
are a primary driver. I haven't heard that.
    There can be--incentives usually happen more in 
acquisitions than in mergers where a smaller hospital wants to 
be acquired by a larger hospital that has more resources, 
particularly if that hospital is struggling.
    Then you can certainly see that. I am not aware of labor 
market issues as being a motive driving these mergers and 
acquisitions.
    Mr. Armstrong. Maybe it is just unique to our geography.
    Well, part of that we have talked about licensing and State 
licensing and states are all very good at putting up their own 
White picket fences and ensuring that a nursing degree or a 
nursing license in Minnesota doesn't apply in North Dakota and 
we work on those at the State level a lot and a lot of 
different states are starting to see that the world is becoming 
a much smaller place.
    So, when these consolidations happen, whether they happen 
for--make economic sense, are there any policies here--and I 
guess, this question would be for everyone--what can we do at 
the federal level that promotes access, whether it is urgent 
care centers or things in rural areas?
    I know they are starting to do strep tests at pharmacies in 
rural areas in our district and before we get into crossing 
pharmacists with doctors or nurses but, just to continue to 
provide some semblance of access in rural America?
    Mr. Gaynor. Well, yeah. There are a number of things. One I 
mentioned previously is making sure that licensing is tailored 
very specifically to the purpose of protecting the public and 
doesn't overstep those bounds so that nurses and pharmacists, 
for example, are permitted to do the things that they have been 
trained to do and qualified to do and that creates more access 
right off the board.
    So, that is a principle. Now, that is State level. The 
Federal Government can try to work with states, try and provide 
information and support to states in this area, and that can 
actually make an important difference.
    Mr. Armstrong. Does anybody else have any? Yes, ma'am.
    Ms. Scott Morton. I would agree. I think occupational 
licensing is often used as a barrier by incumbent licensed 
people to keep out others and if you have a shortage of a 
certain medical worker it is not like human bodies are 
different between North Dakota and South Dakota and any other 
state.
    So, it might be reasonable to imagine that the requirements 
for being a nurse or a doctor are the same across states and if 
we had fewer differences workers could move more easily.
    Mr. Armstrong. Yes, sir?
    Mr. Garthwaite. Yeah. I also know that we are seeing 
private firms start to address this as well. So, some of the 
motivation behind some of the vertical integration we are 
seeing in healthcare and this Committee had a nice hearing on 
CVS-Aetna as a merger.
    Some of the motivation behind that is about finding new 
sites of care, maybe finding ways we can treat chronic 
conditions at retail settings, be it a CVS. Wal-Mart is 
thinking about these things as well.
    Those will provide more access for care in places that 
aren't the traditional general acute care hospital or a 
doctor's office, which can often struggle to be a standalone 
business in a rural area, given the lack of demand.
    Mr. Armstrong. Thank you, and that is important because the 
economies of scale--it is not unique to the medical profession. 
We are seeing more and more of this happen in rural areas as we 
continue to move on.
    Mr. Gaynor. Just one last thought, and this has already 
been addressed in part by Congress, and that is what are called 
site-neutral payments for Medicare. I think you are familiar 
with those.
    The payment for the same kind of service delivered by the 
same kind of professional can be many multiples if it is dubbed 
in a hospital and that creates some distortions that may favor 
those things and then actually end up penalizing people in 
rural areas.
    Mr. Armstrong. Thank you. I yield back my negative 15 
seconds.
    Mr. Cicilline. I thank you, and I now recognize the 
gentlelady from Florida, Ms. Scanlon.
    Ms. Scanlon. Pennsylvania.
    Mr. Cicilline. Pennsylvania.
    Ms. Scanlon. That is a big move. Yes.
    Mr. Cicilline. There is a lot of Florida down on that end. 
My apologies. Pennsylvania--for five minutes.
    Ms. Scanlon. Thank you.
    So, there are a few questions that came up or a few topics 
that came up more frequently when I was running last fall then 
about affordable healthcare and in that sector the biggest 
question I kept getting is what can we do about prescription 
drugs prices, over and over.
