[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]









    EXAMINING BIPARTISAN LEGISLATION TO IMPROVE THE MEDICARE PROGRAM

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 20, 2017

                               __________

                           Serial No. 115-47





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                    COMMITTEE ON ENERGY AND COMMERCE

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


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
TIM MURPHY, Pennsylvania             DORIS O. MATSUI, California
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)




















  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     2
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     6
    Prepared statement...........................................
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     7

                               Witnesses

Christel Aprigliano, CEO, Diabetes Patient Advocacy Coalition....    10
    Prepared statement...........................................    13
Brett Kissela, Professor of Neurology, Chair, Department of 
  Neurology and Rehabilitation Medicine, University of Cincinnati 
  Gardner Neuroscience Institution, On Behalf of American Academy 
  of Neurology...................................................    22
    Prepared statement...........................................    24
Lisa Bardach, Speech-Language Pathologist, ALS of Michigan.......    31
    Prepared statement...........................................    33
Varner Richards, Board Chair, National Home Infusion Association.    39
    Prepared statement...........................................    41
Mary Grealy, President, Healthcare Leadership Council............    46
    Prepared statement \1\.......................................    48
Justin Moore, CEO, American Physical Therapy Association.........    65
    Prepared statement \2\.......................................    67
Stacy Sanders, Federal Policy Director, Medicare Rights Center...    79
    Prepared statement...........................................    81
K. Eric De Jonge, President-Elect, American Academy of Home Care 
  Medicine (AAHCM)...............................................    87
    Prepared statement...........................................    89
Alan E. Morrison, Chair, Diagnostic Services Committee, National 
  Association for the Support of Long Term Care (NASL)...........    95
    Prepared statement...........................................    98
Deepak A. Kapoor, Chairman and CEO, Integrated Medical 
  Professionals..................................................   103
    Prepared statement...........................................   105
Cletis Earle, Chairman-Elect, CHIME Board of Trustees............   110
    Prepared statement...........................................   112

                           Submitted Material

Statement of the National Association for the Support of Long 
  Term Care, submitted by Mr. Guthrie............................   135
Statement of the American Speech-Language-Hearing Association, 
  submitted by Mr. Guthrie.......................................   143
Statement of the American Medical Association, submitted by Mr. 
  Burgess........................................................   149
Statement of the College of Healthcare Information Management 
  Executives, submitted by Mr. Burgess...........................   150
Statement of Health IT Now, submitted by Mr. Burgess.............   151
Statement of Intermountain Healthcare, submitted by Mr. Burgess..   153
Statement of United Surgical Partners, submitted by Mr. Burgess..   154
Statement of Steve Gleason, submitted by Mr. Burgess.............   155
Statement of the ALS Association, submitted by Mr. Burgess.......   157
Statement of the National Multiple Slerosis Society, submitted by 
  Mr. Burgess....................................................   159
Statement of Focus on Therapeutic Outcomes, Inc., submitted by 
  Mr. Green......................................................   164
Statement of the National Association of Rehabilitation Providers 
  and Agencies, submitted by Mr. Green...........................   167
Statement of the National Association for the Support of Long 
  Term Care, submitted by Mr. Green..............................   169
Statement of the American Physical Therapy Association, submitted 
  by Mr. Green...................................................   177
Statement of PTPN, submitted by Mr. Green........................   179
Statement of the Coalition to Preserve Rehabilitation, submitted 
  by Mr. Green...................................................   181
Statement of the Brain Injury Association of America, submitted 
  by Mr. Green...................................................   190
Statement of the American Medical Rehabilitation Providers 
  Association, submitted by Mr. Green............................   199
Statement of Covington, submitted by Mr. Bucshon.................   202
Statement of 12 advocacy groups on prostate cancer, submitted by 
  Mr. Bucshon....................................................   205

----------
\1\ Ms. Grealy's full statement can be found at: http://
  docs.house.gov/meetings/if/if14/20170720/106287/hhrg-115-if14-
  bio-grealym-20170720.pdf.
\2\ Dr. Moore's full statement can be found at: http://
  docs.house.gov/meetings/if/if14/20170720/106287/hhrg-115-if14-
  bio-moorej-20170720.pdf.

 
    EXAMINING BIPARTISAN LEGISLATION TO IMPROVE THE MEDICARE PROGRAM

                              ----------                              


                        THURSDAY, JULY 20, 2017

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:01 a.m., in 
room 2123, Rayburn House Office Building, Hon. Michael Burgess, 
M.D. (chairman of the subcommittee]) presiding.
    Present: Representatives Guthrie, Barton, Shimkus, Murphy, 
Blackburn, McMorris Rodgers, Lance, Griffith, Bilirakis, Long, 
Bucshon, Brooks, Mullin, Hudson, Collins, Carter, Walden (ex 
officio), Green, Butterfield, Matsui, Castor, Schrader, 
Kennedy, Eshoo, Degette, Pallone (ex officio), and Burgess.
    Staff Present: Kelly Collins, Staff Assistant; Jordan 
Davis, Director of Policy and External Affairs; Daryll Dykes, 
Health Fellow; Paul Edattel, Chief Counsel, Health; Adam Fromm, 
Director of Outreach and Coalitions; Jay Gulshen, Legislative 
Clerk, Health; Drew McDowell, Executive Assistant; Alex Miller, 
Video Production Aide and Press Assistant; James Paluskiewicz, 
Professional Staff, Health; Jennifer Sherman, Press Secretary; 
Danielle Steele, Policy Coordinator, Health; Evan Viau, Staff 
Assistant; Jeff Carroll, Minority Staff Director; Una Lee, 
Minority Senior Health Counsel; Samantha Satchell, Minority 
Policy Analyst; Andrew Souvall, Minority Director of 
Communications, Outreach and Member Services; and C.J. Young, 
Minority Press Secretary.
    Mr. Burgess. The Subcommittee on Health will now come to 
order.
    As a housekeeping note, there will be votes on the floor as 
we--probably before we conclude opening statements. The chair 
advises the members that we are keeping an eye on the floor, 
and when the votes are called, obviously, we will consider 
recessing at that point to reconvene immediately after votes.
    Before I recognize myself for an opening statement, I also 
want to acknowledge the majority counsel, this is her last 
hearing. We are going out with a bang with 11 witnesses today. 
But Danielle Steele has done a good job for us, but as they 
say, she is going to a better place over in the other body. But 
thank you, Danielle, thanks for your help on the committee.
    [Applause.]

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. I now recognize myself 5 minutes for an 
opening statement.
    Today, we are going to be discussing 11 bipartisan policies 
led by members of this committee. Each of these policies 
exemplifies our shared commitment to strengthening the Medicare 
program for its current beneficiaries and improving it for 
future generations.
    I would like to thank Representative Dingell for working 
with me on two of the bills that we will be considering today, 
H.R. 3120 and H.R. 3263. I have made it a top priority to 
improve the value of electronic health records for providers 
and patients. And I believe we have made some progress through 
the policies enacted in the Medicare Access and CHIP 
Reauthorization Act of 2015, as well as the 21st Century Cures 
Act of 2016. However, there is more to be done, and H.R. 3120 
will continue to move us in the right direction.
    Meaningful use requirements for physicians in hospitals in 
the Social Security Act demand that the Secretary seek to 
improve the use of electronic health records and health quality 
over time by requiring more stringent measures of meaningful 
use. Time has shown us that simply increasing the rigor of the 
standards does not improve the use of electronic health records 
or the quality of the healthcare delivered.
    As the Secretary has mandated to continue to raise the 
stringency of standards over time, more and more providers 
would possibly fall behind. Therefore, the only clear result of 
increasingly stringent standards for meaningful use has been an 
increasing need for the Department of Health and Human Services 
to grant more waivers. H.R. 3120 will simply remove the mandate 
that meaningful use standards become more stringent over time 
and allow the Department to be deliberative in determining how 
meaningful use can improve electronic health records and the 
quality of care.
    Over the past 5 years, the Independence at Home 
Demonstration program has provided Medicare beneficiaries with 
the unique opportunity to receive home health services that 
they would not otherwise have been able to access. Designed in 
a manner that requires home care providers to improve outcomes 
for patients while reducing the overall cost of care, the 
program continues to be a standard bearer for bipartisan 
collaboration in improving the delivery of care for seniors.
    H.R. 3263 would both extend the program for an additional 2 
years and allow providers currently participating in the 
program to increase the number of patients currently under 
management.
    I want to take a moment to speak to the two discussion 
drafts the subcommittee will also review today. I hope both of 
these drafts show that the committee is open to ideas on ways 
to reform the Medicare program, and is willing to put in the 
long-term bipartisan work necessary to fully develop these 
important policies. For example, reforming the payment system 
for the mobile collection of lab samples offers an opportunity 
to reduce spending and protect program integrity and to move to 
an episodic payment. I hope the committee will see each of 
these bills offers a common sense improvement to the Medicare 
program.
    There is one draft before us I hope we will not have to act 
on, and that is the discussion draft of another simple extender 
of the therapy caps exception process. Much like the 
sustainable growth rate formula, we have a policy inherent to 
the therapy cap that no one supports, and each year, we have to 
find offsets in the Medicare program to simply protect 
beneficiaries from a policy harmful to their access to 
treatment. Also, like the sustainable growth rate formula, this 
year-by-year approach is not cost effective, does not provide 
needed stability for providers and patients. As we did with the 
repeal of the sustainable growth rate formula, it is my hope 
that we can find a permanent policy solution for this issue. 
That work should start and be lead by this subcommittee. I hope 
members will examine these policies and provide feedback to the 
committee staff.
    I do want to thank all of our witnesses for being here 
today. I look forward to hearing from each of you on how these 
bills we are considering can improve the Medicare program.
    And I do want to recognize Mr. Bilirakis to speak on his 
bill.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Today we will be discussing eleven bipartisan policies led 
by members of this Committee. Each of these policies 
exemplifies our shared commitment to strengthening the Medicare 
program for current beneficiaries, and improving it for future 
generations. I would like to thank Representative Dingell for 
working with me on two of the bills we will be considering 
today-H.R. 3120, and H.R. 3263.
    I have made it a top priority to improve the value of 
electronic health records for providers and patients, and I 
believe we have made great progress through policies enacted in 
the Medicare Access and CHIP Reauthorization Act of 2015 as 
well as the 21st Century Cures Act of 2016. However, there is 
still more to be done and H.R. 3120 will continue to move us in 
the right direction.
    Meaningful use requirements for physicians and hospitals in 
the Social Security Act demand that the Secretary ``seek to 
improve the use of electronic health records and health care 
quality over time by requiring more stringent measures of 
meaningful use.'' Time has shown that simply increasing the 
rigor of standards does not improve the use of electronic 
health records or the quality of health care. As the Secretary 
is mandated to continue to raise the stringency of standards 
over time, more and more providers are likely to fall behind. 
Therefore, the only clear result of increasingly stringent 
standards for meaningful use has been an increasing need for 
HHS to grant more hardship waivers. H.R. 3120 will simply 
remove the mandate that meaningful use standards become more 
stringent over time and allow the Department to be deliberative 
in determining how meaningful use can improve the use of EHRs 
and the quality of care.
    Over the past 5 years, the Independence at Home 
Demonstration Program has provided Medicare beneficiaries with 
a unique opportunity to receive home health services that they 
would not otherwise be able to access. Designed in a manner 
that requires home care providers to improve outcomes for 
patients while reducing the overall of cost of care, the 
program continues to be a standard bearer for bipartisan 
collaboration in improving the delivery of care for our 
seniors. H.R. 3263 would both extend the program for an 
additional 2 years, and allow for providers currently 
participating in the program to increase the number of patients 
that they manage under it.
    I want to take a moment and speak to the two discussion 
drafts the subcommittee will also review today. I hope both 
show that the committee is open to ideas on ways to reform the 
Medicare program, and is willing to put in the long-term, 
bipartisan work necessary to fully develop these important 
policies. For example, reforming the payment system for the 
mobile collection of lab samples offers an opportunity to 
reduce spending, protect against program integrity 
vulnerabilities, and move to an episodic payment.
    I hope the committee will see each of these bills offer 
commonsense improvements to the Medicare program, but there is 
one draft before us that I hope we will not have to act on and 
that is the discussion draft of another simple extender of the 
therapy caps exception process. Much like the SGR we have a 
policy inherent to the therapy cap that no one supports and 
each year we must find offsets in the Medicare program to 
simply protect beneficiaries from a policy harmful to their 
access to treatment. Also, like the SGR, this year-by-year 
approach is not cost effective nor does it provide needed 
stability for providers and their patients. As we did with the 
SGR, it is my hope that we can find a permanent policy solution 
to this issue-that work should start and be led by this 
Committee.
    I hope members will examine these policies and provide 
feedback to the Committee staff.
    Thank you to all of our witnesses for being here today, I 
look forward to hearing how each of the bills we are 
considering can improve the Medicare program today and into the 
future.

    Mr. Bilirakis. Thank you very much, Mr. Chairman. I 
appreciate it so much. Thank you again for holding this 
hearing, and I thank the panel for their testimony.
    Last week, we had the largest healthcare fraud takedown in 
history. Four hundred twelve defendants were charged 
nationwide, including more than 80 cases in Florida, for 
Medicare fraud, totaling $1.3 billion in losses.
    Medicare is absolutely critical for seniors in my district 
and across the country. Not only is Medicare fraud an affront 
to hardworking taxpayers, it hurts the millions of seniors who 
rely on the program. That is why I introduced, along with my 
fellow Floridian, Kathy Castor, much needed legislation to 
strengthen penalties against those who commit fraud in the 
Medicare program.
    The Medicare Civil and Criminal Penalties Update Act, H.R. 
3245, cracks down on Medicare fraud and abuse by increasing 
civil and criminal fines. Some of these penalties have not been 
updated in over 20 years. We must ensure the Medicare program 
is strong and sustainable for today's and tomorrow's 
beneficiaries.
    I yield back, Mr. Chairman. Thank you.
    Mr. Burgess. The gentleman yields back. The chair yields 
back.
    The chair now recognizes the subcommittee ranking member, 
Mr. Green, 5 minutes for an opening statement, please.

