[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]


            IMPROVING THE MEDICAID PROGRAM FOR BENEFICIARIES

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 18, 2015

                               __________

                           Serial No. 114-76
                           
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                               ___________
                               
                        
                     U.S. GOVERNMENT PUBLISHING OFFICE
98-433                      WASHINGTON : 2016                     
                      
________________________________________________________________________________________ 
For sale by the Superintendent of Documents, U.S. Government Publishing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].  
                       
                        
                        
                        
                        
                        
                        
                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Chairman Emeritus                    Ranking Member
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILLY LONG, Missouri                 JOSEPH P. KENNEDY, III, 
RENEE L. ELLMERS, North Carolina         Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     3
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     4
Hon. Renee L. Ellmers, a Representative in Congress from the 
  State of North Carolina, prepared statement....................    46

                               Witnesses

Michael Boyle, M.D., Vice President of Therapeutics Development, 
  The Cystic Fibrosis Foundation.................................     6
    Prepared statement...........................................     9
    Answers to submitted questions...............................    57
Tim Clontz, Senior Vice President for Health Services, Cone 
  Health.........................................................    15
    Prepared statement...........................................    17
    Answers to submitted questions...............................    60
Rick Courtney, President, Special Needs Alliance.................    23
    Prepared statement...........................................    25
    Answers to submitted questions...............................    63

                           Submitted Material

Statement of House Coalition, submitted by Mr. Lance.............    47
Statement of the National Academy of Elder Law Attorneys, 
  submitted by Mr. Pitts.........................................    50
Statement of collection of organizations in support of H.R. 670, 
  submitted by Mr. Pitts.........................................    53
Statement of Representative G.T. Thompson of Pennsylvania, 
  submitted by Mr. Pitts.........................................    55

 
            IMPROVING THE MEDICAID PROGRAM FOR BENEFICIARIES

                              ----------                              


                       FRIDAY, SEPTEMBER 18, 2015

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:01 a.m., in 
room 2123, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Present: Representatives Pitts, Guthrie, Shimkus, Lance, 
Griffith, Bilirakis, Long, Ellmers, Bucshon, Brooks, Collins, 
Green, Butterfield, Schrader, Kennedy, and Pallone (ex 
officio).
    Staff Present: Clay Alspach, Chief Counsel, Health; Gary 
Andres, Staff Director; Leighton Brown, Press Assistant; Noelle 
Clemente, Press Secretary; Graham Pittman, Legislative Clerk; 
Michelle Rosenberg, GAO Detailee, Health; Chris Sarley, Policy 
Coordinator, Environment & Economy; Josh Trent, Professional 
Staff Member, Health; Christine Brennan, Minority Press 
Secretary; Jeff Carroll, Minority Staff Director; Tiffany 
Guarascio, Minority Deputy Staff Director and Chief Health 
Advisor; and Samantha Satchell, Minority Policy Analyst.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Pitts. The subcommittee will come to order. The chair 
will recognize himself for an opening statement.
    Today, Medicaid is the world's largest health coverage 
program. Medicaid plays an important role in our healthcare 
system, providing access to needed medical services and long-
term care for some of our Nation's most vulnerable patients.
    The Congressional Budget Office estimates that Federal 
Medicaid expenditures will grow from $343 billion this year to 
$576 billion in 2025. At the same time, state expenditures have 
grown significantly, accounting for more than 25 percent of 
state spending for fiscal year 2014.
    Given the scope of the program and its impact on millions 
of Americans' lives, Congress and states have a responsibility 
to ensure that the program is modernized to better serve some 
of our Nation's neediest citizens.
    Congress can make incremental improvements to this 50-year-
old system in a way that respects taxpayers, empowers patients, 
and promotes more holistic, patient-centered care. That is why 
I am so pleased today to be discussing four bipartisan bills 
that will help strengthen a patient's role in their own care 
and reduce barriers to accessing health care.
    First, the Ensuring Access to Clinical Trials Act of 2015 
would permanently allow individuals with rare diseases, who 
participate in clinical trials, to continue to be able to 
receive up to $2,000 in compensation for participating in 
clinical trials without that compensation counting towards 
their income eligibility limits for SSI or Medicaid.
    Second, Representatives Bilirakis, Lance, and several other 
colleagues have introduced H.R. 3243, which would authorize the 
HHS Secretary to waive certain Medicaid requirements in regards 
to the PACE program. PACE--the Program of All-Inclusive Care 
for the Elderly--is an integrated care program that provides 
comprehensive long-term services and supports to individuals 
age 55 and older who require an institutional level of care, 
many of whom are dually eligible for both Medicare and 
Medicaid.
    The PACE model is limited to those age 55 and older who 
meet State-specified criteria for needing a nursing home level 
of care, but other targeted populations could benefit from the 
successes of the comprehensive PACE model.
    Next, Ranking Member Pallone and G.T. Thompson have 
introduced a bipartisan bill that would extend the special 
needs trust exception to allow nonelderly individuals with 
disabilities to establish a special needs trust on their own 
behalf. If enacted, a special needs trust established by a 
nonelderly, disabled individual would no longer be considered 
an asset in determining that individual's eligibility for 
Medicaid.
    Finally, Representative Collins will be introducing the 
Medicaid Directory of Caregivers Act, or the Medicaid DOC Act. 
This commonsense proposal would require state Medicaid programs 
to provide patients in their fee-for-service Medicaid program 
with a directory of healthcare providers participating in 
Medicaid.
    Medicaid patients in managed care have an identified 
network of providers. However, too often in fee for service 
Medicaid patients struggle to find a doctor who will accept 
Medicaid. And this bill would help solve that problem and 
effectively reduce a Medicaid patient's barriers to care by 
cutting down on the time and energy they have to expend to find 
a doctor to provide care.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    The Subcommittee will come to order.
    The Chairman will recognize himself for an opening 
statement.
    Today, Medicaid is the world's largest health coverage 
program. Medicaid plays a critical role in our health care 
system, providing access to needed medical services and long-
term care for some of our nation's most vulnerable patients.
    The Congressional Budget Office estimates that federal 
Medicaid expenditures will grow from $343 billion this year to 
$576 billion in 2025. At the same time, state expenditures have 
grown significantly, today accounting for more than 25% of 
state spending in FY 2014.
    Given rising federal costs, Congress has a responsibility 
to ensure that proper incentives are put in place to increase 
the accountability inclusiveness of Medicaid, while maintaining 
quality for our nation's neediest citizens.
    To that end, the clarification of eligibility limits and 
thresholds on Medicaid will serve to bring vulnerable 
populations into the program, while confirmingreassuring 
existing enrollees as to their eligibility status.
    As a result, the creation of certainty in the Medicaid 
system will allow us to take another step towards providing 
meaningful access to care, while protecting taxpayer 
investments and ensuring that care is provided for the truly 
needy.
    That's why I'm so pleased today to be discussing several 
bipartisan bills that will help boost the accessibility and 
transparency of the Medicaid program.
    First, a bill to be introduced by Reps. Doggett (TX), 
McGovern (MA), and Marino (PA) would permanently allow 
individuals with rare diseases who participate in clinical 
trials to exempt up to $2,000 in compensation for services 
rendered from their Medicaid eligibility.
    Second, Representatives Bilirakis (FL), Lance (NJ), and 
several other colleagues have introduced H.R. 3243, which would 
authorize the HHS Secretary to waive certain Medicaid 
requirements in regards to the PACE program.
    Next, Ranking Member Pallone (NJ) and Rep. GT Thompson (PA) 
have introduced a bipartisan bill that would allow for a 
special needs trust exception to extend to non-elderly, 
disabled individuals for purposes of Medicaid calculation.
    Finally, Representative Collins (NY) will be introducing 
the Medicaid Directory of Caregivers Act, a bill that would 
require State Medicaid programs to increase patient 
accessibility through the publication of an electronic list of 
Medicaid providers.
    It is my hope that through the steps currently taken in 
these bills, as well as any productive additions that may occur 
henceforth, this committee can come together to take meaningful 
steps towards Medicaid certainty, transparency, and 
accountability.
    I look forward to hearing from our witnesses today, and I 
yield to --------------.

