[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
THE OBAMA ADMINISTRATION'S MEDICARE DRUG EXPERIMENT: THE PATIENT AND
DOCTOR PERSPECTIVE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
MAY 17, 2016
__________
Serial No. 114-146
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California7
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILLY LONG, Missouri JOSEPH P. KENNEDY, III,
RENEE L. ELLMERS, North Carolina Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 4
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 6
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 7
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 116
Witnesses
Debra Patt, M.D., Medical Director, U.S. Oncology Network........ 9
Prepared statement........................................... 12
Michael Schweitz, M.D., National Advocacy Chair, Coalition of
State Rheumatology Organizations............................... 28
Prepared statement........................................... 30
Marcia Boyle, President and Founder, Immune Deficiency Foundation 43
Prepared statement........................................... 45
Answers to submitted questions............................... 269
Heather Block, Patient Advocate.................................. 56
Prepared statement........................................... 58
Joe Baker, President, Medicare Rights Center..................... 63
Prepared statement........................................... 65
Submitted Material
H.R. 5122, A Bill to prohibit further action on the proposed rule
regarding testing of Medicare part B prescription drug models,
submitted by Mr. Pitts......................................... 118
Letter of May 2, 2016, from Hon. Tom Price, et al., to Andy
Slavitt, Acting Administrator, Centers for Medicare & Medicaid
Services, Department of Health and Human Services, submitted by
Mr. Green...................................................... 120
Letter of April 29, 2016, from Chuck Grassley, a United States
Senator from the State of Iowa, to Sylvia Burwell, Secretary,
Department of Health and Human Services, submitted by Mrs.
Blackburn...................................................... 141
Letter of May 2, 2016, from AARP, et al., to Sylvia Burwell,
Secretary, Department of Health and Human Services, and Andy
Slavitt, Acting Administrator, Centers for Medicare & Medicaid
Services, Department of Health and Human Services, submitted by
Ms. Schakowsky................................................. 145
Statement of Ariel A. Gonzalez, Director, Federal Health &
Family, AARP, May 17, 2016, submitted by Ms. Schakowsky........ 149
Statement of American Federation of Labor and Congress of
Industrial Organizations, May 17, 2016, submitted by Ms.
Schakowsky..................................................... 151
Letter of May 16, 2016, from Robert Roach, Jr., President,
Alliance for Retired Americans, et al., to Mr. Upton and Mr.
Pallone, submitted by Ms. Schakowsky........................... 152
Letter of May 16, 2016, from Scott Frey, Director of Federal
Government Affairs, AFSCME, to Representatives in Congress,
submitted by Ms. Schakowsky.................................... 154
Letter of May 16, 2016, from Judith Stein, Executive Director/
Attorney, Center for Medicare Advocacy, to Mr. Upton and Mr.
Pallone, submitted by Ms. Schakowsky........................... 155
Statement of Doctors for America, submitted by Ms. Schakowsky.... 157
Letter of May 17, 2016, from Lynn Quincy, Associate Director,
Health Policy, and Victoria Burack, Policy Analyst, Consumers
Union, to Mr. Pitts and Mr. Green, submitted by Ms. Schakowsky. 159
Statement of Justice in Aging, May 17, 2017, submitted by Ms.
Schakowsky..................................................... 161
Statement of Max Richtman, President and CEO, National Committee
to Preserve Social Security and Medicare, May 17, 2016,
submitted by Ms. Schakowsky.................................... 163
Letter of May 16, 2016, from Holly R. Hart, Assistant to the
International President, Legislative Director, United
Steelworkers, to Ms. Schakowsky, submitted by Ms. Schakowsky... 166
Letter of May 6, 2016, from Gary Harbin, President, Public Sector
HealthCare Roundtable, to Sylvia Burwell, Secretary, Department
of Health and Human Services, and Andy Slavitt, Acting
Administrator, Centers for Medicare & Medicaid Services,
Department of Health and Human Services, submitted by Ms.
Schakowsky..................................................... 168
Statement of the International Union, United Automobile,
Aerospace and Agricultural Implement Workers of America, May
17, 2016, submitted by Ms. Schakowsky.......................... 170
Statement of Wanda Filer, President, American Academy of Family
Physicians, March 10, 2016, submitted by Ms. Schakowsky........ 171
Letter of May 9, 2016, from Ms. Schakowsky, et al., to Andy
Slavitt, Acting Administrator, Centers for Medicare & Medicaid
Services, Department of Health and Human Services, submitted by
Ms. Schakowsky................................................. 173
Letter of May 16, 2016, from Elizabeth Warren, a United States
Senator from the Commonwealth of Massachusetts, et al., to
Sylvia Burwell, Secretary, Department of Health and Human
Services, et al., submitted by Ms. Schakowsky.................. 176
Letter of May 17, 2016, from Clyde Terry, Chairperson, National
Council on Disability, to Andy Slavitt, Acting Administrator,
Centers for Medicare & Medicaid Services, Department of Health
and Human Services, submitted by Mr. Pitts..................... 180
Letter of May 17, 2016, from Mary R. Grealy, President,
Healthcare Leadership Council, to Mr. Pitts and Mr. Green,
submitted by Mr. Pitts......................................... 183
Letter of May 16, 2016, from Susan A. Cantrell, Chief Executive
Officer, Academy of Managed Care Pharmacy, to Mr. Pitts and Mr.
Green, submitted by Mr. Pitts.................................. 188
Letter of March 17, 2016, from 1 in 9: The Long Island Breast
Cancer Action Coalition, et al., to House and Senate
leadership, submitted by Mr. Pitts............................. 191
Letter from the Alliance for the Adoption of Innovations in
Medicine, et al., to House and Senate committee leadership,
submitted by Mr. Pitts......................................... 202
Letter of May 9, 2016, from Tony Coelho, Chairman, Partnership to
Improve Patient Care, et al., to Andy Slavitt, Acting
Administrator, Centers for Medicare & Medicaid Services,
submitted by Mr. Pitts......................................... 205
Letter of April 27, 2016, from Senate Finance Committee Democrats
to Andy Slavitt, Acting Administrator, Centers for Medicare &
Medicaid Services, submitted by Mr. Pitts...................... 214
Letter of May 9, 2016, from Scott H. Peters, a Representative in
Congress from the State of California, to Andy Slavitt, Acting
Administrator, Centers for Medicare & Medicaid Services,
submitted by Mr. Pitts......................................... 217
Letter of May 13, 2016, from House Democrats to Andy Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services,
submitted by Mr. Pitts......................................... 218
Letter of April 28, 2016, from Senate Committee on Finance
Republicans to Andy Slavitt, Acting Administrator, Centers for
Medicare & Medicaid Services, submitted by Mr. Pitts........... 222
Letter of May 9, 2016, from Christopher W. Hansen, President,
American Cancer Society Cancer Action Network, to Sylvia
Burwell, Secretary, Department of Health and Human Services,
submitted by Mr. Cardenas...................................... 225
Letter of May 9, 2016, from Sara Radcliffe, President and CEO,
California Life Sciences Association, to Andy Slavitt, Acting
Administrator, Centers for Medicare & Medicaid Services,
submitted by Mr. Cardenas...................................... 253
Report by the Memorial Sloan Kettering Cancer Center, ``Examining
Congressional comments regarding Medicare's Part B pilot
proposal,'' May 16, 2016, submitted by Mr. Welch............... 255
THE OBAMA ADMINISTRATION'S MEDICARE DRUG EXPERIMENT: THE PATIENT AND
DOCTOR PERSPECTIVE
----------
TUESDAY, MAY 17, 2016
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2123 Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Guthrie, Shimkus,
Murphy, Blackburn, Lance, Griffith, Bilirakis, Long, Ellmers,
Bucshon, Brooks, Collins, Green, Engel, Capps, Schakowsky,
Butterfield, Castor, Sarbanes, Schrader, Kennedy, Cardenas, and
Pallone (ex officio).
Also present: Representative Welch.
Staff present: Mike Bloomquist, Deputy Staff Director; Sean
Bonyun, Communications Director; Rebecca Card, Assistant Press
Secretary; Karen Christian, General Counsel; Paul Edattel,
Chief Counsel, Health; Tim Pataki, Member Services Director;
James Paluskiewicz, Professional Staff Member, Health; Graham
Pittman, Legislative Clerk; Chris Sarley, Policy Coordinator,
Environment and the Economy; Jennifer Sherman, Press Secretary;
Adrianna Simonelli, Legislative Associate, Health; Heidi
Stirrup, Policy Coordinator, Health; John Stone, Counsel,
Health; Sophie Trainor, Policy Advisor, Health; Jeff Carroll,
Democratic Staff Director; Tiffany Guarascio, Democratic Deputy
Staff Director and Chief Health Advisor; Jessica Martinez,
Democratic Outreach and Member Services Coordinator; Samantha
Satchell, Democratic Policy Analyst; Andrew Souvall, Democratic
Director of Communications, Outreach, and Member Services; and
Arielle Woronoff, Democratic Health Counsel.
Mr. Pitts. I will ask all Members to take their seats. The
time of 10:00 has arrived. The subcommittee will come to order.
The Chair will recognize himself for an opening statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Today's hearing will take a closer look at a recent
proposed rule from the Centers for Medicare and Medicaid
Services, CMS, on a Part B drug payment model. This proposal
represents the biggest change in Medicare drug reimbursement in
years.
There are several aspects that are concerning to many,
including the mandatory nature of this so-called demonstration
project, the breadth of the experiment essentially across the
Nation in virtually all primary care service areas and the
timing.
These major changes would take place as early as July and
on top of the current implementation of MACRA, the new payment
structure for physicians that replace the SGR, the sustainable
growth rate.
But perhaps the most concerning aspect of this proposal is
that it came from unelected bureaucrats in this administration
who made the decision behind closed doors affecting our seniors
and their health care.
What happened to the transparency in regard to stakeholders
that we expect when considering proposals of this magnitude? In
fact, these concerns over provider reimbursement under the
Medicare Part B program are so considerable that recently 242
bipartisan Members of Congress wrote to the administration and
asked that the rule be withdrawn.
Several others letters from both the House and Senate have
been sent detailing numerous and serious concerns. Moreover,
our Health Subcommittee colleague, Dr. Larry Bucshon, recently
introduced legislation that would stop this proposal from
advancing.
So today, we're going to hear from doctors and patient
advocates about their views on this proposed rule. I want to
make it clear at the outset that we are not opposed to
demonstration programs and in fact have supported a number
which tests certain models in limited areas to determine
positive or negative outcomes and whether such demonstrations
should be advanced in a larger context.
However, the health and well-being of seniors is nothing to
be experimented with. This particular rule could result in
grave consequences for our seniors. CMS is proposing to reduce
reimbursement for physician-administered drugs with half of the
country's providers seeing dramatic cuts.
The other half will retain current reimbursement levels,
but half of those will be used to test out vague value-based
purchasing arrangements, and after a very long 5 years CMS will
see what happened.
Keep in mind Medicare is the largest payer of provider-
administered drugs. The Part B program covers provider-
administered injectables and certain other drugs for physician
offices and outpatient clinics the provider purchases and
administers the product before submitting a claim to Medicare.
After purchasing a drug from a wholesaler or a specialty
distributor, the provider will store the product at its
location.
The provider then administers the drug to the patient and
after the patient receives the drug and any other medical care,
the provider then submits a claim for reimbursement, hence term
buy and bill, because the medical claim is submitted after the
provider has purchased and administered the drug.
The Medicare Prescription Drug Improvement and
Modernization Act of 2003--MMA-requires Medicare to use a
drug's average sale price--ASP+6 percent for reimbursing
provider-administered injectable drugs.
ASP is based on the manufacturer's actual selling price
minus all price concessions. CMS asserts this system somehow
gives incentives for physicians to prescribe more expensive
drugs and therefore has proposed this nationwide two-phase
experiment which would allow half of the providers to continue
to be reimbursed at ASP+6 percent while the other half would
receive the lower ASP+2.5 percent rate plus a fixed $16.80
payment.
However, with the impact of sequestration calculated in the
reimbursement falls to nearly ASP+0 percent. This proposal is
so far reaching and has caused so much concern it is difficult
to imagine any meaningful conclusions can be drawn because
marketplace realities will undermine the integrity of this
massive and unprecedented experiment on patients and providers.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
The subcommittee will come to order.
The chairman will recognize himself for an opening
statement.
Today's hearing will take a closer look at a recent
proposed rule from the Centers for Medicare and Medicaid
Services (CMS) on a Part B Drug Payment Model.
This proposal represents the biggest change in Medicare
drug reimbursement in years. There are several aspects that are
concerning to many, including: the mandatory nature of this so-
called demonstration project; the breadth of the experiment--
essentially across the Nation in virtually all primary care
service areas; and the timing--these major changes would take
place as early as July and on top of the current implementation
of MACRA--the new payment structure for physicians that
replaced SGR (Sustained Growth Rate).
But perhaps the most concerning aspect of this proposal is
that it came from unelected bureaucrats in this administration
who made decisions behind closed doors affecting our seniors
and their health care. What happened to the transparency and
regard for stakeholders that we expect when considering
proposals of this magnitude?
In fact, these concerns over provider reimbursement under
the Medicare Part B program are so considerable, that recently
242 bipartisan Members of Congress wrote to the administration
and asked that the rule be withdrawn. Several other letters
from both the House and Senate have been sent detailing
numerous and serious concerns. Moreover, our Health
Subcommittee colleague, Dr. Larry Bucshon, recently introduced
legislation that would stop this proposal from advancing. So
today we are going to hear from doctors and patient advocates
about their views on this proposed rule.
I want to make clear at the outset that we are not opposed
to demonstration programs and in fact have supported a number
which test certain models in limited areas to determine
positive (or negative) outcomes and whether such demonstrations
should be advanced in larger contexts. However, the health and
well-being of seniors is nothing to be experimented with.
This particular rule could result in grave consequences for
our seniors. CMS is proposing to reduce reimbursement for
physician administered drugs, with half of the country's
providers seeing dramatic cuts. The other half will retain
current reimbursement levels but half of those will be used to
test out vague value-based purchasing arrangements. And after a
very long 5 years, CMS will see what happened.
Keep in mind, Medicare is the largest payer of provider-
administered drugs. The Part B program covers provider-
administered injectables and certain other drugs. For physician
offices and outpatient clinics, the provider purchases and
administers the product before submitting a claim to Medicare.
After purchasing a drug from a wholesaler or specialty
distributor, the provider will store the product at its
location. The provider then administers the drug to the
patient. After the patient receives the drug and any other
medical care, the provider then submits a claim for
reimbursement. Hence the term, buy-and-bill, because the
medical claim is submitted after the provider has purchased and
administered the drug.
The Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA) requires Medicare to use a
drug's Average Sales Price (ASP) + 6% for reimbursing provider-
administered injectable drugs. ASP is based on the
manufacturer's actual selling price, minus all price
concessions.
CMS asserts this system somehow gives incentives for
physicians to prescribe more-expensive drugs and therefore has
proposed this nationwide two-phase experiment which would allow
half of the providers to continue to be reimbursed ASP + 6%
while the other half would receive the lower ASP + 2.5% rate
plus a fixed $16.80 payment. However, with the impact of
sequestration calculated in, the reimbursement falls to nearly
ASP + 0%.
This proposal is so far-reaching and has caused so much
concern it is difficult to imagine any meaningful conclusions
can be drawn because marketplace realities will undermine the
integrity of this massive and unprecedented experiment on
patients and providers.
Mr. Pitts. My time has expired, so I yield back the balance
of my time and now recognize the ranking member of the
subcommittee, Mr. Green, 5 minutes for his opening statement.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman. Good morning. I thank
our panels for being here today.
As we know, CMS, through the Centers for Medicare and
Medicaid Innovation, recently proposed to test value-driven
payment models for prescription drugs under Medicare Part B.
This proposal has garnered significant reaction and
response from the provider, patient, and the pharmaceutical
communities.
I appreciate the Chair for having this hearing today and
hope this committee will take the opportunity to examine the
proposals, merits and drawbacks.
While the loudest voices have been oppose to the model
outright, it is important to thoroughly evaluate the issues CMS
is attempting to address and look at the proposal with calm and
reason, and I appreciate CMS' consistent goal of strengthening
the Medicare program. However, I have some concerns about the
size and scope of the proposed demonstration and its potential
impact on Medicare beneficiaries' access to physician-
administered drugs now and in the future.
I also question how the demonstration may affect
physicians' participation in existing and upcoming delivery and
payment reform models.
Currently, Medicare Part B pays physicians and hospital
outpatient departments the average sales price, or ASP, of a
drug plus the 6 percent add-on on payment commonly referred to
as ASP+6.
Medicare pays ASP+6 for drugs regardless of the price paid
to acquire the drug. MedPAC and others have raised concern that
the 6 percent add-on may create incentives to use higher priced
drugs when lower priced alternatives are available and
appropriate for the patient.
It's difficult to know the extent in which a percentage
add-on to ASP influences drug-prescribing patterns because few
studies have looked into this issue.
Prescription drug spending in the United States was about
$457 billion in 2015 and roughly 17 percent of the overall
health spending. In 2015, Medicare Part B spent $20 billion on
outpatient drugs administered by physicians and hospital
outpatient departments, which has doubled the amount spent in
2007.
Beneficiary cost sharing under fee for service Medicare
Part B is 20 percent with no out of pocket limit. According to
the GAO, some seniors and people with disabilities have faced
catastrophic expenses amounting to as much as $100,000. The
median annual income for Medicare beneficiaries is less than
$25,000 a year, and one in four have less than $12,000 in
savings.
There's a national conversation occurring about the cost of
prescription drugs. I appreciate CMS for attempting to address
this issue in part by proposing to test tools that reward value
in Medicare Part B similar to the efforts in the private
sector.
Congress should not ask seniors to pay 20 percent of
increasingly expensive therapies without due consideration of
whether their money is being well spent. Healthcare delivery
systems are rightfully changing and Medicare should not be left
behind.