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

    Mr. Green. Thank you, Mr. Chairman. And I welcome our 
witnesses today.
    Since 1965, Medicare has provided affordable health 
insurance coverage and access to the care for our Nation's 
seniors in most vulnerable populations. Few programs have 
improved the lives of Americans as significantly as Medicaid 
and Medicare. Fifty years ago, almost half of elderly Americans 
lacked health insurance, and now Medicare provides lifesaving 
insurance to nearly 100 percent of the adults over 65.
    Today, we are examining 11 bipartisan bills that aim to 
improve the Medicare program, particularly Medicare Part B, 
which covers physician, outpatient, laboratory, and some home 
health services, as well as durable medical equipment.
    One of the discussions we are actually considering will 
extend the therapy cap exceptions process. I have long 
supported repealing the therapy caps, which was enacted in 
1997, and harm some of the most vulnerable beneficiaries. I 
support extending the exceptions process at the very least, but 
I also want to be sure that all the extenders that are included 
in the Medicare Access and CHIP Reauthorization Act, MACRA, are 
set to expire at the end of the fiscal year or calendar year, 
are addressed in a timely fashion.
    Another bill we are considering is H.R. 1148, the 
Furthering Access to Stroke Telemedicine, or FAST Act, is 
worthy of our support. The bill will expand Medicare 
reimbursement for providers for stroke telemedicine services 
beyond those provided in rural areas. Telemedicine, in general, 
holds great promise to improve patient care and lower costs, 
and I am pleased to be part of the bipartisan telemedicine 
working group. Telestroke, in particular, can be critical 
service to patients who need access to a stroke specialist as 
soon as possible after an event.
    H.R. 849, the Protecting Seniors' Access to Medicare Act, 
will repeal the Independent Payment Advisory Board, the IPAB. 
While the recent Medicare Trustees' report concluded that the 
IPAB recommendation process wouldn't be triggered this year, it 
is still important that Congress move to repeal this ill-
conceived board. We should not be outsourcing our 
responsibility to manage and oversee the Medicare program. I 
opposed the IPAB when it was debated during the crafting of the 
Affordable Care Act, and it wasn't part of our bill when we 
passed it in the House, and strongly support its repeal.
    H.R. 3163, the Medicare Part B Home Infusion Services 
Temporary Transitional Payment Act, is another bill worthy of 
our support. It will provide temporary transitional payment for 
home infusion therapy under Medicare. The overpayment of the 
home infusion drugs was addressed in the 21st Century Cures, 
but the timing payment changes for drugs and services 
associated with their administration do not line up, 
potentially resulting in reduction of patient access. This bill 
fixes the problem by providing a temporary bridge from 2019 to 
2021, so patients who need home infusion therapy don't unduly 
lose access to the care they need.
    I also want to highlight H.R. 3271, Protecting Access to 
Diabetes Supplies Act. The bill would make improvements to 
Medicare's competitive bidding program for diabetes testing 
strips by strengthening patient protections and enhancing 
beneficiary choice. It would require CMS to enforce the 
requirement that suppliers provide at least 50 percent of all 
diabetes test supplies that are commercially available before 
implementing a competitive bidding program, prevent suppliers 
from coercing beneficiaries into changing their choice of test 
strips, and make it easier for patients to switch and receive 
different testing supplies if they want to. I have cosponsored 
this legislation in the past, and I will continue to support 
it.
    H.R. 2465, the Steve Gleason Enduring Voices Act, will 
permanently get rid of the durable medical equipment rental cap 
for speech generating devices. SGDs are exempt from the rental 
cap until October 1 of 2018. This bill would make the policy 
permanent. We should ensure beneficiaries who rely on SGDs have 
the access to their necessary and personalized communication 
technology, even if they reside in a nursing home or are 
hospitalized or in a hospice.
    Mr. Chairman, all 11 bills are bipartisan, and will improve 
Medicare participating providers, and more importantly, care 
for our beneficiaries. I look forward to hearing from these 
folks and I yield back the balance of my time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the chairman of the full committee, 
Mr. Walden of Oregon, 5 minutes for an opening statement, 
please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you. Thank you very much, Mr. Chairman. 
Thanks for holding this hearing.
    As we have heard, we are going to look at 11 bipartisan 
bills today as part of reforms to Medicare Part B. Each of 
these have been championed by different members on this 
subcommittee. We care deeply about them. We look forward to 
your testimony.
    Together, we seek to improve the care delivered to our 
Nation's seniors who rely on the Medicare program, whether that 
is by allowing them to stay in their homes and seek care 
through home infusion or receiving home call visits or the 
Independence at Home program.
    We want to improve these programs. We want to improve the 
integrity of them. We want to look at the vulnerabilities and 
the current laboratory fee schedule. We want to update the 
criminal and civil monetary penalties associated with Medicare 
fraud. Fundamentally, no crook should ever be less afraid of 
defrauding the Medicare program or taking advantage of a 
beneficiary simply because the penalties haven't been updated 
in decades. We need to make those penalties have teeth. And 
when we have an extremely successful program like competitive 
bidding, which has saved Medicare and its beneficiaries 
billions of dollars, proper oversight work of our committee 
should not stop. I always believe in oversight. I think it is 
important for programs that we pass, to make sure that they are 
being implemented appropriately, and for programs that have 
been there a long time, to make sure that they are working for 
the people they are intended to serve.
    Today, we will also seek to use the ability of providers to 
deliver care by allowing CMS flexibility in setting goals for 
meaningful use and discuss the permanent solution of the 
arbitrary cap on therapy services. I have heard about that from 
time to time. No doctor should be forced to counsel a patient 
to choose surgery over therapy because they might otherwise run 
out of therapy services.
    Finally, there are times when the current Medicare rules 
just don't make sense. For example, Medicare would take away 
the ability of a beneficiary to speak when their care setting 
changes. A time when communication is most important. Or 
Medicare's current policy that pays for the debilitating impact 
of a stroke and the long-term care services that follow in the 
Medicaid program, instead of paying a trained neurologist to 
examine a patient, providing a telestroke consult, and 
potentially avoiding the cost and the disability altogether.
    So I think all of these are common sense fixes. I believe 
my colleagues here would agree with that. It is more good work 
by this committee and by those of you who have brought these 
issues to our attention.
    We will also address the Independent Payment Advisory 
Board. While the Medicare Trustees have given us some added 
time, we should not delay abolishing this expropriation of 
congressional authority over the Medicare program.
    Finally, I want to thank Mr. Pallone and Mr. Green for 
their willingness to work with us on all of these efforts, and 
particularly, to begin the hard but necessary conversations 
surrounding a permanent policy on the therapy caps. Our 
committee has a long history of taking on these lingering 
problems and dealing with them by working together, and we have 
proven that this year, again, on a lot of different legislative 
fronts, and I look forward to continuing to do so.
    So, again, thanks to our witnesses for being here. And with 
that, I know Mrs. McMorris Rodgers wanted time, if she is able 
to get here from her leadership meeting, but between now and 
then, I would yield the balance to my friend and colleague from 
Tennessee, Mrs. Blackburn.
    Mrs. Blackburn. And I thank the chairman for yielding. And, 
Mr. Chairman, I thank you for this hearing. The topic is 
timely, as you can see, by the panel that is in front of us. 
You all look more like a football team up there ready to go to 
the game. And we are going to focus on a few areas.
    I have 19 counties in my district, 16 of which are rural. 
So looking at what we do with rural access is something that is 
going to be very important to me. And as the chairman outlined 
some of the changes that are in front of us, increasing that 
access to rural providers is going to be important. Rescinding 
flawed systems that really are doing harm rather than 
increasing access, we will want to focus on that, and then 
program integrity. I think you cannot underestimate that. It is 
important, not only to us, but to the providers, and there are 
questions that we are going to have for each of you. So 
welcome. Many of you have been before us before, so we 
appreciate the continued conversation.
    And, Mr. Chairman, I will yield back to the chairman.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the ranking member of the full 
committee, Mr. Pallone, 5 minutes for an opening statement, 
please.

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

    Mr. Pallone. Thank you, Mr. Chairman.
    Today, we will examine 11 bipartisan bills aimed at 
improving care in the Medicare program. Medicare plays a 
critical role in the lives of our Nation's seniors and disabled 
Americans, and it is so important that this committee continue 
to look for ways to strengthen the program and deliver the 
highest quality care to beneficiaries. And I commend the 
chairman for holding this hearing. I look forward to working 
with you on these measures as we move forward.
    First, I want to say I am pleased that we will be 
discussing H.R. 1148, the FAST Act, introduced by 
Representatives Joyce and Griffith. When it comes to stroke, 
every second counts. Stroke telemedicine, also known as 
telestroke, breaks down barriers to care, and is a valuable 
tool for combating our Nation's fifth leading cause of death.
    The FAST Act would expand coverage of telestroke services 
in the Medicare program so that beneficiaries can get the right 
treatment at the right time, no matter where they live. I look 
forward to hearing from Dr. Kissela today about the impact of 
expanding telestroke services in the Medicare program.
    Additionally, I am pleased that we have a discussion draft 
on extending the exceptions process and targeted manual medical 
review for physical therapy caps. It is long past overdue for 
us to have a serious discussion about a permanent policy to 
address these caps. In MACRA, we instructed CMS to eliminate 
manual medical review for all claims above the $3,700 
threshold, and instead put in place a targeted less burdensome 
review. I understand that this process is working quite well 
for both beneficiaries and providers, and I look forward to 
hearing from the American Physical Therapy Association today 
about how targeted medical review can be part of a long-term 
solution that both preserves access for beneficiaries and 
reduces the burden on providers.
    I also look forward to hearing from the National Home 
Infusion Association about H.R. 3163. Home infusion is a 
critically important service that allows Medicare beneficiaries 
to receive infusion drugs at home, rather than other more 
expensive and less convenient sites of care. I support H.R. 
3163, and I am glad that we have been able to work on a 
bipartisan basis on this important bill to ensure continued 
patient access to these important drugs at home.
    I also look forward to hearing from our witnesses on the 
other six bills and the discussion draft on mobile 
laboratories. All of these bills aim to make meaningful changes 
to the Medicare program by protecting beneficiaries, reducing 
provider burden, improving program integrity, or delivering 
comprehensive primary care services to Medicare beneficiaries 
in their home. And I look forward to learning more about these 
bills and working on a bipartisan basis to advance these 
efforts.
    And, finally, H.R. 849, introduced by Representatives Ruiz 
and Roe. This would repeal the Independent Payment Advisory 
Board, or IPAB. This is not the first time we have considered 
repealing IPAB. As I have said in the past, I am opposed to 
IPAB and would be in favor of abolishing it. However, unlike 
the past, I hope we can work in a bipartisan fashion to 
eliminate IPAB. It is my belief that Congress should not be 
ceding legislative authority to independent commissions like 
IPAB by allowing them to play more than an informational role.
    The Affordable Care Act strengthened the Medicare program 
and put it on the pad towards incentivizing value over volume. 
It lengthened the life of the Medicare trust fund and 
contributed to a lower rate of growth of Medicare expenditures. 
It is our job as legislators to continue this work to ensure 
that the program remains strong for future generations. It is 
not the job of an unelected commission.
    So I look forward to learning more from our witnesses about 
all the policies up for discussion today. And unless someone 
else wants my time--I don't think so. I will yield back the 
balance of my time.
    Mrs. McMorris Rodgers. Would the gentleman yield?
    Mr. Pallone. Oh, you want my time? Sure.
    Mrs. McMorris Rodgers. Could I, please? Thank you. Thank 
you. A little bipartisanship going on. I promise not to say 
anything that offends you too much.
    Thank you, Ranking Member Pallone, and everyone on the 
committee. In 2014, I heard from a concerned mom in my 
district, Gail Gleason, who told me a story about her son, 
Steve. Born and raised in Spokane, Washington, Steve was a 
college football and NFL star before being diagnosed with ALS 
in 2011. Gail was afraid outdated and practical Medicare 
payment regulations were preventing people like Steve from 
accessing critical technology, individualized speech generating 
devices. She was right.
    Under the rules issued by CMS, these speech generating 
devices were categorized and covered under a capped rental 
payment. However, if an individual was admitted to a nursing 
home, hospital, or hospice, payment abruptly ended, leading to 
severe access issues. To fix this, we introduced the Steve 
Gleason Act in 2015, which required Medicare to cover these 
devices as routinely purchased medical equipment. This allowed 
patients to continue communicating with their doctors, their 
caregivers, and their loved ones using this cutting edge 
technology, regardless of where they were being treated. Thanks 
to a great deal of hard work right here in this committee, it 
became law later that year.
    But we could only provide the relief for 2 years. The law 
is scheduled to sunset in 2018. This is why my legislation, 
which we will be discussing today, is so important. The Steve 
Gleason Enduring Voices Act makes the changes accomplished in 
the original Steve Gleason Act permanent. Without a permanent 
solution, the short-sided policy decisions previously made by 
CMS could again limit the ability of thousands of men and women 
living with these degenerative diseases to access their only 
means of communication, to tell their husbands, their wives, 
their children, that they love them.
    The Steve Gleason Enduring Voices Act gives a permanent 
voice to the voiceless. And as Steve Gleason says, it ensures 
there are no white flags.
    Thank you, and I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    This concludes with member opening statements. The chair 
would like to remind members that, pursuant to committee rules, 
all members' opening statements will be made part of the 
record.
    The floor is still in amendment debate, so we want to thank 
our witnesses for being here today, for taking time to testify 
before the subcommittee. Each witness will have the opportunity 
to give an opening statement, followed by questions from 
members.
    Today, we are going to hear from Ms. Christel Aprigliano, 
CEO of the Diabetes Patient Advocacy Coalition; Dr. Brett 
Kissela, Professor of Neurology, Chair, Department of Neurology 
and Rehabilitation Medicine, University of Cincinnati Gardner 
Neuroscience Institute, on behalf of the American Academy of 
Neurology; Ms. Lisa Bardach, Speech-language Pathologist, ALS 
of Michigan; Dr. Varner Richards, Board Chair, National Home 
Infusion Association; Ms. Mary Grealy, President, Healthcare 
Leadership Council; Dr. Justin Moore, CEO, American Physical 
Therapy Association; Ms. Stacy Sanders, Federal Policy 
Director, Medicare Rights Center; Dr. Eric De Jonge, President-
elect, American Academy of Home Care Medicine; Mr. Alan E. 
Morrison, Chair, Diagnostic Services Committee, National 
Association for the Support of Long Term Care; Dr. Deepak 
Kapoor, Chairman and CEO, Integrated Medical Professionals; Mr. 
Cletis Earle, Chairman-elect of the Board of Trustees of CHIME.
    We appreciate all of you being here today. And Ms. 
Aprigliano, you are now recognized for 5 minutes to summarize 
your opening statement, please.