    Mr. Pitts. I look forward to hearing from our witnesses 
today. Is anyone seeking time on our side?
    If not, I yield back, and at this point I recognize the 
ranking member of the subcommittee, Mr. Green, 5 minutes for 
his opening statement.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Good morning. And thank each of you for being 
here this morning.
    We are here to examine four bipartisan bills, each of which 
makes key improvements in the Medicaid program. I thank the 
chairman for holding this hearing. It is both an opportunity to 
advance these worthy legislative proposals, but also build on 
our committee's record of bipartisan success for this Congress.
    As we know, nearly 1 in 10 Americans are impacted by a rare 
disease. The Ensuring Access to Clinical Trials Act, introduced 
by Representative Lloyd Doggett, allows patients with rare 
diseases to participate in and benefit from clinical trials 
without risk of losing critical benefits. The bill makes 
permanent the Improving Access to Clinical Trials Act, a law 
enacted in 2010 that permits patients with rare diseases to 
receive compensation for participating in clinical trials 
without that compensation counting towards their income 
eligibility limits for SSI or Medicaid. This is scheduled to 
sunset on October 5, so this is timely legislation. Without 
extending or making IACT permanent, people with rare diseases 
would be discouraged from participating in clinical trials. At 
a time when there is such a great need to develop new 
therapies, promoting access to clinical trials for patients in 
need of treatments is something we should all support.
    H.R. 670, the Special Needs Trust Fairness Act, was 
introduced by Ranking Member Frank Pallone and Representative 
Glenn Thompson. This important legislation will correct an 
error in the law that prevents capable individuals with 
disabilities from creating their own special needs trust.
    People with disabilities often need help covering the high 
cost of long-term services and support. Federal law allows 
individuals to use special needs trusts to retain some assets 
for the purpose of supplementing expenses that are not covered 
by public assistance programs. Unfortunately, an oversight in 
current law makes it incredibly difficult for an individual 
with disabilities to set up a special needs trust on their own. 
This has the impact or effect of deeming all individuals with 
disabilities incapable of handling their own affairs, which is 
blatantly false and discriminatory.
    The Special Needs Trust Fairness Act will correct this 
injustice. I want to thank our ranking member for his long 
history of leadership on this issue.
    The Program of All-Inclusive Care for the Elderly, or PACE, 
is a community-based, long-term service and support program 
designed to provide quality integrated care for some of our 
Nation's most vulnerable citizens. Under this proven care model 
patients who are eligible for nursing homes are able to remain 
in their homes and receive medical support services through the 
adult daycare centers. The PACE Innovation Act of 2015 will 
allow the Centers for Medicare & Medicaid Services, CMS, to 
pilot the PACE care model with new populations where high-
quality, fully integrated care is likely to be effective.
    Finally, the Medicaid Directory of Caregivers Act is a 
draft proposal that responds to recent reports which 
highlighted challenges patients have with provider directories 
in their health systems. Too often it is difficult for patients 
to see if a doctor is affiliated with their health plan and 
providers are uncertain if they have been included in a newly 
established insurance network.
    Confusing or misleading provider directories have led to a 
rise in surprise billing where a patient faces unexpected, 
costly out-of-network medical bills. This timely draft 
legislation requires States that participate in fee-for-service 
Medicaid to publish a provider directory on a regular basis.
    I look forward to working with my colleagues to advance all 
these legislation. I look forward to working with my colleagues 
on the committee to further strengthen Medicaid programs in key 
areas and build on past success. Each of these bills is the 
product of thoughtful, bipartisan consideration and work. And I 
want to thank our witnesses for being here today and look 
forward to discussion on the legislation proposals.
    And I yield back.
    Mr. Pitts. The chair thanks the gentleman, and now I 
recognize the ranking member of the full committee, Mr. 
Pallone, 5 minutes for an opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman.
    Obviously, we have four pieces of legislation in the 
Medicaid program that are having a legislative hearing today, 
and three of the bills have both bipartisan and bicameral 
support and have already passed the Senate.
    In particular, one of the bills under consideration, the 
Special Needs Trust Fairness Act of 2015, would correct an 
unfair anomaly in Federal Medicaid law to allow nonelderly 
individuals with disabilities to establish a special needs 
trust on their own behalf, and this legislation is a proposal 
that I have sponsored for many years. I am happy to see this 
commonsense policy moving forward.
    There is no reason why we should prevent competent 
individuals from establishing their own special needs trust, 
and it is time we fix this unintended problem that undermines 
the rights of those with disabilities.
    I am also pleased to see a proposal with wide bipartisan 
support to promote innovation in the PACE program. The Program 
of All-Inclusive Care for the Elderly, or PACE, is an 
integrated care program that provides comprehensive long-term 
services and supports to individuals age 55 and older who 
require an institutional level of care, many of whom are 
eligible for both Medicare and Medicaid and of course are known 
as dual-eligible beneficiaries.
    This legislation would allow PACE programs to waive certain 
requirements, like expanding to the under-55 population, that 
limit the ability of this successful program to grow. And I 
recently learned that a new PACE program is in my home district 
and I look forward to supporting the continued success of the 
program.
    I also look forward to hearing testimony regarding H.R. 
209, the Ensuring Access to Clinical Trials Act, a bill with 49 
bipartisan cosponsors and one that should be of considerable 
interest to this committee given its rare disease focus.
    This legislation would permanently remove the sunset clause 
that was in the original Improving Clinical Trials Act that was 
signed into law in 2009. It also builds on a 2014 GAO report 
finding that clinical trial compensation for travel to a rare 
disease trial location and time away from work actually acts as 
a deterrent for vulnerable SSI and Medicaid beneficiaries who 
are fearful of losing eligibility for their benefits when they 
need them most.
    The legislation would make certain that beneficiaries can 
disregard up to $2,000 of compensation per year that an 
individual may receive for participation in a clinical trial 
investigating a rare disease.
    And finally we have a draft bill on the agenda that I would 
like to have more time to review, but that shows great promise 
as a bipartisan initiative to improve access to care in 
Medicaid. The draft legislation proposed would require states 
that participate in fee-for-service Medicaid to publish up-to-
date provider directories. And I want to ensure that we go 
about drafting such a requirement in a way that is streamlined 
with managed care provider directory requirements in Medicaid, 
but I feel certain that we will all share the same goal with 
this legislation.
    Let me thank you, Mr. Chairman and our ranking member, Mr. 
Green, for holding the hearing on these legislative initiatives 
in Medicaid with broad bipartisan support from our committee 
members and look forward as we move these bills in the 
subcommittee and full committee. Thank you.
    Mr. Pitts. The chair thanks the gentleman.
    As usual, all the written opening statements of the members 
will be made a part of the record.
    That concludes the opening statements of the members.
    I would like to thank our panel, the witnesses, for coming 
today. I will introduce them in the order that they present 
their testimony.
    And you will each be given 5 minutes to summarize your 
testimony. Your written testimony will be made a part of the 
record.
    First of all, we have Dr. Michael Boyle, vice president of 
therapeutics development, the Cystic Fibrosis Foundation.
    Welcome.
    Then Mr. Tim Clontz, senior vice president for health 
services, Cone Health.
    Welcome.
    And Mr. Rick Courtney, president, Special Needs Alliance.
    Thank you all for coming. And we will begin with Dr. Boyle.
    You are recognized for 5 minutes for your summary.

     STATEMENTS OF MICHAEL BOYLE, M.D., VICE PRESIDENT OF 
 THERAPEUTICS DEVELOPMENT, THE CYSTIC FIBROSIS FOUNDATION; TIM 
CLONTZ, SENIOR VICE PRESIDENT FOR HEALTH SERVICES, CONE HEALTH; 
      AND RICK COURTNEY, PRESIDENT, SPECIAL NEEDS ALLIANCE

                   STATEMENT OF MICHAEL BOYLE

    Dr. Boyle. Thank you, Mr. Chairman.
    My name is Dr. Mike Boyle. I am a professor of medicine 
from Johns Hopkins, where I have run the Adult Cystic Fibrosis 
Program for the last 15 years, and I am vice president at the 
Cystic Fibrosis Foundation, where I oversee clinical trials. 
And on behalf of the CF Foundation and representing the 30,000 
people with cystic fibrosis in the United States, I am really 
grateful for this opportunity to be able to testify in support 
of H.R. 209, the Ensuring Access to Clinical Trials Act. We are 
particularly grateful to Health Subcommittee Chairman Pitts, 
Ranking Member Green, full committee Chairman Upton, and 
Ranking Member Pallone, the bill's sponsor Congressman Doggett, 
and all of those who are working to pass this very important 
legislation.
    Remember, cystic fibrosis is a rare genetic disease that 
primarily affects the lung. It causes the body to produce large 
amounts of thick mucus that congest the lungs and leads to 
life-threatening infections and serious digestive 
complications. In the 1950s, few children with CF lived to 
attend elementary school. But since then, tremendous progress 
and understanding and treatment of CF has led to dramatic 
improvements in length and quality of life for those with CF so 
that many people with CF now can expect to live into their 
thirties, forties, and beyond.
    As a physician, professor, and clinical investigator at 
Johns Hopkins I have seen the devastating impact of this 
disease and the importance of clinical research in developing 
treatments that can change the lives of individuals with CF, I 
am privileged to have played a role in several pivotal trials. 
It is for this reason I am here today to ask that the Ensuring 
Access to Clinical Trials Act be passed without delay.
    As you know, the Ensuring Access to Clinical Trials Act of 
2015 eliminates the 5-year sunset clause from our current laws, 
the Improving Access to Clinical Trials Act, or IACT. It was 
signed into law in 2010, and IACT allows people with rare 
diseases to receive up to $2,000 annually in compensation for 
participating in clinical trials without that compensation 
counting toward their income eligibility limits for SSI and 
Medicaid. But unless Congress acts, this critical law will 
expire on October 5 of this year. The Senate has already passed 
identical legislation by unanimous consent, and we urge similar 
swift consideration of this bill in the House.
    The particular individual that comes to mind when I think 
of the Ensuring Access to Clinical Trials Act is a young man 
with cystic fibrosis by the name of Michael that I was caring 
for in 2009 prior to the original passage of this law. Mike had 
significant lung disease from CF, but for many years had made 
time to participate in clinical trials to help speed the 
development of desperately needed new therapies.
    Yet, in 2009, when a trial of a very promising new therapy 
called ivacaftor started and was looking for CF clinical trial 
participants, Mike didn't participate, not because he didn't 
want to--in fact, he desperately wanted to enroll in the trial 
of a drug which was later found to be the most effective drug 
that has ever been developed for his type of CF--but because he 
had evaluated his finances and was afraid that the modest 
payment of approximately $750 associated with participation in 
the trial would put his Medicaid and SSI support, on which he 
was completely reliant, in jeopardy. He did not enroll. Mike 
even volunteered to participate in the trial without payment, 
but this is not allowed by most hospital review boards for the 
vast majority of clinical trials, including this one.
    Approximately 4 months after deciding not to enroll because 
of financial concerns, Mike died unexpectedly from 
complications of CF. And to this day I still wonder if his 
outcome may have been different had he enrolled.
    Rare disease researchers face a real challenge in 
recruiting participants to test new medications. Securing an 
adequate number of clinical trial participants is essential to 
testing new therapies, so we can't let any obstacles stand in 
the way of being able to let these patients enroll.
    If the Improving Access to Clinical Trials Act were allowed 
to expire and this barrier were reinstated, it would not only 
affect future trial enrollment, it could cause those with rare 
diseases who are currently participating in clinical trials to 
drop out of these trials for fear of losing benefits. This will 
put vital clinical research at risk at a time when the medical 
needs of many people with rare diseases are already not being 
met.
    The advent of precision medicine has allowed specific 
medications to be developed which target the specific genetic 
makeup of patients. Two of these therapies are now available in 
CF, but they only treat a subset of patients. We need to have 
availability of patients for additional trials to treat the 
other half of these patients.
    The mission of the CF Foundation is to find a cure for all 
people with CF, including those with the rarest CF mutations. 
Even then, there might be only a handful of people with those 
mutations who can enroll in these trials. In order to achieve 
this goal, we must ensure that nothing stands in the way of 
carrying this out and developing these breakthrough 
medications. All of these things make the support of this act 
essential.
    Again, I am deeply grateful to the committee for this 
opportunity to offer testimony in favor of the Ensuring Access 
to Clinical Trials Act and I ask for your support of it. The 
Cystic Fibrosis Foundation stands ready to work with this 
committee and congressional leadership to ensure passage of 
this bill to enable those with rare diseases to access life-
sustaining treatments and enjoy the best health and quality of 
life possible. Thank you.
    [The prepared statement of Dr. Boyle follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The chair thanks the gentleman.
    I now recognize Mr. Clontz for 5 minutes for your opening 
statement.