I'm confident that providers will fulfill their calling and
practice medicine, delivering the best care for their patients
rather than pad their bottom lines.
Yet, on behalf of seniors and the sustainability of the
healthcare system at large we cannot put our heads in the sand
and ignore trends. This proposed model is far from perfect and
I have serious concerns about the aspects of it.
Recently, I joined members of this committee in sending a
letter to CMS outlining our concerns with the demonstration and
urging the agency to address them.
I ask for unanimous consent, Mr. Chairman, to submit this
letter for the record.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Green. I look forward to hearing from our witnesses
about their perspective of the model and concerns we've
outlined to the agency.
Taking a step back, I'm going to bring up a related issue
that has become part of the conversation around the
demonstration which is that of prompt pay.
I have long had an interest in preserving seniors' access
to quality care by ensuring Medicare pays at a rate that will
retain a robust network of providers.
H.R. 696, also know and the Prompt Pay bill, is a piece of
legislation I've introduced with my colleague on our committee,
Mr. Whitfield, for several Congresses.
The bill excludes the prompt payment discounts offered by
manufacturers to wholesalers from the average sales price for
drugs and biologics covered under Medicare Part B.
This became an issue when the Medicare Modernization Act
was enacted in 2003. It reduces the amount doctors are
reimbursed for administrative treatments and as a result
patients are pushed to more expensive settings for their care.
Reducing the number of options for patients, diminishing
the access drives up the costs in both short and long term and
is bad policy. The Prompt Pay discount has negatively affected
patients for many years before sequestration and whether we
adopt legislation repealing, replacing or otherwise authoring
the sequester without adopting H.R. 696 the underlying issue
will still exist.
Thank you, Mr. Chairman, and our witnesses here today and I
look forward to a robust discussion about the proposed
demonstration and I yield back my time.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes the vice chair of the full committee, Mrs.
Blackburn, 5 minutes for her opening statement.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman, and I do want to
say welcome to our witnesses. I think that you can tell from
the chairman's statement and you'll find out from the questions
that you hear we are all very concerned about a couple of
things that are happening with the demonstration project.
Number one, rural areas--they're already challenged, and I
have 19 counties in my district in Tennessee and some of the
more rural counties are quite concerned about this and
healthcare providers are very concerned about this and fear
that this may be the type component that pushes some of these
providers to the brink and out of the business in service
areas.
So we are very concerned about that, especially when it
comes to things like cancer and getting the appropriate
treatments. And Mr. Chairman, I would like to include for the
record a letter that is dated April 29th from Senator Grassley
to Secretary Burwell.
Senator Grassley has made specific inquiries of the
secretary if CMS--if this model is in fact a clinical trial but
without the typical patient safeguards.
And I understand that clinical trials are important. In my
district we have a lot of physicians and researchers who
participate in this when it comes to oncology treatment.
I have had the opportunity to visit with some of them, and
they are quite concerned about the way this is moving. So I ask
permission to submit the letter.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mrs. Blackburn. Thank you, Mr. Chairman, and to each of you
again, we're going to look forward to digging a little deeper
on this. Access to the right type care at the right time is
essential for positive outcomes and so we will be seeking your
guidance and with that I will yield to any other member of the
committee seeking time or will yield back.
Mr. Pitts. All right.
Mrs. Blackburn. Yield back.
Mr. Pitts. Without objection the lady yields back, and now
the Chair recognizes the ranking member of the full committee,
Mr. Pallone, 5 minutes for an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman, and thanks to the
witnesses who will be testifying today. I think we would all
agree that it is critical we continue to transform our
healthcare system into one that incentivizes value over volume.
That is the theme we heard time and again when we worked
together to repeal the SGR and replace it with a payment system
that rewards doctors for the quality of care they give to
seniors and we were all in agreement that more care must be
replaced with better care. The status quo, we said, was
unsustainable.
The success of this kind of delivery system reform,
however, is not possible if we do not give Medicare the tools
to stay in business.
Medicare must be able to innovate just like the private
sector is doing and that's why I support the innovation center
that was authorized in the Affordable Care Act because it
allows Medicare to test new models that improve care and save
money.
Now, we've all heard loud and clear that there are concerns
with the center's most recent proposal to change the way we
reimburse doctors for drugs administered in their offices under
Part B. I look forward to hearing more from our witnesses today
about the rule. I don't think anyone here would claim this
proposal is perfect.
I'm particularly interested in hearing about how to ensure
that seniors have access to necessary drugs. I'm also
interested in better understanding how we can assure that the
evaluation of this proposed model is robust and thorough before
it's expanded.
To date, there has been widespread engagement ranging from
comments from stakeholders to letters from Members of Congress.
This feedback is an important part of the process, and I
believe the administration will take into account these
concerns and make changes to address them in the final rule.
So I'd like to now yield the remainder of my time to
Congresswoman Schakowsky.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Thank you Mr. Chairman. And thank you to the witnesses for
testifying today. I think we would all agree that it is
critical we continue to transform our healthcare system into
one that incentivizes value over volume. That is a theme we
heard time and again when we worked together to repeal the SGR
and replaced it with a payment system that rewards doctors for
the quality of care they give to seniors. We were all in
agreement that more care must be replaced with better care. The
status quo, we said, was unsustainable.
The success of this kind of delivery system reform,
however, is not possible if we do not give Medicare the tools
to stay in business. Medicare must be able to innovate, just
like the private sector is doing. That is why I support the
Innovation Center that was authorized in the Affordable Care
Act because it allows Medicare to test new models that improve
care and save money.
Now we have all heard loud and clear that there are
concerns with the Center's most recent proposal to change the
way we reimburse doctors for drugs administered in their
offices under Part B. I look forward to hearing more from our
witnesses today about the rule. I don't think anyone here would
claim this proposal is perfect. I am particularly interested in
hearing about how to ensure that seniors have access to
necessary drugs. I'm also interested in better understanding
how we can ensure that the evaluation of this proposed model is
robust and thorough before it is expanded.
To date, there has been widespread engagement, ranging from
comments from stakeholders to letters from Members of Congress.
This feedback is an important part of the process, and I
believe the administration will take into account these
concerns and make changes to address them in the final rule.
I'd like to yield the remainder of my time to Congresswoman
Schakowsky.
Ms. Schakowsky. I thank the gentleman for yielding. I
strongly believe that lowering drug prices is imperative to the
sustainability of our healthcare system, especially our public
insurance programs like Medicare, and I support CMS' proposal
to create a demonstration project for drugs paid under Part B.
Luckily, I'm not alone. Many organizations that represent
beneficiaries, insurance companies and consumer organizations,
including AARP, Aetna, the AFL-CIO, the Alliance for Retired
Americans, AFSCME, the American Federation of Teachers, Center
for American Progress, Center for Medicare Advocacy, Doctors
for America, Consumers Union, Families USA, Justice in Aging,
Kaiser Permanente, Medicare Rights Center, National Committee
to Preserve Social Security and Medicare, the National
Education Association, the National Partnership for Women &
Families and the Boilermakers, among others, support this
proposal, and I'd like, Mr. Chairman, to enter their letters of
support for the Part B demonstration project into the record.
Mr. Pitts. Without objection, so ordered.
Ms. Schakowsky. I'd also like to enter into the record
several additional statements of support from many of those
same groups as well as the United Steelworkers, the Public
Sector HealthCare Roundtable, United Auto Workers, and the
Academy of Family Physicians supporting CMS' proposal.
Mr. Pitts. Without objection, so ordered.
Ms. Schakowsky. And I--thank you--and I'd also like enter
into the record a letter signed by 20 Members of the House and
a letter signed by 11 Senators supporting CMS' proposal.
Mr. Pitts. Without objection, so ordered.
[The information submitted by Ms. Schakowsky appears at the
conclusion of the hearing.]
Ms. Schakowsky. Yet, every time we attempt to do anything
to rein in drug costs we are met with fierce opposition. We are
actively reforming every other aspect of our healthcare system
to pay for value except pharmaceuticals.
In fact, drug manufacturers are the only one entity that
can charge Medicare anything they want for their products. We
would never accept that from any other entity in our healthcare
system and we should no longer accept it from pharma.
The proposal from CMS is not final. They have committed
themselves to working with stakeholders to address their
concerns. In fact, CMS has indicated that they would be open to
changes including the scope of the proposal and exceptions for
small and rural providers.
But all we hear today is no. With no alternative ideas on
how to realign incentives and reduce drug costs for
beneficiaries and that is not good for anyone anymore.
We cannot continue on this unsustainable path where drug
costs rise faster than overall health costs and patients are
bankrupted in order to pay for the lifesaving drugs that they
need.
You know, in some ways I would rather find out that there
is no cure for a certain disease that I have than know that
that cure is right there in front of me, but I simply cannot
afford it. Because I don't have the dollars to pay for it, I
can't get that cure. This is unconscionable. I think it's also
un-American, and I yield back.
Mr. Pitts. The gentleman's time has expired. As usual, all
opening statements of the Members will be made a part of the
record.
I have a UC request. as well. I'd like to submit the
following documents for the record: statements from the
National Council on Disability, Healthcare Leadership Council,
American College of Rheumatology, Academy of Managed Care
Pharmacy, letters from the ASP Coalition, two dozen members of
the patient community, Partnership to Improve Patient Care, the
American Association of People with Disabilities and over 80
other patient advocacy organizations, Senate Finance Democrats,
Representative Scott Peters, 25 Democratic Members, Senate
Finance Republicans and we also completed a review of 218
comments from State and national groups as well as over 800
individuals. The vast majority of comments express concern and
urge withdrawal.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. So at this point, I'll introduce the witnesses
in the order that you will present testimony. First of all, we
have Dr. Debra Patt, MD, MPH, MBA, Vice President, Texas
Oncology Medical Director, the U.S. Oncology Network Chair,
Clinical Practice Committee of the American Society of Clinical
Oncology, Editor-in-Chief, Journal of Clinical Oncology,
Clinical Cancer Informatics and Board Member of Community on
Oncology Alliance. Welcome.
Then Dr. Michael Schweitz, MD, FACP, MACR, National
Advocacy Chair, Coalition of State Rheumatology Organizations,
CSRO; Ms. Marcia Boyle, President and Founder, Immune
Deficiency Foundation; Ms. Heather Block, a patient advocate
and Mr. Joe Baker, President, Medicare Rights Center.
Thank you for coming today. Your written testimony will be
made a part of the record. We ask that you summarize. We'll
give you each 5 minutes for your summary. So at this point the
Chair recognizes Dr. Patt, 5 minutes for your opening
statement.
STATEMENTS OF DEBRA PATT, M.D., MEDICAL DIRECTOR, U.S. ONCOLOGY
NETWORK; MICHAEL SCHWEITZ, M.D., NATIONAL ADVOCACY CHAIR,
COALITION OF STATE RHEUMATOLOGY ORGANIZATIONS; MARCIA BOYLE,
PRESIDENT AND FOUNDER, IMMUNE DEFICIENCY FOUNDATION; HEATHER
BLOCK, PATIENT ADVOCATE; JOE BAKER, PRESIDENT, MEDICARE RIGHTS
CENTER
STATEMENT OF DEBRA PATT
Dr. Patt. Chairman Pitts and Ranking Member Green, thank
you for the opportunity to testify today on behalf of Texas
Oncology, the U.S. Oncology Network, the Community Oncology
Alliance and the American Society of Clinical Oncology
regarding the oncology community's grave concerns with the
proposed Medicare Part B drug payment model.
My written statement provides numerous arguments against
the CMS-proposed model but with the limited time I have today
as a physician I will tell you why this is bad medicine for
patients.
I am Dr. Deborah Patt and for 13 years I have been
providing care to cancer patients in Texas. As a physician,
quality care and value are the standards by which I practice
every day.
My patients often face life-and-death situations, and my
responsibility is to help them choose and then deliver the
personalized treatment for their disease. Increasingly, the
time I have to spend with patients is consumed with overcoming
a complex maze of administrative obstacles to provide
treatment.
But the CMS-proposed model is not just another hurdle. It's
an experiment that is simply unworkable in cancer care. Let me
explain.
CMS has proposed an experiment that randomizes physicians
by ZIP Codes into test and control groups. The study hypothesis
is that financial disincentives for use of newer more expensive
drugs will cause physicians to choose less expensive treatment
alternatives.
In my world, this is clinical research. Unlike the CMS
experiment, however, my patients have to volunteer their
participation in a clinical trial. But there is no opting out
of this mandatory national experiment.
There is no informed consent for patients, no monitoring
for adverse events, and no ability to evaluate impact on
quality and outcomes. These are central requirements of any
ethical research.
In this experiment, Medicare beneficiaries in certain ZIP
Codes won't have access to treatments that have a known
survival advantage. This is simply unacceptable.
More fundamentally, the underlying hypothesis for this
experiment that these incentives will result in reduced
Medicare spending is simply unfounded. I will let my written
testimony explain how UnitedHealthcare Project has already
disproved the CMS hypothesis.
Today, I'd like to focus on how few opportunities there are
to select therapeutic alternatives based solely on drug price.
Ten years ago when I met my patient Karen, who has metastatic
breast cancer, she couldn't walk. She couldn't stand without
pain. Her bones were riddled with disease and she was told
there was no hope. Within a year of meeting Karen she developed
metastatic breast cancer to her brain. Ten years ago, we knew
that patients with metastatic breast cancer to their brain
lived an average of a few weeks. Karen had an option of a
different treatment because the disease amplified a receptor
called HER2, and she was given a novel and targeted therapy
that we know would change her course dramatically.
In the last 10 years, Karen has had some disease
progression in her brain. But she's lived to see her son get
married and she danced at his wedding. She's lived to see her
first grandchild be born and grown into school age and she
continues to receive targeted treatment today and enjoys a good
quality of life.
These targeted therapies are expensive but the alternative
treatment to these expensive medications would lead to an early
death. Premature death is not a treatment alternative.
When I started my fellowship at the MD Anderson Cancer
Center in 2003, myeloma patients lived an average of 3 years.
Usually they were 3 years of toxic therapy.
Today, an average myeloma patient lives greater than 7
years due to new novel therapies and they live better because
myeloma has become a chronic disease where many patients have
remission for many years.
The treatment is expensive, but the lower cost alternative
would shave years off their life and diminish their quality of
life as well. I remind the committee that Medicare covers 60
percent of cancer patients, and the number of Medicare
beneficiaries are growing every day.
The CMS experiment has the potential to affect treatment
options and outcomes for the most significant and vulnerable
segment of the population fighting cancer. Interfering with the
physician's ability to act in the patient's best interest is
counter to our core values and certainly inconsistent with the
good work Congress has done to advance high quality, high value
care to every American.
It is not who we are. Like everyone here today, I am very
concerned about the increase in cost of treating cancer,
especially rising drug prices.
However, as I outlined in my written testimony, the CMS
proposal will not only fail to reduce drug prices, but in fact
it will likely increase costs.
In closing, I want to thank the members of the committee
for their extraordinary support of community-based cancer care.
Many on this panel and even more on the full committee have
introduced legislation, authored amendments, and wrote letters
to improve cancer care and access for our patients.
Most recently, thank you to Congressman Bucshon for
introducing H.R. 5122. On behalf of oncologists nationwide,
thank you for holding this hearing to highlight the serious
concerns around the CMS proposal.
I know we share the common goal of providing high-quality
medical care to Medicare beneficiaries and thank you for your
work on their behalf. When it's appropriate I'm happy to answer
any questions.
[The statement of Dr. Patt follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. The Chair thanks the gentlelady and now
recognizes Dr. Schweitz, 5 minutes for your opening statement.
STATEMENT OF MICHAEL SCHWEITZ
Dr. Schweitz. Thank you, Chairman Pitts and Ranking Member
Green, for inviting me to testify today on behalf of the
Alliance of Specialty Medicine and the Coalition of State
Rheumatology Organization.
The alliance is a coalition of national medical societies
representing specialty physicians in the United States. The
CSRO is a group of State and regional rheumatology societies
primarily made up of community practitioners formed to ensure
access to the highest quality care for rheumatologic disease.
I am a practicing physician and I spend the vast majority
of my time taking care of patients. I am here today to discuss
our concerns regarding the Part B demonstration project and to
support Dr. Bucshon's bill, H.R. 5122.
I note for the committee that our concerns track those
expressed in the letter CSRO signed together with more than 300
stakeholders urging withdrawal of the demo.
We have expressed our procedural concerns in my written
testimony. But today I will focus on our substantive concerns
including prescriber behavior, patient access and
sustainability.
First, clinical decision making is not influenced by the
add-on cost. We take issue with the underlying premise of the
rule which is the belief by CMS that clinical decision making
is driven by the opportunity to maximize revenue.
Data supporting this premise is not existent. In fact, in a
recent report by Magellan it looked at utilization of
rheumatoid arthritis medications and found that physicians are
not routinely prescribing the most expensive product.
In fact, in 2014 in the physician's office the most
expensive product was one of the least prescribed. Second, many
rheumatology practices will be unable to absorb this reduction.
The current 6 percent add-on already results in practices
without volume purchasing power, being underwater on several
products.
A reduction from 6 to 2.5 percent plus a nominal flat fee
will result in unsustainable cuts, especially considering that
CMS did not incorporate the impact of sequestration in its
calculations.
Specifically, the current reimbursement level is actually
ASP+4.4 percent. Accounting for sequestration, the new rate
will be ASP+0.86 percent with a flat fee.
Rheumatology is a specialty of small practices. For
example, in my State there are only a few practices with seven
or more doctors. Many practices with one or two rheumatologists
do not have the purchasing power to buy at ASP.
Third, and most importantly, is the impact on our patients.
As a result of these unsustainable cuts, if the demo moves
forward patients will lose access to office-based infusions.
CSRO surveyed its members to ascertain the behavioral
response to the CMS proposal and 73.08 percent of respondents
said that infusible Part B biologic options would no longer be
available for Medicare patients in their offices--44.87 percent
of respondents noted that they would refer to hospitals or
external infusion centers to continue therapy.
