[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
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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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
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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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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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