   STATEMENTS OF CHRISTEL APRIGLIANO, CEO, DIABETES PATIENT 
  ADVOCACY COALITION; BRETT KISSELA, PROFESSOR OF NEUROLOGY, 
  CHAIR, DEPARTMENT OF NEUROLOGY AND REHABILITATION MEDICINE, 
 UNIVERSITY OF CINCINNATI GARDNER NEUROSCIENCE INSTITUTION, ON 
 BEHALF OF AMERICAN ACADEMY OF NEUROLOGY; LISA BARDACH, SPEECH-
 LANGUAGE PATHOLOGIST, ALS OF MICHIGAN; VARNER RICHARDS, BOARD 
    CHAIR, NATIONAL HOME INFUSION ASSOCIATION; MARY GREALY, 
 PRESIDENT, HEALTHCARE LEADERSHIP COUNCIL; JUSTIN MOORE, CEO, 
 AMERICAN PHYSICAL THERAPY ASSOCIATION; STACY SANDERS, FEDERAL 
  POLICY DIRECTOR, MEDICARE RIGHTS CENTER; K. ERIC DE JONGE, 
    PRESIDENT-ELECT, AMERICAN ACADEMY OF HOME CARE MEDICINE 
     (AAHCM); ALAN E. MORRISON, CHAIR, DIAGNOSTIC SERVICES 
 COMMITTEE, NATIONAL ASSOCIATION FOR THE SUPPORT OF LONG TERM 
  CARE (NASL); DEEPAK A. KAPOOR, CHAIRMAN AND CEO, INTEGRATED 
MEDICAL PROFESSIONALS; AND CLETIS EARLE, CHAIRMAN-ELECT, CHIME 
                       BOARD OF TRUSTEES

                STATEMENT OF CHRISTEL APRIGLIANO

    Ms. Aprigliano. Thank you.
    Good morning, Chairman Burgess, Ranking Member Green, and 
members of the subcommittee. My name is Christel Marchand 
Aprigliano, and I am speaking to you today as the CEO of the 
Diabetes Patient Advocacy Coalition and as a person with 
diabetes. I am delighted to be here today to talk with you 
about and urge you to enact 3271.
    Today, more than 30.3 million Americans are known to have 
diabetes, with an estimated 84.1 million diagnosed with 
prediabetes. According to CDC calculations, 1 in 3 Americans 
will have diabetes by 2050. And we are on the cusp of a severe 
health crisis.
    The cost of this disease's well-known debilitating 
complications, including heart disease, blindness, nerve 
damage, kidney damage, and amputations, are common among people 
with mismanaged diabetes, and are associated with extraordinary 
consumption of health services. The Medicare program bears much 
of this financial burden. It is also well-known that the tight 
blood glucose control can reduce the risk of these developing 
complications.
    Medicare's competitive bidding program, while saving money 
on diabetes testing products, may be hindering the ability to 
achieve this important control and causing problems that lead 
to higher costs elsewhere within the program. Diabetes testing 
supplies--blood glucose monitors, test strips, lancets, et 
cetera--were included in the first rounds of CBP. Before the 
CBP, Medicare paid between $34 and $38 for a box of 50 test 
strips. Today, Medicare pays $8.32 for a box of 50 test strips. 
For beneficiaries, this remarkable savings makes it easier to 
afford supplies, and I applaud you for that.
    But, while the lower price yields substantial immediate 
savings, it comes at a cost for beneficiaries and for the 
program elsewhere. Since implementation of the national mail 
order CBP in 2013, Congress has seen reports indicating that 
beneficiary access to diabetes testing supplies has dropped 
significantly.
    Recent studies by the IG for the Department of Health and 
Human Services show that the most commonly prescribed testing 
systems, before implementation of the CBP, are now no longer 
available via mail order. Why? Under the CBP, suppliers are 
paid the same amount by Medicare for diabetes testing supplies, 
regardless of which brand they offer. Medicare is incentivizing 
suppliers only to offer the least costly supplies available.
    I have heard from beneficiaries who report suppliers trying 
to switch them to a different blood glucose monitor, presumably 
because those systems are cheaper for the supplier. The 
beneficiary is switched to an unfamiliar meter and despite the 
antiswitching protections. These are not the meters that they 
have been recommended and trained on by health professionals.
    When a patient, particularly an older patient, is given an 
unfamiliar technology, they may not be nimble enough to make 
the transition. They can get frustrated and stop testing. 
Unfortunately, on top of that, if that testing system is of 
inferior qualify, as they too often are, the threat to regular 
and accurate testing is even greater. A recent study by the 
Diabetes Technology Society brings to light the consequences of 
this incentive.
    The data shows that more than 60 percent of the strips 
furnished to beneficiaries between October and December of 
2016, failed the study's accuracy standards, which are the 
FDA's accuracy standards. In other words, more than half the 
systems paid for by Medicare during the last quarter of 2016 
can't be relied on to produce accurate and consistent blood 
glucose readings, according to the study's standard.
    Insulin and oral medications are lifesaving, but they can 
also be harmful, even fatal when misdosed. Inaccurate blood 
glucose readings can cause overdoses and underdoses of insulin 
or oral medications, sending people to the ER and costly 
hospitalization stays.
    If the majority of test systems furnished to beneficiaries 
can no longer be relied upon to produce accurate results, we 
are no longer on the cusp of the public health crisis we see. 
We are in the midst of it, and Medicare is going to bear the 
financial brunt.
    I am not here today advocating for Congress to eliminate 
the CBP. Policy behind Medicare's competitive bidding program 
is sound, shouldn't be abandoned. I do, however, believe it can 
and should be improved to ensure the safety of people with 
diabetes.
    There are a number of steps that Congress should take to 
address these concerns. H.R. 3271 is a step in the right 
direction. Congress and CMS establish beneficiary protections, 
like the 50 percent and antiswitching rules, to prevent the 
shift in product access and deterioration in product quality. 
Nonetheless, these protections clearly are not properly 
implemented and also not sufficient. H.R. 3271 would strengthen 
these existing patient protections and establish new ones to 
better protect Medicare beneficiaries.
    As a person living with diabetes since 1983, I rely on 
access to accurate blood glucose testing systems to mitigate 
both short- and long-term complications. For the more than 8 
million Medicare beneficiaries in my diabetes community, I 
respectfully urge you to enact H.R. 3271 to ensure access to 
these blood glucose monitoring systems.
    Thank you for the honor and the opportunity to speak with 
you today. I am delighted to answer any of your questions.
    [The prepared statement of Ms. Aprigliano follows:]
 
 
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    Mr. Burgess. The chair thanks the gentlelady for your 
testimony.
    Dr. Kissela, you are recognized for 5 minutes, please.

                   STATEMENT OF BRETT KISSELA

    Dr. Kissela. Chairman Burgess, Ranking Member Green, and 
others members of the committee, thank you for the opportunity 
to testify today on behalf the American Academy of Neurology 
about the FAST Act of 2017, the Furthering Access to Stroke 
Telemedicine Act.
    I am a stroke neurologist. And as a neurologist, I care for 
many neurologic diseases, and I am very supportive of the bills 
that are being presented here today, many of which affect 
neurologic patients. But I have extra training and expertise in 
vascular problems of the brain, the most common of which is 
stroke.
    I am going to focus today on ischemic stroke, which is 90 
percent of all strokes, and that occurs when a blood clot 
blocks one of the arteries going to the brain so that the 
downstream tissue is not getting the blood with the oxygen that 
it needs to survive. And that brain tissue is, in a sense, 
dying, suffocating, I tell patients, if we can't do something 
about it. Luckily, we can do something about it.
    We have very successful treatments that we can implement in 
a short timeframe after the stroke starts. We have the clot-
busting drug, tPA, or alteplase, that can be given by a vein, 
and break open the blood clot and restore flow, sending people 
home normal who otherwise might be disabled. And we have 
catheter-based treatment for the largest strokes, which we have 
just literally learned how to use effectively in the last few 
years, to handle the most disabled people who would otherwise 
be impaired by stroke.
    What we have learned over the years with our new treatments 
is that time is brain. Every minute counts. If we waste time 
and have delays, we will have worse outcomes. In fact, if we 
can shorten the time from stroke onset to treatment by 15 
minutes, an additional 5 percent of patients will go home 
normal, as opposed to being disabled by their stroke. So time 
is brain.
    Telestroke is a form of telemedicine that we use to do 
acute stroke evaluations, and it is a tool that saves lives and 
will ultimately save money by improving the outcome for our 
stroke patients.
    I work in Cincinnati, and I will tell you about a typical 
night on call. We have a very unusual situation in our city 
where we have a stroke team that serves the entire region, 27 
hospitals, that are not only in the greater metropolitan area 
of Cincinnati, which includes southeastern Ohio, but also parts 
of Indiana and northern Kentucky. And when there is a stroke at 
one of those hospitals, they give us a call, and we try and 
offer our therapy.
    When I started 20 years ago, we only had phone calls. We 
would take the information as best we could, try and make a 
good decision. If it was at a local hospital, we would drive 
out and make a good decision by evaluating the patient, but 
that wasted valuable time. Now we have telestroke. We started 
with our outlying hospitals, and now we are doing it throughout 
the entire region, because this is the right thing to do. It 
saves time and saves brain and improves the outcome.
    Ninety-four percent of all strokes happen in urban and 
suburban areas, not in rural areas. And therefore, we would 
like to provide Medicare reimbursement for telestroke to all 
stroke patients.
    One of my stroke calls recently was a Saturday night. This 
is how I spend my Saturday nights. I was treating a patient who 
had a large stroke, a health teacher from northern Kentucky, 
who we were able to take his clot out and save him from a 
lifetime of disability, and he is teaching junior high students 
about stroke.
    In the middle of that case, another call came in from, in 
fact, a 35-year-old mother of two. Her husband is an EMT, so he 
saves lives every day by bringing people in on the ambulance, 
and we were called to try and save his wife, who he knew very 
well was having a stroke. By telemedicine, I was able to 
evaluate her quickly, make the right decision, and we saved her 
from being paralyzed on the right and unable to speak to now 
being able to be fully normal, taking care of her family, and 
telling her children that she loves them. They also run a 
charity in Haiti, and they are helping poor people there. 
Thankfully, this woman can still do that. And that is the power 
of telestroke.
    Telestroke will save money. It has been estimated by the 
American Heart and Stroke Association, that the FAST Act could 
save the healthcare system as much as $1.2 billion over the 
next 10 years, if approved. The cost of stroke is all on the 
downstream time. When someone is disabled by stroke and has to 
live in a care facility, that is what the true expense is. 
Telestroke can mitigate this cost. One study of cost utility of 
telestroke networks estimated that by implementing across an 
entire region, more than $1,400 per patient could be saved, 
even after accounting for the cost of implementing the network 
and administering additional treatments.
    The standard of care of stroke has changed, and we have 
improved our ability to treat this devastating disease. And now 
we have a new tool that can help us do it faster and better and 
save money. I would urge that the FAST Act be approved in that 
we have a new standard of care, and the reimbursement model 
should align with that standard of care to incentivize people 
to set up telestroke in all parts of this country and treat all 
Americans with stroke.
    Thank you for your attention to stroke, which is a terrible 
disease that I am very passionate about treating. On behalf of 
the American Academy of Neurology, I greatly appreciate the 
thought and deliberations that went into the development of 
this bill, as well as the opportunity to express our strong 
support at today's hearing. Thank you.
    [The prepared statement of Dr. Kissela follows:]
    
    
    
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    Mr. Burgess. Thank you, Doctor. Thank you for your 
testimony.
    Ms. Bardach, you are recognized for 5 minutes for your 
opening statement, please.

                   STATEMENT OF LISA BARDACH

    Ms. Bardach. Imagine that you have suffered a severe stroke 
or that you are living with ALS. You have been robbed of your 
ability to speak and write. You no longer have control over 
your body. You are completely aware of your surroundings and 
you understand everything that is happening to you. Your son 
comes home from high school and announces that he has just been 
elected class president. You are so proud, but you cannot tell 
him this. Later that evening, as your wife helps you get ready 
for bed, you want to tell her how much you love her. You want 
to tell her how proud you are of the children that you have 
raised, but you cannot do this.
    Communication devices help people talk. This is how 
individuals participate in the myriad of communication 
opportunities that arise every day.
    My name is Lisa Bardach, and I am the speech-language 
pathologist at ALS of Michigan. I am also the owner of a 
private practice called Communicating Solutions, in Michigan, 
that provides evaluation and treatment for people who need 
communication devices. And I am here on behalf of Team Gleason 
as well. But mostly, I am here on behalf of everybody in the 
United States who needs a communication device in order to be 
able to speak.
    People who are unable to communicate verbally use 
communication devices, also known as speech generating devices, 
or SGDs. These are electronic means of communication, and a 
person uses them to speak by accessing stored messages or by 
creating new utterances using pictures, words, text, spelling, 
or any combination thereof. I am here to ask you to support the 
Steve Gleason Enduring Voices Act of 2017, H.R. 2465.
    Steve Gleason, a former NFL player who is living with ALS, 
has provided a tremendous amount of support and inspiration for 
people across the country. But ALS only represents a small 
percentage of people who need communication devices. 
Individuals with multiple sclerosis, Parkinson's disease, 
stroke, cerebral palsy, traumatic brain injury, autism, and 
quite a number of other conditions require communication 
devices.
    Communication devices have been a covered benefit under 
Medicare since 2001. The Steve Gleason Enduring Voices Act of 
2017 permanently reinstates communication devices into the 
payment category that they were originally determined under the 
national coverage decision in 2001. And it also ensures that 
users will have access to the necessary and personalized 
communication technology, regardless of their setting. So if 
they have to leave their home to go to a nursing home or a 
hospice or a hospital, they can take their technology with 
them.
    In 2001, CMS put these devices under the category of 
frequently purchased, meaning Medicare paid one lump sum and 
the beneficiary owned the device, and, therefore, if he or she 
changed residences, that communication technology could go with 
him. In 2014, these devices were placed in the category as 
capped rental. Make no mistake about it, Medicare still covered 
these devices, but the payment was amortized over 13 months in 
the rental period, and, therefore, if at any point during that 
rental period the beneficiary had to change residences, they 
couldn't take their technology with them because Medicare 
stopped paying for it. This resulted in patients delaying 
necessary and critical services. It resulted in them being 
afraid that they would have to relinquish their devices at the 
most vulnerable time in their lives. It resulted in people 
dying without being able to tell the people around them that 
they loved them.
    I would like to share with you the words of Diane, who is a 
stroke survivor. She had a brain stem stroke at age 22. She 
says: I am writing this to you with the help of my mother who 
is writing down words I want to say from nodding my head to the 
alphabet. This is very time consuming and tedious for both of 
us. It seems like forever that my device has been in repair, 
and I am miserable without it.
    Deanna is a person living with ALS. She came to me for a 
communication device in late 2014 when capped rental was in 
place. She was deathly afraid that she would lose the device if 
she got it funded under Medicare. Team Gleason purchased that 
device and amount for her. She continues to use it to this day. 
She wrote to me last night: I have complete peace of mind, as 
does my husband, that if I were to be hospitalized, my device 
would remain active. I can be fully independent in conveying my 
thoughts and desired actions in what may be my most critical 
time.
    Losing a voice under capped rental has an impact that is 
absolutely incalculable. No one knows if or when their 
situation will change. The only way to keep a personally 
configured communication device with the individual who needs 
it at all times is upfront purchase. While the consequences of 
capped rental were unintended, they were deadly.
    I would like to end by sharing a note that I received from 
the family of one ALS patient 1 week after she died. It said: 
Dear Lisa, Debbie's last words were spoken on the ALS eye 
gazer, communication device, 2 hours before she passed. Love 
you all. That included you and the ALS staff, I am sure. 
Thanks.
    Please help ensure that patients who cannot speak have 
unrestricted access to the communication devices they require 
and pass the Steve Gleason Enduring Voices Act of 2017.
    [The prepared statement of Ms. Bardach follows:]
   
   
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    Mr. Burgess. The chair thanks the gentlelady for her 
testimony.
    Dr. Richards, you are recognized for 5 minutes for an 
opening statement, please.