                    STATEMENT OF TIM CLONTZ

    Mr. Clontz. Mr. Chairman, Ranking Member Green, and members 
of the subcommittee, thank you for holding this hearing.
    My name is Tim Clontz, and I am senior vice president at 
Cone Health, a large regional health system in North Carolina 
and a joint venture partner in three PACE programs. It is my 
distinct privilege to testify on behalf of the National PACE 
Association in support of a PACE Innovation Act 2015.
    Programs of All-Inclusive Care for the Elderly, or PACE 
programs, serve some of our most frail and most vulnerable 
populations, those needing nursing home level of care. By 
integrating medical care and community-based, long-term 
services and supports, PACE allows seniors to get the care they 
need at home and with the love and support of their family 
members and friends.
    PACE is a proven high-quality program. Studies show that 
PACE enrollees live longer, with fewer hospitalizations, and 
live at home longer than those receiving care through other 
programs.
    Unfortunately, many individuals cannot access the PACE 
benefit because of arbitrary age restrictions or because they 
are not yet quite sick enough to qualify. These limitations 
have real consequences for real people, their families, and for 
the delivery system.
    Take, for example Jim G., a 53-year-old Virginia resident 
with early onset Alzheimer's disease. He lived at home with his 
wife Karen and school-aged children. Jim tried to enroll in 
PACE but was unable to because he was not old enough.
    Initially, Jim stayed at home alone during the day where he 
was isolated and struggled with activities of daily living, 
such as personal grooming, household chores, and child care. As 
his memory deteriorated, so did his health. Jim was 
hospitalized in 2014 for a lung infection caused by silent 
aspiration, which occurs when the swallowing function is 
weakened by Alzheimer's.
    His wife Karen struggled to care for Jim and her school-
aged children and hold down a full-time job, but eventually had 
to quit her job for Jim. Unfortunately, she quickly discovered 
that his needs were more than she could handle, and following a 
psychotic break and a week in a psychiatric facility, Jim was 
permanently placed in a memory care unit near their home.
    To add to her stress, Karen had to crowd source to raise 
money for his care as this particular facility was not covered 
by Jim's VA benefits. This is no way to treat a 23-year 
veteran.
    This heartbreaking situation might have been avoided had 
Jim been able to enroll in PACE. He could have received daytime 
support that would allow him to continue to live at home with 
his family. He could have received therapies to help him stay 
physically strong and primary care to help avoid the silent 
aspiration and other complications.
    PACE has significant experience with dementia and might 
have prevented or managed his psychiatric deterioration. And 
Karen and her family would have received much needed respite 
services, emotional and social support, and peace of mind.
    The PACE Innovation Act of 2015 would help Jim and many 
others like him by allowing PACE to serve younger individuals 
with disabilities, at-risk populations, and others who would 
benefit from the fully integrated services offer by PACE.
    This legislation is revenue neutral, bipartisan, and has 
been endorsed by many national organizations. Simply put, 
helping people like Jim get the care they need at home with the 
love and support of their family and friends makes sense. 
Integrating medical care and community-based, long-term 
services and supports also makes sense.
    These are two truths that the PACE program has known and 
applied for over 25 years for people age 55 and older who need 
a level of care comparable to a nursing home but who wish to 
continue their lives at home. It is time to build on this 
foundation and extend this effective delivery system to 
additional people through a pilot program.
    The PACE Innovation Act does this. Through this act, the 
PACE model can be adapted to serve people under the age of 55 
and people at risk of needing nursing home level of care. 
People like a man or a woman with early onset Alzheimer's or a 
younger person with physical disabilities or a person with an 
intellectual or a developmental disability deserve the same 
options.
    While the differences in each of these individual needs may 
be significant, the shared challenge of accessing effective, 
integrated, and coordinated medical and long-term services and 
supports is compelling. We can build a more effective delivery 
and financing systems to serve these vulnerable populations. 
With your support, the PACE Innovation Act and the pilot 
programs can help show the way.
    Thank you for the opportunity to address the committee on 
these vital matters.
    [The prepared statement of Mr. Clontz follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The chair thanks the gentleman.
    And I now recognize Mr. Courtney 5 minutes for your 
summary.