Hospital referrals will create challenges for patients with
rheumatoid arthritis including the distance to an outpatient
center and increased personal cost to beneficiaries, especially
those in rural areas.
It also runs counter to the goals of the model as costs of
the Medicare program will be higher when patients must receive
therapy in the outpatient department instead of the physician's
office.
Fourth, value-based purchasing cannot be one size fits all
and will require significant stakeholder input through pre-
rulemaking engagement. One of the concepts in Phase II are
interesting to explore while we believe they are not developed
enough yet to even be in a proposed rule since they do not
contain enough detail for comment meaningfully.
In addition, in rheumatology we don't have comparative
affecting this data to compare treatments. There are very few
studies that do that. On average, it takes two or more drugs in
sequence before finding the one that the patient responds to.
And finally, the cost of these drugs are closely grouped so
there is little reason to apply tools such as reference
pricing.
In conclusion, the alliance and CSRO appreciates CMS'
concern about high drug prices and would like to work with the
Congress and the administration to find solutions.
However, we must oppose the Part B drug payment model as it
suffers from serious procedural and substantial flaws that we
believe render it unworkable and it does nothing to actually
address the issue of drug costs.
As such, we have requested that CMS withdraw the model and
we urge the committee to do the same. The alliance and CSRO
thank the committee for its attention to this critical topic
and for the opportunity to provide the views of practicing
rheumatologists on the Part B model.
[The statement of Dr. Schweitz follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pitts. Chair thanks the gentleman and now recognizes
Ms. Boyle, 5 minutes for her opening statement.
STATEMENT OF MARCIA BOYLE
Ms. Boyle. Well, thank you, Chairman Pitts, Ranking Member
Green and all members of the subcommittee for inviting me to
testify today on behalf of the Immune Deficiency Foundation, or
IDF.
IDF is the national patient organization founded in 1980
dedicated to improving the diagnosis, treatment and quality of
life of people with primary immunodeficiency diseases through
advocacy, education and research.
Primary immunodeficiency, or PI, represents a group of more
than 250 rare chronic genetic diseases in which part of the
body's immune system is missing or functions improperly,
resulting in decreased ability to fight infection.
Approximately 250,000 people are diagnosed with PI in the
United States. Many require lifelong lifesaving treatment with
immunoglobulin replacement therapy, or IG therapy, to replace
antibodies needed to fight infection.
When patients cannot access IG, their lives are threatened
and they experience more doctor visits, hospitalizations and
time away from work and school.
I'm here today representing IDF and patients of PI,
including my own son, who was diagnosed as an infant. We have
serious issues with the Part B model and have asked CMS to
withdraw it.
In addition, we signed a letter expressing these concerns
led by the Arthritis Foundation and 24 groups representing
millions across the country with wide ranging conditions such
as lupus, mental illness, cancer and the healthcare needs our
veterans face.
Our concerns are rooted in our experience with the previous
Medicare reimbursement change that resulted in many of our
Medicare patients losing access to their lifesaving treatment.
Starting in 2005, there was significant reductions in
reimbursement for IG products as a result of the Medicare
Modernization Act, which changed Part B drug reimbursement from
the average wholesale price to ASP+6 percent.
In 2007, two studies by HHS reported on the difficulties
physicians and specialty pharmacies had obtaining IG at the
Medicare reimbursed price and the impact on patients' ability
to obtain their infusions.
One noted the 61 percent of responding physicians that they
had sent patients to hospitals for IVIG treatment because of
their inability to acquire adequate amounts of IVIG or problems
with Medicare payment.
But the problems were even bigger than that. Many patients
lost access to IG not only in the physician's office but in the
home as well. Thankfully, Congress responded by passing the
Medicare IVIG Access Act with overwhelming support including
support from every member of this subcommittee who was in
Congress at that time.
This demonstration is currently underway and IDF
anticipates it will lead to a permanent fix in the current
Medicare home infusion benefit for IVIG.
We are not crying wolf. Patients with PI have personally
experienced the unintended consequences of major payment
changes, which is why we wish CMS had engaged in more pre-
rulemaking dialogue with stakeholders before issuing such a
sweeping proposal that will dramatically impact beneficiaries.
In addition, our fear is that the proposed Part B model
which explicitly includes the ongoing Medicare IVIG access
demonstration will undercut this demo. Some specialty
pharmacies report that they are already close to underwater
with ASP+6 and low payment for their items and services.
With regard to the so-called value-based purchasing tools
contemplated by CMS for Phase II of the model there is
insufficient detail on the concepts proposed to comment one way
or the other and this is particularly troubling because we have
never seen any definition around what value actually means
particularly to patients.
Our patients have extensive experience with private
insurers using the word value as a guise for implementing cost
cutting tools that deny or delay access to needed treatments.
This experiment needs significant stakeholder input and
requires true dialogue with those who will be affected,
especially patients. We also have procedural concerns with the
model. The innovation center is authorized to test innovative
delivery models to reduce program expenditures while preserving
or enhancing the quality of care furnished to beneficiaries.
However, the model is not a test. It contains a Medicare
program change. In addition, we are concerned that this policy
change does not preserve or enhance the quality of care for
beneficiaries. In fact, we are convinced it will reduce quality
and access for our patients.
In conclusion, IDF has urged CMS to withdraw the Part B
drug payment model and request the Congress do everything in
its power to stop this harmful experiment from moving forward.
It jeopardizes beneficiary access to needed medications, is the
result of an opaque and poorly thought out process and may
actually increase costs to the Medicare program.
I thank the committee for its attempt to create
accountability in the CMS process and for the opportunity to
present the potential implications of the model for patients
with PI.
[The statement of Ms. Boyle follows:]
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Mr. Pitts. The Chair thanks the gentlelady and now
recognizes Ms. Block, 5 minutes for your opening statement.
STATEMENT OF HEATHER BLOCK
Ms. Block. Good morning. Thank you, Chairman Pitts, Ranking
Member Green, and distinguished members of the Subcommittee on
Health for inviting me to testify today.
I rarely share my cancer story as I find every cancer story
is unique to the person and often frightening or boring to
everyone else. But due to the importance of this hearing, I'd
like to share my story.
I found a lump in my own breast while managing aid projects
for the State Department and the U.N. in Afghanistan. I was
mystified as no one in my family had ever had cancer before.
I returned to the U.S. for a diagnostic mammograms, and it
was negative, so I returned to Afghanistan. My doctor suggested
it might be a mastitis infection due to an injury. There was a
chance I had bruised myself when I fled an attack that May.
Running and jumping into a police truck will leave some
bruises.
I ignored worsening symptoms as the mammogram had been
conclusively negative. Within three months, I returned again to
the U.S. for a second mammogram, and it was invasive breast
cancer.
I continued to work through a mastectomy and six months of
chemo, by then managing the monitoring and evaluation of aid
projects in Iraq.
A year after my oncologist said I was cured, I learned that
the cancer had returned. It was now in my liver. There was a
chance to surgically remove the cancer from my liver but cancer
cropped up in my lungs within days of a pretty brutal liver
resection.
Stage IV, no cure--I was reeling with the news and my
oncologist told me that 50 percent of women survived 2 years
and only 20 percent approximately survive 5 years and that I
would remain in treatment for the rest of my life.
At 4 \1/2\ years, I'm living beyond most projections.
But this isn't a feel-good story. My personal catch-22 is
that while drugs are keeping me alive, I'm also going through
my savings at an alarming rate.
I spend a ridiculous amount of time and energy trying to
cut costs and drafting budgets based on living longer with less
money and rising drug costs and trying to figure out how to
move closer to my cancer center--I do live in a rural area--
when I cannot sell my house.
It is the only asset that cannot be taken from me if I end
up declaring medical bankruptcy.
I was so relieved when I found out that I qualified for
Medicare, even though I'm well under 65. For those unaware, one
can qualify for Medicare after 29 months on Social Security
disability income if you're unable to work.
My drugs are billed through Part B, as most cancer
treatment drugs are, but my relief was short-lived when I
realized that the drugs are exceedingly expensive, and I am
always on the hook for the 20 percent co-pay.
Medicare right now pays about $2,000 a month for my monthly
treatment. There's no out-of-pocket maximum for Medicare Part
B. This means I'm responsible for paying 20 percent of ever
cancer drug that I receive forever more.
This is why I was pleased to hear about the demo. The CMS
demo proposes to address rising drug prices in a 5-year
evaluation, not an overhaul of Medicare Part B. It's a way for
the Government to begin to shift pricing incrementally based on
what they learn.
By evaluating payment models over a 5-year period CMS can
determine best practices without forcing me to change doctors,
hospitals or affecting my drug coverage.
How else can Medicare continue to ask me to pay for 20
percent of increasingly costly prescription drugs without any
evaluation of whether my money is being well spent.
I want to know that the drugs that are being used to treat
my cancer are the ones that will do the best job and not just
make my doctor the most money.
Every patient deserves that. In all of the uproar over this
proposal I have yet to hear anyone say that the current system
is working. Where did the payment formula of +6 even come from
and why would anyone push to keep a system where prescribing
choices could be motivated by money?
It seems common sense to remove any possibility of
financial incentive and instead create an appropriate handling
or storage fee.
I also think it's worth mentioning that my 20 percent co-
pay is based on whatever Medicare pays. My provider may receive
rebates or discounts. I'm still paying full freight.
I'm betting also that most patients don't know that one
component to be studies reduces or even waives the 20 percent
co-pay and I'm hoping that my ZIP Code is selected for that
part of the demo.
These proposals simply put new options on the table to
evaluate tools that are already being used in the private
sector.
As a taxpayer and a patient, this is exactly what I want
our Government to be doing--getting the best value for our
money. Frankly, we need to start somewhere. The price of drugs
is not sustainable.
CMS needs to test ways to hold down prescription drug
spending. Patients like me should not have to choose between
getting lifesaving drugs or paying our mortgage. No one should
have to fear bankruptcy as much as cancer.
Finally, I'd like to share America's dirty little secret.
We already have drug rationing. It's called affordability. Drug
innovation is meaningless without affordability.
Thank you for the opportunity to address the subcommittee,
and I look forward to answering any questions that you might
have.
[The statement of Ms. Block follows:]
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Mr. Pitts. The Chair thanks the gentlelady and now
recognizes Mr. Baker, 5 minutes for your opening statement.
STATEMENT OF JOE BAKER
Mr. Baker. Thank you. Chairman Pitts, Ranking Member Green
and distinguished members of the Subcommittee on Health, thank
you for the opportunity to testify on the Part B drug payment
model.
As president of the Medicare Rights Center, I lead a
national nonprofit organization that works to ensure access to
affordable health care for older adults and people with
disabilities through counselling and advocacy, educational
programs and public policy initiatives.
The Medicare Rights Center supports the proposed model. The
model seeks to realign perverse payment incentives while
ensuring that healthcare providers can continue to prescribe
the medications best suited to the individual needs of
patients.
The model also brings innovative value-based payment
strategies being used in the private market to the Medicare
program. Transitioning Medicare to a system that reimburses on
the basis of value is an aim supported by diverse voices
including patients and consumers, physicians, hospitals, health
insurers and others.
This objective will not be realized if pursued only in
silos, meaning the prescription drugs including Part B
medications, must be part of these reforms.
Beyond improving the quality of care delivered to
beneficiaries, the proposed model may help the Medicare program
by promoting more efficient use of program funds. Last year,
Medicare spent $22 billion on prescription drugs, double the
amount spent in 2007.
The Medicare Rights Center answers nearly 17,000 questions
on its national help line and provides educational resources to
over 2 million individuals each year through
medicareinteractive.org and other means.
Challenges affording needed health care are a common theme
heard on our help line. Sky-high cost sharing for Part B drugs
is a notable concern most often for cancer and immuno-
suppressant medications.
Many of these cases involve beneficiaries with original
Medicare who lack adequate supplemental coverage. Estimates
suggest that between 10 to 14 of beneficiaries only have
original Medicare, making them responsible for a 20 percent
coinsurance on all Part B services with no out of pocket
maximum. These beneficiaries can be exposed to catastrophic
costs which can reach as high as over $100,000.
Calls to withdraw the Part B payment model fail to
acknowledge the very real and unrelenting beneficiary access
challenges that exist under the current payment system, not
merely hypothetical ones.
We commend the Centers for Medicare and Medicaid Services
for proposing to test solutions that have the potential to
alleviate calamitous cost burdens which cause too many older
adults and people with disabilities to forego care, and we urge
Members of Congress to support and strengthen the proposal.
The Medicare Rights Center engage in this very process. Our
comments on the model focus on the need for enhanced monitoring
and oversight.
Among the topics we addressed were concerns raised about
how the model might shift how care is provided such as from
community practices to hospital settings. Though we note that
such shifts are already occurring and that shifts predicted in
the past were not as draconian or dramatic as projected.
We identified practical solutions that we believe can
address this and similar concerns. Such is the creation of a
dedicated ombudsman for this payment model.
We encourage CMS to carefully weigh comments submitted by
diverse stakeholders and we urge Members of Congress to ensure
that the proposal moves forward with refinements that reflect
concerns identified through the comment process.
Prohibiting the payment model from moving forward would
perpetuate a system that allows patients with less to go
without needed care and halt progress in how--in transforming
how Medicare pays for care and saddle taxpayers and saddle
taxpayers with the unrestrained costs of prescription drugs.
People with Medicare and taxpayers deserve a Medicare program
that pays for high value innovative health care.
We believe the Part B drug payment drug model presents an
important opportunity to ensure that Medicare meets this high
bar.
Thank you.
[The statement of Mr. Baker follows:]
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Mr. Pitts. The Chair thanks the gentleman, thanks each of
the witnesses for sharing your expertise with us. The Chair
would like to note the presence of a former member of this
subcommittee, a very valued member.
Dr. Phil Gingrey of Georgia is with us, sat for many years
here with us on the dais. So welcome, Phil.
I'll begin the questioning and recognize myself for 5
minutes for that purpose. There may be a misperception by some
that the drugs we're talking about being impacted in this
proposal amounts to an issue of simple generic substitution--
that patients can be easily switched to lower cost treatments
without consequences.
However, I know that many of these drugs do not have
alternatives that are clinically interchangeable--that even
treatments that may appear similar can have different effects
on individual patients. Many other patients only have one
effective treatment option.
So, Dr. Patt, we'll start with you and go to Dr. Schweitz.
What have you seen in your own practical experience? What are
some of the adverse effects that could occur if patients aren't
able to access their most appropriate prescribed treatment?
Dr. Patt. Thank you. I think there are many intended
consequences of this policy. When Avalere did an analysis of
the proposed Part B payment model, they demonstrated that for
drugs that cost more than $480 that many practices would be
underwater. We know that even in the ASP+6, which is not really
ASP+6 model today, that 25 commonly used oncology drugs are in
fact underwater.
So high cost drugs would commonly be underwater and this is
a disproportionate burden on oncology practices because we have
a higher percentage of more expensive drugs.
Unfortunately, many of the new innovative products that we
have that are very effect don't have generic treatment
alternatives--don't have interchangeable options that are a
lower cost. And so by not allowing practices to use or not
having practices be able to purchase drugs and give them to
their patients it diminishes the Medicare beneficiary's access
to care.
An example of that is pembrolizumab, which is an
immunotherapy in melanoma. So we all probably know about Jimmy
Carter's story with melanoma-that in August he was diagnosed
with a metastatic melanoma to his brain.
Because of the advent of targeted therapy this
immunotherapy pembrolizumab he informed his Bible school class
in December that he was in remission. He would not have access
to this treatment in Medicare under this new model.
Mr. Pitts. Dr. Schweitz?
Dr. Schweitz. In rheumatology we have a limited number of
agents, some with different mechanisms of action.
Unfortunately, we have no way to predict response. It's pretty
much trial and error.
The average patient goes through at least two drugs before
we find one that is effective for that patient and one of the
tenets we like to follow is you don't change a patient who's
doing well.
We have concerns about the Phase II that may dictate that
we change medications into, quote, ``higher value meds'' and we
don't have a definition of that in rheumatology.
In the private world--in the commercial world--there are,
quote, ``value programs'' which are really only directed at
cost and don't take into account the patient's individual
responses.
So it's a difficult problem to try to change medications to
a, quote, ``more effective'' or a, quote, ``more value-based
medicine'' when it doesn't exist.
Mr. Pitts. Ms. Boyle, did you want to add anything?
Ms. Boyle. Well, I agree with the sentiments because I've
seen my own son, for instance, be on a 5 percent immunoglobulin
product change to a 10 percent and collapse on the floor twice
when they were trying to get used to it.
He is now in his late 30s and has been on a wonderful
immunoglobulin product for years and he's all of a sudden
having reactions. He's having high blood pressure and trying to
control the reactions, and thankfully there's a subcutaneous
option out there that he's able to take--a higher percent
solution.
I have seen, again, private payers say well, we're just
going to use the least expensive. Their value is expense. It's
not patient reactions. If my son or other patients have to
change to that least expensive option du jour they will have
reactions. Their well-being will be compromised and it's
unconscionable.
Mr. Pitts. One more question. There's a lot of speculation
about what drives a doctor's treatment of diseases using
injectables. It appears that there's speculation that decisions
are made based of the ASP.
So Dr. Patt or Dr. Schweitz, would you please tell us
what's more important to you? Is it your patients' need or
preferences, your clinical evidence? Do you decide based on
which drugs have a better reimbursement?
Dr. Patt. Obviously, as a physician I provide the care and
prescribe the care for my patients that is a mutual shared
decision in their best interest and that is solely what drives
our decisions about patient care.
Mr. Pitts. Dr. Schweitz?
Dr. Schweitz. I concur 100 percent. The appropriate choice
of medication is based on what's best for the patient. I can
tell you in our practice of seven rheumatologists if you ask
any one of the doctors what the drugs actually cost or what the
reimbursement is they will not know.