    It is a priority for my constituents and therefore a 
priority for me. In addition to being very worried about this, 
they are also really smart. So, they fed me specific questions.
    Professor Scott Morton, the question of evergreening of 
patents--as I understand, that is tweaking patents to extend 
the amount of time that there is proprietary rights. Can you 
speak to that and how that impacts the prices of drugs?
    Ms. Scott Morton. Yes. This is a tactic whereby--let us say 
there is a drug that is administered twice-a-day and the 
manufacturer invents a once-a-day version and patents that, or 
maybe even takes 50 milligrams and makes a 60 milligram tablet 
and patents that and then releases that new product on the 
market and, in some cases, removes the old product that is 
about to be generic and therefore much less expensive.
    This situation could be really helped with a couple of 
policies. So, one is generally strengthening the antitrust laws 
and allowing the FTC to go after behavior that it feels is 
anticompetitive.
    Another one is reforming the incentives of the PBM. The PBM 
should want everybody to take that generic drug because it is 
cheaper and not steer them to the more expensive one, and when 
we have perverse incentives that latter thing can happen.
    In general, however, we don't want to get into the business 
of saying, is this innovation good or not but, rather, subject 
it to the market test. Once-a-day could be a super valuable 
innovation and if it has to compete head to head with twice-a-
day we will find out.
    If, however, the launch of the once-a-day is accompanied by 
the pulling away of the twice-a-day, we don't have head to head 
competition anymore. That is a situation where it looks like 
the manufacturer didn't think their once-a-day was going to win 
and that is why they took away the twice-a-day.
    Ms. Scanlon. Okay. Thank you for that.
    Mr. Kades, in 2013 the Supreme Court held in FTC v. Actavis 
that ``pay for delay'' settlements, which occur when a branded 
drug company pays a potential generic competitor to delay 
entering the market with a lower cost generic, likely violates 
the antitrust laws absent a justification.
    Can you comment on whether that decision is sufficient or 
insufficient to address the ``pay for delay'' settlements and 
is there something we can do about that?
    Mr. Kades. Yes. Thank you for the question, Representative 
Scanlon.
    So, at one level, the Supreme Court decision was good 
because until that time courts were taking the position that a 
patent holder could pay any amount of money to secure the 
agreement of the generic not to manufacture its drug, and 
because the brand makes so much more than the generic these 
were very common.
    Once the court said you can do this, agreements went up. 
Supreme Court--in principle, the Rule makes sense. The problem 
is that the lines aren't clear and there has been lots of 
litigation. I said in my opening statement there was a case 
that settled just last year and it was filed back in 2006.
    So, what you are having to happen is that the government is 
spending lots of resources to prove that paying your potential 
competitor not to compete is a problem, and we live in a world 
of limited resources.
    As other people have talked about other things, whether it 
be the rebates and the PBMs or other things, the product 
hopping, the government can't even get to those cases because 
they are basically left having to prove these basic ideas that 
we all should agree are anticompetitive.
    Ms. Scanlon. I know one suggestion to address this is to 
establish a presumption that these ``pay for delay'' 
settlements are anticompetitive. Do you think that is a good 
idea or are there other legislative fixes that you would 
suggest?
    Mr. Kades. I think that is an excellent idea. When you look 
at both the economic theory behind what happens in a ``pay for 
delay'' settlement and we actually have evidence that they--
empirical evidence that these types of agreements delay entry, 
then you should start with the proposition that if someone is 
paying a potential competitor in a settlement we should presume 
it is harmful and make them come forward if it is not.
    Instead, we have it the reverse, which makes no sense, 
given what we know about theory and the empirics.
    Ms. Scanlon. Any other suggestions in that ``pay for 
delay'' arena for legislative fixes?
    Mr. Kades. So, I think part of this is making sure it is 
sort of complementary. These are incredibly enticing deals. So, 
in one of the cases I worked on the company paid $60 million 
and managed to protect close to a billion dollars.
    In another one, after the company paid off four generic 
competitors, they boasted, ``We got six years and $4 billion 
that nobody expected.''