                   STATEMENT OF RICK COURTNEY

    Mr. Courtney. Thank you, Chairman Pitts and Ranking Member 
Mr. Green and members of the subcommittee. I am glad to come to 
Washington and testify in strong support of the Special Needs 
Trust Fairness Act, H.R. 670, introduced by Representative 
Glenn Thompson and committee Ranking Member Frank Pallone. 
Their leadership on this has been steadfast and outstanding, 
and we appreciate that.
    I am honored to serve as president of the Special Needs 
Alliance, a nationwide organization of special needs planning 
attorneys. And I am also a member and former member of the 
board of directors of the National Academy of Elder Law 
Attorneys. Both organizations devote substantial resources to 
serving the needs of the special needs and disability community 
and strongly support the Special Needs Trust Fairness Act.
    In 1979, I became the father of twin daughters. My wife and 
I love both our daughters and we are proud parents, but they 
have had very different paths. Melissa was in gifted and 
talented education through secondary school and college, and is 
now the young wife and mother of two elementary school-age 
boys. Melanie, her twin sister, was genetically the same, but 
different. She has cerebral palsy and learning disabilities. 
She is a wheelchair user. But through her determination and 
hard work, she got through high school and community college 
and obtained an associate of arts degree in 3 \1/2\ years. She 
found a job with our state art chapter after college. She was 
the coordinator of a project called My Voice, My Choice, 
teaching young adults with developmental disabilities self-
advocacy skills.
    Suffice it to say she has taught us a lot too. She has 
never wanted help with things she could capably do, and she has 
never easily accepted that she can't do something because she 
is physically disabled. She does, however, need and is 
receiving services through a Medicaid waiver program in our 
State. The cost of attendant care and medical services is high 
and she must rely, like many people with disabilities, on 
essential programs like Medicaid.
    For now, my wife and I are here to be supportive of 
Melanie, but it won't always be so, and her needs my grow as 
she gets older. If she were to receive some money through an 
inheritance or an insurance settlement, she would lose her 
Medicaid waiver benefits that pay her attendant for a few hours 
a day to help her with those activities of daily living she 
requires help with.
    In order to keep those benefits, she would be required to 
put those assets into a special needs trust, also known as a 
supplemental benefits trust or a (d)(4)(A) trust. Under the 
Omnibus Budget Reconciliation Act of 1993, funds held in these 
trusts are not counted as assets or resources for a person's 
SSI or Medicaid eligibility determination, and the trust 
provides a way to provide funds for other life essentials that 
are not covered by Medicaid, such as clothing, furniture, 
telephone, or computer access.
    Unfortunately, that law included a drafting oversight that 
penalizes physically disabled, mentally capable adults in the 
creation of these trusts. By requiring that such trusts can 
only be established by that individual's parent, grandparent, 
legal guardian, or a court, mentally capable adults are forced 
to rely on others to do this for them. The effect of current 
law is they are treated as though they were mentally incapable 
or mentally incompetent and cannot legally act for themselves.
    So Melanie would not be allowed to create a special needs 
trust for herself, and believe me, she would question why. She 
would not understand why, unlike her sister, she can't 
establish a trust to hold funds that come to her. She would 
question why, if her mother and father were deceased, she would 
have to hire a lawyer to go ask a judge to create a trust for 
her, which, unfortunately, some courts have been unwilling to 
do.
    In addition to being demeaning to the individual, this 
barrier places an enormous burden on already strained court 
resources. The individual may be forced into an imposed 
guardianship and even a loss of Medicaid or SSI benefits.
    The barrier in the law creates an equality and fairness 
issue. One should have the right to contract if one has the 
mental capacity to do so. We believe it was a legislative 
drafting oversight that caused the problem and not the intent 
of Congress to deny this basic right to mentally capable adults 
with disabilities.
    The Special Needs Trust Fairness Act would fix this problem 
with two words. By simply introducing the words ``the 
individual'' into the current statute that describes who can 
create a special needs trust, it would permit Melanie and other 
mentally capable adults with disabilities to create such 
trusts.
    On behalf of Melanie and my family and so many other 
clients that we have worked with, I thank you for the 
opportunity to testify here before you today and look forward 
to taking any questions.
    [The prepared statement of Mr. Courtney follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The chair thanks the gentleman.
    We will begin the questioning. I will recognize myself 5 
minutes for that purpose.
    Dr. Boyle, in your experience as a researcher, how has the 
Improving Access to Clinical Trials Act affected recruitment 
for clinical trials since it was implemented in April of 2011?
    Dr. Boyle. Well, the easy answer to that is it has allowed 
an increasing number of patients to be able to participate that 
otherwise either wouldn't have been able to or wouldn't have 
because of fear of exceeding their income limits. We actually 
keep pretty close track of this in terms of talking with 
research coordinators around the country, and the overwhelming 
feedback has been that this has removed a barrier which has 
allowed patients who otherwise, like I said, would have been 
hesitant to participate.
    The reason this is particularly important is obviously not 
just for the individual, but for actually advancing science. As 
we look at some of this precision medicine and we need small, 
specific populations of patients to study that have specific 
genotypes, sometimes a few patients can make a difference. And 
so it has been helpful extremely helpful both for the patients, 
but also for advancing the science.
    Mr. Pitts. Now, you mentioned in your written testimony, 
Dr. Boyle, that many in the cystic fibrosis community consider 
this the year of the clinical trial, with 18 clinical trials 
underway this year. Can you speak to what is on the horizon in 
cystic fibrosis research and how the Ensuring Access to 
Clinical Trials Act might play a role?
    Dr. Boyle. Well, thank you for that question. In some ways 
it follows onto that previous question where we have been--it 
is a great success story, right? We have seen some of this 
recently. It featured President Obama in the State of the 
Union, talking about precision medicine, in which we are 
starting to actually develop medications which treat different 
types of cystic fibrosis based on their underlying genotype, 
their genetic characteristics.
    Again, this gets a little hard because you can't just group 
everybody together. And so one of the exciting things in CF has 
been these new transformative medicines that just don't treat 
the symptoms, that just don't treat cough or mucus, but 
actually treat the underlying cause. So that is a big thing. At 
the same time, we have other trials that are treating the 
ongoing infection, the ongoing inflammation, and nutritional 
problems.
    So it is the year of the clinical trial. We are going to 
have a talk called that in our upcoming national meetings, but 
because it is such an exciting time for advances in CF.
    Mr. Pitts. Thank you.
    Mr. Clontz, I am happy that Pennsylvania leads the country 
in the number of PACE programs, with 19 programs serving 
individuals throughout the State. So I think that PACE 
expansion is a great idea. But serving younger individuals with 
disabilities who are still in the prime of their lives would 
likely be different than serving older adults who are in the 
twilight of their lives. Would PACE be able to adapt to serve 
these new populations? Would younger people be served alongside 
older adults? How would it all work?
    Mr. Clontz. It is important to note that the legislation 
authorizes CMS to do a demonstration project to determine how 
best to serve younger individuals through PACE. So we can test 
a couple of different approaches to figure out what will work 
best for new populations.
    One of the programs in Philadelphia is interested in 
exclusively serving individuals with physical disabilities. 
They want to adhere to the PACE model in some ways, using the 
interdisciplinary team and capitated financing, but incorporate 
other services and benefits that are unique to the needs of the 
individuals with spinal cord or cerebral palsy or other issues. 
So in that case it would be a very unique and distinct program.
    In other areas we will have to be more creative. For 
instance, in remote rural counties there might not be enough 
potential participants to warrant the construction of a program 
exclusive to these individuals. In that case, an existing PACE 
program could leverage its existing care team and resources to 
provide primary care and therapy services while partnering with 
other organizations to provide home-based services and 
supports, employment services, and other services required by a 
younger population.
    Mr. Pitts. Thank you.
    Mr. Courtney, we will start with you on this, but any of 
you can jump in here. Do you have any additional ideas, other 
than the ones presented to us in these bills today, about 
approaches that would improve Medicaid patients' healthcare 
outcomes, curb program outlays, and possibly be bipartisan. I 
think today's hearing and last week's hearing on other Medicaid 
bills demonstrate this committee is ready to work together to 
make some improvements to the program. Would you please 
comment?
    Mr. Courtney. I have looked at the testimony of both the 
gentlemen who have testified today and believe that their 
programs, what they are asking for, is going to help a lot of 
people and benefit the Medicaid program. I don't know that I am 
aware of any additional initiatives to take at this point.
    Mr. Pitts. Mr. Clontz or Dr. Boyle, do you want to continue 
to add?
    Dr. Boyle.
    Dr. Boyle. The answer is, I am a little afraid to shoot 
from the hip on this, but I would love to be able to think 
about this with our team and to be able to submit further to 
you.
    Mr. Pitts. OK. We will send it to you in writing. You can 
respond in writing.
    My time has expired. The chair recognizes the ranking 
member, Mr. Green, 5 minutes for questions.
    Mr. Green. Thank you, Mr. Chairman. I am pleased with this 
committee's continuing commitment to advancement in medical 
science. Although we passed the 21st Century Cures, our work is 
not complete. I believe H.R. 209 highlights another area in 
which the committee must work research on rare diseases.
    Mr. Boyle, what makes clinical trials for rare diseases 
like cystic fibrosis more difficult than a common disorder like 
blood pressure?
    Dr. Boyle. It is all about the numbers. There are only 
30,000 individuals with cystic fibrosis in the United States. 
Most clinical trials, particularly for early development of 
drugs, require adults, so that is about half that number. Then 
you splitting down into specific characteristics of those 
patients that you want to study. There are certain types of 
infections, there are certain types of genetics. So those pools 
get smaller.
    At the same time, we are making sort of amazing advances. 
It is really held up as a disease that is seeing some of the 
most exciting advances in medicine recently. So the biggest 
difference in this for rare disease population is we need those 
numbers because we don't have large numbers like hypertension 
or COPD, other diseases.
    Mr. Green. The GAO report from last year found that the 
average amount of compensation for rare disease clinical trials 
is $568. Is it fair to say that when you factor in travel, time 
off of work, and other expenses, that most patients afflicted 
by rare diseases may in fact lose money in order to participate 
in a clinical trial? And in a smaller group, I know it is 
difficult. I am happy that we are able to shed the spotlight on 
the important issues, and 209 is a good bipartisan piece of 
legislation and hopefully we will pass it on.
    H.R. 670. Mr. Courtney, your biography shows that you were 
the first attorney ever in the State of Mississippi to receive 
the designation of certified elder lawyer attorney. In almost 
40 years of providing legal advice for elderly and disabled 
there are probably very few individuals in the country as much 
experience with you as you need in special needs trust.
    Having practiced probate law in Texas before I got elected 
to Congress, there is obviously a need. Can you recall any 
particular client where passage of this law would have made a 
notable difference in their health and livelihood?
    Mr. Courtney. Yes, sir, we have had several. There was a 
young woman who was injured and she relied on Medicaid waiver 
services to provide care. And she received a settlement, and 
she had to do a special needs trust, but she had no parent or 
grandparent living, she had no legal guardian because she was 
mentally capable. She had to resort to a court. And there were 
some problems with the court that she would have to go to, 
understanding that they had to step in and create the trust. So 