                  STATEMENT OF VARNER RICHARDS

    Dr. Richards. Subcommittee Chair Burgess, Subcommittee 
Ranking Member Green, and members of the subcommittee, thank 
you for inviting me to share the National Home Infusion 
Association's, which I will refer to as NHIA in the further 
part of my discussion, insights on H.R. 3163, the Medicare Part 
B Home Infusion Services Temporary Transitional Payment Act.
    My name is Varner Richards, and I serve as the chair of the 
NHIA board of directors. NHIA is a trade association that 
represents providers of home infusion therapy and other 
companies that supply and otherwise support the delivery of 
infusion therapy in a patient's home. I am also the owner and 
CEO of Intramed Plus, Inc., a home infusion provider in the 
State of South Carolina. We provide services statewide to 
patients in South Carolina and border counties of North 
Carolina from three home infusion pharmacies in Columbia, 
Greenville, and in Charleston. I am also a clinician. I have 
been directly involved with providing infusion services for 
patients in their homes for over 30 years.
    Home infusion is basically defined as a medication being 
infused through a needle or catheter in a patient in their home 
setting. It is usually prescribed for patients where their 
conditions cannot be treated effectively by oral medications. 
Typically, the infusion therapy means the drug is administered 
intravenously, but can also be subcutaneously for certain 
therapies, which is an infusion under the skin.
    Under Medicare Part B DME home infusion coverage, there is 
a limited number of drugs which cover a very small patient 
population. This small population, even though these patients 
suffer from life-threatening illnesses, which include cancer, 
cancer-related pain, viral, fungal infections, immune 
deficiency, and end stage congestive heart failure. For our 
discussions today, I am focused on the Medicare Part B DME 
infusion coverage. Medicare Part B provides coverage under the 
durable medical equipment benefit for a limited set of home 
infusion therapies.
    Before the passage of 21st Century Cures Act, the program 
specifically covered drug, pump, and supplies. There was no 
coverage for home infusion professional services. The available 
drug margin subsidizes payments for some of the home infusion 
professional services. With the passage of the 21st Century 
Cures Act, the Medicare B coverage had two important changes.
    First, the drug reimbursement methodology, which changes in 
the average sales price to align with drug payment with the way 
physicians receive--offices were currently reimbursed. This 
eliminated any drug margin to subsidize clinical services, and 
it became effective January 1, 2017.
    Secondly, a professional clinical service fee was added to 
cover the clinical services for these patients' therapies, and 
that was excellent. The difficulty was scheduled to take effect 
in 2021. We applaud the committee with this addition of this 
important professional fee to ensure these patients received 
effective care in their own home.
    The gap of 4 years between these two implementation dates 
of these provisions needed to be addressed in order to preserve 
access to these medications for home infusion patients until 
2021. Last year, members of this committee pledged to resolve 
this issue this year.
    We thank the committee for your commitments to work on this 
gap transition issue, and that is why we are here today. The 
Medicare Part B Home Infusion Services Temporary Transitional 
Payment Act, H.R. 3163, was introduced on July 6, and 
provisions from this bill was included in H.R. 3178, which was 
recently marked up by the Ways and Means Committee. NHIA knows 
that the legislation marked up by the Ways and Means Committee 
included technical corrections to H.R. 3163, and that this 
committee supports those technical corrections as does NHIA.
    The bill will allow the most vulnerable of patients to 
continue to have access to lifesaving home infusion therapy. 
This legislation will create a temporary transitional payment 
beginning January 1, 2019, the professional services related to 
part B, DME infusion drugs. NHIA supports H.R. 3163 and urges 
passage of the bill.
    While we are discussing part B home infusion drugs, I would 
be remiss if I did not note that most infusion drugs are 
covered by Medicare part D. Medicare part D reimburses 
providers for drug and drug only. It does not cover the 
specialized infusion-related services and equipment and 
supplies. NHIA has and continues to seek and fix this issue as 
part of the Medicare Home Infusion Site of Care Act. 
Congressman Eliot Engel has been a long-time champion of this 
legislation, as you know, with Congressman Pat Tiberi of the 
Ways and Means Committee.
    Thanks to the committee and your staff for the hard work to 
get this legislation prepared for the consideration today. NHIA 
knows that the legislation is very technical in nature, and we 
commend all who are involved in this effort.
    Thank you for your time today, and please accept NHIA's 
support, the home infusion community's support, my company's 
personal support, and all Medicare beneficiaries who benefit 
from this in support of H.R. 3163. Thank you.
    [The prepared statement of Dr. Richards follows:]
   
   
   
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    Mr. Burgess. The chair thanks the gentleman.
    Ms. Grealy, you are recognized for 5 minutes, please, for 
an opening statement.

                    STATEMENT OF MARY GREALY

    Ms. Grealy. Chairman Burgess, Ranking Member Green, members 
of the committee, thank you for the opportunity to testify this 
morning.
    I am speaking today on behalf of the members of the 
Healthcare Leadership Council, comprised of chief executives of 
innovative companies representing every sector of American 
healthcare.
    One of HLC's foremost priorities is the attainment of a 
strong, sustainable, and patient-centered Medicare. And so we 
applaud the committee for your focus on bipartisan solutions to 
improve the program. We believe an initial and critical step in 
making Medicare stronger is to remove an entity that threatens 
to seriously weaken it.
    The Independent Payment Advisory Board, or IPAB, was 
created with the ostensible purpose of controlling Medicare 
spending. But it does so in a way that does not improve the 
health of Medicare beneficiaries. It does not add value to the 
Medicare program, and does not respect the prerogative of the 
elected members of the legislative branch to set Medicare 
policy.
    The Medicare Trustees report released last week, as we all 
know, did not project Medicare spending levels that triggered 
IPAB into action this year. We are fortunate that that has not 
yet occurred. Even though neither President Obama nor President 
Trump has nominated members to the board, the Secretary of 
Health and Human Services still has the legal responsibility to 
initiate the process. That would almost certainly lead to 
arbitrary cuts in what Medicare pays for healthcare services.
    Now, when that process inevitably occurs with its resulting 
cuts to Medicare, we know that the gap between what private 
insurance pays physicians to treat patients and what Medicare 
pays will continue to widen. And this will lead to a future in 
which an expanding Medicare beneficiary population will have 
much greater difficulty finding a physician. Even today, two of 
my personal physicians in Maryland have posted notices in their 
waiting rooms saying that they are no longer taking new 
Medicare patients. IPAB, if implemented, will worsen this 
access problem.
    Nearly 800 organizations representing patients, healthcare 
providers, seniors, employers, veterans, Americans with 
disabilities, and others, are asking Congress to do away with 
the Independent Payment Advisory Board before harm is done to 
Medicare beneficiaries. Fortunately, there is bipartisan 
legislation pending before Congress to do just that.
    H.R. 849, the Protecting Seniors' Access to Medicare Act, 
sponsored by Representatives Phil Roe and Raul Ruiz, is being 
cosponsored by a majority of the House. It should also be noted 
that similar legislation has been introduced in the Senate, and 
that a majority of that body has cosponsored one or more of the 
repeal bills and resolutions that are under consideration.
    But I want to call your attention to the joint resolution, 
H.J. Res. 51, which Congressmen Roe and Ruiz have also 
introduced. There is an unusual provision in the IPAB 
authorizing legislation that allows both Houses of Congress to 
enact a joint resolution by August 15, 2017, which would 
eliminate the IPAB threat once and for all. This joint 
resolution would be fast tracked with no amendments and no 
filibuster allowed in the Senate. We strongly urge lawmakers to 
take advantage of this one-time opportunity that was written in 
to the original law.
    Steps do, of course, need to be taken to make Medicare a 
more value-focused program, to be a more effective combatant 
against rising rates of chronic disease, to save money in the 
long run by helping beneficiaries become healthier and lessen 
their need for hospitalizations and emergency room visits.
    Today you are considering bipartisan legislation that will 
do just that. IPAB with its rapid and indiscriminate approach 
to healthcare spending cuts will not.
    We also believe very strongly that Medicare decision-making 
should be in the hands of the public's elected representatives. 
It does not matter if a future Independent Payment Advisory 
Board is filled with imminently qualified appointees. It also 
does not matter if, in lieu of a board, that power rests with a 
Democratic or Republican HHS Secretary. What does matter and 
what should be opposed is the idea of moving Medicare policy 
making farther away from the millions of Americans who will 
feel the impact of these changes.
    Congress has shown repeatedly, and most recently through 
the MACRA legislation from this committee, that it will act in 
a bipartisan fashion to improve healthcare for Medicare 
beneficiaries. And it is with Congress that this authority 
should remain.
    Thank you again for this opportunity to testify, and I look 
forward to your questions.
    [The prepared statement of Ms. Grealy follows:]
    
    
    
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    [Ms. Grealy's full statement can be found at: http://
docs.house.gov/meetings/if/if14/20170720/106287/hhrg-115-if14-
bio-grealym-20170720.pdf.]
    Mr. Burgess. The chair thanks the gentlelady for her 
testimony.
    Dr. Moore, you are recognized for 5 minutes, please, for an 
opening statement.

                   STATEMENT OF JUSTIN MOORE

    Dr. Moore. Chairman Burgess, Ranking Member Green, and 
members of the Health Subcommittee, my name is Justin Moore, 
CEO of the American Physical Therapy Association. On behalf of 
the American Occupational Therapy Association, the American 
Speech-Language-Hearing Association, and APTA, thank you for 
this opportunity to provide testimony on bipartisan legislation 
to strengthen and improve the Medicare program.
    Today, I will outline our shared perspective on the 
exceptions process to the therapy caps set to expire at the end 
of this year.
    Without action, Medicare will impose financial limitations 
on outpatient physical therapy and speech-language pathology 
and occupational therapy services under Medicare Part B. These 
therapy caps create an arbitrary barrier for Americans who are 
in need of rehabilitation services.
    For 20 years, Congress and this committee have provided 
relief to this barrier through moratoriums and, more recently, 
the exceptions process, which is currently under consideration 
for yet another extension.
    Today, we ask Congress to finally address this issue by 
repealing the therapy caps once and for all. We would like to 
thank Representatives Blackburn and Matsui from this committee, 
Representatives Paulson and Kind, for championing the repeal of 
therapy cap legislation by introducing H.R. 807, which 
currently has 177 cosponsors in the House.
    This pattern of yearly extensions, without a permanent 
solution, creates uncertainly for beneficiaries and providers, 
threatens access to care, and is not in the best interest of 
patients, providers, or the Medicare program. We recognize and 
appreciate that there is a cost to any permanent fix. However, 
the price of solving this problem will only continue to rise. 
With the money spent on these temporary patches over the past 2 
decades, we could easily have paid for a more permanent 
solution.
    ASHA, APTA, and AOTA have been effective partners with 
Congress, this committee, and CMS on this policy over the past 
20 years. We have made significant reforms to preserve the 
integrity of the Medicare program, while simultaneously 
preserving access for beneficiaries. We believe it is time for 
Congress to finally repeal the therapy caps and replace them 
with a thoughtful medical review process that is more targeted, 
ensures that care is delivered to vulnerable patients, 
streamlines the ability of providers to deliver that care, and 
ensures the long-term viability of the Medicare program. Such a 
policy should build upon the lessons learned, the multiple 
reports, and the data gathered through the current exceptions 
process, as well as the current and previous medical review 
programs.
    Representatives from the three therapy groups have been in 
discussions with this committee about ideas for a permanent 
solution. Data shows that the $3,700 threshold and current 
medical review process is providing appropriate oversight of 
therapy spending, and could be improved and incorporated into a 
permanent solution to ensure the continuum of care and decrease 
administrative burdens. This policy per form, coupled with a 
pathway for therapy providers to be part of value-based models, 
will better align therapy services with the transition of 
Medicare to performance-based models.
    To that end, we respectfully propose three principles for a 
permanent fix. First, ensuring patient access. Any permanent 
cap policy should, at its core, ensure patient access to 
outpatient therapy services without unnecessary delays. The 
fundamental flaw in the therapy caps is that it is a barrier 
that does not take into account the individual needs of the 
patient.
    Principle two is a targeted approach to oversight of 
outpatient therapy spending. We support a mechanism to ensure 
appropriate delivery and utilization of outpatient therapy 
services. This can include targeted medical review of therapy 
providers whose claims exceed the $3,700 threshold and who have 
been identified based on specific criteria for additional 
review. However, such oversight should include protections for 
patients and ensure care is not delayed. Blanket mechanisms, 
such as the original therapy cap, or broad application of prior 
authorization, are not effective, restrict access, and 
interrupt the continuum of care.
    Principle three is the alignment with value-based and 
performance-based models. We believe therapy services provided 
in a qualified alternative payment model should be exempt. 
Providers that participate in APMs would already be subject to 
quality and outcome requirements, as well as shared risk for 
the cost of care. In addition, therapy providers are not 
currently part of the MIPS program, but we anticipate being 
added to that program in 2019. A permanent fix is critical to 
effectively bringing therapy providers into value-based 
programs.
    In closing, the therapy community stands ready to work with 
this committee to finally, after 20 years of extensions and 
moratoriums, repeal the therapy cap and find a permanent fix. 
Thank you for your time.
    [The prepared statement of Dr. Moore follows:]




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    [Dr. Moore's full statement can be found at: http://
docs.house.gov/meetings/if/if14/20170720/106287/hhrg-115-if14-
bio-moorej-20170720.pdf.]
    Mr. Burgess. The chair thanks the gentleman for his 
testimony.
    Ms. Sanders, you are recognized for 5 minutes for your 
opening statement, please.

                   STATEMENT OF STACY SANDERS

    Ms. Sanders. Chairman Burgess, Ranking Member Green, and 
distinguished members of the Subcommittee on Health, thank you 
for the invitation to testify. We applaud the committee for 
identifying bipartisan opportunities to improve Medicare.
    The Medicare Rights Center is a national nonprofit consumer 
service organization that works to ensure affordable access to 
healthcare for older adults and people with disabilities 
through counseling and advocacy, educational programs, and 
public policy initiatives. Since 1989, we have been helping 
people with Medicare understand their rights, navigate their 
benefits, and secure the quality healthcare they deserve.
    Medicare Rights answers nearly 20,000 questions on its 
national helpline every year, and nearly 3 million Americans 
turn to our online tool Medicare Interactive. This free 
Medicare encyclopedia explains basic Medicare concepts and 
rules written to a fifth grade reading level. We regularly work 
with congressional offices as well who call us for assistance 
on constituent casework, and we welcome the opportunity to 
serve as a resource to the committee and beneficiaries 
nationwide.
    My testimony focuses on our support for the Medicare Civil 
and Criminal Penalties Update Act of 2017, H.R. 3245. Fraud not 
only harms the Medicare program and the American taxpayer, but 
can have a very real impact on the lives of individual 
beneficiaries. In order to deter fraud and abuse, this bill 
would increase the civil monetary penalties, fines, and 
sentences allowable for specific types of Medicare fraud, such 
as the submission of false claims and the acceptance of 
financial inducements.
    Let me expand on why Medicare fraud is deeply problematic. 
For people with Medicare, fraud and abuse can lead to 
exploitation in the form of increased costs, including 
overcharging for services or even paying for care that was 
never delivered. Seniors and people with disabilities may also 
be harmed if they receive unnecessary services or if needed 
care is withheld. Fraud and abuse also lead to increased and 
inappropriate spending of taxpayer dollars.
    It is critically important that Congress prioritize 
policies to prevent and deter fraud and abuse. Existing 
oversight and enforcement initiatives have proven successful. 
Over the last 3 years, the Office of Inspector General and its 
partners recovered more than $6.10 for every dollar dedicated 
to healthcare fraud investigations. Of course, these or any 
enhanced recovery efforts must be implemented carefully so as 
not to inadvertently curb access to care should providers come 
to fear retribution for minor billing errors or honest 
mistakes.
    A continued and enhanced commitment to fraud prevention and 
recovery can help ensure that people with Medicare are not 
overbilled or otherwise harmed and that taxpayer dollars are 
spent responsibly.
    Many of the administrative sanctions increased by this bill 
were established in 1981, and last revised in 1996, leading us 
to believe that these penalties are due for an update. And in 
2011, the Office of Inspector General cautioned Congress that 
perpetrators of fraud may regard existing penalties as nothing 
more than the cost of doing business.
    It is important to remember that there is a beneficiary-
facing component to preventing Medicare fraud and mitigating 
the harms of abuse.
    The federally funded state health insurance assistance 
programs, known as the SCHIAPs, and senior Medicare patrols 
work together in every state and U.S. territory to educate 
people with Medicare about how to protect themselves from 
fraud, to help them navigate cost-sharing challenges and 
billing errors, and to assist people with reporting suspected 
fraud and abuse.
    We urge Congress to support these essential programs and 
secure their funding. Further, when fraud is uncovered, it is 
legislation like that introduced by Congressman Bilirakis and 
Congresswoman Castor, H.R. 3245, that is needed to ensure that 
those defrauding Medicare are appropriately penalized.
    We look forward to working with the committee on this 
legislation and other bipartisan policies to improve the day-
to-day experiences of people with Medicare and to strengthen 
the program now and into the future. Thank you.
    [The prepared statement of Ms. Sanders follows:]
    
    
    
    
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    Mr. Burgess. The chair thanks the gentlelady. The chair 
notes that a vote has been called on the floor. We are going to 
hear from Dr. De Jonge, and then we will recess for the final 
three witnesses and then be back for witness questions.
    Dr. De Jonge, you are recognized for 5 minutes, please.