    So, you have to have a really strong penalty provision. If 
all the government can do is say, oh, you broke the law--
promise us you won't do it again, that is not going to be 
effective and there is going to be no reason for companies to 
settle. You have to be able--the government has to be able to 
go in and say, no, no, no, you don't get to keep the money 
because you earned it by breaking the law.
    Ms. Scanlon. Thank you.
    Mr. Cicilline. The time of the gentlelady has expired.
    I now recognize the gentleman from Colorado, Mr. Neguse, 
for five minutes.
    Mr. Neguse. Thank you, Mr. Chair.
    I want to thank the panel for being here with us today for 
your testimony. I also want to thank my colleague from 
Wisconsin for raising the important issue regarding rural areas 
in particular where this is very pernicious--certainly, in my 
district.
    I represent a variety of counties--Summit County, Eagle 
County, mountain communities more rural in nature where this is 
a big problem and the effect is very pronounced.
    I want to--so, Dr. Gaynor, I want to call out one 
particular finding, which I think is fairly intuitive but your 
data certainly supports it. From your written testimony here I 
will quote, ``One of our key findings is that hospitals that 
have fewer potential competitors nearby have substantially 
higher prices.
    For example, monopoly hospitals prices are, on average, 12 
percent higher than hospitals with three or more potential 
competitors nearby.''
    That is a very important fact worth repeating and one of 
the recommendations you make, and Dr. Morton makes as well, 
that I believe is particularly compelling is around nonprofit 
hospitals, which is a big part of this discussion that often 
gets left out and I think part of it is because there is a 
misperception about the nature of nonprofit hospital entities, 
in some cases.
    I am sure Members of the panel serve on nonprofit boards. 
Dr. Gaynor, you have created the Healthcare Cost Institute. I 
am curious. I imagine that the CEO of the Healthcare Cost 
Institute does not have a private jet. Would I be right in 
saying that?
    Mr. Gaynor. Well, I am no longer on the board.
    Mr. Neguse. Oh, okay.
    Mr. Gaynor. I would be extraordinarily chagrined were that 
the case.
    Mr. Neguse. All right. They are not making tens of millions 
of dollars, right?
    Mr. Gaynor. No.
    Mr. Neguse. Dr. Kades--I hope I pronounced that right, 
Kades--is that correct?
    Mr. Kades. Kades, yes.
    Mr. Neguse. Kades. Yes, sir. You, of course, are the 
director of a nonprofit entity, the Washington Center for 
Equitable Growth. Is that right?
    Mr. Kades. Actually, I am the director of the Competition 
Policy. The Washington Center for Equitable Growth is a much 
bigger organization.
    Mr. Neguse. Okay. Well, I trust that the director of that 
entity is probably not flying around on a private jet and 
making tens of millions of dollars either.
    Mr. Kades. I think that is a fair assumption.
    Mr. Neguse. All right. So, here is my point. All right.
    Wall Street Journal--this is relatively recent, the last 
two years--as of December 13th-December 30th, 2016, tax filings 
as of that date prepared kind of a summary and you have a 
variety of hospital executives at various large nonprofit 
hospital systems.
    Ascension in St. Louis, $17 million in annual compensation. 
Northwell Health, $10 million. Highmark Health, $9.8 million. 
Mercy Health in Wisconsin, $8 million compensation package.
    A variety, right? You can encourage folks who are watching 
to just Google, nonprofit health CEO and private jet, or 
private chef or any variety of other compensation packages that 
are attached to folks who are working in those industries.
    I think what we have kind of lost sight of there, right, is 
the charity aspect and obligation that a nonprofit hospital 
has, right, embedded in its purpose as an entity.
    The FTC, in 1999--there is a report. Go onto the website. I 
was 15 years old in 1999. This is a long time ago. There is a 
report titled ``Competitive Effects of Not for Profit Hospital 
Mergers,'' and I will quote from it. It says, ``Mergers 
involving not-for-profit hospitals are a legitimate focus on 
antitrust concerns.'' Yet, here we sit 20 years later and the 
FTC has no power to, essentially, engage in this important 
area.