Mr. Pitts. Thank you. My time is expired.
The Chair recognizes the gentleman, Mr. Green, 5 minutes
for questions.
Mr. Green. Thank you, Mr. Chairman.
Mr. Baker, the Medicare Rights Center is a trusted and
respected organization that advocates on behalf of American
seniors. The Medicare Rights Center has come out in support of
the proposed demonstration.
Can you explain to the committee how your organization came
to this conclusion?
Mr. Baker. Well, I think, once again, as I said in my
spoken and my written testimony, we see in a daily way the
consequences of these high drug prices, which Ms. Block
detailed I think so clearly as well in her own experience where
folks just cannot afford the rising prices of these drugs.
The 20 percent co-insurance, if they don't have
supplemental coverage--even those that do have supplemental
coverage that might cover all or part of that 20 percent they
are facing rising premiums for that supplemental coverage.
And then, of course, all people with Medicare see increases
in the Part B premium based upon the rising cost of Part B
medications as well as other services under Part B. And so we
see the proposal as an attempt to, one, restrain those prices
and provide relief to those individuals that are--cannot afford
these drugs and cannot get access to them all at all.
You know, these are patients in effect that are under
water, if you will, and cannot afford the care that they need.
Secondly, we think it will help the program overall, once again
get at high and rising----
Mr. Green. Let me ask another question.
Mr. Baker. Of course. Of course.
Mr. Green. In both your comments of CMS in testimony before
the committee the Medical Rights Center identified ways the
organization believes the model could be improved to ensure
access is maintained and care is not disrupted. Can you
elaborate on these and did CMS adopt any of your suggestions on
the model?
Mr. Baker. Well, as you know, the comments were just
recently submitted and now CMS has an opportunity to review all
of the comments that they received. So we don't know yet
whether they've adopted them.
But what they have done is said up front that there will be
claims monitoring in real time so if there are dislocations
they can be fixed, hopefully in real time. That's what they
said they want to do.
We also have said that we think there should be an
ombudsman as part of this program. So an ombudsman has been
used in the DME purchasing project.
It has been very helpful in identifying problems quickly,
helping individuals with those problems, also helping suppliers
and others with those problems and also bringing systemic
problems to the attention of not only CMS but to you all here
in Congress.
I think the other thing that we're really looking for CMS
to do is engage multiple stakeholders ongoingly and be very
transparent with that monitoring that they're doing of claims
with all stakeholders including Congress, not only transparent
with that monitoring and what they're finding but also with any
corrective action or corrective steps that we're taking.
So we really think that this has to be done transparently.
It needs to be shown that there's clinical effectiveness here.
I mean, if there aren't clinically equivalent drugs they won't
move into this value-based purchasing kind of system that CMS
wants to set up in Phase II of the program.
We think that certainly physicians and other providers with
clinical knowledge, pharmaceutical manufacturers with clinical
studies, need to come to the table, need to work with CMS to
show that there is clinical equivalence.
If there is not there's nothing in this proposal that would
prevent coverage for a prescription drug for someone that needs
it regardless of price. This is----
Mr. Green. The proposed demonstration project--I only have
5 minutes, and if you talk for 4 of them I can't answer.
Mr. Baker. I'm sorry about that.
Mr. Green. The proposed demonstration result in changes in
Medicare payments is going to be all Part B medications over a
5-year period and require 75 percent of the providers to
participate in either one or both of two phases.
Patients, providers and other stakeholders raised concern
about the scope and size of this demonstration, recognizing the
demonstration would affect care for our sickest seniors that's
being treated for serious illness I have concern--I have
concerns and urge CMS to reexamine the size of the proposed
model. Is that one that they share? Because this is a pretty
large model----
Mr. Baker. Right.
Mr. Green [continuing]. To do and I know that we need to
have enough to get good information.
Mr. Baker. Right.
Mr. Green. But it seems like they're actually--the model is
impacting the whole system.
Mr. Baker. Well, we share that concern and many of the
consumer organizations that we work with do share the concern
and have questioned CMS about that.
I know that there is concern about rural providers has been
mentioned and something that I think CMS needs to take a close
look at as well as providers that are represented here at this
table and the switch between facility type of--the types of
facilities that are providing this care.
So I do agree that that size and scope needs to be examined
and needs to be questioned. I also agree that the scope needs
to be large enough to really test these models for payment.
Mr. Green. Thank you. My time is expired.
Mr. Baker. Thank you.
Mr. Pitts. Chair thanks the gentleman. I now recognize the
vice chair of the full committee, Mrs. Blackburn, 5 minutes for
questions.
Mrs. Blackburn. Thank you, Mr. Chairman, and Dr. Patt and
Dr. Schweitz, I want to come to you first. And I mentioned
Senator Grassley's letter to HHS and concerns with the--with
this demonstration project and the fact that in the rule you
have two different terms used, and I'll just read from Senator
Grassley's letter. It's more succinct. ``I'm concerned that
throughout this proposed rule two terms are repeatedly used--
study and test. These terms seem to indicate there is a
component of research going on in this proposal.''
So what I want to ask you--each of you to weigh in on
because you've got oncology, rheumatology. When you have read
this rule do you see this as being clinical research or do you
just see it as being a test that they have thrown out there?
And Dr. Patt, I'll come to you first.
Dr. Patt. Representative Blackburn, thank you. I do see
this as an experiment but we conduct clinical research in our
cancer center and patients have informed consent. They have to
electively consent to clinical trials. They can opt out if
necessary and we follow adverse events and outcomes of those
patients.
In addition, clinical trials are to investigate potential
enhancements. We know that this experiment would decrease the
availability of some treatments that have a survival advantage.
So this is an experiment that would never pass an
institutional review board. You know, as you mentioned your
concerns about rural clinics, as you know, average sales price
is an average. Some large groups like hospital systems and
large practices are able----
Mrs. Blackburn. OK. Dr. Patt, let me just interrupt you
there for the sake of time. So you say it wouldn't pass an IRB.
So should they be forced to go in and get an IRB before they
embark on this?
Dr. Patt. I think that's not a bad idea.
Mrs. Blackburn. OK. All right. Dr. Schweitz?
Dr. Schweitz. You know, when you look at the goals of this
plan, initially it appeared that it was to direct a way to save
costs. But in meeting with CMMI, we were advised that this is
budget neutral and if you look at the rule it's budget neutral.
So the goal of the program then is to collect information,
which makes it a study--a test. So if the goal is to collect
information and the patients are part of that process they
should be signing informed consent. They should be notified
this is going to impact their treatment. There may be changes
in their treatment directed by Phase II, and they should be
part of the process of consent.
Mrs. Blackburn. OK. Thank you for that.
Dr. Patt, I want to come back to you. As I mentioned in my
opening, we are very concerned about access and the impact that
this demo is going to have on access in the rural areas.
And I have talked with so many of my healthcare providers
and I want you just to lay out what you see as being the impact
on rural Medicare access for oncology services.
Dr. Patt. Thank you for that opportunity. I think that this
will be a burden disproportionately hitting small practices in
rural areas and the reason for that is because average sales
price is by its very nature an average.
Some people will pay higher amounts for procurement than
that average and some people will pay lower amounts. Larger
hospital systems and larger practices have the ability to have
contracting arrangements where they purchase at a lower price.
What this means is that smaller practices disproportionately
pay a higher amount.
You can imagine if in the new model, which is ASP+.86
percent, given Prompt Pay discounts, sequestration and the six-
month delay in increasing prices that if you have a 1 percent
difference in smaller practices they will lose money on all the
drugs that they buy.
And so, you know, it will be impossible for smaller
practices in rural areas to be open. What I think that you'll
see is a natural unintended consequence of this policy is that
you'll have a shift inside of service to hospital outpatient
departments and you'll have decreased access where patients in
rural areas will have to travel further distances to receive
care.
I think that that's not in our best interest as we already
have deficiencies in service in rural areas today.
Mrs. Blackburn. I thank you for that and I agree with you.
I think what we're going to see this type of disruption in
the healthcare marketplace is going to lead some people to feel
that they have to abandon a certain protocol or therapy or
course of care and go to something that maybe is not as fitted
to them.
So I yield back my time. Thank you, Mr. Chairman.
Mr. Pitts. Chair thanks the gentlelady. Now recognizes the
ranking member of the full committee, Mr. Pallone, 5 minutes
for questions.
Mr. Pallone. Thank you, Mr. Chairman. My questions are of
Mr. Baker. The Medicare Rights Center's mission is to advocate
for access to health care for Medicare beneficiaries.
In addition to public policy initiatives, Medicare Rights
Center helps beneficiaries on the ground through educational
programs and counselling including a national help line that
provides direct assistance to Medicare beneficiaries and their
friends, family and caregivers, and with beneficiary access as
Medicare Rights Center's sole focus, we in Congress should take
seriously your recommendations to ensure the patient access is
not disrupted by the proposed Part B drug payment demonstration
project.
In your testimony you mentioned some monitoring and
oversight ideas for the proposed demonstration that CMS should
adopt in its final rule.
Could you just please discuss these proposals a little
further and how they can help ensure that patients are getting
the care they need and when have similar provisions worked or
have they worked in other programs in Medicare?
Mr. Baker. Of course. Thank you.
First of all, you know, in the proposal as written there is
claims monitoring, and CMS is saying that they can fix problems
that arise in real time with that claims monitoring.
The thing that we're asking CMS to add to that protection
for both providers and for patient is an ombudsman and an
ombudsman, an ombudsman office was--should be created for this
program, we believe.
The idea actually comes from one that Congress enacted with
bipartisan support with the durable medical equipment
competitive bidding program.
The ombudsman would serve both beneficiaries and providers,
as I said, by tracking complaints, troubleshooting appeals,
monitoring beneficiary and provider experiences and reporting
to CMS and Congress on a regular basis.
We also, as I said earlier, think that CMS should regularly
engage multiple stakeholders as part of the demonstration both
in Phase I and then, of course, in Phase II they need to do
that in order to find these clinically effective drugs and
alternatives.
So that monitoring of claims about how care is received,
where it is received and then publicly release the monitoring
that they are doing and the corrective action that they may
have taken or they will be taking.
So that can be, once again, commented on by all the
stakeholders and, of course, by you in Congress.
Mr. Pallone. Now, I was going to ask, unless you think
you've already answered this, what should CMS do to evaluate
the results of the demonstration projects to ensure that if
they move forward and expand it that Part B drug payment policy
best suits the needs of Medicare beneficiaries?
Mr. Baker. Yes, I think the claims data monitoring is
something that is already in there that will help evaluate it.
We also think there should be additions to that.
So we think that there should be patient experience surveys
and focus groups of patients and providers as part of the
evaluation to track the beneficiary experience with differing
payment models.
I think they've also suggested that they might develop
patient-reported outcome measures, particularly in Phase II of
the model. And so we strongly support that and we actually
think that should be part of the Phase II model.
And I think there should be multiple metrics that CMS uses.
We don't have a patent on what those metrics are. It may be an
iterative process as it moves forward.
But it should definitely be metrics that focus on patient
access, access to particular sites as well as care quality and
the access to particular medications.
Mr. Pallone. All right. Thank you, Mr. Baker.
You did mention in your testimony I noticed a concern that
has been expressed to me by some of the physicians in my
district about shifting from community practices to hospital
settings.
Did you want to talk a little bit more about why that might
happen and whether that's a good or bad thing?
Mr. Baker. Sure. First of all, I would say, you know, we
certainly want to see Medicare beneficiaries have access to
care in whatever setting is appropriate for them and the most
convenient setting to them so, you know, that is important to
us and I think that's why we urge CMS to monitor any unintended
consequences vis-a-vis settings.
I think what we saw when we moved from AWP to ASP was a lot
of concern about settings and moving to different settings and
some of those concerns were proved not to be that significant.
That movement from physicians' offices to hospital
outpatient is happening regardless of this model and so it is
something that we need to be concerned about and that has a
larger causation from a consolidation that's happening across
the healthcare market.
Mr. Pallone. Thank you very much. Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman. I now recognize
the vice chair of the Health Subcommittee, Mr. Guthrie, 5
minutes for questions.
Mr. Guthrie. Thank you. Thank you all for being here to
testify and thank you for your service overseas. I often talk
about the experience I had in Yemen when I--not as a service
person but in my role here and talk about the men and women in
uniform over there serving and then I always point out--I said
there are a lot of people in civilian clothes that are serving
too from the Department of State and putting themselves in
harm's way as well. So thanks for what you do in serving.
But I do have a couple of questions for the physicians
here. I know a couple of you said you view this as a test. Some
of us believe this is a way--the rule actually amends what we
think is a statutorial set formula, which is the price plus 6
percent and subject to sequestration, so it's really quite
less--4.2 percent, I believe. But and so the concern is they're
using this process to amend the statute.
So wherever you are on what the policy should be I think
all of us on this dais up here, both sides, should be concerned
that our essential authority--our legislative authority is
being, I think, infringed upon.
But one thing that we did all agree on was MACRA last year.
We all wanted to put MACRA in place because we all realized
that people are in situations like Ms. Block and we need to
come up with a system that takes care of patients, that's
sustainable, that works.
And I've often said when I'm talking about MACRA if we
don't have everybody together--patients, providers--if it just
comes from Washington it's not going to--and goes out into
the--where I think Mr. Baker was talking about, unintended
consequences that could come needs to be monitored--you know
the way that you eliminate those the most is that you have
everybody involved going forward and because I don't know what
happens in rheumatology practice.
I mean, people who practice it tell me but I think if we
all sit down--fortunately, I haven't had--been through an
oncology practice as well.
But so I just want to look at the way this rule came about
and we were troubled that unlike other CMMI initiatives it was
negotiated behind closed doors, mysteriously placed on a Web
site and then taken down, as far as I can tell without any
input from providers, patients or other affected stakeholders
and can the physicians here--can you speak to CMMI's engagement
with stakeholders prior to issuing this rule?
Dr. Patt. Thank you, Representative Guthrie.
So I'll say that this proposal, unfortunately, did not have
stakeholder input prior to it being air dropped and, to your
point, was put out without stakeholder input during a time of
tremendous system change.
So with the advent of MACRA we've had to infuse tremendous
resources in infrastructure and systems changes. For me as an
oncologist to do things like providing a standard treatment
plan, standards survivorship counselling, patient navigation,
ways to collect patient reported outcomes, ways in which to
collect data for the merit-based incentive payment system, it's
been a tremendous infrastructure investment.
Not only has that been a tremendous infrastructure
investment but my practice, which treats half of Texans, will
participate in the oncology care model and that has been a
tremendous infrastructure investment.
Mr. Guthrie. OK. I have a question. Now I'm going to get
Dr. Schweitz next. But so my next question to you was how is
the way this proposal has come forward different than the way
that you worked on the oncology care model--how that came
forth?
Dr. Patt. We worked in collaboration with 3 years. They got
oncologists' input. We were collaborating on how that model was
formulated and many individuals from the U.S. oncology network
and Texas oncology participated. This CMS-proposed drug
proposal had not input. It was put out there without any
stakeholder input whatsoever.
Mr. Guthrie. The oncology care model was a collaborative
effort to try to----
Dr. Patt. Yes.
Mr. Guthrie [continuing]. Look at costs to people in
oncology care and try to lower the costs for people in oncology
care.
Dr. Patt. Right. And for us in Texas oncology it brings in
parts of that value because within the U.S. oncology network we
have a system of value pathways where we take into account
efficacy, toxicity and cost, looking at the incremental cost
effectiveness in comparison to the next nearest comparator.
So when you have interchangeable drug opportunities we will
always pick the lower cost alternative. And so that's
incorporated in this value-based system that we collaborated
with CMS on.
Mr. Guthrie. There was a big effort legislatively to put
forth last year.
Dr. Schweitz, I only have a minute left. I'd like for you
to comment on.
Dr. Schweitz. We did have extensive involvement with MACRA
pre-rule, pre-law. So we were not involved in the development
of this policy.
In fact, I believe that there was guidance to the MACs even
before the rule was released. So this was being developed
without any knowledge or input of the stakeholders.
Mr. Guthrie. And I think that's a frustration from our side
who are involved along with all of you and patients and MACRA
is that, you know, we put a lot of--that took a lot of time.
The SGR finally went away.
We got MACRA in place and we're looking at accountable care
organizations value based. How do we have sustainable systems
where people get caught in situations like Ms. Block and how do
we avoid that and then all of a sudden this rule comes out when
we're in the middle of that process and that negotiation that
we've all worked so hard on and it came from nowhere and we--or
came from above without any input and we really appreciate your
testimony. My time has expired.
Mr. Shimkus [presiding]. Gentleman's time has expired.
The Chair now recognizes the gentleman from New York, Mr.
Engel, for 5 minutes.
Mr. Engel. Thank you very much, Mr. Chairman.
I want to give a shout out to our colleague, Phil Gingrey,
who served on this committee for many years. Good to see you,
Phil.
Let me say to Ms. Block I was quite moved by your testimony
and I would like to ask you to talk a bit more about why your
personal experiences led you to support this demo even in the
midst of so many voices saying that the demo that would be
harmful to patients.
Ms. Block. Thank you.
I think, first of all, that we need to all remember why
this demo was even put out. With all the talk about drugs being
under water and doctors being under water, patients are already
under water.
We're already there, and I talk to patients all the time
because that's what I do. I end up sitting in chemo rooms
talking to other cancer patients and everyone is struggling.
We're struggling to stay alive.
We're struggling to pay for our drugs. We're struggling to
pay for our mortgage and take care of our kids and do
everything else. We have to start somewhere.
You know, as many things as I'm hearing all of you say that
you don't like about this demo, I say, OK, then let's work
together and get a better finished product.
But you don't throw the baby out with the bathwater, as my
mother would have said. We need to start somewhere, and this is
a start.
I have read the regs through and through and I don't see
any issue with access to drugs--my getting access to the drugs.
So what I see is an attempt to figure out how to support
patients. That's what I'm seeing. So thank you very much.