               STATEMENT OF DR. K. ERIC DE JONGE

    Dr. De Jonge. Thank you. I am a geriatrician here in D.C., 
and I have been making house calls for 25 years. My team and I 
recently had the privileged of making house calls to a 113-
year-old woman, who is one of the oldest people in the United 
States. Home-based primary care, supported by the Independence 
at Home Medicare program, allowed her to remain at home until 
the final day of her life.
    Thank you, Chairman Burgess, and Ranking Member Green, and 
the members of the committee for inviting me to talk about the 
Independence at Home. On behalf of the American Academy of Home 
Care Medicine, we offer full support for the 2-year extension 
of the IAH Medicare demo, which otherwise expires on September 
30.
    Thanks to Representatives Burgess and Dingell, and also 
Representatives Roskam and Thompson for introducing the bill.
    Today, I am going to do three things. I am going to discuss 
why home-based primary care and the IAH model works, review the 
IAH demo results, and highlight the value of the 2-year 
extension.
    First, why does the IAH model work? For seriously ill 
elders and their families, it supports 24/7 mobile, medical, 
and social services in the home until the last day of life. 
That allows life with dignity and skilled care in the home 
throughout the lifespan.
    One of my patients is a Mrs. B. She was a 72-year-old 
woman, who presented for care in 2010 with liver and heart 
failure. In the last 2 years before that, she had been in the 
hospital for admissions 10 times. In the next 5 years, she 
received over 200 medical and social work house calls, hundreds 
of phone calls to family caregivers, mobile x-rays, IV 
treatment, medication delivery, blood tests in the home, and a 
lifesaving procedure for a GI bleed in the ICU at the hospital. 
In those 5 years, she had a total in 5 years of three 
admissions to the hospital and spent over 99 percent of her 
days at home.
    Second, it works for providers and health systems. House 
calls build trust. It leads to more accurate diagnosis and 
better treatment that the patient and family want, better 
outcomes for patients and families, which is really satisfying 
for providers. Health systems get to serve highest cost 
populations in a preferred and lower cost setting, and they 
actually get paid for better results.
    Our IAH consortium in mid-Atlantic with Penn, Virginia 
Commonwealth, and MedStar Health have received shared savings 
payments that have allowed us to grow our programs.
    The VA is a national leader in home-based primary care and 
has also proven the high ratings of patient satisfaction and 
total cost reduction over 10 percent per year in their 40-year 
home-based primary care program. Providers in many other states 
are ready to participate in the IAH model.
    Finally, from Medicare, the IAH model has three big 
results. One, it provides better service to most of the frail 
and sick elders in our communities and their families. It has a 
wonderful side effect of substantial total cost savings, 
because you are caring for people in their home and not calling 
911 and ending up in the high-cost setting. And third, 
practices are held accountable. They have six major quality 
metrics they have to meet. They have incentives to actually 
reduce total cost. So you have to create and be innovative and 
figure out what can I do in the home setting that will be 
better care but also keep them at home, and then they receive 
shared savings payments if they are successful.
    There is also an accountable self-culling measure, where 
you remain in the program only if you meet the quality metrics 
and you produce savings.
    Some of the results of IAH over the last 5 years, we have 
served 11,000 patients and families nationwide so far; we serve 
patients who have serious chronic illnesses, at least two; they 
are physically disabled, and they have been in the hospital the 
past year and have had skilled home health or rehab, so they 
have high cost there proven.
    In year one of the IAH program, 9 of 17 sites exceeded 5 
percent in savings and received payments back for an average of 
$3,000 per patient per year in savings. And in year two, 7 of 
15 cites received that 5 percent savings and received on 
average of $1,000 per patient. The total savings for IAH was 
$32 million in 2 years, about 50 percent of which was paid to 
providers to support the programs.
    So the American Academy of Home Care Medicine supports the 
IAH extension for three major reasons: it will support the 15 
current sites that can maintain the highest level of care and 
continue to save Medicare money; it will send a message to 
patients and providers all around the U.S. that this model is a 
success and can go to rural, urban, and suburban areas; and it 
will be a chance to apply lessons learned from the 5 years of 
the demo in the next 2 years.
    So over 100 years ago when my patient was born, house calls 
were pretty routine. We can go back to that future and help 
keep Medicare solvent, and H.R. 3263 keeps us on that path. So 
I thank you for your attention, and I am glad to take 
questions.
    [The prepared statement of Mr. De Jonge follows:]
   
   
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    Mr. Burgess. The chair thanks the gentleman.
    Just prior to recessing, if the gentleman from Oklahoma 
would be interested in introducing his staffer that he had at 
the dais with him.
    Mr. Mullin. I have the distinct privilege of having my son, 
Andrew, who is actually closed out a committee before. Andrew 
is up here for his birthday. It is his 12th birthday. And I 
always appreciate the committee for indulging me and allowing 
me to bring my kids with me.
    As lawmakers, we are always away from our families. I have 
five kids, and the way that the committee supports us with 
having our kids with us, I really appreciate it. It means the 
world to all of us that are on the committee.
    Thank you, chairman.
    Mr. Burgess. Yes, sir. The Education and Workforce 
Committee would ensure that he was being paid by child care----
    We have votes on the floor. I think it is a series of four 
or five votes, and I cannot give you the exact timeframe, but 
the committee is going to stand in recess subject to the call 
of the chair immediately after the last vote on the floor.
    We stand in recess. We will hear from our last three 
witnesses immediately upon our return.
    [Recess until 12:06 p.m.]
    Mr. Burgess. The subcommittee will come back to order. As 
we recessed for the votes, we were about to take testimony from 
Mr. Morrison.
    Mr. Morrison, you are recognized for 5 minutes for summary 
of your opening statements, please.

                 STATEMENT OF ALAN E. MORRISON

    Mr. Morrison. Good afternoon, Chairman Burgess, Ranking 
Member Green, and members. I am here on behalf of the national 
association for the support of long-term care, and the 
association of providers of services to the patients of the 
post acute care sector, including clinical laboratories serving 
nursing home and homebound beneficiaries.
    The bundled payment proposal in front of this committee 
would modernize very old and complex payment rules for 
laboratory services provided to nursing home and homebound 
beneficiaries. It will combine the three fees now paid, one for 
laboratory tests, one for the collection of specimens, and one 
for travel to the patient's location to collect the specimens 
into a single bundled, per episode payment.
    Personally, I have worked in healthcare for over 40 years. 
We rarely see an initiative that can create program savings, 
ensure beneficiary access, encourage service to rural 
beneficiaries, permit provider efficiency gains, as well as 
address program integrity issue. This proposal does all five of 
these.
    According to an analysis conducted by the Moran Group, it 
saves approximately $130 million over 10 years. It ensures 
beneficiary access during a period of other significant changes 
and how Medicare pays for laboratory services. It provides an 
add-on payment to ensure access for rural beneficiaries. It 
eliminates the ability of unscrupulous providers to overbill 
the Medicare program for the travel fee, and it allows the 
specialized providers of these important services to better 
manage their logistics costs without impacting the quality of 
care.
    We believe the proposed payment model is both good 
healthcare and good fiscal policy.
    Let me explain how these services are provided and why they 
are so important. A very small segment of laboratory providers 
serves these frail elderly beneficiaries. These companies 
provide very basic laboratory studies used by ordering 
physicians to diagnose and monitor a wide range of conditions 
such as diabetes, heart disease, pneumonia, influenza, and 
asthma. They are very low-cost, basic tests with an average 
Medicare fee under $30, some as low as $10. In fact, in 2017, 
the most frequently ordered test was $10.66.
    It is important for these beneficiaries to have access to 
these services. It enables them to receive care in the lowest 
cost setting appropriate for their needs; it avoids the need to 
transport patients for services and the costs, risks, and 
inconvenience to such transports, and by having these services 
available around the clock, we avoid unnecessary ER visits and 
hospital re-admissions, and the substantial associated costs.
    To provide these services, specially trained laboratory 
staff travel to the patient's bedside to draw blood samples and 
collect other specimens. They then transport them to the 
laboratory to process them, and the laboratory reports the 
results to the patient's physicians, and this entire process 
typically takes only 3 to 6 hours.
    Because these patients often suffer from multiple disease 
and disorders, there is a very high percentage of critical 
results. These are immediately reported to the patient's 
physician so the needed treatment can begin at once.
    As I mentioned, this specialized segment of laboratory 
providers serves these beneficiaries. The national laboratory 
companies and almost all hospital laboratories re-emphasize 
serving nursing home and homebound patients several decades 
ago.
    In fact, in 2015, the two largest national laboratory 
companies provided less than 4 percent of these services to 
these frail, elderly beneficiaries.
    The Medicare payment model for these services has been 
unchanged for over 30 years. In fact, we think it is the oldest 
surviving Medicare payment methodology. It is very complex, 
which is three separate payment components, one of which 
requires costly manual recordkeeping to log odometer mileage 
for each trip to each patient's location in order to ensure 
accurate and compliant billing.
    This current payment model is also prone to program 
integrity abuses by unscrupulous providers who gain the billing 
for the travel allowance payment component.
    We believe that the proposal in front of the committee is 
simply a better way to do this. It would bundle the three 
payment components into a single, per episode payment covering 
all included tests provided on a single calendar day to these 
beneficiaries regardless of the number of tests or number of 
trips.
    The bundled payment would apply to the 100 highest volume 
tests, which represent 98 percent of the tests ordered and 
which have remained virtually unchanged over the past 6 years. 
Payment would be limited to one episode per calendar day.
    Further, the proposed payment model includes a rural add-on 
to ensure access by rural beneficiaries. The budget savings 
would come from the Secretary setting payment amounts, such as 
the total payments on this bundled payment model. In 2017, 
equal 97.5 percent of the amount that would have been otherwise 
payable for the same top 100 tests, the specimen collection 
fee, and the travel allowance under current law.
    We believe that with this proposal, we can get budget 
savings as well as good health policy and ensure beneficiary 
access to this population.
    We hope that you share our enthusiasm of this initiative 
and the benefits it can bring to the program and its 
beneficiaries, and we thank you for your time and support.
    [The prepared statement of Mr. Morrison follows:]
  
  
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    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    Dr. Kappor, you are recognized for 5 minutes, please, to 
summarize your opening statement.

                 STATEMENT OF DEEPAK A. KAPOOR

    Dr. Kapoor. Chairman Burgess and Ranking Member Green, 
thank you for inviting me to speak in support of H.R. 2557, the 
Prostate Cancer Misdiagnosis Elimination Act sponsored by 
Representatives Bucshon and Rush.
    My name is Deepak Kappor, and I am a practicing neurologist 
specializing in the care of neurologic malignancies, including 
prostate cancer. I am also chairman and chief executive officer 
of Integrated Medical Professionals, the largest independent 
neurology group practice in the country, as well as clinical 
associate professor of urology at the Icahn School of Medicine 
at Mount Sinai Hospital.
    Issues related to prostate cancer are of particular concern 
to physicians in my group. One out of every 80 men nationwide 
diagnosed and treated with prostate cancer is managed by one of 
my doctors. About one in seven men diagnosed with prostate 
cancer will be diagnosed with prostate cancer during their 
lifetime. This diagnosis is usually established by a test 
called needle biopsy of the prostate. We rely on the result of 
this biopsy to counsel our patients on what treatment options 
are available to them. The modern promise of precision medicine 
and targeted therapy requires complete and total diagnostic 
accuracy in this test. However, despite best laboratory 
practices, the clinical literature has recently revealed a 
troubling persistence of prostate biopsy complications, where a 
relatively high number of specimens have been switched or 
contaminated with tissue from another patient. These are known 
collectively as specimen provenance errors.
    The reason for these errors is that the workflow for 
prostrate biopsy is extremely complex. The chart before you 
shows 10 different places within the diagnostic testing cycle 
where a patient sample can be transposed or contaminated by 
another patient's tissue. These errors can result in the 
patient getting the wrong diagnosis and, tragically, 
inappropriate or unnecessary treatment.
    The literature shows these errors are frighteningly common. 
A 2015 study documented that over 2 1A\1/2\ percent of biopsy 
patients are subject to specimen complications. Perhaps even 
more troubling, the study concluded that at least 1.28 percent 
of patients newly diagnosed with prostate cancer actually did 
not have cancer at all.
    As noted in the recent New York Times article, these 
medical errors have traumatic consequences on patients. 
Patients inaccurately told they have prostate cancer are 
subject to expensive invasive treatments such as surgery and 
radiation therapy. Patients, on the other hand, who were 
inaccurately told they do not have cancer, may miss the narrow 
treatment window, because the cancer is not diagnosed in a 
timely fashion with potentially fatal consequences.
    There is a simple way to eliminate these errors entirely. 
DNA fingerprinting with a DNA specimen provenance assignment 
test, which definitively rules out switching contamination 
errors that could lead to prostate cancer misdiagnosis. This 
process involves obtaining a sample of DNA by a simple 
noninvasive swab of the patient's cheek and comparing that 
reference test to the DNA found within specimens found to have 
prostate cancer.
    In this fashion, all 10 points of potential errors in the 
diagnostic testing cycle are completely bypassed, and the 
provenance of the specimen is 100 percent verified.
    To improve diagnostic accuracy and eliminate medical 
mistakes, our practice changed our treatment protocol to 
require a DPSA test to diagnose the provenance, which is the 
abbreviation for the provenance test, for all positive biopsies 
to ensure the right patient receives the right treatment, or 
where it is appropriate, does not receive treatment at all.
    Importantly, this service is performed by an outside 
laboratory and not billed by my practice. There is no financial 
incentive for our physicians to order this test.
    Not only does this test improve patient care, but 
elimination of diagnostic errors would lead to savings to the 
Medicare program.
    According to an April 26 study by Millimen potential 
savings to the program from eliminating medical errors will be 
at least $539 million over 10 years. DPSA testing is widely 
used today. More than 60,000 prostate cancers per year receive 
the test and is offered by many labs.
    In 2013, Medicare acknowledged that DPSA testing is very 
useful as a tool for avoiding error and misidentification of a 
patient with cancer. Despite this acknowledgement, Medicare 
asserts that it does not have the authority to pay for DPSA 
testing, because it does not explicitly diagnose or treat 
disease. This debatable interpretation of the Medicare statute 
is wasteful of Medicare resources and harmful to patients.
    Congress can solve this problem by enacting H.R. 2577, the 
Prostate Cancer Misdiagnosis Elimination Act, which would 
require Medicare coverage for DPSA test for positive biopsies. 
The bill has the full support of the entire prostate cancer 
provider community, including the American Neurological 
Association, large urology group practice association, the 
men's health network, the Prostate Health Education Network, 
the Vietnam Veterans of America, and ZERO, The End of Prostate 
Cancer, to name but a few. I urge Congress to seize the 
opportunity to eliminate thousands of preventable medical 
errors, improve the healthcare of American men, and reduce the 
costs of the Medicare program by enacting this bill.
    I thank you, again, for your time and attention.
    [The prepared statement of Dr. Kapoor follows:]
   
   
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    Mr. Burgess. Thank you, Dr. Kapoor.
    Mr. Earle, you are recognized for 5 minutes for an opening 
statement, please.

