[Congressional Record Volume 161, Number 140 (Monday, September 28, 2015)]
[House]
[Pages H6276-H6279]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ENSURING ACCESS TO CLINICAL TRIALS ACT OF 2015
Mr. RYAN of Wisconsin. Mr. Speaker, I move to suspend the rules and
pass the bill (S. 139) to permanently allow an exclusion under the
Supplemental Security Income program and the Medicaid program for
compensation provided to individuals who participate in clinical trials
for rare diseases or conditions.
The Clerk read the title of the bill.
The text of the bill is as follows:
S. 139
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Ensuring Access to Clinical
Trials Act of 2015''.
SEC. 2. ELIMINATION OF SUNSET PROVISION.
Effective as if included in the enactment of the Improving
Access to Clinical Trials Act of 2009 (Public Law 111-255,
124 Stat. 2640), section 3 of that Act is amended by striking
subsection (e).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Wisconsin (Mr. Ryan) and the gentleman from Texas (Mr. Doggett) each
will control 20 minutes.
The Chair recognizes the gentleman from Wisconsin.
General Leave
Mr. RYAN of Wisconsin. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks and include extraneous material on S. 139, currently
under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Wisconsin?
There was no objection.
Mr. RYAN of Wisconsin. Mr. Speaker, I yield myself such time as I may
consume.
I rise in support of S. 139, the Ensuring Access to Clinical Trials
Act.
The National Institutes of Health says that there are 7,000 rare
diseases affecting people in the United States, and if we are going to
find cures for those diseases, the first thing we need to do is to get
people to participate in clinical trials. All too often, researchers
cannot find enough participants because so few people have these
diseases in the first place.
Now--no surprise here--the government used to make it more difficult
for researchers to find people. Say you had a rare disease and you were
on public assistance, like SSI or Medicaid. If you got compensated for
participating in one of these trials, you got smaller benefits. That is
why, in 2010, we passed the Improving Access to Clinical Trials Act.
For the past 5 years, this law has allowed people to collect up to
$2,000 per year by participating in rare-disease clinical trials
without threat of losing their SSI or Medicaid benefits. The GAO says
the law is working. Ever since we passed this law, more people on SSI
have been participating in clinical trials as a result of it.
The problem is this law expires next week, on October 5, so this bill
would simply extend current law. That way, more people can participate
in clinical trials without any reason to worry or without any threat to
a loss of their benefits, and that way, we will continue to make
strides in fighting these diseases. CBO tells us this bill will cost
virtually nothing.
My friends, Senator Hatch and Senator Wyden, introduced this bill in
the Senate. It passed the Senate by unanimous consent. In the House, my
colleagues Mr. Doggett and Mr. Marino from Pennsylvania have introduced
it along with 50 other cosponsors.
I will include in the Record a letter listing the many supporters of
this legislation. It is a list of over 70 organizations, including the
Cystic Fibrosis Foundation, the Muscular Dystrophy Association, and the
Huntington's Disease Society of America, just to name a few.
[[Page H6277]]
September 22, 2015.
Hon. Paul D. Ryan,
Chairman, Committee on Ways and Means, House of
Representatives, Washington, DC.
Hon. Sander M. Levin,
Ranking Member, Committee on Ways and Means, House of
Representatives, Washington, DC.
Hon. Charles Boustany, Jr.,
Chairman, Subcommittee on Human Resources, Committee on Ways
and Means, House of Representatives, Washington, DC.
Hon. Lloyd Doggett,
Ranking Member, Subcommittee on Human Resources, Committee on
Ways and Means, House of Representatives, Washington, DC.
Dear Chairmen Ryan and Boustany and Ranking Members Levin
and Doggett: The undersigned organizations, representing
millions of Americans with rare and genetic diseases,
advocates, industry, and academic institutions, write to
express strong support for H.R. 209/S. 139, the Ensuring
Access to Clinical Trials Act of 2015. This legislation will
permanently remove a barrier to clinical research and allow
Supplemental Security Income (SSI) and Medicaid recipients to
participate in and benefit from clinical trials without fear
of losing vital benefits.
The Ensuring Access to Clinical Trials Act of 2015
eliminates the sunset clause from the Improving Access to
Clinical Trials Act of 2009 (IACT), legislation signed into
law in 2010, making the IACT a permanent law. This will allow
patients with rare diseases to continue to receive up to
$2,000 in compensation for participating in clinical trials
without that compensation counting towards their income
eligibility limits for SSI and Medicaid.