    So, I would like to give Dr. Gaynor and Dr. Morton perhaps 
an opportunity to talk about this, because it is a pretty 
simple change in the law that we could make--that Congress 
could make--that would really open this up.
    Again, a lot of not-for-profit hospitals are doing 
incredible work--good work. There is a case to be made for the 
FTC to have expanded authority in this regard.
    Care to comment?
    Mr. Gaynor. Yes. Thank you, Representative. So, I agree 100 
percent. Just to be clear, the FTC does have the authority to 
pursue mergers under the Clayton Act. What they do not 
currently have the authority to do is pursue anticompetitive 
conduct by nonprofits under the FTC Act.
    So, I agree. I think that needs to be revisited and revised 
so that both our antitrust enforcement agencies are using all 
the tools in the antitrust arsenal to address the pressing 
issues in this sector.
    Let me say again, yes, most hospitals in the U.S. are 
technically nonprofit but the numbers you gave out are eloquent 
testimony to the fact that this is big business.
    Once upon a time they were charities but that was a long 
time ago. When healthcare is one-fifth of our entire economy, 
when UPMC is a $10 billion revenue company, the largest private 
employer in the State of Pennsylvania--and that is replicated 
over and over and over again--they are no longer charities. 
They are big businesses.
    Mr. Cicilline. The time of the gentleman has expired. I 
thank you.
    I now recognize the gentlelady from Georgia, Mrs. McBath, 
for five minutes.
    Mrs. McBath. Thank you, Mr. Chair, and once again to 
reiterate, as many of my colleagues have today, I just want to 
thank each of you for coming and sharing your testimony with us 
today, and I would just like to thank you for being here 
because this is--this is something that is extremely important 
to me because it has touched me personally.
    I am a two-time breast cancer survivor and I understand 
what it is like to have your life completely turned upside down 
overnight. Having that diagnosis once was, I can tell you, you 
go into a crisis mode.
    To have it a second time wreaks even more havoc than it did 
the first time and the stress of the financial burdens that 
follow are just--weigh so heavily not only on the individual 
that has been diagnosed but also the entire family.
    Now, I had the benefit of being in a breast cancer study 
that allowed me to have discounted treatment as well as 
pharmaceuticals. So, I realize that I was very fortunate in 
that regard.
    Even though I was fortunate to have very good health 
insurance--I worked for a major corporation, major company. I 
worked for Delta Airlines. I was under a really good group 
health insurance program. I still worried about my medical 
bills and my needs and how would my family be so adversely 
affected by this health crisis.
    So, even though I had good benefits, I could not even 
imagine what it would be like for a family that didn't have the 
ability to have the kind of healthcare that I had the fortune 
of having.
    Now, I want to say that my story is absolutely not unique. 
It is stories like this that we hear every single day from 
Americans across the country, and just this week I heard from a 
family--a woman within my own district in Georgia--who told me 
that she spends $1,500 a month on diabetic supplies for her 
daughter, who has type 1 diabetes, and that is more than her 
monthly mortgage.
    So, Dr. Scott Morton and Mr. Kades, could you speak very 
candidly to what should be done to bring down prescription drug 
prices, those costs, while also supporting innovation and 
research, which is so sorely needed?
    Ms. Scott Morton. I would say that, in my written 
testimony, I describe a way that you could cap out-of-pocket 
prices, which is the most harmful thing that consumers and 
patients are experiencing now and combine that with a ban on 
kickbacks by the pharmaceutical company in the form of coupons, 
financial aid, wraparound services, and so on.
    This would leave patients protected and then enable 
competition because without being able to incentivize the 
patient the manufacturer would have to sell its drug to the PBM 
and then it would have to compete with other drugs in order to 
sell its drug to the PBM.
    So, the key in restraining prices that patients pay out-of-
pocket is to do it in a way that enables as much competition as 
possible so that you keep the prices paid by the insurer low 
because, of course, we all pay premiums.
    So, that is the other way in which this is very expensive, 
not just out-of-pocket costs. So, the two sides need to go 
together.