                   STATEMENT OF CLETIS EARLE

    Mr. Earle. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the subcommittee. My name is Cletis 
Earle, and I am the Chief Information Officer at Kaleida Health 
and the Chairman-Elect of the College of Healthcare Information 
Management Executives, or CHIME, Board of Trustees.
    It is an honor to be here today and to testify on behalf of 
CHIME concerning the Meaningful Use Program and to offer our 
support for H.R. 3120, a bill to reduce the need for Meaningful 
Use Program hardship exemptions.
    In addition to serving as the chair-elect of the CHIME 
board of trustees, I am the CIO of Kaleida Health. Kaleida 
Health is the largest healthcare provider and the largest 
private employer in western New York State with more than 1 
million patient visits recorded annually across our hospitals 
and health systems, 82 clinics and healthcare centers. Kaleida 
Health's economic impact on western New York exceeds $2.7 
billion annually.
    For those of you not familiar, CHIME is an executive 
organization serving nearly 2,400 chief information officers, 
or CIOs, and other senior health information technology leaders 
at hospitals, health systems, and clinics across the Nation.
    CHIME members represent some of the earliest and most 
prolific doctors of electronic health records, or EHRs, and 
other health IT resources for clinicians and patients.
    Since the enactment of the HITECH Act in 2009, which 
established a Medicare and Medicaid electronic health record 
incentive program, also known as the Meaningful Use Program, 
the healthcare industry has made significant shifts in the way 
technology is used to treat and engage with patients.
    Patients and providers have already benefited from the 
Nation's investments into EHRs in ways that would not have been 
possible without the investment made through the HITECH act.
    As an example, in another health system where I previously 
served as CIO, we were able to track hospital re-admissions 
that were related to asthma and correlate asthma-related 
hospital re-admissions to specific neighborhoods and specific 
properties. With that data, we worked with local officials to 
coordinate discussions with landlords to improve the conditions 
of specific properties within those neighborhoods.
    These kinds of population health activities would not have 
been possible if we did not have EHRs and access to data 
digitally.
    Now, more than 8 years after passage of HITECH, we have the 
chance to make policy decisions apart from arbitrary deadlines 
and measures of EHR incentive program. The Meaningful Use 
Program has been plagued by the check the box, one-size-fits-
all approach, that as one of my CIO colleagues put it last 
week, put a Ferrari in every driveway but expect us to drive on 
dirt roads.
    The EHR mandate for use of Meaningful Use programs has made 
a great deal of functionality and promise and could have been 
even greater resourced in patient care; however, as we strive 
to meet CMS program deadlines, we aren't able to pursue 
workflow enhancements with our EHRs or other health IT tools 
that would actually improve outcomes.
    Moreover, our EHR vendors are so focused on meeting this 
specification and certifications that they don't have the 
bandwidth to work with us on functionalities that our 
clinicians actually request.
    Another colleague CIO in a rural area explained that to get 
ready for stage three, which is slated to be in 2018, they have 
to re-evaluate the use of a successful postoperative telehealth 
program as there aren't enough resources to service both 
programs.
    The Meaningful Use program was a resounding success in 
terms of adoption as EHRs use a nearly ubiquitous approach 
across hospitals and provider offices; however, we are all 
familiar with the discontent these systems have caused 
providers. The measure and objectives have not reflected 
improved outcomes for patients' and clinicians' needs. As many 
as 256,000 Medicare physicians in 1 year have been subject to 
financial penalties for the failed attempts at meaningful use 
requirements while as many as 30,000 others have had to apply 
for hardship exemptions.
    Unable to participate in a program, we have an opportunity 
to do better and pursue common sense policies, including H.R. 
3120, which will infuse necessary flexibility to make 
Meaningful Use programs meaningful again.
    As hospitals and providers continue to struggle to meet 
timelines and requirements of Meaningful Use program, there 
will become an increased reliance on hardship exemptions. We 
commend our approach taken in H.R. 3120, rather than propose 
the elimination of Meaningful Use programs or insist the 
requirements remain stagnant in perpetuity, it leaves it to the 
discretion of the Secretary to modify the requirements over 
time as deemed necessary in conjunction with the industry.
    Meeting thousands of pages of requirements places 
unreasonable demands on limited resources and finances. The 
ability to shift away from continual turn would be a welcome 
development for provider community to bring much needed 
stability.
    There is no question the committee's interest in the topic 
is timely, and efforts to usher in an era of digital care is a 
must. On behalf of CHIME and my colleagues and the healthcare 
CIOs, I sincerely thank the committee for allowing me to speak 
on the opportunities to improve Meaningful Use program and 
reiterate our support for H.R. 3120. I look forward to 
answering your questions.
    [The prepared statement of Mr. Earle follows:]
    