Removing barriers to drug trial participation is
particularly important as recent advances in medical research
and technology allow for the development of new and promising
medications. Securing an adequate number of clinical trial
participants is vital for therapies that treat rare
conditions, but rare disease researchers in particular often
have difficulty recruiting drug trial participants, simply
because they have a smaller pool of patients.
Further, with the advent of precision medicine, therapies
are being customized to treat a patient's specific genetic
makeup. These types of trials often require clinical trial
participants bearing specific genetic mutations, which
necessarily creates an even more complex and exclusive
clinical trial recruitment process. Ensuring that all
patients with rare diseases are able to participate in
clinical trials can help open the door for the advancement of
new targeted therapies in many important areas of medicine,
including cancer and rare diseases like cystic fibrosis.
Now is the time to ensure that all patients have access to
clinical trials for potentially life-saving treatments. We
look forward to working with you to secure passage of this
bill to enable Social Security beneficiaries to participate
in clinical trials so that research into life-saving
treatments may continue to advance.
Sincerely,
Actavis
Adult CF Program--Northwestern University
Adult Polyglucosan Body Disease Research Foundation APBDRF
Alpha-1 Foundation
ALS Association
American Association for Respiratory Care (AARC)
American Autoimmune Related Diseases Association (AARDA)
Amyloidosis Support Groups Inc.
Ann & Robert H. Lurie Children's Hospital of Chicago
Antonio J. and Janet Palumbo Cystic Fibrosis Center,
Pediatric and Adult Program, Children's Hospital of
Pittsburgh UPMC
Association of Clinical Research Organizations (ACRO)
Association of Gastrointestinal Motility Disorders, Inc.
(AGMD)
Batten Disease Support and Research Association
Biotechnology Industry Organization (BIO)
CADASIL Association Inc.
Cardio-Facio-Cutaneous International
CARES Foundation, Inc. (Congenital Adrenal hyperplasia
Research, Education and Support Foundation)
CF Care Center at Dayton Children's Hospital
Congenital Hyperinsulinism International (CHI)
COPD Foundation
Cure CMD
Cure SMA
Cystic Fibrosis Foundation
Cystinosis Foundation
Debra of America
FasterCures
First Focus
Foundation Fighting Blindness
Foundation for Prader-Willi Research
Foundation to Eradicate Duchenne
Friedreich's Ataxia Research Alliance (FARA)
Genetic Alliance
Hide & Seek Foundation for Lysosomal Disease Research
Huntington's Disease Society of America
International Fibrodysplasia Ossificans Progressiva
Association (IFOPA)
Indiana University School of Medicine, CF Care Center
International Society of Nurses in Genetics (ISONG)
Lymphangiomatosis & Gorham's Disease Alliance
Lymphedema Advocacy Group
Maine Medical Center CF Program
M-CM Network
MEBO Research, Inc.
Medical College of Wisconsin, Milwaukee Cystic Fibrosis Care
Center
MitoAction
MLD Foundation
Moebius Syndrome Foundation
Muscular Dystrophy Association
Myotonic Dystrophy Foundation
National Gaucher Foundation, Inc.
National MPS Society
National Organization for Albinism and Hypopigmentation
(NOAH)
National Organization for Rare Disorders (NORD)
National PKU Alliance
National Spasmodic Torticollis Association
Parent Project Muscular Dystrophy (PPMD)
Parents and Researchers Interested in Smith-Magenis Syndrome
(PRISMS)
Progeria Research Foundation
ProMedica Toledo Children's Hospital
PXE International
Research! America
Rett Syndrome Research Trust
Stanley Manne Children's Research Institute
Tarlov Cyst Disease Foundation
The Children's Hospital of Philadelphia
The Detroit Medical Reserve Corps
The Massachusetts Medical Society
The National Alopecia Areata Foundation (NAAF)
The State University of New York School of Medicine and
Biomedical Sciences
Trimethylaminuria Foundation
Tuberous Sclerosis Alliance
University of Michigan Health System, Cystic Fibrosis Center
University of Pennsylvania Health System, Cystic Fibrosis
Center
University of Washington, Cystic Fibrosis Care Center
Vertex Pharmaceuticals
Virginia Commonwealth University Health System, Adult Cystic
Fibrosis Program
Wilson Disease Association
Mr. RYAN of Wisconsin. This is common sense, and I urge my colleagues
to adopt this.
There is one more point I would like to make. Nick Gwyn, the minority
staff director of the Human Resources Subcommittee on Ways and Means,
is retiring.
I would like to take a minute to recognize Nick Gwyn for his work on
this issue. He is leaving the staff of Ways and Means after serving on
the committee since 1998. This should be the last of many bills that he
has helped our colleagues manage on the floor.