Mr. Engel. Well, thank you. I think your testimony was
very, very----
Mr. Shimkus. Eliot, would you get a little bit closer to
that mike so----
Mr. Engel. Yes. Sure.
Mr. Shimkus. We want to make sure we hear you.
Mr. Engel. Bring two microphones then. OK. Again, thank
you, Ms. Block. You know, I also want to thank Ms. Boyle for
talking a little bit about her son, and they're all so very
courageous when we're asking people to come up and tell
personal stories. It's really helpful to us and very, very
courageous for the witnesses.
I have been a great supporter of infusion therapy and I'd
like to talk about how the model that we've been discussing
would impact patients who rely on such therapy.
Administering infusion therapies is very much more involved
than administering oral medications.
Infusion therapy necessitates specialized equipment,
supplies and professional services including sterile drug
compounding, care coordination and patient education and
monitoring.
And currently Medicare fully covers infusion therapy when
it's administered in a hospital, a doctor's office or a nursing
home. Medicare's coverage of infusion therapy in the home
though is fractured and does not adequately cover the services
needed to provide home infusions. That's the patient's home.
Not only does this coverage gap force patients into
expensive institutional settings but it also puts patients at
risk of developing additional infections in these environments
and on top of that this coverage gap prevents patients from
receiving the treatment they need in the most comfortable
setting possible--their homes.
In 2003, Congress opted to exclude infusion drugs from the
average sales price, or ASP pricing methodology, put in place
for other Part B drugs, and as I mentioned Medicare does not
reimburse for the services needed for home infusions and ASP
pricing is insufficient to cover those necessary services. It
just doesn't make sense. I want to highlight it because I think
it's important.
Unfortunately, we still have not corrected this coverage
gap and that's why Congressman Pat Tibiri and I have introduced
H.R. 605, the Medicare Home Infusion Site of Care Act, which
would expressly provide coverage for infusion-related services,
equipment and supplies.
Given that this coverage is still not in place though I
think we need to be cautious when considering changes to the
reimbursement structure for infusion drugs.
While CMS has excluded DME infusion drugs from the Phase I
of the Part B drug payment model, these drugs have not been
excluded from Phase II.
So let me ask Mr. Baker, would you agree that more work is
needed to ensure that Medicare beneficiaries can get the
infusion therapy they need in the comfort of their homes?
Mr. Baker. Yes. I think that certainly Medicare doesn't
provide, as you said, adequate coverage right now for home
infusion services and we would agree that this problem could be
resolved outside of the demonstration.
It's not necessarily affected one way or another by the
demonstration, and certainly in part two this could be part of
the resolution where there could be additional legislation that
would bolster this benefit for beneficiaries and make it more
available to them.
Mr. Engel. This is something that, obviously, is better for
the patient but ultimately would involve a savings of money, it
would seem to me. So it seems like a win-win.
Mr. Baker. If the setting is as safe as you're saying and
it's at least a less expensive setting and more convenient to
the patient and that would certainly be a win-win.
Mr. Engel. OK. Thank you. Thank you, Mr. Chairman.
Mr. Shimkus. Gentleman yields back his time.
The Chair now recognizes myself for 5 minutes for
questions.
And first of all, before we start, I ask unanimous consent
that the letter on May 2nd signed by 241 Republicans and one
Democrat in opposition to this rule be placed into the record.
Without objection, so ordered.
Mr. Shimkus. I want to go on, first, to Mr. Baker. Are you
at all concerned that this proposal will force large numbers of
Medicare beneficiaries into a mandatory test?
It was kind of talked about that this is not voluntarily.
No one is signing consent forms. It's a mandatory--so does that
have some--are you concerned about that? I mean, that's not
really how tests are operated.
Mr. Baker. Well, we have a number of demonstrations that
are going on throughout the country and, for example, ACOs----
Mr. Shimkus. Yes. But I mean we're talking about size too.
I mean, this is really not a test. This is in actions a rule,
you know, promulgated because it dwarfs--the test dwarfs the
remaining control group.
Mr. Baker. Right.
Mr. Shimkus. Significantly.
Mr. Baker. And we've done these kinds of, if you want to
call them tests or----
Mr. Shimkus. Of this size, percentage wise?
Mr. Baker. We've changed reimbursement before. We were
talking about a change in reimbursement. And so what I would
posit is that we need to evaluate and monitor that change in
reimbursement very carefully because whenever we do that there
can be unintended consequences.
Mr. Shimkus. OK. Let me ask another question. What's a
larger expense to the individual patient? Twenty percent of a
doctor office oncology service rendered or 20 percent of an
oncology services rendered in a hospital setting?
Mr. Baker. Typically, the hospital settings can be more
expensive than physicians.
Mr. Shimkus. Typically, like, if you find one that's not
please let us know. I just don't think that's possible, which
is part of this debate, because especially in rural districts
you're changing really, in essence, a lifestyle in care of
patients. We have great concerns.
I also, Ms. Block, want to--thank you for your service to
the country. Brats--Army buy, I'm an Army guy so we've both
done the deal.
But I don't--so you got Medicare based upon disability.
When you entered Medicare were you given a choice of
supplemental or a Medicare Advantage?
Ms. Block. Thank you for the question. I was not given the
choice of a supplemental. Supplemental coverage for under 65 is
a whole another issue. So I welcome a hearing on that.
Mr. Shimkus. Well, no. But were--so you could have?
Ms. Block. I could not at that time, no.
Mr. Shimkus. And why?
Ms. Block. They didn't offer policies in my State. That's a
State-by-State issue on whether insurers have to offer policies
for those under 65 that are disabled. Now, you could enter an
Advantage plan but, unfortunately, I live in a rural area and
the Advantage plan doesn't cover any providers.
Mr. Shimkus. Right. OK. Thank you. I wanted to clear that
up. Appreciate it.
Dr. Schweitz and Dr. Patt, CMS continues to reiterate that,
and I quote, nothing in this proposal will prevent doctors or
other clinicians from prescribing the treatment that a patient
needs.
Do you believe this proposal will impact your ability to
prescribe and administer the most appropriate treatments for
your patients in your office? Dr. Patt first.
Dr. Patt. Thank you.
Mr. Shimkus. And pull that mike close.
Dr. Patt. So I don't believe that this will change my
opportunity to prescribe the appropriate therapy. It will alter
my ability to deliver the appropriate therapy to my patients.
So I think that, you know, there are two alternatives. One,
is that you either financially have a hazard for a practice
that's likely to have them closed by having them take money out
of the practice to try to purchase a drug that they cannot
afford or they'll shift the patient's care to a different site
of service like the hospitals.
When we've seen the shift occur in the last decade, we know
that the hospital outpatient department increased 30 percent of
the chemotherapy infusions that they have in the last decade
and the reason for the shift are the financial changes.
We know that during that time period of that 30 percent
shift that the hospital cost is a higher site of service care--
30 percent higher--and the patient outpatient cost is higher in
the hospital outpatient department as well.
Mr. Shimkus. Because the co-pay will have to pay that 30
percent additional cost?
Dr. Patt. In fact, we recently conducted a study with the
Community Oncology Alliance and the Millman Group that looked
at the 10-year shift from 2004 to 2014, and if you take the
drug--if you take the costs in 2014 and attribute the cost only
to site of service shift alone, it's $2 billion in that 1 year.
Mr. Shimkus. Dr. Schweitz?
Dr. Schweitz. I agree with Dr. Patt. It won't impact our
ability to prescribe but our ability to deliver. If, as a
business entity, we are unable to make ends meet we will not be
able to provide the service.
That's the central issue, and if we cannot provide the
service in our office we're going to have to move the patient
to a different site of service, i.e. the hospital.
Mr. Shimkus. And I'll just end on this. My time has
expired. It doesn't make sense to move people out of doctor-
center oncology services and move them into a hospital setting
where they--you have the chance of other infectious diseases
that could occur and we all know of the risks that's involved
in that.
So with that, yield back my time and recognize the nurse,
Ms. Capps, for 5 minutes.
Ms. Capps. Thank you, Mr. Chairman, and thank you all for
being here today. I appreciate that this topic is brought up
today and your expertise on it.
I believe we can all agree that the current system is not
working. Providers have long noted that the ASP+6 drug
reimbursement formula is inaccurate and some patients have
struggled to come up with their 20 percent share of the cost of
their share in these settings.
While the Part B program was intended to relieve our most
vulnerable from catastrophic costs by providing access to
important medications, for some--many individuals, I would say,
it has fallen short.
While the problems with the current system are well known,
how to move forward to address it is more controversial--
complicated.
Through this--though this demonstration project is an
opportunity to explore strategies that could help transition
Medicare into a more value-based system, I remain concerned
about some elements of the project.
Last week, my colleagues and I wrote a letter to CMS with
concerns about certain components of the demonstration,
particularly the nationwide scope of the project, the possible
impact of it on small medical practices in under served areas
and the potential shifting of patients of provider offices to
expensive hospital settings.
As co-chair of the Cancer and Heart and Stroke Caucuses and
as a nurse, my biggest concern is that CMS needs to find ways
to address problems before they strike and have them place a
strong mechanism or strong mechanisms to identify barriers to
care that arise during the demonstration.
But and the very real fact that patients depend on drug
therapies to extend and improve the quality of their lives is
critical to this. But they and the system need to be able to
afford it. In light of this, we must proceed thoughtfully and
in the best interest of patients who will be most affected by
this demonstration.
Ms. Block, you mentioned in your testimony the difficulties
of paying the 20 percent co-insurance for vital drugs as a
Medicare beneficiary.
And Mr. Baker, is Ms. Block's experience common for
Medicare beneficiaries? Should Medicare have an out of pocket
maximum like the one in the Affordable Care Act to address
this?
Mr. Baker. There's about 10 to 14 percent of people with
Medicare that do not have supplemental coverage, as Ms. Block
does not, and they pay the full freight for that 20 percent.
As you note, there's no out of pocket maximum in the
Medicare program so that means that, you know, you're paying
that 20 percent up to infinity.
There's never a place where Medicare takes over that
coverage and provides you with 100 percent of coverage
regardless of how much you're spending out of pocket.
As you say, plans under the Affordable Care Act as well as
plans available to employed individuals usually have some limit
on out of pocket spending.
Ms. Capps. OK. As we look at the plans for this
demonstration program, my primary concern is for the patients
and the tools they will have to address any barriers to care on
the front end rather than afterward.
I know some of my colleagues have touched on this but it is
a great concern to me. So Mr. Baker, as someone who works to
ensure access to affordable health care for Medicare
beneficiaries, are there aspects of the demo that will help
protect patients from disruptions in care?
Are there any other protections that you would like to see?
This is demonstration. This is the time----
Mr. Baker. That's right.
Ms. Capps [continuing]. To look at it. Any other
protections you would like to see to ensure that patient care
is not disrupted?
Mr. Baker. Once again, I think that the ombudsman program
that was used so successfully and the Congress mandated for the
durable medical equipment program is an important protection,
would be--would serve to protect consumers as well as this idea
of getting shared decision-making tools out there for consumers
and physicians to be able to work together and talk through
clinical effectiveness as we move into Phase II.
But I think the ombudsman is why I haven't mentioned the
pre-appeals process that would be used in the Phase II and that
would basically allow providers and/or consumers to do an
appeal and to get relief if they feel that something is
unavailable to them or not reimbursed at the right rate in the
value-based phase of the program.
Ms. Capps. Thank you.
You know, just in concluding, in our efforts to improve the
Part B program we have to keep our eyes on the goal of ensuring
that patients have timely and affordable access to medications
they need. That's got to be the bottom line.
As we move forward, I urge CMS to pay special attention to
the impact the demonstration project will have on our Nation's
most vulnerable and to continue to work with affected
stakeholders to address issues and unintended consequences
before any changes are implemented. This is the time to do
that. So I yield back.
Mr. Shimkus. The gentlelady yields back the time.
The Chair now recognizes the gentleman from Pennsylvania,
Dr. Murphy, for 5 minutes.
Mr. Murphy. Thank you, Mr. Chairman, and I thank the panel
for being here.
Before I start, Mr. Chairman, I just want to say I have a
letter from the National Alliance on Mental Illness I'd like to
submit for the record.
Mr. Shimkus. Without objection, so ordered.
I'd also like to correct the record. There were four
Democrats on my letter, not one. So----
Mr. Murphy. Thank you. That is recognized too.
Now, starting--Dr. Patt and Dr. Schweitz, you both deal
with chronic illnesses of cancer and rheumatoid disorders. I
want to just point a couple of things.
In the area of mental illness you may be aware that 75
percent of people with severe mental illness have at least one
chronic illness. Among them are ones within the areas you
practice.
Fifty percent of people with severe mental illness have at
least two and a third have at least--have three or more other
chronic illness and it is important we deal with those.
As a matter of act, Medicaid reports that they--about 5
percent of Medicaid recipients are responsible for about 55
percent of Medicaid spending and nearly all of them have a
mental illness.
So in the context of this, I want to ask a couple questions
here. Both of you discussed in detail some of the concerns
about the proposed demonstration, the negative impact on
patient access to treat cancer and arthritis.
Hopefully, you're aware that similar concerns are there
also in the area of mental illness drugs, particularly long-
acting injectables, anti-psychotic medications that treat
schizophrenia and other psychotic disorders.
And, of course, when a person is more stable they are
adhering to their other treatments for the diseases that you
treat. When you're not stable they're not following through on
this.
So with regard to this, I see that CMS' proposal is based
on this idea that we should be paying for services based on the
average patient under this Phase II CMS proposal to provide,
quote, ``equal payments for therapeutically similar drug
products'', unquote, and assuming the most clinically effective
drug in a group can be identified.
But in practice--and I need you to answer this both in
about 15 seconds--what impact will these one-size-fits-all
value assessments have on patient access to individualized and
personal medicine?
Can't have a dissertation. Real quick.
Dr. Patt. I think that they will have decreased access to
higher cost appropriate therapies.
Mr. Murphy. Thank you. Dr. Schweitz, would you so agree?
Dr. Schweitz. I agree.
Mr. Murphy. And so would you say with part of this is that,
I mean, certainly you would agree that different people respond
differently to the same medication with regard to effect and
side effects. Would you both agree with that?
Dr. Schweitz. Right.
Mr. Murphy. And also that you need to adjust your
prescriptions in order to decrease side effects and increase
effectiveness and therefore increase adherence. Is that correct
too?
And now, the FDA said that medications not taken as
prescribed occurs about 50 percent of the time and the Center
for Disease Control tells that nonadherence causes 30 to 50
percent of chronic diseases treatment failures and about
125,000 deaths per year.
So I look at this then that--an important safeguard in
current law that says CMS cannot use cost effectiveness as a
threshold to set Medicare average payments or payment policy.
However, in Phase II of the proposal CMS intends to use
cost effectiveness in its analysis to inform value-based
pricing.
Now, would it concern you if CMS said that in order to
implement this proposal they would ignore or waive this
safeguard? Dr. Patt.
Dr. Patt. It would concern me.
Mr. Murphy. Dr. Schweitz.
Dr. Schweitz. Greatly. Greatly.
Mr. Murphy. And with regard to this, it also seems to me
that, you know, obviously people more likely to take a
medication that they--that deal with the side effects--some may
actually take a certain medication because they find the side
effects less objectionable and another one will say I'll deal
with the side effects but I've got to have the treatment for
this too.
But these are all tradeoffs. But it seems to me that the
way this proposal is coming through that it would limit the
patient choice--your choice--and when a patient is not adhering
to those drugs we saw from those statistics from FDA and CDC it
may actually complicate the diseases tremendously and increase
the cost. Now, can you elaborate on that, Dr. Patt and Dr.
Schweitz?
Dr. Patt. So as I said before, I think that we would
continue to prescribe the drugs we think that are appropriate.
But this proposal would impact the patient's ability to receive
those drugs.
Mr. Murphy. And with that, isn't it--it's best that--I
understand adherence works best if you actually have a
conversation with a patient with regard to the drugs.
Dr. Patt. Absolutely.
Mr. Murphy. But if that--and I know you're saying you would
prescribe it anyways--but if there's a difference in
reimbursement or----
Dr. Patt. Well, I'm saying that I would prescribe the drug
anyway. But you can imagine a scenario if someone was in a
rural clinic and a drug is prescribed for them that they cannot
receive in that rural clinic and they have to travel a distance
to a hospital that may be two or 3 hours away to be able to
receive that therapy. That would likely diminish compliance
with a therapeutic regimen.
Mr. Murphy. Dr. Schweitz?
Dr. Schweitz. I would add to that. I'm in a relatively
urban area, and there is no nearby hospital that I can send the
patient to for an infusion.
Most of the hospitals are not treating our patients unless
they're 340Bs. So there is decreased access in that way as well
and our fear is that our patients are going to drop out--that
compliance will drop and they won't get treated.
Mr. Murphy. And my fear is they're going to drop dead,
according to statistics that CDC gives us and that's pretty
frightening. And so we may save a little money in the front end
by not prescribing the drug but the complications of the
overall cost increases need to be taken in account. I thank you
for your insights, and I yield back.
Mr. Shimkus. Gentleman yields back.
At this time the Chair now recognizes my colleague from the
great State of Illinois, Ms. Schakowsky, for 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman.
I want to make a couple of comments and then I want to get
to Ms. Block and Mr. Baker with some questions.
But, you know, I just feel like if you are offended at all
at the suggestions that physicians would prescribe higher cost
drugs because you want to make more money then it seems to me
that the suggestion of CMS, which is that there be a percentage
plus, a lower percentage, plus a flat rate would be something
that would not be objectionable.
Also, I wanted to mention that I found it very curious in
testimony of Dr. Patt as well that there's over two pages
within your testimony that are exactly the same language--
exactly the same language. Even the highlighted important parts
are highlighted in the same--in the same way. I thought that
odd.
But I also wanted to mention that there was a difference.
Dr. Patt and Dr. Schweitz touched--both touched on something in
their testimony.