it caused delays for her and also a temporary loss of benefits 
because of the delays of getting to court to establish a trust. 
We don't feel it was Congress' intent in the initial statute to 
put that burden on her or on the court.
    Mr. Green. When I was practicing law I found out, and it 
wasn't through law school, but it was practice, that in Texas 
we have what I think was called a Miller trust, that a senior, 
Alzheimer's, debilitating illness would sign that trust and 
then they would be eligible for Medicaid because they would put 
whatever income they had and that would be assumed by the 
state. Is that something that is based on state to state?
    And, frankly, it was hard to get that information. The 
state agency did not share it with with questions. But thank 
goodness I had a great law professor who explained it to me. Is 
that common in other states to have something like that?
    Mr. Courtney. The Miller trust that you refer to is in 
subsection (b) of the statute that we are talking about. H.R. 
670 seeks to amend subsection (a), which is the individual 
special needs trust that would hold resources or funds, 
property, and not be counted as assets for Medicaid 
eligibility.
    The Miller trust is one in which someone who needs nursing 
home care or some institutional level of care for Medicaid can 
place income, and the income can go into the Miller trust. But 
that is a separate type trust, and we are not seeking to any 
revision of that statute.
    Mr. Green. OK. Thank you.
    PACE innovation program remains a successful asset in our 
community since 1971. PACE advocates are proud to stand behind 
over 100 programs that help. Mr. Clontz, although PACE has 
consistently grown over the years, unfortunately, it is not 
available to all patients who wish to enroll. What is the 
existing barriers preventing the program from spreading 
further?
    Mr. Clontz. We would love to see more PACE programs as 
well. There are a couple of factors that really affect PACE 
growth and NPA has identified several regulatory and process 
changes that would assist.
    First, PACE is a very capital intensive program. Programs 
must build a day center and hire their full interdisciplinary 
team many months before opening. This investment can run up to 
$4 million to $6 million prior to opening, all to serve 150 or 
so individuals. If CMS would allow programs to leverage 
existing community resources by contracting with adult day 
centers and family physicians, it would allow us to grow more 
efficiently.
    Additionally, the PACE application process is lengthy, time 
consuming, and bureaucratic. The PACE application typically is 
about the size of a phone book. But if CMS was to move to a 
more attestation-based model where programs could assure they 
meet all of the major program requirements it would expedite 
the process.
    Finally, CMS needs to dedicate staff resources to support 
PACE management and growth. PACE responsibilities are split 
across multiple divisions with CMS and we need a dedicated 
staff for PACE.
    As for Houston, there is a program under development in 
Houston that is working with the state on an application, yet 
it has struggled to align PACE with managed care in the state. 
This is a perfect example of how better technical assistance 
and leadership from CMS would be helpful.
    Mr. Green. If you could get me that group in Houston, be 
glad to work with them.
    Thank you, Mr. Chairman.
    Mr. Pitts. Chair thanks the gentleman.
    And I now recognize the vice chair of the subcommittee, Mr. 
Guthrie, 5 minutes of questioning.
    Mr. Guthrie. Thank you.
    My first is for Dr. Boyle. In this position, when I was in 
the state legislature, there are a lot of families that come to 
advocate, and we get to know them and get to know families, 
particularly personally a lot of times. And there were a couple 
of people that I knew that had cystic fibrosis and they said 
that our child is probably going to live to be in their late 
twenties, maybe thirty. I think one lived to be late twenties, 
one early thirties, so they are no longer with us.
    And yesterday I actually was in a discussion with someone 
about the new innovations, a pharmaceutical that has been 
approved, and so there is a lot of promise.
    And we spent a lot of time in this committee this year and 
bipartisan, unanimously passed the 21st Century Cures Act, and 
trying to get cures to the market quicker. And then how will 
the Ensuring Access to Clinical Trials Act help advance the 
discovery, development, and delivery of cures?
    Dr. Boyle. Well, I think in a couple ways. Really the way 
that we make progress at the end of the day is by scientific 
clinical trials. Right? So we have a lot of good ideas, and 
actually the 21st Century Act and those things have opened up 
some possibilities for doing new testing.
    But the biggest thing is we need access to patients. We 
have to partner with them to test these therapies to figure out 
if they are going to really make a difference. And so we can 
test in dishes with cells, we can do all kinds of tests in the 
lab, but at the end of the day, all of these trials have to go 
through patients.
    And so this act enables us to be able to partner with 
patients and make sure that some of the newest, most needy 
patients--remember, over a third of our patients are on 
Medicaid with cystic fibrosis. And so if those patients have a 
barrier to participate, we have lost two things: one, the 
ability to be able to make those advances, but also in some 
ways some of the people who are most needy are missing out.
    Mr. Guthrie. Thank you very much.
    And, Mr. Courtney, I certainly appreciate your testimony. 
Mrs. Eisenhower was always asked, always answered, they said: 
``You must be proud of your son.'' And she would always say: 
``Which one?'' So it sounds like you are very proud of both of 
your daughters. But I can tell you when we were talking about 
Melanie and said if she was told she wasn't able to do 
something, I can see a little pride, and I guess she has a 
little fight in her. So I could just see that in your face. I 
don't know if the people back behind there can see it in your 
face. So that is great that you are advocating.
    I just want to ask you about the difference between the 
special needs trusts. Of course there are pool trusts, and we 
created ABLE. As a matter of fact, I don't know if it is your 
Representative, but a Representative from Mississippi was real 
involved, Greg Harper, in the ABLE accounts. And could you 
explain the difference in those for the populations for which 
they are created?
    Mr. Courtney. We want to thank Congress for passing the 
ABLE Act earlier this year, because it is a wonderful tool for 
people with disabilities. But in certain circumstances, because 
of some limitation based on CBO scoring, it is limited to those 
people who have a disability that occurred prior to age 26. So 
a 28-year-old young woman who becomes disabled from an injury 
would not be able to have an ABLE account.
    It is also limited in the amount of money that can be 
placed into an ABLE account. So $14,000 per year is the maximum 
at this point that could fund the account. So even if my 
daughter Melanie, who had a disability prior to age 26, were to 
receive money and want to open an ABLE account, if she got a 
life insurance settlement from an aunt who left her as 
beneficiary for $50,000, she could only put $14,000 of that in. 
The other money would disqualify her for Medicaid.
    So that is why the ABLE Act is a wonderful tool, but it 
works in coordination with special needs trusts in many 
situations because there are other assets a person with a 
disability may acquire or have that would need to be in a 
special needs trust and could not go into an ABLE account.
    Mr. Guthrie. So the H.R. 670 will still be needed because 
in your daughter's situation the ABLE account wouldn't cover 
the situation you just described?
    Mr. Courtney. Yes, Mr. Vice Chairman, that is true, because 
she would have some assets that would need to be placed in the 
trust so they would not disqualify her for benefits. And at 
this point the deficiency in the act is that she is not able to 
create that trust.
    Mr. Guthrie. Well, are there limits in the amount of money 
that can be put into in a special needs trust and what the 
funds can be used for?
    Mr. Courtney. There are not limits on that in the statute 
that was passed in 1993, because it varies so much. Someone may 
get an inheritance of a few thousand dollars, someone may get 
more.
    Mr. Guthrie. Were there limits in the way the funds can be 
spent?
    Mr. Courtney. There are limits because the act itself says 
that there is a Medicaid payback from that trust, a payback 
reimbursement to Medicaid of any funds left in the trust at the 
beneficiary's death. So that is one protection of the Medicaid 
program. But also state agencies and Social Security's POMS 
policies place criteria on those trusts, special needs trusts. 
And many states have very restrictive rules and policies about 
how disbursements may be made and for what from a special needs 
trust.
    So, yes, there are protections of those moneys. It is an 
irrevocable trust. The beneficiary can't revoke it and undo it 
once they create it or once it is created. We hope they will be 
able to create it.
    Mr. Guthrie. Appreciate it.
    Mr. Courtney. And they also have to appoint an independent 
trustee.
    So those are all protections of the money to protect it 
both for the needs of the beneficiary that are credible and 
reasonable needs based on state policies and also that the 
trustee can monitor.
    Mr. Guthrie. Well, thank you.
    My time has expired, and I really appreciate you guys being 
here.
    Thank you. I yield back.
    Mr. Pitts. I thank the gentleman, and I recognize Mr. 
Schrader from Oregon, 5 minutes for questions.
    Mr. Schrader. Thank you, Mr. Chairman.
    Mr. Clontz, I am very interested in the PACE program. We 
have one, obviously, in Oregon that seems to work very well. I 
think most people realize that in-home care gets you better 
results at the end of the day. Even in my little corner of the 
veterinary medical world my patients do a lot better at home.
    Could you talk a little bit about research that has 
compared health care delivery, health care outcomes with folks 
in PACE versus going to, say, a nursing home?
    Mr. Clontz. Absolutely. Several studies have explored the 
cost effectiveness and quality of PACE. A recent study by 
Mathematica Policy Research determined that PACE costs are 
comparable to the cost of other Medicare options and provide 
better quality of care. The study determined that PACE 
enrollees had a lower mortality rate than comparable 
individuals either in nursing facilities or receiving home and 
community-based services through waiver programs.
    Mr. Schrader. Very good. I would like to get a copy of 
that, if that is possible. That would be really interesting.
    One of the other big problems it deals with of course is 
the dual eligibles, folks both on Medicare and Medicaid, very 
expensive population to take care of, multiple doctors, 
multiple needs. The coordination becomes difficult. Can you 
talk a little bit about how PACE handles that coordination 
compared to a traditional situation?
    Mr. Clontz. Yes. At least in North Carolina the vast 
majority of the participants, in fact 95 percent or more, are 
dual eligible. So it is the population that we work with 
predominantly.
    It really is about the integrated nature of PACE in terms 
of coordinating care, having these individuals on a regular 
basis, typically three times or more a week in the adult day 
center, being able to put eyes on these folks, having direct 
access down the hall from a physician, having therapy when they 
are in the facility. These folks are picked up at their homes, 
drivers go in the homes. They can see whether there are subtle 
changes in their living arrangements. All of this is really 
about an integrated care model.
    Mr. Schrader. Very good. Well, we have enjoyed the same 
good results in Oregon.
    With that, I will yield back, Mr. Chair.
    Mr. Pitts. The chair thanks the gentleman.
    I now recognize the gentleman from Illinois, Mr. Shimkus, 5 
minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. And I appreciate the 
comments from my colleague from Oregon. And I had it out in 
efficient order, but I think I am going to continue with Mr. 
Clontz for a second.
    One of the big concerns is how the high-cost population, as 
we were talking about, the duals, are driving Federal 
healthcare spending. Can you follow up, you were talking about 
this is with Mr. Schrader, but can you, again, talk about how 
PACE programs are reimbursed and what is known about the cost 
effectiveness of these programs?
    Mr. Clontz. PACE programs are essentially on the Federal 
side a Medicare Advantage plan. We received capitated payments 
on a monthly basis for each of our individuals. On the Medicaid 
side, it is obviously different from state to state, but we 
have received an amount that is less than what--a PACE program 
receives fewer dollars than they would receive if they were 
actually in a skilled nursing facility. The payment model is 
actually designed that way.
    Mr. Shimkus. Thank you very much.
    Now, Mr. Courtney, in a follow-up to a hearing we had last 
week, we heard testimony about individuals taking advantage of 
loopholes in Medicaid eligibility policies, such as through the 
use of annuities and promissory notes, to obtain Medicaid 
coverage when they could afford to pay for their own care. Can 