During his time staffing the committee, Nick has worked on numerous
laws related to welfare, disability, and unemployment policy. He also
worked closely with our staff to create bipartisan child welfare laws
that found more loving families for children in need.
We wish Nick well in the next stage of his career, and we thank him
for his service to the committee, the House, and the country.
Mr. Speaker, I reserve the balance of my time.
Mr. DOGGETT. Mr. Speaker, I also wanted to honor Mr. Gwyn, and this
is a good opportunity for us to do that.
I yield such time as he may consume to the gentleman from Michigan
(Mr. Levin), the ranking Democrat on the committee.
Mr. LEVIN. Mr. Doggett and I will say a few words, when many, many
are in order.
Nick Gwyn has been, as our chairman said, a more than valuable member
of this staff and a more than dedicated member of this staff. He has
been invaluable. His dedication has been endless.
Nick is leaving to pursue family and other needs. He knows he is
going to leave us in need, in terms of his immense talents. His
dedication to the subject matter that is, by definition, so directly
involved with people is really beyond estimation.
The subcommittee's work deals, as I said, with the everyday
challenges that so many of the citizens in this country face day in and
day out. It was only a few days ago that we heard from Pope Francis how
important it is for this institution to focus on the individual needs
of people, including those who are poor, some with handicaps, but
everybody who is in need of a hand up, really, as much, if not more
than, a helping hand. And Nick has devoted over a dozen years to this
very purpose.
So, if I might say so, we have worked together with Nick, and we just
want to thank him for more than a job well done. We have been very
proud to serve with him.
Mr. DOGGETT. I yield myself such time as I may consume.
I will just add, Nick, that I know you have spent some 25 years here
on the
[[Page H6278]]
Hill, 17 with our committee. Though I benefited from your good counsel
before becoming the ranking Democrat on the Human Resources
Subcommittee, I particularly appreciated your good counsel during the
last 3 years, whether it was working on child abuse and our successful
work with former Chair Dave Camp and getting a national commission or
dealing with problems of the unemployed.
Just overall, the jurisdiction of our subcommittee is about children,
children in need. Whether they are under this SSI program or child
abuse or child care, they are children who should be able to rely on
the Temporary Assistance for Needy Family program for their needs.
Nick has been an able advocate for children and someone who did work
well, as Chairman Ryan said, with all members of our committee to
advance these purposes. We wish him well in his new endeavors, and we
thank him for his service.
Mr. Speaker, if I might talk just a little bit about the Ensuring
Access to Clinical Trials Act, it is about getting new treatments
quickly into the lives of patients that are suffering from dread
diseases across America, reauthorizing existing law.
Senator Ron Wyden led this effort successfully in the Senate with
Senator Hatch. And here, my colleagues, Mr. Marino and Mr. Jim
McGovern, co-chairs of the Cystic Fibrosis Caucus, joined with me in
the introduction of this legislation in the House.
The National Organization for Rare Disorders, and over 75 other
organizations, has been a strong supporter of this legislation, and I
thank them for their work on behalf of the legislation.
This bill makes permanent a law that is due to expire that will allow
for individuals with certain debilitating conditions to exempt a small
amount of their income gained from participating in medical trials from
Supplemental Security Income, or SSI, and for Medicaid eligibility
determination.
This exemption removes an important barrier to participating in
clinical trials. If it is allowed to expire, patients contributing to
vital research could face the difficult decision of either dropping out
of the trials altogether or losing their benefits.
If you have ever met with someone with cystic fibrosis or someone in
your family has it, you recognize how small the daily challenges that
you face are compared to theirs.
I think of Nicole Flores in Austin, who has two children battling
with rare diseases. She explained that patients shouldn't have to worry
about losing assistance when they are just working hard to stay alive.
Over the past several months, I have heard from a number of families
affected by rare diseases. These are parents who shared with me how
far-reaching the modest relief this bill provides can provide for a
number of people.
One couple recently sent me a picture of their 15-year-old son Mac
Rung, who was diagnosed with cystic fibrosis at birth. Every morning
and every evening, Mac undergoes chest therapy in order to clear his
lungs and to avoid serious damage to help him get through the day. He
takes medications with every meal to help him absorb his food and gain
weight. He is battling a disease that many Americans have never heard
of at an age where he shouldn't have to worry about anything other than
school. And because this disease is progressive, they are really
working against the clock.
Because of the approval of two new drugs, they told me that they
never have had as much hope for Mac and his future as they do today.