    Mrs. McBath. Thank you.
    Mr. Kades. So, I am going to come at this from my 
experience as an antitrust lawyer and what can we do--what is 
wrong with this marketplace in terms of anticompetitive 
conduct, and the issue here is a branded company makes a pile 
of revenue, money, and they are insulated from price 
competition generally until there is a generic--just having the 
generic totally changes and prices go down, they lose most of 
their sales, and so there is a real incentive to do anything 
possible to delay that date.
    So, that can be you pay your competitor not to compete, 
which we were talking about. It can be the product-hopping 
stuff conduct that Fiona was talking about. Right now, the 
antitrust laws have been so weakened that we can't stop this 
conduct.
    The good news is if we strengthen those laws or pass things 
like the CREATES Act it will make it harder to prevent 
competition, but it really shouldn't have any impact on 
innovation because these are all types of strategies that are 
just about obtaining anticompetitive rents. It is not about 
innovation.
    So, this is a really--injecting competition into the 
marketplace gets you the benefit of lower cost without 
undermining incentives to innovate.
    Mrs. McBath. Thank you so much.
    I yield back the balance of my time.
    Mr. Cicilline. I thank the gentlelady. I now recognize 
myself for five minutes. Thank you to the witnesses.
    I want to begin by broadly talking about competition. I am 
very concerned about the rising tide of economic concentration 
throughout our economy and the really crippling effects on 
economic opportunity, innovation, and equality.
    Earlier this week, Professor John Kwoka of Northeastern 
University testified before the Senate Antitrust Subcommittee 
and said concentration has been steadily rising and competition 
declining in a great many sectors of the economy, raising 
legitimate concerns about increasing market power in large 
swaths of the U.S. economy.
    Robert Reisch, the former secretary of labor in the Clinton 
Administration, similarly noted, and I quote, ``America has a 
monopoly problem. America used to have antitrust laws that 
stopped corporations from monopolizing markets and often broke 
up the biggest culprits. Antitrust has faded. The results have 
been hidden upward redistributions of money and power from the 
majority of Americans to corporate executives of and major 
investors in huge concentrations of economic power,'' end 
quote.
    Dr. Scott Morton, I would like to start with you. In your 
written testimony you identified a lack of competition as a 
reason why U.S. healthcare costs are rising so fast and that 
antitrust enforcement has been weakened in the United States 
for a variety of reasons.
    What are, in your view, the primary reasons that 
enforcement has so weakened?
    Ms. Scott Morton. The primary long-run reason is that we 
were all influenced by the Chicago School in the '70s that 
believe things like monopolies are inherently transitory and 
oligopolies will price at marginal cost and courts make bad 
decisions.
    These kinds of presumptions we now know, after 40 years of 
studying the economics literature, are false. They weren't true 
to begin with and we now are much more sure of that.
    In addition, we also see the evidence in front of us, which 
is rising markups, lower labor share, higher profit share, all 
the different evidence that you pointed to.
    So, it is clear that the pendulum has swung past the ideal 
point by quite a bit and we need to turn it around. Because 
courts now interpret the antitrust laws in this way, it is up 
to Congress to instruct the courts that actually Congress would 
like it done a different way.
    Mr. Cicilline. Thank you, Doctor, and that leads to my next 
question to Mr. Kades, who in the end of your testimony just a 
moment ago you talked about the weakening of the antitrust 
enforcement and wondering whether you have suggestions of the 
kind of legislation we should be contemplating that would 
really strengthen antitrust enforcement.
    Mr. Kades. Thank you, Chair, for the question.
    Yes. One of the sort of subtleties about why antitrust is 
weak is we have made it just hard and expensive for--to prove 
an antitrust case, whether it be a government or private 
plaintiff.
    So, we know how to fix that. The way to fix that is to 
create presumptions where we are confident that the conduct is 
likely to be anticompetitive and there is lots of economic 
evidence about certain types of mergers that we can be 
comfortable are likely to be anticompetitive, certain types of 
conduct.
