[Congressional Record (Bound Edition), Volume 161 (2015), Part 11]
[House]
[Pages 14915-14918]
[From the U.S. 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.

[[Page 14916]]




                             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.

                                               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

[[Page 14917]]

     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 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

[[Page 14918]]

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 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.

                          ____________________