And while they are not a family that themselves rely on the bill that
we have today before us, as Chairman Ryan indicated, they, and anyone
with these rare diseases, stand to benefit if we have widespread
participation in clinical trials on the approval of other new promising
drugs like the ones that are already helping Mac.
Financially penalizing vulnerable people for participating in
research does nothing to advance that research. The National Institutes
of Health--NIH, as we know it--estimates that 25 million Americans are
suffering because of rare disease.
I hope now that today, the House will join the Senate in approving
the Ensuring Access to Clinical Trials Act and that we continue this
important effort to support patients across the country.
I reserve the balance of my time.
Mr. RYAN of Wisconsin. Mr. Speaker, I yield 1 minute to the gentleman
from Pennsylvania (Mr. Costello).
Mr. COSTELLO of Pennsylvania. Mr. Speaker, I rise today in support of
H.R. 209, the Ensuring Access to Clinical Trials Act, legislation that
I have cosponsored.
We must continue to ensure barriers do not stall patients from
participating in rare disease clinical trials. This bill will continue
to encourage rare disease patients, even those receiving Social
Security Income or Medicaid benefits, to participate in clinical trials
without jeopardizing their eligibility for those benefits. All patients
should have access to these important and often lifesaving trials that
will advance medical research and work towards improving their health.
The Senate has taken the important step to pass this legislation, and
I encourage my colleagues to advance this commonsense, bipartisan
initiative and send it to the President's desk for his signature. I
thank the chairman and all those involved in the House for their work
on this.
Mr. DOGGETT. Mr. Speaker, I thank Chairman Ryan as well as Chairman
Upton and Ranking Member Frank Pallone, who marked up this bill, and
urge bipartisan approval of it.
I yield back the balance of my time.
Mr. RYAN of Wisconsin. I also urge our colleagues to support this
bill.
I yield back the balance of my time.
Mr. BOUSTANY. Mr. Speaker, I am pleased to support S. 139, the
Ensuring Access to Clinical Trials Act of 2015. This bill will ensure
current Supplemental Security Income (SSI) and Medicaid recipients can
maintain those benefits while participating in clinical trials. Keeping
their benefits will help them, but as a doctor I know that their
participation in such trials stands to benefit countless others as well
who suffer from rare conditions, both in the U.S. and abroad. We should
ensure that public policy encourages that whenever we can, and that's
what this bill does.
Under current law, the Social Security Administration excludes up to
$2,000 annually in compensation received by individuals participating
in rare disease clinical trials when determining their SSI and Medicaid
eligibility and benefits. But this provision, put in place by
bipartisan legislation in 2010, is set to expire on October 5, 2015.
After that date, all payments for participating in such clinical trials
would be counted as income for SSI and Medicaid recipients, reducing or
even ending their eligibility for those benefits.
A number of people with rare diseases like Cystic Fibrosis receive
SSI benefits. If this policy is not made permanent, an individual
participating in a clinical trial for a new treatment for Cystic
Fibrosis could see a reduction or even the complete elimination of
those important benefits.
The reality is, most simply won't take that risk, and will avoid
participating in such trials. As GAO found in a 2014 report, ``some
stakeholders noted that compensation decreased participation in
clinical trials in the past because individuals were concerned about
its impact on their SSI eligibility and benefits.'' On the other hand,
``financial incentives to participate in clinical trials have generally
been found to encourage participation in trials. This is likely because
of the time, inconvenience, and expense that may be involved.''
Ultimately, not continuing this policy could actually prevent
clinical trials from occurring, since it would restrict the already
small number of people able to participate in the trial in the first
place.
That's why the passage of S. 139 is so important, as it will remove
the sunset date for current law--October 5, 2015. Failing to do so
would force individuals to once again choose between maintaining their
current health and disability benefits and the chance to participate in
a clinical trial that could improve or even cure their condition, as
well as help others like them in the future.
This bill is simple and consistent with current SSI program
exemptions. S. 139 strikes the October 5, 2015 sunset date on current
policy, permitting SSI and Medicaid recipients with rare diseases to
participate in such trials that help to advance research into finding
cures. The Congressional Budget Office estimates that S. 139 will
result in insignificant costs to the Federal government over the next
10 years, meaning no offset for this legislation is required.
But its true value to people with rare diseases--and those who in the
future might benefit by their participation in clinical trials
permitted under this legislation--could be enormous. Let's pass this
important legislation.
The SPEAKER pro tempore. The question is on the motion offered by
[[Page H6279]]
the gentleman from Wisconsin (Mr. Ryan) that the House suspend the
rules and pass the bill, S. 139.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
____________________