    In many ways, the CREATES Act is not an antitrust law, but 
it takes that idea that where you have conduct that you are 
confident is not justified, you need to make it easy to prove.
    So, that is what I would say. More presumptions to address 
based on the empirical evidence of where we know things are 
likely to be problematic.
    Mr. Cicilline. Thank you.
    Dr. Gaynor, do we have or do the antitrust agencies have 
enough resources to do the work that we expect them to do and, 
if not, what would you recommend in terms of additional 
resources? Are there other things that you would recommend that 
would help improve merger and antimonopoly enforcement?
    Mr. Gaynor. Chair Cicilline, thanks for your question.
    First, I just want to say I agree with my colleagues, Dr. 
Scott Morton and Mr. Kades, and I think those are important 
issues to be addressed. You turn to the other side, rightly 
so--suppose we do the kinds of things that my colleagues have 
suggested, which I agree with 100 percent, the agencies will 
need more resources to do more. It is that simple. Over the 
past seven to 10 years or so merger filings have risen by about 
57 percent and appropriations in inflation-adjusted terms have 
fallen by 12 percent.
    The number of staff is either constant or declining in the 
Bureau of Competition--Bureau of Economics at the Federal Trade 
Commission.
    As a consequence, what happens is the agencies are faced 
with an extraordinarily difficult choice between how much to do 
based on what is coming in over the transom, which is coming 
out of a power hose, given the rise in merger activity, and 
trying to stay abreast of new developments. They desperately 
need the resources--additional resources to do that.
    Mr. Cicilline. I am just going to squeeze in one last 
question.
    Over the past several years, Sarah Kliff, a reporter for 
Vox, has documented the outrageous practice of surprise billing 
in hospitals and she has reported the price of ordinary drugs 
that could be cheaply purchased at a local pharmacy such as 
generic eye drops or pregnancy tests often cost hundreds of 
dollars and, additionally, patients often painstakingly choose 
to receive care in hospitals that are covered by their 
insurance only to find out that an emergency room doctor who 
treated them was not covered by their insurance. As a result, 
they receive surprise bills that can cost tens of thousands of 
dollars.
    Just wondering, starting with you, Dr. Gaynor, obviously, 
this is further evidence that our current system is 
fundamentally broken. I would also like Dr. Scott Morton to 
reflect on that.
    Mr. Gaynor. Right. A hundred percent. I mean, this is 
unacceptable and can't be allowed to continue and, moreover, 
this sort of thing undermines markets.
    People think they are making a responsible choice by going 
to an in-network hospital and then they get socked with this 
astronomical bill they had no way to prevent.
    Why should they shop? Why should they buy insurance 
policies that ask them to do that? So, it is going to undermine 
the market and there are some relatively simple remedies for 
that.
    Fiona Scott Morton and Zack Cooper have proposed one. So, I 
will yield to her because she is the one who can talk about it.
    Mr. Cicilline. I am thanking my Ranking Member for 
indulgence me one minute. I don't want to abuse my power in my 
first hearing.
    If it is okay, Dr. Scott Morton, if you could just--
    Ms. Scott Morton. Yes. So, this is a really bad problem 
and--
    Mr. Cicilline. Thank you.
    Ms. Scott Morton. --it just comes from the fact that we 
have quite a regulated system and sometimes there is a loophole 
and then financial players can go in there and say, look, there 
is a business model. I insert these doctors into a hospital, 
pull them out of network, and double the charges or triple 
them.
    So, our proposed solution is that hospitals need to sell 
the bundle. They need to sell all the care you get in the 
emergency department.
    The hospital can go out and organize the doctors. They 
could employ them. They could contract with a group. Then at 
least when you arrive at the in-network hospital everything you 
are getting in the ED is in-network.
    Mr. Cicilline. Terrific.
    Thank you again to our witnesses. This concludes today's 
hearing.
    Without objection, all Members will have five legislative 
days to submit additional written questions for the witnesses 
or additional materials for the record.
    The hearing is adjourned.
    [Whereupon, at 3:38 p.m., the Subcommittee was adjourned.]

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