you explain how a special needs trust differs from some of 
these other financial instruments?
    Mr. Courtney. Well, a special needs trust is a creature of 
Federal statute, OBRA 1993 created that and recognized that 
Medicaid does not provide everything that a person with a 
disability may need. It provides what Medicaid pays for for 
medical services, but there are other life needs, like clothing 
and access to the community.
    So the special needs trust is a method and an effective 
method that the law recognized to hold excess resources that 
would not be countable, but subject to a Medicaid reimbursement 
payback to meet other needs that are supplemental to what 
Medicaid would cover.
    Mr. Shimkus. Yes, I have been a member for quite a long 
time, and every once in a while we will then reinvestigate, 
because I know in your opening statement you talked about elder 
law issues.
    There is a concern by many of us of the squirreling away of 
assets for seniors then to become Medicaid qualified when they 
can obviously--I used to tell a story of my grandmother. She 
was in long-term care, 10 years. Every penny of her assets were 
used for the first 3 years. And then the rest came. She then 
qualified for Medicaid, and thank God it was there, and it took 
care of the 7.
    There is a concern that there is ways to avoid people 
paying down their assets to the care before they qualify, and, 
Mr. Chairman, we still need to investigate, because Medicaid 
and Medicare are still going broke, OK, there are still 
programs that have structural actuary problems that we need to 
address.
    My last question for Dr. Boyle. In your experience, is it 
common practice for clinical trial participants to receive 
compensation for participation?
    Dr. Boyle. Yes, it is actually a good question, because I 
think one of the common things when you look at this act is to 
say: Well, why don't patients turn down the money. Compensation 
in clinical trials is actually a really scrutinized area. Every 
trial that we submit there is an ethics review board for the 
local hospitals, as well as our network that looks and sort of 
stipulates how much a patient gets paid.
    And there is a sweet spot. If it is too much, then it feels 
like you are enticing them to participate in a trial that maybe 
we don't know if it is beneficial. Right? So too much actually 
feels that is not ethical.
    On the other hand, almost every ethics review board says 
you can't give patients the option of paying nothing, being 
paid nothing, because they feel like they might feel some 
pressure from the physicians to say: Oh, why don't you not take 
payment?
    So they always set what is considered to be sort of a fair 
amount of payment. It is a modest amount, it covers travel, it 
covers some of their time. The fact that this is only a $2,000 
limit that we are talking about shows how modest it is.
    So, yes, patients get paid. It is way less than the amount 
of time they spent. And they really don't have any choice. The 
amount is stipulated by an ethics board that looks at each 
clinical trial.
    Mr. Shimkus. And if I may, I have another question, Mr. 
Chairman. But I just want to follow up on his response.
    So you are telling me that the payment is designed to make 
sure that they are not being overcompensated, but they are--the 
ethics board seems to believe that they need to give them 
something----
    Dr. Boyle. That is right.
    Mr. Shimkus [continuing]. And that is why they are paid.
    Dr. Boyle. Well, that is right. And so really it is 
designed, it is supposed to basically compensate them for their 
time. It is actually not supposed to be an enticement with too 
much. The too little part, they are a little afraid of treating 
patients differently, as well as the patients who participate 
in trials feeling pressure to decline payment when they may 
need it.
    Mr. Shimkus. Thank you very much.
    Thank you, Mr. Chairman. I yield back.
    Mr. Pitts. The chair thanks the gentlemen.
    Now recognize the gentleman from New Jersey, Mr. Lance, 5 
minutes for questioning.
    Mr. Lance. Thank you, Mr. Chairman. First I request to 
enter into the record a letter from over 50 organizations in 
support of the Ensuring Access to Clinical Trials Act.
    [The information appears at the conclusion of the hearing.]
    Mr. Lance. As Republican co-chair of the rare disease 
caucus, I meet with patients almost weekly who suffer from 
conditions for which there are few or no treatments. These 
disease populations are so small, the challenges for drug 
development are significant. Disease populations with greater 
numbers often struggle to maintain adequate participation in 
clinical trials, but the challenges are far more acute in the 
rare disease space. The Ensuring Access to Clinical Trials Act 
seeks to address this challenge by helping to move clinical 
research forward and to ensure that rare disease patients on 
Medicaid and SSI can participate in clinical trials without 
fear that their compensation will count toward their 
eligibility limits.
    To demonstrate the importance of participation in clinical 
research, I briefly share the story of a young man named Alex 
who lives in the district I serve. As an 8-month-old infant, 
Alex was diagnosed with cystic fibrosis, and his parents were 
told he would live to be about 20 years old. Today Alex is 20, 
and in his lifetime, a life expectancy for a patient with 
cystic fibrosis has more than doubled, due largely to the 
successes of clinical research.
    Clinical trials have brought about cutting edge therapies 
which have made it possible for Alex to live his life, attend 
college, and hope for a brighter future. These benefits from 
the clinical trials that lead to a number of treatments, 
including hypertonic saline, which was brought to market after 
a 10-year study, and continues to benefit Alex as he struggles 
daily to clear his airways of the life threatening mucous and 
bacteria that cystic fibrosis produces. Most recently other 
drugs have been brought to market, Kalydeco and Orkambi, two 
drugs that address the root causes of cystic fibrosis. These 
new therapies have been heralded as historic breakthroughs for 
the treatment of cystic fibrosis and have potentials to address 
decades to the life of Alex and others. And I certainly want to 
work with everyone on this committee as we move forward on 
these important issues. And I thank all on the panel in that 
regard.
    Now, Mr. Courtney, I used to practice law, and I was very 
much interested in your remarks. The Special Needs Trust is 
Federal legislation, obviously, and I would imagine, as you 
state, it was merely an oversight. Certainly anyone who is 
competent, regardless of physical disability should be able to 
document this without having to rely on someone else. And I 
would imagine that legislation would pass easily. Glenn 
Thompson is a very able member of the Congress. He and I are 
classmates, coming in on the same day.
    I do share Congressman Shimkus' concern, and I do not 
attribute this to you or to anyone whom you represent. What is 
the typical amount that is placed in the Special Needs Trust in 
your opinion based upon your experience in the practice of law 
for almost 40 years?
    Mr. Courtney. Thank you, Mr. Lance. I don't believe there 
is a typical amount because as you might understand from having 
practiced law, there might be a small inheritance from a family 
member.
    Mr. Lance. Sure.
    Mr. Courtney. Or there might be a large insurance or 
litigation settlement.
    Mr. Lance. Or a large inheritance, I presume. It is 
possible. Isn't it?
    Mr. Courtney. Yes, sir.
    Mr. Lance. And when the person passes on, then the Federal 
Government and the state government are reimbursed for Medicaid 
payments if there are funds in that trust?
    Mr. Courtney. Current statute does not provide for 
reimbursement to the Federal Government for SSI payments, but 
to Medicaid, the state Medicaid agency where they have received 
Medicaid benefits will get reimbursed.
    Mr. Lance. And is it only the percentage that the state 
pays under the Medicaid, or is it the full 100 percent?
    Mr. Courtney. It is the full amount that Medicaid has paid 
for that individual's care even prior to the Special Needs 
Trust implementation.
    Mr. Lance. I see. So, for example, as I read the figures in 
your great State, Mississippi, which I know because I went to 
Vanderbilt Law School right next door, you have a share--
Mississippi, 74 percent is funded by the Federal Government and 
roughly a quarter by the state government. Is that accurate?
    Mr. Courtney. That math is correct, yes.
    Mr. Lance. That is certainly not true in New Jersey where 
it is 50/50. I have never understood that, but certainly others 
can explain that to me. And so the full 100 percent would be 
reimbursed through the State agency. Is that how it would work?
    Mr. Courtney. Yes. An individual in Mississippi receives 
Medicaid benefits. Then at the death, any assets in the Special 
Needs Trust would go back to reimburse the state in full for 
those benefits the state had paid.
    Mr. Lance. Thank you very much. My time has concluded. I 
yield back, but this reminds me that I did once practice law, 
and it is a very interesting conversation. Thank you, Mr. 
Chairman.
    Mr. Pitts. The chair thanks the gentleman.
    I now recognize the gentleman for New York, Mr. Collins, 5 
minutes for questions.
    Mr. Collins. Well, thank you, Mr. Chairman, for holding 
this hearing. It has been very educational and interesting. I 
want to thank also the committee's taking a balanced approach 
to Medicaid reform. And your testimony is very helpful.
    Last week we held a hearing focused on curbing waste, 
fraud, and abuse in the program, and this week we are 
addressing how we can improve the program for beneficiaries. 
These two aspects really should go hand in hand in order to get 
the country's entitlements under control.
    A bill that I recently drafted, have not quite dropped yet, 
but we are talking about it today, the Medicaid Directory of 
Caregivers or Medicaid DOC Act. This bill is an example, I 
would like to think, where commonsense meets good government. 
The Medicaid DOC Act would require that states who operate a 
fee-for-service or primary care case management program would 
include on the Medicaid program's Web site simply a directory 
of physicians who have served Medicaid patients in the prior 6 
months.
    Today some states have this service; others don't. The bill 
came as a result of hearings by this committee and GAO reports 
that have been citing access to care of primary physicians, a 
problem with Medicaid fee-for-service programs. If 
beneficiaries can't find a doctor who will treat them, what is 
the point in having this kind of insurance?
    So I would welcome any of you to comment on this. Again, I 
like to call it commonsense meets good government, and, again, 
for this hearing hear some opinions or thoughts you might have.
    Dr. Boyle. Well, I can comment, and I can probably comment 
wearing two hats. First of all, as a cystic fibrosis physician, 
a good number of our patients, as we said, over a third are on 
Medicaid, and frequently, although we take care of the majority 
of their CF needs with a CF team, there is specialty care and 
other cares that they need outside of our team. And you are 
right, it is a barrier sometime to be able to identify those 
other caregivers who would accept Medicaid.
    So that list would be helpful, and, actually, as previously 
practicing in primary care for a few years before doing 
specialty training, I think it is true not just for CF 
patients, but for all individuals on Medicaid. So----
    Mr. Clontz. I would add that it is a very commonsense 
approach and another tool for individuals to find a physicians.
    Mr. Collins. Yes. I have to think as we have expanded 
Medicaid, in many cases, certainly in New York, it is just must 
be the most frustrating thing to say: I finally got insurance 
and you are going up and down, and, you know, there is no 
guarantee that someone on the list would maybe accept new 
patients, just kind of a start.
    Do you have any other suggestions youwould like to share 
with the committee, that is the purpose of a hearing, that you 
think and any kind of other commonsense approach to help these 
patients find a primary care physician? I know you must have 
thought it through at some point.
    Mr. Clontz. As a health system who serves a very large 
population of Medicaid recipients and other disadvantaged, 
economically disadvantaged individuals, it is a constant 
process for us to identify physicians, not only who are taking 
Medicaid, but are taking new Medicaid patients.
    One of the things that we have done in addition to having a 
federally qualified health center in our community, we have 
also opened up a pediatric clinic for Medicaid and self-pay 
patients, and an adult clinic as well. So it is a constant 
battle for us, and any tool we can get would be welcomed.
    Mr. Collins. I want to thank you all for those comments, 
and certainly would urge all my fellow members here to support 
the bill as we do move this forward and intend to drop this 
very soon. And with that, Mr. Chairman, I yield back.
    Mr. Pitts. The chair thanks the gentleman.
    I now recognize the gentleman from Florida, Mr. Bilirakis, 
5 minutes for questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it so 
much.
    Mr. Clontz, thank you for testifying today on the PACE 
Innovation Act. I am proud to be a cosponsor of this great 
piece of legislation. The Program for All-Inclusive Care for 