    
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    Mr. Burgess. And the chair thanks the gentleman.
    Thank you to all of our witnesses for providing the 
information this morning. We are now going to move into the 
question-and-answer portion of the hearing.
    And I am going to yield my time to Mr. Griffith of Virginia 
to begin the questioning, 5 minutes.
    Mr. Griffith. Thank you very much, Mr. Chairman. I do 
appreciate that.
    Dr. Kissela, you mentioned that estimates suggest 
approximately 522,000 Medicare beneficiaries would be eligible 
for a telestroke consultation, including those in rural areas 
who currently do not meet the definition of rural for Medicare 
payment of telestroke services.
    Can you elaborate on how patients in many rural communities 
are still facing a barrier to consultation and treatment 
despite the current law?
    Dr. Kissela. Sure. So the definition of rural under 
Medicare is very arbitrary, and there certainly, in our region, 
for example, in our 27 hospitals, we have outlying hospitals 
that really have no access to stroke neurology expertise on a 
moment's notice for an acute stroke emergent situation and 
would not meet the definition.
    And so being able to apply this equally will solve that 
problem for our outlying hospitals as well as helping the speed 
of treatment at our urban and suburban areas where we really 
need to move fast as well where most of the strokes are.
    Mr. Griffith. I believe I saw that the target times to try 
to get the treatment within 60 minutes. Is that correct?
    Dr. Kissela. That is correct. From the minute they reach 
medical attention, the door to needle, as we say, to the first 
time when the drug, TPR, is given, the national goal is 60 
minutes.
    Mr. Griffith. Now, I think we all know the long-term 
consequences for patients who don't properly receive an 
evaluation and treatment for stroke, it can be devastating to 
the quality of life, if not fatal.
    That being said, one of the fights we often have up here is 
about money, and this bill will probably score in the way CBO 
does things is costing money. But my gut is that these patients 
will receive so many services that are going to be covered by 
Medicare if they don't get TPA in a timely fashion that it is 
going to cost us a lot more.
    So could you just confirm that feeling and tell me what 
services the patients often have to seek if they suffer from an 
ischemic stroke and do not receive the TPA within the window?
    Dr. Kissela. Absolutely. So to your point about quality of 
life. It is a devastating disease. People have rated the living 
with stroke to some often worse than death, although it is a 
fatal disease as well. So it is a terrible burden on families 
as well. Families, of course, have to take time to care for 
people who are disabled by stroke.
    But the services specifically that a stroke survivor will 
need would include all forms of therapy services to work on 
trying to recover their deficit. The way to bring recovery 
after a stroke is for the good brain to try to take over the 
function that was lost, but that is a very difficult process. 
It is often unsuccessful. And for the largest of strokes, 
institutional care is necessary.
    So they may live for years in a skilled nursing facility, 
there racks up a tremendous expense. And so even if the 
estimate from the American Heart and Stroke Association that I 
mentioned is too high, I am completely convinced that the 
ability to give TPA and a lifesaving stroke therapies to other 
patients, more patients, in a timely fashion will no question 
save money for the healthcare system at large.
    Mr. Griffith. Well, I am not a medical person. I am a 
country lawyer, but I had a case one time where I had to go to 
an institution where a relatively young man had had a 
significant stroke, and we had to prepare documents for him 
with him blinking. His ability to reason was fine, but he 
couldn't move, and he couldn't talk. And so he just laid there 
and watched. It was heartbreaking for the family, but I 
prepared the legal documents and made sure that they had access 
to everything they needed to have access to legally to take 
care of him.
    But there is a case where I don't know how many--probably 
millions of dollars, because there was absolutely nothing else 
physically wrong with him, but he was expected to live for 
quite some time.
    And while it may not be commonplace, it is not rare. Would 
you agree with that assessment?
    Dr. Kissela. I absolutely agree. It is heartbreaking every 
day when we have opportunities to treat patients effectively, 
and we are not capturing that opportunity.
    Mr. Griffith. And this is not something that is new off the 
shelf. This TPA has been around for how long? 15, 20 years?
    Dr. Kissela. It was approved by the FDA in 1996.
    Mr. Griffith. 1997, so 20 years. It is high time that we 
get it to more people quicker. Wouldn't you agree?
    Dr. Kissela. Absolutely. Thank you, sir, for your support.
    Mr. Griffith. I appreciate it very much.
    Mr. Chairman, I yield back, and I appreciate your patience.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentlelady from California, Ms. 
Eshoo, 5 minutes for questions, please.
    Ms. Eshoo. Thank you, Mr. Chairman. I appreciate your 
recognizing me.
    And I want to thank all of the witnesses. This is really 
quite a panel and it spans so many areas of care and improving 
care in our healthcare system.
    I have to leave. I came back because I wanted to thank you, 
and I just wanted to make a comment about one area, and then I 
have to leave, because I have got to get my flight to get back 
to California.
    So, again, my thanks for the testimony and to all of the 
members that have worked together to produce the bills that are 
being reviewed today.
    I want to make some comments on--and I am going to sound 
look a skunk at the garden party--but I want to make some 
points about the Independent Payment Advisory Board, the IPAB. 
I don't know how many members have read the CRS report on this. 
The most recent one was in March of this year, March 17th, I 
believe. If you haven't read it, I would suggest that you do.
    I understand the resistance to this. Interest always looks 
at things and say, you know what, our ox may be gored.
    I understand that, and some of the things that were said in 
opening comments that Congress is the one that should be in 
charge, I agree with that. But I don't think that we should 
rush to eliminate this. And let me tell you why.
    There isn't anything that is being done about right now. 
There is cost shifting going on with bills relative to our 
healthcare system, but there isn't anything to address the 
costs and how we are going to sustain the costs in the system. 
For those that say Congress shouldn't give up, let me offer a 
very good example.
    Congress recognized years ago that collectively it didn't 
have the political will, because it was really tough to do, to 
close military bases. And the BRAC commission was established. 
And you know what, I think it worked well.
    Now, there are many sensitivities when it comes to the 
decisions relative to Medicare. I think that there still should 
be a commission that is put together that advises the Congress. 
Congress is not going to do this on its own. And just look at 
all of the interests, the beautiful, important interests, that 
are represented here today. Each one has a great case. Nobody 
talked about how we are going to pay for a darn thing. And that 
is not your responsibility to do, but it is ours.
    So I think that there is a case to be made for a mechanism 
that would really review these things with the kind of 
representation that is deserved and should be a part of a 
commission with the seats representing all the various 
stakeholders, because those voices are really important, but 
recognizing that the Congress, yes, should be the one that 
accepts or rejects the advice.
    So I am still driving but with an emergency brake on. I 
think there is a rush to judgment here about the value of 
having an outside group when the triggers come up that would 
review all of this and, overall that together, between an 
advisory commission that would make recommendations to 
Congress, that we make sure that what we are spending and 
investing in is actually sustainable. And I don't think that we 
are taking that into consideration.
    Again, all of these healthcare bills that are out there now 
being debated, the ones that passed, the ones that didn't, the 
ones that are still in the hopper, there is cost shifting in 
it, but there is no mechanism in any of them about how we are 
going to sustain growth and be able to afford the growth that 
is in the program.
    So I am really very hesitant about the bill. I think it 
needs to be reworked and amended. I may be the only one in the 
entire committee that views it this way, but there has been, I 
think, a very good example, BRAC. And BRAC has worked. BRAC has 
worked. And I am not even suggesting that this be set up like 
BRAC, but members are making it sound like all hell is going to 
break loose; the sky's going to cave in, and we just have to 
blow this thing apart and not have any mechanisms whatsoever.
    I think that is a march to folly. We have a responsibility 
here to not only know what improvements need to be made, by 
overall where the costs are going. And we do that because 
Medicare is invaluable. You can't place a price tag on it. But 
whatever the price tags are, we are going to have to come up 
with the money for it.
    So thank you, Mr. Chairman, and I am sorry that there 
aren't more members here to hear what I said, but maybe they 
wouldn't be agreeing with me anyway, but I stayed to thank the 
witnesses and to put my statement into the record, because I 
think it is something that we really need to think through.
    Thank you, and I yield back. And have a great weekend, 
everyone.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentleman from Kentucky, Mr. 
Guthrie, 5 minutes for questions, please.
    Mr. Guthrie. Thank you very much.
    Dr. Kissela, Morgan Griffith asked a lot of what I was 
going to ask. But I want to ask this. He says he is a country 
lawyer. I am not a doctor nor a country lawyer, I am just 
country. But I have a lot of rural areas in my district, and so 
it is something that is important.
    I was actually at a rotary club outside of Lexington, and a 
person came and presented from the neurology center on strokes, 
and said, these are the symptoms, get him to the hospital as 
soon as possible, the stuff they were talking about, and I was 
thinking how we deal with this with telemedicine.
    Because first something, why don't we just give everybody 
the medicine and then one wouldn't be in an ambulance. And the 
reason is, they explain this, that two types of strokes--well, 
there is more. But as a country person would say, one is a 
blood clot and one is bleeding on the brain. And based on what 
they said, if you give medicine for a blood clot and there is 
bleeding on the brain, then you have more damage.
    So how do you actually assess somebody via telemedicine? 
How does that work? We can get that quick diagnosis say, this 
is what you need to do as opposed to the other?
    Dr. Kissela. Absolutely.
    So, first of all, I am just a plumber. So when we log into 
telemedicine, we are visualizing the patient; we are talking to 
them, and so that history and physical is an important part of 
any medical encounter. It is so much better to be able to do 
that yourself rather than rely on somebody's else account of 
what happened and to hear about what the exam looked like, I 
can see it with my eyes.
    And we have a very standardized way of evaluating the 
patient clinically in a very rapid fashion that is helpful. But 
then all the telemedicine systems, these are why the systems 
are kind of costly and expensive to implement. They have to be 
secure. They have to be 100 percent reliable, because this is a 
life-and-death decision where every second counts.
    But it is not just the capability to see the patient but 
also to see the radiologic film. So we do a head CT scan, and 
that tells us if there is a bleeding stroke or a not bleeding 
stroke.
    Mr. Guthrie. Well, thank you for that.
    And, Dr. Kapoor, on the biopsies for prostate, often, in 
your best estimate, do you think the errors in the needle 
occur, errors in the needle biopsy occur? How often does that 
happen?
    Dr. Kapoor. Well, it is important to understand that the 
error is not precisely the biopsies. It is in the analysis of 
the biopsy and the diagnostic testing cycle. So the biopsy----
    Mr. Guthrie. Oh, yes. I said that wrong.
    Dr. Kapoor. But the data shows that it occurs in about 2 
1A\1/2\ percent of cases overall. And unfortunately, nearly 1.3 
percent of the time the patient doesn't have cancer. 
Importantly, the literature----
    Mr. Guthrie. This is always false negative or is it a false 
positive?
    Dr. Kapoor. It could be either way.
    Mr. Guthrie. Right. So some people don't get the treatment 
they need?
    Dr. Kapoor. It depends on the type of error. Because 
sometimes tissue can be contaminated from another patient, 
other times the tissue can be completely switched so that 
patient A is being diagnosed, given the diagnosis of patient B 
and vice versa. So the person that is being read as negative 
actually has cancer, and there is somebody else that is being 
read as positive that doesn't.
    And this does occur at other malignancies as well. There 
was a notable case on Long Island where a woman unfortunately 
had a bilateral mastectomy because of a switching error. It is 
just because with prostate biopsies, we do 12 to 20 core 
samples per patient as opposed to one or two that the errors 
are magnified, because there is just so much more tissue that 
is being handled in a prostrate biopsy.
    Mr. Guthrie. Thank you very much.
    And Dr. Moore, can you detail to the committee why simply 
extending the processes around the therapy caps for another 
year or two is not the best practice for beneficiaries, 
providers, and as matters of Medicare fiscal health?
    Mr. Moore. Yes. Thanks, Congressman. I think the best 
rationale is it is time to make that permanent change. We have 
extended this out at a cost. We have extended this out out at 
uncertainty to the field and to the therapy providers, and we 
now have changes that were made as part of MACRA that the 
chairman recommended--or talked about in his opening statement 
to move to targeted medical review. It seems to be working.
    And so our analysis shows that as we move toward that 
change that was made in MACRA, that we are striking that 
critical balance of ensuring access to care but also 
maintaining the integrity of the program. And so we think that 
extending the exception process only delays and costs more over 
time, and that we have the data and the policy solutions 
available for a permanent fix at this time.
    Mr. Guthrie. OK. Thank you.
    And, Dr. Richards, I am running out of time. This committee 
has worked with Senate Finance, and House Ways and Means on a 
bipartisan basis since the beginning of last year on the issue 
of home infusion. While not everyone got everything they 
wanted, do you believe the policy with further technical 
changes as reported out of committee last week should advance 
to the House floor?
    Mr. Richards. Thank you for that question. Yes, I do. I 
think it will give us an opportunity to see this transitional 
payment plan come through with all support of technical 
changes.
    Mr. Guthrie. OK. Thank you. And I will yield back.
    Mr. Burgess. The gentleman yields back.
    Mr. Guthrie. I have 13 seconds. I have two requests for 
unanimous consent to enter it into the record.
    Mr. Burgess. Start the clock back.
    Mr. Guthrie. National Association for Supportive of Long-
Term Care, and then American Speech-Language-Hearing 
Association.
    Mr. Burgess. Without objection, it will be made part of the 
record.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. The chair recognizes the gentleman from 
Pennsylvania, Mr. Murphy, 5 minutes.
    Mr. Murphy. Thank you, Mr. Chairman. This is fascinating to 
me. I like to use the analogy that if you buy a car off the 
lot, maybe about $25-, $30,000, if you buy the same car from 
the parts department, it may be at least $150,000. That is the 
difference between fee for service and a disorganized system 
versus one that is very coordinated.
    Along these lines, Dr. Richards, when you write about 
disease state management of highly complex chronic illnesses, 
you talk about the care coordination, the drug interaction, 
monitoring, et cetera, et cetera. I might add to that as well, 
on the issues of diabetes, which has massive amounts of 
complications, including behavioral issues, depression, 
anxiety, panic. And we know that a person with a chronic 
illness doubles the risk for psychological problems such as 
depression, and untreated depression doubles the cost, because 
oftentimes, it means the person is not getting better.
    And Dr. De Jonge, you talked about this too in terms of 
working at home. That is the primary care person looking at 
everything. And, Ms. Sanders, when it comes to Medicare and 
looking at patients' rights, people are denying just based upon 
a number versus what does this patient need to make them 
better, especially in the communication area, you end up with a 
lot of complications. A noncommunicative person, perhaps 
because of a stroke, who has all their faculties involved 
increase these problems.
    So I want to know from each of your points of view real 
quickly, do these bills adequately address, do we need to do 
more when it comes to care management, disease management, and 
two, do you think it costs more or less to do that? Let's start 
with talking about diabetes. Give you about 25 seconds, each of 
you. Go.
    Ms. Aprigliano. I think that for anybody who has a chronic 
disease, the importance is to have a successful management plan 
and these individualized. So looking at all of the complex 
issues, it is crucial. When I hear about home-based care, that 
is an essential way for, especially individuals with complex 
diseases like diabetes, to have access to multiple ways to 
treat.
    Mr. Murphy. So does Medicare currently provide a funding 
mechanism for the medical practice people for other people to 
coordinate that care or does this happen because people are 
trying to do themselves? If we need more, let me know.
    Ms. Aprigliano. So for diabetes, we are self-managed. We 
spend very little time with medical professionals. Diabetes is 
24/7. And so we are responsible for making sure that we stay 
healthy. And the onus is on us to have the equipment, to have 
the services so that we can stay healthy to this prevent the 
constant complications we have.
    Mr. Murphy. Dr. Richards.
    I would love to ask this of all of you, but I only have 2 
minutes left, so go ahead.
    Mr. Richards. Most definitely there is a cost savings. And 
the fact that if the patients aren't going to be able to do 
this in the home, and these are long-term threatening 
illnesses, they have to seek a different site of care, which 
typically is going to be a higher cost. I mean, that is the 
bottom line. I mean, home is proven to be cost effective, safe, 
and it is really where patients want to be.
    Mr. Murphy. Ms. Sanders, does Medicare adequately pay for 
making sure that these things are coordinated, such as, for 
example, if a person does need a communication device, do we 
really pay to make sure that there is mechanisms to determine 
if that patient needs it, and it is improving or not improving 
care? Do we have a mechanism now, or do we need to fix that?
    Ms. Sanders. We, Medicare rights center, we certainly know 
from the direct experience on our help line that people 
struggle to coordinate and manage their care on their own. Many 
of our callers are low income. They have multiple chronic 
conditions, and they need help managing the variety of 
services, devices, and otherwise, prescription drugs that they 
need.
    So we have been very supportive of value-based payment 
models and the ways in which Medicare Advantage plans are 
coordinating care. And I think that Congress should commitment 
to those efforts in all parts of Medicare.
    Mr. Murphy. Dr. De Jonge, for about 45 seconds. Because you 
put that measure, quoting about 5 percent of people consume 
about 50 percent of the costs. Do we do enough to really pay 
for people to manage those complex cases?
    Dr. De Jonge. Yes. Right now, there is a lot of fragmented 
billing for these different patients. And if you think about 
having a team that quarterbacks the care of that whole patient 
their whole life until they die and pay them for results and 
not for each little thing you do to them makes a lot more 
sense.
    And Independence at Home, I mention the VA program have 
shown that if you have a team that is mobile, that does all the 
care in the home environment, most of the care in the home 
environment, you can actually have more satisfied patients and 
families, and you can reduce Medicare costs substantially if 
you do coordinate it that way.
    Mr. Murphy. No. I have seen some studies that even say as 
much as the 40 percent savings on some of these. Because every 
time someone shows up in an emergency room, that is preventable 
and preventable hospitalizations, and it goes on and on.
    As we look at other areas to reform the health system, I 
think this is critical if we look at even providing a block 
grant to a state. I think that when we talk about such things 
as high-risk pools--I don't like that term at all. I would much 
rather say for those who are in the 5 to 10 percent that 
consume the cost, the overutilizers, we ought to be thinking of 
a payment system that really pays for coordinated care to help 
them.
    So I appreciate you all highlighting that. I know others 
had it too. But this is very, very important. Thank you very 
much, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Florida, 5 minutes 
for questions, please.
    Mr. Bilirakis. Thank you very much, Mr. Chairman.
    And I agree with Mrs. Blackburn. I think she called you all 
a football team. But, anyway, you all are all stars. There is 
no question. We have an all-star cast here this afternoon, this 
morning when we started.
    Thank you, Mr. Chairman, for putting it together.
    I have a question for Ms. Sanders. I appreciate your 
testimony this morning and the work you do with the Medicare 
beneficiaries. Thanks so very much. And I look forward to 
working with you in the future too on behalf of my 
constituents.
    Medicare fraud is not a victimless crime. You reference in 
your testimony the impact that the Medicare fraud has on 
beneficiaries. Could you give us some additional detail or 
details on that and perhaps a case example. If you could 
elaborate. I know you addressed it to a certain extent this 
morning, but you only had the 5 minutes. So if you want to 
elaborate on that, I would appreciate it.
    Ms. Sanders. Sure. Yes. Thank you for the question.
    So many callers to the Medicare center are calling because 
they either can't afford a bill, or they are concerned that 
they have been overcharged for some type of service. So at the 
Medicare aid center, our counselors then do some investigation 
into what is going on with that case.
    And in one example, in speaking with both the beneficiary 
and the healthcare provider, we saw that the provider had, in 
fact, charged the beneficiary over the Medicare approved 
amount, the allowed cost sharing. That is a case where we would 
refer that beneficiary to the senior Medicare patrol or to the 
Office of the Inspector General to see if this is a simple 
billing error, perhaps it was an honest mistake, or it may be a 
case of fraud.