Dr. Patt, you claimed that drug prices are not truly
increasing faster than the rate of overall health costs. Yet,
Dr. Schweitz, in your testimony you stated that you are keenly
aware of unsustainable rise in drug costs and the effects of
those costs on our patients' ability to adhere to treatment
regimens. That's your quote.
And I have to say, Dr. Schweitz, that I agree with you that
spending on prescription drugs has risen significantly in
recent years, driven by high and rising drug prices and recent
IMS health report found that list prices for brand name drugs
increased by more than 12 percent in 2015, representing the
second year of double-digit increases and on and on.
But I want to get to Ms. Block. Thank you so much for
coming here today and telling your story. I know that there
isn't a family including my own that hasn't gone through the
issue of--related to cancer and treatments that are required
and the issue of affording those treatments.
So you testified that your cancer treatment has been
incredibly expensive. Can you detail some of the costs and how
they've impacted your personal finances?
Ms. Block. I guess I can begin--thank you, first of all--I
think I can begin to say that when you enter cancer world it's
a different world and no one talks about cost at first.
So it's very interesting when costs--when you start to ask
questions and you have difficulty getting answers. I've had
probably--I think I've had six surgeries by now, including one
with a long stay in the hospital.
I've been through full ranges of chemo. This is the third
type of drug that I'm on now. Having metastatic cancer, what
that means is you're constantly changing drugs to keep up with
the cancer, so it's always changing. And the future is stacking
drugs, which means more than one drug at a time. So my expenses
will only go up.
I make up budgets all the time. I think they're probably
meaningless because we don't know how long I'm going to live.
But you do the best you can to try and stay on top of it, and
that's what life is like living with cancer in a country like
ours where the drug prices just continue to rise.
I've actually done my own studies on what my drug costs in
other countries as opposed to the U.S. I did it on social
media. It's an amateur study.
But I was able to find out that I'm paying much more than
every other country that I found, including Dubai, U.K.,
Denmark, you know, Norway, Sweden, on and on. Every other
country that I have friends that were able to come back and
tell me the monthly cost of their drug.
Again, it's an informal amateur study, but I keep looking
at am I going to have to move eventually--is that what my
recourse is as the drug prices continue to rise and my savings
dwindle?
Ms. Schakowsky. Thank you. I want to wish you the best,
too.
Mr. Baker, why is it important that we work to reduce or
eliminate cost sharing for beneficiaries? What impact would
this have on one's ability to access care?
Mr. Baker. I think, once again, certainly for the folks
that go bare, as it were, on the 20 percent it will increase
their ability to access these treatments.
They're disproportionately folks with lower incomes,
anywhere from $10,000 to $25,000 a year, disproportionately
African American.
Ms. Schakowsky. I want to tell you, I have talked to--at my
pharmacy. I said, ``What happens when people are told it's
$1,000?'' He says that often, not most, but often they just
walk away.
Mr. Baker. They walk away. Right. Or they find a way to pay
for it with family friends mortgaging their home and other
situations like that.
So they are, as we were saying, underwater and unable to
access the care.
Mr. Shimkus. Gentlelady yields back her time.
Chair now recognizes the gentleman from Missouri, Mr. Long,
for 5 minutes.
Mr. Long. Thank you, Mr. Chairman.
We are in the 114th Congress which each Congress, of
course, runs for a 2-year period. During the 113th Congress, I
did not miss a single vote in that 2-year period, which there
was about a half dozen of us that had that type of a voting
record, and it's tough when you catch flights, you miss
flights, there's connections, everything.
There's 2-minute votes. You have to be paying attention.
And so voting is very important to me. In this Congress, the
114th Congress, I missed two solid weeks of votes.
Didn't go to the floor for two weeks because our 25-year-
old daughter, youngest daughter, was diagnosed with non-
Hodgkins lymphoma and so I kind of realized what it's like to
go through that process. Thankfully, she's doing great, had her
12 rounds of chemotherapy, lost all her hair, got all her hair
back, curls and all.
So we've been very, very fortunate with the--what's
happened in oncology over this last 20-some years because I
think that if it would have been 20 years ago we might not have
had the same outcome.
So with that as a little background on my personal story
with our daughter's battle, Dr. Patt, supporters say this
proposal will remove incentives to use higher-priced
medications that are no more effective than alternative
therapies. Can you talk about therapeutic alternatives in
oncology?
Dr. Patt. Yes, sir. First of all, I wish your daughter the
very best.
Mr. Long. She's doing great.
Dr. Patt. I think most of us have a personal experience
that we've been touched by at least someone with cancer. And so
being able to deliver high-quality care close to one's home is
critical to maintain quality cancer care for Americans.
With regards to therapeutic alternatives, I'll say that,
you know, this proposal what it does is it disincentivizes
utilization of high-cost options for treatment.
And so if there is a high cost alternative and a low cost
alternative that's equivalent in terms of efficacy and toxicity
obviously----
Mr. Long. And they were closing the door. I didn't hear--in
terms of what?
Dr. Patt. In terms of efficacy and toxicity. Then, you
know, we would want to facilitate utilization of the lower cost
alternative.
In fact, the U.S. Oncology Network--my network, which
treats over 12 percent of Americans with cancer--we use a
pathway system in the network which brings in drugs if there
are alternatives that we only have the option of using the
lower cost alternative. The problem is is there are actually
few instances where a therapeutic alternative that is
equivalent actually exists.
And so, like, my patient in my testimony who receives
Recepten, or a monoclonal antibody, against HER2 there is not a
therapeutic equivalent for that drug and it's changed her
survival from weeks to over a decade.
And so, you know, the therapeutic alternative would be to
give no treatment because there's not a low cost alternative to
that drug.
So it's either our sum scenarios--you know, I think that
the stage two--stage IV second-line treatment colon cancer
drugs are a commonly discussed alternative where there are
drugs that are of equal efficacy and similar toxicity profile
that have a difference in costs. Non-small cell lung cancer is
also another area that's frequently talked about.
But the truth is oncology is a collection of many different
diseases and many of them don't have equivalent therapeutic
alternatives.
And so a decision to provide a lower-cost drug may convey a
diminished survival benefit for patients and that's not an
alternative. We want patients to live better.
We want patients to live, you know, on chronic therapy--to
have even advanced cancer be a chronic disease where they can
live a good quality of life and live a longer life.
Mr. Long. You sound like Michael Milken. That's what he
told me. He said he wanted to make cancer a chronic disease and
they've done a lot of good work in that area.
Also, Dr. Patt, what impact will this proposal have on
consolidation in the oncology space and the continued shift of
care from the physician office to the hospital?
Dr. Patt. That's a great question.
So as you know, in the last 11 years we've seen an over 30
percent shift from community clinics to the hospital outpatient
department.
We recently conducted a study with Millman that
demonstrated that community clinics gave about 84 percent of
therapy in 2004 and only 54 percent in 2014.
We know that that site of service shift would be augmented
with other financial pressures on community oncology practices
and that the natural consequence of that action would be higher
cost for payers and patients.
Mr. Long. OK. Thank you, and I'll yield back my four
seconds, Mr. Chairman.
Mr. Shimkus. We appreciate that. Thank you very much.
Chair now recognizes our veterinarian from Oregon, Dr.
Schrader, for 5 minutes.
Mr. Schrader. Thank you very much, Mr. Chairman. Appreciate
it.
I, like many others, have submitted a letter to CMS
regarding the scope of this demonstration project and also
sympathy particularly for the special need groups and the types
of medications you administer.
You just can't go to a generic. I mean, oftentimes even in
my little world of veterinary medicine there were brand names
drugs that would work and only be the drug that would work for
certain patients of mine.
So I'm hoping and based on past track record that CMS will
be responsive to a lot of the concerns you're talking about as
we go forward and the trick is, as everyone I think has alluded
here tonight or today, is get it right. You know, make sure we
get it right.
I don't think the appropriate way though is to just stop
the rule altogether. I think we're losing a little bit of focus
and this is a proposed rule. CMS hopefully will be listening to
this testimony and come back with something that is better than
what we have seen so far.
I'd be probably not smart to legislate before I actually
see the proposed rule. And the goal is to get to a value-based,
you know, outcome and value-based purchasing is part of that.
I think there's some alternatives that are being discussed.
The second phase I think is pretty interesting. But aside just
dealing with this individual drug or that individual drug,
different incentives are probably very, very appropriate and I
guess I'm hoping that as we talk through this that this--we
can--it continues to be very constructive as we go along.
Shifting gear a little bit, I guess, Dr. Baker, you talk a
little bit about Phase II. We focused here pretty much on Phase
I, but Phase II offers some options and I'd be curious your
take on that.
Mr. Baker. There are many physicians on the panel, but I'm
not one of them so----
Mr. Schrader. Mr. Baker, I do apologize.
Mr. Baker. So, first off, I think there are a number of
value-based initiatives in phase two of this project, reference
pricing, indication-based pricing, outcomes-based risk sharing
agreements and others and, you know, for example, Express
Scripts is looking at implementing a system--is implementing a
system of indication specific pricing with some of its clients
including with cancer drugs, several pharmaceutical companies
and ensures health plans are partnering on outcomes risk--
outcomes-based risk sharing Novartis with Anthem and Cigna on
Entresto for treating heart failure, others with other drugs
around moving cholesterol range, United Health with Gilead on
Harvoni for hepatitis C.
CALPERS, the large California insurer for public sector
employees and Safeway are using reference pricing.
First Safeway used it for colonoscopies because of the
differences in prices in the markets across the country that
they were seeing and within markets where they were--they had
stores and now they're expanding that to other aspects of
health care.
So we see this in use in the private sector, these models
being used--being heavily evaluated and monitored once again in
the private sector and we do believe Medicare in phase two of
this project can take advantage of that experience but also
needs to be very transparent, needs to be very engaged with
stakeholders because as we've heard there are instances where
there are not clinically equivalent pharmaceutical products.
And so we went to make sure that there is access to all of the
products and that an individual determination will still be
able to be made with a patient in a doctor.
That's why the pre-appeals program is important that CMS
has put in there with balance building protection to consumers
which is very important as well to keep their access to all of
the drugs that might be useful for their condition.
Mr. Schrader. Yes, and I do appreciate the tone of your
response because the goal here is to treat the patient. I mean,
we've heard everyone testify that is our goal and, you know,
certainly, the--historically we've seen that through the prism
of our own particular specialty or practice mode and I think
one of the goals of healthcare treatment going forward, whether
or not we like the ACA or not, is to treat the whole patient.
And that usually involves, frankly, getting together as
groups of doctors and hospitals and organizations, not
necessarily giving up their private practice but working with
your colleagues and having a relationship so that Ms. Block or
whoever can get the right referral.
You come in for one issue and you discover another one
maybe much more serious--you want to make sure that that group
takes care of you and I think the focus of this hearing has
been on just a fee for service piece and the real goal, I
think, is to get to bundle payments where different doctors
with their patients get to make that particular choice of what
type of treatment, what medication to get, if a medication is
better than perhaps psychological behavioral treatment.
There's a lot of what we're talking about here focussing
only on a fee for service and I think that's an old way of
treating things. We need to be moving forward and value-based
bundle payments would, I think, a lot of the concerns that have
been expressed here.
And I yield back. Thank you, Mr. Chairman.
Mr. Pitts [presiding]. Chair thanks the gentleman.
Now I recognize the gentleman from Virginia, Mr. Griffith,
5 minutes for questions.
Mr. Griffith. Thank you, Mr. Chairman.
I've heard from ophthalmologists about the proposed
demonstration's potential impact on access to sight-saving
treatments for numerous blinding conditions including age-
related macular degeneration--AMD--which is the leading cause
of blindness in the United States.
Currently, there are three treatment options for AMD and
other ocular conditions. Two are name brand drugs approved for
ocular use and one is a cancer drug, Avastin, that is
repackaged for off-label use by ophthalmologists for the eye.
The demonstration seems to assume that lower cost
alternatives are always available. However, many
ophthalmologists are experiencing increasing difficulties
accessing the lower cost drug, in this case Avastin, due to new
Federal and State regulations on the compounding and
repackaging of drugs.
Also, notwithstanding the fact this committee worked very
hard to allay fears--the fears related to compounding drugs as
a result of the New England Compounding Center scandal and
tragedy has made many patients reluctant to receive a drug that
is compounded and repackaged.
Both of these factors are leading to increased use of the
more expensive brand drugs. Further, I am told that the
continued access to Avastin for the treatment of AMD and other
ocular decisions will effectively end if the FDA finalizes its
pending February 2/15 draft guidance that calls for a maximum
five day beyond use date for compounded or repackaged
biologics.
So I know that it's not directly on point with what you all
have been testifying to this morning and you may not wish to
comment on this.
But I'm just curious if you all would think that perhaps
CMS ought to go back and take a look and instead of including
all Part B drugs if the agency ought to give consideration to
excluding certain classes and, obviously, the one that I just
talked about are classes of drugs that include compounded
repackaged drugs or drugs that are used off label for
demonstration.
So do you think that--and I guess I'll ask you, Dr. Patt,
although I understand it's a little off your subject area.
Dr. Patt. Thank you, Mr. Griffith. So I'm not an
ophthalmologist. But I will say that there have been
discussions of carving out the oncology care model, of carving
out certain segments.
In my opinion, there's not a right way to do the wrong
thing. We need stakeholder engagement from the beginning to
engage with CMS and value-based ways in which we can move
forward like we did with the oncology care model. We want to
participate.
In our oncology practices we have many value-based programs
and have demonstrated pilots that have saved tens of millions
of dollars. And so want to work with CMS on that kind of work.
I don't think that there's a way to exclude certain segments
from this pilot and make it make it better.
I think that we need to go back to the drawing board and
look to projects like the oncology care model that are
collaborative and value-based and have a better path forward.
We would like very much in the oncology community to
participate in that.
Mr. Griffith. Anyone else have a comment on that?
OK. Sticking with you, Dr. Patt, I noticed on Page 11 of
your written testimony--I didn't hear it in your oral testimony
but in your written testimony you did talk about the era of
hospital acquisitions and consolidation in the oncology space
where doctors' practices are being taken over by the hospital
and you think this experiment by CMS will push more of that and
then that makes it even harder for rural districts like my own
and earlier one of the folks said they had a rural district--
they had 19 counties. I have 29 geopolitical subdivisions, most
of whom are rural counties.
Dr. Patt. Yes, sir. So as we mentioned, the current model
which is not really ASP+6, because you have to take out Prompt
Pay sequestration and the six-month lag, has to take into
account not only acquisition but also inventory storing of
drugs, specialized handling of drugs and then--and then
disposal of drugs. So there's a lot that has to go in there.
If you bring it down to ASP+.86 percent you have to know
that average sales prices by its very nature an average. There
are people that pay more than that average and people that pay
less than that average.
Hospital systems in large practices are going to get
preferential contracting to pay less than average on average
and smaller practices are going to have less bargaining ability
because of less volume-based purchasing and have to pay more.
So you can imagine if you're at ASP+6 percent it has to pay
for all of these other functions and you're paying 1 percent
higher. How will you be able to keep your doors open?
And so what we've seen with these financial pressures over
the last decade is the natural consequence of the shift from
community practices to the hospital outpatient department and
we know that that's a 30 percent shift in the last 11 years.
We also know that that conveys on average a higher cost of
over 30 percent and a higher co-pay for patients. And again, if
we look at the cost of that shift in 1 year for cancer
spending, just attributed to the distribution of site of
service alone it's about $2 billion.
Mr. Griffith. I do appreciate it. Thank you very much and I
appreciate all of you being here today. Yield back.
Mr. Pitts. Chair thanks the gentleman and yields 5 minutes
to the gentlelady, Ms. Castor, for questions.
Ms. Castor. Thank you, Mr. Chairman. Thank you to all of
our witnesses for participating today.
Ms. Block, you've heard the testimony from the doctors on
the panel that find the proposed model very problematic. They
say that this will actually harm patient care, that oftentimes
the doctors do not know the cost of drugs. They are focussed on
what is best for the patient. How does this--what's your
response to that?
Ms. Block. I guess I would start by saying in all of the
work that I did in many countries around the world we were told
that you could never even have the appearance of impropriety.
So that we couldn't take a cup of coffee from someone because
there could never even be an appearance of impropriety.
So I guess what I would say is that if there's a chance
that there's financial incentives involved here then we remove
them and come up with an appropriate storage and handling fee.
But as long as there is an appearance of financial
impropriety I'm going to question that, number one. And the
second thing is I am just still not reading where there's going
to be a specific issue with access to any of the drugs.
I know my doctor is limited to what drugs I can get at this
point too. But when I asked him he said he didn't see any issue
with access after reading this demonstration project.
So I understand that maybe in some areas there's some drugs
they're saying that maybe they can't afford to get. But is the
6 percent really making the difference?
So as a patient I really question some of this and just
want to keep bringing the focus back to the patients are
already under water. We already, you know, don't have enough
money to pay for this.
So when everyone's talking about all these issues and
obstacles in the way how do we get back to how to make the
system work better for the patients.
Ms. Castor. And Dr. Schweitz, I mean, the cost of drugs now
is astronomical for many families. You know, it just--it does
oftentimes push care out of reach for them and then when we
have anecdotes about how costs are so much lower in other
countries a lot of my neighbours at home say why, why in
America are drugs--why do they cost so much more.
So what advice can you provide about how we better control
drug prices and Medicare spending?
Dr. Schweitz. That's a very good question. Unfortunately, I
don't have a clear answer. I do know that access to medications
across all medications including generics is becoming
problematic for our patients.
But it's not an easy problem. There is no easy answer. I
think we all have to sit down at the table--patients,
providers, payers and manufacturers--to see how we're going to
work out that problem so that our patients have better access.
Ms. Castor. Dr. Patt, do you have any advice on how we
address the high cost of drugs?
Dr. Patt. Ms. Castor, as you know, I'm very concerned and
oncologists are very concerned about the increase in drug
prices. I know you've heard from Dr. Diaz in your district with
Florida cancer specialists and from others that this is a great
problem.