the Elderly, or PACE, is a unique program that many people may 
not know about. So I appreciate you testifying today.
    In Florida we have four PACE providers that serve 900 
participants in six counties. One of these providers happens to 
be located near me, Suncoast Pace in Pinellas County, the 
county where I reside and I represent part of the county.
    Mr. Clontz, who is eligible for the program currently, and 
under this bill how will that change?
    Mr. Clontz. A potential participant in PACE is eligible if 
they are 55 years of age or older, have been qualified by the 
state as needing skilled nursing facility care, and reside in a 
service area for a PACE organization. So all of those 
qualifications have to be met.
    Mr. Bilirakis. Very good. Thank you.
    Again, as I understand it, the majority of PACE 
beneficiaries are dually eligible for Medicare and Medicaid. Is 
there any data on the extent to which the program's 
effectiveness varies based on whether or not the beneficiaries 
are dual eligibles?
    Mr. Clontz. I am not aware of any that is specific to dual 
eligibles versus those that are Medicare only or private pay, 
if that is your question. We can certainly reach that.
    Mr. Bilirakis. Yes. Please do. Thank you very much.
    Dr. Boyle, again, thanks for your testimony. I am a 
cosponsor of the Access to Clinical Trials bill, and it is an 
important provision for patients, in my opinion. What 
proportion of rare diseases still lack appropriate treatments 
and thus could benefit from additional clinical trials, and how 
many or what proportion of individuals with rare diseases 
receive Medicaid benefits?
    Dr. Boyle. So I am not sure if I know the exact percentage 
of all rare diseases that receive Medicaid benefits, but I can 
tell you that the needy population number is high. Like I said, 
our number is over a third of our patients rely on Medicaid. I 
think that is probably reflective of that population in 
general. And the other thing is that is a particularly needy 
group in terms of new therapies. I think you asked about what 
proportion still needed additional clinical trials.
    Mr. Bilirakis. Exactly.
    Dr. Boyle. I would say there are almost no rare diseases 
right now that we say don't need any more clinical trials. 
Right? So even those who have therapies we know we can continue 
to make progress if we have access to these patients for 
trials, and that the vast majority of them are in early stages 
needing trials to have any type of therapy.
    Mr. Bilirakis. Thanks so much.
    One last question, Mr. Chairman. I guess I have time.
    Dr. Boyle, if FDA allowed the use of biomarkers, would it 
permit for more diverse patient populations in clinical trials 
and make the clinical trials easier to fill? How important are 
biomarkers to future drug development particularly for rare 
diseases of patients?
    Dr. Boyle. Well, that is a very good question and a 
particular area of interest of mine. So biomarkers, as you 
know, would allow us to potentially look at other outcome 
measures for clinical trials that maybe aren't the typical 
things such a lung function which require large populations.
    So I think it depends on the disease how good those 
biomarkers are, but certainly we know that in the future we 
want to be able to try to look at the whole picture and not 
just one measurement in patients but also to use the other 
weapons we have, the other tools that we have to assess a drug. 
So being able to look at tests in the lab, being able to look 
at other markers of how patients are going to do, would allow 
us to have a little smaller cheaper trials to get some of the 
same answers.
    So I think the FDA is already doing a lot and discussing 
with this, but I think that we are looking forward to working 
with them, working with you, on new strategies to incorporate 
that in the whole approval process because it would expedite it 
in getting new therapies to patients.
    Mr. Bilirakis. Very good.
    Thank you, Mr. Chairman, for calling this very important 
hearing. I yield back.
    Mr. Pitts. The chair thanks the gentleman.
    I now recognize the gentlelady from Indiana, Mrs. Brooks, 5 
minutes for questions.
    Mrs. Brooks. Thank you, Mr. Chairman. During the 21st 
Century Cures debate, it's when I personally learned that we 
had--we know there are over 10,000 known diseases and 
conditions with cures and treatments, but there are only a cure 
for 500 of them. And that was somewhat shocking to me.
    And so then to know that we have difficulties with the rare 
disease populations, I would like to ask you if this act 
sunsets, what will actually happen to the patients who are in 
clinical trials who are receiving payments now?
    Dr. Boyle. Thank you for that question, because you are 
right, if this law were to sunset, it wouldn't just affect the 
future. It would affect today----
    Mrs. Brooks. Right.
    Dr. Boyle. Or actually October 6 probably. And that is 
because people who are currently in trials and getting and 
receiving payments would suddenly have to recalculate. Right? 
And they would have to look and say: Can I afford to stay in 
this trial? That could actually have a devastating effect for 
trials if they feel like they are getting close to getting some 
answers when suddenly patients are pulling out. That is 
actually one of the biggest nightmares of researchers when you 
start losing patients because it is hard to assess outcome.
    So you are right. It is not just a down-the-road issue. It 
would be an October 6 issue in terms of advancing therapies for 
those other thousands of rare diseases you discussed.
    Mrs. Brooks. Are clinical trials run differently for 
pediatric therapies versus adult therapies, and where does the 
payment go?
    Dr. Boyle. So they are, and, again, this is a big topic of 
discussion in trying to make sure this is done well. The 
majority of higher risk trials early on are in adults. But once 
there is a little bit of establishment of some safety, then we 
do want to move down to pediatric patients because we want to 
be able to treat those patients early on before they have all 
those diseases. But we need to be able to demonstrate effect on 
those.
    So pediatric trials often times have their own separate 
entity that we run. In some ways they are almost more 
challenging to enroll because obviously as a parent of three 
teen daughters, I would have the same feeling of, ``Hey, do I 
really want to put my child through this, or can I let some 
adults do it?'' So it is a particularly needy group to enroll.
    The payment above the age of 18 goes to the individual. 
Below that it actually goes to the parents. Obviously they can 
work with the child to decide about that, but there is a whole 
area of assent after the age of 12. So patients who are 13 or 
14, they can't sign consent themselves to participate, but they 
do have to sign something that says, ``I understand this.'' I 
have talked about it, and I do want to participate, even though 
they are not legally able to sign. I hope that that answered 
your question.
    Mrs. Brooks. I am curious about the payments because I have 
read in your testimony people can get paid anywhere--is it the 
ethics committee that does the reviews? How is the payment 
determined what patients get for clinical trials? Because I 
have read from $50 up to $2,000.
    What is $50? And why would--that doesn't pay for time and 
travel, I wouldn't imagine, and so why is there that minimal of 
a payment in any case?
    Dr. Boyle. So it all depends on the design of the trial and 
it is supposed to reflect the amount of time spent. So it is 
not supposed to reflect risk. Right? If you are paying people 
more to take more risk, that actually feels like you are 
enticing them to do something unwise.
    So what happens is there are some standards set--in the CF 
community, the Cystic Fibrosis Foundation has played up a large 
part of this with our therapeutic development network. So we 
actually say, calculate the number of hours that this 
individual is going to be participating, and this is the amount 
that they can be compensated based on the amount of hours.
    It is not a reflection of the risk. And then the travel 
that--being reimbursed for travel is a separate issue. That is 
actually not part of the pay--I can tell you nobody gets rich 
doing this. This is basically just trying to be able to make 
sure that they have enough to pay for their time that they have 
because it is affecting all the rest of their lives, whether it 
is in school or it is having a job, it is a way to be able to 
cover them even when most of the time they are just 
volunteering out of altruism.
    Mrs. Brooks. OK. Thank you all for all of your work. This 
has been very helpful today. I yield back.
    Mr. Pitts. The chair thanks the gentlewoman.
    I now recognize the gentleman from Missouri, Mr. Long, 5 
minutes for questions.
    Mr. Long. Thank you, Mr. Chairman. And thank you all for 
being here today.
    Mr. Courtney, currently an individual with a disability 
cannot set up his or her own Special Needs Trust. If this 
individual does not have a parent, grandparent, or legal 
guardian available to set up a trust, what are the next steps?
    Mr. Courtney. Well, the other option in current law is to 
go to a court to do that. And some courts have been reluctant 
or even unwilling to allow a competent person with no 
guardianship to come into court and ask to create a trust or 
have the court create the trust.
    Mr. Long. And if they did allow that, how long does it take 
to petition the court?
    Mr. Courtney. Well, it can takes months or up to a year 
depending or court delays and getting an attorney that would 
understand how to go forward and look at the statute, Federal 
statute, and understand those benefits to be able to approach 
the court. So it can take a lot of lawyers' fees and time and 
court resources for months.
    Mr. Long. So it might take a Ph.D. from MIT to be able to 
sort it out?
    Mr. Courtney. Yes, right. Or an experienced elder law 
attorney that understands those things.
    Mr. Long. Are there any additional costs that would be 
incurred?
    Mr. Courtney. Certainly there are court fees, there are 
lawyers' fees that would have to be paid to hire the lawyer to 
go to court and do that. And then there also might even be the 
need for that individual to pay for their own care during the 
interim if the benefits were cut off because they were 
determined to have too much money yet but not yet in a trust.
    Mr. Long. Can you give specific examples of an individual 
with a disability who has been unable to set up a Special Needs 
Trust without petitioning the court?
    Mr. Courtney. Who has been able to set up a Special Needs--
--
    Mr. Long. Yes. Do you have any examples of individuals that 
have been able to do this without having to petition the court?
    Mr. Courtney. Those individuals who have a surviving parent 
or grandparent, the parent or grandparent could sign the trust 
and----
    Mr. Long. Yes, but I am saying if they don't have the 
parent, the grandparent, or legal guardian.
    Mr. Courtney. No. They can't set up a Special Needs Trust 
if they don't have one of those four entities or people that 
can establish the trust.
    Mr. Long. That is kind of what I was thinking. Do you 
believe that current law which precludes individuals from 
setting up their own Special Needs Trust creates a presumption 
that these individuals lack the mental capacity to create their 
own trust?
    Mr. Courtney. That is exactly how the current law treats 
them, as though they were mentally incapable and incompetent to 
manage their own affairs.
    Mr. Long. And how would making this technical correction in 
the law provide more equitable treatment for individuals with 
disabilities?
    Mr. Courtney. It would allow mentally capable adult with 
physical disabilities to create the trust that Congress has 
recognized as an effective vehicle to hold assets and allow 
that person to do it without the complications of having to go 
through the court process as we mentioned and give them the 
same equity and fairness that other non-disabled adults are 
accorded by law.
    Mr. Long. Without going through this long arduous court 
process that we have ascertained is made to take forever and a 
day.
    Mr. Courtney. That is correct.
    Mr. Long. And it is hard to sort out.
    Mr. Courtney. Yes, sir. That is correct.
    Mr. Long. OK. Thank you all. Mr. Chairman, I yield back.
    Mr. Pitts. The chair thanks the gentleman.
    That concludes the questions from members who are present. 
We will have follow-up questions. We will send them to you in 
writing, other members who were not able to attend I am sure 
will send them. Please we would ask that you respond promptly. 
And that means that members, they have 10 business days to 
submit questions for the record. So members should submit their 
questions by the close of business on Friday, October 2.
    Thank you for your testimony. It has been very clear. You 
have been very, very excellent witnesses in this very important 
issue as we move forward.
    Without objection, the subcommittee is adjourned.
    Let me just add, I have a UC request here to submit the 
following documents for the record: letters from the National 
Academy of Elder Law Attorneys, collection of organizations in 
support of H.R. 670, Special Needs Trust Fairness Act, and a 
statement from Representative G.T. Thompson of Pennsylvania.
    Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. OK. The hearing is now adjourned.
    [Whereupon, at 10:22 a.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

