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98–433 2016

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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

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 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

DORIS O. MATSUI, California 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(V) 

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 

(1) 

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 Med- icaid 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 

2 

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. 

3 

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 

4 

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 

5 

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 AllInclusive 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-forservice 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. 

6 

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. 

7 

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 enVerDate Nov 24 2008 10:52 Mar 01, 2016 Jkt 037690 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-76 CHRIS
8 

sure 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:] 

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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 

16 

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:] 

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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 selfadvocacy 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 

24 

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:] 

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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? 

31 

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, 

32 

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 aver- age 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 

33 

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. 

34 

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 

35 

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. 

36 

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. 

37 

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. 

38 

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 

39 

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. 

40 

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 

41 

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? 

42 

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? 

43 

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 

44 

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? 

45 

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:] 

46 

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. 

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