Unfortunately, doctors don't set the prices for cancer
drugs, and when we look historically at what's happened as a
natural consequence of CMS decreasing reimbursement like the
Prompt Pay discount and sequester, we see that during that time
interval that costs went up tremendously.
And so what we see is that that's not effective at
controlling drug prices. What I'd like to see--what I think
doctors can do and what we can partner with CMS to do within
our realm is to change our system of care delivery to value-
based systems and, again, like I've said before, we would like
to be partners with CMS in that endeavor like we have been with
the oncology care model and like we have done in our practice,
the U.S. Oncology Network, that treats 12 percent of Americans
with value-based pathways for a decade.
Ms. Castor. So Mr. Baker, you've heard what they've said.
It's--gosh, it's very difficult, they don't have all the
answers on drug costs. Dr. Patt says we can look at value-based
and indeed the second phase of the model proposed to examine
the impact of certain value-based and you've mentioned that.
What I haven't heard is how we link this to outcomes as
well. When you're talking about value is there no--is there no
ling currently under Part B prescribing to outcomes? Do we not
have the data and are you confident that this model is actually
gathering that data?
Mr. Baker. I think that right now we don't have a lot of
that data. I think we're starting to get this data in part of
the private sector value-based experiments that I talked about
earlier.
I think those models can lead to further outcomes-based
information that we can use in this space to this model. But I
do think part of the challenge of getting to a good place on
this Phase II is making sure we have the right metrics, that we
have the right feedback loop on outcomes.
And so we recommended that that definitely be a part of
Phase II.
Ms. Castor. Yield back.
Mr. Pitts. Gentlelady yields back. The Chair recognizes the
gentleman, Mr. Bilirakis, 5 minutes for questions.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it. I
thank the panel for their testimony today as well.
Many conditions, especially within the rare disease
community, lack treatment and those that have a treatment do
not have multiple therapies to choose from.
Ms. Boyle and Dr. Patt, under the proposed rule it seems
like it would encourage physicians to prescribe cheaper or
generic alternatives to benefit from a flat fee in the
reimbursement payment. Do many of the Part B drugs have
interchangeable alternatives?
Ms. Boyle. Well, representing the Immunodeficiency
Foundation we have a number of conditions that only have drug.
There is not an alternative.
Whether it's a generic or nongeneric, there's only one drug
and, again, if this experiment reduces the ability of the
physician to provide that drug, when you're talking rare
diseases there are very few physicians or hospitals around that
have the ability to treat the patients.
We experience this with intravenous immunoglobulin back in
2005, '06 and '07 with the change in the MMA and our patients
were shifted from the physician office. Those that could find
hospitals, and that was not always an easy thing to do to
infuse immunoglobulin and where there are no generics but there
are a number of products, we're lucky to find a site of care.
Very often they had to change their product and there were
many who could not find a site of care and had to go without.
There were--the OIG and the ASPE reports did report on adverse
events for these patients--sickness, hospitalizations--and
there just aren't alternatives for the rare disease community.
It's not just our patients, it's many other patients with rare
disorders. So this is very frightening.
Mr. Bilirakis. Thank you. Dr. Patt.
Dr. Patt. So I'll say in the oncology community there are a
few examples of treatment alternatives with equal efficacy and
toxicity that have differences in cost. And in those scenarios,
you know, we think that utilization of the lower cost
alternative would absolutely be appropriate.
The problem is is that these instances are few and far
between. But in order to optimize the ability to give value-
based prescribing, as I mentioned the U.S. Oncology Network had
pioneered value pathways.
ASCO, the American Society of Clinical Oncology, has come
out with a pathways policy statement. There are other pathway
systems which utilize this and the community oncology alliance
has come out with a patient-centered oncology medical home also
trying to utilize a pathway system really to facilitate
appropriate utilization because most of the time there are not
alternatives that are equally efficacious and toxic that are of
different costs where a lower cost alternative is truly
therapeutically interchangeable.
Mr. Bilirakis. Thank you. The second part of the question--
Ms. Boyle again and Dr. Patt-under the proposed rule one value-
based tool is the use of reference pricing. This requires
setting a standard payment rate for an entire group of drugs,
usually using the most clinically effective drug in a group for
therapeutically similar drugs.
Can you do reference pricing when there are no alternative
drugs available?
Ms. Boyle. Well, for instance, in the immunoglobulin
products there are 13 of them. There have never been any
trials--head on trials comparing them. They all are approved by
the FDA but they're all very different.
Some have high sugar content. Some have high salt content
that would be bad for patients with heart conditions or
diabetes. They all have different formulations and patients
react differently.
Some are appropriate for subcutaneous infusion, which some
patients need because they have poor venous access or they have
other adverse events to IV.
Some patients cannot do subcutaneous. They are really not
appropriate. So I don't know how you would put these together.
Patients react differently and when you look at the
administration and talking precision medicine and let's take
best product for the individual patient this proposal runs
counter to that.
Mr. Bilirakis. Dr. Patt, briefly, because I want to ask
another question.
Dr. Patt. And I'll say that we don't today have a way to do
reference and value-based pricing in oncology. But we would
love to partner with CMS to do that instead of having a policy
just drop down to us.
Mr. Bilirakis. Thank you very much. Mr. Chairman, I know I
have seven seconds so more than likely I'll yield back if
you'll give me a couple more. Can I have a few more seconds to
ask another question? Yes? OK. Thank you.
Ms. Boyle and Dr. Patt again, under the proposed rule one
of the value-based tools would have CMS pay more for effective
treatments. Does CMS actually define what an effective
treatment is?
In the world of oncology or IG where treatment is more
personalized, as you said, is it wise to have an unelected
bureaucrat declare what is effective for all seniors, and I'll
start with Ms. Boyle.
Ms. Boyle. No, it's not. Essentially, we want our trained
immunologists who are specialists in treating our patients to
make these decisions. Again, this is important for any
condition.
Let's not take the decision away from the physician that
works with the patient in what is the best treatment and the
best outcome for that patient.
Mr. Bilirakis. Thank you very much. Dr. Patt?
Dr. Patt. I completely agree. I think that think that this
is not something that we want outside of our specialty's
hands--outside of a physician's hands and we would love to ask
in partnership with CMS to think about a better path forward to
try to institute value-based mechanisms for implementation of
cancer care.
Mr. Bilirakis. Makes sense to me. Thank you very much. Mr.
Chairman, I yield back.
Mr. Pitts. The Chair thanks the gentleman and now
recognizes Mr. Cardenas, 5 minutes for questions.
Mr. Cardenas. Thank you very much, Mr. Chairman, and I
appreciate all the panellists for sharing your expertise with
us.
I'm not going to have enough time to ask all the questions
that I'd like to ask. But at this time, Mr. Chairman, I request
that I can submit two letters for the record. Request unanimous
consent to submit the----
Mr. Pitts. Without objection, so ordered.
Mr. Cardenas. One is by the American Cancer Society, Cancer
Action Network, and the second is the California Life Sciences
Association to the CMS on the proposed demonstration. Thank
you, Mr. Chairman.
[The information appears at the conclusion of the hearing.]
OK. With that, my first question is the proposed
demonstration would be made so that three out of four Medicare
Part B providers across the country would have to participate
once we entered Phase II of the demonstration.
I have concerns about the nationwide scope of this
demonstration. Mr. Baker, do you think it's possible for CMS to
modify and narrow the scope of the model and yield efficiently
reliable results to evaluate with respect to the goal of the
model?
Mr. Baker. Our understanding is that the breadth of the
model is in order to, you know, test the model and make the
results generalizable or scalable. That said, I believe that
they have been--they have said that they're open to suggestions
about the scope and breadth of the model.
So I know folks have commented on that in this comment
period and I hope and expect that CMS would take those comments
into consideration in the comment period.
Mr. Cardenas. Dr. Patt, what do you think?
Dr. Patt. I think that, again, as I mentioned we need to do
the right thing. There's not a right way to do the wrong thing.
I think this proposal needs to be pulled back completely. I
think that we would really look forward to the opportunity to
work with CMS on better value models. I sat with four of the
leaders of CMS a month ago and gave them information on value
pathways and how to work towards pathway systems or other
alternative systems to reduce cost. I'll meet with CMS again
tomorrow.
The oncology community would really look forward to the
opportunity to focus on value in a collaborative way and not
have a proposal that's bad medicine put down for patients that
would decrease their access to care.
Mr. Cardenas. OK. Thank you.
This next question is to Mr. Baker and Dr. Patt and also
Ms. Boyle. I'm going to give you a scenario. If I am a senior
who is seeing my doctor for a medicine that's administered in
his or her office and I disagree with the coverage or payment
decision made by Medicare, it can seem daunting to file an
appeal and many patients aren't aware that there is even an
appeal process.
CMS is proposing that a new pre-appeals process would be
most applicable to Phase II of this demonstration.
Beneficiaries and/or providers can request a review of a claim
before it's submitted for payment, giving the provider the
opportunity to discuss why a particular drug or treatment would
be best for a particular beneficiary.
Currently, appeals are handled by the Department of Health
and Human Services Office of Medicine, Hearings and Appeals,
otherwise known as OMHA. OMHA has a significant backlog in the
processing cases.
Although beneficiary appeals generally can be expedited and
the demonstration will establish a separate appeals process,
apparently.
Mr. Baker, what's your experiences been with the Medicare
appeals process and do you think that there should be an
expedited appeals process for patients established in the
demonstration?
Mr. Baker. I definitely think there should be an expedited
appeals process for the demonstration not only in the pre-
appeals process but we've also recommended to CMS, as I've said
before, that there be an ombudsman both in Phase I and Phase
II. And I might add that in Phase II a lot of the consultation
that some of the other panel members are talking about will
occur with regard to, you know, value-based payments.
So I do believe that consultation will ultimately occur
before Phase II value-based ideas are implemented.
Mr. Cardenas. Ms. Boyle or Dr. Patt, do you have any
comments on that?
Dr. Patt. I would be concerned about an appeals processing
causing inappropriate delays in patients receiving treatment.
Ms. Boyle. I would agree on that sentiment because our
experience with appeals through the years have been people
making the decisions on the side of the insurers are not
specialists, particularly when it comes to rare diseases, and
we've just seen patients go through delays getting their
lifesaving infusions.
Mr. Cardenas. Thank you all very much. I yield back.
Mr. Pitts. The Chair thanks the gentleman. Now recognize
the gentlelady from North Carolina, Ms. Ellmers, 5 minutes for
questions.
Ms. Ellmers. Thank you, Mr. Chairman, and thank you to the
panel. This is a very important subcommittee hearing and I
appreciate all of the testimony I am hearing, especially from
the personal side, and I want to take my congressional hat off
for a moment and put my nursing hat on, and I do want to ask
Ms. Block--you have such a compelling story with your cancer
treatments.
You know, I understand whether we're talking about
oncology, whether we're talking about rheumatology or
immunology, I know that the care that is provided is a multi-
disciplinary education-based treatment where physicians and
nurses, other healthcare providers are working with the
patients and families to give the best care possible.
So I am--I am very concerned about some of the issues that
you have brought as patient, especially in your unique
situation with Medicare and the inability to have basically a
secondary or Medicare Advantage availability.
So my question is where are you getting your care? Are you
getting your care at a hospital or are you getting your care at
a community-based oncology clinic or independent physician?
Ms. Block. Sure. Thank you very much for the question.
First of all, for the record, I now have a supplemental
plan only because I drafted a bill and passed it in my own
State legislature.
Ms. Ellmers. Wonderful.
Ms. Block. The only way that I could get it.
Ms. Ellmers. Congratulations. That's great.
Ms. Block. There's more problems coming in the weeds since
Congress last year did away with some of the--selling some of
the plans in the future. So I'm not going to be able to switch.
But that's, again, it's trying to stay ahead of these bills.
Ms. Ellmers. That's what we--unfortunately, what we do so
many times is try to keep putting out those fires.
Ms. Block. Right. So I've got problems that are going to be
coming as my premiums rise to the point that I can no longer
afford to pay them. I do--I get my treatment now at a hospital
outpatient location.
Ms. Ellmers. OK. So but it is a hospital-based facility?
Ms. Block. Yes, and the irony is we don't have any private
oncology practices in the State so that I had great difficulty
at one point because my co-pays would have been so much less
expensive to go to a private practice but there wasn't one.
Ms. Ellmers. Right. Great. OK. Well, I do--I do think that
it's very important that we clarify that point because that
gets back to the issue of cost based on site. The difference
between the availability of having--being a patient at a
primary care or a private practice versus a hospital-based, I
mean, because we're talking about kind of two different beasts
there when we're talking about Medicare. So that is a very
important point to make. But thank you for that because that
was part of my concern.
I guess the next issue I would--this last question for you
as a patient have you had that conversation with your
oncologist? Have you--have you actually asked is there a less
expensive treatment because of this issue that I'm faced with
financially? Is there something else that I could be receiving?
Ms. Block. My oncologist is a rare bird and, when I was
diagnosed with metastatic disease, he sat me down and talked to
me about my finances and I found when----
Ms. Ellmers. Wonderful.
Ms. Block [continuing]. When I talked to other patients
that that was unusual because he said, you know, things are
going to be changing dramatically for you.
Ms. Ellmers. It's an issue. Yes. Definitely.
Ms. Block. But that said, I ask--every single time that I
go for treatment I ask the nurses giving me the treatment, I
ask the doctors I talk to, do you know how much this costs.
Ms. Ellmers. Uh-huh. And they don't, do they? I mean, the
answer is usually no, right?
Ms. Block. For the most part. Especially the people the
administering it.
Ms. Ellmers. Yes.
Ms. Block. No one, and they're all amazed when I tell them.
Ms. Ellmers. Yes. No, and that is typical because, you
know, the healthcare provider is so concerned with providing
for you the best possible care that you can receive that the
issue of cost is not their focus.
It's really the focus of us and for you and we want to do
everything we can to make sure that you are getting that really
good care and I just--there again, I've only got 50 seconds
left.
Thank you, Ms. Block, for your testimony today, and I just
want to thank the physicians who are here--Ms. Boyle and Mr.
Baker as well.
I think we're all in agreement here. Even though this is a
possibility of moving forward, I think we really do need to put
the brakes on this because there are other ways that we can
achieve decreasing costs and I'm kind of a little amazed at
some of my Democrat colleagues--not all, because I think we all
care about patients--but I'm a little concerned because they
seem to have a little bit of amnesia.
And there again, I'll ask Ms. Block--are you aware of our
21st Century Cures Initiative that we passed here in the House?
Ms. Block. No.
Ms. Ellmers. This is actually an effort that we are putting
forward. The Senate is working on their version right now and
basically we are looking at all these issues and we have--we
have gone globally.
We have, you know, worked with other countries--how are you
providing care that's less expensive. We've worked with our
universities, our patient advocacy groups, our hospitals, our
high-end universities, NIH, CMS, FDA, so that we can get drugs
through the process in a more efficient less expensive manner
that takes care of our patients.
So I think we need to stay on that front and move forward
and give the best possible care we can and keep those drugs
costs down as well. So thank you all again. I apologize, Mr.
Chairman. I went over.
Mr. Pitts. The Chair thanks the gentleman.
The Chair now recognizes Dr. Bucshon, 5 minutes for
questions.
Mr. Bucshon. Thank you very much and thank you to all the
panellists for coming and, you know, I'm reading the
legislation to restart this discussion and let me tell you why.
First of all, one thing I want to--I was a practising
cardiovascular and thoracic surgeon for 15 years and to me
discussing the and putting forth the premise of physicians out
there basing therapy, whether it's heart disease like I did or
cancer therapy, based on how much they're going to get
reimbursed from Medicare is just--it's almost an insult to the
medical profession, from my perspective, because are there bad
actors?
There are in all fields. But I can tell you the doctors
that I know and myself never consider that--that we can make
more money if we prescribe something else.
Now, that said, you also can't have something like this
that could force independent practitioners to lose so much
money on these medications that it limits access and puts them
out of business. So I think we have to address that. You know,
but cutting provider reimbursement without addressing the ASP--
the actual costs of the drug in the first place is just the
wrong approach.
And, you know, for the last 30 years CMS has tried to
control healthcare costs by cutting provider reimbursement
almost exclusively and look where we are today. It hasn't
solved the problem.
This is a big problem. I empathize with everyone including
myself and my own family. I've got--my father's had all kinds
of--have had four different cancers. My mother has had
problems, and it is very expensive and costs are a real issue--
no doubt about that.
But it seems CMS proposed this without any substantial
stakeholder input other than MEDPac and threw mud at the wall,
and they're now trying to figure out what's going to stick and
what isn't, and that's just the wrong approach. This should be
scrapped, and we should start from scratch.
We do need to address costs, no doubt about it, but we
should get stakeholder input, and let's all work together--
patients, patient advocates, physicians, and CMS and Congress
to address this issue.
You know, I'm going to ask a question of the physicians.
First, say, for example, there are two practices within the
proximity--in the same geographic area, and for whatever reason
their ZIP Code isn't picked.
How is that going to affect the local or regional care,
potentially, of patients? Dr. Patt, do you want to--I mean,
that could potentially happen, right? You have an urban area--
half this town has this, half doesn't and half the patients are
at one place, half at the other. How is that--how might that
affect this?
Dr. Patt. I think that if I was in a ZIP Code that was
randomized to the experiment, having decreased reimbursement,
that I would recommend my patient get the appropriate care not
at my center.
Mr. Bucshon. So you can see--you have the Federal
Government in Washington, DC, affecting the local marketplace
and health care and picking winners and losers.
Dr. Schweitz. In rheumatology it's a little more
problematic. There aren't many of us and there is usually a
significant backlog to get in to see a rheumatologist.
So if I'm going to refer my patient to the ZIP Code across
the county there's going to be a delay in that patient being
seen and a delay in that patient getting medication--his
treatment.