              Prepared statement of Hon. Renee L. Ellmers

    I want to thank Chairman Pitts and Ranking Member Green, 
and the Committee for their focus today on improving the 
Medicaid program for beneficiaries. This vital safety net 
program has had many successes to date, but as my colleagues 
know Medicaid faces significant challenges as we work to 
modernize the program to ensure it is able to provide 
meaningful access to the most vulnerable patients for decades 
to come.
    While I generally support the bills under consideration 
today by the Subcommittee aimed at improving Medicaid patient 
access to care, I very much believe there is a missing 
component in this discussion.
    I found particularly noteworthy the GAO report this 
committee recently received which found that Medicaid enrollees 
face particular challenges in accessing certain types of care, 
such as obtaining specialty care or dental care. Additionally, 
GAO has previously reported that 38 States experienced 
challenges ensuring enough participating providers.
    These disturbing revelations point to a real policy need to 
address the holes in this vital safety net program and 
facilitate improvements to care among our nation's most 
vulnerable.
    With respect to specialty care, Congresswoman DeGette and I 
have been working on a bipartisan bill to improve Medicaid 
access to care and improve quality outcomes when it comes to 
medically necessary foot and ankle care. The HELLPP Act (H.R. 
1221) would remove Medicaid patient access barriers to the best 
trained and best educated physician specialists of the foot and 
ankle--podiatrists, also known as doctors of podiatric 
medicine.
    Our health-care system increasingly requires the skills of 
podiatrists because they play a critical role in treating lower 
extremity complications related to diabetes, peripheral 
arterial disease, obesity, arthritis, and other chronic 
conditions, as well as treating and preventing complications 
from these conditions. Take diabetes as an example: The early-
warning signs of diabetes are often found in manifestation of 
complications in the lower extremity. As such, podiatrists are 
frequently the first health-care provider to detect, treat, and 
therefore significantly prevent or reduce complications, such 
as lower-limb amputations.
    Foot and ankle care is already a covered benefit under 
Medicaid. However, access to that care is jeopardized because 
currently federal Medicaid law only includes part of the 
Medicare physician definition which results in not ensuring 
access to a podiatrist.
    The HELLPP Act would remedy this access barrier by 
referencing the same Medicare definition of physician to ensure 
that Medicaid patients-who disproportionately suffer from 
chronic conditions-have timely access to the most appropriate 
and best trained providers of foot and ankle care.
    A strong body of evidence shows that when podiatric 
physicians and surgeons are delivering foot and ankle medical 
and surgical care, patient outcomes are better, 
hospitalizations are fewer and shorter, and our health-care 
delivery system saves billions of dollars annually.
    The Energy & Commerce Committee has voted in favor of this 
Medicaid access provision in past legislation (2009). And just 
last congress our Senate colleagues included this podiatry 
access provision in that chamber's main Medicare SGR reform 
bills last congress.
    While the bills before the Subcommittee are important 
elements toward improving Medicaid for beneficiaries, there is 
more we can and should be doing. I very much hope we can take 
additional steps in the near future and also work to advance 
the HELLPP Act this congress.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 

                                 [all]