    So, again, typically, these issues come up with respect to 
billing concerns. Those are the fourth most common call to the 
Medicare right help line, but it is not immediate to us whether 
or not there is fraud. We have to investigate that, our 
partners do.
    Mr. Bilirakis. I see. Does it make sense to have penalties 
that have not been updated in over 20 years?
    Ms. Sanders. No, not from our perspective. We think that 
Congress should certainly update these penalties in order to 
ensure that we have appropriate prevention and we are deterring 
fraud.
    Mr. Bilirakis. Very good.
    I appreciate your support for my bill and Representative 
Castor's bill.
    You mentioned in your testimony some findings by the OIG 
and GAO regarding fraud and how individuals perpetrating fraud 
view the penalties as a cost of doing business. At the same 
time, you also mentioned concerns about enforcement actions to 
put beneficiary access to care at risk by potentially shutting 
down hospitals or other providers. Are you suggesting that 
there needs to be a balanced approach in the application of 
these enhanced penalties?
    Ms. Sanders. Yes, absolutely. I think that balanced 
approach is very important. We need to have strong penalties to 
deter and prevent fraud. But I think we have to recognize that 
the Medicare system is very complex, and there will be 
incorrect billing, and there will be honest mistakes. So we 
really need to lean on the Office of the Inspector General and 
their partners to use their discretion appropriately so that 
they are, in fact, penalizing true fraud and not those 
providers who are doing their best but making mistakes along 
the way.
    Mr. Bilirakis. And does the panel basically agree with that 
statement pretty much? Thank you.
    Mr. Moore, can you detail the various program integrity 
measures your coalition has agreed to over the years?
    Mr. Moore. Yes. Over the years, due to the number of times 
the therapy cap has been addressed, there have been a number of 
measures that have gone into place to ensure the integrity of 
the program, and those include the exception process that is--
expect to expire, but what has worked really well has been the 
targeted medical review that was put in at MACRA. It has really 
allowed the agency to strike that balance to ensure access 
without applying broad-based utilization controls that might 
delay or eliminate access. So that has probably been the most 
successful.
    We also are seeing that transition to quality-based 
programs, whether one of the extensions reporting on functional 
limits has been added to the benefits to understand what is 
going on in therapy and then, obviously, participating in the 
quality programs that have come out of this committee and 
Congress.
    Mr. Bilirakis. Very good. I appreciate that.
    Very good. I appreciate that.
    Thank you very much, Mr. Chairman. I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Georgia, Mr. 
Carter, 5 minutes for questions, please.
    Mr. Carter. Thank you, Mr. Chairman.
    And thank all of you for being here. All of you represent 
areas that are extremely important in the healthcare system, 
and I can't tell you how much I appreciate that.
    As a practicing pharmacist for over 30 years, I have 
interacted with just about every one of you, and I want you to 
know that it is a team approach. And all of you played an 
important role in that, so thank you for what you do.
    I want to start with you, Ms. Grealey, if I could. As the 
president of the Healthcare Leadership Council, you have made 
it clear that you feel like we should be moving more toward a 
patient-centered Medicare system without the Independent 
Advisory Payment Board.
    I know that IPAB was set up to save money and that the main 
way that they were going to be doing that was through cutting 
physicians' fees. What do you think that would have done to 
Medicare? What do you think that will do to Medicare if we 
don't pass the legislation doing away with it?
    Ms. Grealey. I think the number one effect will be to 
reduce access to care for Medicare beneficiaries. There are 
certain protections in this legislation that say you can't cut 
the benefit package for Medicare beneficiaries, you can't 
change their copays and deductibles, you can't change their 
eligibility.
    But what it fails to recognize is cutting payments to 
providers will limit access to those providers for Medicare 
beneficiaries. So there is a very direct effect.
    Mr. Carter. Absolutely. Thank you very much for that.
    I want to move now to Ms. Aprigliano. Was that pretty good? 
I hope it was.
    Ms. Aprigliano. As close as anybody ever gets.
    Mr. Carter. Is that right? Good. Thank you. Thank you.
    I will be quite honest with you. I was not prepared to ask 
you questions when I first came in here, but I was here when 
you gave your opening remarks, and I found it to be very 
relevant particularly with community pharmacists, because I 
know the role that community pharmacists play with consultation 
for all areas, but particularly for diabetics.
    And that is where it is so important. And I was very 
interested in what you had to say about the required mail order 
and how that had actually resulted in something that we 
didn't--that we tried to push onto someone, but what happens is 
that they end up going back to their community pharmacists. And 
why is that? Why do you think that is?
    Ms. Aprigliano. So, while the National Mail-Order Program 
is fantastic in the sense that for individuals who are 
homebound or have difficulties getting to their pharmacy or 
their pharmacy is very far away, this is a great program. 
However, a lot of patients do need that extra support from a 
pharmacist. They are part of their healthcare team.
    And so the other issue is, is that the majority of 
individuals, if they are given a meter that is not accurate, 
they will go to the pharmacist and say, can you tell me why 
this doesn't seem right, because my blood sugars before were 
this and now all of a sudden they are this?
    So we are finding individuals going back to their pharmacy 
and talking with their pharmacist, because these meters that we 
have now shown through the study through the Diabetes 
Technology Society are not accurate. And so this does impact.
    So it is important. National mail order is great for 
individuals who can use it, but we do need to have the ability 
to have the meters that are accurate and the ones that they are 
comfortable working with.
    Mr. Carter. Great. Thank you for that, and I appreciate 
that.
    Mr. De Jonge, I was a consulting pharmacist in long-term 
care setting for many years. And one of the primary reasons 
that people were admitted to the nursing homes, if not the 
primary reason, was medication administration and having 
someone who could make sure that those patients were taking 
their medications.
    I just wanted to get your input on how important of a role 
that is in the home setting.
    Dr. De Jonge. Yes, there is kind of a perfect storm in the 
really frail elders where they are more vulnerable and they 
take a lot more medications. So you need constant vigilance and 
the kind of home-based primary care approach, where you have 
NPs and docs and nurses, and we have pharmacists actually at 
our weekly team meetings who are reviewing the med list with 
us.
    So, on a weekly, if not daily, basis, you need to be 
carefully monitoring the meds, their side effects, and their 
toxicities, and that prevents ER visits and unnecessary 
hospitalization.
    Mr. Carter. So, in the end, it saves money?
    Dr. De Jonge. I think the data both----
    Mr. Carter. And keeps them from going into the nursing home 
many times?
    Dr. De Jonge. Not many people I talk to want to end up in a 
nursing home.
    Mr. Carter. Sure.
    Dr. De Jonge. So, if they can avoid the trip to the ER and 
the hospital, that is often the next step to the nursing home. 
It helps prevent that.
    Mr. Carter. Well, running the risk of being accused of 
being self-serving, I mention all this because it is important, 
because it is a team approach. And, certainly, all of you, as I 
said earlier, play an important role in that. Certainly, 
pharmacists play an important role in that.
    And I want to have a plug-in for my colleague, 
Representative Guthrie, who has a bill, H.R. 592, for Pharmacy 
and Medically Underserved Areas Enhancement Act. I hope that we 
will look at that, Mr. Chairman, because that is a very 
important bill.
    Yes, it will cost some money initially, but right here, you 
see where it will save us a tremendous amount of money. Not 
only will it save money, but it will also increase the level of 
care that patients are getting, and that is the most important 
thing it does.
    And I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from California. Just 
prior to recognizing the gentleman from California, for those 
who were concerned that I was ignoring Dr. Ruiz, he is actually 
not a member of the subcommittee. He is a member of the full 
committee. He is waived onto the subcommittee. Generally, the 
persons who waive onto the subcommittee go after all of the 
committee members have asked their questions. However, the 
chairman is generously going to allow Dr. Ruiz to go first. And 
you are recognized for 5 minutes.
    Mr. Ruiz. He says that because there are a lot of my 
friends out here, see.
    Thank you, Mr. Chairman, for holding this hearing. H.R. 
849, the Protecting Seniors' Access to Medicare Act, which 
repeals the Independent Payment Advisory Board, or IPAB, is a 
terrific example of both sides working together to make 
commonsense changes to help patients and to help seniors.
    In this day and age, it is wonderful to see some bipartisan 
effort to come up with some pragmatic approaches and make some 
changes that will result in good outcomes.
    I appreciate Dr. Roe's leadership on this issue. It has 
been an honor to work with him on this important legislation, 
which will help protect seniors' access to Medicare.
    And there are basically two main reasons why we must repeal 
IPAB: First and foremost, cuts to Medicare should not be made 
by unelected appointees who are not accountable to the American 
people. Seniors will not have a voice on determining whether 
they agree with those cuts or don't agree with those cuts, nor 
should one person in the case, if they don't agree or there is 
not a board, the Secretary of Health and Human Services, 
regardless of party, whether they are Democratic or Republican, 
under the direction of any President, regardless of party, be 
the sole decision maker on this matter.
    That is not how we make decisions in something so 
important. Because Medicare is just simply too important for 
our seniors, who already struggle to make ends meet, to be 
subjected to cuts in this way.
    Furthermore, IPAB efforts to lower Medicare costs, although 
well intended, by cutting Medicare payments is misguided. We 
need to work on lowering overall costs, like the cost of 
medicine and the cost of healthcare, in order to strengthen 
Medicare through cost savings.
    The IPAB approach to cut payments may jeopardize seniors' 
access to care. The American Medical Association shares this 
concern. In a statement released today they state that, 
``Arbitrary IPAB physician payment cuts may create Medicare 
access issues for beneficiaries.'' Specifically, physician 
reimbursements under Medicare could become so low that 
physicians have to stop accepting Medicare patients.
    I ask unanimous consent to submit this statement for the 
record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Ruiz. We need to rein in our out-of-control healthcare 
cost, no doubt about it. This is the primary reason why 
premiums, health insurances are going up. Medicare is having to 
pay too much, like the cost of medicine, in order to strengthen 
the solvency of Medicare not make arbitrary cuts that will hurt 
our seniors. Again, this bill today is a good bipartisan effort 
to put seniors above partisanship and solutions above ideology.
    Ms. Grealey, as we know, IPAB was not triggered this year. 
Can you clarify why we can't or why we shouldn't wait and 
repeal IPAB later?
    Ms. Grealey. Well, Congressman--and, again, thank you so 
much for cosponsoring H.R. 849, very important legislation--we 
can't afford to wait. We have an opportunity right now, through 
the joint resolution that you have sponsored, to go ahead and 
just get rid of IPAB completely.
    We could wait until later in the year and do the repeal 
bill, but either way, it needs to occur as soon as possible. 
Because if IPAB does trigger and that whole process goes into 
effect, there is a very short timeframe. One, the cuts have to 
be achieved within a 1-year time period. And the opportunity 
for Congress to head off those cuts is not much of an 
opportunity at all.
    Mr. Ruiz. So let's talk about that. Let's say they make a 
decision. Cuts are being made. What are the chances of 
overriding it? Tell me about that process, and can Congress 
override recommendations that they don't like or the policies 
that they don't like?
    Ms. Grealey. If Congress does not like the recommendations 
made by IPAB, they would then have to propose cuts equal in 
size to what IPAB was trying to reduce. And they would have a 
very short time period in which to do that.
    Mr. Ruiz. In other words, they are set up to fail that 
endeavor because it is a short time and--I was going to give a 
dig at my friend here, their side, but I won't in the sake of 
bipartisanship. Sometimes it takes a long time to fulfill 
promises that people make to try to----
    Mr. Burgess. Would the gentleman yield?
    Mr. Ruiz. Yes, sir.
    Mr. Burgess. The chair reminds the gentleman that the 
Independent Payment Advisory Board was not supported by a 
single Republican in the 109th Congress.
    Mr. Ruiz. Oh, that is not the promise I was thinking about, 
but never mind. We have a good relationship.
    Many people think that because no one has been appointed to 
IPAB that there can be no cuts at all. Is that true?
    Ms. Grealey. Absolutely not true. If there is no member of 
the board appointed, we don't have a board, that authority, 
legal requirement then goes to the Secretary of HHS. So, today, 
that would be Secretary Tom Price. It could also be a Democrat 
in the future. But, either way, the Secretary of HHS then has 
that legal responsibility to make those cuts.
    Mr. Ruiz. Thank you.
    I know Dr. Burgess and I have had multiple conversations 
about IPAB throughout the years. He is very supportive of this. 
And I urge the chairman and the Democratic leadership to 
expedite this process so that we can have a markup hearing as 
soon as possible. Let's pass some legislation that is a true 
bipartisan effort that will help seniors throughout the Nation.
    Thank you. I yield back my time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    I will recognize myself now for questions. And, Ms. 
Grealey, on the Independent Payment Advisory Board, since Dr. 
Ruiz brought it up--I didn't bring my copy of the Affordable 
Care Act; normally I have it with me and I am able to hold it 
up. I used to have the section on the Independent Payment 
Advisory Board section memorized because it upset me so much. 
And when you look at the list of people who are board members 
on the Independent Payment Advisory Board, it outlines--you 
have government officials. You have eggheads from think tanks. 
At the very last, a practitioner of medicine or osteopathy. 
One. But you must not earn outside income, so that means 
someone who is not in active practice. You have no practicing 
physician on the Independent Payment Advisory Board. And, yet, 
as you point out, Ms. Grealey, it would have an outsized effect 
on patients and providers.
    So, Mr. Morrison, let me just ask you. You spent some time 
talking about bundle payments. I will admit, not a big fan. But 
some of the things that you talked about as you went through 
trying to bring some sense into your world actually did make 
sense. So how did we end up with something that is as 
convoluted as what you describe?
    Mr. Morrison. Beats me.
    Mr. Burgess. The chair thanks the gentleman for his honest 
answer.
    Mr. Morrison. It is about the most convoluted payment 
system in Medicare, and I think it is the oldest existing 
system in Medicare that has not been looked at for at least 
three decades. I wasn't in the industry then, so I bear no 
responsibility for it. But----
    Mr. Burgess. Me either.
    Mr. Morrison [continuing]. We just think it is time to move 
forward. And in deference to the member from Pennsylvania, 
Medicare forces us to bill for parts. We are happy to bill for 
an entire car.
    Mr. Burgess. I got you.
    Well, thank you, and thank you for your testimony today. 
Again, I feel a little bit like Representative Carter. I hadn't 
prepared to ask you a question, but when you detailed how you 
have to circumnavigate the globe to get from point A to point 
B, it really was troubling.
    Mr. Earle, thank you for being here. Thank you for the work 
you do on the efficiency and the efficacy of electronic health 
records. You know the legislation, 3120, that I have 
cosponsored with Representative Dingell from Michigan that 
removes the mandate to make meaningful use standards 
increasingly more stringent.
    I am going to ask you a softball question. Do you support 
the policy?
    Mr. Earle. Absolutely.
    Mr. Burgess. Right answer. Good deal. So why is it 
important to allow providers to catch up?
    Mr. Earle. The ball has been moving significantly when it 
comes to electronic medical records and meaningful use. So this 
will give us the time to, if we are able to pause, it gives us 
the time to actually work at giving and delivering the right 
technology and solutions for our providers, in essence, for our 
patients and provide the right amount of care.
    So pausing it out would allow us that opportunity to, 
again, drive our technology initiatives to have a better 
result.
    Mr. Burgess. And then is there a downside if we don't allow 
that pause?
    Mr. Earle. No. I don't think there is a downside. From our 
perspective, you talk about bundle payments and what we are 
doing with the 21st Century Cures Act.
    What we are seeing is the legislation out there, it is 
really allowing us to continue to push our efforts forward when 
it comes to interoperability and sharing information so that we 
can actually continue improving the system and having better 
results without the stick, as far as you have to make these 
changes every year or in a more routine basis. So I don't see, 
and I don't think our organization sees, a downside. There is 
just upside here.
    Mr. Burgess. OK. And it is sort of a recurrent theme 
throughout the entire panel. Things are written into stone, Mr. 
Morrison. Things are written into Federal law, and, yet, the 
world moves much faster. The real world requires a great deal 
more adaptability.
    And I appreciate all of you being here this morning. We 
have heard some compelling testimony from a number of different 
aspects as to the delivery of healthcare, about how best of 
intentions have made your lives more difficult. And as a 
consequence, the patients on the receiving end have suffered.
    Dr. Kissela, I just want to probably finish up with you. 
Mr. Griffith asked the important questions. 1996 was the FDA 
approval of TPA. Is that what you told us?
    Dr. Kissela. Yes, sir.
    Mr. Burgess. And then Mr. Guthrie had asked the appropriate 
question: Gee, how do you tell who gets what? Or you don't want 
to hurt anyone by giving them the TPA if they have had a 
hemorrhagic stroke.
    I just have to tell you my own experience, 1988, and my dad 
had a very serious stroke. And I remember sitting there in the 
ICU that night wondering if that brand new drug that they were 
giving people with heart attacks could possibly make a 
difference. And, of course, you talk about an off-label 
indication; no one would have gone there.
    I don't know if I asked about it, but I certainly thought 
about it. There had to be a way. Now, with what you described, 
and not just the clot-busting medications, but actually going 
in with a catheter and pulling the offending clot out and 
discarding it in the bedpan, I mean, a wonderful, wonderful 
outcome for that scenario.
    Because I know the other side of that, which was almost 20 
years of survival with never being able to speak a word. Ms. 
Bardach talks about the speech-generating devices. I became 
very familiar with the very rudimentary tools that were 
available, as my dad, who was an accomplished general surgeon, 
spent the rest of his life unable to communicate.
    And so these are not just theoretic concerns. When Mr. 
Griffith brought up the Congressional Budget Office--and, yes, 
we have had a lot of discussion about the Congressional Budget 
Office in this committee the last 6 months, and all of it 
valid. They do good work over there.
    But doggone it, when you look at what you do, and they say, 
well, we are going to calculate, but all we can calculate is 
the cost, because it is the cost of the time under the C-arm, 
it is the time in the fluoroscopy, it is the cost of the 
medication, the cost of the catheters--you really don't capture 
what happens way downstream.
    With someone like my dad, who lives almost 20 years after 
the stroke, the first 10 years, you have captured all the 
costs. But if you were able to prevent what happened next, the 
next 10 years, who knows? Maybe even continuing productive 
life, continuing to be a general surgeon in our little town.
    When we look at CBO stuff--and we will have this 
opportunity on this committee. I feel certain that I am going 
to be successful in bringing this--we look at the cost. But we 
have got to be able to widen out that window, not just to the 
10-year budget cycle to which we are wedded currently, but we 
have got to have a wider look to get to the stuff that Dr. 
Murphy was talking about, even Dr. Ruiz was talking about. We 
have to have the ability to do that.
    So it has been a thought-provoking morning. I want to thank 
all of you for spending so much time with us.
    Do I have another member? I would yield to Mr. Guthrie for 
a followup question since I went over.
    Mr. Guthrie. I am fine. I am good.
    Mr. Burgess. So, seeing that there are no further members 
wishing to ask questions, I once again want to thank all of our 
witnesses for being here today.
    We have received outside feedback from another number of 
organizations on these bills, imagine that. So I would like to 
submit statements from the following for the record: the 
National Multiple Sclerosis Society; the American Medical 
Association; CHIME; Health IT Now; Intermountain Health; United 
Surgical Partners; Steve Gleason; the ALS Association; Focus on 
Therapeutic Outcomes, Incorporated; the NARA; the NASL; the 
Private Practice Section of the APTA; PTPN; the Coalition to 
Preserve Rehabilitation; the Brain Injury Association of 
America; AMRPA; Covington; and a letter from 12 advocacy groups 
on prostate cancer.
    So, without objection, so ordered. Those will be made part 
of the record.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. Pursuant to committee rules, I remind members 
that they have 10 business days to submit additional questions 
for the record.
    And I will just tell you: I have several that I went way 
over my time, but I still have multiple questions that I am 
going to be submitting.
    I ask the witnesses submit their response within 10 
business days upon receipt of the questions.
    And, without objection, the chair again thanks our witness 
panel for a very, very informative morning and afternoon. The 
subcommittee stands adjourned.
    [Whereupon, at 1:13 p.m., the subcommittee was adjourned.]
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