Mr. Bucshon. You know, and this is Washington, DC, so I'll
say there very well could be politics involved in ZIP Code
selection, believe it or not. I just want to put that out
there, and for anyone to think that there won't be is just--
doesn't know Washington, DC.
And people that have substantial political pull in this
town will not be selected to have their reimbursement cut. I'm
just here to tell you. That's what's going to happen, and it's
going to substantially affect practitioners' ability in
different communities to continue to treat their patients.
I mean, again, the other thing is as it relates to
alternative payment models, Dr. Patt and Schweitz, do you see
this affecting the development and resources going into
implementing APMs, for example? Do you see this as an issue?
Dr. Patt. It does. I can say that as a network, the U.S.
Oncology Network will put 10 percent of Medicare beneficiaries
with cancer on the oncology care model and it's been a
tremendous infrastructure investment.
How do you then account for having to not have patients
receive care in your practice because all of a sudden they're
in this experimental arm of this experiment as well? I can't
imagine a foreseeable situation where that will work.
And I'll just say that, you know, we, as a large practice,
have bought into a lot of infrastructure investment in
procuring for these alternative payment models. I cannot
imagine how a smaller practice will buffer that change.
Mr. Bucshon. Yes. My time has expired but I just want to
say this at the end is that I would urge CMS to scrap this
proposal and come to the table with stakeholders and look at
other ways that we can address patient medication costs.
They are--it is an issue. We all know it. But cutting
provider reimbursement, as I said in my opening, is not the
solution to a very, very complicated problem that we all, I
think, agree needs to be addressed.
I yield back.
Mr. Pitts. Chair thanks the gentleman. Now recognizes the
gentleman from Massachusetts, Mr. Kennedy, 5 minutes for
questions.
Mr. Kennedy. Thank you, Mr. Chairman.
In recent years, the cost of prescription medication has
risen sharply, raising concerns for patients and their families
about how to access and pay for needed drugs.
The Boston Globe has reported that prescription drugs
represent the fastest-growing component of health care, and
spending on prescription drugs increased 13 percent from 2014
to 2015.
Given that, in 2016 alone Medicare is expected to cover
about 57 million people. This hearing on Part B could not be
timelier, especially as the entire healthcare system of the
United States moves toward quality and value-based systems.
Delivery system reform are a key part to the future of
medicine and finding ways to reduce costs and ensure patients
have access to affordable effective medications while spurring
innovation is absolutely critical.
Ms. Block, thank you for sharing your deeply personal story
in your testimony earlier this morning. As we know, Medicare
Part B beneficiaries pay 20 percent co-pays with no out of
pocket money. Can you tell us more about how your doctor
decides what course of treatment is right for you?
Ms. Block. Thank you, sir.
Right now, I have limited options because I've already been
through a range of drugs. So there are limits on what my doctor
can offer me, though he is very cognizant of the co-pay and we
spend a lot of time talking about the co-pay and what I can do
to afford it and how to make that work in my life.
Mr. Kennedy. Have you ever had to forego, Ms. Block,
treatment because of those costs and if you have an idea of how
this demo might affect you and patients like you?
Ms. Block. OK. I have never foregone treatment under Part
B. I still have a prescription under Part D sitting in CVS
right now waiting for me to pick up since I can't afford to get
it. But under Part B I have not foregone treatment.
I believe this demo will enhance my life. I think that it's
going to reduce my co-pays. Number one, just off the bat, if
they reduce that +6 percent after the--you know, with ASP
that's a reduction in my co-pay right there. So that's number
one.
Phase II, if I'm lucky enough to be in an area that reduces
or waives the co-pays then again I get a win-win. So I see this
as a very positive move.
Mr. Kennedy. I appreciate that, Ms. Block.
Mr. Baker, in your testimony you highlight that Medicare
paid $22 billion for prescription drugs last year, more than
double the amount that was spent in 2007.
And as we all know, co-pays for beneficiaries aren't
decreasing either, which means that they already face access
problems. As CMS moves forward with the demo, how can they
ensure that the demo doesn't hinder access?
Mr. Baker. I think some of the key pieces are that real-
time claims monitoring that I've been talking about. The other
piece is the ombudsman program that we recommended and that was
used in the durable medical equipment area I think to such
great effect.
And once we're moving into Phase II and the value based
models that could be used in various specialities and with
various drugs the pre-appeals process would be a way of, once
again, getting access where access is needed and ensuring that
it occurs.
And then finally, those kinds of outcomes measures that we
were talking about earlier would be a way not only of
protecting patients but also of gathering research and data.
And finally, we believe focus group testing, patient engagement
surveys as well as provider engagement surveys to make sure
that CMS has a full range of information about the effect of
the model.
Mr. Kennedy. And so I wanted you to clarify as well, sir,
and I think you touched on it a little bit from your testimony
earlier.
But can you clarify if this proposal would require to pick
one drug over another or will doctors retain the ability to
pick the most appropriate treatment for their patients?
Mr. Baker. The proposal--the model as written would allow
doctors to prescribe, you know, whatever drug. This isn't a
formulary, a list of approved drugs or a limited group of
drugs.
Doctors would be allowed to prescribe any drug that they
felt was necessary for their particular patient and if there
were some value-based program that indicated that maybe that
drug wasn't the most clinically effective drug, once again,
that doctor or that patient could use the pre-appeals process
to or an ombudsman program, we would hope, to make the case
that no, this is the most clinically effective drug for this
particular individual because of their particular health
profile or clinical needs.
Mr. Kennedy. I appreciate that, and just before I run out
of time I also want to echo some of the concerns raised by my
colleagues that noted the similarities between testimonies
today. I think that raises some important questions as well. I
yield back.
Mr. Pitts. Chair thanks the gentleman.
Now, I recognize the gentleman from New York, Mr. Collins,
5 minutes for questions.
Mr. Collins. Thank you, Mr. Chairman. I want to thank all
the witnesses. This has been very enlightening. And just to
bring a couple of things up and Ms. Block, I know you said that
you thought your co-pays would go down with this. Well, it
doesn't work that way.
I don't want to be too contradictory but a $100 drug with a
20 percent co-pay is $20 whether it's +6 or +2.5 because it's--
the ASP doesn't change. So your co-pay doesn't go down.
But Dr. Patt, in the big picture what I've heard is doctors
don't even know what the drugs cost, by and large. Maybe their
office manager does.
They're prescribing to treat their patients, as Dr. Bucshon
indicated. So I kind of reject CMS' whole premise that nuancing
the +6, which we know is really 4.3, or the 2.5 which is really
.86, that would only make an impact in prescribing drugs if
these doctors, before they treated a patient, would be bringing
out the spreadsheet to figure that out, which I don't see
happening.
Now, let me go through the math as well. Let's say you've
got a drug that's $1,000 and you go to the 2.5 percent but
under sequester it's .86 and you're one of the randomized,
you're going to get $8.60 as your markup. Then you get $16.80
flat fee. So you get $25.40 for that $1,000 drug.
Now, if there was a $500 version you get $4.30 instead of
$8.60. You get the same $16.80. So now you have $21.10. So if
somebody said that switching it from six to--you know, changing
that would drive a physician to prescribe the lower cost, I
guess I kind of reject that because under the higher cost
you're getting $25.40.
Under the lower one you're getting $21.10. I don't think
either one is adequate. But I think a physician would rather
have $25 than $21.
So the whole idea of driving someone to a lower cost drug
you reject it categorically because the practice is still going
to get more money with a higher priced drug.
The co-pay to the patient may switch with a lower cost. I
don't know that doctors are facing that. So I guess--I just
don't see in the big picture that any of this is going to
impact the cost of drugs.
And I guess I'll throw out there, because I've become the
subject matter expert on 340B pricing, if there's a problem in
the cost of drugs and cancer drugs, it's all the private
oncology practices being purchased by hospital systems--DSH
hospitals who then get a 50 percent break from the
pharmaceutical companies on these expensive drugs and you're
seeing oncology practices bought up every single day so that
the hospitals can cheat and get their 50 percent discount,
which goes to their bottom line, which comes out of the hide of
the pharmaceutical companies.
And at the end of the day, you want to talk about why
prescription--why prices may be high? Every time one of these
drugs is now getting a 50 percent discount, what do you think
the pharmaceutical companies have to do?
I think the bigger savings is to stop the cheating on 340B
pricing where fully covered patients the DSH hospitals are
getting a 50 percent discount and yet the hospital is getting
fully reimbursed by Blue Cross/Blue Shield. I'm just venting a
little.
But, you know, Dr. Patt, as I'm sure you've seen these
oncology practices bought out and I'm sure you've seen them go
to DSH hospitals where under 340B now there's this huge
discount which has to impact you. Would you care----
Dr. Patt. Yes, sir, and also imagine a scenario that's
different than the one that you gave. Imagine that you're in a
rural clinic where you purchased 1 percent above ASP, because
again, ASP is an average.
Mr. Collins. Well, that's the other thing. People think ASP
is the price. It's not. Some smaller practices pay more than
ASP.
Dr. Patt. Right. So imagine you're in a scenario where you
purchased a drug for 1 percent more and let's say it's a high
cost drug. Let's say it costs $10,000 per month to administer.
You can imagine that that would be a substantial loss to
the practice--that if you transition that patient to the
hospital outpatient department--let's say it's an hour away--
where they may have the 340B preferred vendor program and the
ability to purchase drugs at a 30 to 50 percent reduction in
cost then you would, you know, transition that patient's care.
And I think that that trend is a trend we've seen over the last
11 years and we would see it continue to be propagated.
Mr. Collins. Well, and that's--you know, I'm concerned
about--I have a very rural area--access and it's exactly what
we're seeing, that the private practices are being bought up
for one sole purpose and that's so the DSH hospitals can cheat.
Get the 30 to 50 percent discount on the most expensive
drugs--the $10,000 drugs--driving that to their bottom line and
disadvantaging healthcare systems in total, pharmaceutical
companies and ultimately patients.
I yield back.
Mr. Pitts. Chair thanks the gentleman. Without objection,
we have a Member who's not on the subcommittee present who
would like to ask questions.
The Chair now recognizes Mr. Welch, 5 minutes for
questions.
Mr. Welch. Thank you very much, Mr. Chair, and I thank my
colleagues for allowing me to sit in.
I have some sympathy with the point that Dr. Bucshon made
and Mr. Collins made about the cost and the complexities that
are involved. But this is not a case of cutting provider
reimbursement as much as it is about linking physician
reimbursement to the cost of drugs they prescribe.
I share the concern about cutting to the bone the providers
but there is no transparency whatsoever in what medical care
costs are.
Nobody knows, and it's really true with respect to
prescription drugs. And I have to say--I've been in and out but
I am very alarmed at the lack of sense of urgency about
something that is absolutely intolerable--prescription drug
prices.
First of all, prescription drugs save lives. They alleviate
pain. But the market is broken and the cost that the
pharmaceutical companies are charging is starting to kill
patients they're trying to save, and no one's in charge. The
doctor, Mr. Collins says, doesn't know how much the drug is. I
think they should, like Ms. Boyle said.
That's relevant to the everyday lives of people. And what
I've heard Dr. Patt, from you, and Ms. Boyle is sort of the
situation normal. It's all complicated. We want to collaborate.
We have value pathways. But I don't know what that means if
I'm a patient. I literally don't know what it means. What it
sounds like to me is that let's keep rolling.
The problem I have with the prescription drugs is that it's
not a value proposition. It's a broken market. So the price is
set by the pharmaceutical companies and it's whatever the
traffic will bear, and they're protected by patent protection
and they're entitled to that because it's intellectual
property.
But should they be charging $1,000 a day to a patient or to
the taxpayers that have no recourse whatsoever but have a
desperate need for the medication? And where you have--what
we're talking about here is not the global mess of pricing and
health care.
We're talking about this system where the prescriber makes
more money when he or she prescribes a more expensive drug. Dr.
Patt, is that true or not?
Dr. Patt. So I'll say that in my practice that is not true
because our physician compensation model is not in any way
dependent upon the drugs that I write.
Mr. Welch. All right. But the----
Dr. Patt. But there is variability between practices. But
I'll say in my practice.
Mr. Welch. Right. So just--if I am--work at a car store--
you've rented a car and you've seen how much people try to
upsell what it is you're trying to rent, and there's an
incentive for that salesperson, right? Now, if a doctor's going
to prescribe something, let's say a regular--anybody who's
got--and they've got their challenges, like Dr. Bucshon said.
They've got to pay their assistants and they want to do the
right thing. But the model by which they're paid is affected by
whether they prescribe the $50,000 drug or a $3,000 drug.
So just isn't that an incentive that would make one
question whether that affected their decision?
Dr. Patt. Mr. Welch, I think you make some very good
points. But I'll say again that my personal income from my
practice that treats half of Texans is not dependent upon the
drugs that I write.
Mr. Welch. You know, that's great, and I'm talking just
about the pricing model here.
Dr. Patt. Right. So I think there are limitations because
when we talk about value pathways and when you have
opportunities to exchange therapeutic alternatives, to use
those opportunities for better value choices, that that's
really important.
But the issue of drug pricing----
Mr. Welch. But I mean, I don't have much time so let me
interrupt. But thank you.
In this proposal the medical provider is going to be in
control of the final decision about what's the most efficacious
drug. That is agreed, because the patient's entitled to that.
Mr. Bucshon. Will the gentleman yield real quickly? That
depends, I would say, Peter, on whether or not the pricing
results in a massive loss to the practice, and then they may
not be able to absorb that without closing their practice.
Mr. Welch. Thank you. Reclaiming my time.
Then that gets us to the heart of another problem. If we
create this Rube Goldberg situation where you've got to do all
of these maneuvers to try to get your practice to be solvent
instead of paying fair value for the procedure you do but then
not linking your bottom line to whether the prescriptions are
the most expensive drugs then we're going to get a chance to
deal with this.
But I just want to say this is--this is a disaster looming.
The taxpayer can't afford it, employers can't afford it and
patients like--my first wife had cancer 9 years. We had a
fantastic oncologist.
Drugs extended her life. They alleviated her pain. They
made our family much stronger. But you know what? That's out of
reach for more and more Americans and this economy can't
support it.
I really was upset about the lack of urgency on the part of
some of the witnesses here to what I think is a very urgent
problem.
Thank you, Mr. Chairman.
Mr. Pitts. Chair thanks the gentleman and recognizes Dr.
Bucshon for UC request.
Mr. Bucshon. Yes, I just want to ask unanimous consent to
introduce an article from the New York Times from an oncologist
from New York describing how this type of thing may limit their
ability to properly treat cancer patients.
Mr. Pitts. Without objection, so ordered.
Mr. Welch.
Mr. Welch. I'd like to introduce into the record an article
examining congressional comments regarding Medicare's Part B
pilot proposal.
Mr. Pitts. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. That concludes the questions of the Members
present. We will have some follow-up questions. We'll send
those to you in writing. We ask that you please respond.
Thank you very much. This is a very important hearing, very
timely, lots of good information. Members have 10 business days
to submit questions for the record. So they should submit their
questions by the close of business on Tuesday, May 31st.
Without objection, this hearing is adjourned.
[Whereupon, at 12:42 p.m., the committee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Today's hearing is an important exercise in Congressional
oversight on a recently proposed rule from the Centers of
Medicare and Medicaid Services (CMS) on Part B drugs. There is
bipartisan concern that this proposed Medicare drug experiment
will threaten the care of our most vulnerable seniors in
Michigan and throughout the country, and reduce access and
availability of lifesaving drugs.
There are several characteristics that make this proposal
unique when taken together. The new model is mandatory. CMS
proposes to waive entire sections of statute and carefully
negotiated Medicare reimbursement policy, effectively
rerewriting at least seven payment provisions established by
Congress over the years.
Currently, Medicare pays for Part B drugs by reimbursing
providers the Average Sales Price (ASP) plus 6 percent. In the
first phase of the new model, providers in half the country
would be reimbursed ASP plus 2.5 percent and an additional flat
fee of $16.80 per drug per day. Application of sequestration
would effectively bring this payment to 0 percent. Translation:
reimbursement will fall short in covering the costs of
acquisition, storage, and administration of many drugs that
seniors with serious medical conditions need--quite a dangerous
policy change.
CMS has also suggested value based purchasing arrangements
be applied in half of the country under Phase II, including
reference pricing and Indication Based Pricing. CMS would set
payment rates for drugs they believe are therapeutically
similar, despite which drug a patient needs and vary payments
for drugs based on what the Federal Government determined is
their clinical effectiveness. These tools are dramatic
departures from how we approach prescription drugs access in
this Nation and give the Federal Government far too much
control over decisions that should be left between a doctor and
their patient. Another dangerous policy change.
I do support efforts to test models that seek to improve
quality of care, lower cost, and increase access. These themes
are the backbone of our SGR reform legislation, MACRA. In the
past, patient rights and access to care have always been given
serious attention and weight but they are disturbingly lacking
in this proposal. There was no input from patients or
providers. In fact, this proposal threatens to disrupt many
important Medicare models from Accountable Care Organizations
to the CMMI sponsored Oncology Care demonstration. This is
unnecessary and disruptive as providers prepare for MACRA.
Fundamentally though, there is a serious separation of
powers issue that cannot be overlooked. This model represents a
dangerous precedent where future administrations could change
the statutory reimbursement for any provider or service,
anywhere or everywhere in the country, under the guise of a
demonstration, without any input from patients, providers, or
Congress.
Each reason by itself should cause us pause. Taken
together, there is no question that the policy must be
withdrawn. And today, we will examine thoughtful legislation by
Dr. Bucshon to do that and protect seniors.
The potential for harm from the administration's alarming
proposal for seniors in Michigan and across the country is
real. Doctors, patient advocates, and patients are standing up
and vocally declaring the threat this model could have on their
care. We are talking about our moms and dads, grandparents,
friends, neighbors, and our Greatest Generation--and the
Government wants to experiment with their care. Seniors deserve
our respect. They deserve to be treated with nothing but
dignity.
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